BTG Regulatory News (BTG)

BTG plc: Close Period Update

London, UK, 3 October 2012: BTG plc (LSE: BTG), the specialist healthcare company, provides the following update for the six months ended 30 September 2012 ahead of the planned publication of its Interim Results on 8 November 2012.

Trading update

Trading during the first six months has been ahead of expectations, driven principally by high demand for CroFab® (crotalidae polyvalent immune fab (ovine)) during the summer snake biting season, a strong start from Voraxaze® (glucarpidase) following its US nationwide launch at the end of April 2012 and the continued growth of royalties from Johnson & Johnson's Zytiga® (abiraterone acetate). First half revenue also includes £5.4m of additional deferred income relating to a previous licence agreement that has now been fully released following AstraZeneca's decision to terminate the development of AZD9773 (CytoFab™).

As a result of the strong first half performance and a positive outlook for the second half, the Board is raising its revenue estimate for the year ending 31 March 2013 from previous guidance of £190m-£200m to £205m-£215m.

Within Specialty Pharmaceuticals, strong demand for CroFab® was reflected in higher wholesaler stock levels, which are expected to reduce to normal levels during the second half. There was a strong performance from DigiFab® (digoxin polyvalent immune fab (ovine)), which continues to benefit from the withdrawal of the only competing product in H2 2011. Voraxaze® has also performed well since its US launch in April. Voraxaze® has been granted a temporary New Technology Add-on Payment from the Centers for Medicare & Medicaid Services, effective 1 October 2012, which means that the US government will pay up to 50% of the cost of Voraxaze® to hospitals in addition to the standard diagnosis-related group (DRG) reimbursement payment.

Within Interventional Medicine, end-market sales of BTG's interventional oncology Bead products continue to grow at a double-digit percentage. The transition to direct sales in January 2012 has gone well however first-half revenues do not yet fully reflect the underlying end-market sales owing to relatively high levels of customer inventory at the time of the transition. Customer inventory is expected to revert to more normal levels during the second half, with full year revenues in line with expectations.

The strong performance in Licensing & Biotechnology reflects the previously announced final royalty payment from Pfizer relating to BeneFIX® (factor IX) of $22m, the continued growth of Zytiga® royalties and the £5.4m of additional deferred income relating to AZD9773.

Additional marketing applications have been submitted for Zytiga® in the US and EU to extend its use to include the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy and before chemotherapy.

Louise Makin, BTG's CEO, commented: "Based on our strong first-half performance and with a positive outlook for the second half, we have raised our revenue guidance for the second time this year. We are progressing towards submission of the US NDA for Varisolve® at the end of the calendar year. The transition to direct US sales in our Beads business has gone well and we are continuing to actively progress our indication and geographic expansion activities. In addition, we also anticipate progress in the coming months with our partnered programmes, including the potential US and EU approvals of Zytiga® in mCRPC patients who have not yet had chemotherapy."

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About BTG

BTG is an international specialist healthcare company that is developing and commercialising products targeting critical care, cancer and other disorders. The Group is seeking to acquire new products to develop and market to specialist physicians, and is building a sustainable business financed by revenues from sales of its own marketed products and from royalties and milestone payments on partnered products. For further information about BTG please visit our website at www.btgplc.com.