<PAGE>
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
/X/ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 1999
/ / QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the transition period from __________ to __________
Commission file number 0-26758
ALKERMES CLINICAL PARTNERS, L.P.
(Exact name of registrant as specified in its charter)
DELAWARE 043-145043
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(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
64 SIDNEY STREET, CAMBRIDGE, MA 02139-4136
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number including area code: (617) 494-0171
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NOT APPLICABLE
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Former name, former address, and former fiscal year, if changed since last
report
Indicate by check mark whether the registrant (1) has filed all reports
required to be filed by Section 13 or 15(d) of the Securities Exchange Act of
1934 during the preceding 12 months (or for such shorter period that the
registrant was required to file such reports), and (2) has been subject to such
filing requirements for the past 90 days. Yes /X/ No / /
(1)
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ALKERMES CLINICAL PARTNERS, L.P.
INDEX
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PAGE NO.
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PART I - FINANCIAL INFORMATION
Item 1. Financial Statements
Balance Sheets 3
-June 30, 1999 and December 31, 1998
Statements of Operations 4
-Three months ended June 30, 1999 and 1998
-Six months ended June 30, 1999 and 1998
Statements of Cash Flows 5
-Six months ended June 30, 1999 and 1998
Notes to Financial Statements 6
Item 2. Management's Discussion and Analysis of 8
Financial Condition and Results of Operations
PART II - OTHER INFORMATION
Item 6. Exhibits, Financial Statement Schedules and Reports 13
on Form 8-K
SIGNATURES 14
EXHIBIT INDEX 15
</TABLE>
(2)
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ITEM 1. FINANCIAL STATEMENTS:
ALKERMES CLINICAL PARTNERS, L.P.
(A Limited Partnership)
BALANCE SHEETS
(Unaudited)
<TABLE>
<CAPTION>
June 30, December 31,
1999 1998
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<S> <C> <C>
A S S E T S
Total Assets $-- $--
----------------- ----------------
----------------- ----------------
LIABILITIES AND PARTNERS' CAPITAL
----------------- ----------------
Total Liabilities and Partners Capital $-- $--
----------------- ----------------
----------------- ----------------
</TABLE>
See notes to financial statements.
(3)
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ALKERMES CLINICAL PARTNERS, L.P.
(A Limited Partnership)
STATEMENTS OF OPERATIONS
(Unaudited)
<TABLE>
<CAPTION>
Three Months Three Months Six Months Six Months
Ended Ended Ended Ended
June 30, June 30, June 30, June 30,
1999 1998 1999 1998
------------- ------------- ------------- -------------
<S> <C> <C> <C> <C>
Revenue:
Interest income $-- $-- $-- $--
------------- ------------- ------------- -------------
Expenses:
General and administrative 2,695 -- 20,903 --
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2,695 -- 20,903 --
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Net loss ($2,695) $-- ($20,903) $--
------------- ------------- ------------- -------------
------------- ------------- ------------- -------------
Net Loss Per Class A and B Unit $-- $-- $-- $--
------------- ------------- ------------- -------------
------------- ------------- ------------- -------------
Average Units Outstanding 921 921 921 921
------------- ------------- ------------- -------------
------------- ------------- ------------- -------------
</TABLE>
See notes to financial statements.
(4)
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ALKERMES CLINICAL PARTNERS, L.P.
(A Limited Partnership)
STATEMENTS OF CASH FLOWS
(Unaudited)
<TABLE>
<CAPTION>
Six Months Six Months
Ended Ended
June 30, June 30,
1999 1998
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<S> <C> <C>
Cash flows from operating activities:
Net loss ($20,903) $--
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Net cash used for operating activities (20,903) --
---------------- -----------------
Cash flows from financing activities:
General Partner cash capital contributions 20,903 --
---------------- -----------------
Net decrease in cash and cash equivalents -- --
Cash and cash equivalents, beginning of period -- --
---------------- -----------------
Cash and cash equivalents, end of period $-- $--
---------------- -----------------
---------------- -----------------
</TABLE>
See notes to financial statements.
