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 $278.5 million for the quarter ended December 31, 2021, an increase of 7.9% compared to the quarter ended December 31, 2020. Constant currency revenue, organic for the fourth quarter of 2021 increased 8.4% compared to the prior year period. For the year ended December 31, 2021, Merit's revenue was $1.075 billion, up 11.5%  compared to 2020. Constant currency revenue, organic for the year ended December 31, 2021 increased 10.4% when compared to 2020.

Merit’s revenue by operating segment and product category for the three and twelve-month periods ended December 31, 2021 and 2020 was as follows (unaudited; in thousands, except for percentages):

        Three Months Ended         Year Ended
        December 31,          December 31, 
  % Change       2021      2020      % Change       2021      2020
Cardiovascular                                          
Peripheral Intervention 11.0 %   $ 105,543     $ 95,080     18.6 %   $ 405,116     $ 341,568  
Cardiac Intervention 11.7 %     80,438       71,986     14.6 %     320,641       279,671  
Custom Procedural Solutions (6.3 )%     50,450       53,827     (4.6 )%     193,942       203,196  
OEM 15.8 %     33,794       29,175     12.5 %     123,528       109,767  
Total 8.1 %     270,225       250,068     11.7 %     1,043,227       934,202  
                                           
Endoscopy                                          
Endoscopy devices 4.2 %     8,267       7,936     6.2 %     31,524       29,673  
                                           
Total 7.9 %   $ 278,492     $ 258,004     11.5 %   $ 1,074,751     $ 963,875  
                                           

Merit’s GAAP gross margin for the fourth quarter of 2021 was 46.3%, compared to GAAP gross margin of 43.1% for the prior year period. Merit’s non-GAAP gross margin for the fourth quarter of 2021 was 50.0%, compared to non-GAAP gross margin of 47.9% for the prior year period. Merit’s GAAP gross margin for the year ended December 31, 2021 was 45.2%, compared to GAAP gross margin of 41.6% for the prior year. Merit’s non-GAAP gross margin for the year ended December 31, 2021 was 49.3%, compared to non-GAAP gross margin of 47.1% for the prior year.

Merit’s GAAP net income for the fourth quarter of 2021 increased 34% year-over-year to $20.6 million, or $0.36 per share, compared to GAAP net income of $15.4 million, or $0.27 per share, for the fourth quarter of 2020. Merit’s non-GAAP net income for the fourth quarter of 2021 increased 33% year-over-year to $40.8 million, or $0.71 per share, compared to non-GAAP net income of $30.8 million, or $0.54 per share, for the prior year period.

Merit’s GAAP net income for the year ended December 31, 2021 was $48.5 million, or $0.84 per share, compared to GAAP net loss of ($9.8) million, or ($0.18) per share, for 2020. Merit’s non-GAAP net income for the year ended December 31, 2021 increased 46% year-over-year to $136.2 million, or $2.37 per share, compared to non-GAAP net income of $93.3 million, or $1.65 per share, for 2020.

“We delivered fourth quarter performance that drove our 2021 financial results above the high end of our revenue and non-GAAP EPS guidance ranges, reflecting strong execution from our team despite the challenging operating environment,” said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer. “Fourth quarter total revenue increased 8.4% on a constant currency, organic basis, driven by 6.6% growth in the U.S. and 10.8% growth outside the U.S. during the period. By product category, fourth quarter sales growth was driven primarily by low double-digit growth year-over-year in sales of our peripheral intervention and cardiac intervention products and mid-teens growth year-over-year in sales of OEM products. We delivered strong non-GAAP gross margin performance in the fourth quarter driven, in part, by early benefits attributable to our Foundations for Growth initiatives, which offset inflationary pressures in raw materials, freight and logistics expenses in the period. The strong increase in non-GAAP gross margins, combined with prudent operating expense control, resulted in growth in our non-GAAP net income and non-GAAP EPS of 33% and 31%, respectively, year-over-year.”

