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EX-32.1 - CERTIFICATION OF CHIEF EXECUTIVE OFFICER PURSUANT TO SECTION 906 - Independence Resources PLCdex321.htm
EX-31.1 - CERTIFICATION OF CHIEF EXECUTIVE OFFICER PURSUANT TO SECTION 302 - Independence Resources PLCdex311.htm
EX-31.2 - CERTIFICATION OF CHIEF FINANCIAL OFFICER PURSUANT TO SECTION 302 - Independence Resources PLCdex312.htm
EX-32.2 - CERTIFICATION OF CHIEF FINANCIAL OFFICER PURSUANT TO SECTION 906 - Independence Resources PLCdex322.htm
EX-10.128 - SECURED PROMISSORY NOTE FROM SKINVERA LLC - Independence Resources PLCdex10128.htm
EX-10.122 - SECURED CONVERTIBLE PROMISSORY NOTE PAYABLE TO DMRJ GROUP, LLC - Independence Resources PLCdex10122.htm
EX-10.123 - WARRANT AGREEMENT BETWEEN SENETEK PLC AND DMRJ GROUP, LLC - Independence Resources PLCdex10123.htm
EX-10.125 - COLLATERAL PLEDGE AND SECURITY AGREEMENT BETWEEN SENETEK PLC AND DMRJ GROUP LLC - Independence Resources PLCdex10125.htm
EX-10.124 - SECURITIES PURCHASE AGREEMENT BETWEEN SENETEK PLC AND DMRJ GROUP, LLC - Independence Resources PLCdex10124.htm
EX-10.126 - TRADEMARK LICENSE AGREEMENT BETWEEN SENETEK PLC AND SKINVERA LLC - Independence Resources PLCdex10126.htm
EX-10.127 - COLLATERAL PLEDGE AND SECURITY AGREEMENT BETWEEN SENETEK PLC AND SKINVERA LLC - Independence Resources PLCdex10127.htm
EX-10.129 - ASSET PURCHASE AGREEMENT BETWEEN SENETEK PLC AND SKINVERA LLC - Independence Resources PLCdex10129.htm
Table of Contents

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 10-K

(Mark One)

 

x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For The Fiscal Year Ended December 31, 2009

OR

 

¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from                      to                     .

Commission File No. 0-14691

 

 

SENETEK PLC

(Exact Name of registrant as specified in its Charter)

 

England   77-0039728

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

831 Latour Court, Napa, California, U.S.A.   94558
(Address of principal executive offices)   (Zip code)

Registrant’s telephone number, including area code: (707) 226-3900

 

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

  

Name of each exchange on which registered

None    None

Securities registered pursuant to Section 12(g) of the Act:

AMERICAN DEPOSITARY SHARES

(each American Depositary share represents

1 Ordinary share, pound sterling 0.40 par value)

(Title of Class)

 

 

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.  Yes  ¨  No  x

Indicate by check mark if the registrant not required to file reports pursuant to Section 13 or Section 15(d) of the Act.  Yes  ¨  No  x

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.  Yes  x  No  ¨

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).  Yes  ¨  No  ¨

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§ 229.405) is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K.  x

Indicate by 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):

Large accelerated filer  ¨            Accelerated filer  ¨            Non-accelerated filer  ¨            Smaller reporting company  x

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).  Yes  ¨  No  x

The aggregate market value of the registrant’s common stock held by non-affiliates of the registrant, computed by reference to the price at which the common stock was last sold, or the average bid and asked price of such common stock, as of June 30, 2009 was $8,945,588.

As of March 31, 2010, the Registrant had 7,645,802 ordinary shares outstanding, including 7,574,571 shares issued at March 31, 2010 represented by American Depositary shares.

DOCUMENTS INCORPORATED BY REFERENCE

None

 

 

 


Table of Contents

Table of Contents

INDEX

 

          Page
PART I

Item 1.

  

Business

   1

Item 1A.

  

Risk Factors

   13

Item 2.

  

Properties

   13

Item 3.

  

Legal Proceedings

   13

Item 4.

  

Reserved

   13
PART II

Item 5.

  

Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

   14

Item 6.

  

Selected Financial Data

   21

Item 7.

  

Management’s Discussion and Analysis of Financial Condition and Results of Operation

   21

Item 7A.

  

Quantitative and Qualitative Disclosures About Market Risk

   30

Item 8.

  

Financial Statements and Supplementary Data

   30

Item 9.

  

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

   30

Item 9A(T)

  

Controls and Procedures

   30

Item 9B.

  

Other Information

   31
PART III

Item 10.

  

Directors, Executive Officers and Corporate Governance

   32

Item 11.

  

Executive Compensation

   34

Item 12.

  

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

   38

Item 13.

  

Certain Relationships and Related Transactions, and Director Independence

   39

Item 14.

  

Principal Accounting Fees and Services

   39
PART IV

Item 15.

  

Exhibits, Financial Statement Schedules

   42
  

Signatures and Power of Attorney

   54


Table of Contents

FORWARD-LOOKING STATEMENTS

This Annual Report on Form 10-K contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements herein which are not of historical fact may constitute such forward-looking statements. In particular, words such as “may”, “could”, “would”, “should”, “can”, “might”, “expect”, “estimate”, “project”, “anticipate” and the like identify the statement to which they refer as forward-looking. Forward-looking statements by their nature involve substantial uncertainty, and actual results may differ materially from those expressed in such statements. Important factors identified by the Company that it believes could result in such material differences are described in this Annual Report in the sections titled “Competition”, “Government Regulation” and “Intellectual Property” on pages 7 through 11 of this Annual Report and “Management’s Discussion and Analysis of Financial Condition and Results of Operations”, on pages 20 through 30. However, the Company can give no assurance that it has identified all of the important factors that may result in material differences between actual results and its forward-looking statements, and the Company assumes no obligation to correct or update any forward-looking statements which may prove to be inaccurate, whether as a result of new information, future events or otherwise, except as may be required in connection with future reports of the Company pursuant to the Securities Exchange Act of 1934, as amended.

PART I

 

ITEM 1—BUSINESS

Overview

Senetek PLC is a life sciences company engaged in the development of technologies that target the science of healthy aging.

Senetek PLC, together with its subsidiaries (the “Company” which may be referred to as “Senetek”), is a public limited company organized under the laws of England in 1983. Senetek has three wholly-owned subsidiaries, Senetek Drug Delivery Technologies Inc. (“SSDT”) and Carmé Cosmeceutical Sciences Inc. (“CCSI”), both Delaware corporations and Senetek Denmark ApS, formed by Senetek under the laws of Denmark.

For detailed financial information, please consult the Company’s financial statements included in this Annual Report.

The Company’s corporate website, www.senetekplc.com, is currently under construction. During this construction, Senetek’s Annual Report on Form 10-K for the 2008 fiscal year, its interim financial reports of Form 10-Q for fiscal 2009 and 2008, and other SEC filings may be obtained from the Company in electronic or paper format free of charge by writing the Company at ir@senetek.net or at Senetek Investor Relations, 831-A Latour Court, Napa, California, 94558.

Subsequent Events

In March 2010, Senetek and DMRJ Group, LLC, effected a Security Purchase Agreement, a Note and a Warrant Purchase Agreement (“Transaction”). DMRJ Group, LLC is a Delaware limited liability company affiliated with Platinum Partners Value Arbitrage Fund L.P., an accredited institutional investor with its investment manager headquartered in New York, New York.

In conjunction with the Transaction, the Company issued a Secured Convertible Promissory Note to DMRJ in the principal amount of $3.0 million, which bears no interest and is convertible at a price of $1.25 per share at any time from inception to the fifth anniversary of the Note, at which time conversion is mandatory. Except in the event of default, the Note is not repayable in cash. In addition, the Company issued a five-year warrant to

 

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purchase 1.8 million of the Company’s ordinary shares at an exercise price of $1.75 per share. As a result of these transactions, DMRJ has effective control of Senetek and its subsidiaries.

In connection with the Transaction, Frank J. Massino was terminated without cause as Chief Executive Officer and resigned as Chairman of the Board of Directors. Mr. Massino has been retained as a part-time consultant for a three year period to assist in management of certain of the Company’s existing investments and interests, for which he was paid $360,000. Also, William F. O’Kelly was terminated without cause as Chief Financial Officer and Mr. Rodger Bogardus resigned from the Board of Directors. In addition on March 10, 2010, the effective date of the Transaction, all options to purchase Ordinary Shares held by the Company’s officers and directors as of December 1, 2009 became immediately vested and were extended for five years with re-pricing of the exercise price to $1.25 per share or the Market Price on the date of the Transaction, whichever is greater.

John P. Ryan has been appointed to succeed Mr. Massino as Chief Executive Officer and Chairman of the Board of Directors. In addition, Mr. Howard Crosby has been appointed to succeed Mr. O’Kelly as the Chief Financial Officer and to the Board of Directors and Dr. Wesley Holland has been appointed to the Board of Directors.

The Company developed, in consultation with its strategic advisor, Miller Tabak + Co., LLC, a new business strategy to bring revenue, profits and a positive opportunity for Company shareholders. As part of that strategy, the Company decided to divest itself of its skincare business. In conjunction with the Transaction, the Company executed an Asset Purchase Agreement and a Note with Skinvera LLC, a company wholly owned by Frank J. Massino, former Chairman and Chief Executive Officer of the Company, whereby Skinvera purchased all assets and assumed all existing liabilities of the Company’s skincare business (except for assets and liabilities related to Kinetin and Zeatin) and received $1.8 million in cash in return for a $1.8 million Secured Promissory Note which bears interest at 6% per annum and is due on the seventh anniversary of the Note. The Asset Purchase Agreement includes provisions for royalty payments to the Company from Skinvera based on 5% of net direct sales of skincare products and 10% of net skincare royalties; up to a maximum of $5 million. The Company and Mr. Massino have agreed to amend the Asset Purchase Agreement such that in the event of a near-term transaction resulting in (i) the change of control, directly or indirectly, of at least 50% of the equity interests in the Purchaser (as defined in the Asset Purchase Agreement), other than a transfer to a certain affiliate of the Purchaser, or (ii) the sale of substantially all of the Assets (as defined in the Asset Purchase Agreement), the Company shall be entitled to receive (i) 50% of the after-tax purchase price paid to the Purchaser if such sale occurs on or before March 10, 2011 or (ii) 25% of the after-tax purchase price paid to the Purchaser if such sale occurs between March 10, 2011 and March 10, 2012. The loss on the Transaction has not been finalized but is expected to be no less than $331,000 and will be recorded in the first quarter of 2010.

The Company has determined that the skincare segment does not meet the criteria for classification as discontinued operations at December 31, 2009 because the company did not make a decision or have a plan to sell the assets at December 31, 2009. The Company has determined that a sale has occurred during the first quarter of 2010 that will require classification as discontinued operations.

On April 1, 2010, Senetek consummated the purchase for $5.0 million from a partnership that is majority owned by Platinum Partners Value Arbitrage Fund (“Seller”) of the interest in $7.0 million of amounts owed to Seller pursuant to outstanding notes (the “Notes”) and contractual rights (the “Rights”, together with the Notes the “Seller Claims”). The amounts are owed to Seller from an entity (the “Debtor”) focused in the area of natural resources which has filed a petition in the United States Bankruptcy Court. The debtor is a company called Firstgold Corporation and the main asset of Firstgold is the Relief Canyon Mine located near Lovelock, Nevada. Further information on Firstgold and Relief Canyon Mine can be obtained at the website www.firstgoldcorp.com. As disclosed above, on March 10, 2010, Senetek consummated a $3.0 million convertible note financing pursuant to a Securities Purchase Agreement, dated March 4, 2010, with DMRJ Group, LLC, a Delaware limited liability company, an entity affiliated with Platinum Partners Value Arbitrage

 

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Fund L.P and the Seller. The purchase amount for the Seller Claims was determined based upon arms length negotiations between the parties. Senetek received only the following representations from the Seller in substantially the following form: (i) Seller has good and valid title to the Notes and has not pledged or transferred the Notes, or any of the Claims, to any third party, and (ii) upon acquisition of Senetek’s interest in the Seller Claims as contemplated hereby, Senetek will acquire such interest free and clear of any liens or encumbrances made by or through Seller; (iii) Debtor has not in its bankruptcy action, as of the date hereof, contested the validity, perfection or priority of any security interest in collateral securing the Seller Claims and (iv) no consent or filing with the court having jurisdiction in the bankruptcy action is necessary or required in connection with the sale of the Senetek interest in the Seller Claims.

Product Pipeline and Technology

Product Pipeline

Historically, the Company’s strategy had been to leverage its available research and development resources by channeling its efforts through research agreements with third-party consultants, clinicians and research scientists having particular expertise in its areas of interest with a direct focus on getting its products into the market. In 2007, the Company turned its focus to marketing and selling the Pyratine skincare line of products. In conjunction with a transaction in March 2010 (refer to Note 16 to the Consolidated Financial Statements), the Company transferred the assets and liabilities relating to its skincare line, with the exception of assets and liabilities related to Kinetin and Zeatin, to Skinvera LLC (“Skinvera”), a company wholly owned by Frank Massino, former CEO of the Company. In consideration of the sales of the assets to Skinvera, Senetek will receive royalties on all net sales and gross licensing fees received by Skinvera up to the maximum royalties due from Skinvera of $5,000,000. Below Senetek will discuss the status relating to intellectual property and rights retained following this transaction.

