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ICU Medical Announces Second Quarter 2022 Results
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ICU Medical Announces Second Quarter 2022 Results

SAN CLEMENTE, Calif., Aug. 08, 2022 (GLOBE NEWSWIRE) — ICU Medical, Inc. (Nasdaq:ICUI), a leader in the development, manufacture and sale of innovative medical products, today announced financial results for the quarter ended June 30, 2022.

Second Quarter 2022 Results

Second quarter 2022 revenue was $561.0 million, compared to $321.7 million in the same period last year. GAAP gross profit for the second quarter of 2022 was $167.6 million, as compared to $123.5 million in the same period last year. GAAP gross margin for the second quarter of 2022 was 30%, as compared to 38% in the same period last year. GAAP net loss for the second quarter of 2022 was $(7.5) million, or $(0.31) per diluted share, as compared to GAAP net income of 28.4 million, or $1.31 per diluted share, for the second quarter of 2021. Adjusted diluted earnings per share for the second quarter of 2022 was $1.37 as compared to $1.88 for the second quarter of 2021. Also, adjusted EBITDA was $84.7 million for the second quarter of 2022 as compared to $66.9 million for the second quarter of 2021.

Adjusted EBITDA and adjusted diluted earnings per share are measures calculated and presented on the basis of methodologies other than in accordance with GAAP. Please refer to the Use of Non-GAAP Financial Information following the financial statements herein for further discussion and reconciliations of these measures to GAAP measures.

Vivek Jain, ICU Medical’s Chief Executive Officer, said, “Legacy ICU Medical revenues were in line with expectations and results from the acquired Smiths Medical business reflect improvement over the course of the second quarter."

Revenues by product line for the three and six months ended June 30, 2022 and 2021 were as follows (in millions):

As a result of the acquisition of Smiths Medical on January 6, 2022, the following product lines are presented in addition to our legacy product lines: Infusion Systems-Smiths Medical, Vascular Access -Smiths Medical and Vital Care-Smiths Medical.

    Three months ended
June 30,
      Six months ended
June 30,
   
Product Line   2022   2021   $ Change   2022   2021   $ Change
Infusion Consumables   $ 144.5   $ 136.2   $ 8.3     $ 285.0   $ 262.6   $ 22.4  
Infusion Systems     87.3     84.7     2.6       174.3     169.0     5.3  
IV Solutions*     94.1     88.4     5.7       182.6     182.6      
Critical Care     12.3     12.4     (0.1 )     24.5     25.5     (1.0 )
Infusion Systems-Smiths Medical     77.8         77.8       144.1         144.1  
Vascular Access-Smiths Medical     77.1         77.1       156.1         156.1  
Vital Care-Smiths Medical     67.9         67.9       137.5         137.5  
    $ 561.0   $ 321.7   $ 239.3     $ 1,104.1   $ 639.7   $ 464.4  

*IV Solutions includes $14.0 million and $25.1 million of contract manufacturing to Pfizer for the three and six months ended June 30, 2022, respectively. IV Solutions includes $10.4 million and $24.3 million of contract manufacturing to Pfizer for the three and six months ended June 30, 2021, respectively.

Fiscal Year 2022 Guidance Update

The Company is updating its full year 2022 guidance of adjusted EBITDA from a range of $450 million to $500 million to a range of $350 million to $370 million and adjusted diluted earnings per share from a range of $9.00 to $10.50 to a range of $6.20 to $6.80.

Conference Call

The Company will host a conference call to discuss its second quarter 2022 financial results, today at 4:30 p.m. ET (1:30 p.m. PT). The call can be accessed at (877) 300-8521, international (412) 317-6026, conference ID 10169518. The conference call will be simultaneously available by webcast, which can be accessed by going to the Company’s website at www.icumed.com, clicking on the Investors tab, clicking on Event Calendar and clicking on the Webcast icon and following the prompts. The webcast will also be available by replay.

About ICU Medical

ICU Medical (Nasdaq:ICUI) is a global leader in infusion systems, infusion consumables and high-value critical care products used in hospital, alternate site and home care settings. Our team is focused on providing quality, innovation and value to our clinical customers worldwide. ICU Medical is headquartered in San Clemente, California. More information about ICU Medical can be found at www.icumed.com.

