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ROCM > SEC Filings for ROCM > Form 10-Q on 10-Aug-2009All Recent SEC Filings

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Form 10-Q for ROCHESTER MEDICAL CORPORATION


10-Aug-2009

Quarterly Report


Item 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
We develop, manufacture and market a broad line of innovative, technologically enhanced PVC-free and latex-free urinary continence and urine drainage care products for the extended care and acute care markets. Our products are comprised of our base products, which include our male external catheters and standard silicone Foley catheters, and our advanced products, which include our intermittent catheters, our anti-infection Foley catheters and our FemSoft Insert. We market our products under our Rochester Medical brand, which are referred to as branded sales, and also supply our products to several large medical product companies for sale under brands owned by these companies, which are referred to as private label sales. The primary markets for our products are distributors, extended care facilities and individual hospitals and healthcare institutions. We sell our products both in the domestic market and internationally.
For fiscal 2009, we increased our investment in our sales and marketing programs, primarily through cash generated from current operations, to support branded sales growth in the U.S. and Europe. Our advanced products will eventually contribute a higher profit margin than our base products, and our Rochester Medical branded products contribute a higher profit margin than private label sales, particularly branded sales in the United Kingdom and elsewhere in Europe. Increasing our percentage of sales of branded products versus private label sales over time will have a positive impact on our gross margin. Branded sales accounted for 65% of total sales for the quarter ended June 30, 2009, and 65% of total sales year to date, compared to 73% for the quarter ended June 30, 2008 and 68% for the same period last year. Advanced products accounted for 14% of total sales for the quarter ended June 30, 2009, and 14% of total sales year to date, compared to 13% for the quarter ended June 30, 2008 and 12% for the same period last year.
The following discussion pertains to our results of operations and financial position for the quarters and nine month periods ended June 30, 2009 and 2008. Results of the periods are not necessarily indicative of the results to be expected for the complete year. For the third quarter ended June 30, 2009, we reported a net loss of $0.01 per diluted share, compared to a net income of $0.02 per diluted share for the same period last year. Loss from operations was $161,000 for the quarter ended June 30, 2009 compared to a loss of $458,000 for the quarter ended June 30, 2008, with a net loss of $77,000 for the quarter ended June 30, 2009 compared to net income of $312,000 for the same period last year.
As of June 30, 2009, we had $5.3 million in cash and cash equivalents, and $29.7 million invested in marketable securities. The marketable securities primarily consist of $27.1 million invested in U.S. treasury bills and $2.6 million invested in a mutual fund. Our investments in marketable securities are subject to interest rate risk and the value thereof


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could be adversely affected due to movements in interest rates. Our investment choices, however, are conservative and are intended to reduce the risk of loss or any material impact on our financial condition. We are currently reporting an unrealized loss $743,647 related to the mutual fund as a result of the recent fluctuations in the credit markets impacting the current market value. We consider this unrealized loss temporary as we have the intent and ability to hold this investment long enough to avoid realizing any significant losses. Results of Operations
The following table sets forth, for the fiscal periods indicated, certain items from our statements of operations expressed as a percentage of net sales.

                                          Three Months Ended         Nine Months Ended
                                               June 30,                  June 30,
                                           2009          2008        2009          2008
      Net Sales                             100 %        100 %        100 %        100 %
      Cost of Sales                          53 %         55 %         51 %         53 %

      Gross Margin                           47 %         45 %         49 %         47 %

      Operating Expenses:
      Marketing and Selling                  29 %         29 %         29 %         27 %
      Research and Development                4 %          2 %          4 %          3 %
      General and Administrative             16 %         19 %         18 %         20 %

      Total Operating Expenses               49 %         50 %         51 %         50 %

      Loss from Operations                   (2 )%        (6 )%        (2 )%        (3 )%
      Interest Income (Expense), Net          0 %          2 %          0 %          2 %
      Other Income, Net                       0 %          0 %          5 %          0 %

      Net Income (Loss) before Taxes         (2 )%        (4 )%         3 %         (1 )%

      Income Tax (Expense) Benefit            0 %         (8 )%        (1 )%        (2 )%

      Net Income (Loss) after Taxes          (1 )%         4 %          1 %          2 %

