News Column

ICU MEDICAL INC/DE - 10-Q - Management's Discussion and Analysis of Financial Condition and Results of Operations

August 11, 2014

We are a leader in the development, manufacture and sale of innovative medical devices used in infusion therapy, oncology and critical care applications. Our products improve patient outcomes by helping to prevent bloodstream infections and protect healthcare workers from exposure to infectious diseases or hazardous drugs. Our complete product line includes needlefree infusion connectors, custom infusion systems, hemodynamic monitoring systems and Closed System Transfer Devices ("CSTD") and systems for handling hazardous drugs.



Business Overview

In the early 1990s, we launched the Clave, an innovative one-piece, needlefree infusion connection device. The Clave is a leader in worldwide connector sales. The Clave's unique design ensures compliance with needlefree policies because it is rendered non-functional when use of a needle is attempted. Our Clave products accounted for 35% of our revenues in 2013. In the late 1990s, we commenced a transition from a product-centered company to an innovative, fast, efficient, low-cost manufacturer of custom infusion sets, using processes that we believe can be readily applied to a variety of disposable medical devices. This strategy has enabled us to capture revenue on the entire infusion delivery system, and not just a component of the system. We have furthered this effort to include all of our proprietary devices beyond the Clave. One of our growth strategies is through acquisitions of companies, assets or product lines. We are continuously exploring acquisition opportunities, however there is no assurance that we will be successful in finding future acquisition opportunities or integrating new product lines into our existing business. Another strategy for reducing our dependence on our current proprietary products has been to introduce new products. In 2013, we introduced the ChemoLock CSTD. ChemoLock prevents the escape of hazardous drug or vapor concentrations, blocks the transfer of environmental contaminants into the system, and eliminates needlestick injuries. In 2011 and 2012, we introduced the Neutron, a catheter patency device using Clave technology, the NanoClave, a smaller Clave product designed for neonatal and pediatric patients and the Diana Hazardous Drug Compounding System, an automated sterile compounding 9



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system for preparing hazardous drugs. We can provide no assurance that we will be able to successfully manufacture, market and sell these new products.

We are also expanding our business through increased sales to medical product manufacturers, independent distributors and through direct sales to the end users of our product. These expansions include, but are not limited to, our 2014 agreement with Premier, the extension of the term of our agreement with MedAssets and our 2011 agreement with Novation covering all our critical care products. Each of these organizations is a U.S. healthcare purchasing network. We also potentially face substantial increases in competition in our Clave business. Therefore, we are focusing on increasing product development, acquisition, sales and marketing efforts to custom infusion systems, oncology products, critical care products and other products that lend themselves to customization and new products in the U.S. and international markets. Our products are used in hospitals and alternate medical sites in more than 55 countries throughout the world. We categorize our products into three main market segments: Infusion Therapy, Critical Care and Oncology. In prior periods, we included Tego needlefree hemodialysis connector and Lopez enteral valve under "Other". These are now included under Infusion Therapy. Our primary products include: Infusion Therapy •Needlefree connector products •MicroClave and MicroClave Clear •Anti-Microbial MicroClave •Neutron •NanoClave •Clave •Y-Clave •Anti-Microbial Clave •Custom infusion sets •Tego needlefree hemodialysis connector •Lopez enteral valve Critical Care •Hemodynamic monitoring systems •Transpac disposable pressure transducers •Safeset closed needlefree blood conservation systems •CardioFlo hemodynamic monitoring sensor system •Custom monitoring systems •Catheters •Advanced sensor catheters •Pulmonary artery thermodilution catheters •Central venous oximetry catheters •Multi-lumen central venous catheters •Custom angiography and interventional radiology kits



Oncology

•ChemoLock closed system transfer device and components •ChemoClave closed system transfer device and components including: •Genie closed vial access device •Spiros closed male luer •Custom preparation and administration sets and accessories •Diana hazardous drug compounding system Our largest customer is Hospira. Hospira accounted for 35%, 39% and 42% of our worldwide revenues in the first six months of 2014 and each of the years ended 2013 and 2012, respectively. Our relationship with Hospira has been and will continue to be important for our growth. We currently manufacture custom I.V. sets for sale by Hospira and jointly promote the products under the name SetSource. We expect revenues from sales of Clave products, custom infusion sets and new products to Hospira to remain a significant percentage of our revenues. Hospira has a significant share of the I.V. set market in the U.S. and provides us access to that market. We expect that Hospira will continue to be important to our growth for Clave, custom infusion sets and our other products worldwide. 10



