|
UNITED STATES |
SECURITIES AND EXCHANGE COMMISSION |
WASHINGTON, D.C. 20549 |
|
|
FORM 10-Q |
|
|
|
|
(Mark One) |
| |
|
|
|
| x | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2009 | ||
|
|
|
OR | ||
|
|
|
| o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from _______ to ________ |
|
Commission File Number:0-27605 |
|
|
VASCULAR SOLUTIONS, INC. |
(Exact name of registrant as specified in its charter) |
|
|
Minnesota | 41-1859679 |
(State or other jurisdiction of incorporation or organization) | (IRS Employer Identification No.) |
|
|
6464 Sycamore Court | |
Minneapolis, Minnesota 55369 | |
(Address of principal executive offices, including zip code) | |
| |
(763) 656-4300 | |
(Registrant’s telephone number, including area code) | |
| |
Not Applicable | |
(Former name, former address and former | |
fiscal year, if changed since last report) | |
| |
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).
Yeso Noo
|
|
Large accelerated filero | Accelerated filerx |
Non-accelerated filer o | Smaller Reporting Companyo |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No x
The registrant had 16,253,646 shares of common stock, $.01 par value per share, outstanding as of July 20, 2009.
VASCULAR SOLUTIONS, INC.
|
|
|
|
|
|
|
|
| Page |
|
|
| ||
|
| |||
|
|
| ||
|
| 2 | ||
|
|
|
|
|
|
|
| 2 | |
|
|
|
|
|
|
|
| 3 | |
|
|
|
|
|
|
|
| 4 | |
|
|
|
|
|
|
|
| 5 | |
|
|
|
|
|
| Management’s Discussion and Analysis of Financial Condition and Results of Operations |
| 13 | |
|
|
|
|
|
|
| 18 | ||
|
|
|
|
|
|
| 19 | ||
|
|
|
|
|
|
| |||
|
|
| ||
|
| 19 | ||
|
|
|
|
|
|
| 20 | ||
|
|
|
|
|
|
| 20 | ||
|
|
|
|
|
|
| 20 | ||
|
|
|
|
|
|
| 20 | ||
|
|
|
|
|
|
| 20 | ||
|
|
|
|
|
|
| 21 |
Page 1
|
|
Financial Statements |
VASCULAR SOLUTIONS, INC.
Consolidated Balance Sheets
|
|
|
|
|
|
|
|
|
| June 30, 2009 |
| December 31, 2008 |
| ||
|
|
| (unaudited) |
|
| (see note) |
|
Assets |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
| $ | 10,522,000 |
| $ | 7,209,000 |
|
Accounts receivable, net of reserves of $110,000 and $120,000 in 2009 and 2008, respectively |
|
| 8,555,000 |
|
| 8,706,000 |
|
Inventories |
|
| 9,864,000 |
|
| 9,974,000 |
|
Prepaid expenses |
|
| 1,384,000 |
|
| 1,045,000 |
|
Current portion of deferred tax assets |
|
| 2,680,000 |
|
| 2,680,000 |
|
Total current assets |
|
| 33,005,000 |
|
| 29,614,000 |
|
|
|
|
|
|
|
|
|
Property and equipment, net |
|
| 3,742,000 |
|
| 3,887,000 |
|
Intangible assets, net |
|
| 193,000 |
|
| 193,000 |
|
Deferred tax assets, net of current portion and liabilities |
|
| 9,148,000 |
|
| 10,486,000 |
|
Total assets |
| $ | 46,088,000 |
| $ | 44,180,000 |
|
|
|
|
|
|
|
|
|
Liabilities and shareholders’ equity |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Accounts payable |
| $ | 952,000 |
| $ | 2,022,000 |
|
Accrued compensation |
|
| 2,750,000 |
|
| 2,584,000 |
|
Accrued expenses |
|
| 845,000 |
|
| 848,000 |
|
Accrued royalties |
|
| 542,000 |
|
| 576,000 |
|
Current portion of deferred revenue |
|
| 920,000 |
|
| 907,000 |
|
Total current liabilities |
|
| 6,009,000 |
|
| 6,937,000 |
|
|
|
|
|
|
|
|
|
Long-term deferred revenue, net of current portion |
|
| 4,992,000 |
|
| 5,417,000 |
|
|
|
|
|
|
|
|
|
Shareholders’ equity: |
|
|
|
|
|
|
|
Common stock, $0.01 par value: |
|
|
|
|
|
|
|
Authorized shares – 40,000,000 |
|
|
|
|
|
|
|
Issued and outstanding shares – 16,253,646 – 2009; |
|
| 163,000 |
|
| 160,000 |
|
Additional paid-in capital |
|
| 86,225,000 |
|
| 85,292,000 |
|
Other |
|
| 84,000 |
|
| 84,000 |
|
Accumulated deficit |
|
| (51,385,000 | ) |
| (53,710,000 | ) |
Total shareholders’ equity |
|
| 35,087,000 |
|
| 31,826,000 |
|
Total liabilities and shareholders’ equity |
| $ | 46,088,000 |
| $ | 44,180,000 |
|
See accompanying notes.
