AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON JUNE 1, 2001
REGISTRATION NO. 333-
================================================================================
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
-----------
FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
-----------
INTEGRA LIFESCIENCES HOLDINGS CORPORATION
(Exact name of registrant as specified in its charter)
DELAWARE 3841 51-0317849
(State or other jurisdiction of (Primary Standard Industrial (I.R.S. Employer Identification
incorporation or organization) Classification Code Number) Number)
-----------
311-C ENTERPRISE DRIVE
PLAINSBORO, NEW JERSEY 08536
(609) 275-0500
(Address, including zip code, and telephone number, including area
code, of registrant's principal executive offices)
-----------
JOHN B. HENNEMAN, III
CHIEF ADMINISTRATIVE OFFICER AND SECRETARY
311-C ENTERPRISE DRIVE
PLAINSBORO, NEW JERSEY 08536
(609) 275-0500
(Name, address, including zip code, and telephone number,
including area code, of agent for service)
-----------
COPIES TO:
PETER M. LABONSKI, ESQ.
LATHAM & WATKINS
885 THIRD AVENUE, SUITE 1000
NEW YORK, NY 10022
(212) 906-1200
-----------
APPROXIMATE DATE OF COMMENCEMENT OF PROPOSED SALE TO PUBLIC: FROM TIME
TO TIME AFTER THE EFFECTIVE DATE OF THIS REGISTRATION STATEMENT AS DETERMINED BY
MARKET CONDITIONS.
IF THE ONLY SECURITIES BEING REGISTERED ON THIS FORM ARE BEING OFFERED
PURSUANT TO DIVIDEND OR INTEREST REINVESTMENT PLANS, PLEASE CHECK THE FOLLOWING
BOX. [ ]
IF ANY OF THE SECURITIES BEING REGISTERED ON THIS FORM ARE TO BE
OFFERED ON A DELAYED OR CONTINUOUS BASIS PURSUANT TO RULE 415 UNDER THE
SECURITIES ACT OF 1933, OTHER THAN SECURITIES OFFERED ONLY IN CONNECTION WITH
DIVIDEND OR INTEREST REINVESTMENT PLANS, CHECK THE FOLLOWING BOX. [X]
IF THIS FORM IS FILED TO REGISTER ADDITIONAL SECURITIES FOR AN OFFERING
PURSUANT TO RULE 462(b) UNDER THE SECURITIES ACT, PLEASE CHECK THE FOLLOWING BOX
AND LIST THE SECURITIES ACT REGISTRATION STATEMENT NUMBER OF THE EARLIER
EFFECTIVE REGISTRATION STATEMENT FOR THE SAME OFFERING. [ ] ____
IF THIS FORM IS A POST-EFFECTIVE AMENDMENT FILED PURSUANT TO RULE
462(c) UNDER THE SECURITIES ACT, CHECK THE FOLLOWING BOX AND LIST THE SECURITIES
ACT REGISTRATION STATEMENT NUMBER OF THE EARLIER EFFECTIVE REGISTRATION
STATEMENT FOR THE SAME OFFERING. [ ] ____
IF DELIVERY OF THE PROSPECTUS IS EXPECTED TO BE MADE PURSUANT TO RULE
434, PLEASE CHECK THE FOLLOWING BOX. [ ]
-----------
CALCULATION OF REGISTRATION FEE
======================================= =================== ===================
PROPOSED MAXIMUM
AGGREGATE AMOUNT OF
TITLE OF SHARES TO BE REGISTERED OFFERING PRICE (1) REGISTRATION FEE
- --------------------------------------- ------------------- -------------------
Debt Securities..................... $ $
Preferred Stock, $0.01 par value.... $ $
Debt Securities, Preferred Stock and
Common Stock issuable upon conversion
of any Convertible Debt Securities or
Preferred Stock..................... $ $
Common Stock, $0.01 par value....... $ $
Total $75,000,000 $18,750(2)
======================================= =================== ===================
(1) Estimated solely for the purpose of calculating the amount of the
registration fee in accordance with Rule 457(o) under the Securities Act of
1933, as amended (the "Securities Act"). There are being registered an
indeterminate number of Debt Securities, Preferred Stock and Common Stock
of Integra LifeSciences Holdings Corporation.
(2) Registration fee was paid on February 14, 2001.
----------
The Registrant hereby amends this Registration Statement on such date
or dates as may be necessary to delay its effective date until the Registrant
shall file a further amendment that specifically states that this Registration
Statement shall thereafter become effective in accordance with Section 8(a) of
the Securities Act of 1933 as amended, or until the Registration Statement shall
become effective on such date as the Commission, acting pursuant to said Section
8(a), may determine.
================================================================================
SUBJECT TO COMPLETION. DATED JUNE 1, 2001.
- --------------------------------------------------------------------------------
PROSPECTUS
[INTEGRA LOGO]
-----------
INTEGRA LIFESCIENCES HOLDINGS CORPORATION
COMMON STOCK
PREFERRED STOCK
DEBT SECURITIES
-----------
Integra LifeSciences Holdings Corporation may periodically sell common
stock, preferred stock and debt securities to the public. We will provide
specific terms of such securities in supplements to this prospectus. You should
read this prospectus and each applicable supplement carefully before you invest.
The aggregate initial offering price of all of the securities that may be
sold pursuant to this prospectus will not exceed U.S. $75,000,000, or its
equivalent based on the applicable exchange rate at the time of issue in one or
more foreign currencies or currency units as shall be designated by Integra.
Our common stock is listed on the Nasdaq National Market under the symbol
"IART." On May 31, 2001, the reported last sale price of the common stock was
$19.000 per share.
INVESTING IN OUR SECURITIES INVOLVES CERTAIN SIGNIFICANT RISKS. SEE "RISK
FACTORS" BEGINNING ON PAGE 4.
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.
This prospectus may not be used to sell our securities unless it is
accompanied by a prospectus supplement.
----------
THE DATE OF THIS PROSPECTUS IS , 2001.
The information contained in this preliminary prospectus is not complete and may
be changed. These securities may not be sold until the registration statement
filed with the Securities and Exchange Commission is effective. The preliminary
prospectus is not an offer to sell nor does it seek an offer to buy these
securities in any jurisdiction where the offer or sale is not permitted.
No person is authorized to give any information or to make any
representations other than those contained or incorporated by reference in this
prospectus or the accompanying prospectus supplement and, if given or made, such
information or representations must not be relied upon as having been
authorized. This prospectus and accompanying prospectus supplement do not
constitute an offer to sell or the solicitation of an offer to buy any
securities other than the securities described in this prospectus and the
accompanying prospectus supplement or an offer to sell or the solicitation of an
offer to buy such securities in any circumstance in which such offer or
solicitation is unlawful. Neither the delivery of this prospectus or the
accompanying prospectus supplement shall, under any circumstances, create any
implication that there has been no change in the affairs of Integra since the
date of the prospectus supplement accompanying this prospectus or that the
information contained or incorporated by reference in this prospectus or
accompanying prospectus supplement is correct as of any time subsequent to the
date of such information.
(iii)
TABLE OF CONTENTS
PAGE
----
About This Prospectus................................................... v
Prospectus Summary...................................................... 1
Integra................................................................. 1
Summary Consolidated Historical Financial Data.......................... 2
Risk Factors............................................................ 4
Special Note Regarding Forward-Looking Statements...................... 15
Ratio of Earnings to Fixed Charges and Ratio of
Earnings to Combined Fixed Charges and Preferred Stock Dividends ..... 16
Use of Proceeds........................................................ 17
Price Range of Common Stock and Dividends.............................. 17
Capitalization......................................................... 18
Selected Consolidated Financial Data................................... 19
Management's Discussion and Analysis of Financial Condition
And Results of Operations............................................. 21
Business............................................................... 35
Management............................................................. 50
Principal Stockholders................................................. 53
Certain Transactions................................................... 55
Description of Debt Securities......................................... 56
Description of Capital Stock........................................... 67
Plan of Distribution................................................... 70
Legal Matters.......................................................... 71
Experts................................................................ 71
Where to Find Additional Information................................... 71
(iv)
ABOUT THIS PROSPECTUS
This document is called a prospectus and is part of a registration
statement that we filed with the SEC using a "shelf" registration or continuous
offering process. Under this shelf process, we may from time to time sell any
combination of the common stock, the preferred stock and the debt securities
described in this prospectus in one or more offerings which will aggregate up to
a total dollar amount of $75,000,000 including an over-allotment option with
regard to certain securities, as may be determined in an applicable future
prospectus supplement.
This prospectus provides you with a general description of the common
stock, the preferred stock, and the debt securities we may offer. Each time we
sell such securities, we will provide a prospectus supplement containing
specific information about the terms of the securities being offered. That
prospectus supplement may include a discussion of any risk factors or other
special considerations applicable to those securities. The prospectus supplement
may also add, update or change information in this prospectus. If there is any
inconsistency between the information in this prospectus and any prospectus
supplement, you should rely on the information in that prospectus supplement.
You should read both this prospectus and any prospectus supplement together with
the additional information described under the heading "Where You Can Find More
Information."
The registration statement containing this prospectus, including the
exhibits to the registration statement, provides additional information about us
and the securities offered under this prospectus. The registration statement,
including the exhibits, can be read at the SEC website or at the SEC offices
mentioned under the heading "Where You Can Find More Information."
You should rely only on the information incorporated by reference or
provided in this prospectus and the accompanying prospectus supplement. We have
not authorized anyone to provide you with different information. We are not
making an offer or soliciting a purchase of these securities in any jurisdiction
in which the offer or solicitation is not authorized or in which the person
making the offer or solicitation is not qualified to do so or to anyone to whom
it is unlawful to make the offer or solicitation. You should not assume that the
information in this prospectus or the accompanying prospectus supplement is
accurate as of any date other than the date on the front of the document.
The prospectus incorporates business and financial information about us
that is not included or delivered with this document. YOU MAY REQUEST AND OBTAIN
THIS INFORMATION FREE OF CHARGE BY WRITING OR TELEPHONING US AT THE FOLLOWING
ADDRESS: 311-C ENTERPRISE DRIVE, PLAINSBORO, NEW JERSEY 08536, ATTENTION:
DIRECTOR OF FINANCE, TELEPHONE (609) 275-0500.
BioMend(R), Camino(R), Clinical Neuro Systems(TM), CollaCote(R),
CollaPlug(R), CollaStat(TM), CollaTape(R), Dissectron(R), DuraGen(R),
Helistat(R), Helitene(R), Heyer-Schulte(R), INTEGRA(R) Dermal Regeneration
Template, LICOX(R), Neuro Navigational(R), Novus(R), LPV(R), Ommaya(R),
Pudenz(TM), Redmond(TM), Ruggles(TM), Selector(R), Spetzler(R), Sundt(TM),
Ventrix(R), and VitaCuff(R)are some of the trademarks of Integra and its
subsidiaries. All other brand names, trademarks and service marks appearing in
this prospectus are the property of their respective holders.
(v)
- --------------------------------------------------------------------------------
PROSPECTUS SUMMARY
THIS SUMMARY HIGHLIGHTS INFORMATION ABOUT INTEGRA AND THE SECURITIES
OFFERED BY THIS PROSPECTUS. IT DOES NOT CONTAIN ALL THE INFORMATION THAT MAY BE
IMPORTANT TO YOU. YOU SHOULD READ THIS SUMMARY TOGETHER WITH THE MORE DETAILED
INFORMATION AND OUR FINANCIAL STATEMENTS AND NOTES APPEARING ELSEWHERE IN THIS
PROSPECTUS. YOU SHOULD CAREFULLY CONSIDER, AMONG OTHER FACTORS, THE MATTERS SET
FORTH IN "RISK FACTORS." THE TERMS "WE," "OUR," "US" AND "INTEGRA" REFER TO
INTEGRA LIFESCIENCES HOLDINGS CORPORATION AND ITS SUBSIDIARIES UNLESS THE
CONTEXT SUGGESTS OTHERWISE. WHEN WE USE THE TERM INTEGRA PARENT COMPANY IN THIS
PROSPECTUS, WE ARE REFERRING ONLY TO THE PARENT HOLDING COMPANY ENTITY, INTEGRA
LIFESCIENCES HOLDINGS CORPORATION.
INTEGRA
We develop, manufacture and market medical devices, implants and
biomaterials. Our operations consist of (1) Integra NeuroSciences, which is a
leading provider of implants, devices, and monitors used in neurosurgery,
neurotrauma, and related critical care and (2) Integra LifeSciences, which
develops and manufactures a variety of medical products and devices, including
products based on our proprietary tissue regeneration technology which are used
to treat soft tissue and orthopedic conditions. Integra NeuroSciences sells
primarily through a direct sales organization and Integra LifeSciences sells
primarily through strategic alliances and distributors.
Integra was founded in 1989 and over the next decade built a product
portfolio based on resorbable collagen and a product development platform based
on technologies directed toward tissue regeneration. During 1999 and 2000, we
expanded into the neurosurgical market, an attractive niche, through
acquisitions and introductions of new products. Our 2000 revenues increased to
$71.6 million as compared to $42.9 million in 1999, and our revenues for the
first three months of 2001 were $21.7 million compared to $14.5 million for the
first three months of 2000.
Our goal is to become a leader in the development, manufacture and
marketing of medical devices, implants and biomaterials in the markets in which
we compete. Our products are principally used in the diagnosis and treatment of
neurosurgical, soft-tissue and orthopedic conditions and we intend to expand our
presence in those markets. Key elements of our strategy include the following:
o Expand our presence in neurosurgery and closely related surgical
specialties;
o Continue to develop new and innovative medical products; and
o Continue to form strategic alliances for Integra LifeSciences products
and technologies.
-----------
Integra was formed as a Delaware corporation in June 1989. Our executive
offices are located at 311-C Enterprise Drive, Plainsboro, New Jersey 08536. Our
telephone number is (609) 275-0500. Our World Wide Web site address is
http://www.integra-LS.com. The information on our web site is not part of this
prospectus.
- --------------------------------------------------------------------------------
- --------------------------------------------------------------------------------
SUMMARY CONSOLIDATED HISTORICAL
FINANCIAL DATA
(UNAUDITED)
-----------------------------
THREE MONTHS ENDED
MARCH 31, YEARS ENDED DECEMBER 31,
---------------------------- ------------------------------------
2001 2000 2000 1999 1998
---- ---- ---- ---- ----
(IN THOUSANDS, EXCEPT PER SHARE DATA)
Statement of Operations Data (1):
Product sales......................... $20,284 $13,332 $64,987 $40,047 $14,182
Other revenue......................... 1,400 1,199 6,662 2,829 3,379
Total revenue....................... 21,684 14,531 71,649 42,876 17,561
Cost of product sales................. 8,594 6,687 29,511 22,678 7,580
Research and development.............. 2,073 1,890 7,524 8,893 8,424
Selling and marketing................. 4,751 2,949 15,371 9,487 5,901
General and administrative (2)........ 3,204 3,747 28,483 13,324 9,787
Amortization.......................... 680 480 2,481 874 49
Total costs and expenses............ 19,302 15,753 83,370 55,256 31,741
Operating income (loss)............... 2,382 (1,222) (11,721) (12,380) (14,180)
Interest income (expense), net........ (78) 11 (473) 294 1,250
Gain on disposition of product line... -- 115 1,146 4,161 --
Other income (expense) net............ (62) 123 201 141 588
Income (loss) before income taxes..... 2,242 (973) (10,847) (7,784) (12,342)
Income tax expense (benefit) (3)...... 246 62 108 (1,818) --
Income (loss) before cumulative
effect of accounting change......... 1,996 (1,035) (10,955) (5,966) (12,342)
Cumulative effect of change in
accounting for nonrefundable fees
received under research, license
and distribution arrangements (4)... -- (470) (470) -- --
Net income (loss)..................... $ 1,996 $(1,505) $(11,425) $(5,966) $(12,342)
Diluted net income (loss) per share... $0.07 $(0.35) $(0.97) $(0.40) $(0.77)
Weighted average common shares
outstanding......................... 21,849 17,224 17,553 16,802 16,139
(UNAUDITED) DECEMBER 31,
MARCH 31, 2001 2000
------------------- ----------------
(IN THOUSANDS)
Balance Sheet Data (1):
Cash, cash equivalents and short-term investments...................... $19,374 $15,138
Working capital........................................................ 27,992 25,177
Total assets........................................................... 91,079 86,514
Long-term debt......................................................... 3,121 4,758
Accumulated deficit.................................................... (103,733) (105,729)
Total stockholders' equity............................................. 56,874 53,781
- --------------------------------------------------------------------------------------------------------------------
2
- --------------------------------------------------------------------------------
- -----------
(1) As the result of our acquisitions of Rystan Company, Inc. ("Rystan") in
September 1998 and the NeuroCare Group of companies ("NeuroCare") in March
1999, the acquisition of Clinical Neuro Systems and product lines from NMT
Medical, Inc. in 2000, the consolidated financial results and balance sheet
data for certain of the periods presented above may not be directly
comparable.
(2) General and administrative expense in 2000 included a $13.5 million
stock-based compensation charge in connection with the extension of the
employment of the Company's President and Chief Executive Officer.
(3) The 1999 income tax benefit includes a non-cash benefit of $1.8 million
resulting from the reduction of the deferred tax liability recorded in the
NeuroCare acquisition to the extent that consolidated deferred tax assets
were generated subsequent to the acquisition. The 2000 income tax expense
and 1999 income tax benefit include $0.5 million and $0.6 million,
respectively, of benefits associated with the sale of New Jersey state net
operating losses.
(4) As the result of the adoption of SEC Staff Accounting Bulletin No. 101
Revenue Recognition ("SAB 101"), we recorded a $470,000 cumulative effect
of an accounting change to defer a portion of a nonrefundable, up-front fee
received and recorded in other revenue in 1998. The cumulative effect of
this accounting change was measured as of January 1, 2000. As a result of
this accounting change, other revenue in 2000 includes $112,000 of
amortization of the amount deferred as of January 1, 2000.
- --------------------------------------------------------------------------------
3
RISK FACTORS
IN ADDITION TO THE OTHER INFORMATION IN THIS PROSPECTUS, YOU SHOULD
CAREFULLY CONSIDER THE FOLLOWING RISKS BEFORE MAKING AN INVESTMENT DECISION. THE
TRADING PRICE OF OUR COMMON STOCK, PREFERRED STOCK OR DEBT SECURITIES COULD
DECLINE DUE TO ANY OF THESE RISKS, AND YOU COULD LOSE ALL OR A PART OF YOUR
INVESTMENT.
WE MAY BE UNABLE TO RAISE ADDITIONAL FINANCING NECESSARY TO CONDUCT OUR
BUSINESS, MAKE PAYMENTS WHEN DUE OR REFINANCE OUR DEBT.
We may need to raise additional funds in the future in order to implement
our business plan, to make scheduled principal and interest payments, to
refinance our debt, to conduct research and development, to fund marketing
programs or to acquire complementary businesses, technologies or services. Any
required additional financing may be unavailable on terms favorable to us, or at
all. If we raise additional funds by issuing equity securities, you may
experience significant dilution of your ownership interest and these securities
may have rights senior to those of the holders of our preferred or common stock.
If we cannot obtain additional financing when required on acceptable terms, we
may be unable to fund our expansion, develop or enhance our products and
services, take advantage of business opportunities or respond to competitive
pressures.
WHILE OUR CURRENT CAPITAL REQUIREMENTS DO NOT INCLUDE A SIGNIFICANT INCREASE IN
OUR DEBT LEVELS, WERE CIRCUMSTANCES TO ARISE THAT REQUIRE US TO INCUR MORE DEBT,
WE WOULD BE LIMITED BY THE PROVISIONS OF OUR CURRENT DEBT INSTRUMENTS FROM
INCURRING SUCH INDEBTEDNESS.
Historically, the cash we generate from our operating activities, new
equity investments and borrowings has been sufficient to meet our requirements
for debt service, working capital, capital expenditures, and investments in and
advance to our affiliates. Although in the past we have been able to obtain new
debt, there can be no guarantee that we will be able to continue to do so in the
future or that the cost to us or the other terms which would affect us would be
as favorable to us as our current loans and credit agreements. Although we
believe that our business will continue to generate cash, should we need to
borrow additional funds, the covenants in the credit agreements for our current
debt limit our ability to borrow more money.
THE INTEGRA PARENT COMPANY DEPENDS ON ITS SUBSIDIARIES AND OTHER COMPANIES IN
WHICH IT HAS INVESTMENTS TO FUND ITS CASH NEEDS.
The Integra Parent Company directly owns no significant assets other than
stock, equity and other interests in our subsidiaries and in some other
companies. This creates risks regarding our ability to provide cash to the
Integra Parent Company to repay any interest and principal which it might owe,
our ability to pay cash dividends to our preferred and common stockholders in
the future, and the ability of our subsidiaries and other companies to respond
to changing business and economic conditions and to get new loans.
HOLDING COMPANY STRUCTURE AND POTENTIAL IMPACT OF RESTRICTIVE COVENANTS IN
SUBSIDIARY DEBT AGREEMENTS.
Our credit agreements restrict the ability of our subsidiaries to make
payments to the Integra Parent Company. These agreements also place other
restrictions on the borrower's ability to borrow new funds and include
requirements for the borrowers to remain in compliance with the credit
agreements. The ability of a subsidiary to comply with debt restrictions may be
affected by events that are beyond our control. The breach of any of these
covenants could result in a default which could result in all loans and
4
other amounts owed to its lenders, to be due and payable. Our subsidiaries might
not be able to repay in full the accelerated loans.
WE MAY CONTINUE TO INCUR OPERATING LOSSES.
To date, we have experienced significant operating losses in funding the
research, development, manufacturing and marketing of our products and may
continue to incur operating losses. At March 31, 2001, we had an accumulated
deficit of $103.7 million. Our ability to maintain profitability depends in part
upon our ability, either independently or in collaboration with others, to
successfully manufacture and market our products and services. We cannot assure
you that we can sustain profitability on an ongoing basis.
OUR OPERATING RESULTS MAY FLUCTUATE FROM TIME TO TIME, WHICH COULD AFFECT THE
VALUE OF YOUR SHARES.
Our operating results have fluctuated in the past and can be expected to
fluctuate from time to time in the future. Some of the factors that may cause
these fluctuations include:
o the impact of acquisitions;
o the timing of significant customer orders;
o market acceptance of our existing products, as well as products in
development;
o the timing of regulatory approvals;
o the timing of payments received and the recognition of such payments
as revenue under collaborative arrangements and strategic alliances;
o our ability to manufacture our products efficiently; and
o the timing of our research and development expenditures.
THE INDUSTRY AND MARKET SEGMENTS IN WHICH WE OPERATE ARE HIGHLY COMPETITIVE, AND
WE MAY NOT BE ABLE TO COMPETE EFFECTIVELY WITH OTHER COMPANIES.
In general, the medical technology industry is characterized by intense
competition. We compete with established pharmaceutical and medical technology
companies. Competition also comes from early stage companies that have
alternative technological solutions for our primary clinical targets, as well as
universities, research institutions and other non-profit entities. Many of our
competitors have access to greater financial, technical, research and
development, marketing, manufacturing, sales, distribution services and other
resources than we do. Further, our competitors may be more effective at
implementing their technologies to develop commercial products.
Our competitive position will depend on our ability to achieve market
acceptance for our products, implement production and marketing plans, secure
regulatory approval for products under development, obtain patent protection and
secure adequate capital resources. We may need to develop new applications for
our products to remain competitive. Our present or future products could be
rendered obsolete or uneconomical by technological advances by one or more of
our current or future competitors. Our future success will depend upon our
ability to compete effectively against current technology as well as to respond
effectively to technological advances. We can not assure you that competitive
pressures will not adversely affect our profitability.
5
OUR CURRENT STRATEGY INVOLVES GROWTH THROUGH ACQUISITIONS, WHICH REQUIRES US TO
INCUR SUBSTANTIAL COSTS AND POTENTIAL LIABILITIES FOR WHICH WE MAY NEVER REALIZE
THE ANTICIPATED BENEFITS.
In addition to internal growth, our current strategy involves growth
through acquisitions. We cannot assure you that we will be able to continue to
implement our growth strategy, or that this strategy will ultimately be
successful. A significant portion of our growth in revenues has resulted from,
and is expected to continue to result from, the acquisition of businesses
complementary to our own. We engage in evaluations of potential acquisitions and
are in various stages of discussion regarding possible acquisitions, certain of
which, if consummated, could be significant to us. Acquisitions by us may result
in significant transaction expenses, increased interest and amortization
expense, increased depreciation expense and increased operating expense, any of
which could have a material adverse effect on our operating results. As we grow
by acquisitions, we must be able to integrate and manage the new businesses to
realize economies of scale and control costs. In addition, acquisitions involve
other risks, including diversion of management resources otherwise available for
ongoing development of our business and risks associated with entering new
markets with which our marketing and sales force has limited experience or where
experienced distribution alliances are not available. Our future profitability
will depend in part upon our ability to further develop our resources to adapt
to the particulars of such new products or business areas and to identify and
enter into satisfactory distribution networks. We may not be able to identify
suitable acquisition candidates in the future, obtain acceptable financing or
consummate any future acquisitions. If we cannot integrate acquired operations,
manage the cost of providing our products or price our products appropriately
our profitability would suffer. In addition, as a result of our acquisitions of
other healthcare businesses, we may be subject to the risk of unanticipated
business uncertainties or legal liabilities relating to such acquired businesses
for which we may not be indemnified by the sellers of the acquired businesses.
Future acquisitions may also result in potentially dilutive issuances of equity
securities.
TO MARKET OUR PRODUCTS UNDER DEVELOPMENT WE WILL FIRST NEED TO OBTAIN REGULATORY
APPROVAL. FURTHER, IF WE FAIL TO COMPLY WITH THE EXTENSIVE GOVERNMENTAL
REGULATIONS THAT AFFECT OUR BUSINESS, WE COULD BE SUBJECT TO PENALTIES AND COULD
BE PRECLUDED FROM MARKETING OUR PRODUCTS.
Our research and development activities and the manufacturing, labeling,
distribution and marketing of our existing and future products are subject to
regulation by numerous governmental agencies in the United States and in other
countries. The U.S. Food and Drug Administration ("FDA") and comparable agencies
in other countries impose mandatory procedures and standards for the conduct of
clinical trials and the production and marketing of products for diagnostic and
human therapeutic use. The FDA and other regulatory authorities require that our
products be manufactured according to rigorous standards. These regulatory
requirements may significantly increase our production or purchasing costs and
may even prevent us from making or obtaining our products in amounts sufficient
to meet market demand. If we, or a third party manufacturer, change our approved
manufacturing process, the FDA may require a new approval before that process
could be used. Failure to develop our manufacturing capability may mean that
even if we develop promising new products, we may not be able to produce them
profitably, as a result of delays and additional capital investment costs.
Manufacturing facilities, both international and domestic, are also subject to
inspections by or under the authority of the FDA.
Our products under development are subject to approval by the FDA prior to
marketing for commercial use. The process of obtaining necessary FDA approvals
can take years and is expensive and full of uncertainties. Our inability to
obtain required regulatory approval on a timely or acceptable basis could harm
our business. Further, approval may place substantial restrictions on the
indications for which the product may be marketed or to whom it may be marketed.
To gain approval for the use of a product for clinical indications other than
those for which the product was initially evaluated or for significant changes
to the product, further studies, including clinical trials and FDA approvals,
are required. In
6
addition, for products with an approved pre-market approval ("PMA") application,
the FDA requires postapproval reporting and may require postapproval
surveillance programs to monitor the product's safety and effectiveness. Results
of post approval programs may limit or expand the further marketing of the
product.
