<PAGE> 1
Filed Pursuant to Rule 424(b)(3)
Registration Statement File No. 333-82121
- --------------------------------------------------------------------------------
TRIPATH IMAGING, INC.
780 PLANTATION DRIVE
BURLINGTON, NC 27215
(336) 222-9707
- --------------------------------------------------------------------------------
TRIPATH IMAGING, INC.
1,400,000 SHARES
COMMON STOCK
This prospectus relates to 1,400,000 shares of common stock, $0.01 par
value per share, of TriPath. We are registering these shares on behalf of the
selling stockholder named on page 13 of this prospectus, to be offered and sold
and distributed by it from time to time. We are not selling any of these shares
and will not receive any proceeds from the sale of these shares. TriPath common
stock trades on the Nasdaq National Market under the symbol "TPTH." On November
16, 1999, the last reported per share sale price of TriPath common stock was
$6.31
The selling stockholder may sell or distribute the shares of common stock
at various times and in various types of transactions, including sales in the
open market, sales in negotiated transactions and sales by a combination of
these methods. The selling stockholder will pay all brokerage fees and
commissions in connection with the sale of the shares. We are paying expenses
relating to the registration of the shares with the Securities and Exchange
Commission.
------------------------
SEE "RISK FACTORS" BEGINNING ON PAGE 5 OF THIS PROSPECTUS FOR A DISCUSSION
OF CERTAIN FACTORS THAT SHOULD BE CONSIDERED BY PROSPECTIVE PURCHASERS OF SHARES
OF COMMON STOCK.
------------------------
NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES
COMMISSION HAS APPROVED OR DISAPPROVED THESE SECURITIES OR DETERMINED IF THIS
PROSPECTUS IS TRUTHFUL OR COMPLETE. ANY REPRESENTATION TO THE CONTRARY IS A
CRIMINAL OFFENSE.
------------------------
THE DATE OF THIS PROSPECTUS IS NOVEMBER 23, 1999.
<PAGE> 2
TABLE OF CONTENTS
<TABLE>
<S> <C>
Forward-Looking Statements.................................. 3
Prospectus Summary.......................................... 3
TriPath................................................... 3
The Offering.............................................. 3
Recent Developments......................................... 4
Risk Factors................................................ 5
Use of Proceeds............................................. 13
Selling Stockholder......................................... 13
Plan of Distribution........................................ 13
Legal Matters............................................... 14
Experts..................................................... 14
Where You Can Find More Information......................... 14
</TABLE>
2
<PAGE> 3
FORWARD-LOOKING STATEMENTS
This prospectus contains "forward-looking statements" as defined under
securities laws. These statements can be identified by the use of terminology
such as "believes," "expects," "anticipates," "plans," "may," "will,"
"projects," "continues," "estimates," "potential," "opportunity" and so on.
These forward-looking statements may be found in the "Summary," "Risk Factors,"
and other sections of this prospectus. Our actual results or experience could
differ significantly from the forward-looking statements. Factors that could
cause or contribute to these differences include those discussed in "Risk
Factors," as well as those discussed elsewhere in this prospectus. You should
carefully consider that information before you make an investment decision.
You should not place undue reliance on these statements, which speak only
as of the date that they were made. These cautionary statements should be
considered in connection with any written or oral forward-looking statements
that we may issue in the future. We do not undertake any obligation to release
publicly any revisions to these forward-looking statements after completion of
the offering to reflect later events or circumstances or to reflect the
occurrence of unanticipated events.
PROSPECTUS SUMMARY
This summary is qualified by the more detailed information and Financial
Statements and Notes thereto appearing elsewhere in this prospectus and
incorporated by reference into this prospectus. Where the context permits or
requires, references to TriPath also include the cytology and pathology
automation business as conducted by our predecessor, Roche Image Analysis
Systems, Inc.
TRIPATH
TriPath develops, manufactures and markets products to improve cervical
cancer screening. Improved slide preparation technology is delivered through the
AutoCyte PREP System(TM), a proprietary, automated, thin-layer cytology sample
preparation system that produces representative slides with a homogeneous, thin-
layer of cervical cells, and is one of only two sample preparation systems
approved by the FDA as a replacement for the conventional Pap smear. TriPath
also delivers visual intelligence technology to increase accuracy and
productivity in medical testing through the AutoPap(R)Primary Screening System,
which utilizes proprietary technology to distinguish between normal Pap smears
and those that have the highest likelihood of abnormality. In May 1998, AutoPap
was approved by the U.S. Food and Drug Administration as the first and only
fully automated device for primary screening of Pap smear slides. On October 6,
1999, TriPath announced submission of a supplement to the FDA for the screening
of PREP slides by AutoPap.
THE OFFERING
<TABLE>
<S> <C>
Issuer............................................... TriPath Imaging, Inc.
