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8-K - 8-K - MERIT MEDICAL SYSTEMS INCa12312013-8k1.htm


 Exhibit 99.1


1600 West Merit Parkway • South Jordan, UT  84095
Telephone:  801-253-1600 • Fax:  801-253-1688
 PRESSRELEASE
 
FOR IMMEDIATE RELEASE
 
Date:
February 24, 2014
Contact:
Anne-Marie Wright, Vice President, Corporate Communications
Phone:
(801) 208-4167 e-mail: awright@merit.com Fax: (801) 253-1688

 
MERIT MEDICAL REPORTS RECORD REVENUES
FOR THE QUARTER AND YEAR ENDED DECEMBER 31, 2013

Revenues Up 17% for the Quarter and 14% for the Year
4Q 2013 Core Growth Up 12%
GAAP and Non-GAAP Income Up Over 4Q 2012
SAFEGUARD® Product Line Integrated
2014 Guidance Scheduled To Be Given on March 3, 2014



SOUTH JORDAN, UTAH- Merit Medical Systems, Inc. (Nasdaq: MMSI), a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy, today announced record revenues of $120.0 million for the quarter ended December 31, 2013, an increase of 17% over revenues of $102.2 million for the quarter ended December 31, 2012. Revenues for the year ended December 31, 2013 were a record $449.0 million, an increase of 14% over revenues of $394.3 million for the year ended December 31, 2012. Revenues from Merit's core business grew 12% and 7% for the quarter and year ended December 31, 2013, respectively, compared to the corresponding periods of 2012.
Merit's non-GAAP net income for the quarter ended December 31, 2013 was $9.4 million, up 52%, or $0.22 per share, compared to $6.2 million, or $0.15 per share, for the quarter ended December 31, 2012. Merit's non-GAAP net income for the year ended December 31, 2013 was $30.4 million, or $0.71 per share, compared to $30.8 million, or $0.72 per share, for the year ended December 31, 2012.




GAAP net income for the quarter ended December 31, 2013 was $6.5 million, or $0.15 per share, compared to $641,000, or $0.01 per share, for the fourth quarter of 2012. Absent the non-recurring costs recorded in the fourth quarter of 2012 related to Merit’s acquisition of Thomas Medical Products (“Thomas Medical”) of $2.2 million, net of tax, and a capital loss related to an investment in a privately-held company of $1.5 million, net of tax, GAAP net income for the fourth quarter of 2012 would have been approximately $4.4 million, or $0.10 per share. The increase in GAAP earnings for the quarter ended December 31, 2013, when compared to the prior period in 2012, was primarily affected by higher sales and lower selling, general and administrative expenses as a percentage of sales.
GAAP net income for the year ended December 31, 2013 was $16.6 million, or $0.39 per share, compared to $19.7 million, or $0.46 per share, for the year ended December 31, 2012. Absent a non-recurring intangible asset impairment charge of $2.7 million, net of tax, GAAP net income would have been approximately $19.3 million, or $0.45 per share, for the year ended December 31, 2013. Excluding the non-recurring items discussed in the preceding paragraph, plus acquired in process research and development expense of $1.5 million, net of tax, GAAP net income would have been $24.9 million, or $0.58 per share, for the year ended December 31, 2012. The decrease in GAAP net income for the year ended December 31, 2013, compared to the corresponding period of 2012, was primarily due to lower gross margins as discussed below.
Merit’s non-GAAP gross profit was 46.7% of sales for the quarter ended December 31, 2013, compared to 46.1% of sales for the quarter ended December 31, 2012. Non-GAAP gross profit was 45.6% of sales for the year ended December 31, 2013, compared to 47.4% of sales for the year ended December 31, 2012. Non-GAAP gross profit for the fourth quarter and year ended December 31, 2013 would have been 47.6% and 46.6%, respectively, without the implementation of the medical device excise tax imposed by the Patient Protection and Affordable Care Act (the “Affordable Care Act”) in 2013.
GAAP gross profit for the fourth quarter of 2013 was 44.5% of sales, unchanged from 44.5% of sales for the fourth quarter of 2012. GAAP gross profit was 43.3% of sales for the year ended December 31, 2013, compared to 46.2% of sales for the year ended December 31, 2012. GAAP gross profit for the fourth quarter and year ended December 31, 2013 would have been 45.5% and 44.3%, respectively, without the implementation of the medical device excise tax imposed by the Affordable Care Act in 2013. The reduction in GAAP gross profit as a percentage of sales for the year ended December 31, 2013, compared to the year ended December 31, 2012, related primarily to amortization of developed technology costs of 1.3% of sales associated with the acquisitions of Thomas Medical and the assets of Datascope Corp., implementation of the medical device excise tax of 1.0% of sales, imposed by the Affordable Care Act, and higher standard costs of 0.9% of sales resulting from lower production volumes at the beginning of 2013.     

