form 8-k - sec€™s telephone number, including area code: (717) 384-3400 not applicable (former...

0001193125-14-413464.txt : 201411140001193125-14-413464.hdr.sgml : 2014111420141114171501ACCESSION NUMBER:0001193125-14-413464CONFORMED SUBMISSION TYPE:8-KPUBLIC DOCUMENT COUNT:19CONFORMED PERIOD OF REPORT:20141110ITEM INFORMATION:Results of Operations and Financial ConditionITEM INFORMATION:Financial Statements and ExhibitsFILED AS OF DATE:20141114DATE AS OF CHANGE:20141114

FILER:

COMPANY DATA:COMPANY CONFORMED NAME:Unilife CorpCENTRAL INDEX KEY:0001476170STANDARD INDUSTRIAL CLASSIFICATION:SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]IRS NUMBER:271049354STATE OF INCORPORATION:DEFISCAL YEAR END:0630

FILING VALUES:FORM TYPE:8-KSEC ACT:1934 ActSEC FILE NUMBER:001-34540FILM NUMBER:141225470

BUSINESS ADDRESS:STREET 1:250 CROSS FARM LANECITY:YORKSTATE:PAZIP:17406BUSINESS PHONE:(717) 384-3400

MAIL ADDRESS:STREET 1:250 CROSS FARM LANECITY:YORKSTATE:PAZIP:17406

8-K1d819668d8k.htmFORM 8-K

Form 8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 8-K

CURRENT REPORT

PURSUANTTO SECTION 13 OR 15(d)

OF THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): November10, 2014

UNILIFE CORPORATION

(Exact name of Registrant as Specified in Charter)

Delaware001-3454027-1049354

(State or Other Jurisdiction

of Incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

250 Cross Farm Lane, York, Pennsylvania17406

(Address of Principal Executive Offices)(Zip Code)

Registrants telephone number, including area code: (717)384-3400

Not Applicable

(Formername or former address, if changed since last report)

Check theappropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the Registrant under any of the following provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item2.02 Results of Operations and Financial Condition

On November10, 2014, Unilife Corporation (Unilife) issued a corrected press release announcing the financial results for the three monthsended September30, 2014. A copy of the corrected press release is attached hereto as Exhibit99.1.

During a conference call held at 4:30 p.m.U.S. Eastern Standard Time on November10, 2014, Unilifes Chief Executive Officer and Chief Financial Officer discussed the Companys results for the three months ended September30, 2014 and an update on its businesses. Theslide presentation for the conference call is attached hereto as Exhibit 99.2. A copy of the transcript of the conference call is attached hereto as Exhibit 99.3.

Because of an ongoing review of the application of the Companys critical accounting policies for the three months ended September30, 2014, theCompany previously issued a press release on November10, 2014 announcing the financial results for the three months ended September30, 2014. However, that previously issued press release was subsequently corrected and replaced. A copy ofthe previously issued press release is attached hereto as Exhibit99.4.

Item9.01 Financial Statements and Exhibits

(d) Exhibits

99.1 Press release dated November10, 2014(Corrected and replaced).

99.2 Slide presentation.

99.3Transcript of the earnings call.

99.4 Press release dated November10, 2014 (Initial, subsequently corrected and replaced).

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Report to be signed on its behalf bythe undersigned hereunto duly authorized.

Unilife Corporation

Date: November14, 2014

By:

/s/AlanShortall

Alan Shortall

Chairman and Chief Executive Officer

EXHIBIT INDEX

EXHIBIT

NUMBER

DESCRIPTION

99.1Press release dated November 10, 2014 (Corrected and replaced).

99.2Slide presentation.

99.3Transcript of the earnings call.

99.4Press release dated November10, 2014 (Initial, subsequently corrected and replaced).

EX-99.12d819668dex991.htmEX-99.1

EX-99.1

Exhibit 99.1

CORRECTING & REPLACING Unilife Corporation Announces Financial Results

For the First Quarter of Fiscal Year 2015

York, PA (November 10, 2014) Unilife Corporation (Unilife or Company) (NASDAQ:UNIS; ASX: UNS), adeveloper and supplier of injectable drug delivery systems, today announced its financial results for the first quarter of Fiscal Year 2015 ending September30, 2014.

Recent Highlights

In October, Unilife announced the signing of a worldwide Master Services and Commercial Supply Agreement with Sanofi to be the sole provider of cartridge based wearable injectors for all of Sanofis applicablelarge dose volume drugs, excluding insulins, for a minimum of 15 years. Additionally the agreement will allow Sanofi to makeUnilifeswearable injectors available to its partners for use with applicable molecules under jointcollaborations.

At the end of the first quarter of Fiscal Year 2015, Unilife had 15 active customer programs, an increase of three programs since the end of the prior quarter, across all six of its product platforms.

Revenue for the first quarter of Fiscal Year 2015 was $1.4 million. Deferred revenue was $15.6 million, which is expected to be recognized within 24 months.

Net cash used in operating activities was $13.1 million for the first quarter of Fiscal Year 2015, an increase of $3.7 million or 39% compared to the same quarter in the prior year, and a $6.9 million decrease or 34%from the fourth quarter of Fiscal Year 2014.

Subsequent to the end of the first quarter of Fiscal Year 2015, Unilife received additional cash payments from customers and a total of $20 million from OrbiMed.

During the first quarter of Fiscal Year 2015, Unilife commenced initial commercial sales of theUnifill syringe utilizing an existing commercial manufacturing line. Commercial sales of other products from the Unifill family, including the Unifill Finesse and the Unifill Nexus, are scheduled to commence during the rest of this fiscal year on additional manufacturing lines that are either in the process of being configured or are nowoperational and in the process of being qualified. Sales of other Unilife products, including wearable injectors, are also scheduled to commence this fiscal year.

Mr.Alan Shortall, Chairman and CEO of Unilife, commented: Fiscal 2015 is set to be a year of rapid growth in revenue, customers, supply agreementsand production capabilities. We look forward to continuing to generate significant growth in revenue via commercial sales, customization fees and upfront payments from a multitude of customers and active programs. In parallel, we expect to increasecapital expenditures in response to growing customer demand while moderating our investments in R&D and SG&A. We also look forward to completing a number of additional significant supply agreements.

We are on track to generate at least an additional $30 million in cash receipts from customers during the final three quarters of Fiscal Year 2015.There is significant upside potential beyond this range as we look to finalize a number of additional agreements between now and the end of the fiscal year. Mr.Shortall concluded.


250 Cross Farm Lane, York, PA 17406T + 1 717 384 3400F + 717 3843401E [email protected]W www.unilife.com

Financial Results for the First Quarter of Fiscal Year 2015

Revenue for the first quarter of Fiscal Year 2015 was $1.4 million, compared to $3.2 million for the same period in the prior year. Deferred revenue was $15.6million as of September30, 2014. The Companys net loss for the first quarter of Fiscal Year 2015 was $22.3 million, or $0.21 per share, compared to a net loss of $11.2 million, or $0.12 per share, for the same period in the prior year.Net cash used in operating activities was $13.1 million for the first quarter of Fiscal Year 2015, an increase of $3.7 million or 39% compared to the same period in the prior year, and a $6.9 million decrease or 34% from the fourth quarter of FiscalYear 2014.