Note: The balance sheet at December 31, 2008 has been derived from the audited financial statements at that date.
Page 2
VASCULAR SOLUTIONS, INC.
Consolidated Statements of Operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Three Months Ended |
| Six Months Ended |
| ||||||||
|
| 2009 |
| 2008 |
| 2009 |
| 2008 |
| ||||
|
| (unaudited) |
| (unaudited) |
| ||||||||
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenue |
| $ | 16,781,000 |
| $ | 14,871,000 |
| $ | 32,197,000 |
| $ | 28,609,000 |
|
License and collaboration revenue |
|
| 385,000 |
|
| 367,000 |
|
| 779,000 |
|
| 744,000 |
|
Total revenue |
|
| 17,166,000 |
|
| 15,238,000 |
|
| 32,976,000 |
|
| 29,353,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product costs and operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
| 5,765,000 |
|
| 5,360,000 |
|
| 10,980,000 |
|
| 9,941,000 |
|
Collaboration expenses |
|
| 173,000 |
|
| 187,000 |
|
| 355,000 |
|
| 368,000 |
|
Research and development |
|
| 1,803,000 |
|
| 1,553,000 |
|
| 3,719,000 |
|
| 3,019,000 |
|
Clinical and regulatory |
|
| 767,000 |
|
| 759,000 |
|
| 1,379,000 |
|
| 1,610,000 |
|
Sales and marketing |
|
| 5,307,000 |
|
| 5,174,000 |
|
| 10,560,000 |
|
| 10,387,000 |
|
General and administrative |
|
| 1,104,000 |
|
| 1,192,000 |
|
| 2,223,000 |
|
| 2,734,000 |
|
Litigation |
|
| — |
|
| 1,457,000 |
|
| — |
|
| 1,484,000 |
|
Total product costs and operating expenses |
|
| 14,919,000 |
|
| 15,682,000 |
|
| 29,216,000 |
|
| 29,543,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income (loss) |
|
| 2,247,000 |
|
| (444,000 | ) |
| 3,760,000 |
|
| (190,000 | ) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expenses): |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
| 14,000 |
|
| 48,000 |
|
| 37,000 |
|
| 140,000 |
|
Interest expense |
|
| (11,000 | ) |
| (18,000 | ) |
| (20,000 | ) |
| (42,000 | ) |
Foreign exchange gain (loss) |
|
| 7,000 |
|
| (1,000 | ) |
| (5,000 | ) |
| (1,000 | ) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before income taxes |
|
| 2,257,000 |
|
| (415,000 | ) |
| 3,772,000 |
|
| (93,000 | ) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense |
|
| (871,000 | ) |
| (53,000 | ) |
| (1,448,000 | ) |
| (140,000 | ) |
Net income (loss) |
| $ | 1,386,000 |
| $ | (468,000 | ) | $ | 2,324,000 |
| $ | (233,000 | ) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per share – basic |
| $ | 0.09 |
| $ | (0.03 | ) | $ | 0.15 |
| $ | (0.02 | ) |
Net income (loss) per share – diluted |
| $ | 0.09 |
| $ | (0.03 | ) | $ | 0.14 |
| $ | (0.02 | ) |
See accompanying notes.
Page 3
VASCULAR SOLUTIONS, INC.
