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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 10-K
Annual Report Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
For the Fiscal Year Ended December 31, 1997 Commission File No. 0-18554
GENZYME DEVELOPMENT PARTNERS, L.P.
(Exact name of Registrant as specified in its charter)
DELAWARE 04-3065192
(State or other jurisdiction of (I.R.S. Employer Identification No.)
incorporation or organization)
ONE KENDALL SQUARE
CAMBRIDGE, MASSACHUSETTS 02139-1562
(Address of principal executive offices) (Zip Code)
(617) 252-7500
(Registrant's telephone number, including area code)
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Securities registered pursuant to Section 12(b) of the Act:
Name of each exchange
Title of each class on which registered
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None None
Securities registered pursuant to Section 12(g) of the Act:
Class A Limited Partnership Interests
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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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Indicate by check mark if disclosure of delinquent filers pursuant to Item
405 of Regulation S-K is not contained herein, and will not be contained, to the
best of Registrant's knowledge, in definitive proxy or information statements
incorporated by reference in Part III of this Form 10-K or any amendment to this
Form 10-K. [ ]
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NOTE REGARDING FORWARD-LOOKING STATEMENTS:
This Annual Report on Form 10-K for Genzyme Development Partners, L.P. (the
"Partnership") contains forward-looking statements concerning the Partnership's
expected future revenues, operations and expenditures, estimates of the
potential markets for the Partnership's products, assessments of competitors and
potential competitors, projected timetables for the preclinical and clinical
development, regulatory approval and market introduction of the Partnership's
products and estimates of the capacity of manufacturing and other facilities to
support such products. These forward looking statements represent the
expectations of the General Partner as of the filing date of this Form 10-K. The
Partnership's actual results could differ materially from those anticipated by
the forward looking statements due to a number of factors, including (i) the
Partnership's ability to complete successfully preclinical and clinical
development and obtain timely regulatory approval and patent and other
proprietary rights protection for its products, (ii) the content and timing of
decisions made by the U.S. Food and Drug Administration ("FDA") and other
agencies regarding the indications for which the Partnership's products may be
approved, (iii) the actual size and characteristics of markets to be addressed
by the Partnership's products, (iv) market acceptance of the Partnership's
products, (v) the Partnership's ability to obtain reimbursement for its
products, (vi) the accuracy of the Partnership's information concerning the
products and resources of competitors and potential competitors, (vii) funding
of the Partnership's general and administrative expenses and continued funding
of the Partnership's research and development programs by Genzyme Corporation
and (viii) the risks and uncertainties described under the caption "Factors
Affecting Future Operating Results" under Item 7. Management's Discussion and
Analysis of Financial Condition and Results of Operations in this Form 10-K.
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PART I.
Item 1. Business
Genzyme Development Partners, L.P. (the "Partnership") was formed in 1989
to develop, produce and derive income from the sale in the United States and
Canada of products (the "Sepra Products") to be used during surgical procedures
primarily to limit the incidence and severity of postoperative adhesions. The
Sepra Products are based on hyaluronic acid ("HA"), a biopolymer produced
naturally by the body to lubricate and protect tissue.
During surgery, tissues and organs are unavoidably damaged, both directly
as a result of cutting, suturing and cauterization and indirectly as a result of
handling and drying due to exposure. At the site of such damage, tissues or
organs that normally should remain separated often become connected by fibrous
scar tissues called adhesions. The formation of adhesions generally occurs
within the first few days following surgery. Postoperative adhesions can cause
significant complications such as bowel obstruction following abdominal surgery,
infertility and pain following gynecological surgery and restricted limb motion
following musculoskeletal surgery. Adhesions also can increase the complexity,
duration and risk of subsequent surgery.
Genzyme Corporation ("Genzyme"), on behalf of a joint venture between the
Partnership and Genzyme formed to manufacture and market the Partnership's
products (the "Joint Venture"), launched Seprafilm(R) bioresorbable membrane
broadly in the United States during the fourth quarter of 1996 after receipt of
approval from the FDA in August 1996 to market Seprafilm(R) in any open
abdominal or pelvic surgery. Genzyme also launched Seprafilm(R) in Europe during
the second quarter of 1996 and in Canada. The Partnership is entitled to receive
a royalty on European sales of the Sepra Products under certain conditions. In
1997, Genzyme also continued the development of an alternative formulation of
Sepragel(TM) bioresorbable gel for use in laparoscopic surgery. Genzyme ceased
development of Sepracoat(TM) coating solution for the U.S. market as a result of
the recommendation of an advisory panel to the FDA in 1997 that Genzyme not be
granted approval to market Sepracoat(TM) for the reduction of adhesions in
abdominal and pelvic surgery. See "Business - Sepra Products Portfolio" and
"Business - Relationship with Genzyme."
Genzyme has no remaining contractual obligation to fund additional
development of the Sepra Products. However, Genzyme currently intends to
continue funding development of the Sepra Products during 1998 at a level
consistent with prior years and the 1998 budget for the program. In addition,
Genzyme currently intends to fund any administrative expenses in excess of the
Partnership's available cash in 1998. See "Business - Relationship with
Genzyme."
Sepra Products Portfolio
The Partnership's development efforts are focused primarily on Seprafilm(R)
and Sepragel(TM).
Seprafilm (R)
Seprafilm(R) is a solid formulation of modified HA that is used to
separate and protect tissues and organs that have been damaged during surgery.
During the third quarter of 1996, the FDA granted approval to market
Seprafilm(R) in any open abdominal or pelvic surgery. Genzyme, on behalf of
the Joint Venture, launched a broad U.S. marketing effort for Seprafilm(R)
during the fourth quarter of 1996. Genzyme is initially targeting the top 300
hospitals that perform 27% of the colorectal and general abdominal surgeries in
which Seprafilm(R) could be used in the United States. Genzyme is focusing
on high-risk colorectal surgeries, where adhesions are a particular concern. As
of December 31, 1997, in the United States, 258 of the 350 hospitals targeted by
Genzyme had
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purchased Seprafilm(R), with 90% reordering.
Internationally, Genzyme launched sales of Seprafilm(R) in Europe in
1996 after the product was granted the Approval of Conformity Certificate in
accordance with the European Medical Devices Directive. Genzyme also launched
sales of Seprafilm(R) in Canada and Israel in 1997 (a "CE Mark"). Japan granted
Seprafilm(R) regulatory approval in 1997, and working with Kaken
Pharmaceuticals Co., Ltd., Genzyme plans to launch Seprafilm(R) in Japan in
1998. The Partnership does not share in proceeds from sales outside of North
America and Europe. Sales in Japan and Israel, consequently, do not result in
revenue to the Partnership.
Because Seprafilm(R) represents such a notable departure from the
techniques of the past, Genzyme has faced challenges in establishing
Seprafilm(R) as the new standard of care in the surgical industry. To improve
its marketing efforts, Genzyme hired and trained 20 Seprafilm(R) sales
specialists in 1997. Genzyme is also initiating a 1,700-patient, 22-center
clinical trial, designed to measure long-term outcomes related to small bowel
obstruction in patients who receive Seprafilm(R) during surgery compared to
those who do not, thereby providing information about Seprafilm(R)'s cost
effectiveness and role in reducing intestinal obstructions. Genzyme is also
developing a second generation Seprafilm(R) product designed to have
improved elasticity and ease of use that will be suitable for laparoscopic
procedures. Genzyme currently plans to file a supplemental Pre-Marketing
Approval application ("PMA") with the FDA and apply for a CE Mark for the second
generation Seprafilm(R) product in 1998.
The Partnership recognized revenues during 1997 of approximately $44,000
from royalties on Genzyme's European sales of Seprafilm(R).
Sepragel(TM)
Sepragel(TM) is a gel form of modified HA and, like Seprafilm(R), is
intended to be used to separate and protect tissues and organs and thereby
reduce adhesion formation resulting from direct surgical trauma. Sepragel(TM)
is intended to be used in laparoscopic procedures and on tissue surfaces in open
surgery that are inaccessible to Seprafilm(R). Genzyme is continuing
development of an alternative formulation for Sepragel(TM) with improved
properties. Additional patients are expected to be enrolled in the Phase I study
in the next 12 months once work on the formulation is completed.
Sepracoat(TM)
Sepracoat(TM) is a liquid formulation of HA designed to coat tissues and
organs during surgery and thereby reduce adhesions from indirect surgical
trauma. Sepracoat(TM) was granted the CE Mark in 1996 and Genzyme initiated
marketing efforts for Sepracoat(TM) in Europe during the fourth quarter of
1996. In 1997, an advisory panel of the FDA recommended that approval
not be granted to market Sepracoat(TM) for the reduction of adhesions in
abdominal and pelvic surgery. As a result, Genzyme ceased development of
Sepracoat(TM) for the U.S. market.
Manufacturing
On behalf of the Joint Venture and for its own use, Genzyme manufactures
the starting material from which the Sepra Products are produced. Genzyme
manufactures the material at its facilities in the U.K. and ships the material
to the United States for finishing, testing, packaging and labeling. Genzyme
believes that its U.K. facilities have adequate capacity to meet its worldwide
market requirements for this starting material during the foreseeable future.
Seprafilm(R) is produced at Genzyme's manufacturing facilities in
Framingham, Massachusetts. Genzyme engaged a third party to provide the final
finishing and sterile filling for Sepracoat(TM) on a commercial scale for
European sales. During 1995, validation runs required for the Seprafilm(R)
and Sepracoat(TM) PMAs were completed by Genzyme and the contractor and
Genzyme's Seprafilm(R) facilities were inspected by the FDA. Genzyme's
manufacturing plants in the U.S. and the U.K., together with those of the third
party contractor, have been approved by the FDA and received ISO 9000
certification in 1996 to manufacture Seprafilm(R) and Sepracoat(TM).
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Marketing
The Partnership believes that the initial market opportunity for
Seprafilm(R) in the U.S. comprises an estimated 3.1 million procedures
annually, consisting of 1.8 million abdominal operations and 1.3 million
gynecological operations. It is estimated that the Canadian market is roughly
one-tenth the size of the U.S. market. The Partnership and Genzyme believe that
the number of open abdominal and open pelvic procedures that carry a risk of
postoperative adhesion-related complications in Europe is approximately 2.0
million surgeries per year.
The Sepra Products will be purchased primarily by hospitals as surgical
supplies. Accordingly, the Partnership and Genzyme believe that successful
initial market penetration and subsequent maintenance of market share for the
Sepra Products require a specialized hospital-based sales force. On behalf of
the Joint Venture, Genzyme has deployed a sales force to accelerate market
introduction of the Sepra Products in the United States and Europe. Genzyme's
surgical products sales force markets products directly to cardiovascular,
general and gynecologic surgeons and hospital purchasing departments throughout
the United States and Europe. In addition, Genzyme hired and trained 20 sales
representatives dedicated to selling Seprafilm(R) in 1997. Substantial
additional efforts to educate surgeons and hospital administrators as to the
desirability of reducing the incidence and extent of postoperative adhesions and
the benefits of these products will be required in order for the products to
penetrate target markets and gain broad market acceptance. There can be no
assurance that Genzyme will be successful in its efforts to implement a
commercialization strategy for the Sepra Products.
