This Form 10-K contains forward-looking statements that involve risks and
uncertainties. Forward-looking statements include information on:
. Our business outlook and future financial performance;
. Anticipated profitability, revenues, expenses and capital expenditures;
. Anticipated research, development, clinical, regulatory, and reimbursement
progress;
. Future funding and expectations as to any future events; and
. Other statements that are not historical fact and are forward-looking
statements within the meaning of the Private Securities Litigation Reform
Act of 1995 that involve risks and uncertainties.
Although we believe that our plans, intentions and expectations reflected
in or suggested by such forward-looking statements are reasonable, we can give
no assurance that such plans, intentions or expectations will be achieved. When
considering such forward-looking statements, you should keep in mind the risk
factors and other cautionary statements in this Form 10-K. The risk and other
factors noted under the section "Risk factors" beginning on page 5 and
throughout this Form 10-K could cause our actual results to differ materially
from the results contained in any forward-looking statements.
ITEM 1. BUSINESS
Organogenesis Inc. - a tissue engineering company - designs, develops and
manufactures medical products containing living cells and/or natural connective
tissue. We are the developer and manufacturer of the only mass-produced product
containing living human cells to gain Food and Drug Administration ("FDA")
marketing approval. Our product development focus includes living tissue
replacements, a cell-based organ assist device and other tissue-engineered
products. Our lead product, Apligraf living skin substitute, is FDA approved and
marketed for use in the treatment of diabetic foot ulcers and venous leg ulcers.
Novartis Pharma AG ("Novartis") has exclusive global Apligraf marketing rights.
Organogenesis was organized as a Delaware corporation in 1985. Our
principal office is located at 150 Dan Road, Canton, Massachusetts 02021. The
telephone number is 781/575-0775 and the fax number is 781/575-1570. Our
website address is www.organogenesis.com.
PRODUCTS AND PROGRAMS
Organogenesis is utilizing its expertise in living cells and connective
tissue in its product development. In addition to Apligraf, major programs
include a living dermal replacement product candidate Vitrix(TM), a coronary
vascular graft and a liver assist device. These programs are profiled on the
following pages.
Apligraf(R) is a registered trademark of Novartis.
Vitrix(TM) is a trademark of Organogenesis.
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ON THE MARKET - APLIGRAF
Product Description - Apligraf is the only mass-produced product containing
living human cells to gain FDA marketing approval. Apligraf contains living
human skin cells - keratinocytes and fibroblasts - organized in an epidermal and
dermal layer. Apligraf is mass-produced, available to physicians on demand and
does not require hospitalization for use.
[IMAGE APPEARS HERE]
Apligraf compared to human skin under the microscope
Status - Novartis Pharma AG has exclusive global Apligraf marketing
rights. The 2001 amendment to our 1996 agreement with Novartis significantly
increases payments we receive for Apligraf units, as well as provides funding
support for certain facility investments, clinical development activities and up
to $20,000,000 in equity investments. Apligraf gained FDA marketing approval
for use in the treatment of venous leg ulcers in 1998. In June 2000, Apligraf
was also approved in the US for use in the treatment of diabetic foot ulcers.
Apligraf is on the market in select international markets. It is anticipated
that Novartis will submit for marketing approval across the European Union in
Spring 2001.
Current and Potential Markets -
Diabetic foot ulcers: Apligraf is FDA-approved for use in the treatment of
healing-resistant diabetic foot ulcers. Apligraf has been shown to heal more of
these ulcers, and heal them faster, than standard care alone. A common
complication of diabetes, foot ulcers afflict up to 800,000 people in the US.
Unhealed, these wounds can lead to life-threatening infections. They result in
over 50,000 amputations per year. Foot ulcers are also a leading cause of
hospitalization among diabetics. These wounds are estimated to cost the US
healthcare system over $1 billion per year.
Venous leg ulcers: Apligraf is also approved and marketed in the US for the
treatment of healing-resistant venous leg ulcers, chronic wounds caused by poor
blood circulation. Apligraf has also been shown to heal more of these ulcers,
and heal them faster, than standard care alone. Similar in incidence to diabetic
foot ulcers, venous ulcers can take six months or longer to heal. Data on the
cost-effectiveness of Apligraf in the treatment of hard-to-heal venous leg
ulcers were published during 2000.