Adjusted net loss for the first quarter of Fiscal Year 2015 was $15.9 million, or $0.15 per share, compared to $7.1 million or $0.08 per sharefor the same period in the prior year. Adjusted net loss excludes non-cash share-based compensation expense, depreciation and amortization, interest expense and the change in fair value of financial instruments, which is the non-cash adjustment inthe Royalty agreement liability with OrbiMed.

Unilife reported $6.3 million in total cash and restricted cash at the end of the first quarter of FiscalYear 2015. This does not include the receipt of $20.0 million funded by OrbiMed under the Amended Credit Agreement, or other cash receipts generated by customers since September30, 2014.

Conference Call Information

Management hasscheduled a conference call for 4:30 p.m. U.S. EST on Monday, November10, 2014, (Tuesday, November11, 2014 at 8:30 a.m. AEDT), to review the Companys financial results, customer partnerships and future outlook. The conference calland accompanying slide presentation will be broadcast over the Internet as a live listen-only Webcast. An archive of the presentation and webcast will be available for 30 days after the call. To listen, please go to:http://ir.unilife.com/events.cfm.

About Unilife Corporation

Unilife Corporation (NASDAQ:UNIS / ASX: UNS) is a U.S. based developer and commercial supplier of injectable drug delivery systems. Unilifes broadportfolio of proprietary technologies includes prefilled syringes with automatic needle retraction, drug reconstitution delivery systems, auto-injectors, wearable injectors, ocular delivery systems and novel systems. Each of these innovative andhighly differentiated platforms can be customized to address specific customer, drug and patient requirements. Unilifes global headquarters and state-of-the-art manufacturing facilities are located in York, PA. For more information, pleasevisit www.unilife.com or download the Unilife IRapp on your iPhone, iPad or Android device.

Forward-Looking Statements

Thispress release contains forward-looking statements. All statements that address operating performance, events or developments that we expect oranticipate will occur in the future are forward-looking statements.These forward-looking statements are based on managements beliefs and assumptions and on information currently available to our management. Our management believes thatthese 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 topublicly 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 thatcould 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 inItem1A. Risk Factors and elsewhere inourAnnual Report on Form 10-Kand those described from time to time in other reports which we file with the Securities and Exchange Commission.

Non-GAAP Financial Measures

U.S. securities lawsrequire that when we publish any non-GAAP financial measure, we disclose the reason for using the non-GAAP measure and provide reconciliation to the most directly comparable GAAP measure. The presentation



of adjusted net income (loss) and adjusted net income (loss) per share are non-GAAP measures. Adjusted net income (loss) represents net income (loss) calculated in accordance with U.S. GAAP asadjusted for the impact of share-based compensation expense, depreciation and amortization, interest expense and the non-cash adjustment in the royalty liability.

Management believes the presentation of adjusted net income (loss) and adjusted net income (loss) per share provides useful information because these measuresenhance its own evaluation, as well as investors understanding, of the Companys core operating and financial results. Non-GAAP financial measures should be considered in addition to results prepared in accordance with GAAP, but shouldnot be considered a substitute for, or superior to, GAAP results. A reconciliation of net income (loss) to adjusted net income (loss) is included in the attached table.

General: UNIS-G

Investor Contacts (US):Analyst EnquiriesInvestor Contacts (Australia)

Todd Fromer / Garth RussellLeigh SalvoJeff Carter

KCSA Strategic CommunicationsWestwicke PartnersUnilife Corporation

P: + 1 212-682-6300P: + 1 415-513-1281P: + 61 2 8346 6500



UNILIFE CORPORATION AND SUBSIDIARIES

Consolidated Balance Sheets

(unaudited)

September30,2014June30,2014

(inthousands,exceptsharedata)

Assets

Current Assets:

Cash and cash equivalents

$4,231$8,368

Restricted cash

2,0882,400

Accounts receivable

4,6461,860

Inventories

147142

Prepaid expenses and other current assets

8801,108

Total current assets

11,99213,878

Property, plant and equipment, net

56,40854,588

Goodwill

10,98711,830

Other assets

1,3571,472

Total assets

$80,744$81,768

Liabilities and Stockholders Equity (Deficit)

Current Liabilities:

Accounts payable

$6,157$3,583

Accrued expenses

3,7113,339

Current portion of long-term debt

591613

Deferred revenue

1,090717

Total current liabilities

11,5498,252

Long-term debt, less current portion

57,32254,835

Deferred revenue

14,55012,550

Total liabilities

83,42175,637

Stockholders Equity (Deficit):

Preferred stock, $0.01 par value, 50,000,000 shares authorized as of September30, 2014; none issued or outstanding as ofSeptember30, 2014 and June30, 2014

Common stock, $0.01 par value, 250,000,000 shares authorized as of September30, 2014; 109,531,507 and 103,617,278 shares issued,and 109,502,837 and 103,558,608 shares outstanding as of September30, 2014 and June30, 2014, respectively

1,0951,036

Additional paid-in-capital

310,399296,169

Accumulated deficit

(315,993)(293,731)

Accumulated other comprehensive income

1,9622,797

Treasury stock, at cost, 28,670 shares as of September30, 2014 and June30, 2014

(140)(140)

Total stockholders (deficit) equity

(2,677)6,131

Total liabilities and stockholders equity (deficit)

$80,744$81,768




Consolidated Statements of Operations

(unaudited)

Three Months Ended
September30,

20142013


Revenue

$1,380$3,187

Research and development

10,9766,399

Selling, general and administrative

8,2006,520

Depreciation and amortization

1,1001,042

Total operating expenses

20,27613,961

Operating loss

(18,896)(10,774)

Interest expense

1,109480

Change in fair value of financial instruments

2,230

Other expense (income)

27(10)

Net loss

$(22,262)$(11,244)

Net loss per share:

Basic and diluted net loss per share

$(0.21)$(0.12)




Reconciliation of Non-GAAP Measure

(unaudited)

ThreeMonthsEnded
September30,

20142013


Net loss

$(22,262)$(11,244)

Share-based compensation expense

1,8882,636


1,1001,042

Interest expense

1,109480


2,230

Adjusted net loss

$(15,935)$(7,086)

Adjusted net loss per share diluted

$(0.15)$(0.08)



EX-99.23d819668dex992.htmEX-99.2

EX-99.2

Confidential-Unilife CorporationConfidential-Unilife CorporationNovember 10, 2014Earnings CallFirst Quarter of Fiscal Year 2015Exhibit 99.2

Confidential-Unilife CorporationConfidential-Unilife CorporationNovember 10, 2014Thispresentation contains forward looking statements under the safe harbor provisions of the US securities laws. These forward-looking statements are based onmanagements beliefs and assumptions and on information currentlyavailable to our management. Our management believes that theseforward-looking statements are reasonable as and when made. However youshould not place undue reliance on any such forward looking statements asthese 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

Confidential-Unilife CorporationConfidential-Unilife CorporationOur Quantum ShiftAn aspirational discussionA focused discussion on cornerstone deals

Prospective deals

Investment in R&D and business expansion

Executed agreements

Already generating revenue

Commercial Supply Agreement with Sanofi15-Year Master Services and Commercial Supply Agreement Unilife to be the sole provider of wearable injectors for use with all of Sanofis applicable large dose volume drugs(excluding insulin)Sanofihasnon-exclusiveaccesstoUnilifeswearableinjectorsCollaboration to develop other new technologiesfor the delivery of large dose volume biologicsUnilife estimates that Sanofi has between 5 to10 molecules that will be delivered in wearable injectors*Some drugs are expected to be approved for multiple indicationsIt is estimated that each wearable injector drugwill require anominal 5MM units a year on average* Typical commercial ASP for wearableinjectors $25-35* 4*Basedonpublicinformation&industryforecasts.ProducthasnotyetbeenevaluatedbytheFDA.

