Registration No. 333-176951
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Amendment No. 1 to
Form S-1
REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933
BIOZONE PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
Nevada
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7389
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20-5978559
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(State or other jurisdiction
of incorporation or organization)
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(Primary Standard Industrial
Classification Code Number)
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(I.R.S. Employer
Identification Number)
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(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)
Elliot Maza
Chief Executive Officer
550 Sylvan Avenue
Suite 101
Englewood Cliffs, NJ 07632
(201) 608-5101
(Name, address, including zip code, and telephone number, including area code, of agent for service)
Copies to:
Harvey J. Kesner, Esq.
61 Broadway, 32nd Floor
New York, New York 10006
Telephone: (212) 930-9700
Approximate date of commencement of proposed sale to the public: As soon as practicable after the effective date of this registration statement.
If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box. x
If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act of 1933 registration statement number of the earlier effective registration statement for the same offering. o
If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. o
If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. o
Indicate by a check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check One):
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Large Accelerated Filer o
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Accelerated Filer o
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Non-Accelerated Filer o (Do not check if a smaller reporting company)
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Smaller Reporting Company þ
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CALCULATION OF REGISTRATION FEE
Title of Each Class of
Securities to be Registered
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Amount to be Registered (1)
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Proposed Maximum
Offering Price per Share
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Proposed Maximum
Aggregate Offering Price
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Amount of
Registration Fee
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Common stock, par value $.001 per share
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8,345,310
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$3.90
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$32,546,709
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$3,729.85*
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Total
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8,345,310
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(1)
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Pursuant to Rule 416 under the Securities Act, the shares of Common stock offered hereby also include an indeterminate number of additional shares of Common stock as may from time to time become issuable by reason of stock splits, stock dividends, recapitalizations or other similar transactions.
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(2)
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With respect to the shares of Common stock offered by the selling stockholder named herein, estimated at $3.90 per share, the average of the high and low prices of the Common stock as reported on the OTC Bulletin Board on October 27, 2011, for the purpose of calculating the registration fee in accordance with Rule 457(c) under the Securities Act.
*Previously paid.
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THE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR DATES AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT SHALL FILE A FURTHER AMENDMENT WHICH SPECIFICALLY STATES THAT THIS REGISTRATION STATEMENT SHALL THEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH SECTION 8(a) OF THE SECURITIES ACT OF 1933 OR UNTIL THE REGISTRATION STATEMENT SHALL BECOME EFFECTIVE ON SUCH DATE AS THE COMMISSION, ACTING PURSUANT TO SAID SECTION 8(a), MAY DETERMINE.
The information in this prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell these securities and we are not soliciting an offer to buy these securities in any state where the offer or sale is not permitted.
SUBJECT TO COMPLETION, DATED DECEMBER 19, 2011
PRELIMINARY PROSPECTUS
8,345,310 Shares
BIOZONE PHARMACEUTICALS, INC.
Common Stock
This prospectus relates to the sale by the selling stockholder identified in this prospectus of up to 8,345,310 shares of our Common stock. All of these shares of our Common stock are being offered for resale by the selling stockholder.
The prices at which the selling stockholder may sell shares will be determined by the prevailing market price for the shares or in negotiated transactions. We will not receive any proceeds from the sale of these shares by the selling stockholder.
We will bear all costs relating to the registration of these shares of our Common stock, other than any selling stockholder’s legal or accounting costs or commissions.
Our Common stock is quoted on the Over-the-Counter Bulletin Board under the symbol “BZNE.OB”. The last reported sale price of our common stock as reported by the OTC Bulletin Board on October 27, 2011, was $3.90 per share.
Investing in our common stock is highly speculative and involves a high degree of risk. You should carefully consider the risks and uncertainties described under the heading “Risk Factors” beginning on page 4 of this prospectus before making a decision to purchase our Common stock.
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed upon the accuracy or adequacy of this prospectus. Any representation to the contrary is a criminal offense.
The date of this prospectus is _________, 2011
TABLE OF CONTENTS
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Page
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PROSPECTUS SUMMARY
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1 |
THE OFFERING
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SPECIAL NOTE REGARDING FORWARD LOOKING STATEMENTS
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4 |
RISK FACTORS
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USE OF PROCEEDS
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MARKET FOR OUR COMMON STOCK AND RELATED STOCKHOLDER MATTERS
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DIVIDEND POLICY
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MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
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BUSINESS
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MANAGEMENT
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EXECUTIVE OFFICERS AND DIRECTORS
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EXECUTIVE COMPENSATION
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CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
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SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
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SELLING STOCKHOLDER
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DESCRIPTION OF SECURITIES
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PLAN OF DISTRIBUTION
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LEGAL MATTERS
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EXPERTS
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WHERE YOU CAN FIND ADDITIONAL INFORMATION
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FINANCIAL STATEMENTS
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F-1 |
You should rely only on the information contained in this prospectus. We have not authorized any other person to provide you with different information. If anyone provides you with different or inconsistent information, you should not rely on it. We are not making an offer to sell these securities in any jurisdiction where an offer or sale is not permitted. You should assume that the information appearing in this prospectus is accurate only as of the date on the front cover of this prospectus. Our business, financial condition, results of operations and prospects may have changed since that date.
PROSPECTUS SUMMARY
The following summary highlights information contained elsewhere in this prospectus. This summary may not contain all of the information that may be important to you. You should read this entire prospectus carefully, including the sections entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our historical financial statements and related notes included elsewhere in this prospectus. In this prospectus, unless the context provides otherwise, the terms “the Company,” “we,” “us,” and “our” refer to Biozone Pharmaceuticals, Inc.
Overview
We are a manufacturer of pharmaceutical and cosmetic products. In addition, we are conducting research related to potential improvements in certain excipients commonly used in generic pharmaceutical products. We operate through BioZone Pharmaceuticals, Inc. (“BioZone Pharma”) and its four wholly owned subsidiaries: Biozone Laboratories, Inc. (“Biozone Labs”), Equalan LLC (“Equalan”), Equachem LLC (“Equachem”) and Baker Cummins Corp. (“Baker Cummins”).
Our core manufacturing business primarily consists of the development and manufacture of over-the-counter (OTC) pharmaceuticals, cosmetic and beauty products for third party contract manufacturing customers. We utilize certain proprietary drug delivery technology in the topical and liquid products that we manufacture for third parties, which we refer to as QuSomes®, LiquaVail®, HyperSorb® (and together with the EquaSomeTM technology, the “BioZone Technology”). We sell pharmaceutical ingredients containing QuSomes to various healthcare supply manufacturers. In addition, we manufacture and sell two proprietary brands of skin care products: Glyderm® and Baker Cummins®. Our research activity primarily consists of developing our EquaSomeTM drug delivery technology to enhance certain injectable generic pharmaceutical drug products. We do not rely on any third parties to manufacture our products. Our contract manufacturing customers are regional and national distributors and retailers of healthcare products. Our Glyderm and Baker Cummins customers are drug wholesalers, physicians who use and resell our products in their physician practices and customers who purchase our products over the internet.
The BioZone Technology was invented by Dr. Brian Keller, one of the co-founders of BioZone Labs. In the mid-1990s, BioZone Labs licensed a proprietary, patented, phospho lipid delivery technology for use in its contract manufacturing business. Subsequently, Dr. Keller modified the lipid to enhance final product stability, ingredient penetration, ease of manufacture process, and reduction in manufacturing and raw material costs. We obtained three U.S. patents covering the composition of matter of the enhanced lipid and method of manufacturing the resulting lipid vesicle. We modified the lipid through removal of phosphate and PEGylation, which is the process of covalent attachment of polyethylene glycol polymer chains to another molecule, normally a drug or therapeutic protein. We are in the early stages of directing our research and development efforts towards applying the EquaSomeTM Technology to drug molecules currently used in approved, generic prescription (Rx) drugs. In many cases, the benefits of such molecules are limited due to poor stability or bioavailability or variable absorption. In those cases, our technology may increase the benefit of the therapy by improving stability, bioavailability or absorption. The BioZone Technology can be applied to the injectable or oral route of administration as well other delivery pathways, such as topical, buccal, rectal, intra-vaginal or transdermal. The BioZone Technology utilizes a unique, proprietary lipid that spontaneously forms thermodynamically stable lipid vesicles (liposomes), which encapsulate the drug molecule with a membrane that enhances drug stability, bioavailability and absorption.
Our core business strategy for our manufacturing business is to leverage the BioZone Technology as a value added enhancement, which differentiates us from traditional contract manufacturing companies. Our core business strategy for our pharmaceuticals business, which currently is limited to research activity, is to exploit the EquaSomeTM Technology to develop and obtain Food and Drug Administration (“FDA”) approval for the marketing and sale of branded generic pharmaceutical products. As of the date of hereof, our pharmaceuticals business does not constitute a material part of our overall business.
We conduct our manufacturing business through BioZone Labs, our research activity through BioZone Pharma, our proprietary brand business through Equalan and Baker Cummins, and our pharmaceutical ingredient distribution business through Equachem. We have licensed the use of the BioZone Technology (excluding the EquaSomeTM Technology) to BetaZone Pharmaceuticals, LLC (“BetaZone), our 45% owned subsidiary, for application in certain products marketed and to be marketed in Mexico, Central America and South America, and for application in certain products marketed outside of countries in those regions.
Equalan markets the Glyderm brand of skin care products, which can be used to improve skin texture and tone.Baker Cummins markets the “P&S” line of scalp and skin care products, which can be used to treat dry commonly seen skin and scalp conditions. These products are sold OTC and include liquids and lotions.
Our History
We were incorporated under the laws of the State of Nevada on December 4, 2006. On March 1, 2011 we filed a Certificate of Amendment to our Articles of Incorporation in order to change our name to BioZone Pharmaceuticals, Inc. from International Surf Resorts, Inc. Prior to March 2011 we were generally seeking to engage in the business of operating an internet provider of international surf resorts, camps and guided surf tours. We anticipate discontinuing this prior business through the sale of our 55% ownership in ISR de Mexico, S. de R.L. de C.V., a Mexican corporation, in consideration for the return and cancellation of approximately 13,948,001 shares of the Company's common stock.
On May 16, 2011, we acquired the assets and assumed the liabilities of Aero Pharmaceuticals, Inc. (“Aero”) a Florida corporation, pursuant to an asset purchase agreement dated as of May 16, 2011 by and between the Company, Baker Cummins, and Aero. The asset purchase agreement constituted a plan of reorganization within the meaning of Treasury Regulations Section 1.368-2(g) and constituted a plan of liquidation of Aero. As a result of the asset purchase, we acquired the business of Aero consisting of the manufacturing, marketing and distribution of dermatological products under the trade name of Baker Cummins Dermatologicals. In exchange for the asset purchase we issued an aggregate of 8,331,396 shares of our restricted common stock to Aero, which are being registered hereunder. The transaction was intended to be tax-free for federal income tax purposes, as a “reorganization” within the meaning of Section 368(a) of the Internal Revenue Code of 1986, as amended (the “Code”), and the regulations promulgated thereunder. On September 21, 2011, we issued an additional 13,914 shares to Aero due to the late filing of this registration statement, which shares are also registered hereunder.
Under the asset purchase agreement with Aero we acquired the following products and brands, marketed under the Baker Cummins brand: P&S Liquid, P&S Shampoo, Ultra Mide 25 Lotion, Ultra Mide-D, X-Seb T Pearl Shampoo, X-Seb T Plus Shampoo, and Acquaderm Cream.
In the asset purchase agreement we purchased (i) all rights to manufacture, distribute, market and sell the Baker Cummins Assets, (ii) all trademarks, marketing materials, training materials, market data, clinical data, research data, regulatory data, adverse event data, trade dress information and product labeling data associated with the Baker Cummins assets, (iii) all outstanding customer purchase orders for the Baker Cummins assets, (iv) all contracts relating to the Baker Cummins Assets, (v) all of Aero’s existing inventory of the Baker Cummins Assets, (vi) all cash and cash equivalents, (vii) all accounts or notes receivable held by Aero, (viii) all furniture, fixtures, equipment and machinery, books and records related to the Baker Cummins assets, (ix) all technological, scientific, chemical, biological, pharmaceutical, toxicological, regulatory and clinical trial materials and information relating to the Baker Cummins Assets, and (x) all information owned or licensed by Aero relating to specifications and test methods, raw materials, packaging instructions, master formulas, validation reports, stability data, analytical methods, records of complaints, annual product reviews and other master documents necessary for the manufacture, control and release of the Baker Cummins Assets.
On June 30, 2011, we entered into stock purchase agreements with the shareholders of BioZone Labs pursuant to which we purchased 100% of the outstanding common stock of BioZone Labs. Also on that date, we entered into LLC Membership Interest Purchase Agreements with the members of Equalan and Equachem, pursuant to which we purchased 100% of the outstanding membership interests of Equalan and Equachem, and LLC Membership Interest Purchase Agreements with certain members of BetaZone pursuant to which we purchased 45% of the outstanding membership interests of BetaZone.
THE OFFERING
Common stock offered by selling stockholder:
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This prospectus relates to the sale by a single selling stockholder of 8,345,310 shares of our restricted common stock, issued pursuant to an Asset Purchase Agreement dated as of May 16, 2011 by and among the Company, Baker Cummins Corp. and Aero Pharmaceuticals, Inc.
