The following table sets forth, for the periods indicated, certain items from our statements of operations expressed as a percentage of net revenue:
Net revenue increased 13% to $17,166,000 for the quarter ended June 30, 2009 from $15,238,000 for the quarter ended June 30, 2008. The increase in net revenue was a result of an increased market penetration as well as the introduction of new products, principally in the access products and specialty catheters categories. Approximately 88% of our net revenue was earned in the United States and 12% of our net revenue was earned in international markets for both quarters ended June 30, 2009 and June 30, 2008. Net revenue increased 12% to $32,976,000 for the six months ended June 30, 2009 from $29,353,000 for the six months ended June 30, 2008. Approximately 87% of our net revenue was earned in the United States and 13% of our net revenue was earned in international markets for each of the six months ended June 30, 2009 and June 30, 2008.
We recognized $212,000 and $424,000 of licensing revenue during the three and six month periods ending June 30, 2009, respectively, as the result of our License Agreement and Device Supply Agreement with King and our distribution agreement with Nicolai in Germany. We also recognized $173,000 and $355,000 of collaboration revenue during the three and six month periods ending June 30, 2009, respectively, as a result of performing clinical and development work for King under the Device Supply Agreement. We expect to recognize approximately $850,000 of license revenue in 2009, and expect collaboration revenue will continue in 2009 dependent upon our progress with our pre-clinical and clinical projects for King.
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Gross margin across all product lines increased to 66% for the quarter ended June 30, 2009 from 64% for the quarter ended June 30, 2008, principally due to selling mix. We expect product gross margins to be in the range of 64% to 66% for the remainder of 2009, subject to changes in our selling mix between our lower margin products such as the Vari-Lase products and our higher margin products such as the D-Stat Dry. Gross margin across all product lines increased to 66% for the six months ended June 30, 2009 from 65% for the six months ended June 30, 2008.
Research and development expense for the second quarter of 2009 totaled $1,803,000, or 11% of revenue, compared to $1,553,000, or 10% of revenue, for the second quarter of 2008. Research and development expense for the six month period ending June 30, 2009 totaled $3,719,000, or 11% of revenue, compared to $3,019,000, or 10% of revenue, for the six month period ending June 30, 2008. The increase in research and development expenses resulted from additional new products moving through our development system in 2009. We expect our continuing research and development expenses to be approximately 9% to 11% of revenue during 2009 as we continue to pursue additional new products and to move our longer term development projects forward.
Clinical and regulatory expense for the second quarter of 2009 totaled $767,000, or 4% of revenue, compared to $759,000, or 5% of revenue, for the second quarter of 2008. Clinical and regulatory expense for the six month period ending June 30, 2009 totaled $1,379,000, or 4% of revenue, compared to $1,610,000, or 6% of revenue, for the six month period ending June 30, 2008. Clinical and regulatory expenses fluctuate due to the timing of clinical studies and the number of new products coming through the regulatory system. We expect clinical and regulatory expenses to be approximately 4% to 5% of revenue during 2009.
Sales and marketing expense for the second quarter of 2009 totaled $5,307,000, or 31% of revenue, compared to $5,174,000, or 34% of revenue, for the second quarter of 2008. Sales and marketing expense for the six month period ending June 30, 2009 totaled $10,560,000, or 32% of revenue, compared to $10,387,000, or 36% of revenue, for the six month period ending June 30, 2008. We expect to maintain the same relative size of our direct sales force during 2009 at between 85 and 90 full-time sales employees. As a result, we expect our sales and marketing expenses will continue to decline as a percentage of revenue to between 29% and 31% of revenue by the end of 2009.
General and administrative expense for the second quarter of 2009 totaled $1,104,000, or 6% of revenue, compared to $1,192,000, or 8% of revenue, for the second quarter of 2008. General and administrative expense for the six month period ending June 30, 2009 totaled $2,223,000, or 7% of revenue, compared to $2,734,000, or 9% of revenue, for the six month period ending June 30, 2008. The decrease was primarily the result of lower legal fees of approximately $670,000 due to the litigation that was pending in the first half of 2008 (see Note 9 to the Consolidated Financial Statements included in Item 1 of Part I of this Form 10-Q). We expect general and administrative expenses to be approximately 6% to 7% of revenue during 2009.
Litigation expenses were $-0- for both the second quarter and six month period ending June 30, 2009 compared to $1,457,000 and $1,484,000 for the second quarter and six month period ending June 30, 2008. For a complete discussion of litigation matters, see Note 9 to the Unaudited Consolidated Financial Statements in Item 1 of Part 1 of this Form 10-Q.
