Calypte und die Zeit nach AIDS2004 in Bangkok
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Der Tag , der Handel ist noch nicht zu ende
Go 'Caly auf gehts mit dir!!!!!!!!!!!!!!!!!!!!!!
Ich denke doch, entspannt sollten wir alle darauf warten ...
Ich warte seit Monaten auf dieses Ereigniss.. Unser Geduld und Treue wird sich auszahlen...
Gruß
C.O
Gruß
C.O
Form 424B3CALYPTE BIOMEDICAL CORP - CYPTFiled: July 09, 2004 (period: )Form of prospectus reflecting facts events constituting substantive change from last form
Filed Pursuant to Rule 424(b)(3)
Registration Number 333-116491
[LOGO CALYPTE BIOMEDICAL CORPORATION]
PROSPECTUS
CALYPTE BIOMEDICAL CORPORATION
83,056,050 Shares of Common Stock, $0.03 Par Value
o This Prospectus relates to the resale of our common stock by the selling
security holders, all of whom were issued securities pursuant to an
exemption under Regulation S, except for the selling security holders in
the May 2004 PIPE who were issued securities pursuant to an exemption
under Regulation D, of up to:
o 3,088,554 shares of our common stock that have previously been
issued to certain selling security holders as a result of their
conversions of $3,232,000 aggregate original principal amount of our
8% secured convertible notes, plus interest and liquidated damages;
o 4,725,414 shares of our common stock, including 563,538 shares that
may be issued upon the conversion of the remaining $91,597 aggregate
principal amount of our 10% convertible debentures, including
accrued interest, extension fees and other amounts, and 4,161,876
shares that have been previously issued to a selling security holder
upon the conversion of $1,100,072 principal amount of our 10%
convertible debentures, plus accrued interest and liquidated
damages;
o 10,351,061 shares of our common stock, including 682,646 shares that
may be issued upon the conversion of the remaining $66,113 aggregate
principal amount of our 12% convertible debentures including accrued
interest and other amounts, 100,000 shares of common stock
underlying warrants issued as part of the consideration for a 12%
convertible debenture transaction, and 9,568,415 shares previously
issued to certain selling security holders upon their conversions of
$1,933,887 aggregate principal amount of our 12% convertible
debentures, plus accrued interest and liquidated damages;
o 28,333,333 shares of our common stock that have previously been
issued to a selling security holder in connection with a $2,500,000
PIPE transaction at $0.30 per share and a $10,000,000 PIPE
transaction at $0.50 per share;
o 3,265,188 shares of our common stock, including 2,569,727 shares
that have previously been issued to certain selling security holders
in connection with agreements in which we have obtained goods and
services in return for the issuance of shares of our common stock,
and 695,461 shares underlying warrants or other agreements between
us and certain selling security holders in connection with which we
have obtained goods and services;
o 1,275,000 shares of our common stock underlying warrants issued in
connection with a $10,000,000 5% Promissory Note Commitment
Agreement and subsequent amendments thereof; and
o 32,017,500 shares of our common stock, including 23,250,000 shares
that have been previously issued to selling security holders in
connection with a $9,300,000 May 2004 PIPE transaction at $0.40 per
share and an additional 8,767,500 shares underlying warrants to
purchase our common stock at $0.50 per share issued in conjunction
therewith.
o We will not receive any proceeds from the sale of these shares. We will
receive proceeds from the exercise of warrants issued to certain of the
selling stockholders. Any proceeds received will be used for general
corporate purposes.
o The subscribers (as detailed below) may be deemed to be "underwriters"
within the meaning of the Securities Act of 1933, as amended, in
connection with their sales.
o Our common stock is traded on the Over-the-Counter Bulletin Board under
the symbol "CYPT." The last reported sales price for our common stock on
June 30, 2004 was $0..62 per share.
THIS INVESTMENT INVOLVES A HIGH DEGREE OF RISK.
SEE " RISK FACTORS" BEGINNING ON PAGE 5.
We may amend or supplement this Prospectus from time to time
by filing amendments or supplements as required. You should read
the entire Prospectus and any amendments or supplements
carefully before you make your investment decision.
Neither the Securities and Exchange Commission nor any state securities
commission has approved or disapproved of these securities or determined if this
Prospectus is truthful or complete. Any representation to the contrary is a
criminal offense.
The date of this Prospectus is July 9, 2004.
TABLE OF CONTENTS
PAGE
----
PART I. INFORMATION REQUIRED IN PROSPECTUS
Where You Can Find More Information 1
The Company 2
The Offering, including Use of Proceeds and
Determination of Offering Price 4
Risk Factors 5
Summary of Financings May 2002 to June 10, 2004 18
Dilution 26
Selling Security Holders 27
Plan of Distribution 33
Legal Proceedings 34
Directors, Executive Officers, Promoters and Control Persons 35
Security Ownership of Certain Beneficial Owners and Management 40
Description of the Securities 41
Disclosure of Commission Position on Indemnification
for Securities Act Liabilities 52
Description of Business 53
Management's Discussion and Analysis 71
Description of Property 89
Certain Relationships and Related Transactions 89
Market for Common Stock and Related Stockholder Matters 90
Executive Compensation 93
Financial Statements 101
Changes in and Disagreements with Accountants on Accounting
and Financial Disclosure 101
Interest of Named Experts and Counsel 103
Index to Consolidated Financial Statements F-1
WHERE YOU CAN FIND MORE INFORMATION
We file annual, quarterly and special reports, proxy statements and other
information with the Securities and Exchange Commission. You may read and copy
any document we file at the SEC's public reference rooms in Washington, D.C.,
New York, New York and Chicago, Illinois. 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 at the SEC's web site at http://www.sec.gov and at our
website at http://www.calypte.com.
A copy of our Annual Report on Form 10-KSB for the year ended December 31, 2003
is included with this Prospectus. You may request another copy of the 10-KSB, at
no cost, by writing or telephoning us at the following address:
Calypte Biomedical Corporation
5000 Hopyard Road, Suite 480
Pleasanton, California 94588
Attention: President
Telephone: (925) 730-7200.
