Table of Contents

 

 

 

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

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   0-18592

 

MERIT MEDICAL SYSTEMS, INC.

(Exact name of Registrant as specified in its charter)

 

Utah

 

87-0447695

(State or other jurisdiction of incorporation or organization)

 

(I.R.S. Identification No.)

 

1600 West Merit Parkway, South Jordan, UT, 84095

(Address of Principal Executive Offices, including Zip Code)

 

(801) 253-1600

(Registrant’s telephone number, including area code)

 

Indicate by check mark whether the Registrant: (1) has filed all reports required to be filed by Sections 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 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, or a non-accelerated filer. See definition 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

 

Indicate the number of shares outstanding of each of the Registrant’s classes of common stock, as of the latest practicable date.

 

Common Stock

 

28,217,846

Title or class

 

Number of Shares

 

 

Outstanding at August 3, 2010

 

 

 



Table of Contents

 

MERIT MEDICAL SYSTEMS, INC.

 

INDEX TO FORM 10-Q

 

 

 

 

PAGE

PART I.

FINANCIAL INFORMATION

 

 

 

 

 

 

Item 1.

Financial Statements

 

 

 

 

 

 

 

Consolidated Balance Sheets as of June 30, 2010 and December 31, 2009

 

1

 

 

 

 

 

Consolidated Statements of Operations for the three and six months ended June 30, 2010 and 2009

 

3

 

 

 

 

 

Consolidated Statements of Cash Flows for the six months ended June 30, 2010 and 2009

 

4

 

 

 

 

 

Condensed Notes to Consolidated Financial Statements

 

6

 

 

 

 

Item 2.

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

 

12

 

 

 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

 

17

 

 

 

 

Item 4.

Controls and Procedures

 

17

 

 

 

 

PART II.

OTHER INFORMATION

 

 

 

 

 

 

Item 1. Legal Proceedings

 

18

 

 

 

Item 1A. Risk Factors

 

18

 

 

 

Item 6. Exhibits

 

18

 

 

 

SIGNATURES

 

19

 



Table of Contents

 

Part I - FINANCIAL INFORMATION

 

ITEM 1.  FINANCIAL STATEMENTS

 

MERIT MEDICAL SYSTEMS, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

JUNE 30, 2010 AND DECEMBER 31, 2009

(In thousands - unaudited)

 

 

 

June 30,

 

December 31,

 

 

 

2010

 

2009

 

ASSETS

 

 

 

 

 

 

 

 

 

 

 

CURRENT ASSETS:

 

 

 

 

 

Cash and cash equivalents

 

$

4,254

 

$

6,133

 

Trade receivables - net of allowances of $599 and $541, respectively

 

37,010

 

30,954

 

Employee receivables

 

145

 

145

 

Other receivables

 

447

 

827

 

Inventories

 

47,219

 

47,170

 

Prepaid expenses and other assets

 

3,047

 

1,801

 

Deferred income tax assets

 

3,289

 

3,289

 

Income tax refunds receivable

 

177

 

295

 

 

 

 

 

 

 

Total current assets

 

95,588

 

90,614

 

 

 

 

 

 

 

PROPERTY AND EQUIPMENT:

 

 

 

 

 

Land and land improvements

 

10,932

 

9,777

 

Building

 

49,768

 

50,040

 

Manufacturing equipment

 

83,997

 

77,069

 

Furniture and fixtures

 

17,215

 

15,586

 

Leasehold improvements

 

11,870

 

10,280

 

Construction-in-progress

 

11,609

 

13,968

 

 

 

 

 

 

 

Total

 

185,391

 

176,720

 

Less accumulated depreciation

 

(67,319

)

(62,074

)

 

 

 

 

 

 

Property and equipment—net

 

118,072

 

114,646

 

 

 

 

 

 

 

OTHER ASSETS:

 

 

 

 

 

Other intangibles - net of accumulated amortization of $6,782 and $5,450, respectively

 

26,958

 

26,898

 

Goodwill

 

33,002

 

33,002

 

Other assets

 

6,592

 

6,353

 

 

 

 

 

 

 

Total other assets

 

66,552

 

66,253

 

 

 

 

 

 

 

TOTAL ASSETS

 

$

280,212

 

$

271,513

 

 

See notes to consolidated financial statements.

 

(Continued)

 

1



Table of Contents

 

MERIT MEDICAL SYSTEMS, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

JUNE 30, 2010 AND DECEMBER 31, 2009

(In thousands - unaudited)

 

 

 

June 30,

 

December 31,

 

 

 

2010

 

2009

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

 

 

 

CURRENT LIABILITIES:

 

 

 

 

 

Trade payables

 

$

13,456

 

$

13,352

 

Accrued expenses

 

14,309

 

12,196

 

Line of credit

 

 

 

7,000

 

Advances from employees

 

645

 

212

 

Income taxes payable

 

2,246

 

148

 

 

 

 

 

 

 

Total current liabilities

 

30,656

 

32,908

 

 

 

 

 

 

 

DEFERRED INCOME TAX LIABILITIES

 

11,068

 

11,251

 

 

 

 

 

 

 

LIABILITIES RELATED TO UNRECOGNIZED TAX BENEFITS

 

2,945

 

2,945

 

 

 

 

 

 

 

DEFERRED COMPENSATION PAYABLE

 

3,417

 

3,382

 

 

 

 

 

 

 

DEFERRED CREDITS

 

1,817

 

1,874

 

 

 

 

 

 

 

OTHER LONG-TERM OBLIGATIONS

 

263

 

344

 

 

 

 

 

 

 

Total liabilities

 

50,166

 

52,704

 

 

 

 

 

 

 

STOCKHOLDERS’ EQUITY:

 

 

 

 

 

Preferred stock—5,000 shares authorized as of June 30, 2010 and December 31, 2009; no shares issued

 

 

 

 

 

Common stock—no par value; 100,000 shares authorized; 28,205 and 28,181 shares issued at June 30, 2010 and December 31 2009, respectively

 

64,724

 

63,690

 

Retained earnings

 

165,427

 

155,204

 

Accumulated other comprehensive loss

 

(105

)

(85

)

 

 

 

 

 

 

Total stockholders’ equity

 

230,046

 

218,809

 

 

 

 

 

 

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

 

$

280,212

 

$

271,513

 

 

See notes to consolidated financial statements.

