Document


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C.  20549
 
 AMENDMENT NO. 1 TO
FORM 8-K/A

CURRENT REPORT
 
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
 
Date of Report (date of earliest event reported): February 21, 2017
https://cdn.kscope.io/df8b54983127f0462fd54c09c7a34872-a2015mmsilogoaa16.jpg 
Merit Medical Systems, Inc.
(Exact name of registrant as specified in its charter)
 
Utah
 
0-18592
 
87-0447695
(State or other jurisdiction of
 
(Commission
 
(I.R.S. Employer
incorporation or organization)
 
File Number)
 
Identification No.)
 
1600 West Merit Parkway
 
 
South Jordan, Utah
 
84095
(Address of principal executive offices)
 
(Zip Code)
 
(801) 253-1600
(Registrant's telephone number, including area code)
 
N/A
(Former name or former address, if changed since last report)

 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
 
o            Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
o            Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
o            Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
o            Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))




Item 9.01.       Financial Statements and Exhibits.

 On February 21, 2017, Merit Medical Systems, Inc. (the “Company”) filed a Current Report on Form 8-K (the “Initial Report”) in which it (a) furnished, under Item 2.02, a press release announcing the Company’s operating and financial results for the quarter and year ended December 31, 2016 (the “Release”), and (b) furnished, under Item 7.01, a presentation discussing the Company's operating and financial results for the quarter and year ended December 31, 2016 (the “Presentation”). The Company is filing this Amendment No. 1 on Form 8-K/A (this “Amendment”) in order to furnish the Press Release and the Presentation with corrected entries in two line items of the table providing a reconciliation of GAAP and non-GAAP net income for the year ended December 31, 2016. The corrections do not affect the GAAP or non-GAAP numbers highlighted in the text of the Release or the Presentation.

The updated Exhibits furnished in Item 9.01 herewith supersede in their entirety the Exhibits furnished in Item 9.01 with the Initial Report. The information in this Amendment (including the exhibits furnished herewith) is furnished, pursuant to General Instruction B.2. of Form 8-K and shall not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended (the "Securities Act"), or the Exchange Act, except as expressly set forth by specific reference in such a filing.

(d)            Exhibits

99.1 Press Release, dated February 21, 2017, entitled "Merit Medical Reports Results for Fourth Quarter and Year Ended December 31, 2016," including unaudited financial information.
99.2 Conference Call Presentation.



2



SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this Amendment No. 1 to Current Report to be signed on its behalf by the undersigned hereunto duly authorized.
 
 
MERIT MEDICAL SYSTEMS, INC.
 
 
 
 
 
 
Date: February 24, 2017
By:
/s/ Brian G. Lloyd
 
 
Brian G. Lloyd
 
 
Chief Legal Officer and Corporate Secretary
 



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EXHIBIT INDEX
 
 
EXHIBIT 
NUMBER
 
DESCRIPTION
99.1
 
Press Release, dated February 21, 2017, entitled "Merit Medical Reports Results for Fourth Quarter and Year Ended December 31, 2016," including unaudited financial information
99.2
 
Conference Call Presentation.
 



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Exhibit


 Exhibit 99.1

https://cdn.kscope.io/df8b54983127f0462fd54c09c7a34872-bannera18.jpg
FOR IMMEDIATE RELEASE


Date:
February 21, 2017
Contact:
Anne-Marie Wright, Vice President, Corporate Communications
Phone:
(801) 208-4167 e-mail: awright@merit.com Fax: (801) 253-1688

Merit Gives 2017 Guidance

Q4 worldwide revenue of $157.7 million ($159.0 million on a comparable, constant currency* basis), up 14.0% as reported (up 14.9% on a comparable, constant currency* basis) over Q4 2015
FY16 worldwide revenue of $603.8 million ($608.8 million on a comparable, constant currency* basis), up 11.4% as reported (up 12.3% on a comparable, constant currency* basis)
Q4 core revenue* up 7.9% over Q4 2015; FY16 core revenue* up 7.6% over FY15
Q4 GAAP EPS was $0.17; Q4 non-GAAP EPS* was $0.31
FY16 GAAP EPS was $0.45; FY16 non-GAAP EPS* was $1.01
Q4 2016 GAAP gross margin was 44.5%, compared to 43.6% in Q4 2015; Q4 2016 non-GAAP gross margin* was 48.4%, compared to 45.6% for Q4 2015
* Constant currency revenue, core revenue, non-GAAP EPS, non-GAAP gross margin and non-GAAP net income (referenced on the following page) are non-GAAP financial measures. A reconciliation of these and other non-GAAP financial measures used in this release to their most directly comparable GAAP financial measure is included under the heading “Non-GAAP Financial Measures” below.

