As filed with the Securities and Exchange Commission on October 15, 1997.
Registration No. 333-36005
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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON D.C. 20549
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PRE-EFFECTIVE
AMENDMENT NO. 1
TO
FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
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ANGEION CORPORATION
(Exact name of registrant as specified in its charter)
MINNESOTA 41-1579150
(State or other jurisdiction of (I.R.S. Employer Identification No.)
incorporation or organization)
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3650 ANNAPOLIS LANE, SUITE 170
MINNEAPOLIS, MINNESOTA 55447-5434
(612) 550-9388
(Address, including zip code, and telephone number,
including area code, of registrant's principal executive offices)
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DAVID L. CHRISTOFFERSON
3650 ANNAPOLIS LANE, SUITE 170
MINNEAPOLIS, MINNESOTA 55447-5434
(612) 550-9388
(Name, address, including zip code, and telephone number,
including area code, of agent for service)
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Copies to:
Thomas C. Thomas, Esq.
Oppenheimer Wolff & Donnelly
3400 Plaza VII
45 South Seventh Street
Minneapolis, Minnesota 55402
(612) 607-7000
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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.
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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. |_|
---------------
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 OF 1933 OR UNTIL THE REGISTRATION STATEMENT SHALL BECOME
EFFECTIVE ON SUCH DATE AS THE COMMISSION, ACTING PURSUANT TO SAID SECTION 8(a),
MAY DETERMINE.
================================================================================
<PAGE>
PROSPECTUS
100,000 SHARES
ANGEION CORPORATION
COMMON STOCK
-----------------------
This Prospectus relates to 100,000 shares of Common Stock, par value
$0.01 per share (the "Common Stock), of Angeion Corporation (the "Company"),
that may be offered for sale for the account of a certain shareholder of the
Company as stated herein under the heading "Selling Shareholder." The shares
being offered by the Selling Shareholder hereunder include 100,000 currently
outstanding shares of Common Stock issued to the Selling Shareholder in a
private transaction pursuant to a Common Stock Investment Agreement dated as of
September 2, 1997 between the Company and the Selling Shareholder (the
"Investment Agreement"). No period of time has been fixed within which the
shares covered by this Prospectus may be offered or sold.
The Selling Shareholder has advised the Company that sales of the
shares offered hereunder by it, or by its pledgees, donees, transferees or other
successors in interest, may be made from time to time in the over-the-counter
market, through negotiated transactions or otherwise, at market prices
prevailing at the time of sale or at negotiated prices. The shares may be sold
by one or more of the following methods: (a) a block trade in which the broker
or dealer so engaged will attempt to sell the shares as agent but may position
and resell a portion of the block as principal to facilitate the transaction;
(b) purchases by a broker or dealer as principal and resale by such broker or
dealer for its account pursuant to this Prospectus; and (c) ordinary brokerage
transactions and transactions in which the broker solicits purchasers. Sales may
be made pursuant to this Prospectus to or through broker-dealers who may receive
compensation in the form of discounts, concessions or commissions from the
Selling Shareholder or the purchasers of Common Stock for whom such
broker-dealer may act as agent or to whom they may sell as principal, or both
(which compensation as to a particular broker-dealer may be in excess of
customary commissions). To the extent required, one or more supplemental
prospectuses will be filed pursuant to Rule 424 under the Securities Act to
describe any material arrangements for the sales of the shares offered hereunder
when such arrangements are entered into by the Selling Shareholder and any other
broker-dealers that participate in the sale of the shares. In addition, any
shares that qualify for sale pursuant to Rule 144 under the Securities Act may
be sold under Rule 144 rather than pursuant to this Prospectus.
The Selling Shareholder and any broker-dealers or other persons acting
on its behalf in connection with the sale of Common Stock hereunder may be
deemed to be an "underwriter" within the meaning of the Securities Act, and any
commissions received by the Selling Shareholder and any profit realized by it on
the resale of Common Stock as principals may be deemed to be underwriting
commissions under the Securities Act. As of the date hereof, there are no
special selling arrangements between any broker-dealer or other person and the
Selling Shareholder.
The Company will not receive any part of the proceeds of any sales of
shares pursuant to this Prospectus. Pursuant to the terms of the Investment
Agreement, the Company will pay all the expenses of registering the shares,
except for selling expenses incurred by the Selling Shareholder in connection
with this offering, including any fees and commissions payable to broker-dealers
or other persons, which will be borne by the Selling Shareholder. In addition,
the Investment Agreement provides for certain other usual and customary terms,
including indemnification by the Company of the Selling Shareholder against
certain liabilities arising under the Securities Act.