Shares of common stock offered by the selling
stockholder.......................................... 1,400,000
Common stock outstanding as of November 17, 1999..... 28,098,502
Use of Proceeds...................................... TriPath will not receive any proceeds from
sales made hereunder
Listing.............................................. Nasdaq National Market
Trading Symbol....................................... TPTH
</TABLE>
3
<PAGE> 4
RECENT DEVELOPMENTS
On September 30, 1999, we completed our acquisition of NeoPath, Inc.
through a merger of a wholly-owned subsidiary of ours with and into NeoPath.
Approximately 13.8 million shares of our common stock were issued to NeoPath
stockholders in connection with the merger. As a result of the merger, a
substantial portion of our business now consists of the business of NeoPath.
On September 13, 1999, Cytyc Corporation filed suit against us in the
United States District Court for the District of Delaware. The complaint alleges
that our CytoRich(R) proprietary preservative fluid infringe Cytyc's patent
titled "Cell Preservative Solution." The complaint seeks a determination that we
are infringing Cytyc's patent and an injunction preliminarily and permanently
enjoining and restraining us from further infringing Cytyc's patent. The
complaint also seeks treble damages, plus interest, in an amount to be
determined, as well as costs and reasonable attorneys fees. On October 18, 1999,
we filed our response denying Cytyc's claims.
We believe that Cytyc's claims are without factual or legal merit and we
intend to vigorously defend this action. However, given the early stage of this
litigation, we cannot guarantee that we will be successful in our defense of
this claim. If the court were to uphold Cytyc's claims of infringement, in
addition to us paying Cytyc's proven damages, if any, we could then be prevented
from selling our CytoRich preservative fluid or be required to obtain a license
from Cytyc. If such a license were not available, we would need to redesign our
CytoRich preservative fluid to be non-infringing. Any change to the CytoRich
preservative fluid would likely need to be approved by the FDA before we could
sell it in the United States for gynecological applications.
4
<PAGE> 5
RISK FACTORS
WE HAVE INCURRED SUBSTANTIAL LOSSES SINCE WE BEGAN DOING BUSINESS, AND WE MAY
NEVER BE PROFITABLE.
As of September 30, 1999, our accumulated deficit was $164.3 million. We
expect continued losses from our business in 1999, and into 2000, as we continue
to market our products, continue product development initiatives and perform
additional clinical studies.
Our operating expenses have been concentrated in the following areas:
- research and development activities;
- clinical trials;
- preparation and submission of premarket approval applications to the FDA;
and
- general administrative functions.
We expect that our marketing and sales expenses associated with our
products will increase significantly in the future as a result of recently
receiving approval to market PREP, which could contribute to financial losses
for us.
To become profitable, we must:
- successfully market our products in the United States;
- develop and obtain regulatory approval for new products;
- manufacture our products profitably and at an acceptable level of
quality; and
- establish appropriate internal financial controls and other
infrastructure necessary to support large-scale business operations.
WE MAY NOT SUCCESSFULLY INTEGRATE OUR OPERATIONS WITH THOSE OF NEOPATH, INC.,
AND THE INTEGRATION OF OUR BUSINESSES MAY BE COSTLY.
Due to our recent merger with NeoPath, Inc., integration of our operations
may temporarily distract our management's attention from the day-to-day business
of TriPath. If we fail to integrate the companies quickly and efficiently, our
business and results of operations could be impaired.
The integration of our operations will require us to, among other things:
- educate the employees of each company about the technologies and programs
of the other company;
- coordinate or combine research and development efforts;
- manage relationships with suppliers and customers of each of the
companies; and
- align the strategic plans of two previously independent management teams.
These integration efforts may be costly. For some period in the future, we
anticipate that there will be some duplication of functions. In addition, we may
need to pay to relocate people or equipment from one location to another. If we
have underestimated these initial costs of integration, then our initial results
as a combined company will be worse than anticipated.
If we fail or run into difficulties in any of these aspects of our
business, it would harm our future ability to become a profitable company.
OUR ABILITY TO SUCCESSFULLY MARKET AND SELL OUR PRODUCTS DEPENDS ON RECEIVING
AND MAINTAINING FDA APPROVAL OF OUR PRODUCTS.
The U.S. government extensively regulates the manufacture and sale of
medical diagnostic devices for commercial use. Government agencies in certain
other countries impose similar requirements. We must obtain FDA approval of our
products before we can market and sell them for their principal intended use in
the United States.
5
<PAGE> 6
Of our principal products, so far, only PREP and AutoPap have received FDA
approval for their principal intended uses. In addition, the FDA has not yet
approved the use of AutoPap to screen PREP slides. We filed a supplement to the
AutoPap PMA on October 6, 1999 to obtain FDA approval to use AutoPap to screen
PREP slides. This PMA supplement may not be approved on a timely basis, or at
all. If we fail to obtain and maintain FDA approval for any of our future
products, or if FDA approval is delayed or we receive FDA approval for our
products but labeling restrictions make the use of the products uneconomical to
customers, our future product sales will be far less than we anticipate and may
be insufficient to continue our operations.
