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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
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(X) QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended September 30, 1996
OR
( ) 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 0-18554
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GENZYME DEVELOPMENT PARTNERS, L.P.
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(Exact name of registrant as specified in its charter)
Delaware 04-3065192
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(State or other jurisdiction of (IRS Employer
incorporation or organization) Identification No.)
One Kendall Square, Cambridge, Massachusetts 02139
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(Address of principal executive offices) (Zip Code)
(617) 252-7500
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(Registrant's telephone number, including area code)
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
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Total number of pages in document - 12
Exhibit index is located on page 11
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GENZYME DEVELOPMENT PARTNERS, L.P.
(A DEVELOPMENT STAGE ENTERPRISE)
FORM 10-Q, SEPTEMBER 30, 1996
TABLE OF CONTENTS
PAGE NO.
--------
PART I. FINANCIAL INFORMATION
ITEM 1. Unaudited Condensed Financial Statements
Statements of Operations for the Three and Nine Months Ended
September 30, 1996 and 1995 and Cumulative from Inception
(September 7, 1989) ........................................... 3
Balance Sheets as of September 30, 1996 and December 31,1995 ... 4
Statements of Cash Flows for the Nine Months Ended
September 30, 1996 and 1995 and Cumulative from Inception
(September 7, 1989) ........................................... 5
Notes to Unaudited Condensed Financial Statements .............. 6
ITEM 2. Management's Discussion and Analysis of Financial
Condition and Results of Operations ..................... 7-8
ITEM 6. Exhibits and Reports on Form 8-K ........................ 9
Signatures ............................................................. 10
2
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PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
GENZYME DEVELOPMENT PARTNERS, L.P.
(A DEVELOPMENT STAGE ENTERPRISE)
<TABLE>
STATEMENTS OF OPERATIONS
(UNAUDITED, IN THOUSANDS, EXCEPT PER UNIT AMOUNTS)
<CAPTION>
THREE MONTHS ENDED NINE MONTHS ENDED CUMULATIVE
SEPTEMBER 30, SEPTEMBER 30, FROM INCEPTION
----------------- ------------------- (SEPTEMBER 7,
1996 1995 1996 1995 1989)
---- ---- ---- ---- -----
<S> <C> <C> <C> <C> <C>
Investment income ................ $ 7 $ 7 $ 22 $ 22 $ 1,251
Royalty revenue .................. 6 -- 15 -- 15
------- ----- ------- ----- ---------
13 7 37 22 1,266
------- ----- ------- ----- ---------
Costs and expenses:
Professional fees ............. 180 -- 180 -- 180
Retainer fee .................. -- -- -- -- 1,500
Research and development ...... -- -- -- -- 27,060
Management fee ................ -- -- -- -- 2,613
Interest expense .............. -- -- -- -- 933
Amortization of organization
and start-up costs ........... -- -- -- -- 570
Other ......................... -- 68 63 87 911
------- ----- ------- ----- ---------
180 68 243 87 33,767
------- ----- ------- ----- ---------
Net loss ......................... $ (167) $ (61) $ (206) $ (65) $ (32,501)
======= ===== ======= ===== =========
Net loss per partnership unit:
Limited partners
(based on 737 units) ........ $ (224) $ (82) $ (277) $ (87) $ (43,658)
======= ===== ======= ===== =========
General partner
(based on 1 unit) ........... $(1,670) $(610) $(2,060) $(650) $(325,010)
======= ===== ======= ===== =========
</TABLE>
The accompanying notes are an integral part of these
unaudited, condensed financial statements.
3
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GENZYME DEVELOPMENT PARTNERS, L.P.
(A DEVELOPMENT STAGE ENTERPRISE)
<TABLE>
BALANCE SHEETS
(UNAUDITED, IN THOUSANDS)
<CAPTION>
SEPTEMBER 30, DECEMBER 31,
1996 1995
---- ----
<S> <C> <C>
ASSETS
Cash and cash equivalents .......................... $ 317 $ 466
----- -----
Total assets ................................ $ 317 $ 466
===== =====
LIABILITIES AND PARTNERS' CAPITAL
Liabilities:
Payable to Genzyme Corporation .................. 174 117
Partners' capital (including deficit accumulated
during the development stage of $32,501):
General partner ................................ 41 43
Class A limited partners ....................... 136 340
Class B limited partner ........................ -- --
----- -----
177 383
Less: unpaid partners' capital ................. (34) (34)
----- -----
Total partners' capital ...................... 143 349
----- -----
Total liabilities and partners' capital ..... $ 317 $ 466
===== =====
</TABLE>
The accompanying notes are an integral part of these
unaudited, condensed financial statements.
