As filed with the Securities and Exchange Commission on January 15, 1998
Registration No. 333-_____
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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM S-3
REGISTRATION STATEMENT
Under
THE SECURITIES ACT OF 1933
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INTERFERON SCIENCES, INC.
(Exact name of registrant as specified in its charter)
DELAWARE 22-2313648
(State or other jurisdiction (I.R.S. Employer
of incorporation or organization) Identification Number)
783 Jersey Avenue
New Brunswick, New Jersey 08901
(732) 249-3250
(Address, including zip code, and telephone number,
including area code, of registrant's principal executive offices)
LAWRENCE M. GORDON, ESQ.
Chief Executive Officer
Interferon Sciences, Inc.
9 West 57th Street
New York, New York 10019
(212) 230-9513
(Name, address, including zip code, and telephone number,
including area code, of agent for service)
Copies to:
ROBERT J. HASDAY, ESQ.
Duane, Morris & Heckscher
Suite 3300
122 East 42nd Street
New York, New York 10168
(212) 692-1010
Approximate date of commencement of proposed sale to the public: As soon as
practicable 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. [ ]
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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
<TABLE>
<S> <C> <C> <C> <C>
Proposed Proposed
Maximum Maximum Amount of
Title of Each Class of Amount to be Offering Price Aggregate Registration
Securities to be Registered Registered per Share Offering Price Fee
Common Stock, par value $.01 per share 200,000 shares $8-1/32 (1) $1,606,250 (1) $486.74
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</TABLE>
(1) Estimated solely for the purpose of calculating the registration fee based
on the average of the high and low prices of the Common Stock on January
12, 1998 as reported by NASDAQ, pursuant to Rule 457(c)
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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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 wold be unlawful prior
to registration or qualification under the securities laws of any such State.
Subject to Completion, Dated January 15, 1998
PROSPECTUS
Interferon Sciences, Inc.
200,000 Shares of Common Stock
The shares of Common Stock, par value $.01 per share (the "Common Stock"),
of Interferon Sciences, Inc., a Delaware corporation (the "Company"), being
offered hereby are being sold by certain stockholders of the Company (the
"Selling Stockholders"). The Company will not receive any proceeds from the sale
of shares by the Selling Stockholders. See "Selling Stockholders."
The Common Stock is quoted on the NASDAQ National Market System under the
symbol "IFSC." On January 12, 1998, the last reported sale price of the Common
Stock on the NASDAQ National Market System was $8 per share.
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INVESTMENT IN THE SHARES OFFERED HEREBY INVOLVES A HIGH DEGREE OF
RISK. SEE "RISK FACTORS" ON PAGES 3-11 OF THIS PROSPECTUS.
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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.
The date of this Prospectus is January __, 1998
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AVAILABLE INFORMATION
The Prospectus omits certain of the information contained in the
Registration Statement relating to the securities offered hereby which is on
file with the Securities and Exchange Commission (the "Commission"). 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
periodic reports, proxy statements, and other information with the Commission.
Such Registration Statement, reports, proxy statements, and other information
can be inspected, without charge, and copied at the public reference facilities
maintained by the Commission at Judiciary Plaza, 450 Fifth Street, N.W., Room
1024, Washington, D.C. 20549, and at its regional offices located at 7 World
Trade Center, 13th Floor, New York, New York 10048 and Northwestern Atrium
Center, 500 West Madison Street, Chicago, Illinois 60061. Copies of such
material can be obtained at prescribed rates from the Public Reference Section
of the Commission at Judiciary Plaza, 450 Fifth Street, N.W., Room 1024,
Washington, D.C. 20549.
DOCUMENTS INCORPORATED BY REFERENCE
The following documents filed by the Company with the Commission are
incorporated in this Prospectus by reference:
(a) the Company's Annual Report on Form 10-K for the year
ended December 31, 1996;
(b) the Company's Quarterly Reports on Form 10-Q for the
quarters ended March 31, 1997, June 30, 1997, and September 30, 1997;
(c) the Company's Current Report on Form 8-K filed on January
14, 1997; and
(d) the description of the Common Stock contained in the
Company's Prospectus included in the Company's Registration Statement
on Form S-2, File No. 33-59479, as filed pursuant to Rule 424(b) under
the Securities Act of 1933, as amended (the "Securities Act").
All documents filed by the Company pursuant to Section 13(a), 13(c),
14, or 15(d) of the Exchange Act on or after the date of this Prospectus and
prior to the termination of the offering hereby of the Common Stock shall be
deemed to be incorporated by reference in this Prospectus and to be a part
hereof from the date of filing such documents.
Any statement contained in a document 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
modifies, supersedes, or replaces such statement. Any statement so modified or
superseded shall not be deemed, except as so modified or superseded, to
constitute a part of this Prospectus. Any person receiving a copy of this
Prospectus may obtain without charge, upon written or oral request, a copy of
any of the documents incorporated by reference herein, except for exhibits to
such documents (unless such exhibits are specifically incorporated by reference
into the documents which this Prospectus incorporates). Requests should be
directed to: Corporate Secretary, Interferon Sciences, Inc., 783 Jersey Avenue,
New Brunswick, New Jersey 08901, telephone number (732) 249-3250.
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ALFERON(R) and ALFERON LDO(R) are registered trademarks of the Company.
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THE COMPANY
Interferon Sciences, Inc. (the "Company") is a biopharmaceutical company
engaged in the manufacture and sale of pharmaceutical products based on its
highly purified, multispecies, natural source alpha interferon ("Natural Alpha
Interferon"). The Company's ALFERON N Injection(R) (Interferon Alfa-n3) product
has been approved by the United States Food and Drug Administration ("FDA") for
the treatment of certain types of genital warts and is being studied for
potential use in the treatment of HIV, hepatitis C, and other indications. The
Company also is studying ALFERON N Gel(R) and ALFERON LDO(R), the Company's
topical and oral formulations of Natural Alpha Interferon, for the potential
treatment of viral and immune system diseases. The Company's principal offices
and research and production facilities are located at 783 Jersey Avenue, New
Brunswick, New Jersey 08901 and its telephone number is (732) 249-3250.