Mr. Lampropoulos continued: “Our operating and financial performance in fiscal year 2021 was impressive. We delivered more than 10% constant currency revenue growth, expanded our non-GAAP gross and operating margins approximately 220 basis points year-over-year, grew non-GAAP EPS 43% year-over-year and generated more than $119 million of free cash flow. We also made considerable progress in the first year of our Foundations for Growth Program in 2021 and remain committed to the significant improvements in profitability and notable free cash flow generation we have targeted over the course of this multi-year strategic initiative. We introduced our financial guidance for fiscal year 2022 in this afternoon’s press release which calls for total revenue growth, on a constant currency basis, of approximately 4% to 6% year-over-year, continued expansion in our non-GAAP gross and operating margins and strong free cash flow generation.”

As of December 31, 2021, Merit had cash on hand of $68 million, long term debt obligations of $243 million, and available borrowing capacity of $490 million, compared to cash on hand of $57 million, long term debt obligations of $352 million, and available borrowing capacity of $389 million as of December 31, 2020.

Fiscal Year 2022 Financial Guidance

Based upon information currently available to Merit’s management,  Merit estimates for the year ending December 31, 2022, absent material acquisitions, non-recurring transactions or other factors beyond Merit’s current expectations, the following:

  • Net revenue in the range of $1.117 billion to $1.140 billion, representing an increase of approximately 4% to 6% year over year, as compared to net revenue of $1.075 billion for the twelve months ended December 31, 2021. The fiscal year 2022 revenue guidance range assumes:
    • Net revenue from the cardiovascular segment of between $1.083 billion and $1.106 billion, representing an increase of approximately 4% to 6% year-over-year as compared to net revenue of $1.043 billion for the twelve months ended December 31, 2021.
    • Net revenue from the endoscopy segment of between $33.5 million and $34.1 million, representing an increase of approximately 6% to 8% year-over-year as compared to net revenue of $31.5 million for the twelve months ended December 31, 2021.
  • GAAP net income in the range of $75.4 million to $84.0 million, or $1.30 to $1.45 per diluted share, compared to GAAP net income of $48.5 million, or $0.84 per diluted share, for the twelve months ended December 31, 2021.
  • Non-GAAP net income in the range of $140.0 million to $148.7 million, or $2.41 to $2.56 per diluted share, compared to non-GAAP net income of $136.2 million, or $2.37 per diluted share, for the twelve months ended December 31, 2021.

Merit’s financial guidance for the year ending December 31, 2022 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 5259615) today, Thursday, February 24, 2022, 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)

  December 31,          
  2021   December 31, 
  (Unaudited)   2020
ASSETS          
Current Assets          
Cash and cash equivalents $ 67,750     $ 56,916  
Trade receivables, net   152,301       146,641  
Other receivables   17,763       7,774  
Inventories   221,922       198,019  
Prepaid expenses and other assets   16,149       13,120  
Prepaid income taxes   3,550       3,688  
Income tax refund receivables   2,777       3,549  
Total current assets   482,212       429,707  
           
Property and equipment, net   371,658       382,728  
Intangible assets, net   319,269       367,915  
Goodwill   361,741       363,533  
Deferred income tax assets   6,080       4,597  
Operating lease right-of-use assets   65,913       78,240  
Other assets   41,421       37,676  
Total Assets $ 1,648,294     $ 1,664,396  
           
LIABILITIES AND STOCKHOLDERS' EQUITY          
Current Liabilities          
Trade payables $ 55,624     $ 49,837  
Accrued expenses   159,014       111,944  
Current portion of long-term debt   8,438       7,500  
Current operating lease liabilities   10,668       12,903  
Income taxes payable   2,536       2,820  
Total current liabilities   236,280       185,004  
           
Long-term debt   234,397       343,722  
Deferred income tax liabilities   31,503       33,312  
Long-term income taxes payable   347       347  
Liabilities related to unrecognized tax benefits   932       1,016  
Deferred compensation payable   18,111       16,808  
Deferred credits   1,815       1,923  
Long-term operating lease liabilities   61,526       70,941  
Other long-term obligations   23,584       52,748  
Total liabilities   608,495       705,821  
           
