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AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON FEBRUARY 14, 2000
REGISTRATION NO. 33-
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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
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INAMED CORPORATION
(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
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DELAWARE 3842 59-0920629
(STATE OR OTHER JURISDICTION OF (PRIMARY STANDARD INDUSTRIAL (I.R.S. EMPLOYER
INCORPORATION OR ORGANIZATION) CLASSIFICATION CODE NUMBER) IDENTIFICATION NUMBER)
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11 PENN PLAZA, SUITE 946
NEW YORK, NY 10001
(212) 273-3430
(ADDRESS, INCLUDING ZIP CODE, AND TELEPHONE NUMBER, INCLUDING AREA CODE, OF
REGISTRANT'S PRINCIPAL EXECUTIVE OFFICES)
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DAVID E. BAMBERGER, ESQ.
SENIOR VICE PRESIDENT, SECRETARY AND GENERAL COUNSEL
INAMED CORPORATION
5540 EKWILL STREET, SUITE D
SANTA BARBARA, CALIFORNIA 93111
(805) 692-5400
(NAME, ADDRESS, INCLUDING ZIP CODE, AND TELEPHONE NUMBER, INCLUDING AREA CODE,
OF AGENT FOR SERVICE)
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WITH A COPY TO:
LAWRENCE LEDERMAN, ESQ.
MILBANK, TWEED, HADLEY & MCCLOY LLP
ONE CHASE MANHATTAN PLAZA
NEW YORK, NEW YORK 10005
(212) 530-5000
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APPROXIMATE DATE OF COMMENCEMENT OF PROPOSED SALE TO THE PUBLIC: From time
to time after the effective date of this Registration Statement until all the
shares hereunder have been sold.
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, please 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. [ ]
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CALCULATION OF REGISTRATION FEE
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AMOUNT PROPOSED MAXIMUM PROPOSED
TITLE OF EACH CLASS OF TO BE OFFERING PRICE MAXIMUM AGGREGATE AMOUNT OF
SECURITIES TO BE REGISTERED REGISTERED PER UNIT(1) OFFERING PRICE(1) REGISTRATION FEE
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Common Stock, par value $0.01 per
share.......................... 2,000,000 $40.50 $81,000,000 $21,384
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(1) Estimated solely for the purpose of calculating the amount of the
registration fee, based on the average of the high and low prices for Inamed
Corporation's common stock as reported on the Nasdaq National Market on
February 8, 2000 in accordance with Rule 457(c) under the Securities Act.
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THE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR
DATES AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT SHALL
FILE A FURTHER AMENDMENT WHICH SPECIFICALLY STATES THAT THIS REGISTRATION
STATEMENT SHALL THEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH SECTION 8(a) OF
THE SECURITIES ACT OR UNTIL THE REGISTRATION STATEMENT SHALL BECOME EFFECTIVE ON
SUCH DATE AS THE COMMISSION, ACTING PURSUANT TO SECTION 8(a), MAY DETERMINE.
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PROSPECTUS
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PROSPECTUS SUBJECT TO COMPLETION, DATED FEBRUARY 14, 2000
[INAMED LOGO]
2,000,000 SHARES OF COMMON STOCK
THE SHARES OFFERED IN THIS PROSPECTUS INVOLVE A HIGH DEGREE OF RISK. YOU
SHOULD CAREFULLY CONSIDER THE "RISK FACTORS" REFERENCED ON PAGES 1-9 IN
DETERMINING WHETHER TO PURCHASE INAMED CORPORATION'S COMMON STOCK.
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The selling stockholders identified on page 9 of this prospectus are
offering these shares of common stock. For additional information on the methods
of sale, you should refer to the section entitled "Plan of Distribution" on
pages 10-11. Inamed Corporation will not receive any portion of the proceeds
from the sale of these shares.
Inamed Corporation's common stock is quoted on the Nasdaq National Market
under the symbol "IMDC."
On February 8, 2000, the last reported closing price of the common stock on
the Nasdaq National Market was $41.06 per share.
Neither the Securities and Exchange Commission nor any state securities
commission has approved or disapproved of these securities or passed on the
adequacy or accuracy of the disclosures in the prospectus. Any representation to
the contrary is a criminal offense.
THE INFORMATION IN THIS PROSPECTUS IS NOT COMPLETE AND MAY BE CHANGED. WE
MAY NOT SELL THESE SECURITIES UNTIL THE REGISTRATION STATEMENT FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION IS EFFECTIVE. THIS PROSPECTUS IS NOT AN OFFER
TO SELL THESE SECURITIES AND IT IS NOT SOLICITING AN OFFER TO BUY THESE
SECURITIES IN ANY STATE WHERE THE OFFER OR SALE IS NOT PERMITTED.
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TABLE OF CONTENTS
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The Company................................................. 1
Risk Factors................................................ 1
Use of Proceeds............................................. 9
Selling Stockholders........................................ 9
Plan of Distribution........................................ 10
Legal Matters............................................... 11
Experts..................................................... 11
Where You Can Find More Information......................... 11
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YOU SHOULD RELY ONLY ON THE INFORMATION CONTAINED IN THIS PROSPECTUS. WE
HAVE NOT AUTHORIZED ANYONE TO PROVIDE YOU WITH INFORMATION DIFFERENT FROM THAT
CONTAINED IN THIS PROSPECTUS. THE SELLING STOCKHOLDERS ARE OFFERING TO SELL, AND
SEEKING OFFERS TO BUY, SHARES OF COMMON STOCK ONLY IN JURISDICTIONS WHERE OFFERS
AND SALES ARE PERMITTED. THE INFORMATION CONTAINED IN THIS PROSPECTUS IS
ACCURATE ONLY AS OF THE DATE OF THIS PROSPECTUS, REGARDLESS OF THE TIME OF
DELIVERY OF THIS PROSPECTUS OR OF ANY SALE OF OUR COMMON STOCK.
NO ACTION IS BEING TAKEN IN ANY JURISDICTION OUTSIDE THE UNITED STATES TO
PERMIT A PUBLIC OFFERING OF THE COMMON STOCK OR POSSESSION OR DISTRIBUTION OF
THIS PROSPECTUS IN THAT JURISDICTION. PERSONS WHO COME INTO POSSESSION OF THIS
PROSPECTUS IN JURISDICTIONS OUTSIDE THE UNITED STATES ARE REQUIRED TO INFORM
THEMSELVES ABOUT AND TO OBSERVE ANY RESTRICTIONS AS TO THIS OFFERING AND THE
DISTRIBUTION OF THIS PROSPECTUS APPLICABLE TO THAT JURISDICTION.
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THE COMPANY
We are a global surgical and medical device company engaged in the
development, manufacturing and marketing of medical devices for the plastic,
reconstructive and aesthetic surgery markets. We sell a variety of lifestyle
products used to make people look younger and more attractive, including breast
implants for cosmetic augmentation and collagen-based facial implants to correct
facial wrinkles and scars and to enhance lip definition. We also sell products
to address women's health issues, including breast implants for reconstructive
surgery following radical mastectomies, and devices to treat severe obesity.
We recently acquired Collagen Aesthetics, Inc., which designs, develops,
manufactures and markets products that treat aging or defective human tissue.
Collagen's flagship products, Zyderm(R) and Zyplast(R) collagen-based facial
implants, are used by plastic surgeons, dermatologists and other physicians in
aesthetic applications for the correction of facial wrinkles due to aging, and
scars. The Collagen acquisition broadened our portfolio of products to address
the needs of plastic surgeons and other aesthetic practitioners and is expected
to help us take advantage of our existing sales and marketing infrastructure.
