As filed with the Securities and Exchange Commission on December 20, 2001
Registration No. 333-73498
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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
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ORASURE TECHNOLOGIES, INC.
(Exact Name of Registrant as Specified in Its
Charter)
Delaware 36-4370966
(State or Other (IRS Employer
Jurisdiction of Identification Number)
Incorporation or
Organization)
150 Webster Street
Bethlehem, Pennsylvania 18015
(610) 882-1820
(Address, Including Zip Code, and Telephone
Number, Including Area Code, of Registrant's
Principal Executive Offices)
Jack E. Jerrett, Esq.
Vice President and General Counsel
OraSure Technologies, Inc.
150 Webster Street
Bethlehem, Pennsylvania 18015
(610) 882-1820
(Name, Address, Including Zip Code, and
Telephone Number, Including Area Code, of Agent
For Service)
COPIES TO:
Jeffrey P. Libson, Esq.
Steven J. Feder, Esq.
Pepper Hamilton LLP
1235 Westlakes Drive, Suite 400
Berwyn, Pennsylvania 19312-2401
(610) 640-7800
APPROXIMATE DATE OF COMMENCEMENT OF PROPOSED SALE TO THE PUBLIC: From time to
time 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 (the "Securities Act"), 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, 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, 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 WHICH SPECIFICALLY STATES THAT THIS REGISTRATION STATEMENT
SHALL THEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH SECTION 8(A) OF THE
SECURITIES ACT OR UNTIL THE REGISTRATION STATEMENT SHALL BECOME EFFECTIVE ON
SUCH DATE AS THE COMMISSION, ACTING PURSUANT TO SAID SECTION 8(A), MAY
DETERMINE.
THE INFORMATION IN THIS PROSPECTUS IS NOT COMPLETE AND MAY BE CHANGED. 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 THE REGISTRATION OR QUALIFICATION UNDER THE SECURITIES LAWS OF ANY SUCH
STATE.
Subject to Completion, dated December 20, 2001
PROSPECTUS
[GRAPHIC OMITTED]
4,049,882
SHARES OF COMMON STOCK
This prospectus relates to the resale of common stock that we issued and
sold to the selling stockholders listed on page 10. We will not receive any
proceeds from the sale of the shares by the selling stockholders.
The selling stockholders, or their pledgees, donees, transferees or other
successors-in-interest, may offer the common stock through public or private
transactions, at prevailing market prices, at prices related to prevailing
market prices or at privately negotiated prices.
Our common stock is listed on The Nasdaq National Market under the symbol
"OSUR." On December 19, 2001 the reported last sale price of our common stock on
The Nasdaq National Market was $12.52 per share.
Our principal offices are located at 150 Webster Street, Bethlehem,
Pennsylvania 18015, and our telephone number is (610) 882-1820.
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INVESTING IN OUR COMMON STOCK INVOLVES RISKS. YOU SHOULD CAREFULLY CONSIDER THE
"RISK FACTORS" BEGINNING ON PAGE 1 OF THIS PROSPECTUS BEFORE YOU DECIDE TO
INVEST.
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The Securities and Exchange Commission and state securities regulators have not
approved or disapproved 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 , 2001
TABLE OF CONTENTS
WHO WE ARE...................................................................1
RISK FACTORS.................................................................1
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS............................8
USE OF PROCEEDS..............................................................8
SELLING STOCKHOLDERS.........................................................8
PLAN OF DISTRIBUTION.........................................................9
LEGAL MATTERS...............................................................11
EXPERTS.....................................................................11
INDEMNIFICATION.............................................................12
ADDITIONAL INFORMATION......................................................12
You should rely only on the information contained in this prospectus. We
have not authorized anyone to provide you with information different from that
contained or incorporated by reference in this prospectus. The selling
stockholders are offering to sell, and seeking offers to buy, shares of our
common stock only in jurisdictions where offers and sales are permitted. The
information contained in this prospectus is accurate only as of the date of this
prospectus, regardless of the time of delivery of this prospectus or of any sale
of common stock.
Until [_____________], 2001, all dealers that buy, sell or trade the
common stock, whether or not participating in this offering, may be required to
deliver a prospectus. This is in addition to the dealers' obligation to deliver
a prospectus when acting as underwriters and with respect to their unsold
allotments or subscriptions.
WHO WE ARE
Our company was formed in May 2000 under Delaware law solely for the
purposes of combining two companies, STC Technologies, Inc. and Epitope, Inc.,
and changing the state of incorporation of Epitope from Oregon to Delaware. STC
Technologies and Epitope were merged into our company on September 29, 2000. Our
principal offices are located at 150 Webster Street, Bethlehem, Pennsylvania
18015, and our telephone number is (610) 882 -1820.
We develop, manufacture and market oral fluid specimen collection devices
using our proprietary oral fluid technologies, proprietary diagnostic products
including in vitro diagnostic tests, and other medical devices. These products
are sold in the United States and certain foreign countries to government
agencies, clinical laboratories, physician offices, and hospitals, and for
workplace testing.
Our business focuses on the following principal platform technologies: (1)
the OraSure(R) oral fluid collection device, (2) the OraQuick(R) rapid
diagnostics test device, and (3) the new up-converting phosphor technology, or
UPT(TM), including its first application, UPlink(TM).
The OraSure(R) collection device is used to collect a sample of oral
fluid, or saliva, which is then sent to a laboratory for screening and
confirmatory tests for HIV-1 (the virus that causes AIDS) and/or for cocaine and
cotinine (an indicator of the use of nicotine). The OraSure(R) device is sold
predominantly in the insurance market for the screening of life insurance
applicants and in physician offices and in the public health market. A
collection device that is substantially similar to the OraSure(R) device is
marketed under the name Intercept(R) and is used to collect oral fluid to be
tested in a laboratory for various drugs, such as marijuana, cocaine, opiates,
amphetamines, PCP, benzodiapines, barbiturates, and methadone. Intercept(R) is
used primarily by companies to test their employees and prospective employees,
in crime and medical examiner laboratories for forensic toxicology testing, in
the criminal justice system for testing prison inmates and parolees, and in drug
treatment and community/family service programs.
The OraQuick(R) device is a recently developed product designed to test
oral fluid, whole blood or serum/plasma for the presence of HIV. No laboratory
test is required, as the OraQuick(R) test results can be visually read in
approximately 20 minutes after the sample is collected. We plan to market the
OraQuick(R) device in the hospital, physician office and public health markets,
focusing initially on international markets.
Up-converting phosphor technology, or UPT(TM), uses phosphor particles to
detect the presence of small quantities of a variety of substances, such as
drugs, proteins and DNA. The first application of UPT(TM) is called UPlink(TM),
a system which collects, analyzes and measures substances in a variety of
samples, including oral fluid, blood, serum, urine and stool samples, and
provides results in about 10 minutes without laboratory testing. The UPlink(TM)
system provides a high degree of sensitivity and can test for multiple
substances at the same time. We are nearing completion of an UPlink(TM) oral
fluid test for various drugs and are developing UPlink(TM) applications to test
for various infectious diseases.
In addition, we sell certain other products, including the Histofreezer(R)
cryosurgical system for the removal of warts and other skin lesions, certain
tests and related products for insurance risk assessment and forensic toxicology
applications, an oral fluid Western Blot confirmatory test for HIV-1, and the
Q.E.D.(R) saliva alcohol test.
