“We have been though a quantum shift in our business over the last 18 months,” Unilife CEO Alan Shortall told investors Monday during a call to discuss Q1 2015 results. The drug delivery device maker has signed a number of deals over this period with firms including Hikma, Novartis and AstraZeneca’s MedImmune, but Shortall described last month’s commercial supply agreement with Sanofi as “unprecedented.”
“It is arguably the largest and longest supply agreement ever done in our industry,” he said. “We will supply our wearable injectors to Sanofi for use with all of their applicable pipeline drug needs, excluding insulins, for the next 15 years at a minimum.”
The firm already has a deal with the French Pharma Giant to supply prefilled syringes but this agreement sees Unifill as the sole supplier of wearable injectors, a means of administration Shortall said would be used to deliver a significant number of the molecules in Sanofi’s pipeline.
“Sanofi's portfolio includes a significant number of drugs that will likely require large dose volume delivery and consequently be delivered with wearable injectors,” he said on the call. “It is estimated that from among 16 such drugs in Sanofi's pipeline that between five and ten of them will reach commercialization and be delivered in wearable injectors.”
With conservative estimates, “the average molecule at commercial volumes is expected to require a nominal five million wearable injector units per year,” he continued and at an average selling price of $25 (€20) per device, this would equate to $125m of revenue from each product for Unilife during full commercialisation.
Even before this stage, Shortall said Unilife expected to “generate meaningful revenue” based on preclinical and clinical unit volumes of between 10,000 units and 100,000 units per programme at an average selling price “significantly higher than for peak commercial volumes.”
Shortall added: “The size and scope of the agreement reflects the industry trend towards modular device platforms that can broadly therapy needs of a multitude of drugs and indications in a customer's pipeline."
Manufacturing scale-up
Unilife’s facility in York, Pennsylvania, has GMP capacity of one million units per year, and is mostly pre-reserved or pre-sold to its current wearable injector customers. Shortall said the company was looking to expand production capacity and scale up capability to support the Sanofi agreement with further details to come.
However, to fulfill its various supply deals of its prefilled syringes he said:“We are scaling up over the next few years to have a manufacturing capacity of at least 400 million Unifill syringes per year.”
He continued: “Additional demand is projected from other customer seeking access to our Unifill platform of prefilled syringes. We have multiple additional assembly lines at various stages of order, installation and assembly to support the scheduled ramp in customer demand.”
For the first quarter 2015, revenues stood at $1.4m, down from $3.2m over the same period 2014. However, Shortall assured investors that though “initial sales per quarter are relatively small, it will progressively become a more significant share of total revenue through financial year 2015, 2016 and 2017.”