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PROSPECTUS Filed Pursuant to Rule 424(b)(3)
Registration No. 333-47224
1,200,000 SHARES
CERUS CORPORATION
COMMON STOCK
The selling stockholder listed on page 14 is offering up to 1,200,000
shares of Cerus Corporation common stock.
Our common stock trades on the Nasdaq National Market under the symbol
CERS. On November 1, 2000, the last reported sale price of our common stock
was $54.63 per share.
We will not be paying any underwriting discounts or commissions in this
offering.
INVESTING IN OUR COMMON STOCK INVOLVES A HIGH DEGREE OF RISK. SEE "RISK
FACTORS" BEGINNING ON PAGE 4.
NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES
COMMISSION HAS APPROVED OR DISAPPROVED THESE SECURITIES OR DETERMINED IF THIS
PROSPECTUS IS TRUTHFUL OR COMPLETE. ANY REPRESENTATION TO THE CONTRARY IS A
CRIMINAL OFFENSE.
November 1, 2000.
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TABLE OF CONTENTS
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CERUS ........................................................................................................... 3
RISK FACTORS..................................................................................................... 4
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS............................................................. 12
WHERE YOU CAN FIND MORE INFORMATION ABOUT CERUS AND THIS OFFERING................................................ 13
USE OF PROCEEDS.................................................................................................. 14
SELLING STOCKHOLDER.............................................................................................. 14
PLAN OF DISTRIBUTION............................................................................................. 15
LEGAL MATTERS.................................................................................................... 17
EXPERTS ......................................................................................................... 17
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Helinx(TM) is a trademark of Cerus Corporation.
Intercept(TM) is a trademark of Baxter International, Inc.
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CERUS
Cerus is developing products to prevent the transmission of diseases
through blood transfusions. Our systems, which we are developing with our
partner, Baxter Healthcare Corporation, inactivate infectious pathogens in blood
components and inhibit the white blood cell activity that is responsible for
certain adverse immune and other transfusion-related reactions. Blood components
include platelets, fresh frozen plasma and red blood cells. Our Intercept(TM)
blood systems, which are at various stages of pre-commercial development, treat
each of these components. Because our systems are designed to inactivate rather
than merely test for pathogens, they may reduce the risk of transmission of
pathogens that would remain undetected by current testing methods. We believe
that our proprietary Helinx(TM) technology has the potential to inactivate many
new pathogens before they are identified and before screening tests have been
developed to detect them in the blood supply. We also are leveraging our core
technology into programs for decontaminating plasma derivatives and improving
the outcome of bone marrow or stem cell transplants in cancer patients.
We have completed six clinical trials of our Intercept platelet system,
three clinical trials of our Intercept plasma system and two clinical trials of
our Intercept red blood cell system. Our Intercept platelet system has undergone
Phase 3 clinical trials in Europe and is in Phase 3 clinical trials in the
United States. Our Intercept plasma system is in a Phase 3 clinical trial in the
United States. Our Intercept red blood cell system is in Phase 1 clinical trials
in the United States. Our allogeneic cellular immunotherapy, or ACIT, program
for improving the outcomes of stem cell transplants is in a Phase 1 clinical
trial in the United States using Helinx T-cells.
We are a Delaware corporation. Our principal executive offices are
located at 2525 Stanwell Drive, Suite 300, Concord, California 94520, and our
telephone number is (925) 603-9071. In this prospectus, "Cerus," "we," "us," and
"our" refer to Cerus Corporation, unless the context otherwise requires.
RECENT DEVELOPMENTS
On August 22, 2000, we and Baxter announced the results of our European
Phase 3 trial of the Intercept platelet system. Based on these results, we
expect to submit an application for regulatory approval to market the system in
Europe.
On August 28, 2000, we sold 1,200,000 newly-issued shares of our common
stock to Janus Investment Fund, the selling stockholder in this offering, for an
aggregate purchase price of $60 million.
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RISK FACTORS
You should carefully consider the following risk factors, in addition
to other information included or incorporated by reference in this prospectus,
before making an investment decision. The risks described below are not the only
risks we face. Additional risks that we do not yet know of or that we currently
think are immaterial may also impair our business operations. If any of the
events or circumstances described in the following risks actually occurs, our
business may suffer, the trading price of our common stock could decline, and
you may lose all or part of your investment.
OUR PRODUCTS ARE IN AN EARLY STAGE OF DEVELOPMENT, AND THERE IS A HIGH RISK OF
FAILURE.
We have no products that have received regulatory approval for
commercial sale. All of our product candidates are in early stages of
development, and we face the risks of failure inherent in developing medical
devices and biotechnology products based on new technologies. Our products must
satisfy rigorous standards of safety and efficacy before the United States Food
and Drug Administration and international regulatory authorities can approve
them for commercial use. Our platelet, fresh frozen plasma, red blood cell and
stem cell transplantation programs are undergoing clinical testing. Our other
programs are still in the early stages of research and development. We will have
to conduct significant additional research and pre-clinical (animal) and
clinical (human) testing before we can file applications for product approval
with the FDA and foreign regulatory agencies. Clinical trials in particular are
expensive, take many years and have a high risk of failure. In addition, to
compete effectively, our products must be easy to use, cost-effective and
economical to manufacture on a commercial scale. Any of our product candidates
may fail in the testing phase or may not attain market acceptance, which could
prevent us from achieving profitability.
IF OUR PRE-CLINICAL AND CLINICAL TRIALS ARE NOT SUCCESSFUL, WE WILL BE UNABLE TO
COMMERCIALIZE OUR PRODUCTS AND GENERATE REVENUE.
