- Shire plc kept mum on takeover bids from Takeda Pharmaceuticals Co. Ltd. during its first quarter earnings call Thursday, focusing instead on the promise of several products that have experienced headwinds recently.
- Total product sales reached $3.64 billion for the quarter, up 7% from the same period in 2017. Rare disease drugs were a particular bright spot, with sales up 10% year over year due to strong performances from immunoglobin therapies, biotherapeutics and internal medicines. The company's neuroscience business declined 2%, but mostly because it includes the ulcerative colitis drug Lialda, which went generic last year.
- As for 2018 guidance, Shire reiterated estimates of $14.9 billion to $15.3 billion in product sales and $14.90 to $15.50 in diluted earnings per share.
Shire didn't disappoint investors with its first quarter earnings, but rather with the lack of details on acquisition interest from Takeda and other potential suitors. Analysts were undoubtedly eager to talk about the elephant in the room, but CEO Flemming Ornskov made it clear before a question and answer period that the company wouldn't discuss anything related to the topic.
Attention then shifted to Shire's portfolio, wherein several key products are under pressure.
Hemophilia has, of course, been one source of concern. Shire expects newer, long-acting therapies like Roche AG's Hemlibra (emicizumab) to put about 50% of sales from its drug Feiba (anti-inhibitor coagulant complex) at risk by 2022. In the first quarter, sales of Shire's inhibitor therapies were down 5% year over year to $210 million, yet the company believes it's too early to tell how much of an impact Hemlibra will have.
"The reimbursement environment in the U.S. has changed significantly, so I think it will take some time before you really see the full impact of a trajectory of newly launched products," Ornskov said.
Cinryze (C1 esterase inhibitor [human]), a treatment for hereditary angioedema (HAE), was another focal point. Shire ran into difficulty keeping an adequate supply of the drug last year due to external manufacturing problems. Production has since moved in-house, and Shire's already noticing stock levels right-sizing.
"The supply patterns for Cinryze has been a bit erratic at the end of last year. It is starting to get better," Ornskov said, though he noted that "it's going to take a little bit longer before that is normalized."
"The other thing we're seeing is that in the marketplace, having a very strong patient service organization to support the patients as the roll on to the products is very important, and I think we have a very strong leg to stand on in the U.S. with our OnePath service organization," he added.
Also on the HAE front, an approval decision on Shire's lanadelumab should come by Aug. 26. The company anticipates the drug will offer a "potential paradigm shift" in the treatment of HAE, and that, as a monoclonal antibody, it will have higher margins than a plasma-derived product.
Ornskov also fielded questions about Shire's dry eye medicine Xiidra (lifitegrast). While Xiidra's prescription growth was up 27% from last year's first quarter, its $62 million in sales were much lower than Wall Street consensus estimates. Shire leadership argued barriers to Medicare Part D coverage are proving troublesome, but the potential market entry of generic competition to Allergan plc's Restasis (cyclosporin) could help knock some of them down.
"If there were an opportunity to change [Xiidra's] trajectory, it would have to be that we would get access to Medicare Part D more than we have now, and that we will be able to capture the kind of share that we have in the commercial plans," Ornskov said.