Filed
Pursuant to Rule 424(b)(3)
Registration
No. 333-152063
FINAL
PROSPECTUS
4,626,595 Shares
Common Stock
This prospectus relates solely to the resale or other
disposition of shares of common stock issued to the selling
stockholders named in this prospectus. On June 4, 2008,
Zila, Inc. (Zila) issued 4,626,595 shares of
its common stock, par value $0.001 per share (Common
Stock) to holders of its Amended and Restated Senior
Secured Convertible Notes (the Amended and Restated
Notes) to pay a $1,200,000 fee in connection with the
amendment of the terms of the Amended and Restated Notes. These
securities were issued in a private placement that was exempt
from registration under the Securities Act of 1933, as amended
(the Securities Act).
The selling stockholders may sell or otherwise dispose of the
shares from time to time through public or private transactions
or through other means described in the section entitled
Plan of Distribution, beginning on page 9.
These dispositions may be at fixed prices, at prevailing market
prices at the time of sale, at prices related to the prevailing
market price, at varying market prices determined at the time of
sale or at negotiated prices. We are not selling any securities
under this prospectus and will not receive any of the proceeds
from the sale of these shares by the selling stockholders. We
have agreed to pay all costs, expenses and fees relating to
registering such shares of our common stock referenced in this
prospectus. The selling stockholders will pay any brokerage
commissions
and/or
similar charges incurred for the sale of such shares of our
common stock.
Our common stock is quoted on the Nasdaq Global Market under the
symbol ZILA. The last reported sale price for our
common stock on June 27, 2008 was $0.25 per share.
Investment in our common stock involves a high degree of
risk. See the section entitled Risk Factors
beginning on page 2 of this prospectus for more information
regarding these risks.
Neither the Securities and Exchange Commission nor any state
securities commission has approved or disapproved of these
securities or determined if this prospectus is truthful or
complete. Any representation to the contrary is a criminal
offense.
The date of this prospectus is July 15, 2008.
TABLE OF
CONTENTS
|
|
|
|
|
|
|
Page
|
|
|
|
|
i
|
|
|
|
|
i
|
|
|
|
|
ii
|
|
|
|
|
iii
|
|
|
|
|
iii
|
|
|
|
|
1
|
|
|
|
|
2
|
|
|
|
|
8
|
|
|
|
|
8
|
|
|
|
|
9
|
|
|
|
|
11
|
|
|
|
|
11
|
|
ABOUT
THIS PROSPECTUS
You should rely only on the information contained or
incorporated by reference in this prospectus and on the
information contained in any prospectus supplements hereto. We
have not authorized anyone to provide you with additional or
different information. The selling stockholders are not offering
to sell, nor seeking offers to buy, shares of our common stock
in any jurisdiction where it is unlawful to do so. The
information in this prospectus, or any prospectus supplement, is
accurate only as of the date on the front of this document, or
on the prospectus supplement, as appropriate, and any
information we have incorporated by reference is accurate only
as of the date of the document incorporated by reference,
regardless of the time of delivery of this prospectus or of any
sale of our common stock.
Unless the context otherwise requires, references to
Zila, we, us,
our or the company in this prospectus
mean Zila, Inc., together with its wholly-owned direct
subsidiaries.
Zila and our logo, used alone and with the mark Zila, are our
registered service marks and trademarks.
WHERE YOU
CAN FIND MORE INFORMATION
We file reports, proxy statements and other documents with the
Securities and Exchange Commission (SEC). You may
read and copy any document we file at the SECs public
reference room at 100 F Street, N.E.,
Washington, D.C. 20549. You should call
1-800-SEC-0330
for more information on the public reference room. The SEC
maintains an Internet website at
http://www.sec.gov
that contains reports, proxy and information statements, and
other information regarding issuers that file electronically
with the SEC. Our SEC filings are also available to you on the
SECs Internet site, as well as on the Investor Relations
page of our Internet site, www.zila.com.
This prospectus is part of a registration statement that we
filed with the SEC. The registration statement contains more
information than this prospectus regarding us and our common
stock, including certain exhibits and schedules. You can obtain
a copy of the registration statement from the SEC at the address
listed above or from the SECs Internet site.
i
You may also request a copy of any of our filings with the SEC,
or any of the agreements or other documents that are exhibits to
those filings, at no cost, by writing,
e-mailing
or
telephoning us at the following address,
e-mail
address or phone number:
Zila,
Inc.
5227 North 7th Street
Phoenix, Arizona
85014-2800
investor@zila.com
(602) 266-6700
INCORPORATION
OF CERTAIN DOCUMENTS BY REFERENCE
We incorporate by reference in this prospectus certain
information we file with the SEC under Sections 13(a),
13(c), 14 or 15(d) of the Securities Exchange Act of 1934, as
amended (the Exchange Act), including (1) any
filings after the filing of this registration statement and
prior to the effectiveness of the registration statement and
(2) any filings after the date of this prospectus (which
does not include items furnished under Current
Reports on
Form 8-K
or otherwise), until all of the securities to which this
prospectus relates have been sold or this offering is otherwise
terminated. The information that we incorporate by reference is
an important part of this prospectus. Any statement in a
document incorporated by reference will be deemed to be modified
or superseded to the extent that a statement contained in
(1) this prospectus or (2) any other subsequently
filed document that is incorporated by reference into this
prospectus modifies or supersedes such statement.