We must provide the FDA and foreign regulatory authorities with
pre-clinical and clinical data that demonstrate our products are safe and
effective before they can be approved for commercial sale. It may take us
several years to complete our testing, and failure can occur at any stage of
testing. We cannot rely on interim results of trials to necessarily predict
their final results, and acceptable results in early trials might not be
repeated in later trials. Any trial may fail to produce results satisfactory to
the FDA. Pre-clinical and clinical data can be interpreted in different ways,
which could delay, limit or prevent regulatory approval. Negative or
inconclusive results from a pre-clinical study or clinical trial or adverse
medical events during a clinical trial could cause a pre-clinical study or
clinical trial to be repeated or a program to be terminated, even if other
studies or trials relating to a program are successful.
WE MAY FAIL TO COMPLETE OUR CLINICAL TRIALS ON TIME OR BE UNABLE TO COMPLETE
THEM AT ALL.
We typically rely on third-party clinical investigators to conduct our
clinical trials and on other third-party organizations to perform data
collection and analysis. As a result, we have less control over certain aspects
that may delay:
- obtaining approvals from a study site's review board;
- training and qualifying personnel at the study site; and
- enrolling qualified subjects.
In addition, some of our clinical trials involve patient groups with
rare medical conditions, which may increase the difficulty in identifying and
enrolling a sufficient number of patients to complete the trials on time. Our
product development costs will increase if we have delays in testing or
approvals. Significant clinical trial delays could allow competitors to bring
products to market before we do and impair our ability to commercialize our
products.
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BECAUSE OUR PRODUCTS HAVE NOT BEEN MANUFACTURED ON A COMMERCIAL SCALE, WE FACE
MANUFACTURING UNCERTAINTIES THAT COULD LIMIT COMMERCIALIZATION OF OUR PRODUCTS.
Our product candidates, and many of their components, have never been
manufactured on a commercial scale. We intend to use third-party manufacturers
to produce commercial quantities of the inactivation compounds to be used in our
products. The manufacturers will need to develop new methods and processes to
manufacture these compounds on a commercial scale and demonstrate to us, the FDA
and foreign regulatory authorities that their commercial scale manufacturing
processes comply with government regulations. It may be difficult or impossible
to economically manufacture our products on a commercial scale.
Baxter is responsible for manufacturing and assembling our pathogen
inactivation systems. Baxter intends to rely on third parties to manufacture and
assemble system components, many of which are customized and have not been
manufactured on a commercial scale. Baxter has not produced the pathogen
inactivation systems in commercial quantities and may not be able to manufacture
and assemble them on an economical basis.
WE DEPEND ON A LIMITED NUMBER OF SUPPLIERS TO MANUFACTURE OUR PRODUCTS AND THEIR
COMPONENTS.
A limited number of suppliers manufacture our inactivation compounds. We
have contracted with two manufacturers to provide enough S-59, the inactivation
compound we use in our platelet and fresh frozen plasma systems, to meet our
anticipated clinical trial and product development requirements. Only one of
these manufacturers is performing the complete synthesis of S-59. A sole
third-party manufacturer has produced the inactivation compound we use in our
red blood cell systems, S-303. If any of these manufacturers cannot produce our
compounds in the required quantities or to the required standards, we may face
delays and shortfalls before we are able to identify alternate or additional
manufacturers to meet these requirements. Also, any new manufacturer will have
to prove both to us and to the FDA and foreign regulatory agencies that its
manufacturing process complies with government regulations.
Baxter intends to purchase certain key components of the pathogen
inactivation systems from a limited number of suppliers. While we believe there
are alternative suppliers for these components, it would be expensive and
time-consuming to establish additional or replacement suppliers for these
components. If Baxter were unable to find adequate suppliers for these
components, we may be required to redesign the systems, which could lead to
additional testing and clinical trials. If we were required to redesign the
products, our development costs would increase, and our programs could be
delayed significantly.
OUR PRODUCTS MAY NOT ACHIEVE ACCEPTANCE IN THE HEALTH CARE COMMUNITY.
Even if our products receive regulatory approval for commercial sale,
physicians, patients and healthcare payors may not believe that the benefits of
using our systems justify their additional cost, given that the blood supply has
become safer in recent years. We believe that our ability to successfully
commercialize products will depend in part on the availability of adequate
reimbursement for product costs and related treatment of blood components from
governmental authorities and private health care insurers (including health
maintenance organizations), which are increasingly attempting to contain health
care costs by limiting both the extent of coverage and the reimbursement rate
for new tests and treatments. In addition, our products will not inactivate all
known pathogens, and the inability of our systems to inactivate certain
pathogens may inhibit their acceptance. In addition, for logistical and
financial reasons, the transfusion industry has not always integrated new
technologies into their processes, even those with the potential to improve the
safety of the blood supply. If our products fail to achieve market acceptance,
we may never become profitable.
WE WILL NEED TO DEVELOP AND TEST ADDITIONAL CONFIGURATIONS OF OUR PLATELET
PATHOGEN INACTIVATION SYSTEM TO ADDRESS THE ENTIRE MARKET.
We are currently developing our platelet pathogen inactivation system in
the United States to treat apheresis platelets collected on Baxter's automated
collection platform. Apheresis platelets are collected from a single donor using
an automated collection machine. Currently, we estimate that the majority of
platelets are collected by apheresis in the United States with the remainder
prepared from pooled random donor platelets using a manual process. Blood
centers in the United States preparing random donor platelets may be reluctant
to switch to
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apheresis collection, and the FDA may require us to make our systems compatible
with random donor platelets. If we are required to develop a platelet pathogen
inactivation system compatible with random donor platelets, or if we decide to
address the random donor platelet market in the United States, we will need to
perform additional product development and testing, including clinical trials.