Forward-Looking Statements

This press release contains 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. Such statements contain words such as ”will,” ”expect,” ”believe,” ”could,” ”would,” ”estimate,” ”continue,” ”build,” ”expand” or the negative thereof or comparable terminology, and may include (without limitation) information regarding the Company’s expectations, goals or intentions regarding the future. These forward-looking statements are based on management’s current expectations, estimates, forecasts and projections about the Company and assumptions management believes are reasonable, all of which are subject to risks and uncertainties that could cause actual results and events to differ materially from those stated in the forward-looking statements. These risks and uncertainties include, but are not limited to, decreased demand for the Company’s products, decreased free cash flow, the inability to recapture conversion delays or part/resource shortages on anticipated timing, or at all, changes in product mix, increased competition from competitors, lack of growth or improving efficiencies, unexpected changes in the Company’s arrangements with its largest customers, the impact of the ongoing COVID-19 pandemic on the Company and our financial results and the Company’s ability to meet expectations regarding integration of the Smiths Medical business. Future results are subject to risks and uncertainties, including the risk factors, and other risks and uncertainties, described in the Company’s filings with the Securities and Exchange Commission, which include those in the Company’s most recent Annual Report on Form 10-K, as updated by the Company’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2022 and our subsequent filings. Forward-looking statements contained in this press release are made only as of the date hereof, and the Company undertakes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise.


ICU MEDICAL, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)

  June 30,
2022
  December 31,
2021
  (Unaudited)   (1)
ASSETS      
CURRENT ASSETS:      
Cash and cash equivalents $ 255,698     $ 552,827  
Short-term investment securities   13,191       14,420  
TOTAL CASH, CASH EQUIVALENTS AND SHORT-TERM INVESTMENT SECURITIES   268,889       567,247  
Accounts receivable, net of allowance for doubtful accounts   216,124       105,894  
Inventories   583,050       290,235  
Prepaid income taxes   27,111       19,586  
Prepaid expenses and other current assets   94,663       46,847  
TOTAL CURRENT ASSETS   1,189,837       1,029,809  
PROPERTY, PLANT AND EQUIPMENT, net   667,783       468,365  
OPERATING LEASE RIGHT-OF-USE ASSETS   83,323       39,847  
LONG-TERM INVESTMENT SECURITIES   1,837       4,620  
GOODWILL   1,421,216       43,439  
INTANGIBLE ASSETS, net   1,080,329       188,311  
DEFERRED INCOME TAXES   43,942       42,604  
OTHER ASSETS   101,728       63,743  
TOTAL ASSETS $ 4,589,995     $ 1,880,738  
LIABILITIES AND STOCKHOLDERS’ EQUITY      
CURRENT LIABILITIES:      
Accounts payable $ 201,874     $ 81,128  
Accrued liabilities   247,656       118,195  
Current portion of long-term obligations   19,063        
Income tax payable   17,102       1,454  
Contingent earn-out liability   290        
TOTAL CURRENT LIABILITIES   485,985       200,777  
CONTINGENT EARN-OUT LIABILITY   30,119       2,589  
LONG-TERM OBLIGATIONS   1,636,029        
OTHER LONG-TERM LIABILITIES   128,200       41,830  
DEFERRED INCOME TAXES   204,992       1,490  
INCOME TAX LIABILITY   18,804       18,021  
COMMITMENTS AND CONTINGENCIES          
STOCKHOLDERS’ EQUITY:      
Convertible preferred stock, $1.00 par value; Authorized — 500 shares; Issued and outstanding — none          
Common stock, $0.10 par value; Authorized — 80,000 shares; Issued — 23,899 and 21,280 shares at June 30, 2022 and December 31, 2021, respectively, and outstanding — 23,898 and 21,280 shares at June 30, 2022 and December 31, 2021, respectively   2,390       2,128  
Additional paid-in capital   1,309,598       721,412  
Treasury stock, at cost   (92 )     (27 )
Retained earnings   866,245       911,787  
Accumulated other comprehensive loss   (92,275 )     (19,269 )
TOTAL STOCKHOLDERS’ EQUITY   2,085,866       1,616,031  
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $ 4,589,995     $ 1,880,738  

______________________________________________________
(1) December 31, 2021 balances were derived from audited consolidated financial statements.


