When used in this Form 10-K, the words "expects," "anticipates," "estimates" and similar expressions are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties, including those set forth below under "Risks and Uncertainties," that could cause actual results to differ materially from those projected. These forward-looking statements speak only as of the date hereof. Crown Marketing expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company's expectations with regard thereto or any change in events, conditions or circumstances on which any statement is based. This discussion should be read together with the financial statements and other financial information included in this Form 10-K. Readers should carefully review the risk factors described in other documents the Company files from time to time with the Securities and Exchange Commission, including the Quarterly Reports on Form 10-Q to be filed by the Company subsequent to this Annual Report on Form 10-K and any Current Reports on Form 8-K filed by the Company.
Background
Crown Marketing, a Wyoming corporation (the "Company" “us” or “we”) was incorporated on July 6, 2010 and is the successor by merger to Space Launch Financial, Inc. ("SPCL"). SPCL had its stated objective the funding of satellite launches, but did not generate any revenues in this proposed business. In July 2010, SPCL underwent a holding company reorganization under Delaware law, pursuant to which it became a wholly-owned subsidiary of SPCL Holding Corporation, and SPCL, together with its assets and liabilities, was sold to a non-affiliated third party. SPCL Holding Corporation subsequently reincorporated in Wyoming by merger into the Company.
The Company carries on all of its operations through its Wyoming subsidiary, Green4Green, which was formed on July 8, 2009, and Crown Nutraceuticals, which was incorporated on March 28, 2013. The Company, which then had 890,800 shares outstanding (including 317,100 shares held by management), acquired Green4Green (wholly owned by then Management) pursuant to an Agreement and Plan of Reorganization (the “Agreement”). The Company acquired all of the outstanding shares of Green4Green in exchange for 40,000,000 newly issued shares of the Company's Common Stock. Pursuant to the Agreement, the issued and outstanding common shares of Green4Green were exchanged on a one-for-one basis for common shares of the Company. After the merger was completed, the Green4Green shareholders owned approximately 98% of the outstanding shares of common stock of the Company. The transaction was accounted for as a reverse merger (recapitalization) with Green4Green deemed to be the accounting acquirer and the Company deemed to be the legal acquirer. As a result of the reverse merger, the historical accumulated deficit of SPCL was eliminated. Green 4Green is a wholesale distributor of generic pharmaceuticals. On September 9, 2013, the Company filed a Registration Statement on Form S-1, file no. 333-176776 containing complete "Form 10" information.
In June 2013, we acquired patent rights related to controlled release technology from an unaffiliated party. In September, 2013, the Company acquired two additional patents and related intellectual property from Farrington Pharmaceuticals, LLC, a company controlled by our President and Chief Financial Officer, by the issuance of a promissory note in the amount of $140,000 and 122,600,000 restricted shares of common stock. The intellectual property will be held by the Company's wholly-owned licensing subsidiary. The patents protect broad claims for novel controlled release technology applicable to oral and transdermal pharmaceuticals and nutraceuticals, and other applications. In March 2013, we commenced operating our nutraceutical division.
Our Business
Historically we have been engaged in the wholesale distribution of non-addictive generic pharmaceutical products to non-US distributors. With the September 2013 acquisition of the controlled release technology (CDDT), we have devoted most of our resources to (a) seeking to license CDDT to pharmaceutical companies, (b) developing one or more proprietary applications of CDDT to generic pharmaceuticals and/or over-the-counter medications, and (c) developing other applications of CDDT including the nutraceuticals market. In the last quarter of 2013, we also expanded into the nutraceutical market, by financing the marketing of diet products.
The US Pharmaceutical Industry
The following italicized text is taken from the US government website at www. www.selectusa.commerce.gov/industry-snapshots/pharmaceutical-industry-united-states:
The U.S. Pharmaceutical Industry
The United States is the world’s largest market for pharmaceuticals and the world leader in biopharmaceutical research. U.S. firms conduct 80 percent of the world’s research and development in biotechnology and hold the intellectual property rights to most new medicines. In 2010, the pharmaceutical sector employed approximately 272,000 people (source: Bureau of Labor Statistics), and according to the Pharmaceutical Research and Manufacturers of America (PhRMA), those manufacturers spent $67.4 billion on research and development in 2010.
