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Vascular Solutions 10-Q 2010

Table of Contents


 

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, 2010

 

 

 

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: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yes x No o

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).
Yes o No o

 

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer o

Accelerated filer x

Non-accelerated filer o

Smaller Reporting Company o

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 16,820,840 shares of common stock, $.01 par value per share, outstanding as of July 19, 2010.


VASCULAR SOLUTIONS, INC.

TABLE OF CONTENTS

 

 

 

 

 

 

 

 

 

Page

 

 

 

PART I. FINANCIAL INFORMATION

 

 

 

 

 

 

Item 1.

Financial Statements (Unaudited)

 

2

 

 

 

 

 

 

 

Consolidated Balance Sheets

 

2

 

 

 

 

 

 

 

Consolidated Statements of Operations

 

3

 

 

 

 

 

 

 

Consolidated Statements of Cash Flows

 

4

 

 

 

 

 

 

 

Notes to Unaudited Consolidated Financial Statements

 

5

 

 

 

 

 

 

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

14

 

 

 

 

 

 

Item 3.

Quantitative and Qualitative Disclosures about Market Risk

 

20

 

 

 

 

 

 

Item 4.

Controls and Procedures

 

21

 

 

 

 

 

PART II. OTHER INFORMATION

 

 

 

 

 

 

Item 1.

Legal Proceedings

 

22

 

 

 

 

 

 

Item 1A.

Risk Factors

 

22

 

 

 

 

 

 

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

 

22

 

 

 

 

 

 

Item 3.

Defaults upon Senior Securities

 

22

 

 

 

 

 

 

Item 4.

(Removed and Reserved)

 

23

 

 

 

 

 

 

Item 5.

Other Information

 

23

 

 

 

 

 

 

Item 6.

Exhibits

 

23

Page 1


Table of Contents


PART 1. FINANCIAL INFORMATION

 

 

Item 1.

Financial Statements

VASCULAR SOLUTIONS, INC.

Consolidated Balance Sheets

 

 

 

 

 

 

 

 

 

 

June 30, 2010

 

December 31, 2009

 

 

 

 

 

 

 

 

 

 

 

(unaudited)

 

(see note)

 

Assets

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

18,227,000

 

$

17,794,000

 

Accounts receivable, net of reserves of $165,000 and $150,000 in 2010 and 2009, respectively

 

 

10,232,000

 

 

9,143,000

 

Inventories

 

 

12,306,000

 

 

8,977,000

 

Prepaid expenses

 

 

1,498,000

 

 

1,520,000

 

Current portion of deferred tax assets

 

 

4,500,000

 

 

4,500,000

 

Total current assets

 

 

46,763,000

 

 

41,934,000

 

 

 

 

 

 

 

 

 

Property and equipment, net

 

 

4,539,000

 

 

3,793,000

 

Intangible assets, net

 

 

5,134,000

 

 

193,000

 

Deferred tax assets, net of current portion and liabilities

 

 

3,121,000

 

 

5,835,000

 

Total assets

 

$

59,557,000

 

$

51,755,000

 

 

 

 

 

 

 

 

 

Liabilities and shareholders’ equity

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

Accounts payable

 

$

3,756,000

 

$

1,396,000

 

Accrued compensation

 

 

3,116,000

 

 

2,978,000

 

Accrued expenses

 

 

1,054,000

 

 

865,000

 

Accrued royalties

 

 

542,000

 

 

621,000

 

Current portion of deferred revenue

 

 

869,000

 

 

929,000

 

Total current liabilities

 

 

9,337,000

 

 

6,789,000

 

 

 

 

 

 

 

 

 

Long-term deferred revenue, net of current portion

 

 

4,142,000

 

 

4,567,000

 

 

 

 

 

 

 

 

 

Shareholders’ equity:

 

 

 

 

 

 

 

Common stock, $0.01 par value:

 

 

 

 

 

 

 

Authorized shares – 40,000,000
Issued and outstanding shares – 16,848,340 – 2010; 16,557,669 – 2009

 

 

168,000

 

 

166,000

 

Additional paid-in capital

 

 

89,217,000

 

 

88,481,000

 

Other

 

 

84,000

 

 

84,000

 

Accumulated deficit

 

 

(43,391,000

)

 

(48,332,000

)

Total shareholders’ equity

 

 

46,078,000

 

 

40,399,000

 

Total liabilities and shareholders’ equity

 

$

59,557,000

 

$

51,755,000

 

See accompanying notes.

Note: The balance sheet at December 31, 2009 has been derived from the audited financial statements at that date.

Page 2


Table of Contents


VASCULAR SOLUTIONS, INC.

