Critics of Takeda’s $62 billion Shire buyout and Shire’s own investors have fretted lately about the company’s standing in the hemophilia market. But immunology is a different story.
In the third quarter, the unit continued to post “strong growth,” as Jefferies analyst David Steinberg put it in a Thursday note to clients, with revenues checking in at $1.2 billion. The division now represents nearly one-third of the Dublin drugmaker’s business, and that figure could grow if new launcher Takhzyro keeps up its early pace.
After snagging an August FDA approval, the drug—which Steinberg has called a “best-in-class” prospect in hereditary angioedema—racked up $51 million in quarterly sales.
“While still early, we are encouraged by the response to the U.S. launch. Patients are coming from existing prophylaxis therapies, as well as patients new to prophylaxis,” Shire CEO Flemming Ornskov told investors on the biotech’s third-quarter conference call, adding, "We have seen physicians prescribe Takhzyro who have not previously prescribed” fellow Shire HAE-fighter Cynrize.
One reason for the strong early uptake? The company’s Quick Start program, which is “enabling patients to start on therapy now while we engage with payers on their formulary updates,” Ornskov noted. And he’s “very positive” about what he’s seen “in just a few months” on the reimbursement side, he said, suggesting that ultimately snagging reimbursement for those Quick Start patients won’t be a major issue.
Of course, Shire is hoping Takhzyro will step up its immunology sales outside the U.S., too, and that’s where Steinberg sees a big opportunity. Shire “has been unable to aggressively promote prophylaxis HAE treatment ex-U.S., given Cinryze supply constraints in recent years,” he wrote.
Meanwhile, Shire’s hematology business—which has been under major scrutiny since the company’s hemophilia-focused Baxalta buy, and even closer judgment since Roche introduced market disrupter Hemlibra—“remains largely stable,” Steinberg said. While Shire’s inhibitor business declined 11% in the third quarter thanks to Hemlibra’s impact, the dip was “manageable,” and Shire’s unit was bolstered by uptake of long-acting hemophilia A drug Adynovate, he added.