Consolidated Statements of Cash Flows
|
|
|
|
|
|
|
|
|
| Six Months Ended |
| ||||
|
| 2009 |
| 2008 |
| ||
|
| (unaudited) |
| ||||
Operating activities |
|
|
|
|
|
|
|
Net income (loss) |
| $ | 2,324,000 |
| $ | (233,000 | ) |
Adjustments to reconcile net income to net cash provided by operating activities: |
|
|
|
|
|
|
|
Depreciation |
|
| 684,000 |
|
| 742,000 |
|
Stock-based compensation |
|
| 891,000 |
|
| 879,000 |
|
Deferred compensation expense |
|
| — |
|
| 9,000 |
|
Deferred taxes, net |
|
| 1,338,000 |
|
| 3,000 |
|
Loss on disposal of fixed assets |
|
| — |
|
| 40,000 |
|
Change in allowance for doubtful accounts |
|
| (10,000 | ) |
| — |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
Accounts receivable |
|
| 161,000 |
|
| 29,000 |
|
Inventories |
|
| 110,000 |
|
| (1,065,000 | ) |
Prepaid expenses |
|
| (338,000 | ) |
| 63,000 |
|
Accounts payable |
|
| (1,069,000 | ) |
| 519,000 |
|
Accrued compensation and expenses |
|
| 129,000 |
|
| (5,530,000 | ) |
Deferred license fees received |
|
| — |
|
| 191,000 |
|
Amortization of deferred license fees and other deferred revenue |
|
| (412,000 | ) |
| (395,000 | ) |
Net cash provided by (used in) operating activities |
|
| 3,808,000 |
|
| (4,748,000 | ) |
|
|
|
|
|
|
|
|
Investing activities |
|
|
|
|
|
|
|
Purchase of property and equipment, net |
|
| (539,000 | ) |
| (512,000 | ) |
Cash deposits transferred from restricted cash |
|
| — |
|
| 5,473,000 |
|
Net cash provided by (used in) investing activities |
|
| (539,000 | ) |
| 4,961,000 |
|
|
|
|
|
|
|
|
|
Financing activities |
|
|
|
|
|
|
|
Repurchase of common shares |
|
| (333,000 | ) |
| (141,000 | ) |
Payment on long-term debt |
|
| — |
|
| (400,000 | ) |
Proceeds from the exercise of stock options, stock warrants and sale of stock, net of expenses |
|
| 377,000 |
|
| 437,000 |
|
Net cash provided by (used in) financing activities |
|
| 44,000 |
|
| (104,000 | ) |
|
|
|
|
|
|
|
|
Effect of exchange rate changes on cash and cash equivalents |
|
| — |
|
| 10,000 |
|
Increase in cash and cash equivalents |
|
| 3,313,000 |
|
| 119,000 |
|
Cash and cash equivalents at beginning of period |
|
| 7,209,000 |
|
| 5,286,000 |
|
Cash and cash equivalents at end of period |
| $ | 10,522,000 |
| $ | 5,405,000 |
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow |
|
|
|
|
|
|
|
Cash paid for interest |
| $ | 14,000 |
| $ | 46,000 |
|
Cash paid for taxes |
| $ | 107,000 |
| $ | 232,000 |
|
See accompanying notes.
Page 4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Three Months Ended |
| Six Months Ended |
| ||||||||
|
| 2009 |
| 2008 |
| 2009 |
| 2008 |
| ||||
|
| (unaudited) |
| (unaudited) |
| ||||||||
Weighted average shares outstanding – basic |
|
| 15,903,000 |
|
| 15,502,000 |
|
| 15,871,000 |
|
| 15,471,000 |
|
Weighted average shares outstanding – diluted |
|
| 16,207,000 |
|
| 15,502,000 |
|
| 16,202,000 |
|
| 15,471,000 |
|
|
|
(3) | Comprehensive Income (Loss) |
|
|
| Comprehensive income for the Company includes net income and foreign currency translation. Comprehensive income for the three and six months ended June 30, 2009 and 2008 was as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Three Months Ended |
| Six Months Ended |
| ||||||||
|
| 2009 |
| 2008 |
| 2009 |
| 2008 |
| ||||
|
| (unaudited) |
| (unaudited) |
| ||||||||
Net income (loss) |
| $ | 1,386,000 |
| $ | (468,000 | ) | $ | 2,324,000 |
| $ | (233,000 | ) |
Foreign currency translation adjustments |
|
| — |
|
| (7,000 | ) |
| — |
|
| 26,000 |
|
Comprehensive income (loss) |
| $ | 1,386,000 |
| $ | (475,000 | ) | $ | 2,324,000 |
| $ | (207,000 | ) |
Page 5
VASCULAR SOLUTIONS, INC.
