We recognized $212,000 and $637,000 of licensing revenue during the three and nine month periods ending September 30, 2010 and 2009, respectively, as the result of our License Agreement and Device Supply Agreement with King and our distribution agreement with Nicolai. We also recognized $23,000 and $199,000 of collaboration revenue during the three month periods ending September 30, 2010 and 2009, and $175,000 and $554,000 of collaboration revenue during the nine month periods ending September 30, 2010 and 2009, respectively, as a result of performing clinical and development work for King under the Device Supply Agreement.
Gross margin across all product lines remained relatively constant at 65% for the quarter ended September 30, 2010, compared to 66% for the quarter ended September 30, 2009. We expect product gross margins to be in the range of 65% to 66% for the fourth quarter of 2010, 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 remained constant at 66% for the nine months ended September 30, 2010 compared to 66% for the nine months ended September 30, 2009.
Research and development expense for the third quarter of 2010 totaled $2,464,000, or 12% of revenue, compared to $1,988,000, or 11% of revenue, for the third quarter of 2009. Research and development expense for the nine month period ending September 30, 2010 totaled $7,194,000, or 13% of revenue, compared to $5,707,000, or 11% of revenue, for the nine month period ending September 30, 2009. We expect our continuing research and development expenses to be approximately 10% to 12% of revenue in the fourth quarter of 2010 as we continue to pursue additional new products and to move our longer term development projects forward.
Clinical and regulatory expense for the third quarter of 2010 totaled $966,000, or 5% of revenue, compared to $713,000, or 4% of revenue, for the third quarter of 2009. Clinical and regulatory expense for the nine month period ending September 30, 2010 totaled $2,561,000, or 4% of revenue, compared to $2,092,000, or 4% of revenue, for the nine month period ending September 30, 2009. 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 in the fourth quarter of 2010.
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Sales and marketing expense for the third quarter of 2010 totaled $5,927,000, or 30% of revenue, compared to $5,280,000, or 31% of revenue, for the third quarter of 2009. Sales and marketing expense for the nine month period ending September 30, 2010 totaled $17,441,000, or 30% of revenue, compared to $15,840,000, or 32% of revenue, for the nine month period ending September 30, 2009. The decline in sales and marketing expenses as a percentage of revenue primarily resulted from maintaining our direct sales force at between 85 and 90 full-time employees while continuing to grow revenue. We expect to maintain the same relative size of our direct sales force for the remainder of 2010. As a result, we expect our sales and marketing expenses will continue to decline as a percentage of revenue to between 27% and 28% of revenue by the end of 2010.
General and administrative expense for the third quarter of 2010 totaled $1,327,000, or 7% of revenue, compared to $1,152,000, or 7% of revenue, for the third quarter of 2009. General and administrative expense for the nine month period ending September 30, 2010 totaled $4,039,000, or 7% of revenue, compared to $3,375,000, or 7% of revenue, for the nine month period ending September 30, 2009. General and administrative expenses have remained relatively flat as percent of total revenue. We expect general and administrative expenses to be approximately 6% to 7% of revenue in the fourth quarter of 2010.
Litigation income for the nine months ended September 30, 2010 was $3,529,000, or 6% of revenue. The litigation income resulted from an award of damages the Company received in the first quarter of 2010 in the Marine Polymer Technologies, Inc. litigation. For a complete discussion of litigation matters, see Note 8 to the Unaudited Consolidated Financial Statements in Item 1 of Part I of this Form 10-Q.
Amortization of purchased technology and other intangibles was $89,000 and $148,000 for the three and nine months ended September 30, 2010. The amortization resulted from our purchase of the Escalon SMARTNEEDLE and pdACCESS products in April 2010. As part of the asset purchase, we allocated $3,250,000 to purchased technology and other intangibles that are being amortized over a period of 9 – 10 years.
Interest income increased to $9,000 for the three months ending September 30, 2010 from $5,000 for the three months ending September 30, 2009. Interest income decreased to $30,000 for the nine months ending September 30, 2010 from $43,000 for the nine months ending September 30, 2009. The increase in interest income for the three months ending September 30, 2010 is due primarily to maintaining a higher cash deposit balance at September 30, 2010 compared to September 30, 2009. The decrease in interest income for the nine months ended September 30, 2010 was primarily the result of lower interest rates being paid on our deposit funds held at the bank.
Interest expense decreased to $5,000 and $15,000 for the third quarter and nine month period ending September 30, 2010 compared to $9,000 and $30,000 for the third quarter and nine month period ending September 30, 2009. The decrease in interest expense was the result of timing of banking charges as we switched banks in the first quarter of 2010.
Foreign exchange gain was $41,000 for the quarter ending September 30, 2010 compared to a foreign exchange gain of $3,000 for the quarter ending September 30, 2009. Foreign exchange loss was $17,000 for the nine months ended September 30, 2010 compared to a foreign exchange loss of $3,000 for the nine months ended September 30, 2009. Sales to one of our distributors are denominated in Euros and we 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. The increase in foreign exchange losses was the result of the weakening of the Euro against the U.S. Dollar.
