<PAGE> 1
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, 1998
[ ] 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
------------------------------- --------------------
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
64 Sidney Street, Cambridge, MA 02139-4136
- ---------------------------------------- ----------
(Address of principal executive offices) (Zip Code)
Registrant's telephone number including area code: (617) 494-0171
Not Applicable
- --------------------------------------------------------------------------------
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
--- ---
<PAGE> 2
ALKERMES CLINICAL PARTNERS, L.P.
INDEX
Page No.
--------
PART I - FINANCIAL INFORMATION
Item 1. Financial Statements
Balance Sheets 3
-June 30, 1998 and December 31, 1997
Statements of Operations 4
-Three months ended June 30, 1998 and 1997
-Six months ended June 30, 1998 and 1997
Statements of Cash Flows 5
-Six months ended June 30, 1998 and 1997
Notes to Financial Statements 6
Item 2. Management's Discussion and Analysis of 7
Financial Condition and Results of Operations
PART II - OTHER INFORMATION
Item 6. Exhibits, Financial Statement Schedules and Reports 10
on Form 8-K
SIGNATURES 11
EXHIBIT INDEX 12
(2)
<PAGE> 3
ITEM 1. FINANCIAL STATEMENTS:
ALKERMES CLINICAL PARTNERS, L.P.
(A LIMITED PARTNERSHIP)
BALANCE SHEETS
(Unaudited)
<TABLE>
<CAPTION>
June 30, December 31,
1998 1997
-------- ------------
<S> <C> <C>
ASSETS
Total Assets $ -- $ --
====== ======
LIABILITIES AND PARTNERS' CAPITAL
------ ------
Total Liabilities and Partners' Capital $ -- $ --
====== ======
</TABLE>
See notes to financial statements.
(3)
<PAGE> 4
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,
1998 1997 1998 1997
------------ ------------ ---------- ----------
<C> <C> <C> <C>
Revenue:
Interest income $ -- $ 62 $ -- $ 217
---- ----- ---- -------
Expenses:
General and administrative -- 283 -- 2,339
---- ----- ---- -------
-- 283 -- 2,339
---- ----- ---- -------
Net loss $ -- $(221) $ -- $(2,122)
==== ===== ==== =======
Net Loss Per Class A and B Unit $ -- $ -- $ -- $ --
==== ===== ==== =======
Average Units Outstanding 921 921 921 $ 921
==== ===== ==== =======
</TABLE>
See notes to financial statements.
(4)
<PAGE> 5
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,
1998 1997
---------- ----------
<C> <C>
Cash flows from operating activities:
Net loss $ -- $(2,122)
Adjustment to reconcile net loss to net cash used
for operating activities:
Changes in assets and liabilities:
Accrued expenses -- (25,169)
---- -------
Net cash used for operating activities -- (27,291)
---- -------
Net decrease in cash and cash equivalents -- (27,291)
Cash and cash equivalents, beginning of period -- 32,804
---- -------
Cash and cash equivalents, end of period $ -- $ 5,513
==== =======
</TABLE>
See notes to financial statements.
(5)
<PAGE> 6
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, 1998 and 1997,
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, 1997, which includes financial
statements and notes thereto for the years ended December 31, 1997, 1996 and
1995.
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
losses attributable to the General Partner. There were no losses attributable to
the General Partner or the Limited Partners for the three and six months ended
June 30, 1998. The entire net loss for the three and six months ended June 30,
1997, was attributable to the General Partner, and consequently, there were no
losses attributable to the Limited Partners for such periods. In February 1997,
the Financial Accounting Standards Board released Statement of Financial
Accounting Standards No. 128 ("SFAS No. 128"), "Earnings per Share," which the
Partnership adopted in the fourth quarter of 1997. The adoption of SFAS No. 128
did 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, 1998, 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), formerly known as RMP-7, 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.
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, 1998, the Partnership is expected to have no future liquidity or
capital resources requirements other than those funded by Alkermes.
(6)
<PAGE> 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"). 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. Although the General Partner believes that its
expectations are based on reasonable assumptions within the bounds of its
knowledge of its business and operations, the Partnership's and the Company's
businesses are subject to significant risks and there can be no assurance that
actual results of the Partnership's or the Company's development activities and
their respective results of operations will not differ materially from
expectations. Accordingly, the Partnership hereby identifies the following
important factors, among others, which could cause its results to differ from
any results which might be projected, forecasted or estimated by the Partnership
or the General Partner in any such forward-looking statements: (i) the
Partnership and the Company could not be permitted by regulatory authorities to
undertake additional clinical trials for Cereport(TM) (formerly known as
RMP-7(TM)) or clinical trials could be delayed or regulatory authorities could
require additional clinical trials; (ii) Cereport could be ineffective or unsafe
during clinical trials; (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) even if Cereport appears
promising at its current 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 (v) technological change in the
biotechnology or pharmaceutical industries could render Cereport obsolete or
noncompetitive.
