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U.S. 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, 2002
[ ] TRANSITION 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
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
88 Sidney Street, Cambridge, MA 02139-4136
(Address of principal executive offices) (Zip Code)
Registrant's telephone number including area code: (617) 494-0171
64 Sidney Street, Cambridge, MA 02139-4136
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)
ALKERMES CLINICAL PARTNERS, L.P.
(A LIMITED PARTNERSHIP)
INDEX
Page No.
--------
PART I - FINANCIAL INFORMATION
Item 1. Financial Statements
Balance Sheets 3
-June 30, 2002 and December 31, 2001
Statements of Operations 4
-Three and six months ended June 30, 2002 and 2001
Statements of Cash Flows 5
-Six months ended June 30, 2002 and 2001
Notes to Financial Statements 6
Item 2. Management's Discussion and Analysis of 8
Financial Condition and Results of Operations
Item 3. Quantitative and Qualitative Disclosures About Market Risk 10
PART II - OTHER INFORMATION
Item 6. Exhibits, Financial Statement Schedules and Reports 11
on Form 8-K
SIGNATURES 12
EXHIBIT INDEX 13
(2)
ITEM 1. FINANCIAL STATEMENTS:
ALKERMES CLINICAL PARTNERS, L.P.
(A Limited Partnership)
BALANCE SHEETS
(Unaudited)
June 30, December 31,
2002 2001
---- ----
ASSETS
Total Assets $ -- $ --
======== ========
LIABILITIES AND PARTNERS' CAPITAL
Total Liabilities and Partners' Capital $ -- $ --
======== ========
See notes to financial statements.
(3)
ALKERMES CLINICAL PARTNERS, L.P.
(A LIMITED PARTNERSHIP)
STATEMENTS OF OPERATIONS
(Unaudited)
Three Months Three Months Six Months Six Months
Ended Ended Ended Ended
June 30, June 30, June 30, June 30,
2002 2001 2002 2001
---- ---- ---- ----
Revenue $ -- $ -- $ -- $ --
---------- ---------- ---------- ----------
Expenses:
General and administrative 2,947 1,916 7,740 3,959
---------- ---------- ---------- ----------
2,947 1,916 7,740 3,959
---------- ---------- ---------- ----------
Net Loss ($ 2,947) ($ 1,916) ($ 7,740) ($ 3,959)
========== ========== ========== ==========
Net Loss Per Class A and B Unit $ -- $ -- $ -- $ --
========== ========== ========== ==========
Average Class A and B Units Outstanding 921 921 921 921
========== ========== ========== ==========
See notes to financial statements.
(4)
ALKERMES CLINICAL PARTNERS, L.P.
(A LIMITED PARTNERSHIP)
STATEMENTS OF CASH FLOWS
(Unaudited)
Six Months Six Months
Ended Ended
June 30, June 30,
2002 2001
---- ----
Cash flows from operating activities:
Net loss ($ 7,740) ($ 3,959)
---------- ----------
Net cash used by operating activities (7,740) (3,959)
---------- ----------
Cash flows from financing activities:
General Partner's capital contributions 7,740 3,959
---------- ----------
Net cash provided by financing activities 7,740 3,959
---------- ----------
Net decrease in cash -- --
Cash, beginning of period -- --
---------- ----------
Cash, end of period $ -- $ --
========== ==========
See notes to financial statements.
(5)
ALKERMES CLINICAL PARTNERS, L.P.
(A LIMITED PARTNERSHIP)
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, 2002 and 2001,
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, 2001, which includes financial
statements and notes thereto for the years ended December 31, 2001, 2000 and
1999.
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 Alkermes Development Corporation II (the "General
Partner"). There were no losses attributable to the Limited Partners for the
three and six months ended June 30, 2002 and 2001.
3. COMPLETION OF SCHEDULED FUNDING
For the three and six months ended June 30, 2002 and 2001, the Partnership
incurred no research and development expenses related to the RMP(TM) program,
notwithstanding the continuing development of the product candidate. The
Partnership had previously provided funding to Alkermes, Inc. ("Alkermes") for
research and development expenses for Cereport(R) 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)
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, 2002, the Partnership is expected to continue to have no future
liquidity or capital resources requirements other than those funded by Alkermes.
(7)
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," "expects," "anticipates,"
"believes," "estimates," "continues" 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 the Partnership's results of operations will not
differ materially from its expectations. Factors which could cause actual
results to differ from expectations include, among others:
(i) clinical trials for Cereport(R) 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;
(ii) the Company could reduce or discontinue funding of Cereport;
(iii) the Partnership and the Company could not be permitted by regulatory
authorities to undertake additional clinical trials for Cereport or
clinical trials could be delayed or regulatory authorities could require
additional clinical trials before approving Cereport;
(iv) the Company could incur difficulties or set-backs in obtaining the
substantial additional funding required to continue research and
development programs and clinical trials;
(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)
RESULTS OF OPERATIONS
Revenue
The Partnership had no revenue for the three and six months ended June 30, 2002
and 2001. The Partnership anticipates that it will have no revenue in the
foreseeable future.
Expenses
The Partnership had no research and development expenses for the three and six
months ended June 30, 2002 and 2001. There were no research and development
expenses 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,
2002 were $2,947 and $7,740 as compared to $1,916 and $3,959 for the three and
six months ended June 30, 2001. The increase for the three and six months ended
June 30, 2002 compared to June 30, 2001 was mainly a result of increased
professional service fees. 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 and thereby acquires all limited
partnership interests in the Partnership (see Liquidity and Capital Resources).
LIQUIDITY AND CAPITAL RESOURCES
At June 30, 2002, the Partnership had no remaining assets or 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 from
capital contributions received from Partners. Such development was and continues
to be 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.
(9)
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 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. Since the Partnership's current
assets are depleted, Alkermes intends to continue to cause the General Partner
to perform such services at its expense in order 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, 2002, the Partnership is expected to continue to have no future
liquidity or capital resources requirements other than those funded by Alkermes.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK:
Not applicable.
(10)
ITEM 6. EXHIBITS, FINANCIAL STATEMENT SCHEDULES AND REPORTS ON FORM 8-K
(a) Exhibits:
Number Exhibit
------ -------
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.*
99.1 Certification pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002, 18 U.S.C.
Section 1350 by Chief Executive Officer.
99.2 Certification pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002, 18 U.S.C.
Section 1350 by Chief Financial Officer.
* Incorporated by reference to Exhibits to the Registrant's Registration
Statement on Form 10 filed September 13, 1995.
(b) Since the beginning of the quarter ended June 30, 2002, the
Registrant has not filed any reports on Form 8-K.
(11)
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 14, 2002 By: /s/ Richard F. Pops
---------------------------------------
Richard F. Pops
Director, President and Chief Executive
Officer (Principal Executive Officer)
Date: August 14, 2002 By: /s/ James M. Frates
---------------------------------------
James M. Frates
Director, Vice President, Chief
Financial Officer, Treasurer and
Assistant Secretary (Principal
Financial and Accounting Officer)
(12)
EXHIBIT INDEX
Exhibit
Number Description
------ -----------
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.*
99.1 Certification pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002, 18 U.S.C.
Section 1350 by Chief Executive Officer.
99.2 Certification pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002, 18 U.S.C.
Section 1350 by Chief Financial Officer.
* Incorporated by reference to Exhibits to the Registrant's Registration
Statement on Form 10 filed September 13, 1995.
(13)