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AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON DECEMBER 15, 2000
REGISTRATION NO. 333-49246
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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
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AMENDMENT NO. 1
TO
FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
------------------------
CALYPTE BIOMEDICAL CORPORATION
(Exact name of registrant as specified in its charter)
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<S> <C> <C>
DELAWARE 3826 06-1226727
(State or other jurisdiction (Primary Standard Industrial (I.R.S. employer incorporation
of) Classification Code Number) or organizational)
</TABLE>
1265 HARBOR BAY PARKWAY, ALAMEDA, CALIFORNIA 94502, (510) 749-5100
(Address, including zip code, and telephone number, including area code, of
registrant's principal executive offices)
--------------------------
NANCY E. KATZ
Chief Executive Officer, President and Chief Financial Officer
Calypte Biomedical Corporation
1265 Harbor Bay Parkway
Alameda, California 94502
(510) 749-5100
(Name, address, including zip code, and telephone number, including area code,
of agent for service)
------------------------
Copies to:
BRUCE W. JENETT, ESQ.
Heller Ehrman White & McAuliffe
525 University Avenue
Palo Alto, California 94301
(650) 324-7000 (phone)
(650) 324-0638 (fax)
------------------------
APPROXIMATE DATE OF COMMENCEMENT OF PROPOSED SALE TO THE PUBLIC:
As soon as practicable after the effective date of this Registration Statement.
------------------------
If the only securities being registered on this Form are being offered
pursuant to dividend or interest reinvestment plans, please check the following
box. / /
If any of the securities being registered on this Form are to be offered on
a delayed or continuous basis pursuant to Rule 415 under the Securities Act of
1933, as amended, other than securities offered only in connection with dividend
or interest reinvestment plans, check the following box. /X/
If this Form is filed to register additional securities for an offering
pursuant to Rule 462(b) under the Securities Act of 1933, as amended, please
check the following box and list the Securities Act registration statement
number of the earlier effective registration statement for the same
offering. / / _____________________
If this Form is a post-effective amendment filed pursuant to Rule 462(c)
under the Securities Act of 1933, as amended, check the following box and list
the Securities Act registration statement number of the earlier effective
registration statement for the same offering. / / _____________________
If delivery of the prospectus is expected to be made pursuant to Rule 434,
please check the following box. / /
------------------------
THE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR
DATES AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT SHALL
FILE A FURTHER AMENDMENT THAT SPECIFICALLY STATES THAT THIS REGISTRATION
STATEMENT SHALL THEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH SECTION 8(a) OF
THE SECURITIES ACT OF 1933 OR UNTIL THIS REGISTRATION STATEMENT SHALL BECOME
EFFECTIVE ON SUCH DATE AS THE SECURITIES AND EXCHANGE COMMISSION, ACTING
PURSUANT TO SAID SECTION 8(a), MAY DETERMINE.
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INFORMATION CONTAINED HEREIN IS SUBJECT TO COMPLETION OR AMENDMENT. A
REGISTRATION STATEMENT RELATING TO THESE SECURITIES HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION. THESE SECURITIES MAY NOT BE SOLD NOR MAY
OFFERS TO BUY BE ACCEPTED PRIOR TO THE TIME THE REGISTRATION STATEMENT BECOMES
EFFECTIVE. THIS PROSPECTUS SHALL NOT CONSTITUTE AN OFFER TO SELL OR THE
SOLICITATION OF AN OFFER TO BUY NOR SHALL THERE BE ANY SALE OF THESE SECURITIES
IN ANY STATE IN WHICH SUCH OFFER, SOLICITATION OR SALE WOULD BE UNLAWFUL PRIOR
TO REGISTRATION OR QUALIFICATION UNDER THE SECURITIES LAWS OF ANY SUCH STATE.
<PAGE>
SUBJECT TO COMPLETION, DATED DECEMBER 15, 2000
The information in this prospectus is incomplete and may be changed. The selling
security holders may not sell these securities until the registration statement
filed with the Securities and Exchange Commission is effective. This prospectus
is not an offer to sell these securities and is not soliciting an offer to buy
these securities in any state where the offer or sale is not permitted.
------------------------
PRELIMINARY PROSPECTUS
UP TO 6,000,000 SHARES
CALYPTE BIOMEDICAL CORPORATION
COMMON STOCK
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CALYPTE BIOMEDICAL CORPORATION The selling security holder may use this
prospectus to resell up to 6,000,000 shares
of our common stock.
1265 Harbor Bay Parkway We will not receive any of the proceeds from
Alameda, California 94502 the sale of the shares by the selling
(510) 749-5100 security holder. However, we will receive the
sale price of any common stock that we sell
to Townsbury Investments Limited under the
common stock purchase agreement described in
this prospectus or upon the exercise for cash
of the stock purchase warrants held by
Townsbury Investments Limited. We will pay
the costs of registering the resale of such
shares under this prospectus, including legal
fees.
Our common stock is listed on the Nasdaq The selling security holder may offer shares
SmallCap Market under the symbol "CALY". The of common stock of Calypte to purchasers in
last reported sales price for our common transactions on the Nasdaq SmallCap Market,
stock on the Nasdaq SmallCap Market on in negotiated transactions, or otherwise, or
December 13, 2000 was $1.50 per share. by a combination of these methods. The
selling security holder may sell the shares
through broker-dealers who may receive
compensation from the selling security
holders in the form of discounts or
commissions. Townsbury Investments Limited is
an "underwriter" within the meaning of the
Securities Act of 1933 in connection with
such sales.
</TABLE>
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 , 2000
<PAGE>
TABLE OF CONTENTS
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PAGE
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Where You Can Find More Information......................... 2
The Company................................................. 3
Recent Developments......................................... 3
The Offering................................................ 4
Risk Factors................................................ 5
Use of Proceeds............................................. 13
The Common Stock Purchase Agreement......................... 13
Selling Security Holder..................................... 22
Plan of Distribution........................................ 23
Legal Matters............................................... 25
Experts..................................................... 25
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1
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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.
The SEC allows us to "incorporate by reference" the information we file with
them, which means that we can disclose important information to you by referring
you to those documents. The information incorporated by reference is considered
to be part of this Prospectus, and later information filed with the SEC will
update and supersede this information. We incorporate by reference the documents
listed below and any future filings made with the SEC under Section 13(a),
13(c), 14 or 15(d) of the Securities Exchange Act of 1934 (the "Exchange Act").
1. The Company's Annual Report filed on Form 10-K for the fiscal year ended
December 31, 1999.
2. The Company's Quarterly Reports on Form 10-Q for the periods ended
March 31, 2000, June 30, 2000 and September 30, 2000.
4. The description of the common stock contained in the Company's
Registration Statement filed on Form 8-A, as filed with the SEC on
July 10, 1996 and December 16, 1998.
You may request a copy of these filings, at no cost, by writing or
telephoning us at the following address:
Calypte Biomedical Corporation
1265 Harbor Bay Parkway
Alameda, California 94502
Attention: President
Telephone: (510) 749-5100.
You should rely only on information incorporated by reference or provided in
this Prospectus and any prospectus supplement. 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
under the Private Securities Litigation Reform Act of 1995 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 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:
- fluctuations in our operating results;
- announcements of technological innovations or new products which we or our
competitors make;
- FDA and international regulatory actions;
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<PAGE>
- availability of reimbursement for use of our products from private health
insurers, governmental health administration authorities and other
third-party payors;
- developments with respect to patents or proprietary rights;
- public concern as to the safety of products that we or others develop;
- changes in health care policy in the United States or abroad;
- changes in stock market analysts' recommendations regarding Calypte, other
medical products companies or the medical product industry generally;
- fluctuations in market demand for and supply of our products; and
- 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".
THE COMPANY
Calypte Biomedical Corporation ("Calypte" or the "Company") believes that it
is a leader in the development of a urine-based screening test for the detection
of antibodies to the Human Immunodeficiency Virus, Type-1 ("HIV-1"), the
putative cause of Acquired Immunodeficiency Syndrome ("AIDS"). The Company has
integrated several proprietary technologies to develop a test which, in recent
Company-funded clinical trials conducted by or on behalf of the Company,
detected the presence of HIV antibodies in urine with 99.7% sensitivity in
subjects known to be HIV-1 infected (as identified through blood-based screening
tests). In subjects at low risk for HIV ("low risk subjects"), the specificity
of the screening test with a companion Western Blot supplemental test was 100%.
Calypte believes that its proprietary urine-based test offers significant
advantages compared to existing blood-based tests, including ease-of-use, lower
costs, and significantly reduced risk of infection from collecting and handling
specimens. Urine collection is non-invasive and painless, and urine is the most
commonly collected body fluid. The Company estimates that most customers will
find the cost of collecting, handling, testing and disposing of urine specimens
to be significantly less than that of blood or other bodily fluid specimens.
Independent studies report that the likelihood of finding infectious HIV virus
in urine is extremely low, which greatly reduces the risk and cost of accidental
exposure to health care workers, laboratory personnel, and patients being
tested.
We were incorporated as a Delaware corporation in 1996. On October 31, 2000,
we had approximately 65 full-time employees. We are located at 1265 Harbor Bay
Parkway, Alameda, California 94502, telephone number (510) 749-5100.