Approved products are subject to continuing FDA requirements relating to
quality control and quality assurance, maintenance of records and documentation
and labeling and promotion of medical devices. In addition, failure to comply
with applicable regulatory requirements could subject us to enforcement action,
including product seizures, recalls, withdrawal of clearances or approvals,
restrictions on or injunctions against marketing our product or products based
on our technology, and civil and criminal penalties.
Medical device laws and regulations are also in effect in many countries
outside the United States. These range from comprehensive device approval
requirements for some or all of our medical device products to requests for
product data or certifications. The number and scope of these requirements are
increasing. The requirements governing the conduct of clinical trials and
product approvals vary widely from country to country. Failure to comply with
applicable federal, state and foreign medical device laws and regulations would
result in fines or other censures or preclude our ability to market products.
Because more than 20% of our product sales are derived from international sales,
any delay or withdrawal of approval or change in international regulations could
have an adverse effect on our revenues and profitability. See
"Business--Government Regulation."
CERTAIN OF OUR PRODUCTS CONTAIN MATERIALS DERIVED FROM ANIMAL SOURCES, AND MAY
AS A RESULT BECOME SUBJECT TO ADDITIONAL REGULATION.
Certain of our products, including the DuraGen(R) Dural Graft Matrix and
the INTEGRA(R) Dermal Regeneration Template, contain material derived from
animal tissue. Products, including food as well as pharmaceuticals and medical
devices, that contain materials derived from animal sources are increasingly
subject to scrutiny in the press and by regulatory authorities, who are
concerned about the potential for the transmission of disease from animals to
humans via such materials. This public scrutiny has been particularly acute in
Western Europe with respect to products derived from cattle, because of concern
that materials infected with the agent that causes bovine spongiform
encephalopathy, otherwise known as "BSE" or "mad cow disease," may, if ingested
or implanted, cause a variant of the human Creutzfeldt-Jakob Disease, an
ultimately fatal disease with no known cure.
We take great care to provide that our products are safe, and free of
agents that can cause disease. In particular, the collagen used in the
manufacture of our products is derived only from the Achilles tendon of cattle
from the United States, where no cases of BSE have been reported. Scientists and
regulatory authorities classify Achilles tendon as having a negligible risk of
containing the agent that causes BSE (an improperly folded protein known as a
prion) compared with other parts of the body. Additionally, we use processes in
the manufacturing of our products that are believed to inactivate prions.
Notwithstanding the foregoing, products that contain materials derived from
animals, including our products, may become subject to additional regulation, or
even be banned in certain countries, because of concern over the potential for
prion transmission. There can be no assurance that such new regulation, or a ban
of our products, would not have a significant adverse effect on our current
business or our ability to increase our business.
7
LACK OF MARKET ACCEPTANCE FOR OUR PRODUCTS OR MARKET PREFERENCE FOR TECHNOLOGIES
WHICH COMPETE WITH OUR PRODUCTS WOULD REDUCE OUR REVENUES AND PROFITABILITY.
We cannot be certain that our current products, or any other products that
we develop or market, will achieve or maintain market acceptance. Certain of the
medical indications that can be treated by our devices can also be treated by
other medical devices. Currently, the medical community widely accepts many
alternative treatments, and these other treatments have a long history of use.
We cannot be certain that our devices and procedures will be able to replace
such established treatments or that either physicians or the medical community
in general will accept and utilize our devices or any other medical products
that we may develop. In addition, our future success depends, in part, on our
ability to develop additional products. Even if we determine that a product
candidate has medical benefits, the cost of commercializing that product
candidate may be too high to justify development. In addition, competitors may
develop products that are more effective, cost less, or are ready for commercial
introduction before our products. If we are unable to develop additional,
commercially viable products, our future prospects will be adversely affected.
Market acceptance of our products depends on many factors, including our
ability to convince prospective collaborators and customers that our technology
is an attractive alternative to other technologies, manufacture products in
sufficient quantities and at an acceptable cost and place and service, directly,
or through our strategic alliances, sufficient quantities of our products. In
addition, our technology could be harmed by limited funding available for
product and technology acquisitions by our customers, as well as internal
obstacles to customer approvals of purchases of our products. The industry is
subject to rapid and continuous change arising from, among other things,
consolidation and technological improvements. One or more of these factors may
vary unpredictably, which could materially adversely affect our competitive
position. We may not be able to adjust our contemplated plan of development to
meet changing market demands.
OUR BUSINESS DEPENDS SIGNIFICANTLY ON KEY RELATIONSHIPS WITH THIRD PARTIES WHICH
WE MAY NOT BE ABLE TO ESTABLISH AND MAINTAIN.
Our revenue stream and our business strategy depend in part on our entering
into and maintaining collaborative or alliance agreements with third parties
concerning product marketing as well as research and development programs. Our
ability to enter into agreements with collaborators depends in part on
convincing them that our technology can help achieve and accelerate their goals
and strategies. This may require substantial time, effort and expense on our
part with no guarantee that a strategic relationship will result. We may not be
able to establish or maintain these relationships on commercially acceptable
terms. Our future agreements may not ultimately be successful. Even if we enter
into collaborative or alliance agreements, our collaborators could terminate
these agreements or they could expire before meaningful developmental milestones
are reached. The termination or expiration of any of these relationships could
have a material adverse effect on our business.
Much of the revenue that we may receive under these collaborations will
depend upon our collaborators' ability to successfully introduce, market and
sell new products derived from our products. Our success depends in part upon
the performance by these collaborators of their responsibilities under these
agreements.
Some collaborators may not perform their obligations as we expect. Some of
the companies we currently have alliances with or are targeting as potential
alliances offer products competitive with our products or may develop
competitive production technologies or competitive products outside of their
collaborations with us that could have a material adverse effect on our
competitive position. In addition, our role in the collaborations is mostly
limited to the production aspects.
8
As a result, we may also be dependent on collaborators for other aspects of
the development, preclinical and clinical testing, regulatory approval, sales,
marketing and distribution of our products. If our current or future
collaborators do not effectively market our products or develop additional
products based on our technology, our revenues from sales and royalties will be
significantly reduced.
Finally, we have received and may continue to receive payments from
collaborators that may not be immediately recognized as revenue and therefore
may not contribute to reported profits until further conditions are satisfied.
OUR INTELLECTUAL PROPERTY RIGHTS MAY NOT PROVIDE MEANINGFUL COMMERCIAL
PROTECTION FOR OUR PRODUCTS, WHICH COULD ENABLE THIRD PARTIES TO USE OUR
TECHNOLOGY OR VERY SIMILAR TECHNOLOGY AND COULD REDUCE OUR ABILITY TO COMPETE IN
THE MARKET.
Our ability to compete effectively will depend, in part, on our ability to
maintain the proprietary nature of our technologies and manufacturing processes,
which includes the ability to obtain, protect and enforce patents on our
technology and to protect our trade secrets. You should not rely on our patents
to provide us with any significant competitive advantage. Others may challenge
our patents and, as a result, our patents could be narrowed, invalidated or
rendered unenforceable. Competitors may develop products similar to ours which
are not covered by our patents. In addition, our current and future patent
applications may not result in the issuance of patents in the United States or
foreign countries. Further, there is a substantial backlog of patent
applications at the U.S. Patent and Trademark Office, and the approval or
rejection of patent applications may take several years.
OUR COMPETITIVE POSITION IS DEPENDENT IN PART UPON UNPATENTED TRADE SECRETS,
WHICH WE MAY NOT BE ABLE TO PROTECT.
Our competitive position is also dependent upon unpatented trade secrets.
Trade secrets are difficult to protect. We cannot assure you that others will
not independently develop substantially equivalent proprietary information and
techniques or otherwise gain access to our trade secrets, that such trade
secrets will not be disclosed, or that we can effectively protect our rights to
unpatented trade secrets.
In an effort to protect our trade secrets, we have a policy of requiring
our employees, consultants and advisors to execute proprietary information and
invention assignment agreements upon commencement of employment or consulting
relationships with us. These agreements provide that all confidential
information developed or made known to the individual during the course of their
relationship with us must be kept confidential, except in specified
circumstances. We cannot assure you, however, that these agreements will provide
meaningful protection for our trade secrets or other proprietary information in
the event of the unauthorized use or disclosure of confidential information.
OUR SUCCESS WILL DEPEND PARTLY ON OUR ABILITY TO OPERATE WITHOUT INFRINGING OR
MISAPPROPRIATING THE PROPRIETARY RIGHTS OF OTHERS.
We may be sued for infringing the intellectual property rights of others.
In addition, we may find it necessary, if threatened, to initiate a lawsuit
seeking a declaration from a court that we do not infringe the proprietary
rights of others or that these rights are invalid or unenforceable. If we do not
prevail in any litigation, in addition to any damages we might have to pay, we
would be required to stop the infringing activity or obtain a license. Any
required license may not be available to us on acceptable terms, or at all. In
addition, some licenses may be nonexclusive, and, therefore, our competitors may
have access to the same technology licensed to us. If we fail to obtain a
required license or are unable to design around a patent, we may be unable to
sell some of our products, which could have a material adverse effect on our
revenues and profitability.
9
WE MAY BE INVOLVED IN LAWSUITS TO PROTECT OR ENFORCE OUR INTELLECTUAL PROPERTY
RIGHTS, WHICH MAY BE EXPENSIVE.
In order to protect or enforce our intellectual property rights, we may
have to initiate legal proceedings against third parties, such as infringement
suits or interference proceedings. Intellectual property litigation is costly,
and, even if we prevail, the cost of such litigation could affect our
profitability. In addition, litigation is time consuming and could divert
management attention and resources away from our business. We may also provoke
these third parties to assert claims against us.
WE ARE EXPOSED TO A VARIETY OF RISKS RELATING TO OUR INTERNATIONAL SALES AND
OPERATIONS, INCLUDING FLUCTUATIONS IN EXCHANGE RATES AND DELAYS IN COLLECTION OF
ACCOUNTS RECEIVABLE.
We generate significant sales outside the United States, a substantial
portion of which are U.S. dollar denominated transactions conducted with
customers who generate revenue in currencies other than the U.S. dollar. As a
result, currency fluctuations between the U.S. dollar and the currencies in
which such customers do business may have an impact on the demand for our
products in foreign countries where the U.S. dollar has increased compared to
the local currency. We cannot predict the effects of exchange rate fluctuations
upon our future operating results because of the number of currencies involved,
the variability of currency exposure and the potential volatility of currency
exchange rates.
Because we have operating subsidiaries based in Europe and we generate
certain revenues and incur certain operating expenses in foreign currencies, we
will experience currency exchange risk with respect to such foreign currency
denominated revenues or expenses.
Relationships with customers and effective terms of sale frequently vary by
country, often with longer-term receivables than are typical in the United
States.
CHANGES IN THE HEALTH CARE INDUSTRY MAY REQUIRE US TO DECREASE THE SELLING PRICE
FOR OUR PRODUCTS OR COULD RESULT IN A REDUCTION IN THE SIZE OF THE MARKET FOR
OUR PRODUCTS, AND LIMIT THE MEANS BY WHICH WE MAY DISCOUNT OUR PRODUCTS, EACH OF
WHICH COULD HAVE A NEGATIVE IMPACT ON OUR FINANCIAL PERFORMANCE.
Trends toward managed care, health care cost containment, and other changes
in government and private sector initiatives in the United States and other
countries in which we do business are placing increased emphasis on the delivery
of more cost-effective medical therapies that could adversely affect the sale
and/or the prices of our products. For example:
o major third-party payors of hospital services, including Medicare,
Medicaid and private health care insurers, have substantially revised
their payment methodologies, which has resulted in stricter standards
for reimbursement of hospital charges for certain medical procedures;
o Medicare, Medicaid and private health care insurer cutbacks could
create downward price pressure;
o numerous legislative proposals have been considered that would result
in major reforms in the U.S. health care system that could have an
adverse effect on our business;
o there has been a consolidation among health care facilities and
purchasers of medical devices in the United States who prefer to limit
the number of suppliers from whom they purchase
10
medical products, and these entities may decide to stop purchasing our
products or demand discounts on our prices;
o there is economic pressure to contain health care costs in
international markets;
o there are proposed and existing laws and regulations in domestic and
international markets regulating pricing and profitability of
companies in the health care industry; and
o there have been initiatives by third party payors to challenge the
prices charged for medical products which could affect our ability to
sell products on a competitive basis.
Both the pressure to reduce prices for our products in response to these
trends and the decrease in the size of the market as a result of these trends
could adversely affect our levels of revenues and profitability of sales.
In addition, there are laws and regulations that regulate the means by
which companies in the health care industry may compete by discounting the
prices of their products. Although we exercise care in structuring our customer
discount arrangements to comply with such laws and regulations, we cannot assure
you that:
o government officials charged with responsibility for enforcing such
laws will not assert that such customer discount arrangements are in
violation of such laws or regulations, or
o government regulators or courts will interpret such laws or
regulations in a manner consistent with our interpretation.
OUR DEPENDENCE ON SUPPLIERS FOR MATERIALS COULD IMPAIR OUR ABILITY TO
MANUFACTURE OUR PRODUCTS.
Outside vendors, some of whom are sole-source suppliers, provide key
components and raw materials used in the manufacture of our products. Although
we believe that alternative sources for these components and raw materials are
available, any supply interruption in a limited or sole source component or raw
material could harm our ability to manufacture our products until a new source
of supply is identified and qualified. In addition, an uncorrected defect or
supplier's variation in a component or raw material, either unknown to us or
incompatible with our manufacturing process, could harm our ability to
manufacture products. We may not be able to find a sufficient alternative
supplier in a reasonable time period, or on commercially reasonable terms, if at
all, and our ability to produce and supply our products could be impaired.
IF ANY OF OUR MANUFACTURING FACILITIES WERE DAMAGED AND/OR OUR MANUFACTURING
PROCESSES INTERRUPTED, WE COULD EXPERIENCE LOST REVENUES AND OUR BUSINESS COULD
BE SERIOUSLY HARMED.
We manufacture our products in a limited number of facilities. Damage to
our manufacturing, development or research facilities due to fire, natural
disaster, power loss, communications failure, unauthorized entry or other events
could cause us to cease development and manufacturing of some or all of our
products.
WE MAY HAVE SIGNIFICANT PRODUCT LIABILITY EXPOSURE AND OUR INSURANCE MAY NOT
COVER ALL POTENTIAL CLAIMS.
We face an inherent business risk of exposure to product liability and
other claims in the event that our technologies or products are alleged to have
caused harm. We may not be able to obtain
11
insurance for such potential liability on acceptable terms with adequate
coverage, or at reasonable costs. Any potential product liability claims could
exceed the amount of our insurance coverage or may be excluded from coverage
under the terms of the policy. Our insurance may not be renewed at a cost and
level of coverage comparable to that then in effect.
WE ARE SUBJECT TO OTHER REGULATORY REQUIREMENTS RELATING TO OCCUPATIONAL HEALTH
AND SAFETY AND THE USE OF HAZARDOUS SUBSTANCES WHICH MAY IMPOSE SIGNIFICANT
COMPLIANCE COSTS ON US.
We are subject to regulation under federal and state laws regarding
occupational health and safety, laboratory practices, and the use, handling and
disposal of toxic or hazardous substances. Our research, development and
manufacturing processes involve the controlled use of certain hazardous
materials. Although we believe that our safety procedures for handling and
disposing of such materials comply with the standards prescribed by such laws
and regulations, the risk of accidental contamination or injury from these
materials cannot be completely eliminated. In the event of such an accident, we
could be held liable for any damages that result and any such liability could
exceed the limits or fall outside the coverage of our insurance and could exceed
our resources. We may not be able to maintain insurance on acceptable terms, or
at all. We may incur significant costs to comply with environmental laws and
regulations in the future. We may also be subject to other present and possible
future local, state, federal and foreign regulations.
THE LOSS OF KEY PERSONNEL COULD HARM OUR BUSINESS.
We believe our success depends on the contributions of a number of our key
personnel, including Stuart M. Essig, our President and Chief Executive Officer.
If we lose the services of key personnel, that loss could materially harm our
business. We maintain "key person" life insurance on Mr. Essig. In addition,
recruiting and retaining qualified personnel will be critical to our success.
There is a shortage in the industry of qualified management and scientific
personnel, and competition for these individuals is intense. We can not assure
you that we will be able to attract additional personnel and retain existing
personnel.
OUR STOCK PRICE MAY CONTINUE TO BE HIGHLY VOLATILE AND YOU MAY NOT BE ABLE TO
RESELL YOUR SHARES AT OR ABOVE THE PRICE YOU PAID FOR THEM.
The stock market in general, and the stock prices of medical device
companies, biotechnology companies and other technology-based companies in
particular, have experienced significant volatility that often has been
unrelated to the operating performance of and beyond the control of any specific
public companies. The market price of our common stock has fluctuated widely in
the past and is likely to continue to fluctuate in the future. See "Price Range
of Common Stock and Dividends." Factors that may have a significant impact on
the market price of our common stock include:
o actual financial results differing from guidance provided by
management;
o actual financial results differing from that expected by securities
analysts;
o future announcements concerning us or our competitors, including the
announcement of acquisitions;
o changes in the prospects of our business partners or suppliers;
o developments regarding our patents or other proprietary rights or
those of our competitors;
12
o quality deficiencies in our products;
o competitive developments, including technological innovations by us or
our competitors;
o government regulation, including the FDA's review of our products and
developments;
o changes in recommendations of securities analysts and rumors that may
be circulated about us or our competitors;
o public perception of risks associated with our operations;
o conditions or trends in the medical device and biotechnology
industries;
o additions or departures of key personnel; and
o sales of our common stock.
Any of these factors could immediately, significantly and adversely affect
the trading price of our common stock.
WE DO NOT INTEND TO PAY DIVIDENDS IN THE FORESEEABLE FUTURE.
We do not anticipate paying any cash dividends on our common stock in the
foreseeable future. We intend to retain future earnings to fund our growth.
Accordingly, you will not receive a return on your investment in our common
stock through the payment of dividends in the foreseeable future and may not
realize a return on your investment even if you sell your shares. As a result,
you may not be able to resell your shares at or above the price you paid for
them.
OUR MAJOR STOCKHOLDERS COULD MAKE DECISIONS ADVERSE TO YOUR INTERESTS.
Our directors and executive officers and affiliates of certain directors
own or control, and after the completion of an offering of our Common Stock may
still own or control, a majority of our outstanding voting securities and would
be generally able to elect all directors, to determine the outcome of corporate
actions requiring stockholder approval and otherwise to control the business.
Such control could preclude any unsolicited acquisition of Integra and
consequently adversely affect the market price of the common stock. Furthermore,
we are subject to Section 203 of the Delaware General Corporation Law, which
could have the effect of delaying or preventing a change of control.
OUR MANAGEMENT WILL HAVE BROAD DISCRETION IN USING THE PROCEEDS FROM ANY
OFFERING AND, THEREFORE, INVESTORS WILL BE RELYING ON THE JUDGMENT OF OUR
MANAGEMENT TO INVEST THOSE FUNDS EFFECTIVELY.
We intend to use the net proceeds of any offering for general corporate
purposes, which could include, among other things, expanding our sales and
marketing resources, including expanding our business in Europe and Asia,
developing new technologies and products and for working capital and other
general corporate purposes. The amounts and timing of these expenditures will
vary significantly depending upon a number of factors, including the amount of
cash generated or consumed by our operations, the progress of our research and
development activities and the market response to the introduction of any new
products and services. In addition, we may use a portion of the net proceeds
from this offering to acquire or invest in businesses, products, services or
technologies complementary to our current business, through mergers,
acquisitions, joint ventures or otherwise. Our management will retain
13
broad discretion with respect to the expenditure of proceeds. Investors will be
relying on the judgment of our management regarding the application of the
proceeds of this offering.
14
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
We have made statements in this prospectus, including statements under
"Prospectus Summary," "Risk Factors," "Management's Discussion and Analysis of
Financial Condition and Results of Operations" and "Business" which constitute
forward-looking statements within the meaning of Section 27A of the Securities
Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These
forward-looking statements are subject to a number of risks, uncertainties and
assumptions about Integra, including, among other things:
o general economic and business conditions, both nationally and in our
international markets;
o our expectations and estimates concerning future financial
performance, financing plans and the impact of competition;
o anticipated trends in our business;
o existing and future regulations affecting our business;
o our ability to obtain additional debt and equity financing to fund
capital expenditures and working capital requirements if required;
o our ability to complete acquisitions; and
o other risk factors described in the section entitled "Risk Factors" in
this prospectus.
You can identify these forward-looking statements by forward-looking words
such as "believe," "may," "could," "will," "estimate," "continue," "anticipate,"
"intend," "seek," "plan," "expect," "should," "would" and similar expressions in
this prospectus.
We undertake no obligation to publicly update or revise any forward-looking
statements, whether as a result of new information, future events or otherwise.
In light of these risks and uncertainties, the forward-looking events and
circumstances discussed in this prospectus may not occur and actual results
could differ materially from those anticipated or implied in the forward-looking
statements.
15
RATIO OF EARNINGS TO FIXED CHARGES AND RATIO OF EARNINGS TO COMBINED
FIXED CHARGES AND PREFERRED STOCK DIVIDENDS
For purposes of calculating the following ratios:
o earnings consist of income or loss before income taxes and
extraordinary items plus fixed charges, excluding capitalized
interest, and
o fixed charges consist of interest, whether expensed or capitalized,
plus amortization of debt issuance costs plus the assumed interest
component of rent expense.
Three Months
($ amounts in thousands) Ended March 31, Year Ended December 31,
----------------- -----------------------------------------------------------------
2001 2000 1999 1998 1997 1996
----------------- --------- ---------- ------------ ----------- ---------
Ratio of earnings to fixed charges 6.1 N/A N/A N/A N/A N/A
Deficiency of earnings to fixed
charges N/A $(10,847) $(7,784) $(12,342) $(16,964) $(7,528)
Ratio of earnings to combined fixed
charges and preferred stock
dividends 3.1 N/A N/A N/A N/A N/A
Deficiency of earnings to combined
fixed charges and preferred stock
dividends N/A $(12,334) $(8,614) $(12,389) $(16,964) $(7,528)
16
USE OF PROCEEDS
Unless otherwise specified in a prospectus supplement accompanying this
prospectus, we expect to use the net proceeds from the sale of securities under
this prospectus and the prospectus supplement for general corporate purposes,
which could include, among other things, acquisition of product lines or
companies, repayment of indebtedness, expanding our sales and marketing
resources, including expanding our international business, developing new
technologies and products and for working capital and other general corporate
purposes. Pending application of the net proceeds, we may invest the net
proceeds in short term, interest bearing investments. We will not receive any
proceeds from the sale of common stock by any stockholder as a result of
underwriters' exercise of any over-allotment options.
PRICE RANGE OF COMMON STOCK AND DIVIDENDS
Our common stock trades on the Nasdaq National Market under the symbol
"IART". The following table presents the high and low sales prices for our
common stock for each quarter for the periods indicated. All outstanding common
share and per share amounts have been retroactively adjusted to reflect a
one-for-two reverse stock split of our common stock on May 18, 1998.
HIGH LOW
-------- ---------
1999
First Quarter................................ $5.188 $3.00
Second Quarter............................... $7.00 $3.875
Third Quarter................................ $10.375 $5.625
Fourth Quarter............................... $6.4688 $5.375
2000
First Quarter................................ $19.875 $5.875
Second Quarter............................... $12.625 $6.688
Third Quarter................................ $15.000 $9.438
Fourth Quarter............................... $16.125 $9.688
2001
First Quarter................................ $18.3125 $9.875
Second Quarter (through May 31, 2001)........ $19.00 $11.40
The closing price for the common stock on May 31, 2001 was $19.00. The
number of stockholders of record as of March 23, 2001 was approximately 825,
which includes stockholders whose shares were held in nominee name.
We do not currently pay any cash dividends on our common stock and do not
anticipate paying any such dividends in the foreseeable future. Any future
payment of dividends to our stockholders will depend on decisions that will be
made by our board of directors and will depend on then existing conditions,
including our financial condition, contractual restrictions, capital
requirements and business prospects.
17
CAPITALIZATION
The following table sets forth the capitalization of Integra as of
March 31, 2001:
AS OF MARCH 31,
2001
-----------------
(IN THOUSANDS,
EXCEPT PER SHARE
DATA)
Cash, cash equivalents and short-term investments...................... $19,374
Short-term debt........................................................ 9,150
Long-term debt......................................................... 3,121
Stockholders' equity:
Preferred stock; $0.01 par value; 15,000 authorized shares; 100
Series B Convertible shares issued and outstanding at March
31, 2001, $12,000 including a 10% annual cumulative dividend
liquidation preference; 54 Series C Convertible shares issued
and outstanding at March 31, 2001, $5,940 including a 10%
annual cumulative dividend liquidation preference............. 2
Common stock; $0.01 par value; 60,000 authorized shares; 17,658
issued and outstanding at March 31, 2001...................... 177
Additional paid-in capital........................................ 161,564
Treasury stock, at cost; 20 shares at March 31, 2001.............. (180)
Other............................................................. (58)
Accumulated other comprehensive loss.............................. (898)
Accumulated deficit............................................... (103,733)
Total stockholders' equity.................................... 56,874
Total capitalization.......................................... $69,145
18
SELECTED CONSOLIDATED FINANCIAL DATA
The selected financial data as of and for each of the five years ended
December 31 has been derived from consolidated financial statements that have
been audited by PricewaterhouseCoopers LLP, independent accountants. The
selected financial data as of and for each of the three-month periods ended
March 31, 2001 and 2000 has been derived from our unaudited financial
statements. In our opinion, the unaudited financial information includes all
adjustments, consisting only of normal recurring adjustments, considered
necessary for a fair presentation of that information. The information set forth
below is not necessarily indicative of the results of future operations and
should be read in conjunction with our consolidated financial statements and
notes thereto and "Management's Discussion and Analysis of Financial Condition
and Results of Operations" appearing elsewhere in this prospectus.
