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Insmed Announces Financial Results for Third Quarter and Nine-Months Ended September 30, 2010

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RICHMOND, Va., Nov. 3, 2010 /PRNewswire-FirstCall/ -- Insmed Inc. (Nasdaq: INSM), a biopharmaceutical company, today reported results for the third quarter and nine-months ended September 30, 2010.

Total revenues for the third quarter ended September 30, 2010 were $1.8 million, as compared to $2.5 million for the corresponding period in 2009. The $0.7 million decline in revenue was entirely due to lower cost recovery in the most recent quarter from our IPLEX(TM) Expanded Access Program ("EAP") in Italy for the treatment of Amyotrophic Lateral Sclerosis ("ALS"). In 2009, the Company ceased patient enrollment in the EAP in order to preserve inventory for existing patients.

Net loss for the third quarter of 2010 was $0.3 million, break even on a per share basis, compared with a net loss of $0.1 million, also break even on a per share basis, reported in the third quarter of 2009. The $0.2 million change in net loss was primarily due to the $0.7 million decrease in revenues, noted above, and a $0.3 million decrease in investment income, which were largely offset by an overall reduction of $0.8 million in operating expenses.

The $0.8 million decrease in total expenses resulted from a $0.3 million reduction in research and development expenses ("R&D expenses") and a $0.5 million decline in selling, general and administrative expenses ("SG&A expenses"). The lower R&D expenses resulted largely from the elimination of IPLEX(TM) fill-finish costs which we incurred in the third quarter of 2009, while the reduced SG&A expenses were principally due to lower external market research and consultancy fees associated with our ongoing strategic review process.

Investment income for the 2010 third quarter was $345,000, as compared to $682,000 for the same period in 2009; as overall market returns declined in the current quarter versus the corresponding period in 2009.

Total revenues for the nine-months ended September 30, 2010 were $5.6 million, as compared to $7.9 million for the corresponding period in 2009. The $2.3 million decline in revenue was due to a combination of a $1.7 million decline in EAP cost recovery, the receipt, during the first nine months of 2009, of $0.5 million in grant revenue for our exploratory Phase 2 IPLEX(TM) trial in patients with myotonic muscular dystrophy and $0.1 million in lower income from an expired TGF-beta royalty.

Net loss for the first nine-months of 2010 was $0.6 million, break even on a per share basis, compared with net income of $116.0 million, or $0.92 per share, reported in the same period of 2009. The $116.6 million change in net loss was primarily due to the $125.0 million after tax gain on sale of our follow on biologics ("FOB") assets to Merck in March 2009, together with the $2.3 million reduction in revenues noted above, which were partially offset by an overall reduction of $9.5 million in operating expenses, a $0.5 million improvement in investment income and a $0.7 million reduction in interest expense.

The $9.5 million decrease in total expenses resulted from a $6.2 million reduction in R&D expenses and a $3.3 million decline in SG&A expenses. The lower R&D expenses reflected the elimination of manufacturing expenses following the sale of our FOB assets in March 2009, while the reduced SG&A expenses were principally due to lower personnel costs also associated with the asset sale to Merck.

Investment income for the first nine-months of 2010 was $1.3 million. This was an increase of $0.5 million over the corresponding period of 2009, and was due to improved investment returns during the period and a significantly higher cash balance invested for the full nine-months of 2010. The reduction in interest expense for the first nine-months of 2010 as compared the same period in 2009 was entirely due to the elimination of the 2005 convertible notes, which were fully repaid in March 2010.

As of September 30, 2010, the Company had total cash, cash equivalents and short-term investments on hand of $126.4 million, comprised of $114.6 million in short-term investments, $9.7 million in cash and cash equivalents and $2.1 million in a certificate of deposit. This compares to $124.3 million as of December 31, 2009. The $2.1 million increase in cash, cash equivalents and short-term investments was due primarily to the receipt of a $2.0 million income tax refund in 2010 and a $1.1 million improvement in unrealized gain on investments, which was partially offset by $0.8 million of net cash used in operating activities and the $0.2 million final payment on our 2005 convertible notes.

