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As filed with the Securities and Exchange Commission on April 2, 1998
Registration No. 333-
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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM S-3
REGISTRATION STATEMENT
Under
The Securities Act of 1933
MEDI-JECT CORPORATION
(Exact name of registrant as specified in its charter)
MINNESOTA 41-1350192
(State or other jurisdiction of (I.R.S Employer Identification No.)
incorporation or organization)
161 CHESHIRE LANE, SUITE 100
MINNEAPOLIS, MINNESOTA 55441
(612) 475-7700
(Address, including zip code, and telephone number, including area code, of
registrant's principal executive offices)
FRANKLIN PASS, M.D. Copy to: AMY E. AYOTTE, ESQ.
MEDI-JECT CORPORATION DORSEY & WHITNEY LLP
161 CHESHIRE LANE, SUITE 100 220 SOUTH SIXTH STREET
MINNEAPOLIS, MINNESOTA 55441 MINNEAPOLIS, MINNESOTA 55402
(612) 475-7700 (612) 340-6323
(Name, address, including zip code, and telephone number,
including area code, of agent for service)
Approximate date of commencement of proposed sale to the public: From
time to time after the effective date of this Registration Statement.
If the only securities being registered on this Form are being offered
pursuant to dividend or interest reinvestment plans, please check the following
box. [ ]
If any of the securities being registered on this Form are to be
offered on a delayed or continuous basis pursuant to Rule 415 under the
Securities Act of 1933, other than securities offered only in connection with
dividend or interest reinvestment plans, check the following box. [x]
If this Form is filed to register additional securities for an offering
pursuant to Rule 462(b) under the Securities Act, please check the following box
and list the Securities Act registration statement number of the earlier
effective registration statement for the same offering. [ ]
If this Form is a post-effective amendment filed pursuant to Rule
462(c) under the Securities Act, check the following box and list the Securities
Act registration statement number of the earlier effective registration
statement for the same offering. [ ]
If delivery of the prospectus is expected to be made pursuant to Rule
434, please check the following box. [ ]
CALCULATION OF REGISTRATION FEE
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Proposed Proposed
Title of Each Amount Maximum Maximum Amount of
Class of Securities to be Offering Price Aggregate Registration
to be Registered Registered Per Share* Offering Price* Fee
- -------------------- ---------- ---------- --------------- ------------
Common Stock
($.01 par value) 1,224,199 $1-11/16 $2,065,836 $609.42
================================================================================
* Estimated solely for purposes of computing the registration fee and
based upon the average of the high and low sales prices for such Common
Stock on April 1, 1998, as reported on the Nasdaq National Market.
THE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE
OR DATES AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT
SHALL FILE A FURTHER AMENDMENT WHICH SPECIFICALLY STATES THAT THIS REGISTRATION
STATEMENT SHALL THEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH SECTION 8(A) OF
THE SECURITIES ACT OF 1933 OR UNTIL THE REGISTRATION STATEMENT SHALL BECOME
EFFECTIVE ON SUCH DATE AS THE COMMISSION, ACTING PURSUANT TO SAID SECTION 8(A),
MAY DETERMINE.
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Subject to Completion, dated April 2, 1998
PROSPECTUS
MEDI-JECT CORPORATION
--------------------
1,224,199 SHARES
OF
COMMON STOCK
($.01 PAR VALUE)
--------------------
This Prospectus relates to an aggregate of 1,224,199 shares (the
"Shares") of Common Stock, par value $.01 per share (the "Common Stock"), of
Medi-Ject Corporation, a Minnesota corporation ("Medi-Ject" or the "Company"),
that may be sold from time to time by the shareholder named herein (the "Selling
Shareholder"). See "Selling Shareholder." The Company will not receive any
proceeds from the sale of the Shares. The Company has agreed to pay the expenses
of registration of the Shares, including certain legal and accounting fees.
Any or all of the Shares may be offered from time to time in
transactions on the Nasdaq National Market, in brokerage transactions at
prevailing market prices or in transactions at negotiated prices. See "Plan of
Distribution."
The Shares offered hereby have not been registered under the blue sky
or securities laws of any jurisdiction, and any broker or dealer should assure
the existence of an exemption from registration or effectuate such registration
in connection with the offer and sale of the Shares.
The Common Stock is traded on the Nasdaq National Market under the
symbol "MEDJ." On April 1, 1998, the last reported sale price of the Common
Stock as reported on the Nasdaq National Market was $1-5/8 per share.
--------------------
FOR INFORMATION CONCERNING CERTAIN RISKS RELATED TO THIS
OFFERING, SEE "RISK FACTORS" BEGINNING ON PAGE 3 OF
THIS PROSPECTUS.
--------------------
THESE SECURITIES HAVE NOT BEEN APPROVED OR DISAPPROVED BY THE SECURITIES
AND EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION NOR
HAS THE SECURITIES AND EXCHANGE COMMISSION OR ANY STATE
SECURITIES COMMISSION PASSED UPON THE ACCURACY OR
ADEQUACY OF THIS PROSPECTUS. ANY REPRESENTATION
TO THE CONTRARY IS A CRIMINAL OFFENSE.
--------------------
No person has been authorized to give any information or to make any
representations other than those contained in this Prospectus in connection with
the offer contained herein, and, if given or made, such information or
representations must not be relied upon as having been authorized by the
Company. This Prospectus does not constitute an offer to sell, or a solicitation
of an offer to buy, any securities offered hereby in any jurisdiction in which
it is not lawful or to any person to whom it is not lawful to make any such
offer or solicitation. Neither the delivery of this Prospectus nor any sale made
hereunder shall, under any circumstances, create any implication that
information herein is correct as of any time subsequent to the date hereof.
The date of this Prospectus is _____________ 1998.
++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++
Information contained herein is subject to completion or amendment. A
registration statement relating to these securities has been filed with the
Securities and Exchange Commission. These securities may not be sold nor may
offers to buy be accepted prior to the time the registration statement becomes
effective. This prospectus shall not constitute an offer to sell or the
solicitation of an offer to buy nor shall there be any sale of these securities
in any State in which such offer, solicitation or sale would be unlawful prior
to registration or qualification under the securities laws of any such State.
