March 23, 2010

Unilife Reports Fiscal 2010 Second Quarter Financial Results

LEWISBERRY, Pa., March 23, 2010 /PRNewswire via COMTEX News Network/ -- Unilife Corporation ("Unilife" or "Company") (Nasdaq: UNIS; ASX: UNS) today announced financial results for its fiscal 2010 second quarter and six months ended December 31, 2009.

Recent Company Highlights:

  • Successfully redomiciled to the U.S. and listed on the NASDAQ Global Market
  • Agreed to a list of therapeutic drug classes with sanofi-aventis for Unifill(TM) syringes
  • Started commercial manufacturing of Unitract(TM) 1mL safety syringes
  • Donated first shipment of Unitract(TM) 1mL safety syringes to the Haiti relief effort
  • Signed exclusive five-year agreement with Stason Pharmaceuticals including annual minimum orders for the Unitract(TM) 1mL syringe in Japan, China and Taiwan
  • Completed an equity raise of $47.1 million in November 2009

"Unilife continues to meet or exceed its key business milestones," stated Alan Shortall, CEO of Unilife. "The redomiciliation of Unilife to the United States and our listing on the NASDAQ Global Market has been a significant achievement. This move reflects our position as a US based emerging global leader for innovative safety medical devices, and allows Unilife to attract additional world class team members that will support the continued expansion of our business activities, product lines and industrial capabilities.

"I am pleased to say that we have begun to introduce our safety syringe technology into the market, with the initial shipment of Unitract(TM) 1mL safety syringes into Haiti to support humanitarian relief efforts. Stason Pharmaceuticals has also signed an exclusive five-year distribution agreement with us for the sale of the Unitract(TM) 1mL safety syringe within Japan, Taiwan and China. In addition to supporting regulatory approval and business development activities within Asia, Stason Pharmaceuticals has committed to immediately placing an initial commercial order for one million units of the Unitract(TM) 1mL safety syringe. Our Unitract(TM) 1mL syringes will continue to be rolled out across target international markets during the next twelve months.

"Construction of our new manufacturing plant in York, Pennsylvania is progressing according to schedule with the external walls and roof of the main section of the building now in place. This 165,000sf, state of the art facility is scheduled to be completed in late 2010, so that we will be in a position to commence the supply of our Unifill(TM) safety syringes to pharmaceutical customers in early 2011. This timeline puts us more than a year ahead of our original schedule for the industrialization program for the Unifill(TM) syringe.

"In addition, we have agreed to a list of therapeutic drug classes including antithrombotic agents and vaccines within which sanofi-aventis has the exclusive right to purchase the Unifill(TM) syringe. We may now commence formal discussions with other pharmaceutical companies relating to the potential use of the Unifill(TM) syringe within a number of significant therapeutic classes that fall outside of areas retained by sanofi-aventis," Mr. Shortall said.

Financial Results for Three and Six Months Ended December 31, 2009 and 2008

Net revenues for the three months ended December 31, 2009 were $3.2 million, compared to $5.8 million for the same period in 2008. The Company's net loss for the three months ended December 31, 2009 was $(5.9) million, or $(0.13) per diluted share, as compared to a net loss of $(861,000), or $(0.03) per diluted share, for the same period in 2008. Adjusted net loss for the three months ended December 31, 2009, which excludes approximately $2.7 million in share-based compensation expense, depreciation and amortization, interest expense and certain non-recurring costs associated with the redomiciliation and Nasdaq listing was $(3.2) million, or $(0.07) per diluted share.

Net revenues for the six months ended December 31, 2009 were $6.4 million, compared to $8.1 million for the same period in 2008. The Company's net loss for the six months ended December 31, 2009 was $(8.0) million, or $(0.19) per diluted share, as compared to a net loss of $(2.5) million, or $(0.07) per diluted share, for the same period in 2008. Adjusted net loss for the six months ended December 31, 2009, which excludes approximately $4.0 million in share-based compensation expense, depreciation and amortization and certain non-recurring costs associated with the redomiciliation and Nasdaq listing was $(4.0) million, or $(0.10) per diluted share.

As of December 31, 2009, the Company's cash and cash equivalents were $41.4 million.

Future Company Milestones - Calendar 2010:

  • Continued global rollout of Unitract(TM) 1mL Syringes
  • Completion of new headquarters and production facility
  • Installation of Unifill(TM) assembly line (60 million units a year)
  • Completion of Unifill(TM) industrialization program
  • Agreements with additional pharmaceutical companies

Conference Call Information

Management has scheduled a conference call for 4:30 p.m. U.S. Eastern Daylight Time on March 23, 2010, 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 is a U.S.-based medical device company focused on the design, development, manufacture and supply of a proprietary range of retractable syringes. Primary target customers for Unilife products include pharmaceutical manufacturers, suppliers of medical equipment to healthcare facilities and patients who self-administer prescription medication. These patent-protected syringes incorporate automatic, operator controlled needle retraction features which are fully-integrated within the barrel, and are designed to protect those at risk of needlestick injuries and unsafe injection practices. Unilife is ISO 13485 certified and has FDA-registered medical device manufacturing facilities in Pennsylvania.

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 registration statement on Form 10 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 a 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, interest expense and certain non-recurring costs associated with our redomiciliation and Nasdaq listing.

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 tables.