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    "After a difficult beginning to 2013, we made substantial progress throughout the final three quarters," said Fred P. Lampropoulos, Merit's Chairman and Chief Executive Officer. "We were pleased with fourth quarter sales which exceeded robust third quarter sales. During the fourth quarter, we also acquired the SAFEGUARD® Pressure Assisted Device in a relatively seamless process. We expect the SAFEGUARD to be a contributor to our radial program which continues to gain momentum in the United States.”
“We recently received our certificate of occupancy for our new facility in Pearland, Texas,” Lampropoulos continued. “Over the next six months we plan to transfer production from our facility in Angleton, Texas to Pearland. We believe this new facility will mitigate substantial weather-related risks and help with recruitment from nearby Houston.”
"Due to scheduling challenges, we intend to provide sales guidance and an overview of the 2014 business plan on Monday, March 3, 2014,” Lampropoulos added.
For the quarter ended December 31, 2013, compared to the quarter ended December 31, 2012, stand-alone device sales increased 19%; catheter sales were up 18%; Endotek sales increased 9%; custom kit and tray sales grew 8%; inflation device sales rose 7%; and BioSphere sales increased 5%. Excluding decreased sales to an OEM customer, inflation device sales were up 14% for the quarter ended December 31, 2013. Sales related to Merit’s acquisition of Thomas Medical were $7.3 million for the fourth quarter of 2013, compared to $1.9 million for the last 11 days of the fourth quarter of 2012. Merit’s core business sales for the quarter ended December 31, 2013 were up 12% compared to the corresponding period of 2012.
For the year ended December 31, 2013, compared to the year ended December 31, 2012, catheter sales increased 16%; stand-alone device sales grew 10%; custom kit and tray sales rose 10%; Endotek sales were up 7%; BioSphere sales fell 1%; and inflation device sales decreased 4%. Excluding decreased sales to an OEM customer, inflation device sales were up 4% for the year ended December 31, 2013. Sales related to Merit’s acquisition of Thomas Medical were $28.3 million for 2013, compared to $1.9 million for the last 11 days of the year ended December 31, 2012. Merit’s core business sales for the year ended December 31, 2013 were up 7% compared to the year ended December 31, 2012.
GAAP selling, general and administrative expenses were 28.0% and 28.6% of Merit's sales for the quarter and year ended December 31, 2013, respectively, compared with 32.7% and 31.0% of Merit's sales for the corresponding periods of 2012, respectively. GAAP SG&A expenses would have been 27.6% and 28.1% of sales for the quarter and year ended December 31, 2013, respectively, if not for approximately $489,000 and approximately $2.4 million, respectively, of non-recurring transaction costs attributable to acquisition transactions and related severance payments for the quarter and year ended December 31, 2013, respectively. GAAP SG&A expenses would have been 30.1% and 30.3% of sales for the quarter