ICU MEDICAL, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
(In thousands, except per share data)

  Three months ended
June 30,
  Six months ended
June 30,
  2022   2021   2022   2021
TOTAL REVENUES $ 561,004     $ 321,677     $ 1,104,126     $ 639,723  
COST OF GOODS SOLD   393,411       198,148       767,706       403,514  
GROSS PROFIT   167,593       123,529       336,420       236,209  
OPERATING EXPENSES:              
Selling, general and administrative   158,748       73,921       311,960       146,312  
Research and development   22,562       11,385       46,433       22,094  
Restructuring, strategic transaction and integration   13,525       3,753       47,430       6,636  
Change in fair value of contingent earn-out   (27,194 )           (27,194 )      
Contract settlement                     127  
TOTAL OPERATING EXPENSES   167,641       89,059       378,629       175,169  
(LOSS) INCOME FROM OPERATIONS   (48 )     34,470       (42,209 )     61,040  
INTEREST EXPENSE   (16,273 )     (163 )     (29,917 )     (324 )
OTHER (EXPENSE) INCOME, net   (533 )     525       471       1,208  
(LOSS) INCOME BEFORE INCOME TAXES   (16,854 )     34,832       (71,655 )     61,924  
BENEFIT (PROVISION) FOR INCOME TAXES   9,380       (6,434 )     26,113       (9,795 )
NET (LOSS) INCOME $ (7,474 )   $ 28,398     $ (45,542 )   $ 52,129  
NET (LOSS) INCOME PER SHARE              
Basic $ (0.31 )   $ 1.34     $ (1.91 )   $ 2.46  
Diluted $ (0.31 )   $ 1.31     $ (1.91 )   $ 2.40  
WEIGHTED AVERAGE NUMBER OF SHARES              
Basic   23,897       21,200       23,787       21,176  
Diluted   23,897       21,703       23,787       21,718  


ICU MEDICAL, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)
(In thousands) 

  Six months ended
June 30,
  2022   2021
CASH FLOWS FROM OPERATING ACTIVITIES:      
Net (loss) income $ (45,542 )   $ 52,129  
Adjustments to reconcile net (loss) income to net cash (used in) provided by operating activities:      
Depreciation and amortization   119,697       44,319  
Amortization of inventory step-up   22,676        
Noncash lease expense   10,888       4,780  
Provision for doubtful accounts   (99 )     342  
Provision for warranty and returns   1,483       (345 )
Stock compensation   19,854       12,703  
Loss on disposal of property, plant and equipment and other assets   267       829  
Bond premium amortization   211       364  
Debt issuance costs amortization   3,495       144  
Change in fair value of contingent earn-out   (27,194 )      
Usage of spare parts   5,229       5,356  
Other   (2,807 )     1,574  
Changes in operating assets and liabilities, net of amounts acquired:      
Accounts receivable   (1,090 )     2,078  
Inventories   (100,024 )     13,368  
Prepaid expenses and other current assets   4,710       759  
Other assets   (17,323 )     (7,632 )
Accounts payable   22,149       (1,648 )
Accrued liabilities   (33,509 )     (17,068 )
Income taxes, including excess tax benefits and deferred income taxes   (45,798 )     (5,970 )
Net cash (used in) provided by operating activities   (62,727 )     106,082  
CASH FLOWS FROM INVESTING ACTIVITIES:      
Purchases of property, plant and equipment   (48,039 )     (29,693 )
Proceeds from sale of assets   900       203  
Business acquisitions, net of cash acquired   (1,844,164 )      
Intangible asset additions   (4,440 )     (4,136 )
Purchases of investment securities   (3,397 )     (10,034 )
Proceeds from sale and maturities of investment securities   26,198       7,000  
Net cash used in investing activities   (1,872,942 )     (36,660 )
CASH FLOWS FROM FINANCING ACTIVITIES:      
Proceeds from issuance of long-term debt, net of lender debt issuance costs   1,672,631        
Principal repayments of long-term debt   (18,125 )      
Payment of third-party debt issuance costs   (1,852 )      
Proceeds from exercise of stock options   2,992       5,416  
Payments on finance leases   (321 )     (296 )
Tax withholding payments related to net share settlement of equity awards   (10,438 )     (7,819 )
Net cash provided by (used in) financing activities   1,644,887       (2,699 )
Effect of exchange rate changes on cash   (6,347 )     (783 )
NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS   (297,129 )     65,940  
CASH AND CASH EQUIVALENTS, beginning of period   552,827       396,097  
CASH AND CASH EQUIVALENTS, end of period $ 255,698     $ 462,037  