RECENT DEVELOPMENTS
We and Townsbury Investments Limited ("TIL") signed a common stock purchase
agreement dated November 2, 2000 for the future issuance and purchase of our
common stock. The initial closing of the transaction took place on November 2,
2000. The stock purchase agreement establishes what is sometimes termed an
equity line of credit or an equity draw down facility. In general, the draw down
facility operates like this: the investor, TIL, committed up to $25 million to
purchase our common stock over a twelve month period. Once during each draw down
pricing period, we may request a draw of up to $6 million of that money, subject
to a formula based on average stock price and average trading volume, setting
the maximum amount of any request for any given draw. The amount of money that
TIL will provide to us and the number of shares we will issue to TIL in return
for that money is settled twice during a 22 day trading period following the
draw down request based on the formula in
3
<PAGE>
the stock purchase agreement. TIL receives a 5% discount to the market price for
the 22 day period and we receive the settled amount of the draw down. See "The
Common Stock Purchase Agreement" on page 13 of this prospectus.
THE OFFERING
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Common stock outstanding as of October 26,
2000 25,238,037 shares
Shares offered by selling security holder 6,000,000 shares
Risk Factors The shares involve a high degree of risk.
Investors should carefully consider the
information set forth under "RISK FACTORS".
Use of Proceeds We will not receive any proceeds from the
sale of the shares by the selling security
holder.
Nasdaq trading symbol CALY
</TABLE>
4
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RISK FACTORS
In addition to the other information in this Prospectus or incorporated
herein by reference, the following risk factors should be considered carefully
in evaluating our business before purchasing the shares offered in this
Prospectus.
UNCERTAIN MARKET ACCEPTANCE OF OUR UNIQUE METHOD OF DETERMINING THE PRESENCE OF
HIV ANTIBODIES.
Our products incorporate a unique method of determining the presence of HIV
antibodies. There can be no assurance that we will obtain:
- any significant degree of market acceptance among physicians, patients or
health care payors; or
- recommendations and endorsements by the medical community which are
essential for market acceptance of the products.
We have FDA approval to market our urine HIV-1 screening and supplemental tests
and test kits in the United States and we have been marketing these products
since July, 1998. To date, however, these products have only generated limited
revenues and not achieved significant market penetration. The failure of our
products to obtain market acceptance could cause us to cease operations.
WE HAVE LIMITED EXPERIENCE SELLING AND MARKETING OUR HIV-1 URINE-BASED SCREENING
TEST.
We have limited experience marketing and selling our products either
directly or through our distributors. The success of our products depends upon
alliances with third-party distributors. There can be no assurance that:
- our direct selling efforts will be effective;
- our distributors will successfully market our products; or
- if our relationships with distributors terminate, we will be able to
establish relationships with other distributors on satisfactory terms, if
at all.
Any disruption in our distribution, sales or marketing network could reduce our
sales revenues and cause us to expend more resources on market penetration.
OUR DISTRIBUTION AND SALES NETWORK FOR U.S. HOSPITALS, PUBLIC HEALTH AND
REFERENCE LABORATORY MARKETS HAS THUS FAR FAILED TO YIELD SIGNIFICANT SALES AND
REVENUES.
We have entered into distribution agreements with distributors of medical
products to domestic healthcare markets including the distribution agreement
announced in September, 1999 with Carter Wallace Inc. and the Sentinel HIV and
STD testing service announced in May, 2000. Those arrangements have thus far
failed to yield significant sales and revenues. We are continuing to examine
alternative approaches to penetrate domestic healthcare markets including
restructuring our existing distribution relationships and expanding our direct
sales efforts. If our efforts to market our products to domestic hospitals,
public health and reference laboratories fail to yield significant amounts of
revenues, we may have to cease operations.
WE HAVE SUSTAINED LOSSES IN THE PAST AND WE EXPECT TO SUSTAIN LOSSES IN THE
FUTURE.
We have incurred losses in each year since our inception. Our net loss for
the nine months ended September 30, 2000 was $8.4 million and our accumulated
deficit as of September 30, 2000 was $75.2 million. We expect operating losses
to continue as we continue our marketing and sales activities of our
FDA-approved products and conduct additional research and development for
subsequent products.
5
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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:
- actions taken by the FDA or foreign regulatory bodies relating to our
products;
- the extent to which our products and our Sentinel HIV and STD testing
service gain market acceptance;
- the timing and size of distributor purchases; and
- introductions of alternative means for testing for HIV by competitors.
WE MAY NOT BE ABLE TO OBTAIN ADDITIONAL FINANCING THAT WE MAY NEED IN THE
FUTURE.
The report of KPMG LLP covering the December 31, 1999, consolidated
financial statements contains an explanatory paragraph that states that our
recurring losses from operations and accumulated deficit raise substantial doubt
about our ability to continue as a going concern. The consolidated financial
statements do not include any adjustments that might result from the outcome of
that uncertainty. We may need to raise more money to continue to finance our
operations. We may not be able to obtain additional financing on acceptable
terms, or at all. Any failure to raise additional financing will likely place us
in significant financial jeopardy.
WE DEPEND UPON THE VIABILITY OF THREE PRODUCTS--OUR HIV-1 URINE-BASED SCREENING
TEST AND OUR URINE AND BLOOD-BASED SUPPLEMENTAL TESTS.
Our HIV-1 urine-based screening test and our urine and blood-based
supplemental tests are our only products. Accordingly, we may have to cease
operations if our tests fail to achieve market acceptance or generate
significant revenues.
OUR PRODUCTS DEPEND UPON RIGHTS TO TECHNOLOGY THAT WE HAVE LICENSED FROM THIRD
PARTY PATENT HOLDERS AND THERE CAN BE NO ASSURANCE THAT THE RIGHTS WE HAVE UNDER
THESE LICENSING AGREEMENTS ARE SUFFICIENT OR THAT WE CAN ADEQUATELY PROTECT
THOSE RIGHTS.
We currently have the right to use patent and proprietary rights that are
material to the manufacture and sale of our HIV-1 urine-based screening test
under licensing agreements with New York University, Repligen and the Texas A&M
University System. We also have the right to use patent and proprietary rights
that are material to the manufacture and sale of our HIV-1 serum-based
supplemental test under a licensing agreement with National Institutes of
Health.
WE RELY ON SOLE SOURCE SUPPLIERS THAT WE CANNOT QUICKLY REPLACE FOR CERTAIN
COMPONENTS CRITICAL TO THE MANUFACTURE OF OUR PRODUCTS.
Any delay or interruption in the supply of these components could have a
material adverse effect on us by significantly impairing our ability to
manufacture products in sufficient quantities, particularly as we increase our
manufacturing activities in support of commercial sales.
WE HAVE LIMITED EXPERIENCE IN MANUFACTURING OUR PRODUCTS AND LITTLE EXPERIENCE
IN MANUFACTURING OUR PRODUCTS IN COMMERCIAL QUANTITIES.
We may encounter difficulties in scaling-up production of new products,
including problems involving:
- production yields;
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- quality control and assurance;
- raw material supply; and
- shortages of qualified personnel.
THE SUCCESS OF OUR PLANS TO ENTER INTERNATIONAL MARKETS MAY BE LIMITED OR
DISRUPTED DUE TO RISKS RELATED TO INTERNATIONAL TRADE AND MARKETING AND THE
CAPABILITIES OF OUR DISTRIBUTORS.
We anticipate that international distributor sales will generate a
significant portion of our revenues for the next several years. We believe that
our urine-based test can provide significant benefits in countries that do not
have the facilities or personnel to safely and effectively collect and test
blood or other bodily fluid samples. The following risks may limit or disrupt
our international sales:
- the imposition of government controls;
- export license requirements;
- political instability;
- trade restrictions;
- changes in tariffs;
- difficulties in managing international operations; and
- fluctuations in foreign currency exchange rates.
Some of our distributors have limited international marketing experience. There
can be no assurance that these distributors will be able to market successfully
our products in foreign markets.
WE FACE INTENSE COMPETITION IN THE MEDICAL DIAGNOSTIC PRODUCTS MARKET AND RAPID
TECHNOLOGICAL ADVANCES BY COMPETITORS.
Competition in our diagnostic market is intense and we expect it to
increase. Within the United States, our competitors include a number of
well-established manufacturers of HIV tests using blood samples, plus at least
one system for the detection of HIV antibodies using oral fluid samples. Many of
our competitors have significantly greater financial, marketing and distribution
resources than we do. Our competitors may succeed in developing or marketing
technologies and products that are more effective than ours. These developments
could render our technologies or products obsolete or noncompetitive or
otherwise effect our ability to increase or maintain our products' market share.
OUR ABILITY TO MARKET OUR PRODUCTS DEPENDS UPON OBTAINING AND MAINTAINING FDA
AND FOREIGN REGULATORY APPROVALS.
Numerous governmental authorities in the United States and other countries
regulate our products. The FDA regulates our products under federal statutes and
regulations related to pre-clinical and clinical testing, manufacturing,
labeling, distribution, sale and promotion of medical devices in the United
States. If we fail to comply with FDA regulations, or the FDA believes that we
are not in compliance with such regulations, the FDA can:
- detain or seize our products;
- issue a recall of our products;
- prohibit marketing and sales of our products; and
- assess civil and criminal penalties against us, our officers or our
employees.