RISK FACTORS
You should carefully consider the risks described below before making an
investment decision. They are the material risks currently known to us.
Additional risks not presently known to us or that we currently deem immaterial
may also impair our business operations.
Our business, financial condition or results of operations could be
materially adversely affected by any of these risks. The trading price of our
common stock could decline due to any of these risks, and you may lose all or
part of your investment.
1
This prospectus also contains forward-looking statements that involve
risks and uncertainties. Our actual results could differ materially from those
anticipated in these forward-looking statements as a result of certain factors,
including the risks faced by us described below and elsewhere in this
prospectus.
WE FACE INTENSE COMPETITION FROM NEW AND EXISTING DIAGNOSTIC PRODUCTS.
The diagnostic industry is focused on the testing of biological specimens
in a laboratory or at the point of care and is highly competitive and rapidly
changing. Our principal competitors have considerably greater financial,
technical, and marketing resources. As new products enter the market, our
products may become obsolete or a competitor's products may be more effective or
more effectively marketed and sold than ours. If we fail to maintain and enhance
our competitive position, our customers may decide to use products developed by
competitors which could result in a loss of revenues.
OUR RESEARCH AND DEVELOPMENT EFFORTS MAY NOT SUCCEED OR OUR COMPETITORS MAY
DEVELOP MORE EFFECTIVE OR SUCCESSFUL DIAGNOSTIC PRODUCTS.
In order to remain competitive, we must commit substantial resources each
year to research and development. The research and development process generally
takes a significant amount of time from inception to commercial product launch.
This process is conducted in various stages, and during each stage there is a
substantial risk that we will not achieve our goals and will have to abandon a
product in which we have invested substantial amounts.
During the year ended December 31, 2000 and the nine months ended
September 30, 2001, we incurred approximately $10.4 million and $6.8 million,
respectively, in research and development expenses. We expect to continue to
incur significant costs in our research and development activities. Moreover,
there can be no assurance that we will succeed in our research and development
efforts. If we fail to develop commercially successful products, or if
competitors develop more effective products or a greater number of successful
new products, customers may decide to use products developed by our competitors,
which would result in a loss of revenues.
IF ACCEPTANCE AND ADOPTION OF OUR ORAL FLUID TESTING IN THE MARKET DOES NOT
CONTINUE, OUR FUTURE RESULTS MAY SUFFER.
We have made significant progress in gaining acceptance and adoption of
oral fluid testing for HIV in the insurance and public health markets. We also
expect that oral fluid testing for drugs of abuse will continue to be accepted
and adopted in workplace and criminal justice testing markets. Other markets,
particularly the physician market, may resist the adoption of oral fluid testing
as a replacement for other testing methods in use today. There can be no
assurance that we will be able to expand the use of our oral fluid testing
products in these or other markets.
WE MAY REQUIRE FUTURE ADDITIONAL FUNDING TO STAY IN BUSINESS.
Although we have made significant progress in the past toward controlling
expenses and increasing product revenue, we have historically depended, to a
substantial degree, on capital raised through the sale of our equity securities
to fund our operations. Our future liquidity and capital requirements will
depend on numerous factors, including, but not limited to, the costs and timing
of the expansion of our manufacturing capacity, the success of our product
development efforts, the costs and timing of expansion of our sales and
marketing activities, the extent to which existing and new products gain market
acceptance, competing technological and market developments, and the scope and
timing of strategic acquisitions. If additional financing is needed, we may seek
to raise funds through the sale of our equity securities. There can be no
assurance that financing through the sale of our equity securities, or
otherwise, will be available on satisfactory terms, if at all.
OUR FAILURE TO MAINTAIN EXISTING DISTRIBUTION CHANNELS OR DEVELOP NEW
DISTRIBUTION CHANNELS, MAY RESULT IN LOWER REVENUES.
2
We have marketed many of our products by collaborating with diagnostic
companies and distributors. For example, our OraSure(R) oral fluid collection
device is distributed to the insurance industry through major insurance testing
laboratories. Our sales depend to a substantial degree on our ability to develop
product distribution channels and on the marketing abilities of the companies
with which we collaborate. There can be no assurance that such companies will
continue to be able to distribute our products or that new distribution channels
will be available on satisfactory terms.
THE TIME NEEDED TO OBTAIN REGULATORY APPROVALS AND RESPOND TO CHANGES IN
REGULATORY REQUIREMENTS COULD ADVERSELY AFFECT OUR BUSINESS.
Many of our proposed and existing products are subject to regulation by
the United States Food and Drug Administration ("FDA") and other international
governmental agencies. In particular, we are subject to strict governmental
controls on the development, manufacture, labeling, distribution and marketing
of our products. The process of obtaining required approvals from government
agencies varies according to the nature of, and uses for, our specific product
and can involve lengthy and detailed laboratory testing, human clinical trials,
sampling activities, and other costly, time-consuming procedures. The submission
of an application to a regulatory authority does not guarantee that it will
grant us a license to market the product. Each authority may impose its own
requirements and delay or refuse to grant approval, even though our product has
been approved in another country.
In our principal markets, the approval process for a new product can be
complex and lengthy. The time taken to obtain approval varies depending on the
nature of the application and may result in the passage of a significant period
of time from the date of submission of the application. This time span increases
our costs to develop new products and increases the risk that we will not
succeed in introducing or selling them.
Changes in government regulations could also require us to undergo
additional trials or procedures, or could make it impractical or impossible for
us to market our products for certain uses, in certain markets, or at all. Other
changes in government regulations, such as the adoption of the FDA's Quality
System Regulation, may not affect our products directly but may, nonetheless,
adversely affect our financial condition and results of operations by requiring
that we incur the expense of changing or implementing new manufacturing and
control procedures.
In addition, the European Union has established a requirement that
diagnostic medical devices used to test biological specimens must receive
regulatory approval known as a CE mark by December 2003. After that date, export
to the European community of products without the CE mark will be stopped or
delayed until the mark is received. This requirement will affect many of our
products. We will not be permitted to sell our products in European countries
without a CE mark after December 2003, which could lead to the termination of
strategic alliances for sales of those products in Europe. While we intend to
apply for CE marks for certain of our existing and future products, and are not
aware of any material reason why such approvals will not be granted, there can
be no assurance that any CE marks will be received prior to the deadline.
At the present time, we have received FDA clearance or approval for the
OraSure(R) and Intercept(R) oral fluid collection devices, the Histofreezer(R)
portable cryosurgical system, the Q.E.D. (R) saliva alcohol test, the OraSure(R)
oral fluid Western Blot confirmatory test for HIV-1 and various other tests. We
have also received CE mark approval for the OraSure(R), Intercept(R) and
Histofreezer(R) products. We have submitted to the FDA an application for
pre-market approval of our OraQuick(R) rapid HIV test using whole blood and
expect to file an application for oral fluid applications early next year. We
have also submitted an application to the FDA for clearance of the UPlink (TM)
drugs of abuse rapid detection system and are presently gathering additional
data requested by the FDA in response to our application.
WE HAVE A HISTORY OF LOSSES.
We have not achieved full-year profitability. We incurred a net loss of
approximately $12.7 million and $4.2 million for the years ended December 31,
2000 and September 30, 1999, respectively, and a net loss of approximately $1.4
million for the nine months ended September 30, 2001. As of September 30, 2001,
we had an accumulated deficit of approximately $123.8 million.
