CERUS CORP
10-Q, 2000-11-13
BIOLOGICAL PRODUCTS, (NO DIAGNOSTIC SUBSTANCES)
Previous: CAPITAL BEVERAGE CORP, NT 10-Q, 2000-11-13
Next: CERUS CORP, 10-Q, EX-27.1, 2000-11-13



<PAGE>   1
--------------------------------------------------------------------------------


                                  UNITED STATES
                       SECURITIES AND EXCHANGE COMMISSION
                             WASHINGTON, D.C. 20549

                                   FORM 10 - Q

(Mark One)

[X]     QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
        EXCHANGE ACT OF 1934

        FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2000

                                       or

[ ]     TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
        EXCHANGE ACT OF 1934

                         COMMISSION FILE NUMBER 0-21937

                                CERUS CORPORATION
             (Exact name of registrant as specified in its charter)

                  DELAWARE                                  68-0262011
       (State or other jurisdiction of                   (I.R.S. Employer
       Incorporation or organization)                 Identification Number)

                                2411 STANWELL DR.
                            CONCORD, CALIFORNIA 94520
          (Address of principal executive offices, including zip code)

                                 (925) 288-6000
              (Registrant's telephone number, including area code)

        Indicate by check mark whether the registrant (1) has filed all reports
required to be filed by Section 13 or 15 (d) of the Securities Exchange Act of
1934 during the preceding 12 months (or for such shorter period that the
registrant was required to file such reports), and (2) has been subject to such
filing requirements for the past 90 days. YES [X] NO [ ]

        As of October 31, 2000 there were 14,039,804 shares of the Registrant's
Common Stock outstanding.

--------------------------------------------------------------------------------

<PAGE>   2

                                CERUS CORPORATION

                          QUARTERLY REPORT ON FORM 10-Q
                      THREE MONTHS ENDED SEPTEMBER 30, 2000

                                TABLE OF CONTENTS


<TABLE>
<CAPTION>
                                                                                   PAGE NO.
---------------------------------------------------------------------------------------------
<S>                                                                                <C>
PART I         FINANCIAL INFORMATION

Item 1.    Financial Statements (Unaudited)

               Condensed Balance Sheets -
                  September 30, 2000 and December 31, 1999                            3

               Condensed Statements of Operations -
                  Three and nine months ended September 30, 2000 and 1999             4

               Condensed Statements of Cash Flows -
                  Nine months ended September 30, 2000 and 1999                       5

               Notes to Condensed Financial Statements                                6

Item 2.    Management's Discussion and Analysis of
               Financial Condition and Results of Operations                          8

Item 3.    Quantitative and Qualitative Disclosures About Market Risk                13

---------------------------------------------------------------------------------------------

PART II        OTHER INFORMATION

Item 1.    Legal Proceedings                                                         13

Item 2.    Changes in Securities and Use of Proceeds                                 13

Item 3.    Defaults upon Senior Securities                                           14

Item 4.    Submission of Matters to a Vote of Security Holders                       14

Item 5.    Other Information                                                         14

Item 6.    Exhibits and Reports on Form 8-K                                          14

---------------------------------------------------------------------------------------------

SIGNATURES                                                                           15

---------------------------------------------------------------------------------------------
</TABLE>



                                     Page 2
<PAGE>   3

PART I:        FINANCIAL INFORMATION

ITEM I:        FINANCIAL STATEMENTS


                                CERUS CORPORATION

                            CONDENSED BALANCE SHEETS
                                    UNAUDITED
                                 (in thousands)


<TABLE>
<CAPTION>
                                                      September 30,    December 31,
                                                          2000            1999
                                                      -------------    ------------
<S>                                                   <C>              <C>
Assets
Current assets:
    Cash and cash equivalents                           $ 85,154        $  3,537
    Short-term investments                                17,534          36,882
    Accounts receivable from a related party                 152              --
    Other current assets                                     314             238
                                                        --------        --------

Total current assets                                     103,514          40,657

Furniture and equipment, net of depreciation               1,418             999
Other assets                                                 128             124
                                                        --------        --------

Total assets                                            $104,700        $ 41,780
                                                        ========        ========


Liabilities and stockholders' equity
Current liabilities:
    Accounts payable to a related party                 $  2,705        $    531
    Accounts payable                                       2,090           1,480
    Accrued expenses                                       7,314           6,664
    Current portion of capital lease obligations              33              31
                                                        --------        --------