(UNAUDITED)
THREE MONTHS
ENDED MARCH 31, YEARS ENDED DECEMBER 31,
--------------------- ------------------------------------------------------------
2001 2000 2000 1999 1998 1997 1996
----------- -------- --------- --------- --------- ---------- -----------
(IN THOUSANDS, EXCEPT PER SHARE DATA)
Statement of Operations Data (1):
Product sales............................ $20,284 $13,332 $64,987 $40,047 $14,182 $14,103 $11,300
Other revenue............................ 1,400 1,199 6,662 2,829 3,379 745 1,938
Total revenue......................... 21,684 14,531 71,649 42,876 17,561 14,848 13,238
Cost of product sales.................... 8,594 6,687 29,511 22,678 7,580 7,184 6,808
Research and development................. 2,073 1,890 7,524 8,893 8,424 6,406 6,294
Selling and marketing.................... 4,751 2,949 15,371 9,487 5,901 5,405 4,263
General and administrative (2)........... 3,204 3,747 28,483 13,324 9,787 14,764 5,320
Amortization............................. 680 480 2,481 874 49 -- --
Total costs and expenses.............. 19,302 15,753 83,370 55,256 31,741 33,759 22,685
Operating income (loss).................. 2,382 (1,222) (11,721) (12,380) (14,180) (18,911) (9,447)
Interest income (expense), net........... (78) 11 (473) 294 1,250 1,771 1,799
Gain on disposition of product lines..... -- 115 1,146 4,161 -- -- --
Other income (expense), net.............. (62) 123 201 141 588 176 120
Income (loss) before income taxes........ 2,242 (973) (10,847) (7,784) (12,342) (16,964) (7,528)
Income tax expense (benefit) (3)......... 246 62 108 (1,818) -- -- --
Income (loss) before cumulative effect of
accounting change..................... 1,996 (1,035) (10,955) (5,966) (12,342) (16,964) (7,528)
Cumulative effect of change in accounting
for nonrefundable fees received under
research, license and distribution
arrangements (4)...................... -- (470) (470) -- -- -- --
Net income (loss)........................ $1,996 $(1,505) $(11,425) $(5,966) $(12,342) $(16,964) $(7,528)
Diluted net income (loss) per share...... $0.07 $(0.35) $(0.97) $(0.40) $(0.77) $(1.15) $(0.54)
Weighted average common shares
outstanding.............................. 21,849 17,224 17,553 16,802 16,139 14,810 14,057
19
(UNAUDITED)
MARCH 31, YEARS ENDED DECEMBER 31,
--------------------- ------------------------------------------------------
2001 2000 2000 1999 1998 1997 1996
----------- -------- --------- -------- --------- ------- ---------
(IN THOUSANDS)
Balance Sheet Data (1):
Cash, cash equivalents and
short-term investments........... $19,374 $23,572 $15,138 $23,612 $20,187 $26,272 $34,276
Working capital.................. 27,992 27,274 25,177 28,014 23,898 29,407 37,936
Total assets..................... 91,079 73,693 86,514 66,253 34,707 38,356 48,741
Long-term debt................... 3,121 8,204 4,758 7,625 -- -- --
Accumulated deficit.............. (103,733) (95,367) (105,729) (94,304) (88,287) (75,945) (58,981)
Total stockholders' equity....... 56,874 43,482 53,781 37,989 31,366 35,755 46,384
- -----------
(1) As the result of our acquisitions of Rystan Company, Inc. ("Rystan") in
September 1998, the NeuroCare Group of companies ("NeuroCare") in March
1999 and the acquisition of Clinical Neuro Systems and product lines from
NMT Medical, Inc. in 2000, the consolidated financial results and balance
sheet data for certain of the periods presented above may not be directly
comparable.
(2) General and administrative expense in 2000 included a $13.5 million
stock-based compensation charge in connection with the extension of the
employment of the Company's President and Chief Executive Officer. General
and administrative expense in 1997 include the following two non-cash
charges: (a) $1.0 million related to an asset impairment charge; and (b)
$5.9 million related to a stock-based signing bonus for the Company's
President and Chief Executive Officer.
(3) The 1999 income tax benefit includes a non-cash benefit of $1.8 million
resulting from the reduction of the deferred tax liability recorded in the
NeuroCare acquisition to the extent that consolidated deferred tax assets
were generated subsequent to the acquisition. The 2000 income tax expense
and 1999 income tax benefit include $0.5 million and $0.6 million,
respectively, of benefits associated with the sale of New Jersey state net
operating losses.
(4) As the result of the adoption of SAB 101, we recorded a $470,000 cumulative
effect of an accounting change to defer a portion of a nonrefundable,
up-front fee received and recorded in other revenue in 1998. The cumulative
effect of this accounting change was measured as of January 1, 2000. As a
result of this accounting change, other revenue in 2000 includes $112,000
of amortization of the amount deferred as of January 1, 2000.
20
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
THE FOLLOWING DISCUSSION AND ANALYSIS IS BASED UPON OUR FINANCIAL
STATEMENTS AS OF THE DATES AND FOR THE PERIODS PRESENTED IN THIS SECTION. YOU
SHOULD READ THIS DISCUSSION AND ANALYSIS IN CONJUNCTION WITH OUR FINANCIAL
STATEMENTS AND RELATED NOTES CONTAINED IN THIS PROSPECTUS.
OVERVIEW
We develop, manufacture and market medical devices, implants and
biomaterials. Our operations consist of (1) Integra NeuroSciences, which is a
leading provider of implants, devices, and monitors used in neurosurgery,
neurotrauma, and related critical care and (2) Integra LifeSciences, which
develops and manufactures a variety of medical products and devices, including
products based on our proprietary tissue regeneration technology which are used
to treat soft tissue and orthopedic conditions. Integra NeuroSciences sells
primarily through a direct sales organization and Integra LifeSciences sells
primarily through strategic alliances and distributors.
In 1999, we initiated a repositioning of our business to focus selectively
on attractive niche markets. Implementation of this strategy included the
purchase of the NeuroCare Group of companies ("NeuroCare") in March 1999 and the
execution of an agreement (the "Ethicon Agreement") with Johnson & Johnson
Medical, (now merged into Ethicon, Inc. ("Ethicon")) that provides Ethicon with
exclusive marketing and distribution rights to INTEGRA(R) Dermal Regeneration
Template worldwide, excluding Japan. As a result of these transactions, we
formed our Integra NeuroSciences segment and reorganized the remainder of our
products into our Integra LifeSciences segment. The Ethicon Agreement allowed
the Integra LifeSciences segment to focus on strategic collaborative
initiatives. The Integra LifeSciences segment now operates as a provider of
innovative products and development activities through strategic alliances with
marketing partners and distributors. As a result of these activities, our
segment financial results for each of the years 2000, 1999 and 1998 and for the
first three months of 2001 and 2000, may not be directly comparable.
To date, we have experienced significant operating losses and may continue
to incur such losses unless product sales and research and collaborative
arrangements generate sufficient revenue to fund continuing operations. As of
March 31, 2001 we had an accumulated deficit of $103.7 million.
RECENT ACQUISITIONS
On March 29, 1999 we acquired certain assets and stock held by
Heyer-Schulte NeuroCare, L.P. and its subsidiaries, Heyer-Schulte NeuroCare,
Inc., Camino NeuroCare, Inc. and Neuro Navigational, LLC (collectively, the
"NeuroCare Group") through our wholly-owned subsidiaries, NeuroCare Holding
Corporation, Integra NeuroCare LLC and Redmond NeuroCare LLC (collectively,
"Integra NeuroCare"). The purchase price for the NeuroCare Group consisted of
$14.2 million in cash and approximately $11 million of assumed indebtedness
under a term loan from Fleet Capital Corporation. The NeuroCare Group's assets
include a manufacturing, packaging and distribution facility in San Diego,
California and a manufacturing facility in Anasco, Puerto Rico, as well as a
corporate headquarters in Pleasant Prairie, Wisconsin, which we closed in the
third quarter of 1999.
On January 17, 2000, we purchased the business, including certain assets
and liabilities, of Clinical Neuro Systems, Inc. ("CNS") for $6.8 million. CNS
designs, manufactures and sells neurosurgical external ventricular drainage
systems, including catheters and drainage bags, as well as cranial access kits.
The purchase price of the CNS business consisted of $4.0 million in cash and a
5% $2.8 million promissory note issued to the seller. The promissory note, of
which approximately $1.4
21
million remains outstanding, is collateralized by inventory, property and
equipment of the CNS business and by a collateral assignment of a $2.8 million
promissory note from one of our subsidiaries.
On April 6, 2000, we purchased the Selector(R) Ultrasonic Aspirator,
Ruggles(TM) hand-held neurosurgical instruments and Spembly Medical cryosurgery
product lines, including certain assets and liabilities, from NMT Medical, Inc.
("NMT") for $11.6 million in cash.
On April 4, 2001, we acquired all of the outstanding stock of GMSmbH, the
German manufacturer of the LICOX(R) Brain Tissue Oxygen Monitoring System, for
$2.9 million, of which $2.3 million was paid at closing. Prior to the
acquisition, our Integra NeuroSciences division had exclusive marketing rights
to the LICOX(R) products in the United States and certain other markets.
Revenues of the acquired GMS business were approximately $1.2 million in 2000,
consisting primarily of sales of the LICOX(R) products in Germany and to various
international distributors, including Integra.
On April 27, 2001, we acquired Satelec Medical, a subsidiary of the
Satelec-Pierre Rolland group, for $3.6 million in cash. Satelec Medical, based
in France, manufactures and markets the Dissectron(R) ultrasonic surgical
aspirator console and a broad line of related handpieces. The Dissectron(R)
product is the leading ultrasonic surgical system in France. The Dissectron(R)
product has United States FDA 510(k) clearance for neurosurgical applications
and CE Mark Certification in the European Union. Revenues of the acquired
business were approximately $1.5 million in 2000.
These acquisitions have been accounted for using the purchase method of
accounting, and the results of operations of the acquired businesses have been
included in the consolidated financial statements since their respective dates
of acquisition.
PRESENTATION
Management's Discussion and Analysis of Financial Condition and Results of
Operations should be read in conjunction with our consolidated financial
statements, the notes thereto and the other financial information included
elsewhere in this prospectus and in our 2000 Annual Report on Form 10-K and
March 31, 2001 Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission, which are incorporated by reference herein.
RESULTS OF OPERATIONS
THREE MONTHS ENDED MARCH 31, 2001 COMPARED TO THREE MONTHS ENDED MARCH 31, 2000
Product Sales and Gross Margins on Product Sales:
Three Months Ended March 31,
----------------------------
2001 2000
------------- ---------
Integra NeuroSciences:
- Neuro intensive care unit ................. $ 6,532 $ 5,532
- Neuro operating room ...................... 7,945 3,288
------- -------
Total product sales ............................ 14,477 8,820
Cost of product sales .......................... 5,637 4,178
------- -------
Gross margin on product sales .................. 8,840 4,642
Gross margin percentage ........................ 61% 53%
22
Three Months Ended March 31,
----------------------------
2001 2000
------------- ---------
Integra LifeSciences:
- Private label products .................... 3,216 2,488
- Distributed products ...................... 2,591 2,024
------- -------
Total product sales ............................ 5,807 4,512
Cost of product sales .......................... 2,957 2,509
------- -------
Gross margin on product sales .................. 2,850 2,003
Gross margin percentage ........................ 49% 44%
Total product sales .............................. $20,284 $13,332
Consolidated gross margin percentage ............. 58% 50%
In the first quarter of 2001, total revenues increased $7.2 million, or
49%, over the first quarter of 2000 to $21.7 million. Revenue growth was led by
a $7.0 million increase in product sales to $20.3 million, a 52% increase over
the first quarter of 2000. Included in this increase was $2.8 million in sales
of acquired NMT product lines. Sales in the Integra NeuroSciences division
increased $5.7 million to $14.5 million in the first quarter of 2001, and
included $2.3 million in sales of acquired NMT product lines. Contributing to
the strong organic growth of $3.4 million in the Integra NeuroSciences division
were increased sales of the DuraGen(R) Dural Graft Matrix, our intracranial
monitoring and cranial access products for the neuro intensive care unit and
hydrocephalus management products. Gross margin on Integra NeuroSciences'
product sales increased 8 percentage points to 61% in the first quarter of 2001
through an improved sales mix of higher margin products, including the
DuraGen(R) product and acquired product lines. The gross margin reported for the
first quarter of 2000 was reduced by 1 percentage point relating to fair value
inventory purchase accounting adjustments recorded in connection with the CNS
acquisition.
Future product sales in the Integra NeuroSciences division are expected to
benefit from organic growth in the division's existing product lines and the
recent launch of the LICOX(R) Brain Tissue Oxygen Monitoring System and the
Ventrix(R) True Tech Tunneling Catheter for intracranial pressure monitoring.
Sales of Integra LifeSciences division products increased $1.3 million to
$5.8 million in the first quarter of 2001 primarily because of organic growth in
our private label products and $0.5 million in sales of acquired NMT product
lines. Sales of private label products can vary significantly from quarter to
quarter and are dependent upon the efforts of our strategic marketing partners.
Gross margin on Integra LifeSciences' product sales increased 5 percentage
points to 49% in the first quarter of 2001 primarily as a result of a more
favorable sales mix.
Other revenue, which increased $0.2 million to $1.4 million in the first
quarter of 2001, consisted of $0.9 million of research and development funding
from strategic partners and government grants, $0.3 million of royalty income,
and $0.2 million of license and distribution revenues.
23
Research and development expenses were as follows (in thousands):
Three Months Ended March 31,
---------------------------------
2001 2000
--------------- -------------
Integra NeuroSciences.................. $ 688 $ 503
Integra LifeSciences................... 1,385 1,387
----------- ---------
Total.................................. $ 2,073 $ 1,890
----------- ---------
In the Integra NeuroSciences division, research and development expenses
increased as compared to the first quarter of 2000 as a result of the ongoing
Phase III clinical trials on the peripheral nerve conduit that were initiated in
the second quarter of 2000 and the completion of development activities related
to the Ventrix(R) True Tech Catheter.
The future allocation and timing of research and development expenditures
between segments and programs will vary depending on various factors, including
the timing and outcome of pre-clinical and clinical results, changing
competitive conditions, continued program funding levels, potential funding
opportunities and determinations with respect to the commercial potential of our
technologies.
Selling and marketing expenses were as follows (in thousands):
Three Months Ended March 31,
---------------------------------
2001 2000
--------------- -------------
Integra NeuroSciences.................. $ 4,238 $ 2,444
Integra LifeSciences................... 513 505
----------- ----------
Total............................. $ 4,751 $ 2,949
----------- ----------
Integra NeuroSciences selling and marketing expenses increased $1.8 million
as compared to the first quarter of 2000 primarily because of the increase in
the direct sales force in the United States throughout 2000 and into 2001 from
18 to 44 neurospecialists. Additional increases were related to a distribution
facility located in the United Kingdom that was acquired in the NMT acquisition.
Within the Integra LifeSciences division, product sales and marketing
activities are primarily the responsibility of our strategic marketing partners
and distributors.
General and administrative expenses were as follows (in thousands):
Three Months Ended March 31,
---------------------------------
2001 2000
--------------- -------------
Integra NeuroSciences.................. $ 790 $ 890
Integra LifeSciences................... 347 302
Corporate.............................. 2,067 2,555
------------ -----------
Total.............................. $ 3,204 $ 3,747
------------ -----------
24
The $0.5 million decrease in corporate general and administrative expenses
was primarily the result of decreased legal fees associated with the conclusion
of the Merck KGaA patent infringement trial at the end of the first quarter of
2000.
Other income (expense), net for the three months ended March 31, 2000
included $176,000 of gain on sale of investments.
The provision for income taxes increased $184,000 in the first quarter of
2001 to $246,000, or 11% of pre-tax net income, which is our anticipated
effective rate for the year ended December 31, 2001.
Net income for the first quarter of 2001 was $2.0 million, or $0.07 per
share. Net loss for the first quarter of 2000 was $1.5 million, or $0.35 per
share. The net loss per share for the first quarter of 2000 includes the $4.2
million beneficial conversion feature associated with the issuance of
convertible preferred stock and common stock warrants in March 2000, which is
treated as a non-cash dividend in computing per share earnings. The beneficial
conversion feature is based upon the excess of the price of the underlying
common stock as compared to the fixed conversion price of the convertible
preferred stock, after taking into account the value assigned to the warrants.
Included in the first quarter net loss of $1.5 million was a $0.5 million
cumulative effect of an accounting change, $0.1 million of fair value inventory
purchase accounting adjustments, and a $0.1 million gain on the sale of a
product line. Excluding these items and the $4.2 million beneficial conversion
feature associated with the convertible preferred stock, the loss per share for
the first quarter of 2000 would have been $0.08.
International Product Sales and Operations
In the first quarter of 2001, sales to customers outside the United States
totaled $4.4 million, or 21% of consolidated product sales, of which
approximately 55% were to Europe. Of this amount, $1.3 million of these sales
were generated in foreign currencies from our subsidiary based in Andover,
England. Our international sales and operations are subject to the risk of
foreign currency fluctuations, both in terms of exchange risk related to
transactions conducted in foreign currencies and the price of our products in
those markets for which sales are denominated in the U.S. dollar.
In the first quarter of 2000, sales to customers outside the United States
totaled $2.7 million, or 20% of consolidated product sales, of which
approximately 39% were to Europe.
We seek to increase our presence in international markets, particularly in
Europe, through acquisitions of businesses with an existing international sales
and marketing infrastructure or the capacity to develop such an infrastructure.
We acquired operations in Germany and France with the acquisitions of GMS and
Satelec Medical in April 2001.
2000 COMPARED TO 1999
Product Sales and Gross Margins on Product Sales:
2000 1999
---------- ----------
Integra NeuroSciences:
- Neuro intensive care unit.............................. $ 23,521 $ 14,398
- Neuro operating room................................... 21,324 8,014
-------- --------
Total product sales......................................... 44,845 22,412
Cost of product sales....................................... 19,198 12,893
-------- --------
25
Gross margin on product sales............................... 25,647 9,519
Gross margin percentage..................................... 57% 42%
Integra LifeSciences:
- Private label products................................. $ 11,018 $ 10,226
- Distributed products................................... 9,124 7,409
-------- --------
Total product sales......................................... 20,142 17,635
Cost of product sales....................................... 10,313 9,785
-------- --------
Gross margin on product sales............................... 9,829 7,850
Gross margin percentage..................................... 49% 45%
Total product sales........................................... $ 64,987 $ 40,047
Consolidated gross margin percentage.......................... 55% 43%
Total product sales increased $24.9 million, or 62%, in 2000, with sales of
product lines acquired in 2000 accounting for $11.2 million, or 28%, of this
increase. Sales growth for the year was led by the Integra NeuroSciences
division, which reported an increase of $22.4 million, or 100%, from the prior
year. Included in this increase was $9.6 million of sales of product lines
acquired in 2000. The remainder of this increase is the result of a $5.5 million
increase in sales of the DuraGen(R) product, which was launched in the third
quarter of 1999, and organic growth in products acquired in the NeuroCare
acquisition at the end of the first quarter of 1999. Adjusted gross margin on
Integra NeuroSciences' product sales increased 7 percentage points to 58% in
2000 through an improved sales mix of higher margin products, including the
DuraGen(R) product and product lines acquired in 2000. The adjusted gross margin
excludes fair value inventory purchase accounting adjustments recorded in
connection with the acquisitions.
Sales in the Integra LifeSciences division increased $2.5 million, or 14%,
in 2000, with sales of a distributed product line acquired in 2000 accounting
for $1.6 million of this increase. The remainder of this increase relates
primarily to higher sales of private label products, with increased sales or
orthopedic biomaterials to our strategic partners for use in their clinical
trials being slightly offset by lower sales of INTEGRA(R) Dermal Regeneration
Template. Sales of INTEGRA(R) Dermal Regeneration Template decreased because of
the lower transfer price to Ethicon beginning in the second half of 1999.
Adjusted gross margin on Integra LifeSciences' product sales increased from 48%
to 49% in 2000. The improvement in gross margins was primarily related to
increased capacity utilization and increased sales of higher margin products in
2000, both of which were offset by the lower gross margins on sales of the
INTEGRA(R) Dermal Regeneration Template through Ethicon and sales of a lower
margin distributed product line acquired in 2000.
Other revenue, which increased $3.9 million to $6.7 million in 2000,
consisted of $2.8 million of research and development funding from strategic
partners and government grants, $2.3 million of license, distribution, and other
event-related revenues from strategic partners and other third parties, and $1.6
million of royalty income.
Research and development expenses were as follows (in thousands):
2000 1999
---- ----
Integra NeuroSciences.................................. $2,469 $2,080
Integra LifeSciences................................... 5,055 6,813
------ ------
Total......................................... $7,524 $8,893
26
Research and development expense in the Integra NeuroSciences segment
increased in 2000 primarily because there was a full year of research and
development activities from the acquired NeuroCare business in 2000. Significant
ongoing research and development programs of our Integra NeuroSciences segment
include the development of the next generation of intra-cranial monitors and
catheters and shunting products and the continuation of clinical trials
involving the peripheral nerve guide, a bioabsorbable collagen conduit designed
to support guided regeneration of severed nerve tissues.
Research and development activities within the Integra LifeSciences segment
decreased in 2000 primarily because of the elimination of several non-core
research programs throughout 1999, reductions in headcount in our New
Jersey-based research group and reduced spending in the articular cartilage
program. Offsetting these decreases were additional research activities related
to the INTEGRA(R) Dermal Regeneration Template program that were funded by
Ethicon and government grants. The Ethicon Agreement provides us with research
funding of $2.0 million per year through the year 2004. Significant ongoing
research and development programs in the Integra LifeSciences segment include
clinical and development activities related to INTEGRA(R) Dermal Regeneration
Template, additional applications for our orthopedic technologies, and other
activities involving the Company's tissue regeneration technologies.
The future allocation and timing of research and development expenditures
between segments and programs will vary depending on various factors, including
the timing and outcome of pre-clinical and clinical results, changing
competitive conditions, continued program funding levels, potential funding
opportunities and determinations with respect to the commercial potential of our
technologies.
Selling and marketing expenses were as follow (in thousands):
2000 1999
---- ----
Integra NeuroSciences........................... $12,868 $6,244
Integra LifeSciences............................ 2,503 3,243
------- ------
Total.................................... $15,371 $9,487
Integra NeuroSciences selling and marketing expense increased significantly
because of a large increase in the direct sales force to over 50 personnel
throughout 2000, increased sales from acquired products and organic growth in
existing products, and increased tradeshow participation. Through acquisitions
and recruiting of experienced personnel, the Integra NeuroSciences division has
developed a leading sales and marketing infrastructure to market its products to
neurosurgeons and critical care units, which comprise a focused group of
hospital-based practitioners. A further increase in Integra NeuroSciences
selling and marketing expense is expected in 2001, as continuing costs
associated with the larger direct sales force and the national distribution
center opened in the second quarter of 2000 impact the full year 2001 results.
The decrease in Integra LifeSciences selling and marketing expenses is
primarily the result of the transition of INTEGRA(R) Dermal Regeneration
Template selling and marketing activities to Ethicon in June 1999, offset by
costs associated with the opening of our new national distribution center in New
Jersey.
27
General and administrative expenses were as follows (in thousands):
2000 1999
---- ----
Integra NeuroSciences........................ $4,981 $4,726
Integra LifeSciences......................... 3,799 2,433
Corporate.................................... 19,703 6,165
------- -------
Total................................ $28,483 $13,324
Integra NeuroSciences general and administrative expenses increased in 2000
primarily because of acquisitions and an allowance recorded against a
distributor's accounts receivable balance. Offsetting these increases were $1.0
million of severance costs incurred in 1999 in connection with the closure of
NeuroCare's corporate headquarters in July 1999. General and administrative
expense in the Integra LifeSciences segment increased in 2000 primarily due to
additional headcount and acquisitions. The increase in corporate general and
administrative in 2000 was almost entirely related to a $13.5 million
stock-based compensation charge recorded in connection with the extension of the
employment agreement of Integra's President and Chief Executive Officer. A
decrease in legal fees associated with the conclusion of the jury trial in the
patent infringement lawsuit against Merck KGaA in the first quarter of 2000 was
offset by increased corporate headcount.
Net interest expense consisted of interest expense of $1.3 million and
interest income of $0.8 million in 2000. In 1999, net interest income consisted
of $1.0 million of interest income and $0.7 million of interest expense.
Interest expense increased in 2000 consistent with higher average bank loans
outstanding during 2000 and interest associated with the note issued to the
seller of the CNS business. Interest income decreased in 2000 consistent with
lower average cash and marketable securities balances during 2000.
We recorded a $1.1 million pre-tax gain on the disposition of two product
lines in 2000 and a $4.1 million pre-tax gain on the disposition of a product
line in 1999.
Other income (expense), net in 2000 included $176,000 of gain on sale of
investments.
The income tax provision of $0.1 million recorded in 2000 consists of $0.6
million of income tax expense, which was offset by a $0.5 million benefit from
the sale of New Jersey state net operating losses ("NOL's") under a state
sponsored program. The income tax benefit of $1.8 million recorded in 1999
consists of a $1.8 million non-cash benefit resulting from the reduction of the
deferred tax liability recorded in the NeuroCare acquisition to the extent that
consolidated deferred tax assets were generated subsequent to the acquisition. A
tax benefit of $0.6 million associated with the sale of New Jersey state net
operating losses was offset by $0.6 million of income tax expense.
The reported net loss for the year ended December 31, 2000 was $11.4
million, or $0.97 per share. The reported net loss per share includes $1.5
million of preferred stock dividends and a $4.2 million beneficial conversion
feature associated with the issuance of convertible preferred stock and warrants
in March 2000, which is treated as a non-cash dividend in computing per share
earnings. The beneficial conversion dividend is based upon the excess of the
price of the underlying common stock as compared to the fixed conversion price
of the convertible preferred stock, after taking into account the value assigned
to the common stock warrants. Included in the reported net loss of $11.4 million
was a $1.1 million gain on the sale of product lines, the $13.5 million
stock-based compensation charge, a $0.5 million cumulative effect of an
accounting change and $0.4 million of fair value inventory purchase accounting
adjustments. Excluding these items, the Company would have reported net income
of $1.8 million. Excluding these items and the $4.2 million beneficial
conversion feature recorded on the
28
convertible preferred stock, the Company would have reported net income of $0.02
per share for the year ended December 31, 2000.
The reported net loss for the year ended December 31, 1999 was $6.0
million, or $0.40 per share. The reported net loss per share includes $0.8
million of preferred stock dividends. Included in the reported net loss of $6.0
million was a $3.7 million gain (net of tax) on the sale of a product line and a
$1.8 million tax benefit related to the NeuroCare acquisition, $2.5 million of
fair value inventory purchase accounting adjustments and $1.0 million of
severance costs associated with the NeuroCare acquisition. Excluding these
items, the Company would have reported a net loss of $8.0 million, or $0.52 per
share.
Excluding the above items, adjusted Earnings before Interest, Taxes,
Depreciation and Amortization ("EBITDA") would have been $7.8 million in 2000,
as compared to a negative $5.6 million in 1999. EBITDA is calculated by adding
back interest, taxes, depreciation and amortization to net income or loss.
1999 COMPARED TO 1998
1999 1998
------------ -----------
Integra NeuroSciences:
- Neuro intensive care unit................................. $ 14,398 $ -
- Neuro operating room...................................... 8,014 -
Total product sales............................................ 22,412 -
Cost of product sales.......................................... 12,893 -
Gross margin on product sales.................................. 9,519 -
Gross margin percentage........................................ 42% -
Integra LifeSciences:
- Private label products.................................... $ 10,226 $ 11,295
- Distributed products...................................... 7,409 2,887
Total product sales............................................ 17,635 14,182
Cost of product sales.......................................... 9,785 7,580
Gross margin on product sales.................................. 7,850 6,602
Gross margin percentage........................................ 45% 47%
Total product sales.............................................. $ 40,047 $ 14,182
Consolidated gross margin percentage............................. 43% 47%
Total product sales increased $25.9 million, or 182%, in 1999, with sales
of product lines acquired in 1999 accounting for $24.5 million, or 172%, of this
increase. Sales growth for the year was led by the Integra NeuroSciences
division, which reported $21.9 million of sales from product lines acquired in
the NeuroCare acquisition and $0.5 million of sales of the DuraGen(R) product,
which was launched in the third quarter of 1999. Excluding fair value inventory
purchase accounting adjustments recorded in connection with the NeuroCare
acquisition, gross margins on Integra NeuroSciences product sales would have
been 51% in 1999.