 

(Concluded)

 

2



Table of Contents

 

MERIT MEDICAL SYSTEMS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2010 AND 2009

(In thousands, except per common share - unaudited)

 

 

 

Three Months Ended

 

Six Months Ended

 

 

 

June 30,

 

June 30,

 

 

 

2010

 

2009

 

2010

 

2009

 

 

 

 

 

 

 

 

 

 

 

NET SALES

 

$

74,948

 

$

64,837

 

$

142,380

 

$

123,208

 

 

 

 

 

 

 

 

 

 

 

COST OF SALES

 

42,490

 

36,694

 

81,487

 

70,257

 

 

 

 

 

 

 

 

 

 

 

GROSS PROFIT

 

32,458

 

28,143

 

60,893

 

52,951

 

 

 

 

 

 

 

 

 

 

 

OPERATING EXPENSES:

 

 

 

 

 

 

 

 

 

Selling, general, and administrative

 

19,939

 

16,287

 

38,971

 

31,116

 

Research and development

 

3,742

 

2,893

 

6,799

 

4,972

 

 

 

 

 

 

 

 

 

 

 

Total operating expenses

 

23,681

 

19,180

 

45,770

 

36,088

 

 

 

 

 

 

 

 

 

 

 

INCOME FROM OPERATIONS

 

8,777

 

8,963

 

15,123

 

16,863

 

 

 

 

 

 

 

 

 

 

 

OTHER INCOME (EXPENSE):

 

 

 

 

 

 

 

 

 

Interest income

 

12

 

28

 

20

 

150

 

Other income (expense)

 

50

 

(6

)

26

 

46

 

 

 

 

 

 

 

 

 

 

 

Other income - net

 

62

 

22

 

46

 

196

 

 

 

 

 

 

 

 

 

 

 

INCOME BEFORE INCOME TAXES

 

8,839

 

8,985

 

15,169

 

17,059

 

 

 

 

 

 

 

 

 

 

 

INCOME TAX EXPENSE

 

3,124

 

3,144

 

4,946

 

5,681

 

 

 

 

 

 

 

 

 

 

 

NET INCOME

 

$

5,715

 

$

5,841

 

$

10,223

 

$

11,378

 

 

 

 

 

 

 

 

 

 

 

EARNINGS PER COMMON SHARE:

 

 

 

 

 

 

 

 

 

Basic

 

$

.20

 

$

.21

 

$

.36

 

$

.41

 

Diluted

 

$

.20

 

$

.21

 

$

.36

 

$

.40

 

 

 

 

 

 

 

 

 

 

 

AVERAGE COMMON SHARES:

 

 

 

 

 

 

 

 

 

Basic

 

28,194

 

27,924

 

28,184

 

27,990

 

Diluted

 

28,729

 

28,427

 

28,740

 

28,487

 

 

See notes to consolidated financial statements.

 

3



Table of Contents

 

MERIT MEDICAL SYSTEMS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

FOR THE SIX MONTHS ENDED JUNE 30, 2010 AND 2009

(In thousands - unaudited)

 

 

 

Six Months Ended

 

 

 

June 30,

 

 

 

2010

 

2009

 

 

 

 

 

 

 

CASH FLOWS FROM OPERATING ACTIVITIES:

 

 

 

 

 

Net income

 

$

10,223

 

$

11,378

 

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

 

 

 

 

 

Depreciation and amortization

 

6,673

 

5,710

 

Losses on sales and/or abandonment of property and equipment

 

280

 

201

 

Write-off of certain patents and trademarks

 

24

 

72

 

Amortization of deferred credits

 

(57

)

(63

)

Purchase of trading investments

 

(291

)

(221

)

Net unrealized (gains)/losses on trading investments

 

76

 

(185

)

Deferred income taxes

 

(17

)

 

 

Stock-based compensation

 

606

 

575

 

Tax benefit attritutable to appreciation of common stock options exercised

 

(49

)

(422

)

Changes in operating assets and liabilities net of effects from acquisitions:

 

 

 

 

 

Trade receivables

 

(6,618

)

(1,662

)

Employee receivables

 

(11

)

(11

)

Other receivables

 

344

 

344

 

Inventories

 

(49

)

(5,725

)

Prepaid expenses and other assets

 

(1,282

)

(731

)

Income tax refund receivable

 

119

 

(41

)

Deposits

 

 

 

(18

)

Trade payables

 

345

 

3,509

 

Accrued expenses

 

1,968

 

1,656

 

Advances from employees

 

454

 

210

 

Income taxes payable

 

2,190

 

2,212

 

Deferred compensation payable

 

36

 

388

 

Other long-term assets

 

(25

)

 

 

Other long-term obligations

 

(78

)

(1

)

 

 

 

 

 

 

Total adjustments

 

4,638

 

5,797

 

 

 

 

 

 

 

Net cash provided by operating activities

 

14,861

 

17,175

 

 

 

 

 

 

 

CASH FLOWS FROM INVESTING ACTIVITIES:

 

 

 

 

 

Capital expenditures for:

 

 

 

 

 

Property and equipment

 

(8,764

)

(8,358

)

Patents and trademarks

 

(545

)

(782

)

Proceeds from the sale of property and equipment

 

10

 

15

 

Cash paid in acquisitions

 

(500

)

(35,241

)

 

 

 

 

 

 

Net cash used in investing activities

 

(9,799

)

(44,366

)

 

See notes to consolidated financial statements.

 

(Continued)

 

4



Table of Contents

 

MERIT MEDICAL SYSTEMS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

FOR THE SIX MONTHS ENDED JUNE 30, 2010 AND 2009

(In thousands - unaudited)

 

 

 

Six Months Ended

 

 

 

June 30,

 

 

 

2010

 

2009

 

 

 

 

 

 

 

CASH FLOWS FROM FINANCING ACTIVITIES:

 

 

 

 

 

Proceeds from issuance of common stock

 

$

379

 

$

385

 

Additions to long-term debt

 

1,500

 

10,000

 

Payments on long-term debt

 

(8,500

)

(10,000

)

Payment of taxes related to an exchange of common stock

 

 

 

(254

)

Common stock repurchased and retired

 

 

 

(2,474

)

Excess tax benefits from stock-based compensation

 

49

 

422

 

 

 

 

 

 

 

Net cash used in financing activities

 

(6,572

)

(1,921

)

 

 

 

 

 

 

EFFECT OF EXCHANGE RATES ON CASH

 

(369

)

(45

)

 

 

 

 

 

 

NET DECREASE IN CASH AND CASH EQUIVALENTS

 

(1,879

)

(29,157

)

 

 

 

 

 

 

CASH AND CASH EQUIVALENTS:

 

 

 

 

 

Beginning of period

 

6,133

 

34,030

 

 

 

 

 

 

 

End of period

 

$

4,254

 

$

4,873

 

 

 

 

 

 

 

SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION—Cash paid during the period for:

 

 

 

 

 

Interest

 

$

47

 

$

11

 

 

 

 

 

 

 

Income taxes

 

$

2,848

 

$

3,526

 

 

 

 

 

 

 

SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES

 

 

 

 

 

Property and equipment purchases in accounts payable

 

$

1,869

 

$

1,576

 

 

During the six months ended June 30, 2009, 23,829 shares of the Company’s common stock were surrendered in exchange for the Company’s recording of payroll tax liabilities in the amount of approximately $254,000, related to the exercise of stock options.  The shares were valued based upon the closing price of the Company’s common stock on the surrender date.

 

During the six months ended June 30, 2009, 21,556 shares of the Company’s common stock, with a  value of approximately $230,000 were surrendered in exchange for the exercise of stock options.

 

See notes to consolidated financial statements.