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Offering price:
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Market price or privately negotiated prices.
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Common stock outstanding before and after the offering:
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68,110,810 (1)
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Use of proceeds:
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We will not receive any proceeds from the sale of the common stock by the selling stockholder.
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OTC Symbol:
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BZNE.OB
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Risk Factors:
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You should carefully consider the information set forth in this prospectus and, in particular, the specific factors set forth in the “Risk Factors” section beginning on page 4 of this prospectus before deciding whether or not to invest in our common stock
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(1)
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Represents the number of shares of our common stock issued and outstanding as of December 19, 2011.
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SPECIAL NOTE REGARDING FORWARD LOOKING STATEMENTS
This prospectus contains forward-looking statements. Such statements include statements regarding our expectations, hopes, beliefs or intentions regarding the future, including but not limited to statements regarding our market, strategy, competition, development plans (including acquisitions and expansion), financing, revenues, operations, and compliance with applicable laws. Forward-looking statements involve certain risks and uncertainties, and actual results may differ materially from those discussed in any such statement. Factors that could cause actual results to differ materially from such forward-looking statements include the risks described in greater detail in the following paragraphs. All forward-looking statements in this document are made as of the date hereof, based on information available to us as of the date hereof, and we assume no obligation to update any forward-looking statement. Market data used throughout this prospectus is based on published third party reports or the good faith estimates of management, which estimates are based upon their review of internal surveys, independent industry publications and other publicly available information. Although we believe that such sources are reliable, we do not guarantee the accuracy or completeness of this information, and we have not independently verified such information.
RISK FACTORS
Investing in our common stock involves a high degree of risk. Prospective investors should carefully consider the risks described below, together with all of the other information included or referred to in this prospectus, before purchasing shares of our common stock. There are numerous and varied risks as set forth below that may prevent us from achieving our goals. If any of these risks actually occur, our business, financial condition or results of operations may be materially adversely affected. In such case, the trading price of our common stock could decline and investors could lose all or part of their investment.
Risks related to our Company
We have not had profitable operations in recent periods, and we expect our financial losses to continue in the future.
We have recognized net losses for the years ended December 31, 2010 and 2009, respectively, and expect to incur a net loss for the year ended December 31, 2011. We intend to invest substantial amounts in research and development activities through the year ended December 31, 2014 to advance the development of our branded generic pharmaceutical product business. Therefore, we expect our lack of profitable operations to continue in the future.
We are reviewing our manufacturing cost structure to identify inefficiencies and opportunities for reductions and our sales programs to identify opportunities for increasing sales volume. Although we anticipate that these efforts will reduce or eliminate ongoing losses from our manufacturing business and allow us to continue manufacturing operations for the foreseeable future, there can be no assurance that our cost reduction and increased sales efforts will prove successful.
We have negative working capital and have sustained operating losses during the past several years.
As of September 30, 2011, we had negative working capital. We have sustained losses for the years ended December 31, 2010 and 2009. In addition, on August 15, 2011, the holder of BioZone Labs’ and Equalan’s notes payable declared the entire unpaid principal amount and accrued interest of these loans immediately due and payable. As of September 9, 2011, we had paid these loans in full, which reduced our cash balances by approximately $2.3 million. Notwithstanding our negative working capital, we expect that cash flow from manufacturing operations will enable us to continue operations with for the foreseeable future.
Even if we are successful in generating income from our manufacturing business to reduce our negative working capital balance, our pharmaceutical research activities will require substantial additional investment that we have not yet secured. Our failure to raise capital when needed would adversely affect our growth opportunities and investment in capital expenditures and could force us to discontinue our research activities. We believe that we will be able to continue operations with our current level of working capital through December 31, 2012.
We are in default on approximately $2.3 million of convertible promissory notes
As of October 29, 2011, we are in default with respect to secured convertible promissory notes with an aggregate principal balance of $2,250,000 and accrued interest of $131,918, due to the fact that we have not paid the amount due on maturity. The default is continuing as we are unable to pay the amounts due under such notes. We continue to attempt to restructure or extend the obligations due under these notes, however there can be no assurances that we will be able to reach terms acceptable to the holders of the notes. Holders of these notes could bring legal proceedings against us to recover the amounts due to them, and if they were successful in their respective proceedings, they could cause our assets to be sold to satisfy the amounts we owe them. Our inability to satisfy the promissory notes in default, or reach amendments or restructuring agreements acceptable to the holders, poses a risk to our shareholders that our operations may be materially and adversely affected if the note holders commence legal action against us to recover amounts due to them.
Our independent auditor has issued an audit opinion which includes a statement describing a substantial doubt whether we will continue as a going concern, which may have a detrimental effect on our ability to obtain additional financing.
The continuation of the Company as a going concern is dependent upon, among other things, the attainment of profitable operations and the ability of the Company to obtain necessary equity or debt financing. These factors, among others, raise substantial doubt regarding the Company’s ability to continue as a going concern. Accordingly, the audit report prepared by our independent registered public accounting firm relating to the consolidated financial statements for the years ended December 31, 2010 and 2009 for BioZone Labs, our largest subsidiary and major accounting survivor, includes an explanatory paragraph expressing substantial doubt about its ability to continue as a going concern. Our auditor’s going concern opinion may have a detrimental effect on our ability to obtain additional funding.
Risks related to our industry
We operate in a highly regulated industry. An inability to meet current or future regulatory requirements in the United States or foreign jurisdictions could have a material adverse effect on our business, financial position and operating results.
All facilities where Rx and OTC drugs are manufactured, tested, packaged, stored or distributed must comply with the FDA’s Current Good Manufacturing Processes (“cGMPs”). All of our drug products are manufactured, tested, packaged, stored and distributed according to cGMP regulations. The FDA performs periodic audits to ensure that our facilities remain in compliance with all appropriate regulations. Typically, after the FDA completes its inspection, it may or may not issue the Company a report on Form 483, containing the FDA’s observations of possible violations of cGMP. These violations can range from minor to severe in nature. The degree of severity of the violation is generally determined by the time necessary to remediate the cGMP violation, and any adverse consequences for the consumer of our drug products. If the deficiency observations are determined to be severe, the FDA may elect to issue a warning letter to us. FDA guidelines specify that a warning letter be issued only for violations of “regulatory significance” for which the failure to adequately and promptly achieve correction may be expected to result in further enforcement action. In addition to making its concerns public, the FDA could impose sanctions including, among others, fines, product recalls, total or partial suspension of production and/or distribution, suspension of the FDA’s review of product applications, injunctions and civil or criminal prosecution. These enforcement actions, if imposed, could have a material adverse effect on our operating results and financial condition. Under certain circumstances, the FDA also has the authority to revoke previously granted drug approvals. The FDA inspected our manufacturing facilities in January 2011 and again in November 2011. The inspections resulted in numerous observations on Form 483, which we are in the process of remediating. We responded to the FDA on December 8, 2011 with a written statement describing the remedial action taken. As of the date hereof, we have not received any additional correspondence from the FDA regarding these two inspections. We believe that the remedial actions we are taking adequately respond to the FDA’s observations on Form 483. However, the FDA may conclude that our actions are insufficient to meet regulatory standards. If compliance is deemed deficient in any significant way, it could have a material adverse effect on our business.
In addition to the FDA, several U.S. agencies regulate the manufacturing, processing, formulation, packaging, labeling, testing, storing, distribution, advertising and sale of our products. Various state and local agencies also regulate these activities. Should any of our third party pharmaceutical ingredient suppliers fail to adequately conform or comply with manufacturing, quality and testing guidelines and regulations, we could experience a significant adverse impact on our operating results.
Significant increases in the cost of raw materials used in our contract manufacturing business could adversely impact our profit margins and operating results.
Affordable high quality raw materials and packaging components are essential to our business due to the nature of the products we manufacture. Our contract manufacturing customers either supply us with the raw materials and packaging components necessary to manufacture their finished products or reimburse us for the cost of such materials and components. Moreover the raw materials and packaging components that we use are generally available from multiple suppliers and we have not experienced any problems with contaminated raw materials that would impact our business. However, a rapid increase in cost of raw materials from various factors, such as inflationary forces or scarcity, could have a material impact on our financial results if we are unable to pass on these increased costs to our customers.
We face significant competition.
The contract manufacturing business is highly competitive and price sensitive. We face competition from multiple competitors, some of whom are larger and more financially secure than we. They may reduce prices to an unacceptably low level for us in order to increase sales. Therefore, we can make no assurance that we will grow our contract manufacturing business or maintain our current level of sales in the future.
Our Glyderm and Baker Cummins lines of skin care products compete against other similar products marketed by companies much larger than we and who spend much more than us on consumer advertising. The skin care product business is highly promotion sensitive and we have a limited advertising budget. Therefore, we can make no assurance that we will grow sales of our proprietary skin care brands or maintain our current level of sales in the future.
If we fail to obtain, apply for, adequately prosecute to issuance, maintain, protect or enforce patents for our inventions and products, the value of our intellectual property rights and our ability to license, make, use or sell our products would materially diminish or could be eliminated entirely.
Our competitive position and future revenues, especially with regard to our strategy to leverage the BioZone Technology to increase sales, will depend in part on our ability to obtain and maintain patent protection for our inventions and products and for methods, processes and other technologies, as well as our ability to preserve our trade secrets, prevent third parties from infringing on our proprietary rights or invalidating our patents and operate without infringing the proprietary rights of third parties. The risks include the following:
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Some of our issued patents or any patents that are issued to us in the future may be determined to be invalid and/or unenforceable, or may offer inadequate protection against competitive products;
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If we have to defend the validity of our patents or any future patents or protect against third party infringements, the costs of such defense are likely to be substantial and we may not achieve a successful outcome;
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Others may obtain patents claiming aspects similar to those covered by our patents and patent applications, which could enable them to make and sell products similar to ours; and
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We may be estopped from claiming that one or more of our patents is infringed due to amendments to the claims and/or specification, or as a result of arguments that were made during prosecution of such patents in the United States Patent and Trademark Office, or by virtue of certain language in the patent application. The estoppel may result in claim limitation and/or surrender of certain subject matter to the public domain or the ability of competitors to design around our claims and/or avoid infringement of our patents. If our patents or those patents for which we have license rights become involved in litigation, a court could revoke the patents or limit the scope of coverage to which they are entitled.
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If we fail to obtain and maintain adequate patent protection and trade secret protection for our products, proprietary technologies and their uses, we could lose any competitive advantage and the competition we face could increase, thereby reducing our potential revenues and adversely affecting our ability to attain or maintain profitability.
A dispute concerning the infringement or misappropriation of our proprietary rights or the proprietary rights of others could be time consuming and costly and an unfavorable outcome could harm our business.
There is significant litigation in the biotechnology field regarding patents and other intellectual property rights. We may be exposed to future litigation by third parties based on claims that our products, technologies or activities infringe the intellectual property rights of others. Although we try to avoid infringement, and as of the date hereof, there are no claims against us alleging infringement, there is the risk that we will use a patented technology owned or licensed by another person or entity and/or be sued for infringement of a patent owned by a third party. Under current United States law, patent applications are confidential for 18 months following their priority filing date and may remain confidential beyond 18 months if no foreign counterparts are applied for in jurisdictions that publish patent applications. There are many patents relating to the use of lipids and liposomes. If our products or methods are found to infringe any patents, we may have to pay significant damages and royalties to the patent holder or be prevented from making, using, selling, offering for sale or importing such products or from practicing methods that employ such products.
In addition, we may need to resort to litigation to enforce our patents issued to us, protect our trade secrets or determine the scope and validity of third-party proprietary rights. Such litigation could be expensive and there is no assurance that we would be successful. From time to time, we may hire scientific personnel formerly employed by other companies involved in one or more fields similar to the fields in which we are working. Either these individuals or we may be subject to allegations of trade secret misappropriation or similar claims as a result of their prior affiliations. If we become involved in litigation, it could consume a substantial portion of our managerial and financial resources, regardless of whether we win or lose. As a result, we could be prevented from commercializing current or future products or methods.
Confidentiality agreements with employees and others may not adequately prevent disclosure of our trade secrets and other proprietary information and may not adequately protect our intellectual property.
Our success also depends upon the skills, knowledge and experience of our scientific and technical personnel, our consultants and advisors and contractors. We enter into confidentiality agreements with our employees, consultants, outside scientific collaborators, sponsored researchers and other advisors. These agreements generally require that the receiving party keep confidential and not disclose to third parties all confidential information developed by the receiving party or made known to the receiving party by us during the course of the receiving party’s relationship with us. These agreements also generally provide that inventions conceived by the receiving party in the course of rendering services to us will be our exclusive property. However, these agreements may be breached and may not effectively assign intellectual property rights to us. Our trade secrets also could be independently discovered by competitors, in which case we would not be able to prevent use of such trade secrets by our competitors. The enforcement of a claim alleging that a party illegally obtained and was using our trade secrets could be difficult, expensive and time consuming and the outcome would be unpredictable. In addition, courts outside the United States may be less willing to protect trade secrets. The failure to obtain or maintain meaningful trade secret protection could adversely affect our competitive position.
Risks related to management
We rely on key executive officers and consultants, and their knowledge of our business and technical expertise would be difficult to replace.