Consolidated Statements of Operations

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended
June 30,

 

Six Months Ended
June 30,

 

 

 

2010

 

2009

 

2010

 

2009

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(unaudited)

 

(unaudited)

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

Product revenue

 

$

19,262,000

 

$

16,781,000

 

$

37,129,000

 

$

32,197,000

 

License and collaboration revenue

 

 

254,000

 

 

385,000

 

 

576,000

 

 

779,000

 

Total revenue

 

 

19,516,000

 

 

17,166,000

 

 

37,705,000

 

 

32,976,000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product costs and operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of goods sold

 

 

6,510,000

 

 

5,765,000

 

 

12,457,000

 

 

10,980,000

 

Collaboration expenses

 

 

42,000

 

 

173,000

 

 

152,000

 

 

355,000

 

Research and development

 

 

2,266,000

 

 

1,803,000

 

 

4,730,000

 

 

3,719,000

 

Clinical and regulatory

 

 

888,000

 

 

767,000

 

 

1,595,000

 

 

1,379,000

 

Sales and marketing

 

 

5,910,000

 

 

5,307,000

 

 

11,513,000

 

 

10,560,000

 

General and administrative

 

 

1,405,000

 

 

1,104,000

 

 

2,712,000

 

 

2,223,000

 

Litigation

 

 

 

 

 

 

(3,529,000

)

 

 

Amortization of purchased technology and intangibles

 

 

59,000

 

 

 

 

59,000

 

 

 

Total product costs and operating expenses

 

 

17,080,000

 

 

14,919,000

 

 

29,689,000

 

 

29,216,000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating income

 

 

2,436,000

 

 

2,247,000

 

 

8,016,000

 

 

3,760,000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other income (expenses):

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

10,000

 

 

14,000

 

 

20,000

 

 

37,000

 

Interest expense

 

 

(5,000

)

 

(11,000

)

 

(10,000

)

 

(20,000

)

Foreign exchange loss

 

 

(35,000

)

 

7,000

 

 

(58,000

)

 

(5,000

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Income before income taxes

 

 

2,406,000

 

 

2,257,000

 

 

7,968,000

 

 

3,772,000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Income tax expense

 

 

(931,000

)

 

(871,000

)

 

(3,027,000

)

 

(1,448,000

)

Net income

 

$

1,475,000

 

$

1,386,000

 

$

4,941,000

 

$

2,324,000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income per share – basic

 

$

0.09

 

$

0.09

 

$

0.30

 

$

0.15

 

Net income per share – diluted

 

$

0.09

 

$

0.09

 

$

0.29

 

$

0.14

 

See accompanying notes.

Page 3


Table of Contents


VASCULAR SOLUTIONS, INC.

Consolidated Statements of Cash Flows

 

 

 

 

 

 

 

 

 

 

Six Months Ended
June 30,

 

 

 

2010

 

2009

 

 

 

 

 

 

 

 

 

 

 

(unaudited)

 

Operating activities

 

 

 

 

 

 

 

Net income

 

$

4,941,000

 

$

2,324,000

 

Adjustments to reconcile net income to net cash provided by operating activities:

 

 

 

 

 

 

 

Depreciation

 

 

800,000

 

 

684,000

 

Amortization

 

 

59,000

 

 

 

Stock-based compensation

 

 

1,009,000

 

 

891,000

 

Deferred taxes, net

 

 

2,714,000

 

 

1,338,000

 

Change in allowance for doubtful accounts

 

 

15,000

 

 

(10,000

)

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

Accounts receivable

 

 

(1,104,000

)

 

161,000

 

Inventories

 

 

(3,329,000

)

 

110,000

 

Prepaid expenses

 

 

22,000

 

 

(338,000

)

Accounts payable

 

 

2,360,000

 

 

(1,069,000

)

Accrued compensation and expenses

 

 

8,000

 

 

129,000

 

Amortization of deferred license fees and other deferred revenue

 

 

(485,000

)

 

(412,000

)

Net cash provided by operating activities

 

 

7,010,000

 

 

3,808,000

 

 

 

 

 

 

 

 

 

Investing activities

 

 

 

 

 

 

 

Purchase of property and equipment

 

 

(1,307,000

)

 

(539,000

)

Cash paid for acquisition

 

 

(5,000,000

)

 

 

Net cash used in investing activities

 

 

(6,307,000

)

 

(539,000

)

 

 

 

 

 

 

 

 

Financing activities

 

 

 

 

 

 

 

Repurchase of common shares

 

 

(727,000

)

 

(333,000

)

Proceeds from the exercise of stock options, stock warrants and sale of stock, net of expenses

 

 

457,000

 

 

377,000

 

Net cash provided by (used in) financing activities

 

 

(270,000

)

 

44,000

 

Increase in cash and cash equivalents

 

 

433,000

 

 

3,313,000

 

Cash and cash equivalents at beginning of period

 

 

17,794,000

 

 

7,209,000

 

Cash and cash equivalents at end of period

 

$

18,227,000

 

 

10,522,000

 

 

 

 

 

 

 

 

 

Supplemental disclosure of cash flow

 

 

 

 

 

 

 

Cash paid for interest

 

$

7,000

 

$

14,000

 

Cash paid for taxes

 

$

100,000

 

$

107,000

 

See accompanying notes.

