Unilife Corporation Announces Financial Results For Fiscal Year 2013 Second Quarter

YORK, Pa., Feb. 11, 2013 /PRNewswire/ -- Unilife Corporation ("Unilife" or "Company") (NASDAQ:  UNIS; ASX: UNS), a developer and supplier of injectable drug delivery systems, today announced its financial results for the quarter ended December 31, 2012, (the second quarter of Fiscal Year 2013).

Highlights for the Fiscal Year 2013 Second Quarter:

  • In November 2012, Unilife announced that its platform of bolus injection devices had been selected by a global pharmaceutical company to enter a final stage of evaluation as its preferred choice for use in a multi-drug program. Unilife's bolus injectors have also been selected by many other pharmaceutical companies for targeted use with late-stage pipeline drugs. Negotiations for agreements are underway in each case.
  • In December 2012, Unilife announced that a U.S. based pharmaceutical company has commenced stability and evaluation studies of the Unifill® syringe for use with multiple injectable drugs.  The target drugs, which include both pipeline drugs as well as commercially approved drugs that will benefit from lifecycle extension, are high-value therapeutics for chronic diseases and require periodic injections.
  • Unilife continued to supply initial batches of Unifill syringes to many pharmaceutical companies that are in various stages of evaluating its use for a range of approved and late-stage pipeline drugs. In addition to prospective supply and clinical development contracts, we expect other customers to enter their drugs into stability studies with Unifill this calendar year.
  • Unilife announced the development of its Depot-Ject™ and Unilife Ocu-Ject™ platforms for the targeted delivery of drugs to specific regions of the body such as the eye. These high-precision drug delivery platforms are now being pursued by multiple interested parties.
  • The RITA™ disposable auto-injectors and LISA™ reusable auto-injectors were supplied to a number of pharmaceutical companies for evaluation and user studies. Unilife has been advised that these evaluations are progressing favorably.
  • The Unilife EZMix™ drug reconstitution system was selected by a pharmaceutical company for use with a late-stage pipeline drug. Negotiations for an EZMix supply contract with this company are underway.
  • Unilife expanded its commercial development team with the appointment of Douglas Stout, Derek Giersch, Joseph Crusco as Senior Directors of Commercial Development; and Jashin Gugnani as Director of Commercial Development in October 2012; as well as the appointment of Glenn Thorpe as Vice-President of Commercial Development in February 2013.

"During the quarter, we were pleased to provide shareholders with greater insight into the size and scope of our commercial pipeline," stated Mr. Alan Shortall, CEO of Unilife. "Out of 31 active programs selected from our deep and rapidly expanding commercial pipeline, we expect several to generate initial revenues during calendar year 2013.  Given the size and long-term nature of many of these prospective agreements, we are confident they will underpin our future success.

"Over the last few weeks, we raised approximately $13.4 million in net equity capital, which has strengthened our balance sheet as we look to finalize several commercial supply contracts and clinical development agreements.  We are also working to conclude discussions with U.S. institutions to secure long-term debt financing that will support the Company's operational activities and minimize dilution for the foreseeable future," Mr. Shortall concluded.

Financial Results for Three Months Ended December 31, 2012
Revenues for the three months ended December 31, 2012, were $0.7 million compared to $0.9 million for the same period in 2011. The Company's net loss for the three months ended December 31, 2012, was $14.6 million, or $0.19 per share, compared to a net loss of $12.9 million, or $0.19 per share, for the same period in 2011. The increase in the net loss was primarily attributable to the decrease in revenue and an increase in non-cash share-based compensation expenses.

Adjusted net loss for the three months ended December 31, 2012, was $9.7 million, or $0.12 per share, compared to $9.6 million, or $0.14 per share, for the same period in 2011. Adjusted net loss excludes non-cash share-based compensation expense, depreciation and amortization and interest expense.

Unilife had $8.3 million of total cash, including restricted cash, as of December 31, 2012, which does not reflect the $3.8 million in net proceeds the Company received from the implementation of its At-the-Market (ATM) facility with Cantor Fitzgerald in January 2013; or the $9.6 million in net proceeds the Company received from a common stock offering with a U.S. based institutional investor in February 2013. 

Conference Call Information
Management has scheduled a conference call for 4:30 p.m. U.S. EST on Monday, February 11, 2013 (Tuesday, February 12, 2013 at 8:30 a.m. AEDT), to review the Company's financial results, market trends and future outlook.  The conference call and 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. Unilife's broad portfolio of proprietary device technologies includes prefilled syringes with automatic needle retraction, drug reconstitution delivery systems, auto-injectors, bolus injection devices and targeted delivery systems. Each of these innovative and highly differentiated device platforms can be customized by Unilife to address specific customer, drug and patient requirements. Unilife's global headquarters and state-of-the-art manufacturing facilities are located in York, PA. For more information, please visit www.unilife.com or download the Unilife IRapp on your iPhone, iPad or Android device.