We are highly dependent on Elliot Maza, JD, CPA, our Chief Executive and Chief Financial Officer, Dr. Brian Keller, our President and Chief Scientific Officer, and Christian Oertle, our Chief Operating Officer. We do not have “key person” life insurance. The loss of Mr. Maza, Dr. Keller or Mr. Oertle may have an adverse effect on our manufacturing business. We have entered into three year employment contracts with Dr. Keller and Mr. Oertle. In addition, we have entered into a three year employment contract with Daniel Fisher, our Executive Vice President, Director and co-founder of BioZone Labs. Each of the employment agreements may be terminated by the Company at will, subject to an obligation to pay severance for six months at the then applicable monthly base salary. We are competing for employees against companies that are more established than we are, and have the ability to pay more cash compensation than we do. As of the date hereof, we have not experienced problems hiring employees in the recent past.
Because Elliot Maza, our Chief Executive Officer, Chief Financial Officer and Secretary, devotes only a portion of his business time to us, conflicts of interests may arise with respect to his other activities which could materially and adversely affect our Company.
Elliot Maza, our Chief Executive Officer, Chief Financial Officer and Secretary, does not work for us exclusively as he is also the Chief Financial Officer of Intellect Neurosciences, Inc., a biotechnology company focused on the development of therapeutics for Alzheimer’s disease. We do not consider Intellect Neurosciences, Inc. to be a competitor of the Company. It is possible that a conflict of interest may arise with respect to Mr. Maza’s other employment. Mr. Maza devotes approximately 30 hours per week to Company matters, compared to approximately 20 hours per week Mr. Maza devotes to Intellect Neurosciences, Inc. matters. We have not adopted any policies or procedures for the review and approval of any transactions that may cause a conflict of interest.
Our officers and directors hold a substantial number of shares of our common stock.
Our officers and, directors and their affiliates own or control an aggregate of 16,850,000 shares of the Company’s common stock, which represents approximately 24.73% of our issued and outstanding common stock as of December 16, 2011. Therefore, our officers and directors will be able to have substantial influence over any election of our directors and our operations. It should also be noted that for the most part, authorization to modify our Articles of Incorporation, as amended, requires only majority stockholder consent. This concentration of ownership could also have the effect of delaying or preventing a change in control. Additionally, potential conflicts of interest may arise between our officers and directors and our shareholders and our officers and directors may vote their shares in a way that our other shareholders do not approve.
Our obligations to indemnify our directors and officers may pose substantial risks to our financial condition.
We have obtained directors’ and officers’ liability insurance insuring our directors and officers against liability for acts or omissions in their capacities as directors or officers, subject to certain exclusions. Such insurance also insures us against losses which we may incur in indemnifying our officers and directors. In addition, we may enter into indemnification agreements with key officers and directors and such persons shall also have indemnification rights under applicable laws, and the Company’s Articles of Incorporation and Bylaws. Our obligations to indemnify our directors and officers may pose substantial risks to our financial condition, as we may not be able to maintain our insurance or, even if we are able to maintain our insurance, claims in excess of our insurance coverage could materially deplete our assets.
Risks related to our common stock
Shares of our stock suffer from low trading volume and wide fluctuations in market price.
Our common stock is currently quoted on the Over the Counter Bulletin Board trading system under the symbol BZNE.OB. An investment in our common stock currently is illiquid and subject to significant market volatility. This illiquidity and volatility may be caused by a variety of factors including low trading volume and market conditions.
In addition, the value of our common stock could be affected by actual or anticipated variations in our operating results; changes in the market valuations of other similarly situated companies serving similar markets; announcements by us or our competitors of significant acquisitions, strategic partnerships, collaborations, joint ventures or capital commitments; adoption of new accounting standards affecting our industry; additions or departures of key personnel; introduction of new products or services by us or our competitors; actual or expected sales of our common stock or other securities in the open market; conditions or trends in the market in which we operate; and other events or factors, many of which are beyond our control.
Stockholders may experience wide fluctuations in the market price of our securities. These fluctuations may have an extremely negative effect on the market price of our securities and may prevent a stockholder from obtaining a market price equal to the purchase price such stockholder paid when the stockholder attempts to sell our securities in the open market. In these situations, the stockholder may be required either to sell our securities at a market price which is lower than the purchase price the stockholder paid, or to hold our securities for a longer period of time than planned. An inactive market may also impair our ability to raise capital by selling shares of capital stock and may impair our ability to acquire other companies by using common stock as consideration or to recruit and retain managers with equity-based incentive plans.
We cannot assure you that our common stock will become listed on NYSE Amex Equities, Nasdaq or any other securities exchange.
We plan to seek listing of our common stock on NYSE Amex Equities or Nasdaq within the next three years. However, we do not currently meet the initial listing standards of those exchanges and there are no assurances that we will be able to meet the initial listing standards of either of those or any other stock exchange, or that we will be able to maintain a listing of our common stock on either of those or any other stock exchange. Currently, we fall below the bid price requirement of $4.00 per share for Nasdaq and do not currently meet the corporate governance standards of either Nasdaq or NYSE Amex Equities. Until our common stock is listed on NYSE Amex Equities or Nasdaq or another stock exchange, we expect that our common stock will continue to trade on the Over-The-Counter Bulletin Board, where an investor may find it difficult to dispose of our shares of common stock. We believe that we may seek listing on the NYSE Amex Equities or Nasdaq within the next three years.
We will incur significant costs as a result of being an operating public company.
As a public operating company, we will incur significant legal, accounting and other expenses not incurred by a private company. If our stock becomes listed on Nasdaq or another major exchange or if our total assets exceed $10 million at the end of any fiscal year, we will also incur additional compliance expenses. It may be time consuming, difficult and costly for us to develop and implement the additional internal controls, processes and reporting procedures required by the Sarbanes-Oxley Act of 2002, SEC proxy rules, other government regulations affecting public companies and/or stock exchange compliance requirements. As we currently do not have a large financial reporting, internal auditing and other finance staff, we may need to hire additional financial reporting, internal auditing and other finance staff in order to develop and implement appropriate additional internal controls, processes and reporting procedures. We anticipate expending approximately $100,000 in legal costs and $100,000 in accounting costs over the next 12 months as a result of our public company status.
Our common stock is subject to the “Penny Stock” rules of the SEC, which makes transactions in our stock cumbersome and may reduce the value of an investment in our stock.
Our common stock is considered a “Penny Stock”. The Securities and Exchange Commission has adopted Rule 15g-9 which generally defines "penny stock" to be any equity security that has a market price (as defined) less than $5.00 per share or an exercise price of less than $5.00 per share, subject to certain exceptions. Our securities are covered by the penny stock rules, which impose additional sales practice requirements on broker-dealers who sell to persons other than established customers and "accredited investors". The term "accredited investor" refers generally to institutions with assets in excess of $5,000,000 or individuals with a net worth in excess of $1,000,000 or annual income exceeding $200,000 or $300,000 jointly with their spouse. The penny stock rules require a broker-dealer, prior to a transaction in a penny stock not otherwise exempt from the rules, to deliver a standardized risk disclosure document in a form prepared by the SEC which provides information about penny stocks and the nature and level of risks in the penny stock market. The broker-dealer also must provide the customer with current bid and offer quotations for the penny stock, the compensation of the broker-dealer and its salesperson in the transaction and monthly account statements showing the market value of each penny stock held in the customer's account. The bid and offer quotations, and the broker-dealer and salesperson compensation information, must be given to the customer orally or in writing prior to effecting the transaction and must be given to the customer in writing before or with the customer's confirmation. In addition, the penny stock rules require that prior to a transaction in a penny stock not otherwise exempt from these rules; the broker-dealer must make a special written determination that the penny stock is a suitable investment for the purchaser and receive the purchaser's written agreement to the transaction. These disclosure requirements may have the effect of reducing the level of trading activity in the secondary market for the stock that is subject to these penny stock rules. Consequently, these penny stock rules may affect the ability of broker-dealers to trade our securities. We believe that the penny stock rules discourage investor interest in and limit the marketability of our common stock. The Financial Industry Regulatory Authority, or FINRA, has adopted sales practice requirements which may also limit a stockholder's ability to buy and sell our stock. In addition to the "penny stock" rules described above, FINRA has adopted rules that require that in recommending an investment to a customer, a broker-dealer must have reasonable grounds for believing that the investment is suitable for that customer. Prior to recommending speculative low priced securities to their non-institutional customers, broker-dealers must make reasonable efforts to obtain information about the customer's financial status, tax status, investment objectives and other information. Under interpretations of these rules, FINRA believes that there is a high probability that speculative low priced securities will not be suitable for at least some customers. FINRA requirements make it more difficult for broker-dealers to recommend that their customers buy our common stock, which may limit investors’ ability to buy and sell our stock and have an adverse effect on the market for our shares.
Our common stock may be affected by limited trading volume and price fluctuation which could adversely impact the value of our common stock.
There has been limited trading in our common stock and there can be no assurance that an active trading market in our common stock will either develop or be maintained. Our common stock has experienced, and is likely to experience in the future, significant price and volume fluctuations which could adversely affect the market price of our common stock without regard to our operating performance. In addition, we believe that factors such as quarterly fluctuations in our financial results and changes in the overall economy or the condition of the financial markets could cause the price of our common stock to fluctuate substantially. These fluctuations may also cause short sellers to periodically enter the market in the belief that we will have poor results in the future. We cannot predict the actions of market participants and, therefore, can offer no assurances that the market for our common stock will be stable or appreciate over time.
We have never paid nor do we expect in the near future to pay dividends.
We have never paid cash dividends on our capital stock and do not anticipate paying any cash dividends on our common stock for the foreseeable future. Investors should not rely on an investment in our Company if they require income generated from dividends paid on our capital stock. Any income derived from our common stock would only come from rise in the market price of our common stock, which is uncertain and unpredictable.
We and our security holders are not subject to some reporting requirements applicable to most public companies; therefore, investors may have less information on which to base an investment decision.
We do not have a class of securities registered under Section 12(b) or 12(g) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Therefore, we do not prepare proxy or information statements in accordance with Section 14(a) of the Exchange Act with respect to matters submitted to the vote of our security holders, including, but not limited to, an increase in our authorized capital stock or the adoption of stock option plans. Our officers, directors and beneficial owners of more than 10% of our common stock are not required to file statements of beneficial ownership on SEC Forms 3, 4 and 5 pursuant to Section 16 of the Exchange Act, which such forms would disclose the reporting person’s initial ownership interest in our Company and would be subsequently updated to disclose any additional transactions. Beneficial owners of more than 5% of our outstanding common stock are not required to file reports on SEC Schedules 13D or 13G. Therefore, investors in our securities will not have any such information available in making an investment decision.
Our business will require additional capital for continued growth, and our growth may be slowed if we do not have sufficient capital.
The continued growth and operation of our business will require additional funding for working capital. We may be unable to secure such funding when needed in adequate amounts or on acceptable terms, if at all. To execute our business strategy, we may issue additional equity securities in public or private offerings, potentially at a price lower than the market price at the time of such issuance. The issuances of additional securities in public and private offerings will dilute our current investors’ interest in the Company. Similarly, we may seek debt financing and may be forced to incur significant interest expense. The issuance of debt securities may provide such holders with rights superior to existing shareholders. If we cannot secure sufficient funding, we will be forced to forego strategic opportunities or delay, scale back or eliminate operations, acquisitions, and other investments.
Our ability to obtain needed financing may be impaired by such factors as the condition of the economy and capital markets, both generally and specifically in our industry, and the fact that we are not profitable, which could impact the availability or cost of future financings. If the amount of capital we are able to raise from financing activities, together with our revenues from operations, is not sufficient to satisfy our capital needs, even to the extent that we reduce our operations accordingly, we may be required to cease operations. As of the date of this amendment, we have not approached any new sources for additional funding and have not entered into negotiations for a transaction, other than those transactions that have already been disclosed in our filings with the SEC.
We lack proper internal controls and procedures.
We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our Exchange Act reports is recorded, processed, summarized, and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive, as appropriate, to allow timely decisions regarding required disclosure based on the definition of “disclosure controls and procedures” in Rule 13a-15(e). In designing and evaluating the disclosure controls and procedures, our management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
Management has identified certain material weaknesses relating to our internal controls and procedures. The reason for the ineffectiveness of our disclosure controls and procedures was the result of the lack of segregation of duties and responsibilities with respect to our cash control over the disbursements related thereto. The lack of segregation of duties resulted from our limited accounting staff.
We may fail to qualify for continued listing on the OTC Bulletin Board, which could make it more difficult for investors to sell their shares.
Our common stock is quoted on the Over the Counter Bulletin Board (“OTCBB”). There can be no assurance that quotation of our common stock will be sustained. In the event that our common stock fails to qualify for continued quotation, our common stock could thereafter only be quoted on the “pink sheets.” Under such circumstances, shareholders may find it more difficult to dispose of, or to obtain accurate quotations, for our common stock, and our common stock would become substantially less attractive to certain purchasers such as financial institutions, hedge funds and other similar investors.
Investor relations activities, nominal “float” and supply and demand factors may affect the price of our stock.
