For the first quarter of 2013, West Pharmaceutical Services saw sales of the drug delivery system – developed by Japanese company Daikyo Seiko and in use for the first time in its human clinical trial - reach $3.5m (€2.7m), falling within the guidance levels of $12-14m for the year.
Discussing Q1 results, West CEO Donald Morel said a second filling line for the CZ system is being implemented by German contract filler Vetter - which has had a fill and finish partnership with West since 2011 - at a second site in Chicago, “aimed at clinical trial volume to support activity in the United States.”
He told investors: “We have got roughly 5 to 6 million units going into capacity off the line in Germany, and the line in Chicago should come on sometime in the late 2014, early 2015 timeframe.”
The system had previously suffered delays and sales restriction due to lack of validated filling capacity that led to the contract agreement and a dedicated CZ filling line at Vetter’s Ravensburg, Germany which received full cGMP validation last month.
Comprising vials, cartridges and a 1ml long syringe and developed by Japanese company Daikyu Seiko, the CZ ready-to-use prefillable syringe has been billed as a massive future earner for West.
The company has predicted quarterly revenues from the product could rise to over $600m from the recently announced $339m once it is commercially available.
Morel said he expected “CZ revenues to be somewhat modest over the next 18 months,” but told stakeholders to regard the upcoming formal stability trial as “a critical stake in the ground in terms of timing for its commercialization.”
West reported first quarter revenue up 7.3%, and operating income of $43m, an increase of 4%, and cited its packaging technology business - and specifically its Westar and FluroTec products – as the growth driver.
The key role played by West’s packaging business was noted by observers, including Jeffries analyst David Windley, who described the results as “mixed” and argued that “higher packaging earnings offset lower delivery performance.”
However, the sales contribution from West’s smaller delivery systems’ business - accountable for approximately a quarter of total revenue – was still up $7.5m (9% increase) on last year due to “strong demand for contract manufacturing” and “orders for Crystal Zenith vials and cartridges,” according to Morel.