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Dr Andrew Carr

Dr Andrew Carr
President, Amersham Biosciences

Amersham Biosciences

Amersham Biosciences is a leading global provider of products and services used in gene, protein and cell research, drug discovery and development, and biopharmaceutical manufacturing. Comprising two business areas, discovery systems and protein separations, we bridge the gap between life sciences and healthcare. In discovery systems, we provide high throughput systems to help researchers in industry and academia understand the genetic and molecular basis of disease and speed up their drug development. In protein separations, we provide research and manufacturing technologies that enable pharmaceutical and biotech companies to bring new biological drugs to the market. Together, our activities cover the entire gene to drug spectrum.

In 2002, we undertook a number of strategic initiatives. We acquired two filtration companies in the US, adding membrane separation to our product range in industrial-scale protein separations. We strengthened our capability in informatics through the acquisition of a controlling stake in our long-term partner, Cimarron. We bought the CodeLink™ pre-arrayed slides technology from Motorola, building our strength in gene expression and providing us with further opportunities in genotyping, proteomics and diagnostics. In addition, we launched important new products in proteomics and bioassays.

Market conditions were difficult in the life sciences discovery systems market in 2002. Pharmaceutical companies, particularly in the US, saw their sales and profits threatened by patent expirations, generic competition and market pricing, and as a result they spent markedly less on life science research instrumentation. We also saw fewer start-up companies emerging from the biotech sector, reduced later stage public funding and more caution on spending by companies in new areas such as high throughput proteomics.

Importantly, customer spending on consumables, reagents and software remained good for all areas of our business, helping to offset a significant decline in instrument sales. Pharmaceutical companies continued to invest in research and development, and we saw good take-up of new instruments that were viewed as truly enabling and that significantly improved the drug development process, particularly in the later stages. Across the breadth of our global franchise, we saw good sales growth in Europe and Japan.

The market picture was quite different for protein separations, where continued strong demand for biopharmaceutical drugs led to good growth in sales of both engineering-based bioprocess systems and the separations media used in the manufacture of these drugs. Indeed, one of the biggest concerns for our biopharmaceutical customers has been the lack of manufacturing capacity, and new plants are being commissioned or existing facilities expanded to meet the growing demand.

With protein separations continuing to be a strong growth driver, total sales in Amersham Biosciences in 2002 were £670 million, up six per cent. Trading profit increased by one per cent to £163 million. As planned, the rate of growth in R&D expenditure was held back, with investment of £88 million, up three per cent. Operating profit was flat at £75 million. Excluding the dilutive impact of the CodeLink and Cimarron acquisitions, operating profit grew nine per cent, benefiting from the excellent margins in protein separations and the settlement in February of the Applera patent litigation.

Protein separations
Our protein separations business area is the market leader in chromatography systems (instruments, software and media) for the purification of proteins on a laboratory and manufacturing scale. The good growth in this market is driven by the increasing number and volume of biopharmaceuticals (such as insulin, monoclonal antibodies and vaccines) on the market or in clinical trials. Our products are used in the manufacture of over 90 per cent of these biologically-based drugs.

Protein separations sales in 2002 were £276 million, up 15 per cent, driven by excellent growth in bioprocess sales and including first-time benefit from filtration or membrane separation products. Operating profit was up from £96 million to £107 million. Our operating margin was 39 per cent. As anticipated, our sales accelerated through the year, with the fourth quarter being particularly strong as biotech and pharmaceutical companies purchased manufacturing instruments and media for new production plants and for new drugs going into clinical trials. We also saw good replenishment sales of media for existing biopharmaceuticals.

In addition, two further areas contributed to the growth for industrial-scale bioprocess systems in 2002. First, the market for products used in the manufacture of DNA-based pharmaceuticals began to grow rapidly, driving sales of our OligoProcess™ systems. Second, the membrane separation businesses, acquired in January, delivered good sales as biopharmaceutical customers took advantage of our broader product offering. Membrane separation has been successfully integrated into Amersham Biosciences and a new site in Massachusetts, USA, will be completed early in 2003.

The laboratory separations area saw lower instrument sales, following the exceptionally high growth in 2001, and as a result of more cautious spending by pharmaceutical companies. Media sales continued to be good, and a new instrument, ÄKTApilot™, launched in December for the production of clinical grade proteins on the benchtop, has been well received by customers.

We continue to innovate to maintain our market share and leadership, and in 2003 we will be increasing our R&D investment in protein separations. During 2002, a new R&D laboratory was established at our site in Uppsala, Sweden. Good progress was made with a number of new products that will be launched in 2003, including a new Streamline™ resin and column and new filtration membranes.

Discovery systems
Our discovery systems business area provides high throughput systems to improve the effectiveness of life science and pharmaceutical R&D, as well as a broad range of laboratory research tools and technology to purify, detect and analyse biological molecules.

Sales in 2002 were £394 million, down one per cent, impacted by market conditions, notably the slowdown in pharmaceutical company spending on capital equipment. Instrument sales, representing about one quarter of discovery systems sales, were down significantly compared with 2001. However, customer spending on consumables, reagents and software remained good. Discovery systems had an operating loss of £32 million, including the dilutive impact of the CodeLink and Cimarron acquisitions. Excluding this, the operating loss was unchanged from 2001.