We incorporate by reference into this prospectus the following
documents:
|
|
|
|
|
our Annual Report on
Form 10-K
for the fiscal year ended July 31, 2007, filed with the SEC
on October 15, 2007;
|
|
|
|
our Quarterly Reports on
Form 10-Q
for the quarters ended October 31, 2007, January 31,
2008, and April 30, 2008, filed with the SEC on
December 10, 2007, March 11, 2008, and June 9,
2008;
|
|
|
|
our Current Reports on
Form 8-K,
filed with the SEC on August 1, 2007, August 14, 2007,
August 22, 2007, August 31, 2007, October 3,
2007, October 29, 2007, November 9, 2007,
December 19, 2007, December 21, 2007, January 7,
2008, March 26, 2008, April 4, 2008, April 7,
2008, April 15, 2008, May 2, 2008, May 12, 2008,
June 6, 2008, June 12, 2008, and June 18, 2008;
|
|
|
|
our Definitive Proxy Statement on Schedule 14A, filed with
the SEC on November 9, 2007; and
|
|
|
|
the description of our Common Stock contained in our
Registration of Certain Classes of Securities on
Form 8-A,
dated March 1, 1989.
|
ii
FORWARD-LOOKING
STATEMENTS
This prospectus, including information incorporated into this
document by reference, contains forward-looking
statements within the meaning of Section 27A of the
Securities Act and Section 21E of the Exchange Act.
Statements that are not historical facts, including statements
about our beliefs or expectations, are forward-looking
statements, and are contained throughout this prospectus and in
the information incorporated into this prospectus by reference.
Forward-looking statements are identified by words such as
believe, anticipate, expect,
estimate, intend, plan,
project, will, may and
variations of such words and similar expressions. In addition,
any statements that refer to expectations, projections, plans,
objectives, goals, strategies or other characterizations of
future events or circumstances are forward-looking statements.
These forward-looking statements speak only as of the date
stated and we do not undertake any obligation to update or
revise publicly any forward-looking statements, whether as a
result of new information, future events or otherwise, even if
experience or future events make it clear that any expected
results expressed or implied by these forward-looking statements
will not be realized. Although we believe that the expectations
reflected in these forward-looking statements are reasonable,
these expectations may not prove to be correct or we may not
achieve the financial results, savings or other benefits
anticipated in the forward-looking statements. These
forward-looking statements are necessarily estimates reflecting
the best judgment of our senior management and involve a number
of risks and uncertainties, some of which may be beyond our
control, that could cause actual results to differ materially
from those suggested by the forward-looking statements. Factors
that could cause actual results or conditions to differ from
those anticipated by these and other forward-looking statements
are described more fully in the section entitled Risk
Factors and in the reports we have filed with the SEC
under Sections 13(a), 13(c), 14 or 15(d) of the Exchange
Act. Our business, financial condition or results of operations
could also be adversely affected by other factors besides those
listed here. However, these are the risks our management
currently believes are material.
You should carefully consider the trends, risks and
uncertainties described in the section entitled Risk
Factors of this prospectus and other information in this
prospectus or reports filed with the SEC before making any
investment decision with respect to the securities. If any of
the trends, risks or uncertainties set forth in the section
entitled Risk Factors and in our reports we have
filed with the SEC under Sections 13(a), 13(c), 14 or 15(d)
of the Exchange Act actually occurs or continues, our business,
financial condition or operating results could be materially
adversely affected. All forward-looking statements attributable
to us or persons acting on our behalf are expressly qualified in
their entirety by this cautionary statement.
PRINCIPAL
EXECUTIVE OFFICE
Our headquarters are located at 5227 North 7th Street,
Phoenix, Arizona 85014, and our telephone number is
(602) 266-6700.
iii
PROSPECTUS
SUMMARY
The following summary includes basic information about our
company and this offering. Because it is a summary, it does not
contain all of the information that you should consider before
investing in our common stock. For a more comprehensive
understanding of our company and the shares of our common stock
covered by this prospectus, you should read this entire
prospectus carefully, including the risks of investing discussed
under the section entitled Risk Factors and the
information that we have incorporated by reference into this
prospectus.
Zila,
Inc.
Zila, Inc., a Delaware corporation that is headquartered in
Phoenix, Arizona, is an integrated oral diagnostic company
dedicated to the prevention, detection and treatment of oral
cancer and periodontal disease. During fiscal 2007, Zila
successfully completed a multi-step strategic redirection, which
included divesting non-core businesses and acquiring the
national dental products company, Professional Dental
Technologies, Inc. (Pro-Dentec).
Zila manufactures and markets
ViziLite
®
Plus with TBlueTM
(ViziLite
®
Plus), its flagship product for the early detection of
oral abnormalities that could lead to cancer.
ViziLite
®
Plus is an adjunctive medical device cleared by the FDA for use
in a population at increased risk for oral cancer. In addition,
Zila designs, manufactures and markets a suite of proprietary
products sold exclusively and directly to dental professionals
for periodontal disease, including the
Rotadent
®
Professional Powered Brush, the Pro-Select
Platinum
®
ultrasonic scaler and a portfolio of oral pharmaceutical
products for both in-office and home-care use. All of
Zilas products are marketed and sold in the United States
and Canada primarily through the companys direct field
sales force and telemarketing organization. Zilas national
marketing programs reach most of the nations dental
offices and include continuing education seminars for dentists
and their staffs. The company is certified by the American
Dental Association and the Academy of General Dentistry to
provide continuing education seminars. In October 2006, Zila
divested its Nutraceuticals business unit and in May 2007 the
company divested its
Peridex
®
brand of prescription periodontal rinse. With the integration of
the operations of Pro-Dentec with the companys former Zila
Pharmaceuticals business unit and the re-alignment of the
companys Zila Biotechnology business unit to serve as its
research and development division, Zila has organized itself as
one operating segment in accordance with Statement of Financial
Accounting Standards (SFAS) No. 131,
Disclosures about Segments of an Enterprise and Related
Information.