THE SHARES OF COMMON STOCK OFFERED HEREBY INVOLVE CERTAIN RISKS. SEE
"RISK FACTORS" BEGINNING ON PAGE 5 OF THIS PROSPECTUS.
The Company's Common Stock is traded on the Nasdaq National Market
under the symbol "ANGN" On September 16, 1997, the last sale price of the Common
Stock on the Nasdaq National Market was $5.00 per share.
-----------------------
THESE SECURITIES HAVE NOT BEEN APPROVED OR DISAPPROVED BY THE
SECURITIES AND EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION
NOR HAS THE COMMISSION OR ANY STATE SECURITIES COMMISSION PASSED UPON
THE ACCURACY OR ADEQUACY OF THIS PROSPECTUS. ANY REPRESENTATION
TO THE CONTRARY IS A CRIMINAL OFFENSE.
-----------------------
THE DATE OF THIS PROSPECTUS IS ______________, 1997.
<PAGE>
No person has been authorized to give any information or to make any
representations not contained or incorporated by reference in this Prospectus in
connection with the offer described in this Prospectus and, if given or made,
such information and representations must not be relied upon as having been
authorized by the Company or the Selling Shareholder. Neither the delivery of
this Prospectus nor any sale made under this Prospectus shall under any
circumstances create any implication that there has been no change in the
affairs of the Company since the date hereof or since the date of any documents
incorporated herein by reference. This Prospectus does not constitute an offer
to sell or a solicitation of an offer to buy any securities other than the
securities to which it relates, or an offer or solicitation in any state to any
person to whom it is unlawful to make such offer in such state.
AVAILABLE INFORMATION
The Company is subject to the informational requirements of the
Securities Exchange Act of 1934 (the "Exchange Act") and, in accordance
therewith, files reports, proxy statements and other information with the
Securities and Exchange Commission (the "Commission"). Such reports, proxy
statements and other information filed by the Company pursuant to the Exchange
Act may be inspected and copied at the public reference facilities maintained by
the Commission at Judiciary Plaza, 450 Fifth Street, N.W., Washington, D.C.
20549 and at the regional offices of the Commission located at Seven World Trade
Center, Suite 1300, New York, New York 10048 and Citicorp Center, 500 West
Madison Street, Suite 1400, Chicago, Illinois 60661. Copies of such material can
also be obtained from the Public Reference Section of the Commission at
Judiciary Plaza, 450 Fifth Street, N.W., Washington, D.C. 20549, at prescribed
rates. In addition, the Commission maintains a Web site that contains reports,
proxy and information statements and other information regarding registrants
that file electronically with the Commission. The address of the Commission's
Web site is http://www.sec.gov.
The Company has filed with the Commission a Registration Statement on
Form S-3 under the Securities Act. This Prospectus does not contain all of the
information, exhibits and undertakings set forth in the Registration Statement,
certain portions of which are omitted as permitted by the Rules and Regulations
of the Commission. Copies of the Registration Statement and the exhibits are on
file with the Commission and may be obtained, upon payment of the fee prescribed
by the Commission, or may be examined, without charge, at the offices of the
Commission set forth above. For further information, reference is made to the
Registration Statement and its exhibits.
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
The following documents filed with the Commission by the Company (File
No. 0-17019) are incorporated by reference in this Prospectus: (1) the Company's
Annual Report on Form 10-K for the year ended July 31, 1996; (2) the Company's
Quarterly Reports on Form 10-Q for the quarters ended October 31, 1996, January
31, 1997 and April 30, 1997; (3) the Company's Current Report on Form 8-K, as of
April 3, 1997; (4) all other reports filed by the Company pursuant to Sections
13(a) or 15(d) of the Exchange Act since July 31, 1996; (5) the description of
the Company's Common Stock contained in its Registration Statement on Form 8-A
and any amendments or reports filed for the purpose of updating such
description; and (6) the description of the Company's Series B Junior Preferred
Stock and rights to purchase Series B Junior Preferred Stock contained in its
Registration Statement on Form 8-A and any amendments or reports filed for the
purpose of updating such description.
All documents filed by the Company pursuant to Sections 13(a), 13(c),
14 or 15(d) of the Exchange Act after the date of this Prospectus and prior to
the termination of the offering hereunder shall be deemed to be incorporated by
reference in this Prospectus and to be a part hereof from the date of
<PAGE>
filing of such documents. Any statement contained herein or in a document all or
any portion of which is incorporated or deemed to be incorporated by reference
herein shall be deemed to be modified or superseded for purposes of this
Prospectus to the extent that a statement contained herein or in any other
subsequently filed document which also is or is deemed to be incorporated by
reference herein modifies or supersedes such statement. Any such statement so
modified or superseded shall not be deemed, except as so modified or superseded,
to constitute a part of this Prospectus.