Stockholders' Equity          
Common stock   641,533       606,224  
Retained earnings   406,257       357,803  
Accumulated other comprehensive loss   (7,991 )     (5,452 )
Total stockholders' equity   1,039,799       958,575  
Total Liabilities and Stockholders' Equity $ 1,648,294     $ 1,664,396  
               

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

  Three Months Ended      Year Ended
  December 31,    December 31, 
  2021      2020      2021      2020
Net sales $ 278,492     $ 258,004     $ 1,074,751     $ 963,875  
Cost of sales   149,686       146,841       589,418       562,698  
Gross profit   128,806       111,163       485,333       401,177  
                       
Operating expenses:                      
Selling, general and administrative   76,629       79,934       335,690       297,724  
Research and development   20,406       15,133       71,247       57,537  
Legal settlement   10,036       484       10,036       18,684  
Impairment charges         8,199       4,283       36,504  
Contingent consideration expense (benefit)   (161 )     (8,844 )     3,161       (7,960 )
Acquired in-process research and development         250             250  
Total operating expenses   106,910       95,156       424,417       402,739  
                       
Income (loss) from operations   21,896       16,007       60,916       (1,562 )
                       
Other income (expense):                      
Interest income   101       370       769       604  
Interest expense   (1,105 )     (1,938 )     (5,261 )     (9,994 )
Other expense - net   (711 )     (1,194 )     (2,507 )     (2,279 )
Total other expense — net   (1,715 )     (2,762 )     (6,999 )     (11,669 )
                       
Income (loss) before income taxes   20,181       13,245       53,917       (13,231 )
                       
Income tax expense (benefit)   (432 )     (2,133 )     5,463       (3,388 )
                       
Net income (loss) $ 20,613     $ 15,378     $ 48,454     $ (9,843 )
                       
Earnings (loss) per common share                      
Basic $ 0.36     $ 0.28     $ 0.86     $ (0.18 )
Diluted $ 0.36     $ 0.27     $ 0.84     $ (0.18 )
                       
Weighted average shares outstanding                      
Basic   56,489       55,577       56,145       55,434  
Diluted   57,624       56,736       57,359       55,434  
                               

CONSOLIDATED STATEMENTS OF CASH FLOWS(In thousands - unaudited)

  Year Ended
  December 31, 
  2021      2020
CASH FLOWS FROM OPERATING ACTIVITIES:      
Net income (loss) $ 48,454     $ (9,843 )
Adjustments to reconcile net income (loss) to net cash provided by operating activities:          
Depreciation and amortization   84,066       94,070  
Write-off of certain intangible assets and other long-term assets   4,412       36,609  
Amortization of right-of-use operating lease assets   11,718       12,746  
Fair value adjustments to contingent consideration   3,161       (7,960 )
Deferred income taxes   (4,631 )     (11,295 )
Stock-based compensation expense   16,090       14,339  
Other adjustments   1,799       2,366  
Changes in operating assets and liabilities, net of acquisitions and divestitures   (17,838 )     34,238  
Total adjustments   98,777       175,113  
Net cash provided by operating activities   147,231       165,270  
           
CASH FLOWS FROM INVESTING ACTIVITIES:          
Capital expenditures for property and equipment   (27,939 )     (45,988 )
Cash paid in acquisitions, net of cash acquired   (7,171 )     (10,953 )
Other investing, net   (2,051 )     (1,711 )
Net cash used in investing activities   (37,161 )     (58,652 )
           
CASH FLOWS FROM FINANCING ACTIVITIES:      
Proceeds from issuance of common stock   21,306       6,635  
Payments on long-term debt, net   (108,500 )     (88,375 )
Contingent payments related to acquisitions   (10,665 )     (13,100 )
Payment of taxes related to an exchange of common stock   (576 )     (866 )
Net cash used in financing activities   (98,435 )     (95,706 )
Effect of exchange rates on cash   (801 )     1,684  
Net increase in cash and cash equivalents   10,834       12,596  
           