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Income tax expense was $714,000 for the three month period ending September 30, 2010 and $3,741,000 for the nine month period ending September 30, 2010 on income before tax of $2,178,000 and $10,147,000, respectively. The effective income tax rate was 37% for the nine month period ending September 30, 2010. The difference between the effective tax rate of 37% and the U.S. federal statutory income tax rate of 34% was due mainly to the impact of state income taxes. For the three and nine months ended September 30, 2009, income tax expense was $746,000 and $2,194,000, respectively, on income before tax of $2,177,000 and $5,939,000. The effective income tax rate was 37% for the nine month period ending September 30, 2009. We will evaluate the adequacy of the remaining valuation allowance in the fourth quarter of 2010 and anticipate that this evaluation could result in a change that would remove all or part of the remaining valuation allowance. This adjustment to the valuation allowance could result in a significant income tax benefit.
Liquidity and Capital Resources
Our cash and cash equivalents totaled $19,219,000 at September 30, 2010 compared to $17,794,000 in cash and cash equivalents at December 31, 2009, an increase of $1,425,000. 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 $8,954,000 of cash from operations for the nine months ended September 30, 2010, resulting from our income before taxes of $10,147,000 since essentially all of our income taxes are offset by our deferred tax assets. During the first half of 2010 we increased the safety stock levels for a number of our products, which increased our inventory by $3,329,000 from December 31, 2009. At June 30, 2010 we had reached our desired safety stock levels, and therefore we grew our inventory at a more normalized rate of $749,000 in the third quarter. We expect our inventory to increase at the same rate as our sales growth in the fourth quarter of 2010.
Cash used for investing activities.We used $7,291,000 of cash in investing activities for the nine months ended September 30, 2010. We used $5,000,000 of cash in the purchase of the SMARTNEEDLE and pdACCESS assets from Escalon. We also incurred capital expenditures of $2,291,000 relating to purchasing additional manufacturing equipment, expanding our clean room manufacturing area and purchasing additional research and development equipment.
Cash used in financing activities.We used $238,000 of cash in financing activities for the nine months ended September 30, 2010. We used $1,153,000 of cash to repurchase 123,309 common shares on the open market under our stock repurchase plan, and we used $392,000 of cash to repurchase 48,620 shares that vested under outstanding restricted stock awards to satisfy income tax withholding obligations. These purchases were offset by our receipt of $426,000 for purchases of common stock pursuant to our Employee Stock Purchase Plan and $881,000 upon the exercise of outstanding stock options.
We have a $10 million revolving line of credit with US Bank, which has a 12-month term, bears interest at the rate of LIBOR plus 1.60% and is secured by a first security interest on all of our assets. As of September 30, 2010, we were in compliance with the bank covenant 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 $39.5 million at September 30, 2010 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.
Off-Balance Sheet Arrangements
We did not have any off-balance sheet arrangements as of September 30, 2010.
Contractual Obligations
The following table summarizes our contractual cash commitments as of September 30, 2010:
| | | | | | | | | | | | | | | | |
| | Payments Due by Period | |
Contractual Obligations | | Total | | Less than 1 year | | 1 - 3 years | | 3 - 5 years | | More than 5 years | |
Facility operating leases | | $ | 4,119,000 | | $ | 797,000 | | $ | 1,639,000 | | $ | 1,683,000 | | $ | — | |
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 2009 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. Forward-looking statements such as these are based on management’s current expectations as of the date of this report but involve risks, uncertainties and other factors which may cause actual results to differ materially from those contemplated by such forward-looking statements. 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, 2009. 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 and do not intend to revise or update publicly 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 one major bank 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. In international markets, we sell our products to independent distributors who, in turn, sell to hospitals. Sales to independent distributors are denominated in United States dollars, with the exception of Germany, where sales are denominated in Euros.
We distribute certain products on behalf of certain U.S. and international manufacturers. We pay for all distributed products in United States dollars, with the exception of one distributor located in Europe, where purchases are denominated in Euros.
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. A change of 0.1 in the Euro exchange rate would result in an increase or decrease of approximately $16,000 in the amount of United States dollars we receive in payment on accounts receivable from our German distributor Nicolai, GmbH. In addition, we have made advances to a European supplier of one of our distributed products, Zerusa Ltd., for future product deliveries. A change of 0.1 in the Euro exchange rate would result in an increase or decrease of approximately $19,000 in the amount of United States dollars we recognize as exchange rate gains or losses from Zerusa. Under our current policies, we do not use foreign currency derivative instruments to manage exposure to fluctuations in the Euro exchange rate.
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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 LIBOR. 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 September 30, 2010, 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 $19,000 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 control over financial reporting.
During the fiscal quarter ended September 30, 2010, 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 and AngioDynamics, Inc. litigation as described in Note 9 to the 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 additional legal proceedings arising in the normal course of business. As of the date of this report we are 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.
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 |
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None. |
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Item 4. | (Removed and Reserved) |
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Item 5. | Other Information |
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None. |
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Item 6. | Exhibits |
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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)). |
10.1 | | Asset Purchase Agreement dated October 20, 2010 by and between Vascular Solutions, Radius Medical Technologies, Inc., and Radius Medical, LLC |
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.
| | | | |
| VASCULAR SOLUTIONS, INC. |
| | | | |
Date: October 22, 2010 | | By: | /s/ Howard Root | |
| | | Howard Root |
| | | Chief Executive Officer and Director |
| | | (principal executive officer) |
| | | | |
| | By: | /s/ James Hennen | |
| | | James Hennen |
| | | Senior Vice President of Finance and |
| | | Chief Financial Officer |
| | | (principal financial officer) |
| | | | |
| | By: | /s/ Timothy Slayton | |
| | | Timothy Slayton |
| | | Controller |
| | | (principal accounting officer) |
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