++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++
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AVAILABLE INFORMATION
The Company is subject to the informational requirements of the
Securities Exchange Act of 1934, as amended (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 can be inspected and
copied at the public reference facilities of the Commission at 450 Fifth Street,
N.W., Washington, D.C. 20549, and at the Commission's regional offices at 7
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
materials can be obtained from the Public Reference Section of the Commission at
450 Fifth Street, N.W., Washington, D.C. 20549, at prescribed rates. The
Commission maintains a Web site that contains reports, proxy and information
statements and other information regarding registrants that file electronically
with the Commission at (http://www.sec.gov). In addition, the Common Stock of
the Company is listed on the Nasdaq National Market, and reports, proxy
statements and other information concerning the Company can also be inspected at
the offices of the National Association of Securities Dealers, 1735 K. Street,
N.W., Washington, D.C. 20006. This Prospectus does not contain all the
information set forth in the Registration Statement and exhibits thereto which
the Company has filed with the Commission under the Securities Act of 1933, as
amended (the "Securities Act"), and to which reference is hereby made.
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
The following documents of the Company, which have been filed with the
Commission, are hereby incorporated by reference in this Prospectus:
(a) the Annual Report on Form 10-K for the year ended December
31, 1997; and
(b) the description of the Common Stock contained in the
Company's Registration Statement filed pursuant to Section 12 of the
Exchange Act and any amendment or report filed for the purpose of
updating any such description.
All documents filed by the Company pursuant to Section 13(a), 13(c), 14
or 15(d) of the Exchange Act subsequent to the date of this Prospectus and prior
to the termination of the offering of the Common Stock shall be deemed to be
incorporated by reference into this Prospectus and to be a part hereof from the
respective dates of filing of such documents. Any statement contained herein or
in a document all or part 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
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 any person, including any
beneficial owner, to whom this Prospectus is delivered, upon the written or oral
request of such person, a copy of any or all of the foregoing documents
incorporated herein by reference (other than certain exhibits to such
documents). Requests for such copies should be directed to Mark S. Derus,
Medi-Ject Corporation, 161 Cheshire Lane, Suite 100, Minneapolis, Minnesota
55441, telephone number (612) 475-7700.
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RISK FACTORS
This Prospectus, including the information incorporated herein by
reference, contains forward-looking statements as defined under the Private
Securities Litigation Reform Act of 1995, which are intended to qualify for the
"safe harbor" provision thereunder. Forward-looking statements represent
Medi-Ject's expectations or beliefs concerning future events. Medi-Ject cautions
that these statements are further qualified by important factors that could
cause actual results to differ materially from those projected in the
forward-looking statements as a result, in part, of the risk factors set forth
below. In connection with the forward-looking statements that appear in this
Prospectus, including the information incorporated herein by reference,
prospective purchasers of the Common Stock offered hereby should carefully
review the factors set forth below.
UNCERTAINTY OF MARKET ACCEPTANCE; LIMITED CURRENT MARKET FOR NEEDLE-FREE
INJECTION SYSTEMS
The Company's success will depend upon increasing market acceptance of
its needle-free injection systems as an alternative to needle injections. During
the approximately 15 years since their initial commercial introduction, the
Company's needle-free injection systems have had only limited success competing
with traditional needles and syringes because, the Company believes, of the
size, cost and complexity of use and maintenance of the Company's injectors and
the relatively small number of parenteral drugs that have been
self-administered. In order to increase market acceptance, the Company believes
that it must successfully develop improvements in the design and functionality
of future needle-free injection systems that will reduce their cost and increase
their appeal to users, thereby making these systems desirable despite their
premium cost over traditional disposable needles and syringes. Projected
improvements in functionality and design may not adequately address the actual
or perceived complexity of using the Company's needle-free injection systems or
adequately reduce their cost. In addition, the Company believes that its future
success is dependent upon its ability to enter into additional collaborative
agreements with drug and medical device manufacturers for the use of its
needle-free injection systems with new and existing parenteral drugs. There can
be no assurance that the Company will be successful in these efforts or that its
needle-free injection systems will ever gain sufficient market acceptance to
sustain profitable operations.
HISTORY OF OPERATING LOSSES; UNCERTAINTY OF FUTURE PROFITABILITY
The Company has had a history of operating losses and, at December 31,
1997, had an accumulated shareholders' deficit of approximately $14.5 million.
Net losses for the years ended December 31, 1993, 1994, 1995, 1996 and 1997 were
approximately $.5 million, $1.0 million, $1.9 million, $2.2 million and $3.0
million, respectively. The Company expects to continue to incur net losses at
least through 1998, as it introduces new and improved needle-free injection
systems while undertaking research and development, regulatory approval and
commercial introduction activities related to new uses for its needle-free
injection systems. There can be no assurance that the Company will achieve or
sustain profitability in the future.
RISKS ASSOCIATED WITH DEVELOPING NEW PRODUCTS
The Company believes that its future success is in part dependent upon
the development and commercial introduction of needle-free injection systems
that incorporate improvements in design and functionality to reduce their cost
and increase their appeal to users. In the United States, Japan and certain
European countries, the Company's needle-free Medi-Jector system has been
approved only for the injection of insulin and human growth hormone. The
Company's future success depends to a significant degree on its ability to
obtain regulatory approval for and commercialize the use of its needle-free
injection systems for other parenteral drugs. However, the Company has not yet
completed research and development work or obtained regulatory approval for such
improved systems or for use with any drugs other than insulin and human growth
hormone. There can be no assurance that any development work will ultimately be
successful or that unforeseen difficulties will not occur in research and
development, clinical testing, regulatory submissions and approval, product
manufacturing and
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commercial scale up, marketing, or product distribution related to any such
improved systems or new uses. Any such occurrence could materially delay the
commercialization of such improved systems or new uses or prevent their market
introduction entirely.
In September 1997, the Company announced that its customers were
occasionally experiencing certain problems when using the Medi-Jector Choice
system. These problems pertained to the unexpected breakage of the disposable
needle-free syringe portion of the system and the fit of the disposable vial
adapter onto the syringe. As a result of these problems, management initiated a
product recall and replacement campaign for the affected disposable components.
Management conducted the recall campaign under the guidance of the United States
Food and Drug Administration (FDA). These problems resulted in the Company's
inability to ship products until the problems were resolved, resulting in delays
of revenue recognition and possible lost sales. The process of resolving the
product problems and completing the product recall process occurred principally
during the fourth quarter of 1997.
RISKS OF RELATIONSHIP WITH BECTON DICKINSON AND COMPANY
The Company's ability to introduce improved and less expensive needle-free
injection systems will depend in part on the success of its collaborative effort
with Becton Dickinson and Company ("Becton Dickinson") to develop a smaller
needle-free injector with a disposable, single-use, needle-free syringe. This
effort is governed by the terms of a Development and License Agreement between
the Company and Becton Dickinson (the "Becton Dickinson Agreement"), under which
the Company is responsible for developing the injector body and Becton Dickinson
is responsible for developing the needle-free syringe for the system. Until
January 1, 1999, Becton Dickinson may terminate the Becton Dickinson Agreement
without cause by providing six months' written notice and after January 1, 1999,
by providing 12 months' written notice. Since responsibility for developing the
needle-free syringe lies with Becton Dickinson, any termination of the Becton
Dickinson Agreement would adversely affect the timing and the likelihood of
ultimate success of these development efforts. In addition, under the Becton
Dickinson Agreement, Medi-Ject granted Becton Dickinson the exclusive, worldwide
right to sell a proposed new injector for use with insulin and any other
injector that is not designed or calibrated for use with a specific drug made by
a specific drug company and that is intended to be distributed primarily through
pharmacies for non-professional use. Prior to developing a system for use with
any specific drug, the Company and Becton Dickinson must mutually agree on
whether or not such system will be of the type covered by Becton Dickinson's
exclusive sales rights.
