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2 A N N U A L R E P O R T 2000 “We have worked to become a more profitable, efficient company and to expand the sales of products that have been well received in the marketplace. As a result, during the year under review we recorded our highest level of operating income in the past 10 years.” An Interview with the President Focusing on Growth Tanabe has faced a difficult operating environment in recent years, and the Company is aggressively implementing reforms targeting strong growth in the 21st century. Based on the keywords of choice, decision, and focus, these reforms are aimed at rapidly establishing a corporate organization and management structure suitable for the new age. Using these measures to strengthen our market competitiveness and speed up our research and development of innovative new drugs is the most important challenge that we face. During the past year, we continued to implement reforms, and they began to show steady results. Tanabe’s net sales declined slightly in the year under review, but improvement in the composition of the Company’s sales led to a decline in the cost of sales. As a result, operating income increased by a large margin, reaching the highest level in the past 10 years, and net income also rose substantially. Sales of key products were strong. These include fluvastatin (Lochol), an agent for the treatment of hypercholesterolemia that was launched in 1998, as well as two products that are the focus of intensive marketing efforts—imidapril (Tanatril), an ACE inhibitor, and nicergoline (Sermion), a cerebral circulation and metabolism ameliorator. To create a more profitable corporate structure, we have implemented aggressive structural reforms, and those measures are showing steady results. Workforce reductions have been achieved through a voluntary early retirement system, and the number of employees, including those seconded to related companies, has been reduced by about 500 over the past two years, to 4,439 at the end of March 2000. In R&D, to further expedite the organizational reform measures previously implemented, we reorganized our Discovery Research Laboratory into seven departments, including Basic Technology and Biology and Pharmacology. As a result, we have created the fundamental system needed to research and develop new drugs more efficiently and quickly. TANABE SEIYAKU Tanabe’s Growth Strategies 1 2 The Year’s Results Build a more profitable company by focusing resources on selected fields and rationalizing management practices Strengthen our core business in ethical drugs 3 4 Bolster our R&D system and expand our new drug pipeline Reinforce our emphasis on results and strengthen human resources training programs 1 By focusing on high-value-added operations and the promotion of core products, centered on products developed in-house, we have bolstered our Companywide management capabilities and made a transition to a management constitution that can steadily generate profits. In addition, we have reduced the number of employees by about 500 over the past two years, and, at the end of March 2000, we had realized our goal of 4,500 employees. 2 Each of the products that have been selected for intensive marketing—imidapril (Tanatril), fluvastatin (Lochol), ecabet sodium (Gastrom), and nicergoline (Sermion)—achieved sales increases during the year under review. The combined sales of these four products rose 16%, to ¥45.4 billion, and they were the driving force behind the Company’s performance during the year. 3 We have instituted a complete organizational reform of our Discovery Research Laboratory, the center of our R&D activities. The result is a flatter organization that can conduct R&D activities more rapidly. In the new drug pipeline, we have an anti-inflammatory agent in phase I clinical trials in Europe and are preparing to start clinical trials of ED and diabetes agents in Europe and the United States. 4 We believe that the added value created by individual employees is the source of corporate growth. Accordingly, we have thoroughly implemented a performance-based personnel and compensation system. In particular, in the R&D departments, we have made progress in motivating researchers by instituting an aggressive incentive system. In addition, we have decided to introduce a stock option plan for executives. Q. How would you evaluate Tanabe’s performance in the past year? While we do not believe that an overly optimistic outlook is warranted, we are pleased with the way in which our employees worked extremely hard during the past year and achieved strong results in a number of key areas. The domestic ethical drug market remains sluggish under the influence of government measures to control spending on pharmaceuticals, and in these conditions it is not possible to achieve significant improvements in performance without developing new drugs. In addition, competition between companies is intensifying on a global scale, and pharmaceutical companies around the world are faced with the need to research and develop new products through a process that requires huge investments. In this environment, we strove to make continued progress toward becoming a more profitable, efficient company and worked to expand the sales of products that have been well received in the marketplace. Although our consolidated net sales declined about 3%, to ¥185.1 billion, the products that we have selected for intensive marketing efforts, such as imidapril (Tanatril), ecabet sodium (Gastrom), and nicergoline (Sermion), all recorded favorable results. Also, sales of fluvastatin (Lochol) were set in the right direction in its second year on the market. Our increased operational efficiency and the results of our workforce reductions enabled us to achieve operating income of ¥20.4 billion, the highest level in the past 10 years, as well as an increase in net income. Q. What is Tanabe’s strategy for pharmaceuticals in light of the sales trends and forecasts for the Company’s principal products? As I mentioned, despite the difficult operating environment, where the domestic market for ethical drugs is contracting, we have a number of products that are steadily expanding their sales each year. Our fundamental strategy for our ethical drugs operations calls for increasing sales by intensively marketing these high-growth-potential products in their target markets. Our antihypertensive agent imidapril (Tanatril) is recording steady sales growth even though competition with new types of agents is increasing, and it now has the second largest share of the ACE inhibitor market. Imidapril (Tanatril) is highly regarded 3 4 A N N U A L R E P O R T 2000 “We have a number of products that are steadily expanding their sales each year in a difficult operating environment. Our fundamental strategy for our ethical drugs operations calls for intensively promoting these high-growth-potential products in their target markets.” in