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We also plan to sell our products in certain foreign countries where they may be
subject to similar local regulatory requirements. The imposition of any of the
sanctions described above could have a material adverse effect on us by delaying
or reducing the growth in our sales revenue or causing us to expend more
resources to penetrate our target markets. The regulatory approval process in
the United States and other countries is expensive, lengthy and uncertain. We
may not obtain necessary regulatory approvals or clearances in a timely manner,
if at all. We may lose previously obtained approvals or clearances or fail to
comply with regulatory requirements. The occurrence of any of these events would
have a material adverse effect on Calypte by disrupting our marketing and sales
efforts. Before we begin to manufacture our product at the Alameda facility, we
must obtain FDA approval for that facility. Delays in receiving the FDA's
approval or other difficulties which we encounter in scaling-up our
manufacturing capacity to meet demand could affect our ability to maintain
competitive pricing for our products and disrupt the orderly flow of product to
our customers.
THE LEASE OF OUR BERKELEY, CALIFORNIA MANUFACTURING FACILITY EXPIRES ON
DECEMBER 31, 2000, AND THE FDA HAS NOT YET APPROVED OUR ALAMEDA, CALIFORNIA
FACILITY FOR MANUFACTURING.
The FDA conducted its pre-approval inspection of our Alameda manufacturing
facility during November, 2000. The FDA has not yet informed us of its findings
or when we will receive a license to manufacture our products at the Alameda
facility. If the FDA does not license our Alameda facility prior to
December 31, 2000 or if it raises questions regarding the facility due to its
inspection that will require time beyond December 31, 2000 for us to adequately
address, there may be a period of time between the closure of the Berkeley
facility and the approval of the Alameda facility during which we will be unable
to manufacture our licensed urine screening test. Such an interruption could
disrupt the orderly flow of product to customers and result in a decrease in our
sales revenues. We are working with the FDA to ensure continuing product
availability in the event that the license for our Alameda facility is further
delayed.
IN THE PAST WE HAVE RECEIVED WARNING LETTERS FROM THE FDA REGARDING THE
SUFFICIENCY OF OUR MANUFACTURING RECORDS AND PRODUCTION PROCEDURES AND WE MUST
CONTINUE TO SATISFY THE FDA'S CONCERNS IN ORDER TO AVOID REGULATORY ACTION
AGAINST US.
In November 1998, we received a Warning Letter from the FDA following an
inspection by the FDA of our manufacturing facilities in Berkeley and Alameda,
California. On December 11, 1998, we responded in writing to each of the
deficiencies cited in the Warning Letter. We subsequently received another
letter from the FDA requesting further responses regarding certain of the
deficiencies. We responded to the subsequent letter on June 1, 1999. The FDA
conducted a follow-up inspection of our Berkeley and Alameda facilities from
September 28 through October 7, 1999, which resulted in observations requiring
corrective action or response from us. We submitted our written responses to the
FDA's inspection observations on November 4, 1999. On March 21, 2000, we
received a response from the FDA requesting additional information. We met with
and provided information to FDA officials on April 27, 2000 and on May 5, 2000
responded in writing to requests for additional information. On June 6, 2000, we
received a response from the FDA indicating that our responses appear to be
satisfactory and will be verified during a subsequent inspection. During
November 2000, the FDA conducted a pre-approval inspection of our Alameda
facility. We are awaiting the results of the inspection.
In May 1999, we received a Warning Letter from the FDA that cited a number
of significant observations related to its November 20 through December 11, 1998
inspection of our manufacturing plant in Rockville, Maryland. On May 24, 1999,
we responded in writing to each of the deficiencies cited in the Warning Letter.
On November 19, 1999, we received a letter from the FDA stating that our
responses were considered adequate, and the Warning Letter was formally closed.
Between November 30, and December 9, 1999, the FDA conducted a follow-up
inspection of our Rockville
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facility that resulted in observations requiring corrective actions or response
from us. On January 7, 2000, we responded in writing to each of the FDA
observations. On March 21, 2000, we received a response from the FDA requesting
additional information. We met with and provided information to FDA officials on
April 27, 2000 and on May 5, 2000 responded in writing to requests for
additional information. On June 6, 2000, we received a response from the FDA
indicating that our responses appear to be satisfactory and will be verified
during a subsequent inspection.
Although the FDA indicates that it is currently satisfied with our responses
to the items addressed in its inspections, if the FDA subsequently determines
that it is not satisfied with our records, procedures or corrective actions at
either of our Alameda or Rockville facilities, the FDA could take regulatory
actions against us, including license suspension, revocation, and/or denial,
seizure of products and/or injunction, and/or civil penalties or criminal
sanctions. Any such FDA action is likely to have a material adverse effect upon
our ability to conduct operations by limiting our ability to manufacture and
ship our products. In addition, our failure to satisfy the FDA on these matters
may adversely affect receiving approval for manufacturing at our Alameda
facility and/or our ability to export our products to certain international
markets.
OUR RESEARCH AND DEVELOPMENT OF HIV URINE TESTS INVOLVES THE CONTROLLED USE OF
HAZARDOUS MATERIALS.
There can be no assurance that our safety procedures for handling and
disposing of hazardous materials such as azide will comply with applicable
regulations. In addition, we cannot eliminate the risk of accidental
contamination or injury from these materials. We may be held liable for damages
from such an accident and that liability could have a material adverse effect on
us.
WE MAY NOT BE ABLE TO RETAIN OUR KEY EXECUTIVES AND RESEARCH AND DEVELOPMENT
PERSONNEL.
As a small company with only 65 employees, our success depends on the
services of key employees in executive and research and development positions.
The loss of the services of one or more of such employees could have a material
adverse effect on us.
AS A SMALL MANUFACTURER OF A MEDICAL DIAGNOSTIC PRODUCT, WE ARE EXPOSED TO
PRODUCT LIABILITY AND RECALL RISKS FOR WHICH INSURANCE COVERAGE IS EXPENSIVE,
LIMITED AND POTENTIALLY INADEQUATE.
We manufacture medical diagnostic products which subjects us to risks of
product liability claims or product recalls, particularly in the event of false
positive or false negative reports. A product recall or a successful product
liability claim or claims which exceed our insurance coverage could have a
material adverse effect on us. We maintain a $10,000,000 claims-made policy of
product liability insurance. However, product liability insurance is expensive.
In the future we may not be able to obtain coverage on acceptable terms, if at
all. Moreover, our insurance coverage may not adequately protect us from
liabilities which we incur in connection with clinical trials or sales of our
products.
OUR CHARTER DOCUMENTS MAY INHIBIT A TAKEOVER.
Certain provisions of our Certificate of Incorporation and Bylaws could:
- discourage potential acquisition proposals;
- delay or prevent a change in control of Calypte;
- diminish stockholders' opportunities to participate in tender offers for
our common stock, including tender offers at prices above the then current
market price; or
- inhibit increases in the market price of our common stock that could
result from takeover attempts.
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WE HAVE ADOPTED A STOCKHOLDER RIGHTS PLAN THAT HAS CERTAIN ANTI-TAKEOVER
EFFECTS.
On December 15, 1998, the Board of Directors of Calypte declared a dividend
distribution of one preferred share purchase right for each outstanding share of
Common Stock of the Company. The dividend is payable to the stockholders of
record on January 5, 1999 with respect to each share of Common Stock issued
thereafter until a subsequent "distribution date" defined in a Rights Agreement
and, in certain circumstances, with respect to shares of Common Stock issued
after the Distribution Date. The rights have certain anti-takeover effects. The
rights will cause substantial dilution to a person or group that attempts to
acquire the Company without conditioning the offer on the rights being redeemed
or a substantial number of rights being acquired. However, the rights should not
interfere with any tender offer, or merger, which is approved by us because the
rights do not become exercisable in the event of an offer or other acquisition
exempted by Calypte's Board of Directors.
AN INVESTOR'S ABILITY TO TRADE OUR COMMON STOCK MAY BE LIMITED BY TRADING
VOLUME.
The trading volume in our common shares has been relatively limited. A
consistently active trading market for our common stock may not continue. The
average daily trading volume in our common shares on the Nasdaq SmallCap Market
was approximately 375,000 shares for the twelve months ending December 1, 2000.
Our daily trading volume during that period ranged from 17,800 to
22,257,600 shares.
WE MAY BE REMOVED FROM THE NASDAQ SMALLCAP MARKET IF WE FAIL TO MEET CERTAIN
MAINTENANCE CRITERIA.
The Nasdaq Stock Market inquired on two occasions whether we continue to
meet the maintenance criteria for trading on the Nasdaq SmallCap Market. At the
close of our most recent fiscal quarter, September 30, 2000, we met the
maintenance criteria but our ability to continue to do so will depend on whether
we are able to maintain net tangible assets of at least $2,000,000 and whether
the minimum bid price for our common stock exceeds $1.00 per share for at least
ten consecutive business days during any period of 120 consecutive business
days.
As of September 30, 2000, our net tangible assets were $4.3 million. We
currently expect that our access to funds under the equity line of credit will
enhance our ability to meet the Nasdaq net tangible asset criteria. Nonetheless,
we cannot ensure that we will continue to meet Nasdaq's maintenance criteria.
