R&I Rating Methodology by Sector

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1 R&I Rating Methodology by Sector Medical Devices August 8, 2013 The term medical devices refers to equipment and apparatus that are used for the diagnosis and treatment of illnesses, or function as part of the human body. While the types of medical devices cover a broad range, R&I applies this rating methodology mainly to firms that handle the manufacture and sale of medical devices utilized by physicians, nurses and other medical professionals. Specifically the methodology is applied for products ranging from small manufactured items made from steel such as surgical knives, to treatment apparatus such as injection devices and catheters, equipment to assist or provide body functions such as cardiac pacemakers, artificial joints and artificial dialyzers, medical devices for diagnostic systems (including clinical diagnostics) such as endoscopes, X rays and inspection devices, and dental materials, etc, and excludes medical apparatus for home use. R&I bases its rating methodology on the assumption a subject entity operates in a global market. I. Evaluation of Business Risk 1. View of industry risk Because medical devices are developed as products with a high degree of specialization in accordance with criteria such as the contents of the diagnosis and treatment of an illness or operating procedures, the variety of products encompassed is enormous when compared with pharmaceuticals products. Product forms run the gamut from large-scale machines and equipment to various tools and small articles, while their structures also vary, ranging from medical devices comprised of state-of-the-art electronic components to goods assembled from glass, resin, metal and other materials. As can be understood from such differences in application, shape and structure, typically there is little technological connection among individual products. Put another way, all of the products used for medical practice are referred to generically as medical devices, while the aggregation of these segmentalized products forms the huge medical devices market. Although patients are the ultimate beneficiaries of medical devices, the actual users are healthcare professionals including physicians. While demand is constrained by medical care needs, other factors that come into play include the expansion of medical treatment areas because of breakthroughs in medical technology and improvement of the level of medical care in emerging 1/10

2 countries, and the size of the market tends to expand. Because medical devices are products related to medical practice, however, in most countries they are under the control of the medical care system. Products are strongly subject to regulation by authorities, such as approvals or permits and the establishment of set prices (insurance reimbursement prices), which acts as a restraining factor on commercial transactions. Medical device product development typically proceeds by incorporating the opinions and needs of the healthcare professionals who use the medical devices while cooperating with medical care sites (medical-engineering collaboration), an approach that differs greatly from pharmaceuticals, a sector where the principal entities of development are laboratories. Product improvements are sometimes introduced frequently, and product-life cycles generally are short. But because efficacy is demonstrated through the combination of products with the procedures of healthcare professionals, there is a deep-rooted need for the products practitioners are accustomed to using, and consequently a heavy reliance on brand-name goods. Demand for medical devices generally is not susceptible to the economy and is comparatively steady. However, there is a risk as well that demand for an existing medical device will plunge suddenly through changes such as replacement with a competing product that has a superior medical care effect or the establishment of a new treatment procedure or diagnostic approach. In a sector where technological innovation is particularly intensive, introducing new products through continuous R&D investment is indispensable. Viewed as a whole, R&I evaluates the medical devices industry to have a medium degree of industry risk. (1) Market size, market growth potential and market volatility Worldwide the scale of the market for medical devices is estimated to be about 300 billion dollars, while in Japan, which is the world s second largest market, the size exceeds two trillion yen, excluding medical apparatus for home use (about 100 billion yen). Although comparatively large in size, this market is aggregated from various products, each of which comprises a market whose respective form is independent, according to each product s use and function. Because patients and others who require diagnosis and treatment are the beneficiaries of medical care, the demand for medical devices exhibits a strong relationship to macro indicators such as population and income levels. Factors such as the spread and improvement of public health and expansion of the insurance regime in emerging countries, expansion of the medical care field 2/10