SOUTH JORDAN, UTAH- Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading manufacturer and marketer of proprietary disposable devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology and endoscopy, today announced sales of $157.7 million for the quarter ended December 31, 2016, an increase of 14.0% over sales of $138.4 million for the quarter ended December 31, 2015. On a constant currency basis, sales for the fourth quarter of 2016 would have been up 14.9% over sales for the comparable quarter of 2015. For the year ended December 31, 2016, Merit’s sales were $603.8 million, an increase of 11.4% over sales of $542.1 million, for the year ended December 31, 2015. On a




constant currency basis, sales for the year ended December 31, 2016 would have been up 12.3% over sales for 2015.

Merit’s GAAP net income for the fourth quarter of 2016 was $7.5 million, or $0.17 per share, compared to $6.4 million, or $0.14 per share, for the fourth quarter of 2015, up primarily due to decreases in SG&A and R&D expenses as a percentage of sales, partially offset by increased interest expense due to higher debt balances, primarily as a result of Merit’s acquisition of DFINE Inc. in July 2016. Merit’s non-GAAP net income* for the quarter ended December 31, 2016 was $13.8 million, or $0.31 per share, up 28.2% compared to $10.8 million, or $0.24 per share, for the quarter ended December 31, 2015.
  
Merit’s GAAP net income for the year ended December 31, 2016 was $20.1 million, or $0.45 per share, compared to $23.8 million, or $0.53 per share, for the year ended December 31, 2015, down primarily as a result of restructuring costs related to the acquisition of DFINE in July 2016. Merit’s non-GAAP net income* for the year ended December 31, 2016 was $45.1 million, or $1.01 per share, up 17.1% compared to $38.5 million, or $0.87 per share, for 2015.

Merit’s sales by category for the three and twelve months ended December 31, 2016, compared to the corresponding periods in 2015, were as follows:

 
Three Months Ended December 31,
 
Twelve Months Ended December 31,
 
 
 
% Change
 
2016
 
2015
 
% Change
 
2016
 
2015
Cardiovascular
 
 
 
 
 
 
 
 
 
 
 
Stand-alone devices
28.8
%
 
$
51,902

 
$
40,289

 
24.5
%
 
$
193,517

 
$
155,414

Custom kits and procedure trays
5.5
%
 
30,219

 
28,631

 
2.6
%
 
119,392

 
116,368

Inflation devices
5.8
%
 
19,145

 
18,088

 
0.7
%
 
73,919

 
73,373

Catheters
16.3
%
 
28,659

 
24,650

 
14.6
%
 
110,939

 
96,833

Embolization devices
3.4
%
 
12,098

 
11,702

 
2.2
%
 
46,035

 
45,025

CRM/EP
5.6
%
 
9,558

 
9,048

 
7.5
%
 
36,446

 
33,902

Total
14.5
%
 
151,581

 
132,408

 
11.4
%
 
580,248

 
520,915

 
 
 
 
 
 
 
 
 
 
 
 
Endoscopy
 
 
 
 
 
 
 
 
 
 
 
Endoscopy devices
2.3
%
 
6,134

 
5,996

 
11.1
%
 
23,590

 
21,234

 
 
 
 
 
 
 
 
 
 
 
 
Total
14
%
 
$
157,715

 
$
138,404

 
11.4
%
 
$
603,838

 
$
542,149




2



“We are pleased to complete year two of our three-year plan,” said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer. “With the introduction of a number of new products in the beginning of 2017, we look forward to continued growth accompanied by continued expansion of gross margins and profits.”

“We believe the recently announced acquisitions of an Argon Medical Devices business unit and Catheter Connections serve both tactical and strategic objectives,” Lampropoulos said. “We believe the Argon transaction will enable us to participate in tenders which previously were not available due to vacancies in our product line, especially reusable transducers. Additionally, we recently came to a preliminary agreement with our longstanding Japanese distributor to transfer licenses and customers to us. Almost 50% of the Argon business we acquired is sold in Japan and other parts of Asia. We intend to combine the acquired Argon business and the Merit-branded products into one business. When completed, we believe the new combined business unit will substantially improve our growth prospects in Japan.”

“We believe the Catheter Connections products complement the Argon products and provide a substantial value proposition to both domestic hospitals as well as international opportunities,” Lampropoulos continued. “We expect that this product line, which has had substantial distribution gaps globally, will enhance company growth and profits as we integrate the injection molding and a portion of manufacturing. We have already initiated new product development in both of the acquired businesses.”