Our principal executive offices are located at 5540 Ekwill Street, Suite D,
Santa Barbara, California 93111 and our telephone number is (805) 692-5400. We
maintain websites at www.inamed.com and www.collagen.com. Information contained
in these websites does not constitute, and shall not be deemed to constitute,
part of this prospectus.
RISK FACTORS
You should carefully consider the following risk factors and all other
information contained or incorporated by reference in this prospectus before
purchasing our common stock. Investing in our common stock involves a high
degree of risk. Any of the following risks could materially harm our business,
operating results and financial condition and could result in a complete loss of
your investment.
OUR FUTURE PROFITABILITY DEPENDS ON THE SUCCESS OF OUR PRINCIPAL PRODUCTS
Sales of our breast implant, tissue expander and collagen-based facial
implant products account for a substantial majority of our net sales. We expect
our revenues to continue to be based primarily on sales of these principal
products. Adverse rulings by regulatory authorities, product liability lawsuits,
introduction of competitive products by third parties, the loss of market
acceptance or other adverse publicity for these principal products may
significantly and adversely affect our sales of these products and, as a result,
would adversely affect our business, financial condition and results of
operations.
OUR RECENT ACQUISITION OF COLLAGEN MAKES EVALUATING OUR OPERATING RESULTS
DIFFICULT
Our historical results of operations incorporated by reference in this
prospectus give effect to the Collagen acquisition from September 1, 1999 but
otherwise do not give effect to the operations of Collagen. The pro forma
statements of operations incorporated by reference in this prospectus are based
primarily on the separate pre-acquisition financial reports of Inamed and
Collagen. Consequently, our historical results of operations and pro forma
financial information may not give you an accurate indication of how we,
together with Collagen, will perform in the future.
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WE HAVE BEEN PARTY TO SIGNIFICANT BREAST IMPLANT LITIGATION IN THE PAST AND MAY
BE PARTY TO THIS TYPE OF LITIGATION IN THE FUTURE
We face an inherent business risk of exposure to product liability claims
alleging that the use of our technology or products has resulted in adverse
health effects. The risks of litigation exist even with respect to products that
have received or in the future may receive regulatory approval for commercial
sale. If we are unable to avoid significant product liability claims, our
business could be materially harmed. In particular, the manufacture and sale of
breast implant products entails significant risk of product liability claims due
to potential allegations of possible disease transmission and other health
factors, rupture or other product failure and product recalls. The manufacture
and sale of collagen-based implant products also entails risks of product
liability claims. In the past, we were party to and settled claims related to
our breast implant products. In February 1999, we received final judicial
approval of a mandatory non-opt-out settlement relating to a class action
lawsuit arising from our silicone gel-filled and saline-filled breast implant
products that were implanted before June 1, 1993. Under the settlement, we paid
an aggregate amount of $31.5 million to a court appointed escrow agent on behalf
of the plaintiff class and $3.0 million to resolve a significant indemnity claim
by Minnesota Mining and Manufacturing Company (3M). This settlement does not
apply to our breast implant products, predominantly saline-filled implants, that
were implanted after June 1, 1993 or to silicone gel-filled and saline-filled
breast implants sold outside the U.S. Although the time to take an appeal from
the judicial order approving the settlement has passed, we cannot assure you
that this settlement will not be collaterally attacked in state court for lack
of jurisdiction or constitutionally inadequate class notice or representation.
We are not aware of any pending or threatened collateral attacks to the
settlement on any grounds.
We also are currently engaged in ongoing breast implant litigation, which
we are defending in the normal course. As a result of our acquisition of
Collagen, we face exposure to claims regarding Trilucent(R) breast implant
products which were distributed in Europe between January 1996 and March 1999,
and which subsequently have been discontinued. Although we reserved a total of
$11.5 million as part of our discontinuation of the Trilucent(R) breast implant
product in 1999 and recently purchased a product liability insurance policy to
cover liabilities specifically relating to the Trilucent(R) breast implant
product, this reserve and insurance policy may be inadequate to cover all
potential related liabilities.
OUR PRODUCTS EXPOSE US TO LIABILITIES THAT MAY NOT BE ADEQUATELY COVERED BY
INSURANCE AND OUR FINANCIAL RESULTS MAY SUFFER
In addition to the risks we face from product liability claims, we are
subject to the inherent risk that a government authority or third party may
require us to recall one or more of our products. We have liability insurance
that would cover a claim relating to the use or recall of our products under a
limited number of circumstances. In addition, a product liability claim against
us could exceed our insurance coverage. In the event liability insurance would
not sufficiently cover a product liability claim or recall, these events could
have a material adverse effect on our business, financial condition and results
of operations. Adequate product liability insurance may not continue to be
available, either at existing or increased levels of coverage, on commercially
reasonable terms or at all. Even if a claim is covered by insurance, the costs
of defending a product liability, negligence or other action, and the assessment
of damages in excess of insurance coverage, could entail significant expense and
damage our reputation. We cannot assure you that our insurance will be broad
enough to protect us against all future claims, which could have a material
adverse effect on our business, financial condition and results of operations.
Further, liability claims relating to the use of our products or a product
recall could hurt our ability to obtain or maintain regulatory approvals for our
products.
CONCERNS ABOUT THE SAFETY AND EFFICACY OF OUR PRODUCTS AND ANY NEGATIVE
PUBLICITY COULD HARM OUR FINANCIAL RESULTS
Physicians and potential patients may have a number of concerns about the
safety and efficacy of our products, primarily our breast implant products. The
responses of potential patients, physicians, the news media, legislative and
regulatory investigatory bodies and others to information about possible
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complications or alleged complications from our products could result in
negative publicity and could materially reduce market acceptance of our
products. These responses or investigations, and potential resulting negative
publicity, may have a material adverse effect on our business, financial
condition, results of operations or the market price of our stock. In addition,
significant negative publicity could result in an increased number of product
liability claims against us.
OUR QUARTERLY OPERATING RESULTS ARE SUBJECT TO SUBSTANTIAL FLUCTUATIONS AND YOU
SHOULD NOT RELY ON THEM AS AN INDICATION OF OUR FUTURE RESULTS
Our quarterly operating results may vary significantly due to a combination
of factors, many of which are beyond our control. These factors include:
- demand for our products, which historically has been the highest in
the second quarter;
- our ability to meet the demand for our products;
- increased competition;
- the number, timing and significance of new products and product
introductions and enhancements by us and our competitors;
- our ability to develop, introduce and market new and enhanced versions
of our products on a timely basis;
- changes in pricing policies by us and our competitors;
- the timing of significant orders and shipments; and
- general economic factors.
Our recent acquisition of Collagen may make it more difficult for us to
evaluate and predict our future operating performance and we cannot assure you
that our operating performance will continue to improve. Our expense levels are
based, in part, on our expectations of future revenue levels. If revenue levels
are below expectations, operating results are likely to be materially adversely
affected. In particular, because only a small portion of our expenses varies
with revenue in the short term, net income may be disproportionately affected by
a reduction in revenue. Due to the foregoing factors, quarterly revenue and
operating results have been and will continue to be difficult to forecast.
Based upon all of the foregoing, we believe that quarterly revenues and
operating results may vary significantly in the future and that period-to-period
comparisons of our results of operations are not necessarily meaningful and
should not be relied upon as indications of future performance. We cannot assure
you that our revenue will increase or be sustained in future periods or that we
will be profitable in any future period. Any shortfall in revenue or earnings
from levels expected by securities or industry analysts could have an immediate
and significant adverse effect on the trading price of our common stock in any
given period.