The
Offering
|
|
|
Common Stock issued to the selling stockholders in connection
with the amendment of Zilas Amended and Restated Senior
Secured Convertible Notes
|
|
4,626,595 shares
|
|
Common Stock issued and outstanding (including the shares
covered by this Prospectus)
|
|
67,826,861 shares
|
|
Use of proceeds
|
|
Zila will not receive any proceeds from the sale of the shares
of common stock in this offering.
|
|
Nasdaq Global Market symbol
|
|
ZILA
|
1
RISK
FACTORS
You should consider carefully the risk factors described
below, and all other information contained in or incorporated by
reference in this prospectus, before deciding to invest in our
common stock. If any of the following risks actually occur, they
may materially harm our business, financial condition, operating
results or cash flow. As a result, the market price of our
common stock could decline, and you could lose all or part of
your investment. Additional risks and uncertainties that are not
yet identified or that we think are immaterial may also
materially harm our business, operating results or financial
condition and could result in a complete loss of your
investment.
Trends,
Risks and Uncertainties Related to Our Business
Our
lack of earnings history could adversely affect our financial
health and prevent us from fulfilling our payment obligations,
and if we are unable to generate funds or obtain funds on
acceptable terms, we may not be able to develop and market our
present and potential products.
Our liquidity needs have typically arisen from the funding of
our research and development program and the launch of our new
products, such as
ViziLite
®
Plus, working capital and debt service requirements, and future
strategic initiatives. In the past, we have met these cash
requirements through our cash and cash equivalents, cash from
operations and working capital management, the sale of non-core
assets, proceeds from the issuance of common stock under our
employee stock option and stock purchase programs, and proceeds
from certain private placements of our securities.
The development of products, such as
OraTest
®
,
requires the commitment of substantial resources to conduct the
time-consuming research and development, clinical studies and
regulatory activities necessary to bring any potential product
to market and to establish production, marketing and sales
capabilities. Our ability to develop our products, to service
our debt obligations, to fund working capital and capital
expenditures, and for other purposes that cannot at this time be
quantified will depend on our future operating performance,
which will be affected by factors discussed elsewhere and in the
reports we file with the SEC, including, without limitation,
receipt of regulatory approvals, economic conditions and
financial, business, and other factors, many of which are beyond
our control.
After an evaluation of our strategic direction, including an
assessment of the
OraTest
®
regulatory program, we believe that in order to maximize
shareholder value, our resources must be directed to those
products and programs with the greatest probability of financial
return. We believe that our greatest potential lies with our
ability to develop and commercialize our oral cancer screening
product,
ViziLite
®
Plus. Our analysis concluded that the incremental market
potential of
OraTest
®
,
considering the availability of
ViziLite
®
Plus, does not justify the cost, time and uncertain study
outcomes associated with continuing the program in its current
form.
We anticipate that we will be able to pursue our strategy with
our currently available funds through (i) the anticipated
growth in our commercial business; (ii) cost reductions in
research and development expenditures on the
OraTest
®
regulatory program; and (iii) reduced overhead from our
actions to reorganize and streamline our operations. We,
therefore, believe that our cash and cash equivalents along with
cash flows generated from operations and working capital
management will allow us to fund our planned operations over the
next 12 months. However, there can be no assurance that we
will be successful in executing these strategies. If we are
unable to execute these strategies, we may break the financial
covenants of our senior secured debt and be unable to repay the
outstanding balance of such debt.
In addition, our lack of earnings history and our level of debt
could have important consequences, such as:
|
|
|
|
|
making it more difficult for us to satisfy our obligations with
respect to our Second Amended and Restated Senior Secured
Convertible Notes;
|
|
|
|
increasing our vulnerability to general adverse economic and
industry conditions;
|
|
|
|
limiting our flexibility in planning for, or reacting to,
changes in our business and our industry;
|
|
|
|
restricting us from making strategic acquisitions, introducing
new products or exploiting business opportunities;
|
2
|
|
|
|
|
requiring us to dedicate a substantial portion of our cash flow
from operations to payments on our indebtedness, which will
reduce the amount of our cash flow available for other purposes,
including capital expenditures and other general corporate
purposes;
|
|
|
|
requiring us to sell debt securities or to sell some of our core
assets, possibly on unfavorable terms;
|
|
|
|
limiting our ability to obtain additional financing; and
|
|
|
|
placing us at a possible competitive disadvantage compared to
our competitors that may have greater financial resources.
|
Our
debt instruments contain restrictive covenants that could
adversely affect our business by limiting our
flexibility.
Our Second Amended and Restated Secured Notes impose
restrictions that affect, among other things, our ability to
incur debt, pay dividends, sell assets, create liens, make
capital expenditures and investments, merge or consolidate,
enter into transactions with affiliates, and otherwise enter
into certain transactions outside the ordinary course of
business. Our Second Amended and Restated Secured Notes also
require us to maintain defined levels of cash and generate at
least $1 of EBITDA, defined as earnings (loss) before interest,
taxes (benefit), depreciation and amortization for one quarter
ending on or before July 31, 2009. Our ability to comply
with these covenants and restrictions may be affected by events
beyond our control. If we are unable to comply with the terms of
our Second Amended and Restated Secured Notes, or if we fail to
generate sufficient cash flow from operations to service our
debt, we may default on our debt instruments. In the event of a
default under the terms of any of our indebtedness, the debt
holders may, under certain circumstances, accelerate the
maturity of our obligations and proceed against their collateral.
We may
fail to realize the anticipated cost savings, revenue
enhancements, product focus, or other benefits expected from our
recent acquisition of Pro-Dentec.
Our future growth will depend on our ability to implement our
business strategy. We believe that our acquisition of
Pro-Dentec, a privately-held dental products company, will
strengthen our business, including the development and
commercialization of our oral cancer screening products.