(5)
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ALKERMES CLINICAL PARTNERS, L.P.
NOTES TO FINANCIAL STATEMENTS
1. BASIS OF PRESENTATION
The financial statements for Alkermes Clinical Partners, L.P. (the
"Partnership") for the three and six month periods ended June 30, 1999 and 1998,
are unaudited and include all adjustments which, in the opinion of management,
are necessary to present fairly the results of operations for the periods then
ended. All such adjustments are of a normal recurring nature. These financial
statements should be read in conjunction with the Partnership's Annual Report on
Form 10-K for the year ended December 31, 1998, which includes financial
statements and notes thereto for the years ended December 31, 1998, 1997 and
1996.
The results of the Partnership's operations for any interim period are not
necessarily indicative of the results of the Partnership's operations for any
other interim period or for a full year.
2. NET LOSS PER CLASS A AND B LIMITED PARTNERSHIP INTEREST
Net loss per Class A and B limited partnership interest is calculated with the
net loss attributable only to the limited partners of the Partnership (each, a
"Limited Partner" and collectively, the "Limited Partners") and excludes the
loss attributable to the General Partner. There were no losses attributable to
the Limited Partners for the three and six months ended June 30, 1999 and 1998.
The Partnership accounts for earnings per share in accordance with the
provisions of Statement of Financial Accounting Standards No. 128 ("SFAS No.
128"), "Earnings per Share." SFAS No. 128 does not have any impact on the
Partnership's financial statements because the Partnership does not have, and is
not expected to have, any common stock equivalents.
3. COMPLETION OF SCHEDULED FUNDING
For the three and six months ended June 30, 1999, the Partnership incurred no
research and development expenses related to the RMP-TM- program,
notwithstanding the continuing development of such product candidate. The
Partnership was providing funding to Alkermes, Inc. ("Alkermes") for research
and development expenses for Cereport-TM- from capital contributions received
from Partners. Funding to Alkermes ended during the quarter ended June 30, 1996
when such capital contributions were substantially depleted. None of the
Partners of the Partnership is obligated to make any further capital
contributions. Since the funding was not sufficient for Alkermes to complete
clinical trials and seek regulatory approval of Cereport, Alkermes has used its
own resources, and intends to continue to use its own resources, to develop
Cereport. Alkermes has obtained and intends to continue to obtain such resources
through equity offerings, bank borrowings and its collaborative arrangements.
Alkermes is required to fund the development of Cereport to maintain its
Purchase Option with the Limited Partners.
(6)
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Alkermes is also obligated, through the General Partner, to perform
administrative services for the Partnership, such as preparing financial
statements, tax returns and reports to Partners. Alkermes intends to continue to
cause the General Partner to perform such services at its expense since the
Partnership's current assets are depleted, unless it exercises its Purchase
Option and thereby acquires all the interests in the Partnership. The services
performed by Alkermes and the General Partner constitute all of the activities
undertaken by or on behalf of the Partnership.
After June 30, 1999, the Partnership is expected to have no future liquidity or
capital resources requirements other than those funded by Alkermes.
(7)
<PAGE>
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
INTRODUCTION
Alkermes Clinical Partners, L.P. (the "Partnership") was formed on February 7,
1992, and is managed by its general partner, Alkermes Development Corporation II
(the "General Partner"), a wholly owned subsidiary of Alkermes, Inc. ("Alkermes"
or the "Company"). The Partnership was organized to fund the further development
and clinical testing of a family of molecules, designated by Alkermes as
Receptor-Mediated Permeabilizers-TM- ("RMPs-TM-"), for human pharmaceutical use
in the United States and Canada.