You should rely only on information provided in this Prospectus. We have not
authorized anyone else to provide you with different information.
From time to time, information we provide or statements made by our directors,
officers or employees may constitute "forward-looking" statements and are
subject to numerous risks and uncertainties. Any statements made in this
Prospectus, including any statements incorporated herein by reference, that are
not statements of historical fact are forward-looking statements (including, but
not limited to, statements concerning the characteristics and growth of our
market and customers, our objectives and plans for future operations and
products and our liquidity and capital resources). Such forward-looking
statements are based on current expectations and are subject to uncertainties
and other factors which may involve known and unknown risks that could cause
actual results of operations to differ materially from those projected or
implied. Further, certain forward-looking statements are based upon assumptions
about future events which may not prove to be accurate. Risks and uncertainties
inherent in forward looking statements include, but are not limited to:
o fluctuations in our operating results;
o announcements of technological innovations or new products which we or our
competitors make;
o FDA and international regulatory actions;
o developments with respect to patents or proprietary rights;
o changes in stock market analysts' recommendations regarding Calypte, other
medical products companies or the medical product industry generally;
o changes in domestic or international conditions beyond our control that
may disrupt our or our customers' or distributors' ability to meet
contractual obligations;
o changes in health care policy in the United States or abroad;
o our ability to obtain additional financing as necessary to fund both our
long-and short-term business plans;
o fluctuations in market demand for and supply of our products;
o public concern as to the safety of products that we or others develop and
public concern regarding HIV and AIDS;
o availability of reimbursement for use of our products from private health
insurers, governmental health administration authorities and other
third-party payors; and
o price and volume fluctuations in the stock market at large which do not
relate to our operating performance.
For a further discussion of these and other significant factors to consider in
connection with forward-looking statements, see the discussion in this
Prospectus under the heading "RISK FACTORS".
1
THE COMPANY
Calypte Biomedical Corporation ("Calypte" or the "Company") develops,
manufactures and markets in vitro diagnostic tests primarily for the detection
of antibodies to the Human Immunodeficiency Virus ("HIV") and other sexually
transmitted and infectious diseases. We have historically focused our business
on urine-based screening and supplemental tests for use in laboratories. By
integrating several proprietary technologies, we developed urine HIV antibody
tests, the Calypte urine-based enzyme immunoassay ("EIA") HIV Type 1 ("HIV-1")
screening test and the Cambridge Biotech urine-based HIV-1 western blot ("Urine
Western Blot") supplemental test. We also manufacture and market the Cambridge
Biotech serum-based western blot ("Serum Western Blot") supplemental test for
detecting HIV-1 antibodies in serum. Our revenues are currently generated from
sales of these three products, which we refer to collectively as our "ELISA
tests." The ELISA tests are manufactured in formats that make them most suitable
for high-volume laboratory settings.
We are the only company with Food and Drug Administration ("FDA") approval for
the marketing and sale of urine-based HIV-1 antibody tests. Our EIA HIV-1
screening test received FDA approval for use in laboratories in August 1996. Our
Urine Western Blot supplemental test received FDA approval in May 1998. Our
urine-based ELISA tests together, with their screening and confirmatory testing
components, are the only complete FDA approved urine-based HIV testing method.
Our business is also involved in developing new test products for the rapid
detection of HIV-1 and HIV Type 2, a second type of HIV ("HIV-2"), and other
infectious diseases. In November 2003, we filed an Investigational Device
Exemption ("IDE") with the FDA announcing our intent to develop a rapid
serum-based HIV screening test. Rapid tests provide test results in less than 20
minutes and are particularly suitable for point-of-care testing, especially in
lesser developed countries which lack the medical infrastructure to support
laboratory based testing. We are currently developing serum- urine- and oral
fluid-based HIV-1 and HIV-2 rapid tests and anticipate that our primary focus
for the current and longer-term future will be the development, manufacture and
sale of our rapid test products, both internationally and domestically.
We were incorporated in California in 1989 and reincorporated in Delaware in
1996 at the time of our initial public offering. In December 1998, we acquired
certain assets from Cambridge Biotech Corporation, an entity now owned by
bioMerieux, Inc. The acquisition included the Urine Western Blot and Serum
Western Blot supplemental tests and leasehold rights to the Rockville, Maryland
manufacturing facility.
We are headquartered at 5000 Hopyard Road, Suite 480, Pleasanton, California
94588, telephone number (925) 730-7200. During June 2004, we relocated our
headquarters to this location from our previous office and manufacturing site in
Alameda, California. Our manufacturing facility is located in Rockville,
Maryland. Historically, our Alameda facility had manufactured our EIA screening
test and the Rockville facility manufactured our Urine and Serum Western Blot
tests. However, we are currently consolidating our domestic manufacturing
operations by moving all manufacturing to our Rockville facility. We closed the
Alameda facility effective June 30, 2004, when the lease expired. As of July 2,
2004, following the cessation of manufacturing operations at our Alameda
facility, we had approximately 50 full-time and temporary employees.
To successfully implement our business plans, we must obtain sustainable cash
flow and profitability. Our future liquidity and capital requirements will
depend on numerous factors, including successful completion of the development
of our new rapid tests, acquisition and protection of intellectual property
rights, costs of developing our new products, ability to transfer technology,
set up manufacturing and obtain regulatory approvals of our new rapid tests,
market acceptance of all our products, competing products in our current and
anticipated markets, actions by the FDA and other international regulatory
bodies, and the ability to raise additional capital in a timely manner.