Confidential-Unilife CorporationGenerating Revenue from Sanofi agreementUpfront paymentUnilife received an upfront payment from SanofiCustomization paymentsUnilife to receive milestone-based payments to customize its wearable injectors to customer requirements for each applicable drug / indicationEach program expected to generate payments during the customization period. First programs expected to start this fiscal year. Average program length 18months to three years. Unilife anticipates approximately $50MM fromcustomization programs relating to Sanofi molecules and indications* Incremental revenue anticipated via any customization programs under joint collaborations between Unilife and participating Sanofi pharmaceuticalpartners*. Device SalesVolume-based pricing for pre-clinical, clinical and commercial productsInitial sales for clinical and pre-clinical use expected this fiscal yearAverage expected commercial lifecycles for applicable drugs 12 to 15 years5* Based upon number of estimated Sanofi programs,

MedImmune AgreementThe global biologics R&D arm of AstraZenecaLong-term commercial supply agreementUnilife to customize and supply devices from its platform of wearable injectors for use with target MedImmune molecules Several drugs may be selected for use with Unilife's wearable injectorsSome drugs may ultimately be approved for more than one indicationUnilife selected after an extensive evaluation processCustomization programs underway

Confidential-Unilife CorporationSupply Agreements for the Unifill platform7The deal with Unilife will bring added value to our customers, reinforcing the safety aspects of a performing device looking at reducing the risk of needlestick injuries. Sanofi has kept evolving with cutting edge technology for delivering its products. This deal demonstrates an evolution in safety device syringesSanofi spokesman Frederic Lemonde*Thisagreementsupportsourstrategyofdevelopinghighervalue products.WelookforwardtoleveragingUnilifesinnovative platformtodifferentiateourinjectableproducts,strengthenour competitivepositionandincreaseourmarketshare..Thelong-termagreement.willimprovesafetyandestablishamore sustainablelong-termcompetitivepositionintheU.S.SaidDarwazah,CEOofHikmaSanofi for Unifill FinesseHikma for Unifill platform*www.in-pharmatechnologist.com/Drug-Delivery/Sanofi-Inks-Deal-for- Prefilled-Syringes-with-Unilife

Incremental GrowthCommercial Supply Contracts-Sanofi (wearable injectors)-Medimmune (wearable injectors)-Sanofi (Unifill Finesse)-Hikma (Unifill, Nexus, Allure)Active Customer Programs-15 (up from 12 last quarter)Commercial Pipeline-Multiple pharmaceutical and biotech companies-Multiple approved and pipeline drugs and indications per customer-Multiple therapy areas per platform-Many customers seeking multiple Unilife products in parallelA Large, Rapidly Growing Commercial Pipeline8

Confidential-Unilife CorporationScaling Up Manufacturing CapacityFigure 1 Segments of the Manufacturing Process for Wearable Injector Primary Drug ContainersFigure 2 Wearable Injector Primary Drug Containers and Integrated Fluid PathFigure 3 Demonstration of Unilife products being filled9

Confidential-Unilife CorporationIncreasingRevenue.NarrowingourLoss.Continue to strengthen revenue outlook for FY15 and beyondInitial commercial sales commenced, and expected to accelerateIncreasing number of active customer programs supports increasedrevenue from upfront fees and milestone-based customization paymentsOn track to generate at least $30 million in cash receipts from customers during the final three quarters of Fiscal Year 2015. Significant upside potential via signing of additional agreements this fiscal yearExpect to continued to narrowing of our loss Moderating R&D investment and SG&AGradual increase in capital expenditure 10

Confidential-Unilife CorporationConfidential-Unilife CorporationNovember 10, 2014Questions11

Confidential-Unilife CorporationConfidential-Unilife CorporationNovember 10, 2014Final Comments

EX-99.34d819668dex993.htmEX-99.3

EX-99.3

Exhibit 99.3

Unilife Corp (NASDAQ:UNIS)

Q1 2015 Results EarningsConference Call

November10, 2014, 4:30 pm ET

Executives

Todd Fromer - Managing Partner at KCSAStrategic Communications

Alan Shortall - Chairman of the Board, Chief Executive Officer

Dennis Pyers - Interim Chief Financial Officer, Chief Accounting Officer, Vice President, Controller

Ramin Mojdeh - President, Chief Operating Officer

Analysts

Raj Denhoy - Jefferies

Danielle Antalffy - LeerinkPartners

Jeffrey Cohen - Ladenburg Thalmann

Keith Markey- Griffin Securities

Operator

Good day, ladies andgentlemen, and welcome to the Unilife Corporation first quarter fiscal 2015 earnings call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time.(Operator Instructions).

I would now like to introduce your host for todays conference, Mr.Todd Fromer, Managing Partner at KCSA StrategicCommunications. Please go ahead.

Todd Fromer - Managing Partner at KCSA Strategic Communications

Good afternoon, everyone, and good morning to our Australian supporters. Thank you for joining us for the Unilife Corporation fiscal 2015 first quarterconference call. We thank you for your patience.

Before we begin today, I would like to remind everyone that this conference call containsforward-looking statements. All statements that address operating performance, events or developments that we expect or anticipate to occur in the future are forward-looking statements.

These forward-looking statements are based on managements beliefs and assumptions and not 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 suchforward-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 orotherwise, except as required by law.

In addition, forward-looking statements are subject to certain risks and uncertainties that could cause actualresults, 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 Item1A, Risk Factors, andelsewhere in our Annual Report on Form 10-K and those described from time-to-time in other reports which we file with the Securities and Exchange Commission.

During this call, we may also present certain non-GAAP financial measures such as adjusted net loss and certain ratios that use these measures. In our pressrelease with the financial tables issued earlier today which is located on our website at unilife.com, you will find our definition of these non-GAAP measures or a reconciliation of these non-GAAP financial measures with the closest GAAP measuresand a discussion about why we think these non-GAAP measures are relevant. These financial measures are included for the benefit of investors and should be considered in addition to and not instead of GAAP measures.

With nothing further, I would now like to turn the call over to Mr.Alan Shortall, Chairman and Chief Executive Officer of Unilife Corporation. Alan, thefloor is yours.

Alan Shortall - Chairman of the Board, Chief Executive Officer

Thank you, Todd. Good afternoon and good morning to those dialing in from Australia. Joining me on the call today is our President and Chief OperatingOfficer, Dr.Ramin Mojdeh and our CFO, Dennis Pyers.