CHANGES IN THE ECONOMY AND CONSUMER SPENDING COULD ADVERSELY AFFECT OUR ABILITY
TO SELL OUR PRODUCTS
Breast augmentations and collagen-based implants and injections are
elective procedures and are expensive. Other than U.S. federally mandated
insurance reimbursement for post-mastectomy reconstructive surgery, breast
augmentations and other cosmetic procedures are not typically covered by
insurance. A significant adverse change in the economy may cause consumers to
reassess their spending choices and reduce the demand for cosmetic surgery. This
shift could have an adverse effect on our ability to sell our products and could
materially harm our business.
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IF WE ARE UNABLE TO CONTINUE TO DEVELOP AND MARKET NEW PRODUCTS AND
TECHNOLOGIES, WE MAY EXPERIENCE A DECREASE IN DEMAND FOR OUR PRODUCTS OR OUR
PRODUCTS COULD BECOME OBSOLETE, AND OUR BUSINESS WOULD SUFFER
We believe that a crucial factor in the success of a new product is
obtaining the applicable regulatory approvals and marketing the new product
quickly to respond to new user needs or advances in medical technologies,
without compromising product quality. We are continually engaged in product
development and improvement programs. We cannot assure you that we will be
successful in enhancing existing products or developing new products or
technologies that will timely achieve regulatory approval or receive market
acceptance. To the extent that any of our competitors' products are perceived to
be superior to our products or are marketed sooner than ours, demand for our
products could decrease or our products could be rendered obsolete. If one or
more competing products or technologies achieve broader market acceptance or
render our products obsolete, we may lose customers and revenues which could
have a material adverse effect on our business, financial condition and results
of operations.
WE MAY NOT BE ABLE TO MEET UNANTICIPATED DEMAND FOR OUR PRODUCTS, WHICH COULD
CAUSE US TO LOSE REVENUES AND CUSTOMERS
Since the manufacturing processes for many of our products involve long
lead times, specialized production equipment and a significant degree of human
labor, if demand for our products increases in excess of our capacity, we may
not be able to meet this demand. If we cannot meet the demand for our products,
we may lose revenues and customers, which could have a material adverse effect
on our business, financial condition and results of operations.
WE DEPEND ON A SINGLE SUPPLIER FOR OUR SILICONE RAW MATERIALS AND THE LOSS OF
THIS SUPPLIER COULD ADVERSELY AFFECT OUR ABILITY TO MANUFACTURE MANY OF OUR
PRODUCTS
We currently rely on a single supplier for silicone raw materials used in
many of our products. Although we have an agreement with this supplier to
transfer the necessary formulations to us in the event that this supplier cannot
meet our requirements, we cannot assure you that we will be able to timely
produce a sufficient amount of quality silicone raw materials, if at all. In the
event of a disruption, we currently anticipate that we could require a period of
approximately two months before our silicone production facility could become
operational. In addition, we may not be able to quickly establish additional or
replacement suppliers to meet these needs. If we cannot produce or find
replacement suppliers for these materials, our ability to produce our products
could be impaired and we could lose customers and market share. Accordingly, the
loss of this supplier could have a material adverse effect on our business,
financial condition and results of operations.
OUR ABILITY TO SELL BOVINE COLLAGEN-BASED PRODUCTS COULD BE ADVERSELY AFFECTED
IF WE EXPERIENCE PROBLEMS WITH THE CLOSED HERD OF DOMESTIC CATTLE FROM WHICH WE
DERIVE THESE PRODUCTS
We rely on a closed herd of domestic cattle that is kept apart from all
other cattle for the production of our bovine collagen-based products. In the
event of any material diminution in the size of our herd for any reason,
including accident or disease, we would have a limited ability to quickly
increase the supply of acceptable cattle and our bovine-based products from a
similarly segregated source. Further, any stray cattle that enter our herd could
infect our cattle and could affect the purity of our cattle through mating. The
diminution in size or infection of our cattle could have a material adverse
effect on our ability to sell bovine collagen-based products and, as a result, a
material adverse effect on our business, financial condition and results of
operations.
COMPETITION MAY ERODE OUR MARKET SHARE AND REDUCE OUR PROFITABILITY
The markets for many of our products are competitive. In addition, some of
our competitors may be larger or may have greater resources to devote to new
product development, clinical trials, selling and marketing. Customers may
perceive these new products to be more effective, technologically advanced,
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clinically safer or otherwise more appealing, which may cause our products to be
rendered noncompetitive or obsolete. In addition, our competitors may succeed in
obtaining regulatory approvals for competing products faster than us. This would
permit our competitors to introduce their competing products to the market
before us and as a result we may lose market share and experience reduced
margins. If we do not effectively compete with our competitors, our
profitability may be materially affected. We cannot assure you that we will be
able to effectively compete in the future.
OUR INTERNATIONAL BUSINESS EXPOSES US TO A NUMBER OF RISKS
More than one-third of our net sales are derived from international
operations. Accordingly, any material decrease in foreign sales may have a
material adverse effect on our business, financial condition and results of
operations. Most of our international sales are denominated in U.S. dollars,
euros or yen. Depreciation or devaluation of the local currencies of countries
where we sell our products may result in our products becoming more expensive in
local currency terms, thus reducing demand. We manufacture some of our breast
implant products in Ireland and plan to begin manufacturing some breast implant
products in Costa Rica this year. Therefore, some of our operating expenses are
denominated in currencies other than the U.S. dollar. We cannot assure you that
we will not experience unfavorable currency fluctuation effects in future
periods, which could have an adverse effect on our operating results. Our
operations and financial results also may be significantly affected by other
international factors, including:
- the imposition of additional foreign government controls or
regulations on medical devices;
- new export license requirements;
- political instability, inflation or negative economic growth in our
target markets;
- trade restrictions;
- changes in tariffs; and
- difficulties in managing international operations.
WE ARE SUBJECT TO SUBSTANTIAL GOVERNMENT REGULATION, WHICH COULD MATERIALLY
ADVERSELY AFFECT OUR BUSINESS
The production and marketing of our products and our ongoing research and
development, preclinical testing and clinical trial activities are subject to
extensive regulation and review by numerous governmental authorities both in the
U.S. and abroad. Most of the medical devices we develop must undergo rigorous
preclinical and clinical testing and an extensive regulatory approval process
administered by the Food and Drug Administration under the Food, Drug, and
Cosmetic Act and comparable foreign authorities before they can be marketed.
Unless an exemption applies, each medical device that we wish to market in the
U.S. must receive either a "510(k)" clearance or a premarket approval (PMA) from
the FDA. In order to be commercially distributed throughout the European
Community, a medical device must bear a CE conformity marking, indicating that
it conforms with the essential requirements of the applicable European Medical
Devices Directive. These regulations govern the testing, marketing and
registration of new medical devices, in addition to regulating manufacturing
practices, labeling and record keeping procedures. This process makes it longer,
harder and more costly to bring our products to market, and we cannot assure you
that any of our products will be approved. If we do not comply with applicable
regulatory requirements it can result in warning letters, non-approval,
suspensions of regulatory approvals, civil penalties and criminal fines, product
seizures and recalls, operating restrictions, injunctions and criminal
prosecution.