Notes to Unaudited Consolidated Financial Statements-Continued
|
|
(4) | Revenue Recognition |
|
|
| In the United States the Company sells its products directly to hospitals and clinics. Revenue is recognized in accordance with generally accepted accounting principles as outlined in the Securities and Exchange Commission’s Staff Accounting Bulletin No. 104,Revenue Recognition(SAB 104), which requires that four basic criteria be met before revenue can be recognized: (i) persuasive evidence of an arrangement exists; (ii) the price is fixed or determinable; (iii) collectibility is reasonably assured; and (iv) product delivery has occurred or services have been rendered. The Company recognizes revenue as products are shipped based on FOB shipping point terms when title passes to customers. The Company negotiates credit terms on a customer-by-customer basis and products are shipped at an agreed-upon price. All product returns must be pre-approved and, if approved, customers are subject to a 20% restocking charge. |
|
|
| Effective April 1, 2008 the Company entered into a five-year distribution agreement with Nicolai, GmbH. As a result of entering into this distribution agreement, the Company no longer maintains a direct sales force in Germany. In connection with this distribution agreement, the Company received 500,000 Euros from Nicolai, GmbH. The 500,000 Euro payment was deferred and is being recognized ratably over the five-year term of the distribution agreement. The agreement also includes provisions requiring the Company to pay Nicolai, GmbH specific amounts if the Company terminates the distribution agreement prior to the end of the five-year term. The Company does not intend to terminate the distribution agreement and, as such, has not recorded a liability relating to these potential future payments to Nicolai, GmbH. |
|
|
| In all international markets, the Company sells its products to international distributors which subsequently resell the products to hospitals and clinics. The Company has agreements with each of its distributors which provide that title and risk of loss pass to the distributor upon shipment of the products to the distributor. The Company warrants that its products are free from manufacturing defects at the time of shipment to the distributor. Revenue is recognized upon shipment of products to distributors following the receipt and acceptance of a distributor’s purchase order. Allowances are provided for estimated returns and warranty costs at the time of shipment. |
|
|
| The Company also generates revenues from license agreements and research collaborations and recognizes these revenues when earned. In accordance with Emerging Issues Task Force (EITF) Issue No. 00-21,Revenue Arrangements with Multiple Deliverables, for deliverables which contain multiple deliverables, the Company separates the deliverables into separate accounting units if they meet the following criteria: (i) the delivered items have a stand-alone value to the customer; (ii) the fair value of any undelivered items can be reliably determined; and (iii) if the arrangement includes a general right of return, delivery of the undelivered items is probable and substantially controlled by the seller. Deliverables that do not meet these criteria are combined with one or more other deliverables into one accounting unit. Revenue from each accounting unit is recognized based on the applicable accounting literature, primarily Staff Accounting Bulletin (SAB) 104,Revenue Recognition. |
|
|
| In addition, the Company has reviewed the provisions of EITF Issue No. 07-01,Accounting for Collaborative Arrangements,and has determined this EITF has no impact on the amounts recorded under these agreements. |
Page 6
VASCULAR SOLUTIONS, INC.
Notes to Unaudited Consolidated Financial Statements-Continued
|
|
| In accordance with EITF Issue No. 00-10,Accounting for Shipping and Handling Fees and Costs, the Company includes shipping and handling revenues in net revenue, and shipping and handling costs in cost of sales. |
|
|
(5) | Inventories |
|
|
| Inventories are stated at the lower of cost (first-in, first-out method) or market. Appropriate consideration is given to deterioration, obsolescence and other factors in evaluating net realizable value. Inventories are comprised of the following: |
|
|
|
|
|
|
|
|
|
| June 30, |
| December 31, |
| ||
|
| (unaudited) |
|
|
| ||
|
|
|
|
|
|
|
|
Raw materials |
| $ | 4,299,000 |
| $ | 4,943,000 |
|
Work-in process |
|
| 982,000 |
|
| 871,000 |
|
Finished goods |
|
| 4,583,000 |
|
| 4,160,000 |
|
|
| $ | 9,864,000 |
| $ | 9,974,000 |
|
|
|
(6) | Credit Risk and Allowance for Doubtful Accounts |
|
|
| The Company maintains allowances for doubtful accounts for estimated losses resulting from the inability of our customers to make required payments. This allowance is regularly evaluated by the Company for adequacy by taking into consideration factors such as past experience, credit quality of the customer base, age of the receivable balances, both individually and in the aggregate, and current economic conditions that may affect a customer’s ability to pay. Accounts receivable over 60 days past due are considered past due. The Company does not accrue interest on past due accounts receivable. Receivables are written off only after all collection attempts have failed and are based on individual credit evaluation and the specific circumstances of the customer. At June 30, 2009 and December 31, 2008, the allowance for doubtful accounts was $75,000 and $95,000, respectively. |
|
|
| All product returns must be pre-approved and, if approved, customers are subject to a 20% restocking charge. The Company analyzes the rate of historical returns when evaluating the adequacy of the allowance for sales returns, which is included with the allowance for doubtful accounts on our balance sheet. At June 30, 2009 and December 31, 2008, the sales and return allowance was $35,000 and $25,000, respectively. |
|
|
| Accounts receivable are shown net of the combined total of the allowance for doubtful accounts and allowance for sales returns of $110,000 and $120,000 at June 30, 2009 and December 31, 2008, respectively. |
|
|
(7) | Concentrations of Credit and Other Risks |
|
|
| In the United States the Company sells its products directly to hospitals and clinics. In all international markets, the Company sells its products to distributors who, in turn, sell to medical clinics. Loss, termination or ineffectiveness of distributors to effectively promote the Company’s products could have a material adverse effect on the Company’s financial condition and results of operations. |
Page 7
VASCULAR SOLUTIONS, INC.