Firstly, let me tell you, I am sorry that we got to start a few minutes late today, and youwill see that we are refilling the press release that we let out earlier, as we have decided to take a conservative approach to amortizing a milestone payment of $2 million from a customer, and the updated press release reflects this decision. Andyou are going to expect to see out 10-Q filed later this evening.

We have been though a quantum shift in our business over the last 18 months. Back then,our entire dialogue was about the opportunity before our company based upon prospective deals within our commercial pipeline. Since then, we have transformed our aspirations into reality. Today, our discussions about the multiple cornerstonecommercial supply deals we have already executed.

Each one of these deals can sustain a company on its own. They have already started to generate revenue. Thisrevenue will accelerate as each nears the final stage of commercial supply. The dramatic increase in our revenue in financial year 2014 over financial year 2013 was the leading edge of the monetization of these long-term customer relationships. Ouranticipated revenue growth in financial year 2015 over financial year 2014 will continue to demonstrate our accelerated growth trends.

I am now going todiscuss the latest of these deals, namely the wearable injector supply agreement with Sanofi. This supply agreement with Sanofi is unprecedented. It is arguably the largest and longest supply agreement ever done in our industry. We will supply ourwearable injectors to Sanofi for use with all of their applicable pipeline drug needs, excluding insulins, for the next 15 years at a minimum. Unilife will be the sole supplier of wearable injectors to Sanofi, while we will supply our devices toSanofi on a nonexclusive basis.

The size and scope of the agreement reflects the industry trend towards modular device platforms that can broadly therapyneeds of a multitude of drugs and indications in a customers pipeline. Modular device platform solutions are our specialty. Indeed, we lead the market. Based on publicly available information, Sanofis portfolio includes a significantnumber of drugs that will likely require large dose volume delivery and consequently be delivered with wearable injectors.

Such drugs often target andare eventually approved for multiple indications, which means there is more than one disease or treatment for which it can be used. Again, based upon public information and the industry forecasts, it is estimated that from among 16 such drugs inSanofis pipeline and a net of the anticipated attrition during clinical development, that between five to 10 of them will reach commercialization and be delivered in wearable injectors. With additional indications factored in, the total numberwill most likely be higher.

There is significant upside to this agreement. As one example, Sanofi will make our wearable injectors available to theirpharmaceutical partners for use with applicable molecules under joint collaborations. These partners molecules are incremental to those in the Sanofi pipeline. So the formalization of agreements with any of Sanofis partners will generateincremental value.

For those of you who are wondering how to think about the Sanofi wearable injector agreement, we would like to reiterate someinformation included in the press release. We will also use some other reasonable standard industry assumptions without getting into any confidential information specific to this agreement. In addition to an upfront payment from Sanofi, we willreceive revenue during the customization and commercial sale of our wearable injectors for use with each target drug.

We will first talk about commercialsales to be generated after the regulatory approval of a therapy with our wearable injectors. As I said earlier, we expect between five and 10 applicable Sanofi molecules will be approved with our wearable injectors. Based upon conservative industryassumptions, the average molecule at commercial volumes is expected to require a nominal five million wearable injector units per year. It might take an average of three years for a drug to reach peak commercial volumes after its approval andlaunch.

We would then expect recurring sales revenue year-after-year for the commercial lifecycle of the therapy.Typically the commercial lifecycle of such molecules is between 12 to 15 years. This reflects the long-term nature of our agreement with Sanofi and our annuity like business model.

Each new indication that is approved for a molecule will increase total unit volumes. Typically a wearable injector will sell for a range between $25 and $35.However, depending upon factors such as the level of customization required to address specific needs for a target drug, pricing for a wearable injector can go significantly higher.

Prior to the market launch of our wearable injectors, we will also be receiving revenue from customization programs to address the specific needs of eachdrug, as well as the sale of clinical and preclinical devices. We expect to generate approximately $50 million in revenue from customization programs across the five to 10 target drugs that are expected to use our wearable injectors.

It can be assumed that this total customization revenue will be spread over the first five to 10 years of the agreement. Sales of clinical and preclinicaldevices will be in addition to revenue we generate from associated customization programs. These devices will be supplied to support activities such as testing and clinical trials. We expect this phase of sales to Sanofi will commence during thecurrent fiscal year.

An average program to customize and commercialize a device from our wearable injector platform is between 18 months and three years.Preclinical and clinical unit volumes during this period could typically range between 10,000 units and 100,000 units per program. The ASP for each device sold during this period will be significantly higher than for peak commercial volumes. Wetherefore expect to generate meaningful revenue before we reach the final stage of commercial supply.

So in summary, thats an estimated five to 10biologics, five million units per year per drug, an ASP per device of $25, exclusive supply for all applicable drugs over a minimum of 15 years plus additional meaningful revenue from customization programs and preclinical and clinical device sales.We think when you put all this together it would be helpful to better understand the long-term value of our wearable injector deal with Sanofi.

Inaddition to Sanofi. Unilife signed another similar supply agreement for its wearable injectors with a global pharmaceutical company last year. As some investors may have missed the magnitude of this deal when it was first announced, let mereintroduce it to you. This commercial supply agreement was with MedImmune, the biologics arm of AstraZeneca. Its a long-term partnership to customize and supply our platform of wearable injectors for use with applicable drugs acrossMedImmunes portfolio.

Also like Sanofi, there are several injectable molecules in MedImmunes portfolio being targeted for use with wearableinjectors. Some of these molecules may also end up having more than one indication. This partnership with MedImmune is progressing well. Customization programs are well underway, and while there are differences between the Sanofi and MedImmunedeals, there are many similarities between the two arrangements and we hope these details can help you to better understand our long-term wearable injectors supply agreement with MedImmune.

In the category of prefilled syringes, we have all designed two long-term supply agreements that are largecornerstone deals. As a reminder, I will give you a brief summary. The first is a long-term supply agreement with Sanofi for the use of our Unifill Finesse syringe with Lovenox, the largest selling approved prefilled drug in the world. This is acontract that can extend up until 2024, with a minimum 150million units per year to be purchased after a four year ramp plan.

The second is withHikma, a fast-growing leader for generic injectables who will be using multiple Unifill products with at least 20 of their injectable therapies. Hikma will purchase a minimum 175million units per year after the initial ramp plan.

These two supply agreements for our Unifill platform are already generating revenue for Unilife. As combination products reach the market, they are alsoexpected to accumulate significant revenue growth.

Now that we have discussed the supply agreements that we have already executed and are generatingincreasing revenue, let we also make a few comments about other similar deals in the pipeline that we are working on. In addition to Sanofi and MedImmune, there are several other wearable injector programs that are either already underway or aboutto commence. We expect many of these programs will also accumulate in long-term supply agreements.

The average customers have between several to a dozenor more molecules in their pipeline that will require wearable injectors. Many of these drugs will end up having more than one indication. So you should not be surprised if some of these upcoming agreements are of similar magnitude to those we havealready signed. Some may even be greater in size.

Likewise, we expect to sign additional cornerstone deals in all other areas of our product portfolio.These additional agreements and strategic partnerships will relate to products, including our Unifill prefilled syringes, auto-injectors, drug reconstitution delivery systems and ocular delivery systems. An early indication of the large and rapidlygrowing nature of our commercial pipeline is represented in the number of active customer programs that are now underway.

