Filed pursuant to Rule 424(b)(3)
Registration No. 333-85658
PROSPECTUS
5,560,238 SHARES
INVERNESS MEDICAL INNOVATIONS, INC.
COMMON STOCK
(par value $0.001 per share)
This prospectus relates to the offer and sale by the selling stockholders
identified in this prospectus, and any of their pledgees, donees, transferees or
other successors in interest, of up to an aggregate of 5,560,238 shares of
common stock of Inverness Medical Innovations, Inc. The shares include up to
(1) 5,053,826 shares of common stock issued or issuable upon the conversion of
Series A Convertible Preferred Stock and (2) 506,412 shares of common stock
issuable upon the exercise of warrants. We are filing the registration statement
of which this prospectus is a part at this time primarily to fulfill contractual
obligations to do so, which we undertook at the time of the original issuance of
the shares of Series A Convertible Preferred Stock and the warrants. We will not
receive any of the proceeds from the sale of the common stock by the selling
stockholders, but we are bearing the expenses of registration.
Our common stock is listed on the American Stock Exchange under the symbol
"IMA." On May 13, 2002, the last reported sale price of our common stock on the
American Stock Exchange was $27.00.
SEE "RISK FACTORS" BEGINNING ON PAGE 2 FOR A DISCUSSION OF CERTAIN FACTORS
THAT YOU SHOULD CONSIDER BEFORE YOU INVEST IN OUR COMMON STOCK.
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NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES
COMMISSION HAS APPROVED OR DISAPPROVED OF THESE SECURITIES, OR DETERMINED IF
THIS PROSPECTUS IS TRUTHFUL OR COMPLETE. ANY REPRESENTATION TO THE CONTRARY IS A
CRIMINAL OFFENSE.
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The date of this Prospectus is June 3, 2002
TABLE OF CONTENTS
PAGE
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Prospectus Summary.......................................... 1
Risk Factors................................................ 2
Special Statement Regarding Forward-Looking Statements...... 17
Registration Rights of the Selling Stockholders............. 18
The Selling Stockholders.................................... 19
Use of Proceeds............................................. 21
Plan of Distribution........................................ 22
Incorporation of Documents by Reference..................... 24
Where You Can Find More Information......................... 25
Experts..................................................... 25
Legal Matters............................................... 26
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YOU SHOULD RELY ONLY ON THE INFORMATION CONTAINED OR INCORPORATED BY
REFERENCE IN THIS PROSPECTUS. NEITHER WE NOR THE SELLING STOCKHOLDERS HAVE
AUTHORIZED ANYONE ELSE TO PROVIDE YOU WITH DIFFERENT OR ADDITIONAL INFORMATION.
THIS PROSPECTUS IS NEITHER AN OFFER TO SELL NOR A SOLICITATION OF AN OFFER
TO BUY SHARES OF COMMON STOCK IN ANY JURISDICTION IN WHICH AN OFFER OR SALE
WOULD BE UNLAWFUL. YOU SHOULD NOT ASSUME THAT THE INFORMATION CONTAINED IN THIS
PROSPECTUS IS CORRECT ON ANY DATE AFTER THE DATE OF THIS PROSPECTUS STATED AT
THE BOTTOM OF THE COVER PAGE HEREOF, EVEN THOUGH THIS PROSPECTUS IS DELIVERED,
OR THE SELLING STOCKHOLDERS OFFER OR SELL THE SHARES OF COMMON STOCK, ON A LATER
DATE.
PROSPECTUS SUMMARY
THIS SUMMARY ONLY HIGHLIGHTS THE MORE DETAILED INFORMATION APPEARING
ELSEWHERE IN THIS PROSPECTUS OR INCORPORATED HEREIN BY REFERENCE. AS THIS IS A
SUMMARY, IT MAY NOT CONTAIN ALL INFORMATION THAT IS IMPORTANT TO YOU. YOU SHOULD
READ THIS ENTIRE PROSPECTUS CAREFULLY BEFORE DECIDING WHETHER TO INVEST IN OUR
COMMON STOCK.
THIS PROSPECTUS CONTAINS FORWARD-LOOKING STATEMENTS. YOU SHOULD READ THE
EXPLANATION OF THE QUALIFICATIONS AND LIMITATIONS ON SUCH FORWARD-LOOKING
STATEMENTS ON PAGE 17 OF THIS PROSPECTUS. YOU SHOULD ALSO CAREFULLY CONSIDER THE
VARIOUS RISK FACTORS BEGINNING ON PAGE 2 OF THIS PROSPECTUS, WHICH RISK FACTORS
MAY CAUSE OUR ACTUAL RESULTS TO DIFFER MATERIALLY FROM THOSE INDICATED BY SUCH
FORWARD-LOOKING STATEMENTS. YOU SHOULD NOT PLACE UNDUE RELIANCE ON OUR
FORWARD-LOOKING STATEMENTS.
UNLESS THE CONTEXT OTHERWISE REQUIRES, ALL REFERENCES TO "WE," "US," "OUR
COMPANY" OR "THE COMPANY" IN THIS PROSPECTUS REFER COLLECTIVELY TO INVERNESS
MEDICAL INNOVATIONS, INC., A DELAWARE CORPORATION, AND ITS SUBSIDIARIES, AND
THEIR RESPECTIVE PREDECESSOR ENTITIES FOR THE APPLICABLE PERIODS, CONSIDERED AS
A SINGLE ENTERPRISE.
------------------------
ABOUT INVERNESS MEDICAL INNOVATIONS, INC.
We develop, manufacture and market consumer healthcare products, including
self-test diagnostic products for the women's health market and vitamins and
nutritional supplements. To a lesser extent, we develop, manufacture and market
clinical diagnostic products for use by medical professionals. Our consumer
self-test diagnostic products allow individuals to obtain accurate information
regarding various medical conditions on a confidential, non-prescription basis,
without the expense, inconvenience and delay associated with physician visits or
laboratory testing. This information gives individuals greater control over
their health and their lives, allowing them to make informed decisions and take
action to protect their health, alone or in consultation with healthcare
professionals. Our existing self-test products are targeted at the women's
health market, one of the largest existing markets for self-care diagnostics,
and include home pregnancy detection tests and ovulation prediction tests. We
also sell a wide variety of vitamins and nutritional supplements. Our clinical
diagnostic products include test kits used by smaller laboratories, physicians'
offices and other point-of-care sites for the detection of pregnancy and a wide
variety of infectious diseases.
Inverness Medical Innovations, Inc. is a Delaware corporation. Our principal
executive offices are located at 51 Sawyer Road, Suite 200, Waltham, MA 02453.
Our telephone number is (781) 647-3900. Our website is
http://www.invernessmedical.com. Our common stock is listed on the American
Stock Exchange under the symbol "IMA."
THE OFFERING
This prospectus relates to up to 5,560,238 shares of our common stock that
may be offered for sale by the selling stockholders. The shares include up to
(1) 5,053,826 shares of common stock issued or issuable upon the conversion of
Series A Convertible Preferred Stock and (2) 506,412 shares of common stock
issuable upon the exercise of warrants. We are registering the common stock
covered by this prospectus in order to fulfill our contractual obligations to do
so, which we undertook at the time of the original issuance of the shares of
Series A Convertible Preferred Stock and the warrants. Registration of the
common stock does not necessarily mean that all or any portion of such stock
will be offered for sale by the selling stockholders.
We have agreed to bear the expenses of the registration of the common stock
under federal and state securities laws, but we will not receive any proceeds
from the sale of any common stock offered under this prospectus.
PLAN OF DISTRIBUTION
The selling stockholders may sell the securities through agents or dealers,
directly to one or more individuals, institutional or other purchasers or
through any combination of these methods of sale. The distribution of the
securities may be effected in one or more transactions at market prices then
prevailing at the time of sale, at prices related to such prevailing market
prices, or at negotiated prices. See "Plan of Distribution."
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RISK FACTORS
There are various risks, including those described below, which may
materially impact your investment in our company or may in the future, and, in
some cases already do, materially affect us and our business, financial
condition and results of operations. You should consider carefully these
factors, as well as the risk factors identified from time to time in our
periodic filings with the Securities and Exchange Commission, in connection with
your investment in our securities. This section includes or refers to certain
forward-looking statements; you should read the explanation of the
qualifications and limitations on such forward-looking statements on page 17 of
this prospectus.
RISKS RELATED TO THE SPLIT-OFF
On November 21, 2001, we were split-off from Inverness Medical
Technology, Inc. (IMT), our former parent, and became an independent, publicly
owned company as part of a transaction by which IMT was acquired by Johnson &
Johnson. Prior to that time, we had been a majority owned subsidiary of IMT, and
the businesses that we acquired in connection with the restructuring that
preceded the split-off represented approximately 20% of IMT's net product sales
during the calendar quarter concluded immediately prior to the split-off. We
continue to face a unique set of challenges and risks arising out of the
split-off.
OUR BUSINESSES WILL FACE CHALLENGES AS PART OF A STAND-ALONE COMPANY THAT WE DID
NOT EXPERIENCE AS PART OF IMT.
As an independent, publicly owned company, we now face new issues and
challenges that we did not experience when we were part of IMT. Examples of
potential issues include:
- our inability to rely on the long-term financial strength of IMT;
- our inability to rely on the earnings, cash flow, assets and goodwill of
IMT's diabetes business;
- our inability to rely on the experience and business relationships of some
personnel who remained with IMT;
- greater difficulty in obtaining financing on terms satisfactory to us, if
needed;
- greater difficulty in obtaining and maintaining insurance on terms that
are acceptable to us;
- increased costs of hiring and retaining employees in departments
previously shared by all the businesses of IMT, including the legal, risk
management, tax, treasury, human resources and public relations
departments; and
- generally increased overhead and administrative costs as a result of
establishing a stand-alone company.
We may not resolve these issues or overcome these challenges. As a result, we
may not succeed in generating and expanding customer relationships, containing
costs and expenses and enhancing our business. In addition, competitive and
market factors specific to the consumer diagnostics, vitamins and nutritional
supplements and clinical diagnostics industries will more significantly impact
our smaller, less diversified company.
OUR BUSINESSES TRADITIONALLY RELIED ON IMT FOR FINANCIAL ASSISTANCE AND MAY HAVE
DIFFICULTY WITH LIQUIDITY AND CAPITAL REQUIREMENTS WITHOUT THIS ASSISTANCE.
