President and CEO Ned McCoy shared with Becker’s some of the company’s key objectives for the year, including the launch of some of the first medications from its Petersburg, Va.-based plant, the expansion of its insulin program and the continued growth of its hospital and retail portfolios.
Scaling up manufacturing
Since 2022, the company has been focusing on completing and operationalizing its Petersburg plant. Now that the facility is built, Mr. McCoy said the company has started running exhibit batches of drugs through the plant, though they are still in the process of receiving Abbreviated New Drug Application approval. The FDA uses the process to review and potentially approve a generic drug application, and it can take months.
“We’ll be launching our first medication out of the facility in early 2026 and then other medications will follow each month after that,” Mr. McCoy said. “So right now it’s just waiting on the development and approval process.”
He also said that in the meantime, the company has been supplying hospitals with medications by working with other manufacturers to produce and distribute more than 80 drugs. Since its launch, Civica has delivered 210 million doses to member hospital systems.
“Even though we don’t have our manufacturing plants started up, we’re supplying medications today, but this back integration into our own manufacturing site is a real focus for us,” Mr. McCoy said.
Reducing dependence on China
Civica has long prioritized supply chain resilience, which for the company means avoiding dependence on finished products and active pharmaceutical ingredients sourced from China.
“In rare situations, we may have a Chinese material as a backup if there’s no other options, but we generally don’t source from China,” he said. “We did this from the very beginning six or seven years ago, and maybe we were kind of ahead of our time, but we feel like that there’s not as much regulatory oversight in China since it’s more difficult for the FDA to get into China and schedule a site visit versus the U.S. where they can just show up at the plant.”
He said Civica instead follows a structured sourcing strategy, with U.S. suppliers as the top priority for materials, followed by European and Indian manufacturers. According to Mr. McCoy, this has helped the company enhance regulatory oversight, reduce geopolitical risks and ensure a more stable supply chain.
Commitment to affordable insulin
One of the top priorities for Civica continues to be developing more affordable insulin for people with diabetes, with a targeted price cap of $30 per vial and $55 per box of five prefilled pens.
Recently, the company announced a partnership with Biocon Biologics to expand access to insulin aspart, a rapid-acting insulin analog. Under the agreement, Biocon will supply the drug substance while Civica will manufacture the final product at its Petersburg facility, according to a March 6 news release from Civica.
“We’ve signed an agreement with Biocon for the supply of the drug substance for our insulin number two, which is aspart, the active ingredient in Humalog,” Mr. McCoy said. “Civica’s first insulin is a long-acting insulin. The second one is a short-acting insulin.”
Expanding hospital reach, retail offerings
Another initiative Civica is working on heading into 2025 is making strides in the retail pharmaceutical space through its subsidiary, CivicaScript.
The subsidiary is focused on addressing high costs in the retail sector. For example, the company offers abiraterone, a prostate cancer medication that typically has various price points, at a lower price than its competitors.
“If you’re a patient and you are faced with a cancer diagnosis, you’ve got a lot of things to think about,” Mr. McCoy said. “You shouldn’t have to go looking in different places to find the best price for your medication. And our price is the same price to all. There’s no middleman.”
Though this is the only medication the subsidiary is offering, in 2025 CivicaScript plans to launch four additional retail medications, with the first set to debut in the next month.
Civica Rx also plans to continue to expand its reach to more hospitals and health systems in 2025, in addition to the 60 health systems it currently serves.
Four health systems joined other Civica members in December: Winona (Minn.) Health, Boulder (Colo.) Community Health, Stanford (Calif.) Health Care and Duluth, Minn.-based Essentia Health.