As of this quarter, there are15 active customer programs generating initial revenue. This is an increase of three from the dozen active programs that were underway last quarter. Additional customer programs are scheduled to commence through each additional quarter of thisfiscal year. We consider these programs to be a leading indicator of future supply agreements. We expect that some of these agreements could be of a similar magnitude to the deals already signed to-date.

We continue to expand the production capacity and scale up capability of our product portfolio to support increasing demand for our products and services.This is being done in conjunction with a number of established global industry partners. For wearable injectors, our current GMP capacity is up to one million units per year. Much of this capacity is pre-reserved or pre-sold to our wearable injectorcustomers. We expect revenue generated from our wearable injector platforms over the next 18 to 24 months will be meaningful.

In regards to our Unifill platform, we commenced initial commercial supply of the Unifill syringe in the firstquarter of fiscal year 2015. Initial commercial supplies of two additional products will commence during the rest of this fiscal year. While these initial commercial volumes are relatively small, they will scale up over the next 12 to 24 months.

Based upon the minimum unit volume requirements under the agreement with Sanofi and Hikma alone, we are scaling up over the next few years to have amanufacturing capacity of at least 400million Unifill syringes per year. Additional demand is projected from other customer seeking access to our Unifill platform of prefilled syringes. We have multiple additional assembly lines at variousstages of order, installation and assembly to support the scheduled ramp in customer demand.

Much of this capacity has been pre-reserved or pre-sold forexisting customers. We are also expanding production by capacities for other platforms across our portfolio. We expect to share more about this expansion of our manufacturing capabilities in the near future.

I would now like to hand the call over to Dennis to review our financial results.

Dennis Pyers - Interim Chief Financial Officer, Chief Accounting Officer, Vice President, Controller

Thank you, Alan. Revenue for the first quarter of fiscal year 2015 was $1.4 million compared to $3.2 million for the same period in 2014. Deferred revenue was$15.6 million as of September30, 2014. This deferred revenue is expected to be recognized over the next 24 months.

Our operating expenses for thequarter were up $6.3 million or 45% compared to the same quarter in fiscal year 2014. This reflects the growth in our business and the increased investment in R&D that we are making as we continue to deliver on our customer programs. Operatingexpenses excluding non-cash items during the current quarter decreased by $1.2 million or 6%, as compared to the most recent quarter ended June30, 2014 as we moderated our investment in R&D.

Our cash used in operating activities was $13.1 million for the three months ended September30, 2014, compared to $9.4 million in the same period in2013. This also reflects the growth of our business in delivering on the many customer programs we have in place. Our cash used in operating activities in the current quarter decreased by $6.9 million or 34% compared to the most recent quarter endedJune30, 2014, reflecting the moderation of our investment in R&D during the for the current quarter.

For the current quarter endedSeptember30, 2014, our cash invested in purchases of property, plant and equipment was $3.6 million, which decreased by $5.2 million or 59% as compared to the most recent quarter ended June30, 2014 as we had accelerated purchases duringthe prior quarter in response to anticipated demand from customer programs that were pulled forward.

The companys net loss for the three months ended September30, 2014 was $22.3 million or $0.21 pershare, compared to a net loss of $11.2 million or $0.12 per share for the same period in 2013, and compared to a net loss of $15.3 million or $0.15 per share for the previous quarter ended June30, 2014. Adjusted net loss for the three monthsended September30, 2014 was $15.9 million or $0.15 per share, compared to $7.1 million or $0.08 per share for the same period in FY 2013, and compared to $11.7 million or $0.12 per share for the previous quarter ended June30, 2014.

The adjusted net loss excludes non-cash share-based compensation expense, depreciation and amortization, interest expense and the change in fair value offinancial instruments. The change in the fair value of financial instruments is related to the royalty agreement liability with OrbiMed and is adjusted to fair value on a quarterly basis as a non-cash item to the statement of operations. Also, inrelation to OrbiMed, based on cash receipts to-date and anticipated customer payments during the calendar year 2014, we are confident of satisfying applicable covenants under our debt financing.

Unilife reported $6.3 million of total cash and cash equivalents, including restricted cash as of September30, 2014. This does not reflect a receipt of$20 million of additional proceeds from our term-loan with OrbiMed received after September30, 2014 as well as additional cash from customers that has been collected since the end of the quarter.

Alan, back to you.

Alan Shortall - Chairman ofthe Board, Chief Executive Officer

Thank you, Dennis. As we receive increasing levels of customer demand for our products and services, we continue tostrengthen our revenue outlook for fiscal year 2015 and beyond. Revenue being generated by Unilife now includes commercial sales. While initial sales per quarter are relatively small, it will progressively become a more significant share of totalrevenue through financial year 2015, 2016 and 2017.

In parallel, we expect meaningful revenue growth in upfront payments and milestone-based fees fromexisting and new customer programs during fiscal year 2015. Compared to commercial sales, this revenue will be relatively lumpy on a quarter-to-quarter basis due to the timing of milestones. We are on track to generate at least an additional $30million in cash receipts from customers during the final three quarters of fiscal year 2015. There is significant upside potential beyond this range as we look to finalize a number of additional new agreements between now and the end of this fiscalyear.

As we continue to increase revenue, we also look forward to the continued narrowing of our loss at an attractive trend. In this regard, we aremoderating R&D investment as well as SG&A. In parallel, we expect to steadily increase our investments in CapEx. This fiscal year should be about double last year. We expect to continue in that ramp until we level off at approximately $20million a year in the 2016 to 2017 timeframe. Additional agreements may see that number increase.

In summary, we continue to execute in all areas. Year-on-year revenue will increase. Losses will narrow. Saleswill accelerate. Production capacities will expand. Deals will continue.

And with that, I would like to open the call up to questions. Over to you,operator.

Question-and-Answer Session

Operator

(Operator Instructions). Our first question comes from Raj Denhoy from Jefferies. Your line is open.

Raj Denhoy - Jefferies

Well, hi, good evening.Wanted to actually just ask kind of a basic accounting question which I am still struggling a little bit is that you are generating commercial revenue at this point with the implication being you are selling product to your customers and yet youhave recognized any cost of goods against that. And I guess I am just curious how that accounting works? And I do have a couple of follow-ups as well. Thats just

Alan Shortall - Chairman of the Board, Chief Executive Officer

Sure.

Dennis Pyers - Interim Chief FinancialOfficer, Chief Accounting Officer, Vice President, Controller

Sure, Raj. Yes, at this point in time, the cost of product sales are really part of ourR&D expenses, as those items have been purchased as part of those programs and as our commercial product sales ramp off and become more meaningful, we will account for those as a traditional cost of product sales and we will see that developover the course of this fiscal year.


Okay. So at this point, its really still to think about those as really more research and development type of sales in a sense, and thats whatthey are being used for by your customers at this point for their development work.

Dennis Pyers - Interim Chief Financial Officer, ChiefAccounting Officer, Vice President, Controller

No. I would say thats how the items were purchased under those programs as they were put in place.As you will recall, a lot of our agreements have the development period and then move into a supply agreement. So as we shift over to commercial sales, we will start accounting for those purchases of materials and other items as normal inventory andnot as part of the R&D expenses. But for the current items that were using, they were purchased under our R&D expenses.


