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As filed with the Securities and Exchange Commission on May 1, 1997
REGISTRATION NO. 333-24793
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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
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AMENDMENT NO. 2
TO
FORM S-3
REGISTRATION STATEMENT
Under
THE SECURITIES ACT OF 1933
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CEPHALON, INC.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation or organization)
23-2484489
(I.R.S. Employer Identification No.)
145 Brandywine Parkway
West Chester, PA 19380
(610) 344-0200
(Address, including zip code, and telephone number, including area code, of
registrant's principal executive offices)
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BARBARA S. SCHILBERG
Cephalon, Inc.
Senior Vice President and General Counsel
145 Brandywine Parkway
West Chester, PA 19380
(610) 344-0200
(Name, address, including zip code, and telephone number, including area code,
of agent for service)
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Copies to:
David R. King, Esq.
Morgan, Lewis & Bockius LLP
2000 One Logan Square
Philadelphia, PA 19103
(215) 963-5000
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. [ ]
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. [ ]
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THE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR
DATES AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT SHALL
FILE A FURTHER AMENDMENT WHICH SPECIFICALLY STATES THAT THIS REGISTRATION
STATEMENT SHALL THEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH SECTION 8(A) OF
THE SECURITIES ACT 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 AN OFFER, SOLICITATION OR SALE WOULD
BE UNLAWFUL PRIOR TO REGISTRATION OR QUALIFICATION UNDER THE SECURITIES
LAWS OF ANY STATE.
SUBJECT TO COMPLETION, DATED MAY 1, 1997
PROSPECTUS
500,000 SHARES
CEPHALON, INC.
COMMON STOCK
The shares offered hereby (the "Shares") consist of up to 500,000 shares of
common stock, $0.1 par value per share ("Common Stock"), of Cephalon, Inc., a
Delaware corporation ("Cephalon" or the "Company"), which are being offered by
Swiss Bank Corporation, London Branch ("SBC" or the "Selling Stockholder"). The
Shares may be offered from time to time by the Selling Stockholder. All expenses
of registration incurred in connection herewith are being borne by the Company,
but all selling and other expenses incurred by the Selling Stockholder will be
borne by the Selling Stockholder. The Company will not receive any of the
proceeds from the sale of the Shares by the Selling Stockholder.
The Shares are being acquired by SBC, in one or more transactions, in
exchange for one or more capped options to be written by SBC on up to an
aggregate of 2,500,000 shares of Common Stock of the Company. The Company will
purchase each option from SBC and will use the Shares, in lieu of cash, to pay
the premium associated with each option. The option price, as well as the strike
price, cap price, number of shares subject to each option, expiration date and
certain other terms of each option, will be determined following the
effectiveness of the Registration Statement, based upon a number of factors,
including the market price of the Common Stock when each option is issued. See
"Call Option Transaction and Issuance of the Shares."
The Selling Stockholder has advised the Company that the Shares may be sold
from time to time to or through its affiliate SBC Warburg Inc. ("SBC Warburg")
primarily in transactions (which may include block transactions) in the
over-the-counter market at prices then prevailing, or in negotiated
transactions. The Selling Stockholder and SBC Warburg and any other brokers and
dealers through whom sales of Shares may be made may be deemed to be
"underwriters" within the meaning of the Securities Act of 1933, as amended (the
"Securities Act"), and their commissions or discounts and other compensation may
be regarded as underwriters' compensation. See "Plan of Distribution."
The Company's Common Stock is quoted on the Nasdaq National Market under
the symbol "CEPH." On April 30, 1997, the last reported sale price of the Common
Stock was $16.75 per share.
AN INVESTMENT IN THE COMMON STOCK OFFERED HEREBY INVOLVES A HIGH DEGREE OF RISK.
SEE "RISK FACTORS" ON PAGES 4 THROUGH 16 HEREIN.
THESE SECURITIES HAVE NOT BEEN APPROVED OR DISAPPROVED BY THE SECURITIES AND
EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION NOR HAS THE COMMISSION
PASSED UPON THE ACCURACY OR ADEQUACY OF THIS PROSPECTUS. ANY REPRESENTATION TO
THE CONTRARY IS A CRIMINAL OFFENSE.
THE DATE OF THIS PROSPECTUS IS , 1997
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AVAILABLE INFORMATION
The Company is subject to the reporting 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, Judiciary Plaza,
450 Fifth Street, N.W., Washington, D.C. 20549, as well as the following
regional offices of the Commission: Seven World Trade Center, 13th Floor, New
York, New York 10048; and Citicorp Center, 500 West Madison Street, Suite 1400,
Chicago, Illinois 60661. Copies of such material can be obtained from the
Commission by mail at prescribed rates. Requests should be directed to the
Commission's Public Reference Branch, Judiciary Plaza, 450 Fifth Street, N.W.,
Washington, D.C. 20549. Such material also may be accessed electronically by
means of the Commission's home page on the Internet (http://www.sec.gov). In
addition, such reports, proxy statements and other information concerning the
Company can be inspected at the National Association of Securities Dealers,
Inc., 1735 K Street, N.W., Washington, D.C. 20006.
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
The following documents or portions of documents filed by the Company (File
No. 0-19119) with the Commission are incorporated herein by reference.
(a) Annual Report on Form 10-K/A-2 for the fiscal year ended December 31,
1996 filed with the Commission on April 4, 1997.
(b) Current Report on Form 8-K dated January 16, 1997.
(c) Current Report on Form 8-K dated April 8, 1997.
(d) The Company's Proxy Statement related to its 1997 Annual Meeting of
Stockholders filed under the Exchange Act on March 26, 1997.
(e) The description of the Company's Common Stock which is contained in
its Registration Statement on Form 8-A filed under the Exchange Act on
March 15, 1991, including any amendment or reports filed for the purpose
of updating such description.
(f) The description of rights to purchase Series A Junior Participating
Preferred Shares, par value $.01 per share, which is contained in the
Company's Registration Statement on Form 8-A filed under the Exchange
Act on November 22, 1993, including any amendment or reports filed for
the purpose of updating such description.
All reports and other documents subsequently filed by the Company pursuant
to Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act, prior to the filing
of a post-effective amendment which indicates that all securities offered hereby
have been sold or which deregisters all securities remaining unsold, shall be
deemed incorporated by reference herein and to be a part hereof from the date of
the filing of such reports and documents. Any statement contained in a document
incorporated by reference herein shall be deemed to be modified or superseded
for purposes of this Prospectus to the extent that a statement contained or
incorporated by reference herein modifies or supersedes 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.
The Company will provide without charge to each person to whom this
Prospectus is delivered a copy of any or all of such documents which are
incorporated herein by reference (other than exhibits to such documents unless
such exhibits are specifically incorporated by reference into the documents that
this Prospectus incorporates). Written or oral requests for copies should be
directed to Jason Rubin, Vice President, Corporate Communications, Cephalon,
Inc., 145 Brandywine Parkway, West Chester, PA 19380, (610) 344-0200.
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Myotrophin(R) and Provigil(R) are trademarks of Cephalon, Inc. Cephalon has
registered or filed applications to register the trademarks in the United States
and certain other countries. All other trademarks and registered marks in this
Prospectus are the property of their respective holders.
Unless the context otherwise requires, "Cephalon" or the "Company" refers
to Cephalon, Inc. and its wholly-owned subsidiaries.
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THE COMPANY
Cephalon seeks to discover and develop pharmaceutical products for the
treatment of neurological disorders. The Company's research and development
efforts focus primarily on neurodegenerative diseases, which are characterized
by the death of neurons, the specialized conducting cells of the nervous system.
The Company utilizes its technical expertise in molecular biology, molecular
pharmacology, biochemistry, cell biology and chemistry to develop products in
four core technology areas: neurotrophic factors, protease inhibitors, signal
transduction modulators and regulators of gene transcription. Cephalon believes
that its multidisciplinary technology approach provides the basis for the
development of a portfolio of potential products for the treatment of
neurodegenerative disorders such as amyotrophic lateral sclerosis ("ALS" or "Lou
Gehrig's disease"), peripheral neuropathies, Alzheimer's disease and stroke.
Cephalon's business strategy includes forming alliances with other
pharmaceutical companies where collaborations can provide strategic advantages
in technological, financial, marketing, manufacturing and other areas. In these
arrangements, the Company seeks, where appropriate, to retain the rights to
co-promote or otherwise share in the marketing of products, particularly to
neurologists. The Company also seeks to selectively in-license late stage
compounds for development.
The Company has established a 36-person sales organization in the United
States focusing on neurologists, which is presently co-promoting two
Bristol-Myers Squibb Company ("BMS") proprietary products, Stadol NS(R)
(butorphanol tartrate), for the management of pain when the use of an opioid
analgesic is appropriate and Serzone(R) (nefazodone hydrochloride), which is
indicated for the treatment of depression.
The Company has not received approval from any regulatory authority to
market any drug candidate. Two new drug applications ("NDA") have been submitted
by the Company to the U.S. Food and Drug Administration ("FDA"): one for the use
of MYOTROPHIN(R) (rhIGF-I) in treating ALS, and one for the use of PROVIGIL(R)
(modafinil) in treating the excessive daytime sleepiness associated with
narcolepsy. Additionally, marketing applications for PROVIGIL (modafinil) are
pending in the United Kingdom and the Republic of Ireland, and a marketing
authorization application for MYOTROPHIN (rhIGF-I) is being prepared for filing
in Europe. There can be no assurance that the applications will be approved or
that the Company will successfully commercialize any of its potential products.