To obtain FDA approval for our products, we must submit a premarket
approval application to the FDA. Several factors affect our ability to
successfully obtain FDA approval for the sale of our products, including the
following:
- we have only limited experience with the FDA premarket approval
application process;
- the premarket approval application process can be expensive and
time-consuming, frequently lasting three to five years or more;
- we have and may continue to encounter unanticipated delays or significant
unanticipated costs in our efforts to secure FDA approval;
- ultimately, we have no assurance that the FDA will ever approve our
products for their principal intended use; and
- even if we receive approval on the premarket approval applications for
our products, the FDA's approval may still not allow us to make some of
the specific claims for which we sought FDA approval.
In addition to the premarket approval application process, we may face
further difficulties in connection with FDA approval of our products for the
following reasons:
- FDA regulations require submission and approval of a premarket approval
application supplement for certain changes to a product if the changes
affect the safety and effectiveness of the product;
- even if we obtain FDA approval of our premarket approval applications,
that approval may include significant limitations on the indicated uses
for which we may market our products;
- any FDA approval may include significant limitations on the indicated
uses for which we may market our products, such as warnings, precautions
or contraindications, requests for postmarket studies, or additional
regulatory requirements; and
- an approved product is still subject to continual review and regulation
by the FDA and other regulatory agencies, so long as the product is being
marketed. During this continual review process, any subsequent discovery
of previously unknown problems with the product or a failure of the
product to comply with any applicable regulatory requirements can result
in, among other things:
- fines;
- the refusal of the FDA to approve further premarket approval
applications;
- suspension or withdrawal of our FDA approvals;
- product recalls;
- operating restrictions, including total or partial suspension of
production, distribution, sales and marketing;
- injunctions;
- civil penalties; or
- product seizures and criminal prosecution of our company, our officers
or our employees.
6
<PAGE> 7
The FDA may not approve future products or commercial enhancements to our
products on a timely basis, if at all. Our regulatory applications also may be
delayed or rejected based on changes in regulatory policies or regulations.
OUR LONG-TERM SUCCESS DEPENDS ON MARKET ACCEPTANCE OF OUR PRINCIPAL PRODUCTS IN
PLACE OF BOTH CONVENTIONAL PAP SMEARS AND COMPETITORS' PRODUCTS, AND WE CANNOT
GUARANTEE THAT WE WILL ACHIEVE THIS MARKET ACCEPTANCE.
Our success and growth depend primarily on market acceptance by clinical
laboratories, third party payors and health care providers of our products for
their primary intended use in cervical cancer screening. The market may never
widely accept our products. Market acceptance of our products will depend on our
ability to convince the market that:
- there are limitations in the conventional Pap smear process of sample
collection, slide preparation and screening; and
- our products are better than the conventional Pap smear process because
they substantially overcome its shortcomings.
We may not be able to convince the market that our products are cost
competitive compared to the conventional Pap smear process. In addition,
clinical laboratories, third-party payors, and health care providers may not
accept our products as a replacement to the conventional Pap smear collection
process. Even if PREP, AutoPap and other products do gain market acceptance,
their level of sales will still largely depend on the availability and level of
reimbursement from third-party payors, such as private insurance plans, managed
care organizations and Medicare and Medicaid.
THE CERVICAL CANCER DIAGNOSTIC MARKET HAS A NUMBER OF COMPANIES THAT POSSESS
SIGNIFICANT COMPETITIVE ADVANTAGES OVER US.
The diagnostic market for cervical cancer currently consists of both the
conventional Pap smear procedure and new and developing technologies. Some of
these newly-developed technologies have already received FDA approval with
product labeling that says they are significantly more effective than the
conventional Pap smear for the detection of disease in certain patient
populations. We may not be able to successfully compete against companies
marketing products based on competing technologies.
Certain of our existing and potential competitors may have several
competitive advantages over us because they:
- possess greater financial, marketing, sales, distribution and
technological resources;
- have more experience in research and development, clinical trials,
regulatory matters, customer support, manufacturing and marketing; and
- have received third-party payor reimbursement for their products.
These competitors may manufacture, market and sell their products or
services more successfully than us, which could adversely affect our product
sales.
DIRECT COMPETITORS MAY DEVELOP AND MARKET TECHNOLOGIES THAT COMPETE WITH OUR
PRODUCTS, AND THESE COMPETING PRODUCTS MAY REDUCE THE ATTRACTIVENESS OF OUR
PRODUCTS OR RENDER OUR PRODUCTS OBSOLETE.