3
Our limited combined operating history makes it difficult to forecast our
future operating results. In order to achieve sustainable profitability, our
revenue will have to continue to grow at a significant rate. Our ability to
reach our estimated revenue growth will be dependent upon a number of factors
including, without limitation, achieving growth in international markets through
our OraQuick(R) rapid HIV test, our ability to create market acceptance for the
Intercept(R) drugs of abuse products and our ability to commercially develop,
and obtain regulatory approval and create market acceptance for, UPT(TM) and
other products in a time frame consistent with our objectives. We have not yet
achieved these objectives. In the event that we cannot create a significant
commercial market for our OraQuick(R) test, the Intercept(R) and UPT(TM)
products or our other products, our revenue, and consequently profitability,
will be lower than estimated. Even if we achieve profitability, we cannot assure
you that we will be able to sustain such profitability in the future.
FAILURE TO COMPLY WITH FDA REQUIREMENTS MAY REQUIRE US TO SUSPEND PRODUCTION OF
OUR PRODUCTS WHICH COULD RESULT IN A LOSS OF REVENUES.
We can manufacture and sell many of our products, both in the U.S. and in
some cases abroad, only if we comply with regulations of governmental agencies
such as the FDA. We have implemented quality assurance and other systems that
are intended to comply with such applicable regulations. The FDA has issued
warning letters and a letter of intent to revoke our license with respect to the
serum Western Blot product, stating that we are not in compliance with the FDA's
regulations. We have responded to each of these letters. Although we believe
that we are addressing all of the points raised by the FDA, the FDA could force
us to stop manufacturing products if the FDA concludes that we still remain out
of compliance with applicable regulations. Until the FDA agrees that we have
resolved all of the points raised in their letters, we may not be able to obtain
regulatory clearance certificates needed in certain foreign countries. The FDA
could also require us to recall products if we fail to comply with applicable
regulations which could force us to stop manufacturing such products.
A MARKET FOR OUR PRODUCTS MAY NOT DEVELOP.
Our future success will depend, in part, on the market acceptance, and the
timing of such acceptance, of our recently introduced products such as the
Intercept(R) oral fluid drug test service, the OraQuick(R) rapid oral fluid HIV
test, products currently under development such as UPlink(TM) and other products
using up-converting phosphor technology, and other new products or technologies
that may be developed or acquired and introduced in the future. To achieve
market acceptance, we must make substantial marketing efforts and spend
significant funds to inform potential customers and the public of the benefits
of these products. We currently have limited evidence on which to evaluate the
market reaction to products that may be developed, and there can be no assurance
that any products will meet with market acceptance and fill the market need that
is perceived to exist.
OUR SUCCESS DEPENDS ON OUR ABILITY TO PROTECT OUR PROPRIETARY TECHNOLOGY.
The diagnostics industry places considerable importance on obtaining
patent, trademark, and trade secret protection, as well as other intellectual
property rights, for new technologies, products and processes. Our success
depends, in part, on our ability to develop and maintain a strong intellectual
property portfolio of products and technologies both in the United States and in
other countries.
As appropriate, we intend to file patent applications and obtain patent
protection for our proprietary technology. These patent applications and patents
will cover, as appropriate, compositions of matter for our products, methods of
making those products, methods of using those products, and apparatus relating
to the use or manufacture of those products. We will also rely on trade secrets,
know-how and continuing technological advancements to protect our proprietary
technology. We have entered and will continue to enter into confidentiality
agreements with our employees, consultants, advisors and collaborators. However,
these parties may not honor these agreements and we may not be able to
successfully protect our rights to unpatented trade secrets and know-how. Others
may independently develop substantially equivalent proprietary information and
techniques or otherwise gain access to our trade secrets and know-how.
Many of our employees, including scientific and management personnel, were
previously employed by competing companies. Although we encourage and expect all
of our employees to abide by any confidentiality
4
agreement with a prior employer, competing companies may allege trade secret
violations and similar claims against us.
To facilitate development and commercialization of a proprietary
technology base, we may need to obtain licenses to patents or other proprietary
rights from other parties. If we are unable to obtain these types of licenses,
our product development and commercialization efforts may be delayed.
We may collaborate with universities and governmental research
organizations which, as a result, may acquire part of the rights to any
inventions or technical information derived from collaboration with them.
We may incur substantial costs in asserting or protecting our intellectual
property rights, or in defending suits against us related to intellectual
property rights. Disputes regarding intellectual property rights could
substantially delay product development or commercialization activities.
Disputes regarding intellectual property rights might include state or federal
court litigation as well as patent interference, patent reexamination, patent
reissue, or trademark opposition proceedings in the United States Patent and
Trademark Office. Opposition or revocation proceedings could be instituted in a
foreign patent office. An adverse decision in any proceeding regarding
intellectual property rights could result in the loss of our rights to a patent,
an invention, or trademark.
THE SALES POTENTIAL FOR ORAQUICK WILL BE AFFECTED BY OUR ABILITY TO OBTAIN
CERTAIN LICENSES.
There are several factors that will affect the specific countries in which
we will be able to sell our OraQuick(R) rapid HIV test and therefore the overall
sales potential of the test. One factor is whether we can arrange a sublicense
or distribution agreement related to patents for detection of the HIV-2 virus.
HIV-2 is a type of the HIV virus estimated to represent less than 2% of known
HIV cases worldwide. Nevertheless, HIV-2 is considered to be an important
component in the testing regimen for HIV in many markets. HIV-2 patents are in
force in most of the countries of North America and Western Europe, as well as
in Japan, Korea, South Africa and Australia. Access to a license for one or more
HIV-2 patents may be necessary to sell HIV-2 tests in countries where such
patents are in force, or to manufacture in countries where such patents are in
force and then sell into non-patent markets. Since HIV-2 patents are in force in
the U.S., we may be restricted from manufacturing our OraQuick(R) rapid HIV test
in the U.S. and selling into other countries, even if there were no HIV-2
patents in those other countries.
The importance of HIV-2 differs by country, and can be affected by both
regulatory requirements and by competitive pressures. In most countries, any
product used to screen the blood supply will require the ability to detect
HIV-2, although the OraQuick(R) rapid HIV test has not been intended for that
market purpose. In other markets, including the U.S., a test that can detect
only the more prevalent HIV-1 type is generally considered sufficient, except in
testing related to blood supply. Because the competitive situation in each
country will be affected by the availability of other testing products as well
as the country's regulatory environment, we may be at a competitive disadvantage
in some markets without an HIV-2 product even if HIV-2 detection is not required
by regulations.
Another factor that may affect the specific countries in which we will be
able to sell our OraQuick(R) rapid HIV test, and therefore the overall sales
potential, concerns whether we can arrange a sublicense or distribution
agreement related to any patents which claim lateral flow assay methods and
devices covering the OraQuick(R) rapid HIV test or its use. The OraQuick(R)
rapid HIV test is a lateral flow assay device that tests for specific antibodies
or other substances. The term "lateral flow" generally refers to a test strip
through which a sample flows and which produces a visible test result on a
portion of the strip downstream from where the sample is applied. There are
numerous patents in the U.S. and other countries which claim lateral flow assay
methods and devices. Some of these patents broadly cover the type of technology
used in the OraQuick(R) assay and are in force in the U.S and other countries.