CASH AND CASH EQUIVALENTS:          
Beginning of period   56,916       44,320  
End of period $ 67,750     $ 56,916  
               

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 $1.1 million and ($10.3) million to reported revenue for the three and twelve-month periods ended December 31, 2021 were calculated using the applicable average foreign exchange rates for the three and twelve-month periods ended December 31, 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 twelve-month periods ended December 31, 2021, Merit’s constant currency revenue, organic, excludes revenues attributable to the acquisition of KA Medical, LLC in November 2020 (excluded through October 2021).

Core Revenue

For the three and twelve-month periods ended December 31, 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 Cultura™ 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 twelve-month periods ended December 31, 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.

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 acquisitions or other extraordinary transactions, 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 for property and equipment 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 twelve-month periods ended December 31, 2021 and 2020. The non-GAAP income adjustments referenced in the following tables do not reflect non-performance-based stock compensation expense of approximately $3.5 million and $3.0 million for the three-month periods ended December 31, 2021 and 2020, respectively, and approximately $11.1 million and $10.6 million for the twelve-month periods ended December 31, 2021 and 2020.

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

  Three Months Ended
  December 31, 2021
  Pre-Tax   Tax Impact   After-Tax   Per Share Impact
GAAP net income $ 20,181     $ 432     $ 20,613     $ 0.36  
                       
Non-GAAP adjustments:                      
Cost of Sales                      
Amortization of intangibles   10,570       (2,625 )     7,945       0.14  
Operating Expenses                      
Contingent consideration benefit   (161 )     53       (108 )     (0.00 )
Amortization of intangibles   1,786       (447 )     1,339       0.02  
Performance-based share-based compensation (a)   1,036       (110 )     926       0.02  
Corporate transformation and restructuring (b)   1,605       (398 )     1,207       0.02  
Acquisition-related   (2 )           (2 )     (0.00 )
Medical Device Regulation expenses (c)   1,513       (375 )     1,138       0.02  
Other (d)   10,118       (2,508 )     7,610       0.13  
Other (Income) Expense                      
Amortization of long-term debt issuance costs   151       (37 )     114       0.00  
                       
Non-GAAP net income $ 46,797     $ (6,015 )   $ 40,782     $ 0.71  
                       
Diluted shares                     57,624  
  Three Months Ended
  December 31, 2020
  Pre-Tax   Tax Impact   After-Tax   Per Share Impact
GAAP net income $ 13,245     $ 2,133     $ 15,378     $ 0.27  
                       
Non-GAAP adjustments:                      
Cost of Sales                      
Amortization of intangibles   12,543       (3,233 )     9,310       0.16  
Inventory write-off (e)   (24 )     7       (17 )     (0.00 )
Inventory mark-up related to acquisitions   4       (1 )     3       0.00  
Operating Expenses                      
Contingent consideration benefit   (8,844 )     (93 )     (8,937 )     (0.16 )
Impairment charges   8,199       (2,751 )     5,448       0.10  
Amortization of intangibles   1,893       (508 )     1,385       0.02  
Performance-based share-based compensation (a)   1,112       (141 )     971       0.02  
Corporate transformation and restructuring (b)   7,890       (1,985 )     5,905       0.10  
Acquisition-related   393       (101 )     292       0.01  
Medical Device Regulation expenses (c)   365       (98 )     267       0.00  
Other (d)   962       (304 )     658       0.01  
Other (Income) Expense                      
Amortization of long-term debt issuance costs   151       (39 )     112       0.00  
Gain on disposal of business unit   (10 )     2       (8 )     (0.00 )
                       