Cancer Therapy

In 2006, the Nobel Prize was awarded to two American scientists for the discovery of the molecular mechanism behind RNAi. That mechanism within RNA allows for the regulation of gene expression, and represents a new model in genetic therapies for the treatment of cancers and neurological disorders.

In November 2006, Senetek acquired a royalty-based license for RNAi from the Institute of Bio-Organic Chemistry of the Polish Academy of Sciences (PAS). This agreement grants Senetek the exclusive rights to anti-cancer technology for the treatment of brain tumors using interference RNA. The treatment developed by the Institute in cooperation with the Department of Neurosurgery and Neurotramatology, University of Medical Sciences in Poznan, Poland uses RNA interference technology to inhibit the production of tenascin-C, whose expression has been indicated to correlate with the grade of malignancy of brain tumors. Recently, in human clinical trials in Europe, the technology has demonstrated success, based on increased survival rates, in the treatment of patients with glioblastoma.

In December 2008, Senetek acquired a royalty-based license from the PAS for exclusive rights to a new and promising tumor treatment using an RNAi based therapeutic technology for the potential use against a broad range of cancers. This technology, which specifically targets a novel cancer biomarker, was developed by the Institute in cooperation with Department of Neurosurgery and Neurotraumatology University of Medical Sciences in Poznań, Poland. Recent advancements in this technology have developed and are expected to continue in 2010.

The Company’s commercial strategy with respect to these treatments is to partner with a pharmaceutical or RNA specialty company for development, testing and marketing.

 

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Technology

Science Advisory Board and Scientific Collaboration

The Company’s Scientific Advisory Board is headed by Professor Brian Clark, Ph.D., Sc.D. Professor Clark is the discoverer of Initiation Codon for Protein Synthesis, 1965/1966 and the First Crystallization of tRNA, 1968; Head of the European Chinese Biotechnology Transfer Task Force and Past President of the International Union of Biochemistry and Molecular Biology. Board members include:

 

   

Sir John Walker, Ph.D., F.R.S.

Nobel Prize in Chemistry, 1997; Expert in Nutrition & Aging

 

   

Professor Claudio Francheschi, M.D.

Professor, University of Bologna and Scientific Director of the Italian National Research Center on Aging-Department of Gerontological Studies, Bologna, Italy

 

   

Dr. Gerald Weinstein, M.D., Clinical Investigator

University of California Department of Dermatology, Irvine (Emeritus); World Renowned Expert on Photo Damaged Skin and Psoriasis

Scientific collaborators to the Company include:

 

   

Professor Miroslav Strnad

Director, Institute of Experimental Botany, Olomouc Czech Republic

 

   

Professor dr. hab. Jan Barciszewski

Institute of Bioorganic Chemistry, Polish Academy of Sciences, Poznań, Poland

In May 2006, the Company finalized its participation in a consortium named PROTEOMAGE to study evolutionarily conserved mechanisms of aging using advanced proteome analysis. The consortium is comprised of 19 members, principally leading government- and university-based research centers, including the University of Aarhus, which is Project Coordinator, the Austrian Academy of Science, the University of Paris, University College London, the University of Cambridge and the Shanghai Institutes for Biological Sciences, as well as three commercial enterprises including Senetek’s research subsidiary, Senetek ApS, Denmark.

In 2006 the consortium received a 10.7 million Euro grant from the European Commission to be used over a five year period to gain insights into the molecular mechanisms of healthy aging. Consortium members use a proteomic analysis of aging processes in a variety of aging models, including human cell cultures, to study such aging-related activities as changes in protein concentration and protein modification, protein networks and interactions, signaling mediated by extracellular proteins, and protein turnover and degradation. It is hoped that these studies will lead to new protocols for early diagnosis and intervention in age-associated conditions, many with commercial implications. Among the areas to be studied are identification of plant extracts and compounds that stimulate proteasome activity with reduced levels of oxidized and other damaged proteins, and identification of natural and synthetic small molecules that stimulate cellular protein degradation machinery.

Among the benefits of consortium membership is access to a wide range of leading edge know-how and research results and the possibility of forming commercial collaborations with other project participants.

The Company’s research and development expenditures amounted to $1,275,000 and $1,141,000 in 2009 and 2008, respectively. See Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations”. The Company expects research and development spending to decrease significantly as a result of the March 10, 2010 Asset Purchase Agreement with Skinvera LLC. Research and development expenditures associated with cancer therapy are expected to be minimal as the Company intends to partner with a pharmaceutical or an RNA specialty company to fund these costs. Research and development expense associated with Invicorp® are expected to increase as the Company plans to start production of commercial and named patient supplies in Germany for testing and development in Denmark and the United Kingdom. These supplies

 

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will become available in late 2010. Responsibility for new product development for monoclonal antibodies is borne by Senetek’s partner, Covance Antibody Services, Inc.

Commercial Products

Diagnostic Monoclonal Antibodies

In 1995, the Company entered into a license agreement with the Research Foundation for Mental Hygiene (“RFMH”), an agency of the State of New York, under which the Company was granted exclusive rights to certain of RFMH’s cell lines capable of producing monoclonal antibodies for research on various diseases including Alzheimer’s Disease. The license was to expire 10 years from inception as to the cell lines originally covered and, as to cell lines subsequently added to the license, 10 years from their inclusion. Until mid 2000, the Company marketed these cell lines to major pharmaceutical companies, but in that year it decided to enter into an agreement for the remaining term of the RFMH license with Signet Laboratories, Inc. (“Signet”), a leading medical diagnostic and research company, under which Signet assumed the marketing of these monoclonal antibodies and development of new antibodies and assays based on the cell lines covered by the RFMH license, with Senetek to receive percentages of Signet’s net sales, subject to certain minimum royalty guarantees, and Senetek to remit a portion to RFMH in accordance with the terms of its license.

In May 2004, the Company entered into an interim extension of its agreement with RFMH and in April 2005, the Company entered into a further amendment of the agreement with RFMH under which the licenses on all existing cell lines and any new cell lines were extended through July 10, 2011, subject to renewal, on substantially the same terms with a guaranty of royalty receipts to RFMH of $430,000 per year through the new term of the license. In connection therewith, the Company entered into a new agreement with Signet, effective as of April 1, 2005 for its continued manufacture, marketing and sale of all monoclonal antibodies produced from the cell lines licensed by RFMH on revised royalty terms but subject to a guaranty that the Company’s net revenue from such sales would not be significantly less than under the original agreement, for the term of the new agreement.

In May 2006, the Company agreed to assign the Signet agreement to Covance Antibody Services, Inc. (“Covance”) in conjunction with Covance’s acquisition of Signet.

Under the Company’s agreement with Covance, the Company is entitled to receive from Covance 60% of the first $2,000,000 in annual net sales of licensed products and 35% thereafter in order for Covance to remain the exclusive distributor. Should Covance not attain their minimum sales goal of $1,880,000, it has the right to cure by making a payment to Senetek in the fourth quarter in the amount equal to 33% of the amount by which Covance’s net sales are less than $1,880,000. In any case, the Company is entitled to a minimum in total payments from Covance of $860,000 per year. Under the Company’s license agreement with RFMH, RFMH is entitled to receive from Senetek 27% of Covance’s net sales of licensed products, with a minimum annual total of $430,000. In 2009 and 2008, Covance exceeded their minimum sales goal and Senetek met its annual minimum to RFMH.

Erectile Dysfunction

Invicorp® is a highly safe and effective treatment for erectile dysfunction (“ED”), a condition that affects more than 100 million men worldwide. Invicorp®, a combination of vasoactive intestinal peptide (“VIP”) and phentolamine mesylate (“PMS”), has shown excellent results in a wide range of patients, many of whom have failed on other therapies for the treatment of ED. VIP is a 28-amino-acid peptide found naturally in the male and female urogenital tracts, as well as in the central and peripheral nervous systems. It causes erection by binding to smooth-muscle receptors in the corpus cavernosum, inducing smooth-muscle relaxation and increased blood flow. In completed Phase III clinical trials conducted in the United Kingdom, Denmark, Ireland and Australia, Invicorp® demonstrated outstanding efficacy and safety. The most frequently reported side effect was transient facial flushing, which typically subsided within minutes after use.

 

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Unlike many other ED therapies, Invicorp® has no known contraindications. Other significant advantages include: rapid onset of erection after stimulation—typically within two-to-five minutes; the ability to induce an erection up to 2 1/2 hours after administration with natural termination of an erection after ejaculation, as well as efficacy in the treatment of organic ED. Invicorp® is self-administered using a refillable syringe a novel, yet uncomplicated, disposable drug delivery system, Reliaject®, in each case using a super-fine 30 gauge needle for ease of administration (not possible with existing injectable therapies).

In a study released in 2002 of treatment options for Erectile Dysfunction, Decision Resources, Inc., a company providing in-depth research on trends, emerging developments, and market potential in various healthcare industry sectors, indicated the medical community’s enthusiasm for Invicorp®. Among the findings, the study showed that intracavernous injection therapies will continue to be the most effective second-line treatments for moderate-to-severe ED (after oral therapies have been attempted and for patients for whom oral therapies are contraindicated, such as diabetics and hypertension sufferers). Based on physician enthusiasm, the treatment’s high therapeutic index and advantages over current oral therapies, the study predicted that Invicorp® could become the alternative therapy of choice.

Invicorp® could capture a significant share of the moderate-to-severe ED market and become the therapy of choice for second-line ED treatment. Invicorp® is also expected to become first-line treatment for those with diabetes, heart disease and severe organic ED.

In June 2004, the Company entered into an exclusive license with Ardana Bioscience Ltd, a London Stock Exchange traded specialty pharmaceuticals company dedicated to improving reproductive health, for Ardana to manufacture and market Invicorp® in the European Union and European Free Trade Area. Under the license agreement, Ardana assumed full financial responsibility for completing the European drug regulatory process for Invicorp® and seeking national marketing approvals throughout Europe. The license agreement provides for Senetek to receive royalties that potentially reach 12% based on Ardana’s and its sub-licensees’ net sales of Invicorp® plus milestone payments upon regulatory approvals in specified major markets and achievement of specified cumulative net sales in Europe. Under its agreement, Ardana had certain rights with respect to the manufacture and marketing of Invicorp® in other world markets.

Invicorp® was approved for marketing in Denmark in December 2006 under the European Mutual Recognition Procedure (“MRP”) and Ardana began commercial sales of Invicorp® in Denmark and an effort to seek national marketing approvals throughout Europe.

Effective June 27, 2008, the license was terminated pursuant to Senetek’s contractual rights, precipitated by Ardana’s entry into voluntary administration. All rights to manufacture and market Invicorp® in the European Union and European Free Trade Area reverted back to Senetek along with rights with respect to the manufacture and marketing of Invicorp® in other world markets.

In February 2006, the Company entered into an exclusive license with Plethora Solutions Holdings PLC, an AIM London Stock Exchange traded specialty pharmaceuticals company focused on the development and marketing of products for the diagnosis, treatment and management of urological disorders, to manufacture and market Invicorp® in North America. Under the terms of the license agreement, Plethora assumes full financial responsibility for the drug regulatory process for Invicorp® in North America and for establishing this important new therapy in the key North American market, and was granted certain rights with respect to the manufacture and marketing of Invicorp® in other world markets, subject to any prior rights. The license agreement provides for Senetek to participate in the success of Invicorp® through royalties based on Plethora’s and its sub-licensees’ net sales of Invicorp® plus predetermined milestone payments upon achievement of regulatory approvals and cumulative net sales targets.

In 2009 Plethora had several positive interactions with the U.S. Food and Drug Administration that helped further refine the final development program. This has resulted in the removal of certain regulatory hurdles.

 

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Orphan drug status which potentially will accelerate regulatory filing has not yet been obtained but a decision is anticipated in early 2010. An opportunity to market the product under a treatment IND is also being explored.

The Company plans to start production of commercial and named patient supplies in Germany for further testing and development in Denmark and the UK. These supplies are expected to be available late in 2010. Four companies have expressed an interest in the European Union (EU) rights to Invicorp®; Senetek is currently in negations with one of these companies.

Drug Delivery Technology

Senetek developed and patented Reliaject®, a unique auto-injector which employs an ultra-fine gauge needle, preset to achieve the appropriate penetration before drug flow occurs, thereby reducing reliance on the patient’s technique for accuracy and safe delivery. Reliaject® can be adapted for self-administration of a broad range of parenteral drugs including epinephrine, the leading therapeutic agent for the treatment of anaphylaxis, a severe allergic reaction that occurs in response to food, insect venom or medication.

The Company believes that the greater ease of use and patient comfort associated with Reliaject® provides competitive advantages over Epipen®, the leading autoinjector currently marketed for anaphylaxis, accounting for sales of over $250 million a year in North America alone. Reliaject® is well suited to other injectable therapies including Senetek’s Invicorp® for the treatment of ED. Senetek has entered into a partnership with Ranbaxy Pharmaceuticals Inc., for the commercialization of Reliaject®.

