Merit Medical Reports Results for Quarter Ended June 30, 2021

Merit Medical Systems, Inc.
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In this article:

  • Q2 2021 reported revenue of $280.3 million, up 28.4% compared to Q2 2020

  • Q2 2021 constant currency revenue, organic* up 25.5% compared to Q2 2020

  • Q2 2021 GAAP EPS of $0.09, compared to GAAP loss per share of ($0.34) in Q2 2020

  • Q2 2021 non-GAAP EPS* of $0.62, compared to $0.31 in Q2 2020

* Constant currency revenue; constant currency revenue, organic; core revenue; non-GAAP EPS; non-GAAP net income; non-GAAP operating income and margin; non-GAAP gross margin; and free cash flow are non-GAAP financial measures. A reconciliation of these financial measures to their most directly comparable GAAP financial measures is included under the heading “Non-GAAP Financial Measures” below.

SOUTH JORDAN, Utah, July 29, 2021 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading manufacturer and marketer of proprietary medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy, today announced revenue of $280.3 million for the quarter ended June 30, 2021, an increase of 28.4% compared to the quarter ended June 30, 2020. Constant currency revenue, organic* for the second quarter of 2021 was up 25.5% compared to the prior year period.

Merit’s GAAP gross margin for the second quarter of 2021 was 44.3%, compared to GAAP gross margin of 38.6% for the prior year period. Merit’s non-GAAP gross margin* for the second quarter of 2021 was 48.7%, compared to non-GAAP gross margin* of 44.7% for the prior year period.

Merit’s GAAP net income for the second quarter of 2021 was $4.9 million, or $0.09 per share, compared to a GAAP net loss of ($19.1) million, or ($0.34) per share, for the second quarter of 2020. Merit’s non-GAAP net income* for the second quarter of 2021 was $35.3 million, or $0.62 per share, compared to non-GAAP net income* of $17.4 million, or $0.31 per share, for the prior year period.

Merit’s revenue by operating segment and product category for the three and six-month periods ended June 30, 2021, compared to the corresponding periods in 2020, was as follows (unaudited; in thousands, except for percentages):

Three Months Ended

Six Months Ended

June 30,

June 30,

% Change

2021

2020

% Change

2021

2020

Cardiovascular

Peripheral Intervention

45.4

%

$

105,600

$

72,635

24.3

%

$

198,514

$

159,710

Cardiac Intervention

29.8

%

85,653

66,005

15.7

%

160,390

138,596

Custom Procedural Solutions

7.3

%

48,636

45,319

1.2

%

94,057

92,940

OEM

14.8

%

32,403

28,218

6.8

%

60,337

56,475

Total

28.3

%

272,292

212,177

14.6

%

513,298

447,721

Endoscopy

Endoscopy devices

29.7

%

8,033

6,194

12.5

%

15,940

14,175

Total

28.4

%

$

280,325

$

218,371

14.6

%

$

529,238

$

461,896

“We delivered better-than-expected revenue results for the second quarter, driven by strong execution and improving customer demand trends as the global recovery continues to progress,” said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer. “Other financial results for the second quarter were impressive as well; the combination of our strong top-line growth, and contributions from our multi-year strategic initiatives undertaken as part of our Foundations for Growth Program, resulted in significant expansion in our non-GAAP margins* and growth in our non-GAAP net income* and non-GAAP EPS* of 103% and 100%, respectively, year-over-year.”

Mr. Lampropoulos continued: “We are pleased with the strong financial results we have delivered over the first half of 2021 and remain optimistic in our outlook for measured improvement in the operating environment as we move through the remainder of 2021. We have updated our 2021 guidance as a result of our better-than-expected second quarter results and a more favorable outlook for growth in the second half of 2021. We now expect total revenue growth, on a constant currency basis*, of approximately 9% to 10% year-over-year and, importantly, excluding the impact of divestitures and product sales that uniquely benefitted from pandemic-related demand trends in 2020, our constant currency revenue guidance* now reflects growth of approximately 12% to 13% in 2021. We also continue to expect profitability improvement and notable free cash flow* generation driven by strong execution and contributions from our multi-year strategic initiatives undertaken as part of our Foundations for Growth Program.”

