Large-scale manufacturing operations drive AMRI revenue in Q3

Anticipates further growth in outsourcing in 2013

AMRI, a US-based global contract research and manufacturing organisation, increased its total revenue for the third quarter to 30 September to US$55.8m, a rise of 11% compared with the third quarter of 2011.

Total contract revenue, which encompasses discovery services, development and small-scale and large-scale manufacturing, was $45.6m, an increase of 4%.

Discovery services reported revenue of $8.9m, consistent with 2011; development/small-scale manufacturing revenue was $7.4m, a fall of 20% from $9.2m in 2011; and large-scale manufacturing revenue was $29.3m, an increase of 14%.

AMRI earns royalties from worldwide net sales of the non-sedating antihistamine Allegra (Telfast outside the US), as well as certain generic forms of Allegra, and revenue for the third quarter increased by 45% to $9.4m.

Royalty revenue also includes $3.3m under a long-standing contract to provide the active pharmaceutical ingredient for a generic product, which is manufactured in the company’s Rensselaer, NY facility. AMRI is also eligible for royalties on net sales of the final drug product.

Total revenue in the third quarter also includes milestone revenue of $0.8m from the company’s 2005 licensing agreement with Bristol Myers-Squibb.

Net loss under US GAAP was $2.1m, compared with a net loss of $5.9m for the third quarter of 2011.

The improvement in revenue is driven by continued strength in our large-scale manufacturing operations

AMRI chairman, president and CEO Thomas D’Ambra, said: ‘The quarter marks year-over-year and sequential improvement in revenue for our contract services business driven by continued strength in our large-scale manufacturing operations.

‘Although contract service operating margins in the quarter were impacted by the underlying mix of services within each segment, this was offset by the favourable impact of royalties received on product sales from the commercial launch of an FDA approved generic product by one of our customers.

‘On balance, we remain confident in our ability to drive improved financial performance given the positive underlying trends in our business, including continued improvement in customer orders and inquiries, the significant number of products in our pipeline approaching PDUFA dates over the next 24 months, and our ongoing commitment to optimising our cost structure.’

D’Ambra added: ‘In addition to the recently announced agreement with Knopp Biosciences and the multi-year extension of our agreement with Shire, we are actively pursuing several other opportunities with existing and new customers that could potentially provide AMRI with a stronger, more diverse business base as we enter 2013.

‘Although the global economy remains challenging, our outlook for the market remains unchanged with anticipated growth in R&D spending and incremental increases in the level of outsourcing across the biopharmaceutical industry over the coming year.’