Since December 31, 2003, we have entered into new financing arrangements that
management believes will be adequate to sustain our operations at expected
levels through 2004. In May 2004, we completed a private placement of our common
stock with 7 accredited investors and received net proceeds of approximately
$8.8 million. Additionally, in May 2004 Marr Technologies BV, our largest
stockholder and a participant in the private placement, agreed to extend
$5,000,000 of our borrowing availability under the terms of the Marr Credit
Facility through December 31, 2004. If, however, sufficient funds are not
available to fund our operations in 2005 or beyond, we may need to arrange
additional financing or make other arrangements. There can be no assurance that
additional financing, if and as necessary, would be available or, if it is
available, that it would be on acceptable terms. The terms of an additional
financing could involve a change of control and/or require stockholder approval
or could potentially trigger anti-dilution protection clauses that are contained
in existing financing agreements. We would or might be required to consider
strategic opportunities, such as a merger, consolidation, sale or other
comparable transactions, to sustain our operations. We do not currently have any
agreements in place with respect to any such new strategic opportunity, and
there can be no assurance that any such opportunities will be available to us on
acceptable terms, or at all. If additional financing is not available when and
if required or is not available on acceptable terms, or if we are unable to
arrange a suitable strategic opportunity, we will be in significant financial
jeopardy and may be unable to continue our operations at current levels, or at
all.
2
USE OF FORM SB-2 REGISTRATION STATEMENT
We were contacted by the San Francisco District Office of the SEC on October 28,
2003 and advised of an informal inquiry being conducted by the enforcement staff
of the SEC regarding the Company. The staff has requested, among other things,
documents related to certain press releases we issued. We have voluntarily
provided the information sought by the SEC and are cooperating with the SEC in
connection with its informal inquiry. Independently, the Audit Committee of our
Board of Directors has investigated the matter and retained outside counsel to
assist in its investigation by reviewing the press releases and related
information that were the subject matter of the SEC's informal inquiry letter.
The Audit Committee has completed its investigation and reported the results of
its investigation and associated recommendations to the Board of Directors.
Counsel for the Audit Committee advised the Audit Committee and the Board of
Directors that the results of their investigation, interviews and review of
documents provided in response to the SEC's informal inquiry letter indicated no
evidence of management malfeasance with respect to its inquiry. While the SEC
has advised us that the inquiry should not be construed as an indication by the
SEC or its staff that any violation of law has occurred, we informed our former
independent auditors, KPMG LLP ("KPMG") of the inquiry, and they informed us
that they could not complete their quarterly review of our interim financial
statements contained in our Quarterly Report on Form 10-QSB for the quarterly
period ended September 30, 2003 or audit our financial statements for our fiscal
year ended December 31, 2003 until such time as our Audit Committee had
completed its investigation related to the Commission's informal inquiry letter,
the same was reviewed by KPMG, and KPMG was satisfied that, in its opinion, an
adequate investigation was conducted and appropriate conclusions were reached
and actions taken.
The interim financial statements contained in a Form 10-QSB are required to be
reviewed under Statement of Auditing Standards No. 100 ("SAS 100") by an
independent public accountant pursuant to Item 310(b) of Regulation S-B. We
filed our Form 10-QSB for the quarterly period ended September 30, 2003 within
the time permitted, on November 14, 2003, without KPMG having completed its SAS
100 review. On December 23, 2003, the Company dismissed KPMG as independent
auditors for the Company, effective immediately. The decision to dismiss KPMG
was recommended by the Audit Committee of the Board of Directors. As of the date
of KPMG's dismissal, KPMG had advised us that, in KPMG's opinion, the conditions
necessary for KPMG to complete its review had not yet been satisfied. At the
time of KPMG's dismissal, the Audit Committee had completed its investigation,
had reported the results of its investigation and associated recommendations to
the Board of Directors, and the Board of Directors had approved such
recommendations. In addition, at such time, counsel for the Audit Committee had
advised us that it had commenced to provide information to KPMG concerning the
investigation conducted, the conclusions reached and the actions taken by the
Company.
On December 24, 2003, upon approval of the Audit Committee of the Board of
Directors, we engaged Odenberg Ullakko Muranishi & Co. LLP ("OUM") to audit the
consolidated financial statements of the Company for the two years ended
December 31, 2003 and 2002 and to review the interim financial statements of the
Company contained in its amended Quarterly Report on Form 10-QSB for the
quarterly period ended September 30, 2003. OUM completed its SAS 100 review
associated with the Form 10-QSB/A (No.1) for the quarterly period ended
September 30, 2003 that we filed on January 29, 2004.
Although we have filed an amended 10-QSB on which OUM has completed an SAS 100
review, the staff of the SEC has taken the position that our initial Form 10-QSB
was deficient because the required review was not completed on a timely basis.
That means that we are viewed as not being current in our filings under the
Securities Exchange Act of 1934. Accordingly, having been determined to be
deficient in our periodic filings, we are, therefore, ineligible to use Forms
S-2 or S-3 to register securities until all required reports under the
Securities Exchange Act of 1934 have been timely filed for the 12 months
following January 29, 2004. We are currently eligible to use either Form S-1 or
SB-2 to satisfy our obligations under the registration rights agreements we have
entered into with respect to various financing arrangements and we have elected
to use Form SB-2 to register the subject shares of our common stock for resale.
3
THE OFFERING
COMMON STOCK, $0.03 par value
per share ("Common Stock"),
outstanding as of June 30, 2004: 163,997,333 shares
SHARES OFFERED BY SELLING
SECURITY HOLDERS 83,056,050 shares, of which
70,971,905 shares have been
issued to selling security
holders and are included in our
outstanding shares.
RISK FACTORS The shares involve a high degree
of risk. Investors should
carefully consider the
information set forth under
"RISK FACTORS" beginning on page
5.
USE OF PROCEEDS We will not receive any proceeds
from the sale of common stock
offered through this prospectus
by the selling shareholders. To
date, we have received gross
amounts of $3,125,000 from the
8% convertible notes; $400,000
from the 2002 PIPE at $1.50 per
share; $200,000 from the 8%
convertible debentures; $150,000
from the 10% convertible notes;
$1,950,000 from the 10%
convertible debentures;
$2,600,000 from the 12%
convertible debentures;
$2,500,000 from the 2003 Marr
PIPE at $0.30 per share,
$10,000,000 from the 2003 Marr
PIPE at $0.50 per share and
$9,300,000 from the May 2004
PIPE at $0.40 per share. All
proceeds from the aforementioned
financings have been or will be
used for general corporate
purposes, including the
commercialization of our rapid
tests for HIV-1/2 diagnosis that
are currently under development.
