Target Markets

We target many of the fastest-growing, most profitable sectors of the injectable drug delivery device market where there are high barriers to entry, fragmented competition and unmet customer needs

Prefilled Syringes:

Market Value

  1. An estimated 2 billion prefilled syringes used in 2011, with a market value of $2 billion.
  2. 70+ drugs and vaccines are in a prefilled format, with countless more in the clinical pipeline.
  3. Between 3.5 and 5 billion prefilled syringes are projected to be used annually by 2016.

Market Trends

  1. Mandatory needlestick prevention laws in U.S. since 2002.
  2. Mandatory E.U. laws from mid-2013.
  3. Increasing competition between novel, generic and biosimilar rivals in therapeutic drug classes.
  4. Using devices to optimize lifecycles of drugs nearing patent expiration.

Competitive Landscape

  1. A few suppliers of standard glass barrels or elastomers for prefilled syringes.
  2. A few companies market ancillary safety devices for attachment onto prefilled syringes.
  3. High regulatory, financial and technical barriers of entry.

Unilife Value Proposition

  1. The only prefilled syringes with automatic, integrated needle retraction features.
  2. A full platform ready for customization to specific customer or patient needs.
  3. Preferred for use by clinicians and patients due to ease of use and safety

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Auto-Injectors

Market Value

  1. Patient self-injection systems to automatically deliver a prefilled dose at the push of a button.
  2. Many acute and chronic diseases targeting patient self-injection.
  3. Market growing in excess of 17% CAGR.
  4. Expected to be a $1 billion market by 2016.

Market Trends

  1. Disposable device technologies are most commonly used in the market at present.
  2. Growing demand for re-usable, electro-mechanical devices.
  3. Desire for true end-of-dose indicators to prevent drug wastage and improve compliance.

Competitive Landscape

  1. A handful of companies offer disposable auto-injectors. None offer true end-of-dose indicators.
  2. Very few reusable or electromechanical auto-injectors.
  3. Minimal differentiation between current products.

Unilife Value Proposition

  1. Can be customized to drug or patient needs.
  2. Disposable and reusable, electro-mechanical platform technologies.
  3. True end-of-dose indicators via use of Unifill syringe.
  4. Safe, compact, and convenient disposal

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Dual-Chamber Syringes

Market Value

  1. Lyophilization of a drug can help to fast-track the path to approval.
  2. Can enable commercialization when a biologic molecule cannot be made liquid stable.
  3. A third of novel FDA-approved drugs since 2008 have been launched in a lyophilized format.

Market Trends

  1. Traditional reconstitution systems can require a dozen or more steps of use making patient self-injection problematic.
  2. Development of liquid-liquid and liquid-dry drug combination therapies.
  3. Accelerating demand for dual-chamber syringes.

Competitive Landscape

  1. A handful of manufacturers for dual-chamber prefilled syringes.
  2. Current systems can require secondary vent filters for reconstitution, or affect sterility.
  3. Minimal steps of use by clinicians or patients.

Unilife Value Proposition

  1. Suitable for liquid or dry drug combination therapies.
  2. Enables ventless reconstitution.
  3. Automatic, integrated safety features.

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Wearable Injectors

Market Value

  1. 15-20% of pipeline biologics will require delivery in wearable, disposable devices.
  2. Subcutaneous injection or infusion of doses over longer duration periods.
  3. Fast-growing sector set to exceed $500MM in market value by 2016.

Market Trends

  1. Conversion of approved drugs from IV to subcutaneous routes of delivery.
  2. Wearable injectors sought for use in upcoming clinical trials for many pipeline drugs.
  3. Each biologic can have specific formulation and patient needs.

Competitive Landscape

  1. Insulin pumps too expensive and unsuited for many biologics requiring delivery in wearable, disposable devices.
  2. Some competing technologies can require specific or nonstandard materials in the drug container.

Unilife Value Proposition

  1. Modular platform for bolus or rate based therapies.
  2. Scalable sizes for 1 - 30mL doses.
  3. Standard materials in drug container and fluid path.
  4. Intuitive use. Sleek, ergonomic design. Convenient disposal.
  5. Customized to drug/patient needs.

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Novel Delivery Systems

Market Value

  1. Many pipeline drugs targeting diseases with high prevalence rates but no available treatment.
  2. Specialized devices can help move drugs from the laboratory bench-top to clinical trials.
  3. siRNA, microRNA, gene or cell therapy, and targeted organ delivery valued at $10 billion.

Market Trends

  1. Devices can help enable the clinical development of novel pipeline drugs.
  2. Devices can help improve clinical efficacy or minimize systemic toxicity of approved drugs.
  3. Long-term partnerships between drug and device manufacturers.

Competitive Landscape

  1. Commodity devices largely unsuited to address specialized therapy needs.
  2. Unilife is one of a few companies with the expertise to develop and customize devices for localized or targeted delivery.

Unilife Value Proposition

  1. A series of active programs now under way.
  2. Including specialized devices for targeted organ delivery, low dose delivery and implant deployment.
  3. Customization options include fill-at-time of use, prefilled and attachable needles.

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Cautionary Notice: This document contains forward-looking statements. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements. These forward-looking statements are based on management's beliefs and assumptions and on information currently available to our management. Our management believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on any such forward-looking statements because such statements speak only as of the date when made. We do not undertake any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. In addition, forward-looking statements are subject to certain risks and uncertainties that could cause actual results, events and developments to differ materially from our historical experience and our present expectations or projections. These risks and uncertainties include, but are not limited to, those described in "Item 1A. Risk Factors" and elsewhere in our Annual Report on Form 10-K and in other reports that we file from time to time with the Securities and Exchange Commission. This document shall not constitute an offer to sell or the solicitation of an offer to buy any securities of Unilife Corporation. Always seek advice from a qualified investment advisor before making any investment decision.