John Lechleiter, chairman, president and CEO of Eli Lilly ($LLY), and other executives on the third-quarter earnings call remained upbeat on Japan in the coming quarters, but provided no color on the expanded collaborations in China with Innovent and Yabao that have caught recent attention in Asia.
In Japan, however, legal decisions expected in the coming weeks related to Alimta are seen as positive, Lechleiter said.
"The Japan Patent Office issued a notice of closure in the trial regarding the validity of Lilly's vitamin regimen patent for Alimta," Lechleiter said on the Oct. 23 earnings call. "We expect a written decision upholding the validity of the patent in the coming weeks. This is the first of two decisions pending. If the patents are ultimately upheld through all challenges and appeals, they would provide intellectual property protection for Alimta in Japan until June 2021."
Overall in Japan however, pharma revenue decreased 4% in total because of a weaker yen, but Phil Johnson, head of investor relations, said that when adjusted for the currency swing, sales gained 14%. "This performance growth was attributable to many products, chief among them Cymbalta and Cyramza," Johnson said.
On Cyramza, Sue Mahony, president of Lilly Oncology, was upbeat on the fairly recent Japan launch.
"In Japan, we launched the end of June, and feel very good about the uptake in our first quarter in this market," she said on the call. "It is a big opportunity and an unmet need in Japan, two to three times the incidents of gastric cancer there versus the U.S. And the feedback so far is very good. Clearly we have a succession of other hopeful approvals and launches in both lung and colorectal around the world to look forward to too."
Derica Rice, chief financial officer, said that among regulatory submission updates, ixekizumab for both psoriasis and psoriatic arthritis was submitted in Japan.
"Separately, you will now see on www.ClinicalTrials.gov that we are running a new psoriasis trial comparing ixekizumab head-to-head with Stelara."
However, a new geographic designation for sales that reports Australia and New Zealand along with Europe and Canada, dubbed EUCAN, fared less well on constant currency and otherwise.
"The decline in EUCAN revenue of 17% was almost entirely driven by the negative effect of FX while on a constant currency or performance basis, EUCAN revenue decreased 3%," Johnson said. "This decrease was driven by a substantial reduction in European Cymbalta sales resulting from a loss of data package exclusivity. Excluding Cymbalta, EUCAN sales increased 3% in constant currency terms."
And sales in the emerging markets declined 18%, Johnson said, "driven primarily by a negative FX effect of 14%. On a performance basis, emerging market sales declined 4%. This 4% performance decline was driven almost entirely by the negative effect of the Brazil Humulin tender that we had last year but not this year. Also this quarter, our pharma revenue in China declined 2% with 1% driven by FX, and the other percent driven by lower volume."
- here's the release and presentation (PDF) from Eli Lilly