We may not be able to make the OraQuick(R) rapid HIV test in the U.S. and sell
it in countries where there is no patent on the device. We have licenses under
several lateral flow patents and are considering the need for licenses under
others.
5
In the event that it is not possible to negotiate a license or other
agreement under a necessary patent, we may be able to modify the OraQuick(R)
rapid HIV test such that a license would not be necessary. However, this
alternative could delay introduction of the OraQuick(R) rapid HIV test into the
U.S. and other markets.
IF WE LOSE OUR KEY PERSONNEL OR ARE UNABLE TO ATTRACT AND RETAIN QUALIFIED
PERSONNEL AS NECESSARY, OUR BUSINESS COULD BE HARMED.
Our success will depend to a large extent upon the contributions of our
executive officers, management, sales and marketing, and scientific staff. We
may not be able to attract or retain qualified employees in the future due to
the intense competition for qualified personnel among medical products
businesses. If we are not able to attract and retain the necessary personnel to
accomplish our business objectives, we may experience constraints that will
adversely affect our ability to effectively sell and market our products, to
meet the demands of our strategic partners in a timely fashion or to support
internal research and development programs. In particular, product development
programs depend on the ability to attract and retain highly skilled scientists,
including molecular biologists, biochemists and engineers. Recruiting qualified
personnel can be an intensely competitive and time-consuming process. Although
we believe we will be successful in attracting and retaining qualified
personnel, competition for experienced scientists and other personnel from
numerous companies and academic and other research institutions may limit our
ability to do so on acceptable terms. All of our employees, other than a few
senior officers who have employment agreements, are at-will employees, which
means that either the employee or we may terminate their employment at any time.
If we experience difficulty in recruiting and retaining qualified personnel, and
in particular scientific personnel, we may need to provide higher compensation
to such personnel than currently anticipated or we may incur additional expenses
for the recruitment of qualified personnel.
Our business plans will require additional expertise in specific
industries and areas applicable to the development efforts related to
up-converting phosphor technologies. These activities will require the addition
of new personnel, including management, and the development of additional
expertise by existing management personnel. The inability to acquire these
services or to develop this expertise could impair the development, if any, of
products related to this technology.
OUR INCREASING INTERNATIONAL PRESENCE MAY BE AFFECTED BY REGULATORY, CULTURAL OR
OTHER RESTRAINTS.
We intend to devote significant resources to increase international sales
of our OraSure(R), Intercept(R), OraQuick(R) and UPT(TM) products. The Company's
international operations accounted for approximately $4 million or 14% of total
revenues for the year ended December 31, 2000 and approximately $3.9 million or
15.9% of total revenues for the nine months ended September 30, 2001.
Compliance with foreign regulatory requirements can be difficult and can
impede international marketing efforts. In the past, we have not had significant
direct experience with the governmental regulatory agencies in foreign countries
that control sale of products into those countries. In addition to economic and
political issues, a number of factors can slow or prevent international sales,
or substantially increase the cost of international sales, including those set
forth below:
o Regulatory requirements (including compliance with applicable customs
regulations) may slow, limit, or prevent the offering of products in
foreign jurisdictions;
o Cultural and political differences may make it difficult to effectively
market, sell and gain acceptance of products in foreign jurisdictions;
o Inexperience in international markets may slow or limit our ability to
sell products in foreign countries;
o Exchange rates, currency fluctuations, tariffs and other barriers,
extended payment terms and dependence on and difficulties in managing
international distributors or representatives may affect our revenues even
when product sales occur; and
6
o The credit-worthiness of foreign entities may be less certain and accounts
receivable collection may be more difficult.
We have entered into a contract for the manufacture and supply of the
OraQuick(R) HIV device in Thailand. However, we do not have significant direct
experience with the use of international manufacturers. Factors such as economic
and political conditions and foreign regulatory requirements may slow or prevent
the manufacture of our products in countries other than the United States.
Interruption of the supply of our products could reduce revenues or cause us to
incur significant additional expense in finding an alternative source of supply.
WE MAY BE SUED FOR PRODUCT LIABILITIES FOR INJURIES RESULTING FROM THE USE OF
OUR DIAGNOSTIC PRODUCTS.
We may be held liable if any of our products, or any product which is made
with the use or incorporation of any of our technologies, causes injury of any
type or is found otherwise unsuitable during product testing, manufacturing,
marketing, sale or usage. Although we have obtained product liability insurance,
this insurance may not fully cover potential liabilities. As new products come
to market, we may need to increase our product liability coverage. Inability to
obtain sufficient insurance coverage at an acceptable cost or otherwise to
protect against potential product liability claims could affect our decision to
commercialize products that we develop independently or with our strategic
partners. If we are sued for any injury caused by our products, our liability
could exceed our policy limits.
WE MAY NOT BE ABLE TO COMMERCIALIZE OUR UPT(TM) PRODUCTS WHICH COULD NEGATIVELY
AFFECT OUR FUTURE REVENUES.
Our up-converting phosphor technology is new and is in the early stage of
development. Commercial development of UPT(TM) may not be successful. Successful
products require significant development and investment, including testing, to
demonstrate their cost-effectiveness or other benefits prior to their
commercialization. In addition, regulatory approval must be obtained before most
products based upon UPT(TM) 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.
Accordingly, because of these uncertainties, products based upon UPT(TM) may not
be commercialized. The failure to develop UPT(TM) products with commercial
potential would negatively affect our future revenues.
WE ARE DEPENDENT UPON STRATEGIC PARTNERS TO ASSIST IN DEVELOPING AND
COMMERCIALIZING SOME OF OUR DIAGNOSTIC PRODUCTS.
Although we intend to pursue some product opportunities independently,
opportunities that require a level of investment for development and
commercialization may necessitate involving one or more strategic partners. In
particular, our strategy for development and commercialization of UPT(TM) and
certain other products may entail entering into additional arrangements with
corporate partners, universities, research laboratory licensees, and others. We
may be required to transfer material rights to such strategic partners,
licensees, and others. While we expect that our current and future partners,
licensees, and others have and will have an economic motivation to succeed in
performing their contractual responsibilities, the amount and timing of
resources to be devoted to these activities will be controlled by others.
Consequently, there can be no assurance that any revenues or profits will be
derived from such arrangements.
WE ARE DEPENDENT UPON PATENTS, LICENSES AND OTHER PROPRIETARY RIGHTS FROM THIRD
PARTIES, INCLUDING RIGHTS TO UP-CONVERTING PHOSPHOR COMPOSITIONS, METHODS AND
APPARATUSES.
We have licensed the worldwide rights to up-converting phosphor
compositions, methods, and apparatuses for use in diagnostic applications, which
are the subject of nine issued U.S. patents, and of four pending U.S. patent
applications. Corresponding patents and patent applications have been granted or
issued in numerous foreign countries, including, for example, European
countries, Japan, and Canada. We cooperate with the licensor to prosecute such
patent applications and protect such patent rights. If the licensors do not meet
their obligations under the license agreements or do not reasonably consent to
sublicenses by us, or if the license agreement is terminated,
7
we could lose the opportunity to develop the up-converting phosphor technology.
THE RECENT ECONOMIC DOWNTURN AND TERRORIST ATTACKS MAY ADVERSELY AFFECT OUR
BUSINESS.
Since the September 11, 2001 terrorist attacks, the United States economy
has experienced a decline. 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 or may perform less
drug testing because of declining employment levels. 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.