 

(Concluded)

 

5



Table of Contents

 

MERIT MEDICAL SYSTEMS, INC. AND SUBSIDIARIES

CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

 

1Basis of Presentation. The interim consolidated financial statements of Merit Medical Systems, Inc. (“Merit,” “we” or “us”) for the three and six-month periods ended June 30, 2010 and 2009 are not audited. Our consolidated financial statements are prepared in accordance with the requirements for unaudited interim periods, and consequently, do not include all disclosures required to be made in conformity with accounting principles generally accepted in the United States of America. In the opinion of management, the accompanying consolidated financial statements contain all adjustments, consisting of normal recurring accruals, necessary for a fair presentation of our financial position as of June 30, 2010, and our results of operations and cash flows for the three and six-month periods ended June 30, 2010 and 2009. The results of operations for the three and six-month periods ended June 30, 2010 are not necessarily indicative of the results for a full-year period.  These interim consolidated financial statements should be read in conjunction with the financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2009 filed with the Securities and Exchange Commission (the “SEC”).

 

2.   Inventories. Inventories are stated at the lower of cost or market.  Inventories at June 30, 2010 and December 31, 2009 consisted of the following (in thousands):

 

 

 

June 30,

 

December 31,

 

 

 

2010

 

2009

 

Finished goods

 

$

20,962

 

$

24,502

 

Work-in-process

 

8,449

 

5,542

 

Raw materials

 

17,808

 

17,126

 

 

 

 

 

 

 

Total

 

$

47,219

 

$

47,170

 

 

 

3.   Reporting Comprehensive Income.  Comprehensive income for the three and six-month periods ended June 30, 2010 and 2009 consisted of net income and foreign currency translation adjustments.  As of  June 30, 2010 and December 31, 2009, the cumulative effect of such adjustments decreased stockholders’ equity by approximately $105,000 and approximately $85,000, respectively.  Comprehensive income for the three and six-month periods ended June 30, 2010 and 2009 has been computed as follows (in thousands):

 

 

 

Three Months Ended

 

Six Months Ended

 

 

 

June 30,

 

June 30,

 

 

 

2010

 

2009

 

2010

 

2009

 

Net income

 

$

5,715

 

$

5,841

 

$

10,223

 

$

11,378

 

Foreign currency translation

 

8

 

62

 

(20

)

(7

)

Comprehensive income

 

$

5,723

 

$

5,903

 

$

10,203

 

$

11,371

 

 

6



Table of Contents

 

4. Stock-based Compensation.  Stock-based compensation expense for the three and six-month periods ended June 30, 2010 and 2009 has been categorized as follows (in thousands):

 

 

 

Three Months Ended

 

Six Months Ended

 

 

 

June 30,

 

June 30,

 

 

 

2010

 

2009

 

2010

 

2009

 

Cost of sales

 

$

45

 

$

43

 

$

96

 

$

93

 

Research and development

 

15

 

14

 

29

 

27

 

Selling, general and administrative

 

242

 

220

 

481

 

455

 

Stock-based compensation

 

$

302

 

$

277

 

$

606

 

$

575

 

 

The excess income tax benefit created from the exercises of stock options was  $49,000 and $49,000 for the three and six-month periods ended June 30, 2010, respectively, when compared to $50,000 and $422,000 for the three and six-month periods ended June 30, 2009, respectively.  As of June 30, 2010, the total remaining unrecognized compensation cost related to non-vested stock options, net of forfeitures, was approximately $4.0 million and is expected to be recognized over a weighted average period of 3.25 years. During the six month period ended June 30, 2010, there were 100,000 stock award grants and during the six months ended June 30, 2009, there were no stock awards.  We use the Black-Scholes methodology to value the stock-based compensation expense for options.  In applying the Black-Scholes methodology to the option grants, we used the following assumptions:

 

 

 

Six Months

 

 

 

Ended June 30,

 

 

 

2010

 

2009

 

Risk-free interest rate

 

2.24

%

N/A

 

Expected option life

 

6.0

 

N/A

 

Expected price volatility

 

41.40

%

N/A

 

 

For the purpose of determining stock compensation for options, we estimate the average risk-free interest rate using the U.S. Treasury rate in effect as of the date of grant, based on the expected term of the stock option.  We estimate the expected term of the stock options using the historical exercise behavior of our employees.  We estimate the expected price volatility using a weighted average of daily historical volatility of our stock price over the corresponding expected option life and implied volatility based on recent trends of the daily historical volatility.

 

7



Table of Contents

 

5. Shares Used in Computing Net Income Per Share. The following table sets forth the computation of the number of shares used in calculating basic and diluted net income  per share  (in thousands, except per share amounts):

 

 

 

Three Months

 

Six Months

 

 

 

Net

 

 

 

Per Share

 

Net

 

 

 

Per Share

 

 

 

Income

 

Shares

 

Amount

 

Income

 

Shares

 

Amount

 

Period ended June 30, 2010:

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic EPS

 

$

5,715

 

28,194

 

$

0.20

 

$

10,223

 

28,184

 

$

0.36

 

Effect of dilutive stock options and warrants

 

 

 

535

 

 

 

 

 

556

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Diluted EPS

 

$

5,715

 

28,729

 

$

0.20

 

$

10,223

 

28,740

 

$

0.36

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted-average shares under stock options excluded from the calculation of common stock equivalents as the impact was antidilutive

 

 

 

1,063

 

 

 

 

 

1,056

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Period ended June 30, 2009:

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic EPS

 

$

5,841

 

27,924

 

$

0.21

 

$

11,378

 

27,990

 

$

0.41

 

Effect of dilutive stock options and warrants

 

 

 

503

 

 

 

 

 

497

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Diluted EPS

 

$

5,841

 

28,427

 

$

0.21

 

$

11,378

 

28,487

 

$

0.40

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted-average shares under stock options excluded from the calculation of common stock equivalents as the impact was antidilutive

 

 

 

1,360

 

 

 

 

 

1,692

 

 

 

 

6. Acquisitions.   On May 13, 2010, we signed a definitive merger agreement to acquire all of the outstanding shares of  BioSphere Medical, Inc. (“Biosphere”)  in an all cash transaction valued at approximately $96 million, inclusive of all common equity and Series A Preferred preferences.  BioSphere develops and markets embolotherapeutic products for the treatment of uterine fibroids, hypervascularized tumors and arteriovenous malformations.  We anticipate that the proposed acquisition of BioSphere, if completed, will give us a platform technology applicable to multiple therapeutic areas with significant market potential while leveraging existing interventional radiology call points.  Two immediate applications for the embolotherapy are uterine fibroids and primary liver cancer.  On May 12, 2010, we secured a commitment for a five-year senior unsecured revolving credit facility of up to $125 million.  The commitment of the prospective lenders to provide the credit facility is subject to a number of customary conditions, including the negotiation and execution of definitive transaction documents.  The proposed merger remains subject to other customary closing conditions, including the approval of BioSphere’s stockholders.  It is anticipated that the transaction will close during the third calendar quarter of 2010.