Cephalon was incorporated in Delaware in August 1987. The Company's
executive offices and research facility are located at 145 Brandywine Parkway,
West Chester, PA 19380, and its telephone number is (610) 344-0200.
RISK FACTORS
In addition to the other information in this Prospectus, prospective
investors should consider the following factors in evaluating the Company and
its business before purchasing any of the Common Stock offered hereby.
UNCERTAINTIES RELATED TO MYOTROPHIN(R) (RHIGF-I) PHASE III REGULATORY
SUBMISSIONS
In 1995, the Company submitted to the FDA a treatment investigational new
drug application ("T-IND") to permit expanded access to MYOTROPHIN (rhIGF-I) by
patients in the United States suffering from ALS. The FDA referred the
application to the Peripheral and Central Nervous System Drugs Advisory
Committee (the "Advisory Committee"), which held a public hearing in June 1996
to review data from two Phase III studies, one conducted in North America and
one in Europe, for purposes of recommending to the FDA whether there was
sufficient evidence to support use of MYOTROPHIN (rhIGF-I) under a T-IND. At the
hearing, representatives of the FDA indicated their disagreement with the
Company's various analyses of the European study and their opinion that the
study failed to support the results of the North American study. At the
conclusion of the Advisory Committee hearing, the panel members unanimously
recommended approval of the T-IND.
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The FDA approved the T-IND application on June 19, 1996. The FDA's approval
letter noted the views of several Advisory Committee members expressed at the
hearing, including the chairman, concerning the need for an additional study to
support an NDA, and invited Cephalon and Chiron Corporation ("Chiron") to work
with the FDA to develop plans for future studies. The Company continues to
believe that the two completed studies show the beneficial treatment effect of
MYOTROPHIN (rhIGF-I) in ALS patients particularly those with more rapidly
progressing disease and, in collaboration with Chiron, filed an NDA with the FDA
in February 1997 requesting that MYOTROPHIN (rhIGF-I) be approved for the
treatment of ALS in the United States. There can be no assurance that the FDA
will ultimately grant authorization to commercialize MYOTROPHIN (rhIGF-I) in the
United States on the basis of the results of the two completed studies. The FDA
has scheduled a meeting of the Advisory Committee to be held on May 8, 1997 to
review the NDA for MYOTROPHIN (rhIGF-I). The Company has indicated its
willingness to conduct additional studies of MYOTROPHIN (rhIGF-I) as a
post-approval activity. If the FDA were to require additional data prior to
approval of MYOTROPHIN (rhIGF-I) for commercialization, there can be no
assurance that the Company and Chiron would be willing or able to conduct any
study as a Phase III activity or that the results of such study, if conducted,
would be positive. A new study also would be expensive and would take several
years to complete.
Because ALS is a fatal disease, it is expected that some mortalities will
occur while conducting clinical trials in ALS patients. During the double-blind
portion of the European study, an imbalance in death rates was observed in the
drug-treated group compared to the placebo-treated group. The Company believes
that mortalities observed in the North American and European clinical studies
are due to the normal progression of the disease or other circumstances not
attributable to MYOTROPHIN (rhIGF-I). The Company is continuing to furnish
MYOTROPHIN (rhIGF-I) to patients who participated in the ALS studies, to
patients in its Phase II program in peripheral neuropathies, and to patients
under the recently initiated T-IND program. FDA regulations require the
reporting of all patient adverse events (including deaths) experienced in
ongoing trials. There can be no assurance that any such event previously
reported by the Company, or which may occur in the future, will not delay or
prevent the approval of MYOTROPHIN (rhIGF-I) or result in any subsequent FDA
action adverse to the interests of the Company.
The efficacy and safety data from the North American and European studies
of MYOTROPHIN (rhIGF-I) have not yet been formally reviewed by any regulatory
authority outside the United States. The companies are preparing a marketing
authorization application for filing in Europe. If foreign regulatory
authorities do not agree with the Company's interpretation of the results from
the two studies, one or more additional positive studies might be required to be
completed and submitted before MYOTROPHIN (rhIGF-I) could be marketed in such
territories.
There can be no assurance that any regulatory authority will accept the
North American and European studies as evidence of sufficient safety and
efficacy to support marketing approval or that MYOTROPHIN (rhIGF-I) will receive
marketing approval in any jurisdiction for any indication. A delay in obtaining
approval or a failure to obtain any approval for MYOTROPHIN (rhIGF-I) would
materially adversely affect the Company's business and the price of the Common
Stock. See "Volatility of Stock Price; No Dividends".
UNCERTAINTIES RELATED TO PROVIGIL(R) (MODAFINIL) PHASE III REGULATORY
SUBMISSIONS
The Company recently submitted an NDA with the FDA requesting that PROVIGIL
(modafinil) be approved for the treatment of the excessive daytime sleepiness
associated with narcolepsy, based on the results of two Phase III studies
conducted in the United States. There can be no assurance that the FDA or other
regulatory authorities will determine that the results generated from the
Company's clinical trials demonstrate sufficient safety and efficacy to permit
marketing approval.
The Company also is pursuing applications seeking authorization to market
PROVIGIL (modafinil) in the Republic of Ireland and the United Kingdom, which
are other territories licensed from Laboratoire L. Lafon ("Lafon"). The
regulatory authorities in both countries have requested that additional
information be provided with respect to the applications (which were filed by
Lafon under the multi-state procedures of the Committee for Proprietary
Medicinal Products ("CPMP")). There can be no assurance that the Company
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will be able to provide sufficient additional information in order to permit
approval of the applications. Even if those applications are approved, the
Company must also request permission to vary the applications with respect to
certain manufacturing procedures and other matters. There can be no assurance
that any regulatory approvals or variations will be obtained at all or in a
timely manner. The Company is in the process of establishing a sales force in
the U.K. and the Republic of Ireland to sell PROVIGIL (modafini1). Any delays in
accomplishing these activities could delay launch of the product, if it is
approved. The Company is required, under the terms of its license with Lafon, to
launch the product no later than three months after approval.
UNCERTAINTIES RELATED TO PRODUCT DEVELOPMENT, REGULATORY APPROVAL AND
MARKETABILITY
The success of the Company depends to a large degree upon obtaining FDA and
foreign regulatory approval to market products currently under development.
Cephalon has had only limited experience in filing and pursuing applications
necessary to gain regulatory approvals. The Company's analysis and
interpretation of the results of the Company's clinical studies is subject to
confirmation and interpretation by regulatory authorities, which may differ from
the Company's analysis. There can be no assurance that the data or the Company's
interpretation of data will be accepted by any regulatory authority. In
addition, there can be no assurance that any application by the Company to
market a product will be reviewed in a timely manner or that approval to market
a product will be received from the appropriate regulatory authority.
TAP Holdings Inc. ("TAP") has begun a Phase I clinical study of a compound
being developed in collaboration with the Company for the treatment of various
cancers, including prostate cancer. The objective of the multi-center study is
to examine the drug's pharmacokinetic and safety profile in patients with
advanced cancer. Because the compound has never been tested in humans, the risk
of safety problems is unknown. There can be no assurance that the compound will
prove to be safe in humans, or that it will show any therapeutic benefit.
The results of preclinical and initial clinical trials of products under
development by the Company are not necessarily predictive of results that will
be obtained from large-scale clinical testing, and there can be no assurance
that clinical studies of products under development will demonstrate the safety
and efficacy of such products or will result in a marketable product. The safety
and efficacy of a therapeutic product under development by the Company generally
must be supported by statistically significant positive results from Phase III
clinical trials, and the failure to obtain such results could prevent regulatory
approval of the product, which would have a material adverse effect on the
Company.
Even if MYOTROPHIN (rhIGF-I) and PROVIGIL (modafinil) are approved for
commercialization, the Company can not predict at this time the potential
revenues to be received from sales of MYOTROPHIN (rhIGF-I) for use in treating
ALS or from sales of PROVIGIL (modafinil) for use in connection with narcolepsy.
Once approved, there can be no assurance that such products will be accepted and
prescribed by physicians. Moreover, ALS and narcolepsy each qualify as orphan
diseases under the Orphan Drug Law, which generally means that the potential
patient population for each indication is limited.
The administration of any product developed by the Company may produce
undesirable side effects in humans. The occurrence of such side effects could
interrupt or delay clinical studies of such products and could ultimately
prevent their approval by the FDA or foreign regulatory authorities for any or
all targeted indications. The Company or the FDA may suspend or terminate
clinical trials at any time if it is believed that the people participating in
such trials are being exposed to unacceptable health risks. Even after approval
by the FDA and foreign regulatory authorities, products may later exhibit
adverse effects that prevent their widespread use or necessitate their
withdrawal from the market. There can be no assurance that any products under
development by the Company will be safe when administered to patients.
