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Amneal Pharmaceuticals

Merit Medical Systems Reports Results for First Quarter Ended March 31, 2024

April 30, 2024 | Last Trade: US$101.83 0.63 0.62
  • Q1 2024 reported revenue of $323.5 million, up 8.7% compared to Q1 2023
  • Q1 2024 constant currency revenue* up 9.3% compared to Q1 2023
  • Q1 2024 constant currency revenue, organic* up 7.0% compared to Q1 2023
  • Q1 2024 GAAP operating margin of 11.1%, compared to 8.9% in Q1 2023
  • Q1 2024 non-GAAP operating margin* of 17.3%, compared to 16.1% in Q1 2023
  • Q1 2024 GAAP EPS $0.48, up 35.5%, compared to $0.36 in Q1 2023
  • Q1 2024 non-GAAP EPS* $0.77, up 18.7%, compared to $0.64 in Q1 2023

* 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 EPS; 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, April 30, 2024 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading global manufacturer and marketer of healthcare technology, today announced revenue of $323.5 million for the quarter ended March 31, 2024, an increase of 8.7% compared to the quarter ended March 31, 2023. Constant currency revenue, organic, for the first quarter of 2024 increased 7.0% compared to the prior year period.

Merit’s revenue by operating segment and product category for the three-month periods ended March 31, 2024 and 2023 was as follows (unaudited; in thousands, except for percentages):

 Three Months Ended
 Reported    Constant Currency *
 March 31,    Impact of foreign March 31,   
 2024 2023 % Change exchange 2024 % Change
Cardiovascular                 
Peripheral Intervention$134,626 $113,783 18.3 % $367  $134,993 18.6 %
Cardiac Intervention 90,688  85,328 6.3 %  932   91,620 7.4 %
Custom Procedural Solutions 48,794  47,701 2.3 %  403   49,197 3.1 %
OEM 39,266  41,164 (4.6)%  (37)  39,229 (4.7)%
Total 313,374  287,976 8.8 %  1,665   315,039 9.4 %
                  
Endoscopy                 
Endoscopy Devices 10,134  9,589 5.7 %  27   10,161 6.0 %
                  
Total$323,508 $297,565 8.7 % $1,692  $325,200 9.3 %
                     

Merit’s GAAP gross margin for the first quarter of 2024 was 46.9%, compared to GAAP gross margin of 46.5% for the prior year period. Merit’s non-GAAP gross margin* for the first quarter of 2024 was 50.9%, compared to non-GAAP gross margin* of 50.1% for the first quarter of 2023.

Merit’s GAAP net income for the first quarter of 2024 was $28.2 million, or $0.48 per share, compared to GAAP net income of $20.7 million, or $0.36 per share, for the first quarter of 2023. Merit’s non-GAAP net income* for the first quarter of 2024 was $44.8 million, or $0.77 per share, compared to non-GAAP net income* of $37.5 million, or $0.64 per share, for the first quarter of 2023.

“We delivered better-than-expected revenue and financial results in the first quarter,” said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer. “Our constant currency, organic, revenue increased 7.0% year-over-year and our constant currency total revenue increased 9.3%, both of which exceeded the high-end of our expectations. We also delivered year-over-year improvement in profitability with our non-GAAP gross and operating margins increasing 80 bps and 115 bps, respectively, and our non-GAAP earnings per share increasing 19% year-over-year. This strong growth and profitability performance drove free cash flow generation of approximately $25 million of in the quarter as well. We are pleased with the solid start to the fiscal year and remain confident in our team’s ability to deliver continued strong execution, stable constant currency growth, improving profitability and solid free cash flow generation in 2024.”

As of March 31, 2024, Merit had cash and cash equivalents of $581.9 million, total debt obligations of $822.5 million, and available borrowing capacity of approximately $657 million, compared to cash and cash equivalents of $587 million, total debt obligations of $846.6 million, and available borrowing capacity of approximately $626 million as of December 31, 2023.