3 through breakthroughs in medical technology, and the evolution of new medical devices that combine multiple functions, also help maintain high growth potential. In advanced countries, rapid market growth cannot be anticipated, but steady demand can be expected because societies are aging and there is increasing demand for cutting-edge medical care. While there are differences depending on the product, in emerging countries the growth in demand is remarkable, supported by changes such as population growth and rising income levels, and for the world overall, rapid market growth can be expected. With the exception of high-cost diagnoses and treatments that are not directly related to life-threatening crises, medical care-related demand generally is not overly susceptible to fluctuations in the economy. Although influences from a systemic perspective are unavoidable, products are related to individual s lives and the size of the market does not greatly expand or contract over the short term. Market volatility is viewed as being comparatively small. (2) Industry structure (competitive environment) Despite being referred to collectively as medical devices, the competitive environment differs considerably depending on the product. A myriad of products exists, according to medical needs, and for some items the size of the market is quite small. There also are numerous products for which market participants are limited. The market is sometimes segmented by use or product, leading to conditions both in Japan and overseas where the market is formed by a comparatively large number of small and medium-sized market entrants. On the other hand, the larger the size of the market, major domestic and foreign manufacturers will employ their ample funding abilities and technological capabilities to capture a certain share of the market through their broad product line-ups and cost competitiveness. It is in these market areas where the major companies battle it out, and the competition is accordingly severe. Because commercialization is being advanced continually based on product upgrades and improvements and new technologies, depending on its skill in responding to this evolution the possibility exists that a company will lose share in its target market. Because many product segments are growth sectors as well, the number of market participants tends to increase, and competition is viewed as somewhat severe. (3) Customer continuity and stability The efficacy of a medical device is demonstrated in combination with the skill of healthcare 3/10

4 professionals who handle the equipment. This tendency is even stronger for products that are used for difficult operations or diagnoses in particular, because such products' efficacy is related significantly to technical proficiency. For healthcare professionals, this provides a robust incentive to continue using the medical devices they are accustomed to using, in order to demonstrate the effectiveness of diagnosis or treatment to the maximum extent. Medical device manufacturers also use techniques such as offering technical skills training opportunities at their own training centers, providing technical support at medical care sites, and a wealth of information aimed at the prompt development and introduction of improved products, as a means to lock in healthcare professionals. Of course, these are products related to saving lives, and safety and quality are given priority above all else. Based on such an equipment selection characteristics, the confidence in brand-name goods runs correspondingly deep. Despite the accelerating pace of technological innovation in conjunction with the greater sophistication of medical needs, countervailing factors such as restraints on the healthcare expenditures that are the source of purchases and the appearance of emerging country manufacturers, and the fact the risk of replacement by other products has risen in recent years, the need for existing products that have a proven track record still appears deep-rooted. Based on such aspects, customer continuity and stability are comparatively high. (4) Capital and inventory investment cycle Medical devices include both products that are made using methods that approach being hand-made and mass-produced products, a fact that accounts for their differing capital investment burdens. Normally the investment burden grows larger as the relative weighting of the latter increases. While stable supply is regarded as essential for medical devices as products related to human lives, accurate demand forecasting is difficult and a stocking burden is necessary to a certain extent. The greater the number of diverse products and small-volume production runs handled, or the longer a period of time receivables to medical institutions are outstanding in a country where a manufacturer develops business, the larger a manufacturer's working capital will be. Still, because the scale of investment per factory is small compared with other business categories, comparatively stable cash flow can be anticipated and the risk from a capital equipment and inventory investment cycle aspect is comparatively small. 4/10

5 (5) Protection, regulations and public aspects Medical devices also are characterized by the fact product improvements and development are always taking place at medical care sites, and compared with pharmaceuticals the substantive protected period is short. However, legal safeguards are broader than for general products; for example, a patent extension system for medical devices has been introduced (in the United States), based on industrial development by country. Medical devices are strongly affected by the medical care administration and systemic aspects in each country. The point that these procedures and a firm's response to them have become substantial barriers to entry can be evaluated as a positive factor. On the other hand, the national medical expenditures that are also the source of funding for medical device purchases, especially in advanced countries, is putting pressure on fiscal administration, and the trend to rein in such outlays is especially remarkable. Although current conditions, including the ageing of society and expansion of leading-edge medical care, are keeping healthcare costs at a high level, efforts to curtail expenditures are expected to become stronger in the future. Based on this point, R&I does not consider protection and regulation to contribute significantly in either a positive or negative way when evaluating creditworthiness. (6) Cost structure In advanced technology sectors, keen competition with leading overseas medical devices companies continues. Firms are unable to cut back the R&D investment needed to continuously launch competitive products, and cost flexibility is minimal. On the other hand, for throwaway (disposable) medical devices that are difficult to differentiate, such as injection syringe materials purchased using the income from procedure charges and treatment fees as a source of funds, the percentage of the cost accounted for materials costs and processing expenses normally is high because unit selling prices are low. Earnings can come under pressure when the costs of raw materials or labor rise. When products are of various types and specifications, the size of their capital investment burden will vary, but if a product is mass-produced, a commensurate capital investment burden is required and fixed costs such as depreciation and amortization expense can easily become heavy. 2. View of individual firm risk In contrast to industry risk, which highlights the standard risks of the industry of which the subject firms are a part, the business risk of each company will differ depending on the individual 5/10