In March 2006, the Company sold to Ranbaxy Pharmaceuticals Inc. all of its patents, trademarks and automated manufacturing equipment for the Reliaject® device. The Company received a down-payment of $500,000 and under the terms of the sale agreement, the Company is to receive additional milestone payments based on regulatory approvals and cumulative sales targets. In addition, the Company is to receive a specified percentage (similar to a set royalty) for a period of 15 years on Ranbaxy’s and its licensees’ quarterly net sales in North America of Reliaject® pre-filled with either epinephrine or six other scheduled parenteral drugs (including Invicorp®). Percentages will be negotiated on its net sales in any other markets for which it may be licensed and on its net sales in North America of Reliaject® pre-filled with non-scheduled parenteral drugs. Under the agreement, Ranbaxy is assuming all expenses of obtaining regulatory approvals and of marketing the product, and will be making significant infrastructure investments, including building out the required clean room suites at its New Brunswick, New Jersey facility to house the highly automated Reliaject® production line. Ranbaxy is targeting commercialization of Reliaject for 2010. Ranbaxy Pharmaceuticals is a wholly-owned subsidiary of Ranbaxy Laboratories Limited, a worldwide generic pharmaceutical company and a leader in development and marketing of new delivery methodologies for proven drugs.

Ranbaxy is continuing its efforts to commercialize Reliaject® and recently overcame a key obstacle with sterility issues in its manufacturing process. Next Ranbaxy will work to finalize stability for epinephrine.

Skincare and Dermatological Therapeutics

Kinetin and Zeatin

The Company developed and patented Kinetin (N6-furfuryladenine), a first generation cytokinin and its analogue Zeatin.

Through March 30, 2007, Senetek licensed Kinetin to 10 companies, including Valeant Pharmaceuticals International (“Valeant”), Revlon and The Body Shop, in various channels of distribution and geographies and licensed Zeatin exclusively to Valeant.

On March 30, 2007, Senetek terminated its existing license agreement with Valeant and entered into a new license acquisition agreement with Valeant (“License Acquisition Agreement”). Under the terms of the License

 

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Acquisition Agreement, the Company granted Valeant a paid up license for its Kinetin and Zeatin compounds and assigned to Valeant future royalties from other Kinetin license agreements to which it was a party, in return for a cash payment of $21 million, a waiver of $6 million in future marketing credits the Company otherwise would have owed Valeant, and a right to share in half of the future royalties due Valeant from other Kinetin licensees through 2011.

This right to share future royalties with Valeant was excluded from the partial transfer of skincare to Skinvera LLC (refer to Note 16 to the Consolidated Financial Statements for details of the transfer).

Marketing and Manufacturing

Marketing

In the case of Monoclonal Antibodies, the Company’s commercial partner has undertaken full responsibility for sales, distribution and marketing, as well as regulatory compliance. In the case of Invicorp®, the Company will begin manufacturing, distribution and sales in 2010. In the case of cancer therapy, the Company intends to partner with a pharmaceutical or an RNA specialty company to help fund these costs.

Manufacturing

With regard to the Company’s ED medication, Invicorp®, the Company plans to begin manufacture of the product in mid-2010; distribution and sale is expected to begin in late-2010. The active ingredients, VIP and PMS, are currently available from suppliers in quantities believed to be adequate for its manufacture in Germany and distribution and sale in Denmark and the UK. These suppliers have developed synthetic production methods that are included in the product marketing application updates with regulatory authorities in Europe. Management believes that, should these suppliers become unavailable or unable to supply in required volumes, alternative sources of approvable supplies are available, although the Company could experience regulatory delays associated with qualifying the new active ingredient manufacturers. There is only one manufacturer qualified to produce Invicorp®, however management believes the risk is low that Senetek will be unable to manufacture, distribute and sell Invicorp®.

Covance Antibody Services Inc. manufactures and sells the monoclonal antibodies produced from the cell lines licensed to us.

Competition

The Company’s current revenue is derived from agreements for the manufacture and sale of monoclonal antibodies used in research. Regarding the Company’s ED product, Invicorp®, assuming necessary marketing approvals are obtained; the Company or its commercial partners will compete directly with other companies having established ED injectable products in the marketplace, including Pfizer, Schwarz Pharma, and Vivus, which market Caverject®, Edex® and Muse®, respectively. However, although management believes Invicorp® offers advantages over these therapies including a favorable side effect profile, high level of efficacy in organic ED, natural erection and termination, and shorter time to onset. Pfizer, the manufacturer of the oral sildenafil product Viagra®, and two other recent market entrants, Eli Lilly’s Cialis® and Bayer/GlaxoSmithKline’s Levitra®, control the bulk of the ED therapy market, which currently represents in excess of 92% of the worldwide ED market. However, the Company considers Invicorp® to be complementary to, rather than competitive with, these oral therapies as it addresses the needs of patients for whom the oral therapies are contraindicated, not effective or not well-tolerated. Reliaject® is the proprietary autoinjector technology sold to Ranbaxy in 2006 in which the Company has retained continuing rights to participate in net sales and product milestones, assuming necessary marketing approvals are obtained. Ranbaxy will compete directly with King Pharmaceuticals’ Epipen®, the leading autoinjector currently marketed for anaphylactic shock. Management believes that the greater ease of use and patient comfort associated with Reliaject® could provide Ranbaxy with significant competitive advantages over Epipen® for this market as well as in the military and homeland security

 

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sectors for administration of antidotes to chemical and biological agents. The monoclonal antibody market is diverse and fragmented throughout the world and the monoclonal antibodies sold by any one source, including Covance, represent a very small percentage of the total market.

The life science industry, including biopharmaceutical, pharmaceutical and cosmeceutical industries is highly competitive. The Company competes and will continue to compete with research and development programs at biotechnology, biopharmaceutical, pharmaceutical and cosmeceutical companies, as well as academic institutions, government agencies and public and private organizations throughout the world. Virtually all of its existing or potential competitors have substantially greater financial, technical and human resources than Senetek’s. The Company’s commercial competitors have the capability and resources to develop or acquire and market products that compete with its existing and planned products, and the timing of the market introduction of its own and its competitors’ products will be important competitive factors affecting its future results.

The Company cannot predict the extent to which any of the pharmaceutical products the Company currently out-licenses or has sold with ongoing payment rights, will become commercially viable. Assuming that these products are approved for sale in a sufficient number of countries in which approvals are sought, management believes that competition for Invicorp® will be based, among other things, on product efficacy, ease of administration, convenience, speed of onset and third party reimbursement, while competition for Reliaject® will be based, among other things, on price, entry into additional therapeutic categories and marketing acumen. The Company’s competitive position and ability to remain viable in the future also will depend upon its ability to contract for effective and productive research and attract and retain qualified personnel to develop and effectively exploit the results of such research. The Company expects competition to intensify in all fields in which the Company is involved.

Government Regulation

General

The research, pre-clinical development, clinical trials, manufacturing and marketing of the pharmaceutical products are subject to extensive regulation, including pre-marketing approval requirements, of the FDA and equivalent foreign regulatory agencies. Product development and approval within this regulatory framework take a number of years and involve the expenditure of substantial resources. Many products ultimately do not reach the market because of toxicity or lack of effectiveness as demonstrated by required testing. Furthermore, regulatory agencies may suspend clinical trials at any time if it is believed that the subjects participating in such trials are being exposed to unacceptable health risks. In addition, there can be no assurance that this regulatory framework will not change or that additional regulations will not arise at any stage during product development that may affect approval, delay an application, or require additional expenditures. Accordingly, the Company cannot assure that the regulatory requirements for the commercialization of Reliaject® and Invicorp® will be completed successfully within any specified time period, if at all, or that pre-marketing approvals will be granted.

The business comprising the Company’s skincare and dermatological therapeutic products does not currently include any prescription drugs and therefore is generally is not subject to pre-marketing approval. However various statutes and regulatory restrictions apply to this business in the United States and most other countries.

Product Approval—United States

In the United States, the Federal Food, Drug and Cosmetic Act and the Public Health Service Act govern the testing, manufacture, safety, efficacy, labeling, storage, record keeping, approval, advertising and promotion of the Company’s pharmaceuticals. The steps required before a pharmaceutical product may be marketed in the United States include:

 

   

Preclinical laboratory testing;

 

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Submission to the FDA of an Investigational New Drug Application which must become effective before human clinical trials may commence;

 

   

Adequate and well-controlled human clinical trials to establish the safety and efficacy of the drug;

 

   

Submission of a New Drug Application to the FDA; and

 

   

FDA approval of the New Drug Application prior to any commercial sale or shipment of the drug.

Clinical trials of new pharmaceuticals in humans are designed to establish both the safety and the efficacy of the pharmaceutical in treating a particular disease or condition. These studies are usually conducted in three phases of testing. In Phase I, a small number of volunteers are given the new compound in order to identify toxicities and characterize the compound’s behavior in humans. In Phase II, small numbers of patients with the targeted disease are given the compound to test its efficacy in treating the targeted disease and to establish dose levels. Phase III studies are large-scale studies designed to confirm a compound’s efficacy for the targeted disease and identify toxicities that might not have been seen in smaller studies. Once adequate data have been obtained in clinical testing to demonstrate that the compound is both safe and effective for the intended use, all available data is submitted to the FDA as part of the New Drug Application.

Senetek’s Investigational New Drug application to the FDA for Invicorp® was withdrawn. Under the terms of its license agreement with Plethora Solutions, it has agreed to assume all regulatory responsibility and cost in North America, which will include meetings with the FDA to discuss reinstatement of the Investigational New Drug application and the clinical trials and other support that would be required for approval, while there can be no assurance that this effort ultimately will be successful.

In 2009 Plethora had several positive interactions with the US Food and Drug Administration that helped further refine the final development program. This has resulted in the removal of certain regulatory hurdles. Orphan drug status which potentially will accelerate regulatory filing has not yet been obtained but a decision is anticipated in early 2010. An opportunity to market the product under a treatment IND is also being explored.

The Company plans to start production of commercial and named patient supplies in Germany for further testing and development in Denmark and the UK. These supplies are expected to be available late in 2010. Four companies have expressed an interest in the European Union (EU) rights to Invicorp®; Senetek is currently in negations with one of these companies.

Current FDA regulations govern the manufacture, labeling, advertising and marketing of over-the-counter drug products covered by the Federal Food, Drug and Cosmetics Act, which are required to obtain pre-market approval if they do not fall within the parameters of FDA-issued “monographs”. These regulations cover sunscreen products, including certain products of the Company’s existing licensees. Currently, such regulations do not apply to non-drugs, though the FDA does regulate issues such as labeling and has the power to seize products found to be mislabeled or adulterated.

There can be no assurance that the Federal Food, Drug and Cosmetics Act or the regulations thereunder will not be changed so as to increase the pre-marketing approval and pharmacovigilence requirements for products subject to regulation as drugs or to subject non-drug products to increased regulation.

Product Approval—Other Countries

Marketing of pharmaceutical products in other countries requires regulatory approval from the notified bodies in each particular country. The current approval process varies from country to country, and the time to approval may vary from that required for FDA approval, although the review of clinical studies by regulatory agencies in foreign jurisdictions to establish the safety and efficacy of the product generally follows a similar process to that in the United States. Similarly, non-pharmaceutical products generally are not subject to pre-marketing approval requirements in foreign countries although they are regulated in a manner similar to the

 

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United States and, in the case of certain countries such as Japan, such products may require reformulation to remove ingredients, such as certain preservatives, not considered acceptable by the particular country.

Invicorp® was approved for marketing in Denmark in December 2006 under the MRP. Following Denmark’s approval of the MRP dossier for Invicorp® and release of translated copies to those Member States selected to receive it, such Member States will have a period in which they may review and comment upon the dossier, following which each State may grant or withhold marketing authorization or impose conditions or limitations upon such authorization. No assurance can be given as to the number of Member States that will ultimately authorize marketing by Ardana following release of the MRP dossier.

Effective June 27, 2008, Ardana’s license was terminated pursuant to Senetek’s contractual rights, precipitated by Ardana’s entry into voluntary administration. All rights to manufacture and market Invicorp® in the European Union and European Free Trade Area reverted back to Senetek along with rights with respect to the manufacture and marketing of Invicorp® in other world markets. The Company is currently seeking a new partner for the European Union and European Free Trade Area.

Post-Approval

The marketing and manufacture of pharmaceutical products are subject to post-approval regulatory review, and later discovery of previously unknown problems with a product, manufacturer or facility may result in the regulatory agencies requiring further clinical research or imposing restrictions on the product or the manufacturer, including withdrawal of the product from the market. Additionally, any adverse reactions or events involving such products must be reported to these agencies. Previously unidentified adverse events or an increased frequency of adverse events occurring post-approval could result in labeling modifications, additional contraindications and other restrictions that could adversely affect future marketability. Ultimately, marketing approvals may be withdrawn if compliance with regulatory standards is not maintained or if a product is found to present an unacceptable risk. Any such restriction, suspension or revocation of regulatory approvals could have a material adverse effect on us.

Third-Party Reimbursement

Management believes that the availability of third-party reimbursement of all or a portion of the cost of Invicorp® and RNA interference cancer therapy may affect the overall marketability of the products.

In the United States, government-funded and private insurance programs reimburse or pay directly all or a portion of the cost of many medical treatments, prescription drugs and medical devices. The U.S. Health Care Financing Administration (“HCFA”) sets reimbursement policy for the Medicare program in the United States, and has established a national coverage policy for the diagnosis and treatment of ED in Medicare beneficiaries. Private insurance coverage for ED treatment, however, varies widely across the United States, and the introduction and popularity of Pfizer’s Viagra® resulted in some plans establishing broad coverage exclusions for ED treatment. It is not clear whether such plans would include injectable therapy for moderate to severe ED within the same exclusion as these oral therapies.