 

On February 19, 2010, we entered into a manufacturing and technology license agreement with a medical device manufacturer for certain medical products.  We made an initial payment of $250,000 in February of 2010, a second payment of $250,000 in May of 2010 and have accrued an additional $500,000 in accrued expenses.  The additional payments are payable upon reaching certain milestones set forth in the agreement.  We believe there is a reasonable likelihood that we will be required to make those payments.  We have included the $1.0 million intangible asset in license agreements and intend to amortize the asset over an estimated life of 10 years.

 

On June 2, 2009, we entered into an asset purchase agreement with Hatch Medical, L.L.C., a Georgia limited liability corporation (“Hatch”), to purchase the EN Snare® foreign body retrieval system.  We paid $14 million in June 2009 and an additional $7 million on December 31, 2009.  Our financial statements for the three and six-month periods ended June 30, 2009 reflect royalty income subsequent to the acquisition date of approximately $143,000 and  net income of approximately $43,000, related to the Hatch  acquisition.  The purchase price was allocated as follows (in thousands):

 

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Assets Acquired

 

 

 

Intangibles

 

 

 

Developed technology

 

$

8,100

 

Customer list

 

590

 

Non-compete

 

240

 

Trademark

 

650

 

Goodwill

 

11,420

 

Total assets acquried

 

21,000

 

 

 

 

 

Liabilities Assumed

 

None

 

 

 

 

 

Net assets acquired

 

$

21,000

 

 

With respect to the assets we acquired from Hatch, we intend to amortize developed technology over 11 years and non-compete covenant over seven years.  While U.S. trademarks can be renewed indefinitely, we currently estimate that we will generate cash flow from the acquired trademarks for a period of 15 years from the acquisition date.

 

On March 9, 2009, we entered into an asset purchase agreement with Alveolus, Inc., a North Carolina corporation (“Alveolus”), to purchase their non-vascular interventional stents used for esophageal, tracheobronchial, and biliary stenting procedures.  We paid Alveolus $19.1 million in March 2009.  The gross amount of trade receivables we acquired from Alveolus was approximately $1.0 million, of which $49,000 is expected to be uncollectible.  Our consolidated financial statements for the three and six-month periods ended June 30, 2009 reflect sales subsequent to the acquisition date of approximately $1.8 million and $2.3 million, respectively, and a net loss of approximately $780,000 and $1.0 million (includes approximately $220,000 net of tax in legal and accounting costs incurred in the first quarter of 2009), respectively, related to our Alveolus acquisition.  The purchase price was allocated as follows (in thousands):

 

Assets Acquired

 

 

 

Inventories

 

$

1,741

 

Trade receivables

 

974

 

Other assets

 

241

 

Property and equipment

 

547

 

Intangibles

 

 

 

Developed technology

 

5,700

 

Trademarks

 

1,400

 

Customer lists

 

1,100

 

In-process research and development

 

400

 

Goodwill

 

8,028

 

Total assets acquired

 

20,131

 

 

 

 

 

Liabilities Assumed

 

 

 

Accounts payable

 

467

 

Other liabilities

 

572

 

Total liabilities assumed

 

1,039

 

 

 

 

 

Net assets acquired

 

$

19,092

 

 

With respect to the assets we acquired from Alveolus, we intend to amortize the developed technology and trademarks over 15 years and customer lists on an accelerated basis over seven years.  We intend to amortize the in-process research and development over 15 years, which will begin if the resulting product is successfully launched in the market.  The acquired trademarks are scheduled for renewal in 4.03 years (based on a weighted-average calculation, from June 30, 2009 until the trademark renewal date).  While U.S. trademarks can be renewed indefinitely, we currently estimate that we will generate cash flow from the acquired trademarks for a period of 15 years from the acquisition date.

 

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On March 3, 2009, we paid $500,000 to GMA Company, Ltd (“GMA”) representing the final payment due on our distribution agreement.  The total amount paid to GMA under this agreement was approximately $2.0 million and was allocated as a distribution agreement.  We anticipate that the distribution agreement will be amortized over an estimated life of 11 years.

 

On February 19, 2009, we entered into an asset purchase and supply agreement with Biosearch Medical Products, Inc., a wholly-owned subsidiary of Hydromer, Inc., a New Jersey corporation (“Biosearch”), to purchase a bipolar coagulation probe and grafted biliary stents.  We paid $1.1 million in February 2009 and paid an additional $500,000 in June 2009.  Our consolidated financial statements for the three and six-month periods ended June 30, 2009 reflect sales subsequent to the acquisition date of approximately $366,000 and $499,000, respectively, and net income of approximately $60,000 and $90,000, respectively, related to the Biosearch acquisition.  The purchase price was allocated as follows (in thousands):

 

Assets Acquired

 

 

 

Inventories

 

$

188

 

Property and equipment

 

31

 

Intangibles

 

 

 

Developed technology

 

380

 

Customer lists

 

660

 

Non-compete

 

25

 

Goodwill

 

316

 

Total assets acquired

 

1,600

 

 

 

 

 

Liabilities Assumed

 

None

 

 

 

 

 

Net assets acquired

 

$

1,600

 

 

With respect to the assets we acquired from Biosearch, we intend to amortize developed technology over 15 years, customer lists on an accelerated basis over eight years and a non-compete covenant over seven years.

 

The goodwill arising from the acquisitions discussed above consists largely of the synergies and economies of scale we hope to achieve from combining the acquired assets and operations with our historical operations.  The goodwill recognized from these acquisitions is expected to be deductible for income tax purposes.

 

The following table summarizes our unaudited consolidated result of operations for the three and six-month periods ended June 30, 2009, as well as the unaudited pro forma consolidated results of operations as though the Hatch, Alveolus and Biosearch acquisitions had occurred on January 1, 2009:

 

 

 

Three Months Ended

 

Six Months Ended

 

 

 

June 30, 2009

 

June 30, 2009

 

 

 

As Reported

 

Pro Forma

 

As Reported

 

Pro Forma

 

 

 

 

 

 

 

 

 

 

 

Sales

 

$

64,837

 

$

65,091

 

$

123,208

 

$

125,660

 

Net income

 

5,841

 

5,912

 

11,378

 

11,318

 

Earnings per common share:

 

 

 

 

 

 

 

 

 

Basic

 

$

.21

 

$

.21

 

$

.41

 

$

.40

 

Diluted

 

$

.21

 

$

.21

 

$

.40

 

$

.40

 

 

The unaudited pro forma condensed consolidated income statements are for informational purposes only and should not be considered indicative of actual results that would have been achieved if the Hatch, Alveolus and Biosearch acquisitions had been completed at the beginning of 2009, or results that may be obtained in any future period.

