Scios Reports First Quarter 2001 Financial Results

Apr 26, 2001, 01:00 ET from Scios Inc.

    SUNNYVALE, Calif., April 26 /PRNewswire/ -- Scios Inc. (Nasdaq:   SCIO)
 today announced financial results for the first quarter ended March 31, 2001.
 The Company also updated investors on the status of its lead products in
 development, Natrecor(R) (nesiritide) for the treatment of acute Congestive
 Heart Failure (aCHF) and SCIO-469, its p38 MAP kinase inhibitor for the
 treatment of Rheumatoid Arthritis (RA).
     "Scios gained momentum on all fronts during the first quarter as we
 continue to work with the U.S. Food and Drug Administration (FDA) to obtain
 approval to market Natrecor, our flagship product, and continue our
 preparations to launch Natrecor later this year," said Richard B. Brewer,
 Scios' president and chief executive officer.  "Together with Innovex,
 Quintiles Transnational Corp.'s commercialization unit, we are building a
 strong sales and marketing force that will be the largest and the most focused
 in the aCHF market.  To that end, we have hired two area business directors
 who will coordinate and lead the sales effort in the field, and we have hired
 15 (of 18 total) business managers to support the 180-person sales force.
 Also, during the quarter, Natrecor data was presented at the American College
 of Cardiology meeting.  We are now preparing for and look forward to the FDA's
 Cardiovascular and Renal Drugs Advisory Committee meeting May 25th to review
 the amended NDA we submitted earlier this year."
     Mr. Brewer added, "We are also investing in Scios' future by moving
 SCIO-469 into clinical trials as efficiently as possible, selecting a new
 compound from our research pipeline for clinical development, and
 strengthening our core drug discovery capabilities."
 
     First Quarter Financial Results
     Net revenues for the quarter ended March 31, 2001 were $11.9 million
 compared to $3.2 million in the first quarter of 2000.  In connection with
 returning the license to market five psychiatric products to Glaxo SmithKline,
 Scios recognized a one-time $9.4 million fee in the first quarter.  This
 transaction further streamlined the Company's operations, ending Scios'
 involvement with psychiatric sales and marketing activities.
     Total costs and expenses for the first quarter of 2001 were $16.0 million
 versus $12.8 million for the quarter ended March 31, 2000.  The increase in
 costs and expenses for the quarter is largely attributable to the costs
 associated with building a marketing and sales infrastructure for Natrecor.
     The Company reported a net loss of $4.2 million or $0.11 per diluted share
 for the quarter ended March 31, 2001, compared to a net loss of $9.5 million,
 or $0.25 per diluted share, for the comparative quarter in 2000.
     Cash and marketable securities (both current and non-current) balances at
 March 31, 2001 totaled $62.2 million.
 
     Natrecor Update
     During the quarter, Scios initiated the PROACTION (Prospective Randomized
 Outcomes Study of Acutely Decompensated Congestive Heart Failure Treated
 Initially in Outpatients with Natrecor) trial, a pilot study designed to
 compare the clinical effects, safety profile and economic impact of standard
 therapy plus Natrecor to standard therapy plus placebo.  The PROACTION trial
 has enrolled twenty-four of the target number of 250 acute CHF patients so
 far, and Scios expects to complete this study in the third quarter of 2001.
 These patients are being treated in the Emergency Department or Observation
 Unit, where the majority of the one million hospitalizations each year for
 this indication begin.
 
     SCIO-469 Progress
     Scios recently completed a Phase Ia trial of SCIO-469 in which single oral
 doses were shown to be safe and well-tolerated.
     A double-blind, placebo-controlled, multiple oral dose Phase Ib study to
 further determine the safety and tolerability of multiple oral doses of
 SCIO-469 has also been completed, and results will be reported next week by
 Dr. George Schreiner, Scios' chief scientific officer, at the "Advances in
 Anti-Arthritic Agents" conference in London.  A Phase II trial in RA patients
 is expected to begin during the second half of 2001.
 
     Kaken Approval
     Kaken Pharmaceuticals Co., Ltd. has received notice from the Japanese
 Ministry of Health and Welfare that they have been granted marketing approval
 for Fiblast Spray as a treatment for dermal ulcers. The active ingredient in
 Fiblast Spray is recombinant basic Fibroblast Growth Factor (FGF), which Kaken
 licensed from Scios in 1988.  Based on this approval, Scios expects to
 recognize $15.9 million in revenue during 2001 as FGF is shipped to Kaken in
 Japan.  The $15.9 million was previously recognized as deferred revenue on
 Scios' Balance Sheet.
 
