Merit Medical Reports Results for Quarter Ended September 30, 2022

 | Source: Merit Medical Systems, Inc. Merit Medical Systems, Inc.

  • Q3 2022 reported revenue of $287.2 million, up 7.5% compared to Q3 2021
  • Q3 2022 constant currency revenue, organic* up 10.5% compared to Q3 2021
  • Q3 2022 GAAP operating margin of 6.5%, compared to 6.0% in Q3 2021
  • Q3 2022 non-GAAP operating margin* of 16.1%, compared to 14.8% in Q3 2021
  • Q3 2022 GAAP EPS $0.27, compared to $0.21 in Q3 2021
  • Q3 2022 non-GAAP EPS* of $0.64, compared to $0.52 in Q3 2021

* Constant currency revenue; constant currency revenue, organic; non-GAAP EPS; non-GAAP net income; non-GAAP operating income and margin; non-GAAP gross profit and 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, Oct. 26, 2022 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading global manufacturer and marketer of healthcare technology, today announced revenue of $287.2 million for the quarter ended September 30, 2022, an increase of 7.5% compared to the quarter ended September 30, 2021. Constant currency revenue, organic, for the third quarter of 2022 increased 10.5% compared to the prior year period.

Merit’s revenue by operating segment and product category for the three and nine-month periods ended September 30, 2022 and 2021 was as follows (unaudited; in thousands, except for percentages):

                     
 Three Months Ended
 Reported     Constant Currency
 September 30,    Impact of foreign September 30,  
  2022   2021  % Change exchange  2022  % Change
Cardiovascular                    
Peripheral Intervention$110,698  $101,059   9.5% $2,289  $112,987   11.8 %
Cardiac Intervention 86,848   79,813   8.8%  2,841   89,689   12.4 %
Custom Procedural Solutions 45,692   49,435   (7.6)%  2,352   48,044   (2.8)%
OEM 35,711   29,397   21.5%  408   36,119   22.9 %
Total 278,949   259,704   7.4%  7,890   286,839   10.4 %
                     
Endoscopy                    
Endoscopy Devices 8,226   7,317   12.4%  85   8,311   13.6 %
                     
Total$287,175  $267,021   7.5% $7,975  $295,150   10.5 %


                      
 Nine Months Ended
 Reported     Constant Currency
 September 30,   Impact of foreign September 30,    
  2022   2021  % Change exchange 2022 % Change
Cardiovascular                     
Peripheral Intervention$327,426  $299,573   9.3 % $4,013  $331,439   10.6%
Cardiac Intervention 257,909   240,203   7.4 %  5,345   263,254   9.6%
Custom Procedural Solutions 141,047   143,492   (1.7)%  5,261   146,308   2.0%
OEM 106,173   89,734   18.3 %  947   107,120   19.4%
Total 832,555   773,002   7.7 %  15,566   848,121   9.7%
                      
Endoscopy                     
Endoscopy Devices 25,011   23,257   7.5 %  197   25,208   8.4%
                      
Total$857,566  $796,259   7.7 % $15,763  $873,329   9.7%


Merit’s GAAP gross margin for the third quarter of 2022 was 44.8%, compared to GAAP gross margin of 45.1% for the prior year period. Merit’s non-GAAP gross margin* for the third quarter of 2022 was 48.4%, compared to non-GAAP gross margin of 49.1% for the prior year period.

Merit’s GAAP net income for the third quarter of 2022 was $15.3 million, or $0.27 per share, compared to GAAP net income of $12.0 million, or $0.21 per share, for the third quarter of 2021. Merit’s non-GAAP net income* for the third quarter of 2022 was $37.0 million, or $0.64 per share, compared to non-GAAP net income of $30.2 million, or $0.52 per share, for the prior year period.

“We delivered better-than-expected revenue results for the third quarter of 2022, posting 10.5% constant currency sales growth fueled by solid execution from our team and more favorable than anticipated demand trends from customers in the U.S., EMEA and APAC regions.” said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer. “We also delivered better-than-expected profitability in the quarter, with approximately 23% growth year-over-year in both non-GAAP net income and non-GAAP earnings per share, driven by the combination of our strong revenue results and continued benefits from our multi-year strategic initiatives related to the Foundations for Growth Program.”

Mr. Lampropoulos continued: “Our updated guidance expectations for 2022 reflect continued confidence in our ability to drive solid constant currency revenue growth, improvements in our profitability profile and strong free cash flow generation in 2022. Overall, we continue to execute and are excited about the results we are seeing across our business. We remain committed to the financial targets that we outlined in the Foundations for Growth Program for the three-year period ending December 31, 2023, which call for our constant currency, organic revenue to increase at a CAGR of at least 5%, non-GAAP operating margins of at least 18% and cumulative free cash flow of more than $300 million.”