The markets for biologics, over-the-counter (OTC) medicines, and generics show the most potential for growth and have become increasingly competitive. Biologics, valued at $67 billion in 2010 (source: IMS Health), account for a quarter of all new drugs in clinical trials or awaiting Food and Drug Administration approval. OTC market growth will be driven by a growing aging population and consumer trend to self-medication, and the conversion of drugs from prescription to non-prescription or OTC status. Generic drug sales in the United States were valued at $78 billion in 2010 (source: IMS Health).
The U.S. market is the world’s largest free-pricing market for pharmaceuticals and has a favorable patent and regulatory environment. Product success is largely based on competition in product quality, safety and efficacy, and price. U.S. government support of biomedical research, along with its unparalleled scientific and research base and innovative biotechnology sector, make the U.S. market the preferred home for growth in the pharmaceutical industry.
Industry Subsectors
Originator chemically synthesized drugs and biotechnology-derived drugs are developed as a result of extensive research and development (R&D) and clinical trials in both humans and animals. The originator relies on patents and other forms of intellectual property rights to justify the investment required tobring a product to market.
Generic drugs are duplicative copies of originator chemically-synthesized drugs that contain the same active ingredient, are identical in strength, dosage form, and route of administration. The prices of generic drugs are typically lower than the prices of originator drugs, particularly in the U.S. market where they are typically sold at a substantial discount from originator drug prices.
Over-the-Counter (OTC) drugs are distinguished from originator and generic drugs in that consumers do not need a prescription to purchase the drug. OTC drugs are considered by regulators to be safe for self-diagnosis and self-medication.
Active Pharmaceutical Ingredients (APIs) and Excipients. Medication, in dosage form, is composed of active pharmaceutical ingredients (APIs) and excipients. APIs are the ingredients that make drugs effective. Excipients are inert substances that give a medication its form, such as cornstarch (to make a tablet) or sterile water (to make a liquid) and serve as a delivery vehicle to transport the active ingredient to the site in the body where the drug is intended to exert its action.
Biosimilars, or Follow-on Biologics, are versions of biological products that reference the originator product in applications submitted to a regulatory body. With the signing into law of healthcare reform legislation in March 2010, the FDA is authorized to approve biosimilars or follow-on versions of biologic drugs that were approved under the Public Health Service Act. The FDA is in the process of developing implementing guidelines and procedures to determine the extent of testing necessary to establish similarity of a follow-on product with a reference originator biologic.
US pharmaceutical market sales were $279 billion in 2009. Pharmaceutical companies are believed to be under tremendous pressure from generics: from 2011 to 2014, drugs representing sales of $95 billion will go off patent. We believe that our technology can be viewed by the industry as a way for pharmaceutical companies to extend the value of their products using our CDDT.
Controlled Drug Delivery Issues
Our controlled drug delivery technology is patented and, we believe, revolutionizes drug delivery. Although compressed medicine tablets and medicine capsules were invented in the 19th century, the medicine pill dates from ancient times. Tablets or capsules deliver their active ingredients to the bloodstream by first dissolving in the stomach. For every drug there is an optimal therapeutic level. Too little, and the drug is less effective and even harmful (eg, with antibiotics, low amounts merely build resistance). Too much can be toxic and cause undesirable side effects. The rate at which the active ingredient is made available to the bloodstream depends on physiological factors such as stomach pH levels and the chemical characteristics of the active ingredient. Typically, drugs enter the bloodstream at a high level and the plasma concentration declines over time according to the plasma half life of the drug and the individual patient. For example, after 18-50 hours after ingestion, the blood plasma concentration of the muscle relaxant Clonazapam is half of the initial plasma concentration. Ibuprofen has a half life of 2-3 hours. Chemotherapy drug Oxaliplatin has a half life of 14 minutes.