Prior to the split-off, our businesses relied on the earnings, assets and
cash flow of IMT for liquidity, capital requirements and administrative
services. In the past, when the liquidity needs of our businesses exceeded their
cash flow, IMT provided the necessary funds. As a result of the split-off, we
can no longer rely on IMT for financial assistance. Accordingly, if we are
unable to generate sufficient cash flow or borrow sufficient amounts under our
credit facilities to fund our working capital needs and to pay our debts, we
will need to obtain additional financing. We do not know if we can obtain
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additional financing or if the terms of any required financing will be
acceptable to us. If we are unable to fund our working capital needs and
additional growth through our existing credit facilities, cash flow, or
additional financing, or if additional financing is not available under
acceptable terms to us, our business prospects, results of operations, cash flow
and future growth will be negatively affected.
OUR HISTORICAL FINANCIAL INFORMATION MAY NOT BE REPRESENTATIVE OF OUR RESULTS AS
A SEPARATE COMPANY.
Certain historical financial information included in our reports filed from
time to time with the Securities and Exchange Commission, including our annual
report on Form 10-K, as amended, for the year ended December 31, 2001 and our
quarterly report on Form 10-Q for the quarter ended March 31, 2002, reports on
time periods prior to the split-off and reflects the operating history of our
businesses when they were a part of IMT. As a result, this financial information
may not reflect what our results of operations, financial position and cash
flows would have been had we been a separate, stand-alone company during such
periods. This financial information also may not reflect what our results of
operations, financial position and cash flows will be in the future. This is not
only related to the various risks associated with the fact that we have not been
a stand-alone company for a long period of time, but also because:
- various adjustments and allocations were made to the financial statements
included in such reports because IMT did not account for us as a single
stand-alone business for any period prior to the split-off; and
- the information does not reflect many significant changes that occurred in
our financial condition, capital structure and operations as a result of
our separation from IMT.
The adjustments and allocations we made in preparing such financial information
may not appropriately reflect our operations during the periods prior to the
split-off presented as if we had operated as a stand-alone company during such
periods.
THE CHANGE OF SOME PERSONNEL IN OUR COMPANY IN CONJUNCTION WITH THE SPLIT-OFF
MAY IMPACT OUR BUSINESS.
Some of IMT's personnel became our initial employees, while others did not.
In particular, certain significant employees of IMT who were engaged primarily
in the diabetes care products business remained with that business. In addition,
some members of IMT's management who worked substantially for IMT's diabetes
care products business became our employees. Finally, some IMT personnel who
provided services beneficial to our businesses through their work in IMT's
accounting, sales, marketing, operations, quality assurance, regulatory
compliance and other areas did not become part of our company after the
split-off or, in certain cases, their services may only be available to us on a
transitional basis for a short period of time. The loss of certain significant
employees, the transition of personnel from IMT's diabetes business to our
company and the loss of other IMT personnel who will not become our employees
may impact or disrupt our sales and marketing activities, our research and
development efforts or our administrative functions.
OUR STOCK PRICE MAY FLUCTUATE SIGNIFICANTLY AND STOCKHOLDERS WHO BUY OR SELL OUR
COMMON STOCK MAY LOSE ALL OR PART OF THE VALUE OF THEIR INVESTMENT, DEPENDING ON
THE PRICE OF OUR COMMON STOCK FROM TIME TO TIME.
Our common stock has only been listed on The American Stock Exchange since
November 23, 2001. Because we have been listed for only a short period of time,
we cannot assure you that an active trading market in our common stock will
develop or be sustained in the future. Our common stock may experience
volatility until trading values become established. As a result, it could be
difficult to make purchases or sales of our common stock in the market at any
particular time.
IMT stockholders immediately prior to the split-off became stockholders of
our company immediately after the split-off. Some stockholders who received our
common stock in the split-off may
3
decide that they do not want to maintain an investment in a company involved
primarily in consumer and clinical diagnostic products and vitamins and
nutritional supplements or in a public company that has a limited track record
as a stand-alone company. If these stockholders decide to sell all or some of
their shares or if the market perceives that those sales could occur, the
trading value of your shares may decline. In addition, because we will be a
smaller and less diversified company than IMT, market analysts and the
investment community may not follow our common stock as closely as they have
followed IMT common stock in the past. If there is only a limited following by
market analysts or the investment community, the amount of market activity in
our common stock may be reduced, making it more difficult for you to sell your
shares.
In addition, our share price may be volatile due to our operating results,
as well as factors beyond our control. It is possible that in some future
periods the results of our operations will be below the expectations of the
public market. In any such event, the market price of our common stock could
decline. Furthermore, the stock market may experience significant price and
volume fluctuations, which may affect the market price of our common stock for
reasons unrelated to our operating performance. The market price of our common
stock may be highly volatile and may be affected by factors such as:
- our quarterly and annual operating results, including our failure to meet
the performance estimates of securities analysts;
- changes in financial estimates of our revenues and operating results or
buy/sell recommendations by securities analysts;
- the timing of announcements by us or our competitors of significant
products, contracts or acquisitions or publicity regarding actual or
potential results or performance thereof;
- changes in general conditions in the economy, the financial markets or the
health care industry;
- government regulation in the health care industry;
- changes in other areas such as tax laws;
- sales of substantial amounts of common stock or the perception that such
sales could occur;
- changes in investor perception of our industry, our businesses or our
prospects; or
- other developments affecting us or our competitors.
WE ARE OBLIGATED TO INDEMNIFY IMT AND OTHERS FOR LIABILITIES WHICH COULD REQUIRE
US TO PAY IMT AMOUNTS THAT WE MAY NOT HAVE.
The restructuring agreement, post-closing covenants agreement and related
agreements entered into in connection with the split-off and merger transaction
with Johnson & Johnson provide that we will indemnify IMT and other related
persons for specified liabilities related to our businesses, statements in the
proxy statement/prospectus issued in connection with the split-off and merger
about our businesses and breaches of our obligations under the restructuring
agreement, post-closing covenants agreement and related agreements. We are also
required to indemnify IMT for losses, if any, arising from the failure to amend
some outstanding warrants for the purchase of IMT common stock.
In addition, under our tax allocation agreement with IMT and Johnson &
Johnson, we will indemnify Johnson & Johnson and IMT for any unpaid tax
liabilities attributable to the pre-split-off operation of our consumer
diagnostics, vitamins and nutritional supplements and clinical diagnostics
businesses.
While no claims for indemnification have yet been made (and may never be
made), we are unable to predict the amount, if any, that may be required for us
to satisfy our indemnification obligations under these agreements. However, if
claims are made for indemnification and we are liable for such claims, the
amount could be substantial. In such an event, we may not have sufficient funds
available to satisfy our potential indemnification obligations. In addition, we
may be unable to obtain the funds on
4
terms satisfactory to us, if at all. If we are unable to obtain the necessary
funds, we will need to consider other alternatives, including sales of assets,
to raise necessary funds.
RISKS RELATED TO OUR BUSINESS
OUR BUSINESS HAS SUBSTANTIAL INDEBTEDNESS WHICH COULD RESULT IN ADVERSE
CONSEQUENCES FOR US.
As of March 31, 2002, we had approximately $66.7 million of outstanding
indebtedness under our credit facilities and other debt-related instruments. Our
substantial level of debt affects our future operations in several important
ways, including the following:
- our ability to obtain additional financing may be impaired;
- our flexibility to adjust to market conditions is limited, leaving us
vulnerable in a downturn in general economic conditions or in our business
and less able to plan for, or react to, changes in our business and the
industries in which we operate;
- we may need to use a large portion of our cash flow from operations to pay
principal and interest on our indebtedness, which would reduce the amount
of cash available to finance our operations and other business activities
and may require us, in order to meet our debt service obligations, to
delay or reduce capital expenditures or the introduction of new products
and/or forego business opportunities including acquisitions, research and
development projects or product design enhancements; and
- we may be at a competitive disadvantage compared to our competitors that
have less debt.
Furthermore, there can be no assurance that our cash flow from operations and
capital resources will be sufficient to pay our indebtedness. If our cash flow
and capital resources prove inadequate we could face substantial liquidity
problems and might be required to dispose of material assets or operations,
restructure or refinance our debt or seek additional equity capital.
Additionally, the agreements governing our indebtedness subject us to
various restrictions on our ability to engage in certain activities, including,
among other things, our ability to:
- incur additional indebtedness;
- acquire other businesses;
- make capital or finance lease expenditures; and
- dispose of assets.
These restrictions may limit our ability to pursue business opportunities or
strategies that we would otherwise consider to be in the best interests of our
stockholders.
OUR CREDIT FACILITIES CONTAIN CERTAIN FINANCIAL COVENANTS AND OTHER CONDITIONS
THAT WE MAY NOT SATISFY WHICH, IF NOT SATISFIED, COULD RESULT IN THE
ACCELERATION OF THE AMOUNTS DUE UNDER OUR CREDIT FACILITIES AND THE LIMITATION
OF OUR ABILITY TO BORROW ADDITIONAL FUNDS IN THE FUTURE.
As of March 31, 2002, we had approximately $59.3 million of outstanding
indebtedness under our various credit facilities, substantially all of which
were owed to The Royal Bank of Scotland plc and related entities and Congress
Financial Corporation. The agreements governing these various credit facilities
subject us to various financial and other covenants with which we must comply on
an ongoing or periodic basis. These include covenants pertaining to interest
coverage, cash flow coverage, leverage and EBITDA. If we violate any of these
covenants, there may be a material adverse effect on us. Most notably, our
outstanding debt under one or more of our credit facilities could become
immediately due and our ability to borrow additional funds in the future may be
limited. Additionally, under the terms of our credit facilities with The Royal
Bank of Scotland plc and related entities, if either Ron Zwanziger or David
Scott ceases to be a member of our board of directors, the full amount of our
indebtedness under these credit facilities will accelerate. Mr. Zwanziger and
Dr. Scott, both of whom
5
are executive officers of our company, are currently serving on our board of
directors; however, there is no assurance that they will continue to do so.
RISING INTEREST RATES WOULD INCREASE OUR INTEREST COSTS AND REDUCE OUR EARNINGS.
We currently have, and may incur more, indebtedness that bears interest at
variable rates. Accordingly, if interest rates increase, so will our interest
costs, which would adversely affect our earnings, cash flow and our ability to
service debt.
NON-COMPETITION OBLIGATIONS AND OTHER RESTRICTIONS WILL LIMIT OUR ABILITY TO
TAKE FULL ADVANTAGE OF OUR MANAGEMENT TEAM, THE TECHNOLOGY WE OWN OR LICENSE AND
OUR RESEARCH AND DEVELOPMENT CAPABILITIES.
Members of our management team have had significant experience in the
diabetes field, technology we own or license may have potential applications to
this field, and our research and development capabilities could be applied to
this field. In conjunction with the split-off and merger, however, we agreed in
the post-closing covenants agreement not to compete with IMT and Johnson &
Johnson in the field of diabetes. In addition, Ron Zwanziger, our Chairman,
President and Chief Executive Officer, and two of our senior scientists,
Dr. David Scott and Dr. Jerry McAleer, have entered into consulting agreements
with IMT that impose similar obligations. Further, the license agreement
prevents us from using any of the licensed technology in the field of diabetes.