The following table sets forth, for the periods indicated, net sales information by product category (base products and advanced products), marketing method (private label and Rochester Medical® branded sales) and distribution channel (domestic and international markets) (all dollar amounts below are in thousands):

                                                                    Fiscal Quarter Ended June 30,
                                                     2009                                                    2008
                                Domestic          International          Total          Domestic          International          Total
Private label sales:
Base products                  $    2,075        $         1,034        $ 3,109        $    1,605        $           474        $ 2,079
Advanced products                      44                      -             44               144                      -            144

Total private label sales           2,119                  1,034          3,153             1,749                    474          2,223

Branded sales:
Base products                       1,036                  3,544          4,580               930                  4,148          5,078
Advanced products                     772                    403          1,175               677                    263            940

Total branded sales                 1,808                  3,947          5,755             1,607                  4,411          6,018


Total net sales:               $    3,927        $         4,981        $ 8,908        $    3,356        $         4,885        $ 8,241


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                                                                  Fiscal Year to Date Ended June 30,
                                                     2009                                                    2008
                               Domestic          International          Total          Domestic          International          Total
Private label sales:
Base products                  $   5,280        $         3,282        $  8,562        $   5,028        $         2,358        $  7,386
Advanced products                    399                      -             399              749                      -             749

Total private label sales          5,679                  3,282           8,961            5,777                  2,358           8,135

Branded sales:
Base products                      2,963                 10,665          13,628            2,927                 12,207          15,134
Advanced products                  2,114                  1,086           3,200            1,880                    531           2,411

Total branded sales                5,077                 11,751          16,828            4,807                 12,738          17,545


Total net sales:               $  10,756        $        15,033        $ 25,789        $  10,584        $        15,096        $ 25,680

Three Month and Nine Month Periods Ended June 30, 2009 and June 30, 2008 Net Sales. Net sales for the third quarter of fiscal 2009 increased 8% to $8,908,000 from $8,241,000 for the comparable quarter of last fiscal year. The sales increase primarily resulted from an increase in sales of private label products, higher sales of branded products domestically and increased branded sales internationally outside of the U.K. offset by a decrease in branded sales in the U.K. Domestic sales of branded products increased by 12.5% for the quarter compared to the same period last year. Our international branded sales decreased 10.5% compared to the same period last year, primarily as a result of the change in foreign currency exchange rates in the United Kingdom as the U.S. dollar was significantly stronger versus the pound sterling, thereby affecting total branded sales given the significant volume of our branded product sales in the United Kingdom. Private label sales were up 42% from last year, which management believes is the result of the timing of orders from large private label customers. Private label sales accounted for approximately 35% of total sales. Management continues to focus on growth in branded sales, and total branded sales volumes of intermittent catheters and Foley catheters increased for the third quarter compared to last fiscal year. In line with our strategic decision to increase investments in sales and marketing to drive growth in branded sales, we have initiated direct sales efforts into Japan and mainland Europe.
Net sales for the nine months ended June 30, 2009 increased slightly to $25,789,000 from $25,680,000 for the comparable nine-month period of last fiscal year. The increase in sales primarily resulted from an increase in domestic private label sales and increased sales of private label products internationally and branded sales internationally outside of the U.K., offset by a decrease in branded sales in the U.K. as a result of the change in the foreign currency exchange rate in the United Kingdom of the pound sterling to the U.S. dollar from last year. Sales of branded products domestically increased 5.6% compared to the same period last year.
Gross Margin. Our gross margin as a percentage of net sales for the third quarter of fiscal 2009 was 47% compared to 45% for the comparable quarter of last fiscal year. The increase in gross margin this quarter was primarily due to increased sales of higher margin product, including male external catheters and script easy in the U.K. and other international markets, and favorable manufacturing variances and efficiencies, partially offset by the change in the foreign currency exchange rate in the United Kingdom of the pound sterling to the U.S. dollar and increased medical claim costs. Gross margin for the nine months ended June 30, 2009 increased slightly to 49% from 47%. Factors affecting the comparative nine month gross margin are generally consistent with those discussed above for the current quarter.
Marketing and Selling. Marketing and selling expense primarily includes costs associated with base salary paid to sales and marketing personnel, sales commissions, and travel and advertising expense. Marketing and selling expense for the third quarter of fiscal 2009 increased 8% to $2,542,000 from $2,350,000 for the comparable quarter of last fiscal year. The increase in marketing and selling expense is primarily due to increased sales personnel and related expenses incurred through the addition of sales and marketing staff in both our U.S. and U.K. operations, and increased advertising expense related to marketing in the U.K. and the U.S. of our Magic 3 intermittent catheter and preparation for our advanced Strata Foley catheter launch, partially offset by the change in the foreign currency exchange rate in the United Kingdom of the pound sterling to the U.S. dollar from last year. Marketing and selling expense as a percentage of net sales for the fiscal quarters ended June 30, 2009 and 2008 was 29% and 29%, respectively.