Interest income decreased to $14,000 and $37,000 for the second quarter and six month period ending June 30, 2009 compared to $48,000 and $140,000 for the second quarter and six month period ending June 30, 2008. The decrease in interest income was primarily the result of lower cash balance following payments made in settlement of the Diomed litigation and VNUS litigation (see Note 9 to the Consolidated Financial Statements included in Item 1 of Part I of this Form 10-Q) as well as a decrease in interest rates.
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Interest expense decreased to $11,000 and $20,000 for the second quarter and six month period ending June 30, 2009 compared to $18,000 and $42,000 for the second quarter and six month period ending June 30, 2008. The decrease in interest expense was as a result of repaying our equipment line of credit during the year ended December 31, 2008.
Foreign exchange gain was $7,000 for the quarter ending June 30, 2009 compared to a foreign exchange loss of $1,000 for the quarter ending June 30, 2008. Foreign exchange loss was $5,000 for the six month period ending June 30, 2009 compared to a foreign exchange loss of $1,000 for the six month period ending June 30, 2008. Effective April 1, 2008 we began to sell our products to Nicolai (our German distributor) at prices denominated in Euros. We also purchase a small number of inventory items at prices denominated in Euros. As a result, we are exposed to foreign exchange movements during the time between the shipment of the product and payment. We currently have terms of net 60 days with our distributor and net 30 with our vendors under the agreements providing for payments in Euros.
Income tax expense increased to $871,000 and $1,448,000 for the three month and six month periods ending June 30, 2009 on income before tax of $2,257,000 and $3,772,000 resulting in an effective income tax rate of 38%. The difference between the effective tax rate of 38% and the U.S. federal statutory income tax rate of 34% was due mainly to the impact of state income taxes. For the three month and six month periods ending June 30, 2008, income tax expense related to alternative minimum taxes (AMT) was $53,000 and $140,000 as we continued to maintain a full valuation allowance on our tax benefits through September 30, 2008.
Liquidity and Capital Resources
Our cash and cash equivalents totaled $10,522,000 at June 30, 2009 compared to $7,209,000 in cash and cash equivalents at December 31, 2008, an increase of $3,313,000. Our cash equivalents are invested in a money market fund invested in all types of high quality, short-term money market instruments denominated in U.S. dollars such as debt instruments guaranteed by the governments of the United States, Western Europe, Australia, Japan and Canada, high quality corporate issuers and bank obligations. The money market fund’s assets are rated in the highest short-term category by nationally recognized rating agencies, such as Moody’s or Standard & Poor’s.
Cash provided by operations. We generated $3,808,000 of cash from operations in the six months ended June 30, 2009. The cash generated in the first half of 2009 primarily resulted from our income before taxes of $3,772,000 since essentially all of our income taxes are offset by our deferred tax assets.
Cash used for investing activities.We used $539,000 of cash in investing activities in the six months ended June 30, 2009. We incurred capital expenditures of $539,000 relating primarily to leasehold improvements as part of our facility expansion, additional manufacturing equipment and additional research and development equipment.
Cash used for financing activities.We generated $44,000 of cash in financing activities in the six month period ended June 30, 2009. We used $333,000 of cash to repurchase shares that vested under outstanding restricted stock awards for income tax withholding purposes. This was offset by our receipt of $377,000 of cash we received under our Employee Stock Purchase Plan and upon the exercise of outstanding stock options.
We have a $10 million revolving line of credit with Silicon Valley Bank, which has a 24-month term and bears interest at the rate equal to the greater of prime plus 0.5% or 7.25% and is secured by a first security interest on all of our assets. As of June 30, 2009, we were in compliance with all the bank covenants and we had no outstanding balance on the revolving line of credit with an availability of $10 million.
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We currently anticipate that we will experience positive cash flow from our normal operating activities for the foreseeable future. We currently believe that our working capital of $27.0 million at June 30, 2009 will be sufficient to meet all of our operating and capital requirements for the foreseeable future. However, our actual liquidity and capital requirements will depend upon numerous unpredictable factors, including the amount of revenues from sales of our existing and new products; the cost of maintaining, enforcing and defending patents and other intellectual property rights; competing technological and market developments; developments related to regulatory and third party reimbursement matters; and other factors.
If cash generated from operations is insufficient to satisfy our cash needs, we may be required to raise additional funds. In the event that additional financing is needed, and depending on market conditions, we may seek to raise additional funds for working capital purposes through the sale of equity or debt securities. There is no assurance such financing will be available on terms acceptable to us or be available at all.
Off-Balance Sheet Arrangements
We did not have any off-balance sheet arrangements as of June 30, 2009.
