<PAGE>
As filed with the Securities and Exchange Commission on February 13, 1998
Registration No. 333-
- --------------------------------------------------------------------------------
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
----------
FORM S-8
REGISTRATION STATEMENT
Under the Securities Act of 1933
ENAMELON, INC.
(Exact Name of Registrant as Specified in its Charter)
Delaware 13-3669775
(State or other jurisdiction of (I.R.S. Employer
Incorporation or Organization) Identification Number)
15 Kimball Avenue, Yonkers, New York 10704
(Address of principal executive offices) (Zip Code)
1993 Stock Option Plan
1997 Incentive Stock Option Plan
(Full Title of the Plans)
Dr. Steven R. Fox, Chairman
Enamelon, Inc.
15 Kimball Avenue
Yonkers, New York 10704
(914) 237-1308
(Name, address, including zip code, and telephone number,
including area code, of agent for service)
A copy of all communications, including communications sent to the agent
for service should be sent to:
Jack Becker, Esq.
Snow Becker Krauss P.C.
605 Third Avenue
New York, N.Y. 10158-0125
(212) 687-3860
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<CAPTION>
CALCULATION OF REGISTRATION FEE
============================================================================================================================
Title of Each Class of Amount to be Proposed Maximum Proposed Maximum Amount of
Securities to be Registered Registered Offering Price Per Share Aggregate Offering Price Registration Fee
- ----------------------------------------------------------------------------------------------------------------------------
<S> <C> <C> <C> <C>
Stock Options 1,382,125 (1) $ -- $ -- (2)
- ----------------------------------------------------------------------------------------------------------------------------
Common Stock, par value 19,875 (3) $ 13.875 (4) $ 275,766 $ 83.57
$.001 per share 1,362,250 (5) (6) $ 4 .90 (7) $6,675,025 $2,022.73
- ----------------------------------------------------------------------------------------------------------------------------
Stock Options 750,000 (8) $ -- $ -- (2)
- ----------------------------------------------------------------------------------------------------------------------------
Common Stock, par value 140,071 (6) (9) $ 12.97 (7) $1,816,721 $ 550.52
$.001 per share 609,929 (6) (10) $ 13.875 (4) $8,462,765 $2,564.50
- ----------------------------------------------------------------------------------------------------------------------------
Total................................................................................................. $5,221.32
============================================================================================================================
</TABLE>
<PAGE>
(1) Represents options granted or to be granted pursuant to the 1993 Stock
Option Plan (the "1993 Plan") of Enamelon, Inc. (the "Registrant"). Each
option entitles the holder thereof to purchase one share of Common Stock,
$.001 par value (the "Common Stock"), of the Registrant.
(2) No registration fee is required pursuant to Rule 457(h)(2).
(3) Shares previously issued upon exercise of options granted pursuant to the
1993 Plan and not yet resold. Does not include 117,875 shares previously
issued upon exercise of options granted pursuant to the 1993 Plan but
already resold pursuant to Rule 701 of the Securities Act of 1933, as
amended, or the Registrant's Registration Statement on Form S-1 (File No.
333-35187) filed with the Securities and Exchange Commission on October 16,
1997.
(4) Calculated solely for the purpose of determining the registration fee
pursuant to Rule 457 (h) (1) based upon the average of the high and low
sales prices of the Registrant's Common Stock on the Nasdaq National Market
on February 9, 1998.
(5) Shares issuable upon exercise of options previously granted pursuant to the
1993 Plan.
(6) Pursuant to Rule 416, includes an indeterminable number of shares of Common
Stock which may become issuable pursuant to the anti-dilution provisions of
the 1993 Plan or the Company's 1997 Incentive Stock Option Plan (the "1997
Plan") and the options granted or to be granted.
(7) Calculated solely for the purpose of determining the registration fee
pursuant to Rule 457(h)(1) based upon the average exercise price.
(8) Represents options granted or to be granted pursuant to the 1997 Plan. Each
option entitles the holder thereof to purchase one share of Common Stock of
the Registrant.
(9) Shares issuable upon exercise of options previously granted pursuant to the
1997 Plan.
(10) Shares issuable upon exercise of options available for grant under the 1997
Plan.
ii
<PAGE>
PROSPECTUS
ENAMELON, INC.
2,132,125 SHARES
This Prospectus has been prepared by Enamelon, Inc., a Delaware
corporation (the "Company), for use upon resale of shares of the Company's
common stock, par value $.001 per share (the "Common Stock"), by certain
officers and directors of the Company who may be considered "affiliates" (as
defined in Rule 405 under the Securities Act of 1933, as amended (the
"Securities Act")) of the Company and certain other individuals named herein
(collectively, the "Selling Stockholders") who have acquired or may acquire
Common Stock upon exercise of options ("Options") granted or to be granted under
the Enamelon, Inc. 1993 Stock Option Plan (the "1993 Plan") or the Enamelon,
Inc. 1997 Incentive Stock Option Plan (the "1997 Plan") to purchase an aggregate
of 2,132,125 shares of Common Stock (the "Shares") . The maximum number of
Shares which may be offered or sold hereunder is subject to adjustment in the
event of stock splits or dividends, recapitalizations and other similar changes
affecting the Common Stock.
The shares of Common Stock offered hereby may be sold or transferred
for value by the Selling Stockholders, or by pledgees, donees, transferees or
other successors in interest to the Selling Stockholders, in one or more
transactions, from time to time directly to purchasers, or through
broker-dealers who may receive compensation in the form of commissions or
discounts from the Selling Stockholders or purchasers. Sales of shares of Common
Stock may be effected by broker-dealers in ordinary brokerage transactions or
block transactions on the Nasdaq National Market (or any successor stock
exchange) through sales to one or more dealers who may resell as principals, in
privately negotiated transactions or otherwise, at the market price prevailing
at the time of sale, a price related to such prevailing market price or at a
negotiated price. Usual and customary or specifically negotiated brokerage fees
may be paid by the Selling Stockholders in connection therewith. To the
Company's knowledge, none of the Selling Stockholders has entered into any
underwriting arrangements for the sale of the shares of Common Stock offered
hereby. See "Plan of Distribution."
The Company will not receive any proceeds from the sale of the shares
of Common Stock by the Selling Stockholders.
----------------------
THE SECURITIES OFFERED HEREBY ARE SPECULATIVE AND INVOLVE A HIGH DEGREE
OF RISK. FOR A DESCRIPTION OF CERTAIN RISKS REGARDING AN INVESTMENT IN THE
COMPANY, SEE "RISK FACTORS" COMMENCING ON PAGE 8.
THESE SECURITIES HAVE NOT BEEN APPROVED OR DISAPPROVED BY THE SECURITIES
AND EXCHANGE COMMISSION. NOR HAS THE COMMISSION PASSED UPON
THE ACCURACY OR ADEQUACY OF THIS PROSPECTUS.
ANY REPRESENTATION TO THE CONTRARY
IS A CRIMINAL OFFENSE.
The Selling Stockholders may be deemed to be "underwriters" within the
meaning of the Securities Act and any profits realized by them may be deemed to
be underwriting commissions. Any broker-dealers that participate in the
distribution of shares of Common Stock also may be deemed to be "underwriters",
as defined in the Securities Act, and any commissions or discounts paid to them,
or any profits realized by them upon the resale of any securities purchased by
them as principals, may be deemed to be underwriting commissions or discounts
under the Securities Act. The sale of the shares of Common Stock by the Selling
Stockholders is subject to the prospectus delivery and other requirements of the
Securities Act.
The date of this Prospectus is February 13, 1998.
<PAGE>
All costs, expenses and fees in connection with the registration of the
shares of Common Stock offered by the Selling Stockholders will be borne by the
Company. The Selling Stockholders are responsible for the payment of brokerage
commissions and discounts incurred in connection with the sale of their shares
of Common Stock.
No person is authorized to give any information or to make any
representations other than those contained in this Prospectus in connection with
any offer to sell or sale of the securities to which this Prospectus relates,
and if given or made, such information or representations must not be relied
upon as having been authorized. Neither the delivery of this Prospectus nor any
sale made hereunder shall, under any circumstances, imply that there has been no
change in the facts herein set forth since the date hereof. This Prospectus does
not constitute an offer to sell to or a solicitation of any offer to buy from
any person in any state in which any such offer or solicitation would be
unlawful.