Delays in or rejection of FDA approval of our products may be encountered
due to, among other reasons, regulatory review of each new device application or
product license application we submit, as well as changes in regulatory policy
during the period of product development both in the U.S. and abroad. Even if
regulatory approval of a product is granted, this approval may entail
limitations on uses for which the product may be labeled and promoted. Further,
for a marketed product, its manufacturer and the facilities in which the product
is manufactured are subject to continual review and inspection. Later discovery
of previously unknown problems with a product, manufacturer or facility may
result in
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restrictions on the product, manufacturer or facility, including withdrawal of
the product from the market or other enforcement actions.
WE MAY FAIL TO MAINTAIN THE REGULATORY APPROVAL NECESSARY TO CONTINUE LEGALLY
MARKETING OUR SALINE-FILLED BREAST IMPLANT PRODUCT
Our saline-filled breast implant product has been marketed in the U.S.
based upon substantial equivalence to other saline-filled breast implant
products that were in commercial distribution before May 28, 1976. In mid-August
1999, the FDA issued regulations that will eliminate this "grandfather" status
and require all manufacturers of saline-filled breast implant products to obtain
PMA approval in order to enter or remain on the market. These regulations are
known as a "call for PMA applications."
Pursuant to the call for PMA applications, all manufacturers of
saline-filled breast implant products now in commercial distribution must have
had a PMA application accepted for filing by November 17, 1999. The FDA only
accepts a PMA application for filing based upon a determination that it is
sufficiently complete to permit substantive review. Manufacturers who
successfully filed PMA applications by the deadline may continue marketing their
saline-filled breast implant products during the agency's review period.
Manufacturers who did not meet the deadline are required to stop commercially
distributing their saline-filled breast implant products until after they obtain
PMA approval.
We submitted a PMA application for our saline-filled breast implant product
on November 16, 1999. In December 1999, the FDA completed an initial review, and
accepted for filing, our PMA application for our saline-filled breast implant
product. Subsequently, the FDA informed us that an advisory panel will be
convened to hold a public hearing on March 1-3, 2000, at which time our PMA
application will be formally reviewed and considered by the advisory panel.
Thereafter, the advisory panel will make a recommendation to the FDA whether to
accept or reject our PMA application. The FDA could accept or reject the
advisory panel's recommendation. If the FDA declines to accept our PMA
application, the FDA could require us to cease marketing our saline-filled
breast implant product during the agency's review of our PMA application. In
addition, the FDA ultimately could find our PMA application not approvable,
which would preclude us from commercial distribution of this product in the U.S.
Our failure to obtain approval of our PMA application would have a material
adverse effect on our business, financial condition and results of operations.
FUTURE LEGISLATION OR REGULATIONS RELATING TO US OR OUR PRODUCTS COULD
MATERIALLY ADVERSELY AFFECT OUR BUSINESS
If any national healthcare reform or other legislation or regulations are
passed that impose limits on the number or type of medical procedures that may
be performed or that have the effect of restricting a physician's ability to
select specific products for use in his or her procedures, it could have a
material adverse effect on the demand for our products. In the U.S., there have
been, and we expect that there will continue to be, a number of federal and
state legislative proposals and regulations to implement greater governmental
control on the healthcare industry. These proposals create uncertainty as to the
future of our industry and may have a material adverse effect on our ability to
raise capital or to form collaborations, and the enactment of these reforms
could have a material adverse effect on our business, financial condition and
results of operations. In a number of foreign markets, the pricing and
profitability of healthcare products are subject to governmental influence or
control. In addition, legislation or regulations that impose restrictions on the
price that may be charged for healthcare products or medical devices may
adversely affect our business, financial condition and results of operations.
From time to time, legislation or regulatory proposals are introduced and
discussed which could alter the review and approval process relating to medical
device products.
IF WE ARE UNABLE TO HIRE AND RETAIN KEY PERSONNEL, OUR BUSINESS AND GROWTH WILL
SUFFER
We are dependent on a limited number of key management, technical and sales
personnel, the loss of any one of which could have a material adverse effect on
our business, financial condition and results of operations. Our future success
will depend in part upon our ability to attract and retain highly qualified
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personnel. We compete for these personnel with other companies, academic
institutions, government entities and other organizations. We cannot assure you
that we will be successful in hiring or retaining qualified personnel. Our
inability to attract and retain key employees could have a material adverse
effect on our business, financial condition and results of operations.
WE USE PRODUCTS IN THE MANUFACTURING PROCESS WHICH MAY BE HAZARDOUS TO THE
ENVIRONMENT IF NOT HANDLED PROPERLY, WHICH EXPOSES US TO ADDITIONAL LIABILITY
We are subject to foreign and domestic laws and regulations relating to the
protection of the environment. Our business involves the handling, storage and
disposal of materials that are classified as hazardous. Although our safety
procedures for handling, storage and disposal of these materials are designed to
comply with the standards prescribed by applicable laws and regulations, we
cannot assure you that we will not be held liable for any damages that result,
and any related liability could have a material adverse effect on our business,
financial condition and results of operations. Further, we cannot assure you
that the cost of complying with these laws and regulations will not increase
materially in the future.
WE ARE UNCERTAIN ABOUT THE STATUS OF SOME OF OUR PATENTS AND PROPRIETARY
TECHNOLOGY AND ARE INVOLVED IN PATENT LITIGATION WHICH, IF DETERMINED ADVERSELY
TO US, COULD HARM OUR RESULTS OF OPERATIONS
Our success will depend, in part, on our ability and our licensors' ability
to obtain, assert and defend our patents, protect our trade secrets and operate
without infringing the proprietary rights of others. We protect our proprietary
technology through a combination of confidentiality agreements and patents. We
cannot assure you that our owned and licensed patents, products and technology
will prove to be enforceable or that our products and technology do not infringe
the patents or proprietary rights of others. We could also incur substantial
costs in seeking enforcement of our proprietary rights against infringement or
in defending ourselves against claims of infringement by others. Since much of
our technology consists of trade secrets and unpatented know-how, we are exposed
to the risk that others will independently develop similar or superior products
or technologies or that our trade secrets or know-how will become known to
others.
We license some of our products and technology under patents owned by
others. In 1998, we reviewed our portfolio of patents and licenses and
determined in several situations that licensed patents either were invalid, were
unenforceable, were not being utilized or that the licensor had breached its
obligations to us. Accordingly, we ceased paying several million dollars in
annual royalties under several license agreements. We are currently engaged in
litigation with various former licensors over the recovery of past royalties
that were paid and our potential future obligations. One of these litigation
matters is now in the process of being settled based upon a recently executed
agreement in principle to settle on terms that will not have a material adverse
impact on us. If these proceedings are determined against us, we may be liable
for a significant amount of past unpaid and potential future royalty or other
contract payments, which could include a significant amount of damages, interest
and enhanced damages if we are found to have willfully infringed the patents
after ceasing royalty payments, and ultimately may be prohibited from using the
patented technology.
YEAR 2000 PROBLEMS MAY DISRUPT OUR BUSINESS AND SUBJECT US TO INCREASED EXPENSES
To date, we have not experienced any negative impact resulting from the
date change to the year 2000. Although we believe that it is unlikely that we
will experience any problem resulting from the date change to the year 2000 in
the future, there can be no assurance that neither us nor any of our significant
business partners, suppliers or customers will be affected by the date change to
the year 2000.
HISTORICALLY, OUR STOCK PRICE HAS BEEN VOLATILE AND OUR TRADING VOLUME HAS BEEN
LOW
The market prices for securities of medical device companies have
historically been highly volatile. Broad market fluctuations may have a material
adverse effect on the market price of our common stock.