Competition in the medical device industry is intense. Within the
diagnostic market for cervical cancer, we will face direct competition from
companies that manufacture thin-layer slide preparation or automated screening
systems. Our products could be rendered obsolete or uneconomical because of:
- technological advances by current or future competitors;
- the introduction and market acceptance of competitors' products; or
- the introduction and market acceptance of new cervical cancer detection
methods.
Our products must remain competitive in accuracy and effectiveness, cost,
including both charges by us to the laboratory and the laboratory's labor and
overhead costs, convenience, preception among influential cytopathologists and
laboratories, and processing speed and reliability. To effectively compete, we
must keep
7
<PAGE> 8
pace with the rapid product development and technological change in our
industry. Our products must demonstrate accuracy and cost effectiveness that
equals or exceeds conventional preparation and review of Pap smears and the
technology that may be offered by our competitors. We cannot guarantee that the
our products will be competitive in any of these areas.
WE MAY NEED TO RAISE A LARGE AMOUNT OF CAPITAL IN THE FUTURE TO SUSTAIN OUR
OPERATIONS AND THE FUNDING THAT WE MAY NEED MIGHT NOT BE AVAILABLE.
We have had negative cash flow from operations since we began doing
business, and we expect negative cash flow from our operations to continue at
least through 1999. At September 30, 1999, we had approximately $15.9 million in
cash, cash equivalents and marketable securities. We believe that our existing
cash and existing debt and lease financing will be sufficient to enable us to
meet our future cash obligation at least through 2000.
We believe that we will need additional funding to sustain our operations
and cover continuing losses until we are able to sustain our operations from the
sale of our products. We may be unable to obtain adequate funds, whether
obtained through financial markets or from collaborative or other arrangements
with corporate partners or other sources, when we need them, or we may be unable
to find adequate funding on favorable terms, if at all. If we were unable to
fund our future capital requirements, it would significantly harm our ability to
become a profitable company.
The size of our future capital requirements depends on several factors,
including:
- the progress and scope of clinical trials;
- the timing and costs of filing future regulatory submissions;
- the timing and costs required to receive both United States and foreign
governmental approvals;
- the cost of filing, prosecuting, defending and enforcing patent claims
and other intellectual property rights;
- the extent to which our products gain market acceptance;
- the timing and costs of product introductions;
- the extent of our ongoing research and development programs;
- the costs of training laboratory personnel to become proficient with the
use of our products; and
- the costs of developing marketing and distribution capabilities and
manufacturing sufficient quantities of our products.
Many of these factors will be out of our control. We cannot guarantee that
the assumptions underlying our estimates about our needs for future capital will
prove to be accurate.
OUR FUTURE FINANCING ARRANGEMENTS MAY DILUTE THE INTERESTS OF OUR STOCKHOLDERS
OR MAY REQUIRE US TO RELINQUISH IMPORTANT RIGHTS.
We may choose to raise additional funding to meet our future capital
requirements through a variety of financing methods, including:
- lease arrangements;
- debt or equity financings; or
- strategic alliances.
If we were to raise additional funding through the sale of equity or
securities convertible into equity, the value of the existing stockholders'
shares could be reduced. In addition, if we obtain additional funds through
arrangements with collaborative partners, we may have to relinquish rights to
certain of our technologies or potential products that we would otherwise seek
to develop or commercialize ourselves.
8
<PAGE> 9
THERE WILL BE A LIMITED NUMBER OF CUSTOMERS FOR OUR PRODUCTS.
A significant portion of our product sales will be concentrated among a
small number of large clinical laboratories. Moreover, due to consolidation in
the clinical laboratory industry, we expect that the number of potential
domestic customers for our products will decrease. These factors increase our
dependence on sales to the largest clinical laboratories and the bargaining
power of those potential customers. Our market research indicates that over 30%
of all U.S. Pap smears are processed by the two largest laboratories. Each of
these companies operates multiple laboratory facilities nationwide.
We will have to make this number of potential customers aware of our
products and then convince them to accept our products. To gain acceptance of
our products within this small customer base, we will have to successfully
demonstrate the benefits of our products over the conventional Pap smear process
and other alternative methods of sample collection, slide preparation and
cervical cancer screening. In addition, to generate demand for our products
among these clinical laboratories, we believe that we must:
- educate doctors and health care providers on, and convince them of, the
clinical benefits and cost-effectiveness of our products; and
- demonstrate to doctors and health care providers that adequate levels of
third-party payor reimbursement will be available for our products.
Ultimately, we may not be able to successfully sell our products to large
clinical laboratories. Even if we do successfully sell our products to large
clinical laboratories, those sales may not generate enough revenue to make us a
profitable company.