The Company will provide, without charge, to each person to whom a copy
of this Prospectus is delivered, upon written or oral request of such person, a
copy of any or all of the documents referred to above which are incorporated by
reference in this Prospectus (other than exhibits to such documents unless such
exhibits are specifically incorporated by reference into the information that
this Prospectus incorporates). Requests should be directed to Angeion
Corporation, 3650 Annapolis Lane, Suite 170, Minneapolis, Minnesota 55447,
Attention: David L. Christofferson; telephone (612) 550-9388.
<PAGE>
THE COMPANY
THIS PROSPECTUS CONTAINS CERTAIN FORWARD-LOOKING STATEMENTS. FOR THIS
PURPOSE, ANY STATEMENTS CONTAINED IN THIS PROSPECTUS THAT ARE NOT STATEMENTS OF
HISTORICAL FACT MAY BE DEEMED TO BE FORWARD-LOOKING STATEMENTS. WITHOUT LIMITING
THE FOREGOING, WORDS SUCH AS "MAY," "WILL," "EXPECT," "BELIEVE," "ANTICIPATE,"
"ESTIMATE" OR "CONTINUE" OR THE NEGATIVE OR OTHER VARIATIONS THEREOF OR
COMPARABLE TERMINOLOGY ARE INTENDED TO IDENTIFY FORWARD-LOOKING STATEMENTS.
THESE STATEMENTS BY THEIR NATURE INVOLVE SUBSTANTIAL RISKS AND UNCERTAINTIES,
AND ACTUAL RESULTS MAY DIFFER MATERIALLY DEPENDING ON A VARIETY OF FACTORS,
INCLUDING THOSE DESCRIBED UNDER THE CAPTION "RISK FACTORS."
GENERAL
Angeion Corporation designs, develops and manufactures products that
treat irregular heartbeats (arrhythmias). The Company is developing the
SENTINEL(TM) series of implantable cardioverter defibrillators ("ICDs"), which
it believes are among the smallest and most technologically advanced ICDs in
clinical studies or market approved today. ICDs are designed to treat abnormally
rapid heartbeats in the ventricular (or lower) chambers of the heart, a
condition known as ventricular tachycardia ("VT"), and a severe form of VT known
as ventricular fibrillation ("VF"), which if not terminated will lead to sudden
cardiac death ("SCD"). ICDs are electronic devices that are implanted within the
body and are connected to the heart with defibrillator leads. These devices
monitor the patient's heartbeat and, in the event of VT or VF, deliver an
electrical shock to return the heartbeat to normal rhythm.
The Company is also developing a radio frequency ("RF") catheter
ablation system that it believes offers a potential cure for certain forms of
atrial arrhythmias (rapid heartbeats originating in the upper chambers of the
heart) and a laser catheter ablation system that it believes offers a potential
cure for certain forms of VT.
The Company was incorporated in Minnesota in May 1986. The Company's
principal executive offices are located at 3650 Annapolis Lane, Suite 170,
Minneapolis, Minnesota 55447-5434, and its telephone number at that location is
(612) 550-9388.
RECENT DEVELOPMENTS
In October 1997, the Company entered into an Investment and Master
Strategic Relationship Agreement ("Investment Agreement") with Synthelabo, a
French pharmaceutical group, pursuant to which Synthelabo will purchase $15
million in Common Stock at a price equal to a premium to the trading price
formula with respect to the Common Stock as of the initial closing. In addition,
Synthelabo will purchase up to an additional $15 million in Common Stock (in
installments of $5 million) at a price equal to a premium to the then current
trading price formula with respect to the Common Stock upon the achievement by
the Company of certain milestones. In connection with each tranche of Common
Stock purchased, Synthelabo will also receive warrants to purchase, at the
applicable investment price, shares of Common Stock equal to 60% of the number
of shares purchased. The Investment Agreement limits Synthelabo's ownership of
Common Stock to 19.9% of the total outstanding shares, subject to certain
anti-dilution adjustments. In connection with such investment, Synthelabo will
be entitled to certain pre-emptive rights, registration rights and anti-dilution
protection and will be subject to certain standstill provisions. Synthelabo will
also be entitled to nominate one person to serve as a director of the Company.