2
<PAGE>
CAUTIONARY STATEMENT FOR PURPOSES
OF THE "SAFE HARBOR" PROVISIONS OF THE
PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
THIS DOCUMENT AND THE DOCUMENTS INCORPORATED HEREIN BY REFERENCE
CONTAIN FORWARD-LOOKING STATEMENTS OF MANAGEMENT OF THE COMPANY, INCLUDING
REVENUE PROJECTIONS. FORWARD-LOOKING STATEMENTS ARE STATEMENTS THAT ESTIMATE THE
HAPPENING OF FUTURE EVENTS, ARE NOT BASED ON HISTORICAL FACT AND ARE "FORWARD-
LOOKING STATEMENTS" WITHIN THE MEANING OF THE PRIVATE SECURITIES LITIGATION
REFORM ACT OF 1995. FORWARD-LOOKING STATEMENTS MAY BE IDENTIFIED BY THE USE OF
FORWARD- LOOKING TERMINOLOGY SUCH AS "MAY", "WILL", "EXPECT" "ESTIMATE",
"ANTICIPATE", "PROBABLE", "CONTINUE", OR SIMILAR TERMS, VARIATIONS OF THOSE
TERMS OR THE NEGATIVE OF THOSE TERMS. THE "RISK FACTORS" SET FORTH IN THIS
DOCUMENT AND THE DOCUMENTS INCORPORATED HEREIN BY REFERENCE CONSTITUTE
CAUTIONARY STATEMENTS IDENTIFYING IMPORTANT FACTORS THAT COULD CAUSE ACTUAL
RESULTS TO DIFFER MATERIALLY FROM THOSE IN THE FORWARD-LOOKING STATEMENTS. THE
FORWARD-LOOKING STATEMENTS CONTAINED IN THIS DOCUMENT HAVE BEEN COMPILED BY
MANAGEMENT OF THE COMPANY ON THE BASIS OF ASSUMPTIONS MADE BY MANAGEMENT AND
CONSIDERED BY MANAGEMENT TO BE REASONABLE. FUTURE OPERATING RESULTS OF THE
COMPANY, HOWEVER, ARE IMPOSSIBLE TO PREDICT AND NO REPRESENTATION, GUARANTY, OR
WARRANTY IS TO BE INFERRED FROM THOSE FORWARD-LOOKING STATEMENTS. THEREFORE,
PROSPECTIVE PURCHASERS OF SHARES OF COMMON STOCK ARE URGED TO CONSULT WITH THEIR
ADVISORS (THE OPINIONS OF WHICH MAY DIFFER FROM THOSE SPECIFIED IN THOSE
FORWARD-LOOKING STATEMENTS) WITH RESPECT TO THOSE ASSUMPTIONS OR HYPOTHESES.
THE ASSUMPTIONS USED FOR PURPOSES OF THE FORWARD-LOOKING STATEMENTS
CONTAINED IN THIS DOCUMENT AND THE DOCUMENTS INCORPORATED HEREIN BY REFERENCE,
INCLUDING THOSE REVENUE PROJECTIONS, REPRESENT ESTIMATES OF FUTURE EVENTS AND
ARE SUBJECT TO UNCERTAINTY AS TO POSSIBLE CHANGES IN ECONOMIC, LEGISLATIVE,
INDUSTRY, AND OTHER CIRCUMSTANCES. AS A RESULT, THE IDENTIFICATION AND
INTERPRETATION OF DATA AND OTHER INFORMATION AND THEIR USE IN DEVELOPING AND
SELECTING ASSUMPTIONS FROM AND AMONG REASONABLE ALTERNATIVES REQUIRE THE
EXERCISE OF JUDGMENT. TO THE EXTENT THAT THE ASSUMED EVENTS DO NOT OCCUR, THE
OUTCOME MAY VARY SUBSTANTIALLY FROM ANTICIPATED OR PROJECTED RESULTS, AND
ACCORDINGLY, NO OPINION IS EXPRESSED ON THE ACHIEVABILITY OF THOSE
FORWARD-LOOKING STATEMENTS, INCLUDING THOSE REVENUE PROJECTIONS.
THESE FORWARD-LOOKING STATEMENTS, INCLUDING THESE REVENUE PROJECTIONS,
HAVE BEEN COMPILED AS OF THE DATE OF THIS DOCUMENT OR THE DATE OF THE DOCUMENTS
INCORPORATED HEREIN BY REFERENCE, AS THE CASE MAY BE, AND SHOULD BE EVALUATED
WITH CONSIDERATION OF ANY CHANGES OCCURRING AFTER THE DATE HEREOF OR THEREOF. NO
ASSURANCE CAN BE GIVEN THAT ANY OF THE ASSUMPTIONS RELATING TO THE
FORWARD-LOOKING STATEMENTS CONTAINED IN THIS DOCUMENT OR IN ANY DOCUMENT
INCORPORATED HEREIN BY REFERENCE, INCLUDING THOSE REVENUE PROJECTIONS, ARE
ACCURATE OR THAT THEY WILL PROVE TO BE APPLICABLE TO A PARTICULAR PURCHASER OF
THE SHARES OF COMMON STOCK. IT IS THE RESPONSIBILITY OF THE PURCHASERS OF THE
COMMON STOCK AND THEIR ADVISORS TO REVIEW THOSE FORWARD-LOOKING STATEMENTS,
INCLUDING THOSE REVENUE PROJECTIONS, TO CONSIDER THE ASSUMPTIONS ON WHICH THOSE
FORWARD-LOOKING STATEMENTS ARE BASED AND TO ASCERTAIN THEIR REASONABLENESS.
3
<PAGE>
AVAILABLE INFORMATION
The Company is subject to the information requirements of the
Securities Exchange Act of 1934, as amended (the "Exchange Act"), and in
accordance therewith files reports and other information with the Securities and
Exchange Commission (the "Commission"). Such reports, proxy statements and other
information filed by the Company may be inspected and copied at the public
reference facilities maintained by the Commission at 450 Fifth Street, N.W.,
Washington, D.C. 20549 and at the Commission's Northeast Regional Office located
at Seven World Trade Center, New York, New York 10048. Copies of such material
may be obtained, at prescribed rates, by writing to the Commission, Public
Reference Section, 450 Fifth Street, N.W. Washington, D.C. 20549. The Commission
maintains a web site (http://www.sec.gov) that contains reports, proxy and
information statements and other information regarding registrants that file
electronically. The Common Stock is listed on the Nasdaq National Market.
A registration statement on Form S-8 with respect to the Shares (the
"Registration Statement") has been filed with the Commission under the
Securities Act. This Prospectus constitutes the Prospectus of the Company that
is filed with such Registration Statement with respect to the sale of the Shares
by the Selling Stockholders. As permitted by the rules and regulations of the
Commission, this Prospectus omits certain information contained in the
Registration Statement and reference is hereby made to the Registration
Statement for further information with respect to the Company and the Common
Stock.
DOCUMENTS INCORPORATED BY REFERENCE
The Company hereby incorporates by reference in this Prospectus the
documents listed below:
(a) The Company's Annual Report on Form 10-KSB for the fiscal year
ended December 31, 1996 ("Form 10-KSB");
(b) The Company's Quarterly Reports on Form 10-QSB for the quarters
ended March 31, 1997, June 30, 1997 and September 30, 1997 ("Form 10-QSB"); and
(c) The description of the Common Stock contained in the Company's
Registration Statement on Form 8-A filed pursuant to Section 12(g) of the
Exchange Act, including any amendment or report filed for the purpose of
updating such information.
All documents subsequently filed by the Company after the date of this
Prospectus pursuant to Sections 13(a), 13(c), 14, and 15(d) of the Exchange Act
shall be deemed to be incorporated by reference herein and to be a part hereof
from the date of filing of such documents. Any statement contained in a
previously filed document incorporated by reference herein shall be deemed to be
modified or superseded for purposes of this Prospectus to the extent that a
statement herein modifies or supersedes such statement; and any statement
contained herein shall be deemed to be modified or superseded to the extent that
a statement in any document subsequently filed, which is 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 a copy
of this Prospectus is delivered, upon written or oral request of such person, a
copy of any or all of the information that has been incorporated by reference in
this Prospectus (not including exhibits to such information, unless such
exhibits are specifically incorporated by reference into the information which
this Prospectus incorporates) . Written requests for copies of such information
should be directed to the Company at 758 Route 18, Suite 102, East Brunswick, NJ
08816, Attention: Corporate Secretary. Telephone requests may be directed to the
Corporate Secretary at (732) 432-0636.
4
<PAGE>
PROSPECTUS SUMMARY
The following summary is qualified in its entirety by the more detailed
information, financial statements and the notes thereto appearing elsewhere in,
or incorporated by reference into, this Prospectus.
The Company
Enamelon, Inc. is focused on developing and marketing over-the-counter
oral care products that stop cavities before they begin. The Company's products
are based on proprietary formulations and technologies that have been shown in
animal and in vitro studies to enhance remineralization of tooth enamel and to
prevent early stage tooth decay. Enamelon(TM) anticavity fluoride toothpaste
contains the active ingredient sodium fluoride, plus calcium and phosphate ions,
to enhance the remineralization of tooth enamel. The Company has launched its
initial product, Enamelon(TM) all-family toothpaste, into markets comprising
approximately 5% of United States households and expects to begin its national
introduction in the first half of 1998. The Company is also consumer testing an
adult toothpaste for sensitive teeth and expects to begin the national
introduction of that product in late 1998.