Generally speaking, the shorter the half life, the more frequent of an administration is required; and the larger variation in blood plasma concentration (high concentration upon initial ingestion and low concentration after the passage of time). In order to ensure sufficient therapeutic levels of the drug, dosage is often a compromise between the toxicity of the initial concentration and the minimum therapeutic level required. Until CDDT, controlled drug delivery was largely accomplished primarily by chemical means. Either the active ingredient is given a dissolvable coating, is combined with fillers or excipients which slow absorption, or is provided as part of another chemical compound which metabolizes over time into the active ingredient. The principal drawbacks with using chemical means to control oral or transdermal drug delivery are that the rate of the chemical reaction varies among individuals, so that it is not precise, and secondly, formulating, testing, and regulatory approval of the chemical compound can be very expensive and lengthy, since the manufacturer must account for the interaction of the active ingredient and the chemical compound. This extended regulatory process means that a manufacturer may need to obtain regulatory approval twice: once for the original formulation of the drug, and again for the controlled release formula.
CDDT ensures that the optimum therapeutic level of the drug is available to the human body, over a longer time, often 24 hours, and does so in a simple, elegant fashion which is uniform among individuals and usually does not interact with the active ingredient, simplifying regulatory approvals.
How our CDDT Works.
The Company's CDDT works using the principle of diffusion, not via chemical means. No chemical compound or coating is required for water soluble drugs utilizing CDDT; non-soluble drugs only require employment of an emulsifier.
The tablet is formed in the shape set forth in the diagram above, and covered with an impermeable coating. An orifice is then laser drilled through the coating on the top of the tablet. The rate at which the drug exits the pill is a mathematical formula derived based on the angle of the gradient, the size of the drug molecule, and the size of the orifice. Much like gravity causes an hourglass to empty at a constant rate and time, diffusion causes our CDDT pill to release the drug at an exact, constant rate during the its passage through the gastrointestinal tract--regardless of the individual patient's gastrointestinal chemistry. Having delivered its contents, the pill is harmlessly eliminated by the body.
Since CDDT does not require the use of any chemical agent to accomplish controlled delivery, troublesome interactions with controlled release chemicals are simplified and completely eliminated with the majority of drugs which are water soluble. We believe that we can license CDDT to pharmaceutical manufacturers which seek to introduce a controlled release version of their drugs, in a more timely and cost effective manner.
We are also engaged in preliminary development of applications of CDDT to generics and over-the-counter medications and nutraceuticals which we may market and sell under our own label. The development of our own product lines would be much more costly and complicated than licensing, but would probably result in higher revenues to the Company.
Veterinary and Other Applications
We intend to develop applications of our CDDT to the veterinary industry, focusing on the home companion animals (dogs and cats). Since pet owners at times have difficulty administering medications to their pets, we believe that CDDT can enable the prescribing of one pill a day and ease patient compliance.
CDDT is also applicable to any situation in which a dosage is desired to be administered on a measured level over time, such as mosquito control in lakes and ponds.
Existing Generic Pharmaceutical Business
We will continue to devote a limited amount of our resources to developing our generic distribution business as it can eventually be synergistic with our CDDT products.
Nutraceutical Business
In March 2013, we began a venture with a non affiliated party, to market diet products including extracts of green coffee bean and raspberry ketone. Under the venture, the other party developed and paid for the product, and we paid all the media marketing costs. We received the net proceeds after the cost of the product. In the three months ended June 30, 2013, we had sales of $6,627. Sales have continued in fiscal 2014 at approximately the same level.
Employees and Outside Services
The Company's only employee at the present time is its sole executive officer and director, who devotes full time to the affairs of the Company. (See "Management"). Remaining administrative (non-policy making) officers and consultants and technical personnel such as marketing specialists are being compensated as independent contractors. We pay these persons on a contract basis as required. Manufacturing of our proprietary products will also be contracted out to independent third parties.
Intellectual Property
We currently are the assignee on two US patents relating to CDDT, both entitled “Sustained Release Delivery Systems for Solutes,” patent number -2001-0039414, expiring in 2018 and 2003-06569152, expiring in 2020.
The intellectual property supporting the CDDT is comprehensively formulated to allow for the broad application of the technology with regard to the mode of administration, the desired release pattern, the type of compounds employed and the dosage form. The resulting platform encompasses the medicinal use of the technology for the enteral and parenteral administration of drugs with provisions made for local and systemic parenteral uses. In addition, the technology can be employed to regulate time to first release of drug, extent of initial bolus release and duration of controlled release, with considerations given to the different gastric and intestinal environments. The technology is suited for the formulation of ethical and OTC drugs, including the branding of generics. Non-medicinal applications, though not explicitly addressed in this document, include the use of the technology in the areas of water treatment, odor control and experimental research.