RISK FACTORS
Prospective investors should consider carefully the following factors,
together with the other information contained or incorporated by reference in
this Prospectus, in evaluating an investment in the Common Stock offered hereby.
This Prospectus contains or incorporates by reference certain forward- looking
statements reflecting management's current views with respect to future events
and financial performance. These forward-looking statements are subject to
certain risks and uncertainties, all of which are difficult to predict and many
of which are beyond the control of the Company, that could cause actual results
to differ materially from those in the forward-looking statements, including,
but not limited to, the following factors.
Continuing Operating Losses; Accumulated Deficit. The Company has
experienced significant operating losses since its inception in 1980. As of
September 30, 1997, the Company had an accumulated deficit of approximately
$92.5 million. For the nine months ended September 30, 1997 and the years ended
December 31, 1996, 1995, and 1994, the Company had losses from operations of
approximately $10.8 million, $12.4 million, $7.4 million, and $11.8 million,
respectively.
Although the Company received approval to market ALFERON N Injection for the
treatment of genital warts from the FDA in October 1989 and from the comparable
Mexican regulatory authority in December 1994 and entered into an agreement for
Cell Pharm GmbH ("Cell Pharm") to distribute ALFERON N Injection in Germany in
April 1996, it has had only limited revenues from the sale of ALFERON N
Injection to date. In order for the Company to operate profitably, the Company
must sell significantly more ALFERON N Injection. Increased sales in the United
States will depend primarily upon the attainment of FDA approval to market
ALFERON N Injection for additional indications, of which there can be no
assurance. See "Phase 3 Clinical Trials," "Products Under Development" and
"Regulatory Approvals" below in this section. Moreover, the Company cannot
market ALFERON N Injection in other markets unless appropriate regulatory
approvals are obtained. See "Foreign Regulatory Approvals" below in this
section. There can be no assurance that sufficient quantities of ALFERON N
Injection will be sold to allow the Company to operate profitably.
Phase 3 Clinical Trials. In December 1997, the Company concluded a
multi-center Phase 3 clinical trial of ALFERON N Injection in HIV-infected
patients. This randomized, double-blind, placebo-controlled trial was designed
to evaluate the safety and efficacy of ALFERON N Injection in the treatment of
HIV- positive patients, some of whom were taking other FDA-approved antiviral
agents. The trial consisted of a 24-week treatment phase. Over the next several
months, the Company will collect the clinical data from
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the 16 test centers, verify the computer database, evaluate the data for safety
and efficacy, and prepare the clinical summary of the trial. If favorable
results are obtained, the Company anticipates seeking FDA- approval of ALFERON N
Injection in the treatment of HIV-positive patients near the end of the first
quarter of 1998. In addition, after satisfactorily completing the 24-week
treatment phase, patients were eligible to enroll in a separate open-label
continuation study to evaluate the safety and efficacy of three different
maintenance treatment regimens. Approximately 93% of these patients have elected
to enter this continuation study, which is currently in progress.
The Company is also conducting a Phase 3 multi-center, randomized,
controlled clinical trial designed to evaluate the safety and efficacy of
ALFERON N Injection in naive chronic hepatitis C patients. The trial consists of
a 24-week treatment phase and 24-week follow-up. If favorable results are
obtained at the end of the follow-up phase, the Company anticipates seeking
FDA-approval of ALFERON N Injection for the treatment of hepatitis C by the end
of the third quarter of 1998. However, the trial also includes an interim
analysis scheduled to take place by March 1998 on a certain number of patients
who have completed treatment and follow-up. If results at the end of such
interim analysis demonstrate at a very high level of statistical significance
that ALFERON N Injection is effective, the Company anticipates seeking FDA
approval in the second quarter of 1998, while continuing to treat patients
enrolled in the study.
There can be no assurance that ALFERON N Injection for the treatment of
patients with HIV or hepatitis C will be cost-effective, safe, or effective or
that the Company will be able to obtain FDA approval for either of such uses.
Furthermore, even if such approvals are obtained, there can be no assurance that
such product will be commercially successful or will produce significant
revenues or profits for the Company. See "Regulatory Approvals" below in this
section.
Future Capital Needs; Uncertainty of Additional Funding. The Company will
require substantial funds to conduct research and development and preclinical
and clinical testing and to manufacture and market its products. For the nine
months ended September 30, 1997 and the years ended December 31, 1996, 1995, and
1994, the cash utilized by the Company's operations was approximately $14.0
million, $13.3 million, $7.1 million, and $7.8 million, respectively. The
increase in cash utilized by the Company's operations for nine months ended
September 30, 1997 was in large part due to expenditures relating to the
Company's Phase 3 HIV and hepatitis C trials described above. The Company's
future capital requirements will depend on many factors, including: continued
scientific progress in its drug development programs; the magnitude of these
programs; progress with preclinical testing and clinical trials; the time and
costs involved in obtaining regulatory approvals; the costs involved in filing,
prosecuting, and enforcing patent claims; competing technological and market
developments; changes in its existing research relationships; the ability of the
Company to establish collaborative arrangements; and effective commercialization
activities and arrangements.
During the second half of 1997, the Company received net proceeds of
approximately $16.4 million from stock offerings, primarily to institutional
investors, of Common Stock. Such net proceeds were and will be used (i) to
increase the Company's inventory of ALFERON N Injection (a) to meet increased
market demand, (b) for use in the Company's Phase 3 HIV and hepatitis C trials,
and (c) so that inventory will be available in the event such HIV and hepatitis
C trials are successfully concluded and ALFERON N Injection is subsequently
approved for the treatment of one or both of these new indications by the FDA
(of which there can be no assurance), (ii) to expand the Company's manufacturing
facility, which will provide significantly increased production capacity in the
event such HIV and hepatitis C trials are successfully concluded and ALFERON N
Injection is approved for the treatment of one or both of these
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new indications by the FDA, (iii) to increase the Company's marketing and sales
capabilities, and (iv) to fund the Company's clinical programs.