IMPORTANT FACTORS REGARDING FORWARD-LOOKING STATEMENTS
Any statements set forth below or otherwise made in writing or orally by the
Partnership or the General Partner with regard to its expectations as to
financial results and other aspects of its business may constitute
forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995. These statements can be identified by
forward-looking words such as "may", "will", "expect", "anticipate", "believe",
"estimate", "continue" or similar words. Although the General Partner believes
that its expectations are based on reasonable assumptions within the bounds of
its knowledge of its business and operations, there can be no assurance that
actual results of the Partnership's or the Company's development activities and
its results of operations will not differ materially from its expectations.
Factors which could cause actual results to differ from expectations include,
among others:
(i) the Partnership and the Company could not be permitted by regulatory
authorities to undertake additional clinical trials for Cereport-TM- or
clinical trials could be delayed or regulatory authorities could
require additional clinical trials before approving Cereport;
(ii) clinical trials for Cereport may not proceed as planned, the trials may
require more time to enroll patients than anticipated, and even if they
are completed Cereport could prove to be ineffective or unsafe;
(iii) the Company could incur difficulties or set-backs in obtaining the
substantial additional funding required to continue research and
development programs and clinical trials;
(iv) the Company could reduce or discontinue funding of Cereport;
(v) even if Cereport appears promising at an early stage of development, it
could fail to receive necessary regulatory approvals, be difficult to
manufacture on a large scale, be uneconomical, fail to achieve market
acceptance, be precluded from commercialization by proprietary rights
of third parties or experience substantial competition in the
marketplace; and
(vi) technological change in the biotechnology or pharmaceutical industries
and the approval of other drugs or therapies to treat brain tumors
could render Cereport obsolete or noncompetitive.
(8)
<PAGE>
RESULTS OF OPERATIONS
REVENUES
The Partnership did not have any revenue for the three and six months ended June
30, 1999 and 1998. The Partnership anticipates that it will have no interest
income in the foreseeable future as the Partnership's assets were depleted
during the quarter ended September 30, 1997.
EXPENSES
There were no research and development expenses for the three and six months
ended June 30, 1999 and 1998 because of the completion of the development
funding to Alkermes pursuant to the product development agreement between
Alkermes and the Partnership (the "Product Development Agreement").
General and administrative expenses for the three and six months ended June 30,
1999 were $2,695 and $20,903, as compared to zero and zero for the three and six
months ended June 30, 1998. The increase was mainly a result of increased
professional service fees incurred by the Partnership and paid through the
General Partner. Alkermes is obligated through the General Partner to perform
general and administrative services for the Partnership at its expense, unless
Alkermes exercises its Purchase Option (see Liquidity and Capital Resources).
LIQUIDITY AND CAPITAL RESOURCES
At June 30, 1999, the Partnership had no remaining current assets or current
liabilities.
The Partnership's primary source of funding and capital resources had been the
annual capital contributions by the Limited Partners and the General Partner.
The Limited Partners' capital contributions were remitted to the Partnership in
four annual installments, the fourth and final payment of which was due on April
15, 1995. There have been and will be no additional capital contributions
received by the Partnership from the Limited Partners after the quarter ended
June 30, 1996.
The Partnership was funding research and development expenses for Cereport-TM-
from capital contributions received from Partners. Such development is being
conducted for the Partnership by Alkermes pursuant to the Product Development
Agreement. The research and development funding to Alkermes ended during the
quarter ended June 30, 1996 when such capital contributions were substantially
depleted. None of the Partners is obligated to make any further capital
contributions. Because the funding was not sufficient for Alkermes to complete
clinical trials and seek regulatory approval of Cereport, Alkermes has used its
own resources, and intends to continue to obtain such resources through equity
offerings, bank borrowings and its collaborative arrangements. Effective
September 30, 1997, Alkermes entered into an agreement with ALZA Corporation
related to the development and commercialization of Cereport. Alkermes is
required to fund the development of Cereport to maintain its Purchase Option
with the Limited Partners.
The Partnership used its remaining cash and cash equivalents during the quarter
ended September 30, 1997 to pay for administrative services for the Partnership.