The terrorist attacks and any subsequent governmental response 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.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
Because we want to provide you with more meaningful and useful
information, this prospectus contains, and incorporates by reference, certain
forward-looking statements that reflect our current expectations regarding our
future results of operations, performance and achievements. We have tried,
wherever possible, to identify these forward-looking statements by using words
such as "anticipates," "believes," "estimates," "expects," "plans," "intends,"
"may," "will," "should," "could" and similar expressions. These statements
reflect our current beliefs and are based on information currently available to
us. Accordingly, these statements are subject to certain risks, uncertainties
and contingencies, including the factors set forth under the caption "Risk
Factors," which could cause our actual results, performance or achievements for
2001 and beyond to differ materially from those expressed in, or implied by, any
of these statements. You should not place undue reliance on any forward-looking
statements. Except as otherwise required by federal securities laws, we
undertake no obligation to release publicly the results of any revisions to any
such forward-looking statements that may be made to reflect events or
circumstances after the date of this prospectus or to reflect the occurrence of
unanticipated events.
USE OF PROCEEDS
We will not receive any proceeds from the sale by the selling stockholders
of our common stock. The selling stockholders will receive all of the net
proceeds from the sale of the shares.
SELLING STOCKHOLDERS
Each of the selling stockholders was a stockholder of STC Technologies,
Inc. We issued an aggregate of 4,049,882 shares of common stock to the selling
stockholders in the merger of STC Technologies, Inc. and Epitope, Inc. into our
company on September 29, 2000. Mr. William W. Crouse, a member of our board of
directors, is a general partner of HealthCare Partners V, L.P., the general
partner of HealthCare Ventures V, L.P. Mr. Crouse has been a member of the board
since September 29, 2000 and previously was a member of the board of directors
of STC Technologies, Inc. since April 1999. Mr. Michael G. Bolton, a member of
our board of directors, is the managing director of Pennsylvania Early Stage
Partners GP, LLC, the manager of Pennsylvania Early Stage Partners, L.P. Mr.
Bolton has been a member of the board since September 29, 2000 and previously
was a member of the board of directors of STC Technologies, Inc. since April
1999. Messrs. Crouse and Bolton were designated as directors pursuant to the
Agreement and Plan of Merger dated May 6, 2000 between STC Technologies and
Epitope.
8
The shares listed under the column "Number of Shares Being Offered" in the
table below represent the number of shares that may be sold by each selling
stockholder pursuant to this prospectus. Pursuant to Rule 416 under the
Securities Act, the registration statement of which this prospectus is a part
also covers any additional shares of our common stock which become issuable in
connection with such shares because of any stock dividend, stock split,
recapitalization or other similar transaction effected without the receipt of
consideration which results in an increase in the number of outstanding shares
of our common stock.
We do not know when or in what amounts the selling stockholders may offer
shares for sale. The selling stockholders may not sell all or any of the shares
offered by this prospectus. The selling stockholders may distribute the shares,
from time to time, to one or more of its respective limited and/or general
partners, who may sell shares pursuant to this prospectus. We may amend or
supplement this prospectus from time to time to update the disclosure set forth
herein. Because the selling stockholders may from time to time offer all or some
of the shares pursuant to this offering, and because there are currently no
agreements, arrangements or understandings with respect to the sale of any of
the shares that will be held by the selling stockholders after completion of the
offering, we cannot estimate the number of the shares that will be held by the
selling stockholders after completion of the offering. However, for purposes of
the table below, we have assumed that, after completion of the offering, none of
the shares covered by this prospectus will be held by the selling stockholders.
The following table sets forth, to our knowledge, certain information
regarding the beneficial ownership of the shares of common stock by the selling
stockholders as of November 12, 2001. We prepared this table based on the
information supplied to us by the selling stockholders named in the table.
Beneficial ownership is calculated based upon SEC requirements and is not
necessarily indicative of beneficial ownership for any other purpose. The table
is based on 37,209,430 shares of our common stock outstanding as of November 12,
2001:
Shares Shares
Beneficially Owned Number of Beneficially
Prior to Offering Shares Owned
------------------ Being Offered After Offering
------------- --------------
Name of Selling Stockholders(1) Number Percentage Number Percent
- ------------------------------ ------ ---------- ------ -------
Healthcare Ventures V, L.P. (2) 3,115,292 8.4% 3,115,292 0 -
44 Nassau Street
Princeton, New Jersey 08542
Pennsylvania Early Stage 934,590 2.5% 934,590 0 -
Partners, L.P. (3)
Building 500, Suite 510
435 Devon Park Drive
Wayne, Pennsylvania 19087
- ------------------------
(1) Includes partners, donees, transferees, pledgees and other
successors-in-interest selling shares that are received from a named selling
stockholder.
(2) HealthCare Ventures V, L.P. shares voting and dispositive control with
respect to the 3,115,292 shares with HealthCare Partners V, L.P. ("HCP") and
with the six General Partners of HCP, James H. Cavanaugh, William W. Crouse,
Augustine Lawlor, John W. Littlechild, Christopher K. Mirabelli and Harold R.
Werner.
(3) Pursuant to a management agreement, voting and dispositive control with
respect to the 934,590 shares has been delegated to Pennsylvania Early Stage
Partners GP, LLC, which exercises such control through a Board of Managers
consisting of Michael G. Bolton, Robert M. McCord, Warren V. Musser and Paul J.
Schmitt.
PLAN OF DISTRIBUTION
The shares covered by this prospectus may be offered and sold from time to
time by the selling stockholders. The term "selling stockholders" includes
partners, pledgees, donees, transferees or other successors-in-interest selling
shares received after the date of this prospectus from the selling stockholders
as a pledge, gift,
9
partnership distribution or other non-sale related transfer. To the extent
required, we may amend and supplement this prospectus from time to time to
describe a specific plan of distribution.
The selling stockholders will act independently of us in making decisions
with respect to the timing, manner and size of each sale. The selling
stockholders may make these sales at prices and under terms then prevailing or
at prices related to the then current market price. The selling stockholders may
also make sales in negotiated transactions, including pursuant to one or more of
the following methods:
o purchases by a broker-dealer as principal and resale by such broker-dealer
for its own account pursuant to this prospectus;
o ordinary brokerage transactions and transactions in which the broker
solicits purchasers;
o one or more block trades in which the broker-dealer will attempt to sell
the shares as agent but may position and resell a portion of the block as
principal to facilitate the transaction;
o an over-the-counter distribution in accordance with the rules of The
Nasdaq National Market; and
o in privately negotiated transactions.
In connection with distributions of the shares or otherwise, the selling
stockholders may:
o enter into hedging transactions with broker-dealers or other financial
institutions, which may in turn engage in short sales of the shares in the
course of hedging the positions they assume;
o sell the shares short and redeliver the shares to close out such short
positions;
o enter into option or other transactions with broker-dealers or other
financial institutions which require the delivery to them of shares
offered by this prospectus, which they may in turn resell; and
o pledge shares to a broker-dealer or other financial institution, which,
upon a default, they may in turn resell.
In addition, the selling stockholders may sell all or a portion of the
shares that qualify for sale pursuant to Rule 144 and 145 of the Securities Act,
as amended, under Rule 144 or 145 rather than pursuant to this prospectus.