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and year ended December 31, 2012, respectively, if not for $2.7 million of non-recurring transaction costs attributable to the Thomas Medical acquisition for both the quarter and year ended December 31, 2012. Excluding these non-recurring expenses, the decrease in SG&A expenses for the quarter and year ended December 31, 2013 was primarily related to the implementation of cost-cutting initiatives in expenses such as reductions in trade show and convention expenses, 401(k) employer matching payments and employee bonuses. Non-GAAP SG&A expenses for the fourth quarter of 2013 were 26.7% of sales, compared to 28.9% of sales for the fourth quarter of 2012. Non-GAAP SG&A expenses for the year ended December 31, 2013 were 27.1% of sales, compared to 29.2% of sales for the year ended December 31, 2012.
Research and development costs were 7.4% and 7.5% of sales for the quarter and year ended December 31, 2013, respectively, compared to 7.5% and 7.0% of sales for the corresponding periods of 2012, respectively. The increase in research and development expenses for the year ended December 31, 2013 was primarily due to research and development costs associated with the acquisition of Thomas Medical, headcount additions for research and development to support new product development, and personnel increases in Merit's regulatory department to support registrations in foreign countries to expand international product offerings.
Other expense, which consists primarily of interest expense, for the quarter and year ended December 31, 2013 was approximately $2.7 million and $8.0 million, respectively, compared with other expense of approximately $2.5 million and $2.0 million, for the corresponding periods of 2012, respectively. The increase in interest expense for the year ended December 31, 2013 was primarily due to the debt incurred for the Thomas Medical acquisition which closed on December 19, 2012.
Merit's effective income tax rates for the quarter and year ended December 31, 2013 were 20.1% and 16.5%, respectively, compared to 65.3% and 28.6% for the corresponding periods of 2012, respectively. Absent the recognition of a deferred income tax valuation allowance of approximately $631,000 related to certain capital loss carry-forwards, Merit’s effective tax rates would have been 31.2% and 26.3% for the quarter and year ended December 31, 2012, respectively. The decrease in the effective tax rate for both periods was primarily the result of a higher mix of earnings from Merit's foreign operations (primarily Ireland), which are taxed at a lower rate than Merit's U.S. operations and the release of unrecognized tax benefits due to statute of limitation expirations.  In addition, the effective tax rate for the year ended December 31, 2013 was lower than the corresponding period of 2012, due primarily to the reinstatement in 2013 of the federal research and development credit for the 2012 tax year.  The credit was reinstated by the American Taxpayer Relief Act of 2012, which was signed on January 2, 2013 and recognized as a discrete benefit in the first quarter of 2013.

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Merit generated $51.0 million in cash from operations for the year ended December 31, 2013, compared to $46.9 million for the year ended December 31, 2012.

CONFERENCE CALL TODAY
Merit invites all interested parties to participate in its fourth quarter and year-end conference call today, February 24th, 2014, at 5:00 p.m. Eastern (4:00 p.m. Central, 3:00 p.m. Mountain, and 2:00 p.m. Pacific). The domestic phone number is (877) 941-9205, and the international number is (480) 629-9818. A live webcast as well as a rebroadcast can be accessed through the Investors page at www.merit.com.

2014 GUIDANCE CONFERENCE CALL SCHEDULED FOR MARCH 3
Due to a variety of factors, Merit’s management intends to provide 2014 guidance on a conference call scheduled for Monday, March 3rd, 2014, at 5:00 p.m. Eastern (4:00 p.m. Central, 3:00 p.m. Mountain, and 2:00 p.m. Pacific). The domestic phone number is (480) 629-9835, and the international number is (877) 941-0844. A live webcast as well as a rebroadcast can be accessed through the Investors page at www.merit.com.