Competition
The Sepra Products face, and will continue to face significant competition
both from other HA-based products and from non-HA-based products intended to
reduce adhesions resulting from surgical trauma. The Partnership and Genzyme
believe that the principal factor that will affect competition among products is
acceptance by surgeons, which depends, in large part, upon product performance
and price.
There are several companies that produce HA using two principal processes:
extraction from natural sources and fermentation. Although several companies are
pursuing fermentation as a method of producing HA, the Partnership and Genzyme
believe that Genzyme's proprietary fermentation production process and its
ability to create chemically modified forms of HA give it a competitive
advantage in the marketing of HA-based products for surgery.
Potential competitors of the Partnership include companies with financial,
manufacturing and marketing resources that are significantly greater than those
of the Partnership and Genzyme. Such companies may have, due to their size and
experience, a competitive advantage over the Partnership and Genzyme in the form
of greater potential funding for research and development and established drug
manufacturing capabilities and distribution channels. In addition, the products
of these potential competitors may exhibit better product performance.
Relationship with Genzyme
In connection with the Partnership's unit offering in November 1989, the
Partnership entered into certain agreements with Genzyme which are summarized
below. The summaries below are qualified in their entirety by the actual
agreements, which are included as exhibits to this Annual Report on Form 10-K.
Cross License Agreement. Genzyme granted to the Partnership an exclusive,
royalty-free license (with the right to grant sublicenses) within the United
States and Canada (the "Territory") to use all patent and technology rights
owned or controlled by Genzyme or acquired by Genzyme necessary or materially
useful to engage in the manufacture, sale, or other disposition of the Sepra
Products for use in human clinical trials or human surgical procedures, other
than in ophthalmic surgery (the "Field of Activity").
The Partnership granted back to Genzyme an exclusive license to use all
patent and technology rights developed under or otherwise acquired during the
term of the Development Agreement (described below) for all
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purposes other than use within the Field of Activity and within the Territory.
The licenses to Genzyme to use all such patent and technology rights outside of
the Field of Activity and in the Field of Activity outside the Territory and
Europe are royalty-free. The license to Genzyme to use such patents and
technology rights in the Field of Activity within Europe is royalty-bearing.
Accordingly, until the earlier of: (i) the date on which Genzyme exercises its
rights under the Partnership Purchase Option Agreement (described below) and
(ii) December 31, 2019, the Partnership will receive a royalty of 6% of net
revenues recognized from the sale of Sepra Products for use in the Field of
Activity in Europe to the extent necessary to allow the Partnership to pay
certain projected distributions to its partners in any year. The Partnership
will also receive a royalty of 5% of all net revenues received by Genzyme and
its affiliates from the sale of non-HA-based competitive products (defined in
the Cross License Agreement) in the Field of Activity and in the Territory.
Pursuant to the European royalty provision in the Cross License Agreement,
Genzyme made royalty payments of approximately $51,000 to the Partnership in
1997, based on net revenues from sales of Seprafilm(R) and Sepracoat(TM) in
Europe.
Development Agreement. The Partnership entered into a Development Agreement
with Genzyme to perform research, experimentation and development to produce
products for use in the Field of Activity. For these services, the Partnership
paid Genzyme in 1989 a non-refundable fee of $1,500,000 and also reimbursed
Genzyme for its expenditures under the Development Agreement plus a fee equal to
10% of such expenditures, subject to a maximum expenditure of the capital
contributions to the Partnership of the General Partner and the Limited Partners
and the interest earned on such funds less the costs related to the offering of
the Partnership units and certain other commitments and expenditures (the
"Available Funds").
The Development Agreement was scheduled to terminate upon Genzyme's
expenditure of the Available Funds prior to receipt by the Partnership of FDA
approval of any Sepra Product unless Genzyme, on that occasion and annually
thereafter until receipt of such approval, contributed to the Partnership
amounts sufficient to fund the development program for the following twelve
month period. In January 1994, the Development Agreement was amended to provide
that, in lieu of contributing the necessary funds to the Partnership, Genzyme
could deliver to the Partnership an annual undertaking to continue the
development program at no expense to the Partnership for each succeeding
twelve-month period until FDA approval of any Sepra Product. Genzyme has
delivered such an undertaking to the Partnership annually from when the
Partnership's Available Funds were expended in March 1994 until February 1996.
Seprafilm(R) received FDA approval in August 1996. As of March 1, 1997, Genzyme
was no longer obligated to fund additional development of the Sepra Products.
However, Genzyme intends to continue such funding during 1998 at a level
consistent with prior years and the 1998 budget for the program as well as the
Partnership's general and administrative expenses in excess of the Partnership's
available cash in 1998.
Joint Venture Agreement. The Partnership and Genzyme formed the Joint
Venture in September 1989 for the purpose of manufacturing and marketing the
Sepra Products in the Field of Activity in the Territory. The Joint Venture was
not expected to engage in active business until receipt of FDA marketing
approval for a Sepra Product. Following the receipt of such approval for
Seprafilm(R), the Joint Venture made its first commercial sale of Seprafilm(R)
in August 1996 (the "Business Commencement Date"). The Partnership has
contributed to the Joint Venture the use of its technology and $1.7 million in
cash, and Genzyme has contributed its agreement to manufacture and market the
Sepra Products, to make non-interest bearing loans to the Joint Venture in the
amount of any working capital deficiency, to make capital contributions to the
extent deemed necessary by the two venturers in connection with the business of
the Joint Venture and to allow the use of such trademarks, tradenames and logos
as the venturers shall determine to be necessary and advisable for manufacturing
and marketing the Sepra Products within the Field of Activity. The Joint Venture
purchases the products from Genzyme at cost, pursuant to a formula in the Joint
Venture Agreement.
The original Joint Venture Agreement called for the Partnership and Genzyme
to determine, following the Business Commencement Date, the allocation of
profits and losses between the parties and the level of reimbursement to Genzyme
for providing general and administrative services to the Joint Venture.
In March 1997, the Partnership and Genzyme amended and restated the Joint
Venture Agreement (as so amended and restated, the "Amended and Restated Joint
Venture Agreement") to address the matters that the original Joint Venture
Agreement provided were to be agreed upon on or about the time of first
commercial sale
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and to address certain other matters. The Amended and Restated Joint Venture
Agreement is retroactive to August 17, 1996, the date of first commercial sale,
and provides that:
(1) losses generated by the Joint Venture are allocated (a) the first
$200,000 to the Partnership and then (b) 40% to the Partnership and 60% to
Genzyme, provided however, that to the extent a loss allocated to the
Partnership would, pursuant to the terms of the Partnership Agreement, be
allocated to the General Partner rather than the limited partners, such loss is
allocated 100% to Genzyme; and
(2) profits are allocated (a) the first $5,600,000 to the Partnership, (b)
the next $8,400,000 to Genzyme and (c) thereafter, 40% to the Partnership and
60% to Genzyme.
The Amended and Restated Joint Venture Agreement also provides that Genzyme
will receive no reimbursement for the general and administrative services it
provides to the Joint Venture until the first year in which the Joint Venture
generates revenues in excess of $25,000,000, at which time, Genzyme will receive
a quarterly commission equal to 10% of the Joint Venture's revenues for such
quarter. In connection with arriving at agreement on the foregoing matters, the
parties also agreed to amend the Joint Venture Agreement to provide the
Partnership with enhanced oversight mechanisms, including an audit right, and to
eliminate Genzyme's unilateral right to withdraw from the Joint Venture.
Marketing and Distribution Agreement. In connection with negotiating the
Amended and Restated Joint Venture Agreement, the Joint Venture entered into an
exclusive marketing and distribution agreement (the "Marketing and Distribution
Agreement") with Genzyme, whereby Genzyme acts as sole distributor of the Sepra
Products for the Joint Venture. The Joint Venture agreed to sell Sepra Products
to Genzyme at the price at which Genzyme is selling the applicable products to
the end-user less a distributor's discount (subject to a minimum purchase price)
and also agreed to reimburse Genzyme for certain costs incurred in connection
with market introduction of the Sepra Products. The economic terms of the
Marketing and Distribution Agreement are intended to be substantially similar to
those applicable if Genzyme provided such services in its capacity as a venturer
rather than as a distributor.
Tax Indemnification Agreement. At the request of a special committee of
directors of the General Partner consisting of the two directors who are not
affiliated with Genzyme, Genzyme also entered into a tax indemnification
agreement (the "Tax Indemnification Agreement") with the Partnership in which
Genzyme agreed, subject to certain limitations, to indemnify the limited
partners against loss of the benefits of certain research and development
deductions certain limited partners have taken (net of potential tax savings due
to any resultant higher tax basis in the limited partnership interests). The Tax
Indemnification Agreement can be waived by the Partnership in connection with a
purchase of the Partnership by Genzyme.
Partnership Purchase Option Agreement. Under the terms of the Partnership
Purchase Option Agreement, Genzyme has an irrevocable option to purchase all of
the limited partnership interests in the Partnership for an advance payment
(subject to recoupment by Genzyme out of royalty payments in subsequent years)
per limited partnership interest equal to, at Genzyme's option, $35,000 in cash,
an equivalent amount in Genzyme General Division Common Stock (valued at a 5%
discount from the market value of such stock) or a combination of the foregoing,
and quarterly royalty payments for a period of ten years after the buy-out date
equal to 10% of product sales in the United States and Canada (and 6% of such
sales in Europe, but only to the extent necessary to meet certain projections
made in connection with the Partnership's unit offering) and 5% of any revenues
derived by Genzyme from sales in the United States and Canada of non-HA-based
competing products (and 3% of such sales
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in Europe, but only to the extent necessary to meet the projections referred to
above).
Genzyme's option to purchase the limited partnership interests is
exercisable during the 90-day period commencing on August 31, 2000, but such
commencement date may be accelerated to the later of: (i) August 31, 1998 or
(ii) the last day of the first month in which the Partnership has received
distributions from the Joint Venture in an aggregate amount of at least $5.5
million.
Patents and Proprietary Technology
Genzyme has granted to the Partnership an exclusive license to all Genzyme
patents and know-how necessary or materially useful in the manufacture, use and
sale of the Sepra Products in the United States and Canada for use in the Field
of Activity and an exclusive sublicense to all third party licenses held by
Genzyme for use in the Field of Activity and the Territory.
The Partnership, through the exclusive license from Genzyme, has rights to
three issued United States patents and three pending United States patent
applications covering modified HA compositions. This technology is used in
Seprafilm(R) and Sepragel(TM). The Partnership, also through the exclusive
license from Genzyme, has rights to three issued United States patents and four
pending United States patent applications that cover methods for using native HA
solutions to coat body tissues prior to surgical manipulation. This technology
is used in Sepracoat(TM).
Various formulations and uses of HA have been the subject of numerous
issued United States patents, one of which was previously unsuccessfully
asserted against Genzyme. There can be no assurance that any other patent will
not be asserted against the Partnership or Genzyme or that additional patents
concerning HA will not be allowed or issued in the future which would require
the Partnership to obtain licenses thereunder to make, use or sell the Sepra
Products. Nor can there be any assurance as to the availability and cost of such
licenses.
Government Regulation
The Sepra Products require FDA approval prior to marketing in the United
States. The Sepra Products are regulated as Class III "devices" in the United
States since they are tissue protective agents which function as physical
barriers.