Sales through brokers may be made by any method of trading authorized by
any stock exchange or market on which the shares may be listed or quoted,
including block trading in negotiated transactions. Without limiting the
foregoing, such brokers may act as dealers by purchasing any or all of the
shares covered by this prospectus, either as agents for others or as principals
for their own accounts, and reselling such shares pursuant to this prospectus.
The selling stockholders may effect such transactions directly, or indirectly
through underwriters, broker-dealers or agents acting on their behalf. In
effecting sales, broker-dealers or agents engaged by the selling stockholders
may arrange for other broker-dealers to participate. Broker-dealers or agents
may receive commissions, discounts or concessions from the selling stockholders,
in amounts to be negotiated immediately prior to the sale.
In offering the shares covered by this prospectus, the selling
stockholders, and any broker-dealers and any other participating broker-dealers
who execute sales for the selling stockholders, may be deemed to be
"underwriters" within the meaning of the Securities Act in connection with these
sales. Any profits realized by the selling stockholders and the compensation of
such broker-dealers may be deemed to be underwriting discounts and commissions.
In order to comply with the securities laws of certain states, the shares
must be sold in those states only through registered or licensed brokers or
dealers. In addition, in certain states the shares may not be sold unless they
have been registered or qualified for sale in the applicable state or an
exemption from the registration or qualification requirement is available and is
complied with.
10
We have advised the selling stockholders that the anti-manipulation rules
of Regulation M under the Exchange Act may apply to sales of shares in the
market and to the activities of the selling stockholders and their affiliates.
In addition, we will make copies of this prospectus available to the selling
stockholders for the purpose of satisfying the prospectus delivery requirements
of the Securities Act. The selling stockholders may indemnify any broker-dealer
that participates in transactions involving the sale of the shares against
certain liabilities, including liabilities arising under the Securities Act.
At the time a particular offer of shares is made, if required, we will
distribute a prospectus supplement that will set forth:
o the number of shares being offered;
o the terms of the offering, including the name of any underwriter, dealer
or agent;
o the purchase price paid by any underwriter;
o any discount, commission and other underwriter compensation;
o any discount, commission or concession allowed or reallowed or paid to any
dealer; and
o the proposed selling price to the public.
We have agreed to indemnify the selling stockholders against certain
liabilities, including certain liabilities under the Securities Act.
We have agreed with the selling stockholders to keep the registration
statement of which this prospectus constitutes a part effective until the
earlier of (i) such time as all of the shares covered by this prospectus have
been disposed of pursuant to the registration statement, or (ii) the second
anniversary of the effective date of this prospectus, plus any periods during
which the selling stockholders were not permitted to sell the shares covered by
this prospectus.
All costs, expenses and fees in connection with the registration of the
shares offered hereby will be borne by us. Brokerage commissions and similar
selling expenses, if any, attributable to the sale of shares will be borne by
the selling stockholders.
LEGAL MATTERS
The validity of the shares of our common stock offered by this prospectus
will be passed upon for us by Pepper Hamilton LLP, Philadelphia, Pennsylvania.
EXPERTS
The audited annual financial statements incorporated into this prospectus
by reference to our annual report on Form 10-K for the year ended December 31,
2000 have been audited by Arthur Andersen LLP, independent public accountants,
as indicated in their report with respect thereto, and are included herein in
reliance upon the authority of said firm as experts in giving said report.
The financial statements of Epitope, Inc. as of December 31, 1999 and for
the three months ended December 31, 1999 and each of the two years in the period
ended September 30, 1999, incorporated into this prospectus by reference to
OraSure Technologies, Inc.'s Annual Report on Form 10-K for the year ended
December 31, 2000 have been so incorporated in reliance on the report from
PricewaterhouseCoopers LLP, independent accountants, given on the authority of
said firm as experts in auditing and accounting.
11
INDEMNIFICATION
Delaware law authorizes a corporation to limit or eliminate the personal
liability of its directors for monetary damages for breach of a director's
fiduciary duty of care. Delaware law further enables corporations to limit
available relief to equitable remedies such as injunction or rescission. Absent
the limitations authorized by Delaware law, directors are accountable for
monetary damages for conduct constituting gross negligence in the exercise of
their duty of care. Our Certificate of Incorporation limits the liability of our
directors to the fullest extent permitted by Delaware law. Accordingly, our
directors will not be personally liable to us or our stockholders for monetary
damages for breach of a fiduciary duty as a director, except for liability for
breach of the duty of loyalty, for acts or omissions not in good faith or that
involve intentional misconduct or a knowing violation of law, for unlawful
payments of dividends or unlawful stock repurchases or redemptions as provided
in Section 174 of the General Corporation Law of the State of Delaware, or for
any transaction in which a director has derived an improper personal benefit.
Our Bylaws require us to indemnify to the fullest extent permitted by
Delaware law any person who is a party or is threatened to be made a party to
any action, suit or proceeding by reason of the fact that such person is or was
our director, officer, employee or agent, or is serving as a director, officer,
employee or agent of another enterprise at our request. Indemnification is not,
however, permitted under the Bylaws unless the person acted in good faith and in
a manner that such person reasonably believed to be in or not opposed to our
best interests and, with respect to any criminal action or proceeding, that such
person had no reasonable cause to believe such person's conduct was unlawful.
The Bylaws further provide that we shall not indemnify any person for any
liabilities or expenses incurred by such person in connection with an action,
suit or proceeding by or in the right of OraSure Technologies in respect of any
claim, issue or matter as to which such person shall have been adjudged to be
liable to us, unless and only to the extent that the court in which the action,
suit or proceeding is brought determines that the person is entitled to
indemnity for such expenses. The indemnification provided by the Bylaws is not
exclusive of any other rights to which those seeking indemnification may be
otherwise entitled.
We have entered into indemnification agreements with certain of our
directors and officers. The indemnification agreements provide that we will
indemnify these directors and officers against all liabilities and expenses
actually and reasonably incurred in connection with any action, suit or
proceeding (including an action by or in the right of OraSure Technologies) to
which any of them is, was or at any time becomes a party, or is threatened to be
made a party, by reason of their status as a director or officer, or by reason
of their serving or having served at the request or on behalf of OraSure
Technologies as a director, officer, trustee or in any other comparable position
of any other enterprise to the fullest extent allowed by law. No indemnity will
be provided under the indemnification agreements for any amounts for which
indemnity is provided by any other indemnification obligation or insurance
maintained by us or otherwise. Indemnity will not be available to any director
or officer on account of conduct which is finally adjudged by a court to have
been knowingly fraudulent, deliberately dishonest or willful misconduct. No
indemnification will be provided if a final court adjudication determines that
such indemnification is not lawful, or in respect of any suit in which judgment
is rendered against any director or officer for an accounting of profits made
from a purchase or sale of securities of OraSure Technologies in violation of
Section 16(b) of the Exchange Act or of any similar law, or on account of any
remuneration paid to any director or officer which is adjudicated to have been
paid in violation of law.
We have also obtained director's and officer's liability insurance.
ADDITIONAL INFORMATION
This prospectus is part of a registration statement we have filed with the
Securities and Exchange Commission ("SEC"). This prospectus does not contain all
of the information contained in the registration statement or the exhibits to
the registration statement. For further information about us, please see the
complete registration statement. Summaries of agreements or other documents in
this prospectus are not necessarily complete. Please refer to the exhibits to
the registration statement for complete copies of these documents.