As of June 30, 2021, Merit had cash on hand of approximately $70.0 million, long term debt obligations of approximately $293 million, and available borrowing capacity of $444 million, compared to cash on hand of approximately $56.9 million, long term debt obligations of $352 million, and available borrowing capacity of $389 million as of December 31, 2020.

Updated Fiscal Year 2021 Financial Guidance

Based upon information currently available to Merit’s management, Merit is updating net revenue expectations for the year ending December 31, 2021. Absent material acquisitions, non-recurring transactions or other factors beyond Merit’s control, Merit now forecasts the following:

Financial Measure

Prior Guidance

Revised Guidance

Net Sales

$994 - $1,014 million

$1,060 - $1,070 million

GAAP

Net Income

$47.3 - $55.9 million

$43.2 - $51.8 million

Earnings Per Share

$0.83 - $0.98

$0.75 - $0.91

Non-GAAP

Net Income

$104.8 - $112.7 million

$118.8 - $127.1 million

Earnings Per Share

$1.84 - $1.98

$2.07 - $2.22

The updated net revenue range continues to assume a benefit from the changes in foreign currency exchange rates in the range of approximately $10.5 million to $11.5 million. The prior guidance range assumed growth of approximately 3.1% to 5.2% year over year and a benefit from changes in foreign currency exchange rates in the range of approximately $8.0 million to $8.5 million.

The updated fiscal year 2021 net revenue guidance range assumes:

  • Net revenue from the cardiovascular segment of between $1,028 million and $1,038 million, representing an increase of approximately 10% to 11% year-over-year as compared to net revenue of $934.2 million for the twelve months ended December 31, 2020. The prior guidance assumed growth of approximately 3.1% to 5.2% year-over-year.

  • Net revenue from the endoscopy segment of between $32.5 million and $32.7 million, representing an increase of approximately 9.6% to 10.2% year-over-year as compared to net revenue of $29.7 million for the twelve months ended December 31, 2020. The prior guidance assumed growth of approximately 4% to 7% year-over-year.

Merit’s financial guidance for the year ending December 31, 2021 is subject to risks and uncertainties identified in this release and Merit’s filings with the U.S. Securities and Exchange Commission (the “SEC”).

CONFERENCE CALL

Merit will hold its investor conference call (conference ID 3993753) today, Thursday, July 29, 2021, 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 number is (844) 578-9672 and the international number is (508) 637-5656. A live webcast and slide deck will also be available at merit.com.

CONSOLIDATED BALANCE SHEETS
(in thousands)

June 30,

2021

December 31,

(Unaudited)

2020

ASSETS

Current Assets

Cash and cash equivalents

$

69,672

$

56,916

Trade receivables, net

153,443

146,641

Other receivables

8,376

7,774

Inventories

194,524

198,019

Prepaid expenses and other assets

16,541

13,120

Prepaid income taxes

3,683

3,688

Income tax refund receivables

3,543

3,549

Total current assets

449,782

429,707

Property and equipment, net

373,801

382,728

Intangible assets, net

342,792

367,915

Goodwill

362,810

363,533

Deferred income tax assets

4,614

4,597

Operating lease right-of-use assets

70,767

78,240

Other assets

37,827

37,676

Total Assets

$

1,642,393

$

1,664,396

LIABILITIES AND STOCKHOLDERS' EQUITY

Current Liabilities

Trade payables

$

53,809

$

49,837

Accrued expenses

135,013

111,944

Current portion of long-term debt

7,500

7,500

Current operating lease liabilities

11,721

12,903

Income taxes payable

2,561

2,820

Total current liabilities

210,604

185,004

Long-term debt

284,900

343,722

Deferred income tax liabilities

33,271

33,312

Long-term income taxes payable

347

347

Liabilities related to unrecognized tax benefits

1,016

1,016

Deferred compensation payable

17,055

16,808

Deferred credits

1,869

1,923

Long-term operating lease liabilities

65,841

70,941

Other long-term obligations

35,056

52,748

Total liabilities

649,959

705,821

Stockholders' Equity

Common stock

623,591

606,224

Retained earnings

373,677

357,803

Accumulated other comprehensive loss

(4,834

)

(5,452

)