overseas markets, and the number of countries where it is available is steadily expanding. With diltiazem (Herbesser), a calcium antagonist, and bisoprolol (Maintate), a selective ß1 antagonist, we have three once-daily-administration antihypertensive agents with different mechanisms of action. This lineup provides us with an important competitive edge. The market competitiveness of nicergoline (Sermion) was significantly boosted in 1998, when Japan’s Ministry of Health and Welfare completed a reevaluation of the effectiveness of five drugs of this type, and out of the five drugs reevaluated only nicergoline (Sermion) had its effectiveness reconfirmed. Conditions in the market for cerebral circulation and metabolism ameliorators are sluggish in general, but we expect steadily expanding demand for nicergoline (Sermion), which acts on both cerebral circulation and cerebral metabolism. Q. What are your plans for diltiazem (Herbesser), which has been the engine of Tanabe’s performance for many years, and your expectations for the sales of new drugs? Diltiazem (Herbesser), with sales of ¥23.7 billion in the year under review, continues to make a strong contribution to our performance as our top-selling product. The year under review was the 26th since we began sales of diltiazem (Herbesser). Even today, in markets around the world, it is the most highly regarded drug of Japanese origin for treating angina and hypertension. Recently, bulk exports have declined significantly due to the sale of generics in the United States, but this decline is expected to taper off in the next couple of years. Domestically, diltiazem (Herbesser) is influenced by National Health Insurance drug price reductions, but we are confident that it will remain a widely used product in the 21st century. We will also be launching new drugs. Taltireline (Ceredist) and bepotastine (Talion) were approved in July 2000, and we are planning to begin sales in fall 2000. Taltireline (Ceredist), which we developed in-house, is the first oral drug for the treatment of spinocerebellar degeneration, which has been designated as an intractable disease. Taltireline (Ceredist) is expected to make a significant contribution to improving patients’ quality of life. Bepotastine (Talion), an agent for treating allergic rhinitis introduced from Ube Industries, is especially effective at improving nasal obstruction. We will work to expand sales of bepotastine (Talion) by moving quickly to get an additional indication approved for dermatologic conditions, such as urticaria. Q. Would you discuss your fundamental R&D stance and the condition of your new drug pipeline? Our fundamental stance in R&D is to strictly select promising new compounds and then to concentrate our R&D resources in those areas. We also work to increase efficiency and speed in new drug development by aggressively pursuing tie-ups with research institutions and companies in Japan and overseas. Progress in science and technology is moving at a dramatic pace, and to do everything in-house from the basic research stage would require a very large investment and considerable time. In today’s markets, we need to clarify our development policies and our strengths, cooperate with research institutions and companies in Japan and overseas, and thereby accelerate the research and development of new drugs. In the future, while considering strategic tie-ups with drug makers in Japan and overseas, we will continue to focus on strengthening our R&D capabilities. In our new drug pipeline, we currently have filed NDAs for three drugs, and we have five compounds in clinical trials (phase II or later). Remicade (TA-650), introduced from TANABE SEIYAKU “We strictly select promising new compounds and then concentrate our R&D resources in those areas. We also work to increase efficiency and speed in new drug development by aggressively pursuing tie-ups with research institutions and companies in Japan and overseas.” Centocor, of the United States, is a promising drug and we have filed an NDA for Crohn’s disease. In the United States, Centocor has received approval of an additional indication for rheumatoid arthritis, and in Japan we are in bridging trials using the clinical data from the United States. Its launch in Japan as an agent for treating rheumatoid arthritis is expected to improve the treatment of that disease, as current treatment options are limited. In addition, for development candidates that we have formulated in-house, we will increase efficiency and speed in R&D by first conducting clinical trials in the United States and Europe. Currently, we have three drugs that have just started or are in preparation for phase I clinical trials in the U.S. and Europe. Q. Finally, would you discuss the results of the structural reforms that Tanabe has implemented over the past several years and the Company’s performance projections? Over the past several years, Tanabe has implemented thorough reforms targeting the creation of a corporate constitution suitable for an operating environment that is increasingly challenging. Working to focus our resources on the achievement of higher profitability, these measures have included Companywide organizational reforms as well as reforms to personnel systems, IT improvements, workforce reductions, and the integration of production facilities. Although the end results of these reforms have not yet been fully reflected in the numbers, the significant progress that has been made in changing the attitudes of our employees is worth noting. Our improved performance in the year under review was due not only to the effect of our workforce reductions but also to the energetic approach of our employees, which resulted in more efficient administration. In the future, we will maintain an aggressive approach to reforms as we continue working to improve our performance and increase corporate value. In the current year, we expect a small increase in sales. Although there was a revision in National Health Insurance drug prices in April 2000, our domestic ethical drug sales should be strong due to higher sales of fluvastatin (Lochol) and imidapril (Tanatril) and to sales of the soon-to-be launched bepotastine (Talion), an anti-allergy agent, and taltireline (Ceredist), an agent for treating spinocerebellar degeneration. The scale of the increase will be limited, however, by continued decline in bulk exports of dilitiazem (Herbesser). We are also projecting a slight rise in operating income, due principally to an improved cost of sales. We are, however, projecting a small net loss as a result of a one-time ¥34.7 billion expense to eliminate our unfunded pension liability. Although this step will affect the bottom line in the current year, we will have significantly strengthened our management foundation and laid the groundwork for improved performance in the years ahead. July 2000 Toshio Tanaka President and Chief Executive Officer, Representative Director 5