The Company expects to utilize various techniques such as non-deal road shows and investor relations campaigns in order to create investor awareness for the Company. These campaigns may include personal, video and telephone conferences with investors and prospective investors in which our business practices are described. The Company may provide compensation to investor relations firms and pay for newsletters, websites, mailings and email campaigns that are produced by third-parties based upon publicly-available information concerning the Company. The Company does not intend to review or approve the content of such analysts’ reports or other materials based upon analysts’ own research or methods. Investor relations firms should generally disclose when they are compensated for their efforts, but whether such disclosure is made or complete is not under our control. In addition, investors in the Company may, from time to time, also take steps to encourage investor awareness through similar activities that may be undertaken at the expense of the investors. Investor awareness activities may also be suspended or discontinued which may impact the trading market our common stock.
The SEC and FINRA enforce various statutes and regulations intended to prevent manipulative or deceptive devices in connection with the purchase or sale of any security and carefully scrutinize trading patterns and company news and other communications for false or misleading information, particularly in cases where the hallmarks of “pump and dump” activities may exist, such as rapid share price increases or decreases. We, and our shareholders may be subjected to enhanced regulatory scrutiny due to the small number of holders who initially will own the registered shares of our common stock publicly available for resale, and the limited trading markets in which such shares may be offered or sold which have often been associated with improper activities concerning penny-stocks, such as the OTC Bulletin Board or the OTCQB Marketplace (Pink OTC) or pink sheets. Until such time as our restricted shares are registered or available for resale under Rule 144, there will continue to be a small percentage of shares held by a small number of investors, many of whom acquired such shares in privately negotiated purchase and sale transactions, which will constitute the entire available trading market. The Supreme Court has stated that manipulative action is a term of art connoting intentional or willful conduct designed to deceive or defraud investors by controlling or artificially affecting the price of securities. Often times, manipulation is associated by regulators with forces that upset the supply and demand factors that would normally determine trading prices. Since a small percentage of the outstanding common stock of the Company will initially be available for trading, held by a small number of individuals or entities, the supply of our common stock for sale will be extremely limited for an indeterminate amount of time, which could result in higher bids, asks or sales prices than would otherwise exist. Securities regulators have often cited factors such as thinly-traded markets, small numbers of holders, and awareness campaigns as hallmarks of claims of price manipulation and other violations of law when combined with manipulative trading, such as wash sales, matched orders or other manipulative trading timed to coincide with false or touting press releases. There can be no assurance that the Company’s or third-parties’ activities, or the small number of potential sellers or small percentage of stock in the “float,” or determinations by purchasers or holders as to when or under what circumstances or at what prices they may be willing to buy or sell stock will not artificially impact (or would be claimed by regulators to have affected) the normal supply and demand factors that determine the price of the stock.
USE OF PROCEEDS
The selling stockholder will receive all of the proceeds from the sale of the shares offered by them under this prospectus. We will not receive any proceeds from the sale of the shares by the selling stockholder covered by this prospectus.
MARKET FOR OUR COMMON STOCK AND RELATED STOCKHOLDER MATTERS
Our common stock has been quoted on the OTC Bulletin Board under the symbol “BZNE.OB since March 7, 2011 and prior to that under the symbol “ISFR”. The following table sets forth the high and low prices as reported on the OTC Bulletin Board. The quotations reflect inter-dealer prices, without retail mark-up, mark-down or commission, and may not represent actual transactions. Prior to May 19, 2011, there was no active market for our common stock. As of December 19, 2011, there were approximately 86 holders of record of our common stock.
Period
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High
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Low
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May 19, 2011 through June 30, 2011
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$
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5.50
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$
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1.50
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July 1, 2011 through September 30, 2011
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$
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4.65
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$
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1.50
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October 1, 2011 through December 14, 2011
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$
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3.90
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$
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3.90
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The last reported sales price of our Common stock on the OTC Bulletin Board on October 27, 2011 was $3.90 per share.
We have not declared nor paid any cash dividend on our Common stock, and we currently intend to retain future earnings, if any, to finance the expansion of our business, and we do not expect to pay any cash dividends in the foreseeable future. The decision whether to pay cash dividends on our Common stock will be made by our board of directors, in their discretion, and will depend on our financial condition, results of operations, capital requirements and other factors that our board of directors considers significant.
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis should be read in conjunction with our consolidated financial statements and related notes appearing elsewhere in this prospectus. In addition to historical information, this discussion and analysis contains forward-looking statements that involve risks, uncertainties, and assumptions. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of certain factors, including but not limited to those set forth under “Risk Factors”.
The following discussion and analysis is provided to increase the understanding of, and should be read in conjunction with, our unaudited condensed consolidated financial statements and related notes included elsewhere in this registration statement. Historical results and percentage relationships among any amounts in these financial statements are not necessarily indicative of trends in operating results for any future period. This report contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. The statements, which are not historical facts contained in this registration statement, including this Management’s discussion and analysis of financial condition and results of operation, and notes to our unaudited condensed consolidated financial statements, particularly those that utilize terminology such as “may” “will,” “should,” “expects,” “anticipates,” “estimates,” “believes,” or “plans” or comparable terminology are forward-looking statements. Such statements are based on currently available operating, financial and competitive information, and are subject to various risks and uncertainties. Future events and our actual results may differ materially from the results reflected in these forward-looking statements. Factors that might cause such a difference include, but are not limited to, dependence on existing and future key strategic and strategic end-user customers, limited ability to establish new strategic relationships, ability to sustain and manage growth, variability of operating results, our expansion and development of new service lines, marketing and other business development initiatives, the commencement of new engagements, competition in the industry, general economic conditions, dependence on key personnel, the ability to attract, hire and retain personnel who possess the technical skills and experience necessary to meet the service requirements of our clients, the potential liability with respect to actions taken by our existing and past employees, risks associated with international sales, and other risks described herein and in our other filings with the Securities and Exchange Commission.
The safe harbor for forward-looking statements provided by Section 21E of the Securities Exchange Act of 1934 excludes issuers of “penny stock” (as defined under Rule 3a51-1 of the Securities Exchange Act of 1934). Our common stock currently falls within that definition.
All forward-looking statements in this document are based on information currently available to us as of the date of this registration statement, and we assume no obligation to update any forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results to differ materially from any future results, performance or achievements expressed or implied by such forward-looking statements.
Company Overview
Biozone Pharmaceuticals, Inc. (formerly, International Surf Resorts, Inc.) was incorporated under the laws of the State of Nevada on December 4, 2006 to operate as an internet-based provider of international surf resorts, camps and guided surf tours. The Company proposed to engage in the business of vacation real estate and rentals related to its surf business and it owns the website isurfresorts.com (the "Original Business"). During late February 2011, the Company began to explore alternatives to its original business plan. On February 22, 2011, the prior officers and directors resigned from their positions and the Company appointed a new President, Director, principal accounting officer and treasurer and began to pursue opportunities in medical and pharmaceutical technologies and products. On March 1, 2011, the Company changed its name to Biozone Pharmaceuticals, Inc. We anticipate discontinuing our Original Business through the sale of our 55% ownership in ISR de Mexico, S. de R.L. de C.V., a Mexican corporation in consideration for the return and cancellation of approximately 13,948,001 shares of the Company's common stock.
Since March 2011, the Company has been engaged primarily in seeking opportunities related to its intention to engage in medical and pharmaceutical businesses. On May 16, 2011, the Company acquired substantially all of the assets and assumed all of the liabilities of Aero Pharmaceuticals, Inc. pursuant to an Asset Purchase Agreement dated as of that date. Aero manufactures markets and distributes a line of dermatological products under the trade name of Baker Cummins Dermatologicals.
On June 30, 2011, we acquired the Biozone Labs Group which operates as a developer, manufacturer, and marketer of over-the-counter drugs and preparations, cosmetics, and nutritional supplements on behalf of health care product marketing companies and national retailers. In addition, we have been developing our proprietary drug delivery technology as an enhancement for approved, generic prescription drugs that are limited due to poor stability or bioavailability or variable absorption.
Reverse Merger
Pursuant to authoritative accounting guidance, we accounted for the purchase of the BioZone Labs Group as a “Reverse Merger”, with each of BioZone Labs, Equalan and Equachem, treated as the accounting survivor. Accordingly, we have set forth below Management’s Discussion and Analysis of Financial Condition and Results of Operations for each acquiring entity.
As disclosed in our quarterly report on Form 10-Q for the period ended September 30, 2011, our management has concluded that the Company’s disclosure controls and procedures were ineffective as of September 30, 2011 (as defined in Rule 13a-15(e) and 15d-15(e) of the Exchange Act). If we fail to establish and maintain an effective system of internal control, we may not be able to report our financial results accurately or prevent fraud. Any inability to report and file our financial results accurately and timely could harm our reputation and adversely impact the trading price of our common stock.
Results of Operations – On a consolidated basis giving effect to the June 30, 2011 acquisition of the BioZone Labs Group
Three Months Ended September 30, 2011 Compared to the Three Months Ended September 30, 2010:
Revenues. Revenue for the three months ended September 30, 2011 and 2010 was $3,930,503 and $4,515,222 respectively. The decrease in revenue of $584,719 or 12.9% primarily was attributable to delays in customer orders from decreased end-user demand.
Cost of Sales and Gross Profit. Cost of sales for the three months ended September 30, 2011 and 2010 was $2,144,952 and $2,400,005, respectively, resulting in gross profit of $1,785,551 and $2,115,217, respectively. The gross profit percentage for the three months ended September 30, 2011 and 2010 was 45% and 47%, respectively. The decrease in gross profit of $329,666 was primarily attributable to delays in customer orders from decreased end-user demand, while the resulting decrease in gross profit percentage primarily is attributable to increased raw material costs.
Operating Expenses. We had total operating expenses of $4,001,843 for the three months ended September 30, 2011 as compared to $1,826,952 for the three months ended September 30, 2010. The increase in operating expenses of $2,174,891 primarily is attributable to a non-cash payment in stock for strategic consulting services as well as an increase of amortization of deferred financing cost as well as small increases in various other expenses partially offset by a decrease in Research and Development expenses and commissions.
Interest Expense. We incurred interest and other expense of $283,411 for the three months ended September 30, 2011 as compared to $123,415 for the three months ended September 30, 2010. The increase in interest and other expense of $159,996 is primarily the result from an increase in total debt outstanding at an increased average interest rate.
Net Loss / Income. As a result of the foregoing, we realized a net loss of $2,499,903 for the three months ended September 30, 2011 as compared to net income of $256,850 for the three months ended September 30, 2010, an increase in net loss of $2,756,753.
Nine Months Ended September 30, 2011 Compared to the Nine Months Ended September 30, 2010:
Revenues. Revenue for the nine months ended September 30, 2011 and 2010 was $8,937,818 and $11,133,223, respectively. The decrease in revenue of $2,195,405 or 19.7% is primarily was attributable to delays in customer orders from decreased end-user demand.
Cost of Sales and Gross Profit. Cost of sales for the nine months ended September 30, 2011 and 2010 was $4,668,316 and $5,555,191, respectively, resulting in gross profit of $4,269,502 and $5,578,032, respectively. The gross profit percentage for the nine months ended September 30, 2011 and 2010 was 48% and 50%, respectively. The decrease in gross profit of $1,308,530 was primarily attributable to delays in customer orders from decreased end-user demand, while the resulting decrease in gross profit percentage primarily is attributable to increase in raw material costs.
Operating Expenses. We had total operating expenses of $7,375,208 for the nine months ended September 30, 2011 as compared to $4,859,974 for the nine months ended September 30, 2010. The increase in operating expenses of $2,515,234 primarily is attributable to a non-cash payment in stock for strategic consulting services as well as an increase in amortization of deferred financing fees as well as small increases in various other expenses partially offset by a small decrease in Research and Development expenses and commissions.
Interest Expense. We incurred interest and other expense of $505,606 for the nine months ended September 30, 2011 as compared to $323,142 for the nine months ended September 30, 2010. The increase in interest and other expense of $182,464 is primarily the result of an increase in total debt outstanding at an increased average interest rate.
Net Loss / Income. As a result of the foregoing, we realized a net loss of $3,611,312 for the nine months ended September 30, 2011 as compared to net income of $395,612 for the nine months ended September 30, 2010, an increase in net loss of $4,006,924.
Evaluation of Disclosure Controls and Procedures
The reason for the ineffectiveness of our disclosure controls and procedures was the result of the lack of segregation of duties and responsibilities with respect to our cash control over the disbursements related thereto. The lack of segregation of duties resulted from our limited accounting staff. Although neither management nor our independent auditors discovered any significant errors in the preparation of our financial statements, the lack of multiple levels of review and segregation of duties could lead to error or fraud and is considered a per se material weakness in internal controls over financial reporting.
As of the date of filing of this Registration Statement on Form S-1, we have hired additional senior, qualified accounting staff to prepare the financial statements and footnotes related thereto and have restructured the accounting department at our manufacturing facility in California to provide independent levels of review of the financial information included in our financial statements. Management believes that the addition of senior staff and the realignment of accounting duties will remediate this material weakness.
Liquidity and Capital Resources
As of September 30, 2011, our current assets were $6,055,880, as compared to $4,195,769 at December 31, 2010. As of September 30, 2011, our current liabilities were $7,796,043, as compared to $5,034,880 at December 31, 2010. Operating activities used net cash of $40,986 for the nine months ended September 30, 2011, as compared to using net cash of $386,296 for the nine months ended September 30, 2010.