 

7. Recent Accounting Pronouncements. In January 2010, the Financial Accounting Standards Board (“FASB”) issued additional guidance on fair value disclosures. The new guidance clarifies two existing disclosure requirements and requires two new disclosures as follows: (1) a “gross” presentation of activities (purchases, sales, and settlements) within the Level 3 rollforward reconciliation, which will replace the “net” presentation format;

 

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and (2) detailed disclosures about the transfers in and out of Level 1 and 2 measurements. This guidance is effective for the first interim or annual reporting period beginning after December 15, 2009, except for the gross presentation of the Level 3 rollforward information, which is required for annual reporting periods beginning after December 15, 2010, and for interim reporting periods within those years. We adopted the fair value disclosure guidance on January 1, 2010, except for the gross presentation of the Level 3 rollforward information which we are not required to adopt until January 1, 2011.  The adoption of this guidance did not have a material effect on our consolidated financial statements for the three and six-month periods ended June 30, 2010.

 

In October 2009, the FASB issued Accounting Standards Update (“ASU”) 2009-13, Revenue Recognition (Topic 605): Multiple Deliverable Revenue Arrangements — A Consensus of the FASB Emerging Issues Task Force.  This update provides application guidance on whether multiple deliverables exist, how the deliverables should be separated and how the consideration should be allocated to one or more units of accounting.  This update establishes a selling price hierarchy for determining the selling price of a deliverable.  The selling price used for each deliverable will be based on vendor-specific objective evidence, if available, third-party evidence if vendor-specific objective evidence is not available, or estimated selling price if neither vendor-specific or third-party evidence is available.  We will be required to apply this guidance prospectively for revenue arrangements entered into or materially modified after January 1, 2011; however, earlier application is permitted.  We do not expect the adoption of this guidance to have a material effect on our consolidated financial statements.

 

8.  Income Taxes.  Our effective tax rate for the three months ended June 30, 2010 was 35.3%, relatively unchanged compared to 35.0% for the corresponding period of 2009.  For the six months ended June 30, 2010, our effective tax rate was 32.6%, compared to 33.3% for the comparable period of 2009.  The decrease in the effective tax rate for the six-month period ended June 30, 2010, when compared to the corresponding period of 2009, was primarily related to the profitability of our Irish operations which are taxed at a lower tax rate than our U.S. and other foreign operations.

 

9.   Fair Value MeasurementsThe fair value of a financial instrument is the amount that could be received upon the sale of an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date.  Financial assets are marked to bid prices and financial liabilities are marked to offer prices.  Fair value measurements do not include transaction costs.  A fair value hierarchy is used to prioritize the quality and reliability of the information used to determine fair values.  Categorization within the fair value hierarchy is based on the lowest level of input that is significant to the fair value measurement.  The fair value hierarchy is defined into the following three categories:

 

Level 1: Quoted market prices in active markets for identical assets or liabilities.

Level 2: Observable market based inputs or unobservable inputs that are corroborated by market data.

Level 3: Unobservable inputs that are not corroborated by market

 

The following table provides our financial assets and liabilities carried at fair value measured on a recurring basis as of June 30, 2010 (in thousands):

 

 

 

 

 

Fair Value Measurements Using

 

 

 

Total Fair

 

Quoted prices in

 

Significant other

 

Significant

 

 

 

Value at

 

active markets

 

observable inputs

 

Unobservable inputs

 

Description

 

June 30, 2010

 

(Level 1)

 

(Level 2)

 

(Level 3)

 

 

 

 

 

 

 

 

 

 

 

Deferred compensation assets (1)

 

$

3,559

 

 

 

$

3,559

 

 

 

 


(1)          The deferred compensation investments are held in a Rabbi trust under an insurance-based deferred compensation plan.  The investments of the Rabbi trust are valued based upon unit values multiplied by the number of units held.  The unit value is based upon the investment’s net asset value adjusted for some administrative fees.

 

During the six months ended June 30, 2010, we had a write-off of approximately $24,000 related to the measurement of non-financial assets at fair value on a nonrecurring basis subsequent to their initial recognition.

 

The carrying amount of cash and equivalents, receivables and trade payables approximates fair value.

 

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10.   Goodwill and Intangible Assets.   There were no changes in the carrying amount of goodwill for the six months ended June 30, 2010.  Intangible assets at June 30, 2010 and December 31, 2009, consisted of the following (in thousands):

 

 

 

Jun 30, 2010

 

December 31, 2009

 

 

 

Gross

 

 

 

Net

 

Gross

 

 

 

Net

 

 

 

Carrying

 

Accumulated

 

Carrying

 

Carrying

 

Accumulated

 

Carrying

 

 

 

Amount

 

Amortization

 

Amount

 

Amount

 

Amortization

 

Amount

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Covenant not to compete

 

$

315

 

$

(47

)

$

268

 

$

315

 

$

(25

)

$

290

 

Customer lists

 

4,755

 

(2,725

)

2,030

 

4,755

 

(2,380

)

2,375

 

Developed technology

 

17,384

 

(1,145

)

16,239

 

17,513

 

(535

)

16,978

 

Distribution agreement

 

2,426

 

(512

)

1,914

 

2,400

 

(385

)

2,015

 

In-process research and development *

 

400

 

 

 

400

 

400

 

 

 

400

 

License agreements

 

1,428

 

(309

)

1,119

 

403

 

(287

)

116

 

Patents

 

4,227

 

(1,314

)

2,913

 

3,757

 

(1,214

)

2,543

 

Royalty agreements

 

267

 

(240

)

27

 

267

 

(213

)

54

 

Trademark

 

2,538

 

(490

)

2,048

 

2,538

 

(411

)

2,127

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total

 

$

33,740

 

$

(6,782

)

$

26,958

 

$

32,348

 

$

(5,450

)

$

26,898

 

 


* In-process research and development was capitalized in connection with our acquisition of Alveolus.  Our in-process research and development intangible is currently not subject to amortization but amortization will commence upon the related product launch.

 

The aggregate amortization expense for the six months ended June 30, 2010 was approximately $1.3 million.

 

Estimated amortization expense for the intangible assets for the next five years consists of the following (in thousands):

 

Remaining 2010

 

$

      1,336

 

2011

 

2,387

 

2012

 

2,213

 

2013

 

2,183

 

2014

 

2,017

 

 

ITEM 2.  MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

Disclosure Regarding Forward-Looking Statements

 

This Report includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).  All statements in this Report, other than statements of historical fact, are forward-looking statements for purposes of these provisions, including any projections of earnings, revenues or other financial items, any statements of the plans and objectives of management for future operations, any statements concerning proposed new products or services, any statements regarding future economic conditions or performance, and any statements of assumptions underlying any of the foregoing.  All forward-looking statements included in this Report are made as of the date hereof and are based on information available to us as of such date.  We assume no obligation to update any forward-looking statement.   In some cases, forward-looking statements can be identified by the use of terminology such as “may,” “will,” “expects,” “plans,” “anticipates,”  “intends,” “believes,” “estimates,” “potential,” or “continue,” or the negative thereof or other comparable terminology.  Although we believe that the expectations reflected in the forward-looking statements contained herein are reasonable, there can be no assurance that any such expectations or any forward-looking statement will prove to be correct.  Our actual results will vary, and may vary materially, from those projected or assumed in the forward-looking statements.  Our financial condition and

 