Use of Non-GAAP Financial Information

This press release contains financial measures that are not calculated in accordance with U.S. generally accepted accounting principles ("GAAP"). The non-GAAP financial measures should be considered supplemental to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. There are material limitations in using these non-GAAP financial measures because they are not prepared in accordance with GAAP and may not be comparable to similarly titled non-GAAP financial measures used by other companies, including peer companies. Our management believes that the non-GAAP data provides useful supplemental information to management and investors regarding our performance and facilitates a more meaningful comparison of results of operations between current and prior periods. We use non-GAAP financial measures in addition to and in conjunction with GAAP financial measures to analyze and assess the overall performance of our business, in making financial, operating and planning decisions, and in determining executive incentive compensation.

The non-GAAP financial measures include adjusted EBITDA, adjusted revenue, adjusted gross profit, adjusted selling, general and administrative, adjusted research and development, adjusted restructuring, strategic transaction and integration, adjusted change in fair value of contingent earn-out, adjusted (loss) income before income taxes, adjusted benefit (provision) for income taxes, adjusted net (loss) income and adjusted diluted (loss) earnings per share, all of which exclude special items because they are highly variable or unusual and impact year-over-year comparisons.

For the three months ended June 30, 2022 and 2021, special items include the following:

Stock compensation expense: Stock-based compensation is generally fixed at the time the stock-based instrument is granted and amortized over a period of several years. The value of stock options is determined using a complex formula that incorporates factors, such as market volatility, that are beyond our control. The value of our restricted stock awards is determined using the grant date stock price, which may not be indicative of our operational performance over the expense period. Additionally, in order to establish the fair value of performance-based stock awards, which are currently an element of our ongoing stock-based compensation, we are required to apply judgment to estimate the probability of the extent to which performance objectives will be achieved. Based on the above factors, we believe it is useful to exclude stock-based compensation in order to better understand our operating performance.

Intangible asset amortization expense: We do not acquire businesses or capitalize certain patent costs on a predictable cycle. The amount of purchase price allocated to intangible assets and the term of amortization can vary significantly and are unique to each acquisition. Capitalized patent costs can vary significantly based on our current level of development activities. We believe that excluding amortization of intangible assets provides the users of our financial statements with a consistent basis for comparison across accounting periods.

Restructuring, strategic transaction and integration: We incur restructuring and strategic transaction charges that result from events, which arise from unforeseen circumstances and/or often occur outside of the ordinary course of our ongoing business. Although these events are reflected in our GAAP financial statements, these unique transactions may limit the comparability of our ongoing operations with prior and future periods.

Adjustment to reverse the cost recognition related to the purchase accounting write-up of inventory to fair market value: The inventory step-up represents the expense recognition of fair value adjustments in excess of the historical cost basis of inventory obtained through acquisition, these charges are outside of our normal operations and are excluded.

Contract settlement: Occasionally, we are involved in contract renegotiations that may result in one-time settlements. We exclude these settlements as they have no direct correlation to the operation of our ongoing business.

Quality system and product-related remediation: We exclude certain quality system product-related remediation charges in determining our non-GAAP financial measures as they may limit the comparability of our ongoing operations with prior and future periods and distort the evaluation of our normal operating performance.

From time to time in the future, there may be other items that we may exclude if we believe that doing so is consistent with the goal of providing useful information to investors and management.