On a daily basis, teeth lose small amounts of calcium and phosphate,
the major structural ingredients of tooth enamel. This demineralization process
is caused by plaque acids produced during the bacterial breakdown of sugars in
the mouth. If the demineralization process is not balanced by remineralization,
demineralization will eventually destroy the mineral structure of the teeth and
result in cavities, which must be repaired by a dentist. Saliva contains low
levels of calcium and phosphate ions to naturally combat demineralization. The
presence of fluoride in the saliva is known to facilitate the remineralization
process. However, even with the addition of fluoride, remineralization is
limited by the small amounts of calcium and phosphate ions normally present in
saliva. Enamelon(TM) toothpaste simultaneously supplies the active ingredient
sodium fluoride and high concentrations of ions of the inactive ingredients
calcium and phosphate in soluble form during brushing to enhance the
remineralization process.
The Company's in vitro studies have demonstrated that Enamelon(TM)
toothpaste enhances remineralization by increasing levels of fluoride uptake and
that it strengthens and hardens the tooth structure. This makes the tooth less
soluble and more resistant to attacks by acids from decay-causing bacteria.
Based on the Company's studies, it believes that with each application of
Enamelon(TM) toothpaste, teeth will become stronger and more resistant to decay.
The Company currently is conducting intra-oral and small-scale human clinical
studies required by government regulation to support additional advertising
claims. The Company believes that human clinical studies will show that its
toothpaste enhances the tooth remineralization process to a greater degree than
currently available products, which the Company believes will represent one of
the most significant advances in personal dental care since the introduction of
mass-marketed fluoride dental products in the early 1960's.
In March 1997, the Company initiated marketing activities by entering
two Behavior Scan markets and is presently selling Enamelon(TM) toothpaste in
markets comprising approximately 5% of all United States households. The
Company's marketing strategy targets both consumers and dental professionals.
The Company believes that, in the markets it has entered, it has had
considerable success in obtaining retail distribution and has exceeded its
initial goals by obtaining more than 70% retail distribution on an all-commodity
basis.
The worldwide toothpaste market is estimated to exceed $5.0 billion in
annual retail sales. Annual toothpaste sales in the United States were
approximately $1.8 billion in 1997 and are projected to reach $2.0 billion by
the year 2000. Over the last five years, the toothpaste market has become
segmented as new, premium-priced products offering benefits such as tartar
control or whitening or containing ingredients such as baking soda have steadily
attracted consumers away from older, mature products.
The Company holds licenses from the American Dental Association Health
Foundation (the "ADAHF") to use patented technologies (the "ADAHF Patented
Technology") relating to a method for oral use of various amorphous calcium
phosphate compounds that enhance the natural activity of fluoride to prevent
tooth decay. The ADAHF has granted the Company (i) exclusive United States and
foreign licenses to develop, manufacture and market toothpaste and chewing gum
and other food and confectionery products using the ADAHF Patented Technology
and (ii) a non-exclusive international license covering products not covered by
the Company's exclusive licenses (including oral spray, mouth rinse and
professional gel products) using the ADAHF Patented Technology. The Company's
international license is co-extensive with a non-exclusive international license
granted to SmithKline Beecham Corp.
5
<PAGE>
("SmithKline"), which also obtained from the ADAHF an exclusive United States
license covering products not covered by the Company's exclusive licenses.
The Company itself has developed both patented and proprietary
technologies relating to the prevention of tooth decay before it begins (the
"Enamelon Proprietary Technology"). It has received five United States patents
for methods and materials that supply soluble calcium and phosphate salts to
teeth to enhance remineralization and one patent for its dual chamber toothpaste
tube, which is used to dispense Enamelon(TM) toothpaste. In addition, the
Company has 11 patent applications with respect to certain Enamelon Proprietary
Technology pending in the United States and 10 patent applications pending in
foreign jurisdictions.
The Company's objective is to become a leading marketer of a variety of
oral care and chewing gum and other food and confectionery products based on the
ADAHF Patented Technology and/or the Enamelon Proprietary Technology (together,
the "Enamelon Technologies"). The Company's strategic plan for accomplishing
this objective is to (i) market its toothpaste products with sodium fluoride as
the sole active ingredient in compliance with Food and Drug Administration
requirements, (ii) conduct further testing to establish additional advertising
and marketing claims, (iii) collaborate with corporate partners in certain
product areas and international markets and (iv) capitalize on additional
commercial applications of the Enamelon Technologies.
The Company was incorporated in Delaware in June 1992. In October 1996,
the Company completed its initial public offering. The Company's executive
offices are located at 15 Kimball Avenue, Yonkers, New York 10704, and its
telephone number is (914) 237-1308.
The Offering
<TABLE>
<CAPTION>
<S> <C>
Securities Offered................................... 2,132,125 shares of Common Stock acquired or which may
be acquired by the Selling Stockholders upon exercise of
options granted or to be granted pursuant to the 1993 Plan
and the 1997 Plan (together, "the Plans"). See "Selling
Stockholders" and "Plan of Distribution".
Common Stock Outstanding (1)......................... 9,935,932 shares of Common Stock.
Risk Factors......................................... The Securities offered hereby involve a high degree of risk.
Only investors who can bear the loss of their entire
investment should invest. See "Risk Factors".
Nasdaq National Market Symbol........................ ENML
</TABLE>
- ----------------
(1) Excludes an aggregate of 2,781,758 shares of Common Stock
consisting of (i) 1,362,250 shares of Common Stock reserved for issuance upon
the exercise of options granted or available for grant under the 1993 Plan, (ii)
750,000 shares of Common Stock reserved for issuance upon the exercise of
options granted or available for grant under the 1997 Plan and (iii) 654,053
shares of Common Stock reserved for issuance upon exercise of outstanding
warrants.
6
<PAGE>
RISK FACTORS
An investment in the shares of Common Stock offered hereby involves a high
degree of risk. The following risk factors should be considered carefully. In
addition to the other information in this Prospectus before purchasing the
Common Stock offered by this Prospectus.
History of Operating Losses; Uncertainty of Future Profitability
The Company has a limited history of operations and has accumulated net
losses from inception in June 1992 through December 31, 1997, of $15,462,684.
Losses have resulted principally from research and development costs, costs of
manufacturing and test marketing Enamelon(TM) toothpaste and general and
administrative costs. Although the Company commenced test marketing of
Enamelon(TM) toothpaste in March 1997, costs of production and marketing
presently exceed revenues. The Company expects to continue to incur additional
operating losses at least through 1999, principally as a result of expenses of
ongoing clinical testing and anticipated marketing and manufacturing expenses
associated with the national introduction of Enamelon(TM) toothpaste. There can
be no assurance that the Company will ever generate an operating profit or
achieve profitability. See "-Uncertainty of Consumer Acceptance of Enamelon(TM)
Toothpaste".
Dependence on Success of Initial Product
The Company is dependent to a large extent on the success of Enamelon(TM)
toothpaste, which is being sold in markets comprising approximately 5% of United
States households and is expected to be introduced nationally in the first half
of 1998. There can be no assurance that Enamelon(TM) toothpaste will become a
commercially viable product, or that if it does become commercially viable, it
can be produced in a timely manner, can be manufactured economically on a large
scale, can be free from governmental and competitive challenges, or can achieve
and sustain market acceptance. The Company believes that the success of its
initial product will be dependent upon a number of factors, including those
described under "-Uncertainty of Results of Human Clinical Studies," "-
Uncertainty of Consumer Acceptance of Enamelon(TM) Toothpaste" and " -Limited
Marketing Capability."
Uncertainty of Results of Human Clinical Studies
Based upon laboratory studies by the Company and others, the Company
believes that the current formulation of Enamelon(TM) toothpaste will achieve
expected results in humans. Nevertheless, results of in vitro and animal
laboratory studies are not necessarily indicative of results that will be
obtained in human clinical trials, which the Company has recently commenced. The
Company intends to continue to conduct human clinical studies of Enamelon(TM)
toothpaste in order to begin to establish additional advertising claims
concerning efficacy in humans. The Company believes that these advertising
claims will distinguish Enamelon(TM) toothpaste from competitors' products and
give the Company a competitive advantage. However, there can be no assurance
that the results of the human clinical studies will substantiate the anticipated
advertising claims. Adverse or inconclusive human clinical trial results
concerning any of the Company's toothpaste product-formulations could limit the
product claims the Company can make for Enamelon(TM) toothpaste. In such event,
the Company may have to conduct further studies, which would delay its ability
to make expected advertising claims regarding the effectiveness of Enamelon(TM)
toothpaste in humans.
Uncertainty of Consumer Acceptance of Enamelon(TM) Toothpaste
The Company will be dependent upon consumer acceptance of Enamelon(TM)
toothpaste as an alternative to currently well-known brand name toothpastes.