<PAGE>
In connection with the Investment Agreement, the Company also entered
into a Manufacturing and Supply Agreement with ELA Medical, S.A., a subsidiary
of Synthelabo ("ELA Medical"), which provides for the distribution and sale of
the Company's ICD systems and support equipment by ELA Medical in international
markets. The Company's ICD products will be distributed under ELA Medical's
trademarks by ELA Medical's established global direct sales and distribution
network which services over 20 countries worldwide. In addition, the Company
entered into a U.S. Joint Venture Agreement with ELA Medical which provides for
the formation of a U.S.-based joint venture company which will combine the two
companies' sales and marketing functions and serve as the U.S. selling
organization for both parties. The joint venture company will offer a complete
line of cardiac rhythm management products including single and dual chamber ICD
systems for the rapidly growing tachyarrhythmia management market, as well as
pacemaker and lead systems for the established bradyarrhythmia market. The joint
venture company will be owned 50% by each party, and each party will have the
right to designate one-half of the directors. Dennis A. Sellke, a current
director of the Company, will cease to serve as a director of the Company and
will serve as the chief executive officer of the joint venture company,
reporting to the board of directors of the joint venture company. The strategic
relationship between the Company and Synthelabo is subject to approval by the
Federal Trade Commission and the expiration of the waiting period under the
Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.
RISK FACTORS
The following risk factors relating to the Company should be considered
in evaluating an investment in the Common Stock.
CONTINUING OPERATING LOSSES; PROFITABILITY UNCERTAIN; FLUCTUATIONS IN OPERATING
RESULTS
The Company has incurred net operating losses from continuing
operations in each year since its inception in 1986, due primarily to costs
incurred in the research and development of the Company's products, and the
Company expects to incur additional operating losses over the next several years
as the Company continues to fund research and development (including clinical
trials) relating to its ICDs and catheter ablation systems. The Company has had
no significant revenue since the sale of its Angeion Medical Products division
("AMP") in September 1992. The Company expects to incur additional operating
losses over the next several years as the Company continues to fund research and
development (including clinical trials) relating to its ICDs and catheter
ablation systems and invests in building its manufacturing and marketing
capabilities. The Company's ability to achieve profitability is dependent in
part on obtaining regulatory approvals for its products and developing the
capacity to manufacture and sell its products successfully. There can be no
assurance that the Company will obtain the required regulatory approvals on a
timely basis, if at all; successfully develop, commercialize, manufacture and
market its products; or achieve profitability. In addition, the Company's
results of operations may fluctuate significantly from quarter to quarter
depending upon a number of factors, including the availability of third party
reimbursement, the timing of regulatory approvals, progress of product
development and clinical trials, the extent to which the Company's products gain
market acceptance, marketing and manufacturing costs and competition.
<PAGE>
COMPETITION
Competition in the ICD market is intense. Although the Company's ICDs
will also compete with alternative treatments for VT such as drug therapy, open
heart surgery and cardiac ablation, the Company believes that ICD manufacturers
constitute its primary competition. Three companies (Medtronic, Inc.), Cardiac
Pacemakers, Inc. ("CPI"), a division of Guidant Corporation, and Pacesetter,
Inc., a wholly owned subsidiary of St. Jude Medical, Inc. ("Pacesetter")
currently have PMA-approved products in the ICD market and control virtually all
of that market today.
Any product developed by the Company that gains regulatory approval
will have to compete for market acceptance and market share. The timing of
market introduction of competitive products could adversely affect the
competitiveness of the Company's products. Accordingly, the relative speed with
which the Company can develop products, complete clinical testing and the
regulatory approval process and supply commercial quantities of the product to
the market are expected to be important competitive factors. The Company expects
that competition will also be based on device size and weight, longevity, ease
of programmability, ability to provide diagnostic capability, product
reliability, physician familiarity with the device, patent protection, sales and
marketing capability, third-party reimbursement policies, reputation and price.
There can be no assurance that FDA approval will be obtained for the Company's
ICDs, that competitors will not introduce new products with similar features or
that the market will accept the Sentinel series. Most of the Company's
competitors in the ICD market, however, have greater financial, manufacturing,
marketing, distribution and technical resources and greater name recognition
than the Company.
Although catheter ablation offers a potential cure, rather than a
treatment, of VT, catheter ablation technologies must nonetheless compete with
drug therapy, open heart surgery and ICDs. A number of companies, certain of
which have significantly greater resources than the Company, have developed RF
catheter ablation devices to treat SVT. There can be no assurance that
competitors of the Company will not be able to develop and introduce cardiac
ablation systems more quickly than the Company or systems that may be more
effective in treating SVT and VT than the Company's cardiac ablation systems. In
addition, there can be no assurance that the Company's catheter ablation systems
will receive FDA approval or, if approved, that the market will accept such
systems. In addition, catheter ablation technologies also compete with drug
therapy. While historically drug therapy has had limited effectiveness and
caused adverse side effects, new drugs under development may offer improved
treatment outcomes.