Sales in the Integra LifeSciences division increased $3.5 million, or 24%,
in 1999. An increase of $3.9 million from sales of distributed product lines
acquired in 1998 and 1999 was offset by a decrease of
29
$2.1 million of sales of INTEGRA(R) Dermal Regeneration Template through Ethicon
in 1999. The remainder of the increase in 1999 relates to organic sales growth
in existing product lines. Excluding fair value inventory purchase accounting
adjustments, which reduced reported 1998 gross margins by 2 percentage points,
adjusted gross margins on Integra LifeSciences product sales decreased 1
percentage point to 48% in 1999. The decline in adjusted gross margins in 1999
was related to the lower gross margins on sales of the INTEGRA(R) Dermal
Regeneration Template through Ethicon.
Other revenue, which decreased $0.6 million to $2.8 million in 1999,
consisted of $1.3 million of research and development funding from strategic
partners and government grants, $0.9 million of license, distribution and other
event-related revenues from strategic partners and other third parties, and $0.6
million of royalty income. In 1998, other revenue consisted of $1.5 million of
license, distribution and other event-related revenues from strategic partners
and other third parties, $1.6 million of research and development funding from
strategic partners and government grants, and $0.3 million of royalty income.
Research and development expenses were as follows (in thousands):
1999 1998
---- ----
Integra NeuroSciences........................... $2,080 $ 945
Integra LifeSciences............................ 6,813 7,479
------ ------
Total...................................... $8,893 $8,424
Research and development expense in the Integra NeuroSciences segment
increased in 1999 primarily because of the NeuroCare acquisition. Integra
NeuroSciences research and development activities in 1998 consisted of programs
involving the DuraGen(R) product and the peripheral nerve guide. Research and
development activities within the Integra LifeSciences segment decreased in 1999
primarily because of the elimination of several non-core research programs
throughout 1999.
Selling and marketing expenses were as follows (in thousands):
1999 1998
---- ----
Integra NeuroSciences........................... $6,244 $ 628
Integra LifeSciences............................ 3,243 5,273
------ ------
Total...................................... $9,487 $5,901
Integra NeuroSciences selling and marketing expense increased in 1999
primarily because of the NeuroCare acquisition. Additional increases resulted
from expenses related to the domestic and international launch of the DuraGen(R)
product in the third quarter of 1999. The decrease in Integra LifeSciences
selling and marketing expenses is primarily the result of the transition of
INTEGRA(R) Dermal Regeneration Template selling and marketing activities to
Ethicon, offset by a slight increase in sales and marketing costs related to
acquired product lines.
30
General and administrative expenses were as follows (in thousands):
1999 1998
---- ----
Integra NeuroSciences........................... $4,726 $ 437
Integra LifeSciences............................ 2,433 2,111
Corporate....................................... 6,165 7,239
------- ------
Total...................................... $13,324 $9,787
Integra NeuroSciences general and administrative expense increased in 1999
primarily because of the NeuroCare acquisition. Included in this amount is $1.0
million of severance costs associated with the closure of NeuroCare's corporate
headquarters in July 1999. General and administrative expense in the Integra
LifeSciences segment increased in 1999 primarily due to additional headcount.
The decrease in corporate general and administrative expenses in 1999 resulted
primarily from decreased legal fees and costs associated with maintenance of the
Company's intellectual property and the effects of a $0.2 million asset
impairment charge recorded in 1998, offset by increases related to additional
headcount.
Net interest income consisted of interest income of $1.0 million and
interest expense of $0.7 million in 1999. Interest income decreased in 1999
consistent with lower average cash and marketable securities balances during
1999.
Other income decreased in 1999 primarily because of a $0.6 million
favorable litigation settlement recorded in 1998.
International Product Sales and Operations
In 2000, sales to customers outside the United States totaled $13.6
million, or 21% of consolidated product sales, of which approximately 50% were
to Europe. Of this amount, $3.2 million of these sales were generated in foreign
currencies from our subsidiary based in Andover, England, which was acquired in
April 2000. Our international sales and operations are subject to the risk of
foreign currency fluctuations, both in terms of exchange risk related to
transactions conducted in foreign currencies and the price of our products in
those markets for which sales are denominated in the U.S. dollar.
In 1999 and 1998, respectively, sales outside the United States totaled
$9.1 million and $2.3 million, respectively. All of these product sales were
generated from operations based in the United States and were denominated in
U.S. dollars.
LIQUIDITY AND CAPITAL RESOURCES
At March 31, 2001, we had cash, cash equivalents and short-term investments
of approximately $19.4 million and $12.3 million in short and long-term debt.
To date, we have experienced significant cumulative operating losses.
Historically, we have funded our operations primarily through private and public
offerings of equity securities, product revenues, research and collaboration
funding, borrowings under a revolving credit line and cash acquired in
connection with business acquisitions and dispositions. Recently, however, we
have substantially reduced our cash burn rate and, in the first quarter of 2001,
generated positive operating cash flows of
31
$4.5 million. Operating cash flows in the first quarter of 2001 included a $2.2
million use of cash due to inventory growth and a $1.9 million source of cash
from a prepayment relating to the second quarter of 2001 from our strategic
alliance with Johnson & Johnson Ethicon.
Our principal uses of funds during the first quarter of 2001 were $2.2
million of debt repayments and $0.4 million in purchases of property and
equipment. Principal sources of funds were $4.5 million of positive operating
cash flow, $0.8 million of proceeds from short-term borrowings, and $1.4 million
from the issuance of common stock.
Excluding the $13.5 million stock-based compensation charge, we would have
reported operating income of $1.8 million for the year ended December 31, 2000.
However, the Company did not generate positive operating cash flows in 2000
because of a significant increase in working capital.
Our principal uses of funds during 2000 were $4.1 million for the
acquisition of CNS, $12.1 million for the acquisition of certain product lines
from NMT, $3.3 million in purchases of property and equipment, $2.3 million of
term loan repayments, and $5.0 million used in operations. Operating cash flow
was negative in 2000 primarily because of increased inventory to support the
growth in the business, increased accounts receivable balances generated from
higher product sales, and an increase in demonstration equipment and sample
product provided to the significantly larger Integra NeuroSciences sales force.
In 1999, cash flow from operations was positive primarily because of a $5.7
million increase in deferred revenues, most of which was provided by cash
received under the Ethicon Agreement.
In 2000, we raised $5.4 million from the sale of Series C Preferred Stock
and warrants to affiliates of Soros Private Equity Partners LLC, $5.0 million
from a private placement of common stock, $3.2 million from the issuance of
common stock through employee benefit plans, $3.1 million of proceeds from
short-term borrowings, and $1.6 million from the sale of product lines.
We maintain a term loan and revolving credit facility from Fleet Capital
Corporation (collectively, the "Fleet Credit Facility"), which is collateralized
by all of the assets and ownership interests of various of our subsidiaries
including Integra NeuroCare LLC, and NeuroCare Holding Corporation (the parent
company of Integra NeuroCare LLC) has guaranteed Integra NeuroCare LLC's
obligations. Integra NeuroCare LLC is subject to various financial and
non-financial covenants under the Fleet Credit Facility, including significant
restrictions on its ability to transfer funds to us or our other subsidiaries
and restrictions on its ability to borrow more money. The financial covenants
specify minimum levels of interest and fixed charge coverage and net worth, and
also specify maximum levels of capital expenditures and total indebtedness to
operating cash flow, among others. While we anticipate that Integra NeuroCare
LLC will be able to satisfy the requirements of these financial covenants, there
can be no assurance that Integra NeuroCare LLC will generate sufficient earnings
before interest, taxes, depreciation and amortization to meet the requirements
of such covenants. The term loan is subject to mandatory prepayment amounts if
certain levels of cash flow are achieved. In April 2001, Integra NeuroCare LLC
prepaid approximately $2.0 million in principal as a result of such provisions
in addition to the scheduled quarterly principal payment.
In January 2000, we issued a 5% $2.8 million promissory note to the seller
of the CNS business. The promissory note, which is payable in two principal
payments of $1.4 million each, plus accrued interest, is collateralized by
inventory, property and equipment of the CNS business and by a collateral
assignment of a $2.8 million promissory note from one of our subsidiaries. The
first principal payment, including accrued interest, was paid on January 16,
2001. The final payment is due in January 2002.
In the short-term, we believe that we have sufficient resources to fund our
operations. However, in the longer-term, there can be no assurance that we will
be able to generate sufficient revenues to
32
sustain positive operating cash flows or profitability or to find acceptable
alternatives to finance future acquisitions.
QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK
We are exposed to market risks arising from an increase in interest rates
payable on the variable rate Fleet Credit Facility. For example, based on the
remaining term loan and revolving credit facility outstanding at March 31, 2001,
an annual interest rate increase of 100 basis points would increase interest
expense by approximately $110,000.
OTHER MATTERS
REDEMPTION OF SERIES B CONVERTIBLE PREFERRED STOCK
On May 4, 2001, the Company notified the holders of the 100,000 shares of
Series B Preferred of its intention to redeem these shares on June 29, 2001 for
$12.3 million. The holders of the Series B Preferred have the right to convert
their shares into common stock prior to this redemption. Because the conversion
price of $3.82 per share is substantially below the current market value of the
Company's common stock, we expect that the holders of the Series B Preferred
will convert their shares into common stock, although there can be no assurance
in this regard. The Series B Preferred shares are convertible into 2,617,801
shares of common stock.
NET OPERATING LOSSES
At December 31, 2000, we had net operating loss carryforwards ("NOL's") of
approximately $41.6 million and $18.2 million for federal and state income tax
purposes, respectively, to offset future taxable income, if any. The federal and
state NOL's expire through 2020 and 2007, respectively.
At December 31, 2000, several of our subsidiaries had unused NOL and tax
credit carryforwards arising from periods prior to our ownership. Excluding our
Telios Pharmaceuticals, Inc. subsidiary ("Telios"), approximately $9 million of
these NOL's for federal income tax purposes expire between 2001 and 2005. Our
Telios subsidiary has approximately $84 million of net operating losses, which
expire between 2002 and 2010. The amount of Telios' net operating loss that is
available and our ability to utilize such loss is dependent on the determined
value of Telios at the date of acquisition. We have a valuation allowance of $45
million recorded against all deferred tax assets, including the net operating
losses, due to the uncertainty of realization. The timing and manner in which
these acquired net operating losses may be utilized in any year by us are
severely limited by the Internal Revenue Code of 1986, as amended, Section 382
and other provisions of the Internal Revenue Code and its applicable
regulations.
As of December 31, 2000, the Company had provided a $44.8 million valuation
allowance against its consolidated deferred tax asset due to the uncertainty of
its realization. Because the Company has generated taxable income during recent
quarters, management is continuing to reassess the potential realizability of
this asset through the generation of future taxable income. The recognition of
the deferred tax asset could affect the Company's income tax provision in the
near term.
NEW ACCOUNTING PRONOUNCEMENTS
In December 1999 (as amended in March 2000 and June 2000) the staff of the
Securities and Exchange Commission (SEC) issued Staff Accounting Bulletin 101,
Revenue Recognition (the "SAB"). As the result of the adoption of the SAB, the
Company recorded a $470,000 cumulative effect of an accounting change to defer a
portion of a non-refundable, up-front fee received and recorded in other
33
revenue in 1998. The cumulative effect of this accounting change was measured
and recorded as of January 1, 2000.
In June 1998, the Financial Accounting Standards Board issued Statement No.
133, "Accounting for Derivative Instruments and Hedging Activities." Statement
No. 133, as amended by Statement No. 138, "Accounting for Certain Derivative
Instruments and Certain Hedging Activities," requires companies to recognize all
derivatives as either assets or liabilities in the balance sheet and measure
such instruments at fair value. The Company's adoption of Statement No. 133 as
of January 1, 2001 did not have a material effect on the Company's results of
operations or financial position during the first quarter of 2001.
34
BUSINESS
OVERVIEW
Integra develops, manufactures and markets medical devices, implants and
biomaterials. Our operations consist of (1) Integra NeuroSciences, which is a
leading provider of implants, devices, and monitors used in neurosurgery,
neurotrauma, and related critical care and (2) Integra LifeSciences, which
develops and manufactures a variety of medical products and devices, including
products based on our proprietary tissue regeneration technology which are used
to treat soft tissue and orthopedic conditions. Integra NeuroSciences sells
primarily through a direct sales organization, and Integra LifeSciences sells
primarily through strategic alliances and distributors.
Integra was founded in 1989 and over the next decade built a product
portfolio based on resorbable collagen and a product development platform based
on technologies directed toward tissue regeneration. During 1999 and 2000, we
expanded into the neurosurgical market, an attractive niche, through
acquisitions and introductions of new products. Our 2000 revenues increased to
$71.6 million, compared to $42.9 million in 1999 and $17.6 million in 1998.
Revenues for the first quarter of 2001 increased $7.2 million, or 49%, over the
first quarter of 2000 to $21.7 million.
In 2000, we sold over 1,000 different products to over 2,000 hospitals and
other customers in more than 80 countries. We generate revenues from product
sales, strategic alliances and royalties and invested $7.5 million in research
and development relating to new products, including those using our
biomaterials, peptide chemistry and collagen engineering technologies.
Integra NeuroSciences accounted for 64% of total revenues in 2000 and 68%
of total revenues during the first three months of 2001. We market these
products to neurosurgeons and critical care units, which comprise a focused
group of hospital-based practitioners. As a result, we believe we are able to
access this market through a cost-effective sales and marketing infrastructure.
For the majority of the products we manufacture under Integra LifeSciences,
we partner with market leaders, which we believe allows us to achieve our growth
objectives cost effectively while enabling us to focus our management efforts on
developing new products. These non-neurosurgical products address large, diverse
markets, and we believe that they can be more cost effectively promoted through
leveraging marketing partners than through developing a sales infrastructure
ourselves. Our strategic alliances include Ethicon, Inc., a division of Johnson
& Johnson, Sulzer Dental, a division of Sulzer Medica Ltd., the Genetics
Institute division of American Home Products Corporation, and Medtronic Sofamor
Danek.
STRATEGY
Our goal is to become a leader in the development, manufacture and
marketing of medical devices, implants and biomaterials in the markets in which
we compete. Our products are principally used in the diagnosis and treatment of
neurosurgical, soft-tissue and orthopedic conditions and we intend to expand our
presence in those markets. Key elements of our strategy include the following:
EXPAND OUR NEUROSURGERY MARKET PRESENCE. Through acquisitions and internal
growth, we have rapidly grown Integra NeuroSciences into a leading provider of
products for the neurosurgery market. We believe there exists additional growth
potential in this market through:
35
o increasing market share of existing product lines;
o expanding our product portfolio through acquisitions; and
o continuing development and promotion of innovative products, such as
the DuraGen(R)Dural Graft Matrix.
CONTINUE TO DEVELOP NEW AND INNOVATIVE MEDICAL PRODUCTS. As evidenced by our
development of INTEGRA(R) Dermal Regeneration Template, Biomend(R), Biomend(R)
Extend and DuraGen(R), we have a leading proprietary resorbable implant
franchise. INTEGRA(R) Dermal Regeneration Template is a proprietary resorbable
matrix used to enable the human body to regenerate functional dermal tissue. In
1999, we introduced our DuraGen(R) Dural Graft matrix to close brain and spine
membranes. We are currently developing a variety of innovative neurosurgical and
other medical products as well as seeking expanded applications for our existing
products.
CONTINUE TO FORM STRATEGIC ALLIANCES FOR INTEGRA LIFESCIENCES PRODUCTS. We have
collaborated with leading companies to develop and market the majority of our
non-neurosurgical product lines. These products address large and diverse
markets which we believe can be more cost effectively accessed through marketing
partners than through developing our own sales infrastructure. We have partnered
with Ethicon to market our INTEGRA(R) Dermal Regeneration Template and intend to
pursue additional strategic alliances selectively.
ADDITIONAL STRATEGIC ACQUISITIONS. Since March 1999 we have completed five
acquisitions in the neurosurgical market. We intend to seek additional
acquisitions in this market and in other niche medical technology markets
characterized by high margins, fragmented competition and focused target
customers.
PRODUCTS
We manufacture and market a broad range of medical products for the
diagnosis and treatment of spinal and cranial disorders, soft tissue repair and
orthopedic conditions. We are also actively engaged in a variety of research and
development programs relating to new products or product enhancements utilizing
our tissue regeneration technology. Our principal products and product lines are
summarized in the following table.
36
INTEGRA NEUROSCIENCES
PRODUCT LINES APPLICATION STATUS
- ------------- ----------- ------
NEURO INTENSIVE CARE UNIT
Camino(R) and Ventrix(R) fiber Access, drainage and continuous Marketed
optic-based intracranial monitoring monitoring of intracranial pressure,
systems, LICOX(R)(1) oxygen monitoring oxygen and temperature following
systems, Clinical Neuro Systems(TM), injury or neurosurgical procedures
Camino(R) and Heyer-Schulte(R)
drainage systems & cranial access kits
NEURO OPERATING ROOM
Heyer--Schulte(R)neurosurgical shunts Specifically designed for the Marketed
management of hydrocephalus, a
chronic condition involving excess
cerebrospinal fluid in the brain
DuraGen(R)Dural Graft Matrix (absorbable Graft to close brain and spine Marketed
collagen-based) membrane
Selector(R)Integra Ultrasonic Aspirator/ Use ultrasound to ablate cancer tumors Marketed
Dissectron(R) Ultrasonic Surgical
Aspirator
Integra Coblation(R)(1) Neurosurgical System Uses bipolar electrosurgery to ablate Marketed
cancer tumors for neurosurgical
applications
Redmond(TM)-Ruggles(TM)neurosurgical and
spinal instruments Specialized surgical instruments for Marketed
use in brain or spinal surgery
Neuro Navigational(R)flexible endoscopes for For minimally invasive surgical Marketed
neurosurgery access to the brain
Peripheral nerve conduit Repair of peripheral nerves In clinical trials
INTEGRA LIFESCIENCES
PRODUCT LINES APPLICATION STATUS MARKETING/DEVELOPMENT PARTNER
- ------------- ------------ ------ ------------------------------
PRIVATE LABEL PRODUCTS
INTEGRA(R)Dermal Regeneration Regenerate dermis and repair Marketed Ethicon, Inc., a division of
Template skin defects Johnson & Johnson, and Century
Medical, Inc. (Japan)
- ----------
(1) Coblation is a registered trademark of Arthrocare Corporation.
37
DENTAL SURGERY PRODUCTS:
BioMend(R)and Biomend(R)Extend Used in guided tissue Marketed Sulzer Dental, a division of
Absorbable Collagen Membrane regeneration in periodontal Sulzer Medica Ltd.
surgery
CollaCote(R), CollaTape(R)and Used to control bleeding in Marketed Sulzer Dental
CollaPlug(R)absorbable wound dental surgery
dressings
INFECTION CONTROL PRODUCTS
VitaCuff(R) Provides protection against Marketed Bard Access Systems, Inc., Arrow
infection arising from long-term International, Inc., Tyco
catheters International
BioPatch(R)(1) Anti-microbial wound dressing Marketed Ethicon, Inc.
ORTHOPEDICS
Absorbable Collagen Sponge for use Fracture management/enabling Development Genetics Institute division of
with bone morphogenetic protein spinal fusion American Home Products,
(rhBMP-2) Medtronic Sofamor Danek
Tyrosine polycarbonates for Fixation or alignment of Development Bionx Implants, Inc.
fixation devices such as fractures
resorbable screws, plates, pins,
wedges and nails
Articular cartilage repair Regeneration of joint cartilage Development None
DISTRIBUTED PRODUCTS
Helitene(R)and Helistat(R)absorbable Control of bleeding Marketed Various distributors
collagen hemostatic agents
Sundt(TM) and other hemodynamic Carotid endarterectomy shunts Marketed Various distributors
shunts for shunting blood during
surgical procedures involving
blood vessels
Spembly Medical Cryosurgery products Allow surgeon to use low Marketed Various distributors
temperature to more easily
extract diseased tissue
- --------------
(1) Biopatch is a registered trademark of Johnson & Johnson.
38
INTEGRA NEUROSCIENCES
IN GENERAL
We manufacture and market a multi-line offering of innovative neurosurgical
devices used for brain and spine injuries. We intend to be the neurosurgeon's
and neuro-intensive care unit's "one-stop shop" for these products. For the
intensive care unit, we sell the Camino(R), Ventrix(R) and LICOX(R) lines of
intracranial pressure, temperature and oxygen monitoring systems and external
drainage systems manufactured under the Camino(R), Heyer-Schulte(R) and Clinical
Neuro Systems(TM) brand names. For the operating room, we sell a wide range of
products, including Heyer-Schulte hydrocephalus management shunting products,
the DuraGen(R) Dural Graft Matrix, the Selector(R) Integra Ultrasonic Aspirator
and Dissectron(R) Ultrasonic Surgical Aspirator, Integra Coblation(R)
Neurosurgical Systems, Redmond(TM)-Ruggles(TM) neurosurgical instruments and
Neuro Navigational(R) endoscopes.
We sell our neurosurgical products in the United States through a direct
sales force organized into five regions, each with a manager. We employ 44
direct sales personnel called neurospecialists covering 44 territories. We also
employ seven clinical development specialists who directly educate and train
both the neurospecialists and our customers in the use of our products, and a
scientific director with a Ph.D in neurosciences. The sales organization has
more than doubled in size since the acquisition of the first neurosciences
business in early 1999. We believe this expansion allows for smaller, more
focused territories, greater participation in trade shows and more extensive
marketing efforts. We also sell directly in the United Kingdom and plan to sell
through a direct sales force in Germany and France. In the rest of the world, we
sell our products through approximately 80 specialized neurosurgical
distributors and dealers.
INDUSTRY
The neurosurgical device market consists of medical products, implants and
instruments used for the diagnosis, treatment and monitoring of chronic diseases
and acute injuries involving the brain and spinal chord. These products are
primarily used in the operating room and intensive care unit by neurosurgeons
and nurses. According to industry sources, the size of the market for our
products is approximately $400 million and is expected to grow at annual rate of
6-8%.
Integra NeuroSciences addresses the market need created by trauma cases,
cancer, hydrocephalus and other conditions of the brain and spine through its
established market positions in intracranial monitoring, neurosurgical shunting,
dural repair, tumor ablation and specialty neurosurgical instrumentation.
Intracranial monitors are used by neurosurgeons in diagnosing and treating
cases of severe head trauma and other diseases. Integra NeuroSciences currently
has more than 3,000 intracranial monitors installed worldwide. There are
approximately 400,000 cases of head trauma each year in the United State, of
which the portion that requires monitoring and intervention represents a market
of approximately $40 million.
Hydrocephalus is an incurable condition resulting from an imbalance between
the amount of cerebrospinal fluid ("CSF") produced by the body and the rate at
which CSF is absorbed by the brain. This condition causes the ventricles of the
brain to enlarge and the pressure inside the head to increase. Hydrocephalus
often is present at birth, but may also result from head trauma, spina bifida,
intraventricular hemorrhage, intracranial tumors and cysts. The most common
method of treatment of hydrocephalus is the insertion of a shunt into the
ventricular system of the brain to divert the flow of CSF out of the brain. A
pressure valve then maintains the CSF at normal levels within the ventricles.
39
According to the Hydrocephalus Association, hydrocephalus affects approximately
one in 500 children born in the United States. Approximately 80% of total CSF
shunt sales address birth-related hydrocephalus with the remaining 20%
addressing surgical procedures involving excess CSF due to head trauma.
Based on industry sources, we believe that the total United States market
for hydrocephalus management, including monitoring, shunting and drainage, is
approximately $70 million. Of that amount, it is estimated that a little more
than half constitutes sales of monitoring products, and the balance constitutes
sales of shunts and drains for the management of hydrocephalus.
Our Selector(R) Integra Ultrasonic Aspirator, Dissectron(R) Ultrasonic
Surgical Aspirator and Integra Coblation(R) products address the market for the
surgical destruction and removal of malignant and non-malignant tumors and other
tissue. More than 110,000 metastatic brain tumors are diagnosed annually in the
United States. According to the American Cancer Society, brain tumors are the
second fastest growing cause of cancer death among people over 65 and are among
the most common types of cancer found in children.
Our DuraGen(R) Dural Graft Matrix product line addresses the market for
dural substitutes, including cranial and spinal procedures.
Integra NeuroSciences' Redmond(TM)-Ruggles(TM) line of neurosurgery and
spinal instrumentation products, including hand-held spinal and neurosurgery
instruments such as retractors, kerrisons, dissectors and curettes, addresses
the market for neurosurgical instruments.
Integra NeuroSciences' line of minimally invasive neuroendoscopy products
addresses a market growing, in part, because of the introduction of new
procedures called third ventriculostomies which are increasingly substituting
for shunt placement for patients who meet the criteria.
PRODUCTS
NEURO INTENSIVE CARE UNIT
THE MONITORING OF BRAIN PARAMETERS. Integra NeuroSciences sells the
Camino(R) and Ventrix(R) lines of intracranial pressure and temperature
monitoring systems, and the LICOX(R) Brain Tissue Oxygen Monitoring System. The
Camino(R) and Ventrix(R) systems measure the intracranial pressure and
temperature in the brain and ventricles, and the LICOX(R) system allows for
continuous qualitative regional monitoring of dissolved oxygen in cerebral
tissues. Core technologies in the brain parameter monitoring product line
include the design and manufacture of the disposable catheters used in the
monitoring systems, pressure transducer technology, optical detection/fiber
optic transmission technology, sensor characterization and calibration
technology and monitor design and manufacture.
EXTERNAL DRAINAGE SYSTEM PRODUCT LINE. Integra NeuroSciences' ventricular
and lumbar external drainage systems are manufactured under the Camino(R),
Heyer-Shulte(R) and Clinical Neuro Systems(TM) brand names. We manufacture the
drainage systems in both Anasco, Puerto Rico (for sale under the Camino(R) and
Heyer-Schulte(R) brand names) and in Exton, Pennsylvania (for sale under the
Clinical Neuro Systems(TM) brand name).
NEURO OPERATING ROOM
SHUNTS FOR HYDROCEPHALUS MANAGEMENT. Our line of shunting products for
hydrocephalus management includes the Novus(R), LPV(R) and Pudenz(TM) shunts,
ventricular, peritoneal and cardiac
40
catheters, physician-specified hydrocephalus management shunt kits, Ommaya(R)
CSF reservoirs and Spetzler(R) lumbar and syringo-peritoneal shunts. Shunts are
medical devices implanted in the patient to drain excess CSF from the ventricles
of the brain into the peritoneal cavity or externally.
DURAGEN(R) PRODUCT LINE. The DuraGen(R) Dural Graft Matrix is a resorbable
collagen matrix indicated for the repair of the dura mater. The dura mater is
the thick membrane that contains the CSF within the brain and the spine. The
dura mater must be penetrated during brain surgery and is often damaged during
spinal surgery. In either case, surgeons often close or repair the dura mater
with a graft. The graft may consist of other tissue taken from elsewhere in the
patient's body, or it may be one of the dural substitute products currently on
the market which are made of synthetic materials, processed human cadaver, or
bovine pericardium. We believe that the other methods for repairing the dura
mater suffer from shortcomings addressed by the DuraGen(R) Dural Graft Matrix.
Our DuraGen(R) product has been shown in clinical trials to be an effective
means for closing the dura mater without the need for suturing, which allows the
neurosurgeon to conclude the operation more efficiently. In addition, because
the DuraGen(R) product is ultimately resorbed by the body and replaced with new
natural tissue, the patient avoids some of the risks associated with a permanent
implant inside the cranium.