Notes to Unaudited Consolidated Financial Statements-Continued
|
|
| With respect to accounts receivable, the Company performs credit evaluations of its customers and does not require collateral. No single customer represented greater than 10% of gross accounts receivable as of either June 30, 2009 or December 31, 2008. There have been no material losses on customer receivables. |
|
|
| Revenue by geographic destination as a percentage of total net revenue for the six month periods ended June 30, 2009 and 2008 was 87% in the United States and 13% in international markets for both periods. No single customer represented greater than 10% of the total net revenue for the six months ended June 30, 2009 or 2008. |
|
|
(8) | Dependence on Key Suppliers |
|
|
| King Pharmaceuticals |
|
|
| The Company purchases certain key components from single-source suppliers. Any significant component delay or interruption could require the Company to qualify new sources of supply, if available, and could have a material adverse effect on the Company’s financial condition and results of operations. The Company purchases its requirements for thrombin (a component in the D-Stat products) under a Thrombin-JMI Supply Agreement entered into with King Pharmaceuticals, Inc. (King) on January 9, 2007. Under the terms of the Thrombin-JMI Supply Agreement, King agrees to manufacture and supply thrombin to the Company on a non-exclusive basis. The Thrombin-JMI Supply Agreement does not contain any minimum purchase requirements. King agrees to supply the Company with such quantity of thrombin as the Company may order at a fixed price throughout the term of the Thrombin-JMI Supply Agreement as adjusted for inflation, variations in potency and other factors. The Thrombin-JMI Supply Agreement has an initial term of 10 years, followed by successive automatic one-year extensions, subject to termination by the parties under certain circumstances, including: (i) termination by King without cause anytime after the fifth anniversary of the date of the Thrombin-JMI Supply Agreement upon five years prior written notice to the Company, and (ii) termination by the Company without cause anytime after the fifth anniversary of the date of the Thrombin-JMI Supply Agreement upon five years prior written notice to King provided that the Device Supply Agreement, which the Company also entered into with King on January 9, 2007, has expired on its terms or the parties have agreed to terminate it. |
|
|
(9) | Commitments and Contingencies |
|
|
| Diomed Inc. Litigation |
|
|
| On March 4, 2004, the Company was named as the defendant in an intellectual property lawsuit brought by Diomed Inc. (Diomed) in the United States District Court for the District of Massachusetts (the “Court”). The complaint requested a judgment that sales of the Company’s Vari-Lase® procedure kit and Vari-Lase laser console infringe on a single method patent (No. 6,398,777) held by Diomed and asked for relief in the form of an injunction that would prevent the Company from selling the Company’s Vari-Lase products, compensatory and treble damages caused by the manufacture and sale of the Company’s products, and other costs, disbursements and attorneys’ fees. The trial commenced on March 12, 2007, and concluded on March 28, 2007, when the jury reached a verdict that the Company contributed to and induced infringement of Diomed’s patent and awarded monetary damages in the amount of $4,100,000, plus pre-judgment interest. The jury concluded there was no willful infringement by the Company and therefore the award was not subject to treble damages or attorneys’ fees. To settle Diomed’s claims for pre-judgment interest and for additional damages for sales not considered by the jury, the Company agreed to amend the judgment amount to $4,975,000 and accrued this amount together with additional costs and attorney’s fees as of June 30, 2007 in the aggregate amount of $5,690,000. On June 20, 2007 the Company posted a supersedeas bond and appealed the jury verdict to the U.S. Court of Appeals for the Federal Circuit in Washington, D.C. On April 8, 2008, the Company announced that it entered into a settlement agreement with Diomed. Pursuant to the settlement agreement, (i) on April 29, 2008, the Company made a one-time payment of $3,586,000 to Diomed, (ii) the Company and Diomed jointly dismissed the appeal with the United States Court of Appeals for the Federal Circuit, and (iii) Diomed provided to the Company a satisfaction of judgment, releasing the Company from the monetary obligations of the judgment imposed by the Court in its entirety. |
Page 8
VASCULAR SOLUTIONS, INC.