We are registering the shares
for re-sale to provide the
selling shareholders with freely
tradable securities. The
registration of these shares
does not necessarily mean that
any of these shares will be
offered or sold by the selling
shareholders. All proceeds from
the sale of shares sold under
this prospectus will go to the
selling shareholders.
We may receive proceeds from the
selling shareholders' exercise
of warrants or options. Such
proceeds, if any, will be used
for working capital and other
corporate purposes as noted
above. However, warrants held by
certain selling shareholders may
be exercised through a cashless
exercise in certain
circumstances while the
underlying shares are
unregistered, in which event we
would not receive any proceeds
from the exercise.
DETERMINATION OF OFFERING PRICE This prospectus may be used from
time to time by the selling
shareholders who offer the
common stock in transactions
(which may include block
transactions) at prevailing
market prices at the time of
sale, at prices related to the
prevailing market prices, or at
other negotiated prices. The
selling shareholders will act
independently in determining the
offering price of each sale.
OVER-THE-COUNTER BULLETIN
BOARD TRADING SYMBOL CYPT
4
FORWARD-LOOKING INFORMATION
When used in this prospectus, the words "believes," "plans,""anticipates," "will
likely result," "will continue," "projects," "expects," and similar expressions
are intended to identify "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995. Such statements are subject to
certain risks and uncertainties, including those risks defined above, which
could cause actual results to differ materially from those projected.
We caution readers not to place undue reliance on any forward-looking
statements, which are based on certain assumptions and expectations which may or
may not be valid or actually occur, and which involve certain risks, including
these risks defined below. Sales and other revenues may not commence and/or
continue as anticipated due to delays or otherwise. As a result, our actual
results for future periods could differ materially from those anticipated or
projected.
RISK FACTORS
In addition to the other information in this Prospectus, Calypte has identified
a number of risk factors that the Company faces. These factors, among others,
may cause actual results, events or performance to differ materially from those
expressed in any forward-looking statements made in this Prospectus or in other
filings with the Securities and Exchange Commission or in press releases or
other public disclosures. Investors should be aware of the existence of these
factors and should consider them carefully in evaluating our business before
purchasing the shares offered in this Prospectus.
RISK RELATED TO AN INFORMAL SECURITIES AND EXCHANGE COMMISSION INQUIRY
The SEC May Not Have Completed Its Informal Inquiry, and We May Be Subject to a
Further Investigation.
We were contacted by the San Francisco District Office of the SEC on October 28,
2003 and advised that there was an informal inquiry being conducted by the
enforcement staff of the SEC regarding the Company. The staff has requested,
among other things, documents related to certain press releases issued by the
Company. The SEC has advised us that the inquiry should not be construed as an
indication by the SEC or its staff that any violation of law has occurred and we
have voluntarily cooperated with the SEC and have taken part in interviews as
well as provided the SEC with all documents requested. Separately, our Audit
Committee retained independent counsel to investigate the matter addressed in
the SEC's informal inquiry, and the Committee's counsel determined that there
was no evidence of management malfeasance, however, there is no assurance that
the SEC will not continue to pursue the inquiry, or that the SEC will not
commence a formal investigation, or that there will not be sanctions against the
Company or its officers or directors.
RISKS RELATED TO OUR FINANCIAL CONDITION
If We are Unable to Obtain Additional Financing When and If Required We May Have
to Significantly Curtail the Scope of Our Operations and Alter Our Business
Model.
We believe that the aggregate $8.8 million net proceeds of our May 2004 private
placement and the extension through December 31, 2004 of $5,000,000 of borrowing
capability under the terms of the amended Marr Credit Facility will be adequate
to sustain our operations at expected levels through 2004. There can, however,
be no assurance that such resources will be adequate. Further, there can be no
assurance that we will be able to achieve expanded acceptance of or realize
significant revenues from our current or potential new products, including our
rapid tests, or that we will achieve significant improvements in the efficiency
of our manufacturing processes. In addition, there is no assurance that we will
achieve or sustain profitability or positive cash flows in the future. In the
absence of adequate resources from current working capital and existing
financing, we would need to raise additional capital to sustain our operations.
In that case, we would or might be required to consider strategic opportunities,
including merger, consolidation, sale or other comparable transaction, to
sustain our operations. We do not currently have any agreements in place with
respect to any such strategic opportunity, and there can be no assurance that
any such opportunity will be available to us on acceptable terms, or at all. If
additional financing is not available to us when required or is not available to
us on acceptable terms, or we are unable to arrange a suitable strategic
opportunity, we will be in significant financial jeopardy and we may be unable
to continue our operations at current levels, or at all. The terms of a
subsequent financing may involve a change of control, require stockholder
approval, and/or trigger anti-dilution protection clauses contained in existing
financing agreements that would result in substantial dilution to our existing
stockholders or might require us to pledge the rights to our products for
collateral security for the issuance of a convertible debt security.
5
Certain Prospective Investors Were Unable to Participate in the May 2004 PIPE
Financing and We May Not Be Able to Successfully Accommodate Them.
We raised the sum of $9,300,000 through the sale of 23,500,000 shares of our
common stock to accredited investors at $0.40 per share, and issued warrants to
purchase 8,767,500 shares of our common stock at $0.50 per share in our May 2004
PIPE which closed as of May 31, 2004. The shares of common stock are included in
this registration statement.
Certain prospective investors of one of our finders who had been discussing
possible participation of approximately $1.5 million in the May 2004 PIPE were
unable to do so for timing and other reasons. Although we desire to accommodate
these prospective investors, we must complete any such transaction in accordance
with all applicable securities rules and regulations. If we are unable to do so,
we may be unable to accept this potential investment at this time, and the
finder and the prospective investors, or a portion thereof, may choose to bring
certain actions against us. While we would dispute and/or oppose such actions,
should the prospective investors prevail, we may be required to pay damages and
other possible penalties.