Total current liabilities                                 12,142           8,706

Capital lease obligations, less current portion               87             115
Redeemable convertible preferred stock                     5,000           5,000


Total stockholders' equity                                87,471          27,959
                                                        --------        --------

Total liabilities and stockholders' equity              $104,700        $ 41,780
                                                        ========        ========
</TABLE>


                   See notes to condensed financial statements



                                     Page 3
<PAGE>   4

                                CERUS CORPORATION

                       CONDENSED STATEMENTS OF OPERATIONS
                                    UNAUDITED
                      (in thousands, except per share data)


<TABLE>
<CAPTION>
                                                        Three Months Ended                 Nine Months Ended
                                                            September 30,                     September 30,
                                                     -------------------------         -------------------------
                                                       2000             1999             2000             1999
                                                     --------         --------         --------         --------
<S>                                                  <C>              <C>              <C>              <C>
Revenue:
    Development  funding from related parties        $    419         $    719         $  1,436         $  1,504
    Government grants                                      69              273              220              666
                                                     --------         --------         --------         --------

Total revenue                                             488              992            1,656            2,170

Operating expenses:
    Research and development                            9,129            6,009           24,200           15,885
    General and administrative                          1,599            1,185            5,157            3,553
                                                     --------         --------         --------         --------

Total operating expenses                               10,728            7,194           29,357           19,438
                                                     --------         --------         --------         --------

Loss from operations                                  (10,240)          (6,202)         (27,701)         (17,268)

Interest income, net                                    1,083              675            2,548            1,722
                                                     --------         --------         --------         --------

Net loss                                             $ (9,157)        $ (5,527)        $(25,153)        $(15,546)
                                                     ========         ========         ========         ========


Net loss per share - basic and diluted               $  (0.69)        $  (0.47)        $  (1.97)        $  (1.43)
                                                     ========         ========         ========         ========

Shares used in computing net loss per share
    - basic and diluted                                13,219           11,721           12,768           10,908
                                                     ========         ========         ========         ========
</TABLE>


                   See notes to condensed financial statements



                                     Page 4
<PAGE>   5

                                CERUS CORPORATION

                       CONDENSED STATEMENTS OF CASH FLOWS
                                    UNAUDITED
                                 (in thousands)


<TABLE>
<CAPTION>
                                                                           Nine Months Ended
                                                                             September 30,
                                                                       -------------------------
                                                                         2000             1999
                                                                       --------         --------
<S>                                                                    <C>              <C>
Operating activities:
Net loss                                                               $(25,153)        $(15,546)
Adjustments to reconcile net loss to net cash used in operating
  activities:
    Depreciation and amortization                                           404              443
    Amortization of deferred compensation                                     7               34
    Accrued cash dividend on preferred stock, payable to a
      related party                                                        (176)            (296)
    Changes in operating assets and liabilities:
        Accounts receivable from related a party                           (152)              --
        Other current assets                                                (76)             150
        Other assets                                                         (4)              (1)
        Accounts payable to a related party                               2,174          (11,897)
        Accounts payable and accrued expenses                             1,084            1,105
        Accrued cash dividend on preferred stock, payable to
         a related party                                                    176              296
        Deferred revenue                                                     --              187
                                                                       --------         --------

Net cash used in operating activities                                   (21,716)         (25,525)

Investing activities:
Purchases of furniture, equipment and leasehold improvements               (823)            (499)
Purchases of short-term investments                                     (10,766)         (60,534)
Sale of short-term investments                                               --            1,131
Maturities of short-term investments                                     30,114           32,142
                                                                       --------         --------

Net cash provided by (used in) investing activities                      18,525          (27,760)

Financing activities:
Net proceeds from sale of preferred stock                                    --            9,496
Net proceeds from issuance of common stock                               84,835           45,140
Repurchase of common stock                                                   (1)             (10)
Payments on capital lease obligations                                       (26)             (30)
                                                                       --------         --------

Net cash provided by financing activities                                84,808           54,596
                                                                       --------         --------

Net increase in cash and cash equivalents                                81,617            1,311
Cash and cash equivalents, beginning of period                            3,537            6,161
                                                                       --------         --------