2017 GUIDANCE
Based upon information currently available to Merit's management, Merit estimates that for the year ending December 31, 2017, absent material acquisitions or non-recurring transactions, Merit's revenues will be in the range of $713-$723 million, an increase of approximately 18-20%, compared to revenues of $603.8 million for the year ended December 31, 2016. Also, based on information currently available to Merit's management, Merit estimates that, absent material acquisitions or non-recurring transactions, Merit's GAAP earnings per share for 2017 will be in the range of $0.54-$0.60 and non-GAAP* earnings per share will be in the range of $1.15-$1.20. Merit’s financial guidance for the year ending December 31, 2017 is subject to risks and uncertainties, including, but not limited to, potential accounting adjustments attributable to Merit’s ongoing valuation of intangibles and other financial assets acquired from Argon Medical Devices, Inc. and Catheter Connections, Inc., as well as risks and uncertainties identified in Merit’s public filings.

CONFERENCE CALL
Merit will hold its investor conference call (conference ID 62632957) today, Tuesday, February 21, 2017, at 5:00 p.m. Eastern (4:00 p.m. Central, 3:00 p.m. Mountain, and 2:00 p.m. Pacific). The domestic telephone

3



number is (844) 578-9672, and the international number is (508) 637-5656. A live webcast will also be available for the conference call at merit.com.



4



BALANCE SHEET
(In thousands)
                  
 
December 31, 2016 (Unaudited)
 
December 31, 2015
 
 
ASSETS
 
 
 
Current Assets
 
 
 
  Cash and cash equivalents
$
19,171

 
$
4,177

  Trade receivables, net
80,521

 
70,292

  Employee receivables
198

 
217

  Other receivables
5,445

 
6,799

  Inventories
120,695

 
105,999

  Prepaid expenses and other assets
6,226

 
5,634

  Prepaid income taxes
2,525

 
2,955

  Deferred income tax assets
8,219

 
7,025

  Income tax refunds receivable
423

 
905

    Total Current Assets
243,423

 
204,003

 
 
 
 
 Property and equipment, net
276,573

 
267,778

 Intangibles, net
181,697

 
109,354

 Goodwill
211,927

 
184,472

 Deferred income tax assets
171

 
 
 Other assets
29,012

 
13,121

Total Assets
$
942,803

 
$
778,728

 
 
 
 
LIABILITIES AND STOCKHOLDERS' EQUITY
 
 
 
Current Liabilities
 
 
 
  Trade payables
30,619

 
37,977

  Accrued expenses
44,947

 
37,846

  Current portion of long-term debt
10,000

 
10,000

  Advances from employees
572

 
589

  Income taxes payable
2,193

 
1,498

   Total Current Liabilities
88,331

 
87,910

 
 
 
 
Deferred income tax liabilities
25,981

 
10,985

Liabilities related to unrecognized tax benefits
438

 
768

Deferred compensation payable
9,211

 
8,500

Deferred credits
2,550

 
2,721

Long-term debt
314,373

 
197,593

Other long-term obligations
3,730

 
4,148

   Total Liabilities
444,614

 
312,625

 
 
 
 
Stockholders' Equity
 
 
 
  Common stock
206,186

 
197,826

  Retained earnings
293,885

 
273,764

  Accumulated other comprehensive loss
(1,882
)
 
(5,487
)
  Total stockholders' equity
498,189

 
466,103

Total Liabilities and Stockholders' Equity
$
942,803

 
$
778,728

 
 
 
 

5



INCOME STATEMENT
(Unaudited, in thousands except per share amounts)
 
Three Months Ended
 
Year Ended
 
December 31,
 
December 31,
 
2016
 
2015
 
2016
 
2015
 
 
 
 
 
 
 
 
SALES
$
157,715

 
$
138,404

 
$
603,838

 
$
542,149

 
 
 
 
 
 
 
 
COST OF SALES
87,460

 
78,097

 
338,813

 
306,368

 
 
 
 
 
 
 
 
GROSS PROFIT
70,255

 
60,307

 
265,025

 
235,781

 
 
 
 
 
 
 
 
OPERATING EXPENSES
 
 
 
 
 
 
 
  Selling, general and administrative
45,839

 
40,941

 
184,398

 
156,348

  Research and development
11,792

 
11,421

 
45,229

 
40,810

  Contingent consideration expense (benefit)
(38
)
 
(105
)
 
61

 
80

  Acquired in-process research and development
61

 

 
461

 
1,000

    Total
57,654

 
52,257

 
230,149

 
198,238

 
 
 
 
 
 
 
 
INCOME FROM OPERATIONS
12,601

 
8,050

 
34,876

 
37,543

 
 
 
 
 
 
 
 
OTHER INCOME (EXPENSE)
 
 
 
 
 
 
 
  Interest income
26

 
62

 
81

 
272

  Interest (expense)
(2,678
)
 
(1,453
)
 
(8,798
)
 
(6,229
)
  Other income (expense)
(327
)
 
(105
)
 
(773
)
 
(386
)
    Total other (expense) - net
(2,979
)
 
(1,496
)
 
(9,490
)
 
(6,343
)
 
 
 
 
 
 
 