Outside of the United States, most third-party reimbursement programs are governmentally funded. In some countries, no reimbursement currently is made for ED therapy, while other countries limit the amount of reimbursement or limit reimbursement to ED treatment that is related to specific other medical conditions. In addition, in certain European countries, the sales price of a product must be approved. The pricing review period often begins after market approval is granted. Restrictions on the pricing of Invicorp® could adversely affect the profitability of the product.

 

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Intellectual Property

The Company relies on a combination of patents, trade secrets, trademarks and confidentiality agreements to protect its business interests. It believes that patents are of material importance to the success of its business model and that trademarks are also of significance. The Company’s strategy is to consider new products and compounds only if they are patentable and to file patent applications to protect inventions and improvements considered important to the development of its business in the principal countries where protection from manufacture or marketing of infringing products is commercially warranted. As of December 31, 2009, the Company held 89 issued patents and 1 pending patent applications, comprised of patents covering certain combinations of active ingredients for the treatment of ED, granted in 34 countries, patents for the class of cytokinins including Kinetin and Zeatin for ameliorating the effects of aging on skin, granted in 31 countries and pending in one other country, patents for such cytokinins for ameliorating the effects of hyperproliferative skin diseases, including psoriasis, granted in 16 countries, and 22 pending patent applications for composition of matter and use in skin treatment for the class of cytokinins including Pyratine-6™, Pyratine XR™ and other pipeline compounds. As a result of the March 2010 Transaction, the 22 pending patent applications relating to Pyratine-6™ and Pyratine XR™ were transferred to Skinvera LLC.

It is noted, however, that patents, including those for pharmaceuticals and skincare ingredients, generally involve complex legal and factual issues. In the United States, for example, the first inventor to conceive and document a novel invention is generally entitled to patent it, even if another person who subsequently conceived the invention was the first person to file a patent application on it. This issue of priority of invention may be further complicated by the fact that patent applications in the United States are not published until 18 months after filing. Accordingly, a patent-holder may be subject to interference proceedings in the U.S. Patent and Trademark Office (“PTO”) long after the patent was issued based upon another party’s claim of earlier invention. Furthermore, as only novel and unobvious inventions are patentable, a patent-holder may be subject to proceedings in federal court attacking the validity of the patent based on alleged obviousness in view of the “prior art”, or on alleged improprieties in prosecuting the patent in the PTO. Issues of novelty and abuse of patent also may arise under the laws of most foreign countries in which the Company holds patents or has filed patent applications. The Company has successfully defended against claims of invalidity and unenforceability of its patents covering Kinetin and Zeatin. However, while it believes that its patents are valid and enforceable, there can be no assurance that if, in the future, it must enforce any one or more of its patents, or such patents are challenged by a third party, such patents ultimately would be upheld. Similarly, while management believes that the Company’s products do not infringe the valid claims of any third party’s patents, there can be no assurance that it would prevail if a third party sought to enforce its patent against the Company by a suit for an injunction or damages.

Interference and similar proceedings in the PTO or equivalent foreign patent offices, whether brought by the Company to protect its patents or brought by a third party challenging such patents, are time-consuming, disruptive of management time and attention and highly costly, and injunctive and other patent litigation in court is likely to be many times more time-consuming, disruptive and costly. Furthermore, in the United States (unlike many foreign countries) a party generally is not entitled to reimbursement of any portion of its legal fees and expenses even if it is wholly successful in its prosecution or defense, so that the Company could be exposed to costs which could have a material adverse effect on its business even if the Company were successful in enforcing its patents against an infringer or successful in defending against proceedings to invalidate its patents or proceedings alleging infringement by the Company of a third party’s patents. Additionally, if the Company were unsuccessful in proceedings challenging its patents, third parties licensed by the Company under those patents might seek to terminate such licenses and cease paying royalties. If the Company were unsuccessful in defending against a claim that it had infringed a third party’s patent, even unknowingly, the Company could be subject to a permanent injunction against engaging in the infringing business as well as an award of damages measured by the profits obtained from past infringement. Additionally, because of the Company’s relative lack of financial and management resources, it could be less able than its competitors to bear such risks.

 

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Employees

As of December 31, 2009, the Company had nine full-time employees, comprised of two employees at its research facility in Denmark, one employee at its customer care center in Tennessee, and six employees at its Napa, California headquarters.

Status as a Passive Foreign Investment Company

For U.S. Federal income tax purposes, an entity will be a “passive foreign investment company”, or a “PFIC”, for any taxable year if either (1) 75% or more of its gross income is “passive” income or (2) 50% or more of the value of its assets, determined on the basis of a quarterly average, is attributable to assets that produce or are held for the production of passive income. Passive income generally includes dividends, interest, royalties and rents not arising from the active conduct of a trade or business, and gains from the sale of assets that produce such income.

U.S. shareholders in an entity that is a PFIC in any taxable year are generally subject to tax at the highest ordinary income rates applicable to that U.S. holder and are required to pay interest on such tax based on the U.S. holder’s holding period in the shares, on (1) a portion of any gain recognized on the sale of such shares and (2) any “excess distribution” paid on such holders shares (generally, a distribution in excess of 125% of the average annual distributions paid by the entity in the three preceding taxable years).

Based upon advice from its outside professional tax advisors, the Company has determined that it was a PFIC during 2009 and 2008.

A detailed discussion of the implications of the Company’s status as a PFIC for U.S. holder of shares or ADSs is included in this Annual Report on Form 10-K under Item 5—MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES – Passive Foreign Investment Company Considerations.

U.S. shareholders should consult their tax advisers concerning the U.S. federal income tax consequences of holding shares or ADSs in the Company. Depending upon the circumstances, a U.S. Holder that owns shares or ADSs during any year that the Company is a PFIC may need to file IRS Form 8621.

ITEM 1A—RISK FACTORS

Not required for a smaller reporting Company.

ITEM 2—PROPERTIES

The Company leases a 3,000 square foot facility in Napa for its headquarters under a lease expiring at the end of June 2010, following an extension in February 2010.

During October 2003, the Company entered into a quarterly lease agreement at a business park adjacent to Aarhus University in Denmark for approximately 2,000 square feet. The Company terminated this lease effective January 31, 2010 after providing a three month notice, as required by the lease.

In May 2009, the Company signed a lease for office space in Brentwood, Tennessee to accommodate a Customer Care Center. The lease was for an initial three year period from June 2009 through May 2012. On December 31, 2009, the Company terminated the lease agreement in conjunction with the decision to close the Brentwood, Tennessee Customer Care Center and to transfer the operations previously handled at this location to the Company’s Napa, California office. As part of the lease termination, the Company agreed to relinquish the security deposit, pay an early termination fee of $53,000, and surrender all leasehold improvements, including all furniture and equipment in the space.

 

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ITEM 3—LEGAL PROCEEDINGS

None

ITEM 4—RESERVED

 

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PART II

ITEM 5—MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES

There is currently no established public trading market for the Company’s ordinary shares. Senetek ADSs, each representing one ordinary share and evidenced by one American Depositary Share (“ADS”) began trading on the over-the-counter market in the United States in November 1984 and were traded through the NASDAQ Small Cap Market from May 1986 through November 10, 2004. On November 10, 2004, the Company’s ADSs were delisted from the NASDAQ Stock Market and began trading on the electronic over-the-counter quotation system of the National Association of Securities Dealers (the “NASD”) Over-the-Counter Bulletin Board (the “OTCBB”) under the symbol “SNTKY”. On December 13, 2007, the eight-to-one reverse share split authorized by shareholders on December 10, 2007 was effective and Senetek’s symbol changed to “SNKTY”. The OTCBB is a regulated quotation service for subscribing members of the NASD that displays the real-time quotes, last-sale prices and volume information in over-the-counter securities. The OTCBB market quotations reflect inter-dealer prices, without retail mark-up, mark-down or commission and may not represent actual transactions. The depositary for these ADSs is The Bank of New York.

The following table sets out the range of high and low sale prices for the Company’s ADSs for the periods indicated.

Fiscal Year Ended December 31, 2009

 

     HIGH    LOW

QUARTER ENDED:

     

March 31

   $ 1.40    $ 0.87

June 30

     1.40      1.01

September 30

     1.40      1.05

December 31

     1.51      1.15

Fiscal Year Ended December 31, 2008

 

     HIGH    LOW

QUARTER ENDED:

     

March 31

   $ 3.00    $ 1.35

June 30

     2.40      1.27

September 30

     1.95      1.27

December 31

     1.60      0.83

As of March 31, 2010 there were 7,645,802 ordinary shares outstanding and 203 holders of record of ordinary shares. One of which is the Bank of New York which holds ADSs representing 7,574,571 American Depositary shares. The trading prices of the Company’s ADSs on March 31, 2010, were a high of $0.84 and a low of $0.70.

Dividends.    Under the English Companies Act of 1985, a limited company may not declare or pay cash dividends while it has an accumulated deficit. On December 16, 2008, shareholders approved a reclassification of share premium to accumulated deficit for the UK Company. This reclassification, which has no net effect on the equity or financial position of the Company, was undertaken to create distributable reserves. On January 21, 2009, the reclassification was confirmed by the English High Court. Effective with this confirmation, the Company may now pay dividends or repurchase shares up to the level of the positive balance in accumulated profit and loss in the UK Company.

 

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Senetek has not paid, nor does it currently anticipate the payment of, any cash dividends on the ordinary shares. Any future determinations to pay cash dividends will be at the discretion of our Board of Directors and will be dependent upon our financial condition, operating results, capital requirements and other factors that our Board of Directors deems relevant.

Taxation

The following discussion describes the material US Federal income tax and UK tax consequences of the purchase, ownership and disposition of the Company’s shares or ADSs (evidenced by American Depositary Receipts (“ADR”)) for beneficial owners:

 

   

who are residents of the United States for purposes of the United Kingdom/United States Income Tax Convention (the “Income Tax Convention) and the United Kingdom/United States Estate and Gift Tax Convention (the “Estate and Gift Tax Convention” and, together with the Income Tax Convention, the “Conventions”);

 

   

whose ownership of the Company’s shares or ADSs is not, for the purposes of the Conventions, attributable to a permanent establishment in the United Kingdom;

 

   

who otherwise qualify for the full benefits of the Conventions; and

 

   

who are US holders (as defined below).

The statements of US federal income tax and UK tax laws set out below:

 

   

are based on the laws in force and as interpreted by the relevant taxation authorities as at the date of this annual report;

 

   

are subject to any changes in US law or the laws of England and Wales, in the interpretation thereof by the relevant taxation authorities, or in the Conventions, occurring after such date; and

 

   

are based, in part, on representations of the depositary, and assume that each obligation in the Deposit Agreement and any related agreement will be performed in accordance with its terms.

No assurance can be given that taxing authorities or the courts will agree with this analysis.

This discussion does not address all aspects of US and UK taxation that may be relevant to you and is not intended to reflect the individual tax position of any beneficial owner, including tax considerations that arise from rules of general application to all taxpayers or to certain classes of investors or that are generally assumed to be known by investors. The portions of this summary relating to US Federal taxation are based upon the US Internal Revenue Code of 1986, as amended (the “Code”), its legislative history, existing and proposed US Treasury regulations promulgated thereunder, published rulings by the US Internal Revenue Service (“IRS”), and court decisions, all in effect as at the date hereof, all of which authorities are subject to change or differing interpretations, which changes or differing interpretations could apply retroactively. This summary is limited to investors who hold the Company’s shares or ADSs as capital assets within the meaning of Section 1221 of the Code, generally property held for investment, and this summary does not purport to deal with the US Federal or UK taxation consequences for investors in special tax situations, such as dealers in securities or currencies, persons whose functional currency is not the US Dollar, life insurance companies, tax exempt entities, financial institutions, traders in securities that elect to use a “mark-to-market” method of accounting for their securities holdings, regulated investment companies, persons holding the Company’s shares or ADSs as part of a hedging, integrated, conversion or constructive sale transaction or straddle, persons that receive shares of ADSs as compensation for the performance of services, or persons subject to the alternative minimum tax, who may be subject to special rules not discussed below. In particular, the following summary does not address the adverse tax treatment to you that would follow if you own, directly or by attribution, 10% or more of the Company’s outstanding voting share capital and the Company is classified as a “controlled foreign corporation” for US Federal tax purposes.

 

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As used herein, the term “US holder” means a beneficial owner of the Company’s shares or ADSs who or which is:

 

   

a citizen or individual resident of the United States;

 

   

a corporation (or other entity that is treated as a corporation for US Federal income tax purposes) created or organized in or under the laws of the United States or any political subdivision thereof;

 

   

an estate, the income of which is subject to US Federal income taxation regardless of its source; or

 

   

a trust (1) that is subject to the supervision of a court within the United States and the control of one or more US holders as described in section 7701(a)(30) of the Code or (2) that has a valid election in effect under applicable US Treasury regulations to be treated as a US holder.

If a partnership (or an entity that is treated as a partnership for US Federal income tax purposes) holds the Company’s shares or ADSs, the tax treatment of a partner will generally depend upon the status of the partner and the activities of the partnership. If you are a partner of a partnership holding the Company’s shares or ADSs, you should consult your tax advisors.

The summary does not include any description of the tax laws of any State or local government or of any jurisdictions other than the United States and the United Kingdom that may be applicable to the ownership of the Company’s shares or ADSs. You are urged to consult your own tax advisor regarding the US Federal, State, and local tax consequences to you of the ownership of the Company’s shares or ADSs, as well as the tax consequences to you in the United Kingdom and any other jurisdictions.