Based on the Company's estimates of revenues, expenses, and levels of
production, management believes that the cash currently available to the Company
will be sufficient to enable the Company to continue operations at least until
January 1999. However, actual results, especially with respect to revenues, may
differ materially from such estimates, and no assurance can be given that
additional funding will not be required sooner than anticipated or that such
additional funding, whether from financial markets or collaborative or other
arrangements with corporate partners or from other sources, will be available
when needed or on terms acceptable to the Company. Insufficient funds will
require the Company to delay, scale back, or eliminate certain or all of its
research and development programs or to license third parties to commercialize
products or technologies that the Company would otherwise seek to develop itself
or to shut down or curtail its manufacturing facility.
No Guaranteed Source of Required Materials. The Company uses a number of
essential materials in the production of Natural Alpha Interferon, including
human white blood cells, and has limited sources from which to procure such
materials. The Company does not have long-term agreements for the supply of most
of such materials. There can be no assurance that long-term supply agreements
covering essential materials can be entered into on commercially reasonable
terms, if at all. Although the Company currently obtains human white blood cells
from several sources, including the American Red Cross pursuant to a supply
agreement dated April 1, 1997, there can be no assurance that the Company will
be able to obtain all the human white blood cells that it needs. See "Selling
Stockholder." In addition, there can be no assurance that the Company will be
able to renew its agreement with the American Red Cross when it terminates. If
it is unable to obtain required raw materials, the Company may be required to
scale back its operations or stop manufacturing Natural Alpha Interferon. The
costs and availability of products and materials required by the Company for the
commercial production of ALFERON N Injection and other products which the
Company may commercially produce are subject to fluctuation depending on a
variety of factors beyond the Company's control, including competitive factors,
changes in technology, and FDA and other governmental regulation and there can
be no assurance that the Company will be able to obtain such products and
materials on terms acceptable to the Company or at all.
Limited Marketing Program. In May 1997, the Company entered into an
agreement appointing Alternate Site Distributors, Inc. ("ASD"), a subsidiary of
Bergen Brunswig Corporation, the sole United States distributor of ALFERON N
Injection. Pursuant to such agreement, ASD will also provide clinical and
product information, reimbursement information and services, and management of
patient assistant services. In addition, the Company currently has marketing
arrangements for the distribution of ALFERON N Injection in Mexico and Germany.
Unless the Company successfully develops its own sales force or enters into
additional marketing arrangements with other companies, the Company will be
dependent on the ability of its current distributors to sell sufficient
quantities of ALFERON N Injection to allow the Company to operate profitably.
There can be no assurance that the Company will be able to develop its own sales
force or enter into additional marketing agreements on acceptable terms, if at
all, or that the Company will be able to successfully market and sell ALFERON N
Injection or any other product.
Products Under Development. The Company's products under development include
(i) ALFERON N Injection for the potential treatment of HIV, hepatitis C,
multiple sclerosis, and hepatitis B, (ii) ALFERON N Gel for the potential
treatment of cervical dysplasia, intravaginal warts, mucocutaneous herpes in
immuno-compromised patients, and recurrent genital herpes, and (iii) ALFERON LDO
for the
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potential treatment of certain symptoms of patients infected with the HIV virus.
However, there can be no assurance that these products will be cost-effective,
safe, or effective treatments for these diseases, and there is no assurance of
receiving regulatory approvals to market these products. The Company cannot
market such products until such approvals are obtained. Even if such approvals
are obtained, there can be no assurance that any of these products will be
successful or will produce significant revenues or profits for the Company. The
ability of the Company to become profitable depends on the successful commercial
development of these products.
Potential Side Effects. The Company is engaged in the manufacture and sale
of a single FDA approved product, ALFERON N Injection for the treatment of
refractory or recurring external genital warts in adults. In clinical trials
conducted for the treatment of genital warts with ALFERON N Injection, patients
have not experienced serious side effects; however, there can be no assurance
that unexpected or unacceptable side effects will not be found in the future for
this use or other potential uses of this product or for any other product the
Company might develop which could threaten or limit such product's usefulness.
See "Risk of Product Liability" below in this section.
Substantial Competition. In the United States and Mexico, the Company
currently competes with Schering-Plough Corp.'s ("Schering") injectable
recombinant interferon product in the treatment of genital warts. In March 1997,
Minnesota Mining & Manufacturing Co. received FDA approval for its immune-
response modifier, Aldara(R), a self-administered topical cream, for the
treatment of genital warts. ALFERON N Injection also competes with surgical,
chemical, and other methods of treating genital warts. The Company cannot assess
the impact products developed by the Company's competitors or advances in other
methods of the treatment of genital warts will have on the commercial viability
of its product.
If and when the Company obtains additional approvals of uses of its products
(such as the approval obtained by Cell Pharm in Germany), it expects to compete
primarily on the basis of product performance. The Company's potential
competitors have developed or may develop products (containing either alpha
interferon or other therapeutic compounds) or other treatment modalities for
those uses. Many of the Company's potential competitors are among the largest
pharmaceutical companies in the world, are well known to the public and the
medical community, and have substantially greater financial resources, product
development, and manufacturing and marketing capabilities than the Company or
its marketing partners.