7
<PAGE> 11
The trading price of our common stock has been, and may be, subject to wide
fluctuations in response to a number of factors, many of which are beyond our
control. These factors include:
- quarter-to-quarter variations in our operating results;
- the results of testing, technological innovations or new commercial
products by us or our competitors;
- governmental regulations, rules and orders;
- general conditions in the healthcare, medical device or plastic
surgery industries;
- changes in our earnings estimates by securities analysts;
- developments concerning patents or other proprietary rights; and
- litigation or public concern about the safety of our products.
Historically, the daily trading volume of our common stock was relatively
low. On September 30, 1999, our common stock began trading on the Nasdaq
National Market. Since that time, the average trading volume of our common stock
has increased. We cannot assure you that an active public market for our common
stock will be sustained after this offering or that the average trading volume
will remain at present levels or increase.
AS A RESULT OF THEIR OWNERSHIP OF OUR COMMON STOCK, OUR EXECUTIVE OFFICERS,
DIRECTORS AND AFFILIATES MAY EXERCISE SIGNIFICANT INFLUENCE OVER OUR CORPORATE
DECISIONS CONTRARY TO THE INTERESTS OF OTHER STOCKHOLDERS
Following our November 1999 public equity offering, our executive officers,
directors and affiliates beneficially owned approximately 33% of our common
stock. Accordingly, these stockholders have significant influence with respect
to any corporate transaction or other matter submitted to the stockholders for
approval, including mergers, consolidations and the sale of all or substantially
all of our assets. Third parties may be discouraged from making a bid or tender
offer to acquire us because of this concentration of ownership.
OUR CERTIFICATE OF INCORPORATION, BY-LAWS, RIGHTS PLAN AND DELAWARE LAW MAKE IT
DIFFICULT FOR A THIRD PARTY TO ACQUIRE US, DESPITE THE POSSIBLE BENEFIT TO OUR
STOCKHOLDERS
Our certificate of incorporation, bylaws and Delaware law include
provisions that may have the effect of discouraging a third party from pursuing
a non-negotiated takeover of our company and preventing specific changes of
control. In addition, our board of directors has adopted a stockholders' rights
plan providing for discount purchase rights to some of our stockholders upon
some acquisitions of our common stock. The exercise of these rights is intended
to inhibit specific changes of control of Inamed. In addition, we have entered
into agreements with our senior executive officers under which they could
receive substantial payments in connection with a change of control of our
company.
SHARES ELIGIBLE FOR FUTURE SALE BY OUR CURRENT STOCKHOLDERS OR EMPLOYEES MAY
ADVERSELY AFFECT THE MARKET PRICE OF OUR COMMON STOCK
At February 8, 2000, there were 20,226,731 shares of our common stock
outstanding and 4,328,666 shares of our common stock issuable upon the exercise
of outstanding options and warrants. Once vested, the options and warrants
generally may be exercised at any time. In connection with our public equity
offering in November 1999, our executive officers, directors and some of our
principal stockholders, including selling stockholders, agreed that, with some
exceptions, they would not, directly or indirectly, without the prior written
consent of Chase H&Q (formerly Hambrecht & Quist LLC) on behalf of the
underwriters, offer, sell, or otherwise dispose of any shares of our common
stock, options or warrants to acquire shares of common stock or securities
exchangeable for or convertible into shares of common stock owned by them during
the 90-day period following the date of the prospectus for the November 1999
offering. Chase H&Q, on behalf of the underwriters, may in its sole discretion,
release all or any portion of
8
<PAGE> 12
the shares subject to the lock up agreements. Also in connection with our
November 1999 public equity offering, we agreed with some of our holders of our
common stock and our warrants to purchase shares of our common stock (other than
affiliates of Appaloosa Management L.P.) that we would file a registration
statement on an appropriate form under the Securities Act with respect to those
shares of common stock as soon as practicable after March 16, 2000, subject to
reduction as determined by a nationally recognized financial advisor. On
February 14, 2000, we entered into a Letter Agreement with several affiliates of
Appaloosa Management L.P. which own shares of our common stock and warrants to
purchase shares of our common stock. Pursuant to the Letter Agreement, we
agreed, following the effective date of this registration statement, to file one
or more additional registration statements, and to use our best efforts to cause
those registration statements to be declared effective under the Securities Act,
with respect to the remaining shares of common stock beneficially owned by those
affiliates of Appaloosa Management, which filings may be made over a maximum of
four subsequent periods of approximately 45 days each, and in any event no later
than December 31, 2000. Many of our outstanding warrants provide for
anti-dilution adjustment upon the occurrence of certain events, including
certain issuances by us of shares of common stock, or warrants to purchase
shares of our common stock or other rights to purchase common stock, for
consideration or at an exercise price which is less than the current market
price of our common stock (defined in these warrants as the daily volume
weighted average sale price per share of our common stock for the 20 business
days ending five days before the date of determination). The issuance or sale of
a significant number of shares of our capital stock, whether in connection with
the exercise of a significant number of outstanding options or warrants, the
possible operation of these anti-dilution provisions in some of our warrants or
otherwise, could dilute the percentage interest of our other stockholders now or
in the future or materially adversely affect the market price of our common
stock.
USE OF PROCEEDS
We will not receive any proceeds from the sale of the shares of common
stock offered by the selling stockholders pursuant to this prospectus.
SELLING STOCKHOLDERS
The following table sets forth the beneficial ownership of the shares of
our common stock owned as of February 8, 2000 by each of the selling
stockholders. The following table assumes that the selling stockholders sell all
of the shares of common stock being offered by them. We are unable to tell the
exact number of shares that will actually be sold.
<TABLE>
<CAPTION>
SHARES BENEFICIALLY SHARES BENEFICIALLY
OWNED BEFORE OFFERING OWNED AFTER OFFERING
---------------------- NUMBER OF SHARES ----------------------
NAME NUMBER PERCENT(1) BEING OFFERED NUMBER PERCENT(1)
- ---- --------- ---------- ---------------- --------- ----------
<S> <C> <C> <C> <C> <C>
Entities affiliated with Appaloosa Management L.P.
26 Main Street
Chatham, New Jersey 07928.......................... 6,400,052(2) 30.2% 2,000,000 4,400,052 20.8%
</TABLE>
- ---------------------------
(1) The percentages are calculated on the basis of the amount of outstanding
shares of common stock as of February 8, 2000, which is 20,226,731 plus
shares of common stock underlying each holder's options and warrants which
have been issued and are exercisable within 60 days hereof.
(2) Based on the Schedule 13D/A filed jointly in November 1999 by Appaloosa
Management L.P. and David A. Tepper. Mr. Tepper is the President of
Appaloosa Partners Inc., the general partner of Appaloosa Management L.P.
Includes (i) 362,286 shares of common stock issuable upon the exercise of
warrants to purchase shares of common stock at $7.50 per share and (ii)
579,510 shares of common stock issuable upon the exercise of warrants to
purchase shares of common stock at $6.50 per share.