For the purposes of the Conventions and the Code, you will be treated as the owner of the Company’s shares represented by the ADSs evidenced by the ADRs.

Taxation of Capital Gains

United Kingdom

If you are not resident or ordinarily resident in the United Kingdom for UK tax purposes, you will not be liable for UK tax on capital gains realized or accrued on the sale or other disposition of shares or ADSs unless the shares or ADSs are held in connection with your trade or business (which for this purpose includes a profession or a vocation) carried on in the United Kingdom through a branch or agency and the shares or ADSs are or have been used, held or acquired for the purposes of such trade or business or such branch or agency.

An individual US holder of the shares who ceases to be resident or ordinarily resident in the UK for UK tax purposes for a period of less than 5 tax years and who disposes of shares during that period may also be liable on returning to the UK for UK capital gains tax despite the fact that the individual may not be resident or ordinarily resident in the UK at the time of the disposal.

United States

Subject to the Passive Foreign Investment Company discussion below, gain or loss realized by you on the sale or other disposition of the shares or ADSs will be subject to US Federal income tax as capital gain or loss in an amount equal to the difference between your tax basis in the shares or ADSs and the amount realized on the disposition. The capital gain or loss will be long-term capital gain or loss if the US holder has held the shares or ADSs for more than one year at the time of the sale or exchange. A gain or loss realized by you generally will be treated as US source gain or loss for US foreign tax credit purposes.

 

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Passive Foreign Investment Company Considerations

In general

A Non-U.S. corporation will be classified as a “passive foreign investment company,” or a PFIC, for U.S. federal income tax purposes in any taxable year in which, after applying certain look-through rules, either:

 

   

at least 75% of its gross income is “passive income” (generally, dividends, interest, royalties, rents and gains from the sale of assets that give rise to such income); or

 

   

at least 50% of the quarterly average value of its gross assets is attributable to assets that produce “passive income” or are held for the production of passive income.

Based on the Company’s existing operations and assets, the Company has determined that it was a PFIC for the taxable year ended December 31, 2008, for the taxable year ended December 31, 2009, and, depending upon its future operations and assets, there is a substantial risk that the Company could be treated as a PFIC in subsequent years. If the Company is treated as a PFIC, a direct (and in certain cases, indirect) U.S. Holder would be subject to special rules with respect to (i) any gain realized on the sale or other disposition of shares or ADSs and (ii) any “excess distribution” by the Company to the U.S. Holder in respect of the shares or ADSs (generally, any distributions to the U.S. Holder in respect of the shares or ADSs during a single taxable year that total more than 125% of the average annual distributions received by the U.S. Holder in respect of the shares or ADSs during the three preceding taxable years or, if shorter, the U.S. Holder’s holding period for the shares or ADSs).

Under these rules, (a) the gain or excess distribution would be allocated ratably over the U.S. Holder’s holding period for the shares or ADSs, (b) the amount allocated to the taxable year in which the gain or excess distribution was realized or to any year before the Company became a PFIC would be taxable as ordinary income, (c) the amount allocated to each other taxable year would be subject to tax at the highest tax rate in effect for ordinary income for that year and (d) an interest charge generally applicable to underpayments of tax would be imposed in respect of the tax attributable to each such prior year. These rules effectively prevent a U.S. Holder from treating gain on the shares or ADSs as capital gain. For these purposes, gifts, exchanges pursuant to a corporate reorganization and use of the shares or ADSs as security for a loan may be treated as a disposition. Moreover, if the Company is a PFIC, dividends received by individual U.S. Holders and certain other non-corporate U.S. Holders will not be treated as qualified dividend income taxable at reduced rates generally applicable to long term capital gains.

Where a foreign corporation is a PFIC in any year during a U.S. Holder’s holding period, it will generally be treated as a PFIC for each subsequent year absent a “purging” election by the U.S. Holder. Finally, a person who acquires the shares or ADSs from a deceased U.S. Holder generally will be denied a step-up in tax basis for U.S. federal income tax purposes to fair market value at the date of such deceased U.S. Holder’s death, which would otherwise be available with respect to a decedent dying prior to or after 2010. Instead such person will have a tax basis in the shares or ADSs equal to the lower of the fair market value of the shares or ADSs or the U.S. Holder’s historical tax basis therein.

Mark to Market Election

The above results may be mitigated with respect to the Company if a “mark-to-market” election is available. A mark-to-market election is available to a U.S. Holder only if the shares or ADSs are considered “marketable stock”. Generally, stock will be considered marketable stock if it is “regularly traded” on a “qualified exchange” within the meaning of applicable U.S. Treasury regulations. A “qualified exchange” includes a national securities exchange that is registered with the Securities and Exchange Commission or a national market system established under section 11A of the Securities and Exchange Act of 1934 (the “Act”). Since the Company’s shares are only traded on the OTCBB, which is neither a registered national securities exchange nor a national market system established under Section 11A of the Act, a U.S. Holder will not be able to make a mark-to-market election with respect to the Company’s Shares or ADSs.

 

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QEF Election and Deemed Sale Election

The above adverse results can also be eliminated if a U.S. Holder is eligible for and timely makes a valid qualified electing fund, or “QEF” election. If a QEF election were made, such U.S. Holder generally would be required to include in income on a current basis its pro rata share of the Company’s ordinary earnings and net capital gains. In order for a U.S. Holder to be able to make a QEF election, the Company would be required to provide such U.S. Holder with certain information. US Holders of shares or ADSs who sold their shares or ADSs during 2007 and declared a long-term capital gain on their federal income tax filing for 2007 should contact their tax advisor to discuss whether an amended filing is necessary.

The Company does intend to provide information necessary for making a QEF election for the 2009 and 2008 tax years and expects similarly to provide such information for any future tax years in which it is a PFIC. This information will be provided on the Company’s website prior to the end of April 2010. Accordingly, US Holders who wish to make a QEF election for the year ended December 31, 2009 should plan on filing an extension for their U.S. federal income tax returns in order to allow time for the Company to provide the information required for the QEF election and time for their tax advisors to incorporate this information.

US Holders of shares or ADSs who acquired Company shares or ADSs during 2009 and 2008 may file a QEF election for the 2009 or 2008 tax year with a timely filed 2009 or 2008 tax return. However, US Holders of shares or ADSs who acquired such shares or ADSs prior to 2008 who file a QEF election for the 2008 tax year (or who file a QEF election for a later tax year with a timely filed tax return) will not have filed a “timely” QEF election since the election will not apply to the Company’s first year as a PFIC (which was 2007). Nonetheless, a US Holder can still benefit from the QEF election regime so long as the US Holder timely files a so-called “deemed sale election”. In such a case, a US Holder will be treated as having sold his or her shares or ADSs on the first day of the tax year for which the QEF election is made. A US Holder who realizes gain on such a deemed sale will be subject to the US tax consequences as if he had actually sold his shares or ADSs. Thus, any gain realized on the sale would be treated as an excess distribution and would be subject to the rules applicable to a PFIC.

The Company believes that most pre-existing US Holders should be able to make a QEF election and a deemed sale election for either 2008 or 2009 without adverse US tax consequences. A US Holder can make a deemed sale election even if his or her shares or ADSs have a value lower than the US Holder’s basis in the Company’s shares or ADSs. In such a case, the US Holder reports the loss for informational purposes but does not recognize the loss. No change occurs in the basis of the stock. On January 1, 2008, the opening market price of the Company’s ADSs was $2.85 per share. On January 1, 2009 the opening market price of Company’s ADSs was $0.87 per share. The Company expects that most US Holders will be able to make a deemed sale election without adverse tax consequences for either 2008 or 2009 because the depressed price of the Company’s shares or ADSs would result in the US Holder realizing a loss (and not a gain) upon making the deemed sale election, however, because results will vary from US holder to US holder as a result of individual circumstances, it is critical that each US Holder check with its own tax advisor concerning the effect of electing to make a deemed sale election for either 2008 or 2009.

IRS Form 8621

To make a QEF election and a deemed sale election for either the 2008 tax year or the 2009 tax year, a US Holder must attach a properly completed IRS Form 8621 to a timely filed (including extensions) US federal tax return for the year in question. If a US Holder is not required to file a US federal income tax return or other return for the tax year, the IRS Form 8621 should be filed directly with the Internal Revenue Service Center, Ogden, UT, 84201-0201.

PLEASE BE ADVISED THAT EACH SHAREHOLDER MUST MAKE AN INDIVIDUAL DETERMINATION AS TO WHEN AND WHETHER TO MAKE ANY OF THE ABOVE ELECTIONS AND THE CONSEQUENCES THEREOF. ACCORDINGLY, WE ARE UNABLE TO PROVIDE A US

 

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HOLDER SPECIFIC ADVICE IN THIS REGARD AND EACH US HOLDER IS STRONGLY URGED TO CONSULT HIS OR HER OWN TAX ADVISER.

UK Inheritance and Gift Tax

If you are an individual domiciled in the United States and are not a national of the United Kingdom for the purposes of the Estate and Gift Tax Convention, any share or ADS beneficially owned by you will not be subject to UK inheritance tax on your death or on a gift made by you during your lifetime, provided that any applicable US Federal gift or estate tax liability is paid, except where the share or ADS is part of the business property of your UK permanent establishment or pertains to your UK fixed base used for the performance of independent personal services. The Estate and Gift Tax Convention generally provides for tax paid in the United Kingdom to be credited against tax payable in the United States, based on priority rules set out in that Convention, in the exceptional case where a share or ADS is subject to both UK inheritance tax and US Federal gift or estate tax. Where the shares or ADSs have been placed in trust by a settlor who, at the time of the settlement, was a US holder, the shares or ADSs will generally not be subject to UK inheritance tax if the settlor, at the time of the settlement, was domiciled in the United States for the purposes of the Estate and Gift Tax Convention and was not a national of the United Kingdom.

US Gift and Estates Taxes

If you are an individual US holder, you will be subject to US gift and estate taxes with respect to the shares or ADSs in the same manner and to the same extent as with respect to other types of personal property.

UK Stamp Duty and Stamp Duty Reserve Tax

Transfers of ADRs

No UK stamp duty will be payable on an instrument transferring an ADR or on a written agreement to transfer an ADR provided that the instrument of transfer or the agreement to transfer is executed and remains at all times outside the United Kingdom. Where these conditions are not met, the transfer of, or agreement to transfer an ADR could, depending on the circumstances, attract a charge to ad valorem stamp duty at the rate of 0.5% of the value of the consideration (if this charge is no more than £5, the transfer is exempt).

No stamp duty reserve tax will be payable in respect of an agreement to transfer an ADR, whether made in or outside the United Kingdom.

Where no sale is involved and no transfer of beneficial ownership has occurred, a transfer of shares by the depositary or its nominee to the holder of an ADR upon cancellation of the ADR is subject to UK stamp duty of £5 per instrument of transfer.

Issue and Transfer of Ordinary Shares in Registered Form

Except in relation to persons whose business is or includes the issue of depositary receipts of the provision of clearance services or their nominees, the allotment and issue of shares by the Company will not normally give rise to a charge to UK stamp duty or stamp duty reserve tax.

Transfers of shares, as opposed to ADSs, will attract ad valorem stamp duty normally at the rate of 0.5% of the value of the consideration (if this charge is no more than £5, the transfer is exempt). A charge to stamp duty reserve tax, normally at the rate of 0.5% of the consideration, arises, in the case of an unconditional agreement to transfer shares, on the date of the agreement, and in the case of a conditional agreement the date on which the agreement becomes unconditional. The stamp duty reserve tax is payable on the seventh day of the month following the month in which the charge arises. Where an instrument of transfer is executed and duly stamped before the expiry of a period of six years beginning with the date of that agreement, any stamp duty reserve tax

 

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that has not been paid ceases to be payable, and if any stamp duty reserve tax has been paid a claim may be made for its repayment.

Transfer of Ordinary Shares into Depositary or Clearance Services

Subject to certain exemptions, stamp duty will be charged at the rate of 1.5% (if this charge is no more than £5, the transfer is exempt), or there will be a charge to the stamp duty reserve tax at the rate of 1.5% on the amount or value of the consideration paid, or in some circumstances the issue price or open market value, on a transfer or issue of shares (1) to, or to a nominee for, a person whose business is or includes the provision of clearance services, or (2) to, or to a nominee for, a person whose business is or includes the issuing of depositary receipts. It is understood that the UK Inland Revenue Stamp Office considers the depositary to fall within one or the other of the above two categories. The stamp duty reserve tax on the deposit of ordinary shares with the depositary will be payable by the person depositing those shares. Where stamp duty reserve tax is charged on a transfer of shares and ad valorem stamp duty is chargeable on the instrument effecting the transfer, the amount of the stamp duty reserve tax charged is an amount equal to the excess, if any, of the stamp duty reserve tax charge due on the transfer after the deduction of the stamp duty paid.

You will not be entitled to a foreign tax credit with respect to any UK stamp duty or stamp duty reserve tax, but may be entitled to a deduction subject to applicable limitations under the Code. You are urged to consult your own tax advisors regarding the availability of a deduction under their particular circumstances.