RESULTS OF OPERATIONS
Revenues
The Partnership's sole source of revenue for the three and six months ended June
30, 1997 was the interest earned on the investments made with the capital
contributions made by the General Partner and the limited partners of the
Partnership (the "Limited Partners") prior to their disbursement to Alkermes for
research and development and/or other Partnership expenses. There was no
interest income for the three and six months ended June 30, 1998, as compared to
$62 and $217 for the corresponding periods of the prior year. Interest income
for the three and six months ended June 30, 1998 as compared to the same period
in 1997 decreased as a result of the depletion of the Partnership's cash. 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. The decrease in the cash of the Partnership is a result of
the completion of the payment of the development funding to Alkermes during the
quarter ended June 30, 1996. The development funding to Alkermes was made
pursuant to the product development agreement between Alkermes and the
Partnership (the "Product Development Agreement").
(7)
<PAGE> 8
Expenses
There were no research and development expenses for the three and six months
ended June 30, 1998 and 1997 as a result of the completion of the development
funding to Alkermes pursuant to the Product Development Agreement.
There were no general and administrative expenses for the three and six months
ended June 30, 1998, as compared to $283 and $2,339 for the three and six months
ended June 30, 1997. The decrease was mainly a result of the depletion of the
Partnership's assets during the quarter ended September 30, 1997. 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, 1998, 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 installment payments, 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 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.
The Partnership does not own or use any software systems or any other automated
equipment. Alkermes and the companies with which it does business, however, use
software systems and embedded technology in the conduct of their operations.
Many software systems and much technology in use today are unable to distinguish
the year 2000 and the year 1900 because they use a two-digit shorthand for
calendar dates. If Alkermes does not identify and correct any such shorthand
prior to January 1, 2000, its operations could be disrupted. Alkermes'
operations could also be disrupted if the companies with which Alkermes does
significant business similarly are not year 2000 compliant, and such failure
adversely affects their ability to do business with Alkermes.
(8)
<PAGE> 9
To address these issues, Alkermes has undertaken a three-step comprehensive
project. The first step is to identify all of its software and embedded
technology. The second step is to determine whether any of Alkermes' software
and technology use the two-digit shorthand and to determine whether the
companies with which Alkermes does significant business will be year 2000
compliant. The third step is to correct or replace all such software and
technology and then to test the corrected or replacement software and
technology. Alkermes has completed the first step of the project, expects to
complete the second step by the end of calendar year 1998 and will commence the
third step promptly upon completion of the second step. This project is being
conducted by Alkermes using internal resources. Alkermes cannot estimate the
cost of completion of the project until it completes the second step, and there
can be no assurance that the cost of completion of the project will not be
material, that the project will be completed on a timely basis or that the use
of its internal resources to complete the project will not adversely affect
other aspects of its business. In the event that any of the companies with which
Alkermes does significant business do not successfully achieve year 2000
compliance on a timely basis, Alkermes' business could be adversely affected.
After June 30, 1998, the Partnership is expected to have no future liquidity or
capital resources requirements other than those funded by Alkermes.
(9)
<PAGE> 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.*
11 Statement Regarding Computation of Per Share Loss.
27 Financial Data Schedule.
*Incorporated by reference to Exhibits to the Registrant's Registration
Statement on Form 10 filed September 13, 1995.
(b) The Registrant has not filed any reports on Form 8-K during the
quarter ended June 30, 1998.
(10)
<PAGE> 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 12, 1998 By: /s/ Richard F. Pops
---------------------------------------
Richard F. Pops
Director, President and Chief Executive
Officer (Principal Executive Officer)
Date: August 12, 1998 By: /s/ James M. Frates
---------------------------------------
James M. Frates
Director, Vice President, Chief
Financial Officer, Treasurer and
Assistant Secretary (Principal
Financial and Accounting Officer)
(11)
<PAGE> 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.*
11 Statement Regarding Computation of Per Share Loss.
27 Financial Data Schedule.
*Incorporated by reference to Exhibits to the Registrant's Registration
Statement on Form 10 filed September 13, 1995.
(12)
<PAGE> 1
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, 1998 June 30, 1997 June 30, 1998 June 30, 1997
------------- ------------- ------------- -------------
<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>
<ARTICLE> 5
<LEGEND>
THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM THE 10-Q FOR
THE SIX MONTHS ENDED JUNE 30, 1998 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-31-1998
<PERIOD-START> JAN-01-1998
<PERIOD-END> JUN-30-1998
<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> 0
<OTHER-EXPENSES> 0
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> 0
<INCOME-PRETAX> 0
<INCOME-TAX> 0
<INCOME-CONTINUING> 0
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> 0
<EPS-PRIMARY> 0
<EPS-DILUTED> 0
</TABLE>