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Revenues for the first six months of 2014 and the years ended 2013 and 2012 were $151.9 million, $313.7 million and $316.9 million, respectively. We currently sell substantially all of our products to medical product manufacturers, independent distributors and through direct sales to the end user. Most of our independent distributors handle the full line of our infusion administration products. We sell our I.V. administration and oncology products under two agreements with Hospira. Under a 1995 agreement, Hospira purchases Clave products, principally bulk, non-sterile connectors and oncology products. Under a 2001 agreement, we sell custom infusion sets to Hospira under a program referred to as SetSource. Our 1995 and 2001 agreements with Hospira provide Hospira with conditional exclusive and nonexclusive rights to distribute all existing ICU Medical products worldwide with terms that extend through most of 2018. We sell invasive monitoring and angiography products to independent distributors and through direct sales. We also sell certain other products to a number of other medical product manufacturers. We believe that as healthcare providers continue to either consolidate or join major buying organizations, the success of our products will depend, in part, on our ability, either independently or through strategic relationships such as our Hospira relationship, to secure long-term contracts with large healthcare providers and major buying organizations. As a result of this marketing and distribution strategy we derive most of our revenues from a relatively small number of distributors and manufacturers. The loss of a strategic relationship with a customer or a decline in demand for a manufacturing customer's products could have a material adverse effect on our operating results. We believe that achievement of our growth objectives worldwide will require increased efforts by us in sales and marketing and product development; however, there is no assurance that we will be successful in implementing our growth strategy. Product development or acquisition efforts may not succeed, and even if we do develop or acquire additional products, there is no assurance that we will achieve profitable sales of such products. An adverse change in our relationship with Hospira, or a deterioration of Hospira's position in the market, could have an adverse effect on us. Increased expenditures for sales and marketing and product acquisition and development may not yield desired results when expected, or at all. While we have taken steps to control these risks, there are certain risks that may be outside of our control, and there is no assurance that steps we have taken will succeed.



The following table sets forth, for the periods indicated, total revenues by market segment as a percentage of total revenues.

Three months ended June 30, Six months ended June 30, Fiscal year ended Market segment 2014 2013 2014 2013 2013 2012 Infusion therapy 70 % 71 % 70 % 72 % 71 % 72 % Critical care 17 % 16 % 18 % 17 % 17 % 17 % Oncology 12 % 12 % 12 % 11 % 12 % 10 % Other 1 % 1 % - % - % - % 1 % 100 % 100 % 100 % 100 % 100 % 100 %



Seasonality/Quarterly Results

The healthcare business in the United States is subject to quarterly fluctuations due to frequency of illness during the seasons, elective procedures, and over the last few years, the economy. In Europe, the healthcare business generally slows down in the summer months due to vacations resulting in fewer elective surgeries. Also in Europe, hospitals' budgets tend to finish at the end of the year which may cause fewer purchases in the last three months of the year as hospitals await their new budgets in January. In addition, we can experience fluctuations in net sales as a result of variations in the ordering patterns of our largest customers, which may be driven more by production scheduling and their inventory levels, and less by seasonality. Our expenses often do not fluctuate in the same manner as net sales, which may cause fluctuations in operating income that are disproportionate to fluctuations in our revenue. 11



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Quarter-to-Quarter Comparisons

