“We expect a more significant contribution from biologics manufacturing in 2014,” Wuxi spokesman Ron Aldridge told BioPharma-Reporter.com. “We have clinical-trial scale manufacturing facilities that provided us with modest revenues in 2013.
"Most of our biologics revenue in 2013 was from development projects that had not yet reached the manufacturing stage.”
The company now expects to achieve total revenues of approximately $578m (€424m), with expected diluted EPS (earnings per share) for full-year 2013 to slightly exceed the top end of its previous guidance of $1.51-$1.55 (GAAP) and $1.73-$1.77 (non-GAAP).
And biologics manufacturing has been an important driver. In the second quarter, Wuxi's revenues grew 10% due to higher contributions from both its China-based lab services business and its biomanufacturing operations.
This was underlined by Wuxi in its presentation at the JP Morgan Healthcare Conference in San Francisco last week the company highlighted its transformation from a chemistry-based company to one that specializes in large-scale and biologics manufacturing, including for at least one ADC.
Wuxi’s growth in biopharmaceutical manufacturing services began in 2008 when it acquired AppTec Laboratory for $151m. Somewhat ironically one of the first decisions Wuxi made was to cease biologics production at the AppTec facility in Philadelphia later that year.
But despite this the shift towards biopharmaceuticals continued. In 2012 the company opened what it considered to be the first plant to use fully disposable manufacturing equipment and to meet both US and EU GMP (good manufacturing practices) standards.
Wuxi now has six manufacturing sites in China, all of which offer biologics manufacturing, and four non-biologics sites in the US.
Wuxi also recently:
- Expanded small molecule manufacturing for six commercial and 10 Phase III drugs;
- Received FDA approval for the manufacture of Pharmacyclics’ ibrutinib; and
- Installed its first set of 2000 L disposable bioreactors in Asia and completed the first 2000 L run using NSO cells.
“Our outperformance in 2013 mainly came from small-molecule manufacturing and biologics development, although all of our businesses performed well,” Aldridge told us.
Manufacturing is expected to represent about a quarter of the company’s 2013 revenue, which is an increase of about 2% over 2012. The company also says it’s expecting a “major” capacity expansion in 2014 and 2015.
The company plans to report its fourth-quarter and full-year 2013 financial results and to provide 2014 financial guidance in March.