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ICU Medical, Inc. Announces Second Quarter 2019 Results

August 7, 2019 4:04 PM

Company Updates FY 2019 Guidance

SAN CLEMENTE, Calif., Aug. 07, 2019 (GLOBE NEWSWIRE) -- ICU Medical, Inc. (Nasdaq: ICUI), a leader in the development, manufacture and sale of innovative medical products used in infusion therapy and critical care applications, today announced financial results for the quarter ended June 30, 2019.

Second Quarter 2019 Results

Second quarter 2019 revenue was $312.3 million, compared to $360.5 million in the same period last year. GAAP gross profit for the second quarter of 2019 was $103.9 million, as compared to $151.8 million in the same period last year. GAAP gross margin for the second quarter of 2019 was 33%, as compared to 42% in the same period last year. GAAP net income for the second quarter of 2019 was $22.8 million, or $1.06 per diluted share, as compared to GAAP net income of $31.1 million, or $1.44 per diluted share, for the second quarter of 2018. Adjusted diluted earnings per share for the second quarter of 2019 were $1.99 as compared to $2.69 for the second quarter of 2018. Also, adjusted EBITDA was $66.7 million for the second quarter of 2019 as compared to $77.4 million for the second quarter of 2018.

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, “Second quarter revenue, adjusted EBITDA and adjusted EPS were below our expectations. Infusion Consumables and Infusion Systems were generally in line with our expectations but the current market environment in IV Solutions has forced us to lower our expectations for fiscal year 2019.”

Revenues by market segment for the three and six months ended June 30, 2019 and 2018 were as follows (in millions):

Three months ended
June 30,
Six months ended
June 30,
Market Segment 2019 2018 $
Change
%
Change
2019 2018 $
Change
%
Change
Infusion Consumables $117.7 $123.8 $(6.1) (4.9)% $238.2 $243.7 $(5.5) (2.3)%
IV Solutions* 102.6 135.4 (32.8) (24.2)% 215.8 279.8 (64.0) (22.9)%
Infusion Systems 81.3 88.4 (7.1) (8.0)% 165.6 181.8 (16.2) (8.9)%
Critical Care 10.7 12.9 (2.2) (17.1)% 23.6 27.2 (3.6) (13.2)%
$312.3 $360.5 $(48.2) (13.4)% $643.2 $732.5 $(89.3) (12.2)%
*IV Solutions includes $23.0 million and $44.5 million of contract manufacturing to Pfizer for the three and six months ended June 30, 2019, respectively, as compared to $19.5 million and $37.6 million for the same periods in the prior year.

Fiscal Year 2019 Guidance Update

The Company is modifying its full year 2019 guidance of adjusted EBITDA from a range of $315 million to $340 million to a range of $260 million to $275 million and adjusted earnings per share from a range of $9.00 to $9.90 to a range of $7.55 to $8.15.

Conference Call

The Company will host a conference call to discuss second quarter 2019 financial results today at 4:30 p.m. EDT (1:30 p.m. PDT). The call can be accessed at (800) 936-9761, international (408) 774-4587, conference ID 3763366. The conference call will be simultaneously available by webcast, which can be accessed by going to the Company's website at 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, Inc.

ICU Medical, Inc. (Nasdaq: ICUI) develops, manufactures and sells innovative medical products used in infusion therapy, and critical care applications. ICU Medical's product portfolio includes IV smart pumps, sets, connectors, closed system transfer devices for hazardous drugs, sterile IV solutions, cardiac monitoring systems, along with pain management and safety software technology designed to help meet clinical, safety and workflow goals. ICU Medical is headquartered in San Clemente, California. More information about ICU Medical, Inc. 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, and unexpected changes in the Company's arrangements with its largest customers. 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 Annual Report on Form 10-K for the year ended December 31, 2018 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
CONSOLIDATED BALANCE SHEETS
(In thousands)
June 30,
2019
December 31,
2018
(Unaudited) (1)
ASSETS
CURRENT ASSETS:
Cash and cash equivalents$291,867 $344,781
Short-term investment securities21,863 37,329
TOTAL CASH, CASH EQUIVALENTS AND SHORT-TERM INVESTMENT SECURITIES313,730 382,110
Accounts receivable, net of allowance for doubtful accounts230,294 176,298
Inventories329,955 311,163
Prepaid income taxes20,915 11,348
Prepaid expenses and other current assets34,722 46,117
TOTAL CURRENT ASSETS929,616 927,036
PROPERTY AND EQUIPMENT, net436,920 432,641
OPERATING LEASE RIGHT-OF-USE ASSETS36,787
LONG-TERM INVESTMENT SECURITIES2,017 2,025
GOODWILL11,181 11,195
INTANGIBLE ASSETS, net134,054 133,421
DEFERRED INCOME TAXES28,145 38,654
OTHER ASSETS44,197 40,419
TOTAL ASSETS$1,622,917 $1,585,391
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES:
Accounts payable$131,190 $120,469
Accrued liabilities128,772 128,820
TOTAL CURRENT LIABILITIES259,962 249,289
CONTINGENT EARN-OUT LIABILITY200 47,400
OTHER LONG-TERM LIABILITIES40,439 20,592
DEFERRED INCOME TAXES718 721
INCOME TAX LIABILITY3,734 3,734
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 20,668 shares at June 30, 2019 and 20,492 at
December 31, 2018 and outstanding 20,661 shares at June 30, 2019 and 20,491 shares at December 31, 2018
2,067 2,049
Additional paid-in capital657,543 657,899
Treasury stock, at cost(1,650) (95)
Retained earnings674,578 620,747
Accumulated other comprehensive loss(14,674) (16,945)
TOTAL STOCKHOLDERS' EQUITY1,317,864 1,263,655
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY$1,622,917 $1,585,391

______________________________________________________
(1) December 31, 2018 balances were derived from audited consolidated financial statements.