We present income statement data in Part I, Item 1 - Financial Statements. The following table shows, for the three and six months ended June 30, 2014 and 2013 and the year ended December 31, 2013, the percentages of each income statement caption in relation to total revenues. Percentage of revenues Three months ended June 30, Six months ended June 30, Fiscal year 2014 2013 2014 2013 2013 Total revenues 100 % 100 % 100 % 100 % 100 % Gross margin 48 % 48 % 48 % 49 % 49 % Selling, general and administrative expenses 31 % 29 % 31 % 30 % 28 % Research and development expenses 6 % 5 % 5 % 4 % 4 % Total operating expenses 37 % 34 % 36 % 34 % 32 % Income from operations 11 % 14 % 12 % 15 % 17 % Other income - % - % - % - % - % Income before income taxes 11 % 14 % 12 % 15 % 17 % Income taxes 4 % 5 % 4 % 5 % 4 % Net income 7 % 9 % 8 % 10 % 13 % Subsequent Event In late July 2014, we reorganized our U. S. commercial organization, resulting in a reduction in force. We will have a restructuring charge in third quarter of 2014, primarily comprised of severance expenses, estimated to be approximately $3.0 million. Our sales expenses will be favorably impacted from this reduction in force beginning in the third quarter of 2014.



Quarter Ended June 30, 2014 Compared to the Quarter Ended June 30, 2013

Revenues were $78.7 million in the second quarter of 2014 and in the second quarter of 2013.

Infusion Therapy: Net infusion therapy sales were $55.3 million in the second quarter of 2014, a decrease of $0.9 million, or 2%, from the second quarter of 2013. Domestic infusion therapy sales were $40.5 million in the second quarter of 2014, a decrease of $2.6 million, or 6%, from the second quarter of 2013. The decrease in domestic infusion therapy was primarily from $3.2 million in lower sales to Hospira, partially offset by $0.6 million in increased domestic sales to distributors and direct customers. International infusion therapy sales were $14.8 million in the second quarter of 2014, an increase of $1.7 million, or 13%, from the second quarter of 2013. The increase in international infusion therapy sales is from higher unit sales and higher average selling prices ("ASPs") due to change in product mix outside of Europe. Critical Care: Net critical care sales were $13.7 million in the second quarter of 2014, an increase of $1.0 million, or 8%, from the second quarter of 2013. Domestic critical care sales were $9.9 million in the second quarter of 2014, an increase of $0.4 million, or 4%, from the second quarter of 2013 due to higher unit sales and higher average selling prices due to change in product mix. International critical care sales were $3.8 million in the second quarter of 2014, an increase of $0.6 million, or 18%, from the second quarter of 2013 due to higher unit sales and higher ASPs due to change in product mix inside and outside of Europe. Oncology: Net oncology sales were $9.3 million in the second quarter of 2014 and $9.4 million in the second quarter of 2013. Domestic oncology sales were $3.9 million in the second quarter of 2014, a decrease of $0.2 million, or 5%, from the second quarter of 2013. The decrease in domestic oncology was from lower unit sales to Hospira. International oncology sales were $5.4 million in the second quarter of 2014, an increase of $0.1 million, or 4%, from the second quarter of 2013 due to higher unit sales outside of Europe. Gross margins for the second quarters of 2014 and 2013 were 47.7% and 48.4%, respectively. The decrease in gross margin was due to unfavorable change in product mix and temporary rework on one of our product lines, partially offset by lower logistic expenses. 12



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Selling, general and administrative expenses ("SG&A") were $24.3 million, or 31% of revenues, in the second quarter of 2014, compared with $23.2 million, or 29%, of revenues in second quarter of 2013. The increase in SG&A expenses is primarily from $1.0 million in higher stock compensation expense. Research and development expenses ("R&D") were $4.6 million, or 6% of revenue, in the second quarter of 2014 compared to $3.9 million, or 5%, of revenue in the second quarter of 2013. The increase in R&D expenses was primarily from increased compensation and benefits expenses from an increase in employees and increased external R&D project expenses. Our R&D team focuses on filling in product line gaps and product enhancements for our product line target markets and creating additional market opportunities.



Other income was $0.2 million in the second quarter of 2014 and in the second quarter of 2013.

Income taxes were accrued at an estimated effective tax rate of 34% in the second quarter of 2014 and in the second quarter of 2013. The rate differed from the statutory corporate rate of 35% principally because of the effect of foreign and state income taxes, tax credits and deductions for domestic production activities.



Six Months Ended June 30, 2014 Compared to the Six Months Ended June 30, 2013

Revenues were $151.9 million in the first six months of 2014, compared to $153.0 million in the first six months of 2013.