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BALANCE SHEET
(Unaudited in thousands)
 
December 31,
2013
 
December 31,
2012
 
ASSETS
 
 
 
 
 
 
 
 
Current Assets
 
 
 
 
 
 
 
 
  Cash and cash equivalents
$
7,459

 
 
$
9,719

 
 
  Trade receivables, net
 
60,186

 
 
 
53,402

 
 
  Employee receivables
 
224

 
 
 
169

 
 
  Other receivables
 
3,279

 
 
 
2,672

 
 
  Inventories
 
82,378

 
 
 
84,599

 
 
  Prepaid expenses
 
5,121

 
 
 
4,133

 
 
  Prepaid income taxes
 
1,232

 
 
 
1,250

 
 
  Deferred income tax assets
 
5,638

 
 
 
4,976

 
 
  Income tax refunds receivable
 
398

 
 
 
1,076

 
 
    Total Current Assets
 
165,915

 
 
 
161,996

 
 
 
 
 
 
 
 
 
 
 
 Property and equipment, net
 
243,270

 
 
 
234,803

 
 
 Other intangibles, net
 
119,987

 
 
 
118,131

 
 
 Goodwill
 
184,505

 
 
 
175,108

 
 
 Deferred income tax assets
 
800

 
 
 
4,237

 
 
 Other assets
 
13,806

 
 
 
11,034

 
 
Total Assets
$
728,283

 
 
$
705,309

 
 
 
 
 
 
 
 
 
 
 
LIABILITIES AND STOCKHOLDERS' EQUITY
 
 
 
 
 
 
 
 
Current Liabilities
 
 
 
 
 
 
 
 
  Trade payables
 
26,511

 
 
 
34,637

 
 
  Accrued expenses
 
26,713

 
 
 
27,269

 
 
  Current portion of long-term debt
 
10,000

 
 
 
10,000

 
 
  Advances from employees
 
292

 
 
 
551

 
 
  Income taxes payable
 
1,089

 
 
 
547

 
 
   Total Current Liabilities
 
64,605

 
 
 
73,004

 
 
 
 
 
 
 
 
 
 
 
Deferred income tax liabilities
 
2,548

 
 
 
2,373

 
 
Liabilities related to unrecognized tax benefits
 
2,031

 
 
 
2,938

 
 
Deferred compensation payable
 
7,833

 
 
 
5,956

 
 
Deferred credits
 
3,065

 
 
 
2,980

 
 
Long-term debt
 
238,854

 
 
 
227,566

 
 
Other long-term obligations
 
3,641

 
 
 
8,915

 
 
   Total Liabilities
 
322,577

 
 
 
323,732

 
 
 
 
 
 
 
 
 
 
 
Stockholders' Equity
 
 
 
 
 
 
 
 
  Common stock
 
177,775

 
 
 
172,341

 
 
  Retained earnings
 
226,988

 
 
 
210,418

 
 
  Accumulated other comprehensive income (loss)
 
943

 
 
 
(1,182
)
 
 
  Total stockholders' equity
 
405,706

 
 
 
381,577

 
 
Total Liabilities and Stockholders' Equity
$
728,283

 
 
$
705,309

 
 

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INCOME STATEMENT
(Unaudited, in thousands except per share amounts)
 
Three Months Ended
 
Twelve Months Ended
 
December 31,
 
December 31,
 
2013
2012
 
2013
2012
 
 
 
 
 
 
SALES
$
120,016

$
102,231

 
$
449,049

$
394,288

 
 
 
 
 
 
COST OF SALES
66,657

56,768

 
254,682

212,296

 
 
 
 
 
 
GROSS PROFIT
53,359

45,463

 
194,367

181,992

 
 
 
 
 
 
OPERATING EXPENSES
 
 
 
 
 
  Selling, general and administrative
33,640

33,468

 
128,642

122,106

  Research and development
8,822

7,665

 
33,886

27,795

  Intangible asset impairment charge
 
 
 
8,089

 
  Contingent consideration benefit
(19
)
 
 
(4,094
)
 
  Acquired in-process research and development
 
 
 
 
2,450

    Total
42,443

41,133

 
166,523

152,351

 
 
 
 
 
 
INCOME FROM OPERATIONS
10,916

4,330

 
27,844

29,641

 
 
 
 
 
 
OTHER INCOME (EXPENSE)
 
 
 
 
 