Cash and cash equivalents, end of period                               $ 85,154         $  7,472
                                                                       ========         ========
</TABLE>


                   See notes to condensed financial statements



                                     Page 5
<PAGE>   6

                                CERUS CORPORATION

                     NOTES TO CONDENSED FINANCIAL STATEMENTS
                                    UNAUDITED


NOTE 1 - BASIS OF PRESENTATION

The accompanying unaudited condensed financial statements have been prepared in
accordance with generally accepted accounting principles for interim financial
information and pursuant to the instructions to Form 10-Q and Article 10 of
Regulation S-X. Accordingly, they do not include all of the information and
footnotes required by generally accepted accounting principles for complete
financial statements. In the opinion of management, all adjustments, consisting
of normal recurring accrual adjustments, considered necessary for a fair
presentation have been included. Operating results for the three and nine month
periods ended September 30, 2000 are not necessarily indicative of the results
that may be expected for any future period.

These financial statements and notes should be read in conjunction with Cerus
Corporation's audited financial statements and notes thereto for the year ended
December 31, 1999 included in the company's 1999 Annual Report on Form 10-K.


NOTE 2 - COMPREHENSIVE INCOME (LOSS)

Statement of Financial Accounting Standards No. 130, "Reporting Comprehensive
Income," requires that all items that are required to be recognized under
accounting standards as comprehensive income (revenue, expenses, gains and
losses) be reported in a financial statement that is displayed with the same
prominence as other financial statements. Cerus does not have material
components of other comprehensive income. Therefore, comprehensive loss is equal
to net loss for all periods presented.


NOTE 3 - NET LOSS PER SHARE

Cerus' net loss per share has been calculated in accordance with Statement of
Financial Accounting Standards No. 128, "Earnings per Share." Basic and diluted
net loss per share has been computed using the weighted average number of common
shares outstanding during the period. The effect of outstanding stock options is
excluded from the calculation of diluted net loss per share, as its inclusion
would be antidilutive.


NOTE 4 - REVENUE AND RESEARCH AND DEVELOPMENT EXPENSES

Development funding from related parties includes amounts recognized under
development agreements with Baxter Healthcare Corporation and the Consortium for
Plasma Science. Research and development expenses are recognized as incurred.
Development funding revenue is recognized as the related project costs are
incurred.



                                     Page 6
<PAGE>   7

There was no license or milestone revenue recognized in the three and nine
months ended September 30, 2000 and 1999.


NOTE 5 - CAPITAL STOCK TRANSACTIONS

In February 2000, Cerus completed a private placement of 1,000,000 shares of
common stock to accredited investors, including Baxter Healthcare Corporation,
which purchased 390,000 shares. The purchase price was $25.00 per share, and
Cerus received net proceeds of $23.9 million, after deducting related expenses.

In August 2000, Cerus completed a private placement of 1,200,000 shares of
common stock to an institutional investor. The purchase price was $50.00 per
share, and Cerus received net proceeds of $59.8 million, after deducting related
expenses.

NOTE 6 - NEW ACCOUNTING PRONOUNCEMENT

In December 1999, the Securities and Exchange Commission issued Staff Accounting
Bulletin No. 101 "Revenue Recognition in Financial Statements," ("SAB 101"). SAB
101 provides guidance on the recognition, presentation and disclosure of revenue
in financial statements. All registrants are expected to apply the accounting
and disclosures described in SAB 101 and any changes in its revenue recognition
policy resulting from SAB 101 is required to be reported as a change in
accounting principle in the quarter ending December 31, 2000. Management has
determined the effect of adopting SAB 101 will not have a material affect on the
financial statements.



                                     Page 7
<PAGE>   8

ITEM 2:   MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
          RESULTS OF OPERATIONS


This discussion and analysis should be read in conjunction with Cerus' financial
statements and accompanying notes included in this report and the company's 1999
audited financial statements and notes thereto included in its 1999 Annual
Report on Form 10-K. Operating results for the periods presented are not
necessarily indicative of results that may occur in future periods.