SELECTOR(R) INTEGRA ULTRASONIC ASPIRATOR. The Selector(R) Integra
Ultrasonic Aspirator uses very high frequency sound waves to pulverize cancer
tumors, and allows the surgeon to remove the damaged tumor tissue by aspiration.
Unlike other surgical techniques, ultrasonic surgery selectively dissects and
fragments soft tissue leaving fibrous tissues such as nerves and blood vessels
intact. Ultrasonic aspiration facilitates the ablation of unwanted tissue
adjacent or attached to vital structures.
DISSECTRON(R) ULTRASONIC SURGICAL ASPIRATOR. The Dissectron(R) Ultrasonic
Surgical Aspirator system, acquired in April 2001, applies ultrasonic energy to
precisely fragment and emulsify soft tissue, which is subsequently aspirated,
while preserving major blood vessels, nerves and elastic fibers. The system has
been used internationally in a variety of surgical applications, including
neurosurgery. The Dissectron(R) system has United States FDA 510(k) clearance
for neurosurgical applications and CE Mark Certification in the European Union.
However, we have no plans to sell the Dissectron(R) system in the United States.
INTEGRA COBLATION(R). Integra NeuroSciences is the exclusive sales and
distribution partner for ArthroCare Corporation's Coblation(R) based surgical
system for neurosurgery in North American and certain other international
markets. ArthroCare's Coblation(R) products allow surgeons to operate with a
high level of control, limiting damage to surrounding tissue and thereby
potentially reducing pain and speeding recovery for the patient. Coblation(R)
products, including the neurosurgery system that we distribute, operate at lower
temperatures than traditional electrosurgical or laser surgery tools and enable
surgeons to remove, shrink or sculpt soft tissue and to seal bleeding vessels.
ArthroCare's soft-tissue surgery systems consist of a controller unit and an
assortment of disposable devices that are specialized for specific types of
surgery. We are working with ArthroCare to develop handpieces and other
accessories particularly for the neurosurgical application.
REDMOND(TM)-RUGGLES(TM) PRODUCT LINE. We provide neurosurgeons and spine
surgeons with a full line of specialty hand-held spinal and neurosurgical
instruments sold under the Redmond(TM) and Ruggles(TM) brand names. These
products include retractors, kerrisons, dissectors and curettes. Major product
segments include spinal instruments, microsurgical neuro instruments, and
products customized by Integra NeuroSciences and sold through other companies
and distributors. Most of these products are manufactured to Integra's
specifications by specialty surgical steel fabricators in Germany.
41
NEURO NAVIGATIONAL(R) ENDOSCOPE PRODUCT LINE. We manufacture and sell
disposable minimally invasive neuroendoscopy products under the Neuro
Navigational(R) brand name. These fiber optic instruments are used to facilitate
minimally invasive neurosurgery.
PERIPHERAL NERVE CONDUIT. Peripheral nerves are one of the few tissues of
the body that spontaneously regenerate. However, in the majority of cases
regenerating peripheral nerves fail to make useful, functional connections.
Consequently, peripheral nerve injuries often result in permanent loss of
sensation and motor control. The conventional method of treatment for a severed
peripheral nerve is microsurgical repair or nerve grafts. Our peripheral nerve
regeneration device is a collagen tube designed to facilitate regeneration of
the severed nerve and to act as a bridge between the severed nerve ends. The
collagen conduit supports nerve regeneration and is then absorbed into the body.
Our pre-clinical studies have demonstrated the closure of 5-cm gaps in
peripheral nerves in non-human primates with restored nerve function. Our
proprietary resorbable conduit for regenerating and reconnecting peripheral
nerves has entered clinical trials in Europe.
INTEGRA LIFESCIENCES
IN GENERAL
The Integra LifeSciences Division develops and manufactures tissue
regeneration products and surgical products that are primarily sold outside of
neurosurgery and neurotrauma. Many of the current products of Integra
LifeSciences are built on our expertise in resorbable collagen products. Integra
LifeSciences's research and development programs are generally constructed
around strategic alliances with leading medical device companies.
PRODUCTS
PRIVATE LABEL PRODUCTS
INTEGRA(R) DERMAL REGENERATION TEMPLATE. INTEGRA(R) Dermal Regeneration
Template is designed to enable the human body to regenerate functional dermal
tissue. Human skin consists of the epidermis and the dermis. The epidermis is
the thin, outer layer that serves as a protective seal for the body, and the
dermis is the thicker layer underneath that provides structural strength and
flexibility and supports the viability of the epidermis through a vascular
network. The body normally responds to severe damage to the dermis by producing
scar tissue in the wound area. This scar tissue is accompanied by contraction
that pulls the edges of the wound closer which, while closing the wound, often
permanently reduces flexibility. In severe cases, this contraction leads to a
reduction in the range of motion for the patient, who subsequently requires
extensive physical rehabilitation or reconstructive surgery. Physicians treating
severe wounds, such as full-thickness burns, seek to minimize scarring and
contraction.
INTEGRA(R) Dermal Regeneration Template was designed to minimize scar
formation and wound contracture in full thickness skin defects. INTEGRA(R)
Dermal Regeneration Template consists of two layers, a thin
collagen-glycosaminoglycan sponge and a silicone membrane. The product is
applied with the sponge layer in contact with the excised wound. The sponge
material serves as a template for the growth of new functional dermal tissue.
The outer membrane layer acts as a temporary substitute for the epidermis to
control water vapor transmission, prevent re-injury and minimize bacterial
contamination.
INTEGRA(R) Dermal Regeneration Template was approved by the FDA under a
premarket approval application ("PMA") for the post-excisional treatment of
life-threatening full-thickness or deep partial-thickness thermal injury where
sufficient autograft is not available at the time of excision or not desirable
due to the physiological condition of the patient.
42
We estimate that the worldwide market for use of skin replacement products
(such as INTEGRA(R) Dermal Regeneration Template) in the treatment of severe
burns is approximately $75 million. However, the potential market for the use of
INTEGRA(R) Regeneration Template for reconstructive surgery and the treatment of
chronic wounds is much larger, which we estimate to be in excess of $1 billion.
In June 1999, Integra LifeSciences entered into a strategic alliance with
Ethicon to distribute INTEGRA(R) Dermal Regeneration Template throughout the
world, except Japan. As part of that strategic alliance, Ethicon has agreed to
pay for clinical trials to support applications to the FDA for these broader
indications. We cannot be certain that such clinical trials will be completed,
or that INTEGRA(R) Dermal Regeneration Template will receive the approvals
necessary to permit Ethicon to promote it for such indications.
BIOMEND(R) ABSORBABLE COLLAGEN MEMBRANE. Our BioMend(R) Absorbable Collagen
Membrane is used for guided tissue regeneration in periodontal surgery. The
BioMend(R) membrane is inserted between the gum and the tooth after surgical
treatment of periodontal disease, preventing the gum tissue from interfering
with the regeneration of the periodontal ligament that holds the tooth in place.
The BioMend(R) product is intended to be absorbed after approximately four to
seven weeks, avoiding the requirement for additional surgical procedures to
remove a non-absorbable membrane. BioMend(R) Extend has the same indication for
use as BioMend(R), except that it absorbs in approximately 16 weeks. The
BioMend(R) and BioMend(R) Extend Absorbable Collagen Membrane is sold through
the Sulzer Dental division of Sulzer Medica.
COLLAGEN MATRICES FOR USE WITH BONE GROWTH FACTORS. We supply the Genetics
Institute division of American Home Products with absorbable collagen sponges
for use in developing bone regeneration implants. Since 1994, we have supplied
absorbable collagen sponges for use with Genetics Institute's recombinant human
bone morphogenic protein-2 (rhBMP-2). Recombinant human BMP-2 is a manufactured
version of human protein naturally present in very small quantities in the body.
Genetics Institute is developing rhBMP-2 for clinical evaluation in several
areas of bone repair and augmentation and, in February 2001, filed a PMA with
the United States Food and Drug Administration seeking approval for the use of
its rhBMP-2 in conjunction with our Absorbable Collagen Sponge for use in
treatment of acute long-bone fractures requiring open surgical management. Spine
applications are being developed through a related collaboration with Medtronic
Sofamor Danek in North America.
CARTILAGE REPAIR PROGRAM. Damaged articular cartilage, which connects the
skeletal joints, is associated with the onset of progressive pain, degeneration
and, ultimately, long-term osteoarthritis. Normal articular cartilage does not
effectively heal. The conventional procedure for treating traumatic damage to
cartilage involves smoothing damaged portions of the tissue and removing
free-floating material from the joint using arthroscopic surgery with the
objective of reducing pain and restoring mobility. However, this therapy does
not stop joint surface degeneration, often requires two or more surgeries and
results in the formation of fibrocartilage, which is rough and non-weight
bearing over prolonged periods. Moreover, the long-term result of this procedure
often is permanent reduction of joint mobility and an increased risk of
developing osteoarthritis.
We are developing our proprietary technology base toward an approach that
will support in vivo regeneration of the patient's own articular cartilage. This
technology will allow the patient's body to regenerate a smooth, weight-bearing
surface. Our objective in developing this cartilage-specific technology is to
produce a product that provides the proper matrix system to allow the natural
regeneration of the patient's cartilage, with full restoration of function and
diminished risk of osteoarthritis.
TYROSINE POLYCARBONATES FOR ORTHOPEDIC IMPLANTS. We are continuing to
develop additional biomaterial technologies that enhance the rate and quality of
healing and tissue regeneration with synthetic biodegradable scaffolds that
support cell attachment and growth. We are developing a new class of resorbable
polycarbonates created through the polymerization of tyrosine, a naturally
occurring amino
43
acid. A well-defined and commercially scaleable manufacturing process prepares
these materials. Device fabrication by traditional techniques such as
compression molding and extrusion is readily achieved. We believe that this new
biomaterial will be useful in promoting full bone healing when implanted in
damaged sites. This material is currently being developed for orthopedic and
tissue engineering applications where strength and bone compatibility are
critical issues for success of healing. We have entered into agreements to
supply the material to Bionx Implants, Inc. for specified orthopedic implants.
No medical device containing the material has yet been approved for sale.
OTHER SURGICAL PRODUCTS. Other current products of Integra LifeSciences
include the VitaCuff(R)catheter access infection control device (sold to Bard
Access Systems, Inc., Arrow International, Inc. and Tyco International Ltd.),
the BioPatch(R) anti-microbial wound dressing (sold to Ethicon), and a wide
range of resorbable collagen products for hemostasis (sold to Sulzer Dental for
use in periodontal surgery and other distributors under the Helistat(R)and
Helitene(R)Absorbable Collagen Hemostatic Agent names).
Our Sundt(TM) and other carotid endarterectomy shunts are used to divert
blood to vital organs (such as the brain) during carotid artery surgical
procedures.
Finally, our Spembly Medical cryosurgery products allow surgeons to use low
temperatures to more easily extract diseased tissue.
STRATEGIC ALLIANCES
We use distribution alliances to market the majority of our Integra
LifeSciences products. We have also entered into collaborative agreements
relating to research and development programs involving our technology. These
arrangements are described below.
ETHICON. In June 1999, we entered into a strategic alliance with Ethicon to
distribute INTEGRA(R) Dermal Regeneration Template throughout the world, except
in Japan. Ethicon is responsible for marketing and selling the product, has
agreed to make significant minimum product purchases, and will provide $2
million annual funding for research, development and certain clinical trials for
the first five years of the alliance and thereafter based on a percentage of net
sales. In addition, Ethicon is obligated to make contingent payments to Integra
LifeSciences in the event of certain clinical developments and to assist in the
expansion of our manufacturing capacity as we achieve certain sales targets.
Under the agreement, we are obligated to manufacture the product and are
responsible for continued research and development. The initial term of the
agreement is ten years, and Ethicon may at its option extend the agreement for
an additional ten years. Ethicon may terminate the agreement with notice prior
to the end of the initial term. Depending upon the reasons for any such
termination, Ethicon may be obligated to make significant payments to us.
CENTURY MEDICAL, INC. In 1997, we signed an exclusive importation and sales
agreement for INTEGRA(R)Dermal Regeneration Template in Japan with Century
Medical Inc., a subsidiary of ITOCHU Corporation. Under this agreement, Century
Medical, Inc. is conducting a clinical trial in Japan at its own expense to
obtain Japanese regulatory approvals for the sale of INTEGRA(R)Dermal
Regeneration Template in Japan.
OTHER ORTHOPEDICS. In addition to the cartilage program, Integra
LifeSciences has several other programs oriented toward the orthopedic market.
These programs include an alliance with Genetics Institute for the development
of collagen matrices to be used in conjunction with Genetics Institute's
recombinant human bone morphogenetic protein-2 ("rhBMP-2"). If approved, rhBMP-2
is expected to be used in conjunction with our matrices to regenerate bone.
Genetics Institute is developing products based on rhBMP-2 for applications in
orthopedics, oral and maxillofacial surgery and spine surgery. Spine
44
applications are being developed through a related collaboration with Medtronic
Sofamor Danek in North America.
In September 1998, we announced a strategic alliance with Bionx Implants,
Inc. ("Bionx") for developing fixation devices using Integra's polymer
technology. Under the agreement with Bionx, Bionx has responsibility for
clinical trials and any necessary regulatory filings. Products covered under the
agreement with Bionx include a resorbable line of screws, plates, pins, wedges
and nails used for the fixation and/or alignment of fractures or osteotomies in
all areas of the musculoskeletal system except in the spine and cranium.
SULZER DENTAL. Sulzer Medica Ltd.'s dental division, Sulzer Dental, has
marketed and sold BioMend(R) since 1995, BioMend(R) Extend since 1999 and
CollaCote(R), CollaPlug(R) and CollaTape(R) since 1992.
RESEARCH STRATEGY
We have either acquired or secured the proprietary rights to several
important technological and scientific platforms, including collagen matrix
technology, peptide technology, biomaterials technology, and expertise in fiber
optics. These technologies provide support for our critical applications in
neurosciences and tissue regeneration, and additional opportunities for
generating near-term and long-term revenues from medical applications. We have
been able to identify and bring together critical platform technology components
from which we work to develop solutions for both tissue regeneration and
neurosciences. These efforts have led to the successful development of new
products, such as the DuraGen(R) product.
We spent approximately $2.1 million for the three months ended March 31,
2001 and $7.5 million, $8.9 million, and $8.4 million during fiscal years 2000,
1999, and 1998, respectively, on research and development activities. Research
and development activities funded by government grants and contract development
revenues amounted to $0.9 million for the three months ended March 31, 2001, and
$2.8 million, $1.6 million and $1.8 million during fiscal years 2000, 1999, and
1998, respectively.
GOVERNMENT REGULATION
As a manufacturer of medical devices, we are subject to extensive
regulation by the FDA and, in some jurisdictions, by state and foreign
governmental authorities. These regulations govern the introduction of new
medical devices, the observance of certain standards with respect to the design,
manufacture, testing, labeling and promotion of such devices, the maintenance of
certain records, the ability to track devices, the reporting of potential
product defects, the export of devices and other matters. We believe that we are
in substantial compliance with these governmental regulations.
From time to time, we have recalled certain of our products. To date, no
such recall has had a material adverse effect on the company, but we cannot
assure that a future recall would not have such an effect.
Our medical devices introduced in the United States market are required by
the FDA, as a condition of marketing, to secure a Premarket Notification
clearance pursuant to Section 510(k) of the Federal Food, Drug and Cosmetic Act,
an approved Premarket Approval ("PMA") application or a supplemental PMA.
Alternatively, we may seek United States market clearance through a Product
Development Protocol approved by the FDA. Establishing and completing a Product
Development Protocol, or obtaining a PMA or supplemental PMA, can take up to
several years and can involve preclinical studies and clinical testing. In order
to perform clinical testing in the United States on an
45
unapproved product, we are also required to obtain an Investigational Device
Exemption (IDE) from the FDA. In addition to requiring clearance for new
products, FDA rules may require a filing and FDA approval, usually through a PMA
supplement or a 510(k) Premarket Notification clearance, prior to marketing
products that are modifications of existing products or new indications for
existing products. While the FDA Modernization Act of 1997, when fully
implemented, is expected to inject more predictability into the product review
process, streamline post-market surveillance, and promote the global
harmonization of regulatory procedures, the process of obtaining such clearances
can be onerous and costly.
We cannot assure that all the necessary approvals, including approval for
product improvements and new products, will be granted on a timely basis, if at
all. Delays in receipt of, or failure to receive, such approvals could have a
material adverse effect on our business. Moreover, after clearance is given, if
the product is shown to be hazardous or defective, the FDA and foreign
regulatory agencies have the power to withdraw the clearance or require us to
change the device, its manufacturing process or its labeling, to supply
additional proof of its safety and effectiveness or to recall, repair, replace
or refund the cost of the medical device. In addition, federal, state and
foreign regulations regarding the manufacture and sale of medical devices are
subject to future changes. We cannot predict what impact, if any, these changes
might have on its business. However, the changes could have a material impact on
our business.
We are also required to register with the FDA as a device manufacturer. As
such, we are subject to periodic inspection by the FDA for compliance with the
FDA's QSR requirements and other regulations. These regulations require that we
manufacture our products and maintain our documents in a prescribed manner with
respect to design, manufacturing, testing and control activities. Further, we
are required to comply with various FDA requirements for labeling and promotion.
The Medical Device Reporting regulations require that we provide information to
the FDA whenever there is evidence to reasonably suggest that one of our devices
may have caused or contributed to a death or serious injury or, if a malfunction
were to recur, could cause or contribute to a death or serious injury. In
addition, the FDA prohibits us from promoting a medical device before marketing
clearance has been received or promoting an approved device for unapproved
indications. If the FDA believes that a company is not in compliance with
applicable regulations, it can institute proceedings to detain or seize
products, issue a warning letter, issue a recall order, impose operating
restrictions, enjoin future violations and assess civil penalties against the
company, its officers or its employees and can recommend criminal prosecution to
the Department of Justice. Such actions could have a material impact on our
business. Other regulatory agencies may have similar powers.
Medical device laws are also in effect in many of the countries outside the
United States in which we do business. These laws range from comprehensive
device approval and Quality System requirements for some or all of the our
medical device products to simpler requests for product data or certifications.
The number and scope of these requirements are increasing. In June 1998, the
European Union Medical Device Directive became effective, and all medical
devices must meet the Medical Device Directive standards and receive CE mark
certification. CE Mark certification involves a comprehensive Quality System
program, and submission of data on a product to the Notified Body in Europe. The
Medical Device Directive, the ISO 9000 series of standards, and EN46001 are
recognized international quality standards that are designed to ensure we
develop and manufacture quality medical devices. Each of our facilities is
audited on an annual basis by a recognized Notified Body to verify our
compliance with these standards. In 2000, each of our facilities was audited and
we have maintained our certification to these standards.
In addition, we are required to notify the FDA if we export to certain
countries medical devices manufactured in the United States that have not been
approved by the FDA for distribution in the United
46
States. We are also required to maintain certain records relating to exports and
make the records available to the FDA for inspection, if required.
OTHER UNITED STATES REGULATORY REQUIREMENTS
In addition to the regulatory framework for product approvals, we are and
may be subject to regulation under federal and state laws, including
requirements regarding occupational health and safety; laboratory practices; and
the use, handling and disposal of toxic or hazardous substances. We may also be
subject to other present and possible future local, state, federal and foreign
regulations.
Our research, development and manufacturing processes involve the
controlled use of certain hazardous materials. We are subject to federal, state
and local laws and regulations governing the use, manufacture, storage, handling
and disposal of such materials and certain waste products. Although we believe
that our safety procedures for handling and disposing of such materials comply
with the standards prescribed by such laws and regulations, the risk of
accidental contamination or injury from these materials cannot be completely
eliminated. In the event of such an accident, we could be held liable for any
damages that result and any such liability could exceed our resources. Although
we believe that we are in compliance in all material respects with applicable
environmental laws and regulations, there can be no assurance that we will not
incur significant costs to comply with environmental laws and regulations in the
future, nor that our operations, business or assets will not be materially
adversely affected by current or future environmental laws or regulations.
PATENTS AND INTELLECTUAL PROPERTY
We pursue a policy of seeking patent protection of our technology, products
and product improvements both in the United States and in selected foreign
countries. When determined appropriate, we have enforced and plan to continue to
enforce and defend our patent rights. In general, however, we do not rely on our
patent estate to provide us with any significant competitive advantages. We rely
upon trade secrets and continuing technological innovations to develop and
maintain our competitive position. In an effort to protect our trade secrets, we
have a policy of requiring our employees, consultants and advisors to execute
proprietary information and invention assignment agreements upon commencement of
employment or consulting relationships with us. These agreements provide that
all confidential information developed or made known to the individual during
the course of their relationship with us must be kept confidential, except in
specified circumstances.
BioMend(R) Camino(R) Clinical Neuro Systems(TM), CollaCote(R),
CollaPlug(R), CollaStat(TM), CollaTape(R), Dissectron(R), DuraGen(R),
Helistat(R), Extend(TM), Helitene(R), Heyer-Schulte(R), INTEGRA(R) Dermal
Regeneration Template, LICOX(R), Neuro Navigational(R), Novus(R), LPV(R),
Ommaya(R), Pudenz(TM), Redmond(TM), Ruggles(TM), Selector(R), Spetzler(R),
Sundt(TM), Ventrix(R), VitaCuff(R) are some of the trademarks of Integra and its
Subsidiaries. All other brand names, trademarks and service marks appearing in
this prospectus are the property of their respective holders.
COMPETITION
The largest competitors of Integra NeuroSciences in the neurosurgery
markets are the PS Medical division of Medtronic, Inc., the Codman division of
Johnson & Johnson, the Valleylab and Radionics divisions of Tyco International
Ltd., and NMT Neurosciences, a division of NMT Medical, Inc. In addition,
various of the Integra NeuroSciences product lines compete with smaller
specialized companies or larger companies that do not otherwise focus on
neurosurgery. The products of Integra LifeSciences face diverse and broad
competition, depending on the market addressed by the product. In addition,
certain companies are known to be competing particularly in the area of skin
substitution or regeneration,
47
including Organogenesis and Advanced Tissue Sciences. Finally, in certain cases
competition consists primarily of current medical practice, rather than any
particular product (such as autograft tissue as a substitute for
INTEGRA(R)-Dermal Regeneration Template). Depending on the product line, we
compete on the basis of our products' features, strength of our sales
organization or marketing partner, sophistication of our technology, and cost
effectiveness of our solution to the customer's medical requirements.
FACILITIES
Our principal executive offices are located in Plainsboro, New Jersey.
Principal manufacturing and research facilities are located in Plainsboro, New
Jersey, San Diego, California, Anasco, Puerto Rico, Andover, England and
Mielkendorf, Germany, and we have a National Distribution Center ("NDC") in
Cranbury, New Jersey. In addition, we lease several smaller facilities to
support additional administrative, assembly, and storage operations. Our total
office manufacturing and research space approximates 180,000 square feet. Our
Integra LifeSciences products are manufactured in Plainsboro, Anasco and Andover
and distributed through the NDC and the Andover facility. Our Integra
NeuroSciences products are manufactured in the Plainsboro, San Diego, Andover,
Mielkendorf, and Anasco facilities and are distributed through the NDC and the
Andover facility. All of our facilities are leased.
All of our manufacturing and distribution facilities are registered with
the FDA. Our facilities are subject to inspection by the FDA to assure
compliance with QSR requirements. We believe that our manufacturing facilities
are in substantial compliance with QSR, suitable for their intended purposes and
have capacities adequate for current and projected needs for existing products.
Some capacity of the plants is being converted, with any needed modification, to
meet the current and projected requirements of existing and future products.
EMPLOYEES
At May 15, 2001, we had approximately 550 permanent employees engaged in
production and production support (including warehouse, engineering, and
facilities personnel), quality assurance/quality control, research and
development, regulatory and clinical affairs, sales/marketing and administration
and finance. None of our current employees are subject to a collective
bargaining agreement.
LEGAL PROCEEDINGS
In July 1996, we filed a patent infringement lawsuit in the United States
District Court for the Southern District of California against Merck KGaA, a
German corporation, Scripps Research Institute, a California nonprofit
corporation, and David A. Cheresh, Ph.D., a research scientist with Scripps,
seeking damages and injunctive relief. The complaint charged, among other
things, that the defendant Merck KGaA willfully and deliberately induced, and
continues to willfully and deliberately induce, defendants Scripps Research
Institute and Dr. David A. Cheresh to infringe certain of our patents. These
patents are part of a group of patents granted to The Burnham Institute and
licensed by us that are based on the interaction between a family of cell
surface proteins called integrins and the arginine-glycine-aspartic acid (known
as "RGD") peptide sequence found in many extracellular matrix proteins. The
defendants filed a countersuit asking for an award of defendants' reasonable
attorney fees. This case went to trial in February 2000, and on March 17, 2000,
a jury returned a unanimous verdict for us finding that Merck KGaA had infringed
and induced the infringement of our patents, and awarded $15,000,000 in damages.
On September 29, 2000, the United States District Court for the Southern
District of California entered judgment in our favor and against Merck KGaA in
the case. In entering the judgment, the court also granted us pre-judgment
interest of approximately $1,350,000, bringing the total amount to approximately
$16,350,000, plus post-judgment interest. Various post-trial motions are
pending, including a request by
48
Merck KGaA for a judgment as a matter of law notwithstanding the verdict, which
could have the effect of reducing the judgment or reversing the verdict of the
jury. In addition, if we win these post-trial motions, we expect Merck KGaA to
appeal various decisions of the Court. No amounts for this favorable verdict
have been reflected in our financial statements.
We are also subject to other claims and lawsuits in the ordinary course of
our business, including claims by employees and with respect to our products. In
the opinion of management, such other claims are either adequately covered by
insurance or otherwise indemnified, and are not expected, individually or in the
aggregate, to result in a material adverse effect on our financial condition.
Our financial statements do not reflect any material amounts related to possible
unfavorable outcomes of the matters above or others. However, it is possible
that our results of operations, financial position and cash flows in a
particular period could be materially affected by these contingencies.
49
MANAGEMENT
EXECUTIVE OFFICERS AND DIRECTORS
The following table sets forth information with respect to our
executive officers and directors as of the date of this prospectus.
NAME AGE POSITION
- ----- --- --------
Stuart M. Essig, Ph.D................................... 39 President, Chief Executive Officer and Director
George W. McKinney, III, Ph.D........................... 57 Executive Vice President, Chief Operating Officer,
Director
John B. Henneman, III................................... 39 Senior Vice President, Chief Administrative Officer
and Secretary
Judith E. O'Grady....................................... 50 Senior Vice President, Regulatory, Quality Assurance
and Clinical Affairs
Michael D. Pierschbacher, Ph.D.......................... 49 Senior Vice President Research and Development,
Director of the Corporate Research Center
David B. Holtz.......................................... 34 Senior Vice President, Finance and Treasurer
Richard E. Caruso, Ph.D................................. 57 Director and Chairman of the Board of Directors
James M. Sullivan....................................... 57 Director
Keith Bradley, Ph.D..................................... 56 Director
Neal Moszkowski......................................... 35 Director
STUART M. ESSIG, PH.D. has served as President and Chief Executive Officer
and a director of Integra since December 1997. Before joining Integra, Mr. Essig
supervised the medical technology practice at Goldman, Sachs & Co. as a managing
director. Mr. Essig had ten years of broad health care experience at Goldman
Sachs serving as a senior merger and acquisitions advisor to a broad range of
domestic and international medical technology, pharmaceutical and biotechnology
clients. Mr. Essig received an A.B. degree from the Woodrow Wilson School of
Public and International Affairs at Princeton University and an MBA and a Ph.D.
degree in Financial Economics from the University of Chicago, Graduate School of
Business. Mr. Essig also serves on the Board of Directors of Vital Signs
Incorporated and St. Jude Medical Corporation.