Also, the minimum daily bid price for our common stock has exceeded $1.00
per share for the twelve months ending December 1, 2000. If the market
capitalization of Calypte remains constant, a 19.9% increase in the number of
our common shares through sales under the equity line of credit could cause the
corresponding price of our shares to trade closer to or below the maintenance
criteria.
The ability of our stockholders to sell their shares into an active trading
market could be significantly impaired if we fail to meet the maintenance
criteria and are removed from the Nasdaq SmallCap Market. In that case, our
common stock would trade on either the OTC bulletin board, a regional exchange
or in the pink sheets, which would likely result in an even more limited trading
volume.
THE PRICE OF CALYPTE'S 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 $1.13 per share and as high as $7.25
per share in the twelve months ending December 1, 2000. Some of the factors
leading to this volatility include:
- price and volume fluctuations in the stock market at large which do not
relate to our operating performance;
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<PAGE>
- fluctuations in our operating results;
- announcements of technological innovations or new products which we or our
competitors make;
- FDA and international regulatory actions;
- availability of reimbursement for use of our products from private health
insurers, governmental health administration authorities and other
third-party payors;
- developments with respect to patents or proprietary rights;
- public concern as to the safety of products that we or others develop;
- changes in health care policy in the United States or abroad;
- changes in stock market analysts' recommendations regarding Calypte, other
medical products companies or the medical product industry generally; and
- fluctuations in market demand for and supply of our products.
CALYPTE AND THE PRICE OF CALYPTE SHARES MAY BE ADVERSELY EFFECTED BY THE PUBLIC
SALE OF A SIGNIFICANT NUMBER OF THE SHARES ELIGIBLE FOR FUTURE SALE.
All outstanding shares of our common stock are freely tradable. Sales of
common stock in the public market could materially adversely affect the market
price of our common stock. Such sales also may inhibit our ability to obtain
future equity or equity-related financing on acceptable terms.
THE SALE OF STOCK PURSUANT TO THE EQUITY LINE OF CREDIT MAY SUBSTANTIALLY DILUTE
THE INTERESTS OF OTHER SECURITY HOLDERS.
The shares issuable to TIL pursuant to the equity line of credit will be
issued at a 5% discount to the average daily price of our common stock.
Accordingly, the shares of common stock then outstanding will be diluted.
Depending on the price per share of our common stock during the twelve month
period of the equity line of credit, we may need to register additional shares
for resale to access the full amount of financing available, which could have a
further dilutive effect on the value of our common stock.
WE CANNOT DETERMINE THE PRECISE AMOUNT BY WHICH THE INTERESTS OF OTHER SECURITY
HOLDERS WILL BE DILUTED BY DRAW DOWNS UNDER THE EQUITY LINE OF CREDIT BECAUSE
OUR DECISIONS ON THE NUMBER, SIZE AND THE TIMING OF DRAW DOWNS AND THE MINIMUM
THRESHOLD PRICE FOR EACH DRAW DOWN DEPENDS UPON A NUMBER OF FACTORS.
We have substantial discretion over the number, size and timing of the draw
downs that we will make under the equity line of credit. In addition, at the
time we make each draw down request, we have the right to limit the amount of
dilution that will occur by setting a minimum threshold price below which shares
may not be sold in that draw down. However, if we set the minimum threshold
price at a level high enough to limit the sale of our shares, the amount of
funds we can raise in that draw down will also be reduced. Some of the factors
that we will consider in determining the size and amount of each draw down and
the minimum threshold price are:
- our short-term and long-term operating capital requirements;
- our actual and projected revenues and expenses;
- our assessment of general market and economic conditions;
- our assessment of risks and opportunities in our targeted markets;
- the availability and cost of alternative sources of financing; and
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<PAGE>
- the trading price of our common stock and our expectations with respect to
its future trading price.
Our discretion with respect to the number, size and timing of each draw down
request is also subject to a number of contractual limitations that are
described in "The Common Stock Purchase Agreement--Necessary Conditions Before
TIL Is Obliged to Purchase Our Shares" on page 16 of this prospectus.
WE CANNOT DETERMINE THE PRECISE AMOUNT BY WHICH THE INTERESTS OF OTHER SECURITY
HOLDERS WILL BE DILUTED BY OUR SALES UNDER THE EQUITY LINE OF CREDIT BECAUSE THE
NUMBER OF SHARES WE WILL SELL DEPENDS UPON THE TRADING PRICE OF THE SHARES
DURING EACH DRAW DOWN PERIOD.
The number of shares that we will sell is directly related to the trading
price of our common stock during each draw down period. As the price of our
common stock decreases, and if we decide to draw down on the equity line of
credit, we will be required to issue more shares of our common stock for any
given dollar amount invested by TIL. Contractually, we can sell up to 5,022,369
shares of our common stock under the equity line of credit without seeking
stockholder approval to sell additional shares.
Our common stock has traded as low as $1.13 per share and as high as $7.25
per share during the twelve-month period ending December 1, 2000. If the daily
weighted average price of our stock throughout each draw down period is less
than $5.00 per share and we chose to draw down the maximum amount of funds
possible under the equity line of credit, we could sell up to the 5,022,369
shares available without stockholder approval. Our decision on whether to seek
stockholder approval to make additional draw downs under the equity line of
credit after we reach the contractual limit would depend upon the factors
described in the preceding risk factor.
If the daily weighted average price of our stock throughout each draw down
period equals or exceeds $5.00 per share, and we choose to draw down the maximum
amount of funds available under the equity line of credit, we would sell less
than the maximum number of shares available without stockholder approval. For
instance, if the daily weighted average sale price is $6.00 per share, we could
sell up to 4,166,166 shares before drawing down the entire $25 million available
under the equity line of credit.
THE SALE OF MATERIAL AMOUNTS OF OUR COMMON STOCK COULD REDUCE THE PRICE OF OUR
COMMON STOCK AND ENCOURAGE SHORT SALES.
As we sell shares of our common stock to TIL pursuant to the equity line of
credit and then TIL sells the common stock, our common stock price may decrease
due to the additional shares in the market. As the price of our common stock
decreases, and if we decide to draw down on the equity line of credit, we will
be required to issue more shares of our common stock for any given dollar amount
invested by TIL, subject to a designated minimum threshold price specified by
us. This may encourage short sales, which could place further downward pressure
on the price of our common stock.
12
<PAGE>
USE OF PROCEEDS
We will not realize any proceeds from the sale of the common stock by the
selling security holders; rather, the selling security holders will receive
those proceeds directly. However, we will receive cash infusions of capital if
and when TIL purchases our common stock in accordance with the stock purchase
agreement and upon the exercise of warrants held by TIL. We intend to use the
proceeds from the sale of common stock to TIL for general working capital
purposes including the development of new products and the expansion of our
direct sales efforts.
THE COMMON STOCK PURCHASE AGREEMENT
SUMMARY
We and TIL, a British Virgin Islands corporation, signed a common stock
purchase agreement dated November 2, 2000 for the future issuance and purchase
of our common stock. The initial closing for the transaction occurred on
November 2, 2000. The stock purchase agreement establishes what is sometimes
termed an equity line of credit or an equity draw down facility. In general, the
draw down facility operates as follows: the investor, TIL, has committed up to
$25 million to purchase our common stock over a twelve month period. Once per
draw down period, we may request a draw down of up to $6 million of the
committed money, subject to a formula based on average stock price and average
trading volume, setting the maximum amount of any request for any given draw
down. The minimum amount per draw down request is $100,000. The amount of money
that TIL will provide to us and the number of shares we will issue to TIL in
return for that money is settled twice during a 22 day trading period following
the draw down request based on the formula in the stock purchase agreement. TIL
receives a 5% discount to the market price for the 22 day period and we receive
the settled amount of the draw down. At the time of each draw down, we will
issue TIL a warrant (the "Draw Down Warrants") to purchase a number of shares of
our common stock equal to 6% of the draw down, exercisable for a period of three
years. The Draw Down Warrants will be issued as a unit with the draw down shares
as additional consideration to TIL for purchasing the shares of stock at the
agreed-upon purchase price. Each Draw Down Warrant will have an exercise price
equal to 115% of the average daily price of the common stock on the day prior to
the date the warrant is issued.
We are under no obligation to request a draw down for any period. However if
we do not draw down a minimum of $15 million over the term of the agreement, at
the termination of the agreement we must choose either (1) to issue TIL a
warrant (the "Term Warrant") to purchase a number of shares of our common stock
equal to 6% of the difference between (A) the lesser of $15 million and the
maximum amount that the Company could have drawn down subject to the limitations
of the agreement, and (B) the amount actually drawn or (2) to make a cash
payment to TIL equal to 5% of that difference. The limitations of the agreement
that could reduce the maximum amount that we draw down under the agreement to
less than $15 million are described in detail in "The Warrants Issued to TIL" on
page 18 of this prospectus. The Term Warrant, and its alternative cash payment,
are issuable to TIL as compensation for its transaction costs in the event that
we choose not to draw down the minimum commitment amount (the lesser of
$15 million and the maximum amount we could have drawn down subject to the
limitations of the agreement) during the term of the equity line of credit. If
we choose to issue the Term Warrant instead of making a cash payment, the
warrant will have an exercise price equal to 115% of the average daily price on
the date the warrant is issued. The Term Warrant shall be exercisable for a
period of three years.