As a result of these restrictions, we cannot pursue opportunities in the field
of diabetes.
OUR ACQUISITIONS OF CERTAIN ENTITIES AND BUSINESSES (THE UNIPATH BUSINESS) OF
UNILEVER PLC (UNILEVER) AND IVC INDUSTRIES, INC. (IVC) MAY NOT BE PROFITABLE OR
SUCCESSFULLY INTEGRATED AND WILL RESULT IN SIGNIFICANT CHARGES AGAINST EARNINGS.
On December 20, 2001, we acquired the Unipath business from Unilever and
certain affiliated entities. On March 19, 2002, we acquired IVC. The value of
the Unipath business and IVC to us may not be greater than or equal to their
purchase prices. Further, we cannot guarantee that we will realize any of the
benefits or strategic objectives we are seeking to obtain by acquiring the
Unipath business or IVC. In connection with accounting for the acquisition of
the Unipath business, we have recorded a significant amount of intangible
assets. Under Statement of Financial Accounting Standards (SFAS) No. 142,
GOODWILL AND OTHER INTANGIBLE ASSETS, we must assess, at least annually and
potentially more frequently, whether the value of goodwill and other intangible
assets has been impaired. Any reduction or impairment of the value of goodwill
or other intangible assets will result in a charge against earnings which could
materially adversely affect our results of operations in future periods. In
addition, in connection with the acquisition of the Unipath business, the
portion of the purchase price allocated to in-process research and development
projects that had not reached technological feasibility was charged to expense
during the fourth quarter of 2001. To bring these projects to technological
feasibility, high-risk development and testing issues will need to be resolved
that will require substantial additional effort and expense.
WE COULD EXPERIENCE SIGNIFICANT MANUFACTURING DELAYS, DISRUPTIONS TO OUR ONGOING
RESEARCH AND DEVELOPMENT AND INCREASED PRODUCTION COSTS IF UNILEVER IS UNABLE TO
SUCCESSFULLY ASSIGN OR SUBLEASE TO US THE LEASE FOR THE PRIMARY OPERATING
FACILITY OF THE UNIPATH BUSINESS WHICH IS LOCATED IN BEDFORD, ENGLAND.
The primary operating facility of the Unipath business that we acquired from
Unilever is located in Bedford, England. The Bedford facility is a multi-purpose
facility that is registered with the United States Food and Drug Administration
(FDA), contains state-of-the-art research laboratories and is equipped with
specialized manufacturing equipment. This facility currently provides the
manufacturing for the Unipath business that we recently acquired, serves as our
research and development center and serves as the administrative center for our
European operations. We are currently using the Bedford facility pursuant to an
agreement with Unilever entered into in connection with our acquisition of the
6
Unipath business. Unilever currently leases this facility from a third party
landlord. Pursuant to the terms of Unilever's lease, however, Unilever is not
permitted to assign the lease or sublet the Bedford facility without obtaining
the prior written consent of the landlord (which consent may not be unreasonably
withheld). The landlord has recently indicated that it will not consent to an
assignment of the lease to us but will consider a sublease. The terms of our
acquisition of the Unipath business obligate Unilever to use reasonable
endeavors to obtain the landlord's consent to assignment or to a sublease of the
facility and, if necessary, to pursue the assignment or a sublease through the
courts. There are no assurances that Unilever will be successful in obtaining
the landlord's consent to assignment of the lease to us or to a sublease to us.
If Unilever is unable to successfully acquire such consent or otherwise enable
us to realize the benefit of its lease of the Bedford facility, we may be forced
to renegotiate a lease of the Bedford facility on substantially less favorable
terms or seek alternative means of producing our products, conducting our
research and housing our European administrative staff. In either case, we may
experience manufacturing delays and disruptions to our ongoing research and
development while we are resolving these issues and increased production costs
in the future. Additionally, there are no assurances that we will be able to
renegotiate a lease for the Bedford facility on terms that are acceptable to us
or find an acceptable replacement for this facility. Any one or more of these
events may have a material adverse effect on us.
IF WE CHOOSE TO ACQUIRE OR INVEST IN NEW AND COMPLEMENTARY BUSINESSES, PRODUCTS
OR TECHNOLOGIES INSTEAD OF DEVELOPING THEM OURSELVES, THESE ACQUISITIONS OR
INVESTMENTS COULD DISRUPT OUR BUSINESS AND, DEPENDING ON HOW WE FINANCE THESE
ACQUISITIONS OR INVESTMENTS, COULD RESULT IN SIGNIFICANT DILUTION TO OUR
EXISTING STOCKHOLDERS.
Our success depends in part on our ability to continually enhance and
broaden our product offerings in response to changing technologies, customer
demands and competitive pressures. Accordingly, from time to time we may seek to
acquire or invest in complementary businesses, products or technologies instead
of developing them ourselves. Acquisitions and investments involve numerous
risks, including:
- the inability to complete the acquisition or investment;
- disruption of our ongoing businesses and diversion of management
attention;
- difficulties in integrating the acquired entities, products or
technologies;
- difficulties in operating the acquired business profitably;
- the inability to achieve anticipated cost savings;
- potential loss of key employees, particularly those of the acquired
business;
- difficulties in transitioning key customer, distributor and supplier
relationships;
- risks associated with entering markets in which we have no or limited
prior experience; and
- unanticipated costs.
In addition, any future acquisitions or investments may result in:
- dilutive issuances of equity securities, which may be sold at a discount
to market price;
- use of significant amounts of cash;
- the incurrence of debt;
- the assumption of liabilities;
- unfavorable financing terms;
- large one-time expenses; and
- the creation of certain intangible assets, including goodwill, the
writedown of which may result in significant charges to earnings.
7
Any of these factors could materially harm our business or our operating
results.
MANUFACTURING PROBLEMS OR DELAYS COULD SEVERELY AFFECT OUR BUSINESS.
We produce our consumer products in our manufacturing facilities located in
New Jersey and in Bedford, England and Galway, Ireland and our clinical
diagnostic tests in our manufacturing facilities located in Bedford and in
Yavne, Israel. Our production processes are complex and require specialized and
expensive equipment. We rely on third parties to supply production materials and
in some cases there may not be alternative sources immediately available. In
addition, until we are able to consolidate manufacturing of our vitamins and
nutritional supplements in our New Jersey manufacturing facilities, we will
continue to rely, in part, upon third parties to manufacture these products. Any
event impacting these facilities or our contract manufacturers or suppliers
could delay or suspend shipments of products, or could result in the delivery of
inferior products. Our revenues from the affected products would decline until
such time as we were able to put in place alternative contract manufacturers or
suppliers. Even though we carry business interruption insurance policies, we may
suffer losses as a result of business interruptions that exceed the coverage
available under our insurance policies.
IF WE FAIL TO MEET STRICT REGULATORY REQUIREMENTS, WE COULD BE REQUIRED TO PAY
FINES OR EVEN CLOSE OUR FACILITIES.
Our facilities and manufacturing techniques generally must conform to
standards that are established by government agencies, including those of
European governments, as well as the FDA. These regulatory agencies may conduct
periodic inspections of our facilities to monitor our compliance with applicable
regulatory standards. If a regulatory agency finds that we fail to comply with
the appropriate regulatory standards, it may impose fines on us or if such a
regulatory agency determines that our non-compliance is severe, it may close our
facilities. Any adverse action by an applicable regulatory agency could impair
our ability to produce our products in a cost-effective and timely manner in
order to meet our customers' demands.
IF WE DELIVER PRODUCTS WITH DEFECTS, OUR CREDIBILITY MAY BE HARMED, MARKET
ACCEPTANCE OF OUR PRODUCTS MAY DECREASE AND WE MAY BE EXPOSED TO LIABILITY IN
EXCESS OF OUR PRODUCT LIABILITY INSURANCE COVERAGE.
The manufacturing and marketing of consumer and clinical diagnostic products
involve an inherent risk of product liability claims. In addition, our product
development and production are extremely complex and could expose our products
to defects. Any defects could harm our credibility and decrease market
acceptance of our products. In addition, our marketing of vitamins and
nutritional supplements may cause us to be subjected to various product
liability claims, including, among others, claims that the vitamins and
nutritional supplements have inadequate warnings concerning side effects and
interactions with other substances. Potential product liability claims may
exceed the amount of our insurance coverage or may be excluded from coverage
under the terms of the policy. In the event that we are held liable for a claim
for which we are not indemnified, or for damages exceeding the limits of our
insurance coverage, that claim could materially damage our business and our
financial condition.
SALES OF THE NUTRITIONAL SUPPLEMENTS THAT WE SOLD PRIOR TO ACQUIRING IVC HAVE
DECLINED EACH YEAR SINCE 1998 DUE TO THE MATURITY OF THE MARKET SEGMENTS THEY
SERVE AND THE AGE OF THAT PRODUCT LINE AND WE MAY EXPERIENCE FURTHER DECLINES IN
SALES OF THOSE PRODUCTS.
Sales of the nutritional products that we sold prior to acquiring IVC have
declined each year since 1998 and we have budgeted for future sale declines for
those products. We believe that those products have under-performed because they
are, for the most part, aging brands with limited brand retention that face
increasing private label competition. The age of this product line means that we
are subject to future distribution loss for under-performing brands, while our
opportunities for new distribution on the existing product lines are limited.
8
THE VITAMIN AND NUTRITIONAL SUPPLEMENTS MARKET IS SUBJECT TO SIGNIFICANT
FLUCTUATIONS BASED UPON MEDIA ATTENTION AND NEW DEVELOPMENTS.
Most growth in the vitamin and nutritional supplement industry is attributed
to new products that generate attention in the marketplace. Positive media
attention resulting from new scientific studies or announcements can spur rapid
growth in individual segments of the market, and also impact individual brands.
Conversely, news that challenges individual segments or products can have a
negative impact on the industry overall as well as on sales of the challenged
segments or products. Most of our vitamin and nutritional supplements products,
including most of the vitamins and nutritional products that we acquired from
IVC, serve well-established market segments and, absent unforeseen new
developments or trends, are not expected to benefit from rapid growth. A few of
the vitamin and nutritional products acquired with IVC are newer products that
are more likely to be the subject of new scientific studies or announcements,
which could be either positive or negative. News or other developments that
challenges the safety or effectiveness of these product could negatively impact
the profitability of our vitamin and nutritional supplements business.
SALES OF OUR CLINICAL DIAGNOSTICS PRODUCTS COULD SUFFER IF ECONOMIC TRENDS IN
THE HEALTH CARE INDUSTRY HARM OUR NICHE MARKET OF SMALL AND MEDIUM SIZED
LABORATORIES.