12
We are subject to the information requirements of the Securities Exchange
Act of 1934, as amended (the "Exchange Act"), and file reports, proxy statements
and other information with the SEC. You may read and copy such reports, proxy
statements and other information, including the registration statement and all
of its exhibits, at the following SEC public reference rooms:
450 Fifth Street, N.W. Citicorp Center
Judiciary Plaza 500 West Madison Street
Room 1024 Suite 1400
Washington, D.C. 20549 Chicago, IL 60661
You may obtain information on the operation of the SEC public reference
room in Washington, D.C. by calling the SEC at 1-800-SEC-0330. Our SEC filings,
including the registration statement of which this prospectus forms a part and
the documents incorporated by reference that are listed below, are also
available from the SEC's Web site at http://www.sec.gov, which contains reports,
proxy and information statements and other information regarding issuers that
file electronically.
The SEC allows us to "incorporate by reference" into this prospectus
certain information that we file with it. This means that we can disclose
important information to you by referring you to another document that we filed
separately with the SEC. The information incorporated by reference is deemed to
be part of this prospectus, except for any information superseded by information
in this prospectus. You should read the information incorporated by reference
because it is an important part of this prospectus.
We incorporate by reference the following documents that we previously
filed with the SEC pursuant to the Exchange Act and any future filings we will
make with the SEC under Section 13(a), 13(c), 14 or 15(d) of the Exchange Act:
1. Our Annual Report on Form 10-K for our fiscal year ended December 31,
2000.
2. Our Quarterly Report on Form 10-Q for the quarter ended March 31, 2001.
3. Our definitive Proxy Materials for the 2001 Annual Meeting of Stockholders
filed on April 30, 2001.
4. Our Current Report on Form 8-K dated March 30, 2001.
5. Our Current Report on Form 8-K dated April 2, 2001.
6. The description of our common stock contained in Exhibit 99 to our
Quarterly Report on Form 10-Q for the quarter ended March 31, 2001.
7. The description of rights to purchase preferred shares contained in the
Registration Statement on Form 8-A filed with the SEC on June 11, 2001.
8. Our Quarterly Report on Form 10-Q for the quarter ended June 30, 2001.
9. Our Current Report on Form 8-K dated October 31, 2001.
10. Our Quarterly Report on Form 10-Q for the quarter ended September 30,
2001.
The documents incorporated by reference in this prospectus that are not
delivered with this prospectus may be obtained from us without charge. You may
obtain these documents incorporated by reference in this prospectus by
telephoning us at (610) 882-1820 or writing us at the following address:
13
Corporate Secretary
OraSure Technologies, Inc.
150 Webster Street
Bethlehem, Pennsylvania 18015
Our Web site is located at http://www.orasure.com. Information contained in
our Web site is not a part of this prospectus.
14
Part II
Information Not Required In Prospectus
Item 14. Other Expenses of Issuance and Distribution
The following table sets forth the various expenses in connection with the
sale and distribution of the securities being registered. All of the amounts
shown are estimates except the SEC registration fee.
SEC registration fee......................................... $ 10,636
Printing and EDGAR filing fees ............................ 5,000
Legal fees and expenses.................................... 5,000
Accounting fees and expenses .............................. 3,000
Miscellaneous fees and expenses ........................... 5,000
---------
TOTAL ................................................ $ 28,636
Item 15. Indemnification of Directors and Officers
Delaware law authorizes a corporation to limit or eliminate the personal
liability of its directors for monetary damages for breach of a director's
fiduciary duty of care. Delaware law further enables corporations to limit
available relief to equitable remedies such as injunction or rescission. Absent
the limitations authorized by Delaware law, directors are accountable for
monetary damages for conduct constituting gross negligence in the exercise of
their duty of care. Our Certificate of Incorporation limits the liability of our
directors to the fullest extent permitted by Delaware law. Accordingly, our
directors will not be personally liable to us or our stockholders for monetary
damages for breach of a fiduciary duty as a director, except for liability for
breach of the duty of loyalty, for acts or omissions not in good faith or that
involve intentional misconduct or a knowing violation of law, for unlawful
payments of dividends or unlawful stock repurchases or redemptions as provided
in Section 174 of the General Corporation Law of the State of Delaware, or for
any transaction in which a director has derived an improper personal benefit.
Our Bylaws require us to indemnify to the fullest extent permitted by
Delaware law any person who is a party or is threatened to be made a party to
any action, suit or proceeding by reason of the fact that such person is or was
our director, officer, employee or agent, or is serving as a director, officer,
employee or agent of another enterprise at our request. Indemnification is not,
however, permitted under the Bylaws unless the person acted in good faith and in
a manner that such person reasonably believed to be in or not opposed to our
best interests and, with respect to any criminal action or proceeding, that such
person had no reasonable cause to believe such person's conduct was unlawful.
The Bylaws further provide that we shall not indemnify any person for any
liabilities or expenses incurred by such person in connection with an action,
suit or proceeding by or in the right of OraSure Technologies in respect of any
claim, issue or matter as to which such person shall have been adjudged to be
liable to us, unless and only to the extent that the court in which the action,
suit or proceeding is brought determines that the person is entitled to
indemnity for such expenses. The indemnification provided by the Bylaws is not
exclusive of any other rights to which those seeking indemnification may be
otherwise entitled.
We have entered into indemnification agreements with certain of our
directors and officers. The indemnification agreements provide that we will
indemnify these directors and officers against all liabilities and expenses
actually and reasonably incurred in connection with any action, suit or
proceeding (including an action by or in the right of OraSure Technologies) to
which any of them is, was or at any time becomes a party, or is threatened to be
made a party, by reason of their status as a director or officer, or by reason
of their serving or having served at the request or on behalf of OraSure
Technologies as a director, officer, trustee or in any other comparable position
of any other enterprise to the fullest extent allowed by law. No indemnity will
be provided under the indemnification agreements for any amounts for which
indemnity is provided by any other indemnification obligation or insurance
maintained by us or otherwise. Indemnity will not be available to any director
or officer on account of conduct which is finally adjudged by a court to have
been knowingly fraudulent, deliberately dishonest or willful misconduct. No
indemnification will be provided if a final court adjudication determines that
such indemnification is not lawful, or in respect of any suit in which judgment
is rendered against any director or officer for an accounting of profits made
from a purchase or sale of securities of OraSure
11-1
Technologies in violation of Section 16(b) of the Exchange Act or of any similar
law, or on account of any remuneration paid to any director or officer which is
adjudicated to have been paid in violation of law.
We have also obtained director's and officer's liability insurance.
Item 16. List of Exhibits
The exhibits filed as part of this registration statement are as follows:
Exhibit Description
- ----------- ------------------------------------------------------------------
4.1 Specimen certificate representing shares of OraSure Technologies
$.000001 par value Common Stock is incorporated by reference to
Exhibit 4.1 to the Registrant's Registration Statement on Form
S-4 (No. 333-39210).
4.2 Rights Agreement dated as of May 6, 2000 between OraSure
Technologies and ChaseMellon Shareholder Service, L.L.C., as
Rights Agent, is incorporated by reference to Exhibit 4.2 to the
Registrant's Registration Statement on Form S-4 (No. 333-39210).