 
INCOME BEFORE INCOME TAXES
9,622

 
6,554

 
25,386

 
31,200

 
 
 
 
 
 
 
 
INCOME TAX EXPENSE
2,116

 
145

 
5,265

 
7,398

 
 
 
 
 
 
 
 
NET INCOME
$
7,506

 
$
6,409

 
$
20,121

 
$
23,802

 
 
 
 
 
 
 
 
EARNINGS PER COMMON SHARE-
 
 
 
 
 
 
 
     Basic
$
0.17

 
$
0.14

 
$
0.45

 
$
0.54

 
 
 
 
 
 
 
 
     Diluted
$
0.17

 
$
0.14

 
$
0.45

 
$
0.53

 
 
 
 
 
 
 
 
AVERAGE COMMON SHARES-
 
 
 
 
 
 
 
     Basic
44,601

 
44,216

 
44,408

 
44,036

 
 
 
 
 
 
 
 
     Diluted
45,165

 
44,642

 
44,862

 
44,511

 
 
 
 
 
 
 
 


6



Non-GAAP Financial Measures
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 referred to in this release 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. Non-GAAP financial measures used in this release include:
constant currency revenue;
core revenue;
non-GAAP net income;
non-GAAP earnings per share; and
non-GAAP gross margin.
Merit’s management team uses these non-GAAP financial measures to evaluate Merit’s profitability and efficiency, to compare operating results to prior periods, to evaluate changes in the operating results of each segment, and to measure and allocate financial resources internally. However, Merit’s management does not consider such non-GAAP measures in isolation or as an alternative to such measures determined in accordance with GAAP.

Readers should consider non-GAAP measures used in this release 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 may affect Merit's net income. In addition, they are subject to inherent limitations as they reflect the exercise of judgment by management about which items are excluded. Merit believes it is useful to exclude such expenses in the calculation of non-GAAP net income, non-GAAP gross margin and non-GAAP earnings per share (in each case, as further illustrated in the reconciliation table below) because such amounts in any specific period may not directly correlate to the underlying performance of Merit’s business operations and can vary significantly between periods as a result of factors such as new acquisitions, non-cash expense related to amortization of previously acquired tangible and intangible assets, unusual compensation expenses or expense resulting from litigation or governmental proceedings. Merit may incur similar types of expenses in the future, and the non-GAAP financial information included in this release should not be viewed as a statement or indication that these types of expenses will not recur. Additionally, the non-GAAP financial measures used in this release may not be comparable with similarly titled measures of other companies. Merit urges investors and potential investors to review the reconciliations of its non-GAAP financial measures to the comparable GAAP financial measures, and not to rely on any single financial measure to evaluate Merit’s business or results of operations.


7



Constant Currency Reconciliation
Merit’s revenue on a constant currency basis is prepared by translating the current-period reported sales of subsidiaries whose functional currency is other than the U.S. dollar at the applicable foreign exchange rates in effect during the comparable prior-year period. The constant currency revenue adjustments of $1.3 million and $4.9 million for the three and twelve-month periods ended December 31, 2016, respectively, were calculated using the applicable average foreign exchange rates for the three and twelve-month periods ended December 31, 2015.

Core Revenue
Merit’s core revenue is defined as reported revenue excluding revenues from the acquisitions of the HeRO® Graft and DFINE, Inc. in 2016.

Other Non-GAAP Financial Measure Reconciliation
The following table sets forth supplemental financial data and corresponding reconciliations of non-GAAP net income and non-GAAP earnings per share to Merit’s net income and earnings per share prepared in accordance with GAAP, in each case, for the three and twelve-month periods ended December 31, 2016 and 2015. Non-GAAP gross margin is calculated by reducing GAAP cost of sales by amounts recorded for amortization of intangible assets, inventory mark-up and severance expense related to acquisitions. The non-GAAP income adjustments referenced in the following table do not reflect stock-based compensation expense of approximately $593,000 and $600,000 for the three-month periods ended December 31, 2016 and 2015, respectively, and approximately $2.5 million and $2.2 million for the twelve-month periods ended December 31, 2016 and 2015, respectively.