During the nine months ended September 30, 2011, investing activities provided net cash of $428,152, comprised primarily of cash acquired in connection with the Aero acquisition. During the nine months ended September 30, 2010, investing activities used net cash of $352,438.
During the nine months ended September 30, 2011, net cash of $143,084 was provided by financing activities, consisting of proceeds from the issuance of convertible notes of $2,750,000, offset by repayment of notes payable to banks and shareholders of $2,456,552, and payment of deferred financing fees of $150,364, as compared to net cash provided by financing activities of $282,535 during the comparable nine-month period ended September 30, 2010, which consisted of net advances from a shareholder of $376,640, offset by repayments of existing debt of $94,105.
Our net income (loss) for the nine months ended September 30, 2011 and September 30, 2010, respectively was a loss of $3,611,312 and net income of $395,612, respectively. We anticipate that we will continue to generate losses from operations for the foreseeable future as we invest in research and development activities in furtherance of our business plan of advancing our drug delivery technology. As of September 30, 2011, we had cash and cash equivalents of $781,725 and negative working capital of $1,740,163.
As of October 29, 2011 and continuing through the date of filing of this registration statement, the Company is in default with respect to the Convertible Promissory Notes with an aggregate principal balance of $2,250,000 due to the fact that the Company has not paid the amount due on maturity. The obligation to repay these notes will have a material impact on our future liquidity and we have not yet identified a source of funding to eliminate this liquidity demand.
The increase in net loss of $3,189,613 between the year ended December 31, 2010 and the nine months ended September 30, 2011 largely is attributable to our goal of transforming the company into a fully integrated pharmaceutical company and the costs associated with purchasing the Aero assets and investing in our branded generic pharmaceutical business. We intend to continue to invest substantial amounts in research and development activities through the year ended December 31, 2014 to advance the development of our EquaSome Technology and its application to generic pharmaceutical products. This planned investment will require us to obtain additional capital by selling debt or equity securities as we lack any material unused sources of liquid assets to support such investment. The cost of investment in our branded generic pharmaceutical business during the next three years likely will exceed any available cash flow we generate from our contract manufacturing business.
We are in the process of reviewing our contract manufacturing cost structure to identify inefficiencies and opportunities for reductions. Also, we are reviewing our sales efforts and programs to identify opportunities for increasing sales volume. We anticipate that these efforts will reduce or eliminate ongoing losses from our contract manufacturing business and allow us to continue contract manufacturing operations for the foreseeable future.
Our current balances of cash will not meet our working capital and capital expenditure needs for the next twelve months. Because we are not currently generating sufficient cash to fund our operations and we have debt that is in default, we may need to rely on external financing to meet future operating, debt repayment and capital requirements. Any projections of future cash needs and cash flows are subject to substantial uncertainty. We can make no assurance that financing will be available in amounts or on terms acceptable to us, if at all. Further, if we issue equity securities, stockholders may experience additional dilution or the new equity securities may have rights, preferences, or privileges senior to those of existing holders of common stock, and debt financing, if available, may involve restrictive covenants that could restrict our operations or finances. If we cannot raise funds, when needed, on acceptable terms, we may not be able to continue our operations, grow market share, take advantage of future opportunities, or respond to competitive pressures or unanticipated requirements, all of which could negatively impact our business, operating results, and financial condition. These conditions raise substantial doubt about our ability to continue as a going concern.
Off–Balance Sheet Arrangements
As of September 30, 2011, we had no material off-balance sheet arrangements other than operating leases.
Contractual Obligations
On June 30, 2011, the Company entered into three year executive employment agreements with three stockholders, Brian Keller, Christian Oertle and Daniel Fisher, to serve as our President, Chief Operating Officer and Executive Vice President, respectively. The agreements with Messrs. Keller and Fisher provide for annual salaries of $200,000 each and the agreement with Mr. Oertle that provides for an annual salary of $150,000. Pursuant to the terms of the agreements, each of these executives is eligible to participate in the Company’s long term incentive compensation programs and is entitled to an annual bonus if the Company meets or exceeds criteria adopted by the Compensation Committee of the Board, subject to certain claw back rights. The agreements provide for payments of six months’ severance in the event of early termination (other than for cause).
Results of Operations - On a separate company basis
BioZone Labs
Year Ended December 31, 2010 Compared to the Year Ended December 31, 2009:
Sales. Sales for the year ended December 31, 2010 and 2009 were $13,354,712 and $12,594,387 respectively. The increase in sales of $760,325 primarily was attributable to orders from new customers.
Cost of Sales and Gross Profit. Cost of sales for the year ended December 31, 2010 and 2009 was $7,676,217 and $6,726,757 respectively, resulting in gross profit of $5,678,495 and $5,867,630, respectively. The gross profit percentage for the year ended December 31, 2010 and 2009 was approximately 42% and 47%, respectively. The decrease in gross profit of $189,135 and reduction in gross profit percentage primarily is attributable to an increase in sales of product with reduced margins offset by an increase in sales.
Operating Expenses. We had total operating expenses of $6,062,008 for the year ended December 31, 2010 as compared to $5,626,082 for the year ended December 31, 2009. The increase in operating expenses of $435,926 is primarily attributable to an increase in payroll and related costs and a general increase to support the growth in sales.
Interest Expense. We incurred interest expense of $403,555 for the year ended December 31, 2010 as compared to $450,808 for the year ended December 31, 2009. The decrease in interest expense of $47,253 results from reduced borrowings under equipment leases and reduced rates on bank debt.
Net Loss / Income. As a result of the foregoing, we realized a net loss of $691,123 for the year ended December 31, 2010 as compared to net loss of $180,810 for the year ended December 31, 2009 an increase in net loss of $510,313.
Equalan
Year Ended December 31, 2010 Compared to the Year Ended December 31, 2009:
Sales. Sales for the year ended December 31, 2010 and 2009 were $852,465 and $712,333 respectively. The increase in sales of $140,132 primarily was attributable to acquiring new customers.
Cost of Sales and Gross Profit. Cost of sales for the year ended December 31, 2010 and 2009 was $326,348 and $551,114 respectively, resulting in gross profit of $526,117 and $161,219, respectively. The gross profit percentage for the year ended December 31, 2010 and 2009 was approximately 62% and 23%, respectively. The increase in gross profit of $364,898 and increase in gross profit percentage primarily are attributable to a change in mix of products sold and a write down of inventory in 2009.
Operating Expenses. We had total operating expenses of $347,600 for the year ended December 31, 2010 as compared to $345,337 for the year ended December 31, 2009. The increase in operating expenses of $2,263 is primarily attributable to an increase in employee benefit costs.
Interest Expense. We incurred interest expense of $28,803 for the year ended December 31, 2010 as compared to $21,789 for the year ended December 31, 2009. The increase in interest expense of $7,014 results from increased borrowings under our notes payable – bank.
Net Loss / Income. As a result of the foregoing, we realized net income of $149,714 for the year ended December 31, 2010 as compared to a net loss of $205,907 for the year ended December 31, 2009 an increase in net income of 355,621.
Income tax benefit. We received a deferred income tax benefit of $95,945 and $28,450 for the years ended December 31, 2010 and 2009, respectively, due to losses sustained. The effective income tax benefit as a percentage of loss before income tax benefit was approximately 12% and 14% which varies from the expected Federal tax rate of 34% due to valuation allowances applied to net operating loss carryforwards.
Equachem
Year Ended December 31, 2010 Compared to the Year Ended December 31, 2009:
Sales. Sales for the year ended December 31, 2010 and 2009 were $292,015 and $181,394, respectively. The increase in sales of $110,621 primarily was attributable to an increase in sales to our largest customer.
Royalties. Royalties for the year ended December 31, 2010 and 2009 were $95,518 and $48,800, respectively. The increase in royalties of $46,718 primarily was attributable to an increase in royalties from our largest customer.
Cost of Sales and Gross Profit. Cost of sales for the year ended December 31, 2010 and 2009 was $50,067 and $41,035 respectively, resulting in gross profit of $337,466 and $189,159, respectively. The gross profit percentage for the year ended December 31, 2010 and 2009 was approximately 87% and 82%, respectively. The increase in gross profit of $148,307 results from an increase in sales offset by a reduction in gross profit percentage.
Operating Expenses. We had total operating expenses of $217,756 for the year ended December 31, 2010 as compared to $191,973 for the year ended December 31, 2009. The increase in operating expenses of $25,783 is primarily attributable to increased legal fees related to patent prosecution.
Net Loss / Income. As a result of the foregoing, we realized net income of $119,710 for the year ended December 31, 2010 as compared to a net loss of $2,814 for the year ended December 31, 2009 an increase in net income of $122,524.
Liquidity and Capital Resources
BioZone Labs
As of December 31, 2010 our current assets were $3,970,603 as compared to $4,209,289 at December 31, 2009. As of December 31, 2010 our current liabilities were $4,954,319, as compared to $4,465,118 at December 31, 2009. Operating activities used net cash of $359,174 for the year ended December 31, 2010 as compared to providing net cash of $586,373 for the year ended December 31, 2009.
During the year ended December 31, 2010 and 2009 investing activities used net cash of $131,007 and $25,995, respectively, for the purchase of property and equipment.
During the year ended December 31, 2010, net cash of $65,105 was provided by financing activities, consisting of advances from shareholders of $375,321, offset by repayments of existing debt of $257,923 and net shareholder distributions from 580 Garcia LLC of $52,293, as compared to net cash used by financing activities of $227,958 during the year ended December 31, 2009 which consisted of repayments of existing debt of $360,946 and net shareholder distributions from 580 Garcia LLC of $62,755 offset by advances from a shareholder of $195,743.
Our net loss for the year ended December 31, 2010 and 2009 was $691,123 and $180,810, respectively. We anticipate that we will continue to generate losses from operations for the foreseeable future as we invest in research and development activities in furtherance of our business plan of advancing our drug delivery technology. As of December 31, 2010 we had cash and cash equivalents of $117,121 and negative working capital of $983,716.
On August 15, 2011, the holder of the notes payable – bank declared the entire unpaid balance and accrued interest of the notes immediately due and payable as a result of a default caused by the acquisition of the BioZone Labs Group referred to above. On September 9, 2011, the notes and all accrued interest owed by Biozone Labs totaling approximately $1,945,000 were paid in full.
Equalan
As of December 31, 2010 our current assets were $732,582 as compared to $563,244 at December 31, 2009. As of December 31, 2010 our current liabilities were $701,532, as compared to $688,771 at December 31, 2009. Operating activities provided net cash of $78,048 for the year ended December 31, 2010 as compared to providing net cash of $89,620 for the year ended December 31, 2009.
During the year ended December 31, 2010 investing activities used net cash of $961 for the purchase of intangible assets. During the year ended December 31, 2009 there were no cash flows from investing activities.
During the year ended December 31, 2010 and 2009 net cash of $63,097 and $90,000, respectively, was used by financing activities consisting of repayments of existing debt.
Our net income for the year ended December 31, 2010 was $149,714 and our net loss for the year ended December 31, 2009 was $205,907. We anticipate that we will continue to generate losses from operations for the foreseeable future as we invest in research and development activities in furtherance of our business plan of advancing our drug delivery technology. As of December 31, 2010 we had cash and cash equivalents of $53,042 and working capital of $31,052.
On August 15, 2011, the holder of the notes payable – bank declared the entire unpaid balance and accrued interest of the notes immediately due and payable as a result of a default caused by the acquisition of the BioZone Labs Group referred to above. On September 9, 2011, the notes and all accrued interest were paid in full.
Equachem
As of December 31, 2010 our current assets were $617,314 as compared to $293,534 at December 31, 2009. As of December 31, 2010 our current liabilities were $405,268, as compared to $201,198 at December 31, 2009. Operating activities provided net cash of $52,373 for the year ended December 31, 2010 as compared to using net cash of $265 for the year ended December 31, 2009.
During the year ended December 31, 2010 and 2009 there were no cash flows from investing or financing activities.
Our net income for the year ended December 31, 2010 was $119,710 and our net loss for the year ended December 31, 2009 was $2,814. We anticipate that we will continue to generate losses from operations for the foreseeable future as we invest in research and development activities in furtherance of our business plan of advancing our drug delivery technology. As of December 31, 2010 we had cash and cash equivalents of $58,532 and working capital of $212,046.
Off–Balance Sheet Arrangements
As of September 30, 2011, we had no material off-balance sheet arrangements other than operating leases.
Contractual Obligations
On September 30, 2011, the Company entered into three year employment agreements with each of its President/Chief Scientific Officer, Executive Vice President and Chief Operating Officer, who are also shareholders of the Company. Two of such employment agreements provide for annual salaries of $200,000 each and one that provides for an annual salary of $150,000. Pursuant to the terms of the agreements, each of these officers is eligible to participate in the Company’s long term incentive compensation programs and is entitled to an annual bonus if the Company meets or exceeds criteria adopted by the Compensation Committee of the Board, subject to certain claw back rights. The agreements provide for payments of six months’ severance in the event of early termination (other than for cause).
Impact of Inflation
The impact of inflation upon our revenue and income/(loss) from continuing operations during each of the past two fiscal years has not been material to our financial position or results of operations for those years because we do not maintain significant inventories whose costs are affected by inflation.