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Marketing and selling expense for the nine months ended June 30, 2009 increased 9% to $7,556,000 from $6,955,000 for the comparable nine-month period of last fiscal year. Factors affecting the comparative nine-month expense levels are generally consistent with those discussed above for the current quarter.
Research and Development. Research and development expense primarily includes internal labor costs, as well as expense associated with third-party vendors performing validation and investigative research regarding our products and development activities. Research and development expense for the third quarter of fiscal 2009 increased 74% to $352,000 from $202,000 for the comparable quarter of last fiscal year. The increase in research and development expense relates primarily to increased expenses related to testing and development of new and enhanced products as we developed both our Magic3 intermittent technology and our Strata foley technology this year. Research and development expense as a percentage of net sales for the fiscal quarters ended June 30, 2009 and 2008 was 4% and 2%, respectively.
Research and development expense for the nine months ended June 30, 2009 increased 32% to $969,000 from $735,000 for the comparable nine-month period of last fiscal year. Factors affecting the comparative nine-month expense levels are generally consistent with those discussed above for the current quarter.
General and Administrative. General and administrative expense primarily includes payroll expense relating to our management and accounting, information technology and human resources staff, as well as fees and expenses of outside legal counsel and accounting advisors. General and administrative expense for the third quarter of fiscal 2009 decreased 8% to $1,451,000 from $1,578,000 for the comparable quarter of last fiscal year. The decrease in general and administrative expense is primarily related to decreased legal fees, audit related expenses and the change in the foreign currency exchange rate in the United Kingdom of the pound sterling to the U.S. dollar from last year. General and administrative expense as a percentage of net sales for the fiscal quarters ended June 30, 2009 and 2008 was 16% and 19%, respectively.
General and administrative expense for the nine months ended June 30, 2009 decreased 12% to $4,574,000 from $5,210,000 for the comparable nine-month period of last fiscal year. The decrease in general and administrative expenses for the nine month period primarily reflects a decrease in legal and audit fees from the prior year.
Interest Income. Interest income for the third quarter of fiscal 2009 decreased 83% to $40,000 from $233,000 for the comparable quarter of last fiscal year. The decrease in interest income reflects significantly lower interest rates on investments.
Interest income for the nine months ended June 30, 2009 decreased 77% to $241,000 from $1,042,000 for the comparable nine-month period of last fiscal year. Factors affecting the comparative nine-month interest income are generally consistent with those discussed above for the current quarter.
Interest Expense. Interest expense for the third quarter of fiscal 2009 decreased $62,000 to $55,000 from the comparable quarter of last fiscal year. The decrease in interest expense reflects lower amounts of debt as a result of quarterly debt payments and a lower effective interest rate on our debt.
Interest expense for the nine months ended June 30, 2009 decreased $176,000 to $219,000 from $395,000 for the comparable nine-month period of last fiscal year. The decrease in interest expenses for the nine month period are generally consistent with those discussed above for the current quarter.
Income Taxes. For the quarter ended June 30, 2009, we had an effective income tax rate of approximately 47.7%. The tax rate is in line with our expectation due to the volume of incentive stock option activity, of which the book expense is a permanent add-back item for tax purposes and increased our effective tax rate by 15% for the quarter. In future periods of taxable earnings, we expect to report an income tax provision using an effective tax rate in the range of 40 - 42% for U.S. income. The effective tax rate on worldwide income may fluctuate depending upon inter-company eliminations and U.K. operation profitability.