4.3 Stockholders Agreement among STC Technologies, Inc., HealthCare
Ventures V, L.P., RHO Management Trust II, Hudson Trust and
Pennsylvania Early Stage Partners, L.P., dated March 30, 1999, is
incorporated by reference to Exhibit 4.3 to the Registrant's
Registration Statement on Form S-4 (No. 333-39210).
4.4 Amendment to Stockholders Agreement filed as Exhibit 4.3 is
incorporated by reference to Exhibit 4.4 to the Registrant's
Registration Statement on Form S-4 (No. 333-39210).
4.5 Second Amendment to Stockholders Agreement dated as of June 29,
2001 is incorporated by reference to Exhibit 4 to the
Registrant's Quarterly Report on Form 10-Q for the quarter ended
June 30, 2001.
5.1* Opinion of Pepper Hamilton LLP regarding legality of securities
being registered.
23.1* Consent of Arthur Andersen LLP.
23.2* Consent of PricewaterhouseCoopers LLP, Independent Accountants.
23.3* Consent of Pepper Hamilton LLP (included in its Opinion filed as
Exhibit 5.1 hereto).
24.1** Powers of Attorney (included on signature page).
* Filed herewith.
** Previously filed.
Item 17. Undertakings
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;
(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. Notwithstanding the foregoing, any increase or
decrease in volume of securities offered (if the total dollar
value of securities offered would not exceed that which was
registered) and any deviation from the low or high end of the
estimated maximum offering range may be reflected in the form
of prospectus filed with the Commission pursuant to Rule
424(b) if, in the aggregate, the changes in volume and price
represent no more than 20% change in the maximum aggregate
offering price set forth in the "Calculation of Registration
Fee" table in the effective 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;
11-2
provided, however, that paragraphs (i) and (ii) above do not apply
if the Registration Statement is on Form S-3 or Form S-8 and 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 Exchange Act that are incorporated by
reference in the Registration Statement.
(2) That, for the purpose of determining any liability under the
Securities Act, 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.
The undersigned Registrant hereby undertakes that, for purposes of
determining any liability under the Securities Act, each filing of the
Registrant's annual report pursuant to Section 13(a) or Section 15(d) of the
Exchange Act 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.
Insofar as indemnification for liabilities arising under the Securities
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 SEC 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 of 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.
11-3
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, as amended,
the Registrant 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
Registration Statement to be signed on its behalf by the undersigned, thereunto
duly authorized, in Bethlehem, Pennsylvania on December 20, 2001.
OraSure Technologies, Inc.
By: /s/ Robert D. Thompson
--------------------------------
Robert D. Thompson
Chief Executive Officer
Pursuant to the requirements of the Securities Act of 1933, as amended
(the "Securities Act"), this Registration Statement has been signed below by the
following persons in the capacities and on the dates indicated.
Signature Title Date
- ---------------------------- ----------------------------- ------------------
/s/ Robert D. Thompson Chief Executive Officer and December 20, 2001
- ---------------------- Director (Principal Executive
Officer)
/s/ Ronald H. Spair Executive Vice President and
- ------------------- Chief Financial Officer
(Principal Financial Officer)
/s/ Mark L. Kuna Controller
- ------------------ (Principal Accounting Officer)
/s/ Michael J. Gausling President, Chief Operating
- ----------------------- Officer and Director
/s/ Michael G. Bolton Director
- ---------------------
/s/ William W. Crouse Director
- ---------------------
/s/ Frank G. Hausmann Director
- ---------------------
/s/ Roger L. Pringle Director
- --------------------
/s/ Gregory B. Lawless Director
- ----------------------
* By: /s/ Robert D. Thompson
----------------------
Robert D. Thompson
Attorney-in-Fact
Dated: December 20, 2001
11-4
Exhibit Index
Exhibit Description
- ----------- ------------------------------------------------------------------
5.1 Opinion of Pepper Hamilton LLP regarding legality of securities
being registered.
23.1 Consent of Arthur Andersen LLP.
23.2 Consent of PricewaterhouseCoopers LLP, Independent Accountants.
23.3 Consent of Pepper Hamilton LLP (included in its Opinion filed as
Exhibit 5.1 hereto).
Exhibit 5.1
[Pepper Hamilton LLP Letterhead]
December 20, 2001
OraSure Technologies, Inc.
150 Webster Street
Bethlehem, Pennsylvania 18015
Re: Registration Statement on Form S-3
----------------------------------
Ladies and Gentlemen:
We have acted as counsel to OraSure Technologies, Inc., a Delaware
corporation (the "Company"), in connection with the registration under the
Securities Act of 1933, as amended (the "Act"), of an aggregate of 4,094,882
shares of the Company's common stock, $0.000001 par value (the "Shares"), held
by HealthCare Venture Partners V, L.P. and Pennsylvania Early Stage Partners GP,
LLC.
This opinion is delivered in accordance with the requirements of
Item 601(b)(5) of Regulation S-K under the Act.
We have examined originals or copies, certified or otherwise
identified to our satisfaction, of (i) the Registration Statement on Form S-3
covering the Shares (the "Registration Statement"); (ii) the Company's
Certificate of Incorporation and Bylaws, as in effect on the date hereof; (iii)
certain resolutions of the Board of Directors of the Company relating to, among
other things, the issuance of the Shares; and (iv) such other documents relating
to the Company and the proposed issuance of the Shares as we have deemed
necessary or appropriate as a basis for the opinions set forth below.
In our examination, we have assumed the legal capacity of all
natural persons, the genuineness of all signatures, the authenticity of all
documents submitted to us as certified or photostatic copies and the
authenticity of the originals of such latter documents. As to any facts material
to the opinions expressed herein which were not independently established or
verified, we have relied upon statements and representations of officers and
other representatives of the Company and others.
Members of our firm are admitted to the Bar of the Commonwealth of
Pennsylvania, and we express no opinion as to the laws of any other jurisdiction
other than the Federal laws of the United States of America and the General
Corporation Law of the State of Delaware .
Based upon and subject to the foregoing, we are of the opinion that
the Shares have been duly and validly issued and are fully-paid and
non-assessable.
We hereby consent to the filing of this opinion as an exhibit to the
Registration Statement and to the reference to this firm under the caption
"Legal Matters" in the prospectus filed as part of the Registration Statement.
In giving this consent, we do not hereby admit that we are in the category of
persons whose consent is required under Section 7 of the Act.
Very truly yours,
/s/ PEPPER HAMILTON LLP
Exhibit 23.1
CONSENT OF INDEPENDENT PUBLIC ACCOUNTANTS
To OraSure Technologies, Inc.:
As independent public accountants, we hereby consent to the incorporation by
reference in this Form S-3 Registration Statement of our report dated February
23, 2001 included in OraSure Technologies, Inc.'s Form 10-K for the year ended
December 31, 2000 and to all references to our Firm included in this
Registration Statement.
/s/ ARTHUR ANDERSEN LLP
Philadelphia, Pennsylvania
December 20, 2001
Exhibit 23.2
Consent of Independent Accountants
We hereby consent to the incorporation by reference on this Registration
Statement on Form S-3 of our report dated January 15, 2001 relating to the
financial statements of Epitope, Inc., which appears in OraSure Technologies,
Inc.'s Annual Report on Form 10-K for the year ended December 31, 2000. We also
consent to the reference to us under the heading "Experts" in such Registration
Statement.
PricewaterhouseCoopers LLP
Portland, Oregon.
December 20, 2001