As of September 30, 2022, Merit had cash and cash equivalents of $51.5 million, total debt obligations of $216.9 million, and available borrowing capacity of approximately $509 million, compared to cash, cash equivalents and restricted cash of $67.8 million, total debt obligations of $243.1 million, and available borrowing capacity of approximately $490 million as of December 31, 2021.

Updated Fiscal Year 2022 Financial Guidance

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

         
  Revised Guidance As Reported   Prior Guidance
      % Change  
Financial Measure December 31, 2022 December 31, 2021 from Prior Year December 31, 2022
         
Net Sales $1.145 - $1.151 billion $1.075 billion 6.5% - 7.1% $1.123 - $1.135 billion
Cardiovascular Segment $1.112 - $1.117 billion $1.043 billion 6.6% - 7.1% $1.093 - $1.102 billion
Endoscopy Segment $32.7 - $33.2 million $31.5 million 3.8% - 5.4% $30.0 - $34.0 million
         
GAAP        
Net Income $64.8 - $68.3 million $48.5 million   $62.4 - $68.3 million
Earnings Per Share $1.13 - $1.19 $0.84   $1.08 - $1.18
         
Non-GAAP        
Net Income $146.9 - $150.4 million $136.2 million   $139.6 - $145.5 million
Earnings Per Share $2.55 - $2.61 $2.37   $2.42 - $2.52


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 today, Wednesday, October 26, 2022, at 5:00 p.m. Eastern (4:00 p.m. Central, 3:00 p.m. Mountain, and 2:00 p.m. Pacific). To access the conference call, please pre-register using the following link. Registrants will receive confirmation with dial-in details. A live webcast and slide deck will also be available at merit.com.



CONSOLIDATED BALANCE SHEETS
(in thousands)

      
 September 30,   
 2022 December 31,
 (Unaudited) 2021
ASSETS     
Current Assets     
Cash and cash equivalents$51,481  $67,750 
Trade receivables, net 155,828   152,301 
Other receivables 10,827   17,763 
Inventories 246,660   221,922 
Prepaid expenses and other assets 27,388   16,149 
Prepaid income taxes 3,515   3,550 
Income tax refund receivables 4,164   2,777 
Total current assets 499,863   482,212 
      
Property and equipment, net 376,156   371,658 
Intangible assets, net 284,107   319,269 
Goodwill 358,056   361,741 
Deferred income tax assets 5,467   6,080 
Operating lease right-of-use assets 64,700   65,913 
Other assets 44,388   41,421 
Total Assets$1,632,737  $1,648,294 
      
LIABILITIES AND STOCKHOLDERS' EQUITY     
Current Liabilities     
Trade payables$63,206  $55,624 
Accrued expenses 124,504   159,014 
Current portion of long-term debt 11,250   8,438 
Current operating lease liabilities 10,310   10,668 
Income taxes payable 3,765   2,536 
Total current liabilities 213,035   236,280 
      
Long-term debt 205,412   234,397 
Deferred income tax liabilities 31,168   31,503 
Long-term income taxes payable 347   347 
Liabilities related to unrecognized tax benefits 932   932 
Deferred compensation payable 14,786   18,111 
Deferred credits 1,735   1,815 
Long-term operating lease liabilities 59,989   61,526 
Other long-term obligations 16,492   23,584 
Total liabilities 543,896   608,495 
      
Stockholders' Equity     
Common stock 658,198   641,533 
Retained earnings 447,372   406,257 
Accumulated other comprehensive loss (16,729)  (7,991)
Total stockholders' equity 1,088,841   1,039,799 
Total Liabilities and Stockholders' Equity$1,632,737  $1,648,294 



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

            
 Three Months Ended Nine Months Ended
 September 30, September 30,
  2022   2021   2022   2021 
Net sales$287,175  $267,021  $857,566  $796,259 
Cost of sales 158,602   146,527   473,019   439,732 
Gross profit 128,573   120,494   384,547   356,527 
            
Operating expenses:           
Selling, general and administrative 89,780   86,474   259,282   259,061 
Research and development 19,221   16,974   55,074   50,841 
Impairment charges —   —   1,672   4,283 
Contingent consideration expense 915   1,115   4,702   3,322 
Acquired in-process research and development —   —   6,671   — 
Total operating expenses 109,916   104,563   327,401   317,507 
            