Market acceptance will depend on many factors, including (i) the Company's
ability to demonstrate to consumers the effectiveness of Enamelon(TM)
toothpaste, (ii) whether the Company's marketing strategy will achieve desired
results, (iii) the extent to which consumers are willing to pay a premium for
Enamelon(TM) toothpaste and (iv) the response of the Company's competitors to
the national introduction of Enamelon(TM) toothpaste. There can be no assurance
that the Company will be able to market its toothpaste or other products
successfully or that any of its products will be accepted in the marketplace.
See "-Limited Marketing Capability."
7
<PAGE>
Limited Marketing Capability
The Company has limited marketing capabilities and resources. Achieving
market penetration will require significant efforts by the Company to create
awareness of, and demand for, its toothpaste and other proposed products.
Accordingly, the Company's ability to build its customer base will be dependent
on its marketing efforts, including its ability to establish an effective sales
organization or establish strategic marketing arrangements with other companies.
The Company's failure to successfully develop its marketing capabilities, both
internally and through brokers, would have a material adverse effect on the
Company's business. Further, there can be no assurance that the development of
such marketing capabilities will lead to sales of the Company's toothpaste and
other proposed products.
Uncertainties Related to Development of Additional Products
The Company has focused its product development efforts to date on
Enamelon(TM) toothpaste. Accordingly, the Company will require significant
additional efforts to develop other products using the Enamelon Technologies.
All such future product development efforts are subject to certain risks and may
not succeed. These risks include, but are not limited to, the possibility that
(i) new products will be found ineffective or unsafe, (ii) even if safe and
effective, they will be difficult to develop into commercially viable products
or to manufacture economically on a large scale, free of governmental or
competitive challenges and (iii) any such products will fail to achieve and
sustain market acceptance.
Competition
Competition in toothpaste products and other oral care products, as well
as in chewing gum and other food and confectionery products, is intense. The
Company's primary competitors include companies with substantially greater
financial, technological, marketing, personnel and research and development
resources than those of the Company. There can be no assurance that the Company
will be able to compete successfully in these markets. The Company's toothpaste
products will compete with other brand name toothpastes, including Crest,
Colgate, Aquafresh, Mentadent, Arm & Hammer Dental Care and Sensodyne. Further,
new products or future developments by others may provide therapeutic or cost
advantages over the Company's toothpaste and other proposed products. There can
be no assurance that developments by others of similar or more effective
products will not render the Company's products or technologies noncompetitive
or obsolete or that competitors will not challenge the validity of the Company's
patent rights. Since the Company's products and proposed products will be new to
the market and sold in competition with the products of companies with greater
financial and other resources, there can be no assurance that a market for the
Company's products and proposed products will develop.
The Company's non-exclusive license to market products not covered by its
exclusive licenses (including oral sprays, mouth rinses, and professional gels)
outside of the United States is co-extensive with a license granted to
SmithKline, which has financial and other resources that are substantially
greater than those of the Company. Therefore, it is likely that the Company will
not be able to compete with SmithKline for the sale of those products outside of
the United States unless the Company enters into strategic alliances with other
companies having financial and other resources comparable to those of
SmithKline. However, there can be no assurance that the Company will be able to
successfully market products covered by its non-exclusive license, even if it is
able to form such alliances. See "-Uncertain Ability to Protect Patents."
Compliance with the FDA Monograph
The Company's toothpaste products are subject to regulation by the Food
and Drug Administration (the "FDA"). The FDA has published a final monograph,
Anticaries Drug Products for Over-the-Counter Human Use (the "Monograph"), for
over-the-counter ("OTC") anticaries drug products. The Monograph establishes
conditions under which OTC drug products that aid in the prevention of tooth
decay are generally recognized as being safe and effective and not misbranded.
The Company's products may be lawfully marketed without being required to file a
New Drug Application (an "NDA") with the FDA, if they use as their sole active
ingredient one of the active ingredients permitted
8
<PAGE>
in the Monograph and only make labeling claims permitted by the Monograph. The
Company's toothpaste and other proposed OTC drug products have been and are
being developed with the sole active ingredient being sodium fluoride, an active
ingredient permitted under the Monograph, and the Company intends to comply with
the Monograph in all other respects. However, there can be no assurance that the
FDA will determine that the Company's toothpaste and other proposed OTC drug
products meet all of the conditions of the Monograph. The Company will be
limited in the claims it can make with respect to its products in order to
remain in compliance with the Monograph. The Company's inability to market its
toothpaste and other proposed OTC drug products under and in compliance with the
Monograph would have a material adverse effect on the Company.
In order to market its products other than in compliance with the
Monograph, the Company would be required to file an NDA. An NDA would require
substantial testing procedures which are costly and time consuming. Accordingly,
if the Company were required to file an NDA with respect to any of its products,
the Company's ability to sell such products in the United States could be
delayed indefinitely. Further, the Company may not have sufficient financial or
other resources available to complete the NDA process, and assuming that such
financial and other resources are available, there is no assurance that the FDA
would approve the Company's NDA, if one were necessary.
Compliance with Other Government Regulation
In addition to regulation by the FDA under the Monograph, the Company is
subject to additional FDA regulation as well as regulation under various other
federal and state laws and government agencies. Each domestic drug product
manufacturing facility must be registered with the FDA, and each manufacturer
must inform the FDA of every drug product it has in commercial distribution and
keep such list updated. Domestic manufacturing facilities are also subject to at
least biennial inspection by the FDA for compliance with Good Manufacturing
Practices ("GMP's") regulations promulgated by the FDA. Compliance with GMP's is
required at all times during the manufacture and processing of drug products.
Accordingly, to the extent that the Company uses contract manufacturers, such
manufacturers must be in compliance with FDA requirements. To date, the Company
has used, and plans to continue to use, contract manufacturers to manufacture
its Enamelon(TM) toothpaste. If any such manufacturer is not in compliance with
GMP's, the FDA could bring an action to enforce its regulations, which could
lead to closing such manufacturing facility. In that instance, the Company would
be required to contract with another manufacturer, any such contract could
possibly be on terms less favorable to the Company than its former agreement,
and the sales and marketing of the Company's products could be disrupted. See
"-Dependence on Others to Manufacture."
The FDA has issued a tentative final monograph (the "Tentative Final
Monograph"), Oral Health Care Drug Products for Over-the-Counter Human Use,
which proposes to recognize the combination of sodium fluoride and the
desensitizing agent potassium nitrate as generally recognized as safe and
effective and not misbranded. The FDA has issued an enforcement policy
permitting the marketing of an anticaries/desensitizing drug product in
accordance with the terms of the Tentative Final Monograph, pending the
establishment of a final monograph covering this combination. Although the
Company's adult toothpaste for sensitive teeth is being developed to comply with
the Tentative Final Monograph, there can be no assurance that the FDA will
determine that toothpaste meets the conditions of the Tentative Final Monograph
or that the requirements of the final monograph will be the same as those of the
Tentative Final Monograph. In either case, the Company would be required to file
an NDA, reformulate that toothpaste or discontinue its development. Furthermore,
some of the Company's other proposed products may not be covered by an FDA
monograph, but may be subject to other FDA regulations, which could require
additional testing and could limit the claims that could be made for those
products.
Both the Company's products and its product claims may be challenged by
the Company's competitors or by the Federal Trade Commission (the "FTC") or
other governmental or private agencies. Such challenges may include an assertion
that the data obtained by the Company to substantiate the Company's advertising
claims may be inadequate or that such claims are inaccurate. There can be no
assurance that the Company will successfully defend any challenge in this area
or be able to modify its products or the claims with respect thereto to such an
extent that the products remain commercially viable. If the Company is unable to
defend such claims, it may become subject to an FTC cease and desist order,
which would impair its ability to market its products.
9
<PAGE>
The laws and regulations administered by governmental agencies are subject
to change and varying interpretations. While the Company uses and intends to
continue to use its best efforts to comply with relevant laws and regulations,
no assurance can be given that an agency might not assert a claim of
noncompliance against the Company in the future. Unanticipated changes in laws
or adverse interpretations of regulations could materially jeopardize the
Company's ability to distribute its products or engage in its contemplated
business activities.
The marketing of the Company's proposed products abroad will be subject to
significant regulation by foreign cosmetic and/or drug regulatory agencies. No
assurance can be given that the Company will be granted approval to market its
proposed products in foreign countries, and the failure to obtain such required
approvals would have an adverse effect on the Company's ability to market its
products internationally.
Dependence on Licensing Agreements
Since the Company believes that the ADAHF Patented Technology is a key
element in its product development, the Company considers its license agreements
with the ADAHF to be material to the Company's business. If sales of the
Company's products in the United States do not generate royalties of at least
$17,000 during the last year of any exclusivity period under the Company's
exclusive United States license, then the Company will not be entitled to renew
the period of exclusivity, and the ADAHF will be entitled to license the ADAHF
Patented Technology to the Company's competitors in the United States. The
foreign license rights also terminate if the United States license rights
terminate, except as to those countries for which the royalty paid in the
preceding year exceeds $7,000. Furthermore, if the Company fails to pay the
minimum royalties required under the license agreements or otherwise breaches
such agreements, then the ADAHF will be entitled to terminate the agreements if
such breaches remain uncured. In that event, the Company would be unable to use
the ADAHF Patented Technology, which could have a material adverse effect on the
ability of the Company to develop, manufacture and sell its products, or even to
continue in business.