Schering's recombinant interferon product has achieved market dominance for
the treatment of hepatitis C and hepatitis B in the United States and other
markets, and Roche Pharmaceuticals's recombinant interferon product was recently
approved for the treatment of hepatitis C in the United States and for other
medical uses in foreign countries. A number of synthetic antiviral compounds
have been approved in the United States and certain foreign countries for the
treatment, primarily in combination therapy, of HIV and AIDS, including reverse
transcriptase inhibitors (nucleoside analogues) such as Epivir(R) and
Retrovir(R) (manufactured by Glaxo Wellcome Inc.), Hivid(R) (manufactured by
Roche Laboratories, Inc.), and Zerit(R) and Videx(R) (manufactured by
Bristol-Myers Squibb Company) and protease inhibitors such as Crixivan(R)
(manufactured by Merck & Co., Inc.), Invirase(R) (manufactured by Roche
Laboratories, Inc.), and Norvir(R) (manufactured by Abbott Laboratories). Also,
Viramune(R), a non- nucleoside reverse transcriptase inhibitor (manufactured by
Boehringer Ingelheim Corporation), was recently approved by the FDA for use in
combination with nucleoside analogues for the treatment of HIV- infected adults.
In the United States, two recombinant forms of beta interferon have been
approved for the treatment of relapsing-remitting multiple sclerosis. There can
be no assurance that, if the Company is able to obtain regulatory approval of
ALFERON N Injection for the treatment of any of those diseases,
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it will be able to achieve any significant penetration into those markets. In
addition, because certain of the competitive products are not dependent on a
source of human blood cells, such products may be able to be produced in greater
volume and at a lower cost than ALFERON N Injection and the Company's other
Natural Alpha Interferon formulations. Currently, the Company's wholesale price
on a per unit basis of ALFERON N Injection is substantially higher than that of
the competitive recombinant alpha interferon products.
Other companies may succeed in developing products earlier than the Company,
obtaining approvals for such products from the FDA more rapidly than the
Company, or developing products that are more effective than those proposed to
be developed by the Company. While the Company will seek to expand its
technological capabilities in order to remain competitive, there can be no
assurance that research and development by others or other medical advances will
not render the Company's technology or products obsolete or non-competitive or
result in treatments or cures superior to any therapy developed by the Company,
or that any therapy developed by the Company will be preferred to any existing
or newly developed technologies.
Potential Patent Infringement Claims. On March 5, 1985, the United States
Patent and Trademark Office issued a patent to Hoffmann-La Roche, Inc.
("Hoffmann") claiming purified human alpha (leukocyte) interferon (regardless of
how it is produced). F. Hoffmann-LaRoche Ltd. ("Roche"), the parent of Hoffmann,
also has been issued patents covering human alpha interferon in many countries
throughout the world. As of March 31, 1995, the Company obtained a non-exclusive
perpetual license from Hoffmann and Roche which grants the Company the worldwide
rights to make, use, and sell, without a potential patent infringement claim
from Hoffmann or Roche, any formulation of Natural Alpha Interferon. The license
permits the Company to grant marketing rights with respect to Natural Alpha
Interferon products to third parties, except that the Company cannot grant
marketing rights with respect to injectable products in any country in which
Hoffmann or Roche has patent rights covered by the license to any third party
not listed on a schedule of approximately 50 potential marketing partners
without the consent of Hoffmann and Roche, which consent cannot be unreasonably
withheld. There can be no assurance that the Company will not want to grant such
marketing rights to a third party not listed on such schedule, or that Hoffmann
and Roche will not withhold the required consent. In addition, if such license
were terminated, the Company may be subject to a patent infringement lawsuit by
Hoffmann and Roche if it continued to market Natural Alpha Interferon products.
If such a suit were brought, the Company would have to either counterclaim to
attempt to invalidate the Hoffmann and Roche patents or prove that it did not
infringe such patents.
In addition, there may have been other patent applications filed in the
United States and in foreign countries, some of which may have been filed by
potential competitors of the Company, with respect to the technologies and/or
products which may be required by the Company to produce its current and
proposed products. If any of such patents issue in the United States or in
foreign countries in a form which covers the Company's products or processes,
the Company would be required to obtain licenses under such patents in
connection with the domestic and international commercialization of such
products. There can be no assurance that the Company could obtain licenses under
any of such patents if so issued, particularly if they were issued to companies
directly in competition with the Company, or that, even if the Company could
obtain licenses, it could do so on commercially reasonable terms.
If the sale or use of any of the Company's products were to become the basis
of a patent infringement lawsuit, assuming the Company could not obtain a
license on satisfactory terms, the Company may be required to incur substantial
litigation expenses, and such litigation could also consume substantial
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management time, which could have a material adverse effect upon the financial
condition of the Company even if it were to be successful in the litigation. If
the Company proved unsuccessful in such litigation, it may be required to pay a
royalty for the use of the claimed patents or cease producing the products and
redevelop the products in such a way as to avoid infringing any claimed patent
rights. There can be no assurance in such case that the Company could obtain a
license under such patents on commercially reasonable terms or at all, or that
it could successfully redevelop the products to fall outside the scope of the
claim.
It is the Company's policy to seek licenses if it believes that the terms of
such licenses, when weighed against the expense and uncertainties of potential
litigation, are cost effective.
Possible Inability to Protect Technology. To a significant extent, the
ability of the Company to protect its rights in any products or technology it
may develop depends upon its ability to obtain suitable patent or similar
protection. The ability of the Company to obtain patents, and the nature,
extent, and enforceability of the intellectual property rights that are obtained
as a result of the Company's research, involve complex legal and factual issues.
New technology and products developed by the Company may not qualify for patent
protection or, if they do qualify, may be subject to challenge or to protracted
judicial proceedings. In addition, the Company may determine not to seek
additional patent or other protection for its technology or products. It is not
certain that other patents will be issued or, if issued, that they will afford
the Company protection from competitive products. Although the Company's
practice is to require its technical and scientific employees and consultants to
execute confidentiality agreements covering proprietary information, there can
be no assurance that others will not independently make similar discoveries or
otherwise obtain access to proprietary information of the Company. In addition,
the Company has a non-exclusive license agreement with Hoffmann and Roche which
enables the Company to sell its products. There can be no assurance that
Hoffmann or Roche has not granted or will not grant a similar license to another
company with considerably greater financial, technical, and marketing resources
than the Company or that Hoffmann or Roche will not enter the market itself with
a competitive product.