In addition to the above special items, Adjusted EBITDA additionally excludes the following items from net income:

Depreciation expense: We exclude depreciation expense in deriving adjusted EBITDA because companies utilize productive assets of different ages and the depreciable lives can vary significantly resulting in considerable variability in depreciation expense among companies.

Interest, net: We exclude interest in deriving adjusted EBITDA as interest can vary significantly among companies depending on a company’s level of income generating instruments and/or level of debt.

Taxes: We exclude taxes in deriving adjusted EBITDA as taxes are deemed to be non-core to the business and may limit the comparability of our ongoing operations with prior and future periods and distort the evaluation of our normal operating performance.

We also present Free cash flow as a non-GAAP financial measure as management believes that this is an important measure for use in evaluating overall company financial performance as it measures our ability to generate additional cash flow from business operations. Free cash flow should be considered in addition to, rather than as a substitute for, net income as a measure of our performance or net cash (used in) provided by operating activities as a measure of our liquidity. Additionally, our definition of free cash flow is limited and does not represent residual cash flows available for discretionary expenditures due to the fact that the measure does not deduct the payments required for debt service and other obligations or payments made for business acquisitions. Therefore, we believe it is important to view free cash flow as supplemental to our entire statement of cash flows.

The following tables reconcile our GAAP and non-GAAP financial measures:


ICU MEDICAL, INC. AND SUBSIDIARIES
Reconciliation of GAAP to Non-GAAP Financial Measures (Unaudited)
(In thousands, except per share data)

  Adjusted EBITDA
  Three months ended
June 30,
  2022   2021
GAAP net (loss) income $ (7,474 )   $ 28,398  
       
Non-GAAP adjustments:      
Interest, net   15,440       (545 )
Stock compensation expense   7,762       6,681  
Depreciation and amortization expense   66,559       22,164  
Restructuring, strategic transaction and integration   13,525       3,753  
Change in fair value of contingent earn-out   (27,194 )      
Adjustment to reverse the cost recognition related to the purchase accounting write-up of inventory to fair value   8,306        
Quality system and product-related remediation   17,195        
(Benefit) provision for income taxes   (9,380 )     6,434  
Total non-GAAP adjustments   92,213       38,487  
       
Adjusted EBITDA $ 84,739     $ 66,885  


ICU MEDICAL, INC. AND SUBSIDIARIES
Reconciliation of GAAP to Non-GAAP Financial Measures (Unaudited)
(In thousands, except percentages and per share)

The company’s U.S. GAAP results for the three months ended June 30, 2022 included special items which impacted the U.S. GAAP measures as follows:

  Total revenues Gross profit Selling, general and administrative Research and development Restructuring, strategic transaction and integration Change in fair value of contingent earn-out (Loss) income from operations (Loss) income before income taxes Benefit (provision) for income taxes Net (loss) income Diluted (loss) earnings per share
Reported (GAAP) $ 561,004   $ 167,593   $ 158,748   $ 22,562   $ 13,525   $ (27,194 ) $ (48 ) $ (16,854 ) $ 9,380   $ (7,474 ) $ (0.31 )
Reported percent of total revenues (or percent of (loss) income before income taxes for benefit (provision) for income taxes)     30 %   28 %   4 %   2 %   (5 )%   %   (3 )%    55.7 %   (1 )%   
Contract manufacturing   (14,043 )                                    
Stock compensation expense       1,408     (5,945 )   (409 )         7,762     7,762     (1,863 )   5,899     0.24  
Amortization expense       2,943     (38,673 )             41,616     41,616     (9,905 )   31,711     1.33  
Restructuring, strategic transaction and integration                   (13,525 )     13,525     13,525     (2,610 )   10,915     0.46  
Change in fair value of contingent earn-out             27,194     (27,194 )   (27,194 )       (27,194 )   (1.14 )
Adjustment to reverse the cost recognition related to the purchase accounting write-up of inventory to fair value       8,306                   8,306     8,306     (1,952 )   6,354     0.27  
Quality system and product-related remediation       17,195                   17,195     17,195     (4,247 )   12,948     0.54  
Earnings per share impact on net loss due to basic versus diluted weighted average shares                                         (0.02 )
Adjusted (Non-GAAP) $ 546,961   $ 197,445   $ 114,130   $ 22,153   $   $   $ 61,162   $ 44,356   $ (11,197 ) $ 33,159   $ 1.37  
Adjusted percent of total revenues (or percent of (loss) income before income taxes for benefit (provision) for income taxes)     36 %   21 %   4 %   %   %   11 %   8 %   25.2 %   6 %  