Products that are classified as Class III "devices" must receive formal FDA
premarket approval before they can be sold commercially in the United States.
The first stage of obtaining formal FDA premarket approval for this class of
device is submission of an application for an investigational device exemption
("IDE"). The IDE permits clinical evaluation of products on human subjects under
controlled experimental conditions by designated qualified medical institutions.
The second stage of obtaining formal FDA premarket approval is the filing of a
PMA. The PMA, which is submitted after clinical evaluations are completed under
the IDE, requires a comprehensive report of all data and information obtained by
the applicant throughout development and testing. The FDA will grant formal
premarket approval if it finds that the safety and effectiveness of the product
have been sufficiently demonstrated and that the product
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complies with all applicable performance and manufacturing standards. The FDA
may require further clinical evaluation of the product, or it may grant
marketing approval but restrict the number of devices distributed or require
additional patient follow-up for an indefinite period of time.
The data submitted to the FDA for the Sepra Products also should be
sufficient to obtain marketing approval of the Sepra Products from the
appropriate regulatory authorities in Canada after appropriate submission and
review in that country. Approval to market Seprafilm(R) in Canada was
obtained in this manner.
Research and Development Costs
During its fiscal year ended December 31, 1997, the Partnership spent
$7.3 million on research and development activities, all of which was funded by
Genzyme.
Employees
The Partnership does not have any employees. The Partnership's business is
conducted under various agreements with Genzyme. See Note C to the Genzyme
Development Partners, L.P. Financial Statements set forth under Item 8 of this
Form 10-K.
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ITEM 2. PROPERTIES
The Partnership itself does not own or lease any properties. The Partnership's
business is conducted at the facilities of the General Partner, at One Kendall
Square in Cambridge, Massachusetts. Under the Development Agreement, Genzyme
utilizes portions of its facilities in Framingham and Cambridge, Massachusetts
and in Haverhill, England to conduct the research and development activities of
the Partnership.
ITEM 3. LEGAL PROCEEDINGS
None.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
None.
PART II
ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS
No public or other market exists or is expected to develop for ownership
interests in the Partnership. Partnership interests are not transferable without
the consent of the General Partner and satisfaction of certain other conditions
contained in Article 8 of the Agreement of Limited Partnership (the "Partnership
Agreement"). There were approximately 763 holders of record of Class A
Partnership interests and 1 holder of Class B Partnership interests as of March
1, 1998.
There have been no cash distributions to the partners to date. Any distributions
in the future will be made by the General Partner to the partners as soon as
practicable after the end of each fiscal quarter, in proportion to the partners'
respective adjusted capital contributions, subject to certain limitations as
provided in the Partnership Agreement.
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ITEM 6. SELECTED FINANCIAL DATA
<TABLE>
<CAPTION>
FOR THE YEARS ENDED DECEMBER 31,
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(DOLLARS IN THOUSANDS, EXCEPT PER UNIT DATA) 1997 1996 1995 1994 1993
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STATEMENTS OF OPERATIONS DATA:
<S> <C> <C> <C> <C> <C>
Royalty revenues .............................. $ 51 $ 23 $ -- $ -- $ --
Costs and expenses:
Research and development (1) .................. -- -- -- 980 7,458
Management fee ................................ -- -- -- 115 731
Amortization of organization and start-up costs -- -- -- 76
114
Administrative expenses ....................... 154 404 124 81 229
--------- --------- ----- -------- --------
Total operating costs and expenses ............ 154 404 124 1,252 8,532
--------- --------- ----- -------- --------
Operating loss ................................ (103) (381) (124) (1,252) (8,532)
Other income (expenses):
Investment income ............................... 25 29 38 24 152
Equity in net loss of joint venture ........... (908) (200) -- -- --
--------- --------- ----- -------- --------
Total other income (expenses) ................. (883) (171) 38 24 152
--------- --------- ----- -------- --------
Net loss ...................................... $ (986) $ (552) $ (86) $ (1,228) $ (8,380)
========= ========= ===== ======== ========
Net loss per partnership unit:
Limited partners -- based on 737 units (2) .... $ 0 $ (461) $(116) $ (1,650) $(11,257)
========= ========= ===== ======== ========
General partner -- based on 1 unit ............ $(986,000) $(212,000) $(860) $(12,280) $(83,800)
========= ========= ===== ======== ========
Dividends - none
</TABLE>
<TABLE>
<CAPTION>
DECEMBER 31,
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1997 1996 1995 1994 1993
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BALANCE SHEET DATA:
<S> <C> <C> <C> <C> <C>
Working capital................................... $(274) $(196) $349 $420 $1,572
Total assets...................................... 631 159 466 618 1,983
Partners' capital (deficit)....................... 318 (196) 349 420 1,648
</TABLE>
(1) Genzyme has funded the Partnership's research and development activities
since the first quarter of 1994, when all of the Partnership's funds available
for research and development were depleted. Since that time, Genzyme has spent
approximately $7.3 million on the Partnership's development programs in 1997,
$6.0 million in 1996, $6.4 million in 1995 and $6.5 million in 1994. Genzyme
currently intends to fund the programs through 1998 at a level consistent with
prior years and the 1998 budget for the programs.
(2) The Limited Partners had no basis in their respective capital accounts and
therefore no losses were allocated to the Limited Partners in 1997.
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ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
INTRODUCTION
The following discussion is a summary of what the General Partner considers to
be the key factors affecting the Partnership's results of operations, liquidity
and capital resources. Forward-looking statements contained in the following
discussion represent the expectations of the General Partner as of the filing
date of this Form 10-K. The Partnership's actual results could differ materially
from those anticipated by the forward looking statements due to the risk and
uncertainties described under the caption "Factors Affecting Future Operating
Results." Partners and potential investors should consider carefully these risks
and uncertainties in evaluating the Partnership's financial condition and
results of operations.
RESULTS OF OPERATIONS
The net loss for the year ended December 31, 1997 was $986,000 compared to
losses of $552,000 and $86,000 for 1996 and 1995, respectively. In August 1996,
Genzyme received marketing approval for the Partnership's first product,
Seprafilm(R), and commenced commercial sales of Seprafilm(R) in the U.S. on
behalf of the Joint Venture. Of the loss recorded in 1997, $908,000 was the
result of the 40% of losses from the Joint Venture that were allocated to the
Partnership pursuant to the Amended and Restated Joint Venture Agreement. In
1996, the net loss was due to administrative expenses of $404,000 and losses
from the Joint Venture of $200,000. The loss from the Joint Venture in 1996 was
limited to the Partnership's basis in the Joint Venture, which was $200,000.
Losses in 1995 were attributable primarily to administrative expenses.
Under the terms of the Cross License Agreement, the Partnership is entitled to
receive a royalty of 6% of net revenues recognized from European sales of the
Sepra Products under certain conditions. In 1997 and 1996, the Partnership
earned $51,000 and $23,000, respectively, of royalty revenue based on European
sales of the Sepra Products by Genzyme which began in late 1995. The only source
of revenue in 1995 was the interest earned on Partnership capital contributions.
For the years ended December 31, 1997, 1996 and 1995, investment income earned
by the Partnership amounted to $25,000, $29,000, and $38,000, respectively.
No research and development expenses were paid to Genzyme during 1997, 1996 or
1995. Genzyme has funded the Partnership's research and development activities
since the first quarter of 1994, when all of the Partnership's funds available
for research and development were depleted. Genzyme spent approximately $7.3
million on the Partnership's development programs in 1997 as compared to $6.0
million in 1996 and $6.4 million in 1995. Genzyme currently intends to fund the
programs through 1998 at a level consistent with prior years and the 1998 budget
for the programs.
Administrative expenses were $154,000, $404,000, and $124,000 in 1997, 1996 and
1995, respectively, and consisted primarily of legal fees. Of the $304,000 in
legal costs incurred in 1996, $154,000 is attributable to legal costs incurred
in evaluating and responding to Genzyme's offer to purchase substantially all
the assets of the Partnership which was subsequently withdrawn. Genzyme
currently intends to fund any administrative expenses in excess of the
Partnership's available cash in 1998.
FINANCIAL CONDITION
As of December 31, 1997, the Partnership had $22,000 in cash and cash
equivalents. All of such funds are reserved for general and administrative
expenses.
The Partnership's future profitability is entirely dependent upon the Joint
Venture's sales of the Sepra Products. The Joint Venture commenced operations
following receipt of FDA marketing approval of Seprafilm(R) in August 1996.
Seprafilm(R) is the first Sepra Product to obtain FDA marketing approval and
was launched in the United States during the fourth quarter of 1996.
Seprafilm(R) is being marketed in the United States and Canada by Genzyme on
behalf of the Joint Venture. On May 5, 1997, the General and Plastic Surgery
Devices Panel of the FDA's Medical Devices Advisory Committee recommended that
Genzyme not be granted approval to market Sepracoat(TM) coating solution for the
reduction of adhesions in abdominal and pelvic surgery. Genzyme subsequently
withdrew the pre-market approval application for Sepracoat(TM). In December
1997, Genzyme decided to discontinue development of Sepracoat(TM) for the
United States market.
-12-
<PAGE> 13
In 1997, Genzyme contributed $1.5 million to the Partnership. Since inception,
the Partnership has contributed to the Joint Venture the use of its technology
and $1.7 million in cash, including an investment of $1.5 million that was made
in 1997. Genzyme has contributed its agreement to manufacture and market the
Sepra Products, to make non-interest bearing loans to the Joint Venture in the
amount of any working capital deficiency and to make capital contributions to
the extent deemed necessary by the two venturers in connection with the business
of the Joint Venture.
Pursuant to the terms of the Amended and Restated Joint Venture Agreement, the
Partnership will receive the first $5.6 million in profits generated by the
Joint Venture, Genzyme will receive the next $8.4 million in profits and,
thereafter, Genzyme and the Partnership will receive a 60% and 40% share,
respectively, in the profits of the Joint Venture. The first $200,000 of the
Joint Venture's losses are allocated to the Partnership and thereafter losses
are allocated 40% to the Partnership and 60% to Genzyme except to the extent
that any tax losses allocable to the Partnership would result in the allocation
of such loss to the General Partner of the Partnership as a result of the
Partnership's Limited Partners' capital account balance having been previously
reduced to zero. In such an event, 100% of the losses, in excess of the first
$200,000, are allocated to Genzyme.
In 1996, the Partnership's capital account was reduced to zero after the
allocation of $200,000 in losses to the Partnership and, accordingly, 100% of
the losses in excess of $200,000 were allocated to Genzyme. As a result of the
Partnership's capital contributions of $1.5 million in cash to the Joint
Venture in 1997, the Partnership was allocated 40% of the Joint Venture losses
during 1997.
The Joint Venture's revenues from sales of the Sepra Products during 1997 were
$3.2 million as compared to $0.4 million in 1996. For the years ended December
31, 1997 and 1996, the Joint Venture incurred net losses of $2.3 million and
$2.5 million, respectively, primarily attributable to costs associated with the
introduction and marketing of Seprafilm(R) to the healthcare marketplace. In
1997 and 1996, the Limited Partners' shares of the Partnership's losses exceeded
the remaining Limited Partners' capital and, accordingly, approximately $976,000
and $206,000, respectively, of the Partnership's losses which would have been
attributable to the Limited Partners were re-allocated to the General Partner
pursuant to terms of the Partnership Agreement.