8



CONSOLIDATED STATEMENTS OF OPERATIONS - NON-GAAP
 
 
 
FOR THE THREE AND TWELVE MONTHS ENDED DECEMBER 31, 2016 AND 2015 (Unaudited)
 
In thousands, except per share data
 
 
 
 
 
Three Months Ended
 
December 31, 2016
 
Pre-Tax
Tax Impact (a)
After-Tax
Per Share Impact
GAAP net income
$
9,622

$
(2,116
)
$
7,506

$
0.17

 
 
 
 
 
Non-GAAP adjustments:
 
 
 
 
    Cost of Sales
 
 
 
 
        Amortization of intangibles
4,434

(1,653
)
2,781

0.06

        Inventory mark-up related to acquisition
1,581

(615
)
966

0.02

    Selling, General & Administrative
 
 
 


        Severance
848

(330
)
518

0.01

        Acquisition-related (c)
753

(266
)
487

0.01

        Fair value adjustment to contingent consideration (d)
(38
)
15

(23
)
      (0.00)

        Long-term asset impairment charge (b)
13

(5
)
8

0.00

        Acquired in-process research & development
61

(24
)
37

0.00

        Amortization of intangibles
1,298

(499
)
799

0.02

        Special legal expense (f)
1,016

(395
)
621

0.01

    Other Income
 
 
 
 
        Amortization of long-term debt issuance costs
172

(67
)
105

0.00

 
 
 
 
 
Adjusted net income
$
19,760

$
(5,955
)
$
13,805

$
0.31

 
 
 
 
 
Diluted shares
 
 
 
45,165

 
Three Months Ended
 
December 31, 2015
 
Pre-Tax
Tax Impact (a)
After-Tax
Per Share Impact
GAAP net income
$
6,554

$
(145
)
$
6,409

$
0.14

 
 
 
 
 
Non-GAAP adjustments:
 
 
 
 
    Cost of Sales
 
 
 
 
        Amortization of intangibles
2,857

(1,041
)
1,816

0.04

    Selling, General & Administrative
 
 
 
 
        Severance
1,217

(473
)
744

0.02

        Acquisition-related (c)
1,841

(716
)
1,125

0.03

        Fair value adjustment to contingent consideration (d)
(105
)
41

(64
)
      (0.00)

        Long-term asset impairment charge (b)
42

(16
)
26

0.00

        Acquired in-process research & development




        Amortization of intangibles
910

(347
)
563

0.01

    Other Income
 
 
 
 
        Amortization of long-term debt issuance costs
246

(96
)
150

0.00

 
 
 
 
 
Adjusted net income
$
13,562

$
(2,794
)
$
10,768

$
0.24

 
 
 
 
 
Diluted shares
 
 
 
44,642

 
 
 
 
 
(continued)
 
 
 
 

9



In thousands, except per share data
 
 
 
 
 
Year Ended
 
December 31, 2016
 
Pre-Tax
Tax Impact (a)
After-Tax
Per Share Impact
GAAP net income
$
25,386

$
(5,265
)
$
20,121

$
0.45

 
 
 
 
 
Non-GAAP adjustments:
 
 
 
 
    Cost of Sales
 
 
 
 
        Amortization of intangibles
15,122

(5,592
)
9,530

0.21

        Inventory mark-up related to acquisition
2,990

(1,163
)
1,827

0.04

        Severance
56

(22
)
34

0.00

    Selling, General & Administrative
 
 
 
 
        Severance
10,271

(3,878
)
6,393

0.14

        Acquisition-related (c)
4,503

(1,448
)
3,055

0.07

        Fair value adjustment to contingent consideration (d)
61

(24
)
37

0.00

        Long-term asset impairment charge (b)
100

(38
)
62

0.00

        Acquired in-process research & development
461

(179
)
282

0.01

        Amortization of intangibles
4,167

(1,595
)
2,572

0.06

        Special legal expense (f)
1,016

(395
)
621

0.01

    Other Income
 
 
 
 
        Amortization of long-term debt issuance costs
952

(370
)
582

0.01

 
 
 
 
 
Adjusted net income
$
65,085

$
(19,969
)
$
45,116

$
1.01

 
 
 
 
 
Diluted shares
 
 
 
$
44,862.00

 
 
 
 
 
 
Year Ended
 
December 31, 2015
 
Pre-Tax
Tax Impact (a)
After-Tax
Per Share Impact
GAAP net income
$
31,200

$
(7,398
)
$
23,802

$
0.53

 
 
 
 
 
Non-GAAP adjustments:
 
 
 
 
    Cost of Sales
 
 
 
 
        Amortization of intangibles
11,255

(3,779
)
7,476

0.17

    Selling, General & Administrative
 
 
 
 
        Severance
2,934

(1,141
)
1,793

0.04

        Acquisition-related (c)
2,305

(897
)
1,408

0.03

        Fair value adjustment to contingent consideration (d)
80

(31
)
49

0.00

        Long-term asset impairment charge (b)
141

(55
)
86

0.00

        Acquired in-process research & development
1,000

(389
)
611

0.01

        Amortization of intangibles
3,563

(1,359
)
2,204

0.05

        Termination fee (e)
800

(311
)
489

0.01

    Other Income
 
 
 
 
        Amortization of long-term debt issuance costs
987

(384
)
603

0.01

 
 
 
 
 
Adjusted net income
$
54,265

$
(15,744
)
$
38,521

$
0.87

 
 
 
 