Properties
Our facilities are located in Pittsburg, California and Miami, Florida. BioZone Labs manufactures its products in a 20,000 s.f., cGMP facility owned by 580 Garcia Avenue, LLC, its consolidated VIE. Also it fills and stores its products at a 60,000 sq. ft. rented facility located at 701 Willow Road, Pittsburg, CA, which provides for annual rentals of $343,470.
We lease approximately 1,500 square feet of office space at 4400 Biscayne Boulevard, Miami, Florida where we employ one sales professional for our Baker Cummins brand products. The lease expires on October 31, 2012 and provides for annual rentals of approximately $23,700.
In July 2011, we entered into a lease for approximately 3,869 square feet of laboratory space in Princeton, NJ where we intend to establish our lipid manufacturing and scale up facility. The lease expires July 20, 2016. Rent expense is approximately $7,575 per month.
Seasonality
Due to the nature of the products sold by BioZone Labs, which include cough/cold remedies, its business is cyclical. Approximately two thirds of BioZone Labs' revenue is generated in the second half of the calendar year.
Off-Balance Sheet Transactions
We have no material off-balance sheet transactions.
Royalty Obligation – Terminated
Aero was a party to an Asset Purchase Agreement (the "Ivax Agreement"), dated as of September 25, 2006, with Ivax Laboratories, Inc. pursuant to which Aero acquired the Baker Cummins product line. Aero agreed to pay to Ivax a 10% royalty on net sales, until $1 million is paid, and 5% thereafter. Royalty expense for the years ended December 31, 2010 and 2009 were $28,445 and $56,033, respectively. Aero had $278,460 of accrued royalties payable as of December 31, 2010. Upon payment of $224,000 for satisfaction of outstanding royalties, the Ivax Agreement was amended on April 25, 2011 to eliminate all continuing royalty obligations under the Agreement.
Critical Accounting Policies and Estimates
The preparation of financial statements in accordance with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect reported amounts and related disclosures in the financial statements. Management considers an accounting estimate to be critical if it requires assumptions to be made that were uncertain at the time the estimate was made, and changes in the estimate or different estimates that could have been selected could have a material impact on our consolidated results of operations or financial condition.
Basis of Consolidation
The consolidated financial statements BioZone Pharmaceuticals, Inc. include the accounts of BioZone Pharmaceuticals, Inc. and its subsidiaries, all of which are wholly owned except for BetaZone, which is 45% owned. In addition, the Company consolidates the accounts of 580 Garcia Properties, LLC, (“580 Garcia”) which owns the land and building used by BioZone Labs and is owned by one of the former owners of the BioZone Lab Group. The Company is a guarantor of 580 Garcia’s mortgage loan payable on the property.
The consolidated financial statements of BioZone Labs include the accounts of BioZone Laboratories, Inc. and 580 Garcia. We have determined that 580 Garcia meets the conditions of ASC Topic 810 as a Variable Interest Entity, and therefore has consolidated the accounts of 580 Garcia into its financial statements.
Revenue Recognition
BioZone Labs operates as a contract manufacturer and produces finished goods according to customer specifications. Equalan sells its merchandise directly to dermatologists and to an online retailer. Equachem operates as a reseller of pharmaceutical raw materials and licensor of intellectual property. The agreements with customers for each of the companies do not contain any rights of return other than for goods that fail to meet the specifications provided by the customer. None of the companies has experienced any significant returns from customers and accordingly, in management’s opinion, no reserve for returns is provided. We record revenue when persuasive evidence of an arrangement exists, services have been rendered or product delivery has occurred, the selling price to the customer is fixed or determinable and collectability of the revenue is reasonably assured.
Revenue from the licensing of intellectual property is recorded when reported to us by the licensee.
Fair Value Measurements
We adopted the provisions of ASC Topic 820, “Fair Value Measurements and Disclosures”, which defines fair value as used in numerous accounting pronouncements, establishes a framework for measuring fair value and expands disclosure of fair value measurements.
The estimated fair value of certain financial instruments, including cash and cash equivalents, accounts receivable, accounts payable and accrued expenses are carried at historical cost basis, which approximates their fair values because of the short-term nature of these instruments. The carrying amounts of our short and long-term credit obligations approximate fair value because the effective yields on these obligations are comparable to rates of returns for instruments of similar credit risk.
ASC 820 defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. ASC 820 also establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. ASC 820 describes three levels of inputs that may be used to measure fair value:
Level 1 — quoted prices in active markets for identical assets or liabilities
Level 2 — quoted prices for similar assets and liabilities in active markets or inputs that are observable
Level 3 — inputs that are unobservable (for example cash flow modeling inputs based on assumptions)
Concentration of Credit Risk
Financial instruments that potentially expose us to concentrations of credit risk consist principally of cash and cash equivalents. We maintain our cash accounts at high quality financial institutions with balances, at times, in excess of Federally insured limits. Management believes that the financial institutions that hold our deposits are financially sound and therefore pose minimal credit risk.
Research and development
Research and development expenditures are charged to operations as incurred.
Income Taxes
We use the asset and liability method of accounting for income taxes in accordance with ASC Topic 740, “Income Taxes.” Under this method, income tax expense is recognized for the amount of: (i) taxes payable or refundable for the current year and (ii) deferred tax consequences of temporary differences resulting from matters that have been recognized in an entity’s financial statements or tax returns. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in the results of operations in the period that includes the enactment date. A valuation allowance is provided to reduce the deferred tax assets reported if, based on the weight of the available positive and negative evidence, it is more likely than not some portion or all of the deferred tax assets will not be realized.
ASC Topic 740.10.30 clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements and prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. ASC Topic 740.10.40 provides guidance on derecognition, classification, interest and penalties, accounting in interim periods, disclosure, and transition. We have no material uncertain tax positions for any of the reporting periods presented.
Recent Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board or other standard setting bodies that may have an impact on the Company’s accounting and reporting. The Company believes that such recently issued accounting pronouncements and other authoritative guidance for which the effective date is in the future either will not have an impact on its accounting or reporting or that such impact will not be material to its financial position, results of operations, and cash flows when implemented.
In May 2011, the FASB issued ASU 2011-04, “Fair Value Measurement (Topic 820): Amendments to Achieve Common Fair Value Measurement and Disclosure Requirements in U.S. GAAP and IFRSs.” This standard results in a common requirement between the FASB and the International Accounting Standards Board (IASB) for measuring fair value and for disclosing information about fair value measurements. ASU 2011-04 is effective for fiscal years and interim periods beginning after December 15, 2011.
In June, 2011, the FASB issued ASU 2011-05, “Comprehensive Income (Topic 220): Presentation of Comprehensive Income.” ASU 2011-05 requires entities to present net income and other comprehensive income in either a single continuous statement or in two separate, but consecutive, statements of net income and other comprehensive income. ASU 2011-05 is effective for fiscal years and interim periods beginning after December 15, 2011.
BUSINESS
Overview
We are a manufacturer of Over the Counter (“OTC”) drug products and cosmetics. In addition, we are in the early stages of developing branded generic prescription pharmaceutical products utilizing our proprietary EquaSomeTM drug delivery technology, which is designed to increase the benefit of the targeted therapy of each such generic pharmaceutical product by improving stability, bioavailability or absorption.
We operate through BioZone Pharmaceuticals, Inc. (“BioZone Pharma”) and its four wholly owned subsidiaries: Biozone Laboratories, Inc. (“Biozone Labs”), Equalan LLC (“Equalan”), Baker Cummins Corp. (“Baker Cummins”) and Equachem LLC (“Equachem”). In addition, we own a 45% interest in BetaZone Laboratories LLC (“BetaZone”). We refer to BioZone Labs, Equalan and Equachem as the “BioZone Labs Group”.
BioZone Labs develops and manufactures OTC pharmaceuticals and cosmetic and beauty products on behalf of third parties, manufactures our proprietary skin care products, which we market under the brand names of Glyderm® and Baker Cummins® and manufactures raw materials containing QuSomes used in OTC and pharmaceutical products manufactured by others.
Equalan LLC sells our proprietary Glyderm® brand of skin care products to national wholesalers, ecommerce retailers such as Drugstore.com and Skinstore.com, physicians for resale in their offices and consumers.
Baker Cummins sells our proprietary Baker Cummins® brand of skin care products to national wholesalers, ecommerce retailers such as Drugstore.com and Skinstore.com, physician offices and consumers.
Equachem LLC sells raw materials containing QuSomes that are used in OTC and pharmaceutical products to manufacturers of OTC drugs and cosmetics. It also licenses our QuSome technology to BetaZone and other pharmaceutical manufacturers in exchange for sales based royalties. Betazone has yet to pay any material royalties to Equachem as it has yet to generate any significant sales or license payments from products using our licensed technology. Royalties from other pharmaceutical manufacturers are approximately $100,000 per year and do not constitute a material component of our business.
BetaZone is engaged in the development, sales and license of pharmaceutical and cosmetic products in Latin America.
BioZone Pharma is in the early stages of developing branded generic drugs, which will utilize our proprietary EquaSomeTM technology.
BioZone Pharma was incorporated as a Nevada corporation on December 4, 2006 under the name International Surf Resorts Inc. Its name was changed to BioZone Pharmaceuticals, Inc. on March 1, 2011. BioZone Labs was incorporated under the laws of the State of California on June 2, 1992. Equalan was formed as a limited liability company under the laws of the State of California on January 2, 2007. Equachem was formed as a limited liability company under the laws of the State of California on March 12, 2007 under the name Chemdyn, LLC. Its name was changed to Equachem, LLC on July 25, 2007. BetaZone was formed as a Florida limited liability company on November 7, 2006. Baker Cummins Corp. was incorporated under the laws of the State of Nevada on March 31, 2011.
Our principal executive offices are located at 550 Sylvan Avenue, Suite 101, Englewood Cliffs, NJ 07632. Our telephone number is (201) 608-5101.
BioZone®, Glyderm®, P&S®, UltraMide®, Acquaderm®, QuSomes®, LiquaVail® and HyperSorb® are trademarks that we own. Each trademark, trade name or service mark of any other company appearing in this Registration Statement on Form S-1 belongs to its respective holder.
Manufacturing Business
The BioZones Labs Group was founded by Daniel Fisher and Dr. Brian Keller in 1987 as a developer and manufacturer of over-the-counter drugs and preparations, cosmetics, and nutritional supplements.
BioZone Labs is registered with the FDA as a drug manufacturer. We manufacture our products in a 20,000 s.f., cGMP facility located at 580 Garcia Avenue, Pittsburg, CA and we fill, package and store our products at a 60,000 sq. ft. facility located at 701 Willow Pass Road, Pittsburg, CA. Our facilities include a full range of high to moderate speed custom filling and packaging equipment for jars, tubes, and bottles. Our personnel include technical support professionals for product development, packaging and labeling; quality control & quality assurance professionals for attention to conformity with government and customer specifications; and chemists for processing and testing. In addition, we manufacture and sell two proprietary skin care lines: Glyderm®, which we acquired from Valeant Pharmaceuticals in 2007, and Baker Cummins®, which we acquired from Aero Pharmaceuticals in 2011.
We manufacture products for skin care, body care and hair care, liquid soaps, oral drops and sprays, cosmetics, health & beauty aids, nasal sprays, liquid dietary supplements and other OTC drug preparations including topical and gel cap drugs. We do not rely on any third parties to manufacture our products. The following is a list of products that we manufacture:
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OTC Products. Hair conditioners and shampoos for treatment of eczema and psoriasis; external analgesics; skin protectants; anti-fungal products; topical anesthetics; nasal sprays; wound care products; acne products; cough and cold products; anti-itch products; and skin lightening products. In general, these products are regulated by the FDA.
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Cosmetic and Beauty Products. AHA and Beta Hydroxy products; instant firming serums; anti-aging products; body lotions; eye creams; moisture creams and lotions; facial scrubs; and facial masks. In general, these products are not regulated by the FDA.
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Dietary Supplements. Vitamins, minerals and herbal remedies. In general, these products are not regulated by the FDA.
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The primary market for BioZone Labs’ contract manufacturing business is the United States. Our contract manufacturing customers are regional and national distributors and retailers of healthcare products.
In addition to manufacturing products on behalf of third parties, we develop and manufacture two proprietary brands of skin care products and sell those products to national wholesalers, ecommerce retailers such as Drugstore.com and Skinstore.com, physician offices and consumers. We do not outsource any manufacturing. We market our proprietary brands through our wholly-owned subsidiaries, Equalan and Baker Cummins.
Glyderm. We acquired the Glyderm® line of anti-aging products from Valeant Pharmaceuticals Inc. in 2007. Glyderm products have been used by dermatologists for over 20 years in office procedures to treat acne, skin discolorations, removal of fine lines and wrinkles and skin resurfacing. The products include glycolic acid peels and moisturizers. We manufacture the Glyderm line at our manufacturing facility in Pittsburg, California.
The Glyderm® brand, which is manufactured by BioZone Labs and sold by Equalan, consists of the following products:
Product Name
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Indication or Target Market
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Glycolic Acid Peels – 20% to 70%
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Health care practioners for in office use to improve the texture and tone of the skin and clean out pores and help even out pigmentation and give the face a fresher appearance.
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Glyderm Gentle Cleanser (0.2%)
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pH balanced, soap-free, non-irritating formula, which may be used on sensitive skin.