The steps taken in our genomics business at the beginning of 2002, together with the Applera litigation settlement, moved genomics into profit for the year. We are the market leader in enzymology as applied in genomics, and our good sales of reagents and consumables not only reduce our exposure to the market slowdown in instrumentation sales, but also underpin our vision of developing technologies to enable personalised medicine. TempliPhi™, the DNA template preparation kit, continued to make good progress. All of the five major public genome centres now use TempliPhi, with three of them – the Joint Genome Institute, the Whitehead Institute, and Baylor College of Medicine – using it in daily sequence production. It is also seeing very good acceptance in Japan. New products based on this technology are in development, and the first of these, GenomiPhi™, will be launched in 2003 for use in whole genome amplification.

In July, we acquired the CodeLink pre-arrayed slides business from Motorola Life Sciences. The acquisition takes us into the pre-arrayed (ready-to-use) chip market, building on our wellestablished business of spotters and scanners for researchers to make their own arrays. CodeLink has a unique, patented manufacturing process that produces arrays of high quality, sensitivity and reproducibility, and with more useable data points than any other pre-arrayed slide. There are currently six CodeLink products on the market, with several more in development including higher density chips with 20,000 DNA spots per slide. CodeLink has been undergoing comparison tests in customer laboratories and the feedback has been very positive. As anticipated, the pre-arrayed slide distribution agreement with Affymetrix in Japan ended in December.

The proteomics product area also saw good sales growth in reagents and consumables. Our market-leading 2D DIGE technology, which allows the protein content of several samples to be simultaneously analysed and compared, continued to grow well and development work is ongoing to expand further the range of DIGE reagents and software. During 2002, we launched our new MALDI mass spectrometer, the Ettan™ MALDI-TOF Pro for protein characterisation, as part of the complete Ettan range of systems for stand alone or integrated protein analysis. In February 2003 we entered into an alliance with Thermo Electron Corporation to co-market mass spectrometry products to life science researchers. The collaboration enables us to offer customers a complete and user-friendly solution, combining our strong franchise and knowledge of the proteomics market with Thermo Electron’s portfolio of mass spectrometry products and extensive sales and support infrastructure.

Bioassays products are used by researchers to quantify the biological processes involved in cellular activity,metabolism and disease. Pharmaceutical customers use our products to identify drug targets and develop potential new drugs, eliminating poor drug candidates and those with side effects as early as possible, thus reducing the time and cost spent in drug development. We launched two new instruments in 2002. The latest generation LEADseeker™ was launched in September and enables researchers to screen over one million drug compounds a day, in a number of different modalities including radiometric, luminescent and fluorescent. The IN Cell Analyzer high throughput system enabling researchers to study the effects of a potential new drug in living cells in real time, continued to be well received by customers, and a number of systems were sold in the last quarter of the year. As well as its use by pharmaceutical companies, the IN Cell Analyzer is also being used in a collaboration between Amersham and the Sloan-Kettering Institute to study the human genome for disease-related genes. We also saw particularly good growth in custom-labelled products used in the drug development process, as pharmaceutical companies began to outsource more of this work.

Informatics and software continue to be critical elements of the life science market, with researchers needing tools to help them manage, store and analyse the vast amounts of data being generated. In May 2002, we announced an agreement to acquire a controlling stake in our long-term partner, Cimarron, an informatics company based in Salt Lake City, Utah, USA. This has given us increased synergy and flexibility in the development of informatics products, and enabled us to better integrate these products with our existing platforms. We launched a number of new products – Laboratory Workflow Systems for sequencing, microarrays and genotyping – towards the end of the year. Total software sales across Amersham Biosciences grew well in 2002.

Restructuring of discovery systems
Discovery systems is a business area with good long-term growth prospects, and its market franchise and strong portfolio position it well for the future. In light of developments in the life sciences market, a restructuring programme has been put in place to accelerate the move into profitability during 2004.

The research and development portfolio will be refocused on a smaller number of high-value, systems-based products linking instruments with reagents, and on high-value, standalone consumables. Our sales and marketing team will increase efficiency by more effectively targeting the high growth customer segments. Driving to deliver a more efficient manufacturing cost base and focusing research and development on fewer sites will result in the loss of approximately 400 jobs.

Outlook
Following the good performance in 2002, Amersham is well placed to achieve further good growth in 2003. The following guidance is given before the impact of foreign exchange, which is discussed in the Financial review.

Amersham Health is expected to continue the good growth in medical diagnostics excluding Japan, and operating margins are anticipated to be at similar levels to those achieved in 2002. Amersham Health sales in Japan are expected to decline at a lower rate than in 2002.

Within Amersham Biosciences, protein separations is expected to see good growth, with sales growth again expected to be stronger in the second half of the year. Increased investment in R&D will bring operating margins down slightly.

Discovery systems is expected to see good sales growth in reagents, consumables and software.Visibility for capital expenditure on instrumentation remains low. The restructuring plans are expected to bring benefits in 2003 moving the business to profitability during 2004.

Signature: Sir William Castell

Sir William Castell Chief Executive

 
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