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Autor: anton 02 January 2011
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The Pharmaceutical industry is composed of companies that research, develop, produce, market, and sell chemical or biological substances for medical or veterinary use; these products include: prescription, generic, and over-the-counter drugs; vitamins and nutritional supplements; diagnostic substances. The companies also develop and manufacture drug delivery systems. The U.S. Pharmaceutical industry is the world leader in pharmaceutical research and drug production, with worldwide sales expected to reach $650 billion in 2006 (Pharma Executive).
The U.S. Department of Labor and Statistics reports that this industry ranks among the fastest growing manufacturers in the United States. It has enjoyed tremendous growth over the last decade, as annual sales have nearly doubled. The industry has also enjoyed generous profit margins, consistently outperforming the S&P's 500 Index. It is expected that such prosperity will continue unabated.
Some of the factors contributing to this growth are increased life expectancies and the concomitant demographic expansion in older segments of the population, an increase in the standard of living in developing countries, and also increased numbers of untreated persons, such as those with elevated cholesterol levels or diabetes. Not surprisingly, seniors represent the largest market for prescription drugs. As their numbers expand, so does demand for pharmaceuticals (csustan).
The introduction of breakthrough drugs also fuels the industry's growth. In recent years, companies have successfully developed and marketed new treatments for heart disease, cancer, arthritis, depression, diabetes, and HIV. Also of significance is the expanding market for 'quality of life' products- those 'vanity' drugs which help to keep people looking and feeling young, such as Botox, Collagen, and hair restoration products (csustan).
The industry has experienced a high level of consolidation in recent years, and this activity has included international companies. The industry leaders frequently form cooperative ventures with small drug discovery companies and research and development institutions. In the early 1990's, this consolidation was primarily driven by a desire to cut costs. However, in the late 1990's, a strategic shift occurred, and research and development opportunities became the chief focus of the large pharmaceutical companies. This year R&D costs are expected to equal or exceed 20% of the industry's revenues, compared with 15.9% in 1990 and 11.7% in 1980 (csustan).
In 2006, the U.S. pharmaceutical market is projected to account for approximately $280 billion dollars of the total industry growth of $650 billion, an increase of 9% over last yearâ€™s increase of 5 to 7% of the total (Pharma Executive). This growth includes two one-time events: (1) the start of Medicare prescription drug benefits, The Medicare Prescription Drug, Improvement, and Modernization Act (MMA) a program developed in order to provide prescription drug benefits to the elderly and the disabled, (2) the recovery of sales lost after the recall of Vioxx from the market. However, the key driver of sales will be newly released drugs for cancer including; Avastin, Erbitux, Alimita, and Tarceva. â€œThe big one is going to be Avastin, which is expected to get new indications for breast cancer and non-small cell lung cancer, â€œ says Jason McKinnie, pharmaceutical research analyst for Frost & Sullivan (Pharmaceutical Executive).
Prescription drugs currently account for 60% of world wide sales, while over-the-counter medications comprise the remainder. Companies based in the United States make up the majority of worldwide sales, with the top 10 firms reaching or exceeding $20 billion dollars in revenue annually. The U.S. market provides 65% of their sales while 35% of sales are derived from customers outside of the U.S. Previously, from 1994-1998, domestic sales accounted for 60% of industry sales, and international 40%. Also of significance is the fact that, since 1985, pharmaceutical spending in the United States as a percentage of total health care expenditures has risen from 4.9% to 7.2% in 1997 (Wikipedia).
The growth in the domestic market has produced a prosperous environment for the industry leaders. Two key measurements- Return on Assets and Return on Equity- offer proof. Among Fortune 500 companies, those within the pharmaceutical industry have ranked number one in terms of return on assets, and number three in terms of return on equity since 1997. U.S. firms dominate through their ability to patent their innovations, globalize products, and develop new products through biotechnological research. Although the prescription drug industry is made up of several hundred companies around the world, sales within the U.S. are dominated by the ten largest concerns. For example, in 1997, the ten largest companies accounted for 53% of total domestic market sales. Also, U.S. companies engage in 36% of all R & D activity, followed by Japan with just 19%. Consequently, the majority of new medications are developed by the U.S. companies; between 1975 and 1994, nearly 50% of the 152 new drugs introduced into the world market were produced by American companies, with British and Japanese companies together accounting for just 23%. The balance is divided among numerous countries (csustan).