4
<PAGE> 5
GENZYME DEVELOPMENT PARTNERS, L.P.
(A DEVELOPMENT STAGE ENTERPRISE)
<TABLE>
STATEMENTS OF CASH FLOWS
(UNAUDITED, IN THOUSANDS)
<CAPTION>
NINE MONTHS ENDED
SEPTEMBER 30, CUMULATIVE
----------------- FROM INCEPTION
1996 1995 (SEPTEMBER 7, 1989)
---- ---- -------------------
<S> <C> <C> <C>
Cash flow from operating activities:
Net loss .......................................... $(206) $ (65) $(32,501)
Reconciliation of net loss to net cash
used by operating activities:
Amortization ................................... -- -- 570
Organization and start-up costs ................ -- -- (570)
Increase (decrease) in cash from
working capital:
Payable to Genzyme Corporation .................... 57 (115) 174
----- ----- --------
Net cash used by operating activities ............. (149) (180) (32,327)
Cash flow from investing activities:
Purchases of short-term investments ............... -- (300) (45,220)
Sales and maturities of short-term investments .... -- 300 45,220
----- ----- --------
Net cash used by investing activities ............. -- -- --
----- ----- --------
Cash flow from financing activities:
Issuance of partnership units ..................... -- -- 32,644
Issuance of note payable - bank ................... -- -- 4,100
Repayment of note payable - bank .................. -- -- (4,100)
----- ----- --------
Net cash provided by financing activities ......... -- -- 32,644
----- ----- --------
Increase (decrease) in cash and cash equivalents ..... (149) (180) 317
Cash and cash equivalents at beginning of period ..... 466 618 --
----- ----- --------
Cash and cash equivalents at end of period ........... $ 317 $ 438 $ 317
===== ===== ========
</TABLE>
The accompanying notes are an integral part of these
unaudited, condensed financial statements.
5
<PAGE> 6
GENZYME DEVELOPMENT PARTNERS, L.P.
(A DEVELOPMENT STAGE ENTERPRISE)
SEPTEMBER 30, 1996
NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
1. BASIS FOR PRESENTATION
Genzyme Development Partners, L.P. (the "Partnership") was
formed on September 7, 1989 as a development stage enterprise to
develop, produce and derive income from the sale in the United States
and Canada of products (the "Surgical Products") to be used during
surgical procedures to limit the formation of postoperative adhesions
and, in arthroscopic procedures, as a synovial fluid replacement. The
Surgical Products are based on hyaluronic acid, a biopolymer produced
naturally by the body to lubricate and protect tissue. The Partnership
commenced operations on November 3, 1989.
Per partnership unit information is based on the number of
partnership units outstanding at the end of each period. Units
outstanding have not changed since the date of capitalization of the
Partnership.
These unaudited, condensed financial statements should be read
in conjunction with the Partnership's Annual Report on Form 10-K for
the fiscal year ended December 31, 1995 and the financial statements
and footnotes included therein. Certain information and footnote
disclosures normally included in financial statements prepared in
accordance with generally accepted accounting principles have been
condensed or omitted pursuant to the Securities and Exchange Commission
rules and regulations.
The financial statements for the three and nine months ended
September 30, 1996 and 1995 and cumulative from inception (September 7,
1989) are unaudited but include, in the opinion of management, all
adjustments (consisting only of normally recurring accruals) necessary
for a fair presentation of the results for the periods presented.
2. ACCOUNTING POLICIES
The accounting policies, except as noted below, underlying the
quarterly financial statements are those set forth in Note B of the
financial statements included in the Company's Annual Report on Form
10-K for the year ended December 31, 1995.
3. ROYALTY REVENUE RECOGNITION
Pursuant to the European royalty provision in the Cross License
Agreement, the Partnership recognizes royalty revenue due from Genzyme
based on net revenues from the sales of Surgical Products in Europe.
Initial sales of such products have commenced in the Netherlands. In
the three and nine months ended September 30, 1996, royalty revenues
from Genzyme of approximately $6,000 and $15,000, respectively, were
recognized.