These development activities would increase our costs significantly, and may not
be successful. In addition, FDA regulations limit the time from pooling to
transfusion to four hours to minimize the proliferation of bacterial
contamination in the pooled product. As a result, most pooling occurs in
hospitals. Our platelet system is designed for use in blood centers and requires
approximately six hours of processing. Therefore, the FDA's time limit between
pooling and transfusion currently precludes the use of our system with pooled
random donor platelets. Although our system is designed to reduce the risk of
bacterial contamination, we cannot predict whether the FDA would remove this
process time constraint to allow our system to be used with pooled random donor
platelets.
Baxter is one of three primary manufacturers of equipment for the
collection of apheresis platelets. The equipment, design and materials used to
collect the platelets vary from manufacturer to manufacturer. We are conducting
our pre-clinical and clinical studies for apheresis platelets collected using
only Baxter's equipment and materials. As a result, market acceptance of our
platelet system for apheresis platelets will depend on market acceptance of
Baxter's collection equipment. Blood centers using other equipment may be
reluctant to replace their existing equipment, and the regulatory agencies may
require us to make our systems compatible with other equipment. If we are
required to develop platelet pathogen inactivation systems compatible with other
manufacturers' equipment, or if we decide to address this broader market, we
will need to perform additional product development and testing, including
clinical trials. These development activities would increase our costs
significantly, and may not be successful.
A SMALL NUMBER OF CUSTOMERS WILL DETERMINE MARKET ACCEPTANCE OF OUR PRODUCTS.
The market for our pathogen inactivation systems is dominated by a small
number of blood collection centers. In the United States, the American Red Cross
collects and distributes approximately 50% of the nation's supply of blood and
blood components. Other major United States blood centers include the New York
Blood Center and United Blood Services, each of which distributes approximately
6% of the nation's supply of blood and blood components. In Western Europe and
Japan, various national blood transfusion services or Red Cross organizations
collect, store and distribute virtually all of their respective nations' blood
and blood components supply. Failure to properly market, price or sell our
products to any of these large customers could significantly diminish potential
product revenues.
WE RELY HEAVILY ON BAXTER FOR DEVELOPMENT FUNDING, MARKETING AND SALES.
We have development and marketing agreements with Baxter for our
platelet, fresh frozen plasma and red blood cell pathogen inactivation systems,
and we rely on Baxter for significant financial and technical contributions to
these programs. Our ability to develop, manufacture and market these products
successfully depends significantly on Baxter's performance under these
agreements.
- Baxter can terminate our agreements or fail to perform. Baxter
can terminate the agreements without cause under certain
circumstances. If Baxter terminates the agreements or fails to
provide adequate funding to support the product development
efforts, we will need to obtain additional funding from other
sources and will be required to devote additional resources to
the development of our products. We cannot assure you that we
would be able to find a suitable substitute partner in a timely
manner, on reasonable terms or at all. If we fail to find a
suitable partner, our research, development or commercialization
of certain planned products would be delayed significantly which
would cause us to incur additional expenditures.
- We rely on Baxter for the marketing, sales and distribution of
our products. We do not have and currently do not plan to
develop our own marketing and sales organization. Instead, we
plan to rely on Baxter to market and sell the pathogen
inactivation systems. If our joint development agreements with
Baxter are terminated or if Baxter is unable to market the
products successfully, we will be required to find another
marketing, sales and distribution partner or develop these
capabilities ourselves. We may not be able to find a suitable
partner on favorable terms or on a timely basis, if at all.
Developing
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marketing, sales and distribution capabilities ourselves would
delay commercialization of our products and increase our costs.
- We lack control over management decisions. Baxter and we share
responsibility for managing the development programs for the
pathogen inactivation systems. Management decisions are made by
a management board that has equal representation from both
Baxter and us. Our interests and Baxter's may not always be
aligned. If we disagree with Baxter on program direction, a
neutral party will make the decision. The neutral party may not
decide in our best interest. Under the agreements, Baxter may
independently develop a pathogen inactivation system for fresh
frozen plasma using their pre-existing methylene blue
technology. Such an effort by Baxter could create conflicts in
our joint program for the development of a pathogen inactivation
system for fresh frozen plasma.
OUR PRODUCTS ARE SUBJECT TO EXTENSIVE REGULATION BY DOMESTIC AND FOREIGN
GOVERNMENTS.
Our products under development and anticipated future products are
subject to extensive and rigorous regulation by United States local, state and
federal regulatory authorities and by foreign regulatory bodies. These
regulations are wide-ranging and govern, among other things:
- product development;
- product testing;
- product manufacturing;
- product labeling;
- product storage;
- product pre-market clearance or approval;
- product sales and distribution; and
- product advertising and promotion.
The FDA and other agencies in the United States and in foreign countries
impose substantial requirements upon the manufacturing and marketing of products
such as those we are developing. The process of obtaining FDA and other required
regulatory approvals is long, expensive and uncertain. The time required for
regulatory approvals is uncertain and the process typically takes a number of
years, depending on the type, complexity and novelty of the product. We may
encounter significant delays or excessive costs in our efforts to secure
necessary approvals or licenses, or we may not be successful at all.