DEPENDENCE ON COLLABORATIVE RELATIONSHIPS
The Company believes that the introduction and broad acceptance of its
systems depends in part upon the success of its current and any future
development and licensing arrangements with pharmaceutical and medical device
companies covering the development, manufacture or use of the Medi-Jector system
with specific parenteral drug therapies. The Company anticipates, consistent
with past practice, that under these arrangements the pharmaceutical or medical
device company will assist in the development of systems for such drug therapies
and collect or sponsor the collection of the appropriate data for submission for
regulatory approval of the use of the Medi-Jector system with the licensed drug
therapy. The pharmaceutical or medical device company also will be responsible
for distribution and marketing of the systems for these drug therapies either
worldwide or in specific territories. The Company currently is a party to eight
such agreements. There can be no assurance that the Company will be successful
in executing additional agreements with pharmaceutical or medical device
companies or that existing or future agreements will result in the sale of the
Company's needle-free injection systems. As a result of these arrangements, the
Company is dependent upon the development, data collection and marketing efforts
of such pharmaceutical and medical device companies. The amount and timing of
resources such pharmaceutical and medical device companies devote to these
efforts are not within the control of the Company, and such pharmaceutical and
medical device companies could make material decisions regarding these efforts
that could adversely affect the Company's future financial condition and results
of operations. In addition, factors that
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adversely impact the introduction and level of sales of any drug covered by such
licensing arrangements, including competition within the pharmaceutical and
medical device industries, the timing of FDA or other approvals and intellectual
property litigation (such as that surrounding Bio-Technology General
Corporation's human growth hormone, which has delayed the introduction of the
use of the Medi-Jector system with human growth hormone in the United States),
may also negatively affect the Company's sales of Medi-Jector systems for those
uses.
LIMITED MANUFACTURING EXPERIENCE; RISKS ASSOCIATED WITH NEW MATERIALS, NEW
ASSEMBLY PROCEDURES AND INCREASED PRODUCTION LEVELS
The Company's manufacturing experience has related primarily to the
assembly of products in limited quantities. The Company's planned future
needle-free injection systems necessitate significant changes and additions to
the Company's manufacturing and assembly process to accommodate new plastic
components, a new injection power source and significantly larger quantities.
These systems must be manufactured in compliance with regulatory requirements,
in a timely manner and in sufficient quantities while maintaining quality and
acceptable manufacturing costs. In the course of the required changes and
additions to its manufacturing and production methods, the Company may encounter
difficulties, including problems involving yields, quality control and
assurance, product reliability, manufacturing costs, existing and new equipment,
component supplies and shortages of personnel, any of which could result in
significant delays in production. There can be no assurance that the Company
will be able to produce and manufacture successfully the Company's future
needle-free injection systems. Any failure to do so would negatively impact the
Company's business, financial condition and results of operations.
COMPETITION; RISK OF TECHNOLOGICAL OBSOLESCENCE
The Company's current competition is primarily from traditional
hypodermic needles and syringes which are used for the vast majority of
injections administered today. In order to make needles and syringes easier and
safer to use, certain companies have developed syringes with hidden needles,
spring-powered needle injectors and injectors with sheathed needles. In addition
to competing with these types of traditional hypodermic needles and syringes,
the Company's needle-free injection systems also compete with other needle-free
injection devices. Currently, competition in the needle-free injection market is
limited to small companies with modest financial and other resources, but the
barriers to entry are currently low and additional competitors may enter the
needle-free injection systems market, including companies with substantially
greater resources and experience than the Company. There can be no assurance
that the Company will be able to compete effectively against its current or
potential competitors in the needle-free injection market, or that such
competitors will not succeed in developing or marketing products that will be
more accepted in such market. Competition in this market could also force the
Company to reduce the prices of its systems below currently planned levels,
thereby adversely affecting the Company's revenues and future profitability.
In general, injection is used only with drugs for which other drug
delivery methods are not possible, in particular with biopharmaceutical proteins
(drugs derived from living organisms, such as insulin and human growth hormone)
that cannot currently be delivered orally, transdermally (through the skin) or
pulmonarily (through the lungs). Many companies, both large and small (including
Becton Dickinson), are engaged in research and development efforts on novel
techniques aimed at delivering such drugs without injection. The successful
development and commercial introduction of such a non-injection technique would
likely have a material adverse effect on the Company's business, financial
condition, results of operations and general prospects.
NEED TO COMPLY WITH GOVERNMENT REGULATIONS
Government regulation in the United States and certain foreign
countries is a significant factor in the Company's business. In the United
States, the Food and Drug Administration (the "FDA") has principal jurisdiction
over products that are used for human injection. Certain clearances are required
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from the FDA before medical devices, such as the Company's needle-free injection
systems and their use with new drug therapies, can be marketed. The FDA
regulatory process in the United States may delay the marketing of new systems
for lengthy periods and impose substantial additional costs. Moreover, FDA
marketing clearance regulations depend heavily on administrative interpretation,
and there can be no assurance that interpretations made by the FDA or other
regulatory bodies, with possible retroactive effect, will not adversely affect
the Company. There can be no assurance that the Company will be able to obtain
clearance of any future Company systems or any expanded uses of current or
future Company systems in a timely manner or at all. In addition, even if
obtained, FDA clearances are subject to continual review, and if the FDA
believes that the Company is not in compliance with applicable requirements, it
can institute proceedings to detain or seize the Company's systems, require a
recall, suspend production, distribution, marketing and sales, enjoin future
violations and assess civil and criminal penalties against the Company, its
directors, officers or employees. The FDA may also suspend or withdraw market
approval for the Company's systems or require the Company to repair, replace or
refund the cost of any system manufactured or distributed by the Company. The
Company must also demonstrate compliance with current Quality System Regulations
regarding quality control and manufacturing procedures. Compliance with these
requirements requires the Company to expend time, resources and effort in the
areas of production and quality control for itself and for its contract
manufacturers. If violations of the applicable regulations are noted during FDA
inspections, the continued marketing of any systems manufactured by the Company
may be halted or adversely affected.