Total stockholders' equity

992,434

958,575

Total Liabilities and Stockholders' Equity

$

1,642,393

$

1,664,396

CONSOLIDATED STATEMENTS OF INCOME (LOSS)
(Unaudited; in thousands except per share amounts)

Three Months Ended

Six Months Ended

June 30,

June 30,

2021

2020

2021

2020

NET SALES

$

280,325

$

218,371

$

529,238

$

461,896

COST OF SALES

156,186

134,155

293,205

273,896

GROSS PROFIT

124,139

84,216

236,033

188,000

OPERATING EXPENSES:

Selling, general and administrative

91,563

66,767

172,587

145,575

Research and development

17,593

14,026

33,867

28,898

Legal settlement

—

18,200

—

18,200

Impairment charges

4,283

3,875

4,283

7,720

Contingent consideration expense

1,805

343

2,207

5,240

Total operating expenses

115,244

103,211

212,944

205,633

INCOME (LOSS) FROM OPERATIONS

8,895

(18,995

)

23,089

(17,633

)

OTHER INCOME (EXPENSE):

Interest income

92

88

564

167

Interest expense

(1,386

)

(2,715

)

(2,923

)

(5,859

)

Other expense - net

(736

)

(678

)

(1,171

)

(967

)

Total other expense — net

(2,030

)

(3,305

)

(3,530

)

(6,659

)

INCOME (LOSS) BEFORE INCOME TAXES

6,865

(22,300

)

19,559

(24,292

)

INCOME TAX EXPENSE (BENEFIT)

1,949

(3,242

)

3,685

(2,080

)

NET INCOME (LOSS)

$

4,916

$

(19,058

)

$

15,874

$

(22,212

)

EARNINGS (LOSS) PER COMMON SHARE:

Basic

$

0.09

$

(0.34

)

$

0.28

$

(0.40

)

Diluted

$

0.09

$

(0.34

)

$

0.28

$

(0.40

)

WEIGHTED AVERAGE SHARES OUTSTANDING:

Basic

56,061

55,406

55,890

55,326

Diluted

57,277

55,406

57,128

55,326

Non-GAAP Financial Measures

Although Merit’s financial statements are prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”), Merit’s management believes that certain non-GAAP financial measures referenced 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;

  • constant currency revenue, organic;

  • core revenue;

  • non-GAAP gross margin;

  • non-GAAP operating income and margin;

  • non-GAAP net income;

  • non-GAAP earnings per share; and

  • free cash flow.

Merit’s management team uses these non-GAAP financial measures to evaluate Merit’s profitability and efficiency, to compare operating and financial results to prior periods, to evaluate changes in the results of its operating segments, 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 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 generally 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 items in the calculation of non-GAAP earnings per share, non-GAAP gross margin, non-GAAP operating income and margin, and non-GAAP net income (in each case, as further illustrated in the reconciliation tables 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 acquisition or other extraordinary transactions, non-cash expenses related to amortization or write-off of previously acquired tangible and intangible assets, certain severance expenses, expenses resulting from non-ordinary course litigation or administrative proceedings and resulting settlements, corporate transformation expenses, governmental proceedings or changes in tax or industry regulations, gains or losses on disposal of certain assets, and debt issuance costs. 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 readers 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 Revenue

Merit’s constant currency revenue is prepared by converting the current-period reported revenue of subsidiaries whose functional currency is a currency other than the U.S. dollar at the applicable foreign exchange rates in effect during the comparable prior-year period, and adjusting for the effects of hedging transactions on reported revenue, which are recorded in the U.S. The constant currency revenue adjustments of ($6.2) million and ($10.0) million to reported revenue for the three and six-month periods ended June 30, 2021 were calculated using the applicable average foreign exchange rates for the three and six-month periods ended June 30, 2020, respectively.

Constant Currency Revenue, Organic

Merit’s constant currency revenue, organic, is defined, with respect to prior fiscal year periods, as GAAP revenue. With respect to current fiscal year periods, constant currency revenue, organic, is defined as constant currency revenue (as defined above), less revenue from certain acquisitions. For the three and six-month periods ended June 30, 2021, Merit’s constant currency revenue, organic, excludes revenues attributable to the acquisition of KA Medical, LLC in November 2020.