General: UNIS-G



    Investor Contacts (US):
    Todd Fromer /Garth Russell        Stuart Fine
    KCSA Strategic Communications     Carpe DM Inc
    P: + 1 212-682-6300               P: + 1 908-469-1788

    Investor Contacts (Australia):
    Jeff Carter
    Unilife Corporation
    P: + 61 2 8346 6500


                                 (Tables Below)


                       UNILIFE CORPORATION AND SUBSIDIARIES
                       Condensed Consolidated Balance Sheets
                         (in thousands, except share data)
                                    (unaudited)

                                                December  31,    June 30,
                                                     2009         2009
                                                -------------   ---------

                      Assets
    Current Assets:
         Cash and cash equivalents                  $41,354       $3,627

         Accounts receivable                          2,376        7,333
         Inventories                                  1,398        1,097
         Prepaid expenses and other current assets      538          223
                                                     ------       ------
              Total current assets                   45,666       12,280
    Property, plant and equipment, net               15,936        9,137
    Goodwill                                         11,235       10,235
    Intangible assets, net                               45           43
    Other assets                                        196          517
                                                    -------      -------
              Total assets                          $73,078      $32,212
                                                    =======      =======

          Liabilities and Stockholders' Equity
    Current Liabilities:
         Accounts payable                            $1,454       $1,103
         Accrued expenses                               908        6,097
         Current portion of long-term debt              405          405
         Deferred revenue                             2,932        2,642
                                                      -----        -----
              Total current liabilities               5,699       10,247
     Long-term debt, less current portion             2,499        2,728
     Deferred revenue                                 7,330        7,926
                                                      -----        -----
              Total liabilities                      15,528       20,901
                                                     ------       ------

    Commitments and contingencies

    Stockholders' Equity:
    Preferred stock, $0.01 par value,
     50,000,000 shares authorized as of
     December 31, 2009; none issued or
     outstanding as of December 31, 2009
     and June 30, 2009                                    -            -
    Common stock, $0.01 par value,
     250,000,000 shares authorized as
     of December 31, 2009; 51,784,437
     and 36,625,802 shares issued and
     outstanding as of December 31,
     2009 and June 30, 2009, respectively               518          366
    Additional paid-in-capital                      113,430       57,987
    Accumulated deficit                             (57,881)     (49,902)
    Accumulated other comprehensive income            1,483        2,860
                                                      -----        -----
         Total stockholders' equity                  57,550       11,311
                                                     ------       ------
               Total liabilities and
                stockholders' equity                $73,078      $32,212
                                                    =======      =======



                       UNILIFE CORPORATION AND SUBSIDIARIES
                   Condensed Consolidated Statements of Operations
                      (in thousands, except per share data)
                                  (unaudited)

                               Three Months Ended      Six Months Ended
                                  December 31,            December 31,
                                 -------------           -------------
                                 2009          2008     2009          2008
                                 ----          ----     ----          ----
    Revenues                   $3,245        $5,822   $6,353        $8,127
    Cost of sales                 707         1,042    1,572         2,173
                                  ---         -----    -----         -----
      Gross profit              2,538         4,780    4,781         5,954
                                -----         -----    -----         -----
    Operating expenses:
      Research & development      287           216      686           347
      Selling, general
       and administrative       7,517         5,241   11,259         7,663
    Depreciation and
     amortization                 776           155    1,031           299
                                  ---           ---    -----           ---
    Total operating expenses    8,580         5,612   12,976         8,309
                                -----         -----   ------         -----
    Operating loss             (6,042)         (832)  (8,195)       (2,355)
    Interest expense               14           106       61           231
    Interest income              (252)         (165)    (257)         (285)
    Other (income)expense, net    111            88      (20)          176
                                  ---           ---      ---           ---
    Net loss                  $(5,915)        $(861) $(7,979)      $(2,477)
                              ========        ====== ========      ========
    Loss per share:
    Basic loss per share       $(0.13)       $(0.03)  $(0.19)       $(0.07)
                               =======       =======  =======       =======
    Diluted loss per share     $(0.13)       $(0.03)  $(0.19)       $(0.07)
                               =======       =======  =======       =======



                       UNILIFE CORPORATION AND SUBSIDIARIES
                        Reconciliation of Non-GAAP Measure
                      (in thousands, except per share data)
                                   (unaudited)

                             Three Months Ended      Six Months Ended
                                December 31,           December 31,
                                ------------           ------------
                                2009     2008        2009       2008
                                ----     ----        ----       ----
    Net loss                 $(5,915)   $(861)    $(7,979)   $(2,477)
    Share-based
     compensation expense        201    2,205         771      2,298
    Depreciation and
     amortization                776      155       1,031        299
    Interest expense              14      106          61        231
    Non-recurring costs
     associated with
     redomiciliation & US
     listing*                  1,710        -       2,135          -
                               -----      ---       -----        ---
    Adjusted net income
     (loss)                  $(3,214)  $1,605     $(3,981)      $351
                             ========  ======     ========      ====
    Adjusted net income
     (loss) per share -
     diluted                  $(0.07)   $0.05      $(0.10)     $0.01
                              =======   =====      =======     =====

    * Includes legal, consulting and other professional fees incurred in
      connection with the Company's redomiciliation to the United States
      and Nasdaq listing.



SOURCE Unilife Corporation

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