Sales of medical devices outside the United States are subject to
United States export requirements and foreign regulatory requirements. Legal
restrictions on the sale of imported medical devices vary from country to
country. The time and requirements to obtain approval by a foreign country may
differ substantially from those required for FDA approval. There can be no
assurance that the Company will be able to obtain regulatory approvals or
clearances for its products in foreign countries.
FUTURE CAPITAL NEEDS; UNCERTAINTY OF ADDITIONAL FUNDING
The Company anticipates that the cash on hand, interest expected to be
earned thereon and anticipated revenues will be sufficient to finance the
Company's operations for at least the next 12 months, although there can be no
assurance that additional capital will not be required sooner. In order to meet
its needs beyond this period, the Company may be required to raise additional
funds through public or private financings. Such financings may not be available
when needed on terms acceptable to the Company or at all. Moreover, any
additional equity financings may be dilutive to purchasers in this offering, and
any debt financing may involve restrictive covenants. An inability to raise such
funds when needed might require the Company to delay, scale back or eliminate
some or all of its planned system enhancements, market expansion and research
and development activities, and might require the Company to cease operations
entirely.
DEPENDENCE ON PROPRIETARY TECHNOLOGY RIGHTS
The Company's success will depend in part on its ability to protect its
proprietary rights and to operate without infringing on the proprietary rights
of third parties. In appropriate circumstances, the Company may apply for patent
protection for uses, processes, products and systems that it develops. The
Company currently holds six United States patents, one Japanese patent and one
Canadian patent. The Company also has 20 other patent applications being
considered in various countries throughout the world. There can be no assurance
that any of the Company's current or future patent applications will result in
issued patents, that the scope of any current or future patents will prevent
competitors from introducing competitive products or that any of the Company's
current or future patents would be held valid or enforceable if challenged.
Patenting medical devices involves complex legal and factual questions and there
is no consistent policy regarding the breadth of claims pertaining to such
technologies; the ultimate scope and validity of patents issued to the Company
or to its competitors are thus unknown. In addition, there can be no assurance
that measures taken by the Company to protect its unpatented proprietary rights
will be sufficient to protect these rights against third parties. Likewise,
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there can be no assurance that others will not independently develop or
otherwise acquire unpatented technologies or products similar or superior to
those of the Company.
There has been substantial litigation regarding patent and other
intellectual property rights in the medical device industry, and the Company may
in the future be required to defend its intellectual property rights against
infringement, duplication and discovery by third parties or to defend itself
against third-party claims of infringement. Likewise, disputes may arise in the
future with respect to ownership of technology developed by consultants or under
research or development agreements with pharmaceutical companies, or with
respect to the ownership of technology developed by employees who were
previously employed by other companies. Any such disputes or related litigation
could result in substantial costs to, and a diversion of effort by, the Company.
An adverse determination could subject the Company to significant liabilities to
third parties, require the Company to seek licenses from or pay royalties to
third parties or require the Company to develop appropriate alternative
technology. There can be no assurance that any such licenses would be available
on acceptable terms or at all, or that the Company could develop alternate
technology at an acceptable price or at all. Any of these events could have a
material adverse effect on the Company's business, financial condition and
results of operations.
RISKS ASSOCIATED WITH THIRD-PARTY REIMBURSEMENT OF END USERS
Sales of the Company's current and proposed systems in certain markets
are dependent in part on the availability of adequate reimbursement from
third-party healthcare payors. Currently, insurance companies and other
third-party payors reimburse the cost of needle-free injectors on a case-by-case
basis and may refuse reimbursement if they do not perceive benefits to their use
in a particular case. Third-party payors are increasingly challenging the
pricing of medical products and services, and there can be no assurance that
such third-party payors will not in the future increasingly reject claims for
coverage of the cost of needle-free injections. In addition, there can be no
assurance that adequate levels of reimbursement will be available to enable the
Company to achieve or maintain market acceptance of its systems or maintain
price levels sufficient to realize profitable operations. Furthermore, there is
a possibility of increased government control or influence over a broad range of
healthcare expenditures in the future. Any such trend could negatively impact
the market for the Company's needle-free injection systems.
DEPENDENCE ON SINGLE SOURCE SUPPLIERS
The Medi-Jector Choice system contains certain plastic components the
molds for which are located at the facilities of the Company's plastics
suppliers. In addition, certain of the Company's planned systems will contain
plastic disposable needle-free syringe which Becton Dickinson has the exclusive
right to manufacture for the Company under the Becton Dickinson Agreement.
Regulatory requirements applicable to medical device manufacturing can make
substitution of suppliers costly and time-consuming. In the event that the
Company could not obtain adequate quantities of these components from its
suppliers, there can be no assurance that the Company would be able to access
alternative sources of such components within a reasonable period of time, on
acceptable terms or at all. In particular, if the Company were required to
change suppliers for its current plastic components, it would need either to
move the necessary molds or to obtain new molds, either of which would entail
significant delay. Similarly, if Becton Dickinson declined to supply the Company
with disposable needle-free syringe for its proposed systems, while the Company
has the right to obtain a license to use Becton Dickinson's technology, it is
unlikely that the Company could manufacture such components as inexpensively as
Becton Dickinson. The unavailability of adequate quantities, the inability to
develop alternative sources, a reduction or interruption in supply or a
significant increase in the price of components could have a material adverse
effect on the Company's ability to manufacture and market its products.
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RISK OF PRODUCT LIABILITY; LIMITATIONS OF INSURANCE COVERAGE
The Company faces an inherent business risk of exposure to product
liability claims in the event that an end user is adversely affected by use or
misuse of its systems, and the Company has in the past experienced such claims.
The Company currently carries a product liability insurance policy to a level
management deems adequate. As the result either of adverse claim experience or
of medical device or insurance industry trends, however, the Company may in the
future have difficulty in obtaining product liability insurance or be forced to
pay very high premiums, and there can be no assurance that insurance coverage
will continue to be available on commercially reasonable terms or at all. In
addition, there can be no assurance that insurance will adequately cover any
product liability claim against the Company. A successful product liability or
other claim with respect to uninsured liabilities or in excess of insured
liabilities could have a material adverse effect on the Company's business,
financial condition and operations.
FAILURE TO MAINTAIN LISTING STANDARDS FOR CONTINUED LISTING ON NASDAQ; POSSIBLE
DE-LISTING FROM NASDAQ
Medi-Ject's Common Stock is listed on the Nasdaq National Market.