We have substantial discretion over the number, size and timing of the draw
downs that we will make under the equity line of credit. In addition, at the
time we make each draw down request, we have the right to limit the amount of
dilution that will occur by setting a minimum threshold price below which shares
may not be sold in that draw down. However, if we set the minimum threshold
price at a level high enough to limit the sale of our shares, the amount of
funds we can raise in that
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<PAGE>
draw down will also be reduced. Some of the factors that we will consider in
determining the size and amount of each draw down and the minimum threshold
price are:
- our short-term and long-term operating capital requirements;
- our actual and projected revenues and expenses;
- our assessment of general market and economic conditions;
- our assessment of risks and opportunities in our targeted markets;
- the availability and cost of alternative sources of financing;
- the trading price of our common stock and our expectations with respect to
its future trading price; and
- the dilutive effect that the sale of shares will have on the interests of
our other security holders.
Our discretion with respect to the number, size and timing of each draw down
request is also subject to a number of contractual limitations that are
described in "The Common Stock Purchase Agreement--Necessary Conditions Before
TIL Is Obliged to Purchase Our Shares" on page 16 of this prospectus.
In addition, the maximum size of each draw down is further limited by a
formula that is based upon the average price of our shares of common stock and
their trading volume for the preceding three months. The formula is set forth in
the following section.
The aggregate total of all draw downs cannot exceed $25 million.
THE DRAW DOWN PROCEDURE AND THE STOCK PURCHASES
We may request a draw down by faxing a draw down notice to TIL, setting out
the amount of the draw down we wish to exercise and the minimum threshold price,
if any, at which we are willing to sell the shares.
The maximum is $6 million subject to the following limiting formulas:
<TABLE>
<S> <C> <C>
Maximum amount of = 4.5% of Average Stock Price multiplied by Total Trading
draw down Volume
Where
Average Stock Price = Average of the daily volume-weighted price of our shares for
the 3 months before the draw down notice date
Total Trading = Total trading volume for the 3 months before the draw down
Volume notice date.
</TABLE>
The next 22 trading days immediately following the draw down notice are used
to determine the actual amount of money TIL will provide and the number of
shares we will issue in return. The amount of the draw down and the number of
shares to be issued is determined and settled twice for the 22 trading day
period, on the 13th and the 24th trading days following the draw down notice,
and is calculated based on the following formula:
<TABLE>
<S> <C> <C>
Number of shares of = Sum over each of the 22 trading days of 1/22 of the draw
common stock down amount divided by 95% of the volume-weighted average
daily price for our shares on each trading day.
</TABLE>
If the daily price for any given trading day during the draw down period is
below the threshold price we set in the draw down notice, then that day is not
included in the calculation of the number of
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<PAGE>
shares to be issued and the draw down amount that TIL is to pay to us is
correspondingly reduced by 1/22 for that day. Thus, if the daily price for that
day is below the threshold price, we will not issue any shares and TIL will not
purchase any shares for that day. In addition, if trading of our common stock on
Nasdaq SmallCap Market has been suspended for more than three hours in the
aggregate, we will not issue any shares and TIL will not purchase any shares for
that day.
The following is an example of the calculation of the draw down amount and
the number of shares to be issued to TIL in connection with that draw down based
on certain assumptions.
SAMPLE DRAW DOWN AMOUNT CALCULATION
- We provide a draw down notice to TIL that we wish to draw down $5,000,000.
- The average of the daily volume weighted average prices of our common
stock for the 3 months prior to the draw down notice is $2.35.
- The total trading volume for the 3 months prior to the draw down notice is
45,292,200 shares.
- The maximum dollar amount that can be drawn down is: 4.5% of $2.35
multiplied by 45,292,200 or $4,784,746.
On these assumed facts, we could draw down $4,784,746 out of the $5,000,000
requested in the draw down notice. Suppose that our notice specifies a threshold
amount of $1.75, below which we will not sell any shares to TIL during this draw
down period. If the volume-weighted average daily price of our common shares for
each of the 22 days following the draw down notice is at least $1.75, we will be
able to draw down the maximum $4,784,746 amount. If on the other hand the
volume-weighted average daily price of our common shares is below $1.75 on three
of those 22 days, for example, the $4,784,746 would be reduced by 1/22 for each
of those days and our draw down amount would be 19/22 of $4,784,746, or
$4,132,280.
SAMPLE CALCULATION OF NUMBER OF SHARES
Assume that the maximum draw down amount for the draw down period is
$4,784,746 and assume that the daily volume weighted average price for our
shares is as set out in the table below. The number of shares to be issued based
on any trading day during the draw down period is calculated from the formula:
(1/22 of the draw down amount) divided by (95% of the daily price).
For the first trading day in the example in the table below, the calculation
is as follows:
(1/22 of $4,784,746) divided by (95% of $2.00 per share) or 114,468 shares.
The number of shares to be issued for the draw down period in the example is
calculated as follows:
- for each trading day in the 22 day period, the number of shares to be
issued is based on the average daily price of our shares for that day and
calculated using the formula above; and
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<PAGE>
- the number of shares to be issued for each of the 22 trading days is then
totaled to arrive at the number of shares to be issued to TIL for the
purchase price of $4,132,272, the draw down amount.
<TABLE>
<CAPTION>
NUMBER OF
DOWN ISSUED BASED
AVERAGE DAILY AMOUNT OF ON THAT
TRADING DAY STOCK PRICE* $4,784,746 TRADING DAY
--------------------- ------------- ---------- ------------
<S> <C> <C> <C>
1 2.000 217,488 114,468
2 2.062 217,488 111,026
3 2.062 217,488 111,026
4 2.062 217,488 111,026
5 2.000 217,488 114,468
6 2.031 217,488 112,721
7 2.218 217,488 103,218
8 2.437 217,488 93,942
9 1.875 217,488 122,100
10 1.625 -- **
11 1.500 -- **
12 1.625 -- **
13 1.937 217,488 118,191
14 1.937 217,488 118,191
15 2.000 217,488 114,468
16 2.000 217,488 114,468
17 2.093 217,488 109,382
18 2.000 217,488 114,468
19 2.093 217,488 109,382
20 2.281 217,488 100,367
21 2.218 217,488 103,218
22 2.250 217,488 101,750
---------- --------
TOTAL $4,132,272 2,097,890
</TABLE>
------------------------
* The share prices are illustrative only and should not be interpreted as a
forecast of share prices or the expected or historical volatility of the
share prices of our common stock.
** Excluded because the volume-weighted average daily price is below the
threshold specified in our hypothetical draw down notice.
In this fictitious example, and accounting for the three days where no
shares were sold to TIL, we would issue 2,097,890 shares for this draw down
period, and we would receive $4,132,272.00.
The delivery of the requisite number of shares and payment of the draw down
is effected through an escrow agent, Epstein, Becker & Green, P.C. of New York.
Only one draw down can occur during this 22 day draw down period.
NECESSARY CONDITIONS BEFORE TIL IS OBLIGED TO PURCHASE OUR SHARES
The following conditions must be satisfied before TIL is obligated to
purchase the common stock that we wish to sell:
- A registration statement for the shares we will be issuing must be
declared effective by the Securities and Exchange Commission and must
remain effective and available as of the draw down settlement date for
making resales of the common stock purchased by TIL;
16
<PAGE>
- There can be no material adverse effect on our business, operations,
properties, prospects or financial condition that is material and adverse
to us, taken as a whole and/or any condition, circumstance, or situation
that would prohibit or otherwise materially interfere with our ability to
perform any of our material obligations under the stock purchase agreement
or the registration rights agreement or to perform our obligations under
any other material agreement; provided, however, that any adverse change,
event or effect that is directly attributable to conditions affecting the
United States economy or our industry generally shall not be a condition
to TIL's purchase of our shares unless such conditions adversely affect us
in a materially disproportionate manner.
- We must not have merged or consolidated with or into another company or
transferred all or substantially all of our assets to another company
unless the acquiring company has agreed to honor the stock purchase
agreement;
- No statute, rule, regulation, executive order, decree, ruling or
injunction may be in effect which prohibits consummation of the
transactions contemplated by the stock purchase agreement;
- No litigation or proceeding involving the Company or the Company's
affiliates, can be pending, nor any investigation by any governmental
authority threatened against them which seeks to restrain, prevent or
change the transactions contemplated by the stock purchase agreement or
seeking damages in connection with such transactions; and
- Trading in our common stock must not have been suspended by the Securities
and Exchange Commission or the Nasdaq SmallCap Market nor shall minimum
prices have been established on securities whose trades are reported by
the Nasdaq SmallCap Market.
On each draw down settlement date for the sale of common stock, we must
deliver an opinion from our counsel about these matters.
A further condition is that under the stock purchase agreement, we may not
sell to TIL more than 19.9% of our common stock issued and outstanding on the
initial closing date of the agreement, November 2, 2000, without obtaining
approval from our stockholders for such excess issuance. In addition, the stock
purchase agreement does not permit us to draw down funds if the issuance of
shares of common stock to TIL in that draw down would result in TIL and its
affiliates owning more than 9.9% of our common stock outstanding as of the draw
down settlement date.
RESTRICTIONS ON OUR FUTURE FINANCINGS
The stock purchase agreement limits our ability to raise money by selling
our securities for cash at a discount to the current market price for at least
twelve months. Specifically, we may not sell our securities for cash at a
discount to current market price until the earlier of
- twelve months the effective date of the registration statement of which
this prospectus is a part, or
- sixty days after TIL has purchased the maximum of $25 million worth of
common stock from us.
