67 WALL STREET, New York - December 16, 2013 - The Wall Street Transcript has just published its Top 15 CEO Interviews of 2013 Report . This special feature contains expert industry commentary through in-depth interviews with highly successful public company CEOs. The full issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online.
Topics covered: Top 15 CEO Interviews of 2013
Companies include: Unilife Corporation (UNIS)
In the following excerpt from the Top 15 CEO Interviews of 2013 Report, the CEO of Unilife Corporation discusses the outlook for his company for investors:
TWST: Let's begin with a brief history of Unilife and an overview of your injectable product technologies.
Mr. Shortall: I founded Unilife in 2002. At that stage, we were a safety syringe technology development company. We grew from there establishing relationships with companies including Sanofi in 2004. We focused heavily on prefilled syringe technology. There is no safety prefilled syringe in the world with an integrated safety mechanism built into the device, so that became our primary focus.
Until 2007, we had been based in Sydney, Australia, and listed only on the Australian Stock Exchange. In 2007, we acquired a company in Central Pennsylvania, which had FDA-registered manufacturing facilities and the operational expertise we wanted to transition from a technology development company into an industrial producer. This is a big step that many companies fail on. So by taking that operational expertise and then moving over to the U.S. in 2008, we were able to become an industrial manufacturer of medical devices. We are now a Nasdaq-listed company, and while our shares also still trade on the ASX, we're a fully-fledged U.S.-based company.
The issues surrounding moving to USA that others might complain about - the regulatory processes and the stringent rules and regulations and legal processes, Sarbanes-Oxley and Dodd-Frank, etc. - for us, from a medical device perspective, was actually a huge benefit. We embraced those stringent regulations. The USA, through the regulations of agencies such as the FDA, has a reputation for the production and approval of premium, high-quality products, so we embraced those high standards and used it to our advantage.
We had a leased facility when we first moved to Pennsylvania in 2007, but we've since bought 35 acres close to York in Pennsylvania and have built a 165,000-square-foot state-of-the-art facility. This was actually designed by an architectural firm that works for most of the major pharmaceutical companies. It was designed specifically to ensure streamlined operations and optimum manufacturing processes. We don't operate our facility at the level of a typical medical device company; we operate it to the standard of a global pharmaceutical company. That's very important for us. We recently had two FDA inspectors here on-site for four days, and we got a clean bill of health from them, where they found no minor or major nonconformances and were actually very complimentary of the way we manufacture and run our facility and the expertise that we have in-house. As you probably know, an effective, efficient and robust quality system is a critical element of ensuring regulatory approvals at all times.
TWST: You've been quoted as saying that 2013 will be an inflection point for Unilife, the year that revenues begin to improve. Can you give us some insight?
Mr. Shortall: Before I can do that I really need to give you a description of what we do. As I said, we were initially a syringe technology development company. We've since grown into something much greater by recognizing opportunities and changes in the global market for injectable drug delivery systems, and being able to put ourselves in a position to capitalize on those changes...
For more of this interview and many others visit the Wall Street Transcript - a unique service for investors and industry researchers - providing fresh commentary and insight through verbatim interviews with CEOs, portfolio managers and research analysts. This special issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online.