Nasdaq maintains certain requirements for continued listing on the Nasdaq
National Market, including requirements that issuers have net tangible assets of
$4 million, a public float of 750,000 shares, a market value of the public float
of $5 million and a minimum bid price of $1 per share. Failure to meet any of
these requirements could result in the transfer of Medi-Ject's Common Stock from
the Nasdaq National Market to the Nasdaq SmallCap Market or, potentially,
de-listing of Medi-Ject's Common Stock from Nasdaq. Such de-listing would
deprive the Company's shareholders of opportunities to sell their shares of
Common Stock in the secondary market and would severely limit the liquidity of
such shares.
POTENTIAL APPLICATION OF "PENNY STOCK" RULES
If the Company fails to maintain qualifications for its Common Stock to
trade on the Nasdaq National Market and the price of its Common Stock is below
$5.00 per share, the shares may be subject to certain rules of the Commission
relating to "penny stocks." Such rules require broker-dealers to make a
suitability determination for purchases and to receive the purchaser's prior
written consent for a purchase transaction. If the Common Stock is deemed to be
a penny stock, additional disclosure would be required in connection with trades
in the Common Stock, including the delivery of a disclosure schedule explaining
the nature and risks of the penny stock market. Such requirements could severely
limit the liquidity of the Common Stock and the ability of purchasers of this
Offering to sell their Common Stock in the secondary market.
QUARTERLY FLUCTUATIONS IN OPERATING RESULTS
The Company's operating results may vary significantly from quarter to
quarter, in part because of changes in consumer buying patterns, aggressive
competition, the timing of the recognition of licensing or development fee
payments and the timing of, and costs related to, any future system or new drug
use introductions. The Company's operating results for any particular quarter
are not necessarily indicative of any future results. The uncertainties
associated with the introduction of any new system or drug use and with general
market trends may limit management's ability to forecast short-term results of
operations accurately. Fluctuations caused by variations in quarterly operating
results or the Company's failure to meet analysts' projections or public
expectations as to results may adversely affect the market price of the
Company's Common Stock.
POSSIBLE STOCK PRICE VOLATILITY
The trading prices of the Company's Common Stock could be subject to
wide fluctuations in response to events or factors, many of which are beyond the
Company's control. These could include, without limitation, (i) quarter to
quarter variations in the Company's operating results,
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<PAGE>
(ii) announcements by the Company or its competitors regarding the results of
regulatory approval filings, clinical trials or testing, (iii) developments or
disputes concerning proprietary rights, (iv) technological innovations or new
commercial products, (v) material changes in the Company's collaborative
arrangements and (vi) general conditions in the medical technology industry.
Moreover, the stock market has experienced extreme price and volume
fluctuations, which have particularly affected the market prices of many medical
technology and device companies and which have often been unrelated to the
operating performance of such companies.
RELIANCE ON KEY PERSONNEL
The success of the Company is highly dependent, in part, on its ability
to attract and retain highly qualified personnel, including senior management
and scientific personnel. Competition for such personnel is intense, and there
can be no assurance that the Company will be successful in attracting and
retaining key personnel in the future. Any failure to do so could adversely
affect the Company.
POSSIBLE ADVERSE MARKET EFFECT OF SALE OF THE SHARES OFFERED HEREBY
Sales of significant amounts of Common Stock in the public market or
the perception that such sales will occur could adversely affect the market
price of the Common Stock or the future ability of the Company to raise capital
through an offering of its equity securities. As of March 1, 1998, 7,071,589
shares of Common Stock were outstanding, and the 1,224,199 shares offered hereby
represented approximately 17.3% of the outstanding shares of Common Stock (or
other securities of the Company readily convertible into Common Stock). The
Shares offered hereby will be eligible for immediate sale in the public market
and could be sold all at once, which could have a significant adverse effect on
the market price of the Common Stock.
MEDI-JECT CORPORATION
GENERAL
Medi-Ject Corporation is a drug delivery company focused on developing,
manufacturing and marketing needle-free injection systems for the
self-administration of a wide range of parenteral (injectable) drugs. The
Company's product, the Medi-Jector system, is a hand-held, spring-powered device
that injects drugs from a needle-free syringe through the skin, without a
needle, as a narrow, high pressure stream of liquid approximately 7/1000ths of
an inch in diameter. The Medi-Jector system eliminates the need to pierce the
skin with a sharp needle and manipulate a plunger with the needle inserted
through the skin. Therefore, many people perceive injections with the
Medi-Jector system to be less threatening than injections with a needle. Today's
Medi-Jector systems are smaller, easier to use, less expensive and more
comfortable than previous needle-free injection systems. The Company believes
that the key to widespread market acceptance of its needle-free injection
systems depends upon continued improvements in these areas.
The Company believes that individuals who require self-injection will
benefit from the Medi-Jector system because it (i) eliminates the need to pierce
themselves with needles for each injection, which should lead to increased
compliance with a prescribed injection regimen and consequently reduce health
complications, (ii) provides the ability to inject themselves discreetly and
(iii) eliminates the need for sharps disposal of used needles. In addition,
healthcare industry providers and payors may benefit from the decrease in
long-term costs of patient care that may result from improved patient
compliance. Furthermore, based upon discussions with pharmaceutical companies,
the Company believes that those companies are motivated to provide improved drug
delivery methods in an attempt to differentiate their products in the
marketplace and improve patient compliance, which may result in increased sales
and larger market share. Although the single largest indication for
self-injection is the administration of insulin for the treatment of diabetes,
the number of drugs associated with
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<PAGE>
frequent self-injection is increasing as novel biopharmaceuticals are introduced
and some individuals previously managed in the hospital are now cared for in the
home.
The Company has entered into licensing and development agreements with
multi-national pharmaceutical and medical device companies covering the design
and manufacture of customized injection systems for specific drug therapies. In
addition to agreements with pharmaceutical companies, including those with
Ferring NV, JCR Pharmaceuticals Co., Ltd., Schering-Plough Corporation,
Bio-Technology General Corporation, Smithkline Beecham, Organon (Akzo/Nobel) and
Teva Pharmaceuticals Industries, Ltd., the Company has entered into a strategic
alliance with Becton Dickinson. The goal of this alliance is the joint
development and commercialization of new, less expensive and more user friendly
injectors which embody proprietary, advanced technology. The Company will design
and manufacture the injectors, and Becton Dickinson will design and manufacture
the consumable components for the systems. Becton Dickinson has the right to
market the injectors and the consumable components worldwide for use initially
with insulin and potentially with other drugs. Medi-Ject and Becton Dickinson
will collaborate on the development and manufacture of customized versions of
the system and share revenues from sales of injectors and consumables to
pharmaceutical companies and any revenue generated from licensing milestone
payments, development fees and royalties.