Even if our products receive approval for commercial sale, their
marketing and manufacturing will be subject to continuing FDA and other
regulatory requirements, such as requirements to comply with good manufacturing
practices. The failure to comply with these requirements could result in
enforcement action, which could harm our business. Later discovery of problems
with a product, manufacturer or facility may result in additional restrictions
on the product or manufacturer, including withdrawal of the product from the
market. The government may impose new regulations which could further delay or
preclude regulatory approval of our potential products. We cannot predict the
impact of adverse governmental regulation which might arise from future
legislative or administrative action.
We intend to generate some product revenue from sales outside of the
United States. Distribution of our products outside the United States also is
subject to extensive government regulation. These regulations, including the
requirements for approvals or clearance to market, the time required for
regulatory review and the sanctions imposed for violations, vary by country.
Failure to obtain necessary regulatory approvals or any other failure to comply
with regulatory requirements could result in reduced revenue and earnings.
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To support our requests for FDA approval to market our products, we
intend to conduct various types of studies including:
- toxicology studies to evaluate product safety;
- laboratory and animal studies to evaluate product effectiveness;
and
- human clinical trials to evaluate the safety, tolerability and
effectiveness of treated blood components.
We have conducted many toxicology studies to demonstrate our products'
safety, and we plan to conduct additional toxicology studies throughout the
product development process. At any time, the FDA may require further toxicology
or other studies to further demonstrate our products' safety, which could delay
commercialization. We believe the FDA is likely to weigh the potential risks of
using our pathogen inactivation products against the incremental benefits, which
may be less compelling in light of improved safety in the blood supply. In
addition, our clinical development plan assumes that we will not be required to
perform human clinical studies to demonstrate our systems' ability to inactivate
pathogens. Although we have discussed this plan with the FDA, they may find it
unacceptable at any time and may require human clinical trials to demonstrate
efficacy in inactivating pathogens. Trials of this type may be too large and
expensive to be practical.
Regulatory agencies may limit the uses, or indications, for which any of
our products is approved. For example, we believe that we will be able to claim
the inactivation of particular pathogens only to the extent we have laboratory
or animal data to support such claims.
In addition to the regulatory requirements applicable to us and our
products, there are regulatory requirements applicable to our prospective
customers, the blood centers that process and distribute blood and blood
products. Blood centers and others will likely be required to obtain approved
license supplements from the FDA before shipping products processed with our
pathogen inactivation systems interstate. This requirement or FDA delays in
approving these supplements may deter some blood centers from using our
products. Blood centers that do submit supplements may face disapproval or
delays in approval that could provide further delay or deter them from using our
products. The regulatory impact on potential customers could slow or limit the
potential sales of our products.
WE ARE USING PROTOTYPE COMPONENTS IN OUR CLINICAL TRIALS AND HAVE NOT COMPLETED
THEIR COMMERCIAL DESIGN.
The system disposables and ultraviolet light sources we use in our
clinical trials are prototypes. We are developing the commercial design for
these products at the same time. As a result, we plan to perform studies, both
pre-clinical and clinical, to demonstrate the equivalence of the prototype and
the commercial design. However, regulatory agencies may require us to perform
additional studies, both pre-clinical and clinical, using the commercial
versions of the systems, which may increase our expenses and delay the
commercialization of our products. If we fail to develop commercial versions of
the systems on schedule, our competitors may be able to bring products to market
before we do, which would delay or diminish our potential revenues.
WE HAVE ONLY A LIMITED OPERATING HISTORY AND WE EXPECT TO CONTINUE TO GENERATE
LOSSES.
We may never achieve a profitable level of operations. To date, we have
engaged primarily in research and development. Our development and general and
administrative expenses have resulted in substantial losses. As of June 30,
2000, we had an accumulated deficit of approximately $103.7 million. All of our
products are in the research and development stage, and we have not received any
revenue from product sales. We have received all of our revenue under our
agreements with Baxter, the Consortium for Plasma Sciences, and federal research
grants. We will be required to conduct significant research, development,
clinical testing and regulatory compliance activities for each of these
products. We expect our losses to continue at least until our product candidates
are commercialized and achieve significant market acceptance. Our ability to
become profitable will depend on our ability to, among other things:
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- establish adequate protection of our intellectual property
rights;
- complete our product development;
- obtain product regulatory approvals; and
- achieve market acceptance for our products.
WE WILL NEED ADDITIONAL FUNDS.
Our product development programs are capital-intensive. We expect to
continue to spend substantial funds for our operations for the foreseeable
future. We believe that our existing capital resources, together with
anticipated payments from Baxter under our agreements with Baxter and projected
interest income, will support our current and planned operations for at least
the next 18 months. Our cash, liquidity and capital requirements will depend on
many factors, including additional research and development needs, product
testing results, regulatory requirements, competitive pressures and
technological advances and setbacks.
We may require substantial additional funds for our long-term product
development, marketing programs and operating expenses. We do not know if we
will be able to raise additional funds on acceptable terms. If we raise
additional funds by issuing equity securities, our existing stockholders may
experience substantial dilution.
WE OPERATE IN A COMPETITIVE INDUSTRY WITH RAPIDLY CHANGING TECHNOLOGY.