IMPORTANCE OF INTELLECTUAL PROPERTY PROTECTION
Patents and trademarks are critical in the medical device industry.
Although the Company has a number of U.S. and foreign patents and patent
applications, and also owns certain registered trademarks or has applied for
other trademarks in the U.S. and certain foreign countries, there can be no
assurance, however, that patents and trademarks will be granted in the future,
or that any patents and trademarks that the Company now holds or may be granted
or under which it has been granted licenses will be valid or otherwise be of
value to the Company. Even if the Company's patents and trademarks are valid,
others may be able to introduce non-infringing products that are competitive
with those of the Company.
Regardless of the Company's efforts to evaluate the potential
infringement of any proprietary rights of third parties, however, there can be
no assurance that such infringements do not exist or may not arise in the
future. There has been substantial litigation regarding patent and other
intellectual property rights in the medical device industry, particularly in the
ICD market. Litigation, which could result in
<PAGE>
substantial cost to and diversion of effort by the Company, may be necessary to
enforce patents issued to or licensed by the Company, to protect trade secrets
or know-how owned by the Company or to defend the Company against claimed
infringement of the rights of others and to determine the scope and validity of
the proprietary rights of others. Adverse determinations in litigation could
subject the Company to significant liabilities to third parties or could require
the Company to seek licenses from third parties.
Although patent and intellectual property disputes in the medical
device area have often been settled through licensing or similar arrangements,
costs associated with such arrangements may be substantial and there can be no
assurance that necessary licenses would be available to the Company on
satisfactory terms or at all. Accordingly, an adverse determination in a
judicial or administrative proceeding or failure to obtain necessary licenses
could prevent the Company from manufacturing and selling its products, which
would have a material adverse effect on the Company's business, financial
condition and results of operations.
The Company also relies on trade secrets and proprietary know-how,
which it seeks to protect, in part, through confidentiality agreements with
employees, consultants and other parties. There can be no assurance, however,
that these agreements will not be breached, that the Company would have adequate
remedies for any breach, or that the Company's trade secrets will not otherwise
become known to or independently developed by competitors.
LACK OF PMA APPROVAL; LIMITED INITIAL REVENUES; COMPLIANCE WITH GOVERNMENT
REGULATIONS
The medical products the Company intends to market are subject to
regulations in the U.S. by the FDA. The process of complying with such
regulations with respect to new products can be costly and time-consuming. The
first stage of obtaining formal FDA pre-market approval is submission of an
application to an Investigational Device Exemption ("IDE"). To obtain an IDE,
approval of the investigational plan for the applicable system is required from
the institutional review board within each participating medical institution as
well as from the FDA.
The Company's ICD products and its catheter ablation systems are also
subject to a lengthy and expensive pre-market approval process with the FDA.
Such process requires the Company to conduct lengthy human clinical trials with
respect to its products. The data collected in clinical trials (both in and
outside the U.S.) are used to prepare the Pre-Market Approval ("PMA")
applications for such products. If such PMA applications are accepted for filing
by the FDA, they will be reviewed further by the FDA and subsequently by the FDA
Circulatory System Devices Panel. After considering the panel's recommendation,
the FDA will determine whether to approve such PMA applications. Approval of the
Company's applications for PMAs for the Sentinel series and its catheter
ablation systems will depend on a wide variety of factors, many of which are
outside the Company's control. Approval will also require an inspection by the
FDA to determine whether the Company's operations conform with the FDA's current
Good Manufacturing Practices. There can be no assurance that the Company will be
successful in obtaining a PMA for its products, in a timely manner, or at all.
Delays in obtaining marketing approvals and clearances in the U.S. could have
significant adverse consequences on the Company and its operations. The Company
is also subject to certain FDA regulations governing manufacturing practices,
packaging and labeling, and failure to comply with these requirements could have
a material adverse effect on the Company.
Until the Company receives PMA approval, the Company will be subject to
FDA-imposed limitations on the number of ICD implants and catheter ablation
procedures that may be performed as well as the number and location of clinical
sites at which implants and procedures may be performed. As
<PAGE>
the Company approaches these limitations, it would be required to apply to the
FDA for approval of additional implants and procedures, but there can be no
assurance that such approval will be received on a timely basis, if at all. The
Company would be unable to sell additional ICDs systems or conduct additional
catheter ablation procedures in the U.S. should it reach the limits authorized
by the FDA. The timing of both the IDE and PMA review processes is unpredictable
and uncertain, and the failure to obtain the necessary approvals on a timely
basis would have a material adverse effect on the Company.