Our Financial Condition has Adversely Affected Our Ability to Pay Suppliers,
Service Providers and Licensors on a Timely Basis Which May Jeopardize Our
Ability to Continue Our Operations and to Maintain License Rights Necessary to
Continue Shipments and Sales of Our Products.
As of March 31, 2004 our accounts payable totaled $2.0 million, of which $1.5
million was over sixty days old. We currently have primarily cash-only
arrangements with suppliers and certain arrangements require that we pay down
certain outstanding amounts due when we make a current payment. These past due
payments vary monthly depending on the items purchased and range from
approximately $50,000 to $200,000 per month. As of March 31, 2004 we have
accrued an aggregate of approximately $551,000 in royalty obligations to our
patent licensors, of which approximately $387,000 were past due. The licenses
attributable to past due royalty payments relate to technology utilized in both
our urine EIA screening test and our supplemental urine and serum tests. Because
of the interdependence of the screening and supplemental tests in our testing
algorithm, the inability to use any one of the patents could result in the
disruption of the revenue stream from all of our products. While at this time we
are current with our payment plans for past-due amounts, if we are unable to
maintain sufficient working capital, our ability to make payments on past due
negotiated royalty obligations, make timely payments to our critical suppliers,
service providers and to licensors of intellectual property used in our products
will be jeopardized and we may be unable to obtain critical supplies and
services and to maintain licenses necessary for us to continue to manufacture,
ship and sell our products. Additionally, certain vendors and service providers
with whom we have not currently arranged payment plans have or may choose to
bring legal action against us to recover amounts they deem due and owing. While
we may dispute these claims, should a creditor prevail, we may be required to
pay all amounts due to the creditor. If the working capital that will enable us
to make the required payment is not available when required, we will be placed
in significant financial jeopardy and we may be unable to continue our
operations at current levels, or at all.
We Have Incurred Losses in the Past and We Expect to Incur Losses in the Future.
We have incurred losses in each year since our inception. Our net loss for the
quarter ended March 31, 2004 was $4.0 million and for the year ended December
31, 2003 was $26.5 million and our accumulated deficit at March 31, 2004 was
$131.9 million. We expect operating losses to continue during 2004 and perhaps
beyond, as we complete the development and begin commercializing our rapid
tests, complete our manufacturing restructuring and consolidation, and conduct
additional research and development for product improvements and clinical trials
on potential new products.
An Economic Downturn or Terrorist Attacks May Adversely Affect Our Business.
Changes in economic conditions could adversely affect our business. For example,
in a difficult economic environment, customers may be unwilling or unable to
invest in new diagnostic products, may elect to reduce the amount of their
purchases or may perform less HIV testing. A weakening business climate could
also cause longer sales cycles and slower growth, and could expose us to
increased business or credit risk in dealing with customers adversely affected
by economic conditions.
6
Terrorist attacks and subsequent governmental responses to these attacks could
cause further economic instability or lead to further acts of terrorism in the
United States and elsewhere. These actions could adversely affect economic
conditions outside the United States and reduce demand for our products
internationally. Terrorist attacks could also cause regulatory agencies, such as
the FDA or agencies that perform similar functions outside the United States, to
focus their resources on vaccines or other products intended to address the
threat of biological or chemical warfare. This diversion of resources could
delay our ability to obtain regulatory approvals required to manufacture, market
or sell our products in the United States and other countries.
RISKS RELATED TO THE MARKET FOR OUR COMMON STOCK
The Price of Our Common Stock Has Been Highly Volatile Due to Several Factors
Which Will Continue to Affect the Price of Our Stock.
Our common stock has traded as low as $0.11 per share and as high as $1.799 per
share in the twelve months ended March 31, 2004. We believe that some of the
factors leading to the volatility include:
o price and volume fluctuations in the stock market at large which do not
relate to our operating performance;
o fluctuations in our operating results;
o concerns about our ability to finance our continuing operations;
o financing arrangements which may require the issuance of a significant
number of shares in relation to the number of shares currently
outstanding;
o announcements of technological innovations or new products which we or our
competitors make;
o FDA, SEC and international regulatory actions;
o availability of reimbursement for use of our products from private health
insurers, governmental health administration authorities and other
third-party payors;
o developments with respect to patents or proprietary rights;
o public concern as to the safety of products that we or others develop;
o changes in health care policy in the United States or abroad;
o changes in stock market analysts' recommendations regarding Calypte, other
medical products companies or the medical product industry generally;
o fluctuations in market demand for and supply of our products;
o certain world conditions, such as SARS, an economic downturn or terrorist
attacks; and
o anti-American sentiment in certain international markets.
Our Registration of a Significant Amount of Our Outstanding Restricted Stock and
the Availability of a Significant Number of Shares Eligible for Future Sale May
Have a Negative Effect on the Trading Price of Our Stock.
At June 30, 2004, investors in our common stock hold approximately 71 million
shares of restricted stock, of which approximately 41.0 million shares relate to
acquisitions of our common stock by Marr Technologies BV ("Marr" or "MTBV"), the
provider of our current $5 million credit facility and our largest stockholder,
through their participation in private placements in 2003 and 2004 and
conversion of debentures. Approximately 15.75 million additional shares are
related to issuances of restricted shares of our common stock to other
participants in our May 2004 private placement; another 11.6 million shares are
related to issuances pursuant to our convertible notes and debentures and an
additional 2.6 million shares are related to issuances under contracts and
agreements under which we have received goods and services. Further, in the May
2004 private placement we issued warrants that are immediately exercisable or
exercisable on 61 days' notice that could result in the issuance of an
additional 8.8 million shares. Additionally, we could be required to issue
approximately 2.9 million additional shares of our common stock if the holders
of currently outstanding convertible debentures or various warrant holders
elected to convert the remaining principal and accrued interest of their
debentures or exercise their outstanding warrants. This registration statement
includes essentially all of the outstanding restricted shares and the shares
underlying the outstanding convertible debentures and warrants. Although certain
of the Marr agreements require that Marr hold approximately 28.2 million of its
its shares for one year following their purchase, essentially all of the other
shares would be freely tradable upon the effectiveness of this registration
statement and upon conversion of the debentures or exercise of the warrants. If
investors holding a significant number of freely tradable shares decided to sell
them in a short period of time following the effectiveness of the registration
statement, such sales could contribute significant downward pressure on the
trading price of our stock. Such sales might also inhibit our ability to obtain
future equity or equity-related financing on acceptable terms.