Page 4


Table of Contents


VASCULAR SOLUTIONS, INC.
Notes to Unaudited Consolidated Financial Statements-Continued

 

 

(1)

Basis of Presentation

 

 

 

The accompanying unaudited financial statements of Vascular Solutions, Inc. (the Company) have been prepared in accordance with generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q and Regulation S-X. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. In the opinion of management, all normal, recurring adjustments considered necessary for a fair presentation have been included. The financial statements should be read in conjunction with the audited financial statements for the fiscal year ended December 31, 2009 included in the Annual Report on Form 10-K of the Company filed with the Securities and Exchange Commission. Interim results of operations are not necessarily indicative of the results to be expected for the full year or any other interim periods.

 

 

(2)

Net Income per Share

 

 

 

In accordance with Accounting Standards Codification (“ASC”) 260-10-55, basic net income per share for the three and six months ended June 30, 2010 and 2009 is computed by dividing net income by the weighted average common shares outstanding during the periods presented. Diluted net income per weighted average common share is computed by dividing net income by the weighted average common shares outstanding during the period, increased to include dilutive potential common shares issuable relating to outstanding restricted stock, and upon the exercise of stock options and awards that were outstanding during the period.

 

 

 

Weighted average common shares outstanding for the three and six months ended June 30, 2010 and 2009 was as follows:


 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended
June 30,

 

Six Months Ended
June 30,

 

 

 

2010

 

2009

 

2010

 

2009

 

 

 

 

(unaudited)

 

(unaudited)

 

Weighted average shares outstanding – basic

 

 

16,396,000

 

 

15,903,000

 

 

16,358,000

 

 

15,871,000

 

Weighted average shares outstanding – diluted

 

 

16,958,000

 

 

16,207,000

 

 

16,847,000

 

 

16,202,000

 


 

 

(3)

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 ASC 605-10-S99, 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.

Page 5


Table of Contents


VASCULAR SOLUTIONS, INC.
Notes to Unaudited Consolidated Financial Statements-Continued

 

 

 

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 ASC 605-25-25-5, for revenues 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 ASC 605-10-S99-1.

 

 

 

In addition, the Company has reviewed the provisions of ASC 808-10 for Collaborative Arrangements, and has determined this ASC has no impact on the amounts recorded under these agreements.

 

 

 

In accordance with ASC 605-45-45, the Company includes shipping and handling revenues in net revenue, and shipping and handling costs in cost of sales.

 

 

(4)

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,
2010

 

December 31,
2009

 

 

 

 

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

Raw materials

 

$

5,485,000

 

$

4,382,000

 

Work-in process

 

 

1,341,000

 

 

858,000

 

Finished goods

 

 

5,480,000

 

 

3,737,000

 

 

 

$

12,306,000

 

$

8,977,000

 


 

 

(5)

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. 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, 2010 and December 31, 2009, the allowance for doubtful accounts was $130,000 and $105,000, respectively.

Page 6


Table of Contents


VASCULAR SOLUTIONS, INC.
Notes to Unaudited Consolidated Financial Statements-Continued

 

 

 

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, 2010 and December 31, 2009, the sales and return allowance was $35,000 and $45,000, respectively.

 

 

 

Accounts receivable are shown net of the combined total of the allowance for doubtful accounts and allowance for sales returns of $165,000 and $150,000 at June 30, 2010 and December 31, 2009, respectively.

 

 

(6)

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.

 

 

 

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, 2010 or December 31, 2009. 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, 2010 and 2009 was 86% and 87% in the United States and 14% and 13% in international markets, respectively. No single customer represented greater than 10% of the total net revenue for the six months ended June 30, 2010 or 2009.

 

 

(7)

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 Hemostat 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.

Page 7


Table of Contents


VASCULAR SOLUTIONS, INC.
Notes to Unaudited Consolidated Financial Statements-Continued

 

 

(8)

Commitments and Contingencies

 

 

 

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. On December 23, 2009, the U.S. First Circuit Court of Appeals affirmed the judgment against Marine Polymer for product disparagement. As a result, the permanent injunction issued at the conclusion of the trial will remain in effect, prohibiting Marine Polymer and its representatives from making, publishing or disseminating certain disparaging statements concerning the safety of our D-Stat products. Addressing the jury’s award of $4.5 million in damages, the Court determined that, due to differences in opinion among the judges, the Company could either accept a $2.7 million award of damages (plus interest) or insist upon a new trial limited to the issue of determining the reasonable amount of damages. The Company accepted the $2.7 million award of damages plus interest and on January 22, 2010 the Company received $3.56 million as payment in full for the judgment. This amount was recorded as a litigation gain in the first quarter of 2010.