The Company's products are also subject to regulation by agencies
comparable to the FDA in foreign countries. Although the Company has obtained a
CE Mark for the Sentinel 2000 that allows the Company to commence marketing of
the Sentinel 2000 in countries that are members of the EU and the European Free
Trade Association, subject to limited regulations in certain countries, there
can be no assurance that the Company will be successful in obtaining CE Mark
approval for any other products on a timely basis or at all, which could have a
material adverse effect on the Company.
NEED FOR MARKET ACCEPTANCE
Market acceptance of the Company's products will depend, in part, on
the therapeutic capabilities and operating features of its products as compared
to competing products, the Company's ability to convince the medical community
of the clinical efficacy of its products and its ability to gain market
acceptance would have a material adverse effect on the Company's business,
financial condition and results of operations. Although the markets for the
Company's products are expected to grow, there can be no assurance that the
Company will participate in such growth.
DEPENDENCE ON SENIOR MANAGEMENT AND OTHER KEY PERSONNEL
The Company's success depends largely on its senior management and
other key personnel. Competition for personnel with significant experience in
the medical device industry is intense. Accordingly, the loss of the services of
such individuals or the inability to hire additional key individuals as required
could have a material adverse effect on the Company, including its current and
future product development efforts. The Company has purchased $2.0 million
key-person life insurance policy on its Chairman, President and Chief Executive
Officer.
UNCERTAINTY OF THIRD PARTY REIMBURSEMENT AND HEALTH CARE REFORM
The Company's ability to market its products successfully in the U.S.
will depend in part on the extent to which reimbursement for the cost of such
products and related treatment will be available from government health
administration authorities (such as the Health Care Financing Administration
("HCFA"), which determines Medicare reimbursement levels), private health
insurers, health maintenance organizations and other third-party payors. Payors
are increasingly challenging the need for and prices of medical products and
services. Payors may deny reimbursement for procedures that they deem
experimental or for devices that are used other than for FDA-approved
indications. Currently, HCFA does not allow Medicare reimbursement for certain
kinds of products and related procedures that have not received PMA approval and
for which underlying questions of safety and effectiveness have not been
resolved, and certain private third-party payors have also begun denying such
reimbursement. Although the Company's products are currently being reimbursed by
HCFA and third-party payors, there can be no assurance that HCFA and the
third-party payors will continue to reimburse such products in the future. Even
if some products are approved for reimbursement, some payors may deny coverage
until the procedure becomes generally accepted by the medical profession. The
inability of hospitals and
<PAGE>
other providers to obtain reimbursement from third-party payors for the
Company's products and related procedures would have a material adverse effect
on the Company.
The Company expects that there will be continued pressure on
cost-containment throughout the U.S. health care system. Reforms may include
mandated basic health care benefits, controls on health care spending through
limitations on the growth of private health insurance premiums and Medicare and
Medicaid spending, the creation of large insurance purchasing groups and
fundamental changes to the health care delivery system. The Company anticipates
that Congress and state legislatures will continue to review and assess
alternative health care delivery systems and payment methodologies and public
debate of these issues will likely continue in the future. Due to uncertainties
regarding the ultimate features of reform initiatives and their enactment and
implementation, the Company cannot predict which, if any, of such reform
proposals will be adopted, when they may be adopted or what impact they may have
on the Company.
NEED FOR ADDITIONAL FINANCING
The Company may need additional financing depending on a number of
factors, including (i) progress with clinical trials; (ii) time and costs
involved in obtaining regulatory approvals; (iii) costs involved in filing,
prosecuting and enforcing patents or defending against patent infringement
claims; (iv) competing technological and market developments; (v) costs of
manufacturing and marketing scale-up; and (vi) acquisitions of products and
technologies. To the extent that additional financing is needed, however, there
can be no assurance that such additional financing would be available on
acceptable terms or at all, and the failure to obtain any such additional
financing would have a material adverse effect on the Company.
DEPENDENCE ON THIRD PARTY VENDORS
The Company relies on third party vendors for certain of the components
used in the Company's products and for certain contract manufacturing services.
A number of key components, such as capacitors, batteries, integrated circuits
and lead systems, are purchased from sole source suppliers. For certain
components and manufacturing services, there are relatively few alternative
sources of supply, and establishing additional or replacement suppliers for such
components or services cannot be accomplished quickly. In addition, each
supplier and each component must be qualified with the FDA, and the time
required for such qualification may be lengthy. Although the Company tries to
maintain sufficient quantities of inventory of such components to minimize
production delays or interruptions, there can be no assurance that the Company
will find suitable alternatives at reasonable prices, if at all, or that any
such alternatives will remain available to the Company. The Company's inability
to obtain acceptable components in a timely manner or find and maintain suitable
replacement suppliers of components or manufacturing services would have a
material adverse effect on the Company, including its ability to manufacture its
products.