The following discussion includes forward-looking statements that involve risks
and uncertainties. When used herein, the words "believe," "anticipate,"
"expect," "estimate" and similar expressions are intended to identify such
forward-looking statements. There can be no assurance that these statements will
prove to be correct. Certain important factors could cause actual results to
differ materially from those discussed in such statements, including
uncertainties associated with pre-clinical and clinical testing, market
acceptance and other factors discussed below and in the Form 10-K and prospectus
dated November 1, 2000. Cerus undertakes no obligation to update any of the
forward-looking statements contained herein to reflect any future events or
developments.

Helinx is a trademark of Cerus Corporation.

Intercept Blood System, Intercept Platelet System, Intercept Plasma System and
Intercept Red Blood Cell System are trademarks of Baxter International, Inc.


OVERVIEW

Cerus Corporation is developing medical products based on the company's
proprietary Helinx technology. Cerus' Helinx technology has the ability to
prevent the replication of viruses, bacteria and other pathogens and to control
cellular proliferation. The company's most advanced programs are focused on
systems to enhance the safety of the world's blood supply. Cerus and its partner
Baxter Healthcare Corporation are developing the Intercept Blood Systems to
prevent the transmission of infectious diseases, such as HIV and hepatitis B and
C, through blood transfusions, while leaving intact the therapeutic properties
of the blood components. An estimated four million units of platelets, seven
million units of fresh frozen plasma (FFP) and 34 million units of red blood
cells are transfused annually in the Unites States, Western Europe and Japan.

Cerus is currently conducting a Phase 3 clinical trial of the Intercept Platelet
System in the United States and has completed a 103-patient Phase 3 clinical
trial in Europe. Two additional clinical trials of the Intercept Platelet System
are planned for Europe: a 20 patient trial to qualify the commercial set
configuration and a 40 patient clinical trial of the system for apheresis donor
platelets. The Intercept Plasma System is in a Phase 3 clinical trial in the
United States, and the Intercept Red Blood Cell System is in a Phase 1c clinical
trial in the United States. Cerus is also conducting a Phase 1 clinical trial of
its allogeneic cellular immunotherapy (ACIT) program, designed to improve the
outcome of bone marrow transplantation procedures using T-cells treated with the
Helinx technology. Cerus' source plasma pathogen inactivation system is in
pre-clinical development.



                                     Page 8
<PAGE>   9

Since its inception in 1991, Cerus has devoted substantially all of its efforts
and resources to the research, development and clinical testing of medical
systems based on its Helinx technology. Cerus has been unprofitable since
inception and, as of September 30, 2000, had an accumulated deficit of
approximately $112.8 million. All of Cerus' product candidates are in the
research and development stage, and Cerus has not received any revenue from
product sales. Cerus must conduct significant research, development,
pre-clinical and clinical evaluation and regulatory compliance activities on
these product candidates that, together with anticipated general and
administrative expenses, are expected to result in substantial losses at least
until after commercialization. Cerus' ability to achieve a profitable level of
operations in the future will depend on its ability to successfully complete
development, obtain regulatory approvals and achieve market acceptance of the
Intercept Blood Systems. There can be no assurance that Cerus will ever achieve
a profitable level of operations. Further, under the agreements discussed below,
a significant portion of development funding for the Intercept Blood Systems is
provided by Baxter based on an annual budgeting process. There can be no
assurance that these agreements will not be modified or terminated.

Agreement with Baxter for the development of the Intercept Platelet System.
Cerus has a development and commercialization agreement with Baxter for the
joint development of the Intercept Platelet System for inactivation of viruses,
bacteria and other infectious pathogens in platelets used for transfusion (the
"Platelet Agreement"). The Platelet Agreement provides for Baxter and Cerus
generally to share system development costs equally, subject to mutually
determined budgets established from time to time, and for Cerus to receive
approximately 33.5% of revenue from sales of inactivation system disposables
after each party is reimbursed for its cost of goods above a specified level.
Baxter has an exclusive, worldwide distribution license and will be responsible
for manufacturing and marketing the Intercept Platelet System following
regulatory approval. The Platelet Agreement also provides for Baxter to make a
$5 million cash milestone payment to Cerus upon approval by the U.S. Food and
Drug Administration of an application to market products developed under the
platelet program, comparable approval in Europe or termination of the platelet
system development program.

