Aksys Reports First Quarter Results

Apr 19, 2001, 01:00 ET from Aksys, Ltd.

    LINCOLNSHIRE, Ill., April 19 /PRNewswire/ -- Aksys, Ltd. (Nasdaq:   AKSY), a
 pioneer in innovative dialysis systems, today reported results for the first
 quarter ended March 31, 2001.
     For the first quarter, the Company reported a net loss of $4.0 million, or
 $0.22 per share, compared with a net loss of $3.6 million, or $0.24 per share,
 for the first quarter of 2000.  Operating expenses decreased $0.7 million to
 $4.3 million, primarily due to a reduction in research and development
 expenses of $1.2 million.  The reduction in research and development expenses,
 and the related reduction in joint development income, is attributed to the
 completion of the joint development project between Aksys and Teijin.
 Pre-commercialization expenses increased approximately $350,000 to
 $0.5 million during the first quarter of 2001, as the Company continues to
 prepare for the commercial launch of the Personal Hemodialysis (PHD(TM))
 System expected to occur during the second half of 2001, pending clearance
 from the US Food and Drug Administration.  General and administrative expenses
 increased approximately $150,000 to $1.2 million, due primarily to executives
 hired during the second half of 2000.  Interest income increased to $255,000
 from $190,000, due to earnings on net proceeds from the private placements of
 the Company's common shares completed during 2000.  At March 31, 2001, Aksys
 had total cash and short-term investments of $8.7 million, and long-term
 investments of $5.9 million.
     "We began 2001 by accomplishing a major milestone," stated Bill Dow,
 President and CEO.  "We submitted our 510(k) Pre-market Notification to the
 FDA on January 16.  During the agency's review period, we continue to build a
 commercial foundation upon which we expect to introduce the PHD System during
 the second half of this year.  In addition, our recent participation at the
 dialysis conference in New Orleans supported our belief that interest in daily
 hemodialysis continues to increase, and we look forward to making that therapy
 available to end-stage renal disease patients soon."
     Aksys, Ltd. is developing hemodialysis products and services for patients
 suffering from kidney failure.  The Company's lead product in development, the
 PHD System, is a next generation hemodialysis system designed to improve
 clinical outcomes of patients and reduce mortality, morbidity and the
 associated high cost of patient care.  Further information is available on
 Aksys' website: http://www.aksys.com .  This press release contains
 forward-looking statements that involve a number of risks and uncertainties.
 Our actual results or events could differ materially from the results or
 events identified or implied in any forward-looking statement.  These
 statements are based on our views as of the date they are made with respect to
 future results or events.  Factors that could cause such a difference include,
 but are not limited to, (i) risks related to the failure to meet development
 and manufacturing milestones for the PHD System on a timely basis, (ii) risks
 related to the regulatory approval process, (iii) market, regulatory and
 reimbursement conditions, including without limitation patient/clinic
 acceptance of the PHD System, (iv) additional capital requirements with
 respect to among other things the commercialization of the PHD System, (v)
 changing assumptions with respect to projected unit pricing, product cost,
 gross margin and operating profit targets as identified in the business plan,
 which are as yet untested, (vi) risks inherent in relying on a third party to
 manufacture products, (vii) the impact of products which may be developed,
 adapted or may otherwise compete with the PHD System and (viii) changes in QSR
 requirements.  Regulatory approval risks include, without limitation, whether
 and when we will obtain clearance from the FDA of a 510(k) pre-market
 notification and similar clearances from other countries in which we may
 attempt to distribute the PHD System.  Additional clinical trials and/or other
 data may be needed in order to obtain regulatory clearances.
     The Company does not undertake to publicly update or revise its
 forward-looking statements even if experience or future changes make it clear
 that any projected results or events expressed or implied therein will not be
 realized.
 
 
                           AKSYS, LTD. AND SUBSIDIARY
                        (a development stage enterprise)
 
                       CONSOLIDATED STATEMENTS OF OPERATIONS
                                    (Unaudited)
 
                                       Three-month periods ended March 31,
                                            2001                2000
     Revenues:
       Joint development income                 $-           $1,175,000
 
     Operating expenses:
       Research and development          2,585,000            3,796,000
       Business development                527,000              179,000
       General and administrative        1,177,000            1,030,000
 
     Total operating expenses            4,289,000            5,005,000
 
     Operating income (loss)            (4,289,000)          (3,830,000)
 
     Interest income                       255,000              191,000
 
     Net income (loss)                 $(4,034,000)         $(3,639,000)
 
     Net income (loss) per share,
      basic and diluted                     $(0.22)              $(0.24)
 
     Weighted average shares
      outstanding                       18,387,000           15,219,000
 
 
                            SELECTED BALANCE SHEET DATA
 
                                            March 31,    December 31,
                                               2001          2000
 
     Cash and short-term investments      $8,710,000    $19,122,000
     Working capital                       8,045,000     16,636,000
     Long-term investments                 5,847,000        780,000
     Total assets                         17,576,000     22,188,000
     Total liabilities                     1,945,000      2,839,000
     Stockholders' equity                 15,631,000     19,349,000
 