Our Clearview-Registered Trademark- clinical diagnostic products are low
cost alternatives to expensive and time consuming centralized testing marketed
to point-of-care professionals. Orgenics sells clinical diagnostics products
targeted at a niche market of small and medium sized decentralized laboratories
in developing nations. To the extent that trends or changes in the health care
industry favor economies of scale and centralized, automated laboratory testing,
sales of our clinical diagnostics products could suffer.
REVENUE FROM OUR CLINICAL DIAGNOSTICS BUSINESS MAY DECLINE IN THE FUTURE BECAUSE
TRENDS IN THE OVERALL MARKET FAVOR DIRECT DISEASE DETECTION OVER IMMUNE RESPONSE
TESTING.
New technologies have made it possible to directly identify the presence of
disease rather than detecting the presence of antibodies produced through an
immune response. The trend of the overall market currently favors direct
detection over antibody detection. Virus detection through nucleic acid testing,
or NAT, is already mandatory for hepatitis C virus and other markers in France,
Australia and certain other developed nations. We believe that the threat from
direct detection technology in our core market of small and medium sized
decentralized laboratories, small blood banks, physicians and other point of
care facilities, particularly in under developed nations, is several years away.
However, this trend poses a risk to our core clinical diagnostics business in
the long term.
WE MARKET OUR ORGENICS CLINICAL DIAGNOSTICS PRODUCTS TO SMALL AND MEDIUM SIZED
CUSTOMERS IN MORE THAN 90 COUNTRIES AT CONSIDERABLE COST THAT REDUCES THE
OPERATING MARGINS IN OUR ORGENICS CLINICAL DIAGNOSTICS BUSINESS.
Because small and medium sized laboratories are the principal customers of
our Orgenics clinical diagnostic products, we sell these products worldwide in
order to maintain sufficient sales volume. Our Orgenics clinical diagnostics
products are marketed in more than 90 countries, including many third world and
developing nations where smaller laboratories are the norm, where more expensive
technologies are not affordable and where infectious diseases are often more
prevalent. This worldwide sales strategy is expensive and results in lower
margins than would be possible if we could generate sufficient sales volume by
operating in fewer markets.
9
WE COULD SUFFER MONETARY DAMAGES, INCUR SUBSTANTIAL COSTS OR BE PREVENTED FROM
USING TECHNOLOGIES IMPORTANT TO OUR PRODUCTS AS A RESULT OF A NUMBER OF PENDING
LEGAL PROCEEDINGS.
We are involved in various legal proceedings arising out of our consumer
diagnostics, nutritional supplements and clinical diagnostics business. The
current material legal proceedings are:
- a lawsuit by Abbott Laboratories against us and Princeton BioMeditech
Corporation, which manufactured products for our consumer diagnostics
business while it was part of IMT, claiming, among other things, that some
of our products relating to pregnancy detection and ovulation prediction
infringe patents to which Abbott asserts it is the exclusive licensee;
- a lawsuit by Becton, Dickinson and Company alleging that pregnancy and
ovulation test kits that we sell, and which we will continue to sell
through our consumer diagnostics business, infringe U.S. Patent
No. 4,703,017;
- complaints by Intervention, Inc. against us, four of our private label
customers, whom we are defending under agreement, and certain other
parties alleging that under Section 17200 of the California Business and
Professions Code the defendants' labeling on their home pregnancy tests is
misleading as to the level of accuracy under certain conditions; and
- an action brought by 69 consumers in London alleging defects in our
Persona contraceptive device leading to unwanted pregnancies.
Because the above claims each seek damages and reimbursement for costs and
expenses without specific amounts, we are unable to assess the probable outcome
of or potential liability arising from the lawsuits.
In connection with our split-off from IMT, we agreed to assume, to the
extent permitted by law, and indemnify IMT for, its liabilities in these
lawsuits together with any other liabilities arising out of the women's health,
nutritional supplements and clinical diagnostics businesses before or after the
split-off to the extent such liabilities are not otherwise retained by IMT.
Through our acquisitions of the Unipath business and IVC we also assumed or
acquired substantially all of the liabilities of those businesses. We are unable
to assess the materiality or costs associated with these lawsuits at this time.
We cannot assure you that these lawsuits or any future lawsuits relating to our
businesses will not have a material adverse effect on us.
THE PROFITABILITY OF OUR CONSUMER PRODUCTS BUSINESSES MAY SUFFER IF WE ARE
UNABLE TO ESTABLISH AND MAINTAIN CLOSE WORKING RELATIONSHIPS WITH OUR CUSTOMERS.
Our consumer products businesses rely to a great extent on close working
relationships with our customers rather than long-term exclusive contractual
arrangements. With the exception of certain customers of IVC, customers of our
branded and private label consumer products businesses purchase products through
purchase orders only and are not obligated to make future purchases. During
calendar year 2001, purchase orders from Walgreen Co., CVS and Rite Aid
accounted for approximately 29% of the net sales of our consumer products
businesses, excluding the Unipath businesses and IVC. The loss of major
customer, such as Walgreen, CVC or Rite Aid or the failure to generate new
accounts could dramatically reduce revenues or prevent us from achieving
projected growth.
RETAILER CONSOLIDATION POSES A THREAT TO EXISTING RETAILER RELATIONSHIPS AND CAN
RESULT IN LOST REVENUE.
Recent years have witnessed rapid consolidation within the mass retail
industry. Drug store chains, grocery stores and mass merchandisers, the primary
purchasers of our consumer diagnostic products and vitamins and nutritional
supplements, have all been subject to this trend. Because these customers
purchase through purchase orders, consolidation can interfere with existing
retailer relationships, especially private label relationships, and result in
the loss of major customers and significant revenue streams.
10
OUR FINANCIAL CONDITION OR RESULTS OF OPERATIONS MAY BE ADVERSELY AFFECTED BY
INTERNATIONAL BUSINESS RISKS.
A significant number of our employees, including sales, support and research
and development personnel, are located outside of the United States. Conducting
business outside of the United States is subject to numerous risks, including:
- decreased liquidity resulting from longer accounts receivable collection
cycles typical of foreign countries;
- lower productivity resulting from difficulties managing our sales, support
and research and development operations across many countries;
- lost revenues resulting from difficulties associated with enforcing
agreements and collecting receivables through foreign legal systems;
- lost revenues resulting from the imposition by foreign governments of
trade protection measures; and
- higher cost of sales resulting from import or export licensing
requirements.
BECAUSE OUR BUSINESS RELIES HEAVILY ON FOREIGN OPERATIONS AND, TO A LESSER
EXTENT, FOREIGN SALES, CHANGES IN FOREIGN CURRENCY EXCHANGE RATES AND OUR
ABILITY TO CONVERT CURRENCIES MAY NEGATIVELY AFFECT OUR FINANCIAL CONDITION AND
RESULTS OF OPERATIONS.
Our business relies heavily on our foreign operations. Three of our
manufacturing facilities are outside the United States, in Bedford, England,
Galway, Ireland and Yavne, Israel. Orgenics has always made substantially all of
its sales outside of the United States. Through our recent acquisitions of the
Unipath business and IVC, we expect foreign sales to grow significantly. The
Unipath business generated approximately 70% of its net product sales outside of
the United States during 2001 and IVC generated almost 14% of its net product
sales outside of the United States during its fiscal year ending July 31, 2001.
Because of our foreign operations and foreign sales, we face exposure to
movements in foreign currency exchange rates. Our primary exposures are related
to the operations of our European and South American subsidiaries. These
exposures may change over time as business practices evolve and could result in
increased costs or reduced revenue and could impact actual cash flow.
OUR ORGENICS SUBSIDIARY IS LOCATED IN ISRAEL, AND ITS OPERATIONS COULD BE
NEGATIVELY AFFECTED DUE TO MILITARY OR POLITICAL TENSIONS IN THE MIDDLE EAST.
Our wholly-owned subsidiary, Orgenics Ltd., which develops, manufactures and
sells certain of our clinical diagnostic products, is incorporated under the
laws of the State of Israel. The administrative offices and development and
manufacturing operations of our Orgenics business are located in Yavne, Israel.
Although most of Orgenics' sales currently are to customers outside of Israel,
political, economic and military conditions in Israel could nevertheless
directly affect its operations. Since the establishment of the State of Israel
in 1948, a number of armed conflicts have taken place between Israel and its
Arab neighbors and a state of hostility, varying in degree and intensity, has
led to security and economic problems for Israel. Despite its history of
avoiding adverse effects, our Orgenics business could be adversely affected by
any major hostilities involving Israel, including the current armed conflict
with the Palestinian authority.
11
INTENSE COMPETITION COULD REDUCE OUR MARKET SHARE OR LIMIT OUR ABILITY TO
INCREASE MARKET SHARE, WHICH COULD IMPAIR THE SALES OF OUR PRODUCTS AND HARM OUR
FINANCIAL PERFORMANCE.
The medical products industry is rapidly evolving and developments are
expected to continue at a rapid pace. Competition in this industry, which
includes both our consumer diagnostics and clinical diagnostics businesses, is
intense and expected to increase as new products and technologies become
available and new competitors enter the market. Our competitors in the United
States and abroad are numerous and include, among others, diagnostic testing and
medical products companies, universities and other research institutions. Our
future success depends upon our maintaining a competitive position in the
development of products and technologies in our areas of focus. Competitors may
be more successful in:
- developing technologies and products that are more effective than our
products or that render our technologies or products obsolete or
noncompetitive;
- obtaining patent protection or other intellectual property rights that
would prevent us from developing our potential products; or
- obtaining regulatory approval for the commercialization of their products
more rapidly or effectively than we are in doing so.
Also, the possibility of patent disputes with competitors holding foreign patent
rights may limit or delay expansion possibilities for our consumer diagnostics
business in certain foreign jurisdictions. In addition, many of our existing or
potential competitors have or may have substantially greater research and
development capabilities, clinical, manufacturing, regulatory and marketing
experience and financial and managerial resources.
The market for the sale of vitamins and nutritional supplements is also
highly competitive. This competition is based principally upon price, quality of
products, customer service and marketing support. There are numerous companies
in the vitamins and nutritional supplements industry selling products to
retailers such as mass merchandisers, drug store chains, independent drug
stores, supermarkets and health food stores. As most of these companies are
privately held, we are unable to obtain the information necessary to assess
precisely the size and success of these competitors. However, we believe that a
number of our competitors, particularly manufacturers of nationally advertised
brand name products, are substantially larger than we are and have greater
financial resources.
THE RIGHTS WE RELY UPON TO PROTECT THE INTELLECTUAL PROPERTY UNDERLYING OUR
PRODUCTS MAY NOT BE ADEQUATE, WHICH COULD ENABLE THIRD PARTIES TO USE OUR
TECHNOLOGY AND WOULD REDUCE OUR ABILITY TO COMPETE IN THE MARKET.