Skin surgery wounds: For skin surgery wounds, there is a need to improve
the quality of healing, such as reducing scarring. We currently have a pivotal
trial underway to assess the ability of Apligraf to reduce scarring following
skin cancer surgery. We expect to complete this trial and submit to the FDA for
marketing approval within the next twelve months.
Other potential markets: As a skin substitute, Apligraf has a number of
additional potential uses, including pressure ulcers, burns, epidermolysis
bullosa (a genetic skin disorder), and other chronic and acute wounds.
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Reimbursement - In Summer 2000, Apligraf was placed on the Outpatient
Prospective Payment System list by the Health Care Financing Agency (HCFA).
This qualified the product for reimbursement by Medicare when applied in the
hospital outpatient setting, such as hospital-affiliated wound care clinics. In
February 2001, Apligraf was classified by HCFA as a biologic for reimbursement
purposes when used in a doctor's office. This supports the development of local
reimbursement policies for Apligraf by the 42 local administrators of Medicare.
We expect some regions to begin reimbursing Apligraf within the next few
quarters and anticipate many regions will begin reimbursing Apligraf within the
next twelve months.
LIVING DERMAL REPLACEMENT PRODUCTS
Deep wounds involve loss of dermis, the skin's lower layer. Dermal tissue
contributes to wound healing. It also plays an important role in healing
quality. Because dermal tissue, once lost, is not regenerated by the body, a
need exists for living dermal replacement products.
Our lead living dermal replacement product candidate is Vitrix. Vitrix is a
single layer product containing living human dermal cells (fibroblasts) and
dermal structural protein (collagen). Because Vitrix is a single dermal layer,
it can be folded upon itself and inserted into deep wounds. Potential
applications for Vitrix include deep diabetic foot ulcers and deep pressure
sores, such as those extending through skin to underlying bone, ligament or
tendon. We expect to begin human pivotal trials with Vitrix in Spring 2001. The
2001 amendment to the 1996 agreement with Novartis grants Novartis the right to
purchase an exclusive option to negotiate terms to license Vitrix, as well as a
second living dermal replacement product currently in research.
CORONARY VASCULAR GRAFT
Our coronary vascular graft, currently in animal trials, is being developed
for use in coronary artery bypass grafting (CABG) procedures. Approximately
350,000 CABG procedures are performed annually in the US. These procedures are
performed to channel blood around blockages in the arteries that keep the heart
alive. CABG procedures typically require several grafts as patients generally
have multiple blockages. The primary material used for bypass grafts is vein
harvested from the patient's leg. Unfortunately, the patient may not have
sufficient vein available. Additionally, use of a patients vein adds to the
surgical complexity and, thus, cost of the procedure, as well as increases the
risk of post-surgery complications.
Our vascular graft is designed to be an off-the-shelf product, available
upon demand, which would replace the need to use patient vein for grafting
material. As inclusion of living blood vessel cells would cause rejection, our
vascular graft does not contain cells when implanted. It is designed to become
populated with the patient's own cells after implantation. In 1999, we
published data showing that, in small animals, our product performs the critical
functions: it maintains blood flow over time and becomes converted into living
tissue. During 2000, our program focused on tightening the design of the
product and enhancing the reliability of its manufacturing process in
preparation for initiating studies in large animals and then humans.
LIVER ASSIST DEVICE
Each year in the US, approximately 300,000 people are hospitalized for
liver disease and over 25,000 die from liver failure. Our liver assist device
is being developed as a "bridge to transplant" to keep a patient alive until a
donor liver becomes available. The device could also be used in some situations
as an alternative to transplantation, keeping a patient alive for the few weeks
needed for his or her own liver to recover. This would be beneficial as liver
transplantation is risky, invasive and expensive and typically requires lifelong
immunosuppressant drug therapy.
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Our goal in 2001 is to develop a prototype that demonstrates significant
efficacy in large animal models. In 1999, we received a $2 million award under
the Advanced Technology Program of the National Institute for Standards and
Technology to assist us in achieving that goal.