The results of clinical studies of product candidates under development by
the Company which are conducted by collaborators of the Company, including
studies of rhIGF-I being conducted by the Company's licensee in Japan and
clinical studies of modafinil being conducted by Lafon and its licensees in
other countries, are required to be reported by the Company to the FDA and other
regulatory authorities. The reporting of the results of these other studies, if
negative, could adversely affect the regulatory review of the Company's product
approval applications. Negative results from trials by third parties or negative
assessments
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from regulatory authorities would adversely affect the Company's business and
the price of its Common Stock. See "Volatility of Stock Price; No Dividends."
NEED FOR ADDITIONAL FUNDS
The Company expects its negative cash flow to continue due to funding of
research, development, clinical trial, regulatory filing and other costs. In
addition, selling, general and administrative activities in the United States
and Europe may be expanded as the Company evaluates the potential for obtaining
regulatory approvals of MYOTROPHIN (rhIGF-I) and PROVIGIL (modafinil). Any such
expansion would require substantial funding. The Company may also build
inventories of MYOTROPHIN (rhIGF-I) and PROVIGIL (modafinil), which also would
require substantial funding. The capital required to fund the Company's
operations for 1997 may be greater than that of the prior year. The amount
needed to fund operations will depend upon many factors, including the success
of the Company's research and development programs, the extent of any
collaborative research or other funding arrangements, the costs and timing of
seeking regulatory approvals, if any, of its products, technological changes,
competition and the success of the Company's sales and marketing activities.
Schering-Plough Corporation ("Schering") recently decided to conclude its
funding of the research program with the Company related to amyloid protease
inhibitors and Alzheimer's disease. The Company intends to continue the program
using its own resources. Under the terms of its agreement with Schering, the
Company may not conduct the same research program with a third party until the
end of 1997.
In August 1992, Cephalon exclusively licensed to Cephalon Clinical
Partners, L.P. (the "Partnership") rights to MYOTROPHIN (rhIGF-I) for human
therapeutic use within the United States, Canada and Europe (the "Territory") in
return for a non-refundable license fee of $500,000. Through a concurrent
offering of 900 limited partnership interests, the Partnership raised
approximately $38,714,000 in net proceeds (payable to the Partnership in annual
installments, the last of which was paid in August 1995) which it used to fund
the development of MYOTROPHIN (rhIGF-I). The Partnership exhausted its available
funding in 1995. Since that time, the Company has been funding the continued
development of MYOTROPHIN (rhIGF-I) from its own cash resources. The Partnership
granted the Company an exclusive license (the "Interim License") to manufacture
and market MYOTROPHIN (rhIGF-I) within the Territory in return for certain
royalty payments and a payment of approximately $16,000,000 (the "Milestone
Payment") that is to be made if MYOTROPHIN (rhIGF-I) receives regulatory
approval in the United States or certain other countries within the Territory.
The Company has a contractual option to purchase all of the limited partnership
interests in the Partnership (the "Purchase Option").
If the Company is required to make the Milestone Payment and elects to do
so in cash, or if it elects to exercise its contractual option to purchase the
limited partnership interests in the Partnership for cash, as described below
under "Partnership Purchase Option," the Company will be required to make a
substantial cash payment. The Company may consider the purchase of some or all
of the remaining partnership interests other than through exercise of the
Purchase Option. The Company expects that the cost per interest associated with
any such purchase would be substantially greater than the cost incurred in the
1995 purchase of 67 limited partner interests and that, if the Company were to
elect to purchase some or all of the partnership interests in cash, significant
funds could be required.
If the Company does not exercise the Purchase Option or continue funding
the development of MYOTROPHIN (rhIGF-I), its license will terminate and all
rights to manufacture or market MYOTROPHIN (rhIGF-I), in the Territory will
revert to the Partnership, which may then commercialize MYOTROPHIN (rhIGF-I)
itself or license or assign its rights to a third party. The Company would not
receive any benefits from such commercialization.
The Company is obligated under various debt instruments to make principal
and interest payments to various state agencies and banks. Many of these
agreements contain restrictive covenants relating to, among other things, the
maintenance of minimum levels of working capital and limitations on the
incurrence of additional indebtedness that may limit the Company's flexibility
in utilizing its existing financial resources.
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To satisfy its capital requirements, including its continued funding of
MYOTROPHIN (rhIGF-I) and other programs, the Company may seek to access the
public or private equity markets whenever conditions are favorable. The Company
also intends to seek additional funding through corporate collaborations and
other financing vehicles, potentially including "off-balance sheet" financings
through limited partnerships or corporations. There can be no assurance that
such funding will be available at all or on terms acceptable to the Company. If
adequate funds are not available, the Company may be required to significantly
curtail one or more of its research or development programs or obtain funds
through arrangements with existing or future collaborative partners or others
that may require the Company to relinquish rights to certain of its
technologies, product candidates or products.
HISTORY OF OPERATING LOSSES
The Company has not received revenue from the sale of any product developed
by the Company, and has accumulated aggregate losses of $157,967,000 from
inception through December 31, 1996. The Company expects to continue to incur
operating losses unless and until such time as product approvals are obtained
and product sales, if any, exceed operating expenses. The revenues to be
received and costs to be incurred by the Company depend to a large degree on the
results of regulatory actions with respect to the two NDAs recently filed with
the FDA with respect to MYOTROPHIN (rhIGF-I) and PROVIGIL (modafinil) and other
product programs. A majority of the Company's revenues to date have been under
agreements with collaborative partners and the Partnership. The Company expects
to have significant fluctuations in quarterly results based on the level and
timing of recognition of contract revenues and the incurrence of expenses. See
"Dependence on Collaborative Partners." Since the formation of the Partnership,
the Partnership has funded a significant portion of the expenses related to the
development of MYOTROPHIN (rhIGF-I). Due to the funding limitations of the
Partnership, the Company has not recognized revenue from this source since 1995.
Therefore, during that period, the Company funded the development of MYOTROPHIN
(rhIGF-I). In addition, if the Company were to make the Milestone Payment,
exercise the Purchase Option or purchase additional interests outside of the
Purchase Option, a material charge to earnings could result, depending upon the
development status of the underlying technology.
The Company and Chiron are currently developing MYOTROPHIN (rhIGF-I) for
the treatment of ALS and certain peripheral neuropathics. The costs of the
program generally are shared equally by the partners. Revenue or expense to be
recognized by the Company under the collaboration with Chiron will depend on the
relative costs incurred by the two companies.
The Company receives funding to support its research and development
activities conducted in collaboration with SmithKline Beecham plc ("SB") related
to calpain inhibitors, and with TAP, related to the use of certain compounds in
the treatment of cancers, including prostate disease. The funding levels under
these agreements are based on a contract rate for each Cephalon employee
assigned to the program, subject to annual budgetary maximums. The continuation
of the research funding under the agreements with SB and TAP are subject to the
achievement of certain development milestones by the Company and periodic review
by these companies and may be terminated without cause with prior notice. There
can be no assurance that these research programs will be continued or that the
Company's expenses incurred in any of these programs will be fully reimbursed by
its collaborator. Should a collaborator elect to terminate a research program,
the Company's ability to recover costs and expenses proportionately is limited,
because a significant portion of the Company's research expenses, including
depreciation and facility costs, are fixed.
MANUFACTURING UNCERTAINTIES AND RELIANCE ON THIRD-PARTY SUPPLIERS
The Company's ability to conduct clinical trials on a timely basis, to
obtain regulatory approvals and to commercialize its products will depend in
part upon its ability to manufacture its products, either directly or through
third parties, at a competitive cost and in accordance with applicable FDA and
other regulatory requirements, including Good Manufacturing Practice ("GMP")
regulations. SB is responsible for the manufacture of any products developed
under its arrangement with the Company. Cephalon currently has no manufacturing
facilities of its own for clinical or commercial production of any products
under development.
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Cephalon will need to either construct and operate facilities for these products
or will have to find other manufacturing sources.
The MYOTROPHIN (rhIGF-I) currently being used in ongoing clinical trials
was produced at the Company's pilot-scale manufacturing facility in Beltsville,
Maryland (the "Beltsville Facility"). In November 1996, Cephalon sold the
Beltsville Facility. Chiron has completed a U.S. manufacturing facility (the
"Chiron Facility") to produce recombinant proteins at which the collaboration is
producing MYOTROPHIN (rhIGF-I). Once the existing inventory of material from the
Beltsville Facility has been depleted, the Chiron Facility will be the sole
source of supply for any commercial or clinical needs of MYOTROPHIN (rhIGF-I),
including any material which Cephalon may have to supply for use in Japan, as
well as for use in the Company's ongoing clinical trials. There can be no
assurance that Chiron will be able to produce adequate quantities of MYOTROPHIN
(rhIGF-I) in a cost-effective manner or, in the case of material purchased by
Cephalon for use outside the collaboration, on terms satisfactory to Cephalon.
The Company and Chiron will be required to demonstrate that the material
produced from the Chiron Facility is equivalent to the material used in the ALS
clinical trials, which was manufactured at the Beltsville Facility. Although,
based on the results of a bioequivalency study, the companies believe that the
material is equivalent, if regulatory authorities do not agree with that
assessment, regulatory approval of MYOTROPHIN (rhIGF-I) could be delayed.
The manufacturing facilities and operations of the Company and Chiron used
to produce MYOTROPHIN (rhIGF-I) are required to comply with all applicable FDA
requirements, including GMP regulations, and are subject to FDA inspection, both
before and after NDA approval, to determine compliance with those requirements.
