Small molecule manufacturing currently represents more than 27% of total company revenue and higher expectations has led WuXi to raise its expected capital expenditures to between $95m and $100m, which is about $10m more than previously anticipated. The new funding will primarily drive capacity expansion in small-molecule manufacturing, as well as new investments in labs and technology related to genomics, biologics and biology.
An expanding pipeline of early and the late-stage products is leading WuXi to construct a new facility in Changzhou, China. “Facility construction in Phase I will double the company's current manufacturing capacity and will be operational by fourth quarter of 2015,” Li said, according to a transcript of the conference call last week. Upon completion, the site will “triple current capacity and could employ more than 1,500 employees.”
A new high-potency API lab in Shanghai also began operating in Q2 to support other development and the clinical trial supply of high-potency small molecules at a kilogram scale.
William Blair analyst John Kreger sounded upbeat on WuXi in his note to investors last week, noting that “the pharma outsourcing environment in China continues to be strong and the company's rapid expansion into adjacent areas of drug development (such as clinical, API, and biologic manufacturing) should ensure its leadership continues.”
Biologics Manufacturing
In addition to small molecules, WuXi also expects to hone in on biologics manufacturing in the years to come. Li said: “The key source of growth in biologics over the next several years will be manufacturing. We are planning 15 GMP manufacturing campaigns in 2014 and 2015. We're making plans to build the biologics commercial manufacturing facilities to meet the strong demand we are seeing.”
Although biologics manufacturing in Q2 only represented a “low single digit” percentage of WuXi’s overall revenue, Li predicts that in Q3 and Q4, “it's going to exponentially grow.”
In addition, the company is expecting growth in cell therapy manufacturing and is expanding its cell manufacturing capacity in Philadelphia. The company also has “a plan to start to configure building GMP manufacturing suite in China,” Li said.
He added: “For cell therapy, we signed agreement with NewLink Genetics for manufacturing the new cell therapy product candidate for pancreatic cancer currently in Phase III clinical trials. Cell therapy is a fast growing new therapeutic area and we have build capabilities to develop and manufacture post-allergenic and autologous cell-based therapeutics.”
WuXi also for the first time reported in the conference call that the US FDA approved a monoclonal antibody drug candidate that WuXi manufactures in China for TaiMed. The mAB, called ibalizumab, is used in extended access programs for HIV patients.
PRA JV
Li offered an update on the company’s joint venture with CRO PRA Health Sciences, though the JV has yet to fully ramp up.
“So this business is taking hold,” Li said, referring to the JV focused on full-service clinical trials in China, Hong Kong and Macau. “We have been building backlog. But the problem in China, it takes nine to 12 months to get a clinical trial approved. So we don't see a significant revenue this year. But starting from mid-next year, it should ramp up.”