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Exfoliating Cream Series (5%)
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Patients beginning the Glyderm program to help to minimize the appearance of pigmentation irregularities, maintain the results of the six-week office facial program and soften fine lines
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Exfoliating Cream Plus Series (10%)
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Patients who have successfully used the Exfoliating Cream Series (5%)
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Exfoliating Cream Plus Series with Glycolic Acid (12%) and Salicylic Acid
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Patients with dry skin who have successfully used the Glyderm Cream Plus (10%)
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Exfoliate Lotion Series (5%)
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Patients with normal skin to help to minimize the appearance of pigmentation irregularities, maintain the results of the six-week office facial program and soften fine lines
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Exfoliate Lotion Plus (10%)
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Patients who have successfully used the Exfoliate Lotion Series (5%)
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Exfoliate Lotion Lite Series (5%)
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Patients with normal to oily skin to help to minimize the appearance of pigmentation irregularities, maintain the results of the six-week office facial program and soften fine lines.
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Exfoliate Lotion Lite Plus (10%)
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Patients who have successfully used the Exfoliate Lotion Lite Series (5%)
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Exfoliate Solution Series, Solution (5%)
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Patients with oily, non-sensitive skin to help to minimize the appearance of pigmentation irregularities, maintain the results of the six-week office facial program and soften fine lines
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Exfoliate Solution Plus (10%)
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Patients who have successfully used the Exfoliate Solution Series, Solution (5%)
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Exfoliate Solution Plus 12% – Combination of Glycolic and Salicylic acids
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Patients who have successfully used the Exfoliate Solution Plus (10%)
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Hydrotone Moisturizers (Without Glycolic Acid)
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Patients with dry or mature skin to alleviate the appearance of dryness associated with exfoliation
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Hydrotone Lite
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Patients with normal to oily skin
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Hydrotone Max
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Patients with extremely dry or mature skin
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Simply Sunscreen SPF 30
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Paba free, UVA and UVB protection sunscreen for patients of all ages and skin types to help prevent sunburn
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Glyderm Gentle Eye
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Blend of antioxidants and vitamin K to help hydrate skin around the eyes and reduce the appearance of dark under-eye circles
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All Climates Body Lotion (10%)
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Fast-absorbing Glycolic 10% lotion for patients with all skin types for use in all climates and all seasons to alleviate the appearance of dryness
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Gly Mist (0.1%)
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Mineral water spray that contains Glycolic acid for patients with all skin types
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Gly Masque (3%)
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Combination of Glycolic esters and natural rare earth for patients with all skin types to make the skin feel invigorated and smooth
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Intense C Serum PM – 7.5% L-Ascorbic Acid
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Form of vitamin C suitable for topical application to provide antioxidant protection, defend against damaging UVA and UVB rays, and to contribute to collagen synthesis for patients with aging and mature skin types
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The primary market for Glyderm is the United States. Equalan’s customers who purchase Glyderm products are physicians who use and resell our products in their physician practices and customers who purchase our products over the internet. We employ one salesperson who markets Glyderm products directly to physicians for use and resale in their offices. Also, we market Glyderm through ecommerce retailers, such as Drugstore.com. We have no material major customers for this line of products.
Baker Cummins. Baker Cummins is a line of proprietary scalp and skin care products, which can be used to treat dry commonly seen skin and scalp conditions. On May 12, 2011, we acquired the Baker Cummins line of proprietary scalp and skin care products from Aero.
Baker Cummins sells the following products, manufactured by BioZone Labs, which we market under the Baker Cummins® brand:
Product Name
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Indication or Target Market
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P&S Liquid
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Treatment for symptoms of psoriasis and seborrhea dermatitis by helping to loosen and remove dried skin from the scalp.
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P&S Shampoo
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Specially formulated shampoo designed to remove residual P&S Liquid from the hair; contains salicylic acid to control recurrent flaking and scaling of the scalp associated with seborrheic dermatitis and psoriasis
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Ultramide 25 Lotion and Ultra Mide-D
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Skin lotions that soften and moisturize dry, rough, cracked and calloused skin. Ultramide 25 contains a stable 25% urea formulation
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X-Seb T Pearl Shampoo and X-Seb T Plus Shampoo
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Therapeutic tar shampoos that relieve itching, irritation, redness, flaking and scaling associated with dandruff, seborrheic dermatitis and psoriasis of the scalp.
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Acquaderm Cream
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Hypoallergenic, non-comedogenic and non-greasy concentrated facial formula that provides maximum moisturization of the skin
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The primary market for Baker Cummins products is the United States. Baker Cummins’ customers are drug wholesalers, physicians who use and resell our products in their physician practices and customers who purchase our products over the internet. We employ one salesperson who markets Baker Cummins products to physicians for resale in their office and who fills orders received from customers over the internet. We have no material major customers for this line of products.
Equachem. Our wholly-owned subsidiary, Equachem, sells raw materials containing QuSomes to manufacturers of OTC drugs and cosmetics. Also, it licenses our QuSomes® technology to certain of OTC manufacturers and to our 45% owned subsidiary, BetaZone, which is engaged in development and sales of pharmaceutical and cosmetic products in Latin America (Mexico, Central America and South America), and certain products marketed outside of countries in those regions.
The primary market for Equachem’s business is the United States and Latin America. Equachem’s customers are U.S. manufacturers of OTC pharmaceutical and cosmetic products and BetaZone.
Branded Generic Pharmaceutical Business
BioZone Pharma is in the early stages of directing its research and development efforts towards applying the EquaSome technology to drug molecules currently used in approved, generic prescription (Rx) drugs. Our goal is to develop our own proprietary, enhanced versions of certain generic drugs, and market them under our own brands.
In many cases, the benefits of generic prescription drugs are limited due to poor stability or bioavailability or variable absorption. In those cases, our EquaSome technology (described below) may increase the benefit of the therapy by improving stability, bioavailability or absorption. The EquaSome technology can be applied to the injectable or oral route of administration as well other delivery pathways, such as topical, buccal, rectal, intra-vaginal or transdermal. The EquaSome technology utilizes a unique, proprietary lipid that spontaneously forms thermodynamically stable lipid vesicles (liposomes), which encapsulate the drug molecule with a membrane that enhances drug stability, bioavailability and absorption.
The BioZone Technology - QuSomes®, LiquaVail®, HyperSorb® and EquaSomesTM
In the mid-1990s, we licensed a proprietary, patented, phospho lipid delivery technology for use in our contract manufacturing business. Subsequently we modified the lipid to enhance final product stability, ingredient penetration, ease of manufacture process, and reduction in manufacturing and raw material costs. We obtained three U.S. patents covering the composition of matter of the enhanced lipid and method of manufacturing the resulting lipid vesicle. We modified the lipid through removal of phosphate and PEGylation, which is the process of covalent attachment of polyethylene glycol polymer chains to another molecule, normally a drug or therapeutic protein.
We refer to the pegylated lipid (i.e., the lipid modified with the PEGylation process described above) used in dermatological products as QuSomes. Our Glyderm Specialty Product, Intense C Serum PM – 7.5% L-Ascorbic Acid, is formulated with QuSomes. We refer to the pegylated lipid used in liquid oral OTC products as LiquaVail; the pegylated lipid used in gelatin capsules as HyperSorb; and the pegylated lipid that we plan to use in our branded generic pharmaceutical drug products as EquaSomes. Together, we refer to the QuSomes, LiquaVail, HyperSorb and EquaSomes as the “Biozone Technology”.
BetaZone License
BioZone Labs and BetaZone entered into a license agreement on November 7, 2006, as amended on April 4, 2011 and on June 29, 2011. Pursuant to the terms of the agreement, BioZone Labs licensed to BetaZone the rights to manufacture, market, sell and import certain QuSome products in a territory comprised of Mexico and the countries located in Central America, South America, Asia and Eastern Europe, and, notwithstanding the foregoing, BetaZone had the continued right to market and sell the products outside the territory with BioZone Labs’ prior written consent. As consideration, BioZone Labs received equity in BetaZone and BetaZone agreed to develop, manufacture, market and seek sublicensees for the products.
BioZone Pharma, as the parent of BioZone Labs, entered into the second amendment with BetaZone. As set forth in the second amendment, BioZone Pharma consented to BetaZone’s sale of certain QuSome products in certain countries and acknowledged that BetaZone had licensed the BetaZone Technology platform to certain sub-licensees. BetaZone agreed to use its commercially reasonable efforts on a continuous basis to develop, market and sell certain QuSome products. In the event that BetaZone fails to sell or license these products by June 29, 2013, BioZone Pharma shall have the right to withdraw its consent to BetaZone’s future sales or licenses of these products. BetaZone agreed to purchase QuSomes and EquaSomes exclusively from BioZone Pharma or its designees.
The agreement has a term of 25 years and may be extended for successive periods unless terminated by either party with 6 months written notice prior to the end of the term. Upon termination of the agreement, (a) BetaZone shall pay to BioZone Labs all royalties within 60 days of such termination; (b) BetaZone shall immediately transfer to BioZone Labs (i) copies of all information, reports, submissions and data relating to the QuSome products and generated during the term of the agreement and (ii) all rights which BetaZone may possess under the agreement; and (c) all rights and licenses granted to BetaZone pursuant to the agreement shall immediately terminate.
Research and Development
Historically, BioZone Labs has conducted all of our research and development activities, which have been focused on enhanced OTC and cosmetic product formulations and analytical method development for our contract manufacturing customers, and more recently, the development of the BioZone Technology.
Since March 2011, we have shifted our research and development activities related to the BioZone Technology, and the EquaSome technology in particular, to BioZone Pharma. We have established a research facility in Princeton, New Jersey, which is expected to commence full scale operations in December 2011 or January 2012.
In addition to the continued research and development activities for our contract manufacturing customers, we are conducting research and development activities related to drug product formulation and analytical method development for our branded generic pharmaceutical product candidates. We expect this effort to intensify in 2012 as we intend to conduct animal toxicology studies.
We have limited research and development activities focused on drug discovery or clinical trials.
Total research and development costs for the last two fiscal years were $212,042 and $213,991, respectively.
Intellectual Property
The following table lists all patents and patent applications related to the BioZone Technology. All of our granted patents expire 20 years from the filing date or effective date indicated in the table unless otherwise noted.
Patent Title
|
Patent or Application Number
|
Filing or Effective Date
|
Delivery of biologically active material in a liposomal formulation for administration into the mouth
|
5891465
|
April, 1999
|
Liposomal delivery by iontophoresis
|
6048545
|
April, 2000
|
Compounds and methods for inhibition of phospholipase A2 and cyclooxygenase-2
|
6495596
|
December, 2002
|
Self-forming, thermodynamically stable liposomes and their applications
|
6610322
|
August, 2003
|
Oral Liposomal Delivery System
|
6776924
|
April, 2004
|
Self-forming, thermodynamically stable liposomes and their applications
|
6958160
|
October, 2005
|
Compounds and methods for inhibition of phospholipase A2 and cyclooxygenase-2
|
6998421
|
February, 2006
|
Self-forming, thermodynamically stable liposomes and their applications
|
7150883
|
December, 2006
|
Self-forming, thermodynamically stable liposomes and their applications
|
7718190
|
May, 2010
|
Self-forming, thermodynamically stable liposomes and their applications - Japan
|
4497765
|
April, 2010
|
X-conazoles plus Qusomes
|
|
|
EQUA-001 (regular application) "Enhanced Delivery of Antifungal Agents"
|
12/006,820
|
January, 2008
|
EQUA-001 PCT, "Enhanced Delivery of Antifungal Agents"
|
PCT/US2009/000003
|
January, 2009
|
EQUA-001 JP
|
PNLG
|
|
EQUA-001 EP, KEMP (N.111618 JHS/eg)
|
9701160.5
|
January, 2009
|
EQUA-003 (P), "Enhanced Delivery of Antifungal Agents"
|
61/128,011
|
May, 2008
|
EQUA-012 (R)
|
12/454,387
|
May, 2009
|
Pure PEG-Lipid Conjugates
|
|
|
EQUA-013
|
61/217,627
|
June, 2009
|
EQUA-017P
|
61/284,065
|
December, 2009
|
EQUA-024R
|
12/802,197
|
June, 2010
|
EQUA-024 PCT
|
PCT/US2010/001590
|
June, 2010
|
Cyclosporin formulation
|
|
|
EQUA-016P
|
61/273,656
|
August, 2009
|
EQUA-025R
|
12/802,200
|
June, 2010
|
EQUA-025 PCT
|
PCT/US2010/001589
|
June, 2010
|
Rapamycin
|
|
|
EQUA-018P
|
61/276,953
|
September, 2009
|
EQUA-027R - "Method of treatment with Rapamycin"
|
12/924,038
|
September, 2010
|
EQUA-027 PCT - "Pharmaceutical compositions of Rapamycin”
|
PCT/US2010/002547
|
September, 2010
|
We are dependent on three contract manufacturing customers for a significant portion of our business. During 2010 and 2009, approximately 50% of our revenue was generated by sales of products to these customers. Sales to these major customers during each year aggregated approximately 30%, 11% and 9% of combined sales during those years. These customers are national marketers of proprietary branded OTC and cosmetic products who outsource their manufacturing need to third party contract manufacturers, such as Biozone Labs. If any of these three customers discontinues or substantially reduces its purchases from us, it may have a material adverse effect on our business and financial condition. We believe that we have good relationships with our customers.