OTHER POTENTIAL OPPORTUNITIES
During 2000, Organogenesis formed a business unit - Technology Ventures -
to commercialize, through partnerships and distributorships, our engineered
collagen and conditioned medium technologies. During the first half of 2001,
the business unit plans to submit for FDA 510(k) marketing clearance of the
engineered collagen for several different uses. Technology Ventures has
established a collaboration with privately-held Royce(R) Medical Co. That
collaboration is for commercialization of the engineered collagen technology as
a wound dressing to certain targeted audiences. We expect to begin that
commercialization during the second half of 2001. Our goal is to establish
additional collaborations for both the engineered collagen and conditioned
medium technologies.
RISK FACTORS
OUR COMPANY HAS A HISTORY OF LOSSES AND WE EXPECT TO CONTINUE TO INCUR
LOSSES
Organogenesis Inc. was founded in 1985. We have incurred operating losses
in every year of our existence. We incurred net losses of $14,031,000 for the
year ended December 31, 1998, $28,350,000 for the year ended December 31, 1999
and $28,605,000 for the year ended December 31, 2000, which losses are
continuing. As of December 31, 2000, we have an accumulated deficit of
$157,972,000. We have not achieved profitability and expect to continue to incur
net losses through at least the first half of 2002. The extent of future losses
and the time required to achieve profitability is highly uncertain. Moreover,
although our business is not seasonal in nature, our revenues have historically
varied significantly from fiscal quarter to fiscal quarter due to the
recognition of non-refundable research, development and milestone payments.
IN ORDER TO ACHIEVE COMMERCIAL SUCCESS, OUR PRODUCTS MUST GAIN MARKET
ACCEPTANCE
We have one principal product on the market, Apligraf, which is marketed by
Novartis. Products under development, as well as additional uses for Apligraf,
will require additional research and development efforts, including clinical
testing and regulatory approval, prior to commercial use. Our potential products
are subject to the risks of failure inherent in the development of medical
products based on new technologies. These risks include the possibilities that:
. Our approach will not be successful;
. Our potential products will be found to be unsafe, ineffective or
otherwise will fail to meet applicable regulatory standards or receive
necessary regulatory clearances;
. The potential products, if safe and effective, will be difficult to
develop into commercially-viable products, will be difficult to
manufacture on a large scale, will be uneconomical to market, will fail or
be delayed in gaining acceptable insurance reimbursement or will fail to
obtain acceptance by the medical community;
. Proprietary rights of third parties will preclude us from marketing such
products; or
. Third parties will market superior or equivalent products.
Our business results would be hurt if we are unable to demonstrate to the
medical community the efficacy, relative safety and cost-effectiveness of
treating patients with our products or if our products were not accepted as
alternatives to other existing or new therapies.
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OUR MARKETS ARE COMPETITIVE AND OUR COMPETITORS COULD DEVELOP MORE
EFFECTIVE PRODUCTS
We are engaged in the rapidly evolving and competitive field of tissue
engineering for the treatment of skin wounds and other medical needs. Our
competitors include tissue engineering companies, xenotransplant companies,
wound care divisions of major pharmaceutical companies and other pharmaceutical,
biotechnology and medical products companies using traditional technologies to
develop products for wound care. Some of these companies have much greater
resources, research and development staffs and facilities, experience in
conducting clinical trials and obtaining regulatory approvals and experience in
the manufacturing, marketing and distribution of products than we do. Our
competitive position is based upon our ability to:
. create and maintain scientifically-advanced technology and proprietary
products and processes;
. attract and retain qualified personnel;
. obtain patent or other protection for our products and processes;
. obtain required government approvals on a timely basis;
. manufacture products on a cost-effective basis; and
. successfully market products.
If we are not successful in meeting these goals, our business could be
hurt. Similarly, our competitors may succeed in developing technologies,
products or procedures that are more effective than any that we are developing
or that would render our technology and products obsolete, noncompetitive or
uneconomical.
WE CURRENTLY DEPEND UPON NOVARTIS TO MARKET APLIGRAF AND NOVARTIS MAY NOT
BE SUCCESSFUL IN MARKETING APLIGRAF IN THE FUTURE
We currently have limited experience in sales, marketing and distribution
and have developed a long-term strategic relationship with Novartis, who has
marketing and sales forces with technical expertise and distribution capability.