Page 8


Table of Contents


VASCULAR SOLUTIONS, INC.
Notes to Unaudited Consolidated Financial Statements-Continued

 

 

 

AngioDynamics, Inc. Litigation

 

 

 

On July 29, 2009 AngioDynamics, Inc. (AngioDynamics) filed a lawsuit against the Company in the U.S. District Court for the District of Delaware, alleging that the Company has infringed U.S. Patent No. 7,273,478 and U.S. Patent No. 7,559,329. Specifically, AngioDynamics alleges that doctors using the Company’s Bright Tip fibers and procedure kits are using the methods claimed in those patents, and accuses the Company of inducing and contributing to infringement. AngioDynamics has requested injunctive relief and compensatory damages. On December 1, 2009 the Company filed its answer, a counterclaim, and a motion to transfer the case to the U.S. District Court for the District of Minnesota.

 

 

 

The Company has also filed an inter partes request for reexamination of both the ‘478 and ‘329 patents with the United States Patent Office. The Patent Office granted the inter partes requests for reexamination for both the ‘478 and ‘329 patents. The Company expects the reexamination process for each patent will take at least three years to conclude. On January 27, 2010, the Company filed a motion with the U.S. District Court for the District of Delaware to stay all proceedings in the litigation pending the outcome of the inter partes reexaminations.

 

 

 

From time to time, the Company is involved in additional 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.

 

 

 

King Agreements

 

 

 

On January 9, 2007, the Company entered into three separate agreements with King: a License Agreement, a Device Supply Agreement and a Thrombin-JMI® Supply Agreement. Under the License Agreement, the Company licensed the exclusive rights to the Company’s products Thrombi-Pad, Thrombi-Gel and Thrombi-Paste to King in exchange for a one-time license fee of $6,000,000. Under the Device Supply Agreement, the Company agreed to manufacture the licensed products for sale to King in exchange for two separate $1,000,000 milestone payments; one upon the first commercial sale of Thrombi-Gel (which was received on May 31, 2007), and one upon the first commercial sale of Thrombi-Paste. The Company is amortizing the $6,000,000 license fee on a straight-line basis over 10 years. The Company is amortizing the $1,000,000 milestone payment that was received on May 31, 2007 over the remaining 10-year license period, and will amortize the additional $1,000,000 milestone payment for the Thrombi-Paste product over the remaining 10-year license period if it is received. The unamortized license fee was $4,593,000 and $4,945,000 at June 30, 2010 and December 31, 2009, respectively. The amortization of license fee was $352,000 for the six months ended June 30, 2010 and 2009, respectively.

 

 

 

Under the Device Supply Agreement the Company agreed to pursue a surgical indication for the use of the Thrombi-Gel and Thrombi-Paste products from the FDA. The Device Supply Agreement requires the Company to make a one-time payment of $2,500,000 to King if the FDA does not approve the surgical indication of Thrombi-Gel and a one-time payment of $2,500,000 to King if the FDA does not approve the surgical indication of Thrombi-Paste after performing a clinical study and submitting the application. The Company continues to pursue a surgical indication for the use of the Thrombi-Gel product. In 2009 King suspended further development of the Thrombi-Paste product. The Company believes the probability of paying these one-time payments to King is remote, and therefore has not recorded any provision for these payments.

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VASCULAR SOLUTIONS, INC.
Notes to Unaudited Consolidated Financial Statements-Continued

 

 

 

Nicolai, GmbH Agreement

 

 

 

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, which 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. The unamortized license fee was $400,000 and $472,000 at June 30, 2010 and December 31, 2009, respectively. The amortization of license fee was $72,000 for the six months ended June 30, 2010 and 2009, respectively.

 

 

(9)

Lines of Credit

 

 

 

On December 21, 2009, the Company entered into a secured asset-based revolving credit agreement with U.S. Bank National Association. The revolving credit agreement is a one-year, $10,000,000 facility with availability based primarily on eligible customer receivables, inventory and property and equipment. The revolving credit agreement bears interest equal to the one-month LIBOR rate plus 1.60% and is secured by a first security interest on all of the Company’s assets. The revolving credit agreement requires a quarterly payment based on an annual fee of 0.125% of the average unused portion of the committed revolving line as determined by the bank and reviewed by management.

 

 

 

The revolving credit agreement includes one covenant that the Company cannot have a maximum cash flow leverage ratio greater than 2.5 to 1. The calculation of this covenant is determined by multiplying annual lease expense times six and adding any loans, then dividing this amount by the sum of earnings before interest, taxes, depreciation, amortization and annual operating lease payments. The covenant is computed quarterly based on a rolling 12-month period. The Company was in compliance with this covenant as of June 30, 2010.

 

 

 

As of June 30, 2010, the Company had no outstanding balance against the revolving credit agreement. Based on the Company’s eligible customer receivables, inventory, property and equipment and cash balances, $10,000,000 was available for borrowing as of June 30, 2010.

 

 

(10)

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 periods ended June 30, 2010 and June 30, 2009, the Company recorded a provision for taxes of $3,027,000 and $1,448,000 on income before tax of $7,968,000 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.