While the Company has recently been issued a United States patent for
Natural Alpha Interferon produced from human peripheral blood leukocytes and its
production process and has several patent applications pending, it is possible
that others have or may develop equivalent or superior products or technologies
which would not fall within the scope of the Company's patent claims or which
might involve inventions similar in scope to those of the Company for which
patent or similar rights are obtained by others prior to the time that the
Company is able to do so.
Regulatory Approvals. The production and marketing of the Company's products
in the United States, as well as its ongoing research and development
activities, are subject to regulation by governmental agencies, most
significantly the FDA. Such regulation includes requirements for obtaining FDA
approval prior to marketing each of its products in the United States. In order
to obtain such FDA approval, the Company must demonstrate, among other things,
the safety and efficacy of each product through pre-clinical and clinical
testing. Obtaining such approvals is a time-consuming process and requires the
expenditure of substantial resources. Each facility in which the products are
produced and packaged, whether operated by the Company or a third party, must
meet the FDA's standards for current good manufacturing practices and must also
be approved prior to marketing any product produced or packaged in such
facility. Any significant change in the production process which may be
commercially required, including changes in sources of certain raw materials, or
any change in the location of the production facilities will also require FDA
approval. To the extent a portion of the manufacturing process
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for a product is handled by an entity other than the Company, the Company must
similarly receive FDA approval for the participation by such third party in the
manufacturing process. For example, the Company has entered into an agreement
with Abbott Laboratories, Inc. ("Abbott") pursuant to which Abbott formulates
and packages ALFERON N Injection. The Company presently has a biologic
establishment license for the facilities in which it produces ALFERON N
Injection, which includes the facilities in which Abbott formulates and packages
ALFERON N Injection. If the Company's or Abbott's present manufacturing
facilities were damaged or destroyed or the Company's arrangements with Abbott
were terminated, there can be no assurance that FDA approval could be obtained
for another facility or that another facility could be built and approved on a
timely basis or on commercially reasonable terms. Delays in obtaining, or the
failure to obtain, any necessary regulatory approvals could have a material
adverse effect on the Company's ability to develop, produce, and sell its
products. In addition, failure of the Company to comply in any respect with FDA
requirements with respect to the production and marketing of biological drug
products can subject the Company to potential civil and criminal penalties and
its products to seizure and other civil enforcement action. Because of the
uncertain nature of many of these requirements, there can be no assurance that
regulatory problems of this type will not occur.
Foreign Regulatory Approvals. To market its products outside of the United
States, the Company is subject to numerous and varying foreign regulatory
requirements, implemented by foreign health authorities, governing the design
and conduct of human clinical trials and marketing approval. The approval
procedure varies among countries and can involve additional testing, and the
time required to obtain approval may differ from that required to obtain FDA
approval. At present, foreign marketing authorizations are applied for at a
national level, although certain registration procedures are available within
the European Union (the "EU") to companies wishing to market a product in more
than one EU member country. If a regulatory authority is satisfied that adequate
evidence of safety, quality, and efficacy has been presented, marketing
authorization is usually granted. The foreign regulatory approval process
includes all of the risks associated with obtaining FDA approval set forth
above. Approval by the FDA does not ensure approval by other countries. There
can be no assurance that the Company's products will receive such approvals. In
addition, under certain circumstances, the Company may be required to obtain FDA
authorization to export products for sale in foreign countries. For instance, in
most cases, the Company may not export products that have not been approved by
the FDA unless it first obtains an export permit from the FDA. However, these
FDA export restrictions generally do not apply if the Company's products are
exported in conformance with their United States approvals or are manufactured
outside the United States. At the present time, the Company does not have any
foreign manufacturing facilities.
Uncertainty of Pharmaceutical Pricing and Related Matters; Need for
Reimbursement. The future revenues and profitability of, and availability of
capital for, biotechnology companies may be affected by the continuing efforts
of governmental and third-party payors to contain or reduce the costs of health
care through various means. For example, in certain foreign markets, the pricing
and profitability of prescription pharmaceuticals is subject to government
control. In Japan, which is currently the world's largest market for interferon
products, the government imposed price cuts ranging from 13.5% to 22.7% in 1994
on certain interferon products then being marketed in Japan. The Company cannot
predict whether similar price cuts will be imposed on any of the Company's
products in Japan or in any other country at such time as such products are
being marketed in such country or the size or duration of any cuts that may be
imposed. However, there can be no assurance that any such cuts will not have a
material adverse effect on the Company's future results of operations. There
have been, and the Company expects there to continue to be, a number of United
States federal and state proposals to implement similar government control. It
is uncertain what form any health care reform legislation may take or what
actions the federal,
9
<PAGE>
state, and private payors may take in response to the suggested reforms. The
Company cannot predict when any suggested reforms will be implemented, if ever,
or the effect of any implemented reform on the Company's business. There can be
no assurance, however, that any implemented reform will not have a material
adverse effect on the Company's future results of operations. The Company's
long-term ability to market its products successfully may depend in part on the
extent to which reimbursement for the cost of such products and related
treatment will be available from public and private health insurers and other
organizations. Third-party payors are increasingly challenging the prices of
medical products and services. The reimbursement status of newly-approved health
care products is highly uncertain, and there can be no assurance that
third-party coverage will be available or that available third-party coverage
will enable the Company to maintain price levels sufficient to realize an
appropriate return on its investment in product development. While recombinant
alpha interferon products can be produced at a lower cost per unit than the
Company's formulations of Natural Alpha Interferon products, until dose regimens
and treatment durations are determined, the Company is unable to determine
whether the cost of treatment with the Company's products will be greater, equal
to, or less than the cost of competing treatments.