Uncertain Ability to Protect Patents
The Company's ability to compete effectively depends on its success in
protecting the Enamelon Technologies, both in the United States and abroad. No
assurance can be given that the Company's protection of patents or other
proprietary technology within and/or outside of the United States is sufficient
to deter others, legally or otherwise, from developing or marketing competitive
products using the Enamelon Technologies.
The patents and pending patent applications constituting the ADAHF
Patented Technology (the "ADAHF Patent Rights") and certain of the Enamelon
Proprietary Technology (the "Enamelon Patent Rights" and collectively with the
ADAHF Patent Rights, the "Patent Rights") are material to the Company's
business. No assurance can be given that any further patents will be issued from
the United States or foreign patent offices for the Patent Rights or that the
Company will receive any patents in the future based on its continued
development efforts. The Company believes that the protection afforded by the
Patent Rights is material to its future revenues and earnings. There can be no
assurance that any of the Patent Rights will be found to be valid or that any of
the Patent Rights will be enforceable or prevent others from developing and
marketing competitive products or methods. A successful challenge to the
validity of the Patent Rights could have a material adverse effect on the
Company and could jeopardize its ability to engage in its contemplated business.
An infringement action on behalf of the Company to enforce any of the Patent
Rights may require the diversion of substantial funds from the Company's
operations and may require management to expend efforts that might otherwise be
devoted to the Company's operations. Furthermore, there can be no assurance that
the Company will be successful in enforcing the Patent Rights. See
"-Competition."
There can be no assurance that patent infringement claims in the United
States or in other countries will not be asserted against the Company by a
competitor or others, and if asserted, that the Company will be successful in
defending against such claims. If any of the Company's products is determined to
infringe a patent of others, the Company or its sublicensee's may be required to
pay substantial damages, may be enjoined from using and selling such product, or
may be required to obtain a royalty-bearing license. If such a license is not
available, the Company would be required either to redesign those aspects of the
product held to infringe so as to avoid future infringement or to stop
10
<PAGE>
selling the product. In such case, any redesign efforts undertaken by the
Company could require significant expense, be inadequate to avoid infringement,
necessitate an FDA review, delay the introduction or the re-introduction of the
product into certain markets or be so significant as to be impractical.
Protection of Proprietary Technology and Information
The Company also intends to rely on trade secrets, know-how and continuing
technological advancement to establish and maintain a competitive position in
the market for its products. Although the Company has entered into
confidentiality and invention agreements with its employees and consultants, no
assurance can be given that such agreements will be honored or that the Company
will be able to effectively protect its rights to its unpatented trade secrets
and know-how. Moreover, no assurance can be given that others will not
independently develop substantially equivalent proprietary information and
techniques or otherwise gain access to the Company's trade secrets and know-how.
Evolving Product Formulations
The Company expects that the formulation of its toothpaste and other
products will be modified from time to time as a result of the Company's ongoing
research and product testing programs. As a result of such modifications,
products that the Company produces in the future may differ from those that were
the subject of earlier research and testing. Therefore, the research studies
conducted to date and relied upon by the Company for efficacy and claims
substantiation, as well as the Patent Rights obtained at this time, might not
necessarily be applicable to the Company's future product formulations. In that
event, the Company may be required to make significant additional expenditures
on development and testing of these new formulations and in securing relevant
patent rights. Furthermore, there can be no assurance that future product
formulations will comply with the Monograph, that the Company will not be
required to file an NDA in connection with new product formulations, or that any
products using such formulations will be commercially viable. See "-Compliance
with the FDA Monograph" and "-Compliance with Other Governmental Regulation."
Dependence on Others to Manufacture
The Company is using a contract manufacturer to manufacture its toothpaste
products for the United States market. There can be no assurance that if the
Company's present contract manufacturer becomes unavailable, the Company will be
able to retain another qualified manufacturer on terms favorable to the Company.
The Company may seek to sublicense or enter into joint ventures, or strategic
partnerships with major consumer product companies or other entities on either
an exclusive or non-exclusive basis, for manufacturing its products in foreign
markets as well as for manufacturing its other proposed products. Manufacturing
arrangements in these markets are likely to be encompassed in any agreements
establishing such relationships and may place primary manufacturing
responsibility on others. The Company has no plan, agreement, understanding or
arrangement with respect to such relationships, and no assurance can be given
that the Company will enter into any such arrangements.
The Company's dependence upon others to manufacture its products may
adversely affect its future profit margins, if any, and may affect the Company's
ability to sell toothpaste and other proposed products on a timely and
competitive basis. See "-Compliance with Other Government Regulation."
Future Capital Needs; Uncertainty of Additional Financing
The Company's cash requirements may vary materially from those now planned
depending on numerous factors, including the status of the Company's marketing
efforts, the Company's business development activities, the results of human
clinical trials, the regulatory process and competition. Although the Company
currently estimates that its cash and cash equivalents on hand will be
sufficient to finance its working capital and other requirements for a period of
approximately eighteen months, there can be no assurance that the Company's
financial resources will not be exhausted sooner. Thereafter, if the Company is
not profitable, it will need to raise additional funds through public
11
<PAGE>
or private financings, including equity financings, which may be dilutive to
stockholders. There can be no assurance that the Company will be able to raise
additional funds if its capital resources are exhausted, or that funds will be
available on terms attractive to the Company or at all. If adequate funds are
not available, the Company may be required to reduce materially its proposed
operations.
Product Liability
The sale of any over-the-counter consumer product may result in claims of
adverse reactions by users. Although the Company has no intention of marketing
any product without reasonable belief in its safety and efficacy when used in
accordance with its instructions, misuse of the Company's products may result in
consumer injury. In addition, future developments, including possible adverse
medical studies and associated negative publicity, could have a material adverse
impact on the market for the Company's products and on its results of
operations. Further, the Company may be subject to certain consumer claims and
informal complaints relating to its products that are incidental and routine to
its business and for which the Company intends to maintain insurance coverage.
The Company currently maintains product liability insurance of $6 million
per claim and $7 million in the aggregate on a "per occurrence basis." Product
liability insurance coverage is expensive and subject to many exclusions, and
there can be no assurance that the Company will be able to maintain its current
insurance coverage or to obtain additional insurance coverage in sufficient
amounts or on favorable terms. Exclusions or damage limitations may render any
insurance coverage obtained insufficient to protect the Company adequately from
the successful assertion of a product liability claim. There can be no assurance
that the Company's present or future insurance coverage will be sufficient to
satisfy product liability claims, if any, made against the Company with respect
to injuries arising from the use of such products. In the event of a successful
product liability claim against the Company, the insufficiency of insurance
coverage and the negative publicity from such a suit could have a material
adverse effect on the Company and jeopardize its ability to engage in its
contemplated business activities. There also can be no assurance that the
Company will be able to increase such insurance coverage or to maintain such
coverage on acceptable terms. If the Company's insurance coverage were to lapse
or be terminated, then the Company would have no insurance coverage for claims
arising subsequent to the lapse or termination of the policy. Product liability
claims successfully asserted after the lapse or termination of the policy could
have a materially adverse effect on the Company.
Dependence on Key Personnel
The success of the Company will be largely dependent upon the personal
efforts of Dr. Steven R. Fox, D. Brooks Cole, Norman Usen and Anthony E.
Winston. The loss of the services of any of such persons could have a material
adverse effect on the Company's business and prospects. The Company has entered
into a five-year employment agreement with Dr. Fox as Chairman of the Board and
Chief Executive Officer. The Company has also entered into an employment
agreement with Mr. Cole as President and Chief Operating Officer pursuant to
which Mr. Cole serves at the pleasure of the Board of Directors. Although the
Company has entered into employment agreements with each of the aforementioned
individuals, there can be no assurance that the Company will be able to retain
their services. The success of the Company will also be dependent upon its
ability to hire and retain additional qualified management, marketing and
financial personnel. The Company will compete with other companies with greater
financial and other resources for such personnel.
Control by Principal Stockholders
The Company's directors, executive officers and principal stockholders
beneficially own approximately 37.14% of the Common Stock. Consequently, they
have the ability to significantly influence the election of the Company's
directors and the outcome of all other issues submitted to the Company's
stockholders. See "Selling Stockholders."
12
<PAGE>
No Assurance of Active or Continued Public Market; Volatility of Stock Price
Although a public trading market for the Common Stock currently exists,
there can be no assurance that such trading market will provide significant
liquidity with regard to the Common Stock or that such market will be sustained.