Further, we believe that this acquisition could increase our
ability to deliver our products into the dental marketplace and
could result in synergies that enhance our sales capability,
potentially reduce our costs and increase our profits. However,
successful acquisitions in our industry are difficult to
accomplish because they require, among other things, efficient
integration and aligning of product offerings and manufacturing
operations and coordination of sales and marketing and research
and development efforts. The difficulties of integration and
alignment may be increased by the necessity of coordinating
geographically separated organizations, the complexity of the
technologies being integrated and aligned and the necessity of
integrating personnel with disparate business backgrounds and
combining different corporate cultures. The integration and
alignment of operations following an acquisition or alliance
requires the dedication of management resources that may
distract attention from the day-to-day operations of the
business, and may disrupt key research and development,
marketing or sales efforts. In addition, there is no guarantee
that such acquisition will result in the synergies we
anticipate. Ultimately, the success of such acquisition depends
in part on the retention of key personnel. There can be no
assurance that we will be able to retain the acquired
companys key management, technical, sales and customer
support personnel. If we fail to retain such key employees, we
may not realize the anticipated benefits of such acquisition.
Historically
we have been dependent on a few key products and our future
growth is dependent on the growth of
ViziLite
®
Plus and on the development and/or acquisition of new
products.
In the past, nearly all of our revenues were derived from the
sales of
Ester-C
®
,
Peridex
®
and
ViziLite
®
Plus products. We divested our Nutraceuticals Business Unit and
the
Ester-C
®
products in October 2006 and
Peridex
®
in May 2007. With the acquisition and addition of the products
of Pro-Dentec, and the change in our distribution method for
ViziLite
®
Plus, we now sell direct to thousands of dental offices
nationally and we believe we have reduced our dependency on key
customers.
If any of our major products were to become subject to a problem
such as loss of patent protection, unexpected side effects,
regulatory proceedings, publicity adversely affecting user
confidence or pressure from competing
3
products, or if a new, more effective treatment should be
introduced, the impact on our revenues could be significant.
Additionally, we are reliant on third party manufacturers and
single suppliers for our
ViziLite
®
Plus product, and any supply problems resulting from regulatory
issues applicable to such parties or failures to comply with
FDAs current Good Manufacturing Practices could have a
material adverse impact on our financial condition.
Our future growth is dependent on the growth of the
ViziLite
®
Plus product and new product development
and/or
acquisition. New product initiatives may not be successfully
implemented because of many factors, including, but not limited
to, difficulty in assimilation, development costs and diversion
of management time. There can be no assurance that we will
successfully develop and integrate new products into our
business that will result in growth and a positive impact on our
business, financial condition and results of operation.
A number of factors could impact our plans to commercialize our
new products, including, but not limited to, difficulties in the
production process, controlling the costs to produce, market and
distribute the product on a commercial scale, and our ability to
do so with favorable gross margins and otherwise on a profitable
basis; the inherent difficulty of gaining market acceptance for
a new product; competition from larger, more established
companies with greater resources; changes in raw material
supplies that could result in production delays and higher raw
material costs; difficulties in promoting consumer awareness for
the new product; adverse publicity regarding the industries in
which we market our products; and the cost, timing, and ultimate
results of regulatory program studies that we undertake.
We may
be unable to obtain FDA or other regulatory approval for new
drugs, devices or products or to establish markets in the United
States and obtaining regulatory approval is costly and
uncertain.
The rigorous clinical testing and extensive regulatory approval
process mandated by the Food and Drug Administration
(FDA) and equivalent foreign authorities before any
new drug, device or product can be marketed can take a number of
years, require the expenditure of substantial resources, and
approval may not ultimately be obtained.
If FDA approval of a new product is received, such approval may
entail limitations on the indicated uses for which the product
may be marketed and there is no assurance that we will be
successful in gaining market acceptance of that product.
Moreover, a marketed product, its manufacturer, its
manufacturing facilities, and its suppliers are also subject to
continual review and periodic inspections, and later discovery
of previously unknown problems, or the exacerbation of problems
previously deemed acceptable, with a product, manufacturer, or
facility may result in restrictions on such product or
manufacturer, potentially including withdrawal of the product
from the market, which would adversely affect our operations and
financial condition. The length of the FDA regulatory process
and review period varies considerably, as does the amount of
data required to demonstrate the safety and efficacy of a
specific product. If the compounds in testing are modified or
optimized or if certain results are obtained, it may extend the
testing process. Additional testing, delays or rejections may be
encountered based upon changes in FDA policy, personal or prior
understandings during the period of product development and FDA
regulatory review of each investigational new drug application,
new drug application, or product license application. Similar
delays may also be encountered in other countries. There can be
no assurance that even after such time and expenditures we will
obtain regulatory approval for any products we develop.
In its regulation of advertising, the FDA from time to time
issues correspondence to pharmaceutical companies alleging that
some advertising or promotional practices are false, misleading
or deceptive. The FDA has the power to impose a wide array of
sanctions on companies for such advertising practices, and the
receipt of correspondence from the FDA alleging these practices
can result in the following:
|
|
|
|
|
incurring substantial expenses, including fines, penalties,
legal fees and costs to comply with the FDAs requirements
|
|
|
|
changes in the methods of marketing and selling products
|
|
|
|
taking FDA-mandated corrective action, which may include placing
advertisements or sending letters to dental professionals and
physicians rescinding previous advertisements or promotion
|
|
|
|
disruption in the distribution of products and loss of sales
until compliance with the FDAs position is obtained.
|
4
Our
proprietary rights may prove difficult to enforce.
Our current and future success depends on a combination of
patent, trademark, and trade secret protection and nondisclosure
and licensing agreements to establish and protect our
proprietary rights. We own and have exclusive licenses to a
number of United States and foreign patents and patent
applications and intend to seek additional patent applications
as we deem necessary and appropriate to operate our business. We
can offer no assurances regarding the strength of the patent
portfolio underlying any existing or new product
and/or
technology or whether patents will be issued from any pending
patent applications related to a new product
and/or
technology, or if the patents are issued, that any claims
allowed will be sufficiently broad to cover the product,
technology or production process. Although we intend to defend
our proprietary rights, policing unauthorized use of
intellectual property is difficult or may prove materially
costly and any patents that may be issued relating to new
products and technology may be challenged, invalidated or
circumvented.