Reaffirmed Fiscal Year 2024 Financial Guidance

Based upon the information currently available to Merit’s management, for the year ending December 31, 2024, absent material acquisitions, non-recurring transactions or other factors beyond Merit’s current expectations, Merit continues to expect the following:

Revenue and Earnings Guidance*

  Guidance
  Year Ending% Change
Financial Measure December 31, 2024Y/Y
    
Net Sales $1.312 - $1.325 billion4% - 5%
Cardiovascular Segment $1.272 - $1.285 billion4% - 5%
Endoscopy Segment $39.7 - $40.1 million8% - 9%
    
Non-GAAP   
Earnings Per Share $3.28 - $3.359% - 11%
    

*Percentage figures approximated; dollar figures may not foot due to rounding

2024 Net Sales Guidance - % Change from Prior Year (Constant Currency) Reconciliation*

    
 Guidance
 Low High
2024 Net Sales Guidance - % Change from Prior Year (GAAP)4.3% 5.4%
Estimated impact of foreign currency exchange rate fluctuations0.5% 0.5%
2024 Net Sales Guidance - % Change from Prior Year (Constant Currency)4.8% 5.9%
    

*Percentage figures approximated and may not foot due to rounding

Merit does not provide guidance for GAAP reported financial measures (other than revenue) or a reconciliation of forward-looking non-GAAP financial measures to the most directly comparable GAAP reported financial measures (other than revenue) because Merit is unable to predict with reasonable certainty the financial impact of items 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, and changes in governmental or industry regulations. These items are uncertain, depend on various factors, and could have a material impact on GAAP reported results for the guidance period. For the same reasons, Merit is unable to address the significance of the unavailable information, which could be material to future results. Specifically, Merit is not, without unreasonable effort, able to reliably predict the impact of these items and Merit believes inclusion of a reconciliation of these forward-looking non-GAAP measures to their GAAP counterparts could be confusing to investors or cause undue reliance.

Merit’s financial guidance for the year ending December 31, 2024 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, Tuesday, April 30, 2024, 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)
      
 March 31,   
 2024 December 31,
 (Unaudited) 2023
ASSETS     
Current Assets     
Cash and cash equivalents$581,921  $587,036 
Trade receivables, net 180,663   177,885 
Other receivables 10,980   10,517 
Inventories 302,733   303,871 
Prepaid expenses and other assets 24,437   24,286 
Prepaid income taxes 4,088   4,016 
Income tax refund receivables 453   859 
Total current assets 1,105,275   1,108,470 
      
Property and equipment, net 383,661   383,523 
Intangible assets, net 317,484   325,883 
Goodwill 381,539   382,240 
Deferred income tax assets 7,072   7,288 
Operating lease right-of-use assets 72,639   63,047 
Other assets 58,682   54,793 
Total Assets$2,326,352  $2,325,244 
      
LIABILITIES AND STOCKHOLDERS' EQUITY     
Current Liabilities     
Trade payables$48,377  $65,944 
Accrued expenses 113,220   120,447 
Current operating lease liabilities 12,472   12,087 
Income taxes payable 9,275   5,086 
Total current liabilities 183,344   203,564 
      
Long-term debt 800,136   823,013 
Deferred income tax liabilities 5,519   5,547 
Long-term income taxes payable 347   347 
Liabilities related to unrecognized tax benefits 1,912   1,912 
Deferred compensation payable 18,228   17,167 
Deferred credits 1,579   1,605 
Long-term operating lease liabilities 60,141   56,259 
Other long-term obligations 14,956   13,830 
Total liabilities 1,086,162   1,123,244 
      
Stockholders' Equity     
Common stock 649,222   638,150 
Retained earnings 603,424   575,184 
Accumulated other comprehensive loss (12,456)  (11,334)
Total stockholders' equity 1,240,190   1,202,000 
Total Liabilities and Stockholders' Equity$2,326,352  $2,325,244 
        

 

CONSOLIDATED STATEMENTS OF INCOME
(Unaudited, in thousands except per share amounts)
      
 Three Months Ended
 March 31,
 2024 2023
Net sales$323,508  $297,565 
Cost of sales 171,793   159,203 
Gross profit 151,715   138,362 
      
Operating expenses:     
Selling, general and administrative 94,428   90,144 
Research and development 21,482   21,314 
Contingent consideration (benefit) expense (117)  521 
Total operating expenses 115,793   111,979 
      
Income from operations 35,922   26,383 
      
Other income (expense):     
Interest income 7,276   131 
Interest expense (8,046)  (2,011)
Other income (expense) — net (804)  997 
Total other expense — net (1,574)  (883)
      
Income before income taxes 34,348   25,500 
      
Income tax expense 6,108   4,797 
      
Net income$28,240  $20,703 
      
Earnings per common share     
Basic$0.49  $0.36 
Diluted$0.48  $0.36 
      
Weighted average shares outstanding     
Basic 57,958   57,352 
Diluted 58,567   58,183 
        

 

CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited, in thousands)
      