     Today's Conference Call Details
     As previously announced, Scios will host a conference call today at
 7:00 a.m. PT / 10:00 a.m. ET to discuss the results of the first quarter of
 2001.  The dial-in number is 800-314-7867.  The call will also be broadcast
 live and archived on Scios' web site at http://www.sciosinc.com until
 May 3, 2001.  A telephone replay of this conference call will be available
 until May 3, 2001 at 4 p.m. PT by calling 888-203-1112.  The confirmation code
 is 798190.
 
     Scios Inc.
     Scios is a biopharmaceutical company developing novel treatments for heart
 failure and rheumatoid arthritis.  The Company's disease-based technology
 platform integrates expertise in protein biology with combinatorial and
 medicinal chemistry to identify novel targets and rationally design
 protein-based and small-molecule compounds to treat cardiovascular and
 inflammatory diseases.  Additional information about Scios is available at its
 web site located at www.sciosinc.com and in the Company's various filings with
 the Securities and Exchange Commission (SEC).
 
     The statements in this press release that are not historical facts are
 forward-looking statements that involve risks and uncertainties.  These
 include uncertainties associated with the regulatory approval of Natrecor, the
 sales penetration and success of Natrecor, the successful completion of
 additional studies with Natrecor and SCIO-469, the results of competing
 companies attempting to develop or improve other treatments for rheumatoid
 arthritis and acute heart failure, as well as other risks detailed from time
 to time in the reports filed by Scios with the SEC, including the Company's
 annual report on form 10-K for the year ended December 31, 2000.
 
 
                                   SCIOS INC.
                                 AND SUBSIDIARY
 
                          Consolidated Balance Sheets
                       (In thousands, except share data)
 
                                                     March 31,    December 31,
                                                       2001             2000
                                                    (unaudited)
 
     ASSETS
       Current assets:
       Cash and cash equivalents                         $613         $3,291
       Marketable securities                           28,002         35,356
       Accounts receivable                             12,204          5,217
       Prepaid expenses                                 1,043            902
         Total current assets                          41,862         44,766
 
     Marketable securities, non-current                33,564         32,884
     Property and equipment, net                        8,119          8,910
     Other assets                                       2,542          2,007
 
     TOTAL ASSETS                                     $86,087        $88,567
 
 
     LIABILITIES AND STOCKHOLDERS' EQUITY
     Current liabilities:
       Accounts payable                                $3,919         $4,587
       Other accrued liabilities                       10,236         10,749
       Deferred contract revenue                       16,372         16,193
         Total current liabilities                     30,527         31,529
 
     Long-term debt                                    39,944         39,095
         Total liabilities                             70,471         70,624
 
     Stockholders' equity:
       Preferred stock; $.001 par value; 20,000,000
        shares authorized; 4,991 issued and outstanding
       Common stock; $.001 par value;
        150,000,000 shares authorized;
        issued and outstanding
        39,364,224 and
        39,166,373 shares, respectively                    39             39
       Additional paid-in capital                     430,408        428,987
       Notes receivable from stockholders                (406)          (454)
       Deferred compensation, net                        (106)          (417)
       Accumulated other comprehensive income           1,311          1,195
       Accumulated deficit                           (415,630)      (411,407)
         Total stockholders' equity                    15,616         17,943
 
       TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY     $86,087        $88,567
 
 
                                   SCIOS INC.
                                 AND SUBSIDIARY
 
          Consolidated Statements of Operations and Comprehensive Loss
                (In thousands, except share and per share data)
 
                                                        Three months ended
                                                            March 31,
                                                       2001           2000
                                                           (Unaudited)
     Revenues:
         Product sales, co-promotion
          commissions & other related
          revenue, net of expenses                   $10,846         $ 1,331
         Research and development contracts            1,097           1,894
                                                      11,943           3,225
 
     Costs and expenses:
         Research and development                      9,480           9,284
         Marketing, general and administration         6,480           3,476
                                                      15,960          12,760
 
     Loss from operations                             (4,017)         (9,535)
 
     Other income and expenses:
         Investment income                               812           1,384
         Interest expense                               (849)           (991)
         Realized gains (losses) on securities           254             (84)
         Other expense, net                             (423)           (299)
                                                        (206)             10
 
     Net Loss                                        $(4,223)        $(9,525)
 
         Loss per common share:
           Basic and Diluted                          $ (0.11)       $ (0.25)
 
         Weighted average number of
          common shares outstanding
          used in calculation of:
           Basic and Diluted                      39,290,982      37,780,077
 