FACTORS AFFECTING FUTURE OPERATING RESULTS
REQUIREMENTS FOR ADDITIONAL FUNDING
Substantial additional funds will be required to complete the development and
clinical testing of Sepragel(TM) and the other Sepra Products. Genzyme has
funded the research and development program for the Sepra Products on an annual
basis since the first quarter of 1994 when all of the funds of the Partnership
available to develop its products were depleted. Genzyme currently intends to
continue to provide such funding through 1998. Genzyme currently intends to fund
administrative expenses in excess of the Partnership's available cash through
1998. Genzyme is not obligated to provide such funding after 1998.
NO ASSURANCE OF COMMERCIAL SUCCESS
Successful commercialization of the Sepra Products will depend on many factors,
including the breadth of labeling claims allowed by the FDA, the response of
surgeons to the data from clinical trials, market acceptance of the Sepra
Products, Genzyme and the Joint Venture's ability to supply sufficient product
to meet market demand, the degree to which third party reimbursement is
available, and the number and relative efficacy of competitive products that may
subsequently enter the market.
FDA APPROVAL
Sepragel(TM) will require additional FDA approval prior to marketing in the
United States. There can be no assurance that such approval will be obtained or
that the FDA will allow the labeling claims made for the Sepra Products or
permit the marketing of these products for a broad range of applications.
MARKET ACCEPTANCE
The successful commercialization of the Sepra Products will require that
surgeons become convinced of the efficacy of the products in reducing the
formation of postoperative adhesions and incorporate the products as standard
surgical practice in procedures where adhesions are a potential postoperative
complication. Substantial additional efforts to educate surgeons and hospital
administrators as to the benefits of these products will be required, however,
in order for the products to penetrate target markets and gain broad market
acceptance. There can be no assurance that the Sepra Products will gain such
acceptance.
COMPETITION
The Sepra Products will face significant competition both from other HA-based
products and from non-HA-based products intended to reduce adhesions resulting
from surgical trauma. Competitors in the United States and elsewhere are
numerous and include major pharmaceutical, chemical and biotechnology companies,
many of which have
-13-
<PAGE> 14
substantially greater capital resources, marketing experience, research and
development staffs and facilities than the Partnership. These companies may
succeed in developing products that are more effective that any that have been
or may be developed by the Partnership and may also be more successful than
Genzyme and the Joint Venture in producing and marketing these products.
YEAR 2000
Many computer systems experience problems handling dates beyond the year 1999.
Therefore, some computer hardware and software will need to be modified prior to
the year 2000 in order to remain functional. The Partnership relies upon Genzyme
to provide general and administrative and other services, and the Joint Venture
relies upon Genzyme to perform manufacturing, marketing and sales services,
pursuant to certain agreements between Genzyme, the Partnership and the Joint
Venture that involve the use of Genzyme's computer systems (see Note C to the
Genzyme Development Partners, L.P. Financial Statements set forth under Item 8
of this Annual Report). Genzyme is assessing the internal readiness of its
computer systems for handling the year 2000. Genzyme expects to implement
successfully the systems and programming changes necessary to address year 2000
issues, and the Partnership does not believe that the cost of such actions taken
by Genzyme will have a material effect on the Partnership's results of
operations or financial condition. There can be no assurance, however, that
there will not be a delay in, or increased costs associated with, the
implementation of such changes, and Genzyme's inability to implement such
changes could have an adverse effect on future results of operations of the
Partnership.
NEW ACCOUNTING PRONOUNCEMENT
In June 1997, the Financial Accounting Standards Board ("FASB") issued
Statement of Financial Accounting Standards ("SFAS") Nos. 130 and 131.
"Reporting Comprehensive Income" ("SFAS 130") and "Disclosures about Segments
of an Enterprise and Related Information" ("SFAS 131"), respectively
(collectively, the "Statements"). The Statements are effective for fiscal
years beginning after December 15, 1997. SFAS 130 establishes standards for
reporting of comprehensive income and its components in annual financial
statements. SFAS 131 establishes standards for reporting financial and
descriptive information about an enterprise's operating segments in its annual
financial statements and selected segment information in interim financial
reports. Reclassification or restatement of comparative financial statements
or financial information for earlier periods is required upon adoption of SFAS
130 and SFAS 131, respectively. Application of the Statements' disclosure
requirements will have no impact on the Partnerships' financial position,
results of operations or earnings per share data as currently reported.
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not Applicable.
-14-
<PAGE> 15
ITEM 8. FINANCIAL STATEMENTS
<TABLE>
<CAPTION>
PAGE NO.
--------
<S> <C>
Report of Independent Accountants............................................................................... 16
Balance Sheets - December 31, 1997 and 1996..................................................................... 17
Statements of Operations - For the Years Ended December 31, 1997, 1996 and 1995................................. 18
Statements of Cash Flows - For the Years Ended December 31, 1997, 1996 and 1995................................. 19
Statements of Changes in Partners' Capital (Deficit) - For the Years Ended December 31, 1997, 1996 and 1995..... 20
Notes to Financial Statements................................................................................... 21
</TABLE>
All schedules are omitted since the required information is inapplicable or has
been presented in the financial statements and related notes.
-15-
<PAGE> 16
REPORT OF INDEPENDENT ACCOUNTANTS
To the Board of Directors of Genzyme Development Corporation II and Partners of
Genzyme Development Partners, L.P.:
We have audited the financial statements of Genzyme Development Partners, L.P.
(the "Partnership") listed on the index in Item 8 of this Form 10-K. These
financial statements are the responsibility of the Partnership's management. Our
responsibility is to express an opinion on these financial statements based on
our audits.
We conducted our audits in accordance with generally accepted auditing
standards. Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are free of material
misstatement. An audit includes examining, on a test basis, evidence supporting
the amounts and disclosures in the financial statements. An audit also includes
assessing the accounting principles used and significant estimates made by
management, as well as evaluating the overall financial statement presentation.
We believe that our audits provide a reasonable basis for our opinion.
As described in Note A to the financial statements, the Partnership expended all
available research and development funds in 1994. Genzyme Corporation, however,
has funded the research on behalf of the Partnership since 1994 and has
committed to fund research and administrative expenses in 1998.
In our opinion, the financial statements referred to above present fairly, in
all material respects, the financial position of Genzyme Development Partners,
L.P., as of December 31, 1997 and 1996 and the results of its operations, its
changes in partners' capital and its cash flows for each of the three years in
the period ended December 31, 1997 in conformity with generally accepted
accounting principles.
/s/ COOPERS & LYBRAND L.L.P.
Boston, Massachusetts
March 26, 1998
-16-
<PAGE> 17
GENZYME DEVELOPMENT PARTNERS, L.P.
BALANCE SHEETS
(In thousands)
<TABLE>
<CAPTION>
DECEMBER 31,
----------------
1997 1996
---- ----
ASSETS
<S> <C> <C>
Cash and cash equivalents ............................................. $ 22 $ 151
Royalties receivable from Genzyme (Note C) ............................ 17 8
Investment in Joint Venture (Note C) .................................. 592 --
----- -----
Total assets ....................................................... $ 631 $ 159
===== =====
LIABILITIES AND PARTNERS' CAPITAL (DEFICIT)
Accounts payable to Genzyme (Note C) .................................. $ 234 $ 245
Accrued expenses ...................................................... 79 110
----- -----
Total liabilities .................................................. 313 355
----- -----
Commitments and contingencies (Note C) ................................ -- --
Partners' capital (deficit) (including accumulated deficit of $33,833):
General partner .................................................. 345 (169)
Class A limited partners ......................................... -- --
Class B limited partners ......................................... -- --
----- -----
345 (169)
Less: unpaid partners' capital ................................... (27) (27)
----- -----
Total partners' capital (deficit) ............................ 318 (196)
----- -----
Total liabilities and partners' capital (deficit) ............ $ 631 $ 159
===== =====
</TABLE>
The accompanying notes are an integral part of these financial statements.
-17-
<PAGE> 18
GENZYME DEVELOPMENT PARTNERS, L.P.
STATEMENTS OF OPERATIONS
(In thousands, except per unit data)
<TABLE>
<CAPTION>
FOR THE YEARS ENDED DECEMBER 31,
-----------------------------------------
1997 1996 1995
---- ---- ----
<S> <C> <C> <C>
Royalty revenue from Genzyme Corporation (Note C) $ 51 $ 23 --
Costs and expenses:
Administrative expenses ...................... 154 404 124
--------- --------- -----
Operating loss .................................. (103) (381) (124)
Equity in net loss of joint venture (Note C) .... (908) (200) --
Investment income ................................. 25 29 38
--------- --------- -----
Total other income (expenses) ............ (883) (171) 38
--------- --------- -----
Net loss ........................................ $ (986) $ (552) $ (86)
========= ========= =====
Net loss attributable to each partnership unit:
Limited Partners -- based on 737 units ....... $ 0 $ (461) $(116)
========= ========= =====
General Partner -- based on 1 unit ........... $(986,000) $(212,000) $(860)
========= ========= =====
</TABLE>
The accompanying notes are an integral part of these financial statements.
-18-
<PAGE> 19
GENZYME DEVELOPMENT PARTNERS, L.P.
STATEMENTS OF CASH FLOWS
(In thousands)
<TABLE>
<CAPTION>
FOR THE YEARS ENDED DECEMBER 31,
-------------------------------------
1997 1996 1995
---- ---- ----
Cash Flow from Operating Activities:
<S> <C> <C> <C>
Net loss ........................................................... $ (986) $(552) $ (86)
Reconciliation of net loss to net cash used by operating activities:
Equity in net loss of joint venture ............................... 908 200 --
Increase (decrease) in cash from working capital:
Royalties receivable from Genzyme Corporation .................... (9) (8) --
Accounts payable and accrued expenses ............................ (42) 238 (81)
------- ----- -----
Net cash used by operating activities ............................. (129) (122) (167)
Cash Flow from Investing Activities:
Investment in joint venture ....................................... (1,500) (200) --
------- ----- -----
Net cash used by investing activities .............................. (1,500) (200) --
Cash Flow from Financing Activities:
Capital contributed by Genzyme ................................... 1,500 -- --
Proceeds from issuance of partnership units ...................... -- 7 15
------- ----- -----
Net cash provided by financing activities .......................... 1,500 7 15
Decrease in cash and cash equivalents ................................ (129) (315) (152)
Cash and cash equivalents at beginning of period ..................... 151 466 618
------- ----- -----
Cash and cash equivalents at end of period ........................... $ 22 $ 151 $ 466
======= ===== =====
</TABLE>
The accompanying notes are an integral part of these financial statements.
-19-
<PAGE> 20
GENZYME DEVELOPMENT PARTNERS, L.P.