4. DEVELOPMENT AGREEMENT
The Partnership's available funds were fully expended during the
first quarter of 1994. Pursuant to the Development Agreement, Genzyme
has committed to continue funding, for the twelve month period
commencing March 1, 1996, the development program at no expense to the
Partnership.
6
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GENZYME DEVELOPMENT PARTNERS, L.P.
(A DEVELOPMENT STAGE ENTERPRISE)
FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 1996
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
RESULTS OF OPERATIONS
- ---------------------
The Partnership recognized royalty revenue of $6,000 and $15,000,
respectively, in the three and nine months ended September 30, 1996. There were
no sales of Surgical Products in corresponding periods of 1995 and, therefore,
no royalty revenues. Initial sales of Surgical Products commenced in the
Netherlands in late 1995 and selling initiatives are expanding throughout Europe
Administrative expenses increased to $180,000 and $243,000, respectively, in the
three and nine months ended September 30, 1996 and from $68,000 and $87,000,
respectively, in the corresponding periods of 1995 due primarily to increased
legal expenses incurred by the Partnership related to maintenance of its
patents, negotiations related to the Joint Venture formed with Genzyme to
manufacture and market the Partnership's products in the North America and
increased audit fees. The Partnership incurred net losses of $167,000 for the
three months ended September 30, 1996 as compared to a loss of $61,000 in the
corresponding period in 1995. For the nine months ended September 30, 1995 and
1996, net losses increased from $65,000 to $206,000, respectively, due to
increased administrative expenses which were slightly offset by the addition of
royalty revenue not present in 1995 and despite consistent investment income.
Investment income in each of the three and nine months ended September
30, 1996 and 1995 was $7,000 and $22,000, respectively, primarily due to
consistent average cash balances.
FINANCIAL CONDITION
- -------------------
As of September 30, 1996, the Partnership had $317,000 in cash and cash
equivalents which is reserved for general and administrative expenses and the
Partnership's commitment to the Joint Venture. Genzyme, for its own account,
initiated marketing efforts for Seprafilm[TM] in Europe late in 1995. Under the
terms of the Cross License Agreement with Genzyme, the Partnership is entitled
to receive a royalty of 6% of net revenues recognized from European sales of the
Surgical Products to the extent necessary to pay certain projected distributions
to the partners in any year. The General Partner believes that the Partnership
will continue to be eligible to receive such royalties during 1996. The General
Partner believes that substantial additional funds will be required to complete
the development, clinical testing and commercialization of the Surgical
Products. Genzyme has funded the research and development program for the
Surgical Products on an annual basis since the first quarter of 1994, when all
the available funds of the Partnership were substantially depleted, and
currently has committed to provide such funding through February 28, 1997. While
Genzyme was not obligated to fund the research and development program,
Genzyme's option to purchase all of the limited partnership interests would have
terminated unless Genzyme committed annually to provide such funding until
approval from the U.S. Food and Drug Administration ("FDA") of any of the
Surgical Product is obtained. As described further below, the FDA has approved
Seprafilm[TM] bioresorbable membrane for marketing in the United States and,
accordingly, Genzyme will have no further obligation to fund research and
development upon expiration of Genzyme's current commitment in February of 1997.
On August 13, 1996, the FDA granted approval to market Seprafilm[TM]
for use in any open abdominal or pelvic surgery. On behalf of the Joint Venture,
Genzyme officially launched Seprafilm[TM] in the United States in October using
the 70-person sales force of Deknatel Snowden Pencer, Inc. ("DSP"), a surgical
products company acquired by Genzyme in July 1996. Under the terms of agreements
between the Partnership and Genzyme, the Joint Venture formed between Genzyme
and the Partnership will manufacture and market Seprafilm[TM] in North America
under contract with Genzyme. Genzyme and the Partnership expect to conclude
negotiations during the fourth quarter to establish definitive terms for the
Joint Venture, including the allocation between the parties of profits and
losses from the Joint Venture.
Also during the third quarter, Genzyme received the Approval of
Conformity Certificate (the "CE Mark") for Sepracoat[TM] coating solution in
accordance with the European Medical Devices Directive. The CE Mark indicates
that the
7
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product meets quality standards necessary for selling in the 18 countries
included in the European Economic Area. Under the CE Mark, Sepracoat[TradeMark]
can be applied at the beginning of and throughout abdominal, pelvic and thoracic
surgical procedures. Genzyme is preparing for the market introduction of
Sepracoat[TM] in Europe during the fourth quarter.