Royalty Obligations. The Company is a party to certain license agreements
pursuant to which it is obligated to pay royalties based upon the commercial
exploitation of its products. Royalty payments under such license agreements
with respect to ALFERON N Injection, ALFERON N Gel, and ALFERON LDO could
aggregate up to 9.5%, 13.5%, and 19.5%, respectively, of the Company's net sales
of such products. Such royalty obligations, together with any additional
royalties which may be payable by the Company, may limit the Company's marketing
strategies and prevent it from obtaining adequate profit margins and could have
a material adverse effect on the commercial exploitation of the Company's
products.
In connection with the acquisition of certain intellectual property and
technology rights from National Patent Development Corporation ("NPDC"), the
Company agreed to pay NPDC a royalty of $1 million. Such amount is payable if
and when the Company generates income before income taxes, limited to 25% of
such income before income taxes per year until such amount is paid in full.
Risk of Product Liability. The Company's products have undergone or will
undergo extensive clinical testing prior to the granting of any regulatory
approval for the purpose, among other things, of determining the safety of such
products. The Company may sell products which cause unexpected adverse reactions
or result in an allergic or other reaction or which are alleged to have
unacceptable adverse side effects. Product liability risk is inherent in the
testing, manufacture, marketing, and sale of the Company's products, and there
can be no assurance that the Company will be able to avoid significant product
liability exposure. Such liability might result from claims made directly by
consumers or by pharmaceutical companies or others selling such products. It is
impossible to predict the scope of injury or liability from such unexpected
reactions, or the measure of damages which might be imposed as a result of any
claims or the cost of defending such claims. The Company has a product liability
insurance policy in the amount of $10,000,000. Although the Company believes
this amount is sufficient, there is no assurance that the Company will be able
to maintain such coverage, and even if it does maintain it, in the event that
the Company becomes subject to liability claims in excess of any insurance
coverage it may have in effect, the Company may not have sufficient assets or
liquidity to satisfy such claims which could result in the Company's inability
to continue its operations. Furthermore, any published reports or rumors
suggesting a link between a Company product and injury to a person could be
expected to materially impair the Company's ability to market such product.
Retention of Key Personnel. Because of the specialized scientific nature of
the Company's business, it is necessary to attract and retain personnel with a
wide variety of scientific capabilities. Competition
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<PAGE>
for such personnel is intense. There can be no assurance that the Company will
continue to attract and retain personnel of high scientific caliber. None of the
Company's key employees have employment agreements. The Company does not
maintain key man life insurance for any of its key employees and does not intend
to obtain such insurance. The Company's loss of services of certain of its
employees or other members of its staff could have a material adverse effect on
the Company's operations.
Conflicts of Interest. As of January 1, 1998, NPDC beneficially owned
approximately 12% of the outstanding shares of Common Stock. Certain conflicts
of interest may arise as a result of NPDC's stock ownership in the Company and
certain related transactions between the Company and NPDC. Furthermore, the
chief executive officer of the Company also serves as general counsel of NPDC
and may have conflicts of interest in allocating management time, services, and
functions between the Company and NPDC. In addition, certain directors of NPDC
also serve as directors of the Company.
Preferred Stock. The Company's charter provides for 5,000,000 authorized but
unissued shares of Preferred Stock, the rights, preferences, qualifications,
limitations, and restrictions of which may be fixed by the Board of Directors
without any further vote or action by the stockholders. The ability to issue the
Preferred Stock could have the effect of delaying, deferring, or preventing a
change of control of the Company.
Options and Warrants. As of January 1, 1998, the Company had outstanding
options and warrants to purchase __________ shares of Common Stock. For the life
of the outstanding options and warrants, the holders are given, at nominal cost,
the opportunity to profit if the price for the Common Stock in the public market
exceeds the exercise price of the options or warrants, without assuming the risk
of ownership, with a resulting dilution in the interest of other security
holders. If the public market price of the Common Stock does not rise above the
exercise price of the options or warrants during the exercise period, then such
securities will expire worthless. As long as the outstanding options and
warrants remain unexercised, the terms under which the Company could obtain
additional capital may be adversely affected. Moreover, the holders of these
securities may be expected to exercise them at a time when the Company would, in
all likelihood, be able to obtain any needed capital by a new offering of its
securities on terms more favorable than those provided by these securities.
Volatility of Share Price; Lack of Liquidity. There has been significant
volatility in the market prices for publicly traded shares of biotechnology
companies, including the Company. There can be no assurance that the price of
the Common Stock will remain at or exceed current levels. Factors, such as
announcements of technological or product developments by the Company or its
competitors, governmental regulation, or patent or proprietary rights
developments, may have a significant impact on the market price of the Common
Stock.
While 21 firms made a market in the Common Stock as of January 1, 1998, all
or some of such firms may discontinue such activities at any time or from time
to time, which may adversely affect the price and liquidity of the Common Stock.
Dividends on Common Stock Unlikely. The Company does not, in the
foreseeable future, anticipate paying any dividends on the Common Stock.
11
<PAGE>
SELLING STOCKHOLDER
The name of the Selling Stockholder is the American National Red Cross (the
"Selling Stockholder"). The Selling Stockholder beneficially owns 200,000 shares
of Common Stock prior to this offering, which constitutes 1.3% of the
outstanding Common Stock, all of which shares are being offered hereby.
Beneficial ownership by the Selling Stockholder after this offering will depend
on the number of shares sold by the Selling Stockholder.
The Company currently obtains human white blood cells from the Selling
Stockholder pursuant to a supply agreement dated April 1, 1997. The shares being
offered hereby were issued to the Selling Stockholder in partial payment for
human white blood cells. The Selling Stockholder has registration rights with
respect to such shares.