We are
dependent on our senior management and other key
personnel.
Our ability to operate successfully depends in significant part
upon the experience, efforts, and abilities of our senior
management and other key scientific, technical and managerial
personnel. Competition for talented personnel is intense. The
future loss of services of one or more of our key executives
could adversely impact our financial performance and our ability
to execute our strategies. Additionally, if we are unable to
attract, train, motivate and retain key personnel, our business
could be harmed.
We and
our products are subject to regulatory oversight that could
substantially interfere with our ability to do
business.
We and our present and future products are subject to risks
associated with new federal, state, local, or foreign
legislation or regulation or adverse determinations by
regulators under existing regulations, including the
interpretation of and compliance with existing, proposed, and
future regulatory requirements imposed by the FDA. We are also
subject to other governmental authorities such as the Department
of Health and Human Services, the Consumer Products Safety
Commission, the Department of Justice and the United States
Federal Trade Commission with its regulatory authority over,
among other items, product safety and efficacy claims made in
product labeling and advertising. Individual states, acting
through their attorneys general, have become active as well,
seeking to regulate the marketing of prescription drugs under
state consumer protection and false advertising laws. A
regulatory determination or development that affects our ability
to market or produce one or more of our products could have a
material adverse impact on our business, results of operation,
and financial condition and may include product recalls, denial
of approvals and other civil and criminal sanctions.
We are
at risk with respect to product liability claims.
We could be exposed to possible claims for personal injury
resulting from allegedly defective products manufactured by
third parties with whom we have entered into manufacturing
agreements or by us. We maintain $6.0 million in product
liability insurance coverage for claims arising from the use of
our products, with limits we believe are commercially reasonable
under the circumstances, and, in most instances, require our
manufacturers to carry product liability insurance. While we
believe our insurance coverage is adequate, we could be subject
to product liability claims in excess of our insurance coverage.
In addition, we may be unable to retain our existing coverage in
the future. Any significant product liability claims not within
the scope of our insurance coverage could have a material
adverse effect on us.
We
face significant competition that could adversely affect our
results of operation and financial condition.
The pharmaceutical, medical device and related industries are
highly competitive. A number of companies, many of which have
financial resources, marketing capabilities, established
relationships, superior experience and operating history, and
research and development capacities greater than ours, are
actively engaged in the development of products similar to the
products we produce and market. The pharmaceutical industry is
characterized by extensive and ongoing research efforts. Other
companies may succeed in developing products superior to those
we market. It may be difficult for us to maintain or increase
sales volume and market share due to such
5
competition which would adversely affect our results of
operations and financial condition. The loss of any of our
products patent protection could lead to a significant
loss in sales of our products in the United States market.
If the
use of our technology is determined to infringe on the
intellectual property rights of others, our business could be
harmed.
Litigation may result from our use of registered trademarks or
common law marks and, if litigation against us were successful,
a resulting loss of the right to use a trademark could reduce
sales of our products and could result in a significant damage
award. International operations may be affected by changes in
intellectual property legal protections and remedies in foreign
countries in which we do business.
Furthermore, if it were ultimately determined that our
intellectual property rights are unenforceable, or that our use
of our technology infringes on the intellectual property rights
of others, we may be required or may desire to obtain licenses
to patents and other intellectual property held by third parties
to develop, manufacture and market products using our
technology. We may not be able to obtain these licenses on
commercially reasonable terms, if at all, and any licensed
patents or intellectual property that we may obtain may not be
valid or enforceable. In addition, the scope of intellectual
property protection is subject to scrutiny and challenge by
courts and other governmental bodies. Litigation and other
proceedings concerning patents and proprietary technologies can
be protracted, expensive and distracting to management and
companies may sue competitors as a way of delaying the
introduction of competitors products. Any litigation,
including any interference proceedings to determine priority of
inventions, oppositions to patents in foreign countries or
litigation against our partners, may be costly and
time-consuming and could significantly harm our business.
Because of the large number of patent filings in our industry,
our competitors may have filed applications or been issued
patents and may obtain additional patents and proprietary
intellectual property rights relating to products or processes
competitive with or similar to ours. We cannot be certain that
United States or foreign patents do not exist or will not be
issued that would harm our ability to commercialize our products
and product candidates. In addition, our exposure to risks
associated with the use of intellectual property may be
increased as a result of an acquisition as we have lower
visibility into any potential targets safeguards and
infringement risks. In addition, third party claims may be
asserted after we have acquired technology that had not been
asserted prior to such acquisition.
We
require certain raw materials for our manufacturing processes
that may only be acquired through limited sources.
Raw materials essential to our business are generally readily
available. However, certain raw materials and components used in
the manufacture of pharmaceutical and medical device products
are available from limited sources, and in some cases, a single
source. Any curtailment in the availability of such raw
materials could be accompanied by production delays, and in the
case of products, for which only one raw material supplier
exists, could result in a material loss of sales. In addition,
because raw material sources for products must generally be
approved by regulatory authorities, changes in raw material
suppliers could result in production delays, higher raw material
costs and loss of sales and customers. Production delays may
also be caused by the lack of secondary suppliers.
We
have, in the past, received minor deficiencies from regulatory
agencies related to our manufacturing facilities.
The FDA, Occupational Safety and Health Administration (OSHA)
and other regulatory agencies periodically inspect our
manufacturing facilities and certain facilities of our
suppliers. In the past, such inspections resulted in the
identification of certain minor deficiencies in the standards we
are required to maintain by such regulatory agencies. We
developed and implemented action plans to remedy the
deficiencies; however, there can be no assurance that such
deficiencies will be remedied to the satisfaction of the
applicable regulatory body. In the event that we are unable to
remedy such deficiencies, our product supply could be affected
as a result of plant shutdown, product recall or other similar
regulatory actions, which would likely have an adverse affect on
our business, financial condition, and results of operation.