Contractual Obligations
The following table summarizes our contractual cash commitments as of June 30, 2009:
| | | | | | | | | | | | | | | | |
| | Payments Due by Period | |
Contractual Obligations | | Total | | Less than 1 year | | 1 - 3 years | | 3 - 5 years | | More than 5 years | |
Facility operating leases | | $ | 5,055,000 | | $ | 749,000 | | $ | 1,583,000 | | $ | 1,671,000 | | $ | 1,052,000 | |
We do not have any other significant cash commitments related to supply agreements, nor do we have any significant commitments for capital expenditures.
Critical Accounting Policies
Management’s Discussion and Analysis of Financial Condition and Results of Operations addresses our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States for interim financial information. The preparation of our financial statements requires that we make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. On an on-going basis, we evaluate these estimates and judgments. We base our estimates and judgments on historical experience and on various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
The material accounting policies that we believe are most critical to an investor’s understanding of our financial results and condition and which require complex management judgment are discussed in our 2008 Form 10-K under the caption “Critical Accounting Policies.”
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Cautionary Statement Pursuant to the Private Securities Litigation Reform Act of 1995
The Private Securities Litigation Reform Act of 1995 (the Act) provides a “safe harbor” for forward-looking statements to encourage companies to provide prospective information about their business, so long as those statements are identified as forward-looking and are accompanied by meaningful cautionary statements identifying important factors that could cause actual results to differ materially from those discussed in the statement. We desire to take advantage of the safe harbor provisions with respect to any forward-looking statements we may make in this filing, other filings with the Securities and Exchange Commission and any public oral statements or written releases. The words or phrases “will likely,” “is expected,” “will continue,” “is anticipated,” “believe”, “estimate,” “projected,” “forecast,” or similar expressions are intended to identify forward-looking statements within the meaning of the Act. Such statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those projected. We caution readers not to place undue reliance on any such forward-looking statements, which speak only as of the date made. In accordance with the Act, we identify the following important general factors which, if altered from the current status, could cause our actual results to differ from those described in any forward-looking statements: risks associated with defense of patent infringement lawsuits, adoption of our new products, limited profitability, exposure to possible product liability claims, the development of new products by others, dependence on third party distributors in international markets, doing business in international markets, the availability of third party reimbursement, actions by the FDA related to our products, the loss of key vendors, and those factors set forth under the heading “Risk Factors” in Item 1A of Part I of our Annual Report on Form 10-K for the year ended December 31, 2008. This list is not exhaustive, and we may supplement this list in any future filing with the Securities and Exchange Commission or in connection with the making of any specific forward-looking statement. We undertake no obligation to revise or update publically any forward-looking statement for any reason.
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Item 3. | Quantitative and Qualitative Disclosures about Market Risk |
Financial instruments that potentially subject us to concentrations of credit risk consist primarily of cash and cash equivalents and accounts receivables. We maintain our accounts for cash and cash equivalents principally at two major banks and one investment firm in the United States. We have a formal written investment policy that limits our investments to investments in issuers evaluated as creditworthy. We have not experienced any losses on our deposits of our cash and cash equivalents.
With respect to accounts receivable, we perform credit evaluations of our customers and do not require collateral. There have been no material losses on accounts receivables.
In the United States we sell our products directly to hospitals and clinics denominated in United States dollars. In Germany, through April 1, 2008 we sold our products to hospitals and clinics denominated in Euros. Effective April 1, 2008, we began selling our products in Germany through our new distributor Nicolai, GmbH. The sale of our products to Nicolai is denominated in Euros. Product revenue recognized on sales in Germany represented approximately 1.8% of our total product revenue for the six months ended June 30, 2009. The exposure to currency exchange rates on this volume of product sales in Germany would be considered immaterial to our financial statements.
In all other international markets, we sell our products to independent distributors who, in turn, sell to medical clinics. We sell our product in these countries through independent distributors denominated in United States dollars. Loss, termination or ineffectiveness of distributors to effectively promote our product would have a material adverse effect on our financial condition and results of operations.
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We do not believe our operations are currently subject to significant market risks for interest rates, foreign currency exchange rates, commodity prices or other relevant market price risks of a material nature. As we have earned and received all Euro installment payments pursuant to the terms of our distribution agreement with Nicolai, GmbH before the end of 2008, there is no further exposure to fluctuations in the Euro related to this agreement. A change of 0.1 in the Euro exchange would result in an increase or decrease of approximately $22,000 in the amount of United States dollars we receive in payment on accounts receivable from Nicolai, GmbH. Under our current policies, we do not use foreign currency derivative instruments to manage exposure to fluctuations in the Euro exchange rate.