  Interest income
55

50

 
255

226

  Interest (expense)
(2,747
)
(252
)
 
(8,044
)
(604
)
  Other income (expense)
(42
)
(2,278
)
 
(216
)
(1,645
)
    Total other (expense) - net
(2,734
)
(2,480
)
 
(8,005
)
(2,023
)
 
 
 
 
 
 
INCOME BEFORE INCOME TAX EXPENSE
8,182

1,850

 
19,839

27,618

 
 
 
 
 
 
INCOME TAX EXPENSE
1,642

1,209

 
3,269

7,908

 
 
 
 
 
 
NET INCOME
$
6,540

$
641

 
$
16,570

$
19,710

 
 
 
 
 
 
EARNINGS PER SHARE-
 
 
 
 
 
     Basic
$
0.15

$
0.02

 
$
0.39

$
0.47

 
 
 
 
 
 
     Diluted
$
0.15

$
0.01

 
$
0.39

$
0.46

 
 
 
 
 
 
AVERAGE COMMON SHARES-
 
 
 
 
 
     Basic
42,749

42,442

 
42,607

42,176

 
 
 
 
 
 
     Diluted
43,157

42,830

 
42,884

42,610




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Although Merit's financial statements are prepared in accordance with accounting principles which are generally accepted in the United States of America (“GAAP”), Merit's management believes that certain non-GAAP financial measures provide investors with useful information regarding the underlying business trends and performance of Merit's ongoing operations and can be useful for period-over-period comparisons of such operations. The following table sets forth supplemental financial data and corresponding reconciliations to GAAP financial statements for the three- and twelve-month periods ended December 31, 2013 and 2012. Readers should consider these non-GAAP measures in addition to, not as a substitute for, financial reporting measures prepared in accordance with GAAP. These non-GAAP financial measures exclude some, but not all, items that affect Merit's net income. Additionally, these calculations may not be comparable with similarly titled measures of other companies.
    
NON-GAAP FINANCIAL STATEMENTS
 
 
 
 
 
 
 
FOR THE THREE AND TWELVE MONTHS ENDED DECEMBER 31, 2013 AND 2012
 
 
 
Three Months Ended December 31,
 
Twelve Months Ended December 31,
 
2013
 
2012
 
2013
 
2012
Non-GAAP ADJUSTMENTS
 
 
 
 
 
 
 
GAAP net income
$
6,540

 
$
641

 
$
16,570

 
$
19,710

 
 
 
 
 
 
 
 
  Acquisition costs
110

 
2,492

 
636

 
2,559

  Mark-up on finished goods (a)
 
 
831

 
744

 
831

  Severance
379

 
242

 
1,790

 
494

  Long-term asset impairment charges (b)
39

 
116

 
119

 
143

  Intangible asset impairment charge (c)
 
 
 
 
8,089

 
 
  Long-term debt issuance charges
248

 
 
 
845

 
 
  Acquired in-process research and development
 
 
 
 
 
 
2,450

  Amortization of intangible assets
 
 
 
 
 
 
 
    Cost of sales
2,705

 
876

 
9,794

 
4,072

    SG&A expense
1,121

 
943

 
4,443

 
3,441

  Loss on capital investment
 
 
2,368

 
 
 
2,368

  Contingent consideration benefit (expense) (d)
(19
)
 
110

 
(4,094
)
 
480

  Income tax effect of reconciling items (e)
(1,742
)
 
(3,032
)
 
(8,500
)
 
(6,398
)
  Tax effect on capital loss (f)
 
 
631

 
 
 
631

 
 
 
 
 
 
 
 
Non-GAAP net income
$
9,381

 
$
6,218

 
$
30,436

 
$
30,781

 
 
 
 
 
 
 
 
Non-GAAP net income per share
$
0.22

 
$
0.15

 
$
0.71

 
$
0.72

 
 
 
 
 
 
 
 
Diluted shares used to compute Non-GAAP net income
43,157

 
42,830

 
42,884

 
42,610

   per share
 
 
 
 
 
 
 
Merit’s non-GAAP income, after giving effect to the adjustments referenced in the preceding table, does not reflect stock-based compensation expense of approximately $396,000 and approximately $463,000 for the three-month periods ended December 31, 2013 and 2012, respectively, and stock-based

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compensation of approximately $1.5 million and approximately $1.9 million for the years ended December 31, 2013 and 2012, respectively.