 

SOURCE Aksys, Ltd.
    LINCOLNSHIRE, Ill., April 19 /PRNewswire/ -- Aksys, Ltd. (Nasdaq:   AKSY), a
 pioneer in innovative dialysis systems, today reported results for the first
 quarter ended March 31, 2001.
     For the first quarter, the Company reported a net loss of $4.0 million, or
 $0.22 per share, compared with a net loss of $3.6 million, or $0.24 per share,
 for the first quarter of 2000.  Operating expenses decreased $0.7 million to
 $4.3 million, primarily due to a reduction in research and development
 expenses of $1.2 million.  The reduction in research and development expenses,
 and the related reduction in joint development income, is attributed to the
 completion of the joint development project between Aksys and Teijin.
 Pre-commercialization expenses increased approximately $350,000 to
 $0.5 million during the first quarter of 2001, as the Company continues to
 prepare for the commercial launch of the Personal Hemodialysis (PHD(TM))
 System expected to occur during the second half of 2001, pending clearance
 from the US Food and Drug Administration.  General and administrative expenses
 increased approximately $150,000 to $1.2 million, due primarily to executives
 hired during the second half of 2000.  Interest income increased to $255,000
 from $190,000, due to earnings on net proceeds from the private placements of
 the Company's common shares completed during 2000.  At March 31, 2001, Aksys
 had total cash and short-term investments of $8.7 million, and long-term
 investments of $5.9 million.
     "We began 2001 by accomplishing a major milestone," stated Bill Dow,
 President and CEO.  "We submitted our 510(k) Pre-market Notification to the
 FDA on January 16.  During the agency's review period, we continue to build a
 commercial foundation upon which we expect to introduce the PHD System during
 the second half of this year.  In addition, our recent participation at the
 dialysis conference in New Orleans supported our belief that interest in daily
 hemodialysis continues to increase, and we look forward to making that therapy
 available to end-stage renal disease patients soon."
     Aksys, Ltd. is developing hemodialysis products and services for patients
 suffering from kidney failure.  The Company's lead product in development, the
 PHD System, is a next generation hemodialysis system designed to improve
 clinical outcomes of patients and reduce mortality, morbidity and the
 associated high cost of patient care.  Further information is available on
 Aksys' website: http://www.aksys.com .  This press release contains
 forward-looking statements that involve a number of risks and uncertainties.
 Our actual results or events could differ materially from the results or
 events identified or implied in any forward-looking statement.  These
 statements are based on our views as of the date they are made with respect to
 future results or events.  Factors that could cause such a difference include,
 but are not limited to, (i) risks related to the failure to meet development
 and manufacturing milestones for the PHD System on a timely basis, (ii) risks
 related to the regulatory approval process, (iii) market, regulatory and
 reimbursement conditions, including without limitation patient/clinic
 acceptance of the PHD System, (iv) additional capital requirements with
 respect to among other things the commercialization of the PHD System, (v)
 changing assumptions with respect to projected unit pricing, product cost,
 gross margin and operating profit targets as identified in the business plan,
 which are as yet untested, (vi) risks inherent in relying on a third party to
 manufacture products, (vii) the impact of products which may be developed,
 adapted or may otherwise compete with the PHD System and (viii) changes in QSR
 requirements.  Regulatory approval risks include, without limitation, whether
 and when we will obtain clearance from the FDA of a 510(k) pre-market
 notification and similar clearances from other countries in which we may
 attempt to distribute the PHD System.  Additional clinical trials and/or other
 data may be needed in order to obtain regulatory clearances.
     The Company does not undertake to publicly update or revise its
 forward-looking statements even if experience or future changes make it clear
 that any projected results or events expressed or implied therein will not be
 realized.
 
 
                           AKSYS, LTD. AND SUBSIDIARY
                        (a development stage enterprise)
 
                       CONSOLIDATED STATEMENTS OF OPERATIONS
                                    (Unaudited)
 
                                       Three-month periods ended March 31,
                                            2001                2000
     Revenues:
       Joint development income                 $-           $1,175,000
 
     Operating expenses:
       Research and development          2,585,000            3,796,000
       Business development                527,000              179,000
       General and administrative        1,177,000            1,030,000
 
     Total operating expenses            4,289,000            5,005,000
 
     Operating income (loss)            (4,289,000)          (3,830,000)
 
     Interest income                       255,000              191,000
 
     Net income (loss)                 $(4,034,000)         $(3,639,000)
 
     Net income (loss) per share,
      basic and diluted                     $(0.22)              $(0.24)
 
     Weighted average shares
      outstanding                       18,387,000           15,219,000
 
 
                            SELECTED BALANCE SHEET DATA
 
                                            March 31,    December 31,
                                               2001          2000
 
     Cash and short-term investments      $8,710,000    $19,122,000
     Working capital                       8,045,000     16,636,000
     Long-term investments                 5,847,000        780,000
     Total assets                         17,576,000     22,188,000
     Total liabilities                     1,945,000      2,839,000
     Stockholders' equity                 15,631,000     19,349,000
 
 SOURCE  Aksys, Ltd.