9
<PAGE> 13
PLAN OF DISTRIBUTION
Shares of common stock covered hereby may be offered and sold from time to
time by the selling stockholders. The selling stockholders will act
independently of us in making decisions with respect to the timing, manner and
size of each sale. The selling stockholders may sell the shares being offered
hereby: (i) on the Nasdaq National Market, or otherwise at prices and at terms
then prevailing or at prices related to the then current market price; or (ii)
in private sales at negotiated prices directly or through a broker or brokers,
who may act as agent or as principal, or by a combination of those methods of
sale. The selling stockholders and any underwriter, dealer or agent who
participate in the distribution of the shares covered hereby may be deemed to be
underwriters under the Securities Act of 1933, and any discount, commission or
concession received by any of those persons might be deemed to be an
underwriting discount or commission under the Securities Act.
Any broker-dealer participating in a transaction like that described above
as agent may receive commissions from the selling stockholders (and, if acting
as agent for the purchaser of the shares, from the purchaser). Usual and
customary brokerage fees will be paid by the selling stockholders. Broker-
dealers may agree with the selling stockholders to sell a specified number of
shares at a stipulated price per share, and, to the extent such a broker-dealer
is unable to do so acting as agent for the selling stockholders, to purchase as
principal any unsold shares at the price required to fulfill the broker-dealer
commitment to the selling stockholders. Broker-dealers who acquire shares as
principal may thereafter resell those shares from time to time in transactions
(which may involve crosses and block transactions and which may involve sales to
and through other broker-dealers, including transactions of the nature described
above) in the over-the-counter market, in negotiated transactions or by a
combination of those methods of sale or otherwise at market prices prevailing at
the time of sale or at negotiated prices, and in connection with any of those
resales may pay to or receive from the purchasers of those shares commissions
computed as described above.
In effecting sales, brokers or dealers engaged by the selling stockholders
may arrange for other brokers or dealers to participate in the resales. The
selling stockholders may enter into hedging transactions with broker-dealers,
and in connection with those transactions, broker-dealers may engage in short
sales of the shares. The selling stockholders also may sell shares short and
deliver the shares to close out such short positions. The selling stockholders
also may enter into option or other transactions with broker-dealers that
require the delivery to the broker-dealer of the shares, which the broker-dealer
may resell pursuant to this prospectus. The selling stockholders also may pledge
the shares to a broker or dealer, and upon a default, the broker or dealer may
effect sales of the pledged shares pursuant to this prospectus.
The selling stockholders may indemnify any broker-dealer that participates
in transactions involving the sale of the shares against certain liabilities,
including liabilities arising under the Securities Act. Any commissions paid or
any discounts or concessions allowed to any of those broker-dealers, and any
profits received on the resale of such shares, may be deemed to be underwriting
discounts and commissions under the Securities Act if any of those
broker-dealers purchase shares as principal.
In order to comply with the securities laws of certain states, if
applicable, our common stock will be sold in those jurisdictions only through
registered or licensed brokers or dealers. In addition, in certain states, the
common stock may not be sold unless such shares have been registered or
qualified for sale in the applicable state or an exemption from the registration
or qualification requirement is available and is complied with.
We have agreed to pay all expenses, including legal and accounting fees and
expenses, in connection with the registration of the shares of the selling
stockholders pursuant to this prospectus. We have also agreed to indemnify the
selling stockholders against certain liabilities arising under the Securities
Act. The selling stockholders have agreed to indemnify us for liabilities
arising under the Securities Act with respect to written information furnished
to us by the selling stockholders.
We have agreed to maintain the effectiveness of this registration statement
with respect to the shares of common stock offered hereunder by the selling
stockholders until all the shares registered hereunder
10
<PAGE> 14
have been sold. There can be no assurance that the selling stockholders will
sell all or any of the shares of common stock offered hereunder.
LEGAL MATTERS
The validity of the common stock offered by this prospectus will be passed
upon for us by Milbank, Tweed, Hadley & McCloy LLP, New York, New York.
EXPERTS
Our consolidated balance sheets at December 31, 1998 and 1997 and our
consolidated statements of operations, stockholders' deficiency, cash flows and
schedule for the years ended December 31, 1998, 1997 and 1996, incorporated by
reference in this prospectus, have been audited by BDO Seidman, LLP, independent
certified public accountants, and are incorporated by reference herein in
reliance on their reports given upon the authority of that firm as experts in
auditing and accounting.
Ernst & Young LLP, independent auditors, have audited the consolidated
financial statements and schedule of Collagen at June 30, 1999 and 1998, and for
each of the three years in the period ended June 30, 1999, as set forth in their
report. We have incorporated these financial statements and schedule in this
prospectus in reliance on Ernst & Young LLP's report given on their authority as
experts in accounting and auditing.
WHERE YOU CAN FIND MORE INFORMATION
We file annual, quarterly and current reports, proxy statements and other
documents with the Securities and Exchange Commission under the Securities
Exchange Act of 1934. You may read and copy any of those reports, proxy
statements or other documents at the public reference facilities maintained by
the Commission at Room 1024, Judiciary Plaza, 450 Fifth Street, N.W.,
Washington, D.C. 20549 and at its regional offices located at 7 World Trade
Center, New York, New York 10048 and Northwest Atrium Center, 500 West Madison
Street, Suite 1400, Chicago, Illinois 60661. Please call the Commission at
1-800-SEC-0330 for further information on its public reference facilities. These
filings are also available to the public from commercial document retrieval
services and at the Commission's Web site at www.sec.gov.
Our common stock is quoted on the Nasdaq National Market. Reports, proxy
statements and other information concerning Inamed can be inspected at the
National Association of Securities Dealers, Inc., 1735 K Street, N.W.,
Washington, D.C. 20006. In addition, we maintain websites at www.inamed.com and
collagen.com that contain additional information, including news releases, about
our business and operations. Information contained in these websites do not
constitute, and shall not be deemed to constitute, part of this prospectus.
You may also request a copy of any of our filings with the Commission, or
any of the agreements or other documents that constitute exhibits to those
filings, at no cost, by writing or telephoning us at the following address or
phone number:
Assistant Secretary
Inamed Corporation
5540 Ekwill Street, Suite D
Santa Barbara, California 93111
Tel. No. (805) 692-5400
The Commission allows us to "incorporate by reference" in this prospectus
reports that we file with them, which means that we can disclose important
information to you by referring you to those reports. Accordingly, we are
incorporating by reference in this prospectus the documents listed below and any
11
<PAGE> 15
future filings we make with the Commission under Sections 13(a), 13(c), 14 or
15(d) of the Securities Exchange Act of 1934:
(1) Our Annual Report on Form 10-K for the year ended December 31, 1998;
(2) Our Quarterly Reports on Form 10-Q for the quarterly periods ended
March 31, 1999, June 30, 1999 and September 30, 1999;
(3) Our Quarterly Report on Form 10-Q/A for the quarterly period ended
June 30, 1999;
(4) Our Current Reports on Form 8-K dated February 1, 1999, March 4,
1999, March 19, 1999, April 2, 1999, May 10, 1999, September 15,
1999, November 19, 1999, December 30, 1999, January 6, 2000,
February 4, 2000, February 9, 2000 and February 14, 2000;
(5) Our Current Reports on Form 8-K/A dated March 27, 1998 and November
9, 1999;
(6) The description of our common stock set forth on our registration
statement filed with the Commission on May 2, 1973 on Form 10
pursuant to Section 12 of the Exchange Act, including any amendments
or reports filed for the purpose of updating such description; and
(7) Exhibit F to the Schedule 13D/A filed with the Commission by
Appaloosa Management L.P. on July 14, 1997.
The information incorporated by reference is deemed to be part of this
prospectus, except for any information superseded by information contained
directly in this prospectus. Any information that we file later with the
Commission will automatically update and supercede this information.