GEORGE W. MCKINNEY, III, PH.D. has served Integra as Executive Vice
President and Chief Operating Officer since May 1997 and as a member of the
Board of Directors since December 1992. Between 1997 and 1999 Dr. McKinney also
served as Vice Chairman. Between 1990 and 1997, Dr. McKinney was Managing
Director of Beacon Venture Management Corporation, a venture capital firm.
Between 1992 and 1997, Dr. McKinney also served as President and Chief Executive
Officer of Gel Sciences, Inc. and GelMed, Inc., a privately held specialty
materials firm with development programs in both the industrial and medical
products fields. Before 1990, Dr. McKinney held other positions in the venture
capital industry, was President and Chief Executive Officer of American
Superconductor, Inc., and served in various manufacturing, engineering and
financial positions at Corning, Inc. Dr. McKinney holds a B.S. in Management
from MIT and a Ph.D. in Strategic Planning from Stanford University School of
Business. Dr. McKinney announced that he will step down as Executive Vice
President and Chief Operating Officer when his employment agreement expires on
December 31, 2001. Dr. McKinney plans to be available as a consultant to the
Company through June 30, 2002.
JOHN B. HENNEMAN, III is Integra's Senior Vice President, Chief
Administrative Officer and Secretary, and is responsible for the law department,
business development, human resources and investor relations. Mr. Henneman was
our General Counsel from September 1998 until September 2000. Prior to
50
joining Integra in August 1998, Mr. Henneman served Neuromedical Systems, Inc.,
a public company developer and manufacturer of in vitro diagnostic equipment, in
various capacities for more than four years. From 1994 until June 1997, Mr.
Henneman was Vice President of Corporate Development, General Counsel and
Secretary. From June 1997 through November 1997, he served in the additional
capacity of interim Co-Chief Executive Officer and from December 1997 to August
1998 Mr. Henneman was Executive Vice President, US Operations, and Chief Legal
Officer. In March 1999, Neuromedical Systems, Inc. filed a petition under
Chapter 11 of the federal bankruptcy laws. Mr. Henneman practiced law in the
Corporate Department of Latham & Watkins (Chicago, Illinois) from 1986 to 1994.
Mr. Henneman received his A.B. (Politics) from Princeton University in 1983, and
his J.D. from the University of Michigan Law School in 1986.
JUDITH E. O'GRADY, Senior Vice President of Regulatory Affairs, Quality
Assurance and Clinical Research, has served Integra since 1985. Ms. O'Grady has
worked in the areas of medical devices and collagen technology for over 20
years. Prior to joining Integra, Ms. O'Grady worked for Colla-Tec, Inc., a
Marion Merrell Dow Company. During her career she has held positions with
Surgikos, a Johnson & Johnson company, and was on the faculty of Boston
University College of Nursing and Medical School. Ms. O'Grady led the team that
obtained the FDA approval for INTEGRA(R)Dermal Regeneration Template, the first
regenerative product approved by the FDA, and has led teams responsible for more
than 100 510(K) clearances. She received her BS degree from Marquette University
and MSN in Nursing from Boston University.
MICHAEL D. PIERSCHBACHER, PH.D. joined Integra in October 1995 as Senior
Vice President, Research and Development. In May 1998 he was named Senior Vice
President and Director of the Corporate Research Center. From June 1987 to
September 1995, Dr. Pierschbacher served as Senior Vice President and Scientific
Director of Telios Pharmaceuticals, Inc., ("Telios") which was acquired by us in
connection with the reorganization of Telios under Chapter 11 of the federal
bankruptcy code. He was a co-founder of Telios in May 1987 and is the
co-discoverer and developer of Telios' matrix peptide technology. Before joining
Telios as a full-time employee in October 1988, he was a staff scientist at the
Burnham Institute for five years and remained on staff there in an adjunct
capacity until the end of 1997. He received his post-doctoral training at
Scripps Clinical and Research Foundation and at the Burnham Institute. Dr.
Pierschbacher received his Ph.D. in Biochemistry from the University of
Missouri.
DAVID B. HOLTZ joined Integra as Controller in 1993 and has served as Vice
President, Finance and Treasurer since March 1997 and was promoted to Senior
Vice President, Finance and Treasurer in February 2001. His responsibilities
include managing all accounting and information systems functions. Before
joining Integra, Mr. Holtz was an associate with Coopers & Lybrand, L.L.P. in
Philadelphia and Cono Leasing Corporation, a private leasing company. He
received a BS degree in Business Administration from Susquehanna University in
1989 and has been certified as a public accountant.
RICHARD E. CARUSO, PH.D. has served as Integra's Chairman since March 1992.
Prior to December 1997, Dr. Caruso served as Integra's Chief Executive Officer
since March 1992 and as President since September 1995. From 1969 to 1992, Dr.
Caruso was a principal of LFC Financial Corporation, a project finance company,
where he was also a director and Executive Vice President. He has 25 years
experience in finance and entrepreneurial ventures. Dr. Caruso is on the Board
of Susquehanna University, The Baum School of Art and The Uncommon Individual
Foundation (Founder). He received a B.S. degree from Susquehanna University, and
M.S.B.A. degree from Bucknell University and a Ph.D degree from the London
School of Economics, University of London (United Kingdom).
JAMES M. SULLIVAN has been a director since 1992. Since 1986, he has held
several positions with Marriott International, Inc. (and its predecessor,
Marriott Corp.), including Vice President of Mergers and Acquisitions, and his
current position of Executive Vice President of Development for the Lodging
Group
51
of Marriott. From 1983 to 1986, Mr. Sullivan was Chairman, President and Chief
Executive Officer of Tenly Enterprises, Inc., a privately held company operating
105 restaurants. Prior to 1983, he held senior management positions with
Marriott Corp., Harrah's Entertainment, Inc., Holiday Inns, Inc., Kentucky Fried
Chicken Corp. and Heublein, Inc. He also was employed as a senior auditor with
Arthur Andersen & Co. and currently serves as a director of Global Vacation
Group, Inc. Mr. Sullivan received a B.S. degree in Accounting from Boston
College and an M.B.A. degree from the University of Connecticut.
KEITH BRADLEY, PH.D. has been a director since 1992. He is the Professor of
Management at The City University Business School, London, England, and a
Director of Ockham Holdings plc, a London Stock Exchange corporation. Dr.
Bradley was the founder and formerly Executive Director of the London School of
Business Performance Group, an interdisciplinary research institute which
specializes in organizational performance. He has extensive experience as a
consultant to a variety of business, government and international organizations
and has published widely on management and industrial policy. Dr. Bradley has
served as Visiting Professor at Harvard Business School, the UCLA Graduate
School of Management and the Wharton School of the University of Pennsylvania.
Dr. Bradley received a Diploma in Education from Culham College and a Ph.D.
degree in Economics from the University of Essex.
NEAL MOSZKOWSKI has been a director since March 29, 1999 and is the
designee of the holders of our Series B and Series C Preferred Stock. Mr.
Moszkowski has been a partner of Soros Private Equity Partners LLC since August
1998 and is currently an employee of Soros Private Funds Management LLC. Prior
thereto, Mr. Moszkowski was an Executive Director of Goldman Sachs International
and a Vice President of Goldman, Sachs & Co. in its Principal Investment Area,
which he joined in August 1993. He received a B.A. degree from Amherst College
and an M.B.A. degree from Stanford University. Mr. Moszkowski also serves as a
director of Bluefly, Inc. and MedicaLogic/Medscape, Inc.
-----------
Our executive officers serve at the discretion of the Board of Directors.
The only family relationship between any of our executive officers and directors
is that Mr. Holtz is the nephew of Dr. Caruso.
52
PRINCIPAL STOCKHOLDERS
The following table sets forth certain information regarding the beneficial
ownership of Common Stock and Preferred Stock as of May 18, 2001 by: (a) each
person or entity known to Integra to own beneficially five percent or more of
the outstanding shares of Common Stock or Preferred Stock, based upon our
records or Commission records; (b) each of our directors; (c) each of the Named
Officers; and (d) all executive officers and directors of Integra as a group.
Each share of Series B Preferred Stock is currently convertible at the
discretion of the holder into 26.178 shares of Common Stock, and each share of
Series C Preferred Stock is currently convertible at the discretion of the
holder into 11.111 shares of Common Stock in each case subject to certain
adjustments. Except as otherwise indicated, each person has sole voting power
and sole investment power with respect to all shares beneficially owned by such
person. On May 4, 2001, the Company notified the holders of the Series B
Preferred of its intention to redeem these shares on June 29, 2001 for $12.3
million. The holders of the Series B Preferred have the right to convert their
shares into common stock prior to this redemption. Because the conversion price
of $3.82 per share is substantially below the current market value of the
Company's common stock, we expect that the holders of the Series B Preferred
will convert their shares into common stock, although there can be no assurance
in this regard.
COMMON STOCK SERIES B PREFERRED SERIES C PREFERRED
--------------------------- --------------------------- --------------------------
NAME OF BENEFICIAL OWNER SHARES (1) PERCENT SHARES PERCENT SHARES PERCENT
- ----------------------- --------------- ---------- ------------ ------------ ---------- ------------
Richard E. Caruso, Ph.D...... 7,219,418 (2) 40.1%
Trust Partnership............ 7,179,205 (3) 39.9%
Frances C. Holtz............. 7,179,205 (4) 39.9%
Quantum Industrial Partners
LDC....................... 2,955,000 (5) 14.2% 75,000 75.0% 48,699 90.2%
The Dow Chemical Company..... 1,575,280 (6) 8.8%
State of Wisconsin
Investment Board.......... 1,338,979 (7) 7.4%
Elan Corporation, plc........ 1,100,000 (8) 6.1%
SFM Domestic Investments
LLC....................... 802,800 (9) 4.3% 25,000 25.0% 5,301 9.8%
Stuart M. Essig, Ph.D........ 535,221 (10) 2.9%
John B. Henneman, III........ 119,741 (11) *
George W. McKinney, III,
Ph.D...................... 100,367 (12) *
Judith O'Grady............... 59,453 (13) *
Michael D. Pierschbacher,
Ph.D...................... 57,884 (14) *
James M. Sullivan............ 29,041 (15) *
Neal Moszkowski.............. 20,000 (16) *
Keith Bradley, Ph.D.......... 500 (17) *
All directors and executive
officers as a group
(10 persons).............. 8,175,489(18) 43.3%
- -----------
* Less than one percent (1%).
(1) Shares not outstanding but deemed beneficially owned by virtue of the right
of an individual to acquire them within 60 days upon the exercise of an
option or other convertible security are treated as outstanding for
purposes of determining beneficial ownership and the percentage
beneficially owned by such individual.
(2) Includes the 7,179,205 shares held by Trust Partnership, a Pennsylvania
general partnership of which Dr. Caruso is a partner and the President
(also see Note 3 below). Also includes 23,338 shares held by Provco Leasing
Corporation ("Provco") of which Dr. Caruso is President. Provco is a
wholly-owned subsidiary of Cono Industries, a corporation whose
stockholders are trusts whose beneficiaries include Dr. Caruso's children.
Also includes 16,875 shares issuable upon
53
exercise of the vested portion of options held by Dr. Caruso. Dr. Caruso's
address is 919 Conestoga Road, Building 2, Suite 106 Rosemont, Pennsylvania
19010.
(3) The partners of Trust Partnership are Pagliacci Trust, Rigoletto Trust,
Trust for Jonathan Henry Caruso, Trust for Peter James Caruso (the
beneficiaries of all such trusts (the "Trusts") being Dr. Caruso's
children), Dr. Caruso and Provco, each of which may be deemed to
beneficially own the shares held by Trust Partnership; however, such
partners of Trust Partnership disclaim beneficial ownership of all such
shares except to the extent represented by their respective equity and
profit participation interests in Trust Partnership. The Trust
Partnership's address is c/o Richard E. Caruso, Ph.D., 919 Conestoga Road,
Building 2, Suite 106 Rosemont, Pennsylvania 19010.
(4) Frances C. Holtz is a trustee of the Trusts, which collectively have a
controlling interest in Trust Partnership. As such, Ms. Holtz may be deemed
to beneficially own the shares held by Trust Partnership; however, Ms.
Holtz disclaims beneficial ownership of all such shares. Ms. Holtz's
address is 8111 Marshall Avenue, Margate, New Jersey 08402.
(5) Includes (i) 1,963,350 shares of common stock that are issuable upon
conversion of 75,000 shares of Series B Preferred Stock held by Quantum
Industrial Partners LDC ("QIP"); (ii) 541,100 shares of Common Stock
issuable upon conversion of 48,699 shares of Series C Preferred Stock held
by QIP; and (iii) 270,550 shares of Common Stock issuable upon exercise of
warrants held by QIP. The principal address of QIP is at Kaya Flamboyan 9,
Willemsted, Curacao, Netherlands Antilles. QIH Management Investor, L.P.
("QIHMI") is vested (pursuant to constituent documents of QIP) with
investment discretion with respect to the portfolio assets held for the
account of QIP. Pursuant to an agreement between George Soros and Soros
Fund Management LLC ("SFM"), Mr. Soros has agreed to use his best efforts
to cause QIH Management, Inc., as the sole general partner of QIHMI, to act
at the discretion of SFM. Mr. Soros is the Chairman of SFM. Each of QIHMI,
QIH Management, Inc., SFM and Mr. Soros may be deemed the beneficial owner
of the QIP Shares. Each has their principal business office at 888 Seventh
Avenue, 33rd Floor, New York, New York 10106.
(6) The address of The Dow Chemical Company is 2030 Dow Center Office E115,
Midland, Michigan 48674.
(7) The address of the State of Wisconsin Investment Board is 121 East Wilson
Street, Madison, Wisconsin 53702.
(8) Consists of 1,100,000 shares held by Carnrick Laboratories, Inc.
("Carnrick") (collectively, the "Carnrick Shares"). Carnrick is a wholly-
owned subsidiary of Athena Neurosciences, Inc., which is a wholly-owned
subsidiary of Elan Corporation, plc, each of which may be deemed the
beneficial owner of the Carnrick Shares. The address for each of the
foregoing companies is c/o Elan Corporation, plc, Lincoln House, Lincoln
Place, Eighty Pine Street, Dublin 2, Ireland.
(9) Includes 654,450 shares of Common Stock issuable upon conversion of 25,000
shares of Series B Preferred Stock held by SFM Domestic Investments LLC
("SFMDI"); (ii) 58,900 shares of Common Stock issuable upon conversion of
5,301 shares of Series C Preferred Stock held by SFMDI; and (iii) 29,450
shares of Common Stock issuable upon exercise of warrants held by SFMDI.
The principal business office of SFMDI is at 888 Seventh Avenue, 33rd
Floor, New York, New York 10106. George Soros is a managing member of SFMDI
and may be deemed beneficial owner of the SFMDI Shares.
54
(10) Includes 517,084 shares issuable upon exercise of the vested portion of
options held by Mr. Essig. The Restricted Units held by Mr. Essig do not
give him the right to acquire any shares within 60 days of May 18, 2001.
(11) Includes 106,481 shares issuable upon exercise of the vested portion of
options held by Mr. Henneman.
(12) Includes 88,867 shares issuable upon exercise of the vested portion of
options held by Dr. McKinney.
(13) Includes 43,288 shares issuable upon exercise of the vested portion of
options held by Ms. O'Grady.
(14) Includes 2,554 shares held by revocable trusts of which Dr. Pierschbacher
is co-trustee. Also includes 42,861 shares issuable upon exercise of the
vested portion of options held by Dr. Pierschbacher.
(15) Includes 25,500 shares issuable upon exercise of the vested portion of
options held by Mr. Sullivan.
(16) Consists of 20,000 shares issuable upon exercise of the vested portion of
options held by Mr. Moszkowski.
(17) Includes 500 shares issuable upon exercise of the vested portion of options
held by Dr. Bradley.
(18) See Notes 2 and 10 through 17 above. Also, includes 7,046 shares, as well
as 26,818 shares issuable upon exercise of the vested portion of options,
held by one executive officer of the Company and/or its subsidiaries who is
not listed in the table.
CERTAIN TRANSACTIONS
We lease our manufacturing facility in Plainsboro, New Jersey from
Plainsboro Associates, a New Jersey general partnership. Ocirne, Inc., a
subsidiary of Cono Industries ("Cono"), owns a 50% interest in Plainsboro
Associates. Cono is a corporation whose stockholders are trusts whose
beneficiaries include the children of Dr. Richard E. Caruso, our Chairman and a
principal stockholder of the Company. Dr. Caruso is the President of Cono. We
paid $209,848 in rent for this facility during 2000.
During 2000, the Company signed a five year lease related to certain
production equipment, from Medicus Corporation. The sole stockholder of Medicus
is Trust Partnership, a Pennsylvania general partnership, for which Dr. Caruso
is a partner and the President. Under the terms of the lease, the Company paid
$45,000 to Medicus Corporation during 2000.
55
DESCRIPTION OF DEBT SECURITIES
The following description sets forth general terms and provisions of the
debt securities to which any prospectus supplement may relate. We will describe
the particular terms and provisions of the series of debt securities offered by
a prospectus supplement, and the extent to which such general terms and
provisions described below may apply thereto, in the prospectus supplement
relating to such series of debt securities.
The senior debt securities, if any, are to be issued in one or more series
under an indenture, as supplemented or amended from time to time between Integra
and an institution that we will name in the related prospectus supplement, as
trustee. For ease of reference, we will refer to the indenture relating to
senior debt securities as the senior indenture and we will refer to the trustee
under that indenture as the senior trustee. The subordinated debt securities, if
any, are to be issued in one or more series under an indenture, as supplemented
or amended from time to time, between Integra and an institution that we will
name in the related prospectus supplement, as trustee. For ease of reference, we
will refer to the indenture relating to subordinated debt securities as the
subordinated indenture and we will refer to the trustee under that indenture as
the subordinated trustee. This summary of certain terms and provisions of the
debt securities and the indentures is not necessarily complete, and we refer you
to the copy of the form of the indentures which are filed as an exhibit to the
registration statement of which this prospectus forms a part, and to the Trust
Indenture Act. Whenever we refer to particular defined terms of the indentures
in this Section or in a prospectus supplement, we are incorporating these
definitions into this prospectus or the prospectus supplement.
GENERAL
The debt securities will be issuable in one or more series pursuant to an
indenture supplemental to the applicable indenture or a resolution of Integra's
board of directors or a committee of the board. Unless otherwise specified in a
prospectus supplement, each series of senior debt securities will rank pari
passu in right of payment with any of Integra Parent Company's future senior
unsecured obligations. Each series of subordinated debt securities will be
subordinated and junior in right of payment to the extent and in the manner set
forth in the subordinated indenture and the supplemental indenture relating to
that debt. Except as otherwise provided in a prospectus supplement, the
indentures will not limit the incurrence or issuance of other secured or
unsecured debt of Integra, whether under the indentures, any other indenture
that Integra may enter into in the future or otherwise. For more information,
you should read the prospectus supplement relating to a particular offering of
securities.
The applicable prospectus supplement or prospectus supplements will
describe the following terms of each series of debt securities:
o the title of the debt securities and whether such series constitutes senior
debt securities or subordinated debt securities;
o any limit upon the aggregate principal amount of the debt securities;
o the date or dates on which the principal of the debt securities is payable
or the method of that determination or the right, if any, of Integra to
defer payment of principal;
o the rate or rates, if any, at which the debt securities will bear interest
(including reset rates, if any, and the method by which any such rate will
be determined), the interest payment dates on which interest will be
payable and the right, if any, of Integra to defer any interest payment;
56
o the place or places where, subject to the terms of the indenture as
described below under the caption "--Payment and Paying Agents," the
principal of and premium, if any, and interest, if any, on the debt
securities will be payable and where, subject to the terms of the indenture
as described below under the caption "--Denominations, Registration and
Transfer," Integra will maintain an office or agency where debt securities
may be presented for registration of transfer or exchange and the place or
places where notices and demands to or upon Integra in respect of the debt
securities and the indenture may be made;
o any period or periods within, or date or dates on which, the price or
prices at which and the terms and conditions upon which debt securities may
be redeemed, in whole or in part, at the option of Integra pursuant to any
sinking fund or otherwise;
o the obligation, if any, of Integra to redeem or purchase the debt
securities pursuant to any sinking fund or analogous provisions or at the
option of a holder and the period or periods within which, the price or
prices at which, the currency or currencies including currency unit or
units, in which and the other terms and conditions upon which the debt
securities will be redeemed or purchased, in whole or in part, pursuant to
such obligation;
o the denominations in which any debt securities will be issuable if other
than denominations of $1,000 and any integral multiple thereof;
o if other than in U.S. Dollars, the currency or currencies, including
currency unit or units, in which the principal of, and premium, if any, and
interest, if any, on the debt securities will be payable, or in which the
debt securities shall be denominated;
o any additions, modifications or deletions in the events of default or
covenants of Integra specified in the indenture with respect to the debt
securities;
o if other than the principal amount, the portion of the principal amount of
debt securities that will be payable upon declaration of acceleration of
the maturity thereof;
o any additions or changes to the indenture with respect to a series of debt
securities that will be necessary to permit or facilitate the issuance of
the series in bearer form, registrable or not registrable as to principal,
and with or without interest coupons;
o any index or indices used to determine the amount of payments of principal
of and premium, if any, on the debt securities and the manner in which such
amounts will be determined;
o subject to the terms described under "--Global Debt Securities," whether
the debt securities of the series will be issued in whole or in part in the
form of one or more global securities and, in such case, the depositary for
the global securities;
o the appointment of any trustee, registrar, paying agent or agents;
o the terms and conditions of any obligation or right of Integra or a holder
to convert or exchange debt securities into preferred securities or other
securities;
o whether the defeasance and covenant defeasance provisions described under
the caption "--Satisfaction and Discharge; Defeasance" will be inapplicable
or modified
57
o any applicable subordination provisions in addition to those set forth
herein with respect to subordinated debt securities; and
o any other terms of the debt securities not inconsistent with the provisions
of the applicable indenture.
We may sell debt securities at a substantial discount below their stated
principal amount, bearing no interest or interest at a rate which at the time of
issuance is below market rates. We will describe material U.S. federal income
tax consequences and special considerations applicable to the debt securities in
the applicable prospectus supplement.
If the purchase price of any of the debt securities is payable in one or
more foreign currencies or currency units or if any debt securities are
denominated in one or more foreign currencies or currency units or if the
principal of, premium, if any, or interest, if any, on any debt securities is
payable in one or more foreign currencies or currency units, we will set forth
the restrictions, elections, material U.S. federal income tax considerations,
specific terms and other information with respect to such issue of debt
securities and such foreign currency or currency units in the applicable
prospectus supplement.
If any index is used to determine the amount of payments of principal,
premium, if any, or interest on any series of debt securities, we will describe
the material U.S. federal income tax, accounting and other considerations
applicable thereto in the applicable prospectus supplement.
DENOMINATIONS, REGISTRATION AND TRANSFER
Unless otherwise specified in the applicable prospectus supplement, the
debt securities will be issuable only in registered form, without coupons, in
denominations of $1,000 and any integral multiple thereof. Debt securities of
any series will be exchangeable for other debt securities of the same issue and
series, of any authorized denominations of a like aggregate principal amount,
the same original issue date, stated maturity and bearing the same interest
rate.
Holders may present each series of debt securities for exchange as provided
above, and for registration of transfer, with the form of transfer endorsed
thereon, or with a satisfactory written instrument of transfer, duly executed,
at the office of the appropriate securities registrar or at the office of any
transfer agent designated by Integra for such purpose and referred to in the
applicable prospectus supplement, without service charge and upon payment of any
taxes and other governmental charges as described in the indenture. Integra will
appoint the trustee of each series of debt securities as securities registrar
for such series under the indenture. If the applicable prospectus supplement
refers to any transfer agents, in addition to the securities registrar initially
designated by Integra with respect to any series, Integra may at any time
rescind the designation of any such transfer agent or approve a change in the
location through which any such transfer agent acts, provided that Integra
maintains a transfer agent in each place of payment for the series. Integra may
at any time designate additional transfer agents with respect to any series of
debt securities.
In the event of any redemption, neither Integra nor the trustee will be
required to:
o issue, register the transfer of or exchange debt securities of any
series during a period beginning at the opening of business 15 days
before the day of mailing of a notice for redemption of debt
securities of that series, and ending at the close of business on the
day of mailing of the relevant notice of redemption, or
58
o transfer or exchange any debt securities so selected for redemption,
except, in the case of any debt securities being redeemed in part, any
portion not being redeemed.
GLOBAL DEBT SECURITIES
Unless otherwise specified in the applicable prospectus supplement, the
debt securities of a series may be issued in whole or in part in the form of one
or more global securities that we will deposit with, or on behalf of, a
depositary identified in the prospectus supplement relating to such series.
Global debt securities may be issued only in fully registered form and in either
temporary or permanent form. Unless and until it is exchanged in whole or in
part for the individual debt securities represented by it, a global debt
security may not be transferred except as a whole by the depositary for the
global debt security to a nominee of the depositary or by a nominee of the
depositary to the depositary or another nominee of the depositary or by the
depositary or any nominee to a successor depositary or any nominee of the
successor.
The specific terms of the depositary arrangement with respect to a series
of debt securities will be described in the prospectus supplement relating to
the series. Integra anticipates that the following provisions will generally
apply to depositary arrangements.
Upon the issuance of a global debt security, and the deposit of the global
debt security with or on behalf of the applicable depositary, the depositary for
the global debt security or its nominee will credit on its book-entry
registration and transfer system, the respective principal amounts of the
individual debt securities represented by the global debt security to the
accounts of persons, more commonly known as participants, that have accounts
with the depositary. These accounts will be designated by the dealers,
underwriters or agents with respect to the debt securities or by Integra if the
debt securities are offered and sold directly by Integra. Ownership of
beneficial interests in a global debt security will be limited to participants
or persons that may hold interests through participants. Ownership of beneficial
interests in the global debt security will be shown on, and the transfer of that
ownership will be effected only through, records maintained by the applicable
depositary or its nominee with respect to interests of participants and the
records of participants with respect to interests of persons who hold through
participants. The laws of some states require that certain purchasers of
securities take physical delivery of the securities in definitive form. These
limits and laws may impair the ability to transfer beneficial interests in a
global debt security.
So long as the depositary for a global debt security, or its nominee, is
the registered owner of the global debt security, the depositary or its nominee,
as the case may be, will be considered the sole owner or holder of the debt
securities represented by the global debt security for all purposes under the
indenture. Except as provided below, owners of beneficial interests in a global
debt security will not be entitled to have any of the individual debt securities
of the series represented by the global debt security registered in their names,
will not receive or be entitled to receive physical delivery of any debt
securities of the series in definitive form and will not be considered the
owners or holders of them under the indenture.
Payments of principal of, and premium, if any, and interest on individual
debt securities represented by a global debt security registered in the name of
a depositary or its nominee will be made to the depositary or its nominee, as
the case may be, as the registered owner of the global debt security
representing the debt securities. None of Integra, or the trustee, any paying
agent, or the securities registrar for the debt securities will have any
responsibility or liability for any aspect of the records relating to or
payments made on account of beneficial ownership interest of the global debt
security for the debt securities or for maintaining, supervising or reviewing
any records relating to those beneficial ownership interests.