Information Reporting and Backup Withholding

Payments that relate to the ordinary shares or ADSs that are made in the United States or by a US related financial intermediary will be subject to information reporting. Information reporting generally will require each paying agent making payments, which relate to a share or ADS, to provide the IRS with information, including the beneficial owner’s name, address, taxpayer identification number, and the aggregate amount of dividends paid to such beneficial owner during the calendar year. These reporting requirements, however, do not apply to all beneficial owners. Specifically, corporations, securities broker-dealers, other financial institutions, tax-exempt organizations, qualified pension and profit sharing trusts and individual retirement accounts are generally exempt from reporting requirements.

If you are a depositary participant or indirect participant holding shares or ADSs on behalf of a beneficial owner, or paying agent making payments for a share or ADS, you may be required to backup withhold, as a backup against the beneficial owner’s US Federal income tax liability, a portion of each payment of dividends on the Company’s shares or ADSs in the event that the beneficial owner of a share or ADS:

 

   

fails to establish its exemption from the information reporting requirements;

 

   

is subject to the reporting requirements described above and fails to supply its correct taxpayer identification number in the manner required by applicable law; or

 

   

under-reports its tax liability.

This backup withholding tax is not an additional tax and may be credited against US Federal income tax liability if the required information is furnished to the IRS.

Taxation of Dividends

The Company has not included a detailed discussion of the tax consequences to holders of ordinary shares or ADSs for the payment of dividends as Senetek does not currently anticipate the payment of, any cash dividends. The decision whether to pay, and the amount of any dividends, will be based, among other things, upon the Company’s earnings, capital requirements, financial conditions and applicable law. Any dividend, either cash or stock, must be recommended by the Board of Directors and approved by the shareholders through the

 

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Board of Directors. The Board of Directors is empowered to declare interim dividends. Effective January 21, 2009, the English High Court confirmed the reclassification of share premium to accumulated deficit for the UK Company, as approved by the shareholders on December 16, 2008. The reclassification, which has no effect on the equity or financial position of the Company, was undertaken to create distributable reserves.

EQUITY COMPENSATION PLAN INFORMATION

(As of December 31, 2009)

 

Plan category

   Number of
securities to be
issued upon
exercise of
outstanding
options, warrants
and rights
   Weighted-
average
exercise
price  of

outstanding
options,
warrants

and  rights
   Number of
securities remaining
available for
future issuance
under equity
compensation plans
(excluding securities
reflected in
Column 1)

Equity compensation plans approved by shareholders (1)

   1,000,000    $      2.45    —  

Equity compensation plans not approved by shareholders (2)

   64,943    $      2.32    —  

 

(1) Represents options outstanding and shares available for future issuance under the 2006 Senetek Equity Plan. Also includes 62,500 options outstanding under Plan 2 which has been terminated as to future grants.
(2) Represents options issued outside of the 2006 Senetek Equity Plan at the discretion of the Board of Directors.

ITEM 6—SELECTED FINANCIAL DATA

Not required for smaller reporting company; see Regulation S-K Section 229.305(e)

ITEM 7—MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATION

Company Overview

Senetek PLC is a life sciences company engaged in the development of technologies that target the science of healthy aging. Its business is comprised of two segments, Skincare and Pharmaceutical. The skincare segment, with the exception of Kinetin and Zeatin, was transferred to Skinvera LLC on March 10, 2010. Refer to Note 16 to the Consolidated Financial Statements for details of the transfer.

The Skincare segment through March 10, 2010, was comprised of:

 

   

Pyratine-6™, a proprietary second generation cytokinin for the treatment of aging skin and PyratineXR™ for the visible signs and symptoms associated with various conditions such as rosacea, eczema, contact dermatitis and menopause. The Company markets and sells these products exclusively through physicians in the North American market and is pursuing additional commercial opportunities in other channels of distribution and geographies.

 

   

Physician-strength PyratineXR™ is clinically proven to relieve redness (erythema), soothe irritation, increase moisture and repair damaged skin quickly and effectively. Clinical studies have demonstrated that PyratineXR™ significantly reduces the appearance of lesions (papules and pustules), spider veins and dark spots. In addition, PyratineXR™ improves skin texture in just days while improving dry, flaky skin by restoring the skin’s barrier function and increasing moisture retention.

 

   

A clinical study entitled “Topical PRK-124 (0.125%) Lotion for Improving the Signs and Symptoms of Rosacea,” was published in the May 2009 Journal of Drugs in Dermatology, a peer-reviewed dermatologic publication. The 12-week, open-label study concludes that PyratineXR™ (0.125%

 

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furfuryl tetrahydropyranyladenine) improved skin barrier function and the appearance of erythema (redness) and lesions (pustules and papules) associated with mild-to-moderate rosacea during 12 weeks of treatment. According to study data, PyratineXR™ produced a progressive decrease in the symptoms associated with rosacea, with an overall clinical improvement in 80% of subjects, including reduction of redness and lesions. Transepidermal water loss measurements showed a 22% decrease, which supports an improvement in skin barrier function, with a 41% mean improvement in skin dryness as early as week four. All subject self-assessments also showed good tolerability.

 

   

In a follow-up rosacea specific study performed at the University of California, Irvine, data demonstrated that PyratineXR™ (0.125% furfuryl tetrahydropyranyladenine) showed continual improvement for all of the major symptoms of rosacea – redness, lesions and spider veins – throughout the entire course of a 48-week treatment period. This suggests that PyratineXR™ may prove helpful in such conditions as it can be used continuously over a long term unlike other existing treatments. According to the National Rosacea Society, more than 14 million Americans have rosacea, yet only a small fraction receive treatment. The chronic skin disease can affect adults and children of any skin type. While the cause is unknown and there is no cure, scientific advancements are now offering rosacea sufferers hope and a way to control the signs and symptoms of this potentially life-disruptive disorder.

 

   

4HBAP, a proprietary second generation aromatic cytokinin. Representing a new classification of cytokinins, 4HBAP has successfully completed clinical tests for the treatment of photodamaged skin.

 

   

Kinetin is Senetek’s first generation cytokinin. Through March 30, 2007, Senetek licensed Kinetin to 10 companies in various channels of distribution and geographies and licensed Zeatin, Kinetin’s analog, exclusively to Valeant Pharmaceuticals International (“Valeant”). On March 30, 2007, Senetek terminated its existing license agreement with Valeant and entered into a new license acquisition agreement with Valeant (“License Acquisition Agreement”). Under the terms of the License Acquisition Agreement, the Company granted Valeant a paid up license for its Kinetin and Zeatin compounds and assigned to Valeant future royalties from other Kinetin license agreements to which it was a party, in return for a cash payment of $21 million, a waiver of $6 million in future marketing credits the Company otherwise would have owed Valeant, and a right to share in future royalties due Valeant from other Kinetin licensees through 2011.

The Pharmaceutical segment is comprised of:

 

   

Invicorp®, a highly safe and effective treatment for erectile dysfunction (“ED”), a condition that affects more than 100 million men worldwide. Invicorp® is expected to capture a significant share of the moderate-to-severe ED market and become the therapy of choice for second-line ED treatment. Invicorp® has received marketing authorization in Denmark as well as in England. Additionally, Invicorp® has been approved in New Zealand. Senetek has entered into an exclusive licensing and collaborative marketing agreement for the commercialization of Invicorp® with Plethora Solutions for the U.S. market whereby Plethora assumed all expenses of obtaining regulatory approvals and of marketing the products. Senetek is seeking licensees for other worldwide locations.

 

   

Reliaject®; a unique auto-injector system which employs an ultra-fine gauge needle, preset to achieve the appropriate penetration before drug flow occurs, thereby reducing reliance upon the patient’s technique for accuracy and safe delivery. In March 2006, the Company sold to Ranbaxy Pharmaceuticals Inc. all of its patents, trademarks and automated manufacturing equipment for the Reliaject® device. The Company received a down-payment of $500,000 and under the terms of the sale agreement, the Company is to receive additional payments based on regulatory approvals and cumulative sales milestones. In addition, the Company is to receive a specified percentage (similar to a set royalty) for a period of 15 years on Ranbaxy’s and its licensees’ quarterly net sales in North America of Reliaject® pre-filled with epinephrine and other parenteral drugs. Percentages will be negotiated on its net sales in any other markets for which it may be licensed and on its net sales in

 

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North America of Reliaject® pre-filled with non-scheduled parenteral drugs. Under the agreement, Ranbaxy assumed all expenses of obtaining regulatory approvals and of marketing the product.

 

   

Diagnostic monoclonal antibodies used in Alzheimer’s and other disease research which the Company licenses from RFMH and sells to Covance Antibody Services Inc.

 

   

Senetek has acquired two royalty-based licenses for RNA interference from the Institute of Bio-Organic Chemistry of the Polish Academy of Sciences (“PAS”). The agreements grant Senetek the exclusive rights to anti-cancer technology for the treatment of brain tumors using RNAi technology to inhibit the production of tenascin-C, whose expression has been indicated to correlate with the grade of malignancy of brain tumors and RNAi based therapeutic technology for the potential use against a broad range of cancers. Recently this technology associated with treatment of brain tumors has been successfully applied to patients with glioblastoma multiforme, a severe form of brain tumor.

In the case of Invicorp®, the Company plans to begin manufacture of the product in mid-2010; distribution and sale is expected to being in late-2010. In the case of monoclonal antibodies, the Company’s commercial partner has undertaken full responsibility for sales, distribution and marketing, as well as regulatory compliance. In the case of cancer therapy, the Company intends to partner with a pharmaceutical or an RNA specialty company to help fund these costs.

The markets in which the Company competes are highly competitive. The Company continuously strives to make advances and compete based on forward-looking technology, superior performance and quality, and by identifying and developing products that will achieve competitive advantage.

Overview of Operating Results

 

     2009     2008  
     (in thousands)  

Skincare revenue

   $ 539      $ 532   

Pharmaceutical revenue

     1,368        1,313   
                

Total revenue

     1,907        1,845   
                

Gross profit

     1,202        1,092   

Operating expenses

     (6,429     (6,919
                

Operating loss

   $ (5,227   $ (5,827
                

Net loss

   $ (5,105   $ (3,759
                

In 2009 Senetek focused its resources on expanding its Pyratine-6™ product line and customer base with the introduction of Pyratine XR™ in March 2009. The Company also increased its marketing in specific markets in the U.S. to create brand equity. Pursuant to an Asset Purchase Agreement dated March 10, 2010, Senetek transferred the assets and liabilities relating to its skincare line, with the exception of assets and liabilities related to Kinetin and Zeatin, to Skinvera LLC, a company wholly owned by Frank Massino, former CEO of the Company.

For 2009, revenue from Skincare increased slightly as compared to 2008. Skincare revenue for 2009 was $539,000 up 1% from 2008. Pharmaceutical revenue also increased slightly in 2009 as compared to 2008. Pharmaceutical revenue for 2009 was $1,368,000 up 4% from 2008. The increase in 2009 is attributable to increased sales of monoclonal antibodies in 2009 by the Company’s commercial partner, Covance.

The gross profit rate for 2009 was 63% compared to 59% in 2008. This increase was primarily due to higher costs of sales in 2008, the first year of production of Pyratine products.

 

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The Company records compensation expense for stock awards granted. The Company incurred $346,000 and $650,000 in stock based compensation operating expense for 2009 and 2008, respectively. In 2009 and 2008, options for 28,000 and 737,350 shares, respectively, were issued to employees, consultants and directors of Senetek.

Operating expenses in 2009 decreased by 8% from 2008. This is primarily due to decreased stock compensation in 2009 as compared to 2008 due to the stock options issued in January 2008 to employees and Directors of Senetek. These decreases were partially offset by increased advertising and research and development in 2009.

Revenue

 

      Summary of Annual Revenue  
     (in thousands)  
     2009    2008    % change in
2009 versus
2008
 

Segment

        

Skincare

        

Royalties from licensing

   $ 173    $ 172    1

Product sales

     366      360    2
                

Total skincare

     539      532    1
                

Pharmaceutical

        

Royalties on monoclonal antibodies

     1,368      1,311    4

Royalties on ED product

     —        2    n/a   
                

Total pharmaceutical

     1,368      1,313    4
                

Total revenue

   $ 1,907    $ 1,845    3
                

In 2009 Senetek focused its resources on expanding its Pyratine-6™ product line and customer base with the introduction of Pyratine XR™ in March 2009. The Company also increased its marketing in specific markets in the U.S. to create brand equity. Pursuant to an Asset Purchase Agreement dated March 10, 2010, Senetek transferred the assets and liabilities relating to its skincare line, with the exception of assets and liabilities related to Kinetin and Zeatin, to Skinvera LLC, a company wholly owned by Frank Massino, former CEO of the Company.

The Company continues to receive remittances from Covance Antibody Services Inc. on sales of monoclonal antibodies produced from cell lines licensed by the Company from RFMH. On March 30, 2007, Senetek completed a License Acquisition Agreement with Valeant which contains a right to share in future royalties due to Valeant from other Kinetin licensees through 2011. Additionally, if RFMH’s patents were successfully challenged, the Company’s revenue from Covance’s sales would be substantially reduced or eliminated.

Skincare Segment

Skincare revenue showed a slight increase of $7,000, or 1%, for 2009 compared to 2008. This increase was primarily due increased sales of Pyratine-6™ and Pyratine XR™ in the current year.

The Company expects its 2010 product sale revenue and net income to decrease from 2009 as a result of the Asset Purchase Agreement with Skinvera LLC in March 2010.

The Company is also dependent upon successful development and commercialization of new active ingredients for its future revenue growth.