Conference Call

To participate in today's live 8:30 AM ET conference call, please dial 866-356-4281 (U.S. callers) or 617-597-5395 (international), and provide passcode 61751565. A live webcast of the call will also be available at http://phx.corporate-ir.net/playerlink.zhtml?c=122332&s=wm&e=3461146. Please allow extra time prior to the webcast to register, download and install any necessary audio software.

The webcast will be archived for 30 days, and a telephone replay of the call will be available for seven days, beginning at 11:30 AM ET on November 3rd, at 888-286-8010 (U.S. callers) or 617-801-6888 (international), using passcode 28300679.

About Insmed

Insmed Inc. is a biopharmaceutical company with unique protein development experience and a proprietary protein platform aimed at niche markets with unmet medical needs. For more information, please visit http://www.insmed.com.

Forward-Looking Statements

This release contains forward-looking statements which are made pursuant to provisions of Section 21E of the Securities Exchange Act of 1934. Investors are cautioned that such statements in this release, including statements relating to business strategies, plans and objectives of management and our strategic review process, constitute forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the forward-looking statements. The risks and uncertainties include, without limitation, we may be unsuccessful in identifying or reaching agreement with acquisition or merger candidates, our expenses may be higher than anticipated and other risks and challenges detailed in our filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2009. Readers are cautioned not to place undue reliance on any forward-looking statements which speak only as of the date of this release. We undertake no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this release or to reflect the occurrence of unanticipated events.


    Investor Relations Contact:
    Brian Ritchie - FD
    212-850-5683
    brian.ritchie@fd.com

    Media Contact:
    Irma Gomez-Dib - FD
    212-850-5761
    irma.gomez-dib@fd.com


                  INSMED INCORPORATED
              Consolidated Balance Sheets
    (in thousands, except share and per share data)

                                 September      December
                                    30,            31,
                                      2010           2009
                                      ----           ----

    Assets
    Current assets:
      Cash and cash
       equivalents                  $9,687        $12,740
      Short-term
       investments                 114,605        109,441
      Income tax
       receivable                       59          2,023
      Accounts
       receivable, net                 178            245
      Prepaid expenses                 364            159
                                       ---            ---
      Total current
       assets                      124,893        124,608

    Long-term assets:
      Certificate of
       deposit                       2,085          2,085
      Deferred financing
       costs, net                        -              2
      Total long-term
       assets                        2,085          2,087
                                     -----          -----

    Total assets                  $126,978       $126,695
                                  ========       ========

    Liabilities and
     stockholders'
     equity
    Current
     liabilities:
      Accounts payable                $431           $312
      Accrued project
       costs & other                 1,150          1,150
      Payroll
       liabilities                     481            580
      Interest payable                   -              1
      Deferred rent                    132            132
      Deferred revenue                  98            398

      Convertible debt                   -            231
      Debt discount                      -            (23)
         Net convertible
          debt                           -            208
                                       ---            ---

    Total liabilities                2,292          2,781
                                     -----          -----

    Stockholders'
     equity:
    Common stock; $.01
     par value;
     authorized shares
     500,000,000;
     issued and
     outstanding
     shares,
     130,345,819 in
     2010 and
     130,208,099 in
     2009
                                     1,303          1,302
      Additional paid-
       in capital                  350,458        350,243
      Accumulated
       deficit                    (228,666)      (228,076)
      Accumulated other
       comprehensive
       income:
         Unrealized gain on
          investment                 1,591            445
      Net stockholders'
       equity                      124,686        123,914
                                   -------        -------

    Total liabilities
     and stockholders'
     equity                       $126,978       $126,695
                                  ========       ========


               INSMED INCORPORATED
      Consolidated Statements of Operations
      (in thousands, except per share data)

                         Three Months        Nine Months
                             Ended               Ended
                          September           September
                               30,                 30,
                           ----------          ----------
                          2010      2009      2010       2009
                          ----      ----      ----       ----