The sale of shares of Common Stock by the Selling Stockholder may be
effected from time to time in transactions (which may include block transactions
by or for the account of the Selling Stockholder) in the over-the-counter market
or in negotiated transactions, through the writing of options on such shares, a
combination of such methods of sale, or otherwise. Sales may be made at fixed
prices which may be changed, at market prices prevailing at the time of sale, or
at negotiated prices.
The Selling Stockholder may effect such transactions by selling its shares
directly to purchasers, through broker-dealers acting as agents for the Selling
Stockholder, or to broker-dealers who may purchase shares as principals and
thereafter sell the shares from time to time in the over-the-counter market, in
negotiated transactions, or otherwise. Such broker-dealers, if any, may receive
compensation in the form of discounts, concessions, or commissions from the
Selling Stockholder and/or the purchasers for whom such broker-dealers may act
as agents or to whom they may sell as principals or both (which compensation as
to a particular broker-dealer may be in excess of customary commissions).
The Selling Stockholder and broker-dealers, if any, acting in connection
with such sale might be deemed to be "underwriters" within the meaning of
Section 2(11) of the Securities Act and any commission received by them and any
profit on the resale of such shares might be deemed to be underwriting discounts
and commissions under the Securities Act.
LEGAL MATTERS
The legality of the securities offered hereby will be passed on for the
Company by Andrea D. Kantor, Associate General Counsel of the Company. Ms.
Kantor owns 3,881 shares of Common Stock and has options to purchase 24,376
shares of Common Stock, of which options to purchase 10,188 shares of Common
Stock are currently exercisable.
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EXPERTS
The audited consolidated financial statements of the Company and its
subsidiary at December 31, 1996 and 1995, and for each of the years in the three
year period ended December 31, 1996, incorporated by reference herein have been
incorporated by reference herein in reliance upon the report of KPMG Peat
Marwick LLP, independent certified public accountants, incorporated by reference
herein, and upon the authority of said firm as experts in auditing and
accounting.
ADDITIONAL INFORMATION
The Company has filed with the Commission a Registration Statement on Form
S-3 under the Securities Act with respect to the shares of Common Stock being
offered by this Prospectus. This Prospectus does not contain all of the
information set forth in the Registration Statement and the exhibits thereto,
certain portions of which have been omitted as permitted by the rules and
regulations of the Commission. For further information with respect to the
Company and the Offering, reference is made to the Registration Statement,
including the exhibits thereto, which may be inspected without charge at the
Commission's principal office at 450 Fifth Street, N.W., Washington, D.C. 20549.
Copies of the Registration Statement may be obtained from the Commission at its
principal office upon payment of prescribed fees. Statements contained in this
Prospectus as to the contents of any contract or other document are not
necessarily complete, and in each instance where such contract or other document
is an exhibit to the Registration Statement, reference is made to the copy of
such contract or other document filed as an exhibit to the Registration
Statement, each statement being qualified in all respects by such reference.
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<PAGE>
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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 or the Underwriter. This
Prospectus does not constitute an offer to sell or the solicitation of any offer
to buy any of the securities offered hereby to anyone in any jurisdiction in
which such offer or solicitation is unlawful. Neither the delivery of this
Prospectus nor any sale made hereunder shall, under any circumstances, imply
that there has been no change in the affairs of the Company or that the
information herein is correct as of any time subsequent to the dates as of which
such information is given.
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TABLE OF CONTENTS
Page
The Company............................... 3
Risk Factors.............................. 3
Selling Stockholder....................... 12
Legal Matters............................. 12
Experts................................... 13
Additional Information.................... 13
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---------------------------------------------------
Interferon Sciences, Inc.
200,000 Shares
of
Common Stock
---------------------------
PROSPECTUS
---------------------------
January ___, 1998
---------------------------------------------------
<PAGE>
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 14. Other Expenses of Issuance and Distribution.
The following table sets forth an itemized statement of all expenses in
connection with the issuance and distribution of the securities being registered
hereby. All are estimated except the SEC fee.
SEC registration fee $487
Accounting fees and expenses 2,500
Legal fees and expenses 10,000
Miscellaneous 2,013
-----
Total $15,000
Item 15. Indemnification of Directors and Officers
Article 9 of the Company's Restated Certificate of Incorporation provides
that the Company shall, to the full extent then permitted by law, indemnify all
persons whom it may indemnify pursuant thereto. In addition, Article 10 of the
Company's Restated Certificate of Incorporation eliminates personal liability of
its directors to the full extent permitted by Section 102(b)(7) of the General
Corporation Law of the State of Delaware.
Section 145 of the General Corporation Law of the State of Delaware permits
a corporation to indemnify its directors and officers against expenses
(including attorney's fees), judgments, fines and amounts paid in settlements
actually and reasonably incurred by them in connection with any action, suit or
proceeding brought by third parties, if such directors or officers acted in good
faith and in a manner they reasonably believed to be in or not opposed to the
best interests of the corporation and, with respect to any criminal action or
proceeding, had no reason to believe their conduct was unlawful. In a derivative
action, i.e., one by or in the right of the corporation, indemnification may be
made only for expenses actually and reasonably incurred by directors and
officers in connection with the defense or settlement of an action or suit, and
only with respect to a matter as to which they shall have acted in good faith
and in a manner they reasonably believed to be in or not opposed to the best
interest of the corporation, except that no indemnification shall be made if
such person shall have been adjudged liable to the corporation, unless and only
to the extent that the court in which the action or suit was brought shall
determine upon application that the defendant officers or directors are
reasonably entitled to indemnity for such expenses despite such adjudication of
liability.
Section 102(b)(7) of the General Corporation Law of the State of Delaware
provides that a corporation may eliminate or limit the personal liability of a
director to the corporation or its stockholders for monetary damages for breach
of fiduciary duty as a director, provided that such provision shall not
eliminate or limit the liability of a director (i) for any breach of the
director's duty of loyalty to the corporation or its stockholders, (ii) for acts
or omissions not in good faith or which involve intentional misconduct or a
knowing violation of law, (iii) under Section 174 of the General Corporation Law
of the State of Delaware, or (iv) for any transaction from which the director
derived an improper personal benefit. No such provision shall eliminate or limit
the liability of a director for any act or omission occurring prior to the date
when such provision becomes effective.