Our success will depend in part on our ability to develop or acquire
commercially valuable patent rights and to protect our intellectual property.
Our patent position is generally uncertain and involves complex legal and
factual questions. The degree of future protection for our proprietary rights is
uncertain.
The risks and uncertainties that we face with respect to our patents and
other proprietary rights include the following:
- the pending patent applications we have filed or to which we have
exclusive rights may not result in issued patents or may take longer than
we expect to result in issued patents;
- the claims of any patents which are issued may not provide meaningful
protection;
- we may not be able to develop additional proprietary technologies that are
patentable;
- the patents licensed or issued to us or our customers may not provide a
competitive advantage;
12
- other companies may challenge patents licensed or issued to us or our
customers;
- patents issued to other companies may harm our ability to do business; and
- other companies may design around technologies we have licensed or
developed.
In addition to patents, we rely on a combination of trade secrets,
nondisclosure agreements and other contractual provisions and technical measures
to protect our intellectual property rights. Nevertheless, these measures may
not be adequate to safeguard the technology underlying our products. If they do
not protect our rights, third parties could use our technology and our ability
to compete in the market would be reduced. In addition, employees, consultants
and others who participate in the development of our products may breach their
agreements with us regarding our intellectual property and we may not have
adequate remedies for the breach. We also may not be able to effectively protect
our intellectual property rights in some foreign countries. For a variety of
reasons, we may decide not to file for patent, copyright or trademark protection
or prosecute potential infringements of our patents. We also realize that our
trade secrets may become known through other means not currently foreseen by us.
Despite our efforts to protect our intellectual property, our competitors or
customers may independently develop similar or alternative technologies or
products that are equal or superior to our technology and products without
infringing on any of our intellectual property rights or design around our
proprietary technologies.
CLAIMS BY OTHER COMPANIES THAT OUR PRODUCTS INFRINGE ON THEIR PROPRIETARY RIGHTS
COULD ADVERSELY AFFECT OUR ABILITY TO SELL OUR PRODUCTS AND INCREASE OUR COSTS.
Substantial litigation over intellectual property rights exists in both the
consumer and clinical diagnostic industries. We expect that our products and
products in these industries may increasingly be subject to third party
infringement claims as the number of competitors grows and the functionality of
products and technology in different industry segments overlaps. Third parties
may currently have, or may eventually be issued, patents on which our products
or technology may infringe. Any of these third parties might make a claim of
infringement against us. Any litigation could result in the expenditure of
significant financial resources and the diversion of management's time and
resources. In addition, litigation in which we are accused of infringement may
cause negative publicity, have an impact on prospective customers, cause product
shipment delays, require us to develop non-infringing technology or enter into
royalty or license agreements, which may not be available on acceptable terms,
or at all. If a successful claim of infringement were made against us and we
could not develop non-infringing technology or license the infringed or similar
technology on a timely and cost-effective basis, our revenue may decrease and we
could be exposed to legal actions by our customers.
WE HAVE INITIATED, AND MAY NEED TO FURTHER INITIATE, LAWSUITS TO PROTECT OR
ENFORCE OUR PATENTS AND OTHER INTELLECTUAL PROPERTY RIGHTS, WHICH COULD BE
EXPENSIVE AND, IF WE LOSE, COULD CAUSE US TO LOSE SOME OF OUR INTELLECTUAL
PROPERTY RIGHTS, WHICH WOULD REDUCE OUR ABILITY TO COMPETE IN THE MARKET.
We rely on patents to protect a portion of our intellectual property and our
competitive position. In order to protect or enforce our patent rights, we may
initiate patent litigation against third parties, such as infringement suits or
interference proceedings. Litigation may be necessary to:
- assert claims of infringement;
- enforce our patents;
- protect our trade secrets or know-how; or
- determine the enforceability, scope and validity of the proprietary rights
of others.
Currently, we have initiated a number of lawsuits against competitors who we
believe to be selling products that infringe our proprietary rights. These
current lawsuits and any other lawsuits that we
13
initiate could be expensive, take significant time and divert management's
attention from other business concerns. Litigation also puts our patents at risk
of being invalidated or interpreted narrowly and our patent applications at risk
of not issuing. Additionally, we may provoke third parties to assert claims
against us. Patent law relating to the scope of claims in the technology fields
in which we operate is still evolving and, consequently, patent positions in our
industry are generally uncertain. We may not prevail in any of these suits and
the damages or other remedies awarded, if any, may not be commercially valuable.
During the course of these suits, there may be public announcements of the
results of hearings, motions and other interim proceedings or developments in
the litigation. If securities analysts or investors perceive any of these
results to be negative, our stock price could decline.
WE MAY BE UNABLE TO HIRE, RETAIN OR MOTIVATE KEY PERSONNEL, UPON WHOM THE
SUCCESS OF OUR BUSINESS WILL DEPEND.
We are highly dependent upon certain members of our management and
scientific staff, particularly Ron Zwanziger, David Scott and Jerry McAleer. We
believe that our future success will depend in large part upon our ability to
attract and retain highly skilled scientific, managerial and marketing
personnel. We face significant competition for such personnel from other
companies, research and academic institutions, government entities and other
organizations. We may fail to retain our key employees. Further, we may fail to
attract, assimilate, retain or train other needed qualified employees in the
future. We do not have employment agreements with all of our key employees. The
loss of any of our key employees, including our scientists, may impact or
disrupt our sales and marketing activities, our research and development
efforts, our capital-raising efforts or our administrative functions.
WE MAY BE LIABLE FOR CONTAMINATION OR OTHER HARM CAUSED BY HAZARDOUS MATERIALS
THAT WE USE.
Our research and development processes involve the use of hazardous
materials. We are subject to federal, state and local regulation governing the
use, manufacture, handling, storage and disposal of hazardous materials. We
cannot completely eliminate the risk of contamination or injury resulting from
hazardous materials and we may incur liability as a result of any contamination
or injury. We may also incur expenses relating to compliance with environmental
laws. Such expenses or liability could have a significant negative impact on our
financial condition.
OUR OPERATING RESULTS MAY FLUCTUATE DUE TO VARIOUS FACTORS AND AS A RESULT
PERIOD-TO-PERIOD COMPARISONS OF OUR RESULTS OF OPERATIONS WILL NOT NECESSARILY
BE MEANINGFUL.
Factors relating to our business make our future operating results uncertain
and may cause them to fluctuate from period to period. Such factors include:
- the timing of new product announcements and introductions by us and our
competitors;
- market acceptance of new or enhanced versions of our products;
- changes in manufacturing costs or other expenses;
- competitive pricing pressures;
- the gain or loss of significant distribution outlets or customers;
- the availability and extent of reimbursement for our products;
- increased research and development expenses;
- the timing of any future acquisitions;
- general economic conditions; or
- general stock market conditions, other economic or external factors.
14
THE HOLDERS OF OUR SERIES A PREFERRED STOCK ARE ENTITLED TO RECEIVE LIQUIDATION
PAYMENTS IN PREFERENCE TO THE HOLDERS OF OUR COMMON STOCK.
As of March 31, 2002, there were 2,360,246 shares of Series A Preferred
Stock outstanding. Pursuant to the terms of the certificate of designation
creating the Series A Preferred Stock, upon a liquidation or a deemed
liquidation of our company, the holders of the shares of our Series A Preferred
Stock are entitled to receive a liquidation payment prior to the payment of any
amount with respect to the shares of our common stock. The amount of this
preferential liquidation payment is $30 per share of Series A Preferred Stock
(or $40.50 per share in certain circumstances), plus the amount of any dividends
that have accrued on those shares, subject to adjustment in the event of any
stock dividend, stock split, combination or other similar recapitalization
affecting our Series A Preferred Stock. Dividends accrue on the shares of our
Series A Preferred Stock at the rate of up to $2.10 per share per annum based on
the percentage of trading days on which the closing market price of our common
stock is less than $15.00. As a result of these terms, the holders of our common
stock may be disproportionately affected by any reduction in the value of our
assets or fluctuations in the market price of our common stock.
THE ABILITY OF OUR STOCKHOLDERS TO CONTROL OUR POLICIES AND EFFECT A CHANGE OF
CONTROL OF OUR COMPANY IS LIMITED, WHICH MAY NOT BE IN YOUR BEST INTERESTS.
There are provisions in our certificate of incorporation and by-laws which
may discourage a third party from making a proposal to acquire us, even if some
of our stockholders might consider the proposal to be in their best interests.
These provisions include the following:
- our certificate of incorporation provides for three classes of directors
with the term of office of one class expiring each year, commonly referred
to as a staggered board. By preventing stockholders from voting on the
election of more than one class of directors at any annual meeting of
stockholders, this provision may have the effect of keeping the current
members of our board of directors in control for a longer period of time
than stockholders may desire; and
- our certificate of incorporation authorizes our board of directors to
issue shares of preferred stock without stockholder approval and to
establish the preferences and rights of any preferred stock issued, which
would allow the board to issue one or more classes or series of preferred
stock that could discourage or delay a tender offer or change in control.
Additionally, we are subject to Section 203 of the Delaware General Corporation
Law, which, in general, imposes restrictions upon acquirors of 15% or more of
our stock. Finally, the board of directors may in the future adopt a shareholder
rights plan, which could delay, deter or prevent a change of control.
BECAUSE WE DO NOT INTEND TO PAY DIVIDENDS, YOU WILL BENEFIT FROM AN INVESTMENT
IN OUR COMMON STOCK ONLY IF IT APPRECIATES IN VALUE.
We currently intend to retain our future earnings, if any, to finance the
expansion of our business and do not expect to pay any cash dividends in the
foreseeable future. As a result, the success of your investment in our common
stock will depend entirely upon any future appreciation. There is no guarantee
that our common stock will appreciate in value after the offering or even
maintain the price at which you purchased your shares.
15
TERRORIST ATTACKS, SUCH AS THE ATTACKS THAT OCCURRED IN NEW YORK AND WASHINGTON,
D.C. ON SEPTEMBER 11, 2001, AND OTHER ATTACKS OR ACTS OF WAR COULD ADVERSELY
AFFECT OUR OPERATIONS, PROFITABILITY AND THE MARKETS IN WHICH WE OPERATE.
On September 11, 2001, the United States was the target of terrorist attacks
of unprecedented scope. Attacks such as these could cause major instability in
the United States and international financial markets and reduce consumer
confidence. The terrorist attacks and the national and global responses to these
terrorist attacks, many of which are still being formulated, including recent
military, diplomatic and financial responses and any possible reprisals in the
future, could result in disruptions of our manufacturing operations and the
distribution of our products. These developments will subject us to increased
risks and, depending on their magnitude, could have a material adverse effect on
our business.
