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UCB SA - BNP Paribas Fortis

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(b) Failure to develop new products and production technologies will have a negative impact on the<br />

competitive position of the <strong>UCB</strong> Group.<br />

The <strong>UCB</strong> Group significantly depends on the development of commercially viable and sustainable new<br />

products and technologies. Because of the lengthy development process, technological challenges and<br />

intense competition, there is a risk that any of the products which the <strong>UCB</strong> Group is currently<br />

developing will not show the required efficacy and safety, will not be approved by the relevant<br />

authorities, will not be marketable on time or which are launched and subsequently manifest safety<br />

issues or manufacturing abnormalities. Balancing current growth and investment for the future remains<br />

a major challenge, and the <strong>UCB</strong> Group may be unable to meet its expectations and targets with respect<br />

to products which are being developed. The competitive position and operating results of the <strong>UCB</strong><br />

Group could be harmed in the long term if it is unsuccessful in developing new products and quality and<br />

cost efficient manufacturing processes, or if its ability to generate sufficient levels of sales through<br />

investments in new products and expenditures on research and development declines.<br />

The <strong>UCB</strong> Group has recently devolved its research and development function, splitting it between <strong>UCB</strong><br />

NewMedicines and Global Projects & Development. In the event that either of these groups is not<br />

successful, this may have a negative impact on the pipeline of products being developed. Further, the<br />

success of <strong>UCB</strong> NewMedicines is in part reliant on the success of its various partnerships. In the<br />

event that such arrangements are unsuccessful, this may have a negative impact on the success of <strong>UCB</strong><br />

NewMedicines and the pipeline of products for the <strong>UCB</strong> Group.<br />

The <strong>UCB</strong> Group focuses on extracting value from its products by managing their life cycle efficiently<br />

and maximising the patent protection available in various jurisdictions for different indications. In the<br />

event that the <strong>UCB</strong> Group fails to maximise the value obtained from the products while such protection<br />

is in place, this may have a negative impact on sales in the medium to long term, since patent protection<br />

will be diminished. Such a reduction in product sales may have a material adverse effect on the<br />

revenues of the <strong>UCB</strong> Group and its ability to reinvest in research and development.<br />

(c) The <strong>UCB</strong> Group depends in the near term on a small number of products which may also be<br />

subject to competitive forces<br />

The <strong>UCB</strong> Group has to date depended, and will continue to depend to a large extent on the sales of a<br />

few products. Historically, key products include Zyrtec®, Keppra® and Xyzal®, which are<br />

approaching or have reached the end of their patent-protected timeframe. The current key products for<br />

the <strong>UCB</strong> Group include Cimzia®, Neupro® and Vimpat®. The continuing sales volume of these<br />

products significantly depend on their patent protection but also on other factors such as regulatory<br />

approvals, regulation of pricing, product liability or competition. A significant decrease in the sales of<br />

any of these products could have a material adverse impact on the results of operations of the <strong>UCB</strong><br />

Group.<br />

The <strong>UCB</strong> Group cannot predict with accuracy the timing or impact of the introduction of competitive<br />

products or their possible effect on its sales. Products that compete with the <strong>UCB</strong> Group’s products,<br />

including some of its best-selling medicines, are launched from time to time. Launches of a number of<br />

competitive products have occurred in recent years, and certain potentially competitive products are in<br />

various stages of development, some of which have been filed for approval with the FDA and with<br />

regulatory authorities in other countries.<br />

A11250830/2.25/23 Oct 2009 16

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