OUR HEAVY RELIANCE ON THE DEVELOPMENT AND PROTECTION OF PROPRIETARY TECHNOLOGY
MAKES US VULNERABLE TO THE INHERENT UNCERTAINTIES INVOLVED IN THE PROCESS OF
PATENT APPROVAL AND THE PROTECTION OF PROPRIETARY TECHNOLOGY.
To protect our proprietary technology, rights and know-how, we rely on a
combination of:
- patents;
- trade secrets;
- copyrights; and
- confidentiality agreements.
We hold 31 foreign patents, 100 U.S. patents (issued or allowed), and have
25 additional U.S. patents pending. These patents will expire in 2012-2018. Our
reliance on patents poses the following risks for our company:
- our pending patent applications may not ultimately issue as patents;
- patents we obtain may not be broad enough to protect our proprietary
rights;
- the claims allowed in any of our existing or future patents may not
provide competitive advantages for our products;
- competitors may challenge or circumvent our patents or pending
applications; and
- in certain foreign countries, protection of our patent and other
intellectual property may be unavailable or very limited.
In addition, the large role that patents play in our industry in general
may pose the following risks for our company:
- we cannot be sure that our products or technologies do not infringe
patents of competitors that may be granted in the future pursuant to
pending patent applications;
9
<PAGE> 10
- we cannot be sure that our products do not infringe any existing patents
or proprietary rights of third parties; and
- we cannot be sure that a court would rule that our products do not
infringe any existing third-party patents or would invalidate any
existing patents in our favor.
If a court were to uphold any claims of infringement made by existing
patent holders, we could then be:
- prevented from selling our products;
- required to obtain licenses from the owners of the patents; or
- required to redesign our products.
In the event that a court were to uphold a claim of patent infringement
against us, we may not be able to obtain licenses from the owners of the patents
or be able to successfully redesign our products to avoid patent infringement.
If we were unable to obtain the necessary licenses or successfully redesign our
products, it could seriously harm our ability to become a profitable company.
THE SUCCESSFUL SALE OF OUR PRODUCTS DEPENDS ON WHETHER THIRD-PARTY PAYORS WILL
ADEQUATELY REIMBURSE THEIR CUSTOMERS FOR THE USE OF OUR PRODUCTS, AND
THIRD-PARTY PAYORS MAY PROVIDE LITTLE IF ANY REIMBURSEMENT FOR THE USE OF OUR
PRODUCTS.
Our ability to successfully sell our products for cervical cancer screening
in the United States and other countries depends on the availability of adequate
reimbursement from third-party payors such as private insurance plans, managed
care organizations and Medicare and Medicaid. Virtually all of our revenues will
be dependent on customers who rely on third party reimbursement. Third-party
healthcare payors in the United States are increasingly sensitive to containing
healthcare costs and heavily scrutinize new technology as a primary factor in
increased healthcare costs. Third-party payors may influence the pricing or
perceived attractiveness of our products and services by regulating the maximum
amount of reimbursement they provide or by not providing any reimbursement.
Medical community or third-party healthcare payors may deny or delay acceptance
of our products or may provide reimbursement at levels that are inadequate to
support adoption of our technologies.
If these payors do not reimburse for our preparation and screening
products, or provide reimbursement significantly below the amount laboratories
charge patients to perform screening with our products, our potential market and
revenues will be significantly limited. Use of our products may never become
widely reimbursed, and the level of reimbursement we obtain may never be
sufficient to permit us to generate substantial revenue.
Convincing third-party payors to provide reimbursement is a costly and time
consuming process for the following reasons:
- reimbursement approval is required from each payor individually; and
- obtaining this approval from the third-party payor requires us to provide
scientific and clinical data to support the use of our products to each
payor separately.
Ultimately, whether a third-party payor is willing to provide reimbursement
for the use of our products at a level that can allow our company to succeed
depends on several unpredictable factors, including:
- the level of demand for our products by physicians;
- the payor's determination that our products are an improvement over the
conventional Pap smear process; and
- the payor's determination that our products are safe and effective,
medically necessary, appropriate for specific patient populations, and
cost effective.
We may face particular difficulties convincing third-party payors that our
products are cost effective because the up-front, direct costs of using our
products will initially be greater than the cost of the
10
<PAGE> 11
conventional Pap smear. As a result, we will need to convince third-party payors
that the use of our products will result in a net overall cost savings to the
health care system because our products will allow earlier detection of cervical
cancer and thus reduce the number of biopsies and colposcopies that need to be
performed. We may not be able to successfully convince third-party payors that
our products will prove cost effective in the long run.
WE NEED TO INCREASE OUR MARKETING AND SALES CAPABILITIES, AND WE MAY NOT BE ABLE
TO DO THIS SUCCESSFULLY.