 
Diluted shares
 
 
 
44,511

 
 
 
 
 
(concluded)
 
 
 
 

10




(a)
Reflects the tax effect of the non-GAAP adjustments
(b)
Represents abandoned patents
(c)
Represents costs related to acquisitions
(d)
Represents changes in the fair value of contingent consideration liabilities and contingent receivables as a result of acquisitions
(e)
Costs associated with the termination of our agreement with a third-party contract manufacturer in Tijuana, Mexico
(f)
Costs incurred in responding to an inquiry from the U.S. Department of Justice

Reconciliation of Reported Revenue to Core Revenue (Non-GAAP)
 
 
 
 
For the three and twelve months ended December 31, 2016
 
 
 
 
(Unaudited, in thousands)
 
 
 
 
 
 
 
 
 
 
 
 
 
Three months ended December 31,
 
Twelve months ended December 31,
 
% Change
2016
2015
 
% Change
2016
2015
Reported Revenue
 
$
157,715

$
138,404

 
 
$
603,838

$
542,149

 
 
 
 
 
 
 
 
LESS Sales from:
 
 
 
 
 
 
 
Hero/DFINE*
 
                8,355


 
 
              20,579


 
 
 
 
 
 
 
 
Core Revenue
7.9%
$
149,360

$
138,404

 
7.6%
$
583,259

$
542,149

 
 
 
 
 
 
 
 
* Represents the combined sales from the acquisitions of the Hero Graft in February 2016 and DFINE Inc. in July 2016


11



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, diagnostic and therapeutic 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 4,500 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Malvern, Pennsylvania; Rockland, Massachusetts; San Jose, California; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Markham, Ontario, Canada; Melbourne, Australia; Tokyo, Japan; and Singapore.

FORWARD-LOOKING STATEMENTS
Statements contained in this release which are not purely historical, including, without limitation, statements regarding Merit's forecasted plans, revenues, net income, financial results or anticipated or completed 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, 2015 and Quarterly Reports on Form 10-Q filed during 2016.  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; governmental scrutiny and regulation of the medical device industry, including governmental inquiries, investigations and proceedings involving Merit; reforms to the 510(k) process administered by the U.S. Food and Drug Administration; restrictions on Merit's liquidity or business operations resulting from its current debt agreements; 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 or regulations; laws and regulations targeting fraud and abuse in the healthcare industry; potential for significant adverse changes in governing regulations; 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 or other countries; termination or interruption of relationships with Merit's suppliers, or failure of such suppliers to perform; fluctuations in exchange rates; concentration of a substantial portion 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 healthcare policies or markets related to healthcare reform initiatives; failure to comply with applicable environmental laws; changes in key personnel; work stoppage or transportation risks; introduction of products in a timely fashion; price and product competition; availability of labor and materials; fluctuations in and obsolescence of inventory; and other factors referred to in Merit's Annual

12



Report on Form 10-K for the year ended December 31, 2015 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 likely 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.

TRADEMARKS
Unless noted otherwise, trademarks and registered trademarks used in this release are the property of Merit Medical Services, Inc., in the United States and other jurisdictions.


# # #
 

13
a4q2016slidedeckamended
1 Fourth Quarter and FY2016 Results 2017 Guidance FRED LAMPROPOULOS Chairman & CEO BERNARD BIRKETT CFO EXHIBIT 99.2