6 firm risk as explained below. (1) Product sector, product competitiveness and product line-up For medical devices the size of the market and rate of growth, need for the product and other considerations differ greatly depending upon the individual products. Consequently R&I emphasizes the scale of the market for a company's core products. Additionally, R&I considers market share to be a key indicator highlighting overall competitiveness. If a product enjoys a high market share, this is evidence as well of the product's acceptance by the healthcare providers who are the professionals in that field, and can be said to show that the product s brand power and the company's product development prowess are superior. Because of the immense number of products, many companies develop their business by specializing in diagnosis and treatment sectors that play to their strengths. If a company has enhanced its product line-up in one sector, this brings advantages such as a wider range of choices and simplification of purchasing for healthcare professionals and medical institutions, which in turn has a favorable effect on the firm s brand power and sales capabilities. Provided it offers products that can serve as a source of revenues and earnings, even if the products are in other sectors where the technical innovation risk, system change risk and other unknowns are different, a company's ability to cope with changes in the operating environment will be enhanced. In general, medical devices are products that benefit from comparatively high customer continuity and stability. In cases such as diagnostic system medical devices that are purchased with relative infrequency by medical institutions, however, a manufacturer cannot count on always receiving an order again when the equipment is renewed. If sales of related products such as consumables, in addition to maintenance and repairs, help to achieve transaction continuity and stability and help define product competitiveness, or if earnings are generated through incidental services, R&I can evaluate a firm's products and product lineup highly. (2) Global sales capability The growth potential and trend in demand for medical devices differ by region and country. If the regions and countries where a company sells its products are diversified, this not only broadens earnings opportunities but can also mitigate the risks accompanying changes to the medical care systems in the countries and regions the company will develop. 6/10

7 (3) Production technology capabilities Even in the case of high-end products, medical devices are accepted with comparative ease provided they are equipped with epoch-making functions or corresponding quality. For goods that are locked into increasingly tough competition with similar products, or products that are evolving into becoming commodity items, it is easy to reach a situation where winning or losing is determined solely by price. On the other hand, when diverse products in small-volume production runs are required depending on the product in order to broadly support the needs of medical institutions, or when measures from a safety and hygiene aspect are demanded because products are related to the living human body, costs can easily mount up. For manufacturing processes that will affect the manufacturing cost for example, when there is a mechanism that can lower the cost through the use of inexpensive raw materials or by shortening working hours and operations it will be possible to respond sufficiently to these issues as well. (4) Product development prowess For business continuity, taking into consideration the needs of the medical care workplace, and introducing new or improved products when products achieve their longevity are a must. It is additionally important to create epoch-making products that will find a need in the future as well. From the viewpoint of technology and know-how accumulation, R&I will surmise a firm's new product development capacity and flexibility in response to alternative products and technical innovations. II. Evaluation of Financial Risk In addition to quantitative factors in the form of financial data, R&I also evaluates qualitative factors, such as a firm s financial management policy and liquidity risk, in its analysis of financial risk. Because of industry characteristics, R&I emphasizes the following financial indicators for the medical devices industry. (1) Earning capacity EBITDA (earnings before interest, taxes, depreciation and amortization) margin, operating income margin, EBITDA/average total assets While medical devices can be expected to produce comparatively steady earnings, downward pressure on prices will grow stronger with the time passage as both new and improved products are 7/10