Our revenues will depend upon the efforts of Novartis, who may or may not be
successful in marketing and selling Apligraf or gaining international approvals
for the product. We may not be able to maintain our long-term strategic
relationship with Novartis. To the extent that we choose not to maintain our
relationship with Novartis, we may need more capital and resources to undertake
a commercialization program at our own expense. In addition, we may encounter
significant delays in introducing Apligraf into certain markets or find that the
commercialization of Apligraf in such markets may be adversely affected by the
absence of a collaborative agreement.
OUR ABILITY TO COMMERCIALIZE OUR PRODUCTS DEPENDS UPON OUR COMPLIANCE WITH
GOVERNMENT REGULATIONS
Our present and proposed activities are subject to extensive and rigorous
regulation by governmental authorities in the US and other countries. To
clinically test, produce and market medical devices for human use, we must
satisfy mandatory procedural and safety and efficacy requirements established by
the FDA and comparable state and foreign regulatory agencies. Typically, such
rules require that products be approved by the government agency as safe and
effective for their intended use prior to being marketed. The approval process
is expensive, time consuming and subject to unanticipated delays. Our product
candidates may not be approved. In addition, our product approvals could be
withdrawn for failure to comply with regulatory standards or due to unforeseen
problems after the product's marketing approval.
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Testing is necessary to determine safety and efficacy before a submission
may be filed with the FDA to obtain authorization to market regulated products.
In addition, the FDA imposes various requirements on manufacturers and sellers
of products under its jurisdiction, such as labeling, Good Manufacturing
Practices, record keeping and reporting requirements. The FDA also may require
post-marketing testing and surveillance programs to monitor a product's effects.
Furthermore, changes in existing regulations or the adoption of new regulations
could prevent us from obtaining, or affect the timing of, future regulatory
approvals or could negatively affect the marketing of our existing products. We
would not be able to commercialize our products as planned and our operating
results would be hurt if:
. the regulatory agencies find our testing protocols to be inadequate;
. the appropriate authorizations are not granted on a timely basis, or at
all;
. the process to obtain authorization takes longer than expected or we have
insufficient funds to pursue such approvals;
. we lose previously-received authorizations; or
. we do not comply with regulatory requirements.
Medical and biopharmaceutical research and development involves the
controlled use of hazardous materials, such as radioactive compounds and
chemical solvents. We are subject to federal, state and local laws and
regulations governing the use, manufacture, storage, handling and disposal of
such materials and waste products. In addition, we handle and dispose of human
tissue. Although we believe that our safety procedures for handling these
materials are adequate, if accidental contamination or injury were to occur, we
could be liable for damages.
WE RELY HEAVILY UPON OUR PATENTS AND PROPRIETARY TECHNOLOGY AND ANY FUTURE
CLAIMS THAT OUR PATENTS ARE INVALID COULD SERIOUSLY HARM OUR BUSINESS
We rely upon our portfolio of patent rights, patent applications and
exclusive licenses to patents and patent applications relating to living tissue
products, organ assist treatments and other aspects of tissue engineering. We
currently have 26 patents issued in the US, 11 patents issued in Europe and 6
patents issued in Japan. As part of our continuing interest in protecting
intellectual property rights, we have filed and are prosecuting 15 other patent
applications in the US. We also license some of our technologies under an
exclusive patent license agreement with the Massachusetts Institute of
Technology ("MIT"). The agreement with MIT covers certain US patents and
corresponding patents in Europe and Japan. The earliest patent expiration is in
2006 for the US. Pursuant to the MIT agreement, we have been granted an
exclusive, worldwide license to make, use and sell the products covered by the
patents and to practice the procedures covered by the patents. Additionally, we
have purchased intellectual property from Baxter Healthcare Corporation related
to our liver assist device program, which includes two US patents - one issued
and one pending - as well as corresponding international patents. We are not
currently a party in any infringement claim.
We expect to aggressively patent and protect our proprietary technologies.