The Company's focus is on the market for the delivery of
self-administered parenteral drugs, the largest, most developed portion of which
consists of the delivery of insulin. In the United States, over 3.2 million
people inject insulin for the treatment of diabetes, resulting in an estimated
2.3 billion injections annually, and the Company believes that the number of
insulin injections will increase with time as the result of new diabetes
management techniques that recommend more frequent use. Other parenteral drugs
that presently are self-administered and are or may be suitable for injection
with the Medi-Jector system include therapies for the treatment of multiple
sclerosis, migraine headaches, growth retardation, impotence, hormone therapy,
AIDS and hepatitis. The Company also believes that other existing parenteral
drugs will be self-administered in the future and that additional parenteral
drugs that are under development will be deemed appropriate for
self-administration.
Medi-Ject was incorporated in Minnesota in February 1979. The Company's
principal executive offices are located at 161 Cheshire Lane, Suite 100,
Minneapolis, Minnesota 55441, telephone number (612) 475-7700.
CERTAIN TRANSACTIONS
On September 27, 1993, the Selling Shareholder, Ethical Holdings, plc
(also referred to as "Ethical") and the Company entered into a Preferred Stock
Purchase Agreement pursuant to which Ethical purchased 380,808 shares of Series
B Convertible Preferred Stock for a price of $1.31 per share. At the same time,
the Company and Ethical also entered into (i) an Option Agreement (the "Ethical
Option") pursuant to which Ethical obtained the right to purchase 761,615 shares
of Series B Convertible Preferred Stock at a price of $1.31 per share (subject
to adjustment to $2.62 per share upon the occurrence of certain events) at any
time before the first to occur of March 10, 1995, or the effectiveness of a
registration statement under the Securities Act registering the Common Stock and
(ii) a Technology License and Co-Development Agreement (the "Ethical License
Agreement"). In a letter dated December 10, 1993, Ethical and the Company
amended the Ethical Option to provide that the $1.31 per share price should in
all events remain valid as to 380,808 shares through September 30, 1994. On
March 24, 1995, pursuant to the terms of the Ethical Option, the exercise price
was adjusted to $2.62 upon the Company raising in excess of $1,000,000 through
the sale of additional shares of capital stock at a price of at least $2.62 per
share. On September 16, 1994, Ethical and the Company executed a Waiver and
Notice of Exercise Agreement pursuant to which (i) the parties agreed to waive a
380,808 share minimum exercise amount provision in the Ethical Option, (ii) the
parties agreed to a 152,323 share minimum exercise amount for the Ethical
Option, (iii) the parties agreed to extend the $1.31 per share exercise price on
380,808 shares subject to the Ethical Option through October 31, 1994, and (iv)
Ethical exercised the Ethical Option as to 152,323 shares of Series B
Convertible Preferred Stock
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<PAGE>
for $1.31 per share. On February 10, 1995, in return for a commitment by Ethical
to exercise $100,000 worth of the Ethical Option under certain circumstances,
the Company and Ethical amended the Ethical Option to extend its term through
September 10, 1995. Ethical exercised the Ethical Option as to 76,161 shares of
Series B Convertible Preferred Stock in February 1995, at a price of $1.31 per
share. Pursuant to an Agreement dated September 1, 1995, between Ethical and the
Company, (i) the parties agreed to waive the 380,808 share minimum exercise
increment in the Ethical Option, (ii) the Company agreed to extend the Ethical
Option through February 29, 1996, provided that Ethical exercise the Ethical
Option as to at least 152,323 shares by September 1, 1995, (iii) Ethical
exercised the Ethical Option as to 152,323 shares of Series B Convertible
Preferred Stock for $1.64 per share (with the Company agreeing to such price)
and (iv) the parties agreed that the Company would have the unilateral right to
terminate the Ethical License Agreement at any time (which the Company did in
January 1996).
On December 22, 1995, Ethical and the Company entered into a Loan
Agreement (the "Ethical Loan") pursuant to which the Company borrowed $312,500
from Ethical in three installments in December 1995 and January 1996; amounts
outstanding under the Ethical Loan bore interest at the rate of 10% per year. In
connection with the Ethical Loan, the Company and Ethical again amended the
Ethical Option to reduce the per share exercise price on 190,404 of the shares
of Series B Convertible Preferred Stock subject to the Ethical Option from $2.62
to $1.64 and to extend the term of the Ethical Option through the later of
February 29, 1996, or the repayment date of the Ethical Loan. On February 28,
1996, the Company issued 190,404 shares of Series B Convertible Preferred Stock
to Ethical at a price of $1.64 per share in repayment of all principal amounts
advanced under the Ethical Loan and paid $1,301 interest in cash. On the same
date, Ethical exercised the remainder of the Ethical Option and purchased
190,404 shares of Series B Convertible Preferred Stock for $2.62 per share.
Ethical elected to convert all of the Series B Convertible Preferred
Stock it held into Common Stock. As the result of certain anti-dilution
protections applicable to the Series B Convertible Preferred Stock sold to
Ethical, the shares converted into 1,224,199 shares of Common Stock.
Geoffrey Guy, a director of the Company and a member of the
Compensation Committee of the Board of Directors, founded Ethical in 1985.
Dr.Guy served as Ethical's Chief Executive Officer and was Ethical's Chairman of
the Board. In December 1997, Dr.Guy resigned from Ethical and no longer
represents Ethical in any capacity.
SELLING SHAREHOLDER
The following table sets forth certain information, as of April 1,
1998, as to the maximum number of Shares that may be sold by the Selling
Shareholder pursuant to this Prospectus.
Number of
Shares Owned Number of Number of
Prior to the Shares Offered Shares Owned
Name Offering Hereby After the Offering
- --------------------- ------------- --------------- ------------------
Ethical Holdings, plc 1,224,199 1,224,199 0
The Selling Shareholder acquired the 1,224,199 shares of Common Stock
owned by it in several private transactions with the Company. See "Certain
Transactions."
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<PAGE>
PLAN OF DISTRIBUTION
The Shares will be offered and sold by the Selling Shareholder for its
own account. The Company will not receive any proceeds from the sale of the
Shares pursuant to this Prospectus. The Company has agreed to pay the expenses
of registration of the Shares, including a certain amount of legal and
accounting fees.
The Selling Shareholder may offer and sell the Shares from time to time
in transactions on the Nasdaq National Market, in brokerage transactions at
prevailing market prices or in transactions at negotiated prices. Sales may be
made to or through brokers or dealers who may receive compensation in the form
of discounts, concessions or commissions from the Selling Shareholder or the
purchasers of Shares for whom such brokers or dealers may act as agent or to
whom they may sell as principal, or both.