Alkermes is
(9)
<PAGE>
obligated, through the General Partner, to perform administrative services for
the Partnership, such as preparing financial statements, tax returns and reports
to the Limited Partners. Alkermes intends to continue to cause the General
Partner to perform such services at its expense (since the Partnership's current
assets are depleted) to maintain its Purchase Option with the Limited Partners,
unless it exercises its Purchase Option and thereby acquires all limited
partnership interests in the Partnership. The activities performed by Alkermes
and the General Partner constitute all of the activities undertaken by or on
behalf of the Partnership.
After June 30, 1999, the Partnership is expected to have no future liquidity or
capital resources requirements other than those funded by Alkermes.
YEAR 2000 READINESS DISCLOSURE
The Year 2000 problem concerns the application of computer systems written using
six (e.g., 12/31/99) versus eight (e.g., 12/31/1999) digits to define the
applicable date. This could result, among other things, in computer systems
recognizing "00" as the year 1900 rather than the year 2000. Computer hardware,
software and embedded chip equipment are potentially affected, and, if such
systems and components are not remediated satisfactorily, could lead to
operational interruptions and business misinformation.
The Partnership does not own or use any hardware, software or other equipment
because the General Partner and Alkermes conduct all of the research,
development and general administrative operations of the Partnership.
Alkermes' Year 2000 Compliance Plan provides for a four-phase process:
inventory, assessment, remediation and testing, and preparation of
contingency plans. Alkermes has identified its mission critical and medium
priority internal systems which will require remediation to provide for
Alkermes' continuing business operations after January 1, 2000. The remaining
systems are considered to be of low priority because they are judged to have
no direct impact on safety or the business.
The inventory phase is completed for Alkermes, except that Alkermes' new
subsidiary, AIR, is in the final stages of completing its inventory. The
assessment phase is substantially completed, except for information not yet
received from external suppliers, vendors and manufacturers. Progress
continues to be made in the remediation phase of Alkermes' plan in which
systems that are not Year 2000 compliant are repaired, replaced or retired,
and remediated systems are tested and returned to active use. Alkermes has
requested all suppliers of mission critical equipment owned or leased by
Alkermes containing embedded chip technology to provide Alkermes with each
supplier's Year 2000 testing methodology and results and/or Alkermes has
performed in-house testing on such equipment. As of August 13, 1999, there
has been an approximate 34% response rate to Alkermes' requests for
information sent to vendors and manufacturers of equipment, hardware and
software purchased or leased by Alkermes. This percentage reflects new
information obtained in Alkermes' continuing efforts to bring its new
subsidiary, AIR, up to date with Alkermes' Year 2000 Compliance Plan and
finalizes inventory information for all of Alkermes' departments. Based on
the responses received as of August 13, 1999, approximately 1% of Alkermes'
mission critical systems are not compliant. Alkermes has determined what is
required to make these systems
(10)
<PAGE>
compliant and is either in the process of remediation or will begin remediation
soon. All assessment and remediation efforts are scheduled to be completed by
September 30, 1999.
Alkermes believes its mission critical and medium priority internal computer
systems will be Year 2000 compliant in a timely manner. However, Alkermes'
computer systems are complex, highly interdependent and there are a number of
risks associated with the complexity and high degree of integration of the
systems. For example, an incorrect classification of the importance of a system
or systems, or the cumulative effect of a number of low priority systems that
have not been remediated, could result in an unpredicted failure or shutdown in
one or more of Alkermes' business, processing or manufacturing systems, which
could have a material adverse effect on production or cost of operations.
Alkermes' current belief is that this has a relatively low probability of
occurring. To minimize these risks, Alkermes is utilizing its skilled and
knowledgeable internal resources and has employed contract personnel in its
decision-making processes and to perform integrated systems testing.
Alkermes is continuing a process of requesting and assessing compliance
information from all of its suppliers, strategic partners and other
organizations with which Alkermes does business (each a "Third Party").
Certain of these Third Parties may refuse to respond to a readiness survey or
request for information. It is possible that Third Parties may, in fact, be
prepared to address Year 2000 concerns, but simply refuse to respond.