Income from operations 18,657   15,931   57,146   39,020 
            
Other income (expense):           
Interest income 116   104   316   668 
Interest expense (1,831)  (1,233)  (4,180)  (4,156)
Other income (expense) — net 660   (625)  (808)  (1,796)
Total other expense — net (1,055)  (1,754)  (4,672)  (5,284)
            
Income before income taxes 17,602   14,177   52,474   33,736 
            
Income tax expense 2,330   2,210   11,359   5,895 
            
Net income$15,272  $11,967  $41,115  $27,841 
            
Earnings per common share           
Basic$0.27  $0.21  $0.73  $0.50 
Diluted$0.27  $0.21  $0.71  $0.49 
            
Weighted average shares outstanding           
Basic 56,835   56,302   56,707   56,033 
Diluted 57,586   57,549   57,573   57,274 



CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands - unaudited)

      
 Nine Months Ended
 September 30,
  2022   2021 
CASH FLOWS FROM OPERATING ACTIVITIES:   
Net income$41,115  $27,841 
Adjustments to reconcile net income to net cash provided by operating activities:     
Depreciation and amortization 61,312   63,173 
Loss on disposition of business 1,389   — 
Write-off of certain intangible assets and other long-term assets 1,733   4,412 
Amortization of right-of-use operating lease assets 7,819   8,941 
Adjustments and payments related to contingent consideration liability 2,888   3,322 
Acquired in-process research and development 6,671   — 
Stock-based compensation expense 13,691   11,589 
Other adjustments 568   1,002 
Changes in operating assets and liabilities, net of acquisitions and divestitures (50,903)  (18,864)
Total adjustments 45,168   73,575 
Net cash, cash equivalents, and restricted cash provided by operating activities 86,283   101,416 
      
CASH FLOWS FROM INVESTING ACTIVITIES:     
Capital expenditures for property and equipment (32,539)  (19,612)
Cash paid in acquisitions, net of cash acquired (4,712)  (1,858)
Other investing, net (2,817)  (1,084)
Net cash, cash equivalents, and restricted cash used in investing activities (40,068)  (22,554)
      
CASH FLOWS FROM FINANCING ACTIVITIES:   
Proceeds from issuance of common stock 6,733   17,814 
Proceeds from (payments on) long-term debt, net (26,257)  (72,625)
Contingent payments related to acquisitions (32,862)  (10,579)
Payment of taxes related to an exchange of common stock (2,125)  (576)
Net cash, cash equivalents, and restricted cash used in financing activities (54,511)  (65,966)
Effect of exchange rates on cash (5,862)  (908)
Net increase (decrease) in cash, cash equivalents and restricted cash (14,158)  11,988 
      
CASH, CASH EQUIVALENTS AND RESTRICTED CASH:     
Beginning of period 67,750   56,916 
End of period$53,592  $68,904 
      
RECONCILIATION OF CASH, CASH EQUIVALENTS AND RESTRICTED CASH TO THE CONSOLIDATED BALANCE SHEETS:     
Cash and cash equivalents 51,481   68,904 
Restricted cash reported in prepaid expenses and other current assets 2,111   — 
Total cash, cash equivalents and restricted cash$53,592  $68,904 


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;
  • non-GAAP gross profit and 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 profit and 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. dollar. The constant currency revenue adjustments of $8.0 million and $15.8 million to reported revenue for the three and nine-month periods ended September 30, 2022, were calculated using the applicable average foreign exchange rates for the three and nine-month periods ended September 30, 2021.

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 nine-month periods ended September 30, 2022, there were no revenues from acquisitions excluded in the calculation of Merit’s constant currency revenue, organic.

Non-GAAP Gross Profit and Margin

Non-GAAP gross profit is calculated by reducing GAAP cost of sales by amounts recorded for amortization of intangible assets and certain inventory write-offs. Non-GAAP gross margin is calculated by dividing non-GAAP gross profit by reported net sales.

Non-GAAP Operating Income and Margin

Non-GAAP operating income is calculated by adjusting GAAP operating income 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 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 nine-month periods ended September 30, 2022 and 2021. The non-GAAP income adjustments referenced in the following tables do not reflect non-performance-based stock compensation expense of approximately $3.2 million and $3.2 million for the three-month periods ended September 30, 2022 and 2021, respectively and $9.3 million and $7.6 million for the nine-month periods ended September 30, 2022 and 2021, respectively.