Agreement with Baxter for the development of the Intercept Red Blood Cell System
and Intercept Plasma System. Cerus also has a development and commercialization
agreement with Baxter for the joint development of the Intercept Red Blood Cell
System and the Intercept Plasma System for inactivation of viruses, bacteria and
other infectious pathogens in red blood cells and FFP for transfusion (the
"RBC/FFP Agreement"). The RBC/FFP Agreement provides for Baxter and Cerus
generally to share Intercept Red Blood Cell System development costs equally,
subject to mutually determined budgets established from time to time. Cerus is
solely responsible for funding the development costs of the Intercept Plasma
System. Baxter has an exclusive, worldwide distribution license and will be
responsible for manufacturing and marketing the Intercept Red Blood Cell System
and Intercept Plasma System following regulatory approvals. The RBC/FFP
Agreement also provides for an equal sharing of revenue from sales of Intercept
Red Blood Cell System disposables, and for Cerus to receive 75% and Baxter to
receive 25% of revenue from sales of Intercept Plasma System disposables, after
each party is reimbursed for its cost of goods and a specified percentage
allocation, not to exceed 14% of revenue, is retained by Baxter for marketing
and administrative expenses.



                                     Page 9
<PAGE>   10

From inception through September 30, 2000, Cerus has received $46.7 million in
equity investments from Baxter and has recognized $23.0 million in revenue from
Baxter. Development funding is in the form of balancing payments made by Baxter
to Cerus, if necessary, to reimburse Cerus for development spending in excess of
the levels determined by Baxter and Cerus. Development funding revenue is
recognized as the related project costs are incurred.

Agreement with the Consortium for Plasma Science. In December 1998, Cerus and
the Consortium for Plasma Science entered into an agreement for the development
of a pathogen inactivation system for source plasma used for fractionation. The
Consortium is co-funded by four plasma fractionation companies: Alpha
Therapeutics Corporation, Aventis Behring, Bayer Corporation and Baxter. The
Consortium, which is a separate entity from its members, provides research and
development funding worldwide for technologies to improve the safety of source
plasma. Under the agreement, the Consortium is funding development of Cerus'
proprietary technology for use with source plasma, subject to a periodic review
process. Subject to the Consortium meeting certain funding requirements, Cerus
will pay the Consortium a royalty based on a percentage of product sales, if
any. Development activities are ongoing under this agreement, which may be
extended periodically upon mutual approval of a development plan and budget.
There is no guarantee that the agreement will be extended.

RESULTS OF OPERATIONS

THREE AND NINE MONTH PERIODS ENDED SEPTEMBER 30, 2000 AND 1999

Revenue. Cerus anticipates that its sources of revenue until product sales occur
will be limited to payments under collaboration agreements, including Cerus'
development and commercialization agreements with Baxter and development
agreement with the Consortium, and payments from the United States government
under research grant programs. Development revenue from Baxter and the
Consortium decreased 42% to $0.4 million for the three months ended September
30, 2000 from $0.7 million for the comparable period in 1999, and decreased 5%
to $1.4 million for the nine months ended September 30, 2000 from $1.5 million
for the comparable period in 1999. The decrease for both periods was principally
from decreased development revenue from Baxter for the Intercept Platelet
System, resulting primarily from increased expenses incurred by Baxter relative
to Cerus on this program in 2000. Revenue earned under the agreements with
Baxter is dependent on the relative spending by Cerus and Baxter on the programs
for which development costs are shared. Cerus did not recognize any license or
milestone revenue in the three and nine months ended September 30, 2000 and
1999.

Government grant revenue decreased 75% to $0.1 million for the three months
ended September 30, 2000 from $0.3 million for the comparable period in 1999,
and decreased 67% to $0.2 million for the nine months ended September 30, 2000
from $0.7 million for the comparable period in 1999. The decrease for both
periods was primarily due to the expiration of certain government grants. Cerus
currently has one government grant which expires in September 2002. There can be
no assurance that Cerus will receive additional government grants in the future.

Research and Development Expenses. Research and development expenses increased
52% to $9.1 million for the three months ended September 30, 2000 from $6.0
million for the comparable period in 1999, and increased 52% to $24.2 million
for the nine months ended



                                    Page 10
<PAGE>   11

September 30, 2000 from $15.9 million for the comparable period in 1999. The
increase for both periods was due principally to the addition of scientific
personnel and increased costs for clinical trials. Cerus anticipates that its
research and development expenses will continue to increase as Phase 3 clinical
trials of the Intercept Platelet System and Intercept Plasma System continue,
and as research and development activity relating to its other programs
increases.

