April 04, 2012
BTG plc: Close Period Update

London, UK, 04 April 2012

BTG plc (LSE: BGC), the specialist healthcare company, provides the following update for the year ended 31 March 2012 ahead of the planned publication of its Final Results on 21 May 2012.

Trading update
Trading within both the Specialty Pharmaceuticals and Interventional Medicine business areas has been in line with expectations. Trading in the Licensing & Biotechnology business area has been significantly ahead of expectations, driven by higher than anticipated royalties from BeneFIX® (factor IX) and Zytiga® (abiraterone acetate).

As a result, BTG is raising its revenue estimate for the year ended 31 March 2012 from previous guidance of £160m-£165m to £190m-£195m. The new revenue estimate reflects revised expectations of approximately £29m in royalties on BeneFIX® inventory following patent expiry in March 2011, the strong performance from Zytiga® and also includes an unchanged estimate of approximately £10m of milestone payments.

Operating update
A summary of the key operating highlights for the year ended 31 March 2012 in BTG's three business areas follows.

Specialty Pharmaceuticals

  • Strong performance from the Acute Care sales team in the first snake biting season selling CroFab® (crotalidae polyvalent immune fab (ovine)) directly in the US.
  • DigiFab® (digoxin immune fab (ovine)) revenues boosted by withdrawal of only competitor product; DigiFab® approved and launched in the UK and launched in Canada.
  • Voraxaze® (glucarpidase) BLA submitted in the US in July 2011 and granted priority review; approved in January 2012 as a treatment for life-threatening toxicity associated with high-dose methotrexate use in patients with renal impairment; US nationwide launch anticipated by the end of April 2012.
  • US marketing rights to uridine triacetate, under development to treat toxicity associated with 5-FU overdose, acquired from Wellstat Therapeutics Corporation.

Interventional Medicine

  • New team of Account Managers and Medical Science Liaisons commenced direct sales and support of the LC Bead™ in the US in January 2012.
  • DC Bead® regulatory application under review by Japanese regulator; 40-patient study completed in China.
  • Varisolve® (polidocanol endovenous microfoam (PEM)) US Phase III trials completed recruitment; positive top-line data published from first pivotal trial in January 2012.

Licensing & Biotechnology

  • Zytiga® (abiraterone acetate) approved in the US and EU for men with advanced prostate cancer who have previously received docetaxel chemotherapy; second Phase III trial in chemo-naïve patients unblinded after interim analysis in March 2012.
  • Positive data published on Lemtrada™ (alemtuzumab) from two Phase III trials in multiple sclerosis; Sanofi anticipates US and EU regulatory submissions in Q2 2012.
  • AZD9773 (CytoFab™) completed recruitment of 300-patient Phase IIb study in severe sepsis.

Louise Makin, BTG's CEO, commented: "We have delivered a strong financial and operating performance across the business. Our development programmes are on track and we have made good progress in our Interventional Medicine business. We anticipate another busy year ahead including the US launch of Voraxaze®, our planned New Drug Application for our varicose veins programme Varisolve® and data from AstraZeneca's Phase IIb study of AZD9773."

For further information contact:

Andy Burrows, Director of Investor Relations
+44 (0)20 7575 1741; Mobile: +44 (0)7990 530605

Rolf Soderstrom, Chief Financial Officer
+44 (0)20 7575 0000

FTI Consulting
Ben Atwell
+44 (0)20 7831 3113