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

               
 Three Months Ended
 September 30, 2022
 Pre-Tax Tax Impact After-Tax Per Share Impact
GAAP net income$17,602  $(2,330) $15,272  $0.27 
               
Non-GAAP adjustments:              
Cost of Sales              
Amortization of intangibles 10,487   (2,571)  7,916   0.14 
Operating Expenses              
Contingent consideration expense 915   —   915   0.02 
Amortization of intangibles 1,554   (384)  1,170   0.02 
Performance-based share-based compensation (b) 1,353   (70)  1,283   0.02 
Corporate transformation and restructuring (c) 8,535   (1,796)  6,739   0.12 
Acquisition-related 667   (163)  504   0.01 
Medical Device Regulation expenses (d) 3,873   (948)  2,925   0.05 
Other (e) 116   (28)  88   0.00 
Other (Income) Expense              
Amortization of long-term debt issuance costs 151   (37)  114   0.00 
Loss on disposal of business unit 135   (32)  103   0.00 
               
Non-GAAP net income$45,388  $(8,359) $37,029  $0.64 
               
Diluted shares            57,586 


               
 Three Months Ended
 September 30, 2021
 Pre-Tax Tax Impact After-Tax Per Share Impact
GAAP net income$14,177  $(2,210) $11,967  $0.21 
               
Non-GAAP adjustments:              
Cost of Sales              
Amortization of intangibles 10,573   (2,626)  7,947   0.14 
Operating Expenses              
Contingent consideration expense 1,115   (16)  1,099   0.02 
Amortization of intangibles 1,793   (449)  1,344   0.02 
Performance-based share-based compensation (b) 1,639   (207)  1,432   0.02 
Corporate transformation and restructuring (c) 4,282   (1,061)  3,221   0.06 
Acquisition-related 2,866   (711)  2,155   0.04 
Medical Device Regulation expenses (d) 1,129   (280)  849   0.01 
Other (e) 159   (78)  81   0.00 
Other (Income) Expense              
Amortization of long-term debt issuance costs 151   (37)  114   0.00 
               
Non-GAAP net income$37,884  $(7,675) $30,209  $0.52 
               
Diluted shares            57,549 

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



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

               
 Nine Months Ended
 September 30, 2022
 Pre-Tax Tax Impact After-Tax Per Share Impact
GAAP net income$52,474  $(11,359) $41,115  $0.71 
               
Non-GAAP adjustments:              
Cost of Sales              
Amortization of intangibles 31,539   (7,733)  23,806   0.41 
Operating Expenses              
Contingent consideration expense 4,702   (17)  4,685   0.08 
Impairment charges 1,672   (318)  1,354   0.02 
Amortization of intangibles 4,749   (1,176)  3,573   0.06 
Performance-based share-based compensation (b) 4,354   (413)  3,941   0.07 
Corporate transformation and restructuring (c) 20,432   (4,702)  15,730   0.27 
Acquisition-related 1,901   (465)  1,436   0.02 
Medical Device Regulation expenses (d) 8,451   (2,069)  6,382   0.11 
Other (e) 7,845   (1,863)  5,982   0.10 
Other (Income) Expense              
Amortization of long-term debt issuance costs 453   (111)  342   0.01 
Loss on disposal of business unit 1,390   (32)  1,358   0.02 
               
Non-GAAP net income$139,962  $(30,258) $109,704  $1.91 
               
Diluted shares            57,573 


               
 Nine Months Ended
 September 30, 2021
 Pre-Tax Tax Impact After-Tax Per Share Impact
GAAP net income$33,736  $(5,895) $27,841  $0.49 
               
Non-GAAP adjustments:              
Cost of Sales              
Amortization of intangibles 31,884   (7,918)  23,966   0.42 
Inventory write-off (a) 1,620   (202)  1,418   0.02 
Operating Expenses              
Contingent consideration expense 3,322   (2)  3,320   0.06 
Impairment charges 4,283   (481)  3,802   0.07 
Amortization of intangibles 5,397   (1,352)  4,045   0.07 
Performance-based share-based compensation (b) 3,998   (494)  3,504   0.06 
Corporate transformation and restructuring (c) 17,044   (4,223)  12,821   0.22 
Acquisition-related 8,475   (2,101)  6,374   0.11 
Medical Device Regulation expenses (d) 2,523   (625)  1,898   0.03 
Other (e) 6,534   (468)  6,066   0.11 
Other (Income) Expense              
Amortization of long-term debt issuance costs 453   (112)  341   0.01 
               
Non-GAAP net income$119,269  $(23,873) $95,396  $1.67 
               
Diluted shares            57,274 

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



Reconciliation of Reported Operating Income to Non-GAAP Operating Income

(Unaudited; in thousands except percentages)