Although the U.S. is the worldâ€™s biggest consumer of pharmaceutical products, it actually spends less per capita on pharmaceuticals than many other industrialized nations. U.S. spending actually ranks 4th per capita in the world behind Japan, France and Belgium. As a percentage of the Gross Domestic Product (GDP), spending on pharmaceuticals is lead by France with 1.7%, Japan with 1.5%, and the U.S. with 1.1%. Daily U.S. per capita spending for pharmaceutical products is $0.64 as compared with daily per capita spending for alcohol of $0.91, $1.07 for telephone service, $2.84 for clothing, $7.94 for food and $8.45 for housing (csustan).
One significant trend in the industry has been the increase in sales of over-the-counter medications. Sales in this category have more than doubled since 1987. This may be explained by both effective marketing strategies and also the proliferation of information now available to customers over the internet. The marketers have emphasized both product information and a 'do-it-yourself' approach to the treatment of numerous ailments.
Brand recognition continues to be of great importance to capturing market share. Consequently, many companies have increased their advertising budgets in order to promote the therapeutic benefits of their drugs in an effort to distinguish their products from their competitors. While many existing pharmaceutical compounds are standardized formulations that vary little in efficacy among manufacturers, the attempt to differentiate product continues to be a primary marketing strategy. It is the hope of the industry leaders that their efforts will bear fruit in the form of a blockbuster drug such as Viagra (Wikipedia).
The preoccupation with developing a blockbuster treatment reflected in huge R&D expenditures. Such spending currently amounts to 19.6% of total industry revenues, versus 4% of sales for the average U.S. manufacturing industry. Nearly one third of R & D expenditures are allocated strictly to promising drug compounds in clinical human trials. Phase I, II, and III trials account for 26% of R & D expenses while phase IV after product introduction trials account for 5.8%. Process development consumes 10% of research expenses, while 41% is allocated to pre-clinical functions, 11.8% for chemical compound evaluation, and toxicology and safety account for 5.4%. New products are allocated approximately 80% of total R & D expenditures with the balance going towards the continuous improvement of existing products (csustan).
Risk is high in the pharmaceutical industry as expenditures for the R & D of each new drug typically last for a period of 10 to 15 years before that drug actually reaches the market. Furthermore, it takes an average of 16 months to get FDA approval for new treatments. The likelihood that a newly developed compound will ever actually be used in the retail environment is only about 1 in every 5000, with less than one third of all marketed drugs providing a return to recoup only the R & D expenditures. As a result, the average cost to bring a drug to market is $500 million while the product life of a prescription drug averages just 10 years. Consequently, only a small percentage of the drugs developed provide significant profit. And, if the companies are to succeed, the profits derived from such drugs must compensate them for the high percentage of failures.
Pharmaceutical distribution is done primarily through wholesalers with hospitals, managed care organizations and retail pharmacies as the biggest customers. Direct sales to physicians, retailers, hospitals and others accounts for approximately 30% of total distribution. Bulk purchasing practices have given large buyers considerable buying power as hospitals and managed care organizations continue to seek reductions in expenses (csustan).
The demand for pharmaceutical drugs has several key underlying trends. One trend is that of the increasing life expectancy of the aging baby boomer generation. Life expectancy rates are expected to increase the demand for prescription drugs over the next 25 years. The number of people between 45 and 64 years old will increase 41% by 2015. Growth in the industry should remain in an upward trend due to both the rise in the aged population and life expectancy rates, and also the increased level of pharmaceutical use by aging individuals.
General Economic Conditions Affecting the Industry
The pharmaceutical industry is relatively immune from the effects of economic cycles. For the most part, demand for the industry's product remains constant. However, it should be noted that foreign investment and exchange rates have increased many of the risks as globalization of the industry has increased. Many of the firms in this industry seek to minimize these risks by using hedging practices such as foreign currency forward-exchange contracts, borrowing in foreign markets, and using currency swaps. But, overall, the industry is poised to reap the benefits of an aging population and increasing life expectancy rates throughout the world. The increased emphasis on minimal global health standards will further stimulate demand for the industry's products (Morningstar).
