Takeda F3Q15 – Nesina (alogliptin) sales grow 13% YOY to $112M and year-end revenues grow 12% to $401M; Japanese Actos (pioglitazone) revenues declined 18% YOY to $19M and year-end revenues down 21% - February 24, 2016

Takeda recently provided its F3Q15 (calendar 4Q15) update in a call led by CEO Mr. Christophe Weber. There was no commentary on diabetes during the call but according to the supplementary materials, global DPP-4 inhibitor Nesina (alogliptin) sales grew 13% year-over-year (YOY) operationally to $112 million (13.6 billion JPY) and grew 10% sequentially. Revenues grew 12% operationally to $401 million (48.6 billion JPY) for the full calendar year 2015. By region, much of the growth has been driven by ex-Japan sales. This slight steady growth over recent quarters may be attributed to the somewhat favorable comparison of EXAMINE vs. SAVOR (which was again highlighted in the supplementary materials). Similar to the F2Q15 update, the supplementary materials stated that Takeda submitted an NDA for the fixed-dose combination of Nesina and metformin for type 2 diabetes in Japan – a smart move in our eyes as metformin combinations seem to be driving much of the DPP-4 inhibitor class’ growth (see the progress of Merck’s Janumet [sitagliptin/metformin combination]). Regarding the overall class, DPP-4 inhibitor revenues fell 9% YOY to $2.1 billion in 4Q15 and fell 2% YOY to $8.7 billion for full year sales, with Nesina holding ~5% of the market.

As for TZD Actos (pioglitazone), Takeda only released revenues in Japan (another possible sign of the company’s declining attention toward the drug): sales continued its downward trend, declining 18% and remaining flat sequentially at $19 million (2.3 billion JPY); year-end revenues in Japan fell 21% to $76 million (9.2 billion JPY). As for the bladder cancer litigation, the supplementary materials state that Takeda has agreed to pay $2.4 billion into a settlement fund (worth the verified ~97% of eligible litigants opting into the resolution program). However, similar to recent quarters, the company continued to highlight that it “will continue to vigorously defend” the case and pointed out its recent findings of no association between bladder cancer and Actos. As the IRIS trial has recently found that Actos reduces risk of stroke and MI in high-risk patients without diabetes but with insulin resistance, we will be curious to see if Takeda will dedicate more attention to the drug and the possibility of an expanded label indication for the generic product in the future.

Lastly, while Orexigen-partnered obesity drug Contrave (naltrexone/bupropion extended-release) similarly received no attention during the call, supplementary information showed that the drug’s revenues remained flat sequentially at $13 million in 4Q15 (the drug’s upward trend seems to be leveling off) – we expect to learn more on this in Orexigen’s call Friday.

-- by Melissa An and Kelly Close