Trading volume and prices for the Common Stock have been and could
continue to be subject to wide fluctuations in response to quarterly variations
in operations, financial results, announcements with respect to sales and
earnings, technological innovations, new product developments, the sale or
attempted sale of a large amount of securities in the public market, and other
events or factors that cannot be foreseen or predicted by the Company. In
addition, various factors affecting consumer products companies, as well as
price and volume volatility affecting small and emerging growth companies
generally, but not necessarily related to their particular operating
performance, may have a significant impact on the market price of the Common
Stock.
Shares Eligible for Future Sale
Future sales of Common Stock by existing stockholders pursuant to Rule 144
("Rule 144") promulgated under the Securities Act of 1933, as amended (the
"Securities Act"), pursuant to registration rights granted to certain holders of
warrants to purchase the Common Stock, or pursuant to other registrations or
exemptions from registration under the Securities Act, could have an adverse
effect on the price of the shares of Common Stock. As of February 9, 1998, the
Company had approximately 9,935,932 shares of Common Stock outstanding. In
addition, the Company has reserved for issuance (i) 1,362,250 shares of Common
Stock upon the exercise of options granted or available for grant under the 1993
Plan, (ii) 750,000 shares of Common Stock reserved for issuance upon the
exercise of options granted or available for grant under the 1997 Plan and (iv)
654,053 shares of Common Stock reserved for issuance upon exercise of
outstanding warrants (the "Warrants").
Of the 9,935,932 shares of Common Stock issued and outstanding, 1,700,000
were sold publicly in the Company's initial public offering, approximately
485,050 shares have been sold publicly pursuant to Rule 144, and 673,950 shares
may be sold publicly pursuant to a registration statement that was declared
effective by the Securities and Exchange Commission on August 11, 1997. The
remaining 7,076,932 outstanding shares of Common Stock are "restricted
securities," as that term is defined in Rule 144, and may only be sold pursuant
to a registration statement under the Securities Act or an applicable exemption
from registration thereunder, including exemptions provided by Rule 144. All of
such shares are presently eligible for resale under Rule 144. In addition,
certain of the holders of 558,399 shares of Common Stock and Warrants to
purchase 634,617 shares of Common Stock at prices ranging from $3.60 to $5.75
per share have three demand registration rights exercisable until October 24,
2001, and unlimited piggyback registration rights exercisable until January 23,
2003 (subject to certain limitations), and holders of Warrants to purchase
170,000 shares of Common Stock at $8.40 per share have one demand registration
right exercisable after October 23, 1997, and certain piggyback registration
rights exercisable until October 29, 2001. Employees, consultants, and other
eligible holders of options to purchase approximately 1,256,089 shares of Common
Stock granted under the 1993 Plan also have the right to exercise their options
and immediately sell the shares of Common Stock received upon exercise under the
Registration Statement on Form S-8 pursuant to which this Prospectus was filed.
No prediction can be made as to the effect that future sales of Common Stock, or
the availability of shares of Common Stock for future sales, will have on the
market prices for the Common Stock prevailing from time to time. Sales of
substantial amounts of Common Stock, or the perception that such sales could
occur, could adversely affect prevailing market prices for the Common Stock and
could impair the Company's ability to raise capital through the future sale of
its equity securities. See "Selling Stockholders."
Issuance of Preferred Stock; Antitakeover Provisions of Delaware Law
The Company's Amended Certificate of Incorporation authorizes the issuance
of 5,000,000 shares of Preferred Stock with such designations, rights and
preferences as may be determined from time to time by the Board of Directors.
Accordingly, the Board of Directors is empowered, without obtaining stockholder
approval, to issue Preferred Stock
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<PAGE>
with dividend, liquidation, conversion, voting or other rights that could
adversely affect the voting power or other rights of the holders of the Common
Stock. In the event of issuance, the Preferred Stock could be used, under
certain circumstances, as a method of discouraging, delaying or preventing a
change in the control of the Company. Certain provisions of Delaware law may
also discourage third party attempts to acquire control of the Company.
USE OF PROCEEDS
The Company will not receive any of the proceeds from the sale of the
Shares. However, the Company expects to use the proceeds from the exercise of
the Options to purchase such Shares for working capital and other general
corporate purposes.
SELLING STOCKHOLDERS
The shares of Common Stock to which this Prospectus relates are being
registered for reoffers and resales by the Selling Stockholders who have
acquired or may acquire such Shares pursuant to the exercise of Options. The
Selling Stockholders named below may resell all, a portion or none of such
Shares from time to time.
Participants under the Plans who are deemed to be "affiliates" of the
Company who may acquire Common Stock under the Plans may be added to the Selling
Stockholders listed below from time to time by use of a prospectus supplement
filed pursuant to Rule 424(b) under the Securities Act of 1933. An "affiliate"
is defined in Rule 405 under the Securities Act as a "person that directly, or
indirectly, through one or more intermediaries, controls or is controlled by, or
is under common control with," the Company.
The table below sets forth with respect to each Selling Stockholder, based
upon information available to the Company as of February 9, 1998, the number of
shares of Common Stock beneficially owned before and after the sale of the
shares offered hereby, the number of shares to be sold, and the percent of the
outstanding shares of Common Stock owned before and after the sale of the Common
Stock offered hereby.
14
<PAGE>
<TABLE>
<CAPTION>
Number of Percentage
Number of Shares Shares Bene- of Shares
Beneficially Percentage of Number of ficially Owned
Owned Shares Owned Shares to be Owned After
Selling Stockholders Before Reoffer(1) Before Reoffer(2) Reoffered(3) After Reoffer Reoffer (2)
-------------------- ----------------- ----------------- ------------ ------------- -----------
<S> <C> <C> <C> <C> <C>
Dr. Steven R. Fox 2,964,240(4) 28.4% 462,500 2,501,740 24%
(Chairman, Chief
Executive Officer
and Director)
Norman Usen 175,762(5) 1.7% 175,762 0 -
(Vice President of
Operations and
Product
Development and
Secretary)
Anthony E. Winston 160,000(6) 1.6% 160,000 0 -
(Vice President of
Technology and
Clinical Research)
D. Brooks Cole 90,000(7) * 90,000 0 -
(President and Chief
Operating Officer)
Eric D. Horodas 112,762(8) 1.1% 28,753 84,009 *
(Director)
Richard A. Gotterer 82,512(8) 1.0% 28,753 53,759 *
(Director)
Dr. S.N. Bhasker 72,256(9) * 72,256 0 -
(Director)
Dr. Bert Gaster 17,253(10) * 17,253 0 -
(Director)
Edwin Diaz 12,500(11) * 12,500 0 -
(Vice President of
Finance, Chief
Financial Officer and
Treasurer)
Thomas Duncan 3,000(12) * 3,000 0 -
(Vice President of
Manufacturing)
Dr. Jason M. Tanzer 9,000(13) * 9,000 0 -
Dr. Joseph L. Henry 5,000(14) * 5,000 0 -
Harvey Klaris 5,875(15) * 5,875 0 -
</TABLE>
* Represents less than 1% of the issued and outstanding Common Stock.
15
<PAGE>
(1) Unless indicated, the Company believes that all persons named in the table
have sole voting and investment power with respect to all shares of the
Company Common Stock beneficially owned by them. For purposes of this
table, any security which such person has the right to acquire within 60
days after such date is deemed to be outstanding for the purpose of
computing the percentage ownership for such person, but is not deemed to be
outstanding for the purpose of computing the percentage of any other
person.
(2) Based on 9,935,932 shares of Common Stock outstanding as of February 9,
1998.
(3) Does not include shares that may be acquired by the individuals listed upon
exercise of options which subsequently may be granted pursuant to the 1993
Plan or the 1997 Plan which shares (if any) will be added to the number of
shares listed by one or more supplements to this Prospectus. Furthermore,
the inclusion in this Prospectus of the stated number of shares does not
constitute a commitment to sell any or all of such shares. The number of
shares offered shall be determined from time to time by each Selling
Stockholder at his or her sole discretion.
(4) Includes 36,348 shares held in trust for the benefit of Dr. Fox's minor
children. Also includes 462,500 shares issuable upon exercise of currently
exercisable stock options, but does not include options to purchase 187,500
shares, that have not vested. Shares owned directly by Dr. Fox are owned
jointly with his wife.
(5) Represents 175,762 shares issuable upon exercise of currently exercisable
stock options, but does not include options to purchase 13,000 shares that
have not vested.
(6) Represents 160,000 shares issuable upon exercise of currently exercisable
stock options, but does not include options to purchase 13,000 shares that
have not vested.
(7) Represents 90,000 shares issuable upon exercise of currently exercisable
stock options, but does not include options to purchase 37,500 shares that
have not vested.
(8) Includes 28,753 shares issuable upon exercise of currently exercisable
stock options.
(9) Represents 72,256 shares issuable upon exercise of currently exercisable
stock options.
(10) Represents 17,253 shares issuable upon exercise of currently exercisable
stock options.
(11) Represents 12,500 shares issuable upon exercise of currently exercisable
stock options, but does not include options to purchase 37,500 shares that
have not vested.
(12) Represents 3,000 shares issuable upon exercise of currently exercisable
stock options, but does not include options to purchase 24,216 shares that
have not vested.