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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 ASC 740-10. Upon adoption, the Company had $425,000 of unrecognized income tax benefits and the adoption of ASC 740-10 had no effect on shareholders’ equity. The Company has recorded an ASC 740-10 reserve of $727,000 as of December 31, 2009. The impact of tax related interest and penalties is recorded as a component of income tax expense. For the six months ended June 30, 2010, 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, 2010, the Company was not under examination by any of these taxing authorities and the open tax years are 2007 through 2009.

 

 

(11)

Acquisitions and IPR&D Charges

 

 

 

During the first quarter of fiscal year 2010, the Company adopted ASC 805 related to business combinations. The new authoritative guidance establishes principles and requirements for how an acquirer recognizes and measures in its financial statements the identifiable assets acquired, the liabilities assumed, any noncontrolling interests in the acquiree and the goodwill acquired. The underlying purchase method of accounting for acquisitions was retained, but the new guidance incorporates a number of changes. These changes include the capitalization of purchased in-process research and development (IPR&D), expensing of acquisition related costs and the recognition of contingent purchase price consideration at fair value at the acquisition date. In addition, changes in accounting for deferred tax asset valuation allowances and acquired income tax uncertainties after the measurement period will be recognized in earnings rather than as an adjustment to the cost of the acquisition. This accounting treatment for taxes is applicable to acquisitions consummated both prior to and subsequent to the adoption of the new authoritative guidance. The adoption of the new authoritative guidance did not change the requirement to expense IPR&D immediately with respect to asset acquisitions. The adoption of the new authoritative guidance did not have a material impact on our consolidated financial statements during the three and six months ended June 30, 2010.

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VASCULAR SOLUTIONS, INC.
Notes to Unaudited Consolidated Financial Statements-Continued

 

 

 

When the Company acquires another company or a group of assets, the purchase price is allocated, as applicable, among IPR&D, other identifiable intangible assets, net tangible assets and the remainder, if any, gets recognized to goodwill, as required by U.S. GAAP. Goodwill represents the excess of the aggregate purchase price over the fair value of net assets, including IPR&D, of acquired businesses. The values assigned to IPR&D and other identifiable intangible assets are based on valuations as determined by independent third party appraisers. The techniques used by these appraisers include estimating the future cash flows of each project or technology and discounting the net cash flows back to their present values utilizing an appropriate risk-adjusted rate of return (discount rate). The discount rate used is determined at the time of the acquisition in accordance with accepted valuation methods. For IPR&D, these methodologies include consideration of the risk of the project not achieving commercial feasibility and include a factor that takes into account the uncertainty surrounding the successful development of the IPR&D.

 

 

 

At the time of acquisition, the Company plans that all acquired IPR&D will reach technological feasibility, but there can be no assurance that the commercial viability of these products will actually be achieved. The nature of the efforts to develop the acquired technologies into commercially viable products consists principally of planning, designing and conducting clinical trials necessary to obtain regulatory approvals. The risks associated with achieving commercialization include, but are not limited to, delay or failure to obtain regulatory approvals to conduct clinical trials, delay or failure to obtain required market clearances, and patent issuance, validity and litigation, if any. If commercial viability were not achieved, the Company would likely look to other alternative uses for the same technology.

 

 

 

Escalon Vascular Access, Inc.

 

 

 

On April 30, 2010, the Company acquired the assets related to the SMARTNEEDLE® and pdACCESS® Doppler guided needle access business from Escalon Vascular Access, Inc., (Escalon) a division of Escalon Medical Corporation. Under the terms of the agreement the Company will pay Escalon a total of $5,750,000, consisting of $5,000,000 paid in cash at April 30, 2010 and $750,000 payable in cash upon successful completion of the transfer of the manufacturing processes from Escalon to the Company. The SMARTNEEDLE and pdACCESS products consist of a hand-held monitor and one-time use needles designed to provide auditory ultrasound guided access to arteries and veins during catheterization procedures.

 

 

 

In addition to the SMARTNEEDLE and pdACCESS products, the Company has acquired the assets related to the new VascuView TAP™ visual ultrasound system and will pay Escalon a one-time cash earn-out payment in an amount equal to 25% of the net sales of the VascuView TAP products sold between July 1, 2010 and June 30, 2011.

 

 

 

The Company accounted for the transaction as a purchase of assets and technology in the second quarter of 2010. In accordance with ASC 805 the purchase price is being allocated based on estimates of the fair value of assets acquired, as no liabilities were assumed.

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VASCULAR SOLUTIONS, INC.
Notes to Unaudited Consolidated Financial Statements-Continued

 

 

 

The purchase price will be allocated as follows:


 

 

 

 

 

Inventory

 

$

500,000

 

Property and Equipment

 

 

250,000

 

Purchased technology

 

 

2,500,000

 

Other intangibles

 

 

750,000

 

Goodwill

 

 

1,750,000

 

 

 

$

5,750,000

 


 

 

 

The developed technology and other intangible assets have an estimated useful life of 9 – 10 years. The establishment of goodwill was primarily due to the expected revenue growth that is attributable to increased market penetration from future customers.