 
                      MAKE YOUR OPINION COUNT - Click Here
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SOURCE Scios Inc.
    SUNNYVALE, Calif., April 26 /PRNewswire/ -- Scios Inc. (Nasdaq:   SCIO)
 today announced financial results for the first quarter ended March 31, 2001.
 The Company also updated investors on the status of its lead products in
 development, Natrecor(R) (nesiritide) for the treatment of acute Congestive
 Heart Failure (aCHF) and SCIO-469, its p38 MAP kinase inhibitor for the
 treatment of Rheumatoid Arthritis (RA).
     "Scios gained momentum on all fronts during the first quarter as we
 continue to work with the U.S. Food and Drug Administration (FDA) to obtain
 approval to market Natrecor, our flagship product, and continue our
 preparations to launch Natrecor later this year," said Richard B. Brewer,
 Scios' president and chief executive officer.  "Together with Innovex,
 Quintiles Transnational Corp.'s commercialization unit, we are building a
 strong sales and marketing force that will be the largest and the most focused
 in the aCHF market.  To that end, we have hired two area business directors
 who will coordinate and lead the sales effort in the field, and we have hired
 15 (of 18 total) business managers to support the 180-person sales force.
 Also, during the quarter, Natrecor data was presented at the American College
 of Cardiology meeting.  We are now preparing for and look forward to the FDA's
 Cardiovascular and Renal Drugs Advisory Committee meeting May 25th to review
 the amended NDA we submitted earlier this year."
     Mr. Brewer added, "We are also investing in Scios' future by moving
 SCIO-469 into clinical trials as efficiently as possible, selecting a new
 compound from our research pipeline for clinical development, and
 strengthening our core drug discovery capabilities."
 
     First Quarter Financial Results
     Net revenues for the quarter ended March 31, 2001 were $11.9 million
 compared to $3.2 million in the first quarter of 2000.  In connection with
 returning the license to market five psychiatric products to Glaxo SmithKline,
 Scios recognized a one-time $9.4 million fee in the first quarter.  This
 transaction further streamlined the Company's operations, ending Scios'
 involvement with psychiatric sales and marketing activities.
     Total costs and expenses for the first quarter of 2001 were $16.0 million
 versus $12.8 million for the quarter ended March 31, 2000.  The increase in
 costs and expenses for the quarter is largely attributable to the costs
 associated with building a marketing and sales infrastructure for Natrecor.
     The Company reported a net loss of $4.2 million or $0.11 per diluted share
 for the quarter ended March 31, 2001, compared to a net loss of $9.5 million,
 or $0.25 per diluted share, for the comparative quarter in 2000.
     Cash and marketable securities (both current and non-current) balances at
 March 31, 2001 totaled $62.2 million.
 
     Natrecor Update
     During the quarter, Scios initiated the PROACTION (Prospective Randomized
 Outcomes Study of Acutely Decompensated Congestive Heart Failure Treated
 Initially in Outpatients with Natrecor) trial, a pilot study designed to
 compare the clinical effects, safety profile and economic impact of standard
 therapy plus Natrecor to standard therapy plus placebo.  The PROACTION trial
 has enrolled twenty-four of the target number of 250 acute CHF patients so
 far, and Scios expects to complete this study in the third quarter of 2001.
 These patients are being treated in the Emergency Department or Observation
 Unit, where the majority of the one million hospitalizations each year for
 this indication begin.
 
     SCIO-469 Progress
     Scios recently completed a Phase Ia trial of SCIO-469 in which single oral
 doses were shown to be safe and well-tolerated.
     A double-blind, placebo-controlled, multiple oral dose Phase Ib study to
 further determine the safety and tolerability of multiple oral doses of
 SCIO-469 has also been completed, and results will be reported next week by
 Dr. George Schreiner, Scios' chief scientific officer, at the "Advances in
 Anti-Arthritic Agents" conference in London.  A Phase II trial in RA patients
 is expected to begin during the second half of 2001.
 
     Kaken Approval
     Kaken Pharmaceuticals Co., Ltd. has received notice from the Japanese
 Ministry of Health and Welfare that they have been granted marketing approval
 for Fiblast Spray as a treatment for dermal ulcers. The active ingredient in
 Fiblast Spray is recombinant basic Fibroblast Growth Factor (FGF), which Kaken
 licensed from Scios in 1988.  Based on this approval, Scios expects to
 recognize $15.9 million in revenue during 2001 as FGF is shipped to Kaken in
 Japan.  The $15.9 million was previously recognized as deferred revenue on
 Scios' Balance Sheet.
 