The GMP regulations are complex, and failure to be in compliance could lead to
the need for remedial action, penalties and delay- in production of material
acceptable to the FDA. The Company has only limited experience in manufacturing
activities. There can be no assurance that the facilities for MYOTROPHIN
(rhIGF-I) have complied and will continue to comply with applicable
requirements. Should the Chiron Facility fail to operate for any reason or not
be able to produce sufficient quantities of MYOTROPHIN (rhIGF-I) in accordance
with applicable regulations, the collaboration would have to obtain MYOTROPHIN
(rhIGF-I) from another source. There can be no assurance that Cephalon or the
collaboration would be able to locate an alternative, cost-effective source of
supply of MYOTROPHIN (rhIGF-I).
If Chiron ceases its participation in the collaboration, Cephalon, under
certain circumstances, would have the right to purchase supplies of these
products from Chiron or it could have the manufacturing technology transferred
to Cephalon on a royalty basis. There can be no assurance that supplies of
products could be obtained from Chiron on a cost-effective basis, that Cephalon
would be able to manufacture the products itself in a cost-effective manner and
without an interruption of supplies or that a suitable alternative source of
MYOTROPHIN (rhIGF-I) could be located. Failure to locate an alternative supply
of MYOTROPHIN (rhIGF-I) could result in significant costs and delays to the
program, damage the commercial prospects for MYOTROPHIN (rhIGF-I) and have a
material adverse effect on the Company. Furthermore, the Company is aware of
patents and patent applications owned by third parties that may cover certain
aspects of the collaboration's current method of manufacturing MYOTROPHIN
(rhIGF-I). See "Patents and Proprietary Technology".
Kyowa Hakko Kogyo Co. Ltd. ("Kyowa Hakko") and Lafon are responsible for
manufacturing bulk compounds under the Company's respective agreement with each
company. The facilities used for manufacture of drug substance are required to
comply with all applicable FDA requirements, and are subject to FDA inspection
both before and after NDA approval. There can be no assurance that the
facilities or the material produced by Kyowa Hakko or Lafon will comply with
regulatory standards or that sufficient quantities will be available to meet the
Company's needs. If either Lafon or Kyowa Hakko were unable to supply the
Company with the applicable compound, Cephalon is permitted to make such
compound itself or to purchase it from third parties. There can be no assurance
that Cephalon would be able to manufacture any such compound, that a third-party
manufacturer could be located or that either alternative would be cost-
effective.
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The Company will be responsible for producing tablets or other forms of
finished product from the bulk compounds produced by Lafon and Kyowa Hakko.
There can be no assurance that a cost-effective commercial manufacturing process
can be developed. The Company has also entered into an agreement with a third
party to manufacture tablets for commercial use from bulk modafinil provided by
Lafon. There can be no assurance that such manufacturer will be able to make
sufficient quantities of tablets in accordance with appropriate FDA guidelines.
including GMP, and in a cost effective manner. Should such a manufacturer be
unable to supply tablets for any reason, there can be no assurance that the
Company would be able to identify a suitable alternative supplier at all or
without delaying the commercial launch of PROVIGIL (modafinil).
Under the Company's agreement with TAP, the Company is obligated to provide
finished product for use in clinical trials and ultimately for commercial
purposes. The Company has contracted with a third-party supplier to manufacture
material for use in clinical trials. The Company has not contracted for
synthesis of product for commercial use. There can be no assurance that the
Company can contract with a facility to manufacture finished products or enter
into a suitable third-party manufacturing arrangement for its commercial needs.
DEPENDENCE ON COLLABORATIVE PARTNERS
The Company's collaborations with Chiron, SB, Kyowa Hakko, TAP and others
provide the Company with research funding, rights to technology and development,
marketing and manufacturing resources. These arrangements are subject to certain
rights of termination by the collaborator.
There can be no assurance that any funds received under these arrangements
will be sufficient, individually or in the aggregate, to cover the costs
incurred by the Company in support of the related collaborative programs.
Moreover, the amount and timing of resources to be devoted to these activities
by such partners is not within the control of the Company. There can be no
assurance that the interests of the Company will continue to coincide with those
of its collaborators or that the collaborators will not develop products
independently or with third parties which could compete with the Company's
products, or that disagreements over rights to technology or other proprietary
information will not occur. Further, there can be no assurance that the
collaborative agreements will be extended at the end of their respective terms.
If any of the Company's collaborators breaches or terminates its agreement with
the Company, or otherwise fails to conduct its collaborative activities in a
timely manner, the development or commercialization of the product candidate or
research program under such collaborative agreement may be delayed, the Company
may be required to undertake additional responsibilities or to devote previously
unanticipated additional resources to such development or commercialization, or
such development or commercialization could be terminated. Further, termination
of the agreements could result in the loss of certain technology rights. Any
such event could adversely affect the Company.
LIMITED SALES AND MARKETING EXPERIENCE; UNCERTAIN PRODUCT MARKETING AND
DISTRIBUTION ARRANGEMENTS
Cephalon has limited experience in the distribution, marketing and sale of
products. The Company has established a sales force in the United States which
initially is being used to co-promote Stadol NS and Serzone, approved products
of BMS, to neurologists in the United States. The co-promotion agreement expires
at the end of 1998 unless BMS and Cephalon elect to renew the arrangements.
There can be no assurance that additional products will be available for sale by
the Company's sales force or that Cephalon's sales and marketing efforts will be
successful. With respect to those products under development by Cephalon for
which it has retained marketing rights, Cephalon may choose to augment any of
its own sales efforts through sales and marketing arrangements with other
pharmaceutical companies. There can be no assurance that such marketing
arrangements will be available at all or on terms satisfactory to Cephalon or
that such arrangements will lead to the successful commercialization of
products.
Cephalon does not have a sales, marketing or distribution organization
outside the United States. The Company is in the process of establishing a sales
and marketing capability focusing on neurology in certain countries in Europe.
The Company's agreement with Lafon requires the Company to commence sales and
marketing activities within three months after receiving approval to market
PROVIGIL (modafinil) in the
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United Kingdom and the Republic of Ireland. If the Company fails to initiate
such activities within the specified time frame, its license could be terminated
by Lafon in the applicable country. There can be no assurance that the Company
will be able to establish a commercially viable sales, marketing and
distribution capability outside the United States in a timely or cost-effective
manner or at all.
Under the collaborative agreement with Chiron, the Company believes that
the existing Chiron distribution infrastructure will be used for MYOTROPHIN
(rhIGF-I). The Company is evaluating alternatives for the distribution of its
other product candidates.
PATENTS AND PROPRIETARY TECHNOLOGIES
An important part of the Company's product development strategy is to seek,
when appropriate protection for its product candidates and proprietary
technology through the use of various U.S. and foreign patents, trademarks and
contractual arrangements. The degree of the Company's success depends in part on
its ability to obtain patents, maintain trade secret protection and operate
without infringing on the proprietary rights of third parties. The Company
believes that patent protection of products or processes that may result from
the research and development efforts of the Company, its licensees or its
collaborators also is important
to the potential commercialization of the Company's product candidates. The
Company has filed various applications for U.S. and foreign patents, has
licensed various U.S. and foreign patent applications from third parties, and
owns or licenses certain U.S. and foreign patents.
With regard to MYOTROPHIN (rhIGF-I), the Company believes that the
composition of rhIGF-I is in the public domain and therefore cannot be patented
under a composition-of-matter patent. Cephalon has filed patent applications in
the United States, Canada, Europe and Japan covering the use of IGF-I in the
peripheral neuropathies and other neurological disorders. The issued patents and
all patent applications relating to IGF-I in the United States, Canada and
Europe have been licensed to the Partnership.
There can be no assurance that any of the Company's patent applications for
rhIGF-I uses will issue, that patents, if obtained, will be as broad in scope as
such patent applications or that the claims of any issued patents will withstand
challenge. Even in those jurisdictions where rhIGF-I is or may be covered by the
claims of a use patent, "off-label" sales by a third party might occur,
especially if another company markets rhIGF-I for other uses at a price that is
less than the price of MYOTROPHIN (rhIGF-I), thereby potentially reducing sales
of MYOTROPHIN (rhIGF-I). It is not always possible to detect "off-label" sales
and therefore enforcement of use patents can be difficult. Furthermore, some
jurisdictions outside of the United States restrict the manner in which patents
claiming uses of a product may be enforced.