II-1
<PAGE>
The Company currently has a $1,000,000 directors' and officers' liability
insurance policy.
Item 16. Exhibits.
5.1 -- Opinion of Andrea D. Kantor, Esq., Associate General
Counsel, Registrant, as to the legality of the securities being
registered*
23.1 -- Consent of Independent Auditors*
23.2 -- Consent of Andrea D. Kantor (included in Exhibit 5.1)*
- ----------
* Filed herewith.
Item 17. Undertakings.
Insofar as indemnification for liabilities arising under the Securities Act,
as amended (the "Securities Act") may be permitted to directors, officers and
controlling persons of the Registrant pursuant to the foregoing provisions, or
otherwise, the Registrant has been advised that in the opinion of the Securities
and Exchange Commission such indemnification is against public policy as
expressed in the Securities Act and is, therefore, unenforceable. In the event
that a claim for indemnification against such liabilities (other than the
payment by the Registrant of expenses incurred or paid by a director, officer or
controlling person of the Registrant in the successful defense of any action,
suit or proceeding) is asserted by such director, officer or controlling person
in connection with the securities being registered, the Registrant will, unless
in the opinion of its counsel the matter has been settled by controlling
precedent, submit to a court of appropriate jurisdiction the question whether
such indemnification by it is against public policy as expressed in the
Securities Act and will be governed by the final adjudication of such issue.
A. The undersigned Registrant hereby undertakes that, for purposes of
determining any liability under the Securities Act, each filing of the
Registrant's annual report pursuant to section 13(a) or section 15(d) of the
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 this
Registration Statement shall be deemed to be a new registration statement
relating to the securities offered herein, and the offering of such securities
at that time shall be deemed to be the initial bona fide offering thereof.
B. 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;
(ii) To reflect in the prospectus any facts or events arising after
the effective date of the registration statement (or the most recent
post-effective amendment thereof) which individually or in the
aggregate, represent a fundamental change in the information set forth
in the registration statement. Notwithstanding the foregoing, any
increase or decrease in volume of securities offered (if the total
dollar value of securities offered would not exceed that which was
registered) and any
II-2
<PAGE>
deviation from the low or high end of the estimated maximum offering
range may be reflected in the form of prospectus filed with the
Commission pursuant to Rule 424(b) if, in the aggregate, the changes in
volume and price represent no more than 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 to such information in the registration
statement;
Provided, however, That paragraphs (1)(i) and (1)(ii) do not apply if
the information required to be included in a post-effective amendment by
those paragraphs is contained in periodic reports filed with or furnished to
the Commission by the Registrant pursuant to section 13 or section 15(d) of
the Securities Exchange Act of 1934 that are incorporated by reference in
this Registration Statement.
(2) That, for the purpose of determining any liability under the
Securities Act, 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 remains unsold at the
termination of the offering.
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 New York, and the State of New York, on this 13th day
of January, 1998.
INTERFERON SCIENCES, INC.
By: /s/ LAWRENCE M. GORDON
Lawrence M. Gordon
Chief Executive Officer
Pursuant to the requirements of the Securities Act of 1933, this
Registration Statement has been signed by the following persons in their
capacities on January 13, 1998.
/s/ SAMUEL H. RONEL, PH.D. Chairman of the Board
Samuel H. Ronel, Ph.D.
/s/ LAWRENCE M. GORDON Chief Executive Officer and Director
Lawrence M. Gordon (Principal Executive Officer)
/s/ STANLEY G. SCHUTZBANK, PH.D. President and Director
Stanley G. Schutzbank, Ph.D.
Director
Leon Botstein, Ph.D.
/s/ JEROME I. FELDMAN Director
Jerome I. Feldman
Director
Sheldon L. Glashow, Ph.D
/s/ SCOTT N. GREENBERG Director
Scott N. Greenberg
Director
Roald Hoffmann, Ph.D
Director
Martin M. Pollak
/s/ DONALD W. ANDERSON Controller (Principal Accounting and
Donald W. Anderson Financial Officer)
The foregoing constitute a majority of the members of the Board of
Directors.
II-4
<PAGE>
INDEX TO EXHIBITS
Sequentially
Exhibit Numbered
Number Description Page
5.1 -- Opinion of Andrea D. Kantor, Esq., Associate General
Counsel, Registrant, as to the legality of the
securities being registered*
23.1 -- Consent of Independent Auditors*
23.2 -- Consent of Andrea D. Kantor (included in Exhibit 5.1)*
- ----------
* Filed herewith.
EXHIBIT 5.1
Interferon Sciences, Inc. [LOGO] [LETTERHEAD]
January 13, 1998
Interferon Sciences, Inc.
783 Jersey Avenue
New Brunswick, New Jersey 08901
Gentlemen:
Reference is made to the Registration Statement on Form S-3 of Interferon
Sciences, Inc. (the "Company") relating to the registration of shares of the
Company's common stock, par value $.01 per share (the "Common Stock").
I am Associate General Counsel of the Company, and have examined such
corporate records and other documents as I have deemed relevant. Based upon the
above, I am of the opinion that the Common Stock to be sold pursuant to the
Registration Statement is validly authorized and issued, fully paid, and
non-assessable.
I hereby consent to the filing of this opinion as an exhibit to the
Registration Statement and the use of my name in the Prospectus.
Very truly yours,
Andrea D. Kantor
EXHIBIT 23.1
CONSENT OF INDEPENDENT AUDITORS
Board of Directors
Interferon Sciences, Inc.
We consent to the use of our report incorporated herein by reference and to the
reference to our firm under the heading "Experts" in the prospectus.
KPMG PEAT MARWICK LLP
New York, New York
January 13, 1998