Okay. Dennis, on the cash, its encouraging to hear you still confident that $30 million in cash receipts over the balance of the year. I guess I amcurious if you could maybe articulate in which programs are you expecting to receive those from? Or anything more you can give us in terms of where that is going to be coming from?

Ramin Mojdeh - President, Chief Operating Officer

Yes, Raj, this is Ramin Mojdeh. I dont really want to give a lot of details on that. This would span across a number of programs that are already inplace and we have announced a number of them as you know and there are a number of new programs that we anticipate commencing over balance of this year, all of which will generate cash receipts for us.


Okay and just my lastquestion is just a follow-up on the huge program with Sanofi. The original Sanofi deal for Lovenox and the Hikma deal as well, both of those have pretty significant minimum commitments, but there is this ramp up period to get to those commitmentsand I am curious just if there is anything you can give us in terms of where we are? Have we started up that ramp in each of those? Or are we on the ramp?


So that ramp that we are talking about would begin around when you see the combination products. That is the drug in our device. It already has a market. Sothat would be the initial part of the ramp. And depending on what the drugs are and what that strategy is by Sanofi and Hikma, we are going to see that ramp obviously accelerate. We cant really comment on how long that ramp will be, but weanticipate that the uptake for these products will be swift and significant and we are optimistic about the ramp being relatively short.

RajDenhoy - Jefferies

But anything you can give us in terms of where we are, in terms of the stability testing or development work thatsnecessary to bring the products on the Unifill delivery devices? How long it will take to do the upfront work that you can begin to experience that ramp, if thats the right way to put it?


Sure, Raj. You know, I cant really speak for the customer and provide information on their programs as stability and those kinds of activities and theregulatory process are really led by our customers. But I can tell you, when you look at the blended picture, you can see the beginning of that ramp significantly and meaningfully in 2016 and beyond.


Okay. Thats helpful. Thank you.

AlanShortall - Chairman of the Board, Chief Executive Officer

Thank you, Raj.

Operator

Thank you. Our next question comes fromDanielle Antalffy with Leerink Partners. Your line is open.

Danielle Antalffy - Leerink Partners

Thanks so much. Good afternoon, guys and thanks for taking the question. Alan, a great job on controlling costs in the quarter, getting that cash burn ratedown. Just wondering how to think about that going forward? Obviously now you guys have $26 million or so, I guess, on the books the including the OrbiMed. You expect at least $30 million in cash receipts for the remainder of the year. So I was justwondering where we should have that cash burn sort of sitting as we look out over the next few quarters? And where is it coming from as well?

AlanShortall - Chairman of the Board, Chief Executive Officer

Well, of course, December30 seems like a long time ago to now. So itsobviously historical. We have had customer receipts since then and the $20 million thats coming from Sanofi. But I think you can typically see, you know, what we have been in terms of our cash loss is going to be reduced as we go forward asrevenue increases. And I think you will continue to see that trend. And as I said in the call earlier, compared to commercial sales, which will kick in as we go into their calendar year 2015, the revenue will be relatively lumpy be on aquarter-to-quarter basis, due to the timing of these milestones and the recognition of them. But the key thing is, that we are on track to generate at least an additional, as I said, at least an additional $30 million in cash receipts from customersand these are programs which are already committed to.


Okay. Thats helpful. And then, wondering on as far as margins go for some of these deals, I know we have talked in the past about 40%-ish operatingmargins for the business across all the products on average. So I guess, I am just wondering, how you guys are viewing, where you need to be from a volume perspective to get cash flow breakeven or net breakeven actually, given the contracts, the 15deals that you have already signed, appreciating that the Sanofi wearable injector deal isnt likely to kick in, from a commercial perspective, for some years, but you are starting to generate accelerating commercial sales now today. So justsort of how do we think about that and operating margins on the deals you have today?


Sure. In terms of the operating margins, obviously, I think thats the blended operating margin that we have talked about which is 40% or north of thatand we anticipate achieving that in the 2018 to 2020 timeframe. We certainly will be approaching that prior to that and we certainly cross that threshold in that timeline we fully anticipate.

In terms of cash flow breakeven and positive, again please understand that our strategy has always been to invest in the growth of the company. We arecurrently investing in what will drive our growth in the five to seven year period. And we have been very happy with the results that we gotten in terms of the outcome of our pipeline and the traction that we have had from our customers and webelieve that thats a great investment for the future of our company.

On this current trend and with the current strategy and by the way, having nowmoderated the R&D investment as we have said in the past quarter, because we now believe that we have achieved critical mass, I anticipate crossing that threshold in the 2018 to 2020 timeframe, probably earlier in that period than later. Andthat is essentially where I anticipate that our revenue and our gross margins and that curve will cross essentially our cash burn in that time period, including the CapEx that we anticipate reinvesting.


Danielle, if I can just add to that. Thank you, Ramin. The reason why we can generate such attractive operating margins, expected north of 40% blended isbecause its really the uniqueness of our business model and the annuity type of business that it is. Such as with the agreement with Sanofi for a 15 year contract, our sales and marketing costs are pretty much negligible. We have got that dealin the back pocket now. But I just want to reiterate, we will never rely on the contractual obligation of our customers and accept that we have that 15 years just locked in. We will continue to outperform our customers expectations andthats how we will continue to grow our business. But the operating margins can be rather attractive because of the uniqueness of our business model.


Okay.Thanks, guys.


Thank you, Danielle.

Alan Shortall - Chairman ofthe Board, Chief Executive Officer

Thank you, Danielle.

Operator

Our next question comes from Jeffrey Cohen with Ladenburg Thalmann. Your line is open.

Jeffrey Cohen - Ladenburg Thalmann

Hi, Alan,Dennis, Ramin. How are you?


Hi, Jeffrey. How are you?

Jeffrey Cohen -Ladenburg Thalmann

I am doing fine. I guess I wanted to circle around perhaps to some of the initial questions that Raj asked. So firstly, the $30million in receipts is not necessarily a revenue recognition. So as you are recognizing over 24 months, you anticipate about 38% of that to hit the revenue line? Is that accurate?

Dennis Pyers - Interim Chief Financial Officer, Chief Accounting Officer, Vice President, Controller

Jeff, I dont think we are going to get into the revenue recognition and those numbers. We will not going to provide guidance. But again, I mean I willjust take that comment on face value that we anticipate that amount in cash receipts and thats a conservative estimate at this time.

JeffreyCohen - Ladenburg Thalmann

Okay. Got it.


And I want to also reemphasize what Alan said earlier, and that is that, please understand that for some time until we have the most significant part of ourrevenue from commercial sales for some time this revenues is going to be lumpy from quarter-to-quarter.


Got it. Okay, and secondly if you could comment a little bit, if you could talk about the capacity and the anticipated throughput as far as some of thevolumes that you had spoken about earlier? If you could talk about perhaps the Finesse and Unifill, what that might look like over by the end of fiscal 2015 or by the end of fiscal 2016? If you could talk about the wearable injectors? Are we talkingabout thousands or tens of thousands of injectors by the end of 2015? And in the same line for Finesse or Unifill, you know what types of a range of volumes can we anticipate?