Under its collaboration with Chiron, Chiron has the primary responsibility
for manufacturing commercial supplies of MYOTROPHIN (rhIGF-I). The Company has
obtained a license under certain patent rights of Chiron related to rhIGF-I,
including patents and patent applications covering the manufacture of
recombinant proteins such as rhIGF-I. One of Chiron's issued patents related to
certain methods for the manufacture of recombinant proteins, including rhIGF-I,
is currently the subject of an interference proceeding before the U.S. Patent
and Trademark Office ("USPTO") involving patent applications owned by an
unrelated third party. It is not known when or how the USPTO will ultimately
conclude the interference proceeding. Another related patent application of
Chiron, which may cover the current process for manufacturing rhIGF-I, was the
subject of another interference proceeding. Chiron prevailed in the interference
proceeding and thereafter prevailed in a district court appeal brought by the
other party. That decision has been appealed to the Court of Appeals for the
Federal Circuit by the other party. There can be no assurance that Chiron will
prevail in any appeal of the decision. The Company is aware of other patents and
patent applications owned by third parties, which patents and patent
applications, if issued with the claims as filed, may cover certain aspects of
the current method of manufacturing rhIGF-I. The Company and Chiron intend to
either seek licenses under any valid patents related to the manufacturing of
rhIGF-I as required or, alternatively, modify the manufacturing process. There
can be no assurance that, if required, such licenses can be obtained at all or
on acceptable terms or that a modified manufacturing process can be implemented
at all or without substantial cost or delay. If neither approach were feasible,
the Company could be subject to a claim of patent infringement which, if
successful,
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could prevent the Company from manufacturing or selling MYOTROPHIN (rhIGF-I) in
the United States. In such event, the Company could be materially adversely
affected.
Even if patents issue on the pending applications owned or licensed by the
Company, there can be no assurance that applications filed by others will not
result in patents that would be infringed by the manufacture, use or sale of
MYOTROPHIN (rhIGF-I). The Company is aware of a published application filed
under the Paris Convention Treaty, designating the United States, that relates
to the use of IGF-I in treating certain disorders of the nervous system. The
Company believes that even if the subject matter were deemed to overlap the
subject matter of a patent application filed by the Company in the United
States, based on the filing date of the third party's application, it would not
take priority over the Company's application. Further, the Company believes that
a third party has filed a U.S. patent application which may contain a claim
which, if issued, might broadly cover the use of rhIGF-I to treat many
neurological conditions, including ALS and peripheral neuropathies. Clark &
Elbing LLP, patent counsel to the Company, has advised the Company that, in its
opinion, such a claim would not be patentable. If such a claim should issue, the
Company could be prevented from selling MYOTROPHIN (rhIGF-I) in the United
States for use in treating ALS or peripheral neuropathy unless it obtained a
license to the patent. The third-party patent application might also contain a
narrower claim covering the use of rhIGF-I to treat diabetic neuropathy. If such
a claim should issue, the Company could be prevented from selling MYOTROPHIN
(rhIGF-I) in the United States for use in treating diabetic neuropathy unless it
obtained a license to the patent. The owner of such third-party patent
application has asserted for several years that the subject matter claimed in
its application interferes with claims of the Company's patent with respect to
the use of rhIGF-l in treating ALS. Clark & Elbing LLP has advised the Company
that, in its opinion, no interference should be declared between such
third-party patent application and the Company's patent, but there can be no
assurance that the USPTO will agree with that opinion. If an interference were
declared and the third party prevailed, the Company could be prevented from
selling MYOTROPHIN (rhIGF-I) in the United States for use in treating ALS and
peripheral neuropathies unless it obtained a license to the patent. There can be
no assurance that any such licenses could be obtained from the third party at
all or on acceptable terms. Furthermore, one or more claims of the Company's
existing patent could be declared invalid.
PROVIGIL (modafinil), which the Company has exclusively licensed from Lafon
for the United States, Mexico, the United Kingdom, the Republic of Ireland and
Japanese markets, is covered by the claims of a composition-of-matter patent in
the United States that expires in 1998 (under the transitional provisions of the
General Agreement on Tariffs and Trade ("GATT")). The Company may also seek an
extension of the patent under the Drug Price Competition and Patent Term
Restoration Act of 1984 (the "DPC Act") equal to one-half the period of time
elapsed between the filing of an IND for PROVIGIL (modafinil) and the filing of
the corresponding NDA, plus the period of time between the filing of the NDA for
PROVIGIL (modafinil) and FDA approval. However, to obtain the full length of any
such extension, the Company must receive FDA approval of PROVIGIL (modafinil)
before expiration of the original term of the patent. There can be no assurance
that the Company will be able to take advantage of the marketing exclusivity or
patent extension benefits of the DPC Act.
No assurance can be given that any additional patents will issue on any of
the patent applications owned by the Company or licensed from third parties.
Furthermore, even if such patents issue, there can be no assurance that any
issued patents will provide protection against competitive products or otherwise
be commercially valuable, or that applications filed by others will not result
in patents that would be infringed by the manufacture, use or sale of the
Company's products. In addition, patent law relating to the scope of claims in
the biotechnology field is still evolving and the biotechnology patent rights of
the Company are subject to this additional uncertainty. There can be no
assurance that others will not independently develop similar products, duplicate
any of the Company's products, or, if patents are issued to the Company, design
around any products developed by the Company.
The products of the Company could infringe the patent rights of others. If
licenses required under any such patents or proprietary rights of third parties
are not obtained, the Company could encounter delays in product market
introductions, or could find that the development, manufacture or sale of
products requiring such licenses is foreclosed. In addition, patent litigation
is both costly and time-consuming, even if the
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outcome is favorable to the Company. In the event that the Company is a
defendant in such litigation, an adverse outcome would subject the Company to
significant liabilities to third parties, require the Company to license
disputed rights from third parties, or require the Company to cease selling its
products.
The Company also relies upon trade secrets and other unpatented proprietary
information in its product development activities. All of the Company's
employees have entered into agreements providing for confidentiality and the
assignment of rights to inventions made by them while employed by the Company.
The Company also has entered into non-disclosure agreements to protect its
confidential information delivered to third parties in conjunction with possible
corporate collaborations and other purposes. There can be no assurance that
these types of agreements will effectively prevent disclosure of the Company's
confidential information.
PARTNERSHIP PURCHASE OPTION
The Partnership has licensed to the Company the exclusive rights to
manufacture and market MYOTROPHIN (rhIGF-I) in the Territory in return for
certain royalty payments and the Milestone Payment if MYOTROPHIN (rhIGF-l)
receives regulatory approval in certain countries in the Territory. The
Milestone Payment is payable by the Company in cash, Common Stock or any
combination of the two.
The Company has a contractual option to purchase all of the limited
partnership interests in the Partnership. In order to exercise the Purchase
Option, Cephalon is required to make an advance payment of $40,275,000 in cash
or, at Cephalon's election, $42,369,000 in shares of Common Stock, valued at the
market price at the time the Purchase Option is exercised. The Purchase Option
will become exercisable for a 45-day period commencing on the date which is the
earlier of (a) the date which is the later of (i) the last day of the first
month in which the Partnership shall have received Interim License payments
equal to fifteen percent (15%) of the limited partners' capital contributions
(excluding the Milestone Payment), and (ii) the last day of the 24th full month
after the date of the Company's first commercial sale, if any, of Myotrophin
within the Territory that generates a payment to the Partnership, and (b) the
last day of the 48th full month after the date of such first commercial sale, if
any, in the Territory. A payment in cash would have a significant adverse effect
on the Company's capital resources. A payment in shares of Common Stock would
result in a decrease in the percentage ownership of the Company's stockholders
at that time. If the Company were to make the Milestone Payment, exercise the
Purchase Option, or purchase additional interests outside of the Purchase
Option, a material charge to earnings could result, depending upon the
development status of the underlying technology.
If the Company does not exercise the Purchase Option, its license will
terminate and all rights to manufacture or market MYOTROPHIN (rhIGF-I) in the
Territory will revert to the Partnership, which may then commercialize
MYOTROPHIN (rhIGF-I) itself or license or assign its rights to a third party.
The Company would not receive any benefits from such commercialization. There
can be no assurance that disputes will not arise between the Company and the
Partnership over the parties' respective rights to technology or their other
rights and obligations under these arrangements.
TECHNOLOGICAL CHANGE AND COMPETITION
Competition in the Company's fields of interest from large and small
companies is intense and is expected to increase. Furthermore, academic
institutions, governmental agencies, and other public and private research
organizations will continue to conduct research, seek patent protection, and
establish collaborative arrangements for product development. Products developed
by any of these entities may compete directly with those developed by the
Company. Many of these companies and institutions have substantially greater
capital resources, research and development staffs and facilities than the
Company, and substantially greater experience in conducting clinical trials,
obtaining regulatory approvals and manufacturing and marketing pharmaceutical
products. These entities represent significant competition for the Company. In
addition, competitors developing products for the treatment of neurodegenerative
disorders might succeed in developing technologies and products that are more
effective than any being developed by the Company or that would render its
technology and products obsolete or noncompetitive. There can be no assurance
that competition
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and innovation from these or other sources will not materially adversely affect
any sales of products which might be developed by the Company or make them
obsolete. Advances in current treatment methods may also adversely affect the
market for such products. The approval and introduction of therapeutic products
that compete with compounds being developed by the Company could also adversely
affect the Company's ability to attract and maintain patients in clinical
studies for the same indication or otherwise successfully complete its clinical
studies.
With respect to MYOTROPHIN (rhIGF-I), Rilutek(R) (Riluzole) has been
approved and is being marketed by Rhone-Poulenc Rorer in the U.S. and certain
countries in Europe for the treatment of ALS. In addition, the Company believes
that other companies are developing therapeutic agents for the treatment of ALS
and peripheral neuropathies. Because the potential patient population for ALS is
limited, competition from other products may adversely affect potential sales of
MYOTROPHIN (rhIGF-I).