Core Revenue

For the three and six-month periods ended June 30, 2020, Merit’s core revenue excludes revenues attributable to its distribution agreement with NinePoint Medical, Inc., which was suspended during the first quarter of 2020, revenues attributable to the manufacture of Merit’s Hypotube product which was divested in August 2020, revenues attributable to the ITL Healthcare Pty Ltd (“ITL”) procedure pack business in Australia which was closed in December 2020, and revenue attributable to sales of the CulturaTM nasopharyngeal swabs and test kits (which benefited from high demand in 2020 resulting from the COVID-19 pandemic but which are not expected to contribute significant revenue in the future).

With respect to the three and six-month periods ended June 30, 2021, core revenue is defined as constant currency revenue, organic (as defined above), less revenue attributable to sales of the Cultura nasopharyngeal swabs and test kits, and revenue attributable to the final sales of products from the closed ITL procedure pack business in the first quarter of 2021.

Non-GAAP Gross Margin

Non-GAAP gross margin is calculated by reducing GAAP cost of sales by amounts recorded for amortization of intangible assets, certain inventory write-offs, and inventory mark-up related to acquisitions, divided by reported net sales.

Non-GAAP Operating Income and Margin

Non-GAAP operating income is calculated by adjusting GAAP operating income (loss) for certain items which are deemed by Merit’s management to be outside of core operations and vary in amount and frequency among periods, such as expenses related to new acquisitions, non-cash expenses related to amortization or write-off of previously acquired tangible and intangible assets, certain severance expenses, performance-based stock compensation expenses, corporate transformation expenses, expenses resulting from non-ordinary course litigation or administrative proceedings and resulting settlements, governmental proceedings or changes in industry regulations, as well as other items referenced in the tables below. Non-GAAP operating margin is calculated by dividing non-GAAP operating income by reported net sales.

Non-GAAP Net Income

Non-GAAP net income is calculated by adjusting GAAP net income (loss) for the items set forth in the definition of non-GAAP operating income above, as well as for expenses related to debt issuance costs, gains or losses on disposal of certain assets, changes in tax regulations, and other items set forth in the tables below.

Non-GAAP EPS

Non-GAAP EPS is defined as non-GAAP net income divided by the diluted shares outstanding for the corresponding period.

Free Cash Flow

Free cash flow is defined as cash flow from operations calculated in accordance with GAAP, less capital expenditures calculated in accordance with GAAP, as set forth in the consolidated statement of cash flows.

Non-GAAP Financial Measure Reconciliations

The following tables set forth supplemental financial data and corresponding reconciliations of non-GAAP financial measures to Merit’s corresponding financial measures prepared in accordance with GAAP, in each case, for the three and six-month periods ended June 30, 2021 and 2020. The non-GAAP income adjustments referenced in the following tables do not reflect non-performance-based stock compensation expense of approximately $1.8 million and $2.4 million for the three-month periods ended June 30, 2021 and 2020, respectively, and approximately $4.4 million and $4.7 million for the six-month periods ended June 30, 2021 and 2020.

Reconciliation of GAAP Net Income (Loss) to Non-GAAP Net Income
(Unaudited; in thousands except per share amounts)

Three Months Ended

June 30, 2021

Pre-Tax

Tax Impact

After-Tax

Per Share Impact

GAAP net income

$

6,865

$

(1,949

)

$

4,916

$

0.09

Non-GAAP adjustments:

Cost of Sales

Amortization of intangibles

10,631

(2,640

)

7,991

0.14

Inventory write-off (a)

1,620

(202

)

1,418

0.02

Operating Expenses

Contingent consideration expense

1,805

6

1,811

0.03

Impairment charges

4,283

(481

)

3,802

0.07

Amortization of intangibles

1,788

(448

)

1,340

0.02

Performance-based share-based compensation (b)

1,343

(168

)

1,175

0.02

Corporate transformation and restructuring (c)

7,316

(1,816

)

5,500

0.10

Acquisition-related

826

(205

)

621

0.01

Medical Device Regulation expenses (d)

1,013

(251

)

762

0.01

Other (e)

6,236

(355

)

5,881

0.10

Other (Income) Expense

Amortization of long-term debt issuance costs

151

(37

)

114

0.00

Non-GAAP net income

$

43,877

$

(8,546

)