LIMITED MANUFACTURING AND MARKETING EXPERIENCE
To date, the Company's products have been manufactured in limited
quantities for clinical testing purposes and European market sales and have not
been manufactured on a commercial scale. As a result, there can be no assurance
that the Company will not encounter difficulties in scaling up its manufacturing
capabilities, including problems involving production yields, quality control,
component supply and shortages of qualified manufacturing personnel. Any
significant manufacturing difficulties could have a material adverse effect on
the Company.
<PAGE>
Management of the Company has limited experience in marketing the
Company's ICD and catheter ablation products, sales of which to date have
consisted of limited quantities for use in clinical trials and European market
sales. There can be no assurance that the Company will be able to recruit and
retain the necessary sales managers, direct salespersons or distributors needed
or that the Company's efforts to scale up its marketing capabilities will be
successful.
POSSIBLE OBSOLESCENCE DUE TO TECHNOLOGICAL CHANGE
The medical device industry is subject to rapid technological
innovation and, consequently, the life cycle of a particular product tends to be
relatively short. The life cycle of ICDs has been reduced significantly within
the last two years. The Company is engaged in a field characterized by extensive
research and development efforts. There can be no assurance that alternative
treatments or other discoveries and developments with respect to ICDs or
catheter ablation systems will not render the Company's products obsolete. The
greater financial and other resources of many of the Company's competitors may
permit such competitors to respond more rapidly than the Company to
technological advances.
POTENTIAL INSUFFICIENCY OF PRODUCT LIABILITY INSURANCE
The testing, manufacturing, marketing and sale of medical devices
involves risk of liability claims and product recalls. As a result, the Company
currently carries product liability insurance covering its products with policy
limits of $25.0 million per occurrence and $25.0 million in the aggregate. It
cannot be predicted, however, whether such insurance is sufficient, or if not,
whether the Company will be able to obtain such insurance as is sufficient, to
cover the risks associated with the Company's business or whether such insurance
will be available at premiums that are commercially reasonable. Lack of
sufficient insurance could expose the Company to substantial damages in
connection with product liability claims or product recalls.
ANTI-TAKEOVER CONSIDERATIONS
The Company's Restated Articles of Incorporation (i) authorize the
Company's Board of Directors, without any action by the shareholders, to
establish the rights and preferences of up to 3,000,000 shares of undesignated
preferred stock (of which 2,700,000 shares remain undesignated as of the date of
this Prospectus) and (ii) provide that the affirmative vote of at least
two-thirds of the voting power of the shares entitled to vote is necessary in
connection with a merger, consolidation or transfer of substantially all of the
Company's assets. The Company also is subject to certain "anti-takeover"
provisions of the Minnesota Business Corporations Act. In addition, in April
1996 the Company's Board of Directors adopted a Shareholder Rights Plan
designated to protect the Company and its shareholders from unsolicited attempts
or inequitable offers to acquire the Company. These measures may, in certain
circumstances, deter or discourage takeover attempts and other changes in
control of the Company not approved by the Board. As a result, the Company's
shareholders may lose opportunities to dispose of their shares at the higher
prices generally available in takeover attempts or that may be available under a
merger proposal. In addition, these measures may have the effect of permitting
the Company's current members of the Board to retain their positions and place
them in a better position to resist changes that shareholders may wish to make
if they are dissatisfied with the conduct of the business of the Company.
<PAGE>
LACK OF PROSPECTIVE DIVIDENDS
The Company has not paid dividends on its Common Stock and does not
anticipate paying cash dividends in the foreseeable future. The Company intends
to retain any earnings to finance the development of its business. In addition,
as long as shares of Preferred Stock are outstanding, in the event that
dividends are paid on the Common Stock, holders of such Preferred Stock shall be
entitled to an equivalent dividend on the basis of the number of shares of
Common Stock into which the Preferred Stock is then convertible. There can be no
assurance that the Company will ever pay cash dividends.
VOLATILITY OF STOCK PRICE
The market prices for securities of medical device companies have
historically been highly volatile, including the market price of shares of the
Company's Common Stock. Future announcements by the Company or its competitors,
including announcements concerning strategic collaborations, results of clinical
testing, technological innovations or new commercial products, changes in
government regulations, regulatory actions, health care legislation, proprietary
rights, litigation and public concerns as to safety of the Company's or its
competitors' products, as well as period-to-period variances in financial
results, could cause the market price of the Common Stock to fluctuate
substantially for reasons that may be unrelated or disproportionate to the
operations of the Company.