6
Trends,
Risks and Uncertainties Related to Our Capital Stock
The
Private Placements and other financing arrangements or corporate
events could significantly dilute existing
ownership.
Following the August 13, 2007 and June 3, 2008
restructurings of the securities issued in the private
placements that the company consummated in November 2006, an
additional approximately 13,950,000 shares of our common
stock would be issued should investors convert all Second
Amended and Restated Secured Notes and exercise all warrants
issued in connection with the private placements, which would
dilute existing shareholders current ownership percentages and
voting power. If we choose to raise additional funds through the
issuance of shares of our common stock, or securities
convertible into our common stock, significant dilution of
ownership in our company may occur, and holders of such
securities may have rights senior to those of the holders of our
common stock. If we obtain additional financing by issuing debt
securities, the terms of these securities could restrict or
prevent us from paying dividends and could limit our flexibility
in making business decisions. Moreover, other corporate events
such as the exercise of outstanding options would result in
further dilution of ownership for existing shareholders.
In the
past, we have experienced volatility in the market price of our
common stock and we may experience such volatility in the
future.
The market price of our common stock has fluctuated
significantly in the past. Stock markets have experienced
extreme price volatility in recent years. This volatility has
had a substantial effect on the market prices of securities we
and other pharmaceutical and health care companies have issued,
often for reasons unrelated to the operating performance of the
specific companies.
In the past, stockholders of other companies have initiated
securities class action litigation against such companies
following periods of volatility in the market price of the
applicable common stock. We anticipate that the market price of
our common stock may continue to be volatile. If the market
price of our common stock continues to fluctuate and our
stockholders initiate this type of litigation, we could incur
substantial costs and expenses and such litigation could divert
our managements attention and resources, regardless of the
outcome, thereby adversely affecting our business, financial
condition and results of operation.
We may
take actions which could dilute current equity ownership or
prevent or delay a change in our control.
In December 2006, our Board of Directors and stockholders
approved an increase in our authorized capital stock from
67,500,000 to 150,000,000 and an increase in authorized common
stock from 65,000,000 to 147,500,000. Some of these newly
authorized shares are reserved for issuance upon the exercise or
conversion of certain securities issued in the November 2006
private placements. Subject to the rules and regulations
promulgated by Nasdaq and the SEC, our Board of Directors could
authorize the sale and issuance of additional shares of common
stock, which would have the effect of diluting the ownership
interests of our stockholders.
In addition, our Board of Directors has the authority, without
any further vote by our stockholders, to issue up to
2,500,000 shares of Preferred Stock in one or more series
and to determine the designations, powers, preferences and
relative, participating, optional or other rights thereof,
including without limitation, the dividend rate (and whether
dividends are cumulative), conversion rights, voting rights,
rights and terms of redemption, redemption price and liquidation
preference. On February 1, 2001, we issued
100,000 shares of our Series B Convertible Preferred
Stock in connection with an acquisition. As of July 31,
2007 and the date of this filing, all of these shares remained
outstanding. If the Board of Directors authorizes the issuance
of additional shares of Preferred Stock, such an issuance could
have the effect of diluting the ownership interests of our
common stockholders.
Failure
to maintain NASDAQ Marketplace Rules could materially and
adversely affect our business.
On March 20, 2008, Zila received a Nasdaq Staff Deficiency
Letter indicating that for the prior 30 consecutive business
days, the bid price of its common stock has closed below $1.00
per share. As a result, the company fails to comply with the
minimum bid price requirement for continued listing set forth in
Marketplace Rule 4450(a)(5). In
7
accordance with Marketplace Rule 4450(e)(2), the company
has been provided 180 calendar days, or until September 16,
2008, to regain compliance. Zila will achieve compliance, if
before September 16, 2008, the bid price of the
companys common stock closes at $1.00 per share or more
for a minimum of 10 consecutive business days. If the company
does not regain compliance by September 16, 2008, but can
demonstrate as of that date that the company meets the criteria
for initial listing set forth in Marketplace Rule 4310(c)
(other than the bid price requirement) and its application is
approved, the company will have an additional 180 days to
regain compliance while on The Nasdaq Capital Market. In the
event that we were delisted from the NASDAQ Global Market, our
common stock would become significantly less liquid, which would
adversely affect its value. Although our common stock would
likely be traded over-the-counter or on pink sheets, these types
of listings involve more risk and trade less frequently and in
smaller volumes than securities traded on the NASDAQ Global
Market.
In addition, our Audit Committee is currently only comprised of
two directors. In accordance with NASDAQ Marketplace
Rule 4350(d), we are required to have an audit committee
consisting of at least three independent directors in order to
remain listed on the NASDAQ Global Market. We have until the
earlier of our next annual shareholders meeting or one year from
the vacancy that caused the failure to comply with this
requirement to regain compliance with NASDAQs rule on
audit committee composition.
USE OF
PROCEEDS
We are registering these shares pursuant to the registration
rights granted to the selling stockholders. We are not selling
any securities under this prospectus and will not receive any of
the proceeds from the sale or other disposition of these shares
by the selling stockholders. We have agreed to pay all costs,
expenses and fees relating to registering such shares of our
common stock referenced in this prospectus. The selling
stockholders will pay any brokerage commissions
and/or
similar charges incurred for the sale of such shares of our
common stock.
SELLING
STOCKHOLDERS
This prospectus relates to the possible resale or other
disposition by the selling stockholders of 4,626,595 shares
of Common Stock that we issued on June 4, 2008 to pay a
$1,200,000 fee in connection with the amendment of the terms of
our Amended and Restated Secured Notes. On June 3, 2008, we
entered into a registration rights agreement with the selling
stockholders, which obligates us to register the shares of
Common Stock that we issued to pay the amendment fee.
