Supply shortages weigh on Pfizer’s sterile injectables business in Q3

• The ongoing challenges to Pfizer’s sterile injectables manufacturing have dragged on, weighing on Pfizer’s top line in the third quarter of 2018.
• These have caused supply shortages and delays that Pfizer doesn’t expect to be over until 2019.
• According to the company’s third quarter 2018 results, the sterile injectable product portfolio has declined by 9% in developed markets, one reason Pfizer modestly narrowed its revenue expectations for 2018.

Pfizer completed its acquisition of Hospira, a provider of injectable drugs and infusion technologies, just over three years ago, but the subsidiary has been dogged by manufacturing issues.

These include a number of voluntary recalls over sterility concerns, violations of good manufacturing practices, and third-party issues following hurricanes in Puerto Rico.

This has carried through to Pfizer’s financials. In its third quarter 2018 results, Pfizer narrowed its guidance on 2018 revenue from $53 to $55 billion to between $53 billion to $53.7 billion, reducing the midpoint by $650 million.

“[This] was largely related to lower-than-anticipated Essential Health revenues, primarily due to continued legacy Hospira sterile injectable product shortages in the U.S. and recent unfavorable changes in foreign exchange rates,” Pfizer CEO Ian Read said on the company’s third quarter results call.

Pfizer continues to invest in this business, though, with $465 million earmarked for a sterile injectable manufacturing plant in Portage, Michigan, that’s expected to begin production in 2024.

“We see the global sterile injectables market as being a very attractive market,” said Angela Hwang, Pfizer’s group president for essential health. “It’s large, it’s growing, it has high barriers to entry due to the complexity of manufacturing. And for that reason, we are very focused on our remediation efforts as a critical success factor in this market.”

Hwang said she expects supply to improve significantly towards the end of 2019.

https://www.biopharmadive.com/news/supply-shortages-weigh-on-pfizers-sterile-injectables-business-in-q3/541180/