We currently have a limited marketing and sales force. To effectively
market our products, we may need to substantially increase our direct sales
force. Even if we increase the size of our direct sales force, our present or
future sales force may not be able to successfully promote our products to
clinical laboratories, health care providers or third-party payors. In addition,
we must educate health care providers and third-party payors regarding the
clinical benefits and cost-effectiveness of our products because of the market's
limited awareness of our products. We may not be able to recruit and retain
skilled marketing, sales, service or support personnel to help us achieve these
goals. Even if we are able to recruit and retain skilled marketing, sales,
service or support personnel, they may not be successful.
Our marketing success in the United States and abroad will depend on
whether we can:
- obtain required regulatory approvals;
- successfully demonstrate the cost-effectiveness and
clinical-effectiveness of our products;
- further develop our direct sales capabilities; and
- establish arrangements with contract sales organizations, distributors
and marketing partners.
If we cannot successfully expand our marketing and sales capabilities in
the United States and in international markets, we may never become a profitable
company.
WE PLAN TO MANUFACTURE PREP, BUT WE HAVE LIMITED MANUFACTURING EXPERIENCE AND
CAPACITY.
We intend to manufacture PREP at our Burlington facility. Currently we have
limited manufacturing experience and capabilities.
We expect that we may have to substantially increase our manufacturing
capabilities. We may not be able to recruit and retain skilled manufacturing
personnel to establish sufficient manufacturing capability and capacity. Even if
we are able to establish sufficient manufacturing capability and capacity, we
still may be unable to manufacture our products:
- in a timely manner;
- at a cost or in quantities necessary to make them commercially viable;
- in conformance with Quality System requirements; or
- in a manner which otherwise insures our products' quality.
If we cannot successfully increase our manufacturing capability and
capacity, or successfully contract with third parties to manufacture our
products, we may never become a profitable company.
WE MAY BE UNABLE TO ATTAIN OR MAINTAIN REQUIRED COMPLIANCE WITH REGULATIONS
GOVERNING MANUFACTURING OF MEDICAL DIAGNOSTIC DEVICES, AND OUR FAILURE TO DO SO
COULD PREVENT US FROM SELLING OUR PRODUCTS.
Manufacturers of medical diagnostic devices face strict federal regulations
regarding the quality of manufacturing. For example, the FDA periodically
inspects the manufacturing facilities of diagnostic device manufacturers to
determine compliance with regulations. Our current and future manufacturing and
design operations must comply with these and all other applicable regulations,
including regulations imposed by other governments. If we fail to comply with
quality systems regulations we could face civil or criminal penalties or
enforcement proceedings. These proceedings may require us to recall a product,
to stop placing our products in
11
<PAGE> 12
service or to stop selling our products. Similar results could occur if we
violate equivalent foreign regulations. We may not be able to attain or maintain
compliance with quality systems requirements. Any failure to comply with the
applicable manufacturing regulations would have a material adverse effect on our
business.
WE DEPEND ON SINGLE AND LIMITED SOURCE SUPPLIERS FOR CERTAIN COMPONENTS IN OUR
PRODUCTS.
We currently obtain certain components of our products on a single source
basis from certain suppliers. If we were unable to successfully obtain
sufficient quantities of components on a cost-competitive and timely basis from
these single and limited source suppliers, we would not be able to manufacture
our products in a cost effective or timely manner. If we cannot manufacture our
products in a cost effective or timely manner, it would harm our ability to
become a profitable company.
If any of the components of our products were no longer available in the
marketplace, we could be forced to further develop our technology to incorporate
alternate components. We also may try to establish relationships with additional
suppliers or vendors for components for our products, so long as we are not
prohibited from doing so by any existing contractual obligations. We may not be
able to further develop our technology to incorporate new components or
establish relationships with additional suppliers or vendors for the necessary
components of our products.
The use of any new components or replacement components from alternative
suppliers into our products may require us to submit premarket approval
application supplements to the FDA. We would then need FDA approval on any
premarket approval application supplements we have filed before we could market
our products with new or replacement components.
Ultimately, we may not be able to successfully develop, obtain, or
incorporate replacement components into our products. Even if we were able to
successfully incorporate new components into our products, the FDA may not
approve these new components quickly, if at all.
FUTURE PRODUCT LIABILITY CLAIMS MAY STRAIN OUR FINANCIAL RESOURCES AND HARM OUR
BUSINESS REPUTATION.
The commercial screening of Pap smears has generated significant
malpractice litigation. As a result, we face product liability, errors and
omissions or other claims if our products are alleged to have caused a false-
negative diagnosis. Although we have product liability insurance, it could
become increasingly difficult for us to obtain and maintain reasonable product
liability coverage. Our product liability coverage could be limited to amounts
less than we desire. Substantial increases in insurance premium costs often make
coverage economically impractical. We may not be able to obtain adequate product
liability insurance at a reasonable cost. Thus, product liability claims may
strain our financial resources and harm our business reputation.
INTENSE COMPETITION FOR THE SERVICES OF OUR KEY PERSONNEL COULD CAUSE THEM TO
LEAVE TRIPATH.
