It's all about growing the business in the right way, which protects the qualities of bravery and nimbleness that have made Shire a special place to work, and have been directly responsible for so much of our success.

Today we have a physical presence in over 20 markets, and sell our products in more than 40. We've already stated that our ambition is to generate 50% of our sales from outside the US, and 25% of those sales from what's become known as the 'pharmerging' countries like Brazil, China and India, rather than the more established markets within Europe.

There are both immediate and long-term challenges that we need to address to achieve this goal. In the long term it's all about growing the business in the right way, which protects the qualities of bravery and nimbleness that have made Shire a special place to work, and have been directly responsible for so much of our success. In the short term there are issues relating to the ADHD business in the US over the next year, which we are well positioned to address, but which still need to be actively managed in the next few months.

A pivotal year for ADHD
There's no question that the next twelve months will see huge changes in the worldwide ADHD market, which will also have implications for Shire. An authorized generic version of ADDERALL XR, Shire's longstanding market leader, will probably be available in the early part of 2009, which raises inevitable questions about the impact of this on the price of our other drugs, and on our overall revenue.

But as Mike Yasick, Senior Vice President of the ADHD business unit, says, "We are as prepared as we can be for this event. We have known this would happen for a long time, and we've been planning for it by developing a whole new generation of ADHD treatments. ADDERALL XR is a great product so our challenge has been to improve upon it. VYVANSE is the first example of the fruits of that effort and has significant benefits for patients with ADHD. VYVANSE has a novel mechanism of action based on 'CarrierWave' technology. The effects are consistent throughout the day and they can last up to 13 hours-meaning VYVANSE may improve ADHD symptoms beyond work and school hours to important home time."

At the same time the number of prescriptions for adults in North America is accelerating, making it the fastest-growing segment of the market: there are up to ten million adults with the condition in the US, compared with only five million children, but while 80% of those children are receiving medication, the figure for adults is as low as 25%. There's also a growing awareness of the condition elsewhere in the world, and a new willingness to consider medication as well as behavioral therapies. This is especially true in Europe, which is currently quite a small market of around $350 million, but could eventually become as significant as the US, where total annual turnover is around $4.4 billion. If the industry is to achieve that Shire will need to help grow the whole market, as well as our own share within it, just as we did so successfully in the US in the 90s. That will mean more investment in raising awareness of the condition among physicians, opinion-formers, patients and carers. We've done it before, and we're well-placed to do it again.

The benefits of VYVANSE should also be attractive for the European market. There's still a lot to do in terms of filings and registration for VYVANSE, but Shire now has a significant advantage of a full portfolio of ADHD products, some of which are further along with DAYTRANA, our methylphenidate patch, is one of these, and a part of our overall strategy for ADHD. It has its own distinct advantages-it's not only provided in a format that's well understood in the US, but the effects of the drug can be easily regulated by simply removing the patch. Launching DAYTRANA in Europe ahead of VYVANSE will enable us to start developing the relationships with key physicians that will be key to long-term success.

We're also in the process of developing INTUNIV, which is a completely new type of ADHD drug, because it's a non-stimulant treatment for ADHD. After four years as the market leader, we're still at the cutting edge of the science for this important and still under-appreciated condition. As Mike Yasick says, "This is a good time to be in this business. In fact it's a perfect storm of opportunity."

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