59
Integra expects that the depositary for a series of debt securities or its
nominee, upon receipt of any payment of principal, premium or interest in
respect of a permanent global debt security representing any of the debt
securities, immediately will credit participants' accounts with payments in
amounts proportionate to their respective beneficial interest in the principal
amount of the global debt security for the debt securities as shown on the
records of the depositary or its nominee. Integra also expects that payments by
participants to owners of beneficial interests in the global debt security held
through the participants will be governed by standing instructions and customary
practices, as is now the case with securities held for the accounts of customers
in bearer form or registered in "street name." These payments will be the
responsibility of these participants.
Unless otherwise specified in the applicable prospectus supplement, if the
depositary for a series of debt securities is at any time unwilling, unable or
ineligible to continue as depositary and a successor depositary is not appointed
by Integra within 90 days, Integra will issue individual debt securities of the
series in exchange for the global debt security representing the series of debt
securities. In addition, unless otherwise specified in the applicable prospectus
supplement, Integra may at any time and in its sole discretion, subject to any
limitations described in the prospectus supplement relating to the debt
securities, determine not to have any debt securities of the series represented
by one or more global debt securities and, in such event, will issue individual
debt securities of the series in exchange for such global debt securities.
Further, if Integra so specifies with respect to the debt securities of a
series, an owner of a beneficial interest in a global debt security representing
debt securities of the series may, on terms acceptable to Integra, the trustee
and the depositary for the global debt security, receive individual debt
securities of the series in exchange for such beneficial interests, subject to
any limitations described in the prospectus supplement relating to the debt
securities. In any such instance, an owner of a beneficial interest in a global
debt security will be entitled to physical delivery of individual debt
securities of the series represented by the global debt security equal in
principal amount to its beneficial interest and to have the debt securities
registered in its name. Individual debt securities of the series so issued will
be issued in denominations, unless otherwise specified by Integra, of $1,000 and
integral multiples thereof. The applicable prospectus supplement may specify
other circumstances under which individual debt securities may be issued in
exchange for the global debt security representing any debt securities.
PAYMENT AND PAYING AGENTS
Unless otherwise indicated in the applicable prospectus supplement, payment
of principal of, and premium, if any, and any interest on debt securities will
be made at the office of the trustee in New York or at the office of such paying
agent or paying agents as Integra may designate from time to time in the
applicable prospectus supplement, except that at the option of Integra payment
of any interest may be made:
o except in the case of global debt securities, by check mailed to the
address of the person or entity entitled thereto as such address shall
appear in the securities register; or
o by transfer to an account maintained by the person or entity entitled
thereto as specified in the securities register, provided that proper
transfer instructions have been received by the regular record date.
Unless otherwise indicated in the applicable prospectus supplement, we
will make payment of any interest on debt securities to the person or
entity in whose name the debt security is registered at the close of
business on the regular record date for the interest payment, except
in the case of defaulted interest. Integra may at any time designate
additional paying agents or rescind the designation of any paying
agent; however, Integra will at all times be required to maintain a
paying agent in each place of payment for each series of debt
securities.
60
Any moneys deposited with the trustee or any paying agent, or held by
Integra in trust, for the payment of the principal of, and premium, if any, or
interest on any debt security and remaining unclaimed for two years after such
principal, and premium, if any, or interest has become due and payable will, at
the request of Integra, be repaid to Integra or released from such trust, as
applicable, and the holder of the debt security will thereafter look, as a
general unsecured creditor, only to Integra for payment.
OPTION TO DEFER INTEREST PAYMENTS OR TO PAY-IN-KIND
If provided in the applicable prospectus supplement, Integra will have the
right, at any time and from time to time during the term of any series of debt
securities, to defer the payment of interest for such number of consecutive
interest payment periods as may be specified in the applicable prospectus
supplement, subject to the terms, conditions and covenants, if any, specified in
such prospectus supplement, provided that an extension period may not extend
beyond the stated maturity of the final installment of principal of the series
of debt securities. If provided in the applicable prospectus supplement, Integra
will have the right, at any time and from time to time during the term of any
series of debt securities, to make payments of interest by delivering additional
debt securities of the same series. Certain material U.S. federal income tax
consequences and special considerations applicable to the debt securities will
be described in the applicable prospectus supplement.
SUBORDINATION
Except as set forth in the applicable prospectus supplement, the
subordinated indenture will provide that the subordinated debt securities are
subordinated and junior in right of payment to all senior indebtedness of
Integra. If:
o Integra defaults in the payment of any principal, or premium, if any,
or interest on any senior indebtedness when the same becomes due and
payable, whether at maturity or at a date fixed for prepayment or
declaration or otherwise; or
o an event of default occurs with respect to any senior indebtedness
permitting the holders thereof to accelerate the maturity thereof and
written notice of such event of default, requesting that payments on
subordinated debt securities cease, is given to Integra by the holders
of senior indebtedness,
then unless and until the default in payment or event of default shall have been
cured or waived or shall have ceased to exist, no direct or indirect payment, in
cash, property or securities, by set-off or otherwise, will be made or agreed to
be made on account of the subordinated debt securities or interest thereon or in
respect of any repayment, redemption, retirement, purchase or other acquisition
of subordinated debt securities.
Except as set forth in the applicable prospectus supplement, the
subordinated indenture will provide that in the event of:
o any insolvency, bankruptcy, receivership, liquidation, reorganization,
readjustment, composition or other similar proceeding relating to
Integra, its creditors or its property;
o any proceeding for the liquidation, dissolution or other winding-up of
Integra, voluntary or involuntary, whether or not involving insolvency
or bankruptcy proceedings;
o any assignment by Integra for the benefit of creditors; or
61
o any other marshaling of the assets of Integra;
all present and future senior indebtedness, including, without limitation,
interest accruing after the commencement of the proceeding, assignment or
marshaling of assets, will first be paid in full before any payment or
distribution, whether in cash, securities or other property, will be made by
Integra on account of subordinated debt securities. In that event, any payment
or distribution, whether in cash, securities or other property, other than
securities of Integra or any other corporation provided for by a plan of
reorganization or a readjustment, the payment of which is subordinate, at least
to the extent provided in the subordination provisions of the indenture, to the
payment of all senior indebtedness at the time outstanding and to any securities
issued in respect thereof under any such plan of reorganization or readjustment
and other than payments made from any trust described in the "Satisfaction and
Discharge; Defeasance" below, which would otherwise but for the subordination
provisions be payable or deliverable in respect of subordinated debt securities,
including any such payment or distribution which may be payable or deliverable
by reason of the payment of any other indebtedness of Integra being subordinated
to the payment of subordinated debt securities will be paid or delivered
directly to the holders of senior indebtedness, or to their representative or
trustee, in accordance with the priorities then existing among such holders
until all senior indebtedness shall have been paid in full. No present or future
holder of any senior indebtedness will be prejudiced in the right to enforce
subordination of the indebtedness evidenced by subordinated debt securities by
any act or failure to act on the part of Integra.
The term "senior indebtedness" is defined as the principal, premium, if
any, and interest on:
o all indebtedness of Integra, whether outstanding on the date of the
issuance of subordinated debt securities or thereafter created,
incurred or assumed, which is for money borrowed, or which is
evidenced by a note or similar instrument given in connection with the
acquisition of any business, properties or assets, including
securities;
o any indebtedness of others of the kinds described in the first bullet
point above for the payment of which Integra is responsible or liable
as guarantor or otherwise; and
o amendments, renewals, extensions and refundings of any such
indebtedness;
unless in any instrument or instruments evidencing or securing such indebtedness
or pursuant to which the same is outstanding, or in any such amendment, renewal,
extension or refunding, it is expressly provided that such indebtedness is not
superior in right of payment to subordinated debt securities. The senior
indebtedness will continue to be senior indebtedness and entitled to the
benefits of the subordination provisions irrespective of any amendment,
modification or waiver of any term of the senior indebtedness or extension or
renewal of the senior indebtedness.
Except as provided in the applicable prospectus supplement, the
subordinated indenture for a series of subordinated debt does not limit the
aggregate amount of senior indebtedness that may be issued by Integra. As of
March 31, 2001, senior indebtedness of Integra aggregated approximately $12.3
million and there was no senior indebtedness of the Integra Parent Company
outstanding. In addition, because Integra is a holding company, the subordinated
debt securities are effectively subordinated to all existing and future
liabilities of Integra Parent Company's subsidiaries.
MODIFICATION OF INDENTURES
From time to time, Integra and the trustees may modify the indentures
without the consent of any holders of any series of debt securities with respect
to some matters, including:
62
o to cure any ambiguity, defect or inconsistency or to correct or
supplement any provision which may be inconsistent with any other
provision of the indenture;
o to qualify, or maintain the qualification of, the indentures under the
Trust Indenture Act; and
o to make any change that does not materially adversely affect the
interests of any holder of such series of debt securities.
In addition, under the indentures, Integra and the trustee may modify some
rights, covenants and obligations of Integra and the rights of holders of any
series of debt securities with the written consent of the holders of at least a
majority in aggregate principal amount of the series of outstanding debt
securities; but no extension of the maturity of any series of debt securities,
reduction in the interest rate or extension of the time for payment of interest,
change in the optional redemption or repurchase provisions in a manner adverse
to any holder of the series of debt securities, other modification in the terms
of payment of the principal of, or interest on, the series of debt securities,
or reduction of the percentage required for modification, will be effective
against any holder of the series of outstanding debt securities without the
holder's consent.
In addition, Integra and the trustees may execute, without the consent of
any holder of the debt securities, any supplemental indenture for the purpose of
creating any new series of debt securities.
EVENTS OF DEFAULT
The indentures will provide that any one or more of the following described
events with respect to a series of debt securities that has occurred and is
continuing constitutes an "event of default" with respect to that series of debt
securities:
o failure for 60 days to pay any interest or any sinking fund payment on
the series of debt securities when due, (subject to the deferral of
any due date in the case of an extension period);
o failure to pay any principal or premium, if any, on the series of the
debt securities when due whether at maturity, upon redemption, by
declaration or otherwise;
o failure to observe or perform in any material respect certain other
covenants contained in the indenture for 90 days after written notice
has been given to Integra from the trustee or the holders of at least
25% in principal amount of the series of outstanding debt securities;
o default resulting in acceleration of other indebtedness of Integra for
borrowed money where the aggregate principal amount so accelerated
exceeds $25 million and the acceleration is not rescinded or annulled
within 30 days after the written notice thereof to Integra by the
trustee or to Integra and the trustee by the holders of 25% in
aggregate principal amount of the debt securities of the series then
outstanding, provided that the event of default will be remedied,
cured or waived if the default that resulted in the acceleration of
such other indebtedness is remedied, cured or waived; or
o certain events in bankruptcy, insolvency or reorganization of Integra.
The holders of a majority in outstanding principal amount of the series of
debt securities have the right to direct the time, method and place of
conducting any proceeding for any remedy available to the trustee of the series.
The trustee or the holders of not less than 25% in aggregate outstanding
principal
63
amount of the series may declare the principal due and payable immediately upon
an event of default. The holders of a majority in aggregate outstanding
principal amount of the series may annul the declaration and waive the default
if the default (other than the non-payment of the principal of the series which
has become due solely by the acceleration) has been cured and a sum sufficient
to pay all matured installments of interest and principal due otherwise than by
acceleration has been deposited with the trustee of the series.
The holders of a majority in outstanding principal amount of a series of
debt securities affected thereby may, on behalf of the holders of all the
holders of the series of debt securities, waive any past default, except a
default in the payment of principal or interest, unless the default has been
cured and a sum sufficient to pay all matured installments of interest and
principal due otherwise than by acceleration has been deposited with the trustee
of the series, or a default in respect of a covenant or provision which under
the related indenture cannot be modified or amended without the consent of the
holder of each outstanding debt security of the series. Integra is required to
file annually with the trustees a certificate as to whether or not Integra is in
compliance with all the conditions and covenants applicable to it under the
indentures.
In case an event of default shall occur and be continuing as to a series of
debt securities, the trustee of the series will have the right to declare the
principal of and the interest on the debt securities, and any other amounts
payable under the indenture, to be forthwith due and payable and to enforce its
other rights as a creditor with respect to the debt securities.
No holder of any debt securities will have any right to institute any
proceeding with respect to the indenture or for any remedy thereunder, unless
the holder shall have previously given to the trustee written notice of a
continuing event of default and unless also the holders of at least 25% in
aggregate principal amount of the outstanding debt securities of the series
shall have made written request and offered reasonably indemnity to the trustee
of the series to institute the proceeding as a trustee, and unless the trustee
shall not have received from the holders of a majority in aggregate principal
amount of the outstanding debt securities of the class a direction inconsistent
with the request and shall have failed to institute the proceeding within 60
days. However, these limitations do not apply to a suit instituted by a holder
of a debt security for enforcement of payment of the principal or interest on
the debt security on or after the respective due dates expressed in the debt
security.
CONSOLIDATION, MERGER, SALE OF ASSETS AND OTHER TRANSACTIONS
Unless otherwise indicated in the applicable prospectus supplement, the
indentures will provide that Integra will not consolidate with or merge into any
other person or entity or sell, assign, convey, transfer or lease its properties
and assets substantially as an entirety to any person or entity unless:
o either Integra is the continuing corporation, or any successor or
purchaser is a corporation, partnership, or trust or other entity
organized under the laws of the United States of America, any State
thereof or the District of Columbia, and the successor or purchaser
expressly assumes Integra's obligations on the debt securities under a
supplemental indenture; and
o immediately before and after giving effect thereto, no event of
default, and no event which, after notice or lapse of time or both,
would become an event of default, shall have happened and be
continuing.
Unless otherwise indicated in the applicable prospectus supplement, the
general provisions of the indentures will not afford holders of the debt
securities protection in the event of a highly leveraged or other transaction
involving Integra that may adversely affect holders of the debt securities.
64
SATISFACTION AND DISCHARGE; DEFEASANCE
The indentures will provide that when, among other things, all debt
securities not previously delivered to the trustee for cancellation:
o have become due and payable, or
o will become due and payable at their stated maturity within one year,
and Integra deposits or causes to be deposited with the trustee, as trust funds
in trust for the purpose, an amount in the currency or currencies in which the
debt securities are payable sufficient to pay and discharge the entire
indebtedness on the debt securities not previously delivered to the trustee for
cancellation, for the principal, and premium, if any, and interest to the date
of the deposit or to the stated maturity, as the case may be, then the indenture
will cease to be of further effect (except as to Integra's obligations to pay
all other sums due pursuant to the indenture and to provide the officers'
certificates and opinions of counsel described therein), and Integra will be
deemed to have satisfied and discharged the indenture.
The indentures will provide that Integra may elect either:
o to terminate, and be deemed to have satisfied, all its obligations
with respect to any series of debt securities, except for the
obligations to register the transfer or exchange of such debt
securities, to replace mutilated, destroyed, lost or stolen debt
securities, to maintain an office or agency in respect of the debt
securities and to compensate and indemnify the trustee ("defeasance");
or
o to be released from its obligations with respect to certain covenants,
("covenant defeasance") upon the deposit with the trustee, in trust
for such purpose, of money and/or U.S. Government Obligations, as
defined in the indenture, which through the payment of principal and
interest in accordance with the term used will provide money, in an
amount sufficient (in the opinion of a nationally recognized firm of
independent public accountants) to pay the principal of, interest on
and any other amounts payable in respect of the outstanding debt
securities of the series.
Such a trust may be established only if, among other things, Integra has
delivered to the trustee an opinion of counsel (as specified in the indenture)
with regard to certain matters, including an opinion to the effect that the
holders of the debt securities will not recognize income, gain or loss for
Federal income tax purposes as a result of the deposit and discharge and will be
subject to Federal income tax on the same amounts and in the same manner and at
the same times as would have been the case if the deposit and defeasance or
covenant defeasance, as the case may be, had not occurred.
REDEMPTION
Unless otherwise indicated in the applicable prospectus supplement, debt
securities will not be subject to any sinking fund requirements.
Unless otherwise indicated in the applicable prospectus supplement, Integra
may, at its option, redeem the debt securities of any series in whole at any
time or in part from time to time, at the redemption price set forth in the
applicable prospectus supplement plus accrued and unpaid interest to the date
fixed for redemption, and debt securities in denominations larger than $1,000
may be redeemed in part but only in integral multiples of $1,000. If the debt
securities of any series are so redeemable only on
65
or after a specified date or upon the satisfaction of additional conditions, the
applicable prospectus supplement will specify the date or describe the
conditions.
Integra will mail notice of any redemption at least 30 days but not more
than 60 days before the redemption date to each holder of debt securities to be
redeemed at the holder's registered address. Unless Integra defaults in the
payment of the redemption price, on and after the redemption date interest shall
cease to accrue on the debt securities or portions thereof called for
redemption.
CONVERSION OR EXCHANGE
If and to the extent indicated in the applicable prospectus supplement, the
debt securities of any series may be convertible or exchangeable into other
securities. The specific terms on which debt securities of any series may be so
converted or exchanged will be set forth in the applicable prospectus
supplement. These terms may include provisions for conversion or exchange,
either mandatory, at the option of the holder, or at the option of Integra, in
which case the number of shares of other securities to be received by the
holders of debt securities would be calculated as of a time and in the manner
stated in the applicable prospectus supplement.
CERTAIN COVENANTS
The indentures will contain certain covenants regarding, among other
matters, corporate existence, payment of taxes and reports to holders of debt
securities. If and to the extent indicated in the applicable prospectus
supplement, these covenants may be removed or additional covenants added with
respect to any series of debt securities.
GOVERNING LAW
The indentures and the debt securities will be governed by and construed in
accordance with the laws of the State of New York.
INFORMATION CONCERNING THE TRUSTEES
Each trustee shall have and be subject to all the duties and
responsibilities specified with respect to an indenture trustee under the Trust
Indenture Act. Subject to these provisions, each trustee is under no obligation
to exercise any of the powers vested in it by the indenture at the request of
any holder of the debt securities, unless offered reasonable indemnity by the
holder against the costs, expenses and liabilities which might be incurred
thereby. Each trustee is not required to expend or risk its own funds or
otherwise incur personal financial liability in the performance of its duties if
the trustee reasonably believes that repayment or adequate indemnity is not
reasonably assured to it.
66
DESCRIPTION OF CAPITAL STOCK
Our authorized capital stock as stated in our Amended and Restated
Certificate of Incorporation (the "Certificate of Incorporation") consists of
60,000,000 shares of common stock, $.01 par value per share, and 15,000,000
shares of preferred stock, $.01 par value per share. The following summary of
our common stock and preferred stock is not complete and may not contain all the
information you should consider before investing in our common stock. This
description is subject to and qualified in its entirety by provisions of our
Certificate of Incorporation and bylaws, which are included as exhibits to the
registration statement of which this prospectus is a part, and by provisions of
applicable Delaware law.
COMMON STOCK
As of March 23, 2001, there were 20,874,955 shares of common stock
outstanding and held of record by approximately 825 stockholders, assuming
conversion of all outstanding shares of preferred stock. Holders of common stock
are entitled to one vote for each share held on all matters submitted to a vote
of stockholders and do not have cumulative voting rights. Accordingly, holders
of a majority of the outstanding shares of common stock entitled to vote in any
election of directors may elect all the directors standing for election. Holders
of common stock are entitled to receive ratably such dividends, if any, as may
be declared by our board of directors out of funds legally available therefor.
If we are liquidated, dissolved or wound-up, holders of common stock are
entitled to receive ratably our net assets available for distribution after the
payment of, or adequate provision for, all of our debts and other liabilities,
subject to prior and superior rights of the holders of Preferred Stock. Holders
of common stock have no preemptive, subscription, redemption, sinking fund or
conversion rights. Immediately upon consummation of this offering, all of the
then-outstanding shares of common stock will be validly issued, fully paid and
nonassessable.
PREFERRED STOCK
The board of directors, without further stockholder authorization, is
authorized to issue, from time to time, up to 15,000,000 shares of Preferred
Stock in one or more series, to establish the number of shares to be included in
any such series and to fix the designations, powers, preferences and rights of
the shares of each such series and any qualifications, limitations or
restrictions thereof, including dividend rights and preferences over dividends
on the Common Stock, conversion rights, voting rights, redemption rights, the
terms of any sinking fund therefor and rights upon liquidation. The ability of
the board of directors to issue Preferred Stock, while providing flexibility in
connection with financing, acquisitions and other corporate purposes, could have
the effect of discouraging, deferring or preventing a change in control or an
unsolicited acquisition proposal, since the issuance of Preferred Stock could be
used to dilute the share ownership of a person or entity seeking to obtain
control of us. In addition, because the board of directors has the power to
establish the preferences, powers and rights of the shares of any such series of
Preferred Stock, it may afford the holders of any Preferred Stock preferences,
powers and rights (including voting rights) senior to the rights of the holders
of Common Stock, which could adversely affect the rights of holders of Common
Stock.
As of March 23, 2001, we had designated three series of Preferred Stock,
but only two were outstanding.
SERIES A PREFERRED STOCK.
Our board of directors have authorized 2,000,000 shares of Series A
Convertible Preferred Stock (the "Series A Preferred Stock"), of which 500,000
were issued in connection with a series of agreements with Century Medical, Inc.
("CMI"), a wholly-owned subsidiary of ITOCHU Corporation, under which
67
CMI distributes certain of our products in Japan. CMI has converted its Series A
Preferred Stock into Common Stock. We do not expect to issue new Series A
Preferred Stock.
SERIES B PREFERRED STOCK.
Our board of directors has authorized 120,000 shares of Series B
Convertible Preferred Stock (the "Series B Preferred Stock"), 100,000 of which
were issued in connection with the acquisition of the NeuroCare Group in March
1999. The purchase price for the acquisition was financed in part through the
sale of $10 million of the Series B Preferred Stock and related warrants to SFM
Domestic Investments LLC and Quantum Industrial Partners LDC, affiliates of
Soros Private Equity Partners LLC. The shares of Series B Preferred Stock are
convertible into 2,617,800 shares of our common stock. The warrants issued at
the time of the sale of the Series B Preferred Stock were exercised in March
2001.
On May 4, 2001, the Company notified the holders of the Series B Preferred
of its intention to redeem these shares on June 29, 2001 for $12.3 million. The
holders of the Series B Preferred have the right to convert their shares into
common stock prior to this redemption. Because the conversion price of $3.82 per
share is substantially below the current market value of the Company's common
stock, we expect that the holders of the Series B Preferred will convert their
shares into common stock, although there can be no assurance in this regard.
We do not expect to issue new Series B Preferred Stock.
SERIES C PREFERRED STOCK
Our board of directors have authorized 54,000 shares of Series C
Convertible Preferred Stock (the "Series C Preferred Stock"), all of which were
issued on March 29, 2000 to investment affiliates of Soros Private Equity
Partners LLC, resulting in proceeds to Integra of $5.4 million. In connection
with such investment, we also issued to affiliates of Soros Private Equity
Partners LLC warrants to purchase 300,000 shares of common stock at $9.00 per
share. The warrants expire on December 31, 2001. The shares of Series C
Preferred Stock are convertible into 600,000 shares of our common stock.
DESIGNATION/RANKING. The Series C Preferred Stock rank equal to our Series B
Preferred Stock and senior to our common stock and all of our Series A Preferred
Stock with respect to the payment of distributions on liquidation, dissolution
or winding up of Integra or with respect to the payment of dividends.
DIVIDENDS. Holders of the Series C Preferred Stock are entitled to receive
annual cumulative dividends which shall accrue at the rate of 10% per annum,
payable upon the liquidation, dissolution or winding up Integra.
CONVERSION. Holders of the Series C Preferred Stock are entitled, at their
option at any time, to convert the Series C Preferred Stock so held into such
number of fully paid and nonassessable shares of common stock as obtained by (i)
multiplying the number of shares of Series C Preferred Stock so to be converted
by $100.00 and (ii) dividing the result by the conversion price (which is $9.00
per share, subject to adjustment in accordance with the terms of the certificate
of designation for the Series C Preferred Stock).
VOTING RIGHTS. Holders of the Series C Preferred Stock shall be entitled to
notice of any stockholders meeting. Except as otherwise required by law, each
outstanding share of Series C Preferred Stock is entitled to the number of votes
equal to the number of full shares of common stock into which such share of
Series C Preferred Stock is convertible on the record date for any meeting of
stockholders. Except as otherwise required by law, the Series C Preferred Stock
and the common stock vote together as a single class on each matter submitted to
the stockholders, and not by separate class or series.
68
OPTIONAL REDEMPTION. If, at any time after March 15, 2002, for a period of not
less than thirty (30) consecutive trading days, the average closing price of our
common stock on the Nasdaq National Market has been equal to or greater than the
Target Market Price (as defined below), then we may redeem from any source of
funds legally available therefor, in whole or in part, any or all whole number
of shares of Series C Preferred Stock at any time outstanding for a cash amount
per share equal to the liquidation preference at such date of redemption.
Notwithstanding the foregoing, at any time and from time to time after March 1,
2004, we may redeem from any source of funds legally available therefor, in
whole or in part, any or all whole number of shares of Series C Preferred Stock
at any time outstanding for an amount per share to be redeemed equal to the
liquidation preference at such date of redemption. The "Target Market Price"
shall mean an amount equal to 2.5 times the conversion price as last adjusted
and then in effect.
REGISTRATION RIGHTS
Under the terms of stockholder and registration rights agreements between
us and certain of our stockholders, Holders of an aggregate of 7,883,081 shares
of our common stock (including shares issuable upon the exercise of certain
warrants and stock options, upon conversion of certain preferred securities, and
shares underlying certain "restricted units"), are entitled to demand that we
register those shares under the Securities Act. Additionally, if we propose to
register any of our securities under the Securities Act, either for our own
account or for the account of any other stockholder, the parties to certain of
our stockholder and registration rights agreements are entitled to notice of the
registration and to include their shares of common stock in the registration.
These registration rights are subject to limitations and conditions, including
the right of the underwriters of the offering to limit the number of shares
included in any such registration. In general, we are required to indemnify the
holders of such registrable securities under described circumstances and to bear
the expense of registrations, except for the selling stockholders' pro rata
portion of the underwriting discounts and commissions.
DELAWARE ANTI-TAKEOVER LAW
Section 203 of the Delaware General Corporation Law prohibits certain
"business combination" transactions between a Delaware corporation and any
"interested stockholder" owning 15% or more of the corporation's outstanding
voting stock for a period of three years after the date on which such
stockholder became an interested stockholder, unless:
o the board of directors approves, prior to such date, either the
proposed business combination or the proposed acquisition of stock
which resulted in the stockholder becoming an interested stockholder;
o upon consummation of the transaction in which the stockholder becomes
an interested stockholder, the interested stockholder owned at least
85% of those shares of the voting stock of the corporation which are
not held by the directors, officers or certain employee stock plans;
or
o on or subsequent to the date on which such stockholder became an
interested stockholder, the business combination with the interested
stockholder is approved by the board of directors and also approved at
a stockholder's meeting by the affirmative vote of the holders of at
least two-thirds of the outstanding shares of the corporation's voting
stock other than shares held by the interested stockholder.
69
Under Delaware law, a "business combination" includes a merger, asset sale
or other transaction resulting in a financial benefit to the interested
stockholder. Section 203 does not apply, however, to those stockholders who own
15% or more of our voting stock prior to this offering.