Other companies are developing rhIGF-I as a therapeutic product for
disorders other than ALS or peripheral neuropathy, including Genentech, Inc.
which is evaluating IGF-I in diabetes. Notwithstanding the patents and patent
applications relating to MYOTROPHIN (rhIGF-I), if the sale of rhIGF-I by third
parties is approved for other indications, such products might be used in
competition with MYOTROPHIN (rhIGF-I) through "off-label" use, especially if
such product is priced below MYOTROPHIN (rhIGF-I).
With respect to PROVIGIL (modafinil), there are presently several products
used in the United States to treat narcolepsy, all of which are available
generically and have been available for a number of years. There can be no
assurance that PROVIGIL (modafinil) possesses benefits over such other products,
or that the Company will be able to demonstrate the value of any such benefits
to prescribing physicians and their patients.
Lafon has licensed rights to modafinil to third parties in Canada as well
as certain countries in Europe, and may license other territories to other third
parties in the future. There is no contractual requirement that the licensees
and Lafon coordinate their marketing activities related to modafinil.
Furthermore, individual reimbursement policies in each country and applicable
antitrust laws prohibit the coordination of the pricing of modafinil in various
jurisdictions. The marketing activities of the other licensees therefore may
adversely affect the Company's marketing of PROVIGIL (modafinil) in its
territories.
Cephalon is marketing two proprietary products of BMS to neurologists in
the United States: Stadol NS, indicated for the management of pain, including
migraine pain; and Serzone, indicated for the treatment of depression. A number
of therapeutic agents are currently approved and are being marketed both for the
treatment of migraine and for the treatment of depression. Stadol NS also
competes directly with other pain medications, including narcotics, and
indirectly with medications approved explicitly for treatment of migraine. The
Company also believes that other products to treat migraine with a nasal spray
delivery system may be introduced into the U.S. market in 1997 and may compete
directly with Stadol NS.
There are significant efforts by others, including many large
pharmaceutical companies and academic institutions, to develop therapeutic
products which may compete with the products being developed by the Company to
treat neurological disorders, including Alzheimer's disease, head and spinal
injury and stroke. Some of these products may be at a more advanced stage of
development than the Company's products.
LITIGATION
The Company and certain of its officers have been named as defendants in a
number of civil actions filed in the U.S. District Court for the Eastern
District of Pennsylvania, which have been consolidated. Several of the
plaintiffs have been designated by the Court, collectively, as the "lead
plaintiff" for purposes of the Private Securities Litigation Reform Act of 1995.
The consolidated complaint, filed in October 1996 by the lead plaintiffs,
extended and expanded the class period to include purchasers of the Company's
securities as well as options to purchase or sell those securities during the
period between June 12, 1995 and June 7, 1996. Plaintiffs allege, based in part
on statements and opinions expressed at the June 7, 1996 meeting of the Advisory
Committee, that earlier statements by the Company about the North American and
European trial results were misleading. The plaintiffs seek unspecified damages
and other relief. The Company's motion to
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dismiss the case is pending, and discovery related to the merits of the
allegations in the complaint has been postponed until the motion is decided. The
Company intends to vigorously defend the action. However, management believes
that it is too early in the proceedings to predict the outcome of this action
with any certainty.
DEPENDENCE ON KEY PERSONNEL
The success of the Company depends, in large part, upon the Company's
ability to attract and retain highly qualified scientific and management
personnel. The Company faces competition for such personnel from other
companies, research and academic institutions, government entities and other
organizations. There can be no assurance that the Company will be successful in
hiring or retaining key personnel.
NO ASSURANCE OF ADEQUATE REIMBURSEMENT
The Company's ability to commercialize its products successfully will
depend in part on the extent to which appropriate reimbursement levels for the
cost of such products and related treatment are obtained from government
authorities, private health insurers and other organizations, such as health
maintenance organizations ("HMOs"). Third-party payors are increasingly
challenging the prices charged for medical products and services. Also, the
trend towards managed health care in the United States and the concurrent growth
of organizations such as HMOs, which could control or significantly influence
the purchase of health care services and products as well as legislative
proposals to reform health care or reduce government insurance programs, may all
result in lower prices for the Company's products. The cost containment measures
that health care providers are instituting and the effect of any health care
reform could affect the Company's ability to sell its products and may have a
material adverse effect on the Company.
There can be no assurance that reimbursement in the United States or
foreign countries will be available for any of the Company's products, or if
available, will not be decreased in the future, or that reimbursement amounts
will not reduce the demand for, or the price of, the Company's products. The
unavailability or inadequacy of third-party reimbursement for the Company's
products would have a material adverse effect on the Company. Moreover, the
Company is unable to forecast what additional legislation or regulation, if any,
relating to the health care industry or third-party coverage and reimbursement
may be enacted in the future or what effect such legislation or regulation would
have on the Company's business.
POTENTIAL PRODUCT LIABILITY
The Company faces an inherent risk of exposure to product liability claims
if the use of its products is alleged to have resulted in an injury or adverse
effect on patients. Such risk exists with respect to products being tested in
human clinical trials, as well as products being developed by the Company, if
any, that receive regulatory approval for commercial sale. The Company maintains
product liability insurance for clinical studies. However, there can be no
assurance that such coverage will be adequate to cover claims, or that adequate
insurance coverage for future clinical or commercial activities will be
available at acceptable costs. There can be no assurance that the Company will
not experience a significant product liability claim or recall, which if
uninsured could have a material adverse effect on the Company.
VOLATILITY OF STOCK PRICE; NO DIVIDENDS
The market price for shares of the Company's Common Stock has historically
been highly volatile. Future negative announcements concerning the Company, its
competitors or other companies in the biopharmaceutical industry, including the
results of testing and clinical trials, regulatory hearings and decisions,
technological innovations or commercial products, patents, government
regulations, developments concerning proprietary rights, litigation or public
concern as to the safety or commercial value of the Company's products may have
a significant adverse effect on the market price of the Common Stock. The
Company has not paid any cash dividends on its Common Stock and does not
anticipate paying any dividends in the foreseeable future.
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The Company believes that SBC, in connection with its sale to the Company
of Options (as defined herein), will attempt to hedge its position by
periodically buying and selling shares of the Company's Common Stock in the
over-the-counter market or otherwise, at prices then prevailing. In addition,
SBC's hedging activities may include entering into derivative instruments
relating to the Common Stock with third parties, which in turn may engage in
hedging transactions involving purchases and sales of the Common Stock. Such
purchases and sales could result in an increase in the volatility of the price
of the Company's Common Stock immediately before and during the option term. In
addition, at the expiration of the option term, SBC is expected to liquidate its
holdings of Common Stock, if any, unless the Options expire "in-the-money" and
the Company elects to settle the Options by requiring the delivery of shares of
Common Stock, rather than in cash. This liquidation could negatively affect the
market price of the Company's Common Stock.
EFFECT OF EXERCISE OF OPTIONS AND WARRANTS
The Company grants stock options to employees, directors and consultants.
As of December 31, 1996, the Company had 3,181,020 outstanding options at
exercise prices ranging from $0.15 to $31.00 per share. In addition, at December
31, 1996 warrants to purchase 2,898,104 shares of Common Stock were outstanding
at exercise prices ranging from $11.32 to $18.50 per share. Options and warrants
granted represent approximately 25% of the shares of Common Stock currently
outstanding. If all or substantially all such options and warrants were
exercised, the subsequent sale of the shares of Common Stock could adversely
affect the price of the Common Stock.
ANTI-TAKEOVER PROVISIONS
The ability of the Board of Directors of the Company to issue shares of
preferred stock without stockholder approval and a shareholder rights plan
adopted by the Company may, alone or in combination, have certain anti-takeover
effects. The Company also is subject to provisions of the Delaware General
Corporation Law which may make certain business combinations more difficult.
USE OF PROCEEDS
The Company will not receive any proceeds from the sale of the Shares by
the Selling Stockholder.
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CALL OPTION TRANSACTION AND ISSUANCE OF THE SHARES
Statements under this caption contain forward looking information within
the meaning of the Private Securities Litigation Reform Act of 1995, and should
be read in connection with cautionary statements contained thereunder and
contained in the "Risk Factors" section of this Prospectus. The following is
not intended to limit in any way the characterization of other cautionary
statements contained in this Prospectus as well as any other documents
incorporated herein or other statements by the Company.
GENERAL
The Shares are being issued by the Company, and are being acquired by SBC,
in one or more transactions, in exchange for one or more capped call options
(the "Options") to be written by SBC on up to an aggregate of 2,500,000 shares
of Common Stock of the Company. Issuance of the Shares will be governed by an
Agreement in Regard to Premium Shares (the "Share Agreement") to be executed by
the Company, SBC and SBC Warburg. The Share Agreement is conditioned upon the
effectiveness of the Registration Statement (the "Registration Statement") of
which this Prospectus forms a part, and the Company will not issue any Shares
until after the Registration Statement has been declared effective by the
Commission. The Options will be issued pursuant to an ISDA Master Agreement,
including a Confirmation (the "Confirmation") with respect to each Option (the
"Master Agreement") to be executed by the Company and SBC following the
effectiveness of the Registration Statement. Copies of the forms of Share
Agreement and Master Agreement (including a form of Confirmation) have been
filed as exhibits to the Registration Statement, and reference is made to the
exhibits for the complete terms of these agreements. Shares are being issued to
SBC in a private placement transaction pursuant to Section 4(2) of the
Securities Act of 1933.