STATEMENTS OF CHANGES IN PARTNERS' CAPITAL (DEFICIT)
(In thousands)
<TABLE>
<CAPTION>
GENERAL CLASS A CLASS B TOTAL
PARTNERS' LIMITED LIMITED UNPAID PARTNERS'
CAPITAL PARTNERS' PARTNERS' PARTNERS' CAPITAL
(DEFICIT) CAPITAL CAPITAL CAPITAL (DEFICIT)
--------- ------- ------- ------- ---------
<S> <C> <C> <C> <C> <C>
Balance at December 31, 1994 .. $ 44 $ 425 $-- $(49) $ 420
Capital paid during 1995 ...... -- -- -- 15 15
Net Loss ...................... (1) (85) -- -- (86)
------ ----- --- ---- ------
Balance at December 31, 1995 43 340 -- (34) 349
Capital paid during 1996 ...... -- -- -- 7 7
Net Loss ...................... (212) (340) -- -- (552)
------ ----- --- ---- ------
Balance at December 31, 1996 (169) -- -- (27) (196)
Capital paid during 1997 ...... 1,500 -- -- -- 1,500
Net Loss ...................... (986) -- -- -- (986)
------ ----- --- ---- -----
Balance at December 31, 1997 $ 345 $ -- $-- $(27) $ 318
====== ===== === ==== ======
</TABLE>
The accompanying notes are an integral part of these financial statements.
-20-
<PAGE> 21
GENZYME DEVELOPMENT PARTNERS, L.P.
NOTES TO FINANCIAL STATEMENTS
NOTE A - ORGANIZATION
Genzyme Development Partners, L.P. (the "Partnership"), a Delaware limited
partnership, was formed in September 1989 with the objective to develop, produce
and derive income from the sale of products (the "Sepra Products") intended to
be used to limit the incidence and severity of postoperative adhesions. The
Sepra Products are based on hyaluronic acid ("HA"), a naturally occurring
biopolymer with unique physical properties. In August 1996, Genzyme Corporation
("Genzyme") received marketing approval from the U.S. Food and Drug
Administration ("FDA") for the Partnership's first product, Seprafilm(R)
bioresorbable membrane, and commenced commercial sales of Seprafilm(R) in the
U.S. on behalf of Genzyme Ventures II (the "Joint Venture"), a joint venture
between the Partnership and Genzyme.
The Partnership has entered into agreements (described in Note C) with Genzyme
for the development of the Sepra Products and for their manufacture and
marketing.
The General Partner of the Partnership is Genzyme Development Corporation II
("GDC II" or the "General Partner"), a wholly-owned subsidiary of Genzyme. The
Partnership sold 735 Class A Limited Partnership interests and two Class B
Limited Partnership interests for $50,000 per interest less discounts for
certain interests. Each interest was sold with warrants to purchase 5,200 shares
of Genzyme common stock subject to certain anti-dilution adjustments. The
warrants expired in October 1996.
Profits and losses of the Partnership are generally allocated 99% to the Limited
Partners and 1% to the General Partner. After the Class A Limited Partners have
received distributions aggregating 100% of their capital contribution to the
Partnership, the Class B Limited Partner will be entitled to receive 5% of
profits and losses allocated to the Class A Limited Partners. Losses allocable
to the Limited Partners in excess of their capital contributions to the
Partnership are allocated to the General Partner. In 1997 and 1996,
approximately $976,000 and $206,000, respectively, of losses allocable to the
Limited Partners, but in excess of their capital contribution, were re-allocated
to the General Partner pursuant to the terms of the Partnership Agreement.
The Partnership has incurred net losses since inception and substantially all
funding, except for a cash reserve of $22,000 at December 31, 1997, for general
and administrative expenses, was spent by the end of the first quarter of 1994.
The General Partner believes that substantial additional funds will be required
to complete the development and clinical testing and commercialization of the
the Sepra Products. Genzyme funded these activities in 1994, 1995, 1996 and 1997
and currently intends to continue such funding through December 31, 1998.
Genzyme also currently intends to fund administrative expenses in excess of the
Partnership's cash through December 31, 1998.
On January 30, 1996, Genzyme made a proposal to a special committee of the Board
of Directors of the General Partner, offering to purchase substantially all of
the assets of the Partnership for approximately $93.0 million payable in shares
of Genzyme General Division Common Stock. Negotiations between Genzyme and the
special committee did not result in a definitive agreement, however, and in May
1996, Genzyme withdrew its offer. The withdrawal of the offer did not affect the
respective rights and obligations of the parties under any of the existing
agreements between the parties.
NOTE B - ACCOUNTING POLICIES
ACCOUNTING METHOD
The financial statements have been prepared under the accrual method of
accounting in conformity with generally accepted accounting principles.
FISCAL YEAR END
The General Partner has determined that the fiscal year end of the Partnership
is December 31.
USE OF ESTIMATES
The preparation of financial statements in conformity with generally accepted
accounting principles requires management to make certain estimates and
assumptions that effect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities at the date of the financial
statements and the reported amounts of revenues and expenses during the reported
period. Actual results could differ from those estimates.
-21-
<PAGE> 22
INVESTMENT IN JOINT VENTURE
As described in Note C, the Partnership and Genzyme formed a joint venture in
September 1989 that began to engage in business activities on August 17, 1996
(commencement of operations). The Partnership accounts for its investment in the
Joint Venture under the equity method and, therefore, reflects its share of the
Joint Venture's losses in its statement of operations.
CASH AND CASH EQUIVALENTS
Cash equivalents, consisting of non-government money market funds with initial
maturities of three months or less, are valued at cost plus accrued interest
which approximates market value.
REVENUE RECOGNITION
The Partnership records royalty revenue upon the sale of the Sepra Products by
Genzyme to third parties.
INCOME TAXES
The Partnership's financial statements do not include a provision for income
taxes. Taxes, if any, are the liability of the Limited Partners and the General
Partner. Research and development expenditures have been reported as Internal
Revenue Code Section 174 deductions on the Partnership's federal income tax
return. There is, however, a possibility that the Internal Revenue Service may
contend that such amounts should be treated as capitalized costs of obtaining
and developing rights to the technology.
UNCERTAINTIES
The Partnership is subject to risks common to companies in the biotechnology
industry, including, but not limited to, development by the Partnership or its
competitors of new technological innovations, protection of proprietary
technology, healthcare cost containment initiatives, product liability, market
acceptance and new products and compliance with FDA government regulations.
The successful commercialization of the Sepra Products will require that
surgeons become convinced of the efficacy of the products in reducing the
formation of postoperative adhesions and incorporate the products as standard
surgical practice in procedures where adhesions are a potential postoperative
complication. Substantial additional efforts to educate surgeons and hospital
administrators as to the benefits of these products will be required, however,
in order for the products to penetrate target markets and gain broad market
acceptance. There can be no assurance that the Sepra Products will gain such
acceptance.
NEW ACCOUNTING PRONOUNCEMENT
In June 1997, the Financial Accounting Standards Board ("FASB") issued
Statement of Financial Accounting Standards ("SFAS") Nos. 130 and 131.
"Reporting Comprehensive Income" ("SFAS 130") and "Disclosures about Segments
of an Enterprise and Related Information" ("SFAS 131"), respectively
(collectively, the "Statements"). The Statements are effective for fiscal
years beginning after December 15, 1997. SFAS 130 establishes standards for
reporting of comprehensive income and its components in annual financial
statements. SFAS 131 establishes standards for reporting financial and
descriptive information about an enterprise's operating segments in its annual
financial statements and selected segment information in interim financial
reports. Reclassification or restatement of comparative financial statements
or financial information for earlier periods is required upon adoption of SFAS
130 and SFAS 131, respectively. Application of the Statements' disclosure
requirements will have no impact on the Partnerships' financial position,
results of operations or earnings per share data as currently reported.
NOTE C - AGREEMENTS WITH GENZYME CORPORATION
The Partnership has entered into the following agreements with Genzyme:
DEVELOPMENT AGREEMENT
The Development Agreement calls for Genzyme to develop the Sepra Products for
the Partnership to be used as surgical aids to limit the incidence and severity
of postoperative adhesions. The Partnership was required to reimburse Genzyme
for all direct costs, a reasonable allocation of indirect costs as they relate
to the development effort and a ten percent (10%) management fee, up to the
available Partnership funds. A non-refundable retainer fee of $1.5 million was
paid by the Partnership to Genzyme when the Partnership commenced. The General
Partner has the authority to terminate the research program at any time if it is
deemed to be unfeasible or uneconomical. Genzyme has no obligation to fund the
programs beyond the available Partnership funds but has done so after the
available Partnership funds were expended in the first quarter of 1994. Genzyme
spent approximately $7.3 million, $6.0 million and $6.4 million on the
Partnership's development programs in 1997, 1996 and 1995, respectively, and
currently intends to fund the programs through 1998 on a level consistent with
previous years and the 1998 budget for the program.
-22-
<PAGE> 23
CROSS LICENSE AGREEMENT
Under the Cross License Agreement, Genzyme granted the Partnership an exclusive,
royalty free license to use all patent and technology rights owned or controlled
by Genzyme to engage in the development and manufacture of the Sepra Products.
The Partnership granted to Genzyme an exclusive license to use all patent rights
and technology rights for all purposes other than use within the Field of
Activity and within the Territory.
The Partnership will receive a 5% royalty on sales of non-HA based competitive
products by Genzyme within the United States and Canada.
The Partnership also granted Genzyme an exclusive license to manufacture and
market the products in Europe in exchange for a royalty of 6% of net revenues of
European sales of the Sepra Products, payable to the extent necessary for the
Partnership to pay projected distributions not otherwise funded through sales in
the Territory.
JOINT VENTURE AGREEMENT
In March 1997, The Partnership and Genzyme reached agreement concerning the
operation of and allocations of profits and losses from the Joint Venture. Under
the terms of these agreements, Genzyme purchases product from the Joint Venture
for resale by Genzyme as sole distributor for the Joint Venture. Genzyme
purchases the products from the Joint Venture at Genzyme's price to the end-user
less a distributor's discount (subject to a minimum price) and receives
reimbursement for certain costs incurred in connection with the market
introduction of the Sepra Products. Genzyme is not entitled to reimbursement for
general and administrative services it provides to the Joint Venture until the
first year in which the Joint Venture generates more than $25.0 million in
revenues, at which time Genzyme will receive a quarterly commission for general
and administrative services in an amount equal to 10% of the Joint Venture's
gross revenues. Pursuant to the terms of the Amended and Restated Joint Venture
Agreement, the Partnership will receive the first $5.6 million in profits
generated by the Joint Venture, Genzyme will receive the next $8.4 million in
profits and, thereafter, the Partnership and Genzyme will receive a 40% and 60%
share, respectively, in the profits of the Joint Venture. The first $200,000 of
the Joint Venture's losses are allocated to the Partnership and thereafter
losses are allocated 40% to the Partnership and 60% to Genzyme except to the
extent that any losses allocable to the Partnership would result in the
allocation of such loss to the General Partner of the Partnership as a result of
the Partnership's Limited Partners' capital account balance having been
previously reduced to zero. In such an event, 100% of the losses, in excess of
the first $200,000, are allocated to Genzyme. These financial statements reflect
the terms of the Amended and Restated Joint Venture Agreement.