However, we cannot be sure that any additional patents will be issued to us as a
result of our domestic or foreign patent applications or that any of our patents
will withstand challenges by others. Patents issued to or licensed by us may be
infringed or third parties may independently develop either the same or similar
technology. Similarly, our patents may not provide us with meaningful protection
from competitors, including those who may pursue patents which may prevent,
limit or interfere with our products or will require licensing and the payment
of significant fees or royalties by us to such third parties in order to enable
us to conduct our business. We may sue or be sued by third parties regarding
patents and other intellectual property rights. These suits are costly and would
divert funds and management and technical resources from our operations.
7
We also rely upon unpatented proprietary technology, know-how and trade
secrets and seek to protect them through confidentiality agreements with
employees, consultants and advisors. We request that any corporate sponsor with
which we enter into a collaborative agreement do so as well. If these
confidentiality agreements are breached, we may not have adequate remedies for
the breach. In addition, others may independently develop or otherwise acquire
substantially the same proprietary technology as our technology and trade
secrets.
We have relationships with a number of academic consultants who are not
employed by us. Accordingly, we have limited control over their activities and
can expect only limited amounts of their time to be dedicated to our activities.
These persons may have consulting, employment or advisory arrangements with
other entities that may conflict with or compete with their obligations to us.
Our consultants typically sign agreements that provide for confidentiality of
our proprietary information and results of studies. However, in connection with
every relationship, we may not be able to maintain the confidentiality of our
technology, the dissemination of which could hurt our competitive position and
results of operations. To the extent that our scientific consultants develop
inventions or processes independently that may be applicable to our proposed
products, disputes may arise as to the ownership of the proprietary rights to
such information, and we may not win those disputes.
WE MUST BE ABLE TO MANUFACTURE OUR PRODUCTS SUCCESSFULLY
The process of manufacturing our products is complex, requiring strict
adherence to manufacturing protocols. We have been producing our lead product,
Apligraf, for commercial sale since the second half of 1997 in adherence with
these manufacturing protocols. However, with increasing demand for Apligraf, we
must further transition from small-scale to full-scale production of our
products. If we do not make the full-scale transition successfully, we will not
be able to satisfy the demand for our products and our results of operations
will be hurt.
We are required to maintain a manufacturing facility in compliance with
Good Manufacturing Practices. Manufacturing facilities and processes must pass
an inspection before the FDA issues any product licenses necessary to market
medical therapeutics and are subject to continual review and periodic
inspection. Foreign regulatory agencies can also have manufacturing controls
and inspections. We may not be able to maintain the necessary regulatory
approvals for our manufacturing operations or manufacture our products in a
cost-effective manner. If we were unable to manufacture potential products
independently or obtain or retain third party manufacturing on commercially
acceptable terms, the submission of products for final regulatory approval and
initiation of marketing would be delayed. This, in turn, may cause us to be
unable to commercialize product candidates as planned, on a timely basis or on a
profitable basis.
WE MUST BE ABLE TO OBTAIN ADEQUATE SOURCES OF SUPPLY
We manufacture Apligraf for commercial sale, as well as for use in clinical
trials, at our Canton, Massachusetts facility. Among the fundamental raw
materials needed to manufacture Apligraf are keratinocyte and fibroblast cells.
Because these cells are derived from donated infant foreskin, they may contain
human-borne pathogens. We perform extensive testing of the cells for pathogens,
including the HIV or "AIDS" virus. Our inability to obtain cells of adequate
purity, or cells that are pathogen-free, would limit our ability to manufacture
sufficient quantities of our products.
8
Another major material required to produce our products is collagen, a
protein obtained from animal source tissue. We have developed a proprietary
method of procuring our own collagen that we believe is superior in quality and
strength to collagen available from commercial sources. We currently obtain
animal source tissue from US suppliers only. We may not be able to obtain
adequate supplies of animal source tissue to meet our future needs or on a cost-
effective basis. The thermo-formed tray assembly that is used in the
manufacturing process of Apligraf is available to us under a supply arrangement
with only one manufacturing source. Because the FDA approval process requires
manufacturers to specify their proposed materials of certain components in their
applications, FDA approval of a new material would be required if a currently
approved material became unavailable from a supplier. If we are unable to obtain
adequate supplies of thermo-formed tray assemblies to meet future Apligraf
manufacturing needs or if we cannot obtain such assemblies on a cost-effective
basis, our operations would be hurt.