$

35,331

$

0.62

Diluted shares

57,277


Three Months Ended

June 30, 2020

Pre-Tax

Tax Impact

After-Tax

Per Share Impact

GAAP net loss

$

(22,300

)

$

3,242

$

(19,058

)

$

(0.34

)

Non-GAAP adjustments:

Cost of Sales

Amortization of intangibles

12,807

(3,300

)

9,507

0.17

Inventory write-off (a)

345

(104

)

241

0.00

Inventory mark-up related to acquisitions

146

(37

)

109

0.00

Operating Expenses

Contingent consideration expense

343

45

388

0.01

Impairment charges

3,875

(1,100

)

2,775

0.05

Amortization of intangibles

1,975

(533

)

1,442

0.03

Performance-based share-based compensation (b)

1,064

(140

)

924

0.02

Corporate transformation and restructuring (c)

1,676

(477

)

1,199

0.02

Acquisition-related

340

(84

)

256

0.00

Medical Device Regulation expenses (d)

303

(78

)

225

0.00

Other (e)

20,492

(1,226

)

19,266

0.34

Other (Income) Expense

Amortization of long-term debt issuance costs

151

(39

)

112

0.00

Non-GAAP net income

$

21,217

$

(3,831

)

$

17,386

$

0.31

Diluted shares (f)

56,250

____________________________
Note: Certain per share impacts may not sum to totals due to rounding.

Reconciliation of GAAP Net Income (Loss) to Non-GAAP Net Income
(Unaudited; in thousands except per share amounts)

Six Months Ended

June 30, 2021

Pre-Tax

Tax Impact

After-Tax

Per Share Impact

GAAP net income

$

19,559

$

(3,685

)

$

15,874

$

0.28

Non-GAAP adjustments:

Cost of Sales

Amortization of intangibles

21,310

(5,292

)

16,018

0.28

Inventory write-off (a)

1,620

(202

)

1,418

0.02

Operating Expenses

Contingent consideration expense

2,207

14

2,221

0.04

Impairment charges

4,283

(481

)

3,802

0.07

Amortization of intangibles

3,604

(902

)

2,702

0.05

Performance-based share-based compensation (b)

2,359

(287

)

2,072

0.04

Corporate transformation and restructuring (c)

12,761

(3,162

)

9,599

0.17

Acquisition-related

5,608

(1,390

)

4,218

0.07

Medical Device Regulation expenses (d)

1,394

(346

)

1,048

0.02

Other (e)

6,375

(389

)

5,986

0.10

Other (Income) Expense

Amortization of long-term debt issuance costs

302

(75

)

227

0.00

Non-GAAP net income

$

81,382

$

(16,197

)

$

65,185

$

1.14

Diluted shares

57,128


Six Months Ended

June 30, 2020

Pre-Tax

Tax Impact

After-Tax

Per Share Impact

GAAP net loss

$

(24,292

)

$

2,080

$

(22,212

)

$

(0.40

)

Non-GAAP adjustments:

Cost of Sales

Amortization of intangibles

25,624

(6,604

)

19,020

0.34

Inventory write-off (a)

1,776

(472

)

1,304

0.02

Inventory mark-up related to acquisitions

146

(37

)

109

0.00

Operating Expenses

Contingent consideration expense

5,240

66

5,306

0.09

Impairment charges

7,720

(1,193

)

6,527

0.12

Amortization of intangibles

4,157

(1,124

)

3,033

0.05

Performance-based share-based compensation (b)

1,511

(192

)

1,319

0.02

Corporate transformation and restructuring (c)

3,452

(920

)

2,532

0.05

Acquisition-related

647

(164

)

483

0.01

Medical Device Regulation expenses (d)

603

(155

)

448

0.01

Other (e)

22,075

(1,634

)

20,441

0.36

Other (Income) Expense

Amortization of long-term debt issuance costs

302

(78

)

224

0.00

Non-GAAP net income

$

48,961

$

(10,427

)

$

38,534

$

0.69

Diluted shares (f)

56,133


____________________________
Note: Certain per share impacts may not sum to totals due to rounding

Reconciliation of Reported Operating Income (Loss) to Non-GAAP Operating Income
(Unaudited; in thousands except percentages)