ICU MEDICAL, INC. AND SUBSIDIARIES
Reconciliation of GAAP to Non-GAAP Financial Measures (Unaudited)(continued)
(In thousands, except percentages and per share)

The company’s U.S. GAAP results for the three months ended June 30, 2021 included special items which impacted the U.S. GAAP measures as follows:

  Total revenues Gross profit Selling, general and administrative Research and development Restructuring, strategic transaction and integration Income from operations Income before income taxes Provision for income taxes Net income Diluted earnings per share
Reported (GAAP) $ 321,677   $ 123,529   $ 73,921   $ 11,385   $ 3,753   $ 34,470   $ 34,832   $ (6,434 ) $ 28,398   $ 1.31
Reported percent of total revenues (or percent of income before income taxes for benefit provision for income taxes)     38 %   23 %   4 %   1 %   10 %   10 %   18.5 %   8 %  
Contract manufacturing   (10,377 )                                  
Stock compensation expense       958     (5,401 )   (322 )       6,681     6,681     (1,603 )   5,078     0.24
Amortization expense       45     (5,769 )           5,814     5,814     (1,371 )   4,443     0.20
Restructuring, strategic transaction and integration                   (3,753 )   3,753     3,753     (901 )   2,852     0.13
Adjusted (Non-GAAP) $ 311,300   $ 124,532   $ 62,751   $ 11,063   $   $ 50,718   $ 51,080   $ (10,309 ) $ 40,771   $ 1.88
Adjusted percent of total revenues (or percent of income before income taxes for provision for income taxes)     40 %   20 %   4 %   %   16 %   16 %   (20.2 )%   13 %  


ICU MEDICAL, INC. AND SUBSIDIARIES
Reconciliation of Net Cash (Used in) Provided by Operating Activities to Free Cash Flow (Unaudited)
(In thousands)

  Three months ended
June 30
  Six months ended
June 30
  2022   2021   2022   2021
Net cash (used in) provided by operating activities $ (61,385 )   $ 54,762     $ (62,727 )   $ 106,082  
Purchase of property, plant and equipment   (24,433 )     (15,665 )     (48,039 )     (29,693 )
Proceeds from sale of assets         148       900       203  
Free cash flow $ (85,818 )   $ 39,245     $ (109,866 )   $ 76,592  


ICU MEDICAL, INC. AND SUBSIDIARIES
Fiscal Year 2022 Outlook (Unaudited)
(In millions, except per share data)

  Low End of Guidance   High End of Guidance
GAAP net income $ (109 )   $ (94 )
       
Non-GAAP adjustments:      
Interest, net   67       67  
Stock compensation expense   37       37  
Depreciation and amortization expense   238       238  
Restructuring, strategic transaction and integration   81       81  
Quality and regulatory initiatives and remediation   80       80  
Adjustment to reverse the cost recognition related to the purchase accounting write-up of inventory to fair market value   23       23  
Change in fair value of contingent earn-out   (27 )     (27 )
Provision for income taxes   (40 )     (35 )
Total non-GAAP adjustments $ 459     $ 464  
       
Adjusted EBITDA $ 350     $ 370  
       
       
       
GAAP diluted earnings per share $ (4.50 )   $ (3.88 )
       
Non-GAAP adjustments:      
Stock compensation expense   1.53       1.53  
Amortization expense   5.95       5.95  
Restructuring, strategic transaction and integration   3.35       3.35  
Quality and regulatory initiatives and remediation   3.31       3.31  
Adjustment to reverse the cost recognition related to the purchase accounting write-up of inventory to fair market value   0.95       0.95  
Change in fair value of contingent earn-out   (1.12 )     (1.12 )
Estimated income tax impact from adjustments   (3.27 )     (3.29 )
Adjusted diluted earnings per share $ 6.20     $ 6.80  

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