Interruptions in our supply of materials may occur in the future or we may
have to obtain alternative vendors for these materials. Any significant supply
interruption would adversely affect the production of Apligraf. In addition, an
uncorrected impurity or a supplier's variation in a raw material, either unknown
to us or incompatible with our manufacturing process, could hurt our ability to
manufacture products.
THE RETENTION OF KEY PERSONNEL IS IMPORTANT TO OUR COMPETITIVE POSITION
Because of the specialized nature of our business, our success will depend
upon our ability to attract and retain highly qualified personnel and to develop
and maintain relationships with leading research institutions. The competition
for those relationships and for experienced personnel amongst the biotechnology,
pharmaceutical and healthcare companies, universities and non-profit research
institutions is intense. If we are unable to continue to attract and retain such
personnel or relationships, our competitive position could be hurt.
WE MAY BE SUBJECT TO PRODUCT LIABILITY SUITS; OUR INSURANCE MAY NOT BE
SUFFICIENT TO COVER DAMAGES
Our business exposes us to potential liability risks that are inherent in
the testing, manufacturing, marketing and sale of medical products. The use of
our products and product candidates, whether for clinical trials or commercial
sale, may expose us to product liability claims or product recall and possible
adverse publicity. Although we have product liability insurance coverage, the
level or breadth of our coverage may not be adequate to fully cover potential
liability claims. In addition, we may not be able to obtain additional product
liability coverage in the future at an acceptable cost. A successful claim or
series of claims brought against us in excess of our insurance coverage and the
effect of product liability litigation upon the reputation and marketability of
our technology and products, could negatively affect our business.
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OUR BUSINESS IS SUBJECT TO THE UNCERTAINTY OF THIRD-PARTY REIMBURSEMENT AND
HEALTH CARE REFORM MEASURES WHICH MAY LIMIT MARKET ACCEPTANCE
In both domestic and foreign markets, our ability to commercialize our
product candidates will depend, in part, upon the availability of reimbursement
from third-party payors, such as government health administration authorities,
private health insurers and other organizations. Third-party payors are
increasingly challenging the price and cost-effectiveness of medical products.
If our products are not considered cost-effective, third-party payors may limit
reimbursement. Government and other third-party payors are increasingly
attempting to contain healthcare costs by limiting both coverage and the level
of reimbursement for new therapeutic products approved for marketing by the FDA
and by refusing, in some cases, to provide any coverage for uses of approved
products for disease indications for which the FDA has not granted marketing
approval. If government and third party payors do not provide adequate coverage
and reimbursement levels for uses of our products, the market acceptance of our
products would be limited.
There have been a number of federal and state proposals during the last few
years to subject the pricing of pharmaceuticals to government control and to
make other changes to the health care system of the US. It is uncertain what
legislative proposals will be adopted or what actions federal, state or private
payors for health care goods and services may take in response to any health
care reform proposals or legislation. We cannot predict the effect health care
reforms may have on our business.
OUR STOCK PRICE IS VOLATILE AND CAN FLUCTUATE SIGNIFICANTLY BASED ON EVENTS
NOT IN OUR CONTROL AND GENERAL INDUSTRY CONDITIONS
The biotechnology sector seems particularly vulnerable to abrupt changes in
investor sentiment. Stock prices of companies in the biotechnology industry,
including ours, can swing dramatically, with little relationship to operating
performance. Our stock price may be affected by a number of factors including,
but not limited to:
. clinical trial results, regulatory decisions and other product development
events;
. the outcome of litigation;
. decisions relating to intellectual property rights;
. the entrance of competitive products into our market;
. changes in reimbursement policies or other practices related to the
pharmaceutical industry; or
. other industry and market changes or trends.
During the past three years, the price of our common stock, adjusted for
stock splits, has ranged from $6.75 to $35.19 per share. These fluctuations can
occur due to events outside of our control, regulatory actions such as
government approval of products or reimbursements, and general market conditions
affecting the biotechnology sector or the stock market generally.
