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.
Crystal Research Report – Unilife 4/16/10
Griffin Securities Research Report 3/31/10
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.
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Unilife Key Results for Year 2009
Financial Results
- 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
Commercial Agreements
- 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.
Proprietary Products
- 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.
Business Expansion
- 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
