Jefferies Healthcare Conference · Business Overview 3 Design, develop, manufacture and supply...

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Jefferies Healthcare Conference June 1, 2015

Transcript of Jefferies Healthcare Conference · Business Overview 3 Design, develop, manufacture and supply...

Page 1: Jefferies Healthcare Conference · Business Overview 3 Design, develop, manufacture and supply injectable drug delivery systems Long-term strategic partnerships with pharmaceutical

Jefferies Healthcare Conference

June 1, 2015

Page 2: Jefferies Healthcare Conference · Business Overview 3 Design, develop, manufacture and supply injectable drug delivery systems Long-term strategic partnerships with pharmaceutical

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

Page 3: Jefferies Healthcare Conference · Business Overview 3 Design, develop, manufacture and supply injectable drug delivery systems Long-term strategic partnerships with pharmaceutical

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

Page 4: Jefferies Healthcare Conference · Business Overview 3 Design, develop, manufacture and supply injectable drug delivery systems Long-term strategic partnerships with pharmaceutical

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

Page 5: Jefferies Healthcare Conference · Business Overview 3 Design, develop, manufacture and supply injectable drug delivery systems Long-term strategic partnerships with pharmaceutical

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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

Page 6: Jefferies Healthcare Conference · Business Overview 3 Design, develop, manufacture and supply injectable drug delivery systems Long-term strategic partnerships with pharmaceutical

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.

Page 7: Jefferies Healthcare Conference · Business Overview 3 Design, develop, manufacture and supply injectable drug delivery systems Long-term strategic partnerships with pharmaceutical

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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

Page 8: Jefferies Healthcare Conference · Business Overview 3 Design, develop, manufacture and supply injectable drug delivery systems Long-term strategic partnerships with pharmaceutical

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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

Page 9: Jefferies Healthcare Conference · Business Overview 3 Design, develop, manufacture and supply injectable drug delivery systems Long-term strategic partnerships with pharmaceutical

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

Page 10: Jefferies Healthcare Conference · Business Overview 3 Design, develop, manufacture and supply injectable drug delivery systems Long-term strategic partnerships with pharmaceutical

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

Page 11: Jefferies Healthcare Conference · Business Overview 3 Design, develop, manufacture and supply injectable drug delivery systems Long-term strategic partnerships with pharmaceutical

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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

Page 12: Jefferies Healthcare Conference · Business Overview 3 Design, develop, manufacture and supply injectable drug delivery systems Long-term strategic partnerships with pharmaceutical

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

Page 13: Jefferies Healthcare Conference · Business Overview 3 Design, develop, manufacture and supply injectable drug delivery systems Long-term strategic partnerships with pharmaceutical

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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Page 14: Jefferies Healthcare Conference · Business Overview 3 Design, develop, manufacture and supply injectable drug delivery systems Long-term strategic partnerships with pharmaceutical

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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