 
2 DISCLOSURE REGARDING FORWARD-LOOKING STATEMENTS This presentation and any accompanying management commentary include “forward-looking statements,” as defined within applicable securities laws and regulations. All statements in this presentation, other than statements of historical fact, are “forward-looking statements”, including projections of earnings, revenues or other financial items, statements regarding our plans and objectives for future operations, statements concerning proposed products or services, statements regarding the integration, development or commercialization of our business or any business, assets or operations we have acquired or may acquire, statements regarding future economic conditions or performance, statements regarding governmental inquiries, investigations or proceedings and statements of assumptions underlying any of the foregoing. All forward-looking statements, including financial projections, included in this presentation are made as of the date of this presentation, and are based on information available to us as of such date. We assume no obligation to update or disclose revisions to any forward-looking statement. In some cases, forward-looking statements can be identified by the use of terminology such as “may,” “will,” “likely,” “expects,” “plans,” “anticipates,” “intends,” “believes,” “estimates,” “projects,” ”forecast,” “potential,” “plan,” or other comparable terminology. Forward-looking statements are based on our current beliefs, expectations and assumptions regarding our business, domestic and global economies, regulatory and competitive environments and other conditions. There can be no assurance that such beliefs, expectations or assumptions or any of the forward-looking statements will prove to be correct. Actual results will likely differ, and may differ materially, from those projected or assumed in the forward-looking statements. Our future financial and operating results and condition, as well as any forward-looking statements, are subject to inherent risks and uncertainties such as those described in our Annual Report on Form 10-K for the year ended December 31, 2015 and other filings with the U.S. Securities and Exchange Commission. Such risks and uncertainties include risks relating to our 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 approvals of our products and risks that such products may not be developed successfully or approved for commercial use; governmental scrutiny and regulation of the medical device industry, including governmental inquiries, investigations or proceedings; reforms to the 510(k) process administered by the U.S. Food and Drug Administration; restrictions on our liquidity or business operations resulting from our debt agreements; infringement of our technology or the assertion that our technology infringes the rights of other parties; the potential of fines, penalties or other adverse consequences if our employees or agents violate the U.S. Foreign Corrupt Practices Act or other laws or regulations; laws and regulations targeting fraud and abuse in the healthcare industry; potential for significant adverse changes in governing regulations; 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 or other countries; termination or interruption of relationships with our suppliers, or failure of such suppliers to perform; fluctuations in exchange rates; concentration of a substantial portion of our revenues among a few products and procedures; development of new products and technology that could render our existing products obsolete; market acceptance of new products; volatility in the market price of our common stock; modification or limitation of governmental or private insurance reimbursement policies; changes in healthcare policies or markets related to healthcare reform initiatives; failure to comply with applicable environmental laws; changes in key personnel; work stoppage or transportation risks; introduction of products in a timely fashion; price and product competition; availability of labor and materials; and fluctuations in and obsolescence of inventory. All forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by these cautionary statements. The financial projections set forth in this presentation are based on a number of assumptions, estimates and forecasts. The inaccuracy of any one of those assumptions, estimates or forecasts could materially impact our financial results. Inevitably, some of those assumptions, estimates or forecasts will not occur and unanticipated events and circumstances will occur subsequent to the date of this presentation. In addition to changes in the underlying assumptions, our future performance is subject to a number of risks and uncertainties with respect to our existing and proposed business, and other factors that may cause our actual results or performance to be materially different from any predicted or implied. Although we have attempted to identify important assumptions in the financial projections, there may be other factors that could materially affect our actual financial performance, and no assurance can be given that all material factors have been considered in the preparation of the financial projections. Accordingly, you should not place undue reliance on such projections. Future operating results are, in fact, impossible to predict.


 
3 NON-GAAP FINANCIAL MEASURES 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. Certain financial measures included in this presentation, or which may be referenced in management’s discussion of Merit’s historical and future operations and financial results, have not been calculated in accordance with GAAP, and, therefore, are referenced as non-GAAP financial measures. Readers should consider non-GAAP measures used in this presentation 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 may affect Merit's net income. In addition, they are subject to inherent limitations as they reflect the exercise of judgment by management about which items are excluded. Additionally, non-GAAP financial measures used in this presentation may not be comparable with similarly titled measures of other companies. Merit urges investors and potential investors to review the reconciliations of its non-GAAP financial measures to the comparable GAAP financial measures, and not to rely on any single financial measure to evaluate Merit’s business or results of operations. Please refer to “Notes to Non-GAAP Financial Measures” at the end of these materials for more information. TRADEMARKS Unless noted otherwise, trademarks used in this presentation are the property of Merit Medical Systems, Inc., in the United States and other jurisdictions.


 
4 Financial Summary GAAP Q4 2016 Q4 2015 FY2016 FY2015 Revenue $157.7M $138.4M $603.8M $542.1M Gross Margin 44.5% 43.6% 43.9% 43.5% Net Income $7.5M $6.4M $20.1M $23.8M EPS $0.17 $0.14 $0.45 $0.53


 
5 Financial Summary Non-GAAP Q4 2016 Q4 2015 FY2016 FY2015 Revenue (Constant Currency) $159.0M $138.4M $608.8M $542.1M Revenue (Reported) $157.7M $138.4M $603.8M $542.1M Gross Margin 48.4% 45.6% 46.9% 45.6% Net Income $13.8M $10.8M $45.1M $38.5M EPS $0.31 $0.24 $1.01 $0.87


 
6 Q4 2016 Revenue by Market United States 59.2% (59.7% GAAP) Other International 24.2% (24.0% GAAP) EMEA 16.6% (16.3% GAAP) Q4 2016 Revenue by Market in Constant Currency 11.7% 23.8% 9.4% 11.7% 25.9% 12.2% 0.0% 5.0% 10.0% 15.0% 20.0% 25.0% 30.0% Revenue Growth: Q416 to Q415 United States Other International EMEA


 
7 2016 YTD Revenue by Market United States Other International EMEA 2016 Revenue by Market in Constant Currency 12.9% 15.1% 1.3% 12.9% 16.6% 4.6% 0.0% 2.0% 4.0% 6.0% 8.0% 10.0% 12.0% 14.0% 16.0% 18.0% Revenue Growth: 2016 to 2015