Infusion Therapy: Net infusion therapy sales were $106.1 million in the first six months of 2014, a decrease of $3.3 million, or 3%, from the first six months of 2013. Domestic infusion therapy sales were $75.7 million in the first six months of 2014, a decrease of $6.4 million, or 8%, from the first six months of 2013. The decrease in domestic infusion therapy was from $7.5 million in lower sales to Hospira, partially offset by $1.1 million in increased domestic sales to distributors and direct customers. International infusion therapy sales were $30.4 million in the first six months of 2014, an increase of $3.1 million, or 11%, from the first six months of 2013. The increase in international infusion therapy sales is primarily from higher unit sales and higher ASPs due to change in product mix outside of Europe. Net critical care sales were $26.8 million in the first six months of 2014, an increase of $1.4 million, or 6%, from the first six months of 2013. Domestic critical care sales were $19.2 million in the first six months of 2014, an increase of $0.5 million, or 3%, from the first six months of 2013 due to higher unit sales and higher average selling prices due to change in product mix. International critical care sales were $7.6 million in the first six months of 2014, an increase of $0.9 million, or 13%, from the first six months of 2013 due to higher unit sales and higher ASPs due to change in product mix inside and outside of Europe. Net oncology sales were $18.3 million in the first six months of 2014, an increase of $0.8 million, or 5%, from the first six months of 2013. Domestic oncology sales were $7.8 million in the first six months of 2014, an increase of $0.3 million, or 4%, from the first six months of 2013. The increase in domestic oncology was from higher unit sales to distributors and direct customers. International oncology sales were $10.5 million in the first six months of 2014, an increase of $0.5 million, or 5%, from the first six months of 2013 due to higher unit sales in Europe. Gross margins for the first half of 2014 and 2013 were 48.4% and 48.9%, respectively. The decrease in gross margin was due to unfavorable change in product mix and temporary rework of one of our product lines, partially offset by lower logistic expenses. SG&A were $46.8 million, or 31% of revenues, in the first six months of 2014, compared with $46.0 million, or 30% of revenues, in the first six months of 2013. The increase was primarily from $1.5 million in higher stock compensation expense and $0.8 million in higher legal expenses, partially offset by $0.9 million in lower travel expenses and $0.6 million in lower incentive compensation expenses. R&D were $8.2 million, or 5% of revenue, in the first six months of 2014 compared to $5.8 million, or 4% of revenue, in the first six months of 2013. The increase in R&D expenses was primarily from increased compensation and benefit expenses from an increase in R&D employees and increased external R&D project expenses.



Other income was $0.4 million in the first six months of 2014 and in the first six months of 2013.

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Income taxes were accrued at an estimated effective tax rate of 34% in the first six months of 2014 compared to 31% in the first six months of 2013. The rate differed from the statutory corporate rate of 35% principally because of the effect of foreign and state income taxes, tax credits, deductions for domestic production activities and discrete tax items.



Liquidity and Capital Resources

During the first six months of 2014, our cash, cash equivalents and investment securities increased by $18.9 million from $296.9 million at December 31, 2013 to $315.8 million at June 30, 2014.



Operating Activities: Our cash provided by operating activities is subject to fluctuations, principally from changes in net income, accounts receivable, inventories and the timing of tax payments.