TERMS OF THE CALL OPTIONS
The Company will purchase each Option from SBC and will use the Shares, in
lieu of cash, to pay the premium associated with each Option (the "Option
Price"). Payment by the Company to SBC of the Option Price within an as
yet-to-be determined number of business days after the trade date of each Option
is a condition to SBC's obligations to the Company under the Share Agreement.
The Option Price, as well as the strike price, cap price, number of shares
subject to such Option, expiration date and certain other terms of each Option,
will be determined following the effectiveness of the Registration Statement,
based upon a number of factors, including the market price of the Common Stock
when the Option is issued. Although the precise terms of the Call Options are
not yet determinable, the Company currently expects that the potential benefit
from the Call Options will be capped at between $15 and $20 per share. In
addition, the Company expects each Call Option to have a term of six months.
Although at this time the Company expects that the Options will be cash
settled, the Company may elect to physically settle the Options by requiring
delivery by SBC to the Company of shares of the Common Stock. In the event that
an Option is settled in cash, SBC or its affiliates would likely sell shares of
the Common Stock, which may include some or all of the Shares, then held by them
as a hedge with respect to that Option. In the event that an Option is
physically settled, SBC will deliver shares of Common Stock to the Company,
which likely would include some or all of the Shares, upon payment by the
Company of the applicable exercise price.
This Prospectus covers the resale of an assumed maximum number of Shares to
be issued by the Company in payment of the aggregate Option Price, making
certain assumptions regarding the share price of the Common Stock at the time
the Options are purchased by the Company.
COMPANY REASONS FOR THE OPTION TRANSACTION; RISKS TO THE COMPANY
The Company intends to purchase the Options to allow the Company to
benefit, subject to the terms of the Options, from any appreciation in the
market value of the Company's Common Stock at expiration of the Options. If the
Company elects cash settlement, it will receive on exercise of each Option an
amount in cash equal to the excess of (i) an average of the market prices of the
Common Stock during a specified period prior to expiration, determined in
accordance with the Master Agreement or (ii) the cap price of the Option,
whichever is less, over the strike price of the Option. If the Company elects
stock settlement, it will receive on exercise of each Option one share of Common
Stock against payment of an amount equal to the sum of (x) the strike price of
the Option and (y) the excess, if any, of the market price of the Common Stock
at expiration over the cap price of the Option. The Company's board of directors
has determined that the purchase of the Options, in exchange for the Shares, is
an appropriate method to take advantage of any stock price appreciation.
17
<PAGE> 19
The funds received from the exercise of any Options may be used by the
Company to fund a portion of its payment obligations related to the Partnership.
If MYOTROPHIN (rhIGF-I) were to be approved for commercialization in the United
States or certain other territories, the Company is obligated to make a
$16,000,000 milestone payment to the Partnership. See "Risk Factors -- Need for
Additional Funds." In addition, at a specified time following commercialization,
the Company is required to purchase the outstanding limited partnership
interests for approximately $40,000,000 plus royalties, in order to retain its
rights to commercialize MYOTROPHIN in the United States and Europe. See "Risk
Factors -- Partnership Purchase Option."
As an alternative to making these payments, the Company may seek to acquire
some or all of the remaining limited partnership interests. Although the Company
has actively discussed this possibility with the General Partner of the
Partnership, there can be no assurance that any agreement can be reached with
the General Partner to acquire the limited partnership interests. Even if an
agreement can be reached, the Company estimates that to reach an agreement the
purchase price could be significant, possibly in the $125 million range. In
addition to using the proceeds, if any, from the Options, the Company would
explore one or more additional financing alternatives, after the May 8th meeting
of the Advisory Committee, if it were to proceed with an acquisition of limited
partnership interests.
Any funds received from the exercise of any Options that are not used to
fund the Company's obligations related to the Partnership would be used to fund
the research and development activities of the Company and the acquisition of
technologies, and for other general corporate purposes.
Any purchase of Options by the Company involves certain risks.
Particularly, as described above, the purchase of an Option will benefit the
Company only if the market price of the Common Stock appreciates to a level
above the strike price of the Option during the term of such Option and remains
at such level at the expiration of the Option. If the market price of the Common
Stock at expiration of an Option does not exceed such Option's strike price, the
Company will have sold Shares for a consideration which, at expiration of the
Option, has no value. If the market price of the Common Stock at expiration of
an Option exceeds such Option's strike price, but by less than the premium for
such Option, the Company will have issued Shares for a consideration which, at
the expiration of such Option, is worth less than the market value of the Shares
when they were sold. The benefit to the Company would, in each case, be affected
by applicable transaction costs. In any event, the number of the Company's
issued and outstanding shares of Common Stock will increase by the 500,000
Shares, representing a dilution of approximately 2% based on the number of
shares of Common Stock currently outstanding.
One near-term event that is expected to directly affect the value of the
Options is the scheduled meeting of the FDA's Peripheral and Central Nervous
System Drugs Advisory Committee (the "Advisory Committee") on May 8, 1997. See
"Risk Factors -- Uncertainties Related to MYOTROPHIN (rhIGF-I) Phase III
Regulatory Submissions." The Company has not received any indication as to the
outcome of the Advisory Committee meeting or any subsequent FDA decision on the
NDA. If the Advisory Committee recommends approval of MYOTROPHIN (rhIGF-I) and
if the FDA subsequently approves the commercialization of the product, the
market price of the Company's Common Stock may increase, in which case the
Company could realize a financial benefit from the Options. If the Advisory
Committee does not recommend approval of the NDA or if the FDA does not approve
the NDA, the price of the Common Stock is likely to decrease and the Options
will have no value.
Because the Option financing is innovative and is structured to take
advantage of increases in the price of the Company's Common Stock, there is a
risk that a third party could assert that the Company has not fully complied
with its applicable disclosure obligations. Although the Company believes that
it has complied with its obligations under applicable securities laws, there can
be no assurance that such a claim will not be asserted. Defense of any such
claim could be costly to the Company and there can be no assurance that any such
defense would be successful.
18
<PAGE> 20
SELLING STOCKHOLDER
The following table sets forth certain information regarding the beneficial
ownership of the Common Stock of the Selling Stockholder and as adjusted to give
effect to the sale of the Shares offered hereby. The Shares are being registered
to permit public secondary trading of the Shares, and the Selling Stockholder
may offer the Shares for resale from time to time. See "Plan of Distribution."
The Shares being offered hereby by the Selling Stockholder may be acquired,
from time to time, as described above under "Call Option Transaction and
Issuance of the Shares."
In recognition of the fact that the Selling Stockholder wishes to be
legally permitted to sell its Shares when it deems appropriate, the Company has
filed with the Commission, under the Securities Act, a Registration Statement on
Form S-3, of which this Prospectus forms a part, with respect to the resale of
the Shares from time to time on the Nasdaq National Market of The Nasdaq Stock
Market or in privately-negotiated transactions and has agreed to prepare and
file such amendments and supplements to the Registration Statement as may be
necessary to keep the Registration Statement effective until the Shares are no
longer required to be registered for the sale thereof by the Selling
Stockholder.
<TABLE>
<CAPTION>
BENEFICIAL OWNERSHIP
NUMBER OF AFTER OFFERING
NUMBER OF SHARES SHARES ---------------------
NAME OF BENEFICIALLY OWNED BEING NUMBER OF
SELLING STOCKHOLDER PRIOR TO OFFERING OFFERED SHARES PERCENT
- --------------------------------------------- ------------------ --------- --------- -------
<S> <C> <C> <C> <C>
Swiss Bank Corporation, London Branch........ 500,000(1) 500,000(1) 0 --%
</TABLE>
- ---------------
(1) Represents an assumed maximum number of Shares to be issued by the Company
in payment of the aggregate price of the Options, making certain assumptions
regarding the share price of the Common Stock at the time the Options are
purchased by the Company.
19
<PAGE> 21
PLAN OF DISTRIBUTION
The Shares may be sold from time to time by SBC, or by transferees or
successors in interest, including one or more affiliates of SBC. SBC plans to
sell the Shares principally to or through SBC Warburg, a registered
broker-dealer that is a wholly-owned subsidiary of Swiss Bank Corporation. SBC
Warburg may sell Shares directly or to or through unaffiliated brokers and
dealers, and SBC Warburg and such other brokers and dealers may receive
compensation from SBC or SBC Warburg, as the case may be, in the form of
discounts, concessions or commissions (which compensation is not expected to be
in excess of customary amounts). Such sales may be made in the over-the-counter
market or otherwise at prices then prevailing, or in negotiated transactions.
SBC has advised the Company that it may from time to time engage in
transactions to hedge all or part of its risk relating to the Options. Such
hedging activities, which will not take place prior to effectiveness of the
Registration Statement, may include the sale or the retention by SBC or its
affiliates of all or a portion of the Shares and purchases and sales in the
over-the-counter market or otherwise of other shares of Common Stock and may
include entering into derivative instruments with third parties relating to the
Common Stock, such as options and equity swaps, which third parties may in turn
engage in hedging transactions. SBC has advised the Company that it does not
intend to engage in short sales as part of its hedging activities.