General and Administrative Expenses. General and administrative expenses
increased 35% to $1.6 million for the three months ended September 30, 2000 from
$1.2 million for the comparable period in 1999, and increased 45% to $5.2
million for the nine months ended September 30, 2000 from $3.6 million for the
comparable period in 1999. The increase for both periods was primarily
attributable to the addition of administrative personnel associated with
expansion of Cerus' operations and increased outside consultant expenses. Cerus
expects its general and administrative expenses to continue to increase as
development activities expand.

Net Interest Income. Net interest income increased 61% to $1.1 million for the
three months ended September 30, 2000 from $0.7 million for the comparable
period in 1999, and increased 48% to $2.5 million for the nine months ended
September 30, 2000 from $1.7 million for the comparable period in 1999. The
increase for both periods was attributable primarily to increased average cash
and investments balances related to proceeds from the private placement of
common stock to accredited investors, including Baxter, in February 2000 and the
private placement of common stock to an institutional investor in August 2000.
Cerus typically maintains substantial balances of cash equivalents and
short-term investments to fund future research and development activities. Cerus
expects to earn interest at market rates in proportion to the balances it
maintains.

LIQUIDITY AND CAPITAL RESOURCES

Cerus' sources of capital to date have consisted of public offerings and private
placements of equity securities, payments received under its agreements with
Baxter and the Consortium, United States government grants and interest income.
To date, Cerus has not received any revenue from product sales, and it will not
derive revenue from product sales unless and until one or more products under
development receives regulatory approval and achieves market acceptance.

In February 2000, Cerus completed a private placement of 1,000,000 shares of
common stock at $25.00 per share and received net proceeds of $23.9 million,
after deducting related expenses. The shares were purchased by institutional and
other accredited investors, including Baxter, which purchased 390,000 shares.

In August 2000, Cerus completed a private placement of 1,200,000 shares of
common stock at $50.00 per share and received net proceeds of $59.8 million,
after deducting related expenses. The shares were purchased by an institutional
investor.

At September 30, 2000, Cerus had cash, cash equivalents and short-term
investments of $102.7 million.

Net cash used in operating activities was $21.7 million for the nine months
ended September 30, 2000, compared to $25.5 million for the same period in 1999,
resulting primarily from the net



                                    Page 11
<PAGE>   12

loss of $25.2 million during the period, offset by changes in other operating
balances. Net cash provided by investing activities in the nine months ended
September 30, 2000 of $18.5 million resulted principally from the maturities of
$30.1 million of short-term investments, offset by the purchases of $10.8
million of short-term investments. Working capital increased to $91.4 million at
September 30, 2000 from $32.0 million at December 31, 1999, primarily due to
increased cash balances from financing activities, partially offset by a
decrease in short-term investment balances.

Cerus believes that its available cash balances, together with anticipated cash
flows from existing development and grant arrangements, will be sufficient to
meet its capital requirements for at least the next 12 months. These near-term
capital requirements are dependent on various factors, including the development
progress of the Intercept Blood Systems and other programs; payments by Baxter
and the Consortium; and costs related to creating, maintaining and defending
Cerus' intellectual property position. Cerus' long-term capital requirements
will be dependent on these factors and on Cerus' ability to raise capital
through public or private equity or debt financings or through additional
collaborative arrangements or government grants, the achievement of milestones,
regulatory approval and successful commercialization of the Intercept Blood
Systems and other products under development, competitive developments and
regulatory factors. Future capital funding transactions may result in dilution
to investors in Cerus. Capital may not be available on favorable terms, or at
all. There can be no assurance that Cerus will be able to meet its capital
requirements for this or any other period.

FINANCIAL INSTRUMENTS

Cerus maintains an investment portfolio of various issuers, types and
maturities. These securities are generally classified as available for sale and,
consequently, are recorded on the balance sheet at fair value with unrealized
gains or losses reported as a separate component of stockholders' equity, if
material. Unrealized gains and losses at September 30, 2000 and December 31,
1999 were not material. Cerus' investments primarily consist of short-term money
market mutual funds, United States and state government obligations and
commercial paper. Of Cerus' investments balance of $102.7 million at September
30, 2000, approximately 83% have original maturity dates of less than 90 days
and approximately 12% of this balance have original maturities of 90 days to one
year. Cerus does not believe its exposure to interest rate risk to be material
given the short-term nature of its investment portfolio.