Non-GAAP net income $ 37,879     $ (7,112 )   $ 30,767     $ 0.54  
                       
Diluted shares                     56,736  
                         

_______________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)

  Year Ended
  December 31, 2021
  Pre-Tax   Tax Impact   After-Tax   Per Share Impact
GAAP net income $ 53,917     $ (5,463 )   $ 48,454     $ 0.84  
                             
Non-GAAP adjustments:                            
Cost of Sales                            
Amortization of intangibles   42,453       (10,543 )     31,910       0.56  
Inventory write-off (e)   1,620       (202 )     1,418       0.02  
Operating Expenses                            
Contingent consideration expense   3,161       52       3,213       0.06  
Impairment charges   4,283       (481 )     3,802       0.07  
Amortization of intangibles   7,183       (1,798 )     5,385       0.09  
Performance-based share-based compensation (a)   5,035       (604 )     4,431       0.08  
Corporate transformation and restructuring (b)   18,649       (4,620 )     14,029       0.24  
Acquisition-related   8,473       (2,100 )     6,373       0.11  
Medical Device Regulation expenses (c)   4,036       (1,001 )     3,035       0.05  
Other (d)   16,652       (2,977 )     13,675       0.24  
Other (Income) Expense                            
Amortization of long-term debt issuance costs   604       (150 )     454       0.01  
                             
Non-GAAP net income $ 166,066     $ (29,887 )   $ 136,179     $ 2.37  
                             
Diluted shares                         57,359  
  Year Ended
  December 31, 2020
  Pre-Tax   Tax Impact   After-Tax   Per Share Impact
GAAP net loss $ (13,231 )   $ 3,388     $ (9,843 )   $ (0.18 )
                       
Non-GAAP adjustments:                      
Cost of Sales                      
Amortization of intangibles   50,696       (13,065 )     37,631       0.67  
Inventory write-off (e)   1,752       (465 )     1,287       0.02  
Inventory mark-up related to acquisitions   191       (49 )     142       0.00  
Operating Expenses                      
Contingent consideration benefit   (7,960 )     466       (7,494 )     (0.13 )
Impairment charges   36,504       (7,115 )     29,389       0.52  
Amortization of intangibles   7,943       (2,141 )     5,802       0.10  
Performance-based share-based compensation (a)   3,735       (475 )     3,260       0.06  
Corporate transformation and restructuring (b)   14,175       (3,700 )     10,475       0.19  
Acquisition-related   1,229       (317 )     912       0.02  
Medical Device Regulation expenses (c)   1,379       (359 )     1,020       0.02  
Other (d)   24,438       (3,815 )     20,623       0.37  
Other (Income) Expense                      
Amortization of long-term debt issuance costs   604       (155 )     449       0.01  
Gain on disposal of business unit   (517 )     133       (384 )     (0.01 )
                       
Non-GAAP net income $ 120,938     $ (27,669 )   $ 93,269     $ 1.65  
                       
Diluted shares (f)                     56,374  
                         

_______________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   Year Ended   Year Ended
  December 31, 2021   December 31, 2020   December 31, 2021   December 31, 2020
  Amounts   % Sales   Amounts   % Sales   Amounts   % Sales   Amounts   % Sales
Net Sales as Reported $ 278,492           $ 258,004           $ 1,074,751         $ 963,875        
                                               