Data from the pivotal study evaluating HAL-S[TradeMark] made available
during the third quarter showed some improvement in the rehabilitation rate of
patients. In light of the relatively modest improvement and the small potential
market size, however, no formal decision has been made concerning whether to
continue the development of HAL-S[Trademark].
8
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GENZYME DEVELOPMENT PARTNERS, L.P.
FORM 10-Q, SEPTEMBER 30, 1996
PART II. OTHER INFORMATION
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
(a) Exhibits
27 Financial Data Schedule for Genzyme Development Partners,
L.P. (for EDGAR filing purposes only).
(b) Reports on Form 8-K
No reports on Form 8-K were filed during the quarter ending
September 30, 1996.
9
<PAGE> 10
GENZYME DEVELOPMENT PARTNERS, L.P.
FORM 10-Q, SEPTEMBER 30, 1996
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.
GENZYME DEVELOPMENT PARTNERS, L.P.
(Registrant)
By: GENZYME DEVELOPMENT CORPORATION II
General Partner
DATE: November 14, 1996 By: /s/ David J. McLachlan
-------------------------------------
David J. McLachlan
Duly Authorized Officer and
Principal Financial Officer
10
<PAGE> 11
GENZYME DEVELOPMENT PARTNERS, L.P.
FORM 10-Q, SEPTEMBER 30, 1996
EXHIBIT INDEX
Exhibit
No. Description Page No.
- ------- ----------- --------
27 Financial Data Schedule for Genzyme Development
Partners, L.P. (for EDGAR filing purposes only). 12
11
WARNING: THE EDGAR SYSTEM ENCOUNTERED ERROR(S) WHILE PROCESSING THIS SCHEDULE.
<TABLE> <S> <C>
<ARTICLE> 5
<LEGEND>
THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM THE
CONDENSED FINANCIAL STATEMENTS OF GENZYME DEVELOPMENT PARTNERS, L.P. (THE
"PARTNERSHIP") FOR THE NINE MONTHS ENDED SEPTEMBER 30, 1996 AND IS QUALIFIED IN
ITS ENTIRETY BY REFERENCE TO SUCH FINANCIAL STATEMENTS. EARNINGS FOR THE
PARTNERSHIP ARE REPORTED BASED ON PARTNERSHIP UNITS, THEREFORE EARNINGS PER
SHARE DATA IS NOT APPLICABLE AND HAS BEEN EXCLUDED FROM THESE SCHEDULES. NET
LOSS PER PARTNERSHIP UNIT FOR LIMITED PARTNERS, BASED ON 737 UNITS WAS $4(280)K
PER UNIT FOR THE NINE MONTHS ENDING SEPTEMBER 30, 1996. THE NET LOSS FOR THE
GENERAL PARTNER BASED ON ONE UNITE FOR THE NINE MONTHS ENDING SEPTEMBER 30,
1996 WAS $(650)K.
</LEGEND>
<MULTIPLIER> 1,000
<CURRENCY> US DOLLARS
<S> <C>
<PERIOD-TYPE> 9-MOS
<FISCAL-YEAR-END> DEC-31-1996
<PERIOD-START> JAN-01-1996
<PERIOD-END> SEP-30-1996
<EXCHANGE-RATE> 1
<CASH> 317
<SECURITIES> 0
<RECEIVABLES> 0
<ALLOWANCES> 0
<INVENTORY> 0
<CURRENT-ASSETS> 317
<PP&E> 0
<DEPRECIATION> 0
<TOTAL-ASSETS> 317
<CURRENT-LIABILITIES> 175
<BONDS> 0
<COMMON> 0
0
0
<OTHER-SE> 0
<TOTAL-LIABILITY-AND-EQUITY> 142
<SALES> 0
<TOTAL-REVENUES> 0
<CGS> 0
<TOTAL-COSTS> 0
<OTHER-EXPENSES> 180
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> 0
<INCOME-PRETAX> (206)
<INCOME-TAX> 0
<INCOME-CONTINUING> (206)
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> (206)
<EPS-PRIMARY> N/A
<EPS-DILUTED> N/A
</TABLE>