 

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Pharmaceuticals Segment

2009 Pharmaceutical revenue was $1,368,000, a 4% increase from 2008. Royalties on monoclonal antibodies increased $57,000, or 4%, as a result of increased sales by Covance.

Revenue from sales of monoclonal antibodies is expected to continue to fluctuate as the sales of these products follow patterns determined by project-driven research organizations. The Company’s agreement with Covance guarantees Senetek minimum payments for monoclonal antibodies of $860,000 in 2010 and $442,000 in 2011, partially offset by Senetek’s guaranteed payments to RFMH of $430,000 in 2010 and $221,000 in 2011.

Gross Profit

 

      Summary of Gross Profit  
     (in thousands)  
     2009     2008     % change in
2009 versus
2008
 

Segment

      

Skincare

   $ 504      $ 408      24

Pharmaceutical

     698        684      2
                  

Total

   $ 1,202      $ 1,092      10
                  

As a % of skincare revenue

     94     77  

As a % of pharmaceutical revenue

     51     52  

As a % of total revenue

     63     59  

Gross profit for 2009 increased from 2008 due to higher Skincare costs in 2008 for start-up of the Pyratine-6™ product line. Pharmaceutical gross profit was relatively stable in 2009 as compared to 2008.

Gross margin increased in 2009 as the Company began selling higher margin Pyratine-XR™ products. In March 2010, Senetek sold the majority of its skincare line, retaining only its interests in Kinetin and Zeatin. Following this sale, the Company expects its revenue and gross margin to decrease.

Gross profit from monoclonal antibodies is expected to fluctuate as the sales of these products follow patterns determined by project-driven research organizations. The Company’s agreement with RFMH guarantees RFMH minimum royalty payments from Senetek for monoclonal antibodies of $430,000 in 2010 and $221,000 in 2011 in conjunction with the Company’s agreement with Covance which guarantees Senetek minimum payments from Covance for monoclonal antibodies of $860,000 in 2010 and $442,000 in 2011.

Research and Development

 

     Summary of Research and Development  
         2009             2008         % change
in 2009
versus
    2008    
 
     (in thousands)  

Research and development

   $ 1,275      $ 1,141      12

As a % of total revenue

     67     62  

Research and development expense consists primarily of employee related expenses, contract costs of research agreements with third-party consultants, clinicians and research scientists and product testing.

Research and development spending in 2009 was relatively stable as compared to 2008.

 

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Following the closure of its research facility in Aarhus, Denmark, Senetek expects a significant decrease in research and development expense in 2010.

Administration, Sales and Marketing

 

     Summary of Administration, Sales and
Marketing
 
         2009             2008         % change
in 2009
versus
    2008    
 
     (in thousands)  

Administration, sales and marketing

   $ 5,154      $ 5,778      (11 )% 

As a % of total revenue

     270     313  

For the years ended December 31, 2009 and 2008, the following administration, sales and marketing expenses were incurred:

 

      2009    2008
     (in thousands)

Expense Category

     

Payroll, benefits and consulting

   $ 1,956    $ 1,926

Stock-based compensation expense

     345      648

Advertising and marketing

     950      307

Co-marketing expense

     —        926

Legal and accounting

     484      828

Other professional services

     10      —  

Travel and related

     569      470

Rent and office expenses

     505      368

Insurance-liability

     206      215

Depreciation and other non-cash expenses

     8      6

Other

     121      84
             

Total

   $ 5,154    $ 5,778
             

Administration, sales and marketing expenses decreased in 2009 as compared to 2008 primarily due to decreases in stock based compensation expense, legal fees and co-marketing expense partially offset by the increase in advertising and marketing. In mid-2009 Senetek began an advertising and marketing campaign for Pyratine-6™ and Pyratine-XR™ to create brand recognition. Conversely, co-marketing expense and associated legal fees decreased in 2009 as compared to 2008 due to the 2008 termination of a co-marketing agreement.

Other Income and Expense

The primary recurring component of other income and expense is interest income on cash accounts and short-term investments. Interest income decreased in 2009, as compared to 2008, due to declining cash and investment balances.

2009 other income is negligible. 2008 other income is primarily attributed to a one-time settlement payment received in the second quarter of 2008, following the termination of a co-marketing agreement.

Taxation

Refer to Income Taxes below and Note 12 to the Consolidated Financial Statements for discussion of the Company’s significant deferred tax assets and liabilities and net operating loss carryforwards. At December 31,

 

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2008, a net tax benefit of $303,000 represented expected refunds in the U.S. and the U.K. from net operating losses available to carry back to prior years. In 2009, the tax $3,000 tax expense represented franchise taxes paid.

Contractual Obligations

The Company has contractual obligations related to non-cancelable lease agreements and purchase obligations as listed below. Contractual obligations related to employment agreements are detailed in “Executive Compensation” under Part III, Item 11 of this report on Form 10-K.

 

     Total    Less
than 1
year
   1-3
years
     (in thousands)

Operating lease obligations

   $ 39    $ 37    $ 2

Purchase obligations:

        

Research Foundation for Mental Hygiene (1)

     651      430      221
                    
   $ 690    $ 467    $ 223
                    

 

(1) The Company has a contractual obligation to RFMH for minimum payments of $430,000 (on a pro-rata basis) per year through July 10, 2011. In conjunction, Senetek receives contractual minimum payments from Covance of $860,000 (on a pro-rata basis) per year, without right of offset, for the same period.

Government Policy

It is the Company’s opinion that there are no aspects of government policy which, as far as can be foreseen, are likely to have a material effect on the conduct of its business, except as generally described in Part I, Item 1, of this Form 10-K under the heading “Government Regulation.”

Impact of Inflation

Management believes that inflation has not had any material effect on the results of the Company’s operations to date.

Critical Accounting Policies

A “critical accounting policy” is one which is both important to the portrayal of the Company’s financial condition and results of operations and requires management’s most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. The Company’s significant accounting policies are described in the Notes to the consolidated financial statements included in this Form 10-K. Management believes that the following accounting policies fit the definition of critical accounting policies. The critical accounting policies were discussed with the entire board of directors of the Company.

Revenue Recognition

The Company recognizes revenue when (i) persuasive evidence of an arrangement exists, (ii) shipment of products has occurred, (iii) the sales price charged is fixed or determinable, and (iv) collection is reasonably assured. The Company’s shipment terms are FOB shipping point.

The Company recognizes revenue from skincare product sales in the physician channel of distribution when the product is shipped. For sales of skin care products the Company provides no return right to its customers.

 

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For its other channel of distribution, the Company has a 30-day return policy. Therefore, revenue associated with this channel is deferred for 30 days following the sale. Revenue recognized for the years ended December 31, 2009 and 2008 in this channel was $17,000 and $0, respectively. Deferred revenue as of December 31, 2009 and 2008 was $2,000 and $0, respectively.

Included in revenue are fees charged to customers for shipping and handling. Such revenue amounted to $1,000 and $500 at December 31, 2009 and 2008, respectively. Shipping and handling costs incurred in a sales transaction to ship products to customers are included as a component of cost of sales.

Remittances received from the Company’s marketer, Covance Antibody Services, Inc. (“Covance”) on its sales of monoclonal antibodies are recognized based upon a percentage of actual Covance sales pursuant to the contract terms. Upfront license fees received from the licensing of manufacturing and distribution rights for the Company’s skincare products where the Company has substantive continuing obligations are deferred and recognized as revenue is earned, which is generally on a straight-line basis over the life of the contract. When the Company does not have substantive continuing obligations, such license fees are recognized as revenue. The Company receives sales reports from the licensee and based upon this information, plus subsequent cash receipts, records royalty revenue.

Impairment of Intangibles and Other Long-lived Assets

The Company assesses the impairment of other long-lived assets such as property and equipment and intangibles whenever events or changes in circumstances indicate that the carrying value may not be recoverable. Factors it considers important which could trigger an impairment review include the following:

 

   

Significant underperformance relative to expected historical or projected future operating results;

 

   

Significant changes in the manner of the Company’s use of the acquired assets or the strategy for its overall business;

 

   

Significant negative industry or economic trends.

When the Company determines that the carrying value of other long-lived assets such as property and equipment or intangibles may not be recoverable based upon the existence of one or more of the above indicators of impairment, it measures any impairment based on a projected discounted cash flow method using a discount rate determined by its management to be commensurate with the risk inherent in its current business model. Patent costs, representing legal costs to apply for, renew and defend patents, are expensed as incurred.

Assessing impairment involves significant assumptions and estimates. These assumptions and estimates are based on the Company’s best judgments.

Income Taxes

The Company has significant U.S. deferred tax assets, primarily for its subsidiary which holds its Reliaject® assets, that could be utilized if it generates future taxable income for Reliaject® and is otherwise required to pay income taxes. Pursuant to the “change in ownership” provisions of the Tax Reform Act of 1986, utilization of its net operating loss that carries over may be limited if a cumulative change of ownership of more than 50% occurs within any three-year period. The Company has determined that such a change in ownership has not occurred through December 31, 2009. As a result of the March 2010 transaction described in Subsequent Events below, the Company believes it may have undergone a change in ownership, but it has yet to perform an analysis of the transaction and the potential effect on its net operating losses (“NOLs”).

 

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Management believes that it will ultimately generate future taxable income for Reliaject® but due to lack of operating history and general uncertainty, it provided for a 100% valuation allowance against its entire deferred tax asset. Should the Company’s operating results indicate that its profitability is more likely than not to lead to the utilization of all or a portion of the deferred tax asset, it will reverse all or a portion of the Company’s valuation allowance. Subsequent changes to the estimated net realizable value of the deferred tax asset could cause its provision for income taxes to vary significantly from period to period, although its cash tax payments would remain unaffected until the benefit of the NOL is utilized, assuming that a “change in ownership” does not limit those losses.

The Company is actively looking for partners to promote regulatory approval and commercialization of Invicorp® in the UK and the European Union and believes that this continuation of trade preserves the Company’s UK NOLs. Management is budgeting for improved performance and future operating results which may generate future taxable income and it may reduce the valuation allowance when realization is deemed to be more likely than not. The United Kingdom tax-loss carryforwards are available indefinitely against profits from the same trade carried on in the United Kingdom, but could be limited if there was a greater than 50% change in ownership in any three-year period.

Effective January 1, 2007, the Company adopted FASB ASC 740-10 (Financial Accounting Standards Interpretation FIN No. 48, “Accounting for Uncertainty in Income Taxes – an interpretation of FASB Statement No. 109” (FIN48)). ASC 740-10 prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of uncertain tax positions taken or expected to be taken in a company’s income tax return and provides guidance on derecognition, classification, interest and penalties, accounting in interim periods, disclosure, and transition. As a result of the implementation of ASC 740-10, the Company recognized no change in the liability for unrecognized tax benefits related to tax positions taken in prior periods and no corresponding change in retained earnings. As a result of the implementation of ASC 740-10, the Company recognized no material adjustment in the liability for unrecognized income tax benefits as of the January adoption date and at December 31, 2009. The Company does not expect there to be any material change to the assessment of uncertain tax positions over the next twelve months.

Stock-Based Compensation

The Company records compensation expense for all awards granted. After assessing alternative valuation models and amortization assumptions, the Company has selected the Black-Scholes-Merton option-pricing formula and amortization of compensation expense over the requisite service period of the grant. The Company will reconsider use of this model if additional information becomes available in the future that indicates another model would be more appropriate, or if grants issued in future periods have characteristics that cannot be reasonably estimated using this model.

Liquidity and Capital Resources

 

     2009     2008  
     (in thousands)  

Cash, cash equivalents and short-term investments

   $ 10,732      $ 15,976   

Current ratio

     8.53        9.42   

Decrease in cash and cash equivalents

   $ (5,244   $ (4,003

As of December 31, 2009, the Company’s principal sources of liquidity included cash, cash equivalents and short-term investments resulting from Company operations. Management believes its cash, cash equivalents, short-term investments and cash expected to be generated from royalties on monoclonal antibodies will be sufficient to meet its working capital needs for at least the next twelve months. Should the Company be faced

 

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with currently unanticipated significant cash requirements in connection with gaining regulatory approvals of its products currently in development or in connection with protecting its patents or defending against patent infringement litigation, the Company’s present capital resources might be inadequate to fund its capital needs. Additionally, if the Company were to engage in a business combination transaction, its current cash position could be adversely impacted and its need for additional financing accelerated, although the impact of any such transaction cannot be evaluated at this time.

Senetek has carefully considered the ability of its financial institutions to safeguard its cash, cash equivalents and short-term investments. Short-term investments represent investment in fully insured Certificates of Deposit Accounts Registry Service (“CDARS”) with original maturities of six months in increments just below $100,000. Its cash and cash equivalents are held in one of the largest banks in the U.S.

Net cash used by continuing operating activities totaled $5,215,000 and $3,971,000 for 2009 and 2008, respectively. The change is primarily attributed to the increase in loss in 2009 as compared to 2008. 2008 loss was reduced by $1,125,000 representing a one-time settlement payment received following the termination of a co-marketing agreement.

Cash and cash equivalents decreased to $4,232,000 at December 31, 2009 from $5,833,000 at December 31, 2008, principally reflecting the net cash used by operations of $5,215,000 in 2009, partially offset by redemption of short-term securities of $3,643,000.

The financial statements set forth in Part IV of this Report have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) and are presented in U.S. dollars.

