For the first time since its public listing in 2002,
Unilife Medical Solutions (Australia: UNI.AX) (U.S. ADR: UNIFF.PK) posted a net profit which came in at $11M for the six-month period ending 12/31/08. Unilife posted a 43% increase in revenue to $2.7M, compared to the year-ago period and net income was driven by $23.4M in other income (largely accounted for by a major licensing deal for the Company's pre-filled syringe). The Company ended the year with $10.9M in cash/equivalents and total liabilities of $7.4M ($3.2M current, $4.2M long-term).
Unilife has manufacturing subsidiaries registered with the FDA in China and near Harrisburg, PA. The Company and its subsidiaries include about 70 staff across the U.S., China, and Australia. Unilife is ISO 13485:2003 certified, which means that the Company meets the requirements for providing medical devices and related services that consistently meet customer requirements and regulatory (FDA) requirements.
The core business segments for Unilife include pre-filled syringes for pharmaceutical companies to deliver injectable medications, sharps safety devices for healthcare facilities, and contract manufacturing of medical devices. The Company estimates that nearly 50 medications delivered by pre-filled syringes are being sold worldwide with sales of nearly $50B.
The Company's product line-up of safety syringes are sold under the
Unitract brand and allow users to control the speed of automatic needle retraction through a fully integrated safety syringe to nearly eliminate the risk of needle-stick injuries and disease transmission for healthcare providers.
Click here for a full explanation and demonstration of the integrated safety features for Unitract 1mL syringes, which received 510(k) marketing clearance from the FDA last October
Unilife has a fully-owned U.S. subsidiary through its acquisition of Integrated BioSciences, which is located near Harrisburg, PA, and employs the majority of the Company's staff (50) at a FDA registered manufacturing facility for the large-scale production of medical devices. This facility produces the Unitract safety syringes and also handles contract manufacturing of medical devices for healthcare and pharmaceutical companies.
The Company's strategic partner for exclusive manufacturing and distribution of sharps safety products is Shanghai Kindly Enterprise Development Group (KDL). This facility currently produces Unitract 1mL syringes and MedPro blood collection safety devices using semi-automated assembly systems developed and qualified by Unilife. KDL is the second largest medical device manufacturer in China and has two-thirds market share of the Chinese needle market, manufacturing over 5 billion needles and 600 million syringes per year.
The major business partner for Unilife is Sanofi-Aventis (SNY), which is the largest buyer of pre-filled syringes in the world for injectable products such as the blood thinner Lovenox and influenza vaccines such as Fluzone marketed by the Company. Last July, Unilife and SNY agreed to a five-year exclusive licensing agreement for the Unilife Pre-Filled syringe.
SNY paid a $13.3M U.S. Dollar exclusivity fee ($10M euros, currency conversion current as of 3/29/09) for the right to purchase the syringes over the next five years and also agreed to finance Unilife's plans for expanding manufacturing capacity for the syringes (with a first-year production target of 40 million units by early 2011), for an additional cash commitment of $20-$22.6M.
The industrialization agreement between the two companies will determine the amount and scheduling of payments by SNY, but Unilife has already received a payment of over $2M as part of this deal. Additional agreements between the two companies are also possible to provide Unilife with more cash infusions and a strong business partner to drive demand at its expanding manufacturing facilities in PA.
Gerresheimer Buende is one of the world's largest manufacturers of prefilled syringe systems, and a key supplier to a number of major pharmaceutical companies including Unilife's pharmaceutical partner, SNY. Unilife and Buende are working towards a collaborative commercial relationship that will be capable of producing in excess of 400 million units of the Unitract Pre-Filled Syringe per year.
West Pharmaceutical Services (WST) supplies medical device components to a variety of companies in the healthcare sector. WST is a PA-based company with a market cap over $1B with over 20 manufacturing facilities on a global basis. Unilife has a development agreement with WST for the provision of specialist components such as seals for Unitract products.
Earlier this year, Unilife announced plans to relocate its global headquarters by the end of 1Q09 into a building being occupied by fully-owned subsidiary Integrated BioSciences in Lewisberry, PA. The Company also appointed a U.S.-based chief financial officer, Mr. Daniel Calvert, around the same time as part of plans to apply for listing on a U.S. stock exchange and expanding the number of people at the manufacturing plant in Lewisberry (near Harrisburg) to around 100 while retaining a small R&D team in Sydney, Australia.
The rapid expansion of Unilife will soon become more apparent to U.S. investors as the Company expects to list for trading here later in the year. Also, the extensive partnership with Sanofi-Aventis provides Unilife with the necessary capital to expand its U.S. manufacturing capacity and will provide a major source of demand for the Company's pre-filled syringes by early 2011 with a production target of 40 million units per year at that time.
$27.73 (03/31/09)