We expect our products to encounter significant competition. Our
products may compete with other approaches to blood safety and improving the
outcome of stem cell transplantation currently in use, as well as with future
products developed by biotechnology and pharmaceutical companies, hospital
supply companies, national and regional blood centers, and governmental
organizations and agencies. Our success will depend in part on our ability to
respond quickly to medical and technological changes through the development and
introduction of new products. Product development is risky and uncertain, and we
cannot assure you that we will develop our products successfully. Competitors'
products or technologies may make our products obsolete or non-competitive
before we are able to generate any significant revenue. Many of our competitors
or potential competitors have substantially greater financial and other
resources than we have. They may also have greater experience in pre-clinical
testing, human clinical trials and other regulatory approval procedures. Our
ability to compete successfully will depend, in part, on our ability to:
- attract and retain skilled scientific personnel;
- develop technologically superior products;
- develop lower cost products;
- obtain patent or other proprietary protection for our products
and technologies;
- obtain required regulatory approvals for our products;
- be early entrants to the market; and
- manufacture, market and sell our products, independently or
through collaborations.
Several companies are developing technologies which are, or in the
future may be, the basis for products that will directly compete with or reduce
the market for our pathogen inactivation systems. A number of companies are
specifically focusing on alternative strategies for pathogen inactivation in
various blood components. In May 1998, the FDA approved solvent-detergent for
use in treating fresh frozen plasma in the United States. If the treatment of
fresh frozen plasma by solvent-detergent becomes a widespread practice, which
has not happened to date, it could impair our ability to market our fresh frozen
plasma pathogen inactivation system in the United States.
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At least one other company is currently marketing solvent-detergent based
pathogen inactivation systems for fresh frozen plasma in Europe.
Other groups are developing synthetic blood product substitutes and
products to stimulate the growth of platelets. Development of any of these
technologies could impair the potential market for our products.
FAILURE TO ATTRACT AND RETAIN KEY EMPLOYEES WILL IMPAIR OUR BUSINESS.
Because of the scientific nature of our business, we depend on the
principal members of our management and scientific staff. Our success will
depend largely on our ability to attract and retain highly skilled scientific
and managerial personnel. Competition for scientific and managerial personnel is
particularly intense in the San Francisco Bay Area where we, together with
numerous other life sciences companies, universities and research institutions,
maintain our operations. The failure to maintain our management and scientific
staff and to attract additional key personnel could impede significantly
achievement of our research and development and commercialization objectives.
Although we intend to provide incentive compensation to attract and retain our
key personnel, we cannot guarantee these efforts will be successful.
WE MAY NOT BE ABLE TO PROTECT OUR INTELLECTUAL PROPERTY OR OPERATE OUR BUSINESS
WITHOUT INFRINGING INTELLECTUAL PROPERTY RIGHTS OF OTHERS.
Our technology will be protected from unauthorized use by others only to
the extent that it is covered by valid and enforceable patents or effectively
maintained as trade secrets. As a result, our success depends in part on our
ability to:
- obtain patents;
- protect trade secrets;
- operate without infringing upon the proprietary rights of
others; and
- prevent others from infringing on our proprietary rights.
We cannot be certain that our patents or patents that we license from
others will be enforceable and afford protection against competitors. Our
patents or patent applications, if issued, may be challenged, invalidated or
circumvented. Our patent rights may not provide us with proprietary protection
or competitive advantages against competitors with similar technologies. Others
may independently develop technologies similar to ours or independently
duplicate our technologies. Due to the extensive time required for development,
testing and regulatory review of our potential products, our patents may expire
or remain in existence for only a short period following commercialization. This
would reduce or eliminate any advantage of the patents.
We cannot be certain that we were the first to make the inventions
covered by each of our issued or pending patent applications or that we were the
first to file patent applications for such inventions. We may need to license
the right to use third-party patents and intellectual property to continue
development and marketing of our products. We may not be able to acquire such
required licenses on acceptable terms, if at all. If we do not obtain such
licenses, we may need to design around other parties' patents or we may not be
able to proceed with the development, manufacture or sale of our products.
We may face litigation to defend against claims of infringement, assert
claims of infringement, enforce our patents, protect our trade secrets or
know-how, or determine the scope and validity of others' proprietary rights.
Patent litigation is costly. In addition, we may require interference
proceedings declared by the United States Patent and Trademark Office to
determine the priority of inventions relating to our patent applications.
Litigation or interference proceedings could be expensive and time consuming,
and we could be unsuccessful in our efforts to enforce our intellectual property
rights.
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WE MAY BE LIABLE IF OUR PRODUCTS HARM PEOPLE.
We are exposed to potential liability risks inherent in the testing and
marketing of medical devices and products. We may be liable if any of our
products causes injury, illness or death. We intend to obtain product liability
insurance before the commercial introduction of any product, but do not know
whether we will be able to obtain and maintain such insurance on acceptable
terms. Any insurance we obtain may not provide adequate coverage against
potential liabilities. If we cannot successfully defend ourselves against
product liability claims, we may incur substantial liabilities or be required to
limit commercialization of our products.
WE USE HAZARDOUS SUBSTANCES THAT ARE SUBJECT TO ENVIRONMENTAL REGULATION.
Our research and development involves the controlled use of hazardous
materials, including certain hazardous chemicals, radioactive materials and
pathogens. Accordingly, we are subject to federal, state and local laws
governing the use, handling and disposal of these materials. We may incur
significant costs to comply with additional environmental and health and safety
regulations in the future. Although we believe that our safety procedures for
handling and disposing of hazardous materials comply with regulatory
requirements, we cannot eliminate the risk of accidental contamination or
injury. If an accident occurs, we could be held liable for any damages that
result.
THE MARKET PRICE OF OUR STOCK MAY BE HIGHLY VOLATILE.
The market prices for our securities and those of other emerging medical
device and biotechnology companies have been, and may continue to be, volatile.
