Hemophilia rivalry eats away at post-Shire Takeda—and its Natpara recall bites, too

Christophe Weber
Takeda CEO Christophe Weber said the hemophilia franchise's decline was fully expected. (Takeda)

Before Takeda scored its $59 billion Shire takeover, critics pointed out threats to the Irish drugmaker’s bread-and-butter hemophilia franchise. Their fear has become reality.

In the six months ended in September, the first half of Takeda's fiscal year, its rare disease business was the only one of its five key areas that declined. Underlying revenue from that unit—which includes the hemophilia drugs—dropped 11% year over year.

“There is one area which is under competitive pressure, and that is the hemophilia area,” Takeda CEO Christophe Weber said during a media briefing Thursday.

Sales of Advate, once Shire’s flagship hemophilia A drug and the new Takeda’s third-best-selling product, plummeted 16% at constant currencies in the first half to JPY 83.2 billion ($766 million).

That’s likely the work of Roche’s fast-growing Hemlibra. The drug’s CHF 921 million ($933 million) haul in the first nine months of 2019 came at the price of almost all hemophilia A players in the market, including Takeda, Bayer and Sanofi.

To hear execs tell it, Takeda had fully expected the decline and factored it into its Shire purchase price. Weber did admit the downward trend will continue because of competition, but Chief Financial Officer Costa Saroukos stressed, “the erosion is in line to our expectations." And because it knew what was coming, Takeda shouldn't need to write down the value of Shire's assets down the road, he said.

Still, it can't be enjoyable to report the double whammy Takeda’s rare disease franchise suffered in its fiscal second quarter. In September, the company had to recall its hypoparathyroidism drug Natpara in the U.S. after rubber particles turned up in some vials. The drug's sales dropped to JPY 4.5 billion ($41.5 million), from JPY 7.9 ($72.9 million) in the three months ended in June. Weber said the company is working closely with the FDA to resume supply as soon as possible.

RELATED: Recall of Takeda's Natpara leaves patients in health limbo

“Eventually hemophilia impact will be behind us, and [rare disease] is a segment we’ll grow in the future,” the CEO said.

One drug that will carry the weight moving forward is hereditary angioedema (HAE) therapy Takhzyro. A follow-up to Shire’s old Firazyr, which has gone generic, Takhzyro was hailed as a best-in-class prospect—and a blockbuster in the making—when it snagged an FDA nod last August.

In Takeda’s second quarter, it racked up JPY 16.2 billion ($150 million). And now Takhzyro is driving growth of the entire U.S. HAE prophylaxis market, the company said, with about a third of Takhzyro patients new to a preventive treatment. And the drug just nabbed a recommendation from England’s drug cost watchdog, the National institute for Health and Care Excellence, for coverage on the National Health Service.

Natpara and Takhzyro are among 14 drugs Weber has laid out as key growth drivers for Takeda. Others include inflammatory bowel disease therapy Entyvio, six-month sales of which jumped 34% and amounted to JPY 168.4 billion ($1.56 billion). Legacy Shire’s short bowel syndrome therapy Gattex and ADHD med Vyvanse “are benefiting from the combination of the two companies because they get more promotional support,” Weber said.

RELATED: Takeda wraps 30 emerging markets drugs in $200M selloff to Swiss pharma Acino

Meanwhile, Takeda has been ramping up its global expansion. During a recent speech at the Nikkei Global Management Forum, Weber said Takeda is preparing to launch more than 10 new medicines in China over the next three years, according to Nikkei Asian Review.

The Japanese pharma has also made further progress in reducing its debt, partly by selling drugs outside of its focus areas of oncology, gastroenterology, neuroscience, rare disease and plasma-derived therapies. It has paid down JPY 584.5 billion ($5.4 billion) of debt this fiscal year and lowered its net debt/EBITDA ratio to 3.9x, down from 4.4x at the end of June.

Overall, Takeda registered JPY 1,660 billion ($15.3 billion) in revenue, down 0.2% on a pro forma basis. For the full year ending March 2020, it’s expecting reported revenue to stand at JPY 3,260 billion ($30.1 billion), lower than its previous forecast, mainly because of a strong yen and the surprising Natpara recall.