Yes, Jeff. I can give you some minimums. And the minimums that I give you is based on commitments that we already have with customers. And some of the mathfollows the material that we have disclosed from the press releases. But in terms of the volumes, in terms of prefilled syringes, I would put that number in the timeframe that you mentioned, say be the end of 2016 around 400million units, ifnot higher. And I will also put the capacity for wearable injectors in the order of three to five million units in that timeframe. And we have a number of other products that we are also ramping up and as customer demand firms and as the clinicaldevelopment nears completion, we will be discussing those more openly and we will be discussing more regarding the capacity of those products as well.


Okay. Ramin,if you can give me just a better sense of that, you think that not total production, but the capacity by, say, the end of fiscal 2016, which is seven months away could be on the order of an annualized rate of 400million units? Is that how Ishould think about it?


Well, fiscal 2016 as a little later than seven months away. Thats probably a year and seven months away. Maybe I misheard you.


So fiscal endof 2015, which would be nine months.


Yes, you know I will just say, between now and in the 2016, 2017 timeframe ramp, we are steadily ramping up to those numbers. I cant delineate for youas to exactly what that number is going to be at the end of this year or in a certain number of months from now. Those are significant capacities that we bring online in big chunks. But I can tell you that that ramp is going to continue toaccelerate and in the timeframe of 2016, 2017, you are going to see those capacities installed.


Okay. So just to clarify the numbers you are talking about, would be annualized capacities.


Yes.


As an example. Okay. And just one more question for me. So could you tell us now as far as the facility, whattypes of lines are running and what types of line are operational, whether manual, whether automated and for both syringes and injectors or any other platforms that you have?


Well, we have lines operating in across all of the product platforms and product lines that we have and they are at various stages of scaling. Today, in ourplant, you will see a number of automatic lines that are manufacturing different prefilled syringes in the Unifill prefilled syringe family. You would also see lines with significant capacity as we mentioned earlier, a million units plus in thewearable injectors and this is across all the different components of it, including primary containers and also the devices as well and again other products that we are also ramping up. But those are two areas that you would see significant scale upas we speak in our plat today.


And Jeff, I would like to add to that as well, that with the one million , up to the million unit capacity for wearable injectors at the moment, bear in mindthat the selling price for those for clinical trials, et cetera. is in the hundreds of dollars. Soviet that can generate significant revenues.


Got it. Okay.Guys, thanks for taking my questions.


Thank you, Jeff.

Alan Shortall - Chairman of theBoard, Chief Executive Officer

Thank you.

Operator

Thank you. Our next question comes from Keith Markey with Griffin Securities. Your line is open.

Keith Markey - Griffin Securities

Hi. Thank youfor taking my questions. Just a couple. I was wondering if you could remind us of the size of the upfront payment that you got from Sanofi? And how you are going to recognize that?


Hello, Keith. We have not disclosed the fees that we have received from Sanofi and those are confidential. Andsuffice it to say that those fees will become accounted appropriately, amortized over the length of the agreement.

Keith Markey - GriffinSecurities

So that will be 15 years.

RaminMojdeh - President, Chief Operating Officer

Well, I dont have the accounting in front of me. I dont remember exactly if thatsgoing to be amortized over the development period versus the supply period. But its going to be amortized appropriately according to the most conservative accounting standards.


Okay. Thanks.


But, Keith, if I can add and that most importantly, is that the cash is coming in now. So for me, thats the most thing.


Yes, cash inhand is good.


Yes.


And then secondly, I was just wondering, you mentioned very clearly that you are going to have at least $30 million coming in this next three quarters and Iwas wondering if you could remind us what the revised OrbiMed agreements covenants are pertaining to cash receipts specifically for calendar 2015?


The covenants on the amended agreement with OrbiMed is, I believe, $20 million by the end of December31 cash receipt.


Thats correct.


And its the same. It hasnt been changed for 2015 calendar year, except its just been broken in two pieces, $20 million by June30 and thenthe balance by the end of the year. We have already basically got $18 million of the $20 million for this year, and we are very confident we will have no problem with those covenants.


Okay. Thankyou very much.


Okay. Thank you, Keith

Operator

Thank you. I am showing no further at this time. I would like to turn it back over to management for any closing remarks.


Yes, thank you, everybody. I just want to clarify something in relation something we said earlier about cash flow positive potentially between 2018 to 2020.This always a choice on our part. As we invest heavily in supplying and signing contracts with our pharmaceutical customers and building an unassailable position in the drug delivery business, we will make that choice as we go forward. But I believethat those dates are very conservative. So before we end the call, I would like to take this final opportunity to remind eligible shareholders that our Annual General Meeting will be held in New York this Thursday afternoon. While voting inAustralia has now closed, we encourage holders of common stock to vote on favorable resolutions before the deadline. Thank you.

Operator

Ladies and gentlemen, thank you for participating in todays conference. This does conclude todays program. You may all disconnect. Everyone have agreat day.

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EX-99.45d819668dex994.htmEX-99.4

EX-99.4

Exhibit 99.4

INITIAL PRESS RELEASE, SUBSEQUENTLY

CORRECTED AND REPLACED

Unilife Corporation Announces Financial Results

For the First Quarter of Fiscal Year 2015

York, PA (November 10, 2014) Unilife Corporation (Unilife or Company) (NASDAQ:UNIS; ASX: UNS), adeveloper and supplier of injectable drug delivery systems, today announced its financial results for the first quarter of Fiscal Year 2015 ending September30, 2014.

Recent Highlights

In October, Unilife announced the signing of a worldwide Master Services and Commercial Supply Agreement with Sanofi to be the sole provider of cartridge based wearable injectors for all of Sanofis applicablelarge dose volume drugs, excluding insulins, for a minimum of 15 years. Additionally the agreement will allow Sanofi to makeUnilifeswearable injectors available to its partners for use with applicable molecules under jointcollaborations.

At the end of the first quarter of Fiscal Year 2015, Unilife had 15 active customer programs, an increase of three programs since the end of the prior quarter, across all six of its product platforms.

Revenue for the first quarter of Fiscal Year 2015 was $3.4 million. Deferred revenue was $13.6 million, which is expected to be recognized within 24 months.

Net cash used in operating activities was $13.1 million for the first quarter of Fiscal Year 2015, an increase of $3.7 million or 39% compared to the same quarter in the prior year, and a $6.9 million decrease or 34%from the fourth quarter of Fiscal Year 2014.

Subsequent to the end of the first quarter of Fiscal Year 2015, Unilife received additional cash payments from customers and a total of $20 million from OrbiMed.

During the first quarter of Fiscal Year 2015, Unilife commenced initial commercial sales of theUnifill syringe utilizing an existing commercial manufacturing line. Commercial sales of other products from the Unifill family, including the Unifill Finesse and the Unifill Nexus, are scheduled to commence during the rest of this fiscal year on additional manufacturing lines that are either in the process of being configured or are nowoperational and in the process of being qualified. Sales of other Unilife products, including wearable injectors, are also scheduled to commence this fiscal year.

