EX-99.1 2 a02242017-8kpressreleaseex.htm EXHIBIT 99.1
Exhibit 99.1
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 |

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“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
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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.
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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 |

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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 |

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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.
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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.
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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) |  |  |  |

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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) |  |  |  |

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(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

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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, 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
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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.
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