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results of operations, as well as any forward-looking statements, are subject to inherent risks and uncertainties, including, unanticipated consequences of Merit’s recent, proposed or future acquisitions; challenges associated with Merit’s efforts to pursue new market opportunities, including opportunities in the gastroenterology and pulmonary markets; infringement of Merit’s technology or the assertion that Merit’s technology infringes the rights of other parties; product recalls and product liability claims; downturn of the national economy and its effect on Merit’s revenues, collections and supplier relations; termination of supplier relationships, or failure of suppliers to perform; inability to successfully manage growth through acquisitions; delays in obtaining regulatory approvals, or the failure to maintain such approvals; concentration of Merit’s revenues among a few products and procedures; development of new products and technology that could render Merit’s products obsolete; market acceptance of new products; introduction of products in a timely fashion; price and product competition; availability of labor and materials; cost increases; and fluctuations in and obsolescence of inventory; volatility of the market price of Merit’s common stock; foreign currency fluctuations; changes in key personnel; work stoppage or transportation risks; modification or limitation of governmental or private insurance reimbursement procedures; changes in health care markets related to health care reform initiatives; and other factors referred to in our press releases and reports filed with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2009. All subsequent forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by these cautionary statements.  Additional factors that may have a direct bearing on our operating results are discussed in Part I, Item 1A “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2009.

 

Overview

 

For the quarter ended June 30, 2010, we reported record revenues of $74.9 million, up 16% from the quarter ended June 30, 2009 of $64.8 million.  Revenues for the six months ended June 30, 2010 were a record $142.4 million, compared with $123.2 million for the first six months of 2009, a gain of 16%.

 

Gross margins were 43.3% and 42.8% of sales for the three and six-month periods ended June 30, 2010, respectively, compared to 43.4% and 43.0% of sales for the three and six-month periods ended June 30, 2009, respectively.  The slight decrease in gross margins can be attributed primarily to higher average fixed overhead unit costs as the result of higher production costs and a decrease in productivity as fixed costs are shared over a decreased number of units produced and an increase in material costs, all of which were partially offset by an increase of approximately 1.0% in gross margin improvement related primarily to the launch of our En Snare® device in January 2010.

 

Net income for the quarter ended June 30, 2010 was $5.7 million, or $0.20 per share, compared to $5.8 million, or $0.21 per share, for the comparable quarter of 2009.  Net income for the six-month period ended June 30, 2010 was $10.2 million, down 10% to $0.36 per share, compared to $11.4 million, or $0.40 per share, for the comparable period of 2009. When compared to the prior year period, net income for the three and six month periods ended June 30, 2010 was primarily affected by the cost of hiring additional sales and marketing people in the U.S. and Europe, acquisition costs of approximately $1.1 million related to our proposed acquisition of BioSphere, increased research and development expenses for the Endotek product line and a legal settlement of approximately $477,000.

 

On May 13, 2010, we signed a definitive merger agreement to acquire all of the outstanding shares of BioSphere in an all cash transaction valued at approximately $96 million, inclusive of all common equity and Series A Preferred preferences.  BioSphere develops and markets embolotherapeutic products for the treatment of uterine fibroids, hypervascularized tumors and arteriovenous malformations.  We anticipate that the proposed acquisition of BioSphere will give us a platform technology applicable to multiple therapeutic areas with significant market potential while leveraging existing interventional radiology call points.  Two immediate applications for the embolotherapy are uterine fibroids and primary liver cancer.  On May 12, 2010, we secured a commitment for a five-year senior unsecured revolving credit facility of up to $125 million.  The commitment of the prospective lenders to provide the credit facility is subject to a number of customary conditions, including the negotiation and execution of definitive transaction documents.  We anticipate that the transaction will close during the third calendar quarter of 2010.

 

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Results of Operations

 

The following table sets forth certain operational data as a percentage of sales for the three and six-month periods ended June 30, 2010 and 2009:

 

 

 

Three Months Ended

 

Six Months Ended

 

 

 

June 30,

 

June 30,

 

 

 

2010

 

2009

 

2010

 

2009

 

Sales

 

100.0

%

100.0

%

100.0

%

100.0

%

Gross profit

 

43.3

 

43.4

 

42.8

 

43.0

 

Selling, general and administrative expenses

 

26.6

 

25.1

 

27.4

 

25.3

 

Research and development expenses

 

5.0

 

4.5

 

4.8

 

4.0

 

Income from operations

 

11.7

 

13.8

 

10.6

 

13.7

 

Other income

 

0.1

 

0.0

 

0.0

 

0.2

 

Net income

 

7.6

 

9.0

 

7.2

 

9.2

 

 

Sales.  Sales for the three months ended June 30, 2010 increased by 16%, or approximately $10.1 million, compared to the corresponding period of 2009.   Sales for the six months ended June 30, 2010 increased by 16%, or approximately $19.2 million, compared to the corresponding period of 2009.   We report sales in five product categories.  Listed below are the sales relating to these product categories for the three and six-month periods ended June 30, 2010 and 2009 (in thousands):

 

 

 

Three Months Ended

 

Six Months Ended

 

 

 

June 30,

 

June 30,

 

 

 

% Change

 

2010

 

2009

 

% Change

 

2010

 

2009

 

Stand-alone devices

 

17

%

$

  22,981

 

$

  19,587

 

18

%

$

    43,747

 

$

    37,021

 

Custom kits and procedure trays

 

8

%

20,869

 

19,280

 

10

%

40,379

 

36,677

 

Inflation devices

 

15

%

16,897

 

14,707

 

7

%

31,121

 

28,994

 

Catheters

 

30

%

11,791

 

9,070

 

26

%

22,251

 

17,704

 

Gastroenterology devices

 

10

%

2,410

 

2,193

 

74

%

4,882

 

2,812

 

Total

 

16

%

$

  74,948

 

$

  64,837

 

16

%

$

  142,380

 

$

  123,208

 

 

The sales growth of 16% for the three and six-month periods ended June 30, 2010, when compared to the comparable periods of 2009, was primarily due to stand-alone sales of the En Snare® device sales of $1.9 million and $4.0 million, respectively, for the three and six-month periods ended June 30, 2010.  Sales were also favorably affected by increased sales of catheters (particularly our Prelude® sheath product line, cardiology diagnostic catheters and mini access catheter product line), custom kits and procedure trays, and inflation devices sold to an OEM customer.

 

Gross Profit.  Gross margins were 43.3% and 42.8% of sales for the three and six-month periods ended June 30, 2010, respectively, compared to 43.4% and 43.0% of sales for the three and six-month periods ended June 30, 2009, respectively.  The slight decrease in gross margins can be attributed primarily to higher average fixed overhead unit costs as the result of higher production costs, a decrease in productivity as fixed costs are shared over a decreased number of units produced and an increase in material costs, all of which were partially offset by an increase of approximately 1.0% in gross margin improvement related primarily to the launch of our En Snare® device in January 2010.