7
From inception through June 30, 2004, we have issued approximately 164.0 million
shares of our common stock and raised approximately $139 million. At a Special
Meeting of Stockholders on February 14, 2003, our stockholders approved an
increase in the number of authorized shares of the Company's common stock from
200 million to 800 million. Although we have no plans to do so, at June 30,
2004, we have the ability, without further stockholder approval, to issue in
excess of 500 million shares of our common stock for financing or for other
purposes. The perceived risk of dilution from this amount of authorized but
unissued stock may cause our existing stockholders and other holders to sell
their shares of stock, which would contribute to a decrease in our stock price.
In this regard, significant downward pressure on the trading price of our stock
may also cause investors to engage in short sales, which would further
contribute to significant downward pressure on the trading price of our stock.
Our Issuance of Warrants, Options and Stock Grants to Consultants for Services
and the Granting of Registration Rights for the Underlying Shares of Common
Stock May Have a Negative Effect on the Trading Price of Our Common Stock.
As we continue to look for ways to minimize our use of cash while obtaining
required services, we have issued and may continue to issue warrants and options
at or below the current market price or make additional stock bonus grants.
During 2003, we issued warrants, options and stock bonuses for nearly 19.8
million shares, including approximately 10.0 million shares from employee
benefit plans and the 2003 Non-Qualified Stock Option Plan, in payment for
consulting services. In the first quarter of 2004, we issued approximately
596,000 additional shares in payment for consulting services. In addition to the
potential dilutive effect of a large number of shares and a low exercise price
for the warrants and options, there is the potential that a large number of the
underlying shares may be sold on the open market at any given time, which could
place downward pressure on the trading price of our common stock.
Our Stockholders May Experience Substantial Dilution as a Result of Our Recent
PIPE Financing and the Anti-Dilution Provisions Contained Therein or as a Result
of Future Financings.
The current market price of our common stock and the price at which investors in
our May 2004 PIPE purchased shares of our common stock is significantly higher
than the book value of our common stock. Had the May 2004 PIPE transaction
occurred as of March 31, 2004, the investors would have invested, net of fees,
an amount equal to approximately $11.0 million in excess of our total
stockholders' equity as of that date, but would own only approximately 15% of
our outstanding common stock.
Although we believe that we have sufficient funds to continue our operations
through 2004, we may need to arrange additional financing to fund our operations
in 2005 or thereafter. There can be no assurance that additional financing would
be available, or it if is available, that it would be on acceptable terms.
Additionally, the shares issued pursuant to the May 2004 PIPE and the related
warrants have an anti-dilution feature that will require us to issue additional
shares to the PIPE investors and modify their outstanding warrants if we
subsequently issue additional equity at a per share price of less than $0.40 for
a period of one year from the closing date, except under the provisions of
previously outstanding convertible debt, option plans, or option or warrant
agreements. If we find it necessary to issue additional common stock to fund our
operations in the year following the May 2004 PIPE, all of our stockholders will
experience dilution; if the terms of the potential future financing require that
we issue shares of our common stock at a price of less than $0.40 per share,
holders of our common stock prior to the 2004 PIPE will experience even greater
proportional dilution.
8
Our Common Stock is Subject to the "Penny Stock" Rules of the SEC and the
Trading Market In Our Securities is Limited, Which Makes Transactions in Our
Stock Cumbersome and May Reduce the Value of an Investment in Our Stock.
Shares of our common stock are "penny stocks" as defined in the Exchange Act,
which are traded in the Over-The-Counter Market on the OTC Bulletin Board. As a
result, investors may find it more difficult to dispose of or obtain accurate
quotations as to the price of the shares of the common stock being registered
hereby. In addition, the "penny stock" rules adopted by the Commission under the
Exchange Act subject the sale of the shares of our common stock to certain
regulations which impose sales practice requirements on broker/dealers. For
example, brokers/dealers selling such securities must, prior to effecting the
transaction, provide their customers with a document that discloses the risks of
investing in such securities. Included in this documents are the following:
o the bid and offer price quotes in and for the "penny stock", and the
number of shares to which the quoted prices apply.
o the brokerage firm's compensation for the trade.
o the compensation received by the brokerage firm's sales person for the
trade.
In addition, the brokerage firm must send the investor:
o a monthly account statement that gives an estimate of the value of each
"penny stock" in the investor's account.
o a written statement of the investor's financial situation and investment
goals.
Legal remedies, which may be available to you as an investor in "penny stocks",
are as follows:
o if "penny stock" is sold to you in violation of your rights listed above,
or other federal or states securities laws, you may be able to cancel your
purchase and get your money back.
o if the stocks are sold in a fraudulent manner, you may be able to sue the
persons and firms that caused the fraud for damages.
o if you have signed an arbitration agreement, however, you may have to
pursue your claim through arbitration.
If the person purchasing the securities is someone other than an accredited
investor or an established customer of the broker/dealer, the broker/dealer must
also approve the potential customer's account by obtaining information
concerning the customer's financial situation, investment experience and
investment objectives. The broker/dealer must also make a determination whether
the transaction is suitable for the customer and whether the customer has
sufficient knowledge and experience in financial matters to be reasonably
expected to be capable of evaluating the risk of transactions in such
securities. Accordingly, the Commission's rules may limit the number of
potential purchasers of the shares of our common stock.
Resale restrictions on transferring "penny stocks" are sometimes imposed by some
states, which may make transaction in our stock more difficult and may reduce
the value of the investment. Various state securities laws pose restrictions on
transferring "penny stocks" and as a result, investors in our common stock may
have the ability to sell their shares of our common stock impaired.