Conversely, various Third Parties may respond that they are Year 2000 ready,
when, in fact, they are not ready. As of August 13, 1999, approximately 50%
of all Third Parties have responded to the survey. Approximately 48% of all
Third Parties have responded that they are or will be Year 2000 compliant on
a timely basis. These percentages reflect responses from all Third Parties.
If the Year 2000 problem causes suppliers and utility providers to fail to
deliver essential materials and services, multiple disruptions in Alkermes'
operations, computer infrastructure or telecommunications systems could
result. Because of the inherent uncertainties associated with the Year 2000
problem, including understanding the Year 2000 readiness of the Third
Parties, it is not possible to quantify the potential impact. However,
failure of key suppliers, utility providers, strategic partners, other
organizations or Alkermes to address properly and timely the Year 2000
problem could have a material adverse effect on Alkermes' financial
condition, results of operations or liquidity. Furthermore, there can be no
guarantee that any contingency plans developed by Alkermes will prevent such
failures from having a material adverse effect. Alkermes believes that there
is a low probability that these multiple failures will occur.
Contingency plans are being formulated by each of Alkermes' various departments.
The plans are to be completed by September 30, 1999 for each of Alkermes'
mission critical systems. These plans may be updated or revised during the
remainder of 1999. Alkermes currently expects total external expenditures to
become Year 2000 compliant to be less than $1 million. To date, Alkermes has
incurred external expenditures of approximately $500,000. In addition, Alkermes
has dedicated significant internal resources, including staff and equipment, to
Year 2000 projects, but does not track such costs and therefore cannot provide
an estimate of the amount of such internal costs. Alkermes will fund Year 2000
expenditures from cash and expects that total
(11)
<PAGE>
remediation costs, including the reallocation of internal resources, will not
have a material adverse effect on Alkermes' financial condition, results of
operations or liquidity.
The foregoing information reflects management's best estimates. These estimates
are based upon many assumptions, including: assumptions about cost, availability
and ability of resources to identify and classify systems properly; properly
identifying them as needing remediation; locating, remediating and modifying
affected systems; and making various assessments of Year 2000 readiness of key
Third Parties. Based upon its activities to date, Alkermes does not believe that
these factors will cause its current cost and timetable projections to differ
significantly from those estimated. However, Alkermes cannot reasonably estimate
the potential impact on its financial condition, results of operations or
liquidity if critical Third Parties, including suppliers and governments, do not
become Year 2000 compliant on a timely basis.
(12)
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ITEM 6. EXHIBITS, FINANCIAL STATEMENT SCHEDULES AND REPORTS ON FORM 8-K
(a) Exhibits:
<TABLE>
<CAPTION>
NUMBER EXHIBIT
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<S> <C>
3.1 Alkermes Clinical Partners, L.P. Agreement of Limited
Partnership, dated as of February 7, 1992.*
3.1(a) Amendment No. 1 to Alkermes Clinical Partners, L.P. Agreement
of Limited Partnership, dated as of September 29, 1992.*
3.1(b) Amendment No. 2 to Alkermes Clinical Partners, L.P. Agreement
of Limited Partnership, dated as of March 30, 1993.*
4.1 Alkermes Clinical Partners, L.P. Agreement of Limited
Partnership, dated as of February 7, 1992.*
4.1(a) Amendment No. 1 to Alkermes Clinical Partners, L.P. Agreement
of Limited Partnership, dated as of September 29, 1992.*
4.1(b) Amendment No. 2 to Alkermes Clinical Partners, L.P. Agreement
of Limited Partnership, dated as of March 30, 1993.*
11 Statement Regarding Computation of Per Share Loss.
27 Financial Data Schedule.
</TABLE>
* Incorporated by reference to Exhibits to the Registrant's Registration
Statement on Form 10 filed September 13, 1995.
(b) During the quarter ended June 30, 1999, the Registrant filed
a report on Form 8-K dated April 7, 1999 under Item 5.