Our cash provided by operations was $29.3 million in the first six months of 2014. Net income plus adjustments for non-cash net expenses contributed $27.1 million to cash provided by operations. Changes in operating assets and liabilities contributed $2.1 million to cash provided by operations. The $4.8 million decrease in accounts receivable and $3.5 million increase in inventory were the largest changes in operating assets and liabilities. The decrease in accounts receivable was primarily due to improved day sales outstanding and from lower revenue in the second quarter of 2014 compared to the fourth quarter of 2013. The increase in inventory was primarily due to higher finished goods inventory and work in progress inventory. Investing Activities: Our cash used by investing activities was $23.3 million in the first six months of 2014, which was primarily comprised of $12.7 million in capital purchases and net investment purchases of $10.2 million. Our property, plant and equipment purchases were primarily for the plant expansion, machinery, equipment and mold additions in our Salt Lake City plant, machinery and equipment additions in our Mexico plant and investments in IT that benefit world-wide operations. While we can provide no assurances, we estimate that our capital expenditures in 2014 will approximate $16.0 million to $19.0 million. The construction for the expansion of our Salt Lake City plant was completed in June 2014. Capital expenditures for the plant expansion were approximately $7.0 million in the first six months of 2014. We also anticipate making additional investments in molds, machinery and equipment in our manufacturing operations in the United States and Mexico to support new and existing products and investments in IT that benefit world-wide operations. We expect to use our cash and investments to fund our capital purchases. These planned amounts of spending are estimates and actual spending may substantially differ from these amounts. Financing Activities: Our cash provided by financing activities was $4.6 million in the first six months of 2014. Cash and tax benefits provided by the exercise of stock options and shares purchased by our employees under the employee stock purchase plan was $10.4 million in the first six months of 2014. In the first six months of 2014, we withheld 2,763 shares of our common stock from option exercises and 4,232 shares of our common stock from vested restricted stock units as consideration for $0.2 million in payments for the employee's share award tax withholding obligations. In July 2010, our Board of Directors approved a share purchase plan to purchase up to $40.0 million of our common stock. We purchased $5.6 million in our common stock in the first half of 2014, all in the first quarter. As of June 30, 2014, we purchases $17.5 million of our common stock pursuant to this plan, leaving a balance of $22.5 million available for future purchases. This plan has no expiration date. We may purchase additional shares in future quarters and expect we would use our cash and investments to fund the share purchases. We have a substantial cash and investment security position generated from profitable operations and stock sales, principally from the exercise of employee stock options. We maintain this position to fund our growth, meet increasing working capital requirements, fund capital expenditures, and to take advantage of acquisition opportunities that may arise. Our primary investment goal is capital preservation, as further described in Part 1, Item 3. Quantitative and Qualitative Disclosures about Market Risk. As of June 30, 2014, we have $17.8 million of cash and cash equivalents held by our foreign subsidiaries, the majority of which is available to fund foreign operations and obligations. We believe that our existing cash, cash equivalents and investment securities along with funds expected to be generated from future operations will provide us with sufficient funds to finance our current operations for the next twelve months. In the event that we experience illiquidity in our investment securities, downturns or cyclical fluctuations in our business that are more severe or longer than anticipated or if we fail to achieve anticipated revenue and expense levels, we may need to obtain or seek alternative sources of capital or financing, and we can provide no assurances that the terms of such capital or financing will be available to us on favorable terms, if at all.



Off Balance Sheet Arrangements

In the normal course of business, we have agreed to indemnify our officers and directors to the maximum extent permitted under Delaware law and to indemnify customers as to certain intellectual property matters related to sales of our products. There is no maximum limit on the indemnification that may be required under these agreements. Although we can provide no assurances, we have never incurred, nor do we expect to incur, any material liability for indemnification. 14



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We have contractual obligations, at June 30, 2014, of approximately the amount set forth in the table below. This amount excludes inventory related purchase orders for goods and services for current delivery. The majority of our inventory purchase orders are blanket purchase orders that represent an estimated forecast of goods and services. We do not have a commitment liability on the blanket purchase orders. Since we do not have the ability to separate out blanket purchase orders from non-blanket purchase orders for inventory related goods and services for current delivery, amounts related to such purchase orders are excluded from the table below. We have excluded from the table below pursuant to ASC 740-10-25 (formerly FIN 48), an interpretation of ASC 740-10 (formerly SFAS 109), a non-current income tax liability of $2.7 million due to the high degree of uncertainty regarding the timing of future cash outflows associated with the liabilities. (in thousands) Contractual Obligations Total 2014 2015 2016 2017 Operating leases $ 361$ 147$ 151$ 63 - Service agreements 256 227 13 13 3 Purchase obligations 4,394 4,394 - - - $ 5,011$ 4,768$ 164$ 76 3



