Unilife Corp. (NASDAQ: UNIS) is an emerging medical device manufacturer with business segments that include pre-filled syringes for pharmaceutical companies to deliver injectable medications, sharps safety devices for healthcare facilities, and contract manufacturing of medical devices.
More than two billion prefilled syringes are currently used each year on a global basis and pharmaceutical companies are making the switch to products such as Unilife’s safety syringe which are compliant with needle-stick prevention laws (e.g. Federal Needlestick Prevention Act, 2000).
Key differentiating features of Unilife’s fully-integrated (within the barrel of the syringe) safety syringes include the following:
1.) a passive needle retraction system that is activated inside the body
2.) healthcare providers / shot administrators control the speed of needle retraction
3.) auto-disabling prevents re-use or tampering with used syringes.
The market opportunity for prefilled syringes includes 50 drugs (primary anti-coagulant / hematology medications, vaccines, and other biological agents) that are delivered by injection, including an estimated 3 billion prefilled syringes in use by 2012.
Unilife has a distinct advantage with a disruptive technology since there are currently no prefilled syringes to deliver medications with fully-integrated safety features so pharmaceutical companies must add these features – which adds to production / shipping costs and increases the overall packaging size by up to 60%, resulting in both waste disposal and marketing issues.
Unilife Key Results for Year 2009
- Total Revenues of A$40,413,706 (2008-2009) and increase of 869% year over year
- Net Profit after tax of A$12,806,496 compared to a loss of A$8,617,238 the previous year
- July 1, 2008 – Unilife signs Exclusive Agreement with Sanofi-Aventis. Receipt of A$16.4 million fee in exchange for the exclusive right to negotiate for the purchase of the Unilife Ready-to-Fill Syringe and to bear the costs of it industrializations subject to the signing of the Industrialization Agreement and the completion of agreed quarterly milestones.
- June 30, 2009 – Unilife signs Industrialization Agreement with Sanofi-Aventis. Commitment to complete and fund the A$30 million industrialization program for the Unilife Ready-to-Fill Syringe. Unilife retains the right to negotiate with other pharmaceutical companies within therapeutic drug classes.
- Unilife Ready-to-Fill Syringe. Industrialization Program targeted for completion in late 2010 (ONE YEAR ahead of the originally projected schedule) with the receipt-to-date of A$17 million in milestone payments.
- Unitract 1mL Syringes: U.S. production commenced on an automated assembly system developed and operated out of Unilife’s FDA-registered manufacturing facility in Pennsylvania. Clearance for U.S. sale and marketing by the FDA.
- Pipeline Products: Significant progress made on additional pipeline safety syringe products targeted for use in healthcare and pharmaceutical markets.
- Consolidation of key commercial and operational functions to Unilife’s facility in Pennsylvania and the expansion of its world-class team with the appointment of 35 management and professional personnel since July 1, 2008
- Review underway to establish a major new U.S. production facility with strong support received from the Pennsylvania government.
- Commencement of initial discussions with additional pharmaceutical customers interested in the right to purchase the Ready-to-Fill Syringe
- Proposed redomiciliation from Australia to the U.S. with proposed listing on NASDAQ