Jefferies Healthcare Conference. June 1, 2015

Transcription

1 Jefferies Healthcare Conference June 1, 2015

2 Cautionary Note Regarding Forward-Looking Statements This presentation contains forward looking statements under the safe harbor provisions of the US securities laws. 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 as these are subject to risks and uncertainties. Please refer to our press releases and our SEC filings for more information regarding the use of forward looking statements. 2 Confidential-Unilife

3 Business Overview Design, develop, manufacture and supply injectable drug delivery systems Long-term strategic partnerships with pharmaceutical and biotech companies A broad, highly differentiated portfolio for injectable biologics, drugs and vaccines Cash receipts from multiple sources, including device sales, upfront fees, milestone payments Several cornerstone supply agreements in place Anticipated recurring revenue over avg years with attractive operating margins at scale Business development efforts are active 3

4 Select Financial Information R&D investment accounts for more than half of total operating expense 60% 55% 54% 50% 45% 40% 41% R&D SG&A 35% 30% FY 2012 FY 2013 FY months to March 31, 2015 Revenue Cash Receipts from Customers Ending cash, and cash equivalents at March 31, 2015 (1) Quarter ended March 31, 2015 $2.9 $8.9 $ (1) Includes $2.1 M of restricted cash

5 Converging Market Trends Accelerating demand for safe, simple and convenient injectable drug delivery systems Complex Biologics Improving Therapy Compliance Reducing Healthcare Costs Enhancing Patient Lifestyles Patient Self- Injection Maximizing Drug Brand Differentiation 5

6 $m Large, Fast Growing Market for Injectable Drug Delivery Systems Projected market growth from $4B in 2015 to $15B by $18,000 $16,000 $14,000 $12,000 Wearable injectors^ $10,000 $8,000 $6,000 $4,000 Prefilled syringes* $2,000 $- Auto-injectors Reconstitution Ocular delivery Novel delivery ) ^ Roots Resarch. Wearable Bolus Injectors * VisionGain Medical Device Leader Series and Company estimates.

7 Our Business Strategy Commercial Pipeline Business development discussions are active Multiple potential drug candidates / customers Active Programs Device customization and other activities to prepare for commercial launch Signed customer agreements Upfront or milestone based cash receipts Programs may span 1 3 years or more prior to launch Commercial Supply Agreements Supply agreements signed prior to commercial launch yr. duration common Potential for multiple supply agreements per customer for various drugs, indications and / or devices 7

8 A Selection of Device Categories Customizable, Modular Product Platforms for Injectable Biologics, Drugs and Vaccines Prefilled Syringes Reconstitution Systems Auto-Injectors Wearable Injectors Ocular & Novel Delivery Systems 8

9 A Selection of Devices From Various Platforms Prefilled Syringes For prefilled drugs, vaccines and biologics Reconstitution Systems For liquid-liquid or liquid dry drug combinations Auto-Injectors Handheld self-injection therapies 9 Wearable Injectors For wearable self-injection therapies Ocular & Novel Delivery Systems For accurate, precise delivery to the eye and other organs

10 Integration of Drugs, Devices and Data for Therapy Adherence Aligned with customer programs and new commercial opportunities Integration of digital connectivity into select Unilife device platforms such as Smart reusable auto-injectors Integrated Data Hubs HIPAA authorized stakeholders such as: Patients Payers Prescribers Pharmaceutical Wearable injectors Custom options include Bluetooth LE, 4G and WIFI Adding healthcare value and patient outcomes Enhanced patient care Improved rates of therapy adherence Reduced healthcare costs 10

11 A Typical Strategic Customer Relationship Elements of a Strategic Relationship Commercial Benefits to Unilife Large portfolio of injectable drugs Customer has a multitude of biologics, drugs or vaccines in development and / or approved Multiple shots on goal Minimizes risk for launch Subsequent launches can increase revenue and rate of revenue growth Access to one or more Unilife device categories Customer desires platform for efficient customization of devices to specific needs of each drug Minimal sales and marketing Model expected to support attractive operating margins over time Long-term continuity of supply Customer requires assurance of device supply during development and commercial lifecycle Predictable, recurring revenues Supply agreements can span 10 to 15 years or more Minimum annual revenue anticipated during supply term Potential Exclusivity Customer seeks to maximize differentiation from competitors to build user preference and maximize market share Pre- Commercial Revenue Fees for exclusive access in disease area or indication Fees to customize device to specific brand requirements 11

12 A Selection of Long-Term Customer Agreements Customer Device Key Terms^ Sanofi AstraZeneca / MedImmune Sanofi Hikma Novartis Global biopharma company Unifill Finesse Wearable Injectors Wearable Injectors Unifill, Unifill Nexus, Unifill Allure Novel device for targeted organ delivery Unifill Finesse and LISA reusable auto-injector Global commercial supply for Lovenox. 10-Years. $50MM aggregate payments received. Min. 150MM units / year after ramp period. Global development and supply agreement. Several target biologics in MedImmune portfolio. Terms not disclosed. Unilife sole provider for all applicable large dose volume drugs. Global commercial supply biologics anticipated. 15-Years min. Global commercial supply. 20 generic injectables. 15-Years. $40MM in upfront and milestone payments. Min. 175MM units after ramp. Clinical development and supply. Terms not disclosed. Strategic agreement. $5MM for exclusive right to form and enter into mutually-agreeable development and supply agreement. Biodel EZMix Genesis Global supply for proprietary Glucagon product. 15-Years. Confidential Depot-ject Global commercial supply for approved ocular drug. 10-Years. Confidential Ocu-ject Confidential. Terms not disclosed. 12 ^ Refer to relevant press releases / SEC filings for additional information

13 Preparing for Commercial Rollout to Support Customer Ramp Programs Production Facilities 160,000 sq. ft. FDA-registered manufacturing facility in York, PA 11 clean rooms over 22,000 sq. ft. supporting existing programs Installation of extra 24,000 sq. ft of cleanroom space underway Strategic partnership with Flextronics provides access to Established production sites across four continents Efficient capital investment strategy to reduce cash flow needs during scale up Manufacturing Lines Unifill prefilled syringe platform Two lines in place Two lines scheduled CY st one million units expected to be shipped by the end of CY2015 Acceleration through Wearable injector platform Existing capacity up to 1MM units Initiate procurement of highspeed line during CY2015 Scale-up in other platforms according to customer ramp schedules Supplier Relationships Relationships with a series of established material suppliers for supply of components Primary and back-up suppliers in place for Unifill, wearable injectors and other platforms Open architecture model allows Unilife and customers to select preferred component materials Ability to leverage buying power of Flextronics and customers 13

14 Upcoming Milestones Existing Agreements Continued scale-up to commercial launch Commencement of new programs with additional molecules Anticipated human clinical studies with some target molecules Additional Agreements Multiple supply agreements with new and existing customers Other Commercial and Operational Highlights Development of additional Unilife products / device categories Financial Highlights Cash receipts from sales, customization programs and milestone-based fees Potential for significant upfront fees from customers seeking exclusivity access 14