In 1997, Genzyme contributed $1.5 million to the Partnership. The Partnership
has contributed its technology and $1.7 million to the Joint Venture and Genzyme
has contributed its agreement to manufacture and market the Sepra Products, to
make non-interest bearing loans to the Joint Venture in the amount of any
working capital deficiency, to make capital contributions to the extent deemed
necessary by the two venturers in connection with the business of the Joint
Venture and to allow the use of such trademarks, tradenames and logos as the
venturers shall determine to be necessary and advisable for manufacturing and
marketing the Sepra Products within the United States and Canada. The Joint
Venture began to engage in active business after receipt of FDA marketing
approval for Seprafilm(R) on August 17, 1996 (commencement of operations). The
allocation of the Joint Venture's losses for the year ending December 31, 1997
and losses for the period from August 17, 1996 through December 31, 1996 are
pursuant to the terms of the Amended and Restated Joint Venture Agreement, which
is retroactive to August 17, 1996. For the year ending December 31, 1997, the
Joint Venture earned revenues of $3.2 million from the sales of Sepra Products
and incurred net losses of $2.3 million due largely to the costs of marketing
the Sepra Products in North America. In 1997, the net losses for the Joint
Venture were allocated $908,000 to the Partnership and $1.4 million to Genzyme.
Condensed financial information of the Joint Venture is summarized below:
<TABLE>
<CAPTION>
PERIOD FROM
AUGUST 17, 1996
(COMMENCEMENT
FOR THE OF OPERATIONS)
YEAR ENDED THROUGH
DECEMBER 31, DECEMBER 31,
(DOLLARS IN THOUSANDS) 1997 1996
--------------------------------------------------------------------------------------------
<S> <C> <C>
Revenues............................................ $ 3,210 $ 435
Operating expenses.................................. (5,479) (2,914)
Net loss............................................ (2,269) (2,479)
</TABLE>
-23-
<PAGE> 24
<TABLE>
<CAPTION>
DECEMBER 31,
-------------------------
(DOLLARS IN THOUSANDS) 1997 1996
----------------------------------------------------------------------------------------
<S> <C> <C>
Joint venturer's capital (deficit) - Genzyme........ 1,108 (2,279)
Joint venturer's capital-GDP........................ 592 --
</TABLE>
MARKETING AND DISTRIBUTION AGREEMENT
In connection with negotiating the Amended and Restated Joint Venture Agreement,
the Joint Venture entered into an exclusive marketing and distribution agreement
(the "Marketing and Distribution Agreement") with Genzyme, whereby Genzyme will
act as sole distributor of the Sepra Products for the Joint Venture. The Joint
Venture agreed to sell Sepra Products to Genzyme at the price at which Genzyme
is selling the applicable products to the end-user less a distributor's discount
(subject to a minimum purchase price) and also agreed to reimburse Genzyme for
certain costs incurred in connection with market introduction of the Sepra
Products. The economic terms of the Marketing and Distribution Agreement are
intended to be substantially similar to those applicable if Genzyme provided
such services in its capacity as a venturer rather than as a distributor.
TAX INDEMNIFICATION AGREEMENT
At the request of a special committee of directors of the General Partner
consisting of the two directors who are not affiliated with Genzyme, Genzyme
also entered into a tax indemnification agreement (the "Tax Indemnification
Agreement") with the Partnership in which Genzyme agreed, subject to certain
limitations, to indemnify the limited partners against loss of the benefits of
certain research and development deductions certain limited partners have taken
(net of potential tax savings due to any resultant higher tax basis in the
limited partnership interests). The Tax Indemnification Agreement can be waived
by the Partnership in connection with a purchase of the Partnership by Genzyme.
PARTNERSHIP PURCHASE OPTION AGREEMENT
The Partnership Purchase Option Agreement grants Genzyme the option to purchase
the limited partnership interests during the 90-day period commencing on August
31, 2000, but such commencement date may be accelerated to the later of August
31, 1998 or the last day of the month in which the aggregate Joint Venture
distributions to the Partnership are equal to at least $5.5 million. If Genzyme
exercises the Partnership Purchase Option Agreement, each Limited Partner will
receive approximately $35,000 per partnership unit, in cash, Genzyme common
stock or any combination of the two. Additionally, the Limited Partners will
receive quarterly royalty payments for a period of ten years after the buyout
date.
-24-
<PAGE> 25
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND
FINANCIAL DISCLOSURE
None.
PART III
ITEM 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT
Exclusive management and control of the business of the Partnership is vested in
the General Partner. Accordingly, the following information pertains to the
directors and executive officers of the General Partner:
<TABLE>
<CAPTION>
NAME AGE POSITION
---- --- --------
<S> <C> <C>
Henri A. Termeer.......................... 52 President and director since September 1989
W. Gerald Austen, M.D..................... 68 Director since February 1990
David J. McLachlan........................ 59 Treasurer since June 1990
Earl M. Collier, Jr....................... 51 Director since September 1997
Peter N. Reikes........................... 38 Director since February 1996
</TABLE>
Directors of the General Partner are elected annually by Genzyme, its sole
stockholder, and each officer's term of office extends until the meeting of the
Board of Directors following the next annual meeting of stockholders and until a
successor is elected and qualified.
Pursuant to a voting agreement between Genzyme and PaineWebber R&D Partners II,
L.P. (the "Fund"), the holder of 15% of the Class A Limited Partnership
Interests, Genzyme has agreed to nominate and vote its shares for the election
of directors such that at least half of the directors of the General Partner
consist of persons designated by the Fund. Mr. Reikes and Dr. Austen are the
directors designated by the Fund. Directors designated by the Fund may not be
removed without the written approval of the Fund. No mechanism has been provided
to resolve a deadlock on the Board of Directors.
Mr. Termeer has served as President and a director of the General Partner since
September 1989. Mr. Termeer has been President of Genzyme since October 1983,
Chief Executive Officer of Genzyme since December 1985 and Chairman of the Board
of Genzyme since May 1988. For ten years prior to joining Genzyme, Mr. Termeer
worked for Baxter Travenol Laboratories, Inc., a manufacturer of human health
care products. Mr. Termeer is a member of the Board of Directors of Genzyme
Transgenics Corporation and, until its acquisition by Genzyme in December 1996,
was Chairman of the Board of Neozyme II Corporation. Mr. Termeer is also a
director of ABIOMED, Inc., AutoImmune Inc., Diacrin, Inc., and GelTex
Pharmaceuticals, Inc., and a trustee of Hambrecht & Quist Healthcare Investors
and Hambrecht & Quist Life Sciences Investors.
Dr. Austen has served as a director of the General Partner since February 1990.
Dr. Austen currently is President and Chief Executive Officer of the
Massachusetts General Physicians Organization. In addition, Dr. Austen is the
Edward D. Churchill Professor of Surgery at the Harvard Medical School. Dr.
Austen is also a director of ABIOMED, Inc.
Mr. McLachlan has served as Treasurer of the General Partner since June 1990. He
has served as Executive Vice President, Finance of Genzyme since September 1996.
Mr. McLachlan served as Senior Vice President, Finance from December 1989 to
September 1996 and has held the position of Chief Financial Officer since 1989.
Prior to joining Genzyme, he served for more than five years as Chief Financial
Officer for Adams-Russell Electronics, Inc., a defense electronics manufacturer,
and Adams-Russell Co., Inc., a cable television company. Mr. McLachlan is a
director of HearX, Ltd., a company providing products and services to the
hearing impaired.
Mr. Collier has served as a director of the General Partner since September
1997. He joined Genzyme in January 1997 as Senior Vice President, Health Systems
and has served as Executive Vice President, Health Systems and Surgical Products
since July 1997. Mr. Collier is responsible for Genzyme's surgical products
business. Prior to joining Genzyme, Mr. Collier was President of Vitas
HealthCare Corporation (formerly Hospice Care Incorporated), a provider of
health care services, from October 1991 until August 1995. Prior to that, Mr.
Collier was a partner in the Washington, D.C. law firm Hogan & Hartson, which he
joined in 1981.
-25-
<PAGE> 26
Mr. Reikes has served as a director of the General Partner since February 1996.
He is a Managing Director of the Health Care Group within the Investment Banking
Division of PaineWebber Incorporated. Mr. Reikes joined PaineWebber Incorporated
in 1985. Mr. Reikes is a director of the corporate general partners of Alkermes
Clinical Partners, L.P., Cephalon Clinical Partners, L.P., Gensia Clinical
Partners, L.P. and Repligen Clinical Partners, L.P.
EXCHANGE ACT SECTION 16(a) BENEFICIAL OWNERSHIP COMPLIANCE
The executive officers and directors of the General Partner are required under
Section 16(a) of the Exchange Act to file reports of ownership of Partnership
securities and changes in ownership with the Securities and Exchange Commission
(the "SEC"). Copies of those reports must be furnished to the Company.
Based solely on a review of the copies of reports furnished to the Partnership
and written representations that no other reports were required, the General
Partner believes that during 1997 the executive officers and directors of the
General Partner complied with all applicable Section 16(a) filing requirements,
except that Mr. Collier filed a Form 3 with the SEC on January 9, 1998 that was
due in September 1997.
ITEM 11. EXECUTIVE COMPENSATION
The directors and officers of the General Partner other than Dr. Austen, who is
paid $2,500 for each meeting of the Board of Directors, do not receive any
compensation or benefits from the Partnership.
-26-
<PAGE> 27
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
The following table sets forth certain information regarding the ownership of
the Partnership's securities by persons known to the Partnership to be
beneficial owners of more than five percent of any class of Partnership
interests as of February 28, 1998. No directors or officers of the Partnership
own any securities of the Partnership.
<TABLE>
<CAPTION>
Name and Address Amount and Nature Percentage
Title of Class of Beneficial Owner of Beneficial Ownership of Class
- ------------------- -------------------------- ----------------------- ------------
<S> <C> <C> <C>
General Partner Genzyme Development One General 100.0%
Interest Corporation II Partner Interest
One Kendall Square
Cambridge, MA 02139
Class B Limited PaineWebber Development Two Class B 100.0%
Partnership Interest Corporation Limited Partner
1285 Avenue of the Americas Interests
New York, NY 10019
Class A Limited PaineWebber R&D 111 Class A 15.1%
Partnership Interest Partners II, L.P. Limited Partner
1285 Avenue of the Americas Interests
New York, NY 10019
</TABLE>
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
Mr. Termeer, Mr. McLachlan and Mr. Collier are executive officers of Genzyme.
The Partnership is a party to certain agreements with Genzyme, the contents of
which are summarized in Part I, Item 1 of this Annual Report under the caption
"Relationship with Genzyme".
PART IV
ITEM 14. EXHIBITS, FINANCIAL STATEMENTS AND REPORTS ON FORM 8-K
(a) 1. Financial Statements
The financial statements are listed under Item 8 of this
Annual Report.
2. Financial Statements Schedules
None.
3. Exhibits
The exhibits are listed below under Part IV, Item 14(c) of
this Annual Report.
(b) Reports on Form 8-K
No reports on Form 8-K were filed during the quarter ended
December 31, 1997.
(c) Exhibits
-27-
<PAGE> 28
EXHIBIT NO. DESCRIPTION
- ----------- -----------
3 Agreement of Limited Partnership dated as of September 13, 1989
between Genzyme Development Corporation II, as General Partner,
and each of the Limited Partners named therein. Filed as Exhibit
10(aa) to the Registration Statement of Genzyme Corporation on
Form S-4, File No. 33-32343, and incorporated herein by
reference.
