For the first six months of fiscal year 2015, the injectable device developer and manufacturer reported sales of just $6.8m (€6m), unchanged from the same period last year, while net losses increased 51% to $42m.
Despite this, the firm will continue to ramp up the capacity for both its auto-injector Unifill platforms and its wearable injectors, CEO Alan Shortall said in a call discussing results yesterday, as demand from customers looking to combine their drugs with devices grows.
“The second manufacturing line within our Unifill program is now operational with a third nearing completion,” Shortall said, adding with sales expected to surpass one million units later this year the firm will “continue to scale up capacity to support growing customer demand.”
Similarly with wearables, production volumes have already been ramped up to over 500,000 units annually, and Shortall told investors Unilife will “initiate the procurement of a high-speed manufacturing line” to up capacity.
The devices are produced from the company’s 165,000sq ft manufacturing facility in York, Pennsylvania, and in November 2014 a deal was inked with Flextronics to further expand the capacity and scale-up capability of Unilife’s portfolio.
$15bn market opportunity
As of the end of 2014, Unilife had 20 active programmes with customers, and - if deals like the 15-year wearable injector supply deal penned with Sanofi in November pay off – such contracts could be lucrative.
Already this year AbbVie entered into a global strategic agreement to access the full portfolio of delivery systems and paid a $5m holding fee for a specific system with an undisclosed auto-immune treatment, and Shortall said he expects to steadily increase the number of active programs under way in the coming quarters.
“There is a major shift in the drug industry to biologics,” he said with over a 1,000 biologics either approved or in clinical development, most of which must be injected into the body. “Sophisticated delivery systems are required to contain and administer these complex and high value drugs and support the regulatory approval within specific indications.”
Furthermore, he argued, when combined with drug companies targeting diseases where self-administration is a major preference for buyers and patients, an industry trend is created.
“Pharmaceutical companies are shifting to the use of innovative patient-centric devices to gain patient preference and differentiate their injectable therapies from the competition,” he said, and this will make the market opportunity for a firm like Unilife grow from $4bn this year to up to $15bn within 10 years.