 

 

 

Pro Forma Information

 

 

 

The following unaudited pro forma summary combines the Company’s results with those of Escalon as if the acquisition had occurred at the beginning of each of the periods presented. This unaudited pro forma information is not intended to represent or be indicative of the Company’s consolidated results of operations or financial condition that would have been reported for the periods presented had the acquisition been completed at the beginning of each of the periods presented, and should not be taken as indicative of the Company’s future consolidated results of operations or financial condition:


 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months
Ended June 30,

 

Six Months
Ended June 30,

 

 

 

2010

 

2009

 

2010

 

2009

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenue

 

$

19,836,000

 

$

18,126,000

 

$

39,084,000

 

$

34,948,000

 

Net Income

 

 

1,552,000

 

 

1,457,000

 

 

5,061,000

 

 

2,446,000

 

Net income per share

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

0.09

 

$

0.09

 

$

0.31

 

$

0.15

 

Diluted

 

$

0.09

 

$

0.09

 

$

0.30

 

$

0.15

 


 

 

 

Certain pro forma adjustments have been made to reflect the impact of the purchase transaction, primarily consisting amortization of intangible assets with determinable lives and income taxes to reflect the Company’s effective tax rate for the periods presented.

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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,

 

 

 

2010

 

2009

 

 

 

Net
Revenue

 

Percent
Change

 

Net
Revenue

 

Percent
Change

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Catheter products

 

$

19,203,000

 

 

31

%

$

14,649,000

 

 

24

%

Hemostat products

 

 

12,608,000

 

 

2

%

 

12,301,000

 

 

3

%

Vein products

 

 

5,318,000

 

 

1

%

 

5,247,000

 

 

14

%

Total product revenue

 

$

37,129,000

 

 

15

%

$

32,197,000

 

 

13

%

License and collaboration

 

 

576,000

 

 

(26

%)

 

779,000

 

 

5

%

Total revenue

 

$

37,705,000

 

 

14

%

$

32,976,000

 

 

12

%


 

 

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

Executive Level Overview

          Vascular Solutions, Inc. (we, us or Vascular) is focused on bringing clinically advanced solutions to interventional cardiologists and interventional radiologists worldwide. As a vertically-integrated medical device company, we generate ideas, create new interventional medical devices, and then deliver these products to physicians through our direct domestic sales force and our international distribution network. We were incorporated in the state of Minnesota in December 1996, and began operations in February 1997. Our products are divided into three categories:

 

 

 

 

Catheter products, principally consisting of a variety of catheters used in specific clinical indications such as the Pronto® extraction catheters, Langston® dual lumen catheters and Minnie® support catheters, and also including products used in connection with percutaneous access to the vasculature such as micro-introudcer kits, guidewires and the Guardian® hemostasis valve,

 

 

 

 

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, and

 

 

 

 

Vein products, principally consisting of the Vari-Lase® endovenous laser, a laser console and procedure kit used for the treatment of varicose veins,

          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, we made the strategic decision to develop additional products. We have grown from net revenue of $6.2 million in 2000 to net revenue of $68.4 million in 2009. This increase in revenue represents a compound annual growth rate of 31% and is driven by our commitment to the research and development of multiple new devices to diagnose and treat existing and new vascular conditions.

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          The interventional medical device industry is characterized by intense competition, rapidly-evolving technology, and a high degree of government regulation. To grow our business, we have focused on continually developing and commercializing new products. Looking ahead, we expect our business may be impacted by the following trends and opportunities:

 

 

 

 

The future regulatory approval of newly-developed products. Any new products that we develop must be approved by the Food and Drug Administration in the United States and by similar regulatory bodies in other countries before they can be sold. The requirements for obtaining product approval have undergone change and are likely to continue to change. We monitor the changing regulatory landscape and modify our regulatory submissions as necessary to obtain product approvals.

 

 

 

 

Successfully integrating acquired products into our existing operations. The acquisition of products complementary to our existing product portfolio and customer call point provides an additional business opportunity, provided that we successfully integrate the acquired products into our existing business structure. As a first step in this process, in April 2010 we acquired the SMARTNEEDLE and pdACCESS Doppler guided needle products from Escalon (see Note 11 to the Unaudited Consolidated Financial Statements in Item 1 of Part I) and have recently begun to integrate these products into our operations.

 

 

 

 

Managing intellectual property. The interventional medical device industry is characterized by numerous patent filings and litigation claims made to protect new and evolving product ideas. To maximize the profitability of new product ideas, we seek patent protection for those product design and method concepts which we believe have the potential to provide substantial product revenue. We are involved in litigation with AngioDynamics, Inc., concerning our Vari-Lase product line (See “Legal Proceedings” In Item 1 of Part II of this Form 10-Q). Managing intellectual property assets and claims is an important challenge for our business.