ADDITIONAL RISKS

Cerus' business is subject to significant additional risks, including, but not
limited to, the risks and uncertainties inherent in its research and development
efforts, including pre-clinical and clinical trials; the lengthy, expensive and
uncertain process of seeking regulatory approvals; dependence on Baxter and
other third parties; uncertainties associated both with obtaining and enforcing
its patents and with the patent rights of others; technological change and
competition; manufacturing uncertainties; and uncertainties regarding government
reforms and of product pricing and reimbursement levels.

Cerus' programs are in the research and development stage and will require
significant additional pre-clinical and clinical testing prior to submission of
any regulatory application for commercial use. Cerus has not filed a product
approval application with the FDA or made corresponding



                                    Page 12
<PAGE>   13

regulatory filings in Europe for the Intercept Platelet System or for any of its
other products under development. No assurance can be given that such filings
will be made or that any of Cerus' development programs will be successfully
completed; that any further Investigational New Drug or Investigational Device
Exemption applications will become effective or that additional clinical trials
will be allowed by the FDA or other regulatory authorities; that future clinical
trials will commence as planned; that required United States or foreign
regulatory approvals will be obtained on a timely basis, if at all; or that any
products for which approval is obtained will be commercially successful.

In addition, the market price of Cerus' common stock, like that of the common
stock of many other companies in similar industries, is likely to be highly
volatile. Factors such as the announcements of scientific achievements or new
products by Cerus or its competitors; governmental regulation; health care
legislation; developments in patent or other proprietary rights of Cerus or its
competitors, including litigation; fluctuations in Cerus' operating results;
comments made by analysts, including changes in analysts' estimates of Cerus'
financial performance; and market conditions for health care stocks in general
could have significant impact on the future price of the common stock. In
addition, the stock market has from time to time experienced extreme price and
volume fluctuations, which may be unrelated to the operating performance of
particular companies. There can be no assurance that fluctuations in the price
and volume of Cerus' common stock will not occur in the future.


ITEM 3:   QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

The information called for by this item is provided under the caption "Financial
Instruments" under Item 2 - Management's Discussion and Analysis of Financial
Condition and Results of Operations.


PART II   OTHER INFORMATION

ITEM 1.   LEGAL PROCEEDINGS

Not Applicable.


ITEM 2.   CHANGES IN SECURITIES AND USE OF PROCEEDS

On August 28, 2000, the Company sold 1,200,000 shares of unregistered common
stock in a private placement to an institutional investor for an aggregate
purchase price of $60.0 million. Net proceeds were $59.8 million, after
deducting related expenses. Such sale of common stock was exempt from
registration under the Securities Act of 1933 pursuant to section 4(2) thereof,
as a transaction not involving any public offering.



                                    Page 13
<PAGE>   14

ITEM 3.   DEFAULTS UPON SENIOR SECURITIES

Not Applicable.


ITEM 4.   SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS

Not Applicable.


ITEM 5.   OTHER INFORMATION

Not Applicable.


ITEM 6.   EXHIBITS AND REPORTS ON FORM 8-K

(a)     Exhibit

        27.1     Financial Data Schedule


(b)     Reports on Form 8-K

        The Company filed a report on Form 8-K, dated August 22, 2000, reporting
        the results of its European Phase 3 clinical trial of the Intercept
        Platelet System.



                                    Page 14
<PAGE>   15

                                   SIGNATURES


        Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.


                                    CERUS CORPORATION



Date: November 13, 2000             /s/ Gregory W. Schafer
      -----------------             --------------------------------------------
                                    Gregory W. Schafer
                                    Chief Financial Officer
                                    (Principal Financial and Accounting Officer)



                                    Page 15
<PAGE>   16

CERUS CORPORATION

INDEX TO EXHIBITS

<TABLE>
<CAPTION>
                                                                          Sequentially
Exhibit                                                                     Numbered
  No.                           Description                                   Page
-------        ----------------------------------------------             ------------
<S>            <C>                                                        <C>
  27.1           Financial Data Schedule                                       ---
</TABLE>


© 2022 IncJournal is not affiliated with or endorsed by the U.S. Securities and Exchange Commission