Mr.Alan Shortall, Chairman and CEO of Unilife, commented: Fiscal 2015 is set to be a year of rapid growth in revenue, customers, supply agreementsand production capabilities. We look forward to continuing to generate significant growth in revenue via commercial sales, customization fees and upfront payments from a multitude of customers and active programs. In parallel, we expect to increasecapital expenditures in response to growing customer demand while moderating our investments in R&D and SG&A. We also look forward to completing a number of additional significant supply agreements.



We are on track to generate at least an additional $30 million in cash receipts from customers during thefinal three quarters of Fiscal Year 2015. There is significant upside potential beyond this range as we look to finalize a number of additional agreements between now and the end of the fiscal year. Mr.Shortall concluded.

Financial Results for the First Quarter of Fiscal Year 2015

Revenue for the first quarter of Fiscal Year 2015 was $3.4 million, compared to $3.2 million for the same period in the prior year. Deferred revenue was $13.6million as of September30, 2014. The Companys net loss for the first quarter of Fiscal Year 2015 was $20.3 million, or $0.19 per share, compared to a net loss of $11.2 million, or $0.12 per share, for the same period in the prior year.Net cash used in operating activities was $13.1 million for the first quarter of Fiscal Year 2015, an increase of $3.7 million or 39% compared to the same period in the prior year, and a $6.9 million decrease or 34% from the fourth quarter of FiscalYear 2014.

Adjusted net loss for the first quarter of Fiscal Year 2015 was $13.9 million, or $0.13 per share, compared to $7.1 million or $0.08 per sharefor the same period in the prior year. Adjusted net loss excludes non-cash share-based compensation expense, depreciation and amortization, interest expense and the change in fair value of financial instruments, which is the non-cash adjustment inthe Royalty agreement liability with OrbiMed.

Unilife reported $6.3 million in total cash and restricted cash at the end of the first quarter of FiscalYear 2015. This does not include the receipt of $20.0 million funded by OrbiMed under the Amended Credit Agreement, or other cash receipts generated by customers since September30, 2014.

Conference Call Information

Management hasscheduled a conference call for 4:30 p.m. U.S. EST on Monday, November10, 2014, (Tuesday, November11, 2014 at 8:30 a.m. AEDT), to review the Companys financial results, customer partnerships and future outlook. The conference calland accompanying slide presentation will be broadcast over the Internet as a live listen-only Webcast. An archive of the presentation and webcast will be available for 30 days after the call. To listen, please go to:http://ir.unilife.com/events.cfm.

About Unilife Corporation

Unilife Corporation (NASDAQ:UNIS / ASX: UNS) is a U.S. based developer and commercial supplier of injectable drug delivery systems. Unilifes broadportfolio of proprietary technologies includes prefilled syringes with automatic needle retraction, drug reconstitution delivery systems, auto-injectors, wearable injectors, ocular delivery systems and novel systems. Each of these innovative andhighly differentiated platforms can be customized to address specific customer, drug and patient requirements. Unilifes global headquarters and state-of-the-art manufacturing facilities are located in York, PA. For more information, pleasevisit www.unilife.com or download the Unilife IRapp on your iPhone, iPad or Android device.

Forward-Looking Statements

Thispress release contains forward-looking statements. All statements that address operating performance, events or developments that we expect oranticipate will occur in the future are forward-looking statements.These forward-looking statements are based on managements beliefs and assumptions and on information currently available to our management. Our management believes thatthese 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 topublicly 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 thatcould 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 inItem1A. Risk Factors and elsewhere inourAnnual Report on Form 10-Kand those described from time to time in other reports which we file with the Securities and Exchange Commission.



Non-GAAP Financial Measures

U.S. securities laws require that when we publish any non-GAAP financial measure, we disclose the reason for using the non-GAAP measure and providereconciliation to the most directly comparable GAAP measure. The presentation of adjusted net income (loss) and adjusted net income (loss) per share are non-GAAP measures. Adjusted net income (loss) represents net income (loss) calculated inaccordance with U.S. GAAP as adjusted for the impact of share-based compensation expense, depreciation and amortization, interest expense and the non-cash adjustment in the royalty liability.

Management believes the presentation of adjusted net income (loss) and adjusted net income (loss) per share provides useful information because these measuresenhance its own evaluation, as well as investors understanding, of the Companys core operating and financial results. Non-GAAP financial measures should be considered in addition to results prepared in accordance with GAAP, but shouldnot be considered a substitute for, or superior to, GAAP results. A reconciliation of net income (loss) to adjusted net income (loss) is included in the attached table.

General: UNIS-G

Investor Contacts (US):Analyst EnquiriesInvestor Contacts (Australia)

Todd Fromer / Garth RussellLeigh SalvoJeff Carter

KCSA Strategic CommunicationsWestwicke PartnersUnilife Corporation

P: + 1 212-682-6300P: + 1 415-513-1281P: + 61 2 8346 6500




Consolidated Balance Sheets

(unaudited)

September30,2014June30,2014

(in thousands, except share data)

Assets

Current Assets:

Cash and cash equivalents

$4,231$8,368

Restricted cash

2,0882,400

Accounts receivable

4,6461,860

Inventories

147142

Prepaid expenses and other current assets

8801,108

Total current assets

11,99213,878

Property, plant and equipment, net

56,40854,588

Goodwill

10,98711,830

Other assets

1,3571,472

Total assets

$80,744$81,768

Liabilities and Stockholders Equity (Deficit)

Current Liabilities:

Accounts payable

$6,157$3,583

Accrued expenses

3,7113,339

Current portion of long-term debt

591613

Deferred revenue

1,090717

Total current liabilities

11,5498,252

Long-term debt, less current portion

57,32254,835

Deferred revenue

12,55012,550

Total liabilities

81,42175,637

Stockholders Equity (Deficit):

Preferred stock, $0.01 par value, 50,000,000 shares authorized as of September30, 2014; none issued or outstanding as ofSeptember30, 2014 and June30, 2014

Common stock, $0.01 par value, 250,000,000 shares authorized as of September30, 2014; 109,531,507 and 103,617,278 shares issued,and 109,502,837 and 103,558,608 shares outstanding as of September30, 2014 and June30, 2014, respectively

1,0951,036

Additional paid-in-capital

310,399296,169

Accumulated deficit

(313,993)(293,731)

Accumulated other comprehensive income

1,9622,797

Treasury stock, at cost, 28,670 shares as of September30, 2014 and June30, 2014

(140)(140)

Total stockholders (deficit) equity

(677)6,131

Total liabilities and stockholders equity(deficit)

$80,744$81,768




Consolidated Statements of Operations

(unaudited)

Three Months Ended

September30,

20142013


Revenue

$3,380$3,187

Research and development

10,9766,399

Selling, general and administrative

8,2006,520


1,1001,042

Total operating expenses

20,27613,961

Operating loss

(16,896)(10,774)

Interest expense

1,109480


2,230

Other expense (income)

27(10)

Net loss

$(20,262)$(11,244)

Net loss per share:

Basic and diluted net loss per share

$(0.19)$(0.12)




Reconciliation of Non-GAAP Measure

(unaudited)

Three Months Ended
September30,

20142013


Net loss

$(20,262)$(11,244)

Share-based compensation expense

1,8882,636


1,1001,042

Interest expense

1,109480


2,230

Adjusted net loss

$(13,935)$(7,086)

Adjusted net loss per share diluted

$(0.13)$(0.08)



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