WE WILL NEED TO RAISE ADDITIONAL FUNDS, WHICH COULD ADVERSELY AFFECT YOUR
INVESTMENT
Based upon our current plans, we believe existing working capital at
December 31, 2000, together with the proceeds of product and other revenues in
2001 and proceeds available from exercising a portion or all of a $20,000,000
equity security put with Novartis, which is at our discretion, will be
sufficient to finance operations through at least the first quarter of 2002. We
expect to raise additional funds in 2001 through equity financing. However,
this statement is forward-looking and changes may occur that would significantly
decrease available cash before such time. Factors that may change our cash
requirements include:
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. Sales volume forecasts not achieved;
. Delays in obtaining regulatory approvals of products in different
countries, if needed, and subsequent timing of product launches;
. Delays in commercial acceptance and reimbursement when product launches
occur;
. Changes in the progress of research and development programs; and
. Changes in the resources devoted to outside research collaborations or
projects, self-funded projects, proprietary manufacturing methods and
advanced technologies.
Any of these events could adversely impact our capital resources, requiring
us to raise additional funds. Management believes that additional funds may be
available through equity or debt financing, strategic alliances with corporate
partners, capital lease arrangements, or other sources of financing in the
future. There can be no assurances that these funds will be available when
required on terms acceptable to us, if at all. If adequate funds are not
available when needed, we would need to delay, scale back or eliminate certain
research and development programs or license to third parties certain products
or technologies that we would otherwise undertake ourselves, resulting in a
potential adverse effect on our financial condition and results of operations.
OUR ANTI-TAKEOVER MEASURES MAY AFFECT THE VALUE OF OUR STOCK
We, as a Delaware corporation, are subject to the General Corporation Law
of the State of Delaware, including Section 203, an anti-takeover law enacted in
1988. In general, Section 203 restricts the ability of a public Delaware
corporation from engaging in a "business combination" with an "interested
stockholder" for a period of three years after the date of the transaction in
which the person became an interested stockholder. As a result of the
application of Section 203 and certain provisions in our certificate of
incorporation and bylaws, potential acquirors may be discouraged from attempting
to acquire us, thereby possibly depriving our stockholders of acquisition
opportunities to sell or otherwise dispose of our stock at above market prices
typical of such acquisitions.
We have also adopted a shareholder rights plan, which gives holders of
common stock the right to purchase shares of our Series B Junior Participating
Preferred Stock if a potential acquiror purchases or plans to make a tender
offer to purchase 15% or more of our outstanding common stock. The existence of
this plan may make it more difficult for a third party to acquire control of us.
We are authorized to issue up to 1,000,000 shares of preferred stock, $1.00
par value per share and to determine the price, privileges and other terms of
such shares. The issuance of any preferred stock with superior rights to the
common stocks could reduce the value of the common stock. In particular,
specific rights granted to future holders of preferred stock could be used to
restrict our ability to merge with or sell our assets to a third party, thereby
preserving control of Organogenesis by present owners and management and
preventing our holders of common stock from realizing a premium on their shares.
THE VALUE OF YOUR SECURITIES MAY DECREASE IF OTHER SECURITY HOLDERS
EXERCISE THEIR OPTIONS AND WARRANTS OR CONVERT THEIR DEBT INTO COMMON STOCK
At December 31, 2000, 34,489,459 shares of our common stock are
outstanding, which excludes 85,000 treasury shares. We have reserved an
additional 9,583,539 shares of common stock for future issuance or conversion of
stock options, warrants and the convertible debentures (excluding 1,911,075
shares of common stock remaining under a shelf registration declared effective
on February 14, 2000). We plan to issue additional options in the future. If
any of these securities are exercised or converted, investors may experience
dilution in the market value and earnings per share of the common stock into
which these securities are convertible.
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COLLABORATIVE AND OTHER AGREEMENTS
In January 1996, we entered into a collaborative agreement with Novartis
granting Novartis exclusive global marketing rights to Apligraf. Under the
agreement, we have received equity investments, non-refundable research,
development and milestone support payments, product payments and other payments.
During March 2000, we received $5,000,000 from Novartis, which represented a
support payment received in advance of achievement of a milestone related to the
diabetic foot ulcer indication. In June 2000, we recognized support revenue
when achievement of the milestone was met upon FDA approval of Apligraf for use
in diabetic foot ulcers. The following table summarizes by year all equity
investments, non-refundable research, development and milestone support payments
received to date. Product and other payments are included under the captions
"Product sales to related party" and "Other revenues" in our financial
statements.