Notes to Unaudited Consolidated Financial Statements-Continued
|
|
| Marine Polymer Technologies, Inc. Litigation |
|
|
| On May 11, 2005 the Company initiated a lawsuit for product disparagement and false advertising against Marine Polymer Technologies, Inc., a Delaware corporation (Marine Polymer). In the lawsuit, the Company alleged that Marine Polymer made defamatory and disparaging statements concerning the Company’s D-Stat® Dry hemostatic bandage. The Company sought relief in the form of an injunction to enjoin Marine Polymer from continuing to defame and disparage the Company’s products, damages as a result of such statements, and other costs, disbursements and attorneys’ fees. Marine Polymer brought a counter-claim against the Company including, among other claims, business defamation and product disparagement for statements allegedly made by the Company concerning Marine Polymer’s SyvekPatch®. Marine Polymer sought relief in the form of monetary damages, costs, disbursements and attorneys’ fees. The trial commenced on March 24, 2008 in the United States District Court for the District of Massachusetts. At the conclusion of the trial on April 7, 2008 the jury returned a verdict in favor of the Company and against Marine Polymer for product disparagement concerning statements made regarding the safety of the Company’s D-Stat Dry hemostat product. In its verdict, the jury found that Marine Polymer’s statements were false and disparaged the D-Stat Dry product and awarded the Company $4,500,000 in monetary damages. The jury rejected Marine Polymer’s counter-claims in their entirety. Following post trial motions, on June 30, 2008, the Court upheld the jury verdict, granted the Company’s request for a permanent injunction against Marine Polymer for the statements that the jury found were false, and added prejudgment interest on the jury verdict award in the amount of $592,124. On July 14, 2008, Marine Polymer filed a Notice of Appeal with the U.S. First Circuit Court of Appeals seeking to overturn the monetary damages and injunction issued against them. Marine Polymer did not appeal the Court’s rejection of its counter-claims against the Company. On February 4, 2009, oral arguments by both parties on Marine Polymer’s appeal were heard by the U.S. First Circuit Court of Appeals. |
|
|
| VNUS® Medical Technologies Litigation |
|
|
| On October 13, 2005, the Company was named as one of three defendants in an intellectual property lawsuit brought by VNUS® Medical Technologies, Inc. (VNUS) in the United States District Court for the Northern District of California. The complaint requested a judgment that the Company’s Vari-Lase® procedure kit and Vari-Lase® laser console infringe on four patents held by VNUS and asked for relief in the form of an injunction that would prevent the Company from selling the Company’s Vari-Lase® products, compensatory and treble damages caused by the manufacture and sale of these products, and other costs, disbursements and attorneys’ fees. VNUS subsequently indicated that it was not pursuing its allegation of infringement concerning one of the four patents. On June 2, 2008, the Company entered into a settlement agreement with VNUS for the purpose of resolving the lawsuit. Under the terms of the settlement agreement, (i) on June 4, 2008, the Company paid VNUS a royalty payment in the aggregate amount of $3,116,000 related to all Vari-Lase products shipped within the United States through the end of the first quarter of 2008, (ii) the Company agreed to pay a quarterly royalty on all on-going U.S. shipments of Vari-Lase laser and kit products payable quarterly during the remaining life of the applicable patents, (iii) VNUS granted the Company a non-exclusive and non-sublicensable license to the applicable patents for use in endovenous laser therapy, and (iv) all litigation between the parties was dismissed. |
Page 9
VASCULAR SOLUTIONS, INC.
Notes to Unaudited Consolidated Financial Statements-Continued
|
|
| From time to time, the Company is involved in legal proceedings arising in the normal course of business. As of the date of this report the Company is 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 the Company’s results of operations or financial condition. |
|
|
(10) | Long-term Debt |
|
|
| On December 26, 2007, the Company modified and extended its secured asset-based loan and security agreement with Silicon Valley Bank dated December 31, 2003 (as previously amended December 28, 2006 and December 29, 2005), consisting of an operating line of credit and an equipment line of credit. The operating line of credit is a two-year, $10,000,000 facility with availability based primarily on eligible customer receivables and inventory. The interest rate is the greater of prime plus 0.5% or 7.25%. As of June 30, 2009, the Company had no outstanding balance against the operating line of credit. Based on the Company’s eligible customer receivables, inventory and cash balances, $10,000,000 was available for borrowing as of June 30, 2009. The operating line of credit requires an annual fee of 0.25% of the average unused portion of the committed revolving line as determined by the bank. |
|
|
| The equipment line of credit was paid in full on July 9, 2008 and the Company no longer has the ability to borrow any additional funds under the equipment line of credit portion of the credit facility. |
|
|
| The credit facility includes three covenants: a minimum of $10,000,000 in tangible net worth, a minimum of $3,000,000 of unrestricted cash in deposit accounts with Silicon Valley Bank and an adjusted net income for each financial reporting period. The adjusted net income covenant requires an adjusted net income greater than $500,000 for each rolling three month period for the remaining term of the agreement. The amount required as a minimum tangible net worth will increase by an amount equal to the sum of 50% of the Company’s quarterly net profit and all consideration received by the Company upon the issuance of equity securities. The Company was in compliance with all of the covenants as of June 30, 2009. |
|
|
(11) | Income Taxes |
|
|
| The Company is subject to income tax in numerous jurisdictions and at various rates and the use of estimates is required in determining the provision for income taxes. For the six month period ended June 30, 2009, the Company recorded a tax provision of $1,448,000 on income before tax of $3,772,000 resulting in an effective income tax rate of 38%. For the six months ended June 30, 2009, 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 six month period ended June 30, 2008, the Company recorded a tax provision of $140,000 related to alternative minimum taxes (AMT) as the Company continued to maintain a full valuation allowance on its tax benefits. |
Page 10
VASCULAR SOLUTIONS, INC.