RISKS RELATED TO OUR BUSINESS
We May Be Unsuccessful in Implementing Our Consolidation, Development and
Marketing Plans as Anticipated.
We are in the process of consolidating our manufacturing facilities in a single
facility at our Rockville, Maryland location. In addition to internal validation
and comparability studies that we conduct in conjunction with our manufacturing
consolidation, the FDA must approve our facility changes and urine EIA
manufacturing operations in Rockville before we will be permitted to sell urine
EIA tests manufactured at that facility in the US. If the consolidation does not
proceed as planned, or if the FDA does not approve the facility changes on the
timeline anticipated, the anticipated cost reductions as well as increased
efficiencies may not occur. There can be no assurance that we will successfully
complete the development and commercialization of our rapid tests currently
under development, or that our international marketing efforts with respect to
these tests will result in significant additional sales. Additionally, there can
be no assurance that we will be able to successfully negotiate government or
private-sector contracts for mass-testing applications. Consequently, our
current financial resources and available financing may be inadequate, and we
may have to seek additional financing, which may not be available on the
timetable required or on acceptable terms, or we may have to curtail our
operations, or both.
9
In conjunction with our manufacturing consolidation, we expect that we will be
unable to produce our HIV-1 Urine EIA product for sale in the US until we
complete the required validation and comparability studies at our Rockville
facility that will be necessary for FDA review and approval. We expect FDA
review and approval of our Rockville facility to be completed during the first
quarter of 2005. We believe we have manufactured sufficient inventories of our
HIV 1 Urine EIA test to continue to satisfy expected customer orders during the
transition period. We have considered historical sales levels and the length of
time required to complete the consolidation and obtain FDA approval in
determining the amount of inventory required to bridge the transition period.
Demand could significantly exceed historical levels, and consolidation of
operations or FDA approval could take longer than expected. If one or more of
these events occur, then our transition inventory may not be sufficient to
supply customer orders and we may lose business that we may find difficult, or
impossible, to replace. Alternatively, demand could fall significantly below
historical levels, in which case we will have built excess inventory that we may
have to dispose of at additional cost, or at a loss.
Our Customers May Not Be Able to Satisfy Their Contractual Obligations and We
May Not Be Able to Deliver Our Products as a Result of the Impact of Conditions
Such as Severe Acute Respiratory Syndrome ("SARS") or Other World Events.
Our expected first quarter 2003 shipment of urine HIV screening tests to our
distributor in the People's Republic Of China was delayed until the third
quarter of 2003 in part as a result of the impact of the SARS outbreak in that
country. Our distributor has reported that both potential patients and medical
personnel were reluctant to visit or report for work at hospitals, clinics and
other sites for fear of contracting or spreading SARS and, consequently, both
diagnostic and therapeutic procedures were postponed. Additionally,
governmentally-imposed facility closures and quarantine restrictions disrupted
the ability of the distributor to receive and distribute our HIV tests. This
situation may recur.
Our business model and future revenue forecasts call for a significant expansion
of sales in the People's Republic of China as well as in Russia and Africa upon
successful completion of the rapid product evaluation and regulatory approval.
Should conditions beyond our control, such as SARS, redirect attention from the
worldwide HIV/AIDS epidemic, our customers' ability to meet their contractual
purchase obligations or our ability to supply product internationally for either
evaluation or commercial use may prevent us from achieving the revenues we have
projected. As a result, we may have to seek additional financing beyond that
which we have projected, which may not be available on the timetable required or
on acceptable terms that are not substantially dilutive to our stockholders, or
we may have to curtail our operations, or both.
Our Quarterly Results May Fluctuate Due to Certain Regulatory, Marketing and
Competitive Factors Over Which We Have Little or No Control.
The factors listed below, some of which we cannot control, may cause our
revenues and results of operations to fluctuate significantly:
o actions taken by the FDA or foreign regulatory bodies relating to our
existing products or products we are currently developing or seeking to
develop;
o the extent to which our current or proposed new products gain market
acceptance;
o the timing and size of purchases by our laboratory customers, distributors
or joint venture partners;
o introductions of alternative means for testing for HIV by competitors;
o changes in the way requlatory authorities evaluate HIV testing, including
supplemental testing of the domestic blood supply; and
o customer concerns about the stability of our business which could cause
them to seek alternatives to our product.
10
Our Research, Development and Commercialization Efforts May Not Succeed or Our
Competitors May Develop and Commercialize More Effective or Successful
Diagnostic Products.
In order to remain competitive, we must regularly commit substantial resources
to research and development and the commercialization of new products.
The research and development process generally takes a significant amount of
time and money from inception to commercial product launch. This process is
conducted in various stages. During each stage there is a substantial risk that
we will not achieve our goals on a timely basis, or at all, and we may have to
abandon a product in which we have invested substantial amounts of money.
During the year ended December 31, 2003 and in the first quarter of 2004, we
incurred $1.5 million and $0.5 million, respectively, in research and
development expenses. We expect to incur even more significant costs from our
research and development activities in the future.
A primary focus of our efforts has been, and is expected to continue to be,
rapid HIV tests, which are currently under development. However, there can be no
assurance that we will succeed in our research and development efforts with
respect to rapid tests or other technologies or products.
Successful products require significant development and investment, including
testing, to demonstrate their cost-effectiveness or other benefits prior to
commercialization. In addition, regulatory approval must be obtained before most
products may be sold. Additional development efforts on these products will be
required before any regulatory authority will review them. Regulatory
authorities may not approve these products for commercial sale. In addition,
even if a product is developed and all applicable regulatory approvals are
obtained, there may be little or no market for the product, or we may be unable
to obtain the requisite licenses to sell the product or to qualify for a
government tender, which are often requirements in third world countries where
the greatest need and largest market for HIV diagnostic testing exists.