OUR INDEPENDENT PUBLIC ACCOUNTANT, ARTHUR ANDERSEN LLP, HAS BEEN INDICTED ON
FEDERAL OBSTRUCTION OF JUSTICE CHARGES. THE INDICTMENT MAY IMPAIR OUR ABILITY TO
ACCESS THE CAPITAL MARKETS, TO MAKE TIMELY FILINGS WITH THE SECURITIES AND
EXCHANGE COMMISSION AND TO SATISFY ANY CLAIMS ARISING FROM THE PROVISION OF
AUDITING SERVICES TO US.
Our independent public accountant, Arthur Andersen LLP, has informed us that
on March 14, 2002, an indictment was unsealed charging it with federal
obstruction of justice arising from the government's investigation of Enron
Corp. Arthur Andersen has indicated that it intends to contest vigorously the
indictment. As a public company we are required to file periodically with the
Securities and Exchange Commission financial statements audited or reviewed by
an independent public accountant. The Securities and Exchange Commission has
recently adopted rules under which it will continue accepting financial
statements audited or reviewed by Arthur Andersen. However, our access to the
capital markets and our ability to make timely Securities and Exchange
Commission filings, including filings incorporated by reference into this
prospectus, could be impaired if the Securities and Exchange Commission ceases
accepting financial statements audited by Arthur Andersen or if for any reason
Arthur Andersen is unable to perform auditing services for us.
Although we do not believe that the outcome of the current indictment would
materially adversely affect us, should we seek to access the public capital
markets after we complete the offering of the securities offered hereby, and, if
prior to that time the Securities and Exchange Commission ceases accepting
financial statements audited by Arthur Andersen or if Arthur Andersen becomes
unable to make the representations to us required by the Securities and Exchange
Commission, it is possible that our existing audited financial statements might
not satisfy the Securities and Exchange Commission's requirements. In that case,
we may be unable to access the public capital markets unless another independent
accounting firm is able to audit the financial statements originally audited by
Arthur Andersen.
It is also possible that events arising out of the indictment may adversely
affect the ability of Arthur Andersen to satisfy any claims arising from its
provision of auditing services to us, including claims that may arise out of
Arthur Andersen's audits of our financial statements incorporated by reference
into this prospectus.
Any delay or inability to access the public capital markets caused by these
circumstances could have a material adverse effect on our business,
profitability and growth prospects.
16
SPECIAL STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
This prospectus contains forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended. You can identify these statements
by forward-looking words such as "may," "could," "should," "would," "intend,"
"will," "expect," "anticipate," "believe," "estimate," "continue" or similar
words. You should read statements that contain these words carefully because
they discuss our future expectations, contain projections of our future results
of operations or of our financial condition or state other "forward-looking"
information. There may be events in the future that we are not able to predict
accurately or control and that may cause our actual results to differ materially
from the expectations we describe in our forward-looking statements. We caution
investors that all forward-looking statements involve risks and uncertainties,
and actual results may differ materially from those we discuss in this
prospectus. These differences may be the result of various factors, including
those factors described in the "Risk Factors" section of this prospectus. Some
important additional factors that could cause our actual results to differ
materially from those projected in any such forward-looking statements are as
follows:
- economic factors, including inflation and fluctuations in interest rates
and foreign currency exchange rates, and the potential effect of such
fluctuations on revenues, expenses and resulting margins;
- competitive factors, including technological advances achieved and patents
attained by competitors and generic competition;
- domestic and foreign healthcare changes resulting in pricing pressures,
including the continued consolidation among healthcare providers, trends
toward managed care and healthcare cost containment and government laws
and regulations relating to sales and promotion, reimbursement and pricing
generally;
- government laws and regulations affecting domestic and foreign operations,
including those relating to trade, monetary and fiscal policies, taxes,
price controls, regulatory approval of new products and licensing;
- manufacturing interruptions, delays or capacity constraints or lack of
availability of alternative sources for components for our products;
- difficulties inherent in product development, including the potential
inability to successfully continue technological innovation, complete
clinical trials, obtain regulatory approvals in the United States and
abroad, gain and maintain market approval of products and the possibility
of encountering infringement claims by competitors with respect to patent
or other intellectual property rights which can preclude or delay
commercialization of a product;
- significant litigation adverse to us including product liability claims,
patent infringement claims and antitrust claims;
- product efficacy or safety concerns resulting in product recalls or
declining sales;
- the impact of business combinations, including acquisitions and
divestitures, and organizational restructuring consistent with evolving
business strategies;
- our ability to satisfy the financial covenants and other conditions
contained in our credit facilities;
- our ability to obtain required financing on terms that are acceptable to
us; and
- the issuance of new or revised accounting standards by the American
Institute of Certified Public Accountants, the Financial Accounting
Standards Board or the Securities and Exchange Commission.
The foregoing list sets forth many, but not all, of the factors that could
impact upon our ability to achieve results described in any forward-looking
statements. Readers should not place undue reliance on our forward-looking
statements. Before you invest in our common stock, you should be aware that the
occurrence of the events described in the "Risk Factors" section and elsewhere
in this prospectus could harm our business, prospects, operating results and
financial condition. We do not undertake any obligation to update any
forward-looking statements as a result of future events or developments.
17
REGISTRATION RIGHTS OF THE SELLING STOCKHOLDERS
We are filing this registration statement pursuant to the terms of
registration rights granted to the selling stockholders in connection with
certain capital raising transactions, described below, used to help finance our
acquisition of the Unipath business. We acquired the Unipath business on
December 20, 2001.
On December 20, 2001, we sold 1,995,000 shares of Series A Convertible
Preferred Stock to private investors, including certain of our directors and
related persons, at a purchase price of $30.00 per share for aggregate
consideration of $59.85 million. The Series A Convertible Preferred Stock is
currently convertible into common stock at a 2-for-1 ratio. As of March 31,
2002, 166,667 of these shares of Series A Convertible Preferred Stock were
converted into 333,334 shares of common stock. Accordingly, as of March 31,
2002, the 1,828,333 of these shares of Series A Convertible Preferred Stock that
remained outstanding were convertible into 3,656,666 shares of common stock.
Under the terms of the related securities purchase agreement, we agreed to file
the registration statement of which this prospectus is a part to register the
sale by those investors of the shares of common stock underlying the shares of
Series A Convertible Preferred Stock acquired by them. We also agreed to use our
best efforts to cause the registration statement to be declared effective by the
Securities and Exchange Commission by June 20, 2002, and to keep the
registration statement effective until the earliest of (1) December 20, 2003,
(2) the date on which the investors may sell their shares within a three-month
period in accordance with Rule 144(k) and (3) such time as all of such shares
have been sold pursuant to a registration statement.
On December 20, 2001, we sold subordinated promissory notes and warrants to
private investors, including Zwanziger Family Ventures, LLC, an entity
affiliated with Ron Zwanziger, our Chairman, President and Chief Executive
Officer, for an aggregate purchase price of $20.0 million. The notes were
subsequently retired using the proceeds from the sale of additional shares of
Series A Convertible Preferred Stock, as discussed below. The warrants, however,
are still outstanding and are exercisable for an aggregate of 55,189 shares of
common stock at an exercise price of $18.12 per share. Under the terms of the
related note and warrant purchase agreement, in connection with the filing of
the registration statement of which this prospectus is a part, we agreed to use
our reasonable best efforts to register the sale by the warrant holders of the
shares of common stock issuable upon exercise of their warrants.
On December 20, 2001, we obtained a mezzanine credit facility from RBS
Mezzanine Limited for an aggregate principal amount of up to $10.0 million. In
connection with the provision of this facility, we issued to RBS Mezzanine
Limited a warrant to purchase 65,000 shares of common stock at an exercise price
of $0.001 per share. Under the terms of the warrant agreement, in connection
with the filing of the registration statement of which this prospectus is a
part, we agreed to use our reasonable best efforts to register the sale by RBS
Mezzanine Limited of the shares of common stock issuable upon exercise of this
warrant.
As a condition to our obtaining the mezzanine credit facility, RBS Mezzanine
Limited required Zwanziger Family Ventures, LLC to enter into a lock-up
agreement pursuant to which it agreed not to sell or transfer shares of common
stock for a three-year period (subject to continuing volume limitations after
such period). In consideration of such agreement, we issued to Zwanziger Family
Ventures, LLC a warrant to purchase 385,000 shares of common stock at an
exercise price of $17.15 per share. Under the terms of the warrant agreement, in
connection with the filing of the registration statement of which this
prospectus is a part, we agreed to use our reasonable best efforts to register
the sale by Zwanziger Family Ventures, LLC of the shares of common stock
issuable upon exercise of this warrant.
In addition, on March 6, 2002, we sold an additional 531,913 shares of
Series A Convertible Preferred Stock to private investors at a purchase price of
$39.01 per share for an aggregate consideration of $20.75 million. The proceeds
from the sale of these shares were used primarily to retire the subordinated
promissory notes issued on December 20, 2001. As of March 31, 2002, these shares
of Series A Convertible Preferred Stock were convertible into 1,063,826 shares
of common stock. The investors purchasing these shares of Series A Convertible
Preferred Stock have the same registration rights as the investors who purchased
shares of Series A Convertible Preferred Stock on December 20, 2001.
18
THE SELLING STOCKHOLDERS
The following table sets forth the number of shares of common stock
beneficially owned by the selling stockholders as of March 31, 2002, the number
of shares of common stock covered by this prospectus and the total number of
shares of common stock that the selling stockholders will beneficially own upon
completion of this offering. This table assumes that the selling stockholders
will offer for sale all of the shares of common stock covered by this
prospectus.
The common stock offered by this prospectus may be offered from time to time
by the selling stockholders named below, or by any of their pledgees, donees,
transferees or other successors in interest. The amounts set forth below are
based upon information provided to us by representatives of the selling
stockholders, or on our records, as of March 31, 2002 and are accurate to the
best of our knowledge. It is possible, however, that the selling stockholders
may acquire or dispose of additional shares of common stock from time to time
after the date of this prospectus.
COMMON
STOCK
BENEFICIALLY
OWNED AS COMMON STOCK
OF COMMON STOCK TO BE OWNED PERCENTAGE OF
MARCH 31, OFFERED AFTER ALL COMMON
NAME 2002(1) HEREBY OFFERING(2) STOCK(3)
---- ------------ ------------ ------------ -------------
Auda Classic PLC........................ 16,022 5,852(4) 10,170 *
The Avram J. Goldberg and Carol R.