Performance Analysis â€“ The Top Firms Within the Industry
The industry remains very attractive, especially when you consider that the operating margin for companies such as Pfizer, Merck, Bristol-Myers Squibb, and Amgen have been at approximately 25 to 30% since 1996 (Morningstar). These high profit margins enjoyed by the big pharmaceutical corporations are a product of their lower interest expenses, raw materials costs, tax rates and general and administrative costs. Compared to other industries, these costs represent a much smaller percentage of the pharmaceutical industry's sales. Consequently, the top companies in the industry are especially profitable. As of 2002, the average gross margin for Pfizer, Merck, Bristol-Myers Squibb, and Amgen was 87.5, 36.2, 64.7, and 86.7 respectively (Morningstar).
Comparing the liquidity ratios with the companies and the industry, we see that many of the companies were below the industry average of 1.63 for current ratio and 1.11 for quick ratio. Pfizer has a liquidity ratio of 1.34, followed by Merck and Bristol Myers at 1.20 and Amgen at 2.21. The current ratio is an indication of a firmâ€™s ability to pay its short term debts. The higher the ratio the more liquid a company is. Based on this information, it appears that many of these firms are in relatively good short term financial standing (Morningstar).
In the following paragraphs we will provide an analysis of the pharmaceutical industry using Michael Porterâ€™s 5 Forces Driving Industry competitions.
Bargaining Power of Buyers
In Michael E. Porterâ€™s book Competitive Strategy â€“ Techniques for Analyzing Businesses and Competitors the author describes bargaining power as the ability of a buyer to negotiate a lower price from the seller. In the pharmaceutical industry there are many different types of buyers including: managed care organizations, hospitals and hospital boards, patients, family members of patients, the finance departments, and pharmacists (csustan.edu). In various ways, buyers can have an affect on a business or an industry by seeking price reductions, demanding higher quality products, and by demanding better service. According to Porter, buyers are powerful relative to firms in an industry when it is easy for them to switch to another supplier, when they are highly concentrated and when the product is commodity-like (gbr.pepperdine.edu). In addition, a buyer is considered powerful when they purchase in large volumes, when they buy your products from other suppliers because they are standardized, and when they are knowledgeable and can make demands on the product based upon their knowledge and experience.
The Pharmaceutical Industry is not unlike many other industries in that buyers can exercise their power in two different ways. The first is related to the buyerâ€™s price sensitivity. If each brand of a product is similar to all of the others, then the buyer will base their purchase decision largely on price. This will increase the competitive rivalry amongst companies with in the industry, resulting in lower prices and lower profitability. The other type of buyer power relates to negotiating power. Larger buyers tend to have more leverage with the firm, and can negotiate lower prices. Buyers can exercise their power by seeking price reductions and leveraging the threat of moving to another supplier to purchase their products. The services often demanded by powerful buyers can be costly. Higher quality products and service are extremely costly to an organization and are very difficult to pass along to customers when many of them are asking for price reductions. One example of a buyer's request for increased quality and service can be seen in the federal governmentâ€™s requirement of in-depth product analysis and information, as well as up-to-date and relevant medical information. Both of these services are extremely costly and yet vital to the overall success of both the product and business.
Recently, there has been increased pressure put upon pharmaceutical manufacturers to contain price increases. The power of large bulk buyers such as the managed care organizations and hospitals has made it essential that manufactures to contain costs. Conversely, recent price increases in alternatives such as generic drugs have actually reduced buyer's bargaining leverage, where as previously generic pharmaceuticals were thought of as a way to actually contain costs in that they do not have the same costs associated with research and development or marketing. As a result, generic drugs have typically sold for 60 to 90% lower than brand name drugs.
There are several factors that have an impact on the ability of suppliers to exert pressure on buyers. Buyer group concentration, buyerâ€™s costs, degree of standardization, and the threat of backward integration. First, regarding buyer concentration, if the buyers are concentrated, meaning that there are only a few large buyers, and they buy from a large number of suppliers, they can pressure the suppliers to lower costs and thus affect the profitability of the industry from which they buy from. Next, buyerâ€™s costs are affected by the importance of an item to a buyer. The greater the importance, the more sensitive the buyer will be to the price it pays (bbc.co.uk). For example, if the item sold by the supplier represents 50% of the cost of the buyerâ€™s product, the buyer will bargain hard to get the best price for that item. In addition, degree of standardization is the degree to which a supplierâ€™s product differs from its competitors affects the buyerâ€™s bargaining power. For example, a buyer who is purchasing a standard product like the corn syrup that goes into soft drinks can play one supplier against another until it gets the best combination of price and service. Lastly, there is the threat of backward integration. The bargaining power of buyers can be enhanced if there is a credible threat that the buyer might actually enter the supplierâ€™s industry by manufacturing their own products.
