Actos Drives H1 Sales, as Takeda Raises Forecast

Takeda's Faltering Lead

Japanese industry leader Takeda today announced its interim results for fiscal year (FY) 2006/07, covering the two quarters ending 30 September; it will make a presentation tomorrow. While overall top and bottom-line results are comparatively favourable, they disguise significant unrest at the healthcare giant. Sales rose by 7.1% to ¥642.4 billion (US$5.4 billion), driven largely by the prescription (Rx) drugs segment, which gained 12% on the year, and accounts for 87% of total sales. Domestic Japanese sales actually fell by 1.9%, to ¥331 billion, making up 51% of total sales; if current trends continue, the domestic market will account for less than half of total sales by this time next year. North American sales were particularly strong, gaining 28% to ¥206 billion.

The arrival of four new drugs in Takeda’s portfolio—Rozerem (ramelteon), Amitizia (lubiprostone; stomach), Competact (pioglitazone/metformin; diabetes) and Duetact (pioglitazone/sulfonylurea; diabetes)—and the commencement of direct-to-consumer (DTC) advertising for one of these (Rozerem) is pushing up the cost base somewhat, with SGA spend gaining 6.3% during the first half. R&D expenditure rose by 17%, to equate to 15% of sales, as the pipeline now includes Phase II hypertension candidate TAK-491 and newly in-licensed Hematide (AF-37702; anaemia). Overall operating income was up by 10% to ¥236.2 billion.

On the product front, Actos continues to stand out, with growth in the 44-52% range across all of its markets (Japan, the Americas, Europe and Asia); North American sales reached ¥133.2 billion. Meanwhile, Blopress/Atacand (candesartan; hypertension) is slowing down somewhat, although overseas growth was still up by 15% to ¥37.6 billion, and Japanese growth reached 5%, to ¥63.2 billion. The company's oncology and gastric ulcer portfolios continue to stall, with Leuplin (leuprorelin) down by 1.7% in the United States, to ¥38.4 billion, and Prevacid (lansoprazole) falling by 21% to ¥19.5 billion in Europe. Total sales of Leuplin and Prevacid showed negligible growth of 0.7% (to ¥91.4 billion) and 1.9% (to ¥196.8 billion) respectively. Domestically, the company was hit by the April 2006 price cuts, which particularly targeted diabetes drug Basen (voglibose); this treatment faced a 14% price cut, and underwent a corresponding 14% reduction in sales, to ¥28.4 billion.

Outlook and Implications

Takeda needs to move quickly out of the downward trajectory that has so far darkened the company’s outlook in FY2006/07, due largely to the frequency of its pipeline setbacks. Coupled with impending patent expirations (Prevacid and Blopress in 2009, Actos in 2011), Takeda may need to look into restructuring its base. A purchase of TAP (the company's joint venture (JV) with Abbott (U.S.)) may be on the cards once more, but Takeda has previously refused to be rushed into any acquisition, and it seems set on ensuring that the right price is paid for the JV.

Actos, and its new combination products Competact and Duetact, remains the company's guiding light, and its share of the prescription market has grown from 45% in December 2005 to 49.5% in August 2006. The release of CHICAGO and PERISCOPE studies this year is likely to further enhance its clinical competitiveness. In the pipeline, we expect few data to emerge in the near term, and the nearest milestones will be Phase II results for TAK-428 (diabetic neuropathy) and TAK-536 (azilsartan; hypertension), in early-2007. The main candidates to look out for remain fast-tracked severe sepsis drug TAK-242 (Phase III in Japan, the United States and Europe), Prevacid follow-up TAK-390MR (Phase III in the United States) and Phase II anaemia candidate Hematide. We still consider Takeda’s in-licensed DPP-IV inhibitor SYR-322 to be a low potential earner, due to the congested market in this segment.