 Three Months Ended
 March 31,
 2024 2023 
CASH FLOWS FROM OPERATING ACTIVITIES:   
Net income$28,240  $20,703 
Adjustments to reconcile net income to net cash provided by operating activities:     
Depreciation and amortization 23,599   20,537 
Write-off of certain intangible assets and other long-term assets 202    
Amortization of right-of-use operating lease assets 3,122   2,662 
Adjustments related to contingent consideration liabilities (117)  521 
Stock-based compensation expense 5,234   3,969 
Other adjustments 1,486   332 
Changes in operating assets and liabilities, net of acquisitions and divestitures (25,550)  (34,179)
Total adjustments 7,976   (6,158)
Net cash, cash equivalents, and restricted cash provided by operating activities 36,216   14,545 
      
CASH FLOWS FROM INVESTING ACTIVITIES:     
Capital expenditures for property and equipment (11,682)  (12,785)
Issuance of note receivables (6,162)   
Cash paid in acquisitions, net of cash acquired (3,346)  (2,000)
Other investing, net (861)  (71)
Net cash, cash equivalents, and restricted cash used in investing activities (22,051)  (14,856)
      
CASH FLOWS FROM FINANCING ACTIVITIES:   
Proceeds from issuance of common stock 7,730   4,028 
Payments on long-term debt (24,063)  (365)
Contingent payments related to acquisitions (78)  (2,568)
Payment of taxes related to an exchange of common stock (1,592)  (1,592)
Net cash, cash equivalents, and restricted cash used in financing activities (18,003)  (497)
Effect of exchange rates on cash (1,319)  376 
Net decrease in cash, cash equivalents and restricted cash (5,157)  (432)
      
CASH, CASH EQUIVALENTS AND RESTRICTED CASH:     
Beginning of period 589,144   60,558 
End of period$583,987  $60,126 
      
RECONCILIATION OF CASH, CASH EQUIVALENTS AND RESTRICTED CASH TO THE CONSOLIDATED BALANCE SHEETS:     
Cash and cash equivalents 581,921   57,945 
Restricted cash reported in prepaid expenses and other current assets 2,066   2,181 
Total cash, cash equivalents and restricted cash$583,987  $60,126 
        

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 the 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 gross profit and margin, non-GAAP operating income and margin, non-GAAP net income, and non-GAAP earnings per share (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 their most directly comparable GAAP financial measures included herein, 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 adjustment of $1.7 million to reported revenue for the three-month period ended March 31, 2024 was calculated using the applicable average foreign exchange rates for the three-month period ended March 31, 2023.

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-month period ended March 31, 2024, Merit’s constant currency revenue, organic, excludes revenues attributable to certain assets acquired from AngioDynamics, Inc. (“AngioDynamics”) in June 2023.

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. 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, and changes in governmental or 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-month periods ended March 31, 2024 and 2023. The non-GAAP income adjustments referenced in the following tables do not reflect non-performance-based stock compensation expense of approximately $3.1 million and $2.7 million for the three-month periods ended March 31, 2024 and 2023, respectively.

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

            
 Three Months Ended
 March 31, 2024
 Pre-Tax Tax Impact After-Tax Per Share Impact
GAAP net income$34,348  $(6,108) $28,240  $0.48 
            
Non-GAAP adjustments:           
Cost of Sales           
Amortization of intangibles 12,805   (3,028)  9,777   0.17 
Operating Expenses           
Contingent consideration benefit (117)  47   (70)  (0.00)
Amortization of intangibles 1,764   (417)  1,347   0.02 
Performance-based share-based compensation (a) 2,128   (294)  1,834   0.03 
Corporate transformation and restructuring (b) 1,000   (236)  764   0.01 
Acquisition-related 38   (9)  29   0.00 
Medical Device Regulation expenses (c) 2,207   (521)  1,686   0.03 
Other (d) 122   (30)  92   0.00 
Other (Income) Expense           
Amortization of long-term debt issuance costs 1,477   (348)  1,129   0.02 
            
Non-GAAP net income$55,772  $(10,944) $44,828  $0.77 
            
Diluted shares          58,567 
             

 

 Three Months Ended
 March 31, 2023
 Pre-Tax Tax Impact After-Tax Per Share Impact
GAAP net income$25,500 $(4,797) $20,703 $0.36
            