Announcements may have a significant impact on the market price of our common
stock. Such announcements may include:
- biological or medical discoveries;
- technological innovations or new commercial services by us or
our competitors;
- developments concerning proprietary rights, including patents
and litigation matters;
- regulatory developments in both the United States and foreign
countries;
- public concern as to the safety of new technologies;
- general market conditions;
- comments made by analysts, including changes in analysts'
estimates of our financial performance; and
- quarterly fluctuations in our revenue and financial results.
The stock market has from time to time experienced extreme price and
volume fluctuations, which have particularly affected the market prices for
emerging biotechnology and medical device companies, and which have often been
unrelated to the operating performance of such companies. These broad market
fluctuations may adversely affect the market price of our common stock. In the
past, following periods of volatility in the market price of a company's stock,
securities class action litigation has occurred against the issuing company.
Such litigation could result in substantial costs and a diversion of
management's attention and resources, which could have a material adverse effect
on our revenue and earnings. Any adverse determination in such litigation could
also subject us to significant liabilities.
ANTI-TAKEOVER PROVISIONS IN OUR CHARTER DOCUMENTS AND UNDER DELAWARE LAW MAY
MAKE IT MORE DIFFICULT TO ACQUIRE US, EVEN THOUGH AN ACQUISITION MAY BE
BENEFICIAL TO OUR STOCKHOLDERS.
Provisions of our certificate of incorporation and bylaws could make it
more difficult for a third party to acquire us, even if doing so would benefit
our stockholders. These provisions:
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- establish that members of the board of directors may be removed
only for cause upon the affirmative vote of stockholders owning
at least two-thirds of our capital stock;
- authorize the issuance of "blank check" preferred stock that
could be issued by our board of directors to increase the number
of outstanding shares and thwart a takeover attempt;
- limit who may call a special meeting of stockholders;
- prohibit stockholder action by written consent, thereby
requiring all stockholder actions to be taken at a meeting of
our stockholders; and
- establish advance notice requirements for nominations for
election to the board of directors or for proposing matters that
can be acted upon at stockholder meetings.
In November 1999, our board of directors adopted a stockholder rights
plan, commonly known as a "poison pill." The provisions described above, our
poison pill and provisions of the Delaware General Corporation Law relating to
business combinations with interested stockholders may discourage, delay or
prevent a third party from acquiring us, even if our stockholders might receive
a premium for their shares in the acquisition over then current market prices.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
Some of the statements in this prospectus and the documents incorporated
by reference are forward-looking statements. These statements are based on our
current expectations, assumptions, estimates and projections about our business
and our industry, and involve known and unknown risks, uncertainties and other
factors that may cause our or our industry's results, levels of activity,
performance or achievement to be materially different from any future results,
levels of activity, performance or achievements expressed or implied in or
contemplated by the forward-looking statements. Words such as "believe,"
"anticipate," "expect," "intend," "plan," "will," "may," "should," "estimate,"
"predict," "potential," "continue," or the negative of such terms or other
similar expressions, identify forward-looking statements. In addition, any
statements that refer to expectations, projections or other characterizations of
future events or circumstances are forward-looking statements. Our actual
results could differ materially from those anticipated in such forward-looking
statements as a result of several factors more fully described under the caption
"Risk Factors" and in the documents incorporated by reference. The
forward-looking statements made in this prospectus relate only to events as of
the date on which the statements are made.
12.
<PAGE> 13
WHERE YOU CAN FIND MORE INFORMATION ABOUT CERUS AND THIS OFFERING
You should rely only on the information provided or incorporated by
reference in this prospectus. We have authorized no one to provide you with
different information. We are not making an offer of these securities in any
state where the offer is not permitted. You should not assume that the
information in this prospectus or any prospectus supplement is accurate as of
any date other than the date on the front of the document.
We have filed with the SEC a registration statement on Form S-3 to
register the common stock offered by this prospectus. However, this prospectus
does not contain all of the information contained in the registration statement
and the exhibits and schedules to the registration statement. We strongly
encourage you to carefully read the registration statement and the exhibits and
schedules to the registration statement.
We file annual, quarterly and special reports, proxy statements and
other information with the SEC. You may read and copy any document we file at
the SEC's public reference rooms in Washington, DC, New York, New York and
Chicago, Illinois. You can request copies of these documents by contacting the
SEC and paying a fee for the copying cost. Please call the SEC at 1-800-SEC-0330
for further information on the public reference rooms. Our SEC filings are also
available to the public from the SEC's website at www.sec.gov.
The SEC allows us to "incorporate by reference" the information
contained in documents that we file with them, which means that we can disclose
important information to you by referring to those documents. The information
incorporated by reference is considered to be part of this prospectus.
Information in this prospectus supersedes information incorporated by reference
which we filed with the SEC prior to the date of this prospectus, while
information that we file later with the SEC will automatically update and
supersede this information. We incorporate by reference the documents listed
below and any future filings we will make with the SEC under Sections 13(a),
13(c), 14 or 15(d) of the Securities Exchange Act of 1934.
The following documents filed with the SEC are incorporated by reference
in this prospectus:
1. Our Annual Report on Form 10-K for the year ended
December 31, 1999;
2. Our Quarterly Reports on Form 10-Q for the quarters
ended March 31 and June 30, 2000;
3. Our Current Report on Form 8-K, dated August 22, 2000;
and
4. The description of our common stock set forth in our
registration statement on Form 8-A, filed with the SEC
on January 8, 1997.