8 introduced and competition with lower-priced alternatives heats up. To address such risk a company will find it necessary to improve its earning capacity level sufficiently as a firm. When examining earnings capacity, R&I emphasizes the EBITDA margin, which excludes the impact of the investment burden, because depreciation and amortization expense and working capital vary according to the products handled. To view the available capacity for R&D, which requires that a firm generate sufficient earnings after depreciation and amortization expenses, R&I also evaluates the operating income margin. R&I checks the ratio of EBITDA to average total assets as well from the viewpoint of reviewing asset efficiency and the progress of investment recovery. For companies where the profit contribution level of entities such as overseas joint ventures that are subject to equity method accounting has risen, R&I appropriately reflects the effect of the equity method investment profit or loss in its evaluation. (2) Scale and investment capacity EBITDA, equity capital R&I looks closely at not only the EBITDA margin but also the level of EBITDA, which indicates the amount of investment capacity. To develop over the long term as a firm, expanding production capacity and pursuing global development, together with undertaking strategic investments in R&D and domestic and overseas acquisitions of businesses and corporations, are indispensable, and this as well requires the ability to continually generate sufficient cash flow, in order to make such investments flexibly. R&I also focuses on equity capital for measuring ability to raise funds because it functions as a risk buffer. However, because of the progress of globalization, companies exhibit a tendency to increase acquisitions of overseas assets, and R&I evaluates the strength or weakness of a firm s substantive financial base by taking into consideration factors such as the accounting effects of the translation adjustments account and gain or loss from securities valuations, and an evaluation of goodwill. (3) Debt redemption period Ratio of net debt to EBITDA While commodity sector products enjoy a long product life cycle, there also are sectors such as leading-edge medical care fields where life cycles are comparatively short. Because product development is undertaken continuously by drawing on the need for improvements at medical care 8/10

9 sites, improved products are introduced frequently, which tends to shorten actual product-life cycles. Being able to recover this investment over a timeframe corresponding to the characteristics of the business is critical. On the other hand, companies have an obligation to ensure the stable supply of their life-saving products to medical institutions. With the need for manufacturers as well to maintain a certain level of finished goods inventory, working capital can easily balloon. Even when these factors are considered, however, companies are compelled to flexibly execute strategic capital investments and R&D to provide against future changes in the business environment. Medical devices companies cannot allow the balance between their net debt and cash flow (EBIDTA) to deteriorate. (4) Financial profile Equity ratio, net D/E ratio (ratio of net debt to equity capital) Although medical device manufactures can anticipate comparatively steady cash flow, not only must they continuously shoulder a substantial R&D burden centered on high-value-added medical devices products with a rapid pace of technical innovation, their business risk has continued to increase in recent years, including a deterioration of the earnings environment that has accompanied measures to rein in healthcare costs. Maintaining a healthy debt-equity structure and improving risk resilience are critical for responding to such structural changes. III. Rating for Medical Devices Issuer Rating Individual Firm Risk Financial Risk Importance Indicator Importance Product sector, product competitiveness Earning EBITDA margin and product line-up capacity Operating income margin Global sales capability EBITDA/average total assets Production technology capabilities Scale and EBITDA Product development prowess investment capacity Equity capital Debt redemption period Ratio of net debt to EBITDA Financial profile Equity ratio Net D/E ratio Industry Risk: Medium Note) Importance is indicated by : extremely important, : important, or relatively important. 9/10

10 The Rating Determination Policy and the Rating Methodologies R&I uses in connection with evaluation of creditworthiness (collectively, the "Rating Determination Policy and Methodologies") are R&I's opinions prepared based on R&I's own analysis and research, and R&I makes no representation or warranty, express or implied, as to the accuracy, timeliness, adequacy, completeness, merchantability, fitness for any particular purpose, or any other matter with respect to the Rating Determination Policy and Methodologies. Further, disclosure of the Rating Determination Policy and Methodologies by R&I does not constitute any form of advice regarding investment decisions or financial matters or comment on the suitability of any investment for any party. R&I is not liable in any way for any damage arising in respect of a user or other third party in relation to the content or the use of the Rating Determination Policy and Methodologies, regardless of the reason for the claim, and irrespective of negligence or fault of R&I. All rights and interests (including patent rights, copyrights, other intellectual property rights, and know-how) regarding the Rating Determination Policy and Methodologies belong to R&I. Use of the Rating Determination Policy and Methodologies, in whole or in part, for purposes beyond personal use (including reproducing, amending, sending, distributing, transferring, lending, translating, or adapting the information), and storing the Rating Determination Policy and Methodologies for subsequent use, is prohibited without R&I's prior written permission. Japanese is the official language of this material and if there are any inconsistencies or discrepancies between the information written in Japanese and the information written in languages other than Japanese the information written in Japanese will take precedence. 10/10

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