In particular, the patent applications cover drug delivery devices that allow for linear, sustained-release of solutes with adjustable initial release kinetics. The drug delivery device is comprised of at least one dispenser having a solute reservoir element defined by a fluid-impervious or solute-impervious wall and having an orifice, source element, in fluid registry with a gradient forming element that has a release orifice. It is the gradient forming element that prevents an initial burst and release of solute while promoting controlled, prolonged near-zero-order release.
We are also in the process of developing other intellectual property and are the assignee on an additional provisional patent application relating to controlled release on a weight loss formulation
Maintaining patents, defending patents against infringement claims, and prosecuting competitors who might seek to infringe upon our patents can be costly. We have limited resources for patent litigation.
Competition
CDDT will compete with existing technologies, primarily chemical based, for the controlled release of drugs. Our competitors generally have more financial resources and longer operating history than we do. We believe that we can compete on the basis of better technology, but there can be no assurance that competitors will not attempt to design around our patent nor that new technologies could be invented. The worldwide generic pharmaceutical distribution industry is highly competitive and largely fragmented. Some of the strongest competition will likely arise from the countless online distributors that cater to regional markets.
Item 1A. RISK FACTORS.
This item is inapplicable because we are a "smaller reporting company" as defined in Exchange Act Rule 12b-2.
Item 1B. UNRESOLVED STAFF COMMENTS
Item 2. PROPERTIES
We use a limited amount of office space from our officer and director. We plan to locate approximately 500 to 1,000 square feet of dedicated office space in or near the Research Triangle area near Chapel Hill in the future.
Item 3. LEGAL PROCEEDINGS
Not Applicable.
Item 4. MINE SAFETY DISCLOSURES
PART II
Item 5.
MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
Market information and issuance of unregistered securities
The Company's Common Stock has traded on the OTC Bulletin Board under the symbol CWNM.OB since June 8, 2013. There has been limited trading of the common stock through June 30, 2013. The shares traded in the following quarters:
Quarter Ending
High
Low
September 30, 2012
.50
December 31, 2012
1.01
.10
March 31, 2013
.31
.05
.07
.04
The above quotations reflect inter-dealer prices, without retail markup, markdown, or commission and may not necessarily represent actual transactions. The last sale price of our common stock on September 27, 2013 was $.01 per share.
Holders
As of September 30, 2013, there were approximately 100 record holders of Company common stock.
Dividends
The Company has not paid any dividends on its common stock. The Company currently intends to retain any earnings for use in its business, and therefore does not anticipate paying cash dividends in the foreseeable future.
(d)
Equity Compensation Plans
Equity Compensation Plan Information as of June 30, 2013
Number of Securities
remaining available
for future issuance
Weighted Average
under equity
To be issued upon
exercise price of
compensation plans
exercise of existing outstanding options, (excluding securities
Options, warrants
warrants and
reflected in
Plan Category
and rights
column (a)
Equity compensation
--
--
plans approved by
security holders
_-
plans not approved
Total
Company repurchases of common stock during the years ended June 30, 2013 and 2012.
None
(e)
Performance Graphic. The Company is not required to provide a performance graph since it is a "smaller reporting company" as defined in Regulation S-K Rule 10(f).
Share issuances in 2013
All share issuances have been previously reported.
Item 6.
SELECTED FINANCIAL DATA
As a smaller reporting company we are not required to respond to this item.
Item 7.
MANAGEMENT'S DISCUSSION AND ANALYSIS OR PLAN OF OPERATIONS
Disclaimer Regarding Forward-Looking Statements
This Current Report on Form 10-K contains forward-looking statements within the meaning of the federal securities laws. These include statements about our expectations, beliefs, intentions or strategies for the future, which we indicate by words or phrases such as “anticipate,” “expect,” “intend,” “plan,” “will,” “we believe,” “believes,” “management believes” and similar language. Except for the historical information contained herein, the matters discussed in this “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and elsewhere in this report are forward-looking statements that involve risks and uncertainties. The factors listed in the section captioned “Risk Factors,” as well as any cautionary language in this report; provide examples of risks, uncertainties and events that may cause our actual results to differ materially from those projected. Except as may be required by law, we undertake no obligation to update any forward-looking statement to reflect events after the date of this Form 10-K.