Goldberg Charitable Remainder
Unitrust(12).......................... 16,666 16,666(4) 0 *
BNP Paribas............................. 1,223 1,223(5) 0 *
J. Alexander Bodkin..................... 43,332 33,334(4) 9,998 *
Ernest A. Carabillo, Jr.(13)............ 25,549 20,000(4) 5,549 *
Martin Carmichael III(14)............... 4,133 3,334(4) 799 *
Stephen W. Carr (14).................... 6,666 6,666(4) 0 *
CLSP, L.P............................... 170,200 170,200(4) 0 *
CLSP II, L.P............................ 34,624 34,624(4) 0 *
CLSP Overseas Ltd....................... 52,096 52,096(4) 0 *
CLSP SBS-I, L.P......................... 51,110 51,110(4) 0 *
CLSP SBS-II, L.P........................ 25,304 25,304(4) 0 *
Howard A. Cubell (14)................... 1,666 1,666(4) 0 *
The Dialogue Fund LP.................... 30,000 30,000(4) 0 *
Galleon Healthcare Offshore, Ltd........ 442,192 442,192(6) 0 *
Galleon Healthcare Partners, L.P........ 147,486 147,486(7) 0 *
Richard Gibbs........................... 46,666 46,666(4) 0 *
Thelma N. Gibbs......................... 23,774 13,334(4) 10,440 *
GKJK Holdings, LP....................... 51,268 51,268(4) 0 *
Orit Goldstein(15)...................... 909,832 666,666(4) 243,166 2.48%
GS Private Equity Partners 2000, L.P.... 194,852 194,852(4) 0 *
GS Private Equity Partners 2000 --
Direct Investment Fund, L.P........... 72,642 72,642(4) 0 *
GS Private Equity Partners 2000 Offshore
Holdings, L.P......................... 65,838 65,838(4) 0 *
Irwin Heller............................ 20,000 20,000(4) 0 *
IMA, LLC................................ 133,334 133,334(4) 0 *
Robert P. Khederian(13)................. 210,000 200,000(4) 10,000 *
mRNA Fund II, L.P.(16).................. 3,820 3,820(4) 0 *
Lawrie Okurowski........................ 47,740 5,519(8) 42,221 *
19
COMMON
STOCK
BENEFICIALLY
OWNED AS COMMON STOCK
OF COMMON STOCK TO BE OWNED PERCENTAGE OF
MARCH 31, OFFERED AFTER ALL COMMON
NAME 2002(1) HEREBY OFFERING(2) STOCK(3)
---- ------------ ------------ ------------ -------------
Oxford Bioscience Partners IV
L.P.(16).............................. 380,780 380,780(4) 0 *
John D. Patterson, Jr.(17).............. 3,334 3,334(4) 0 *
Jay Pearlstein.......................... 39,611 33,334(4) 6,277 *
Perry Partners International, Inc....... 446,074 408,664(4) 37,410 *
Perry Partners LP....................... 200,853 170,710(4) 30,143 *
RBS Mezzanine Limited................... 65,000 65,000(9) 0 *
Leroy Schecter.......................... 479,336 333,334(4) 146,002 1.54%
Andre A. Schwartz....................... 12,594 8,334(4) 4,260 *
Paul D. Schwartz(14).................... 23,361 13,334(4) 10,027 *
Machelle M. Seibel...................... 31,101 20,000(4) 11,101 *
Sidney R. Rabb Trust f/b/o Carol R.
Goldberg(18).......................... 16,666 16,666(4) 0 *
US Boston Corporation PSRP U/A/D 10/1/84
A/C L. Okurowski...................... 50,868 8,279(8) 42,589 *
The Willard L. Umphrey 1996 Revocable
Trust U/A/D 3/26/96(19)............... 198,302 103,517(10) 94,785 *
Arie H. Zwanziger and Miriam
Zwanziger(20)......................... 113,044 66,666(4) 46,378 *
Zwanziger Family Ventures, LLC(21)...... 1,686,285 1,412,594(11) 273,691 2.60%
TOTAL................................... 6,595,244 5,560,238 1,035,006
========= ========= =========
------------------------
* Less than one percent
(1) Includes shares issuable upon conversion of Series A Convertible Preferred
Stock or exercise of warrants.
(2) Assumes that the selling stockholders will sell all shares of common stock
offered by them under this prospectus.
(3) For each selling stockholder, this number represents the percentage of
common stock to be owned by such selling stockholder after completion of the
offering, based on the number of shares of common stock outstanding as of
March 31, 2002 (9,126,588 shares) and assuming (i) all shares of Series A
Convertible Preferred Stock and warrants held by such selling stockholder
have been converted or exercised, as applicable, and (ii) none of the shares
of Series A Convertible Preferred Stock and warrants held by other persons
have been converted or exercised, as applicable.
(4) Represents shares of common stock issuable upon conversion of Series A
Convertible Preferred Stock.
(5) Represents 1,223 shares of stock issuable upon exercise of warrants held by
BNP Paribas.
(6) Represents (i) 249,934 shares of common stock issued upon conversion of
Series A Convertible Preferred Stock and (ii) 192,258 shares of common stock
issuable upon conversion of Series A Convertible Preferred Stock.
(7) Represents (i) 83,400 shares of common stock issued upon conversion of
Series A Convertible Preferred Stock and (ii) 64,086 shares of common stock
issuable upon conversion of Series A Convertible Preferred Stock.
20
(8) Represents shares of common stock issuable upon exercise of warrants issued
in connection with our $20.0 million private placement of subordinated notes
and warrants.
(9) Represents shares of common stock issuable upon exercise of a warrant
granted to the selling stockholder in connection with the provision of our
$10.0 million mezzanine credit facility.
(10) Represents (i) 89,720 shares of common stock issuable upon conversion of
Series A Convertible Preferred Stock and (ii) 13,797 shares of common stock
issuable upon exercise of warrants issued in connection with our
$20.0 million private placement of subordinated notes and warrants.
(11) Represents (i) 1,000,000 shares of common stock issuable upon conversion of
Series A Convertible Preferred Stock, (ii) 27,594 shares of common stock
issuable upon exercise of warrants issued in connection with our
$20.0 million private placement of subordinated notes and warrants and
(iii) 385,000 shares of common stock issuable upon exercise of a warrant
issued to the selling stockholder in consideration of its agreement not to
sell or transfer shares of common stock for a three-year period (subject to
continuing volume limitations after such period), which agreement was
required by the banks as a condition to our obtaining the $10.0 million
mezzanine credit facility.
(12) Carol R. Goldberg, one of our directors, is a trustee of The Avram J.
Goldberg and Carol R. Goldberg Remainder Unitrust.
(13) Selling stockholder is a director of our company.
(14) Selling stockholder is the owner and president of a professional
corporation that is a partner of Goodwin Procter LLP, our legal counsel.
(15) Orit Goldstein is the sister of Ron Zwanziger, our Chairman, Chief
Executive Officer and President. Of the shares attributed to her,
Ms. Goldstein disclaims beneficial ownership of (i) 4,894 shares of common
stock owned by her husband, (ii) 900 shares of common stock held in her
husband's IRA and (iii) 100,230 shares of common stock owned by the
Zwanziger Family Trust, of which Ms. Goldstein is a trustee.
(16) Jonathan Fleming, general partner of the selling stockholder's general
partner, is a former director of our former parent, Inverness Medical
Technology, Inc.
(17) John D. Patterson, Jr. is a partner of Foley, Hoag & Eliot LLP, our legal
counsel.
(18) Carol R. Goldberg, one of our directors, is a trustee and sole beneficiary
of the Sidney R. Rabb Trust f/b/o Carol R. Goldberg.
(19) Willard Umphrey, the trustee and beneficiary of the selling stockholder, is
a former director of both our company and our former parent, Inverness
Medical Technology, Inc.
(20) Arie H. Zwanziger and Miriam Zwanziger are the parents of Ron Zwanziger,
our Chairman, Chief Executive Officer and President.
(21) Zwanziger Family Ventures, LLC is a beneficial owner of over 5% of our
common stock. Ron Zwanziger, our Chairman, Chief Executive Officer and
President, is a manager of Zwanziger Family Ventures, LLC.
USE OF PROCEEDS
We will not receive any proceeds from the sale by the selling stockholders
of the common stock covered by this prospectus. We will, however, receive the
proceeds from the exercise of the warrants, if and when exercised by selling
stockholders holding warrants. If those selling stockholders exercise in full
their respective warrants covering an aggregate of 506,412 shares of common
stock, we estimate that our net proceeds would be approximately $7,617,442. We
expect to use substantially all of the net proceeds from the exercise of the
warrants for working capital and other general corporate purposes.
21
PLAN OF DISTRIBUTION
The selling stockholders, or their pledgees, donees, transferees, or any of
their successors in interest, may sell the securities from time to time on the
American Stock Exchange or any other stock exchange or automated interdealer
quotation system on which the securities are listed, in the over-the-counter
market, in privately negotiated transactions or otherwise, at fixed prices that
may be changed, at market prices prevailing at the time of sale, at prices
related to prevailing market prices or at prices otherwise negotiated. The
"selling stockholders" as used in this section of the prospectus shall refer to
the selling stockholders, or their pledgees, donees, transferees, or any of
their successors in interest. The selling stockholders may sell the securities
by one or more of the following methods, without limitation:
(a) block trades in which the broker or dealer so engaged will attempt to
sell the securities as agent but may position and resell a portion of the
block as principal to facilitate the transaction;
(b) purchases by a broker or dealer as principal and resale by the broker or
dealer for its own account pursuant to this prospectus;
(c) a special offering, an exchange distribution or a secondary distribution
in accordance with the rules of any stock exchange on which the
securities are listed;
(d) ordinary brokerage transactions and transactions in which the broker
solicits purchases;
(e) privately negotiated transactions;
(f) short sales;
(g) through the writing of options on the securities, whether or not the
options are listed on an options exchange;
(h) through the distribution of the securities by any selling stockholder to
its partners, members or stockholders;
(i) one or more underwritten offerings on a firm commitment or best efforts
basis;
(j) sales at other than a fixed price to or through a market maker or into
an existing trading market, on an exchange or otherwise, for such
securities;
(k) through agreements between a broker or dealer and one or more of the
selling stockholders to sell a specified number of the securities at a
stipulated price per share; and
(l) any combination of any of these methods of sale.
The selling stockholders may also transfer the securities by gift. We do not
know of any arrangements by the selling stockholders for the sale of any of the
securities.
The selling stockholders may arrange for other brokers or dealers to
participate in effecting sales of the securities. These brokers, dealers or
underwriters may act as principals or agents of a selling stockholder.
Broker-dealers may agree with a selling stockholder to sell a specified number
of the securities at a stipulated price per security. If the broker-dealer is
unable to sell securities acting as agent for a selling stockholder, it may
purchase as principal any unsold securities at the stipulated price.