Critical Accounting Policies

In our Annual Report on Form 10-K for the year ended December 31, 2013, we identified the critical accounting policies which affect our more significant estimates and assumptions used in preparing our consolidated financial statements. We have not changed these policies from those previously disclosed in our Annual Report. New Accounting Pronouncements See Note 2 to Part I, Item 1. Financial Statements. Forward Looking Statements Various portions of this Quarterly Report on Form 10-Q, including this Management's Discussion and Analysis of Financial Condition and Results of Operations, describe trends in our business and finances that we perceive and state some of our expectations and beliefs about our future. These statements about the future 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 we identify them by using words such as "anticipate," "believe," "expect," "estimate," "intend," "plan," "will," "continue," "could," "may," and by similar expressions and statements about aims, goals and plans. The forward looking statements are based on the best information currently available to us and assumptions that we believe are reasonable, but we do not intend the statements to be representations as to future results. They include, without limitation, statements about: • future growth; future operating results and various elements of operating results, including future expenditures on sales and marketing and product development; future sales of products; expected increases or decreases in sales; production costs; gross margins; litigation expense; SG&A and R&D expenses; future costs of expanding our business; income; losses; cash flow; capital expenditures; source and sufficiency of funds for capital purchases and operations; tax rates; changes in working capital items such as receivables and inventory; selling prices; and income taxes; • factors affecting operating results, such as shipments to specific customers; reduced dependence on current proprietary products; expansion in international markets and use of foreign currency, selling prices; foreign exchange rate fluctuations, economic conditions in European and other international markets; future increases or decreases in sales of certain products and in certain markets and distribution channels; increases in systems capabilities; introduction and sales of new products; planned increases in marketing efforts; inventory requirements; planned capital purchases for molds, machinery and equipment in our manufacturing operations and investments in information technology; results of R&D; business seasonality and fluctuations in quarterly results; customer ordering patterns, production scheduling and inventory levels and the effects of new accounting pronouncements; and • expansion of our custom products business; expectations regarding revenues from our custom infusion sets, custom critical care and custom oncology products and the importance of these products in the future; our focus on increasing product development,



acquisition,

sales and marketing efforts to custom products and similar products; new or extended contracts with manufacturers and buying organizations; dependence on a 16



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small number of customers; future sales to and revenues from Hospira and the importance of Hospira to our growth and our positioning with respect to new product introductions and market share; expectations regarding days' sales outstanding in Hospira accounts receivable; the outcome of our strategic initiatives; outcome of litigation; competitive and market factors, including continuing development of competing products by other manufacturers; our dependence on securing long-term contracts with large healthcare providers and major buying organizations; working capital requirements; liquidity and realizable value of our investment securities; future investment alternatives; our expectations regarding liquidity and capital resources over the next twelve months; future share repurchases; acquisitions of other businesses or product lines, indemnification liabilities and contractual liabilities. Forward-looking statements involve certain risks and uncertainties, which may cause actual results to differ materially from those discussed in each such statement. First, one should consider the factors and risks described in the statements themselves or otherwise discussed herein. Those factors are uncertain, and if one or more of them turn out differently than we currently expect, our operating results may differ materially from our current expectations. Second, investors should read the forward looking statements in conjunction with the Risk Factors discussed in Part I, Item 1A of our Annual Report on Form 10-K with the SEC for the year ended December 31, 2013 and our other reports and registration statements filed with the SEC. Also, actual future operating results are subject to other important factors and risks that we cannot predict or control, including without limitation, the following:



• general economic and business conditions, in the U.S., Europe and other

international locations;



• unexpected changes in our arrangements with Hospira or our other large

customers; •outcome of litigation;



•fluctuations in foreign exchange rates and other risks of doing business internationally;

•increases in labor costs or competition for skilled workers;

•increases in costs or availability of the raw materials need to manufacture our products;

•the effect of price and safety considerations on the healthcare industry;

•competitive factors, such as product innovation, new technologies, marketing and distribution strength and price erosion;

•the successful development and marketing of new products;

•unanticipated market shifts and trends;

•the impact of legislation affecting government reimbursement of healthcare costs;

• changes by our major customers and independent distributors in their

strategies that might affect their efforts to market our products;

•the effects of additional governmental regulations;

•unanticipated production problems; and

•the availability of patent protection and the cost of enforcing and of defending patent claims.

The forward-looking statements in this report are subject to additional risks and uncertainties, including those detailed from time to time in our other filings with the Securities and Exchange Commission. These forward-looking statements are made only as of the date hereof and, except as required by law, we undertake no obligation to update or revise any of them, whether as a result of new information, future events or otherwise.


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