UNIS- Unilife: Investing in R&D for Long-Term Shareholder Value

UNIS- Unilife: Investing in R&D for Long-Term Shareholder Value

Unilife (NASDAQ: UNIS) develops and commercializes advanced drug delivery systems through collaborations with bio-pharmaceutical companies to delivery injectable drugs and biological products such as vaccines. The Company’s flagship product is the Unifill syringe, which is the only available prefilled syringe that includes fully-integrated safety features, in addition to other proprietary technologies for drug reconstitution delivery systems, auto-injectors, auto-infusion pump systems and specialized devices for targeted organ delivery. Unilife Homepage

On 7/30/12, Unilife reported its financial results for the final quarter and full-year of Fiscal Year 2012 (FY12) which ended on 6/30/12. DuringFY12, the Company doubled its pipeline to include over 40 pharmaceutical companies that represent current and potential customers with the goal of securing several long-term commercial partnerships through these efforts that include a focus on research and development (R&D) activities to deliver innovative drug delivery products and systems in response to customer demand for differentiated brands.

Unilife is currently making shipments of small batches of the Unifill pre-filled syringe to several pharmaceutical companies, which are evaluating the device for its potential across a variety of marketed and late-stage pipeline drugs and the Company also expects to begin making Unifill shipments to new global pharmaceutical companies in the coming months.

The Company also reported progress on its AutoInfusorDevices (disposable subcutaneous delivery systems) for the delivery of large dose volume drugs (e.g. monoclonal antibodies) capable of delivering 1-30mLvolumes. Unilife reported that several global pharmaceutical companies have selected its Precision-Therapy and Flex Therapy product lines for next-phase evaluation for potential use with a several pipeline drugs that may culminate in long-term development and commercial supply agreements with additional evaluations scheduled during 2H12.

Unilife reported a pro-forma cash balance of $32.6 million(M) at the end of FY12, including net proceeds of $18.8M received in July from the sale of common stock. Revenue for FY12 was $5.5M, resulting in an adjusted (excluding non-cash related and interest expenses) net loss of ($37.7M) compared to ($27.1M)in FY11 with the larger loss this year primarily reflecting increased R&D expenses reflected in expansion of the Company’s growing portfolio of innovative drug delivery devices and systems.

The Company’s significant and growing investments in R&D; an estimated 5-10 global pharmaceutical customer relationships have reached the advanced stages of negotiation that is expected to result in recurring and growing revenue streams from long-term development and commercial supply agreements. In addition, Unilife is targeting a 25% reduction in quarterly operating expenses during FY13 (i.e. from around $12M to $9M per quarter) while focusing R&D efforts on high-cost, low unit-volume drugs ranging in cost from hundreds to thousands of dollars per dose with competitive device related pricing that exceeds $1 per unit.

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