There are important exceptions to this limitation. We can sell our shares
for cash at a discount to the current market price:
- in a registered public offering of our securities underwritten by one or
more established investment banks;
- in one or more private placements where the purchasers do not have
registration rights;
- under any employee benefit plan approved by our stockholders;
- under any compensatory plan for a full-time employee or key consultant;
17
<PAGE>
- upon the exercise of any currently outstanding warrants;
- in one private placement for up to $5 million in proceeds with
registration rights; provided that the financing is arranged through
Ladenburg Thalmann & Co. Inc.;
- in one or more private placements with registration rights; provided that
for each such private placement, the Company has drawn down the maximum
amount allowed under the agreement for two consecutive months immediately
prior to the month during which such financing is entered into;
- in connection with a strategic partnership or other business transaction,
the principal purpose of which is not simply to raise money; or
- in a transaction for which TIL has given its written approval.
THE WARRANTS ISSUED TO TIL
Under the stock purchase agreement, at the time of each draw down, we will
issue TIL a Draw Down Warrant to purchase a number of shares of our common stock
equal to 6% of the draw down, exercisable for a period of three years. Each such
warrant will have an exercise price equal to 115% of the daily price of the
common stock on the trading day prior to the draw down.
We are under no obligation to request a draw down for any period. However if
we do not draw down a minimum of $15 million over the term of the agreement, at
the termination of the agreement we must choose either (1) to issue TIL a Term
Warrant to purchase up to a number of shares of our common stock equal to 6% of
the difference between (A) the lesser of $15 million and the maximum amount that
the Company could have drawn down subject to the limitations of the agreement
and, (B) the amount actually drawn down or (2) to make a cash payment to TIL
equal to 5% of that difference. The aggregate total of all draw downs cannot
exceed $25 million.
The common stock purchase agreement contains limitations on the number of
draws and the size of each draw down that could reduce the maximum amount that
we can draw down during the term of the equity line of credit to less than
$15 million. If the maximum aggregate amount that we can draw down is less than
$15 million, then the size of the Term Warrant or cash payment issuable to TIL,
if we choose to draw down less than the maximum aggregate amount, at the
conclusion of the equity line would be reduced.
LIMIT ON NUMBER OF DRAW DOWNS.
Under the equity line of credit, we cannot make more than one draw down in
each draw down pricing period. Each draw down pricing period consists of 22
consecutive trading days. Therefore, we cannot make more than eleven draw downs
during the twelve month term of the equity line of credit. The draw down pricing
period is further described in "The Common Stock Purchase Agreement--The Draw
Down Procedure and the Stock Purchases" on page 14 of this prospectus.
LIMIT ON THE SIZE OF EACH DRAW DOWN.
Under the equity line of credit, the maximum size of each draw down is the
lesser of $6 million or an amount equal to 4.5% of our average stock price
multiplied by the total trading volume of our shares for the three months
preceding the draw down. As a result, the maximum size of each draw down could
be substantially less than $6 million. This formula is further described in "The
Common Stock Purchase Agreement--The Draw Down Procedure and the Stock
Purchases" on page 14 of this prospectus.
Due to the limitations on the number of draw downs and the size of each draw
down, the maximum amount that we can draw down under the equity line of credit
could be limited to less than
18
<PAGE>
$15 million. For instance, if the maximum draw down amount for several draw down
periods was less than $1 million, the maximum aggregate total of the eleven
draws that are possible during the term of the equity of line of credit could be
less than $15 million and the size of the Term Warrant or cash payment issuable
to TIL, if we choose to draw down less than the maximum aggregate total, would
be reduced.
COSTS OF CLOSING THE TRANSACTION
At the initial closing of the transaction on November 2, 2000, we delivered
the requisite opinion of counsel to TIL and paid the escrow agent, Epstein
Becker & Green P.C. $70,000, consisting of $35,000 for TIL's legal,
administrative and escrow costs and $35,000 as a non-accountable expense
allowance.
TERMINATION OF THE STOCK PURCHASE AGREEMENT
TIL may terminate the equity draw down facility under the stock purchase
agreement if any of the following events occur:
- we suffer a material adverse change in our business, operations,
properties, or financial condition and we have not cured the condition
within sixty days;
- our common stock is delisted from the Nasdaq SmallCap Market unless the
delisting is in connection with the listing of such shares on a comparable
stock exchange in the United States; or
- we file for protection from creditors.
INDEMNIFICATION OF TIL
TIL is entitled to customary indemnification from us on any losses or
liabilities suffered by it based upon material misstatements or omissions
contained in the registration statement and the prospectus, except as they
relate to information supplied by TIL to us for inclusion in such registration
statement and prospectus.
TIL'S RESALE OF THE COMMON STOCK
TIL has agreed that its trading and distribution activities with respect to
the common stock will be in compliance with all applicable United States state
and federal securities laws, rules and regulations, and the rules and
regulations of the Nasdaq SmallCap Market. All sales by TIL must be made in
compliance with Regulation M under the Securities and Exchange Act of 1934.
To permit TIL to resell the common stock issued to it under the stock
purchase agreement or under the warrants, we agreed to register those shares and
to maintain that registration. To that end, we will prepare and file such
amendments and supplements to the registration statement and the prospectus as
may be necessary in accordance with the Securities Act and the rules and
regulations promulgated thereunder, in order to keep it effective until the
earlier of any of the following dates:
- the date that none of the shares of common stock covered by the
registration statement of which this prospectus is a part are or may
become issued and outstanding;
- the date that all of the shares of common stock covered by the
registration statement of which this prospectus is a part have been sold
pursuant to the registration statement;
- the date that all of the shares of common stock have been otherwise
transferred to persons who may trade such shares without restriction under
the Securities Act of 1933 and we have delivered new certificates or other
evidences of ownership of such common stock without any restrictive
legend; or
19
<PAGE>
- the date that all of such shares of common stock may be sold without any
time, volume or manner limitations under Rule 144(k), any volume
limitations under Rule 144 or similar provision then in effect under the
Securities Act of 1933.
THE NUMBER OF SHARES WE WILL ISSUE TO TIL
The number of shares of common stock that we will issue to TIL is limited by
the terms of the agreement and depends on six key factors:
- the number of draw downs we exercise;
- the average trading volumes for our common stock for the three months
before each draw down period;
- the average stock price for our common stock for the three months before
each draw down period;
- the average daily prices for our common stock on each of the 22 days
during a draw down period;
- the limitation that following the purchase of the shares issued in a draw
down, TIL may not hold more than 9.9% of our outstanding shares; and
- the limitation that we may not issue more than 5,022,369 shares, which is
19.9% of our issued and outstanding common stock on November 2, 2000,
without the approval of our stockholders.
The fewer the number of draw downs we exercise, the fewer the shares we will
issue to TIL. The stock purchase agreement provides for 1 draw down in each draw
down period consisting of 22 trading days. Thus, any decision by us to delay or
forego any draw down opportunity may result in our being unable to exercise all
draw downs available in the 12 month period.
The average stock price and the total trading volume prior to a draw down
period determine the maximum amount of the draw down for that period. A decline
in the trading volume or price of our stock may result in a reduction in the
amount of money we are able to draw down and a corresponding reduction in the
number of shares we must issue for that period.
The average daily price for each of the 22 trading days within a draw down
period and the draw down amount determine the number of shares we will issue to
TIL. TIL will purchase those shares at a 5% discount to the average daily price.
For any given draw down period, the lower the average daily price, the more
shares of common stock TIL will receive for the draw down amount. The table in
the section of this prospectus entitled "The Common Stock Purchase Agreement"
and under the headings "The Draw Down Procedure and the Stock Purchases" and
"Sample Calculation of Number of Shares" illustrates how a change in the daily
stock price can affect the number of shares issued for a constant amount of draw
down. This table uses a constant draw down amount of $217,488 for each day. When
the stock price goes down, the number of shares issued goes up. Conversely, when
the stock price goes up, the number of shares issued goes down.
However, lower average daily prices through the term of the stock purchase
agreement may not necessarily have the effect of substantially increasing the
number of shares issued. Lower stock prices during one draw down period will
reduce the average stock price for the next draw down period. Assuming
relatively constant trading volumes, this reduction may limit the draw down
amount and the number of shares we can issue for that next draw down period.
Based on a review of our trading volume and stock price history, a
consideration of the factors above and the number of authorized but unissued and
unreserved shares, we are registering 6,000,000
20
<PAGE>
shares of common stock for possible issuance under the stock purchase agreement
including shares underlying the warrants for common stock that will be granted
to TIL. If we determine that it is in our best interests, we may file additional
registration statements to register additional shares at some future date for
issuance under the stock purchase agreement.
In order to comply with the listing requirements of the Nasdaq SmallCap
Market that restrict the number of shares we can sell at a price lower than
their market value, we may not issue more than 19.9% of the number of
then-outstanding shares through draw downs under the equity line of credit
without approval of our stockholders. In addition, we are bound by a similar
contractual limitation in the common stock purchase agreement. As of
November 2, 2000, the initial closing date of the common stock purchase
agreement, there were 25,238,037 shares of Calypte common stock outstanding.