This prospectus constitutes a part of a registration statement on Form S-3
filed by us with the Commission under the Securities Act. This prospectus does
not contain all the information that is contained in the registration statement,
some of which we are allowed to omit in accordance with the rules and
regulations of the Commission. We refer to the registration statement and to the
exhibits filed with the registration statement for further information with
respect to Inamed. Copies of the registration statement and the exhibits to the
registration statement are on file at the offices of the Commission and may be
obtained upon payment of the prescribed fee or may be examined without charge at
the public reference facilities of the Commission described above. Statements
contained in this prospectus concerning the provisions of documents are
summaries of the material provisions of those documents, and each of those
statements is qualified in its entirety by reference to the copy of the
applicable document filed with the Commission. Since this prospectus may not
contain all of the information that you may find important, you should review
the full text of these documents.
12
<PAGE> 16
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 14. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION
The following table sets forth the estimated costs and expenses, other than
the underwriting discounts and commissions, payable by Inamed Corporation (the
"Registrant") in connection with the sale of the common stock being offered by
the selling stockholders.
<TABLE>
<CAPTION>
AMOUNT TO
BE PAID
---------
<S> <C>
SEC registration fee........................................ $ 21,384
Legal fees and expenses..................................... 50,000
Accounting fees and expenses................................ 20,000
Printing expenses........................................... 40,000
Miscellaneous............................................... 20,000
--------
Total............................................. $151,384
========
</TABLE>
ITEM 15. INDEMNIFICATION OF DIRECTORS AND OFFICERS
The Registrant is a Delaware corporation. Subsection (b)(7) of Section 102
of the Delaware General Corporation Law (the "DGCL") enables a corporation in
its original certificate of incorporation or an amendment thereto to eliminate
or limit the personal liability of a director to the corporation or its
stockholders for monetary damages for violations of the director's fiduciary
duty, except (i) for any breach of the director's duty of loyalty to the
corporation or its stockholders, (ii) for acts or omissions not in good faith or
which involve intentional misconduct or a knowing violation of law, (iii)
pursuant to Section 174 of the DGCL (providing for liability of directors for
unlawful payment of dividends or unlawful stock purchases or redemptions) or
(iv) for any transaction from which a director derived an improper personal
benefit. Article Fifteen of the Restated Certificate of Incorporation of the
Registrant provides that, to the fullest extent permitted by the DGCL, no
director of the Registrant shall be personally liable to the corporation or any
of its stockholders for monetary damages for breach of fiduciary duty as a
director.
The bylaws of the Registrant provide for the indemnification of directors
and officers on an individual basis upon a determination by the Board of
Directors that actions by a director or officer meet a certain standard of
conduct.
Subsection (a) of Section 145 of the DGCL empowers a corporation to
indemnify any director or officer, or former director or officer, who was or is
a party or is threatened to be made a party to any threatened, pending or
completed action, suit or proceeding, whether civil, criminal, administrative or
investigative (other than an action by or in the right of the corporation) by
reason of the fact that such person is or was a director or officer of the
corporation or is or was serving at the request of the corporation as a
director, officer, employee or agent of another corporation, partnership, joint
venture, trust or other enterprise, against expenses (including attorneys'
fees), judgments, fines and amounts paid in settlement actually and reasonably
incurred in connection with such action, suit or proceeding provided that such
director or officer acted in good faith in a manner reasonably believed to be
in, or not opposed to, the best interests of the corporation, and, with respect
to any criminal action or proceeding, provided further that such director or
officer has no reasonable cause to believe his conduct was unlawful.
Subsection (b) of Section 145 empowers a corporation to indemnify any
director or officer, or former director or officer, who was or is a party or is
threatened to be made a party to any threatened, pending or completed action or
suit by or in the right of the corporation to procure a judgment in its favor by
reason
II-1
<PAGE> 17
of the fact that such person acted in any of the capacities set forth above,
against expenses (including attorneys' fees) actually and reasonably incurred in
connection with the defense or settlement of such action or suit provided that
such director or officer acted in good faith and in a manner he reasonably
believed to be in, or not opposed to, the best interests of the corporation,
except that no indemnification may be made in respect of any claim, issue or
matter as to which such director or officer shall have been adjudged to be
liable to the corporation unless and only to the extent that the Court of
Chancery or the court in which such action or suit was brought shall determine
upon application that despite the adjudication of liability but in view of all
of the circumstances of the case, such director or officer is fairly and
reasonably entitled to indemnity for such expenses which the Court of Chancery
or such other court shall deem proper.
Section 145 further provides that (i) to the extent a director or officer
of a corporation has been successful in the defense of any action, suit or
proceeding referred to in subsections (a) and (b) or in the defense of any
claim, issue or matter therein, he shall be indemnified against expenses
(including attorneys' fees) actually and reasonably incurred by him in
connection therewith; and (ii) indemnification and advancement of expenses
provided for, by or granted pursuant to, Section 145 shall not be deemed
exclusive of any other rights to which the indemnified party may be entitled In
addition, Section 145 empowers the corporation to purchase and maintain
insurance on behalf of any person who is or was a director or officer of the
corporation, or is or was serving at the request of the corporation as a
director, officer, employee or agent of another corporation, partnership, joint
venture, trust or other enterprise against any liability asserted against him or
incurred by him in any such capacity, or arising out of his status as such,
whether or not the corporation would have the power to indemnify him against
such liabilities under Section 145.
ITEM 16. EXHIBITS
<TABLE>
<CAPTION>
EXHIBIT
NUMBER EXHIBIT DESCRIPTION
- ------- -------------------
<C> <S>
5.1 Opinion of Milbank, Tweed, Hadley & McCloy LLP with respect
to the validity of securities being offered.
23.1 Consent of Milbank, Tweed, Hadley & McCloy LLP (included in
Exhibit 5.1).
23.2 Consent of BDO Seidman, LLP, independent certified public
accountants.
23.3 Consent of Ernst & Young LLP, independent auditors.
24 Power of Attorney (included on the signature page of this
registration statement).
</TABLE>
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:
(a) To include any prospectus required by Section 10(a)(3) of the
Securities Act of 1933;
(b) 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 Securities and
Exchange Commission pursuant to Rule 424(b) if, in the aggregate, the
changes in volume and price represent no more than a 20 percent change in
the maximum aggregate offering price set forth in the "Calculation of
Registration Fee" table in the effective registration statement;
II-2
<PAGE> 18
(c) To include any material information with respect to the plan of
distribution not previously disclosed in the registration statement or any
material change to such information in the registration statement;
provided, however, that paragraphs (1)(a) and (1)(b) do not apply if the
registration statement is on Form S-3, Form S-8 or Form F-3, and the information
required to be included in a post-effective amendment by those paragraphs is
contained in periodic reports filed with or furnished to the Commission by the
registrant pursuant to Section 13 or 15(d) of the Securities Exchange Act of
1934 that are incorporated by reference in the registration statement.
(2) That, for the purpose of determining any liability under the Securities
Act, each 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
this offering.
(4) That, for purposes of determining any liability under the Securities
Act, each filing of the Registrant's annual report pursuant to Section 13(a) or
Section 15(d) of the Exchange Act of (and, where applicable, each filing of an
employee benefits plan's annual report pursuant to Section 15(d) of the Exchange
Act) that is incorporated by reference in the registration statement shall be
deemed to be a new registration statement relating to the securities offered
therein, and the offering of such securities at that time shall be deemed to be
the initial bona fide offering thereof.