ICU MEDICAL, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
(In thousands, except per share data)
Three months ended
June 30,
Six months ended
June 30,
2019 2018 2019 2018
TOTAL REVENUES$312,282 $360,460 $643,214 $732,493
COST OF GOODS SOLD208,413 208,660 404,042 431,692
GROSS PROFIT103,869 151,800 239,172 300,801
OPERATING EXPENSES:
Selling, general and administrative67,824 81,816 140,457 166,831
Research and development11,199 13,575 24,022 26,161
Restructuring, strategic transaction and integration37,041 18,690 61,433 40,259
Contract settlement1,039 3,822 28,917
Change in fair value of contingent earn-out(39,500) 6,000 (47,200) 2,000
TOTAL OPERATING EXPENSES77,603 120,081 182,534 264,168
INCOME FROM OPERATIONS26,266 31,719 56,638 36,633
INTEREST EXPENSE(139) (130) (272) (265)
OTHER INCOME (EXPENSE), net1,479 (1,992) 4,670 (2,948)
INCOME BEFORE INCOME TAXES27,606 29,597 61,036 33,420
(PROVISION) BENEFIT FOR INCOME TAXES(4,773) 1,457 (7,205) 2,509
NET INCOME$22,833 $31,054 $53,831 $35,929
NET INCOME PER SHARE
Basic$1.11 $1.53 $2.62 $1.77
Diluted$1.06 $1.44 $2.50 $1.67
WEIGHTED AVERAGE NUMBER OF SHARES
Basic20,622 20,352 20,577 20,304
Diluted21,520 21,569 21,546 21,536

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 included in this press release are adjusted EBITDA and adjusted diluted earnings per share ("Adjusted Diluted EPS").

Adjusted EBITDA excludes the following items from net income:

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.

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.

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.

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.

Change in fair value of contingent earn-out: We exclude the impact of certain amounts recorded in connection with business combinations. We exclude items that are either non-cash or not normal, recurring operating expenses due to their nature, variability of amounts, and lack of predictability as to occurrence and/or timing.

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.

Supply chain restructuring: Occasionally, we incur 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.

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.

Adjusted Diluted EPS excludes from diluted EPS, net of tax, intangible asset amortization expense, stock compensation expense, restructuring, strategic transaction and integration, change in fair value of contingent earn-out, contract settlement, and supply chain restructuring. The tax effect on the above adjustments is calculated using the specific tax rate applied to each adjustment based on the nature of the item/or the tax jurisdiction in which the item has been recorded.

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.

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)
Adjusted EBITDA
Three months Ended
June 30,
2019 2018
GAAP net income$22,833 $31,054
Non-GAAP adjustments:
Interest, net(1,565) (787)
Stock compensation expense6,229 6,297
Depreciation and amortization expense18,764 17,604
Restructuring, strategic transaction and integration37,041 18,690
Change in fair value of contingent earn-out(39,500) 6,000
Contract settlement1,808
Supply chain restructuring16,349
Provision (Benefit) for income taxes4,773 (1,457)
Total non-GAAP adjustments43,899 46,347
Adjusted EBITDA$66,732 $77,401


Adjusted diluted earnings per share
Three months ended
June 30,
2019 2018 (1)
GAAP diluted earnings per share$1.06 $1.44
Non-GAAP adjustments:
Stock compensation expense$0.29 $0.29
Amortization expense$0.19 $0.19
Restructuring, strategic transaction and integration$1.72 $0.87
Change in fair value of contingent earn-out$(1.84) $0.28
Contract settlement$0.08 $
Supply chain restructuring$0.76 $
Estimated income tax impact from adjustments$(0.27) $(0.38)
Adjusted diluted earnings per share$1.99 $2.69

_______________________________________________

(1) During 2019, we changed our methodology when computing adjusted diluted earnings per share to remove interest, net from the calculation, accordingly we conformed the prior year adjusted diluted earnings per share to the current year presentation.

ICU Medical, Inc. and Subsidiaries
Reconciliation of GAAP to Non-GAAP Financial Measures - Fiscal Year 2019 Outlook (Unaudited)
(In millions, except per share data)
Low End of Guidance High End of Guidance
GAAP net income$87 $100
Non-GAAP adjustments:
Interest, net(5) (5)
Stock compensation expense25 25
Depreciation and amortization expense80 80
Restructuring, strategic transaction and integration67 67
Change in fair value of contingent earn-out(48) (48)
Contract settlement6 6
Write-off of assets13 13
Supply chain restructuring16 16
Provision for income taxes19 21
Total non-GAAP adjustments173 175
Adjusted EBITDA$260 $275
GAAP diluted earnings per share$4.03 $4.63
Non-GAAP adjustments:
Stock compensation expense$1.16 $1.16
Amortization expense$0.76 $0.76
Restructuring, strategic transaction and integration$3.10 $3.10
Change in fair value of contingent earn-out$(2.19) $(2.19)
Contract settlement$0.27 $0.27
Write-off of assets$0.59 $0.59
Supply chain restructuring$0.75 $0.75
Estimated income tax impact from adjustments$(0.92) $(0.92)
Adjusted diluted earnings per share$7.55 $8.15

CONTACT:
ICU Medical, Inc.
Scott Lamb, Chief Financial Officer
(949) 366-2183

ICR, Inc.
John Mills, Partner
(646) 277-1254

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