Therefore, if we wish to draw down amounts under the stock purchase agreement
which would cause the sale of more than 5,022,369 shares, we must receive
stockholder approval prior to any such draw down.
In addition to the 5,022,369 shares that we may sell to TIL through draw
downs, we are registering an additional 977,621 shares that are issuable under
the Draw Down Warrants and the Term Warrant. The exercise prices of these
warrants are set above market value, so they are not subject to the Nasdaq and
the contractual 19.9% limitations.
21
<PAGE>
SELLING SECURITY HOLDER
The 6 million shares of common stock registered for resale under this
prospectus by TIL constitutes 23.8% of our issued and outstanding common stock
on November 2, 2000.
TIL is engaged in the business of investing in publicly-traded equity
securities for its own account. TIL's principal offices are located at 21
Southhampton Row, London, WC1B5HS England. Investment decisions for TIL and
decisions related to the voting of stock held by TIL are made by Dr. Kurt Alig
and Hans Gassner, members of its Board of Directors.
TIL does not own any of our common stock or any other of our securities as
of the date of this prospectus, and other than its obligations to purchase
common stock under the stock purchase agreement, it has no other commitments or
arrangements to purchase or sell any of our securities. There are no business
relationships between TIL and us other than the stock purchase agreement.
Assuming that we fully utilize the $25 million available in the stock purchase
agreement and that TIL sells all shares it acquired under that agreement or upon
exercise of the warrants, TIL will no longer hold any of our common stock.
22
<PAGE>
PLAN OF DISTRIBUTION
GENERAL
TIL is offering the common stock for its account as statutory underwriter
within the meaning of Section 2(a)(ii)(1) of the Securities Act of 1933, as
amended, and not for our account. We will not receive any proceeds from the sale
of common stock by TIL. TIL may be offering for sale up to approximately
6 million shares of common stock acquired by it either upon exercise of the
warrant for common stock or pursuant to the terms of the stock purchase
agreement more fully described under the section above entitled "The Common
Stock Purchase Agreement." TIL has agreed to be named as a statutory underwriter
within the meaning of the Securities Act of 1933 in connection with such sales
of common stock and will be acting as an underwriter in its resales of the
common stock under this prospectus. TIL has, prior to any sales, agreed not to
effect any offers or sales of the common stock in any manner other than as
specified in the prospectus and not to purchase or induce others to purchase
common stock in violation of Regulation M under the Exchange Act.
The common stock may be sold from time to time by TIL or by pledgees,
donees, transferees or other successors in interest. Such sales may be made on
the Nasdaq SmallCap Market, on the over-the-counter market or otherwise at
prices and at terms then prevailing or at prices related to the then current
market price, or in negotiated private transactions, or in a combination of
these methods. TIL is an underwriter in connection with such sales.
The common stock may be sold in one or more of the following manners:
- a block trade in which the broker or dealer so engaged will attempt to
sell the shares as agent, but may position and resell a portion of the
block as principal to facilitate the transaction;
- purchases by a broker or dealer for its account under this prospectus; or
- ordinary brokerage transactions and transactions in which the broker
solicits purchases.
In effecting sales, brokers or dealers engaged by the selling security
holders may arrange for other brokers or dealers to participate. Except as
disclosed in a supplement to this prospectus, no broker-dealer will be paid more
than a customary brokerage commission in connection with any sale of the common
stock by the selling security holders. Brokers or dealers may receive
commissions, discounts or other concessions from the selling security holders in
amounts to be negotiated immediately prior to the sale. The compensation to a
particular broker-dealer may be in excess of customary commissions. Profits on
any resale of the common stock as a principal by such broker-dealers and any
commissions received by such broker-dealers may be deemed to be underwriting
discounts and commissions under the Securities Act of 1933. Any broker-dealer
participating in such transactions as agent may receive commissions from the
selling security holders (and, if they act as agent for the purchaser of such
common stock, from such purchaser). Broker-dealers may agree with the selling
security holders to sell a specified number of shares of common stock at a
stipulated price per share, and, to the extent such a broker dealer is unable to
do so acting as agent for the selling security holders, to purchase as principal
any unsold common stock at price required to fulfill the broker-dealer
commitment to the selling security holders. Broker-dealers who acquire common
stock as principal may thereafter resell such common stock from time to time in
transactions (which may involve crosses and block transactions and which may
involve sales to and through other broker-dealers, including transactions of the
nature described above) in the over-the-counter market, in negotiated
transactions or otherwise at market prices prevailing at the time of sale or at
negotiated prices, and in connection with such resales may pay to or receive
from the purchasers of such common stock commissions computed as described
above. Such brokers or dealers and any other participating brokers or dealers
may be deemed to be underwriters in connection with such sales.
23
<PAGE>
In addition, any shares of common stock covered by this prospectus which
qualify for sale pursuant to Rule 144 may be sold under Rule 144 rather than
pursuant to this prospectus.
We will not receive any of the proceeds from the sale of these shares of
common stock, although we have paid the expenses of preparing this prospectus
and the related registration statement of which it is a part and have reimbursed
TIL $35,000 for its legal, administrative and escrow costs. In addition, we have
reimbursed Ladenburg, Thalmann & Co., an investment bank which introduced us to
TIL, $35,000 in consideration of the introduction to TIL.
The selling security holders are subject to the applicable provisions of the
Exchange Act, including without limitation, Rules 10b-5 and Regulation M
thereunder. Under applicable rules and regulations under the Exchange Act, any
person engaged in a distribution of the common stock may not simultaneously
engage in market making activities with respect to such securities for a period
beginning when such person becomes a distribution participant and ending upon
such person's completion of participation in a distribution, including
stabilization activities in the common stock to effect covering transactions, to
impose penalty bids or to effect passive market making bids.
In addition, in connection with the transactions in the common stock, we and
the selling security holders will be subject to applicable provisions of the
Exchange Act and the rules and regulations under that Act, including, without
limitation, the Rules set forth above, and in so far as we and the selling
security holders are distribution participants, Regulation M. These restrictions
may affect the marketability of the common stock. The selling security holders
will pay all commissions and certain other expenses associated with the sale of
the common stock.
We will use our best efforts to file, during any period in which offers or
sales are being made, one or more post effective amendments to the registration
statement of which this prospectus is a part to describe any material
information with respect to the plan of distribution not previously disclosed in
this prospectus or any material change to such information in this prospectus.
This obligation may include, to the extent required under the Securities Act of
1933, that a supplemental prospectus be filed, disclosing
- the name of any such broker-dealers;
- the number of shares of common stock involved;
- the price at which the shares of common stock are to be sold;
- the commissions paid or discounts or concessions allowed to such
broker-dealers, where applicable;
- that such broker-dealers did not conduct any investigation to verify the
information set out or incorporated by reference in this prospectus, as
supplemented; and
- any other facts material to the transaction.
The price at which we will issue the common stock to TIL under the stock
purchase agreement will be 95% of current market price, measured as the average
daily price of the common stock as traded on the Nasdaq SmallCap Market, for
each day in the pricing period with respect to each draw down request, all as
further defined in the stock purchase agreement. Assuming an average daily price
of $2.00 (based on recent daily prices of the common stock as traded on the
Nasdaq SmallCap Market in October, 2000), assuming we use the entire
$25 million of financing available under the stock purchase agreement,
underwriting compensation for TIL based on the discounted purchase price will be
$1,250,000, or $.10 per share.
24
<PAGE>
LIMITED GRANT OF REGISTRATION RIGHTS
We granted the registration rights to TIL described under the section
entitled "The Common Stock Purchase Agreement".
In connection with any such registration, we will have no obligation:
- to assist or cooperate with TIL in the offering or disposition of such
shares;
- to indemnify or hold harmless the holders of any such shares (other than
TIL) or any underwriter designated by such holders;
- to obtain a commitment from an underwriter relative to the sale of any
such shares; or
- to include such shares within an underwritten offering of our shares of
common stock.
We will assume no obligation or responsibility whatsoever to determine a
method of disposition for such shares or to otherwise include such shares within
the confines of any registered offering other than the registration statement of
which this prospectus is a part.
We will use our best efforts to file, during any period during which we are
required to do so under our registration rights agreement with TIL, one or more
post-effective amendments to the registration statement of which this prospectus
is a part to describe any material information with respect to the plan of
distribution not previously disclosed in this prospectus or any material change
to such information in this prospectus. See the section above entitled "The
Common Stock Purchase Agreement."
LEGAL MATTERS
The validity of the issuance of the shares being offered hereby will be
passed upon for us by Heller Ehrman White & McAuliffe LLP, Palo Alto,
California.
EXPERTS
The consolidated financial statements and schedule of Calypte Biomedical
Corporation and subsidiary as of December 31, 1999 and 1998, and for each of the
years in the three-year period ended December 31, 1999, have been incorporated
by reference herein and in the registration statement in reliance upon the
reports of KPMG LLP, independent certified public accountants, incorporated by
reference herein, and upon the authority of said firm as experts in accounting
and auditing.
The reports of KPMG LLP covering the December 31, 1999, consolidated
financial statements and schedule contain an explanatory paragraph that states
that the Company's recurring losses from operations and accumulated deficit
raise substantial doubts about the entity's ability to continue as a going
concern. The consolidated financial statements and schedule do not include any
adjustments that might result from the outcome of this uncertainty.