We will furnish without charge to you, on written or oral request, a
copy of any or all of the documents incorporated by reference, including
exhibits to these documents. You should direct any requests for documents to
Cerus Corporation, Attention: Investor Relations Officer, 2525 Stanwell Drive,
Suite 300, Concord, California 94520, telephone: (925) 603-9071.
Our common stock is quoted on the Nasdaq National Market under the
symbol "CERS". You may inspect reports and other information concerning us at
1735 K Street, N.W., Washington, D.C. 20006
-----------------
WE HAVE NOT AUTHORIZED ANY DEALER, SALESPERSON OR OTHER PERSON TO GIVE
ANY INFORMATION OR REPRESENT ANYTHING NOT CONTAINED IN THIS PROSPECTUS. YOU
SHOULD RELY ONLY ON THE INFORMATION PROVIDED OR INCORPORATED BY REFERENCE IN
THIS PROSPECTUS. YOU SHOULD NOT RELY ON ANY UNAUTHORIZED INFORMATION. THIS
PROSPECTUS DOES NOT OFFER TO SELL OR BUY ANY SHARES IN ANY JURISDICTION IN WHICH
IT IS UNLAWFUL. THE INFORMATION IN THIS PROSPECTUS IS CURRENT AS OF THE DATE ON
THE COVER.
13.
<PAGE> 14
USE OF PROCEEDS
The proceeds from the sale of the common stock offered pursuant to this
prospectus are solely for the account of the selling stockholder. We will not
receive any proceeds from the sale of these shares of common stock.
SELLING STOCKHOLDER
We are registering the shares covered by this prospectus on behalf of
the selling stockholder named in the table below. We issued all of the shares to
the selling stockholder in a private placement transaction. We have registered
the shares to permit the selling stockholder and its pledgees, donees,
transferees or other successors-in-interest that receive their shares from the
selling stockholder as a gift, partnership distribution or other non-sale
related transfer after the date of this prospectus to resell the shares.
The following table sets forth the name of the selling stockholder, the
number of shares owned by it, the number of shares that may be offered under
this prospectus and the number of shares of our common stock owned by the
selling stockholder as of September 29, 2000, the number of shares that may be
offered under this prospectus and the number of shares of our common stock owned
by the selling stockholder after this offering is completed. The selling
stockholder has not had a material relationship with us within the past three
years. The number of shares in the column "Number of Shares Being Offered"
represents all of the shares that the selling stockholder may offer under this
prospectus. The selling stockholder may sell some, all or none of its shares. We
do not know how long the selling stockholder will hold the shares before selling
them and we currently have no agreements, arrangements or understandings with
the selling stockholder regarding the sale of any of the shares. The shares
offered by this prospectus may be offered from time to time by the selling
stockholder.
The percentages of shares owned prior to the offering are based on
14,031,564 shares of our common stock outstanding, giving effect to the sale of
1,200,000 shares to the selling stockholder in the private placement.
<TABLE>
<CAPTION>
SHARES BENEFICIALLY OWNED NUMBER OF SHARES SHARES BENEFICIALLY
PRIOR TO OFFERING BEING OWNED AFTER OFFERING
NAME NUMBER PERCENT OFFERED(1) NUMBER PERCENT
------------------------------------------------- --------- --------- --------- --------- ---------
<S> <C> <C> <C> <C> <C>
Janus Investment Fund on behalf of its series(2) 1,474,650 10.5% 1,200,000 274,650 2.0
</TABLE>
--------------------
(1) Consists of 700,000 shares offered by the Janus Global Life Sciences Fund
and 500,000 shares offered by the Janus Venture Fund. Thomas Malley manages the
Global Life Sciences Fund, and Jonathan Coleman and William Bales manage the
Venture Fund. Each manager has dispositive power with respect to the shares in
the respective managed fund.
(2) Janus Capital Corporation, the registered investment advisor for Janus
Investment Fund, may be deemed to be a beneficial owner of shares of Cerus
common stock. However, Janus Capital does not have the right to receive any
dividends from, or the proceeds from the sale of, such securities and disclaims
any ownership associated with such rights. Thomas H. Bailey owns approximately
12.2% of Janus Capital. Mr. Bailey also serves as President and Chairman of the
Board of Janus Capital. Mr. Bailey does not own of record any shares of Cerus
common stock and he has not engaged in any transaction in Cerus common stock.
However, as a result of his position, Mr. Bailey may be deemed to have the power
to exercise or to direct the exercise of such voting and/or dispositive power
that Janus Capital may have with respect to Cerus common stock. Mr. Bailey
specifically disclaims beneficial ownership over any shares of Cerus common
stock that he or Janus Capital may be deemed to beneficially own.
14.
<PAGE> 15
PLAN OF DISTRIBUTION
The selling stockholder may sell the shares from time to time. The
selling stockholder will act independently of us in making decisions regarding
the timing, manner and size of each sale. The sales may be made on one or more
exchanges or in the over-the-counter market or otherwise, at prices and at terms
then prevailing or at prices related to the then current market price, or in
privately negotiated transactions. The selling stockholder may effect these
transactions by selling the shares to or through broker-dealers. The selling
stockholder may sell its shares in one or more of, or a combination of:
- a block trade in which the broker-dealer will attempt to sell
the shares as agent but may position and resell a portion of the
block as principal to facilitate the transaction;
- purchases by a broker-dealer as principal and resale by a
broker-dealer for its account under this prospectus;
- an exchange distribution in accordance with the rules of an
exchange;
- ordinary brokerage transactions and transactions in which the
broker solicits purchasers; and
- privately negotiated transactions.