We will depend heavily on the principal members of our management and
scientific staff. The loss of their services might impede achievement of our
strategic objectives or research and development. Our success depends on our
ability to retain key employees and to attract additional qualified employees,
which may be particularly difficult to do in the future. Competition for highly
skilled scientific and management personnel is intense, particularly in the
geographic areas in which we currently are located, and these resources are
scarce relative to the needs of a growing high technology business sector. The
failure to recruit such personnel or the loss of existing personnel could
adversely affect our business.
12
<PAGE> 13
USE OF PROCEEDS
The selling stockholders will receive all of the net proceeds from sales of
the common stock sold pursuant to this prospectus.
SELLING STOCKHOLDER
The following table and footnotes set forth certain information regarding
the beneficial ownership of the selling stockholder named in the table:
<TABLE>
<CAPTION>
SHARES OF
NUMBER OF SHARES COMMON STOCK
OF COMMON STOCK BENEFICIALLY OWNED
BENEFICIALLY AFTER OFFERING(1)
OWNED PRIOR NUMBER OF SHARES --------------------
SELLING STOCKHOLDER TO OFFERING BEING OFFERED SHARES PERCENT
------------------- ---------------- ---------------- --------- -------
<S> <C> <C> <C> <C>
Neuromedical Systems, Inc.,
as debtor and debtor in possession(2)...... 1,400,000 1,400,000 -- --
10 Mountainview Road, Suite C-100
Upper Saddle River, NJ 07458
</TABLE>
- ---------------
(1) The selling stockholder named in the table has sole voting and investment
power with respect to the shares beneficially owned by it.
(2) As discussed in the "Plan of Distribution" the selling stockholder acquired
the shares in exchange for certain assets purchased by us from the selling
stockholder out of the bankruptcy proceedings.
PLAN OF DISTRIBUTION
The selling stockholder is a debtor in proceedings for reorganization under
Chapter 11 of the United States Bankruptcy Code and received the shares covered
by this prospectus in exchange for certain assets purchased by us from the
selling stockholder as the result of a sale process conducted in the bankruptcy
proceedings. The selling stockholder holds the shares as assets of the debtor
and debtor in possession in the Chapter 11 proceedings for the benefit of its
creditors and may sell or distribute the shares only as authorized in the
Chapter 11 proceedings. Subject thereto, the selling stockholder (and donees,
pledgees, transferees or other successors in interest receiving shares from the
selling stockholder after the date of this prospectus) may offer the shares of
common stock covered by this prospectus from time to time in privately
negotiated transactions, including transactions with its creditors and
shareholders, or in open market transactions, including transactions in the
over-the-counter market, on any exchange where the common stock is then listed,
with broker-dealers or third-parties other than in the over-the-counter market
or on an exchange (including in block sales), in connection with short sales, in
connection with writing call options or in other hedging arrangements, or in
transactions involving a combination of such methods.
The selling stockholder may sell its shares at market prices prevailing at
the time of sale, at prices related to such prevailing market prices, at
negotiated prices or at fixed prices.
The selling stockholder may use dealers, agents or underwriters to sell its
shares. Underwriters may use dealers to sell such shares. If this happens, the
dealers, agents or underwriters may receive compensation in the form of
discounts or commissions from the selling stockholder, purchasers of shares or
both (which compensation to a particular broker might be in excess of customary
compensation).
The selling stockholder and any dealers, agents or underwriters that
participate with the selling stockholder in the distribution of the shares may
be deemed to be "underwriters" as such term is defined in the Securities Act of
1933, as amended. Any commissions paid or any discounts or concessions allowed
to any such persons, and any profits received on the resale of such shares of
common stock offered by this prospectus, may be deemed to be underwriting
commissions or discounts under the Securities Act.
As of the date of this prospectus, the selling stockholder has not advised
us that it has made, or the court has approved, any arrangements as to the
distribution of the shares covered by this prospectus in the form of a
13
<PAGE> 14
plan of reorganization or otherwise except for the transfer of a certain number
of shares to Houlihan, Lockey, Howard & Zuckin for services rendered to the
selling stockholder. To the extent required, we will amend or supplement this
prospectus to disclose material arrangements regarding the plan of distribution.
To comply with the securities laws of certain jurisdictions, the shares
offered by this prospectus may need to be offered or sold in such jurisdictions
only through registered or licensed brokers or dealers.
Under applicable rules and regulations under the Securities Exchange Act,
any person engaged in a distribution of the shares of common stock covered by
this prospectus may be limited in its ability to engage in market activities
with respect to such shares. The selling stockholder, for example, will be
subject to applicable provisions of the Securities Exchange Act of 1934 and the
rules and regulations under it, which provisions may limit the timing of
purchases and sales of any shares of common stock by the selling stockholder.