Forward-Looking Statements
This press release contains forward-looking statements. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements. These forward-looking statements are based on management's beliefs and assumptions and on information currently available to our management. Our management believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on any such forward-looking statements because such statements speak only as of the date when made. We do not undertake any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. In addition, forward-looking statements are subject to certain risks and uncertainties that could cause actual results, events and developments to differ materially from our historical experience and our present expectations or projections. These risks and uncertainties include, but are not limited to, those described in "Item 1A. Risk Factors" and elsewhere in our Annual Report on Form 10-K and 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 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 as adjusted for the impact of share-based compensation expense, depreciation and amortization and interest expense.

Management believes the presentation of adjusted net income (loss) and adjusted net income (loss) per share provides useful information because these measures enhance its own evaluation, as well as investor's understanding, of the Company's core operating and financial results.  Non-GAAP financial measures should be considered in addition to results prepared in accordance with GAAP, but should not 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 Enquiries     

Investor Contacts (Australia)

Todd Fromer / Garth Russell          

Lynn Pieper               

Jeff Carter

KCSA Strategic Communications      

Westwicke Partners  

Unilife Corporation

P: + 1 212-682-6300                        

P: + 1 415-202-5678    

P: + 61 2 8346 6500

 (Tables Below)

 

UNILIFE CORPORATION AND SUBSIDIARIES

Consolidated Balance Sheets

(unaudited)


December 31, 2012

June 30, 2012


(in thousands, except share data)

Assets



Current Assets:



Cash and cash equivalents           

$           5,914

$    11,410

Restricted cash    

2,400

2,400

Accounts receivable         

104

1,042

Inventories           

156

212

Prepaid expenses and other current assets

714

676




Total current assets  

9,288

15,740

Property, plant and equipment, net        

51,375

52,514

Goodwill          

12,993

12,734

Intangible assets, net    

31

34

Other assets    

1,275

1,286




Total assets 

$          74,962

$    82,308




Liabilities and Stockholders' Equity



Current Liabilities:



Accounts payable

$           1,845

$      2,399

Accrued expenses

2,430

2,209

Current portion of long-term debt  

5,804

5,655

Deferred revenue  

2,649

2,595




Total current liabilities           

12,728

12,858

Long-term debt, less current portion      

20,615

23,110

Deferred revenue          

1,374

2,595




Total liabilities          

34,717

38,563




Stockholders' Equity:



Preferred stock, $0.01 par value, 50,000,000 shares authorized as of

   December 31, 2012; none issued or outstanding as of December 31, 2012 and

   June 30, 2012        

Common stock, $0.01 par value, 250,000,000 shares authorized as of

   December 31, 2012; 83,288,081 and 75,849,439 shares issued, and

   83,259,411 and 75,820,769 shares outstanding as of December 31, 2012 and

   June 30, 2012, respectively

833

758

Additional paid-in-capital  

235,720

212,326

Accumulated deficit          

(199,771 )

(172,634 )

Accumulated other comprehensive income

3,603

3,435

Treasury stock, at cost, 28,670 shares as of December 31, 2012 and June 30,

   2012    

(140 )

(140 )




Total stockholders' equity 

40,245

43,745




Total liabilities and stockholders' equity 

$          74,962

$    82,308




 

UNILIFE CORPORATION AND SUBSIDIARIES

Consolidated Statements of Operations

(unaudited)

 


Three Months Ended


Six Months Ended


December 31,


December 31,


2012


2011


2012


2011


(in thousands, except per share data)

Revenues:








Industrialization and development fees

$             —


$           249


$              —


$        1,689

Licensing fees

663


646


1,326


1,318

Product sales and other

36


17


65


35

Total revenues

699


912


1,391


3,042

Cost of product sales

22


16


81


90

Gross profit

677


896


1,310


2,952

Operating expenses:








Research and development

4,994


5,262


9,732


9,560

Selling, general and administrative

8,327


6,712


14,904


12,895

Depreciation and amortization

1,365


1,157


2,588


2,150

Total operating expenses

14,686


13,131


27,224


24,605

Operating loss

(14,009)


(12,235)


(25,914)


(21,653)

Interest expense

645


639


1,261


922

Interest income

(14)


(26)


(38)


(56)

Other expense, net


2



36

Net loss

$    (14,640)


$    (12,850)


$    (27,137)


$    (22,555)

Net loss per share:








Basic and diluted net loss per share

$        (0.19)


$        (0.19)


$        (0.35)


$        (0.35)

 

UNILIFE CORPORATION AND SUBSIDIARIES

Reconciliation of Non-GAAP Measure

(unaudited)

 


Three Months Ended


Six Months Ended


December 31,


December 31,


2012


2011


2012


2011


(in thousands, except per share data)

Net loss

$    (14,640)


$    (12,850)


$    (27,137)


$    (22,555)

Share-based compensation expense

2,963


1,485


4,518


3,385

Depreciation and amortization

1,365


1,157


2,588


2,150

Interest expense

645


639


1,261


922

Adjusted net loss

$      (9,667)


$      (9,569)


$    (18,770)


$    (16,098)

Adjusted net loss per share – diluted

$        (0.12)


$        (0.14)


$        (0.24)


$        (0.25)

 

 

SOURCE Unilife Corporation



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