Non-GAAP adjustments:           
Cost of Sales           
Amortization of intangibles 10,616  (2,553)  8,063  0.14
Operating Expenses           
Contingent consideration expense 521  (45)  476  0.01
Amortization of intangibles 1,665  (402)  1,263  0.02
Performance-based share-based compensation (a) 1,287  (87)  1,200  0.02
Corporate transformation and restructuring (b) 3,546  (851)  2,695  0.05
Acquisition-related 255  (61)  194  0.00
Medical Device Regulation expenses (c) 3,658  (878)  2,780  0.05
Other (d) 34  (8)  26  0.00
Other (Income) Expense           
Amortization of long-term debt issuance costs 151  (36)  115  0.00
            
Non-GAAP net income$47,233 $(9,718) $37,515 $0.64
            
Diluted shares          58,183
            

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
 March 31, 2024 March 31, 2023
 Amounts % Sales Amounts % Sales
Net Sales as Reported$323,508     $297,565   
            
GAAP Operating Income 35,922  11.1 %  26,383 8.9%
Cost of Sales           
Amortization of intangibles 12,805  4.0 %  10,616 3.6%
Operating Expenses           
Contingent consideration (benefit) expense (117) (0.0)%  521 0.2%
Amortization of intangibles 1,764  0.5 %  1,665 0.6%
Performance-based share-based compensation (a) 2,128  0.7 %  1,287 0.4%
Corporate transformation and restructuring (b) 1,000  0.3 %  3,546 1.2%
Acquisition-related 38  0.0 %  255 0.1%
Medical Device Regulation expenses (c) 2,207  0.7 %  3,658 1.2%
Other (d) 122  0.0 %  34 0.0%
            
Non-GAAP Operating Income$55,869  17.3 % $47,965 16.1%
              

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 consulting expenses related to transformation projects under our Foundations for Growth Program, and in 2023, includes restructuring costs of $1.6 million associated with employee termination benefits related to corporate initiatives.

c) Represents incremental expenses incurred to comply with the E.U. Medical Device Regulation (“MDR”).

d) Represents costs to comply with Merit’s corporate integrity agreement with the U.S. Department of Justice (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
   March 31, 
 % Change 2024
 2023
Reported Revenue8.7%$323,508  $297,565
        
Add: Impact of foreign exchange   1,692   
        
Constant Currency Revenue (a)9.3%$325,200  $297,565
        
Less: Revenue from certain acquisitions   (6,728)  
        
Constant Currency Revenue, Organic (a)7.0%$318,472  $297,565
         

(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 
 March 31,  
 2024 2023
Reported Gross Margin46.9% 46.5%
      
Add back impact of:     
Amortization of intangibles4.0% 3.6%
      
Non-GAAP Gross Margin50.9% 50.1%
      

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

ABOUT MERIT

Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture, and distribution of proprietary disposable medical devices used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling more than 700 individuals. Merit employs approximately 7,000 people worldwide.

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, revenues, 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 which may be achieved through, Merit’s Continued Growth Initiatives 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, 2023 (the “2023 Annual Report”) and other filings with the SEC. Such risks and uncertainties include inherent risks and uncertainties associated with Merit’s integration of products acquired from AngioDynamics and its ability to achieve anticipated financial results, product development and other anticipated benefits of the AngioDynamics acquisition; uncertainties as to whether Merit will achieve sales, gross and operating margins, net income and earnings per share performance consistent with its forecasts associated with that acquisition; disruptions in Merit’s supply chain, manufacturing or sterilization processes; reduced availability of, and price increases associated with, commodity components and other raw materials; adverse changes in freight, shipping and transportation expenses; negative changes in economic and industry conditions in the United States or other countries, including inflation; 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; risks associated with Merit’s ongoing or prospective manufacturing transfers and facility consolidations; 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; consequences associated with a Corporate Integrity Agreement executed between Merit and the DOJ; 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; litigation and other judicial proceedings affecting Merit; 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; 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; 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 jurisdictions; termination of relationships with Merit’s suppliers, or failure of such suppliers to perform; 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; dependance on distributors to commercialize Merit’s products in various jurisdictions outside the United States; 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; fluctuations in and obsolescence of inventory; and other factors referenced in the 2023 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., its subsidiaries, or its licensors.

Contacts: 
PR/Media Inquiries:
Teresa Johnson
Merit Medical
Investor Inquiries:
Mike Piccinino, CFA, IRC
Westwicke – ICR
+1-801-208-4295+1-443-213-0509
This email address is being protected from spambots. You need JavaScript enabled to view it.This email address is being protected from spambots. You need JavaScript enabled to view it.

 


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