Insofar as indemnification for liabilities arising under the Securities Act
may be permitted to directors, officers and controlling persons of the
Registrant pursuant to the foregoing provisions, or otherwise, the Registrant
has been advised that in the opinion of the Commission such indemnification is
against public policy as expressed in the Act and is, therefore, unenforceable.
In the event that a claim for indemnification against such liabilities (other
than the payment by the Registrant of expenses incurred or paid by a director,
officer or controlling person of the Registrant in the successful defense of any
action, suit or proceeding) is asserted by such director, officer or controlling
person in connection with the securities being registered, the Registrant will,
unless in the opinion of its counsel the matter has been settled by controlling
precedent, submit to a court of appropriate jurisdiction the question whether
such indemnification by it is against public policy as expressed in the Act and
will be governed by the final adjudication of such issue.
II-3
<PAGE> 19
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the Registrant
certifies that it has reasonable grounds to believe that it meets all of the
requirements for filing on Form S-3 and has duly caused this registration
statement to be signed on its behalf by the undersigned, thereunto duly
authorized, in Santa Barbara, California, on February 7, 2000.
INAMED CORPORATION
By: /s/ RICHARD G. BABBITT
--------------------------------------
Name: Richard G. Babbitt
Title: Chairman of the Board of
Directors and Chief Executive
Officer
POWER OF ATTORNEY
Pursuant to the requirements of the Securities Act, this registration
statement has been signed by the following persons in the capacities and on the
dates indicated. Each person whose name appears below hereby constitutes and
appoints each of Richard G. Babbitt and Ilan K. Reich, or any of them, each
acting alone, such person's true and lawful attorney-in-fact, with full power of
substitution to sign for such person and in such person's name and capacity
indicated below, in connection with this Registrant's registration statement on
Form S-3, including to sign this registration statement and any and all
amendments to this registration statement, including Post-Effective Amendments,
and to file the same with the Securities and Exchange Commission, hereby
ratifying and confirming such person's signature as it may be signed by said
attorneys-in-fact to any and all amendments.
<TABLE>
<CAPTION>
SIGNATURE TITLE DATE
- --------- ----- ----
<S> <C> <C>
/s/ RICHARD G. BABBITT Chairman of the Board of February 7, 2000
- --------------------------------------------------- Directors and Chief
Richard G. Babbitt Executive Officer
(Principal Executive
Officer)
/s/ JAMES E. BOLIN Director February 14, 2000
- ---------------------------------------------------
James E. Bolin
/s/ MALCOLM R. CURRIE, PH.D. Director February 7, 2000
- ---------------------------------------------------
Malcolm R. Currie, Ph.D.
/s/ JOHN F. DOYLE Director February 7, 2000
- ---------------------------------------------------
John F. Doyle
/s/ ILAN K. REICH Director and President February 7, 2000
- ---------------------------------------------------
Ilan K. Reich
/s/ MITCHELL S. ROSENTHAL, M.D. Director February 7, 2000
- ---------------------------------------------------
Mitchell S. Rosenthal, M.D.
/s/ DAVID A. TEPPER Director February 14, 2000
- ---------------------------------------------------
David A. Tepper
/s/ JOHN E. WILLIAMS, M.D. Director February 7, 2000
- ---------------------------------------------------
John E. Williams, M.D.
/s/ MICHAEL J. DOTY Senior Vice President and February 7, 2000
- --------------------------------------------------- Chief Financial Officer
Michael J. Doty (Principal Financial and
Accounting Officer)
</TABLE>
II-4
<PAGE> 20
EXHIBIT INDEX
<TABLE>
<CAPTION>
EXHIBIT
NUMBER EXHIBIT DESCRIPTION
- ------- -------------------
<C> <S>
5.1 Opinion of Milbank, Tweed, Hadley & McCloy LLP with respect
to the validity of securities being offered.
23.1 Consent of Milbank, Tweed, Hadley & McCloy LLP (included in
Exhibit 5.1).
23.2 Consent of BDO Seidman, LLP, independent certified public
accountants.
23.3 Consent of Ernst & Young LLP, independent auditors.
24 Power of Attorney (included on the signature page of this
registration statement).
</TABLE>
<PAGE> 1
Exhibit 5.1
Opinion of Milbank, Tweed, Hadley & McCloy LLP
February 11, 2000
Inamed Corporation
11 Penn Plaza, Suite 946
New York, NY 10001
Ladies and Gentlemen:
We have examined the registration statement on Form S-3 to be filed by you
with the Securities and Exchange Commission on or about February 11, 2000 (the
"Registration Statement") in connection with the registration under the
Securities Act of 1933 of shares of your common stock, par value $0.01 per share
(the "Shares"), to be offered and sold from time to time by the selling
stockholders identified in the Registration Statement.
Based on these examinations, it is our opinion that upon the completion of
the proceedings being taken, or which we, as your special counsel, contemplate
will be taken prior to the sale of the Shares, the Shares when offered and sold
in the manner referred to in the Registration Statement will be legally and
validly issued, fully paid and non-assessable.
The foregoing opinion is limited to matters involving the Federal laws of
the United States of America and the General Corporate Law of the State of
Delaware, and we do not express any opinion as to the laws of any other
jurisdiction.
We hereby consent to the filing of this opinion as an exhibit to the
Registration Statement and the reference to the name of our firm therein,
without thereby admitting that we are "experts" under the Securities Act of
1933, as amended, or the rules and regulations of the Securities and Exchange
Commission thereunder for the purposes of any part of the Registration
Statement.
Very truly yours,
/S/ Milbank, Tweed, Hadley & McCloy LLP
Milbank, Tweed, Hadley & McCloy LLP
RSR/ABP
<PAGE> 1
EXHIBIT 23.2
CONSENT OF INDEPENDENT
CERTIFIED PUBLIC ACCOUNTANTS
Inamed Corporation and subsidiaries
New York, New York
We hereby consent to the incorporation by reference in the Prospectus
constituting a part of this Registration Statement of our report dated February
12, 1999, except for note 14, which is as of March 3, 1999, relating to the
consolidated financial statements and schedule of Inamed Corporation and
subsidiaries appearing in the Company's Annual Report on Form 10-K for the year
ended December 31, 1998.
We also consent to the reference to us under the caption "Experts" in the
Prospectus.
/S/ BDO SEIDMAN, LLP
BDO SEIDMAN, LLP
New York, New York
February 7, 2000
<PAGE> 1
EXHIBIT 23.3
CONSENT OF ERNST & YOUNG LLP, INDEPENDENT AUDITORS
We consent to the reference to our firm under the caption "Experts" in the
Registration Statement (Form S-3) and related Prospectus of Inamed Corporation
for the registration of 2,000,000 shares of its common stock and to the
incorporation by reference therein of our report dated July 30, 1999, with
respect to the consolidated financial statements of Collagen Aesthetics, Inc.
included in the Form 8-K/A of Inamed Corporation filed with the Securities and
Exchange Commission on November 9, 1999.
Our audit also included the financial statement schedule of Collagen
Aesthetics, Inc. included in the Form 8-K of Inamed Corporation filed with the
Securities and Exchange Commission on February 4, 2000. This schedule is the
responsibility of Collagen's management. Our responsibility is to express an
opinion based on our audits. In our opinion, the financial statement schedule
referred to above, when considered in relation to the basic financial
statements taken as a whole, presents fairly in all material respects the
information set forth therein.
/s/ ERNST & YOUNG LLP
Palo Alto, California
February 4, 2000