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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
June 30,

 

Six Months Ended
June 30,

 

 

 

2010

 

2009

 

2010

 

2009

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

Product revenue

 

 

99

%

 

98

%

 

99

%

 

98

%

License and collaboration revenue

 

 

1

%

 

2

%

 

1

%

 

2

%

Total revenue

 

 

100

%

 

100

%

 

100

%

 

100

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product costs and operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of goods sold

 

 

33

%

 

34

%

 

33

%

 

34

%

Collaboration expenses

 

 

 

 

1

%

 

 

 

1

%

Research and development

 

 

12

%

 

11

%

 

13

%

 

11

%

Clinical and regulatory

 

 

5

%

 

4

%

 

4

%

 

4

%

Sales and marketing

 

 

30

%

 

31

%

 

31

%

 

32

%

General and administrative

 

 

7

%

 

6

%

 

7

%

 

7

%

Litigation

 

 

 

 

 

 

(9

%)

 

 

Amortization of purchased technology and intangibles

 

 

 

 

 

 

 

 

 

Total product costs and operating expenses

 

 

87

%

 

87

%

 

79

%

 

89

%

Operating income

 

 

13

%

 

13

%

 

21

%

 

11

%

Other income and expenses, net

 

 

 

 

 

 

 

 

 

Income before income taxes

 

 

13

%

 

13

%

 

21

%

 

11

%

Income taxes

 

 

5

%

 

5

%

 

8

%

 

4

%

Net income

 

 

8

%

 

8

%

 

13

%

 

7

%

Three and six months ended June 30, 2010, compared to three and six months ended June 30, 2009

          Net revenue increased 14% to $19,516,000 for the quarter ended June 30, 2010 from $17,166,000 for the quarter ended June 30, 2009. Net revenue related to the SMARTNEEDLE and pdACCESS products we acquired from Escalon was $847,000 for the quarter ended June 30, 2010 accounting for 36% of the overall revenue increase. The remaining new product introductions, which include any product with no sales in the comparable period in 2009, represented 36% of the overall increase in revenue for the quarter ended June 30, 2010. An increase in the volume of product sales also contributed to the increase in revenue, while product pricing did not have a material impact on the revenue increase for the quarter ended June 30, 2009. Approximately 86% of our net revenue was earned in the United States and 14% of our net revenue was earned in international markets for the quarter ended June 30, 2010, while approximately 88% of our net revenue was earned in the United States and 12% of our net revenue was earned in international markets for the quarter ended June 30, 2009. Net revenue increased 14% to $37,705,000 for the six months ended June 30, 2010 from $32,976,000 for the six months ended June 30, 2009. The increase in net revenue was a result of an increase in the volume of product sales and the introduction of new products. Net revenue related to the SMARTNEEDLE and pdACCESS products we acquired from Escalon was $847,000 for the six months ended June 30, 2010 accounting for 18% of the overall revenue increase. The remaining new product introductions represented 31% of the overall increase in revenue for the six months ended June 30, 2010. Product pricing did not have a material impact on the revenue increase for the six months ended June 30, 2010. Approximately 86% of our net revenue was earned in the United States and 14% of our net revenue was earned in international markets for the six months ended June 30, 2010, while approximately 87% of our net revenue was earned in the United States and 13% of our net revenue was earned in international markets for the six months ended June 30, 2009.

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          We recognized $212,000 and $424,000 of licensing revenue during the three and six month periods ending June 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 $42,000 and $173,000 of collaboration revenue during the three month periods ending June 30, 2010 and 2009, and $152,000 and $355,000 of collaboration revenue during the six month periods ending June 30, 2010, respectively, as a result of performing clinical and development work for King under the Device Supply Agreement.

          Gross margin across all product lines remained constant at 66% for the quarter ended June 30, 2010, compared to 66% for the quarter ended June 30, 2009. We expect product gross margins to be in the range of 65% to 67% for the remainder 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 six months ended June 30, 2010 compared to 66% for the six months ended June 30, 2009.

          Research and development expense for the second quarter of 2010 totaled $2,266,000, or 12% of revenue, compared to $1,803,000, or 11% of revenue, for the second quarter of 2009. Research and development expense for the six month period ending June 30, 2010 totaled $4,730,000, or 13% of revenue, compared to $3,719,000, or 11% of revenue, for the six month period ending June 30, 2009. We expect our continuing research and development expenses to be approximately 10% to 11% of revenue for the remainder 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 second quarter of 2010 totaled $888,000, or 5% of revenue, compared to $767,000, or 4% of revenue, for the second quarter of 2009. Clinical and regulatory expense for the six month period ending June 30, 2010 totaled $1,595,000, or 4% of revenue, compared to $1,379,000, or 4% of revenue, for the six month period ending June 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 for the remainder of 2010.

          Sales and marketing expense for the second quarter of 2010 totaled $5,910,000, or 30% of revenue, compared to $5,307,000, or 31% of revenue, for the second quarter of 2009. Sales and marketing expense for the six month period ending June 30, 2010 totaled $11,513,000, or 31% of revenue, compared to $10,560,000, or 32% of revenue, for the six month period ending June 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 through-out 2010. As a result, we expect our sales and marketing expenses will continue to decline as a percentage of revenue to between 27% and 29% of revenue by the end of 2010.