Notes to Unaudited Consolidated Financial Statements-Continued
|
|
| Through the third quarter of 2008, the Company maintained a full valuation allowance on its deferred tax assets. The Company regularly assesses the likelihood that the deferred tax assets will be recovered from future taxable income. The Company considers projected future taxable income and ongoing tax planning strategies, then records a valuation allowance to reduce the carrying value of the net deferred taxes to an amount that is more likely than not to be realized. |
|
|
| As of December 31, 2008, based upon the Company’s assessment of all available evidence, including previous three year cumulative income before unusual and infrequent expenses (litigation and thrombin qualification expenses), estimates of future profitability, and the Company’s overall prospects of future business, the Company determined that it is more likely than not that the Company will be able to realize a portion of the deferred tax assets in the future, and as a result recorded a $13,200,000 income tax benefit for the year ended December 31, 2008. To determine the amount of the reduction in the valuation allowance, the Company used a discounted projection of its revenue and income over the next five years, which would approximate the ten-year life of the Company’s three most significant products as of December 31, 2008. The amount of the valuation allowance reduction was based on the Company’s projected discounted taxable income. The Company will continue to assess the potential realization of deferred tax assets on an annual basis, or an interim basis if circumstances warrant. If the Company’s actual results and updated projections vary significantly from the projections used as a basis for this determination, the Company may need to increase or decrease the valuation allowance against the gross deferred tax assets. The Company would adjust earnings for the deferred tax in the period the determination was made. |
|
|
| Effective January 1, 2007, the Company adopted FIN 48,Accounting for Uncertainty in Income Taxes — an Interpretation of FASB Statement No. 109. Upon adoption, the Company had $425,000 of unrecognized income tax benefits and the adoption of FIN 48 had no effect on shareholders’ equity. The Company has recorded a FIN 48 reserve of $597,000 as of December 31, 2008. The impact of tax related interest and penalties is recorded as a component of income tax expense. For the six months ended June 30, 2009, the Company has recorded $0 for the payment of tax related interest and there were no tax penalties or interest recognized in the statements of operations. |
|
|
| The Company is subject to income tax examinations in the U.S. Federal jurisdiction, as well as in Germany and various state jurisdictions. At June 30, 2009, the Company was not under examination by any of these taxing authorities and the open tax years are 2006 through 2008. |
Page 11
VASCULAR SOLUTIONS, INC.
Notes to Unaudited Consolidated Financial Statements-Continued
|
|
(12) | Products and Services |
|
|
| The following tables set forth, for the periods indicated, net revenue by product line along with the percent change from the previous period: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Six Months Ended June 30, |
| ||||||||||
|
| 2009 |
| 2008 |
| ||||||||
|
| Net |
| Percent |
| Net |
| Percent |
| ||||
| |||||||||||||
Hemostat products |
| $ | 12,164,000 |
|
| 3 | % | $ | 11,856,000 |
|
| (5 | %) |
Extraction catheters |
|
| 8,147,000 |
|
| 15 | % |
| 7,070,000 |
|
| 29 | % |
Vein products |
|
| 5,192,000 |
|
| 14 | % |
| 4,557,000 |
|
| 19 | % |
Access products |
|
| 3,474,000 |
|
| 50 | % |
| 2,312,000 |
|
| 108 | % |
Specialty catheters |
|
| 2,719,000 |
|
| 19 | % |
| 2,279,000 |
|
| 30 | % |
Other |
|
| 501,000 |
|
| (7 | %) |
| 535,000 |
|
| 16 | % |
Total product revenue |
| $ | 32,197,000 |
|
| 13 | % | $ | 28,609,000 |
|
| 14 | % |
License and collaboration |
|
| 779,000 |
|
| 5 | % |
| 744,000 |
|
| 153 | % |
Total revenue |
| $ | 32,976,000 |
|
| 12 | % | $ | 29,353,000 |
|
| 16 | % |
Page 12
|
|
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
Overview
Vascular Solutions, Inc. (we, us or Vascular) is a medical device company focused on bringing clinically advanced solutions to interventional cardiologists and interventional radiologists worldwide. We were incorporated in the state of Minnesota in December 1996, and began operations in February 1997. Our main product lines consist of the following:
|
|
• | Hemostat (blood clotting) products, principally consisting of the D-Stat® Dry hemostat, a topical thrombin-based pad with a bandage used to control surface bleeding, and the D-Stat® Flowable, a thick yet flowable thrombin-based mixture for preventing bleeding in subcutaneous pockets, |
|
|
