Jefferies Healthcare Conference · Business Overview 3 Design, develop, manufacture and supply...
Transcript of Jefferies Healthcare Conference · Business Overview 3 Design, develop, manufacture and supply...
Jefferies Healthcare Conference
June 1, 2015
Confidential-Unilife
Corporation
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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.
Cautionary Note Regarding Forward-Looking Statements
Business Overview
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● 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. 10 – 15 years with attractive operating margins at scale
● Business development efforts are active
54%
41%
30%
35%
40%
45%
50%
55%
60%
FY 2012 FY 2013 FY 2014 9 months to March 31,2015
R&D investment accounts for more than half of total operating expense
R&D
SG&A
Select Financial Information
4(1) Includes $2.1 M of restricted cash
RevenueCash Receipts from
CustomersEnding cash, and cash equivalents
at March 31, 2015 (1)
Quarter ended March 31, 2015 $2.9 $8.9 $39.2
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Accelerating demand for safe, simple and convenient injectable drug delivery systems
Complex Biologics
Patient Self-
Injection
Converging Market Trends
Improving Therapy
Compliance
Reducing Healthcare
Costs
Enhancing Patient
Lifestyles
Maximizing Drug Brand
Differentiation
Large, Fast Growing Market for Injectable Drug Delivery Systems
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$-
$2,000
$4,000
$6,000
$8,000
$10,000
$12,000
$14,000
$16,000
$18,000
2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
$m
Projected market growth from $4B in 2015 to $15B by 20251
Wearable injectors^
Prefilled syringes*
Auto-injectors
Reconstitution
Ocular delivery
Novel delivery
1) ^ Roots Resarch. Wearable Bolus Injectors. 2014. * VisionGain Medical Device Leader Series 2014-2024 and Company estimates.
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Our Business Strategy
Commercial Pipeline
Active Programs
Commercial Supply Agreements
• Business development
discussions are active
• Multiple potential drug
candidates / customers
• 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
• Supply agreements signed prior
to commercial launch
• 10-15 yr. duration common
• Potential for multiple supply
agreements per customer for
various drugs, indications and /
or devices
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Prefilled Syringes Reconstitution Systems Auto-Injectors Wearable Injectors Ocular & Novel Delivery Systems
Customizable, Modular Product Platforms for Injectable Biologics, Drugs and Vaccines
A Selection of Device Categories
A Selection of Devices From Various Platforms
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Prefilled Syringes For prefilled drugs, vaccines and biologics
Reconstitution SystemsFor liquid-liquid or liquid dry drug combinations
Auto-InjectorsHandheld self-injection therapies
Wearable InjectorsFor wearable self-injection therapies
Ocular & Novel Delivery SystemsFor accurate, precise delivery to the eye and other organs
Integrated Data Hubs
HIPAA authorized stakeholders such as:
• Patients
• Prescribers
• Payers
• Pharmaceutical
Integration of Drugs, Devices and Data for Therapy Adherence
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Integration of digital
connectivity into select Unilife
device platforms such as
Smart reusable auto-injectors
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
Aligned with customer programs and new commercial opportunities
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A Typical Strategic Customer Relationship
Elements of a Strategic Relationship Commercial Benefits to Unilife
• Minimizes risk for launch
• Subsequent launches can increase revenue and rate of revenue growth
Multiple shots on goal
• Model expected to support attractive operating margins over time
Minimal sales and marketing
• Supply agreements can span 10 to 15 years or more
• Minimum annual revenue anticipated during supply term
Predictable, recurring revenues
• Fees for exclusive access in disease area or indication
• Fees to customize device to specific brand requirements
Pre-Commercial
Revenue
• Customer has a multitude of biologics, drugs or vaccines in development and / or approved
Large portfolio of injectable
drugs
• Customer desires platform for efficient customization of devices to specific needs of each drug
Access to one or more Unilife
device categories
• Customer requires assurance of device supply during development and commercial lifecycle
Long-term continuity of
supply
• Customer seeks to maximize differentiation from competitors to build user preference and maximize market share
Potential Exclusivity
A Selection of Long-Term Customer Agreements
Customer Device Key Terms^
Sanofi Unifill Finesse™Global commercial supply for Lovenox®. 10-Years. $50MM aggregate payments received. Min. 150MM units / year after ramp period.
AstraZeneca / MedImmune
Wearable Injectors Global development and supply agreement. Several target biologics in MedImmune portfolio. Terms not disclosed.
Sanofi Wearable InjectorsUnilife sole provider for all applicable large dose volume drugs. Global commercial supply. 5-10 biologics anticipated. 15-Years min.
HikmaUnifill®, Unifill Nexus™, Unifill Allure™
Global commercial supply. 20 generic injectables. 15-Years. $40MM in upfront and milestone payments. Min. 175MM units after ramp.
NovartisNovel device for targeted organ delivery
Clinical development and supply. Terms not disclosed.
Global biopharmacompany
Unifill Finesse™ and LISA™ reusable auto-injector
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
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 CY2015
• 1st one million units expected to be shipped by the end of CY2015
• Acceleration through 2016-2017
• Wearable injector platform
• Existing capacity up to 1MM units
• Initiate procurement of high-speed 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
Preparing for Commercial Rollout to Support Customer Ramp Programs
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Upcoming Milestones
• Continued scale-up to commercial launch
• Commencement of new programs with additional molecules
• Anticipated human clinical studies with some target molecules
Existing Agreements
• Multiple supply agreements with new and existing customers
Additional Agreements
• Development of additional Unilife products / device categories
Other Commercial and Operational Highlights
• Cash receipts from sales, customization programs and milestone-based fees
• Potential for significant upfront fees from customers seeking exclusivity access
Financial Highlights
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