Broker-dealers who acquire securities as principals may thereafter resell the
securities from time to time in transactions in any stock exchange or automated
interdealer quotation system on which the securities are then listed, at prices
and on terms then prevailing at the time of sale, at prices related to the
then-current market price or in negotiated transactions. Broker-dealers may use
block transactions and sales to and through broker-dealers, including
transactions of the nature described above. Broker-dealers will receive
commissions or other compensation from the selling stockholders in amounts to be
22
negotiated immediately prior to the sale that will not exceed those customary in
the types of transactions involved. Broker-dealers may also receive compensation
from purchasers of the securities which is not expected to exceed that customary
in the types of transactions involved. The selling stockholders may also sell
the securities in accordance with Rule 144 under the Securities Act of 1933, as
amended, rather than pursuant to this prospectus, regardless of whether the
securities are covered by this prospectus.
From time to time, one or more of the selling stockholders may pledge,
hypothecate or grant a security interest in some or all of the securities owned
by them. The pledgees, secured parties or persons to whom the securities have
been hypothecated will, upon foreclosure in the event of default, be deemed to
be selling stockholders. The number of a selling stockholder's securities
offered under this prospectus will decrease as and when it takes such actions.
The plan of distribution for that selling stockholder's securities will
otherwise remain unchanged. In addition, a selling stockholder may, from time to
time, sell the securities short, and, in those instances, this prospectus may be
delivered in connection with the short sales and the securities offered under
this prospectus may be used to cover short sales.
To the extent required under the Securities Act of 1933, the aggregate
amount of selling stockholders' securities being offered and the terms of the
offering, the names of any agents, brokers, dealers or underwriters and any
applicable commission with respect to a particular offer will be set forth in an
accompanying prospectus supplement. Any underwriters, dealers, brokers or agents
participating in the distribution of the securities may receive compensation in
the form of underwriting discounts, concessions, commissions or fees from a
selling stockholder and/or purchasers of a selling stockholder's securities, for
whom they may act (which compensation as to a particular broker-dealer might be
in excess of customary commissions).
The selling stockholders and any underwriters, brokers, dealers or agents
that participate in the distribution of the securities may be deemed to be
"underwriters" within the meaning of the Securities Act of 1933, and any
discounts, concessions, commissions or fees received by them and any profit on
the resale of the securities sold by them may be deemed to be underwriting
discounts and commissions.
A selling stockholder may enter into hedging transactions with
broker-dealers and the broker-dealers may engage in short sales of the
securities in the course of hedging the positions they assume with that selling
stockholder, including, without limitation, in connection with distributions of
the securities by those broker-dealers. A selling stockholder may enter into
option or other transactions with broker-dealers that involve the delivery of
the securities offered hereby to the broker-dealers, who may then resell or
otherwise transfer those securities. A selling stockholder may also loan or
pledge the securities offered hereby to a broker-dealer and the broker-dealer
may sell the securities offered hereby so loaned or upon a default may sell or
otherwise transfer the pledged securities offered hereby.
The selling stockholders and other persons participating in the sale or
distribution of the securities will be subject to applicable provisions of the
Securities Exchange Act of 1934, as amended, and the rules and regulations
thereunder, including Regulation M. This regulation may limit the timing of
purchases and sales of any of the securities by the selling stockholders and any
other person. The anti-manipulation rules under the Securities Exchange Act of
1934 may apply to sales of securities in the market and to the activities of the
selling stockholders and their affiliates. Furthermore, Regulation M may
restrict the ability of any person engaged in the distribution of the securities
to engage in market-making activities with respect to the particular securities
being distributed for a period of up to five business days before the
distribution. These restrictions may affect the marketability of the securities
and the ability of any person or entity to engage in market-making activities
with respect to the securities.
We have agreed to indemnify and hold harmless the selling stockholders and
each person, if any, who controls a selling stockholder within the meaning of
the Securities Act of 1933 (and, with respect
23
to one selling stockholder, its officers, directors and underwriters) against
specified liabilities, including liabilities under the federal securities laws.
The selling stockholders have agreed to indemnify and hold harmless us, certain
directors, officers and control persons against specified liabilities, including
liabilities under the federal securities laws.
The securities offered hereby were originally issued to the selling
stockholders pursuant to an exemption from the registration requirements of the
Securities Act of 1933. We agreed to register the securities under the
Securities Act of 1933. We will pay all expenses relating to the offering and
sale of the securities, with the exception of commissions, discounts and fees of
underwriters, broker-dealers or agents, taxes of any kind and any legal,
accounting and other expenses incurred by the selling stockholders.
We will not receive any proceeds from the sale by the selling stockholders
of the common stock covered by this prospectus.
We can not assure you that the selling stockholders will sell all or any
portion of the securities offered hereby.
We will supply the selling stockholders and any stock exchange upon which
the securities are listed with reasonable quantities of copies of this
prospectus. To the extent required by Rule 424 under the Securities Act of 1933
in connection with any resale or redistribution by a selling stockholder, we
will file a prospectus supplement setting forth:
- the aggregate number of shares to be sold;
- the purchase price;
- the public offering price;
- if applicable, the names of any underwriter, agent or broker-dealer; and
- any applicable commissions, discounts, concessions, fees or other items
constituting compensation to underwriters, agents or broker-dealers with
respect to the particular transaction (which may exceed customary
commissions or compensation).
If a selling stockholder notifies us that a material arrangement has been
entered into with a broker-dealer for the sale of shares through a block trade,
special offering, exchange, distribution or secondary distribution or a purchase
by a broker or dealer, the prospectus supplement will include any other facts
that are material to the transaction. If applicable, this may include a
statement to the effect that the participating broker-dealers did not conduct
any investigation to verify the information set out or incorporated by reference
in this prospectus.
INCORPORATION OF DOCUMENTS BY REFERENCE
The Securities and Exchange Commission allows us to incorporate by reference
the information that we file with them. Incorporation by reference means that we
can disclose important information to you by referring you to other documents
that are legally considered to be part of this prospectus and later information
that we file with the Securities and Exchange Commission will automatically
update and supersede the information in this prospectus, any supplement and the
documents listed below. We incorporate by reference the specific documents
listed below and any future filings made with the Securities and Exchange
Commission under Section 13(a), 13(c), 14, or 15(d) of the Securities Exchange
Act until the selling stockholders sell all of the securities registered
hereunder:
- our Annual Report on Form 10-K, as amended, for the year ended
December 31, 2001;
- our Current Report on Form 8-K, event date December 20, 2001, which was
filed on January 4, 2002, as amended by our Current Report on Form 8-K/A
filed on March 5, 2002 and our Current Report on Form 8-K/A filed on
May 7, 2002;
24
- our Current Report on Form 8-K, event date March 6, 2002, which was filed
on March 14, 2002;
- our Current Report on Form 8-K, event date March 19, 2002, which was filed
on March 29, 2002, as amended by our Current Report on Form 8-K/A filed on
April 24, 2002;
- our Current Report on Form 8-K, event date April 11, 2002, which was filed
on April 11, 2002;
- our Quarterly Report on Form 10-Q for the quarter ended March 31, 2002;
- our Current Report on Form 8-K, event date May 28, 2002, which was filed
on May 29, 2002; and
- the description of our common stock contained in our Registration
Statement on Form 8-A, filed on November 21, 2001, and all amendments and
reports updating such description.
Upon oral or written request and at no cost to the requester, we will
provide to any person, including a beneficial owner, to whom a prospectus is
delivered, a copy of any or all of the information that has been incorporated by
reference in this prospectus but not delivered with this prospectus. All
requests should be made to: Inverness Medical Innovations, Inc., 51 Sawyer Road,
Suite 200, Waltham, Massachusetts 02453, Attn: Corporate Secretary. Telephone
requests may be directed to the Corporate Secretary at (781) 647-3900. You
should rely only on the information incorporated by reference or provided in
this prospectus. We have not authorized anyone to provide you with different
information. You should not assume that the information in this prospectus or
the documents incorporated by reference is accurate as of any date other than
the date on the front of this prospectus or those documents.
WHERE YOU CAN FIND MORE INFORMATION
We are subject to the informational requirements of the Securities Exchange
Act of 1934, as amended, and we are required to file reports and proxy
statements and other information with the Securities and Exchange Commission.
You may read and copy these reports, proxy statements and information at the
Securities and Exchange Commission's Public Reference Room at 450 Fifth Street,
N.W., Room 1024, Washington, D.C. 20549. You may also obtain copies at the
prescribed rates from the Public Reference Section of the Securities and
Exchange Commission at its principal office in Washington, D.C. You may obtain
information on the operation of the Public Reference Room by calling the
Securities and Exchange Commission at 1-800-SEC-0330. The Securities and
Exchange Commission maintains a web site that contains reports, proxy and
information statements and other information regarding registrants, including
Inverness Medical Innovations, Inc., that file electronically with the
Securities and Exchange Commission. You may access the Securities and Exchange
Commission's web site at http://www.sec.gov.
EXPERTS
The consolidated financial statements of Inverness Medical
Innovations, Inc. as of December 31, 2001 and 2000, and for each of the three
years in the period ended December 31, 2001, incorporated by reference in this
prospectus and elsewhere in the registration statement have been audited by
Arthur Andersen LLP, independent public accountants, as indicated in their
report with respect thereto, and are incorporated by reference herein in
reliance upon the authority of said firm as experts in accounting and auditing
in giving said reports.
The financial statements of the Unipath Division of Unilever Plc as of
November 30, 2001 and December 31, 2000, and for the eleven months ended
November 30, 2001 and each of the two years in the period ended December 31,
2000, incorporated by reference in this prospectus and elsewhere in the
registration statement have been audited by Arthur Andersen LLP, independent
public accountants, as indicated in their report with respect thereto, and are
incorporated by reference herein in reliance upon the authority of said firm as
experts in accounting and auditing in giving said report.
25
The consolidated financial statements of IVC Industries, Inc. as of
July 31, 2001 and 2000, and for each of the three years in the period ended
July 31, 2001, incorporated by reference in this prospectus and elsewhere in the
registration statement have been audited by Amper, Politziner & Mattia P.A.,
independent public accountants, as indicated in their reports with respect
thereto, and are incorporated by reference herein in reliance upon the authority
of said firm as experts in accounting and auditing in giving said reports.
LEGAL MATTERS
The validity of the issuance of the shares of common stock offered hereby
will be passed upon by our counsel, Goodwin Procter LLP. The owners and
presidents of four professional corporations, which are partners in the firm of
Goodwin Procter LLP, beneficially own an aggregate of approximately 4,133 shares
of our common stock, 6,666 shares of our common stock, 1,666 shares of our
common stock and 23,361 shares of our common stock, respectively.
26
5,560,238 SHARES
INVERNESS MEDICAL INNOVATIONS, INC.
COMMON STOCK
---------------------
PROSPECTUS
---------------------
JUNE 3, 2002