          General and administrative expense for the second quarter of 2010 totaled $1,405,000, or 7% of revenue, compared to $1,104,000, or 6% of revenue, for the second quarter of 2009. General and administrative expense for the six month period ending June 30, 2010 totaled $2,712,000, or 7% of revenue, compared to $2,223,000, or 7% of revenue, for the six month period ending June 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 for the remainder of 2010.

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          Litigation income for the six months ended June 30, 2010 was $3,529,000, or 9% 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 $59,000 for the three and six months ended June 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 decreased to $10,000 and $20,000 for the second quarter and six month period ending June 30, 2010 compared to $14,000 and $37,000 for the second quarter and six month period ending June 30, 2009. The decrease in interest income 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 $10,000 for the second quarter and six month period ending June 30, 2010 compared to $11,000 and $20,000 for the second quarter and six month period ending June 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 loss was $35,000 for the quarter ending June 30, 2010 compared to a foreign exchange gain of $7,000 for the quarter ending June 30, 2009. Foreign exchange loss was $58,000 for the six months ended June 30, 2010 compared to $5,000 for the six months ended June 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 in the second quarter of 2010.

          Income tax expense increased to $931,000 and $3,027,000 for the three month and six month periods ending June 30, 2010 on income before tax of $2,406,000 and $7,968,000 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 and six months ended June 30, 2009, income tax expense was $871,000 and $1,448,000 on income before tax of $2,257,000 and $3,772,000, resulting in an effective income tax rate of 38%.

Liquidity and Capital Resources

          Our cash and cash equivalents totaled $18,227,000 at June 30, 2010 compared to $17,794,000 in cash and cash equivalents at December 31, 2009, an increase of $433,000. 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.

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          Cash provided by operations. We generated $7,010,000 of cash from operations for the six months ended June 30, 2010. The cash generated in the six months ended June 30, 2010 primarily resulted from our income before taxes of $7,968,000 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 expect our inventory to increase at our sales growth rate for the remainder of 2010.

          Cash used for investing activities. We used $6,307,000 of cash in investing activities for the six months ended June 30, 2010. We incurred capital expenditures of $1,307,000 relating to purchasing additional manufacturing equipment, expanding our clean room manufacturing area and purchasing additional research and development equipment. We also used $5,000,000 of cash in the purchase of the SMARTNEEDLE and pdACCESS products from Escalon.

          Cash provided by financing activities. We used $270,000 of cash in financing activities for the six months ended June 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 $387,000 of cash to repurchase 48,212 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 $844,000 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 June 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.

          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 $37.4 million at June 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 June 30, 2010.

Contractual Obligations

          The following table summarizes our contractual cash commitments as of June 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

 

$

4,306,000

 

$

785,000

 

$

1,628,000

 

$

1,683,000

 

$

210,000

 

          We do not have any other significant cash commitments related to supply agreements, nor do we have any significant commitments for capital expenditures.

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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.”

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.

 

 

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.

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          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 $20,000 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 $16,000 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.

          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 June 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 $18,000 on an annual basis.

 

 

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 June 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.

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PART II. OTHER INFORMATION

 

 

Item 1.

Legal Proceedings

          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

          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.

 

 

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

          Purchase of Equity Securities by the Issuer and Affiliated Purchasers:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Period

 

Total Number
of Shares
Purchased

 

Average
Price Paid
per Share

 

Total Number of
Shares Purchased
as Part of a Publicly
Announced Plans or
Programs(1)

 

Maximum Number of
Shares that May Yet be
Purchased Under the
Plans or Programs

 

April 1 – 30, 2010

 

 

38,277

 

$

9.63

 

 

38,277

 

 

895,616

 

May 1 – 31, 2010

 

 

18,925

 

$

10.04

 

 

18,925

 

 

876,691

 

June 1 – 30, 2010

 

 

 

 

 

 

 

 

876,691

 


 

 

 

(1) On January 29, 2010, our Board of Directors approved a Common Stock Repurchase Plan (the “Repurchase Plan”), whereby we have the option to repurchase up to a maximum of 1,000,000 shares of our common stock on the open market at the current market price. The Repurchase Plan expires on December 31, 2010.


 

 

Item 3.

Defaults Upon Senior Securities

          None.

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Item 4.

(Removed and Reserved)

 

 

Item 5.

Other Information

 

 

          None.

 

 

Item 6.

Exhibits


 

 

 

 

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 April 30, 2010 by and between Vascular Solutions and Escalon Vascular Access, Inc.

10.2

 

Asset Purchase Agreement dated April 30, 2010 by and between Vascular Solutions and Escalon Vascular IP Holdings, Inc.

10.3

 

Manufacturing and Supply Agreement dated April 30, 2010 by and between Vascular Solutions and Escalon Vascular Access, Inc.

10.4

 

Guarantee dated April 30, 2010, delivered by Escalon Medical Corp. for the benefit of Vascular Solutions, Inc.

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: July 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)

Page 24


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