Bargaining power within the pharmaceutical industry will continue to be an issue as the industry battles both rising costs brought on by the increased emphasis on health standards and quality, as well as the need for affordable healthcare and drugs. With that being said, the industry remains vital and even with increasing costs, maintains an average operating profit margin of 30%, with net sales of nearly 18% (csustan.edu).
Bargaining Power of Suppliers
In Porterâ€™s model, there are a number of factors which determine the relative strength of the suppliers in their relationship with what he labels participants in an industry. Within the pharmaceutical industry, the participants are the drug companies; for the purpose of this discussion, the suppliers we will focus on are the companies which produce the raw materials from which the drugs are manufactured. Of less consequence is the labor supplied by the highly skilled professionals that conduct research and develop the drugs.
In analyzing the buyer-supplier relationship, Porter identifies conditions which tend to make the suppliers powerful, and also those which tend to weaken their position. The raw materials (chemicals) supplied to the drug companies are fairly standardized. For Porter, this lack of differentiation operates to lessen the power of the suppliers of these materials. Furthermore, the pharmaceutical industry is dominated by a relatively small number of companies and is thus highly concentrated. In Porter's scheme, suppliers selling to more fragmented buyers will usually be able to exert considerable influence over prices, quality, and terms; but the suppliers of the raw materials to the pharmaceutical companies do not possess this advantage.
Also, according to Porter, a highly concentrated group of suppliers will translate to greater power on their part. Although the suppliers have experienced significant consolidation in recent years, it has not resulted in a tipping of the balance of power. Porter also identifies a high cost to switch suppliers as operating in the suppliers favor. As the chemicals are standardized, the cost of switching is fairly low. Also absent is a credible threat of forward integration by the suppliers; entry costs into manufacturing drugs is simply too high. Finally, the customers of the drug companies are not powerful. This, according to Porter, also works in the drug makerâ€™s favor. Drugs are a necessity, not a leisure product that can be easily substituted for. Thus, the drug makers do not face a threat of boycott by unhappy customers.
One of the conditions which lessen the supplierâ€™s power is the competitive nature of the suppliers industry. As the product supplied is standardized, this fosters greater competition. A second condition which weakens the supplierâ€™s position is the credible threat of backward integration by the drug makers. Considering the above the conditions, it is fair to conclude that the suppliers of raw materials possess little bargaining power in their relationship to the pharmaceutical manufacturers. The relatively high profit margins enjoyed by the drug companies also support this conclusion. If the suppliers within an industry are powerful, they can exert their influence to obtain a greater percentage of the industryâ€™s profits. In the case of the pharmaceutical industry, this apparently has not occurred.
Yet, in analyzing this buyer-supplier relationship, the role of the government in regulating the industry must be considered. As Porter argues, "no structural analysis is complete without a diagnosis of how present and future government policy...will affect structural conditions." This observation is particularly apt when we consider the relationship of the pharmaceutical companies to society. The government may possess the incentive to preserve the company's profitability by promulgating regulations which tend to further weaken the suppliers' power.
Rivalry among Existing Firms
There are an increasing number of rivals in the Pharmaceutical Market due to advancing competition in research and development. Competition is fierce as companies compete to get drugs produced first in order to hold the patent and reap the benefits of being the patent holder on a new drug. While companies feel pressure to speed up the introduction of new drugs to keep up with their competition, the FDA approval process slows down the process. In addition, improvements in technology have made it easier to copy drugs.