The following table presents information regarding the selling
stockholders and the shares that they may offer and sell from
time to time under this prospectus. This table is prepared based
on information supplied to us by the selling stockholders, and
reflects holdings as of June 5, 2008. As used in this
prospectus, the term selling stockholders includes
the entities listed below and any donees, pledges, transferees
or other successors in interest selling shares received after
the date of this prospectus from any of the selling stockholders
as a gift, pledge or other transfer. Except as set forth in the
footnotes below, beneficial ownership is determined in
accordance with
Rule 13d-3(d)
promulgated by the SEC under the Exchange Act.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares of Common Stock
|
|
|
|
|
|
Shares of Common Stock
|
|
|
|
Beneficially Owned
|
|
|
Number of
|
|
|
Beneficially Owned
|
|
|
|
Prior to Offering
|
|
|
Shares being
|
|
|
after Offering
|
|
Security Holders
|
|
Number(1)
|
|
|
Percent(2)
|
|
|
Offered
|
|
|
Number(3)
|
|
|
Percent(3)
|
|
|
Atlas Master Fund, Ltd.
(c/o BAM)(4)
|
|
|
3,326,711
|
|
|
|
4.76
|
%
|
|
|
771,099
|
|
|
|
2,555,612
|
|
|
|
3.66
|
%
|
Atlas Master Fund, Ltd.
(c/o Visium)(5)
|
|
|
492,258
|
|
|
|
*
|
|
|
|
233,880
|
|
|
|
258,378
|
|
|
|
*
|
|
Visium Balanced Fund, LP(5)
|
|
|
1,841,046
|
|
|
|
2.68
|
%
|
|
|
874,707
|
|
|
|
966,339
|
|
|
|
1.41
|
%
|
Visium Balanced Offshore Fund, Ltd(5)
|
|
|
3,065,788
|
|
|
|
4.44
|
%
|
|
|
1,456,599
|
|
|
|
1,609,189
|
|
|
|
2.33
|
%
|
Visium Long Bias Fund, LP(5)
|
|
|
567,078
|
|
|
|
*
|
|
|
|
269,427
|
|
|
|
297,651
|
|
|
|
*
|
|
Visium Long Bias Offshore Fund, Ltd(5)
|
|
|
2,148,709
|
|
|
|
3.13
|
%
|
|
|
1,020,883
|
|
|
|
1,127,826
|
|
|
|
1.64
|
%
|
8
|
|
|
*
|
|
Less than one percent.
|
|
(1)
|
|
Represents all of the shares owned by the selling stockholder as
of June 5, 2008, including those issuable upon the exercise
of any warrants and/or the conversion of any convertible
securities owned by the selling stockholder. The number of
shares beneficially owned by the selling stockholder may
increase as a result of accrued dividends or anti-dilution
adjustments.
|
|
(2)
|
|
The percentage of shares beneficially owned prior to the
offering is based on 67,826,861 shares of our common stock
outstanding as of June 5, 2008. Shares of common stock
subject to options or warrants currently exercisable or
exercisable within 60 days of the date of this prospectus,
and shares of common stock subject to convertible securities
currently convertible or convertible within 60 days of the
date of this prospectus, are deemed outstanding for computing
the percentage of the person holding such options, warrants or
convertible securities, but are not deemed outstanding for
computing the percentage for any other selling stockholder.
|
|
(3)
|
|
The number of shares and percentage of ownership in these
columns assumes that the selling stockholders will offer and
sell all of the shares of common stock registered under this
prospectus. The selling stockholders may elect to sell some, all
or none of their shares. We do not know how long the selling
stockholders will hold the shares before selling them. Other
than an agreement by the selling stockholders that they will
retain at least one-half of the shares registered hereunder
until at least September 1, 2008, we currently have no
agreements, arrangements or understandings with the selling
stockholders regarding the sale of any of the shares. Shares of
common stock subject to options or warrants currently
exercisable or exercisable within 60 days of the date of
this prospectus, and shares of common stock subject to
convertible securities currently convertible or convertible
within 60 days of the date of this prospectus, are deemed
outstanding for computing the percentage of the person holding
such options, warrants or convertible securities, but are not
deemed outstanding for computing the percentage for any other
selling stockholder.
|
|
(4)
|
|
Dmitry Balyasny, as Managing Member of Balyasny Asset
Management, L.P. (BAM), has voting and dispositive
power with respect to the shares of this selling stockholder
that are registered under this prospectus. Mr. Balyasny
disclaims beneficial ownership of any such shares.
|
|
(5)
|
|
Jacob Gottlieb as Managing Member of Visium Asset Management,
LLC (Visium), the investment advisor to the selling
stockholder and Dmitry Balyasny as Managing Member of BAM, the
investment sub-advisor to Visium, have voting and dispositive
power with respect to the shares of this selling stockholder
that are registered under this prospectus. Both
Messrs. Gottlieb and Balyasny disclaim beneficial ownership
of any such shares.
|
PLAN OF
DISTRIBUTION
The selling stockholders, which as used herein includes donees,
pledgees, transferees or other
successors-in-interest
selling shares of common stock or interests in shares of common
stock received after the date of this prospectus from a selling
stockholder as a gift, pledge, partnership distribution or other
transfer, may, from time to time, sell, transfer or otherwise
dispose of any or all of their shares of common stock or
interests in shares of common stock on any stock exchange,
market or trading facility on which the shares are traded or in
private transactions. These dispositions may be at fixed prices,
at prevailing market prices at the time of sale, at prices
related to the prevailing market price, at varying prices
determined at the time of sale, or at negotiated prices.