The foregoing may affect the marketability of the shares offered by this
prospectus.
We will pay certain expenses of the offering and issuance of the shares
covered by this prospectus, including the printing, legal and accounting
expenses we incur and the registration and filing fees imposed by the SEC or the
Nasdaq National Market. We also have agreed to indemnify the selling
stockholders against certain civil liabilities, including liabilities under the
Securities Act. We will not pay brokerage commissions or taxes associated with
sales by the selling stockholders or any legal, accounting and other expenses of
the selling stockholder.
We have agreed with the selling stockholder, subject to certain conditions,
to keep the registration statement of which this prospectus constitutes a part
effective until the selling stockholder may sell all of the shares without
registration pursuant to Rule 144(k) under the Securities act or, if earlier,
such time as all of the shares have been disposed of pursuant to and in
accordance with the registration statement.
LEGAL MATTERS
Palmer & Dodge LLP, Boston, Massachusetts, counsel to TriPath, is giving
TriPath an opinion on the validity of the shares covered by this prospectus.
EXPERTS
Ernst & Young LLP, independent auditors, have audited our supplemental
consolidated financial statements and schedules as of December 31, 1998 and 1997
and for each of the three years in the period ended December 31, 1998 as set
forth in their reports. Our financial statements are incorporated herein by
reference in reliance upon Ernst & Young LLP's reports given upon their
authority as experts in accounting and auditing.
Ernst & Young LLP, independent auditors, have audited our consolidated
financial statements as of December 31, 1998 and 1997 and for the years ended
December 31, 1998 and 1997 and for the period from November 22, 1996 (inception)
to December 31, 1996 and of the Cytology and Pathology Automation Business of
Roche Image Analysis Systems as of December 31, 1995 and November 21, 1996 and
for the years ended December 31, 1994 and 1995 and for the period from January
1, 1996 to November 21, 1996 as set forth in their report. Our financial
statements are incorporated herein by reference in reliance upon Ernst & Young
LLP's reports given upon their authority as experts in accounting and auditing.
Ernst & Young LLP, independent auditors, have audited NeoPath's
consolidated financial statements and schedules as of December 31, 1998 and 1997
and for each of the three years in the period ended December 31, 1998 as set
forth in their reports. NeoPath's financial statements are incorporated herein
by reference in reliance upon Ernst & Young LLP's reports given upon their
authority as experts in accounting and auditing.
WHERE YOU CAN FIND MORE INFORMATION
We file annual, quarterly and special reports, proxy statements and other
information with the SEC. You may read and copy any reports, statements or other
information that we file at the SEC's public reference
14
<PAGE> 15
rooms at Room 1024, Judiciary Plaza, 450 Fifth Street, N.W., Washington, D.C.
20549, and at the SEC's Regional Offices located at 7 World Trade Center, Suite
1300, New York, New York 10048 and at Citicorp Center, 500 West Madison Street,
Suite 1400, Chicago, Illinois 60661-2511. Please call the SEC at 1-800-SEC-0330
for further information on the public reference rooms. Our SEC filings should
also be available to the public from commercial document retrieval services and
at the Internet web site maintained by the SEC at http://www.sec.gov.
The SEC allows us to "incorporate by reference" information contained in
documents we file with them, which means that we may disclose important
information by referring to those documents. The information incorporated by
reference is a part of this prospectus and will automatically be updated and
superseded by the information that we later file. We incorporate by reference
the documents listed below and any future filings we make with the SEC under
Sections 13(a), 13(c), 14 or 15(d) of the Securities Exchange Act of 1934 prior
to the sale of all the shares covered by this prospectus:
1. Annual Report on Form 10-K filed with the SEC on March 24, 1999.
2. Quarterly Reports on Form 10-Q filed with the SEC on May 14, 1999,
August 13, 1999 and November 15, 1999.
3. Current Reports on Form 8-K filed with the SEC on March 17, 1999, June
4, 1999, September 30, 1999, and November 18, 1999.
4. The description of our capital stock contained in our Registration
Statement on Form 8-A filed with the SEC on July 25, 1997.
If you are a stockholder, we may have sent you some of the documents
incorporated by reference, but you can obtain any of them through us, the SEC or
the SEC's Internet web site as described above. You may request a copy of any of
our filings, at no cost, by writing or telephoning us at the following address
or number:
TriPath Imaging, Inc.
780 Plantation Drive
Burlington, North Carolina 27215
(336) 222-9707
You should rely only on the information contained or incorporated by
reference in this prospectus or any supplement. We have not authorized anyone to
provide you with information that is different from what is contained in this
prospectus. The selling stockholders will not make an offer of these shares in
any state where the offer is not permitted. You should not assume that the
information contained in this prospectus or any supplement is accurate as of any
date other than the date on the front of those documents.
15