More than half the time a drug in under patent is spent in the product development and approval process (Federal Trade Commission â€œCompetitionâ€, p 2). This means that companies have less time to bring in revenue from the drug once it is actually released to the public. As soon as the patent is up, generic copies of the drug can be released which decreases the market share for with the brand name drug. In order to get the lead in the generic market, the owner of the patent on a drug can also release generics before the patent is up (Wikipedia). Then the company will lose less revenue once the patent is up as they already are bringing in additional revenue from the generic. The marketing of pharmaceuticals to the general public has become a priority for companies marketing team. Previously marketing focus was directed at physicianâ€™s offices, as they are the ones who wrote the prescriptions for patients and controlled how much of a drug is sold. Today patients have become more vocal about which brand name prescriptions they would like their doctor to prescribe. Companies now spend a large portion of their marketing budget on radio, televisions, and print advertisements for their drugs. Another factor that influences what drugs physicians prescribe is linked to public and private insurers as they, â€œaffect the writing of prescriptions by physicians through formularies that restrict the number and types of drugs that the insurer will coverâ€ (Wikipedia). Physicians can now look up what drugs a patientâ€™s insurance will cover and only prescribe those drugs. The companies that form deals with insurers will increase their profits by ensuring their drug is prescribed over another drug.
The overall climate in the pharmaceutical industry is severely competitive. The few very large companies dominate the market by having the capital to invest in the extensive research and development that is required to release a new drug. The merging of companies has also allowed for smaller companies to pool their resources and become competitors in the market.
Threat of New Entrants
There are numerous growth opportunities in the Pharmaceutical industry due to several factors. There is an aging population that has increasing health problems with inadequate treatment available to treat them. Any new entrants need to be able to find their own unique competitive position in order to be a player in the industry. The pharmaceutical industry has a regimented structure that needs to be followed in order for companies to obtain approval for any new products they want to release. The new company would need to employ cutting-edge scientists to develop a new and innovative drug to introduce.
While there is great potential for growth, the downside of entry is the steep research and development costs. Drug development is considered a costly and intensive process due to the amount of time spent in development, clinical trials, and safety monitoring. Only a small fraction of all drugs submitted are eventually approved. Companies spend great amounts of time and money on a drug that may never pass FDA inspection and therefore never bring in any revenue. According to the FDA, the approval process is a lengthy one that begins with pre-clinical trials, which involve animal testing. Following these tests, the FDA grants approval for human clinical trials that cover four phases of testing. Once it is known how the drug will react within the human body, a New Drug Application is submitted for FDA approval to market the drug. An example of this is Merckâ€™s drug Singulair submitted in 1992 for approval to begin clinical trials on humans. Upon completion, â€œthe company submitted a new drug application in February 1997. The FDA approved Singulair in February 1998â€ (Meadows). This arduous process provides a large barrier to entry for new companies, which means the threat of new entrants is very low.
Threat of Substitute Products
The threat of substitute products in the pharmaceutical industry comes from within. The Pharmaceutical industry can be divided into two strategic groups. The first group focuses on creating new brand-name drugs and spends vast sums of money on researching and developing these new drugs. The second group within the industry focuses on manufacturing and selling of generic drugs once the patent on the brand-name drugs expires and therefore, they do not spend large amounts of money on research and development. Because these two strategic groups are directly competing with each other, the largest threat of substitute products in the pharmaceutical industry comes from within the industry.
As a pharmaceutical company is attempting to invent a new drug, they apply for a patent on the drug. These patents last twenty years. Typically, up to half of the twenty years expires during the research and development phase. (Ginsberg) Once the new drug is approved by the FDA, the company then has a monopoly on the manufacture and sale of that drug until the patent expires. Before the patent expires, the brand-name drug maker hopes to recover all the research and development money that it spent on the drug in order to profit from the drug. The expiration of patents has an enormous effect on a brand-name companyâ€™s bottom line. For instance, Pfizerâ€™s patent on the antidepressant Zoloft expired in 2005. Pfizer recorded $2.7 billion of sales in 2004 from Zoloft. Industry analysts estimate that Pfizer will lose one third of its total revenue over the next three years because of the expiring patents on Zoloft and other drugs. (Ginsberg) Another example of the effect of patent expiration is Merckâ€™s cholestoral drug Zocor. Merck brings in $4.5 billion per year on sales of Zocor. (Duprey) Merckâ€™s patent for Zocor expires in June. The industryâ€™s leading generic drug maker, Teva Pharmaceutical Industries has been approved to produce Simvastatin, the generic form of Zocor. It is estimated that Merckâ€™s revenues from Zocor will be 50% less. (Duprey) In 2006, there are approximately $20 billion of drugs coming off patent across the industry. (Smith)
Once a patent expires, a generic drug maker can apply for an abbreviated new drug application (ANDA) with the FDA. This allows them to produce a generic form of the brand-name drug. Because the generic drug maker does not have to spend the same funds on research and development to create a new drug, they are able to sell their generic drug for much less than the brand-name drug makers. The lower price that the generic drug maker offers directly effects the brand-name drug makers. According to Miller, â€œthe first generic version of a brand-name drug to hit the market usually costs 30 percent to 40 percent less than the brand-name drug. As more generic versions become available, the price can drop as much as 70 to 80 percent.â€
The threat of substitute products in the pharmaceutical industry comes from within. Using Porterâ€™s method, the industry can be divided into two strategic groups. The first group focuses on creating new brand-name drugs and spends vast sums of money on researching and developing these new drugs. The second group within the industry focuses on manufacturing and selling of generic drugs once the patent on the brand-name drugs expire and therefore, they do not spend large amounts of money on research and development. Because these two strategic groups are directly competing with each other, the largest threat of substitute products in the pharmaceutical industry comes from within the industry itself.