 

Operating Expenses.  Selling, general and administrative expenses increased to 26.6% of sales for the three months ended June 30, 2010, compared with 25.1% of sales for the three months ended June 30, 2009.   For the six months ended June 30, 2010, selling, general and administrative expenses increased to 27.4% compared with 25.3% of sales for the six months ended June 30, 2009.  Selling, general and administrative expenses increased 22% to $19.9 million for the three months ended June 30, 2010 from $16.3 million for the three months ended June 30, 2009.  These increased expenses were primarily attributable to acquisition costs of approximately $1.1 million related to our proposed acquisition of BioSphere.   Selling, general and administrative expenses increased 25% to $39.0 million for the six months ended June 30, 2010 from $31.1 million for the six months ended June 30, 2009.  These expense increases primarily related to the cost of hiring additional sales and marketing people in the U.S. and Europe, acquisition costs of approximately $1.1 million related to our proposed acquisition of BioSphere and a legal settlement of approximately $477,000. Research and development expenses increased to 5.0% of sales for the three months ended June 30, 2010, compared with 4.5% of sales for the three months ended June 30, 2009.

 

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Research and development expenses increased to 4.8% of sales for the six months ended June 30, 2010, compared to 4.0% of sales for the six months ended June 30, 2009.  Research and development expenses increased 29% to $3.7 million for the three months ended June 30, 2010 from $2.9 million for the three months ended June 30, 2009.  For the six months ended June 30, 2010 research and development expenses increased 37% to $6.8 million from $5.0 million during the six months ended June 30, 2009.  The increase in research and development expenses related primarily to the development of several new products for the Endotek product line.

 

Other Income (Expense).  Other income for the second quarter of 2010 was approximately $62,000, compared to other income of approximately $22,000 for the comparable period in 2009.  The net increase in the three month period ended June 30, 2010, when compared to the comparable period in 2009, was primarily the result of foreign exchange transaction gains. Other income for the six months ended June 30, 2010 was approximately $46,000, compared to other income of approximately $196,000 for the corresponding period in 2009.  The net change in other income for the six-month period ended June 30, 2010, when compared to the comparable period of 2009, was primarily the result of a decrease in interest income attributable to lower average cash balances.

 

Income Taxes.  Our effective tax rate for the three months ended June 30, 2010 was 35.3%, relatively unchanged compared to 35.0% for the corresponding period of 2009.  For the six months ended June 30, 2010, our effective tax rate was 32.6%, compared to 33.3% for the comparable period in 2009.  The decrease in the effective tax rate for the six-month period ended June 30, 2010, when compared to the corresponding period of 2009, was primarily related to the profitability of our Irish operations which are taxed at a lower tax rate than our U.S. and other foreign operations.

 

Income.  During the second quarter of 2010, we reported income from operations of approximately $8.8 million, compared to approximately $9.0 million for the comparable period of 2009.  For the six months ended June 30, 2010, we reported income from operations of $15.1 million, a decrease of 9% from $16.9 million for the comparable period in 2009. When compared to the corresponding period of 2010, income from operations for the six-month period ended June 30, 2009, was negatively affected by costs attributable to hiring additional sales and marketing people in the U.S. and Europe, acquisition costs of approximately $1.1 million related to our proposed acquisition of BioSphere, increased research and development expenses for the Endotek product line and a legal settlement of approximately $477,000.  These factors contributed to a decrease in net income to $5.7 and $10.2 million for the three and six-month periods ended June 30, 2010, respectively, compared to net income of $5.8 million and $11.4 million for the same periods of 2009.

 

Liquidity and Capital Resources

 

Our working capital as of June 30, 2010 and December 31, 2009 was $64.9 million and $57.7 million, respectively.  The increase in working capital was primarily the result of an increase in accounts receivable related to record quarterly sales.   As of June 30, 2010, we had a current ratio of 3.1 to 1.

 

On May 12, 2010, we entered into a commitment letter agreement pursuant to which Wells Fargo Bank, National Association and Wells Fargo Securities, LLC committed to provide to us with a five-year senior unsecured revolving credit facility of up to $125 million.  The commitment of the prospective lenders to provide the credit facility described in the commitment letter is subject to a number of customary conditions, including the negotiation and execution of definitive transaction documents.  The principal purpose of the credit facility, if obtained, is to allow us to finance, in part, the transactions contemplated by the merger agreement with BioSphere.  We also intend to use the credit facility for general corporate purposes.

 

On December 7, 2006, we entered into an unsecured loan agreement with Bank of America, N.A. (“Bank of America”), whereby Bank of America agreed to provide us a line of credit in the amount of $30 million.  Our outstanding borrowings on this loan as of June 30, 2010 and December 31, 2009 were $0 and $7.0 million, respectively.  Our interest rate as of June 30, 2010 and December 31, 2009 was set at approximately 1.0%.  Available borrowings under this line of credit as of June 30, 2010 and December 31, 2009 were $30 million and $23 million, respectively.

 

On December 8, 2006, we entered into an unsecured loan agreement with Zions First National Bank (“Zions”), whereby Zions agreed to provide us a line of credit in the amount of $1 million.  The loan originally expired on December 1, 2009; but was extended for an additional three years to December 1, 2012.  We had $0 outstanding and $1.0 million available under this line of credit as of June 30, 2010 and December 31, 2009.

 

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Historically, we have incurred significant expenses in connection with new facilities, production automation, product development and the introduction of new products.  During 2009, we spent a substantial amount of cash, $46.2 million, in connection with our acquisition of certain assets and product lines.  In the event we pursue and complete similar transactions or acquisitions in the future, additional funds will likely be required to meet our strategic needs, which may require us to consider raising additional funds in the debt or equity markets.  We currently believe that our existing cash balances, anticipated future cash flows from operations, sales of equity and existing lines of credit and committed debt financing will be adequate to fund our current and future planned operations for the next twelve months and the foreseeable future.

 

Critical Accounting Policies

 

The SEC has requested that all registrants address their most critical accounting policies.  The SEC has indicated that a “critical accounting policy” is one which is both important to the representation of the registrant’s financial condition and results and requires management’s most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain.  We base our estimates on past experience and on various other assumptions our management believes to be reasonable under the circumstances, the results of which form the basis for making judgments about carrying values of assets and liabilities that are not readily apparent from other sources.  Actual results will differ, and may differ materially from these estimates under different assumptions or conditions.  Additionally, changes in accounting estimates could occur in the future from period to period.  Our management has discussed the development and selection of our most critical financial estimates with the audit committee of our Board of Directors.  The following paragraphs identify our most critical accounting policies:

 

Inventory Obsolescence Reserve Our management reviews on a quarterly basis inventory quantities on hand for unmarketable or slow-moving products that may expire prior to being sold.  This review includes quantities on hand for both raw materials and finished goods.  Based on this review, we provide a reserve for any slow-moving finished good products or raw materials that we believe will expire prior to being sold or used to produce a finished good and any products that are unmarketable. This review of inventory quantities for unmarketable or slow moving products is based on forecasted product demand prior to expiration lives.