    Royalties               $1       $21        $3        $79
    Grant revenue            -         -         -        544
    Other expanded
     access program
     income, net         1,806     2,454     5,597      7,262
                         -----     -----     -----      -----
      Total revenues     1,807     2,475     5,600      7,885

    Operating
     expenses:
    Research and
     development           769     1,143     2,304      8,483
    Selling, general
     and
     administrative      1,636     2,096     5,058      8,419
                         -----     -----     -----      -----
      Total expenses     2,405     3,239     7,362     16,902
                         -----     -----     -----     ------

    Operating loss        (598)     (764)   (1,762)    (9,017)

    Investment
     income                345       682     1,280        817
    Interest expense         -       (68)      (28)      (730)
    Gain on sale of
     asset, net              -         -         -    127,768
                           ---       ---       ---    -------
    Income (loss)
     before taxes         (253)     (150)     (510)   118,838

    Income tax
     expense                77         -        80      2,794
                           ---       ---       ---      -----

    Net (loss)
     income              $(330)    $(150)    $(590)  $116,044
                         =====     =====     =====   ========

    Basic net (loss)
     income per
     share              $(0.00)   $(0.00)   $(0.00)     $0.92
                        ======    ======    ======      =====

    Shares used in
     computing basic
     net (loss)
     income per
     share             130,301   129,442   130,253    126,072
                       =======   =======   =======    =======

    Diluted net
     (loss) income
     per share          $(0.00)   $(0.00)   $(0.00)     $0.92
                        ======    ======    ======      =====

    Shares used in
     computing
     diluted net
     (loss) income
     per share         130,301   129,442   130,253    126,256
                       =======   =======   =======    =======



               INSMED INCORPORATED
      Consolidated Statements of Cash Flows
                  (in thousands)

                                     Nine Months Ended
                                       September 30,
                                       2010       2009
                                       ----       ----
    Operating activities
    Net income                        $(590)  $116,044
    Adjustments to
     reconcile net income
     to net cash
      (used in) provided by
       operating
       activities:
      Depreciation and
       amortization                      25        661
      Stock based
       compensation expense             215      2,425
      Gain on sale of
       asset, net                         -  (127,768)
      Change in trading
       securities                         -       (498)
      Realized loss on
       investments                        -          -
      Changes in operating
       assets and
       liabilities:
        Accounts receivable              67       (197)
        Income tax receivable         1,964          -
        Prepaid expenses               (205)      (162)
        Accounts payable                119       (696)
        Accrued project costs
         & other                          -        288
        Payroll liabilities             (99)       (32)
        Income tax liability              -        625
        Deferred rent                     -        (65)
        Deferred revenue               (300)       (71)
        Restricted stock unit
         liability                        -       (113)
        Asset retirement
         obligation                       -     (2,217)
        Interest payable                 (1)       (11)
                                        ---        ---
    Net cash provided by
     (used in) operating
     activities                       1,195    (11,787)
                                      -----    -------

    Investing activities
        Cash received from
         asset sale                       -    127,768
        Sales of short-term
         investments                 90,739          -
        Purchases of short-
         term investments           (94,757)   (94,646)
    Net cash provided by
     (used in) investing
     activities                      (4,018)    33,122
                                     ------     ------

    Financing activities
    Proceeds from
     issuance of common
     stock                                -        580
    Repayment of
     convertible notes                 (231)    (1,016)
    Certificate of
     deposits                             -         10
    Warrants converted
     into shares                          -      3,493
    Other                                 1         39
    Net cash provided by
     (used in) financing
     activities                        (230)     3,106
                                       ----      -----

    Increase (decrease)
     in cash and cash
     equivalents                     (3,053)    24,441
    Cash and cash
     equivalents at
     beginning of period             12,740      2,397
                                     ------      -----

    Cash and cash
     equivalents at end
     of period                       $9,687    $26,838
                                     ======    =======


SOURCE Insmed Inc.



 
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