 
8 Global Reach


 
9 Growth Drivers for 2017 • New Products - CorVocet™ Biopsy System - SwiftNINJA® Steerable Microcatheter - Elation™ GI & Pulmonary Balloons - TWISTER® PLUS Rotatable Retrieval Device - PreludeEASE™ Hydrophilic Sheath Introducer - PreludeSync™ Radial Compression Device


 
10 Growth Drivers for 2017 • New Products - HeRO® Graft - Super HeRO® - True Form™ Guide Wires - Heartspan® Transseptal Sheath - Amplatz Guide Wires - Merit PAK™ Pedal Access • Wholesale to Retail - Japan


 
11 Growth Drivers for 2017 • New Products - Critical Care Products from Argon® - DualCap® Disinfection & Protection


 
12 2017 Guidance Revenues $713M - $723M Gross Margin GAAP 45.0% - 45.5% Gross Margin Non-GAAP 48.0% - 48.5% EPS GAAP $0.54 - $0.60 EPS Non-GAAP $1.15 - $1.20


 
13 1 2 3 4 Disciplined, customer-focused enterprise Guided by strong core values to globally address unmet or underserved healthcare needs Target high-growth, high-return opportunities Through understanding, innovating, and delivering in peripheral, cardiac, OEM, and endoscopy business lines Optimize operational capability Through lean processes, cost effective environments, and asset utilization Enhance growth and profitability Through R&D, sales model optimization, cost discipline, and operational focus


 
14 NOTES TO NON-GAAP FINANCIAL MEASURES For additional details, please see the accompanying press release and forward-looking statement disclosure. These presentation materials and associated commentary from Merit’s management, as well as the press release issued today, use non-GAAP financial measures, including: • constant currency revenue; • core revenue; • non-GAAP net income; • non-GAAP earnings per share; and • non-GAAP gross margin. Merit’s management team uses these non-GAAP financial measures to evaluate Merit’s profitability and efficiency, to compare operating results to prior periods, to evaluate changes in the operating results of each segment, and to measure and allocate financial resources internally. However, Merit’s management does not consider such non-GAAP measures in isolation or as an alternative to such measures determined in accordance with GAAP. Readers should consider 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 may affect Merit's net income. In addition, they are subject to inherent limitations as they reflect the exercise of judgment by management about which items are excluded. Merit believes it is useful to exclude such expenses in the calculation of non-GAAP net income, non-GAAP earnings per share and non-GAAP gross margin (in each case, as further illustrated in the reconciliation table below) because such amounts in any specific period may not directly correlate to the underlying performance of Merit’s business operations and can vary significantly between periods as a result of factors such as new acquisitions, non-cash expense related to amortization of previously acquired tangible and intangible assets, unusual compensation expenses or expenses resulting from litigation or governmental proceedings. Merit may incur similar types of expenses in the future, and the non-GAAP financial information included in this presentation should not be viewed as a statement or indication that these types of expenses will not recur. Additionally, the non-GAAP financial measures used in this presentation may not be comparable with similarly titled measures of other companies. Merit urges investors and potential investors to review the reconciliations of its non-GAAP financial measures to the comparable GAAP financial measures, and not to rely on any single financial measure to evaluate Merit’s business or results of operations. Constant Currency Reconciliation Merit’s revenue on a constant currency basis is prepared by translating the current-period reported sales of subsidiaries whose functional currency is other than the U.S. dollar at the applicable foreign exchange rates in effect during the comparable prior-year period. The constant currency revenue adjustments of $1.3 million and $4.9 million for the three and twelve-month periods ended December 31, 2016, respectively, were calculated using the applicable average foreign exchange rates for the three and twelve-month periods ended December 31, 2015.


 
15 NOTES TO NON-GAAP FINANCIAL MEASURES (continued) Core Revenue Merit’s core revenue is defined as reported revenue, excluding revenues attributable to the acquisition of the HeRO® Graft and DFINE, Inc. in 2016. Other Non-GAAP Financial Measure Reconciliation The following table sets forth supplemental financial data and corresponding reconciliations of non-GAAP net income and non-GAAP earnings per share to Merit’s net income and earnings per share prepared in accordance with GAAP, in each case, for the three and twelve-month periods ended December 31, 2016 and 2015. Non-GAAP gross margin is calculated by reducing GAAP cost of sales by amounts recorded for amortization of intangible assets, inventory mark-up and severance expense related to acquisitions. The non-GAAP income adjustments referenced in the following table do not reflect stock-based compensation expense of approximately $593,000 and $600,000 for the three-month periods ended December 31, 2016 and 2015, respectively, and approximately $2.5 million and $2.2 million for the twelve-month periods ended December 31, 2016 and 2015, respectively.


 
16


 
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