The selling stockholders may use any one or more of the
following methods when disposing of shares or interests therein:
|
|
|
|
|
ordinary brokerage transactions and transactions in which the
broker-dealer solicits purchasers;
|
|
|
|
block trades in which the broker-dealer will attempt to sell the
shares as agent, but may position and resell a portion of the
block as principal to facilitate the transaction;
|
|
|
|
purchases by a broker-dealer as principal and resale by the
broker-dealer for its account;
|
|
|
|
an exchange distribution in accordance with the rules of the
applicable exchange;
|
|
|
|
privately negotiated transactions;
|
9
|
|
|
|
|
short sales effected after the date the registration statement
of which this Prospectus is a part is declared effective by the
SEC;
|
|
|
|
through the writing or settlement of options or other hedging
transactions, whether through an options exchange or otherwise;
|
|
|
|
broker-dealers may agree with the selling stockholders to sell a
specified number of such shares at a stipulated price per share;
|
|
|
|
a combination of any such methods of sale; and
|
|
|
|
any other method permitted by applicable law.
|
The selling stockholders may, from time to time, pledge or grant
a security interest in some or all of the shares of common stock
owned by them and, if they default in the performance of their
secured obligations, the pledgees or secured parties may offer
and sell the shares of common stock, from time to time, under
this prospectus, or under an amendment to this prospectus under
Rule 424(b)(3) or other applicable provision of the
Securities Act amending the list of selling stockholders to
include the pledgee, transferee or other successors in interest
as selling stockholders under this prospectus. The selling
stockholders also may transfer the shares of common stock in
other circumstances, in which case the transferees, pledgees or
other successors in interest will be the selling beneficial
owners for purposes of this prospectus.
In connection with the sale of our common stock or interests
therein, the selling stockholders may enter into hedging
transactions with broker-dealers or other financial
institutions, which may in turn engage in short sales of the
common stock in the course of hedging the positions they assume.
The selling stockholders may also sell shares of our common
stock short and deliver these securities to close out their
short positions, or loan or pledge the common stock to
broker-dealers that in turn may sell these securities. The
selling stockholders may also enter into option or other
transactions with broker-dealers or other financial institutions
or the creation of one or more derivative securities which
require the delivery to such broker-dealer or other financial
institution of shares offered by this prospectus, which shares
such broker-dealer or other financial institution may resell
pursuant to this prospectus (as supplemented or amended to
reflect such transaction).
The aggregate proceeds to the selling stockholders from the sale
of the common stock offered by them will be the purchase price
of the common stock less discounts or commissions, if any. Each
of the selling stockholders reserves the right to accept and,
together with their agents from time to time, to reject, in
whole or in part, any proposed purchase of common stock to be
made directly or through agents. We will not receive any of the
proceeds from this offering.
The selling stockholders also may resell all or a portion of the
shares in open market transactions in reliance upon
Rule 144 under the Securities Act of 1933, provided that
they meet the criteria and conform to the requirements of that
rule.
The selling stockholders and any underwriters, broker-dealers or
agents that participate in the sale of the common stock or
interests therein may be underwriters within the
meaning of Section 2(11) of the Securities Act. Any
discounts, commissions, concessions or profit they earn on any
resale of the shares may be underwriting discounts and
commissions under the Securities Act. Selling stockholders who
are underwriters within the meaning of
Section 2(11) of the Securities Act will be subject to the
prospectus delivery requirements of the Securities Act.
To the extent required, the shares of our common stock to be
sold, the names of the selling stockholders, the respective
purchase prices and public offering prices, the names of any
agents, dealer or underwriter, any applicable commissions or
discounts with respect to a particular offer will be set forth
in an accompanying prospectus supplement or, if appropriate, a
post-effective amendment to the registration statement that
includes this prospectus.
In order to comply with the securities laws of some states, if
applicable, the common stock may be sold in these jurisdictions
only through registered or licensed brokers or dealers. In
addition, in some states the common stock may not be sold unless
it has been registered or qualified for sale or an exemption
from registration or qualification requirements is available and
is complied with.
10
We have advised the selling stockholders that the
anti-manipulation rules of Regulation M under the Exchange
Act may apply to sales of shares in the market and to the
activities of the selling stockholders and their affiliates. In
addition, to the extent applicable we will make copies of this
prospectus (as it may be supplemented or amended from time to
time) available to the selling stockholders for the purpose of
satisfying the prospectus delivery requirements of the
Securities Act. The selling stockholders may indemnify any
broker-dealer that participates in transactions involving the
sale of the shares against certain liabilities, including
liabilities arising under the Securities Act.
We have agreed to indemnify the selling stockholders against
liabilities, including liabilities under the Securities Act and
state securities laws, relating to the registration of the
shares offered by this prospectus.
We have agreed with the selling stockholders to keep the
registration statement of which this prospectus constitutes a
part effective until the earlier of (1) such time as all of
the shares covered by this prospectus have been disposed of
pursuant to and in accordance with the registration statement or
(2) the date on which the shares may be sold without
restriction pursuant to Rule 144 of the Securities Act.
LEGAL
MATTERS
The validity of the securities being offered by this prospectus
will be passed upon for us by Snell & Wilmer L.L.P.,
of Phoenix, Arizona.
EXPERTS
The financial statements and schedules as of July 31, 2007
and 2006 and for each of the three years in the period ended
July 31, 2007 and managements assessment of the
effectiveness of internal control over financial reporting as of
July 31, 2007 incorporated by reference in this Prospectus
have been so incorporated in reliance on the reports of BDO
Seidman, LLP, an independent registered public accounting firm,
incorporated herein by reference, given on the authority of said
firm as experts in auditing and accounting.
11
Zila (NASDAQ:ZILA)
Historical Stock Chart
From May 2024 to Jun 2024
Zila (NASDAQ:ZILA)
Historical Stock Chart
From Jun 2023 to Jun 2024