                                
 Three Months Ended Three Months Ended Nine Months Ended Nine Months Ended
 September 30, 2022 September 30, 2021 September 30, 2022 September 30, 2021
 Amounts % Sales Amounts % Sales Amounts % Sales Amounts % Sales
Net Sales as Reported$287,175      $267,021      $857,566      $796,259     
                                
GAAP Operating Income 18,657   6.5%  15,931   6.0%  57,146   6.7%  39,020   4.9%
Cost of Sales                               
Amortization of intangibles 10,487   3.7%  10,573   4.0%  31,539   3.7%  31,884   4.0%
Inventory write-off (a) —   —   —   —   —   —   1,620   0.2%
Operating Expenses                               
Contingent consideration expense 915   0.3%  1,115   0.4%  4,702   0.5%  3,322   0.4%
Impairment charges —   —   —   —   1,672   0.2%  4,283   0.5%
Amortization of intangibles 1,554   0.5%  1,793   0.7%  4,749   0.6%  5,397   0.7%
Performance-based share-based compensation (b) 1,353   0.5%  1,639   0.6%  4,354   0.5%  3,998   0.5%
Corporate transformation and restructuring (c) 8,535   3.0%  4,282   1.6%  20,432   2.4%  17,044   2.1%
Acquisition-related 667   0.2%  2,866   1.1%  1,901   0.2%  8,475   1.1%
Medical Device Regulation expenses (d) 3,873   1.3%  1,129   0.4%  8,451   1.0%  2,523   0.3%
Other (e) 116   0.0%  159   0.1%  7,845   0.9%  6,534   0.8%
                                
Non-GAAP Operating Income$46,157   16.1% $39,487   14.8% $142,791   16.7% $124,100   15.6%

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 consulting expenses related to the Foundations for Growth Program and other transformation costs, including severance related to corporate initiatives.
d)Represents incremental expenses incurred to comply with the E.U. Medical Device Regulation (“MDR”).
e)The three-month period ended September 30, 2022 includes costs to comply with Merit’s corporate integrity agreement with the U.S. Department of Justice (the “DOJ”). The 2022 year-to-date period also includes acquired in-process research and development charges of $6.7 million and legal costs associated with a shareholder derivative proceeding. 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 corporate integrity agreement with the DOJ.



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

                        
     Three Months Ended     Nine Months Ended
     September30,      September30, 
  % Change  2022 2021  % Change  2022 2021
Reported Revenue 7.5% $287,175  $267,021   7.7% $857,566  $796,259 
                        
Add: Impact of foreign exchange     7,975   —       15,763   — 
                        
Constant Currency Revenue (a) 10.5% $295,150  $267,021   9.7% $873,329  $796,259 
                        
Less: Revenue from certain acquisitions     —   —       —   — 
                        
Constant Currency Revenue, Organic (a) 10.5% $295,150  $267,021   9.7% $873,329  $796,259 

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



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

                
 Three Months Ended Nine Months Ended
 September 30, September 30,
  2022   2021   2022   2021 
Reported Gross Margin 44.8%  45.1%  44.8%  44.8%
                
Add back impact of:               
Amortization of intangibles 3.7%  4.0%  3.7%  4.0%
Inventory write-off (a) —   —%  —%  0.2%
                
Non-GAAP Gross Margin 48.4%  49.1%  48.5%  49.0%


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.

ABOUT MERIT

Founded in 1987, Merit Medical Systems, Inc. is a leading global manufacturer and marketer of healthcare technology. Merit serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling in excess of 700 individuals. Merit employs approximately 6,900 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 (GAAP and non-GAAP), operating income and margin (GAAP and non-GAAP), gross profit and margin (GAAP and non-GAAP), earnings per share (GAAP and non-GAAP), free cash flow, and other financial measures, 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, 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, 2021 (the “2021 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; disruptions in Merit’s supply chain, manufacturing or sterilization processes; reduced availability of, and price increases associated with, commodity components; adverse changes in freight, shipping and transportation expenses; 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, including inflation; fluctuations in interest or foreign currency exchange rates; 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; difficulties, delays and expenditures relating to development, testing and regulatory approval or clearance of Merit’s products, including the pursuit of approvals under the MDR, 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; risks and uncertainties associated with the COVID-19 pandemic and Merit’s response thereto; 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 2021 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:Investor Inquiries:
Teresa JohnsonMike Piccinino, CFA, IRC
Merit MedicalWestwicke - ICR
+1-801-208-4295+1-443-213-0509
tjohnson@merit.commike.piccinino@westwicke.com