PLAN OF DISTRIBUTION
We sell our securities through agents, underwriters, dealers or directly to
purchasers.
o Unless we indicate otherwise in our prospectus supplement, our agents
will act on a best efforts basis for the period of their appointment.
o Our agents may be deemed to be underwriters under the Securities Act
of any of our securities that they offer or sell.
We may use an underwriter or underwriters in the offer or sale of our
securities.
o If we use an underwriter or underwriters, we will execute an
underwriting agreement with the underwriter or underwriters at the
time that we reach an agreement for the sale of our securities.
o We will include the names of the specific managing underwriter or
underwriters, as well as any other underwriters, and the terms of the
transactions, including the compensation the underwriters and dealers
will receive, in our prospectus supplement.
o The underwriters will use our prospectus supplement to sell our
securities.
We may use a dealer to sell our securities.
o If we use a dealer, we, as principal, will sell our securities to the
dealer.
o The dealer will then sell our securities to the public at varying
prices that the dealer will determine at the time it sells our
securities.
o We will include the name of the dealer and the terms of our
transactions with the dealer in our prospectus supplement.
We may solicit directly offers to purchase our securities, and we may
directly sell our securities to institutional or other investors. We will
describe the terms of our direct sales in our prospectus supplement.
We may indemnify agents, underwriters, and dealers against certain
liabilities, including liabilities under the Securities Act. Our agents,
underwriters, dealers, or their affiliates, may be customers of, engage in
transactions with or perform services for us, in the ordinary course of
business.
We may authorize our agents and underwriters to solicit offers by certain
institutions to purchase our securities at the public offering price under
delayed delivery contracts.
o If we use delayed delivery contracts, we will disclose that we are
using them in our prospectus supplement and will tell you when we will
demand payment and delivery of the securities under the delayed
delivery contracts.
70
o These delayed delivery contracts will be subject only to the
conditions that we set forth in our prospectus supplement.
o We will indicate in our prospectus supplement the commission that
underwriters and agents soliciting purchases of our securities under
delayed contracts will be entitled to receive.
LEGAL MATTERS
Latham & Watkins in New York, New York will pass upon the validity of the
shares of common stock offered under this prospectus and certain other legal
matters.
EXPERTS
The financial statements incorporated in this Prospectus by reference to
the Annual Report on Form 10-K/A of Integra LifeSciences Holdings Corporation
for the year ended December 31, 2000, have been so incorporated in reliance on
the report of PricewaterhouseCoopers LLP, independent accountants, given on the
authority of said firm as experts in auditing and accounting.
WHERE TO FIND ADDITIONAL INFORMATION
Integra is subject to the informational requirements of the Securities
Exchange Act of 1934, and files annual, quarterly and special reports, proxy
statements and other information with the SEC. You may read and copy any
reports, proxy statements and other information we file at the SEC's public
reference room at 450 Fifth Street, N.W., Washington, D.C. 20549 and at the
SEC's regional offices at Seven World Trade Center, 13th Floor, New York, New
York 10048 and Citicorp Center, 500 West Madison Street, Suite 1400, Chicago,
Illinois 60661-2511. Please call the SEC at 1-800-SEC-0300 for further
information on the public reference rooms. You may also access filed documents
at the SEC's Website at www.sec.gov.
We have filed a registration statement on Form S-3 and related exhibits
with the SEC under the Securities Act of 1933. The registration statement
contains additional information about Integra and the securities. You may
inspect the registration statement and exhibits without charge and obtain copies
from the SEC at prescribed rates at the locations above.
The SEC allows us to incorporate by reference the information we file with
it, which means that we can disclose important information to you by referring
to those documents. The information incorporated by reference is an important
part of this prospectus, and information that we file later with the SEC will
automatically update and supersede this information. We incorporate by reference
the following documents we have filed, or may file, with the SEC:
o Our 2000 Annual Report on Form 10-K/A filed with the SEC on May 24,
2001;
o Our Quarterly Report for the quarterly period ended March 31, 2001, on
Form 10-Q filed with the SEC on May 15, 2001;
o Our Proxy Statement for the 2001 Annual Meeting of Stockholders filed
with the SEC on April 20, 2001;
o Our Current Reports on Form 8-K filed with the SEC on January 8, 2001
and May 25, 2001; and
71
o All documents filed by us with the SEC under Sections 13(a),
13(c), 14 or 15(d) of the Securities Exchange Act of 1934 after
the date of this prospectus and before the termination of this
offering.
A statement contained in a document incorporated by reference herein shall
be deemed to be modified or superceded for purposes of this prospectus to the
extent that a statement contained herein or in any other subsequently filed
document which is also incorporated herein modifies or replaces such statement.
Any statements so modified or superceded shall not be deemed, except as so
modified or superceded, to constitute a part of this prospectus.
You may request a free copy of any of the documents incorporated by
reference in this prospectus by writing or telephoning us at the following
address:
Integra LifeSciences Holdings Corporation
311-C Enterprise Drive
Plainsboro, NJ 08536
(609) 275-0500
Attn: Director of Finance
You should rely only on the information incorporated by reference or
provided in this prospectus and any supplement. We have not authorized anyone
else to provide you with different information. You should not assume that the
information in this prospectus or any prospectus supplement is accurate as of
any date other than the dates on the front of these documents.
72
[INTEGRA LOGO]
INTEGRA LIFESCIENCES HOLDINGS CORPORATION
PROSPECTUS
, 2001
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 14. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION OF INTEGRA
The following table sets forth the various expenses in connection with
the sale and distribution of the securities being registered, other than the
underwriting discounts and commissions. All amounts shown are estimates except
for the SEC registration fee and the NASD filing fee. All of these fees are
being paid by Integra.
Registration fee.............................................$18,750(1)
NASD Filing Fee.............................................. --
Blue Sky Fees and Expenses................................... 5,000
Legal fees and expenses...................................... 150,000
Accounting fees and expenses................................. 150,000
Printing and engraving expenses.............................. 110,000
Miscellaneous................................................ 50,000
Total........................................................ $483,750
(1) Registration fee has been previously paid.
ITEM 15. INDEMNIFICATION OF OFFICERS AND DIRECTORS
Officers and directors of Integra are covered by certain provisions of the
DGCL, the charter, the bylaws and insurance policies which serve to limit, and,
in certain instances, to indemnify them against, certain liabilities which they
may incur in such capacities. These various provisions are described below.
ELIMINATION OF LIABILITY IN CERTAIN CIRCUMSTANCES. In June 1986, Delaware
enacted legislation which authorizes corporations to limit or eliminate the
personal liability of directors to corporations and their stockholders for
monetary damages for breach of directors' fiduciary duty of care. This duty of
care requires that, when acting on behalf of the corporation, directors must
exercise an informed business judgment based on all significant information
reasonably available to them. Absent the limitations now authorized by such
legislation, directors are accountable to corporations and their stockholders
for monetary damages for conduct constituting negligence or gross negligence in
the exercise of their duty of care. Although the statute does not change
directors' duty of care, it enables corporations to limit available relief to
equitable remedies such as injunction or rescission. The charter limits the
liability of directors to Integra or its stockholders (in their capacity as
directors but not in their capacity as officers) to the fullest extent permitted
by such legislation. Specifically, the directors of Integra will not be
personally liable for monetary damages for breach of a director's fiduciary duty
as director, except for liability: (1) for any breach of the director's duty of
loyalty to Integra or its stockholders; (2) for acts or omissions not in good
faith or which involve intentional misconduct or a knowing violation of law; (3)
for unlawful payments of dividends or unlawful share repurchases or redemptions
as provided in Section 174 of the DGCL; or (4) for any transaction from which
the director derived an improper personal benefit.
INDEMNIFICATION AND INSURANCE. As a Delaware corporation, Integra has the
power, under specified circumstances generally requiring the director or officer
to act in good faith and in a manner he reasonably believes to be in or not
opposed to Integra's best interests, to indemnify its directors and officers in
connection with actions, suits or proceedings brought against them by a third
party or in the name of Integra, by reason of the fact that they were or are
such directors or officers, against expenses,
II-1
judgments, fines and amounts paid in settlement in connection with any such
action, suit or proceeding. The bylaws generally provide for mandatory
indemnification of Integra's directors and officers to the full extent provided
by Delaware corporate law. In addition, Integra has entered into indemnification
agreements with its directors and officers which generally provide for mandatory
indemnification under circumstances for which indemnification would otherwise be
discretionary under Delaware law.
Integra intends to purchase and maintain insurance on behalf of any person
who is or was a director or officer of Integra, or is or was a director or
officer of Integra serving at the request of Integra as a director, officer,
employee or agent of another corporation, partnership, joint venture, trust,
employee benefit plan or other enterprise against any liability asserted against
him and incurred by him in any such capacity, or arising out of his status as
such, whether or not Integra would have the power or obligation to indemnify him
against such liability under the provisions of the bylaws.
ITEM 16. EXHIBITS
EXHIBIT
NUMBER DESCRIPTION
- ------ -----------
1.1+ Form of Underwriting Agreement
2.1(1) Asset Purchase Agreement, dated as of January 14, 2000, by and among Clinical Neuro Systems, Inc., Surgical Sales
Corporation (trading as CONNELL NEUROSURGICAL) and George J. Connell
2.2(2) Purchase Agreement, dated January 5, 1999, among Integra LifeSciences Corporation, Rystan Company, Inc., and
Healthpoint, Ltd.**
2.3(3) Asset Purchase Agreement, dated as of March 29, 1999, by and among Heyer-Schulte Neurocare, L.P., Neuro
Navigational, L.L.C., Integra Neurocare LLC and Redmond Neurocare LLC**
2.4(6) Purchase Agreement, dated March 20, 2000, by and among NMT Medical, Inc., NMT Neurosciences (US), Inc., NMT
Neurosciences Holdings (UK) Ltd., NMT Neurosciences (UK) Ltd., Spembly Medical Ltd., Spembly Cryosurgery Ltd.,
Swedemed AB, Integra NeuroSciences Holdings (UK) Ltd. and Integra Selector Corporation
2.5(6) Asset Purchase Agreement, dated March 20, 2000, by and among NMT Neurosciences (US), Inc., NMT Medical, Inc. and
Integra Selector Corporation
4.1(4) Certificate of Designation, Preferences and Rights of Series A Convertible Preferred Stock as filed with the
Delaware Secretary of State on April 14, 1998
4.2(5) Certificate of Designation, Preferences and Rights of Series B Convertible Preferred Stock as filed with the
Delaware Secretary of State on March 12, 1999
4.3(3) Warrant to Purchase 60,000 shares of Common Stock of Integra LifeSciences Corporation issued to SFM Domestic
Investments LLC 4.4 (3) Warrant to Purchase 180,000 shares of Common Stock of Integra LifeSciences Corporation
issued to Quantum Industrial Partners LDC.
II-2
4.4(7) Certificate of Designation, Rights and Preferences of Series C Convertible Preferred Stock of Integra LifeSciences
Holdings Corporation dated March 21, 2000.
4.5(7) Certificate of Amendment of Certificate of Designation, Rights and Preferences of Series B Convertible Preferred
Stock of Integra LifeSciences Holdings Corporation dated March 21, 2000.
4.6(7) Warrant to Purchase 270,550 Shares of Common Stock of Integra LifeSciences Holdings Corporation issued to Quantum
Industrial Partners LDC.
4.7(7) Warrant to Purchase 29,450 Shares of Common Stock of Integra LifeSciences Holdings Corporation issued to SFM
Domestic Investments LLC.
4.8(8) Stock Option Grant and Agreement dated December 22, 2000 between Integra LifeSciences Holdings Corporation and
Stuart M. Essig (Exhibit A to Amended and Restated Employment Agreement).
4.9(8) Stock Option Grant and Agreement dated December 22, 2000 between Integra LifeSciences Holdings Corporation and
Stuart M. Essig (Exhibit A-2 to Amended and Restated Employment Agreement).
4.10(8) Restricted Units Agreement dated December 22, 2000 between Integra LifeSciences Holdings Corporation and Stuart M.
Essig (Exhibit C to Amended and Restated Employment Agreement).
4.11(9) Second Amendment to Certificate of Rights, Designations and Preferences of Series B Convertible Preferred Stock.
4.12(9) First Amendment to Certificate of Rights, Designations and Preferences of Series C Convertible Preferred Stock.
12.1* Statement of the Calculation of Ratio of Earnings to Fixed Charges and Statement of the Calculation of Ratio of Earnings
to Combined Fixed Charges and Preferred Stock Dividends.
21.1 Subsidiaries of the Company
23.1+ Opinion of Latham & Watkins
23.2* Consent of PricewaterhouseCoopers LLP, independent accountants
24.1 * Power of Attorney (included in signature page)
- -----------
* Filed herewith
** Schedules and other attachments to the indicated exhibit were omitted. We
agree to furnish supplementally to the SEC upon request a copy of any
omitted schedules or attachments.
+ To be filed by amendment
(1) Filed as an exhibit to Integra's Current Report on Form 8-K dated January
14, 2000, and incorporated herein by reference.
(2) Filed as an exhibit to Integra's Current Report on Form 8-K dated January
5, 1999, and incorporated herein by reference.
(3) Filed as an exhibit to Integra's Current Report on Form 8-K dated March 29,
1999, and incorporated herein by reference.
II-3
(4) Filed as an exhibit to Integra's Quarterly Report on Form 10-Q for the
quarter ended March 31, 1998, as filed with the SEC on May 15, 1998, and
incorporated by reference herein.
(5) Filed as an exhibit to Integra's Annual Report on Form 10-K for the fiscal
year ended December 31, 1998, as filed with the SEC on March 31, 1999, and
incorporated herein by reference.
(6) Filed as an exhibit to Integra's Current Report on Form 8-K dated March 20,
2000, and incorporated herein by reference.
(7) Filed as an exhibit to Integra's Current Report on Form 8-K dated March 29,
2000, and incorporated herein by reference.
(8) Filed as an exhibit to Integra's Current Report on Form 8-K dated December
22, 2000, and incorporated herein by reference.
(9) Filed as an exhibit to Integra's Current Report on Form 8-K dated May 15,
2001, and incorporated herein by reference.
II-4
ITEM 17. UNDERTAKINGS.
The undersigned registrant hereby undertakes:
(1) To file, during any period in which offers or sales are being
made, a post-effective amendment to this registration statement:
(i) to include any prospectus required by Section 10(a)(3) of the
Securities Act of 1933;
(ii) to reflect in the prospectus any facts or events arising
after the effective date of the registration statement (or the most
recent post-effective amendment thereof) which, individually or in the
aggregate, represent a fundamental change in the information set forth
in the registration statement. Notwithstanding the foregoing, any
increase or decrease in volume of securities offered (if the total
dollar value of securities offered would not exceed that which was
registered) and any deviation from the low or high end of the
estimated maximum offering range may be reflected in the form of
prospectus filed with the Commission pursuant to Rule 424(b) if, in
the aggregate, the changes in volume and price represent no more than
20 percent change in the maximum aggregate offering price set forth in
the "Calculation of Registration Fee" table in the effective
registration statement;
(iii) to include any material information with respect to the
plan of distribution not previously disclosed in the registration
statement or any material change to such information in the
registration statement.
(2) That, for the purpose of determining any liability under the
Securities Act of 1933, each such post-effective amendment shall be deemed
to be a new registration statement relating to the securities offered
therein, and the offering of such securities at that time shall be deemed
to be the initial bona fide offering thereof.
(3) To remove from registration by means of a post-effective amendment
any of the securities being registered which remain unsold at the
termination of the offering.
(4) If the registrant is a foreign private issuer, to file a
post-effective amendment to the registration statement to include any
financial statements required by Rule 3-19 of this chapter at the start of
any delayed offering or throughout a continuous offering. Financial
statements and information otherwise required by Section 10(a)(3) of the
Act need not be furnished, provided, that the registrant includes in the
prospectus, by means of a post-effective amendment, financial statements
required pursuant to this paragraph (a)(4) and other information necessary
to ensure that all other information in the prospectus is at least as
current as the date of those financial statements. Notwithstanding the
foregoing, with respect to registration statements on Form F-3, a
post-effective amendment need not be filed to include financial statements
and information required by Section 10(a)(3) of the Act or Rule 3-19 of
this chapter if such financial statements and information are contained in
periodic reports filed with or furnished to the Commission by the
registrant pursuant to Section 13 or Section 15(d) of the Securities
Exchange Act of 1934 that are incorporated by reference in the Form F-3.
(a) The undersigned Registrant hereby undertakes that, for purposes of
determining any liability under the Securities Act of 1933, each filing of
the Registrant's annual report pursuant to Section 13(a) or Section 15(d)
of the Securities Exchange Act of 1934 (and, where applicable, each filing
of an
II-5
employee benefit plan's annual report pursuant to Section 15(d) of the
Securities Exchange Act of 1934) that is incorporated by reference in the
registration statement shall be deemed to be a new registration statement
relating to the securities offered therein, and the offering of such
securities at that time shall be deemed to be the initial bona fide
offering thereof.
(b) Insofar as indemnification for liabilities arising under the
Securities Act of 1933 may be permitted to directors, officers and
controlling persons of the registrant under provisions described in Item 14
or otherwise, the registrant has been advised that in the opinion of the
SEC such indemnification is against public policy as expressed in the
Securities Act of 1933 and is, therefore, unenforceable. If a claim for
indemnification against such liabilities (other than the payment by the
registrant of expenses incurred or paid by a director, officer or
controlling person of the registrant in the successful defense of any
action, suit or proceeding) is asserted by such director, officer or
controlling person in connection with the securities being registered, the
registrant will, unless in the opinion of its counsel the matter has been
settled by controlling precedent, submit to a court of appropriate
jurisdiction the question whether such indemnification by it is against
public policy as expressed in the Securities Act of 1933 and will be
governed by the final adjudication of such issue.
(c) The undersigned Registrant hereby undertakes that:
(1) For purposes of determining any liability under the
Securities Act, the information omitted from the form of
prospectus filed as a part of this Registration Statement in
reliance upon Rule 430A and contained in the form of prospectus
filed by the Registrant pursuant to Rule 424(b)(1) or (4) or
497(h) under the Securities Act of 1933 shall be deemed part of
this Registration Statement as of the time it was declared
effective.
(2) For the purpose of determining any liability under the
Securities Act of 1933, each post-effective amendment that
contains a form of prospectus shall be deemed to be a new
Registration Statement relating to the securities offered
therein, and the offering of such securities at such time shall
be deemed to be the initial bona fide offering thereof.
II-6
SIGNATURES
Under the requirements of the Securities Act of 1933, as amended, the
Registrant certifies that it has reasonable grounds to believe that it meets all
of the requirements for filing on Form S-3, and has duly caused this
Registration Statement on Form S-3 to be signed on its behalf by the
undersigned, thereunto duly authorized, in the City of Plainsboro, State of New
Jersey, on June 1, 2001.
INTEGRA LIFESCIENCES HOLDINGS CORPORATION
By: /s/ JOHN B. HENNEMAN, III
------------------------------------------
John B. Henneman, III
Senior Vice President,
Chief Administrative Officer
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature
appears below constitutes and appoints Stuart M. Essig, John B. Henneman, III
and David Holtz and each of them, as his true and lawful attorneys-in-fact and
agents, with full power of substitution and resubstitution, for him and in his
name, place, and stead, in any and all capacities, to sign any and all
amendments (including post-effective amendments, exhibits thereto and other
documents in connection therewith) to this Registration Statement and any
subsequent registration statement filed by the registrant pursuant to Rule
462(b) of the Securities Act of 1933, as amended, which relates to this
Registration Statement, and to file the same, with all exhibits thereto, and
other documents in connection therewith, with the Securities and Exchange
Commission, granting unto said attorneys-in-fact and agents, and each of them,
full power and authority to do and perform each and every act and thing
requisite and necessary to be done in connection therewith, as fully to all
intents and purposes as he might or could do in person, hereby ratifying and
confirming all that said attorneys-in-fact and agents, or any of them, or their
or his substitute or substitutes, may lawfully do or cause to be done by virtue
hereof.
II-7
Under the requirements of the Securities Act of 1933, as amended, this
Registration Statement has been signed by the following persons in the
capacities and on the dates indicated.
SIGNATURE TITLE DATE
- --------- ----- ----
/S/ STUART M. ESSIG President, Chief Executive Officer June 1, 2001
- -----------------------------------
Stuart M. Essig, Ph.D and Director
/S/ GEORGE W. MCKINNEY, III Executive Vice President, Chief June 1, 2001
- -----------------------------------
George W. McKinney, III, Ph.D Operating Officer and Director
/S/ DAVID B. HOLTZ Senior Vice President, Finance and June 1, 2001
- -----------------------------------
David B. Holtz Treasurer
/S/ RICHARD E. CARUSO Chairman and Director June 1, 2001
- -----------------------------------
Richard E. Caruso, Ph.D
/S/ JAMES M. SULLIVAN Director June 1, 2001
- -----------------------------------
James M. Sullivan
/S/ KEITH BRADLEY Director June 1, 2001
- -----------------------------------
Keith Bradley, Ph.D
/S/ NEAL MOSZKOWSKI Director June 1, 2001
- -----------------------------------
Neal Moszkowski
II-8
EXHIBIT INDEX
EXHIBIT
NUMBER DESCRIPTION
- ------ -----------
12.1 Statement of the Calculation of Ratio of Earnings to Fixed Charges and Statement of the Calculation of Ratio of
Earnings to Combined Fixed Charges and Preferred Stock Dividends.
21.1 Subsidiaries of the Company
23.2 Consent of PricewaterhouseCoopers LLP, independent accountants
24.1 Power of Attorney (included in signature page)
EXHIBIT 12.1
Statement of the Calculation of Ratio of Earnings To Fixed Charges
(Dollars in Thousands)
For the Three For the Year Ended December 31,
Months Ended March -------------------------------------------------------------
31, 2001 2000 1999 1998 1997 1996
------------------- --------- --------- --------- ---------- --------
Computation of Earnings:
Pre tax income (loss) ................................ $ 2,242 $(10,847)(A) $ (7,784) $(12,342) $(16,964)(B) $ (7,528)
Fixed Charges:
Interest expense ..................................... 285 1,277 712 -- -- --
Assumed interest component of rent expense ........... 152 474 319 260 213 218
-------- -------- -------- -------- -------- --------
Total fixed charges .................................. 437 1,751 1,031 260 213 218
Earnings [Pre tax income (loss) + Total fixed charges] $ 2,679 $ (9,096) $ (6,753) $(12,082) $(16,751) $ (7,310)
Total fixed charges .................................. $ 437 $ 1,751 $ 1,031 $ 260 $ 213 $ 218
Ratio of earnings to fixed charges ................... 6.1 N/A N/A N/A N/A N/A
For the years ended December 31, 2000, 1999, 1998, 1997 and 1996, Integra did
not generate sufficient earnings to cover its fixed charges by the following
amounts:
For the Year Ended December 31,
-------------------------------------------------------------
2000 1999 1998 1997 1996
------- --------- --------- ---------- --------
$ 10,847 $ 7,784 $ 12,342 $ 16,964 $ 7,528
(A) Includes a $13.5 million equity-based signing bonus for our President and
Chief Executive Officer in connection with the renewal of his employment
agreement.
(B) Includes the following two non-cash charges: 1) $1.0 million related to an
asset impairment charge and 2) $5.9 million related to an equity-based signing
bonus for our President and Chief Executive Officer.
Statement of the Calculation of Ratio of Earnings To Combined Fixed
Charges and Preferred Stock Dividends
(Dollars in Thousands)
For the Three For the Year Ended December 31,
Months Ended March -------------------------------------------------------------
31, 2001 2000 1999 1998 1997 1996
------------------- --------- --------- --------- ---------- ---------
Computation of Earnings:
Pre tax income (loss) ................................ $ 2,242 $(10,847)(A) $ (7,784) $(12,342) $ (16,964)(B) $ (7,528)
Fixed Charges:
Interest expense ..................................... 285 1,277 712 -- -- --
Assumed interest component of rent expense ........... 152 474 319 260 213 218
-------- -------- -------- --------- -------- --------
Total fixed charges .................................. 437 1,751 1,031 260 213 218
Earnings [Pre tax income (loss) + Total fixed charges] $ 2,679 $ (9,096) $ (6,753) $ (12,082) $(16,751) $ (7,310)
Preferred stock dividend requirements ................ $ 385 $ 1,472(C) $ 830 $ 47 $ -- $ --
Ratio of pretax income (loss) to net income (loss) ... 1.12 1.01 N/A N/A N/A N/A
-------- -------- -------- --------- -------- --------
Preferred stock dividend factor ...................... 431 1,487 830 47 -- --
Total fixed charges .................................. 437 1,751 1,031 260 213 218
-------- -------- -------- --------- -------- --------
Total fixed charges and preferred stock dividends .... $ 868 $ 3,238 $ 1,861 $ 307 $ 213 $ 218
Ratio of earnings to combined fixed charges and
preferred stock dividends .................... 3.1 N/A N/A N/A N/A N/A
For the years ended December 31, 2000, 1999, 1998, 1997 and 1996, Integra did
not generate sufficient earnings to cover its combined fixed charges and
preferred stock dividends by the following amounts:
For the Year Ended December 31,
-------------------------------------------------------------
2000 1999 1998 1997 1996
-------- --------- --------- ---------- --------
$ 12,334 $ 8,614 $12,389 $ 16,964 $ 7,528
(A) Includes a $13.5 million equity-based signing bonus for our President and
Chief Executive Officer in connection with the renewal of his employment
agreement.
(B) Includes the following two non-cash charges: 1) $1.0 million related to an
asset impairment charge and 2) $5.9 million related to an equity-based signing
bonus for our President and Chief Executive Officer.
(C) Excludes $4.17 million of non-recurring amounts recorded as preferred stock
dividends because such amounts were recorded as preferred stock dividends as a
result of the issuance of convertible preferred stocks with a beneficial
conversion feature.
12.1-2
Exhibit 21.1
Subsidiaries of Integra LifeSciences Holdings Corporation
State or Country of
Name of Subsidiary Incorporation or Organization
- ------------------ -----------------------------
1. Camino NeuroCare, Inc. Delaware
2. Heyer-Schulte NeuroCare, Inc. Delaware
3. Integra LifeSciences Corporation Delaware
4. Integra NeuroCare LLC Delaware
5. NeuroCare Holding Corporation Delaware
6. Integra Selector Corporation Delaware
7. Telios Pharmaceuticals, Inc. Delaware
8. Clinical Neuro Systems Holdings LLC Delaware
9. Clinical Neuro Systems LLC Delaware
10. Caveangle Corporation United Kingdom
11. Integra NeuroSciences Holdings Ltd. United Kingdom
12. Integra NeuroSciences Ltd. United Kingdom
13. Spembly Medical Ltd. United Kingdom
14. GMS Gesellschaft fur medizinische
Sondentechnic mbH Germany
15. Satelec Medical France
EXHIBIT 23.2
CONSENT OF INDEPENDENT ACCOUNTANTS
We hereby consent to the incorporation by reference in this Registration
Statement on Form S-3 of our report dated February 23, 2001, except for Note 18,
as to which the date is March 16, 2001, and Note 2, as to which the date is May
14, 2001 relating to the financial statements and financial statement schedules,
which appears in Integra LifeSciences Holdings Corporation's Annual Report on
Form 10-K/A for the year ended December 31, 2000. We also consent to the
references to us under the heading "Experts" and "Selected Consolidated
Financial Data" in such Registration Statement.
/S/ PRICEWATERHOUSECOOPERS LLP
- -------------------------------
Florham Park, New Jersey
June 1, 2001