The Selling Shareholder and any brokers or dealers acting in connection
with the sale of the Shares hereunder may be deemed to be "underwriters" within
the meaning of Section 2(11) of the Securities Act, and any commissions received
by them and any profit realized by them on the resale of Shares as principals
may be deemed underwriting compensation under the Securities Act.
EXPERTS
The financial statements of the Company incorporated by reference in
this Prospectus and elsewhere in the Registration Statement have been audited by
KPMG Peat Marwick LLP, independent certified public accountants, as indicated in
their report with respect thereto, and incorporated herein by reference in
reliance upon the authority of such firm as experts in accounting and auditing.
LEGAL MATTERS
The validity of the Shares offered hereby has been passed upon for the
Company by Dorsey & Whitney LLP, 220 South Sixth Street, Minneapolis, Minnesota
55402.
-12-
<PAGE>
================================================================================
No dealer, salesperson or any other person has been authorized to give
any information or to make any representations other than those contained in
this Prospectus, and, if given or made, such information or representations must
not be relied upon as having been authorized by the Company, the Selling
Shareholder or any other person. This Prospectus does not constitute an offer to
sell or a solicitation of an offer to buy to any person in any jurisdiction in
which such offer or solicitation would be unlawful or to any person to whom it
is unlawful. Neither the delivery of this Prospectus nor any offer or sale made
hereunder shall, under any circumstances, create any implication that there has
been no change in the affairs of the Company or that the information contained
herein is correct as of any time subsequent to the date hereof.
----------
TABLE OF CONTENTS
PAGE
Available Information.......................... 2
Incorporation of Certain Documents
By Reference.............................. 2
Risk Factors................................... 3
Medi-Ject Corporation.......................... 9
Selling Shareholder............................ 12
Plan of Distribution........................... 12
Experts........................................ 12
Legal Matters.................................. 12
================================================================================
================================================================================
1,224,199 Shares
MEDI-JECT CORPORATION
Common Stock
------------
PROSPECTUS
------------
, 1998
================================================================================
<PAGE>
PART II.
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 14. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION
Commission Registration Fee............................... $ 610
Accounting Fees and Expenses.............................. 2,500
Legal Fees and Expenses................................... 6,000
Miscellaneous ............................................ 890
--------
Total............................................ $10,000
All fees and expenses other than the Commission registration fee are
estimated. The expenses listed above will be paid by the Company.
ITEM 15. INDEMNIFICATION OF OFFICERS AND DIRECTORS
Minnesota Statutes Section 302A.521 provides that a corporation shall
indemnify any person made or threatened to be made a party to a proceeding by
reason of the former or present official capacity of such person against
judgments, penalties, fines (including, without limitation, excise taxes
assessed against such person with respect to any employee benefit plan),
settlements and reasonable expenses, including attorneys' fees and
disbursements, incurred by such person in connection with the proceeding, if,
with respect to the acts or omissions of such person complained of in the
proceeding, such person (1) has not been indemnified therefor by another
organization or employee benefit plan; (2) acted in good faith; (3) received no
improper personal benefit and Section 302A.255 (with respect to director
conflicts of interest), if applicable, has been satisfied; (4) in the case of a
criminal proceeding, had no reasonable cause to believe the conduct was
unlawful; and (5) reasonably believed that the conduct was in the best interests
of the corporation in the case of acts or omissions in such person's official
capacity for the corporation or reasonably believed that the conduct was not
opposed to the best interests of the corporation in the case of acts or
omissions in such person's official capacity for other affiliated organizations.
Article7 of the Company's Second Amended and Restated Articles of Incorporation
provides that the Company shall indemnify directors to the fullest extent
permitted by the Minnesota Business Corporation Act as now enacted or hereafter
amended.
The Company also maintains an insurance policy to assist in funding
indemnification of directors and officers for certain liabilities.
ITEM 16. LIST OF EXHIBITS
4.1 Specimen Certificate of Common Stock (incorporated by reference to
Exhibit 4.1(a) of the Company's Registration Statement on Form S-1,
Commission File No. 333-6661).
5.1 Opinion of Dorsey & Whitney LLP.
23.1 Consent of KPMG Peat Marwick LLP.
23.2 Consent of Dorsey & Whitney LLP (included in Exhibit5.1 to this
Registration Statement).
24.1 Power of Attorney.
II-1
<PAGE>
ITEM 17. UNDERTAKINGS
The undersigned registrant hereby undertakes:
(1) To file, during any period in which offers or sales are
being made, a post-effective amendment to this registration statement:
(i) To include any prospectus required by section
10(a)(3) of the Securities Act of 1933;
(ii) To reflect in the prospectus any facts or events
arising after the effective date of the registration statement
(or the most recent post-effective amendment thereof) which,
individually or in the aggregate, represent a fundamental
change to such information in the registration statement.
Notwithstanding the foregoing, any increase or decrease in
volume of securities offered (if the total dollar value of
securities offered would not exceed that which was registered)
and any deviation from the low or high end of the estimated
maximum offering range may be reflected in the form of
prospectus filed with the Commission pursuant to Rule 424(b)
under the Securities Act if, in the aggregate, the changes in
volume and price represent no more than a 20% change in the
maximum aggregate offering price set forth in the "Calculation
of Registration Fee" table in the effective registration
statement; and
(iii) To include any material information with
respect to the plan of distribution not previously disclosed
in the registration statement or any material change in the
information set forth in the registration statement;
Provided, however, that paragraphs (a)(1)(i) and (a)(1)(ii) do
not apply if the registration statement is on Form S-3 or Form
S-8, and the information required to be included in a
post-effective amendment by those paragraphs is contained in
periodic reports filed by the registrant pursuant to Section
13 or Section 15(d) of the Securities Exchange Act of 1934
that are incorporated by reference in the registration
statement.
(2) That, for the purpose of determining any liability under
the Securities Act of 1933, each such post-effective amendment shall be
deemed to be a new registration statement relating to the securities
offered therein, and the offering of such securities at that time shall
be deemed to be the initial bona fide offering thereof.
(3) To remove from registration by means of a post-effective
amendment any of the securities being registered which remain unsold at
the termination of the offering.
The undersigned registrant hereby undertakes that, for purposes of
determining any liability under the Securities Act of 1933, each filing of the
registrant's annual report pursuant to Section 13(a) or 15(d) of the Securities
Exchange Act of 1934 (and, where applicable, each filing of an employee benefit
plan's annual report pursuant to Section 15(d) of the Securities Exchange Act of
1934) that is incorporated by reference in the registration statement shall be
deemed to be a new registration statement relating to the securities offered
therein, and the offering of such securities at that time shall be deemed to be
the initial bona fide offering thereof.