Accordingly, if we fail to develop commercially successful products, or if
competitors develop more effective products or a greater number of successful
new products, or there are governmental limitations affecting our ability to
sell our products, customers may decide to use products developed by our
competitors. This would result in a loss of revenues and adversely affect our
results of operations, cash flows and business.
We Have Limited Experience Selling and Marketing Our HIV-1 Urine ELISA Tests and
No Experience Marketing a Rapid Test.
Our urine-based ELISA products incorporate a unique method of determining the
presence of HIV antibodies and we have limited experience marketing and selling
them either domestically or internationally. Further, we have no experience
marketing and selling blood or oral fluid products. Our company's success
depends upon alliances with third-party international distributors and joint
venture partners and upon our ability to penetrate expanded markets. There can
be no assurance that:
o our international distributors and joint ventures will successfully market
our products;
o our domestic selling efforts will be effective;
o we will obtain any expanded degree of market acceptance among physicians,
patients or health care payors; or others in the medical or public health
community, including governments and humanitarian funding sources critical
in may international markets, which are essential for acceptance of our
products; or
o if our relationships with distributors terminate, we will be able to
establish relationships with other distributors on satisfactory terms, if
at all.
We have had FDA approval to market our current urine HIV-1 screening and
supplemental tests in the United States and have been marketing these products
since 1998. We have not yet introduced either an HIV-1/2 product or a rapid
point of care test, both of which are necessary in many areas of the world.
Further, we have not achieved significant market penetration with our current
ELISA tests within domestic or international markets. A disruption in our
distribution, sales or marketing network could reduce our sales revenues and
cause us to either cease operations or expend more resources on market
penetration efforts than are available to us without affecting other parts of
our business.
11
We Currently Depend Upon the Viability of Three Primary Products -- Our HIV-1
Urine-Based Screening Test and Our Urine and Blood Based Supplemental Tests.
Our HIV-1 urine-based screening test and urine and blood-based supplemental
tests are our current products. Our sales of these products for the quarter
ended March, 2004 increased by 24% compared to the comparable period in 2003.
There can be no assurance, however, that such a trend will continue and, even
with the increase, we still incurred a loss from operations for the quarter. If
we cannot profitably introduce new products on a timely basis and if these
products and our screening and supplemental tests fail to achieve market
acceptance or generate significant revenues, we may have to cease operations.
We May Not be Able to Success
Optionen
| Boardmail an "Kade_I" |
Wertpapier: Calypte Biomedical |
Optionen
| Boardmail an "Kade_I" |
Wertpapier: Calypte Biomedical |
erst stürzt der Kurs von 0,74 $ auf 0,685 $ ab, dann kauft einer in 3x200.000 Blöcke ein das sind ca. 400.000 $, und jetzt geht der Kurs nochmal runter !!!
Mehr Käufer als Verkäufer und trotzdem geht Caly runter, sehr interessant
gruß werweiß
dieses SEC-Filing hab ich auch bei HP u. Compaq gesehen, oder ist das eine Vorbereitung für die AMEX, auf jedenfall nichts schlechtes, sonst würden alle wie blöd verkaufen !!!
Nichts ist unmöglich Calypte
gruß werweiß
Grüße
Kade_I
Optionen
| Boardmail an "Kade_I" |
Wertpapier: Calypte Biomedical |
und warten, denke mal am Montag gehn einige in Deutschland raus, deshalb drücken die jetzt in Amerika den Kurs, die wollen uns nicht den Vortritt geben, und dann ab 20.00 Uhr Montag oder Dienstag gehts ab !!!
Gruß werweiß
Lasst uns die weiteren News verfolgen, ich bin ganz Ohr
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n/a
19:25:07
0.685
2'500
n/a
19:25:07
0.685
2'500
n/a
19:24:35
0.685
550
n/a
19:24:30
0.68
1'000
n/a
19:24:07
0.685
5'000
n/a
19:21:45
0.685
7'500
n/a
19:21:02
0.685
2'000
n/a
19:20:04
0.685
10'000
n/a
19:19:11
0.685
2'500
n/a
19:18:58
0.685
7'500
n/a
19:18:38
0.685
3'500
n/a
19:17:27
0.68
5'000
n/a
19:17:06
0.68
10'000
n/a
19:15:42
0.68
2'699
n/a
19:15:35
0.68
3'000
n/a
19:14:54
0.68
1'000
n/a
19:11:53
0.68
2'000
n/a
19:09:25
0.68
2'500
n/a
19:09:11
0.68
250
n/a
19:08:01
0.67
10'000
n/a
19:07:34
0.68
2'000
n/a
19:05:40
0.68
5'000
n/a
19:04:31
0.68
2'500
n/a
19:03:29
0.68
2'500
n/a
19:03:14
0.68
2'000
n/a
19:02:51
0.68
10'000
n/a
19:02:39
0.68
1'000
n/a
19:02:09
0.68
1'000
n/a
18:59:27
0.685
1'500
n/a
18:58:23
0.685
1'000
n/a
18:57:02
0.675
5'033
n/a
18:56:57
0.68
2'000
n/a
18:54:47
0.685
27'000
n/a
18:54:42
0.68
8'000
n/a
18:53:15
0.68
7'500
n/a
18:52:45
0.68
5'000
n/a
18:52:40
0.68
2'500
n/a
18:52:36
0.68
5'000
n/a
18:51:05
0.685
1'000
n/a
18:47:49
0.685
10'000
n/a
18:47:47
0.685
3'334
n/a
18:47:03
0.685
200'000
n/a
18:46:54
0.685
200'000
n/a
18:46:54
0.685
200'000
7/9/2004 Choose your broker
After Hours: 0.70 +0.08 13.01% 290,600 !!!!!!!!!!!!!!!!
gruß werweiß
quelle: cbs.marketwatch.com
Optionen
| Boardmail an "Kade_I" |
Wertpapier: Calypte Biomedical |
ich melde mich zwar nur selten - aber der Spaß geht weiter !
und die richtig guten haben ihre Euronen im Sack - das schlimme ist ////
ich gönn es Ihnen von ganzen Herzen !
Gruß
leo