To the extent required, this prospectus may be amended or supplemented
from time to time to describe a specific plan of distribution. If the plan of
distribution involves an arrangement with a broker-dealer for the sale of shares
through a block trade, special offering, exchange distribution or secondary
distribution or a purchase by a broker or dealer, the amendment or supplement
will disclose:
- the name of the selling stockholder and of the participating
broker-dealer(s);
- the number of shares involved;
- the price at which the shares were sold;
- the commissions paid or discounts or concessions allowed to the
broker-dealer(s), where applicable;
- that a broker-dealer(s) did not conduct any investigation to
verify the information set out or incorporated by reference in
this prospectus; and
- other facts material to the transaction.
From time to time, the selling stockholder may transfer, pledge, donate
or assign its shares of common stock to lenders or others and each of such
persons will be deemed to be a "selling stockholder" for purposes of this
prospectus. The number of shares of common stock beneficially owned by the
selling stockholder will decrease as and when it takes such actions. The plan of
distribution for the selling stockholder's shares of common stock sold under
this prospectus will otherwise remain unchanged, except that the transferees,
pledgees, donees or other successors will be selling stockholders hereunder.
Upon being notified by a selling stockholder that a donee or pledgee intends to
sell more than 500 shares, we will file a supplement to this prospectus.
The selling stockholder may enter into hedging transactions with
broker-dealers in connection with distributions of the shares or otherwise. In
these transactions, broker-dealers may engage in short sales of the shares in
the course of hedging the positions they assume with the selling stockholder.
The selling stockholder also may sell shares short and redeliver the shares to
close out short positions. The selling stockholder may enter into option or
other transactions with broker-dealers which require the delivery to the
broker-dealer of the shares. The broker-dealer may then resell or otherwise
transfer the shares under this prospectus. The selling stockholder also may loan
15.
<PAGE> 16
or pledge the shares to a broker-dealer. The broker-dealer may sell the loaned
shares, or upon a default the broker-dealer may sell the pledged shares under
this prospectus.
In effecting sales, broker-dealers engaged by the selling stockholder
may arrange for other broker-dealers to participate in the resales.
Broker-dealers or agents may receive compensation in the form of commissions,
discounts or concessions from the selling stockholder. Broker-dealers or agents
may also receive compensation from the purchasers of the shares for whom they
act as agents or to whom they sell as principals, or both. Compensation as to a
particular broker-dealer might be in excess of customary commissions and will be
in amounts to be negotiated in connection with the sale. A broker-dealer or
agent and any other participating broker-dealer or the selling stockholder may
be deemed to be an "underwriter" within the meaning of Section 2(11) of the
Securities Act of 1933, as amended, in connection with sales of the shares.
Accordingly, any commission, discount or concession received by them and any
profit on the resale of the shares purchased by them may be deemed to be
underwriting discounts or commissions under the Securities Act. Because the
selling stockholder may be deemed to be an "underwriter" within the meaning of
Section 2(11) of the Securities Act, the selling stockholder will be subject to
the prospectus delivery requirements of the Securities Act. In addition, any
securities covered by this prospectus that qualify for sale under Rule 144
promulgated under the Securities Act may be sold under Rule 144 rather than
under this prospectus. The selling stockholder has advised that it has not
entered into any agreements, understandings or arrangements with any
underwriters or broker-dealers regarding the sale of its securities. There is no
underwriter or coordinating broker acting in connection with the proposed sale
of shares by the selling stockholder.
The shares will be sold only through registered or licensed brokers or
dealers if required under applicable state securities laws. In addition, in some
states the shares may not be sold unless they have been registered or qualified
for sale in the applicable state or an exemption from the registration or
qualification requirement is available and is complied with.
Under applicable rules and regulations under the Securities Exchange Act
of 1934, as amended, any person engaged in the distribution of the shares may
not simultaneously engage in market making activities with respect to our common
stock for a period of two business days prior to the commencement of the
distribution. In addition, the selling stockholder will be subject to applicable
provisions of the Exchange Act and the associated rules and regulations under
the Exchange Act, including Regulation M, which provisions may limit the timing
of purchases and sales of shares of our common stock by the selling stockholder.
We will make copies of this prospectus available to the selling stockholder and
have informed the selling stockholder of the need to deliver copies of this
prospectus to purchasers at or prior to the time of any sale of the shares.
We will bear all costs, expenses and fees in connection with the
registration of the shares. The selling stockholder will pay all commissions and
discounts, if any, attributable to the sales of the shares. The selling
stockholder may agree to indemnify any broker-dealer or agent that participates
in transactions involving sales of the shares against specific liabilities,
including liabilities arising under the Securities Act. The selling stockholder
has agreed to indemnify specific persons, including broker-dealers and agents,
against specific liabilities in connection with the offering of the shares,
including liabilities arising under the Securities Act.
We have agreed to maintain the effectiveness of this registration
statement until the selling stockholder can sell all of the shares it holds
under Rule 144(k) promulgated under the Securities Act. The selling stockholder
may sell all, some or none of the shares offered by this prospectus.
16.
<PAGE> 17
LEGAL MATTERS
The validity of the shares of common stock offered hereby will be passed
upon by Cooley Godward LLP, Palo Alto, California.
EXPERTS
Ernst & Young LLP, independent auditors, have audited our financial
statements included in our Annual Report on Form 10-K for the year ended
December 31, 1999, as set forth in their report, which is incorporated by
reference in this prospectus and elsewhere in the registration statement. Our
financial statements are incorporated by reference in reliance upon Ernst &
Young LLP's report given on their authority as experts in accounting and
auditing.
17.
