Dive Brief:

• Baxter on Thursday raised its 2018 earnings per share guidance on strong second quarter results, with $2.8 billion in revenue, an increase of 9% compared to the same period last year.
• But on a call with investors, company leadership noted that its distribution of small IV bags is still negatively impacted by Hurricane Maria, which ravaged Puerto Rico last year.
• Drivers of the company’s revenue growth included increased sales of injectable drugs, its renal care and acute therapies businesses and its compounding and contract manufacturing businesses.

Dive Insight:

The company pointed to its diverse holdings as one growth driver, and highlighted the FDA clearance and Health Canada approval of its Spectrum IQ Infusion System. Yearly EPS guidance was raised to $2.48-2.59 per share.

The system is designed for bi-directional electronic medical record integration with the goal of ensuring correct medications are given to patients.

Baxter has worked with the FDA to gain temporary permission to import small volume parenterals (small IV bags) from Baxter facilities in Ireland, Australia, Canada, Mexico, England, Italy and Brazil after supply was hit by Hurricane Maria. But its supply continues to be under pressure, according to Baxter CEO José (Joe) Almeida.

“We hope that by the end of the year, early next year, MINI-BAG Plus and MINI-BAG will be off allocation,” the CEO told investors on an earnings call.

Baxter told MedTech Dive in June that it is working with FDA to gain permanent approval to import the small bags, which “would provide flexibility to support product supply in the U.S. in the event it was needed.”

But it is unclear if FDA will agree to the request. In April, FDA told MedTech Dive that it is closely monitoring requests for expedited reviews, noting that Laboratorios Grifols and Fresenius Kabi’s approvals were expected to help overall supply.

“Once the shortage is over, temporary importations are expected to end. However, we cannot speculate on any requests for permanent availability from any manufacturer,” press officer Megan McSeveney said in an email.

Hospital systems have struggled with the disruption of the small IV bags.

“We have been short pretty much since immediately after the hurricane when Baxter stopped shipping. We've had to change the way that give patients medicines, we've had to move some medicines into a syringe, give them an injection instead of an infusion. In some cases that can actually cause more side effects, so we're reasonably worried about safety and monitoring,” Erin Fox, senior director of drug information and support services at University of Utah Health, told MedTech Dive.

FDA Commissioner Scott Gottlieb recently announced the creation of a new drug shortages task force, noting the impact that Hurricane Maria had on the U.S. health system. “Staff across the FDA stand ready to work with manufacturers to prevent and mitigate any potential storm-related drug shortages,” he said in a statement.