Three Months Ended

Three Months Ended

Six Months Ended

Six Months Ended

June 30, 2021

June 30, 2020

June 30, 2021

June 30, 2020

Amounts

% Sales

Amounts

% Sales

Amounts

% Sales

Amounts

% Sales

Net Sales as Reported

$

280,325

$

218,371

$

529,238

$

461,896

GAAP Operating Income (Loss)

8,895

3.2

%

(18,995

)

(8.7

)

%

23,089

4.4

%

(17,633

)

(3.8

)

%

Cost of Sales

Amortization of intangibles

10,631

3.8

%

12,807

5.8

%

21,310

4.0

%

25,624

5.6

%

Inventory write-off (a)

1,620

0.6

%

345

0.2

%

1,620

0.3

%

1,776

0.5

%

Inventory mark-up related to acquisitions

—

—

146

0.1

%

—

—

146

0.0

%

Operating Expenses

Contingent consideration expense

1,805

0.6

%

343

0.2

%

2,207

0.4

%

5,240

1.1

%

Impairment charges

4,283

1.5

%

3,875

1.8

%

4,283

0.8

%

7,720

1.7

%

Amortization of intangibles

1,788

0.6

%

1,975

0.9

%

3,604

0.7

%

4,157

0.9

%

Performance-based share-based compensation (b)

1,343

0.5

%

1,064

0.5

%

2,359

0.4

%

1,511

0.3

%

Corporate transformation and restructuring (c)

7,316

2.6

%

1,676

0.8

%

12,761

2.4

%

3,452

0.7

%

Acquisition-related

826

0.3

%

340

0.1

%

5,608

1.1

%

647

0.1

%

Medical Device Regulation expenses (d)

1,013

0.4

%

303

0.1

%

1,394

0.3

%

603

0.1

%

Other (e)

6,236

2.2

%

20,492

9.4

%

6,375

1.2

%

22,075

4.8

%

Non-GAAP Operating Income

$

45,756

16.3

%

$

24,371

11.2

%

$

84,610

16.0

%

$

55,318

12.0

%

___________________________
Note: Certain percentages may not sum to totals due to rounding

a)

Represents the write-off of inventory related to the divestiture or exit of certain businesses or product lines.

b)

Represents performance-based share-based compensation expense, including stock-settled and cash-settled awards.

c)

Includes severance related to corporate initiatives, write-offs and valuation adjustments of other long-term assets associated with restructuring activities, expenses related to Merit’s Foundations for Growth program, and other transformation costs.

d)

Represents incremental expenses incurred to comply with the Medical Device Regulation (“MDR”) in Europe.

e)

The 2021 periods include accrued contract termination costs of $6.1 million to renegotiate certain terms of an acquisition agreement and costs to comply with Merit’s settlement agreement with the U.S. Department of Justice. The 2020 periods include a settlement of $18.2 million with the U.S. Department of Justice (“DOJ”) to fully resolve the DOJ’s investigation, costs incurred in responding to the DOJ inquiry, activist shareholder recovery fees, and expense from abandoned patents.

f)

For the three and six-months periods ended June 30, 2020, the non-GAAP net income per diluted share calculation includes approximately 844,000 and 807,000 shares, respectively, that were excluded from the GAAP net loss per diluted share calculation.


Reconciliation of Reported Revenue to Constant Currency Revenue (Non-GAAP), Constant Currency Revenue, Organic (Non-GAAP), and Core Revenue (Non-GAAP)
(Unaudited; in thousands except percentages)

Three Months Ended

Six Months Ended

June 30,

June 30,

% Change

2021

2020

% Change

2021

2020

Reported Revenue

28.4

%

$

280,325

$

218,371

14.6

%

$

529,238

$

461,896

Add: Impact of foreign exchange

(6,173

)

—

(9,999

)

—

Constant Currency Revenue (a)

25.5

%

$

274,152

$

218,371

12.4

%

$

519,239

$

461,896

Less: Revenue from certain acquisitions

(72

)

—

(110

)

—

Constant Currency Revenue, Organic (a)

25.5

%

$

274,080

$

218,371

12.4

%

$

519,129

$

461,896

Less: Revenue from Cultura

(512

)

(4,566

)

(1,451

)

(4,566

)

Less: Revenue from certain dispositions

—

(2,171

)

(179

)

(5,700

)

Core Revenue (a)

29.3

%

$

273,568

$

211,634

14.6

%

$

517,499

$

451,630

___________________________
(a) A non-GAAP financial measure. For a definition of this and other non-GAAP financial measures, see the Non-GAAP Financial Measures section above in this release.