 

Forecasted unit demand is derived from our historical experience of product sales and production raw material usage.  If market conditions become less favorable than those projected by our management, additional inventory write-downs may be required.  During the years ended December 31, 2009, 2008 and 2007, we provided on an annual basis an obsolescence reserve expense of between $1.1 million to $1.5 million and have written off against such reserves between $1.2 million and $1.3 million on an annual basis.  Based on this historical trend, we believe that the amount included in our obsolescence reserve represents an accurate estimate of the unmarketable or slow moving products that may expire prior to being sold.

 

Allowance for Doubtful Accounts A majority of our receivables are with hospitals which, over our history, have demonstrated favorable collection rates.  Therefore, we have experienced relatively minimal bad debts from hospital customers.  In limited circumstances, we have written off bad debts as the result of the termination of our business relationships with foreign distributors.  The most significant write-offs over our history have come from U.S. packers who bundle our products in surgical trays.

 

We maintain allowances for doubtful accounts relating to estimated losses resulting from the inability of our customers to make required payments.  The allowance is based upon historical experience and a review of individual customer balances.  If the financial condition of our customers were to deteriorate, resulting in an impairment of their ability to make payments, additional allowances may be required.

 

Stock-Based Compensation.  We measure share-based compensation cost at the grant date based on the value of the award and recognize the cost as an expense over the term of the vesting period.  Judgment is required in estimating the fair value of share-based awards granted and their expected forfeiture rate.  If actual results differ significantly from these estimates, stock-based compensation expense and our results of operations could be materially impacted.

 

Income Taxes.  Under our accounting policies, we initially recognize a tax position in our financial statements when it becomes more likely than not that the position will be sustained upon examination by the tax authorities.

 

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Such tax positions are initially and subsequently measured as the largest amount of tax positions that has a greater than 50% likelihood of being realized upon ultimate settlement with the tax authorities assuming full knowledge of the position and all relevant facts.  Although we believe our provisions for unrecognized tax positions are reasonable, we can make no assurance that the final tax outcome of these matters will not be different from that which we have reflected in our income tax provisions and accruals.  The tax law is subject to varied interpretations, and we have taken positions related to certain matters where the law is subject to interpretation.  Such differences could have a material impact on our income tax provisions and operating results in the period(s) in which we make such determination.

 

Goodwill and Intangible Assets Impairment.  We test our goodwill balances for impairment as of July 1 of each year, or whenever impairment indicators arise.  We utilize several reporting units in evaluating goodwill for impairment.  We assess the estimated fair value of reporting units based on discounted future cash flows.  If the carrying amount of a reporting unit exceeds the fair value of the reporting unit, an impairment charge is recognized in an amount equal to the excess of the carrying amount of the reporting unit goodwill over implied fair value of that goodwill.  This analysis requires significant judgments, including estimation of future cash flows and the length of time they will occur, which is based on internal forecasts, and a determination of a discount rate based on our weighted average cost of capital.

 

We evaluate the recoverability of intangible assets whenever events or changes in circumstances indicate that its carrying amount may not be recoverable.  This analysis requires similar significant judgments as those discussed above regarding goodwill, except that undiscounted cash flows are compared to the carrying amount of intangible assets to determine if impairment exists.  All of our intangible assets are subject to amortization.

 

ITEM 3.  QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

Our principal market risk relates to changes in the value of the Euro and Great Britain Pound (“GBP”) relative to the value of the U.S. Dollar.  We also have a limited market risk relating to the Swedish and Danish Kroner.    Our consolidated financial statements are denominated in, and our principal currency is, the U.S. Dollar.  A portion of our revenues ($7.2 million, representing approximately 9.6% of aggregate revenues), for the three months ended June 30, 2010 was attributable to sales that were denominated in foreign currencies.  All other international sales were denominated in U.S. Dollars.  Certain of our expenses for the quarter ended June 30, 2010 were also denominated in foreign currencies, which partially offset risks associated with fluctuations of exchanges rates between foreign currencies on the one hand, and the U.S. Dollar on the other hand.   During the three months ended June 30, 2010, the exchange rate between our foreign currencies against the U.S. Dollar resulted in a decrease of our gross revenues of approximately $411,000 and an increase of 0.12% in gross profit.  This improvement in gross profits was the result of a decrease in our Irish manufacturing expenses which are primarily denominated in Euros.

 

On May 31, 2010, we forecasted a net exposure for June 30, 2010 representing the difference between the Euro- and GBP-denominated receivables and Euro and GBP-denominated payables of approximately 48,000 Euros 278,000 GBPs, respectively.  In order to partially offset such risks, on May 31, 2010 we entered into a 30-day forward contract for Euros and GBPs.  We generally enter into similar economic transactions at various times during the year to partially offset exchange rate risks we bear throughout the year.  During the quarter ended June 30, 2010, we recorded a net gain of approximately $58,000 on foreign currency transactions.  We do not purchase or hold derivative financial instruments for speculative or trading purposes.  The fair value of our open positions at June 30, 2010 was not material to our consolidated financial statements.

 

As of June 30, 2010, we had no variable rate debt. As long as we do not have variable rate debt, our interest expense would not be affected by changes in interest rates.

 

ITEM 4.  CONTROLS AND PROCEDURES

 

(a) Evaluation of disclosure controls and procedures

 

An evaluation of the effectiveness of our disclosure controls and procedures as of June 30, 2010 was performed under the supervision and with the participation of our management, including our Chief Executive Officer and our Chief Financial Officer.  Based on that evaluation, our management, including our Chief Executive Officer and Chief Financial Officer, concluded that our disclosure controls and procedures are effective to ensure that

 

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information required to be disclosed in our reports filed or submitted under the Securities Exchange Act of 1934, as amended, is recorded, processed, summarized and reported as specified in the SEC’s rules and forms.

 

(b) Changes in Internal Control Over Financial Reporting

 

There was no change in our internal control over financial reporting during the quarter ended June 30, 2010 that materially affected, or that we believe is reasonably likely to materially affect, our internal control over financial reporting.

 

PART II - OTHER INFORMATION

 

ITEM 1.   LEGAL PROCEEDINGS

 

We are subject to certain legal actions which we consider routine to our business activities.  As of June 30, 2010, our management concluded, after consultation with legal counsel, that the ultimate outcome of such legal matters is not likely to have a material adverse effect on our financial position, liquidity or results of operations.

 

ITEM 1A.   RISK FACTORS

 

In addition to other information set forth in this Report, you should carefully consider the factors discussed in Part I, “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2009, which could materially affect our business, financial condition or future results.  The risks described in our Annual Report on Form 10-K are not the only risks we face.  Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially and adversely affect our business, financial condition and/or operating results.

 

ITEM  6.  EXHIBITS

 

Exhibit No.

 

Description

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.

 

 

MERIT MEDICAL SYSTEMS, INC.

REGISTRANT

 

 

Date:

August 6, 2010

 

/s/ Fred P. Lampropoulos

 

 

FRED P. LAMPROPOULOS

 

 

PRESIDENT AND CHIEF EXECUTIVE OFFICER

 

 

 

 

 

 

Date:

August 6, 2010

 

/s/ Kent W. Stanger

 

 

KENT W. STANGER

 

 

CHIEF FINANCIAL OFFICER

 

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