(13) Represents 9,000 shares upon the exercise of stock options granted under
the 1993 Plan.
(14) Represents 5,000 shares previously acquired upon the exercise of stock
options granted under the 1993 Plan.
(15) Represents 5,875 shares previously acquired upon the exercise of stock
options granted under the 1993 Plan.
PLAN OF DISTRIBUTION
The Shares may be sold or transferred for value by the Selling
Stockholders, or by pledgees, donees, transferees or other successors in
interest to the Selling Stockholders, in one or more transactions on the Nasdaq
National Market (or any successor stock exchange), in negotiated transactions or
in a combination of such methods
16
<PAGE>
of sale, at market prices prevailing at the time of sale, at prices related to
such prevailing market prices or at prices otherwise negotiated. The Selling
Stockholders may effect such transactions by selling the Shares to or through
broker-dealers, and such broker-dealers may receive compensation in the form of
underwriting discounts, concessions or commissions from the Selling Stockholders
and/or the purchasers of the Shares for whom such broker-dealers may act as
agent (which compensation may be less than or in excess of customary
commissions). The Selling Stockholders and any broker-dealers that participate
in the distribution of the Shares may be deemed to be "underwriters" within the
meaning of Section 2(11) of the Securities Act, and any commissions received by
them and any profit on the resale of the Shares sold by them may be deemed to be
underwriting discounts and commissions under the Securities Act. The sale of the
Shares of the Common Stock by the Selling Stockholders is subject to the
prospectus delivery and other requirements of the Securities Act.
Upon the Company's being notified by a Selling Stockholder that any
material arrangement has been entered into with a broker or dealer for the sale
of shares through a secondary distribution, or a purchase by a broker or dealer,
a supplemented Prospectus will be filed, if required, pursuant to Rule 424(b)
under the Securities Act, disclosing (a) the name of each of such Selling
Stockholder and the participating broker-dealers, (b) the number of Shares
involved, (c) the price at which such Shares are being sold, (d) the commissions
paid or the discounts or concessions allowed to such broker-dealers, (e) where
applicable, that such broker-dealers did not conduct any investigation to verify
the information set out or incorporated by reference in the Prospectus, as
supplemented, and (f) other facts material to the transaction.
In addition to any such number of Shares sold hereunder, a Selling
Stockholder may, at the same time, sell any shares of Common Stock, including
the Shares, owned by him in compliance with all of the requirements of Rule 144
under the Securities Act, regardless of whether such shares are covered by this
Prospectus.
There is no assurance that any of the Selling Stockholders will sell
any or all of the Shares offered hereby.
The Company will pay all expenses in connection with this offering,
other than commissions and discounts of underwriters, dealers or agents. All
selling and other expenses incurred by individual Selling Stockholders will be
borne by such Selling Stockholders.
LEGAL MATTERS
The validity of the shares of Common Stock offered hereby has
been passed upon for the Company by Snow Becker Krauss P.C., 605 Third Avenue,
New York, New York 10158. SBK Investment Partners, a partnership consisting of
members of Snow Becker Krauss P.C., counsel to the Company, owns 96,600 shares
of Common Stock and holds a currently exercisable option to purchase 32,628
shares of Common Stock at $3.22 per share. In addition, certain members of Snow
Becker Krauss P.C. beneficially own Common Stock individually.
EXPERTS
The financial statements of Enamelon, Inc. at December 31, 1996 and for
each of the two years in the period ended December 31, 1996, appearing in the
Company's Annual Report (Form 10-KSB) for the year ended December 31, 1996 have
been audited by BDO Seidman LLP, independent auditors, as set forth in their
reports thereon included therein and incorporated herein by reference. Such
financial statements are incorporated herein by reference in reliance upon such
reports given upon the authority of such firm as experts in accounting and
auditing.
17
<PAGE>
SIGNATURES
In accordance with 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-8 and has duly caused this registration
statement to be signed on its behalf by the undersigned, thereunto duly
authorized, in the City of Yonkers, State of New York, on this 13th day of
February, 1998.
ENAMELON, INC.
By: /s/ Dr. Steven R. Fox
--------------------------------------------------
Dr. Steven R. Fox, Chief Executive Officer
and Chairman of the Board of Directors
POWERS OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature
appears below constitutes and appoints Dr. Steven R. Fox as his true and lawful
attorneys-in-fact and agents, with full power of substitution and resubstitution
, for him and in his name, place and stead, in any and all capacities, to sign
any and all amendments (including post-effective amendments) and supplements to
this Registration Statement, and to file the same with the Commission, granting
unto said attorneys-in-fact and agents, and each of them, full power and
authority to do and perform each and every act and thing requisite and necessary
to be done in connection therewith, as fully to all intents and purposes as he
might or could do in person, hereby ratifying and confirming all that said
attorneys-in-fact and agents, or any of them or their substitute or substitutes,
may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Act of 1933 this
registration statement has been signed below by the following persons, in the
capacities indicated, on February 13, 1998
/s/ Dr. Steven R. Fox
- -----------------------------------
Dr. Steven R. Fox, Chairman, Chief
Executive Officer and Director
/s/ Edwin Diaz /s/ Dr. S.N. Bhaskar
- ----------------------------------- ----------------------------
Edwin Diaz, Vice President - Finance Dr. S.N. Bhaskar, Director
and Chief Financial Officer (Principal
Financial and Accounting Officer)
/s/ Richard A. Gotterer /s/ Dr. Bert Gaster
- ----------------------------------- ----------------------------
Richard A. Gotterer, Director Dr. Bert Gaster, Director
18
<PAGE>
PART II
INFORMATION REQUIRED IN THE REGISTRATION STATEMENT
Item 3. Incorporation of Documents By Reference.
The following documents filed with the Securities and Exchange
Commission (the "Commission") by Enamelon, Inc., a Delaware corporation (the
"Registrant"), pursuant to the Securities Exchange Act of 1934, as amended (the
"Exchange Act"), are incorporated by reference in this registration statement.
(1) The Registrant's Annual Report on Form 10-KSB for the fiscal year
ended December 31, 1996;
(2) The Registrant's Quarterly Reports on Form 10-QSB for the quarters
ended March 31, 1997, June 30, 1997 and September 30, 1997;
(3) The description of the Registrant's common stock, par value $.001
per share (the "Common Stock"), contained in the Registrant's Registration
Statement on Form 8-A pursuant to Section 12(g) of the Exchange Act, including
any amendment or report filed for the purpose of updating such information.
All documents subsequently filed by the Registrant pursuant to Sections
13(a), 13(c), 14 and 15(d) of the Exchange Act, prior to the filing of a
post-effective amendment which indicates that all securities offered have been
sold or which deregisters all securities then remaining unsold, shall be deemed
to be incorporated by reference herein and to be a part hereof from the date of
filing of such documents. Any statement contained in a document incorporated or
deemed to be incorporated by reference herein shall be deemed to be modified or
superseded for purposes of this registration statement to the extent that a
statement contained herein or in any other subsequently filed document which
also is incorporated or deemed to be incorporated by reference herein modifies
or supersedes such statement. Any such statement so modified or superseded shall
not be deemed, except as so modified or superseded, to constitute a part of this
registration statement.
Item 4. Description of Securities.
Not applicable.
Item 5. Interests of Named Experts and Counsel
SBK Investment Partners, a partnership consisting of members of Snow
Becker Krauss P.C., counsel to the Company, owns 96,600 shares of Common Stock
and holds a currently exercisable option to purchase 32,628 shares of Common
Stock at $3.22 per share. In addition, certain members of Snow Becker Krauss
P.C. beneficially own Common Stock individually. Snow Becker Krauss P.C. is
rendering an opinion upon the validity of the securities being registered
hereby.
Item 6. Indemnification of Directors and Officers.
Under Section 145 of the Delaware General Corporation Law, the
Registrant has broad powers to indemnify it directors and officers against
liabilities they may incur in such capacities, including liabilities under the
Securities Act of 1933, as amended (the "Securities Act"). The Registrant's
Bylaws provide that the Registrant will indemnify its directors, executive
officers, other officers, employees and agents to the fullest extent permitted
by Delaware law.
The Registrant's Certificate of Incorporation provides for the
elimination of liability for monetary damages for breach of the directors'
fiduciary duty of care to the Registrant and its stockholders. These provisions
do not eliminate the directors' duty of care and, in appropriate circumstances,
equitable remedies such as injunctive or other forms of
II-1
<PAGE>
non-monetary relief will remain available under Delaware law. In addition, each
director will continue to be subject to liability for breach of the director's
duty of loyalty to the Registrant, for acts or omissions not in good faith or
involving intentional misconduct for knowing violations of law, for any
transactions from which the director derived an improper personal benefit, and
for payment of dividends or approval of stock repurchases or redemptions that
are unlawful under Delaware law. The provision does not affect a director's
responsibilities under any other laws, such as federal laws or state or federal
environmental laws.