Reconciliation of Reported Gross Margin to Non-GAAP Gross Margin (Non-GAAP)
(Unaudited; as a percentage of reported revenue)

Three Months Ended

Six Months Ended

June 30,

June 30,

2021

2020

2021

2020

Reported Gross Margin

44.3

%

38.6

%

44.6

%

40.7

%

Add back impact of:

Amortization of intangibles

3.8

%

5.9

%

4.0

%

5.6

%

Inventory write-off (a)

0.6

%

0.1

%

0.3

%

0.4

%

Inventory mark-up related to acquisitions

—

0.1

%

—

0.0

%

Non-GAAP Gross Margin

48.7

%

44.7

%

48.9

%

46.7

%

___________________________
Note: Certain percentages may not sum to totals due to rounding

(a) Represents the write-off of inventory related to the divestiture or exit of certain businesses or product lines.

ABOUT MERIT

Founded in 1987, Merit Medical Systems, Inc. is a leading manufacturer and marketer of proprietary medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling in excess of 500 individuals. Merit employs approximately 6,300 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Aliso Viejo, California; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Ontario, Canada; Melbourne, Australia; Tokyo, Japan; Reading, United Kingdom; Johannesburg, South Africa; and Singapore.

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

Statements contained in this release which are not purely historical, including, without limitation, statements regarding Merit’s forecasted plans, net sales, net income or loss (GAAP and non-GAAP), operating income and margin (GAAP and non-GAAP), gross margin (GAAP and non-GAAP), earnings per share (GAAP and non-GAAP), free cash flow, and other financial measures, the potential impact, scope and duration of, and Merit’s response to, the COVID-19 pandemic and the potential for recovery from that pandemic, future growth and profit expectations or forecasted economic conditions, or the implementation of, and results achieved through, Merit’s Foundations for Growth program or other expense reduction initiatives, or the development and commercialization of new products, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, 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, 2020 (the “2020 Annual Report”) and other filings with the SEC. Such risks and uncertainties include inherent risks and uncertainties relating to Merit’s internal models or the projections in this release; risks and uncertainties associated with the COVID-19 pandemic and Merit’s response thereto; disruptions in Merit’s supply chain, manufacturing or sterilization processes; risks relating to Merit’s potential inability to successfully manage growth through acquisitions generally, including the inability to effectively integrate acquired operations or products or commercialize technology developed internally or acquired through completed, proposed or future transactions; negative changes in economic and industry conditions in the United States or other countries; risks and uncertainties associated with Merit’s information technology systems, including the potential for breaches of security and evolving regulations regarding privacy and data protection; governmental scrutiny and regulation of the medical device industry, including governmental inquiries, investigations and proceedings involving Merit; litigation and other judicial proceedings affecting Merit; restrictions on Merit’s liquidity or business operations resulting from its debt agreements; infringement of Merit’s technology or the assertion that Merit’s technology infringes the rights of other parties; product recalls and product liability claims; changes in customer purchasing patterns or the mix of products Merit sells; 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; reduced availability of, and price increases associated with, commodity components; 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, including reforms to the procedures for approval or clearance of Merit’s products by the U.S. Food & Drug Administration or comparable regulatory authorities in other jurisdictions; changes in tax laws and regulations in the United States or other countries; termination 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 or future 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; failure to introduce products in a timely fashion; price and product competition; availability of labor and materials; fluctuations in and obsolescence of inventory; and other factors referenced in the 2020 Annual Report and other materials filed with the SEC. 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. Those estimates and all other forward-looking statements included in this document are made only as of the date of this document, and except as otherwise required by applicable law, Merit assumes no obligation to update or disclose revisions to estimates and all other forward-looking statements.

TRADEMARKS

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

Contacts:

PR/Media Inquiries:
Teresa Johnson
Merit Medical

Investor Inquiries:
Mike Piccinino, CFA, IRC
Westwicke - ICR

+1-801-208-4295

+1-443-213-0509

tjohnson@merit.com

mike.piccinino@westwicke.com


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