We currently have no indebtedness, but if we were to borrow amounts from our revolving credit line, we would be exposed to changes in interest rates. Advances under our revolving credit line bear interest at an annual rate indexed to prime. We will thus be exposed to interest rate risk with respect to amounts outstanding under the line of credit to the extent that interest rates rise. As we had no amounts outstanding on the line of credit at June 30, 2009, we have no exposure to interest rate changes on this credit facility. Under our current policies, we do not use interest rate derivative instruments to manage exposure to interest rate changes. Additionally, we will be exposed to declines in the interest rates paid on deposited funds. A 0.1% decline in the current market interest rates paid on deposits would result in interest income being reduced by approximately $11,000 on an annual basis.
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Item 4. | Controls and Procedures |
Evaluation of disclosure controls and procedures.
Under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we evaluated the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Exchange Act). Based upon that evaluation, the Chief Executive Officer and Chief Financial Officer concluded that, as of the end of the period covered by this report, our disclosure controls and procedures were effective.
Changes in internal controls.
During the fiscal quarter ended June 30, 2009, there has been no change in our internal control over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act) that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
PART II. OTHER INFORMATION
The legal proceedings for the Marine Polymer Technologies, Inc. litigation as described in Note 9 to Unaudited Consolidated Financial Statements in Item 1 of Part I of this Form 10-Q is incorporated into this Item 1 of Part II by reference.
From time to time, we are involved in legal proceedings arising in the normal course of business. As of the date of this report we were not a party to any legal proceeding not described in this section in which an adverse outcome would reasonably be expected to have a material adverse effect on our results of operations or financial condition.
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Item 1A, (“Risk Factors”) of our most recently filed Form 10-K sets forth information relating to important risks and uncertainties that could materially adversely affect our business, financial condition or operating results. There have been no material changes from the Risk Factors described in our annual report on Form 10-K; however, those Risk Factors continue to be relevant to an understanding of our business, financial condition and operating results and, accordingly, you should review and consider such Risk Factors in making any investment decision with respect to our securities. An investment in our securities continues to involve a high degree of risk.
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Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds |
None.
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Item 3. | Defaults Upon Senior Securities |
None.
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Item 4. | Submission of Matters to a Vote of Security Holders |
Our annual meeting of shareholders was held on April 21, 2009, at which time (1) seven nominees were elected to the Board of Directors for one-year terms, and (2) the appointment of Baker Tilly Virchow Krause, LLP as our independent registered public accounting firm was ratified. We solicited proxies pursuant to Section 14(a) of the Exchange Act, and there was no solicitation in opposition to management’s solicitations. All nominees for directors as listed in the proxy statement were elected.
The voting results were as follows:
| | | | | | | | | | | | | |
| | For | | Against | | Withheld | | Broker Non-Vote | |
Election of Directors: | | | | | | | | | | | | | |
Jon Erb | | | 14,494,796 | | | — | | | 258,021 | | | — | |
Michael Kopp | | | 14,493,626 | | | — | | | 259,191 | | | — | |
Richard Nigon | | | 14,676,279 | | | — | | | 76,538 | | | — | |
Paul O’Connell | | | 14,607,444 | | | — | | | 145,373 | | | — | |
Howard Root | | | 13,298,510 | | | — | | | 1,454,307 | | | — | |
Jorge Saucedo | | | 14,676,731 | | | — | | | 76,086 | | | — | |
Charmaine Sutton | | | 12,845,520 | | | — | | | 1,907,297 | | | — | |
| | | | | | | | | | | | | |
Approval of Independent Registered Public Accounting Firm: | | | 14,713,951 | | | 20,543 | | | 18,323 | | | — | |
None.
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| | | |
Exhibit Number | | Description | |
3.1 | | Amended and Restated Articles of Incorporation of Vascular Solutions, Inc. (incorporated by reference to Exhibit 3.1 to Vascular Solutions’ Form 10-Q for the quarter ended September 30, 2000). |
3.2 | | Amended and Restated Bylaws of Vascular Solutions, Inc. (incorporated by reference to Exhibit 3.1 of Vascular Solutions’ Form 8-K dated October 19, 2007). |
4.1 | | Specimen of Common Stock certificate (incorporated by reference to Exhibit 4.1 of Vascular Solutions’ Registration Statement on Form S-1 (File No. 333-84089)). |
31.1 | | Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
31.2 | | Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
32.1 | | Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
32.2 | | Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
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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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| VASCULAR SOLUTIONS, INC. |
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Date: July 22, 2009 | | By: | /s/ Howard Root | |
| | | Howard Root |
| | | Chief Executive Officer and Director |
| | | (principal executive officer) |
| | | | |
| | By: | /s/ James Hennen | |
| | | James Hennen |
| | | Chief Financial Officer |
| | | (principal financial officer) |
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