1996 1997 1998 1999 2000
----------- ----------- ----------- ----------- ------------
Equity investments $ 5,000,000 $ - $ 6,000,000 $ - $ -
Up front non-refundable research and
development support payments 6,500,000 2,500,000 750,000 - -
Non-refundable milestone payments - - 6,000,000 - 5,000,000
----------- ----------- ----------- ------------ ------------
Total $11,500,000 $ 2,500,000 $12,750,000 $ - $ 5,000,000
=========== =========== =========== ============ ===========
|
During February 2001, we amended our collaborative agreement with Novartis,
effective January 2, 2001. The amended agreement:
. Grants Novartis the right to purchase an exclusive option to negotiate
terms to license Organogenesis's product Vitrix, soon to commence human
pivotal trials, and also for a second living dermal replacement product
currently in Organogenesis research;
. Provides Organogenesis with significantly higher payments for units of
Apligraf;
. Grants Organogenesis the right for three years to sell, at its discretion,
to Novartis up to $20 million in equity;
. Includes funding support from Novartis to upgrade Organogenesis's
manufacturing facility and for the facility investment needed for approval
and sale of Apligraf in the European Union;
. Includes funding support for Apligraf clinical development activities
(e.g., to further broaden its approved uses); and
. Includes development funding support for each living dermal replacement
product for which Novartis purchases an option to commence licensing
negotiations.
We supply Novartis's global requirements for Apligraf and receive a product
payment based on net product sales.
In 1994, we signed a license agreement with Toyobo Ltd. granting Toyobo a
license to manufacture and market TestSkin(TM) in Japan in exchange for royalty
payments. Additionally, Toyobo may, but is not obligated to, purchase collagen
and other products from us. Revenues under this arrangement are included in
other revenues and are not significant. This agreement is coterminous with
certain patents.
RESEARCH AGREEMENTS
We have entered into various collaborative research agreements that are
generally funded over a one or two-year period. Each agreement is reviewed at
least annually and the amounts to be funded for the next period are then
determined. Either party may cancel the agreement upon advance written notice.
Total payments made by us to third parties under these agreements were $648,000,
$662,000 and $542,000 for 1998, 1999 and 2000, respectively. All our research
agreements are early stage today, but have the potential to develop into more
material relationships in the future.
Testskin(TM) is a trademark of Organogenesis.
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RESEARCH AND DEVELOPMENT
We plan to continue to focus product development efforts on high-quality
cell therapy and connective tissue scaffolds for use in a variety of areas,
including wound care, surgery, cardiovascular medicine and liver disease.
Our research and development staff consists of scientists and laboratory
assistants with technical expertise in cell and developmental biology,
engineering, chemistry, immunology, cryopreservation, molecular biology and
clinical medicine.
For 1998, 1999 and 2000, research and development expenses were
$17,542,000, $19,066,000, and $17,511,000, respectively, which consist of costs
associated with research, development, clinical and process development,
facilities and engineering support used in R&D. All amounts expended were for
company-sponsored research and development.
EMPLOYEES
As of March 5, 2001, we had 236 full-time employees, inclusive of: 134 in
Operations; 67 in Research and Clinical; and 35 in General and Administrative.
In total we have 15 employees with PhDs. We have established a stock option plan
providing equity incentives, an employee stock purchase plan and a 401(k) plan
for all full-time employees. We believe that, through equity participation,
attractive fringe benefit programs and the opportunity to contribute to the
development and commercialization of new products using new technology, we will
continue to be able to attract highly-qualified personnel.
SCIENTIFIC ADVISORY BOARD
We have a Scientific Advisory Board ("SAB") composed of five physicians,
professors and scientists in various fields of medicine and science. The SAB
meets from time to time to advise and consult with management and our scientific
staff. Each member of the SAB is expected to devote only a portion of his time
to us and may have consulting or other advisory arrangements with other entities
that may conflict or compete with his obligations to us. Members of the SAB
have no formal duties, authority or management obligations.