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Liquidity and Capital Resources
Our cash, cash equivalents and marketable securities were $35 million at June 30, 2009 compared to $37 million at September 30, 2008. The decrease in cash primarily resulted from capital expenditures, repayment of long-term debt and the repurchase of common shares offset by cash provided from operations, borrowing on our new credit facility and the sale of common shares upon exercise of options. As of June 30, 2009, we had $29.7 million invested in marketable securities as a result of the cash settlements received from lawsuits. The marketable securities primarily consist of $27.1 million invested in U.S. treasury bills and $2.6 million invested in a mutual fund. We are currently reporting an unrealized loss $743,647 related to the mutual fund as a result of the recent fluctuations in the credit markets impacting the current market value. We consider this unrealized loss temporary as we have the intent and ability to hold this investment long enough to avoid realizing any significant losses.
During the nine-month period ended June 30, 2009, we generated $1,405,000 of cash from operating activities compared to $621,000 of cash provided by operations during the comparable period of the prior fiscal year. Increased net cash from operating activities in the first nine months of fiscal 2009 primarily reflects net income before depreciation and decreases in other current assets and increases in other current liabilities, offset by increases in inventories and decreases in accounts payable. Accounts receivable balances during this period decreased 3% or $184,000, primarily due to increased collections. Inventories increased 11% or $957,000, as we built up inventories in anticipation of our launch of our Magic 3 intermittent catheter and our advanced Strata Foley catheter. Accounts payable decreased 23% or $489,000, primarily reflecting timing of expenses. Other current liabilities increased 18% or $206,000, primarily reflecting payments of annual executive bonuses offset by timing of normal operating accruals. In addition, capital expenditures during this period were $904,000 compared to $1,112,000 for the comparable period last year.
In June 2006, we entered into a $7,000,000 credit facility with U.S. Bank National Association. The credit facility consisted of a $5,000,000 term loan payable in five years and accruing interest at a rate equal to 4.77%, and a revolving line of credit of up to $2,000,000, maturing annually on March 31, with interest payable monthly at a floating rate based on the quoted one-month LIBOR rate plus 1.60%. In March 2009, we paid off the entire term loan and terminated the revolving line of credit.
In February 2009, we entered into a $14,000,000 credit facility with UBS Financial. The credit facility consists of a revolving line of credit of up to $14,000,000 with interest accruing monthly at a floating rate based on the quoted one-month LIBOR rate plus 0.50%. As of June 30, 2009, we had an outstanding balance of $2,000,000 under the revolving line of credit. Our obligations under the credit facility are payable on demand and are secured by our investments in marketable securities held at UBS.
We believe that our capital resources on hand at June 30, 2009, together with cash generated from sales, will be sufficient to satisfy our working capital requirements for the foreseeable future as described in the Liquidity and Capital Resources portion of Management's Discussion and Analysis of Financial Condition and Results of Operations in our Annual Report on Form 10-K for the fiscal year ended September 30, 2008. In the event that additional financing is needed, we may seek to raise additional funds through public or private financing. Any additional equity financing may be dilutive to shareholders, and debt financing, if available, may involve significant restrictive covenants. Failure to raise capital when needed could have a material adverse effect on our business, financial condition and results of operations. There can be no assurance that such financing, if required, will be available on terms satisfactory to us, if at all. Cautionary Statement Regarding Forward Looking Information Statements other than historical information contained herein constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may be identified by the use of terminology such as "believe," "may," "will," "expect," "anticipate," "predict," "intend," "designed," "estimate," "should" or "continue" or the negatives thereof or other variations thereon or comparable terminology. Such forward-looking statements involve known or unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors include, among other things, the following:


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• the uncertainty of current domestic and international economic conditions that could adversely affect the level of demand for our products and increased volatility in foreign exchange rates;

• the uncertainty of market acceptance of new product introductions;

• the uncertainty of gaining new strategic relationships;

• the uncertainty of timing of revenues from private label sales (particularly with respect to international customers);

• the uncertainty of successfully growing our U.K. operations and the risks associated with operating an international business;

• FDA and other regulatory review and response times;

• the securing of Group Purchasing Organization contract participation;

• the uncertainty of gaining significant sales from secured GPO contracts;

and other risk factors listed from time to time in our SEC reports, including, without limitation, the section entitled "Risk Factors" in our Annual Report on Form 10-K for the year ended September 30, 2008.

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