• | Extraction catheters, principally consisting of the Pronto® V3 and Pronto® LP extraction catheters, mechanical systems for the removal of soft thrombus from arteries, |
|
|
• | Vein products, principally consisting of the Vari-Lase® endovenous laser, a laser and procedure kit used for the treatment of varicose veins, |
|
|
• | Access products, principally consisting of micro-introducer kits, MICROElite™ and EXPROElite™ snares, the Guardian® hemostasis valve, and guidewires used in connection with percutaneous access to the vasculature, and |
|
|
• | Specialty catheters, consisting of a variety of catheters for clinical niches including the Langston® dual lumen catheters, Twin-Pass® dual access catheters, Gandras™ catheters, Minnie™ support catheter, and Gopher™ support catheter. |
In 2000 we received FDA clearance for our first product, the Duett™ sealing device, which is used to seal the puncture site following catheterization procedures. In 2001, due to competitive developments in the sealing device market, we made the strategic decision to develop additional products and de-emphasize the promotion of our Duett sealing device. We have grown from net revenue of $6.2 million in 2000 solely from the Duett device to net revenue of $61.2 million in 2008, with 98% of our 2008 net revenue resulting from products other than the Duett device. This increase in revenue represents a compound annual growth rate of 33% and is driven by our commitment to the research and development of multiple new devices to diagnose and treat existing and new vascular conditions.
As a vertically-integrated medical device company, we generate ideas and create new interventional medical devices and then deliver these products directly to the physician through our direct domestic sales force and our international distribution network. We currently have in development several additional products that leverage our existing infrastructure to bring additional solutions to the interventional cardiologist and interventional radiologist.
Page 13
Results of Operations
The following table sets forth, for the periods indicated, certain items from our statements of operations expressed as a percentage of net revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Three Months Ended |
| Six Months Ended |
| ||||||||
|
| 2009 |
| 2008 |
| 2009 |
| 2008 |
| ||||
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenue |
|
| 98 | % |
| 98 | % |
| 98 | % |
| 97 | % |
License and collaboration revenue |
|
| 2 | % |
| 2 | % |
| 2 | % |
| 3 | % |
Total revenue |
|
| 100 | % |
| 100 | % |
| 100 | % |
| 100 | % |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product costs and operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
| 34 | % |
| 35 | % |
| 34 | % |
| 34 | % |
Collaboration expenses |
|
| 1 | % |
| 1 | % |
| 1 | % |
| 1 | % |
Research and development |
|
| 11 | % |
| 10 | % |
| 11 | % |
| 10 | % |
Clinical and regulatory |
|
| 4 | % |
| 5 | % |
| 4 | % |
| 6 | % |
Sales and marketing |
|
| 31 | % |
| 34 | % |
| 32 | % |
| 36 | % |
General and administrative |
|
| 6 | % |
| 8 | % |
| 7 | % |
| 9 | % |
Litigation |
|
| — |
|
| 10 | % |
| — |
|
| 5 | % |
Total product costs and operating expenses |
|
| 87 | % |
| 103 | % |
| 89 | % |
| 101 | % |
Operating income |
|
| 13 | % |
| (3 | %) |
| 11 | % |
| (1 | %) |
Other income and expenses, net |
|
| — |
|
| — |
|
| — |
|
| — |
|
Income before income taxes |
|
| 13 | % |
| (3 | %) |
| 11 | % |
| (1 | %) |
Income taxes |
|
| 5 | % |
| — |
|
| 4 | % |
| — |
|
Net income |
|
| 8 | % |
| (3 | %) |
| 7 | % |
| (1 | %) |
Three and six months ended June 30, 2009, compared to three and six months ended June 30, 2008
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.
Page 14
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.
Page 15
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.
Page 16
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 - 3 years |
| 3 - 5 years |
| More than |
| |||||
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.”
Page 17
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.
|
|
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.
Page 18
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.
|
|
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.
|
|
Legal Proceedings |
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.
Page 19
|
|
Risk Factors |
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.
|
|
Unregistered Sales of Equity Securities and Use of Proceeds |
None.
|
|
Defaults Upon Senior Securities |
None.
|
|
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 |
| ||||
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 |
|
| — |
|
|
|
Other Information |
None.
Page 20
|
|
Exhibits |
|
|
|
|
Exhibit |
| 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. |
Page 21
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: 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) |
Page 22