10.1 Cross License Agreement dated as of September 13, 1989 between
Genzyme Corporation and Genzyme Development Partners, L.P. Filed
as Exhibit 10(bb) to Genzyme's Registration Statement on Form
S-4, File No. 33-32343, and incorporated herein by reference.
10.2 Development Agreement dated as of September 13, 1989 between
Genzyme Corporation and Genzyme Development Partners, L.P. Filed
as Exhibit 10(cc) to Genzyme's Registration Statement on Form
S-4, File No. 33-32343, and incorporated herein by reference.
10.3 Partnership Purchase Option Agreement dated as of September 13,
1989 between Genzyme Corporation, Genzyme Development Corporation
II, Genzyme Development Partners, L.P., each Class A Limited
Partner and the Class B Limited Partner. Filed as Exhibit 10(dd)
to Genzyme's Registration Statement on Form S-4, File No.
33-32343, and incorporated herein by reference.
10.4 Partnership Purchase Agreement, undated and unexecuted, between
Genzyme Corporation, Genzyme Development Corporation II, Genzyme
Development Partners, L.P., each Class A Limited Partner and the
Class B Limited Partner, as the case may be. Filed as Exhibit
10(ee) to Genzyme's Registration Statement on Form S-4, File No.
33-32343, and incorporated herein by reference.
10.5 Amendment No. 1 to Development Agreement dated January 4, 1994
between Genzyme Corporation and Genzyme Development Partners,
L.P. Filed as Exhibit 10.14 to Genzyme's Form 10-K for 1993, File
No. 0-14680, and incorporated herein by reference.
10.6 Notice dated January 4, 1994 from Genzyme Corporation to Genzyme
Development Partners, L.P. Filed as Exhibit 10.15 to Genzyme
Corporation's Form 10-K for 1993, File No. 0-14680, and
incorporated herein by reference.
10.7 Notice dated January 13, 1995 from Genzyme Corporation to Genzyme
Development Partners, L.P. Filed as Exhibit 10.16 to Genzyme
Corporation's Form 10-K for 1994, File No. 0-14680, and
incorporated herein by reference.
10.8 Notice dated February 22, 1996 from Genzyme Corporation to
Genzyme Development Partners, L.P. Filed as Exhibit 10.17 to
Genzyme Corporation's Form 10-K for 1995, File No. 0-14680, and
incorporated herein by reference.
10.9 Amended and Restated Joint Venture Agreement between Genzyme
Corporation and Genzyme Development Partners, L.P. Filed as
Exhibit 10.1 to Genzyme Development Partners, L.P.'s Report on
Form 10-Q as of March 31, 1997, File No. 0-18554 and incorporated
herein by reference.
10.10 Tax Indemnification Agreement between Genzyme Corporation and
Genzyme Development Partners, L.P. Filed as Exhibit 10.2 to
Genzyme Development Partners, L.P. Report on Form 10-Q as of
March 31, 1997, File No. 0-18554 and incorporated herein by
reference.
10.11 Marketing and Distribution Agreement between Genzyme Corporation
and Genzyme Venture II. Filed as Exhibit 10.3 to Genzyme
Development Partners, L.P. Report on Form 10-Q as of March 31,
1997, File No. 0-18554 and incorporated herein by reference.
27 Financial Data Schedule for Genzyme Development Partners, L.P.
Filed herewith.
-28-
<PAGE> 29
99 Financial Statements of Genzyme Ventures II for the year ended
December 31, 1997 and for the period from August 17, 1996
(commencement of operations) to December 31, 1996. Filed
herewith.
-29-
<PAGE> 30
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities 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.
By: GENZYME DEVELOPMENT CORPORATION II,
General Partner
Date: March 31, 1998 By: /s/ David J. Mclachlan
----------------------
David J. McLachlan
Treasurer
Pursuant to the requirements of the Securities Exchange Act of 1934, this report
has been signed below by the following persons on behalf of the Registrant and
in the capacities and on the dates indicated.
SIGNATURE TITLE DATE
- --------- ----- ----
/s/ Henri A. Termeer Director and Principal March 31, 1998
- ------------------------ Executive Officer
Henri A. Termeer
/s/ David J. Mclachlan Principal Financial and March 31, 1998
- ------------------------ Accounting Officer
David J. McLachlan
/s/ W. Gerald Austen Director March 31, 1998
- ------------------------
W. Gerald Austen
/s/ Earl M. Collier, Jr. Director March 31, 1998
- ------------------------
Earl M. Collier, Jr.
/s/ Peter N. Reikes Director March 31, 1998
- ------------------------
Peter N. Reikes
-31-
<PAGE> 31
EXHIBIT INDEX
EXHIBIT
NO. DESCRIPTION
- --- -----------
3 Agreement of Limited Partnership dated as of September 13, 1989
between Genzyme Development Corporation II, as General Partner,
and each of the Limited Partners named therein. Filed as Exhibit
10(aa) to the Registration Statement of Genzyme Corporation on
Form S-4, File No. 33-32343, and incorporated herein by
reference.
10.1 Cross License Agreement dated as of September 13, 1989 between
Genzyme Corporation and Genzyme Development Partners, L.P. Filed
as Exhibit 10(bb) to Genzyme's Registration Statement on Form
S-4, File No. 33-32343, and incorporated herein by reference.
10.2 Development Agreement dated as of September 13, 1989 between
Genzyme Corporation and Genzyme Development Partners, L.P. Filed
as Exhibit 10(cc) to Genzyme's Registration Statement on Form
S-4, File No. 33-32343, and incorporated herein by reference.
10.3 Partnership Purchase Option Agreement dated as of September 13,
1989 between Genzyme Corporation, Genzyme Development Corporation
II, Genzyme Development Partners, L.P., each Class A Limited
Partner and the Class B Limited Partner. Filed as Exhibit 10(dd)
to Genzyme's Registration Statement on Form S-4, File No.
33-32343, and incorporated herein by reference.
10.4 Partnership Purchase Agreement, undated and unexecuted, between
Genzyme Corporation, Genzyme Development Corporation II, Genzyme
Development Partners, L.P., each Class A Limited Partner and the
Class B Limited Partner, as the case may be. Filed as Exhibit
10(ee) to Genzyme's Registration Statement on Form S-4, File No.
33-32343, and incorporated herein by reference.
10.5 Amendment No. 1 to Development Agreement dated January 4, 1994
between Genzyme Corporation and Genzyme Development Partners,
L.P. Filed as Exhibit 10.14 to Genzyme's Form 10-K for 1993, File
No. 0-14680, and incorporated herein by reference.
10.6 Notice dated January 4, 1994 from Genzyme Corporation to Genzyme
Development Partners, L.P. Filed as Exhibit 10.15 to Genzyme
Corporation's Form 10-K for 1993, File No. 0-14680, and
incorporated herein by reference.
10.7 Notice dated January 13, 1995 from Genzyme Corporation to Genzyme
Development Partners, L.P. Filed as Exhibit 10.16 to Genzyme
Corporation's Form 10-K for 1994, File No. 0-14680, and
incorporated herein by reference.
10.8 Notice dated February 22, 1996 from Genzyme Corporation to
Genzyme Development Partners, L.P. Filed as Exhibit 10.17 to
Genzyme Corporation's Form 10-K for 1995, File No. 0-14680, and
incorporated herein by reference.
10.9 Amended and Restated Joint Venture Agreement between Genzyme
Corporation and Genzyme Development Partners, L.P. Filed as
Exhibit 10.1 to Genzyme Development Partners, L.P.'s report on
Form 10-Q as of March 31, 1997, File No. 0-18554 and incorporated
herein by reference.
10.10 Tax Indemnification Agreement between Genzyme Corporation and
Genzyme Development Partners, L.P. Filed as Exhibit 10.2 to
Genzyme Development Partners, L.P.'s Report on Form 10-Q as of
March 31, 1997, File No. 0-18554 and incorporated herein by
reference.
10.11 Marketing and Distribution Agreement between Genzyme Corporation
and Genzyme Ventures II. Filed as Exhibit 10.3 to Genzyme
Development Partners, L.P.'s Report on Form 10-Q as of March 31,
1997, File No. 0-18554 and incorporated herein by reference.
-31-
<PAGE> 32
27 Financial Data Schedule for Genzyme Development Partners, L.P.
Filed herewith.
99 Financial Statements of Genzyme Ventures II for the year ended
December 31, 1997 and for the period from August 17, 1996
(commencement of operations) to December 31, 1996. Filed
herewith.
-32-
<TABLE> <S> <C>
<ARTICLE> 5
<LEGEND>
THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM (A) THE
FINANCIAL STATEMENTS OF GENZYME DEVELOPEMENT PARTNERS, L.P. AND IS QUALIFIED IN
ITS ENTIRETY BY REFERENCE TO SUCH (B) FINANCIAL STATEMENTS AS INCLUDED IN THE
ANNUAL REPORT ON FORM 10-K FOR 1997 FOR GENZYME DEVELOPMENT PARTNERS, L.P.
</LEGEND>
<CURRENCY> U.S. DOLLARS
<S> <C>
<PERIOD-TYPE> YEAR
<FISCAL-YEAR-END> DEC-31-1997
<PERIOD-START> JAN-01-1997
<PERIOD-END> DEC-31-1997
<EXCHANGE-RATE> 1
<CASH> 22
<SECURITIES> 0
<RECEIVABLES> 0
<ALLOWANCES> 0
<INVENTORY> 0
<CURRENT-ASSETS> 39
<PP&E> 0
<DEPRECIATION> 0
<TOTAL-ASSETS> 631
<CURRENT-LIABILITIES> 313
<BONDS> 0
0
0
<COMMON> 0
<OTHER-SE> 318
<TOTAL-LIABILITY-AND-EQUITY> 631
<SALES> 0
<TOTAL-REVENUES> 0
<CGS> 0
<TOTAL-COSTS> 0
<OTHER-EXPENSES> 154
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> 0
<INCOME-PRETAX> (986)
<INCOME-TAX> 0
<INCOME-CONTINUING> (986)
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> (986)
<EPS-PRIMARY> 0
<EPS-DILUTED> 0
<FN>
<F1>GENZYME DEVELOPMENT PARTNERS, L.P. IS A DELAWARE LIMITED PARTNERSHIP. NET
EARNINGS OR LOSS ARE REPORTED PER PARTNERSHIP UNIT INSTEAD OF PER SHARE. FOR
THE YEAR ENDED DECEMBER 31, 1997, THE PARTNERSHIP'S NET LOSS WAS ALLOCATED $0
PER LIMITED PARTNERSHIP UNIT (737 UNITS IN TOTAL) AND $986,000 TO THE GENERAL
PARTNER (1 UNIT).
</FN>
</TABLE>
<PAGE> 1
Exhibit 99
REPORT OF INDEPENDENT ACCOUNTANTS
To the Venturers of Genzyme Ventures II:
We have audited the balance sheets of Genzyme Ventures II (the "Joint Venture")
as of December 31, 1997 and 1996, and the statements of operations, cash flows
and changes in venturers' capital (deficit) for the year ending December 31,
1997 and the period from August 17, 1996 (commencement of operations) to
December 31, 1996. These financial statements are the responsibility of the
Joint Venture's management. Our responsibility is to express an opinion on these
financial statements based on our audits.