INSOFAR AS INDEMNIFICATION FOR LIABILITIES ARISING UNDER THE
SECURITIES ACT MAY BE PERMITTED TO DIRECTORS, OFFICERS AND CONTROLLING PERSONS
OF THE REGISTRANT PURSUANT TO THE FOREGOING PROVISIONS, OR OTHERWISE, THE
REGISTRANT HAS BEEN ADVISED THAT IN THE OPINION OF THE SECURITIES AND EXCHANGE
COMMISSION SUCH INDEMNIFICATION IS AGAINST PUBLIC POLICY AS EXPRESSED IN THE
SECURITIES ACT AND IS, THEREFORE, UNENFORCEABLE.
Item 7. Exemption From Registration Claimed.
This Registration Statement covers an aggregate of 19,875 shares of
Common Stock previously issued to three employees or consultants of the
Registrant upon exercise of stock options granted pursuant to the 1993 Plan. The
issuance and purchase of these shares was exempt from registration pursuant to
Rule 701 promulgated under the Securities Act.
Item 8. Exhibits.
<TABLE>
<CAPTION>
Exhibit No. Description of Exhibit
----------- ----------------------
<S> <C>
4.1 Enamelon, Inc. 1993 Stock Option Plan (the "1993 Plan").*
4.2 Enamelon, Inc. 1997 Incentive Stock Option Plan (the "1997 Plan").**
5.1 Opinion of Snow Becker Krauss P.C.
23.1 Consent of Snow Becker Krauss P.C. (included in Exhibit 5.1 hereto).
23.2 Consent of BDO Seidman LLP.
24.1 Powers of Attorney (included on the signature page of this Registration
Statement).
</TABLE>
- ----------------
* Incorporated by reference to the Registrant's Registration Statement on
Form S-1 (File No. 333-06455) filed with the Securities and Exchange
Commission on October 22, 1996.
** Incorporated by reference to the Registrant's Registration Statement on
Form S-1 (File No. 333-31163) filed with the Securities and Exchange
Commission on July 11, 1997.
Item 9. Undertakings.
(a) The undersigned Registrant hereby undertakes that it will:
(1) File, during any period in which offers or sales are being
made, a post-effective amendment to this Registration Statement to:
(i) Include any prospectus required by Section 10 (a) (3)
of the Securities Act of 1933;
II-2
<PAGE>
(ii) 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,
represents a fundamental change in the information set forth in the Registration
Statement;
(iii) Include any material information with respect to the
plan of distribution not previously disclosed in the Registration Statement or
any material change to such information in the Registration Statement;
provided, however, that paragraphs (a)(1)(i) and (a)(1)(ii) do not apply if the
Registration Statement is on Form S-3 or Form S-8 and the information required
to be included in a post-effective amendment by those paragraphs is contained in
periodic reports filed by the Registrant pursuant to Section 13 or Section 15(d)
of the Securities Exchange Act of 1934 that are incorporated by reference in the
Registration Statement.
(2) 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; and
(3) 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.
(b) 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 (and, where applicable, each filing of an
employee benefit plan's annual report pursuant to Section 15 (d) of the
Securities Exchange Act of 1934) that is incorporated by reference in the
registration statement shall be deemed to be a new registration statement
relating to the securities offered therein, and the offering of such securities
at that time shall be deemed to be the initial bona fide offering thereof.
(c) Insofar as indemnification for liabilities arising under the
Securities Act of 1933 may be permitted to directors, officers or controlling
persons of the Registrant pursuant to any arrangement, provision 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 of 1933 and is, therefore, unenforceable. In the event
that a claim for indemnification against such liabilities (other than the
payment by the Registrant of expenses incurred or paid by a director, officer or
controlling person of the Registrant in the successful defense of any action,
suit or proceeding) is asserted by such director, officer or controlling person
in connection with the securities being registered, the Registrant will, unless
in the opinion of its counsel the matter has been settled by controlling
precedent, submit to a court of appropriate jurisdiction the question whether
such indemnification by it is against public policy as expressed in the
Securities act of 1933 and will be governed by the final adjudication of such
issue.
II-3
<PAGE>
EXHIBIT INDEX
<TABLE>
<CAPTION>
Exhibit No. Description of Exhibit
----------- ----------------------
<S> <C>
4.1 Enamelon, Inc. 1993 Stock Option Plan (the "1993 Plan").*
4.2 Enamelon, Inc. 1997 Incentive Stock Option Plan (the "1997 Plan").**
5.1 Opinion of Snow Becker Krauss P.C.
23.1 Consent of Snow Becker Krauss P.C. (included in Exhibit 5.1 hereto).
23.2 Consent of BDO Seidman LLP.
24.1 Powers of Attorney (included in the signature page of this Registration Statement).
</TABLE>
- ----------
* Incorporated by reference to the Registrant's Registration Statement on
Form S-1 (File No. 333-06455) filed with the Securities and Exchange
Commission on October 22,1996.
** Incorporated by reference to the Registrant's Registration Statement on
Form S-1 (File No. 333-31163) filed with the Securities and Exchange
Commission on July 11, 1997.
<PAGE>
EXHIBIT 5.1
OPINION OF SNOW BECKER KRAUSS P.C.
<PAGE>
EXHIBIT 5.1
February 13, 1998
Enamelon, Inc.
15 Kimball Avenue
Yonkers, New York 10704
Re: Registration Statement on Form S-8 Relating to 2,132,125 Shares
of Common Stock, Par Value $. 001 Per Share, of Enamelon, Inc.
Issuable Under the 1993 Stock Option Plan or the 1997 Incentive
Stock Option Plan
---------------------------------------------------------------
Gentlemen:
We are counsel to Enamelon, Inc., a New York corporation (the
"Company"), in connection with the filing by the Company with the Securities and
Exchange Commission pursuant to the Securities Act of 1933, as amended (the
"Securities Act"), of a registration statement on Form S-8 (the "Registration
Statement") relating to 2,132,125 shares (the "Shares") of the Company's common
stock, par value $.001 per share (the "Common Stock"), issuable upon the
exercise of options granted, as well as stock options to be granted, pursuant to
the Company's 1993 Stock Option Plan or the 1997 Incentive Stock Option Plan
(together the "Plans").
We have examined and are familiar with originals or copies, certified
or otherwise identified to our satisfaction, of the Certificate of Incorporation
and By-Laws of the Company, as each is currently in effect, the Registration
Statement, the Plans, resolutions of the Board of Directors of the Company
relating to the adoption of the Plans and the proposed registration and issuance
of the Shares and such other corporate documents and records and other
certificates, and we have made such investigations of law as we have deemed
necessary or appropriate in order to render the opinions hereinafter set forth.
In our examination, we have assumed the genuineness of all signatures,
the legal capacity of all natural persons, the authenticity of all documents
submitted to us as originals, the conformity to original documents of all
documents submitted to us as certified or photostatic copies and the
authenticity of the originals of such latter documents. As to any facts material
to the opinions expressed herein which were not independently established or
verified, we have relied upon statements and representations of officers and
other representatives of the Company and others.
Based upon and subject to the foregoing, we are of the opinion that the
Shares to be issued upon exercise of any options duly granted pursuant to the
terms of the Plans have been duly and validly authorized and, when the Shares
have been paid for in accordance with the terms of the Plans and certificates
therefore have been duly executed and delivered, such Shares will be duly and
validly issued, fully paid and non-assessable.
We hereby consent to the filing of this opinion as an exhibit to the
Registration Statement and to the reference in the Registration Statement to
this firm under the heading "Interests of Named Experts and Counsel." In giving
this consent, we do not hereby admit that we are within the category of persons
whose consent is required under Section 7 of the Securities Act, or the rules
and regulations of the Securities and Exchange Commission thereunder.
<PAGE>
SBK Investment Partners, a partnership consisting of members of this
firm, owns 96,600 shares of Common Stock and holds a currently exercisable
option to purchase 32,628 shares of Common Stock at $3.22 per share. In
addition, certain members of this firm beneficially own Common Stock
individually.
Very truly yours,
/s/ Snow Becker Krauss P.C.
--------------------------------
SNOW BECKER KRAUSS P.C.
<PAGE>
EXHIBIT 23.2
CONSENT OF BDO SEIDMAN LLP
<PAGE>
Exhibit 23.2
Consent of Independent Public Accountants
Enamelon, Inc.
Yonkers, New York
We hereby consent to the incorporation by reference in the Prospectus
constituting a part of this Registration Statement of our report dated February
11, 1997, relating to the consolidated financial statements of Enamelon, Inc.
appearing in the Company's Annual Report on Form 10-KSB for the year ended
December 31, 1996, included in Enamelon, Inc.'s Form 10-KSB for the year ended
December 31, 1996, and to all references to our Firm included in this
Registration Statement.
We also consent to the reference to us under the caption "Experts" in
the Prospectus.
BDO SEIDMAN, LLP
New York, New York
February 13, 1998