Upon exercise by the Company of the Options, the Company may elect to
receive shares of Common Stock. See "Call Option Transaction and Issuance of the
Shares." In such event, all or a portion of the Shares may, to the extent they
are still held by SBC, be transferred by SBC to the Company in satisfaction of
such exercise.
SBC, SBC Warburg and any dealers through whom sales of the Shares may be
made may be deemed to be "underwriters" within the meaning of the Securities
Act, and commissions or discounts and other compensation received by them may be
regarded as underwriters' compensation.
The Company has agreed to indemnify SBC and SBC Warburg against certain
liabilities, including liabilities under the Securities Act, and to contribute
to payments SBC or SBC Warburg may be required to make in respect thereof.
LEGAL MATTERS
The validity of the Common Stock offered hereby will be passed upon for the
Company by Morgan, Lewis & Bockius LLP, Philadelphia, Pennsylvania.
EXPERTS
The financial statements incorporated by reference in this Prospectus have
been audited by Arthur Andersen LLP, independent public accountants, as
indicated in their report with respect thereto, and are incorporated by
reference herein in reliance upon the authority of said firm as experts in
giving said reports.
20
<PAGE> 22
======================================================
NO DEALER, SALESMAN OR 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. 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
INFORMATION CONTAINED HEREIN IS CORRECT AS OF ANY TIME SUBSEQUENT TO THE DATE
HEREOF.
------------------
TABLE OF CONTENTS
<TABLE>
<CAPTION>
PAGE
----
<S> <C>
Available Information................. 2
Incorporation of Certain Documents by
Reference........................... 2
The Company........................... 4
Risk Factors.......................... 4
Use of Proceeds....................... 16
Call Option Transaction and Issuance
of the Shares....................... 17
Selling Stockholder................... 19
Plan of Distribution.................. 20
Legal Opinion......................... 20
Experts............................... 20
</TABLE>
======================================================
======================================================
500,000 SHARES
CEPHALON, INC.
COMMON STOCK
---------------------------
PROSPECTUS
---------------------------
, 1997
======================================================
<PAGE> 23
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 14. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION
The following table shows the estimated expenses of the issuance and
distribution of the securities offered hereby:
<TABLE>
<S> <C>
Securities and Exchange Commission Registration Fee.......................... $ 2,832
Legal Fees and Expenses...................................................... 25,000
Nasdaq Listing Fees.......................................................... 10,000
Miscellaneous................................................................ 5,000
-------
Total........................................................................ $42,832
=======
</TABLE>
ITEM 15. INDEMNIFICATION OF DIRECTORS AND OFFICERS
Section 145 of the Delaware General Corporation Law ("Section 145") permits
indemnification of directors, officers, agents and controlling persons of a
corporation under certain conditions and subject to certain limitations. Article
VII of the Registrant's Bylaws, requires the Registrant to indemnify directors
and officers of the Registrant or any other authorized representative against
expenses, judgments and any settlement amounts incurred in a third party
proceeding brought by reason of the fact that the person is an authorized
representative of the Registrant. The Bylaws also permit indemnification of
expenses incurred by an authorized representative in connection with a
proceeding brought in the name of the corporation. The Bylaws further specify
procedures for such indemnification. Section 145 also empowers the Registrant to
purchase and maintain insurance that protects its officers, directors, employees
and agents against any liabilities incurred in connection with their service in
such positions.
ITEM 16. EXHIBITS, FINANCIAL STATEMENT SCHEDULES AND INDEX TO SUCH EXHIBITS AND
SCHEDULES
The exhibits filed as part of this registration statement are as follows:
<TABLE>
<CAPTION>
EXHIBIT
NUMBER DESCRIPTION
------ ------------------------------------------------------------------------------
<C> <S>
5.1** Opinion of Morgan, Lewis & Bockius LLP regarding legality of securities being
registered.
10.1* Form of ISDA Master Agreement by and between the Registrant and Swiss Bank
Corporation, London Branch, together with form of Schedule thereto.
10.2* Form of Confirmation to be entered into pursuant to ISDA Master Agreement by
and between the Registrant and Swiss Bank Corporation, London Branch.
10.3* Form of Agreement in Regard to Premium Shares by and among the Registrant,
Swiss Bank Corporation, London Branch and SBC Warburg Inc.
23.1* Consent of Morgan, Lewis & Bockius LLP (included in its opinion filed as
Exhibit 5.1 hereto).
23.2** Consent of Arthur Andersen LLP
23.3* Consent of Clark & Elbing LLP
24.1* Powers of Attorney (included on the signature page).
</TABLE>
- ---------------
* Previously filed.
** Filed herewith.
ITEM 17. UNDERTAKINGS
The undersigned Registrant hereby undertakes that, for purposes of
determining any liability under the Securities Act of 1933, each filing of the
Registrant's annual report pursuant to Section 13(a) or Section 15(d) of the
Securities Exchange Act of 1934 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.
II-1
<PAGE> 24
Insofar as indemnification for liabilities arising under the Securities Act
may be permitted to directors, officers and controlling persons of the
Registrant pursuant to its Certificate of Incorporation, its Bylaws, 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 a public policy as expressed in the
Securities Act and will be governed by the final adjudication of such issue.
The undersigned Registrant hereby undertakes:
(1) To file, during any period in which offers or sales are being
made, a post-effective amendment to this registration statement:
(i) To include any prospectus required by section 10(a)(3) of the
Securities Act of 1933;
(ii) To reflect in the prospectus any facts or events arising after the
effective date of the registration statement (or the most recent
post-effective amendment thereof) which, individually or in the
aggregate, represent a fundamental change in the information set forth
in the registration statement;
(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 paragraph (1)(i) and (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.
II-2
<PAGE> 25
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 Amendment No. 2 to
the Registration Statement to be signed on its behalf by the undersigned,
thereunto duly authorized, in the City of West Chester, Commonwealth of
Pennsylvania on the 1st day of May, 1997.
CEPHALON, INC.
By: /s/ FRANK BALDINO, JR.,
PH.D.
------------------------------------
Frank Baldino, Jr., Ph.D.
Director, President and Chief
Executive Officer
Pursuant to the requirements of the Securities Act of 1933, this Amendment
No. 2 to the Registration Statement has been signed by the following persons and
by Frank Baldino, Jr. as attorney-in-fact for the specified persons in the
capacities and on the dates indicated.
<TABLE>
<CAPTION>
NAME TITLE DATE
- ------------------------------------- ------------------------------------------ ------------
<C> <S> <C>
/s/ FRANK BALDINO, JR., PH.D. Director, President and Chief Executive May 1, 1997
- ------------------------------------- Officer (Principal Executive Officer)
Frank Baldino, Jr., Ph.D.
* Director, Executive Vice President and May 1, 1997
- ------------------------------------- Chief Operating Officer
Bruce A. Peacock
* Director May 1, 1997
- -------------------------------------
William P. Egan
* Director May 1, 1997
- -------------------------------------
Robert J. Feeney, Ph.D.
* Director May 1, 1997
- -------------------------------------
Martyn D. Greenacre
* Director May 1, 1997
- -------------------------------------
Kevin E. Moley
* Director May 1, 1997
- -------------------------------------
Horst Witzel, Dr.-Ing.
* Senior Vice President, Finance and Chief May 1, 1997
- ------------------------------------- Financial Officer (Principal
J. Kevin Buchi Financial and Accounting Officer)
*By: /s/ FRANK BALDINO, JR., PH.D.
- -------------------------------------
Frank Baldino, Jr., Ph.D.
Attorney-in-Fact
</TABLE>
<PAGE> 26
EXHIBIT INDEX
<TABLE>
<CAPTION>
EXHIBIT NUMBER DOCUMENT PAGE
-------------- --------------------------------------------------------------------- ----
<C> <S> <C>
5.1* Opinion of Morgan, Lewis & Bockius LLP regarding legality of
securities being registered
10.1* Form of ISDA Master Agreement by and between the Registrant and Swiss
Bank Corporation, London Branch, together with form of Schedule
thereto.
10.2* Form of Confirmation to be entered into pursuant to ISDA Master
Agreement by and between the Registrant and Swiss Bank Corporation,
London Branch.
10.3* Form of Agreement in Regard to Premium Shares by and among the
Registrant, Swiss Bank Corporation, London Branch and SBC Warburg
Inc.
23.1* Consent of Morgan, Lewis & Bockius LLP (included in its opinion filed
as Exhibit 5.1 hereto)
23.2** Consent of Arthur Andersen LLP
23.3* Consent of Clark & Elbing LLP
24.1* Powers of Attorney (included on the signature page)
</TABLE>
- ---------------
* Previously filed.
** Filed herewith.
<PAGE> 1
Exhibit 23.2
ARTHUR ANDERSEN LLP
CONSENT OF INDEPENDENT PUBLIC ACCOUNTANTS
As independent public accountants, we hereby consent to the incorporation by
reference in this registration statement of our report dated March 3, 1997
included in Cephalon, Inc.'s Form 10-K/A-2 for the year ended December 31, 1996
and to all references to our Firm included in this registration statement.
ARTHUR ANDERSEN LLP
Philadelphia, PA
May 1, 1997