We conducted our audits in accordance with generally accepted auditing
standards. Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are free of material
misstatement. An audit includes examining, on a test basis, evidence supporting
the amounts and disclosures in the financial statements. An audit also includes
assessing the accounting principles used and significant estimates made by
management, as well as evaluating the overall financial statement presentation.
We believe that our audits provide a reasonable basis for our opinion.
In our opinion, the financial statements referred to above present fairly, in
all material respects, the financial position of the Joint Venture, as of
December 31, 1997 and 1996 and the results of its operations, its change in
Venturers' capital (deficit) and its cash flows for the year ending December 31,
1997 and the period from August 17, 1996 (commencement of operations) to
December 31, 1996 in conformity with generally accepted accounting principles.
/s/ COOPERS & LYBRAND L.L.P.
Boston, Massachusetts
March 26, 1998
-33-
<PAGE> 2
GENZYME VENTURES II
BALANCE SHEETS
<TABLE>
<CAPTION>
(AMOUNTS IN THOUSANDS) DECEMBER 31,
- ----------------------------------------------------------------------------------------------
1997 1996
---- ----
ASSETS
<S> <C> <C>
Cash and cash equivalents ................................... $1,700 $ 0
====== =======
LIABILITIES AND VENTURERS' CAPITAL (DEFICIT)
Accounts payable to Genzyme (Note C) ........................ -- 2,279
Commitments and contingencies (Note D) ...................... -- --
Venturers' capital (deficit):
Genzyme Corporation ...................................... 1,108 (2,279)
Genzyme Development Partners, L.P. ....................... 592 --
------ -------
Total Venturers' capital (deficit) .......................... 1,700 (2,279)
Total liabilities and Venturers' capital (deficit) ......... $1,700 $ 0
====== =======
</TABLE>
The accompanying notes are an integral part of these financial statements.
-34-
<PAGE> 3
GENZYME VENTURES II
STATEMENTS OF OPERATIONS
(In thousands)
<TABLE>
<CAPTION>
FOR THE
PERIOD FROM
AUGUST 17, 1996
(COMMENCEMENT
FOR THE OF OPERATIONS)
YEAR ENDED TO
DECEMBER 31, DECEMBER 31,
1997 1996
------------ ----------------
<S> <C> <C>
Net product sales............................................................... $ 3,210 $ 435
Operating costs and expenses:
Cost of products sold........................................................ (868) (234)
Selling and marketing expenses............................................... (4,611) (2,680)
------- -------
Total operating costs and expenses........................................ (5,479) (2,914)
------- -------
Net loss........................................................................ $(2,269) $(2,479)
======= =======
</TABLE>
The accompanying notes are an integral part of these financial statements.
-35-
<PAGE> 4
GENZYME VENTURES II
STATEMENTS OF CASH FLOWS
(In thousands)
<TABLE>
<CAPTION>
FOR THE
PERIOD FROM
AUGUST 17, 1996
(COMMENCEMENT
FOR THE OF OPERATIONS)
PERIOD ENDING TO
DECEMBER 31, DECEMBER 31,
1997 1996
------------ ---------------
<S> <C> <C>
Cash Flow from Operating Activities:
Net loss ........................................................... $(2,269) $(2,479)
Reconciliation of net loss to net cash used by operating activities:
Increase in payable to Genzyme Corporation ........................ -- 2,279
------- -------
Net cash provided by (used in) operating activities ............... (2,269) (200)
Cash Flow from Financing Activities:
Capital contributed by Genzyme ................................... 2,469 --
Capital contributed by GDP ....................................... 1,500 200
------- -------
Net cash provided by financing activities .......................... 3,969 200
------- -------
Increase in cash ..................................................... 1,700 --
Cash at beginning of period .......................................... -- --
------- -------
Cash at end of period ................................................ $ 1,700 $ --
======= =======
Supplemental disclosure of non-cash transaction:
Conversion of accounts payable to Genzyme Corporation to Capital - Note D
</TABLE>
The accompanying notes are an integral part of these financial statements.
-36-
<PAGE> 5
GENZYME VENTURES II
STATEMENTS OF CHANGES IN VENTURERS' CAPITAL (DEFICIT)
(In thousands)
<TABLE>
<CAPTION>
GENZYME
DEVELOPMENT
GENZYME PARTNERS, TOTAL
CORPORATION L.P. VENTURERS'
CAPITAL CAPITAL CAPITAL (DEFICIT)
----------- ----------- -----------------
<S> <C> <C> <C>
Balance as of August 17, 1996
(commencement of operations) ... $ -- $ -- $ --
Capital contribution ............ -- 200 200
Net loss ........................ (2,279) (200) (2,479)
------- ------- -------
Balance at December 31, 1996 (2,279) -- (2,279)
------- ------- -------
Capital contribution ............ 4,748 1,500 6,248
Net loss ........................ (1,361) (908) (2,269)
------- ------- -------
Balance at December 31, 1997 $ 1,108 $ 592 $ 1,700
======= ======= =======
</TABLE>
The accompanying notes are an integral part of these financial statements.
-37-
<PAGE> 6
GENZYME VENTURES II
NOTES TO FINANCIAL STATEMENTS
NOTE A. ORGANIZATION
Genzyme Development Partners, L.P. ("GDP") and Genzyme Corporation ("Genzyme")
formed a joint venture, Genzyme Ventures II (the "Joint Venture"), under the
terms and provisions of the Delaware Uniform Partnership Act in September 1989
for the purpose of manufacturing and marketing GDP's surgical products (the
"Sepra Products" or the "Products") in the United States and Canada for use
in human clinical trials or human surgical procedures, other than in ophthalmic
surgery. The Sepra Products are intended to be used to limit the incidence and
severity of postoperative adhesions.
GDP has contributed its technology and $1.7 million to the Joint Venture and
Genzyme has contributed its agreement to manufacture and market the Sepra
Products, to make non-interest bearing loans to the Joint Venture in the amount
of any working capital deficiency, to make capital contributions to the extent
deemed necessary by GDP and Genzyme in connection with the business of the Joint
Venture and to allow the use of such trademarks, tradenames and logos as GDP and
Genzyme shall determine to be necessary and advisable for manufacturing and
marketing the Products within the United States and Canada. In August 1996,
Genzyme received marketing approval U.S. Food and Drug Administration ("FDA")
for GDP's first product, Seprafilm(R) bioresorbable membrane, and commenced
commercial sales of Seprafilm(R) in the U.S. on behalf of the Joint Venture on
August 17, 1996 (commencement of operations).
NOTE B - ACCOUNTING POLICIES
ACCOUNTING METHOD
The financial statements have been prepared under the accrual method of
accounting in conformity with generally accepted accounting principles.
FISCAL YEAR END
GDP and Genzyme, as joint venturers, have determined that the fiscal year end of
the Joint Venture is December 31.
USE OF ESTIMATES
The preparation of financial statements in conformity with generally accepted
accounting principles requires management to make certain estimates and
assumptions that effect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities at the date of the financial
statements and the reported amounts of revenues and expenses during the reported
period. Actual results could differ from those estimates.
REVENUE RECOGNITION
Revenues and corresponding cost of sales from product sales are recognized when
goods are shipped by Genzyme to the end customer as per the Amended and Restated
Joint Venture Agreement (See Note C).
INCOME TAXES
The Joint Venture's financial statements do not include a provision for income
taxes. Taxes, if any, are the liability of GDP and Genzyme, as partners.
UNCERTAINTIES
The Joint Venture is subject to risks common to companies in the biotechnology
industry, including but not limited to, development by its competitors of new
technological innovations, protection of proprietary technology, health care
cost containment initiatives, product liability, market acceptance of the
Products and compliance with the government regulations, including those of the
U.S. Department of Health and Human Services and the FDA. In addition, the Joint
Venture is dependent upon Genzyme's ability to produce and market the Products.
-38-
<PAGE> 7
GENZYME VENTURES II
NOTES TO FINANCIAL STATEMENTS (CONTINUED)
NOTE C. JOINT VENTURE AGREEMENT BETWEEN GDP AND GENZYME CORPORATION
In March 1997, Genzyme and GDP reached agreement concerning the operation of and
allocations of profits and losses from the Joint Venture. Under the terms of
these agreements, Genzyme purchases product from the Joint Venture for resale by
Genzyme as sole distributor for the Joint Venture. Genzyme purchases the
products from the Joint Venture at Genzyme's price to the end-user less a
distributor's discount (subject to a minimum price) and receives reimbursement
for certain costs incurred in connection with the market introduction of the
Sepra Products. Genzyme holds the inventory of the Sepra Products and sells it
to the Joint Venture upon sales to third parties. Genzyme is not entitled to
reimbursement for general and administrative services it provides to the Joint
Venture until the first year in which the Joint Venture generates more than
$25.0 million in revenues, at which time Genzyme will receive a quarterly
commission for general and administrative services in an amount equal to 10% of
the Joint Ventures' gross revenues. Pursuant to the terms of the Amended and
Restated Joint Venture Agreement, GDP will receive the first $5.6 million in
profits generated by the Joint Venture, Genzyme will receive the next $8.4
million in profits and, thereafter, Genzyme and GDP will receive a 60% and 40%
share, respectively, in the profits of the Joint Venture. The first $200,000 of
the Joint Venture's losses are allocated to GDP and thereafter losses are
allocated 40% to GDP and 60% to Genzyme except to the extent that any losses
allocable to GDP would result in the allocation of such loss to Genzyme
Development Corporation II ("GDC II") as the General Partner of GDP as a result
of the GDP Limited Partners' capital account balance having been previously
reduced to zero. In such an event, 100% of the losses, in excess of the first
$200,000, are allocated to Genzyme. These financial statements reflect the terms
of the Amended and Restated Joint Venture Agreement.
GDP has contributed its technology and $1.7 million to the Joint Venture and
Genzyme has contributed its agreement to manufacture and market the Sepra
Products, to make non-interest bearing loans to the Joint Venture in the amount
of any working capital deficiency, to make capital contributions to the extent
deemed necessary by the two venturers in connection with the business of the
Joint Venture and to allow the use of such trademarks, tradenames and logos as
the venturers shall determine to be necessary and advisable for manufacturing
and marketing the Sepra Products within the United States and Canada. The Joint
Venture began to engage in active business after receipt of FDA marketing
approval for Seprafilm(R) on August 17, 1996 (commencement of operations). The
allocation of the Joint Venturer's losses for the year ending December 31, 1997
and losses for the period from August 17, 1996 through December 31, 1996 are
pursuant to the terms of the Amended and Restated Joint Venture Agreement, which
is retroactive to August 17, 1996. For the year ending December 31, 1997, the
Joint Venture earned revenues of $3.2 million from the sales of Sepra Products
and incurred net losses of $2.3 million due largely to the costs of marketing
the Sepra Products in North America. In 1997, the net losses for the Joint
Venture were allocated $908,000 to GDP and $1.4 million to Genzyme.
NOTE D. JOINT VENTURE CAPITAL
In 1997, Genzyme contributed $1.5 million to GDP. In 1997 and 1996, GDP
contributed $1.5 million and $200,000, respectively, to the Joint Venture and
Genzyme funded the operating losses of the Joint Venture in each respective
period.
In 1997, Genzyme converted its receivable from the Joint Venture of $2.3 million
to capital.
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