Insofar as indemnification for liabilities arising under the Securities
Act of 1933 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 Securities and Exchange
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 liabilities (other than the payment by the registrant of
expenses incurred or paid by a director, officer
II-2
<PAGE>
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>
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 the City of Minneapolis, State of Minnesota, on April 2, 1998.
MEDI-JECT CORPORATION
By /S/ MARK DERUS
--------------------------------------
Mark Derus
Vice President of Finance,
Chief Financial Officer
Pursuant to the requirements of the Securities Act of 1933, this
Registration Statement has been signed by the following persons in the
capacities and on the dates indicated.
* Dated: April 2, 1998
- -----------------------------
Franklin Pass, M.D.
President, Chief Executive Officer and
Director (principal executive officer)
/S/ MARK DERUS
- ----------------------------- Dated: April 2, 1998
Mark Derus
Vice President of Finance, Chief
Financial Officer (principal finance
and accounting officer)
*
- ----------------------------- Dated: April 2, 1998
Kenneth Evenstad
Director
*
- ----------------------------- Dated: April 2, 1998
Geoffrey Guy
Director
*
- ----------------------------- Dated: April 2, 1998
Norman Jacobs
Director
* Dated: April 2, 1998
- -----------------------------
Fred Shapiro, M.D.
Director
*
- ----------------------------- Dated: April 2, 1998
Stanley Goldberg
Director
*
- ----------------------------- Dated: April 2, 1998
Karl Groth
Director
/S/ MARK DERUS
- ----------------------------- Dated: April 2, 1998
* By Mark Derus
Attorney-In-Fact
II-4
<PAGE>
EXHIBIT INDEX
EXHIBIT
NO. DESCRIPTION
- ------- -----------
4.1 Specimen Certificate of Common Stock (incorporated by reference to
Exhibit 4.1(a) of the Company's Registration Statement on Form S-1,
Commission File No. 333-6661)
5.1 Opinion of Dorsey & Whitney LLP regarding legality
23.1 Consent of KPMG Peat Marwick LLP
23.2 Consent of Dorsey & Whitney LLP (included in Exhibit 5.1)
24.1 Power of Attorney
<PAGE>
EXHIBIT 5.1
[Dorsey & Whitney LLP Letterhead]
April 2, 1998
Medi-Ject Corporation
161 Cheshire Lane
Minneapolis, Minnesota 55441
Re: Registration Statement on Form S-3
Ladies and Gentlemen:
We have acted as counsel to Medi-Ject Corporation, a Minnesota
corporation (the "Company"), in connection with a Registration Statement on Form
S-3 (the "Registration Statement") to be filed with the Securities and Exchange
Commission under the Securities Act of 1933, as amended, relating to the sale of
up to 1,224,199 shares of common stock of the Company, par value $.01 per share
("Common Stock"), of which all such shares will be sold from time to time by the
Selling Shareholder named in the Registration Statement, on the Nasdaq National
Market or otherwise, directly or through underwriters, brokers or dealers.
We have examined such documents and have reviewed such
questions of law as we have considered necessary and appropriate for the
purposes of our opinions set forth below.
In rendering our opinions set forth below, we have assumed the
authenticity of all documents submitted to us as originals, the genuineness of
all signatures and the conformity to authentic originals of all documents
submitted to us as copies. We have also assumed the legal capacity for all
purposes relevant hereto of all natural persons and, with respect to all parties
to agreements or instruments relevant hereto other than the Company, that such
parties had the requisite power and authority (corporate or otherwise) to
execute, deliver and perform such agreements or instruments, that such
agreements or instruments have been duly authorized by all requisite action
(corporate or otherwise), executed and delivered by such parties and that such
agreements or instruments are the valid, binding and enforceable obligations of
such parties. As to questions of fact material to our opinions, we have relied
upon certificates of officers of the Company and of public officials.
Based on the foregoing, we are of the opinion that the shares
of Common Stock to be sold by the Selling Shareholder pursuant to the
Registration Statement have been duly authorized by all requisite corporate
action, and are validly issued, fully paid and nonassessable.
Our opinions expressed above are limited to the laws of the
State of Minnesota.
We hereby consent to the filing of this opinion as an exhibit
to the Registration Statement, and to the reference to our firm under the
heading "Legal Matters" in the Prospectus constituting part of the Registration
Statement.
Very truly yours,
/s/ Dorsey & Whitney LLP
AEA
<PAGE>
EXHIBIT 23.1
CONSENT OF INDEPENDENT AUDITORS
The Board of Directors
Medi-Ject Corporation:
We consent to the incorporation by reference in this registration
statement of our report dated February 25, 1998, included in Medi-Ject
Corporation's Annual Report on Form 10-K for the year ended December 31, 1997,
and to the reference to our firm under the heading "Experts" in the prospectus.
/s/ KPMG Peat Marwick LLP
Minneapolis, Minnesota
April 2, 1998
<PAGE>
EXHIBIT 24.1
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature
appears below hereby constitutes and appoints Franklin Pass, M.D. and Mark
Derus, or either of them (with full power to act alone), as his or her true and
lawful attorneys-in-fact and agents, with full powers of substitution and
resubstitution, for him or her and in his or her name, place and stead, in any
and all capacities to execute a Registration Statement on Form S-3 to be filed
under the Securities Act of 1933, as amended, for the registration of the resale
of 1,224,199 shares of Common Stock of Medi-Ject Corporation by the Selling
Shareholder named therein, and any and all post-effective amendments thereto,
and to file the same, with all exhibits thereto, and other documents in
connection therewith, with the Securities and Exchange Commission, granting unto
said attorneys-in-fact and agents full power and authority to do and perform all
intents and purposes as he or she might or could do in person, hereby ratifying
and confirming all that said attorneys-in-fact and agents, or their substitutes,
may lawfully do or cause to be done by virtue hereof.
Dated: March 16, 1998
SIGNATURE TITLE
--------- -----
/S/ FRANKLIN PASS, M.D.
- ---------------------------------- President, Chief Executive Officer and
Franklin Pass, M.D. Director (principal executive officer)
/S/ MARK DERUS
- ---------------------------------- Vice President of Finance, Chief
Mark Derus Financial Officer (principal finance
and accounting officer)
/S/ KENNETH EVENSTAD
- ---------------------------------- Director
Kenneth Evenstad
/S/ GEOFFREY GUY
- ---------------------------------- Director
Geoffrey Guy
/S/ NORMAN JACOBS
- ---------------------------------- Director
Norman Jacobs
/S/ FRED SHAPIRO, M.D.
- ---------------------------------- Director
Fred Shapiro, M.D.
/S/ STANLEY GOLDBERG
- ---------------------------------- Director
Stanley Goldberg
/S/ KARL GROTH
- ---------------------------------- Director
Karl Groth