GAAP Operating Income (Loss)   21,896     7.9 %     16,007     6.2 %     60,916   5.7 %     (1,562 )   (0.2 )%
Cost of Sales                                              
Amortization of intangibles   10,570     3.8 %     12,543     4.9 %     42,453   4.0 %     50,696     5.3 %
Inventory write-off (e)             (24 )   (0.0 )%     1,620   0.2 %     1,752     0.2 %
Inventory mark-up related to acquisitions             4     0.0 %             191     0.0 %
Operating Expenses                                              
Contingent consideration expense (benefit)   (161 )   (0.1 )%     (8,844 )   (3.4 )%     3,161   0.3 %     (7,960 )   (0.8 )%
Impairment charges             8,199     3.2 %     4,283   0.4 %     36,504     3.8 %
Amortization of intangibles   1,786     0.6 %     1,893     0.7 %     7,183   0.7 %     7,943     0.8 %
Performance-based share-based compensation (a)   1,036     0.4 %     1,112     0.4 %     5,035   0.5 %     3,735     0.4 %
Corporate transformation and restructuring (b)   1,605     0.6 %     7,890     3.1 %     18,649   1.7 %     14,175     1.5 %
Acquisition-related   (2 )   (0.0 )%     393     0.2 %     8,473   0.8 %     1,229     0.1 %
Medical Device Regulation expenses (c)   1,513     0.5 %     365     0.1 %     4,036   0.4 %     1,379     0.1 %
Other (d)   10,118     3.6 %     962     0.4 %     16,652   1.5 %     24,438     2.5 %
                                               
Non-GAAP Operating Income $ 48,361     17.4 %   $ 40,500     15.7 %   $ 172,461   16.0 %   $ 132,520     13.7 %
                                                     

_______________Note: Certain percentages may not sum to totals due to rounding

a) Represents performance-based share-based compensation expense, including stock-settled and cash-settled awards. b) Includes severance related to corporate initiatives, write-offs and valuation adjustments of other long-term assets associated with restructuring activities, expenses related to the Foundations for Growth Program, and other transformation costs.c) Represents incremental expenses incurred to comply with the Medical Device Regulation (“MDR”) in Europe.d) The 2021 periods include accrued class action litigation settlement costs in the fourth quarter of approximately $10 million, net of expected insurance proceeds, accrued contract termination costs of approximately $6 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 “DOJ”). The 2020 periods include $18.7 million of settlement costs to fully resolve an investigation conducted by the DOJ, costs incurred in responding to the DOJ inquiry, activist shareholder settlement fees, and expense from abandoned patents. e) Represents the write-off of inventory related to the divestiture or exit of certain businesses or product lines.f) For the twelve-month period ended December 31, 2020, the non-GAAP net income per diluted share calculation includes approximately 940,000 shares 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         Year Ended
        December 31,         December 31,
  % Change   2021   2020   % Change   2021   2020
Reported Revenue 7.9 %   $ 278,492     $ 258,004     11.5 %   $ 1,074,751     $ 963,875  
                                   
Add: Impact of foreign exchange         1,135                   (10,307 )      
                                   
Constant Currency Revenue (a) 8.4 %   $ 279,627     $ 258,004     10.4 %   $ 1,064,444     $ 963,875  
                                   
Less: Revenue from certain acquisitions         (18 )                 (227 )      
                                   
Constant Currency Revenue, Organic (a) 8.4 %   $ 279,609     $ 258,004     10.4 %   $ 1,064,217     $ 963,875  
                                   
Less: Revenue from certain dispositions               (2,532 )           (179 )     (11,273 )
Less: Revenue from Cultura         (951 )     (4,946 )           (3,257 )     (19,115 )
                                   
Core Revenue (a) 11.2 %   $ 278,658     $ 250,526     13.6 %   $ 1,060,781     $ 933,487  
                                           

_______________(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   Year Ended
  December 31,   December 31,
  2021   2020   2021   2020
Reported Gross Margin 46.3 %   43.1 %   45.2 %   41.6 %
                       
Add back impact of:                      
Amortization of intangibles 3.8 %   4.9 %   4.0 %   5.3 %
Inventory write-off (a)     (0.0 )%   0.2 %   0.2 %
Inventory mark-up related to acquisitions     0.0 %       0.0 %
                       
Non-GAAP Gross Margin 50.0 %   47.9 %   49.3 %   47.1 %
                       

_______________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 6,700 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; reduced availability of, and price increases associated with, commodity components; 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; 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+1-801-208-4295tjohnson@merit.com   Investor Inquiries:Mike Piccinino, CFA, IRCWestwicke - ICR+1-443-213-0509mike.piccinino@westwicke.com
     
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