We have agreements with our contract manufacturing customers, which include prompt payment discount, and various fee and rebate obligation arrangements. Our agreements do not require customers to purchase any specific volumes of our products.
BioZone Labs employs two sales professionals who market R&D, formulation and manufacturing services to potential contract manufacturing customers. Equalan employs two sales who market Glyderm to physicians, ecommerce retailers and customers via the internet. Baker Cummins employs one sales professional who sells Baker Cummins products to drug wholesalers and online customers located throughout the United States.
Manufacturing
The primary raw materials used in making products for our contract manufacturing customers either are supplied by our customers or are readily available in large quantities from multiple sources. Similarly, the primary raw materials used in making our proprietary brand products are readily available in large quantities from multiple sources. We believe that our manufacturing capabilities comply with the FDA’s current Good Manufacturing Practice (“cGMP”). We do not outsource any manufacturing.
Growth Strategy
Our growth strategy for our contract manufacturing business is to increase sales by establishing a dedicated sales team with industry experience who will leverage the BioZone Technology (other than the EquaSome Technology) and our expertise in product formulation to attract new contract manufacturing customers. Our growth strategy for our proprietary brand business is to hire dedicated salespeople who will introduce our proprietary brand products to regional and national wholesalers, retailers and physicians for resale in their offices.
Our strategy for our branded generic pharmaceutical business is to invest in our research and development activities to exploit the EquaSome Technology and apply it to certain generic pharmaceutical products. We intend to establish manufacturing capabilities to produce EquaSomes; advance any product candidates through toxicology studies; pursue registration of any drug product candidates under the 505(b)(2) regulatory approval pathway; create final pharmaceutical formulations to demonstrate commercialization; and obtain regulatory approval for, and market our own proprietary branded generic products.
Competition
The market for contract manufacturing services is highly competitive and price sensitive and gross margins are low. Our direct competition consists of numerous contract manufacturers, such as Perrigo Company ( Nasdaq : PRGO), many of which have greater financial and other resources than we do. If one or more other OTC contract manufacturers significantly reduce their prices in an effort to gain market share, our gross revenue from health care supply services, profitability or market position could be adversely affected.
The market for OTC health care products is highly competitive and promotion sensitive. Our direct competition consists of numerous drug manufacturers and marketers, many of which have greater financial and other resources than we do. If one or more other pharmaceutical manufacturers significantly reduce their prices or significantly increase their promotional activity in an effort to gain market share, our gross revenue from sales of proprietary health care products, profitability or market position could be adversely affected.
The market for generic and branded generic prescription drugs is subject to intense competition from other generic drug manufacturers, brand-name pharmaceutical companies launching their own generic version of a branded product (known as an authorized generic), manufacturers of branded drug products that continue to produce those products after patent expirations and manufacturers of therapeutically similar drugs.
Government Regulation
The manufacturing, processing, formulation, packaging, labeling, testing, storing, distributing, advertising and sale of our products are subject to regulation by one or more U.S. agencies, including the FDA, the FTC, the DEA and the Consumer Product Safety Commission (CPSC), as well as several foreign, state and local agencies in localities in which our products are sold. In addition, we manufacture and market certain of our products in accordance with standards set by organizations, such as the United States Pharmacopeial Convention, Inc. (USP) and NSF International (NSF). We believe that our policies, operations and products comply in all material respects with existing regulations.
U.S. Food and Drug Administration
The FDA has jurisdiction over our ANDA, NDA and OTC monograph drug products and dietary supplements. The FDA’s jurisdiction extends to the manufacturing, testing, labeling, packaging, storage and distribution of these products.
The majority of our OTC pharmaceuticals are regulated under the OTC monograph system and subject to certain FDA regulations. OTC medicines, other than those approved by an ANDA or NDA application, are marketed under regulations referred to as “OTC monographs”, which have been established through the FDA’s OTC Review that follow notice-and-comment rulemaking procedures. Under the OTC monograph system, selected OTC drugs are generally recognized as safe and effective and do not require the submission and approval of an ANDA or NDA prior to marketing. The FDA OTC monograph system includes well-known ingredients and specifies requirements for permitted indications, required warnings and precautions, allowable combinations of ingredients and dosage levels. Drug products marketed under the OTC monograph system must conform to specific quality and labeling requirements; however, these products generally can be developed with fewer regulatory hurdles than those products that require the filing of an ANDA or NDA.
It is, in general, less costly to develop and bring to market a product produced under the OTC monograph system. From time to time, adequate information may become available to the FDA regarding certain ANDA or NDA drug products that will allow the reclassification of those products as no longer requiring the approval of an ANDA or NDA prior to marketing. For this reason, there may be increased competition and lower profitability related to a particular product should it be reclassified to the OTC monograph system. In addition, regulations may change from time to time, requiring formulation, packaging or labeling changes for certain products. The Company cannot predict whether new legislation regulating our activities will be enacted or what effect any legislation would have on our business.
We intend to market generic prescription drugs. These products require approval by the FDA through its ANDA or NDA processes prior to commercialization. Based on current FDA regulations, ANDAs and NDAs provide information on chemistry, manufacturing and change control, bioequivalence, packaging and labeling. The ANDA development process generally requires less time and expense for FDA approval than the NDA process. For approval of an ANDA, we must demonstrate that the product is bioequivalent to a marketed product that has previously been approved by the FDA and that our manufacturing process meets FDA standards. This approval process for an ANDA may require that bioequivalence studies be performed using a small number of subjects in a controlled clinical environment, and for certain topical generic products, demonstration of efficacy in comparative full end-point clinical studies. Depending on the specific product, other types of studies may be required by the FDA. Approval time for the industry currently averages 26.7 months from the date an ANDA is submitted. Changes to a product marketed under an ANDA or NDA are governed by specific FDA regulations and guidelines that define when proposed changes can be implemented and whether prior FDA notice and/or approval is required.
Under the Drug Price Competition and Patent Term Restoration Act of 1984 (the Hatch-Waxman Amendments to the Federal Food, Drug and Cosmetic Act), a company submitting an NDA can obtain a three-year period of marketing exclusivity for an Rx product or an Rx to OTC switch product if the company performs a clinical study that is essential to FDA approval of the NDA. Longer periods of exclusivity are possible for new chemical entities and orphan drugs. These exclusivity periods prevent other companies from obtaining approval of any ANDAs for a similar or equivalent generic product. Where three years of exclusivity is granted to the initiating company, we will be unable to market the product unless we establish a relationship with the company having exclusive marketing rights. There can be no assurance that, in the event we apply for FDA approvals, we will obtain the approvals to market Rx products.
Under the Federal Food, Drug and Cosmetic Act (FFDCA), a manufacturer may obtain an additional six months (which, under certain circumstances, may be extended to one year) of exclusivity if the innovator conducts pediatric studies requested by the FDA on the product. This exclusivity will, in certain instances, delay FDA approval and the sales by us of certain ANDA and other products.
If we are first to file our ANDA and meet certain requirements relating to the patents owned or licensed by the brand company, we may be entitled to a 180-day generic exclusivity period for that product. When a company submits an ANDA, the company is required to include a patent non-infringement certification to certain patents that cover the innovator product. If the ANDA applicant challenges the validity of the innovator’s patent or certifies that its product does not infringe the patent, the product innovator may sue for infringement. The legal action would not ordinarily result in material damages but could prevent us from introducing the product if it is not successful in the legal action. We would, however, incur the cost of defending the legal action and that action could have the effect of triggering a statutorily mandated delay in FDA approval of the ANDA for a period of up to 30 months. In addition, if exclusivity is granted to us, there can be no assurance that we will be able to market the product at the beginning of the exclusivity period or that the exclusivity will not be shared with other generic companies, including authorized generics. It is possible that more than one applicant files the first ANDA on the same day and exclusivity is shared. This may happen by chance, but more likely when there is a certain type of innovator exclusivity that prevents the filing of all ANDAs until a specific date. As a result of events that are outside of our control, we may forfeit our exclusivity. Finally, if we are not first to file our ANDA, the FDA may grant 180-day exclusivity to another company, thereby effectively delaying the launch of our product.
All facilities where Rx and OTC drugs are manufactured, tested, packaged, stored or distributed must comply with FDA cGMPs. All of our ANDA, NDA and OTC drug products are manufactured, tested, packaged, stored and distributed according to cGMP regulations. The FDA performs periodic audits to ensure that our facilities remain in compliance with all appropriate regulations. The failure of a facility to be in compliance may lead to a breach of representations made to store brand customers or to regulatory action against our related to the products made in that facility, including suspension of or delay in ANDA approvals, seizure, injunction or recall. Serious product quality concerns could also result in governmental actions against us that, among other things, could result in the suspension of production or distribution of our products, product seizures, loss of certain licenses or other governmental penalties, and could have a material adverse effect on our financial condition or operating results. In addition, several bills have been introduced in Congress that could, if enacted, affect the manufacture and marketing of Rx and OTC drugs. We cannot predict whether new legislation regulating our activities will be enacted or what effect any legislation would have on our business.
On June 25, 2007, the FDA issued Final Good Manufacturing Practice (GMP) Regulations specific to Dietary Supplements, which became effective as they relate to our company on June 25, 2008. These regulations had no significant impact on our business. We believe that we are in compliance with the regulations.
Consumer Product Safety Commission
Under the Poison Prevention Packaging Act (PPPA), the CPSC has authority to designate that dietary supplements and pharmaceuticals require child-resistant packaging to help reduce the incidence of accidental poisonings. The CPSC has published regulations requiring iron-containing dietary supplements and numerous pharmaceuticals to have child resistant packaging, and has established rules for testing the effectiveness of child-resistant packaging and for ensuring senior adult effectiveness.
The Consumer Product Safety Improvement Act of 2008 (CPSIA) amended the Consumer Product Safety Act (CPSA) to require that the manufacturer of any product that is subject to any CPSC rule, ban, standard or regulation certify that based on a reasonable testing program the product complies with such requirements. This certification applies to pharmaceuticals and dietary supplements that require child-resistant packaging under the PPPA. The CPSC has lifted the stay of enforcement of the certification requirement and the regulation has been in effect since February 9, 2010.
Federal Trade Commission
The FTC exercises primary jurisdiction over the advertising and other promotional practices of marketers of dietary supplements and OTC pharmaceuticals and often works with the FDA regarding these practices. The FTC considers whether a product’s claims are substantiated, truthful and not misleading. The FTC is also responsible for reviewing mergers between and acquisitions of pharmaceutical companies exceeding specified thresholds and investigating certain business practices relevant to the healthcare industry. The FTC could challenge these business practices in administrative or judicial proceedings. For example, in accordance with the Medicare Prescription Drug Improvement and Modernization Act of 2003, agreements between NDA and ANDA holders relating to settlements of patent litigation involving paragraph IV certifications under the Hatch-Waxman Act, as well as agreements between generic applicants that have submitted ANDAs containing paragraph IV certifications where the agreement concerns either company’s 180-day exclusivity, must be submitted to the FTC (and the United States Department of Justice) for review.
State Regulation
Most states regulate foods and drugs under laws that generally parallel federal statutes. We are also subject to other state consumer health and safety regulations that could have a potential impact on our business if we are ever found to be non-compliant. Additionally, logistics facilities that distribute generic prescription drugs are required to be registered within each state. License requirements and fees vary by state.
United States Pharmacopeial Convention
The USP is a non-governmental, standard-setting organization. By reference, the Federal Food, Drug and Cosmetic Act incorporates the USP quality and testing standards and monographs as the standards that must be met for the listed drugs, unless compliance with those standards is specifically disclaimed on the product’s labeling. USP standards exist for most Rx and OTC pharmaceuticals and many nutritional supplements. The FDA typically requires USP compliance as part of cGMP compliance.
Product Liability
The sale of pharmaceutical products can expose the manufacturer or marketer of such products to product liability claims by consumers. A product liability claim, if successful and in excess of our insurance coverage, could have a material adverse effect on our financial condition. We maintain product liability insurance policies which provide coverage in the amount $5 million per claim and $5 million in the aggregate.
Seasonality
Due to the nature of the products sold by BioZone Labs, which include cough/cold remedies, its business is cyclical. Approximately two thirds of BioZone Labs' revenue is generated in the second half of the calendar year.
Properties
Our facilities are located in Pittsburg, California and Miami, Florida. BioZone Labs manufactures its products in a 20,000 s.f., cGMP facility owned by 580 Garcia Avenue, LLC, its consolidated VIE. Also it fills and stores its products at a 60,000 sq. ft. rented facility located at 701 Willow Road, Pittsburg, CA, which provides for annual rentals of $343,470.
We lease approximately 1,500 square feet of office space at 4400 Biscayne Boulevard, Miami, Florida where we employ one sales professional for our Baker Cummins brand products. The lease expires on October 31, 2012 and provides for annual rentals of approximately $23,700.
Our rent expense for our Miami facility is as follows:
|
Monthly
|
Yearly
|
Nov 1, 2009 - Oct 31, 2010
|
$1,928
|
$23,132
|
Nov 1, 2010- Oct 31, 2011
|
$1,995
|
$23,941
|
Nov 1, 2011 - Oct 31, 2012
|
$2,064
|
$24,779
|