(13)
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
ALKERMES CLINICAL PARTNERS, L.P.
(Registrant)
By its General Partner
ALKERMES DEVELOPMENT CORPORATION II
Date: August 16, 1999 By: /s/ RICHARD F. POPS
-------------------------------------
Richard F. Pops
Director, President and Chief Executive
Officer (Principal Executive Officer)
Date: August 16, 1999 By: /s/ JAMES M. FRATES
------------------------------------
James M. Frates
Director, Vice President, Chief
Financial Officer, Treasurer and
Assistant Secretary (Principal
Financial and Accounting Officer)
(14)
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EXHIBIT INDEX
<TABLE>
<CAPTION>
EXHIBIT
NUMBER DESCRIPTION
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<S> <C>
3.1 Alkermes Clinical Partners, L.P. Agreement of Limited
Partnership, dated as of February 7, 1992.*
3.1(a) Amendment No. 1 to Alkermes Clinical Partners, L.P. Agreement
of Limited Partnership, dated as of September 29, 1992.*
3.1(b) Amendment No. 2 to Alkermes Clinical Partners, L.P. Agreement
of Limited Partnership, dated as of March 30, 1993.*
4.1 Alkermes Clinical Partners, L.P. Agreement of Limited
Partnership, dated as of February 7, 1992.*
4.1(a) Amendment No. 1 to Alkermes Clinical Partners, L.P. Agreement
of Limited Partnership, dated as of September 29, 1992.*
4.1(b) Amendment No. 2 to Alkermes Clinical Partners, L.P. Agreement
of Limited Partnership, dated as of March 30, 1993.*
11 Statement Regarding Computation of Per Share Loss.
27 Financial Data Schedule.
</TABLE>
* Incorporated by reference to Exhibits to the Registrant's Registration
Statement on Form 10 filed September 13, 1995.
<PAGE>
EXHIBIT 11
STATEMENT REGARDING COMPUTATION OF PER SHARE LOSS
<TABLE>
<CAPTION>
Three Months Three Months Six Months Six Months
Ended Ended Ended Ended
June 30, 1999 June 30, 1998 June 30, 1999 June 30, 1998
------------- ------------- ------------- -------------
<S> <C> <C> <C> <C>
Net loss-Limited Partners $0 $0 $0 $0
Average Class A and B units outstanding 921 921 921 921
Net loss per Class A and B unit $0 $0 $0 $0
</TABLE>
<TABLE> <S> <C>
<PAGE>
<ARTICLE> 5
<LEGEND>
THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM THE 10-Q FOR
THE SIX MONTHS ENDED JUNE 30, 1999 AND IS QUALIFIED IN ITS ENTIRETY BY REFERENCE
TO SUCH FINANCIAL STATEMENTS.
</LEGEND>
<MULTIPLIER> 1,000
<S> <C>
<PERIOD-TYPE> 6-MOS
<FISCAL-YEAR-END> DEC-31-1999
<PERIOD-START> JAN-01-1999
<PERIOD-END> JUN-30-1999
<CASH> 0
<SECURITIES> 0
<RECEIVABLES> 0
<ALLOWANCES> 0
<INVENTORY> 0
<CURRENT-ASSETS> 0
<PP&E> 0
<DEPRECIATION> 0
<TOTAL-ASSETS> 0
<CURRENT-LIABILITIES> 0
<BONDS> 0
0
0
<COMMON> 0
<OTHER-SE> 0
<TOTAL-LIABILITY-AND-EQUITY> 0
<SALES> 0
<TOTAL-REVENUES> 0
<CGS> 0
<TOTAL-COSTS> 20,903
<OTHER-EXPENSES> 0
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> 0
<INCOME-PRETAX> (20,903)
<INCOME-TAX> 0
<INCOME-CONTINUING> (20,903)
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> (20,903)
<EPS-BASIC> 0
<EPS-DILUTED> 0
</TABLE>