As a pharmaceutical company is attempting to invent a new drug, they apply for a patent on the drug. These patents last twenty years. Typically, up to half of the twenty years expires during the research and development phase. (Ginsberg) Once the FDA approves the new drug, the company then has a monopoly on the manufacture and sale of that drug until the patent expires. Before the patent expires, the brand-name drug maker hopes to recover all the research and development money that it spent on the drug in order to profit from the drug. The expiration of patents has an enormous effect on a brand-name companyâ€™s bottom line. For instance, Pfizerâ€™s patent on the antidepressant Zoloft is set to expire. Pfizer recorded $2.7 billion of sales in 2004 from Zoloft and industry analysts estimate that Pfizer will lose one third of its total revenue over the next three years because of the expiring patents on Zoloft and other drugs. (Ginsberg)
Once a patent expires, a generic drug maker can apply for an abbreviated new drug application (ANDA) with the FDA. This allows them to produce a generic form of the brand-name drug. Because the generic drug maker does not have to spend the same funds on research and development to create a new drug, they are able to sell their generic drug for much less than the brand-name drug makers. The lower price that the generic drug maker offers directly affects the brand-name drug makers. According to Miller, â€œthe first generic version of a brand-name drug to hit the market usually costs 30 percent to 40 percent less than the brand-name drug. As more generic versions become available, the price can drop as much as 70 to 80 percent.â€
Another threat the pharmaceutical industry faces is the gray market. The gray market issue that affects the pharmaceutical industry is the re-importation of products. Pharmaceuticals are sold for less outside of the U.S., so products are bought legally outside the U.S. for cost savings. Many consumers within the U.S. are crossing the Canadian and Mexican borders to purchase cheaper drugs. Pharmaceutical consultants estimate that the gray market between the U.S. and Canadian border was worth nearly $1.1 billion in 2003 and $1.9 billion between the U.S and Mexico (Morais).
According to a recent Newsweek article, lawmakers in Congress have been proposing legislation to regulate the importation of drugs from Canada. They believe that the FDA should try to regulate these imports. The opponents have argued that aside from the cost involved in this, there is also the issue of the size of the Canadian pharmaceutical market. Canada, a nation of approximately 40 million, could not feasibly supply all the drugs that 300 million Americans need (Rosenberg).
There is much to indicate continued prosperity for the U.S. pharmaceutical industry. First, the general nature of their product, a necessity for which there are no substitutes, protects the industry from the harmful effects of economic cycles. In such downturns, the demand for most of the industryâ€™s products and services remain constant. Second, growth in demand will continue to be stimulated by the demographic expansion of their largest market, the elderly. Third, the companies that dominate the industry occupy strong positions in relation to both the buyers of their product and the suppliers of the raw materials that their products are composed of. Finally, although there exists fierce competition within the industry to develop and market the next great success, there exist very steep barriers for companies contemplating entering the industry. This is in large part a function of the overall health of the global population. The industry will continue to benefit from the aging population and increasing life expectancy rates throughout the world, as well as an increase in the potential number of candidates for pharmaceutical use.
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