     Today's Conference Call Details
     As previously announced, Scios will host a conference call today at
 7:00 a.m. PT / 10:00 a.m. ET to discuss the results of the first quarter of
 2001.  The dial-in number is 800-314-7867.  The call will also be broadcast
 live and archived on Scios' web site at http://www.sciosinc.com until
 May 3, 2001.  A telephone replay of this conference call will be available
 until May 3, 2001 at 4 p.m. PT by calling 888-203-1112.  The confirmation code
 is 798190.
 
     Scios Inc.
     Scios is a biopharmaceutical company developing novel treatments for heart
 failure and rheumatoid arthritis.  The Company's disease-based technology
 platform integrates expertise in protein biology with combinatorial and
 medicinal chemistry to identify novel targets and rationally design
 protein-based and small-molecule compounds to treat cardiovascular and
 inflammatory diseases.  Additional information about Scios is available at its
 web site located at www.sciosinc.com and in the Company's various filings with
 the Securities and Exchange Commission (SEC).
 
     The statements in this press release that are not historical facts are
 forward-looking statements that involve risks and uncertainties.  These
 include uncertainties associated with the regulatory approval of Natrecor, the
 sales penetration and success of Natrecor, the successful completion of
 additional studies with Natrecor and SCIO-469, the results of competing
 companies attempting to develop or improve other treatments for rheumatoid
 arthritis and acute heart failure, as well as other risks detailed from time
 to time in the reports filed by Scios with the SEC, including the Company's
 annual report on form 10-K for the year ended December 31, 2000.
 
 
                                   SCIOS INC.
                                 AND SUBSIDIARY
 
                          Consolidated Balance Sheets
                       (In thousands, except share data)
 
                                                     March 31,    December 31,
                                                       2001             2000
                                                    (unaudited)
 
     ASSETS
       Current assets:
       Cash and cash equivalents                         $613         $3,291
       Marketable securities                           28,002         35,356
       Accounts receivable                             12,204          5,217
       Prepaid expenses                                 1,043            902
         Total current assets                          41,862         44,766
 
     Marketable securities, non-current                33,564         32,884
     Property and equipment, net                        8,119          8,910
     Other assets                                       2,542          2,007
 
     TOTAL ASSETS                                     $86,087        $88,567
 
 
     LIABILITIES AND STOCKHOLDERS' EQUITY
     Current liabilities:
       Accounts payable                                $3,919         $4,587
       Other accrued liabilities                       10,236         10,749
       Deferred contract revenue                       16,372         16,193
         Total current liabilities                     30,527         31,529
 
     Long-term debt                                    39,944         39,095
         Total liabilities                             70,471         70,624
 
     Stockholders' equity:
       Preferred stock; $.001 par value; 20,000,000
        shares authorized; 4,991 issued and outstanding
       Common stock; $.001 par value;
        150,000,000 shares authorized;
        issued and outstanding
        39,364,224 and
        39,166,373 shares, respectively                    39             39
       Additional paid-in capital                     430,408        428,987
       Notes receivable from stockholders                (406)          (454)
       Deferred compensation, net                        (106)          (417)
       Accumulated other comprehensive income           1,311          1,195
       Accumulated deficit                           (415,630)      (411,407)
         Total stockholders' equity                    15,616         17,943
 
       TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY     $86,087        $88,567
 
 
                                   SCIOS INC.
                                 AND SUBSIDIARY
 
          Consolidated Statements of Operations and Comprehensive Loss
                (In thousands, except share and per share data)
 
                                                        Three months ended
                                                            March 31,
                                                       2001           2000
                                                           (Unaudited)
     Revenues:
         Product sales, co-promotion
          commissions & other related
          revenue, net of expenses                   $10,846         $ 1,331
         Research and development contracts            1,097           1,894
                                                      11,943           3,225
 
     Costs and expenses:
         Research and development                      9,480           9,284
         Marketing, general and administration         6,480           3,476
                                                      15,960          12,760
 
     Loss from operations                             (4,017)         (9,535)
 
     Other income and expenses:
         Investment income                               812           1,384
         Interest expense                               (849)           (991)
         Realized gains (losses) on securities           254             (84)
         Other expense, net                             (423)           (299)
                                                        (206)             10
 
     Net Loss                                        $(4,223)        $(9,525)
 
         Loss per common share:
           Basic and Diluted                          $ (0.11)       $ (0.25)
 
         Weighted average number of
          common shares outstanding
          used in calculation of:
           Basic and Diluted                      39,290,982      37,780,077
 
 
                      MAKE YOUR OPINION COUNT - Click Here
                http://tbutton.prnewswire.com/prn/11690X12827537
 
 SOURCE  Scios Inc.