<PAGE>
SELLING SHAREHOLDER
This Prospectus relates to the offering of 100,000 shares of Common
Stock of the Company by the Selling Shareholder named below. The shares being
offered by the Selling Shareholder hereunder include 100,000 currently
outstanding shares of Common Stock issued to the Selling Shareholder in a
private transaction pursuant to a Common Stock Investment Agreement dated as of
September 2, 1997 (the "Investment Agreement") between the Company and the
Selling Shareholder. The Company agreed to provide registration rights pursuant
to the Investment Agreement that require the Company to register the 100,000
shares of Common Stock issued to the Selling Shareholder. The 100,000 shares of
Common Stock have been registered hereunder pursuant to such registration
rights. The following table sets forth certain information, as of September 16,
1997, and as adjusted to reflect the sale of the shares offered hereby, with
respect to the beneficial ownership of the Common Stock by the Selling
Shareholder. The Selling Shareholder possesses sole voting and investment power
with respect to the shares shown.
<TABLE>
<CAPTION>
SHARES BENEFICIALLY
OWNED AFTER
SHARES OF COMMON NUMBER OF COMPLETION OF
STOCK BENEFICIALLY SHARES THE OFFERING (2)
OWNED PRIOR TO THE BEING -----------------------------
SELLING SHAREHOLDER OFFERING (1) OFFERED NUMBER % OF CLASS (3)
- ------------------- ------------ ------- ------ --------------
<S> <C> <C> <C> <C>
Promethean Investment Group, L.L.C. 100,000 100,000 0 *
</TABLE>
- --------------------------------------
* Less than one percent (1%)
(1) Shares not outstanding but deemed beneficially owned by virtue of the right
of a person or member of a group to acquire them within 60 days are treated as
outstanding only when determining the amount and percentage owned by such person
or group.
(2) This assumes all shares being offered and registered hereunder are sold,
although the Selling Shareholder is not obligated to sell any shares.
(3) Based upon 30,692,383 shares of Common Stock outstanding as of September 16,
1997.
VALIDITY OF COMMON STOCK
The validity of the shares of Common Stock offered hereby will be
passed upon for the Company by Oppenheimer Wolff & Donnelly, Minneapolis,
Minnesota.
EXPERTS
The consolidated financial statements of the Company as of July 31,
1996 and 1995, and for each of the three years in the period ended July 31,
1996, incorporated by reference in this Prospectus, have been audited by KPMG
Peat Marwick LLP, independent certified public accountants. Such consolidated
financial statements have been incorporated by reference in this Prospectus in
reliance upon the report of KPMG Peat Marwick LLP, incorporated by reference
herein, and upon the authority of such firm as experts in accounting and
auditing. To the extent that KPMG Peat Marwick LLP audits and reports on the
consolidated financial statements of the Company issued at future dates and
consents to the use of their reports thereon, such consolidated financial
statements also will be incorporated by reference in this Prospectus in reliance
upon their report and said authority.
<PAGE>
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
Pre-Effective Amendment No. 1 to Registration Statement to be signed on its
behalf by the undersigned, thereunto duly authorized, in the City of Minneapolis
and State of Minnesota, on October 14, 1997.
ANGEION CORPORATION
By /s/ Whitney A. McFarlin
-------------------------------------
Whitney A. McFarlin
President and Chief Executive Officer
Pursuant to the requirements of the Securities Act of 1933, this
Registration Statement has been signed by the following persons on October 14,
1997 in the capacities indicated.
SIGNATURE TITLE
--------- -----
/s/ Whitney A. McFarlin Chairman of the Board, President and Chief
- ----------------------------- Executive Officer (principal executive officer)
Whitney A. McFarlin
* Vice President, Chief Financial Officer and
- ----------------------------- Secretary (principal financial and accounting
David L. Christofferson officer)
* Director
- -----------------------------
Arnold A. Angeloni
* Director
- -----------------------------
Dennis E. Evans
* Director
- -----------------------------
Lyle D. Joyce, M.D., Ph.D.
* Director
- -----------------------------
Joseph C. Kiser, M.D.
* Director
- -----------------------------
Donald Maurer
* Director
- -----------------------------
Dennis L. Sellke
* Director
- -----------------------------
Glen Taylor
* By /s/ Whitney A. McFarlin
-------------------------
Whitney A. McFarlin
Attorney-in-Fact