(a) Increase in cost of goods sold related to the mark-up of finished goods associated with Merit's acquisition of Thomas Medical.
(b) Amounts represent abandoned patents.
(c) Represents changes in fair value of certain intangible assets.
(d) Represents changes in the fair value of contingent consideration liabilities for recent acquisitions.
(e) Reflects an estimated annual income tax rate of 38% on a non-GAAP basis.
(f) Reflects the deferred income tax valuation allowance related to certain capital loss carry forwards.




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ABOUT MERIT

Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture and distribution of proprietary disposable medical devices used in interventional and diagnostic procedures, particularly in cardiology, radiology and endoscopy.  Merit serves client hospitals worldwide with a domestic and international sales force totaling approximately 200 individuals. Merit employs approximately 3,000 people worldwide with facilities in South Jordan, Utah; Angleton, Texas; Richmond, Virginia; Malvern, Pennsylvania; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; and Rockland, Massachusetts.

Statements contained in this release which are not purely historical, including, without limitation, statements regarding Merit's forecasted revenues, net income, financial results or anticipated acquisitions, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties such as those described in Merit's Annual Report on Form 10-K for the year ended December 31, 2012. Such risks and uncertainties include risks relating to Merit's potential inability to successfully manage growth through acquisitions, including the inability to commercialize technology acquired through completed, proposed or future transactions; product recalls and product liability claims; expenditures relating to research, development, testing and regulatory approval or clearance of Merit's products and risks that such products may not be developed successfully or approved for commercial use; greater governmental scrutiny and regulation of the medical device industry; reforms to the 510(k) process administered by the U.S. Food and Drug Administration; compliance with governmental regulations and administrative procedures; potential restrictions on Merit's liquidity or its ability to operate its business by its current debt agreements; possible infringement of Merit's technology or the assertion that Merit's technology infringes the rights of other parties; the potential of fines, penalties, or other adverse consequences if Merit's employees or agents violate the U.S. Foreign Corrupt Practices Act or other laws and regulations; laws targeting fraud and abuse in the healthcare industry; potential for significant adverse changes in, or failure to comply with, governing regulations; the effect of changes in tax laws and regulations in the United States or other countries; increases in the prices of commodity components; negative changes in economic and industry conditions in the United States and other countries; termination or interruption of relationships with Merit's suppliers, or failure of such suppliers to perform; fluctuations in Euro and GBP exchange rates; Merit's need to generate sufficient cash flow to fund its debt obligations, capital expenditures, and ongoing operations; concentration of Merit's revenues among a few products and procedures; development of new products and technology that could render Merit's existing products obsolete; market acceptance of new products; volatility in the market price of Merit's common stock; modification or limitation of governmental or private insurance reimbursement policies; changes in health care markets related to health care reform initiatives; failure to comply with applicable environmental laws; changes in key personnel; work stoppage or transportation risks; uncertainties associated with potential healthcare policy changes which may have a material adverse effect on Merit; introduction of products in a timely fashion; price and product competition; availability of labor and materials; cost increases; fluctuations in and obsolescence of inventory; and other factors referred to in Merit's Annual Report on Form 10-K for the year ended December 31, 2012 and other materials filed with the Securities and Exchange Commission. All subsequent forward-looking statements attributable to Merit or persons acting on its behalf are expressly qualified in their entirety by these cautionary statements. Actual results will differ, and may differ materially, from anticipated results. Financial estimates are subject to change and are not intended to be relied upon as predictions of future operating results, and Merit assumes no obligation to update or disclose revisions to those estimates.
  
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