25
<PAGE>
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 14. Other Expenses of Issuance and Distribution.
<TABLE>
<S> <C>
SEC registration fee................................... $ 3,118.00
Nasdaq listing fee..................................... 35,000.00
Legal fees and expenses................................ 80,000.00
Accountants' fees...................................... 15,000.00
Miscellaneous.......................................... 6,000.00
-----------
Total.................................................. $139,118.00
===========
</TABLE>
Item 15. Indemnification of Directors and Officers.
Section 145 of the Delaware General Corporation Law permits a corporation to
include in its charter documents, and in agreements between the corporation and
its directors and officers, provisions expanding the scope of indemnification
beyond that specifically provided by the current law.
Article VIII of the Registrant's Certificate of Incorporation provides for
the indemnification of directors to the fullest extent permissible under
Delaware law.
Article VI of the Registrant's Bylaws provides for the indemnification of
officers, directors and third parties acting on behalf of the corporation if
such person acted in good faith and in a manner reasonably believed to be in and
not opposed to the best interest of the corporation, and, with respect to any
criminal action or proceeding, the indemnified party had no reason to believe
his conduct was unlawful.
Calypte has entered into indemnification agreements with its directors and
executive officers, in addition to indemnification provided for in Calypte's
Bylaws, and intends to enter into indemnification agreements with any new
directors and executive officers in the future.
Item 16. Exhibits.
The exhibits filed as part of this Registration Statement are as follows:
<TABLE>
<CAPTION>
EXHIBIT
NUMBER DESCRIPTION
--------------------- ------------------------------------------------------------
<C> <S>
4.1 Form of Stock Purchase Warrant to purchase common stock
issued to TIL*
5.1 Form of Opinion of Heller Ehrman White & McAuliffe LLP
10.1 Common Stock Purchase Agreement between Calypte and TIL
dated November 2, 2000
10.2 Registration Rights Agreement between Calypte and TIL dated
November 2, 2000*
10.3 Escrow Agreement among Calypte, TIL and Epstein, Becker &
Green, P.C. dated November 2, 2000*
23.1 Consent of KPMG LLP, Independent Auditors
23.2 Consent of Heller Ehrman White & McAuliffe LLP (included in
opinion filed as Exhibit 5.1)
24.1 Power of Attorney (included on signature page to this
Registration Statement)
</TABLE>
------------------------
* Previously filed with this Registration Statement.
II-1
<PAGE>
Item 17. Undertakings
(a) The undersigned Registrant hereby undertakes:
1. To file, during any period in which offers or sales are being made, a
post-effective amendment to this Registration Statement:
(i) to include any prospectus required by Section 10(a)(3) of the
Securities Act of 1933, as amended;
(ii) to reflect in the prospectus any facts or events arising after the
effective date of the Registration Statement (or the most recent
post-effective amendment thereof), which, individually or in the
aggregate, represent a fundamental change in the information set
forth in the Registration Statement; and
(iii) to include any material information with respect to the plan of
distribution not previously disclosed in the Registration
Statement or any material change to such information in the
Registration Statement.
Provided, however, that paragraphs (a)(1)(i) and (a)(1)(ii) of this
section do not apply if the information required to be included in a
post-effective amendment by those paragraphs is contained in periodic
reports filed with or furnished to the Commission by the Registrant
pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of
1934, as amended, that are incorporated by reference in the Registration
Statement.
2. That, for the purpose of determining any liability under the Securities
Act of 1933, as amended, each such post-effective amendment shall be
deemed to be a new registration statement relating to the securities
offered therein, and the offering of such securities at that time shall
be deemed to be the initial bona fide offering thereof.
3. To remove from registration by means of a post-effective amendment any
of the securities being registered which remain unsold at the termination
of the offering.
4. The undersigned Registrant hereby undertakes that, for purposes of
determining any liability under the Securities Act of 1933, as amended,
each filing of the Registrant's Annual Report pursuant to Section 13(a)
or Section 15(d) of the Securities Exchange Act of 1934, as amended, that
is incorporated by reference in the Registration Statement shall be
deemed to be a new registration statement relating to the securities
offered therein, and the offering of such securities at that time shall
be deemed to be the initial bona fide offering thereof.
5. Insofar as indemnification for liabilities arising under the Securities
Act of 1933, as amended (the "Act"), may be permitted to directors,
officers and controlling persons of the Registrant pursuant to the
foregoing provisions, or otherwise, the Registrant has been advised that
in the opinion of the Securities and Exchange Commission such
indemnification is against public policy as expressed in the Act and is,
therefore, unenforceable. In the event that a claim for indemnification
against such liabilities (other than the payment by the Registrant of
expenses incurred or paid by a director, officer or controlling person of
the Registrant in the successful defense of any action, suit or
proceeding) is asserted by such director, officer or controlling person
in connection with the securities being registered, the Registrant will,
unless in the opinion of its counsel the matter has been settled by
controlling precedent, submit to a court of appropriate jurisdiction the
question whether such indemnification by it is against public policy as
expressed in the Act and will be governed by the final adjudication of
such issue.
II-2
<PAGE>
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the registrant,
Calypte Biomedical Corporation, certifies that it has reasonable grounds to
believe that it meets all of the requirements for filing on Form S-3 and has
duly caused this Amendment No. 1 to the Registration Statement on Form S-3 to be
signed on its behalf by the undersigned, thereunto duly authorized, in the city
of Alameda, State of California, on the 15th day of December, 2000.
CALYPTE BIOMEDICAL CORPORATION
By: /s/ NANCY E. KATZ
------------------------------------------
Nancy E. Katz
CHIEF EXECUTIVE OFFICER, PRESIDENT, CHIEF
FINANCIAL OFFICER AND DIRECTOR
POWER OF ATTORNEY
Each person whose signature appears below constitutes and appoints Nancy E.
Katz his or her true and lawful attorneys in fact and agents, each acting alone,
with full power of substitution and resubstitution, for him or her and in his
name, place and stead, in any and all capacities, to sign any or all amendments
(including post effective amendments) to the Registration Statement, and to sign
any registration statement for the same offering covered by this Registration
Statement that is to be effective upon filing pursuant to Rule 462(b) under the
Securities Act of 1933, as amended, and all post effective amendments thereto,
and to file the same, with all exhibits thereto, and all documents in connection
therewith, with the Securities and Exchange Commission, granting unto said
attorneys-in-fact and agents, full power and authority to do and perform each
and every act and thing requisite and necessary to be done in and about the
premises, as fully to all intents and purposes as he or she might or could do in
person, hereby ratifying and confirming all that said attorneys-in-fact and
agents, each acting alone, or his or her substitute or substitutes, may lawfully
do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Act of 1933, this Amendment
No. 1 to the Registration Statement on Form S-3 has been signed below by the
following persons in the capacities and on the dates indicated:
<TABLE>
<CAPTION>
SIGNATURE TITLE DATE
--------- ----- ----
<C> <S> <C>
/s/ NANCY E. KATZ Chief Executive Officer, December 15, 2000
------------------------------------ President, Chief Financial Officer
Nancy E. Katz and Director
/s/ DAVID COLLINS Chairman of Board of Directors December 15, 2000
------------------------------------
David Collins
/s/ HOWARD B. URNOVITZ, PH.D. Chief Science Officer and Director December 15, 2000
------------------------------------
Howard B. Urnovitz, Ph.D.
</TABLE>
II-3
<PAGE>
<TABLE>
<CAPTION>
SIGNATURE TITLE DATE
--------- ----- ----
<C> <S> <C>
/s/ WILLIAM A. BOEGER Director December 15, 2000
------------------------------------
William A. Boeger
Director
------------------------------------
John J. DiPietro
/s/ PAUL FREIMAN Director December 15, 2000
------------------------------------
Paul Freiman
/s/ JULIUS R. KREVANS, M.D. Director December 15, 2000
------------------------------------
Julius R. Krevans, M.D.
/s/ MARK NOVITCH, M.D. Director December 15, 2000
------------------------------------
Mark Novitch, M.D.
/s/ ZAFAR I. RANDAWA, PH.D. Director December 15, 2000
------------------------------------
Zafar I. Randawa, Ph.D.
/s/ CLAUDIE E. WILLIAMS Director December 15, 2000
------------------------------------
Claudie E. Williams
</TABLE>
II-4
<PAGE>
EXHIBIT INDEX
<TABLE>
<CAPTION>
EXHIBIT
NUMBER DESCRIPTION
--------------------- ------------------------------------------------------------
<C> <S>
4.1 Form of Stock Purchase Warrant to purchase common stock
issued to TIL*
5.1 Form of Opinion of Heller Ehrman White & McAuliffe LLP
10.1 Common Stock Purchase Agreement between Calypte and TIL
dated November 2, 2000
10.2 Registration Rights Agreement between Calypte and TIL dated
November 2, 2000*
10.3 Escrow Agreement among Calypte, TIL and Epstein, Becker &
Green, P.C. dated November 2, 2000*
23.1 Consent of KPMG LLP, Independent Auditors
23.2 Consent of Heller Ehrman White & McAuliffe LLP (included in
opinion filed as Exhibit 5.1)
24.1 Power of Attorney (included on signature page to this
Registration Statement)
</TABLE>
------------------------
* Previously filed with this Registration Statement.