ITEM 7A—QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Not required for smaller reporting company; see Regulation S-K Section 229.305(e)

ITEM 8—FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

Statement of information furnished

The accompanying consolidated financial statements have been prepared in accordance with Form 10-K instructions for a smaller reporting company and in the opinion of management contain all adjustments necessary to present fairly the consolidated financial position as of December 31, 2009 and 2008, the results of operations and cash flows for the years then ended. These results have been determined on the basis of U.S. generally accepted accounting principles and practices applied consistently. Refer to Item 15.

 

ITEM 9—   CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

None

ITEM 9A(T)—CONTROLS AND PROCEDURES

Evaluation of disclosure controls and procedures

In connection with the March 2010 Transaction (refer to Note 16 to the Consolidated Financial Statements), John P. Ryan has been appointed to succeed Frank Massino as Chief Executive Officer and Howard Crosby has been appointed to succeed William O’Kelly as the Chief Financial Officer. The Company’s chief executive officer and its principal financial officer have evaluated the effectiveness of its disclosure controls and procedures, as defined under Exchange Act Rules 13a-15(e) and 15d-15(e), as of December 31, 2009. Based on that evaluation, its chief executive officer and its principal financial officer have concluded that its disclosure controls and procedures were effective to provide reasonable assurance that information that it is required to disclose in reports that the Company files with the SEC is recorded, processed, summarized and reported within the time periods specified by the Exchange Act rules.

 

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Changes in internal control over financial reporting

There were no changes in the Company’s internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(e) or Rule 15d-15(e) promulgated under the Exchange Act that occurred during the quarter ended December 31, 2009, that has materially affected, or is reasonably likely to materially affect, its internal control over financial reporting.

Management’s annual report on internal control over financial reporting

Our management is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over financial reporting is defined in Rule 13a-15(f) and 15d-15(f) promulgated under the Exchange Act as a process designed by, or under the supervision of, the Company’s principal executive officer and principal financial officer and effected by the Company’s board of directors, management, and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and includes those policies and procedures that:

 

   

Pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets of the Company;

 

   

Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the Company are being made only in accordance with authorizations of management and directors of the Company; and

 

   

Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the Company’s assets that could have a material effect on the financial statements.

Because of its inherent limitations, the Company’s internal control over financial reporting may not prevent or detect misstatements. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation. Projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

Our management assessed the effectiveness of our internal control over financial reporting as of December 31, 2009. In make this assessment, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”) in Internal Control-Integrated Framework. Based on our assessment, management concluded that the Company’s internal controls over financial reporting were effective as of December 31, 2009.

This annual report does not include an attestation report of the Company’s registered public account firm regarding internal control over financial reporting. Management’s report was not subject to attestation by the Company’s registered public accounting firm pursuant to temporary rules of the SEC that permit the Company to provide only the management’s report in this annual report.

ITEM 9B—OTHER INFORMATION

None

 

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PART III

ITEM 10—DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

As of March 10, 2010, the Company had five Directors.

 

Name

  

Position with Company

   Director
Since
   Age

John P. Ryan

  

Chairman of the Board of Directors and Chief Executive Officer

   2010    47

Howard Crosby

  

President, Chief Financial Officer and Director

   2010    57

Anthony Williams    

  

Corporate Secretary and Director

   2003    64

Wesley Holland

  

Director

   2010    56

Kerry Dukes

  

Director

   2006    47

 

 

Frank Massino was Chairman of the Board of Directors and Chief Executive Officer from 1998 until March 10, 2010. Rodger Bogardus was a member of the Board of Directors from 2006 until March 10, 2010. Both resigned their positions as a result of the March 10, 2010 Transaction detailed in Subsequent Events (refer to Note 16 to the Consolidated Financial Statements).

John P. Ryan, age 47, was appointed to the position of Chief Executive Officer effective March 10, 2010. Mr. Ryan has been the President of Fontana Capital Corporation, a closely held consulting company for the last ten years as well as an Officer and/or Director of a number of public companies including High Plains Uranium, Inc., U.S. Silver Corporation, and Gold Crest Mines, Inc.

Howard Crosby, age 57, was appointed to the position of President, effective March 10, 2010. Mr. Crosby has been the President of Crosby Enterprises, Inc., a closely held family investment company for more than twenty years as well as an Officer and Director of a number of public companies including High Plains Uranium, Inc., White Mountain Titanium Corporation, and Cadence Resources Corporation.

Anthony Williams was appointed a Director in February 2003 and was most recently re-elected by shareholders at the Annual General Meeting in December 2007. Mr. Williams was appointed Vice Chairman of the Board of Directors in October 2003. He is a partner of DLA Piper US, LLP. Until November 2009, Mr. Williams was a partner of Baker & McKenzie LLP, a global law firm headquartered in Chicago. Until September 2005, Mr. Williams was a partner at Coudert Brothers LLP, a New York City-based international law firm and previously served as Chairman of the Executive Committee and as Administrative Partner of the firm, responsible for worldwide operations. Mr. Williams was affiliated with Coudert Brothers LLP from 1973 through September 2005, first as an associate and then as a partner. In September 2006, Coudert Brothers LLP filed for Chapter 11 bankruptcy protection in the Southern District of New York Bankruptcy Court. He received an A.B. in Government and Economics from Harvard University and a Juris Doctor from New York University School of Law. He has been admitted to the Bars of the United States Supreme Court, the State of New York and State of California. In connection with the March 2010 Transaction Mr. Williams is the Corporate Secretary (refer to Note 16 to the Consolidated Financial Statements).

Wesley R. Holland, MD, was appointed to the Board of Directors, effective March 10, 2010. Dr. Holland has nearly 30 years of experience in diagnostic radiology. He was licensed in California from 1981 to 1994 and is currently licensed in South Carolina and in Florida. His specific expertise is in utilizing critical molecular and nuclear diagnostic imaging procedures to diagnose and treat disease and disorders such as heart disease and cancer.

Kerry Dukes was appointed a Director in May 2006 and was most recently re-elected by the shareholders at the Annual General Meeting in December 2009. Mr. Dukes is Chief Executive Officer and co-founder of Ardour Capital Investments LLC, a registered investment banking and securities broker-dealer firm in New York City, where he is responsible for the organization, recruitment, financing and implementation of Ardour’s business

 

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plan. Mr. Dukes has more than 20 years experience in the investment banking and securities businesses. Prior to co-founding Ardour, Mr. Dukes served as Director/Senior Managing Partner/Head of Global Activities for BlueStone Capital Partners and Trade.com, where he started-up and grew the firm’s brokerage operations and was instrumental in negotiating and selling a significant interest in the company to ABN Amro Bank, N.V. Prior to BlueStone, Mr. Dukes served as a Board Member, Chief Operating Officer and Managing Director of Commonwealth Associates. Mr. Dukes began his career in the management program at Shearson Lehman, an investment bank. He has served on the boards of numerous public companies, including Commonwealth Associates Growth Fund and Food Integrated Resources. Mr. Dukes attended the State University of New York.

Executive Officers

John P. Ryan is Chairman of the Board of Directors and Chief Executive Officer (see above). In connection with the March 2010 Transaction, Frank Massino was terminated without cause as Chief Executive Officer and resigned as Chairman of the Board of Directors (refer to Note 16 to the Consolidated Financial Statements).

Howard Crosby is the President, Chief Financial Officer and a member of the Board of Directors, effective March 10, 2010. In connection with the March 2010 Transaction Mr. O’Kelly was terminated without cause as Chief Financial Officer and resigned as Secretary of the Company (refer to Note 16 to the Consolidated Financial Statements).

 

Executive officers serve in their offices (without fixed terms) at the pleasure of the Board of Directors.

Independent Directors

The Board has determined that the following Directors of the Company (constituting a majority of all Directors) are “independent” within the meaning of the listing standards of the NASDAQ Stock Market: Mr. Williams, Mr. Dukes and Dr. Holland. In connection with the March 2010 Transaction Mr. Bogardus resigned as member of the Board of Directors (refer to Note 16 to the Consolidated Financial Statements).

Financial Expert

The Board of Directors has determined that Mr. Dukes is an “audit committee financial expert” by reason, among other things, of his experience as chief executive officer of a registered securities investment banking and broker-dealer firm and as an investment banker involved in over 20 registered public offerings of securities. Mr. Dukes, Mr. Williams and Dr. Holland constitute the Audit Committee of the Board. In connection with the March 2010 Transaction Mr. Bogardus resigned as member of the Board of Directors (refer to Note 16 to the Consolidated Financial Statements).

Communication with Directors

Individuals may submit communications to the Board or to the non-management Director by sending the communications in writing to the attention of the Secretary of the Company at Senetek PLC, 831 Latour Court, Napa, CA 94558. All communications that relate to matters that are within the scope of responsibilities of the Board and the Committees will be forwarded to the appropriate Director.

Director Nomination Process

All four of the seats on the Nominating Committee are currently vacant and the functions of the Committee are performed by the full Board which includes one non-independent member and Mr. Massino who is the Company’s Chief Executive Officer at December 31, 2009. The duties of the Nominating Committee consist, among other things, of identifying individuals qualified to become Board members, selecting, or recommending to the Board, the Director nominees for the next Annual General Meeting, selecting, or recommending to the Board, Director candidates to fill any vacancies on the Board, and receiving proposals for Director nominees from beneficial holders of the Company’s ordinary shares. A copy of the Nominating Committee’s charter is available on the Company’s website at www.senetekplc.com. The Nominating Committee makes an assessment of the suitability of candidates for election to the Board, taking into account business experience, independence, and character. The Board has not, thus far, considered it appropriate to adopt specific, minimum objective criteria for director nominees. There have been no material changes to the procedures by which security holders may recommend nominees to the Board since the distribution of the Company’s last proxy statement for its election of directors.

 

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Section 16(a) Beneficial Ownership Reporting Compliance

Section 16(a) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), requires the Company’s directors and executive officers, and persons who own more than ten percent of a registered class of its equity securities, to file with the Commission and any exchange or other system on which such securities are traded or quoted, initial reports of ownership and reports of changes in ownership of common shares and other equity securities of the Corporation.

To its knowledge, based solely on a review of the copies of such reports furnished to the Company, it believes that all reporting obligations of its officers, directors and greater than 10% shareholders under Section 16(a) were satisfied during the year ended December 31, 2009.

Code of Ethics

The Company has adopted a code of ethics that applies to all of its employees, Directors and consultants, and includes additional provisions specifically applicable to its chief executive officer and senior financial officers. A copy of this code of ethics (which is entitled “Senetek PLC – Code of Business Conduct”) can be found on the Company’s website at senetekplc.com. In the event of any amendment to, or waiver from, the code of ethics, the Company will publicly disclose the amendment or waiver by posting the information on its website.

ITEM 11—EXECUTIVE COMPENSATION

Executive Compensation Tables and Narrative Disclosure

Current Compensation

SUMMARY COMPENSATION TABLE

 

Name and Principal Position

  Year   Salary     Bonus   Stock
Awards (2)
  Option
Awards (2)
  All Other
Compensation (1)
  Total

Frank J. Massino

  2009   $ 370,000 (3)    $ —     $ —     $ 246,120   $ 69,510   $ 685,630

Chairman and Chief Executive Officer (PEO)

  2008     384,231 (3)      —       —       475,347     53,074     912,652

William F. O’Kelly

  2009     222,310 (3)      —       —       22,568     20,259     265,137

Chief Financial Officer and Secretary (PFO)

  2008     230,860 (3)      —       —       47,622     19,472     297,954

 

(1) Detail of All Other Compensation

 

     Year    401(k)
Employer
Match
    Life
Insurance
   Disability
Insurance
   Car
Allowance
   Other    Total

Frank J. Massino

   2009    $ 23,416 (4)    $ 14,067    $ 13,498    $ 16,500    $ 2,029    $ 69.510
   2008      4,133        14,067      13,498      12,000      9,376      53,074

William F. O’Kelly

   2009      10,869 (4)      —        —        8,100      1,290      20,259
   2008      7,750        —        —        6,000      5,722      19,472

 

(2) See Note 9 of Notes to Consolidated Financial Statements for stock and option compensation computation details.
(3) 2009 includes the January 1, 2010 payroll paid on December 31, 2009 due to the holiday. 2008 includes the January 2, 2009 payroll paid on December 31, 2008 due to the holiday.
(4) 2009 includes 401(k) match true-up from 2005-2008.

Effective January 1, 2008, Mr. Massino’s base salary was increased from $360,000 to $370,000. Effective January 1, 2008, Mr. O’Kelly’s base salary was increased from $215,000 to $222,310.

 

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GRANTS OF PLAN-BASED AWARDS

As at December 31, 2009

 

Name and Principal Position

   Grant Date    Number of Shares
      Estimated
Future
Payouts
Under Equity
Incentive Plan
Awards
   All Other
Stock
Awards
   All Other
Option
Awards
   Exercise
Price
   Grant Date
Fair Value
of Stock
and Option
Awards

Frank J. Massino

Chairman and Chief Executive Officer (PEO)

   January 18, 2008

January 18, 2008

   458,750

81,850

   —  

—  

   —  

—  

   $

$

2.50

2.50

   $

$

729,725

135,967

William F. O’Kelly

Chief Financial Officer and Secretary (PFO)

   January 18, 2008    48,750    —      —      $ 2.50    $ 80,982

No equity grants were awarded in 2009. The Compensation Committee awarded the equity grants included in the “Grants of Plan-Based Awards” table in 2008. The Compensation Committee did not award annual cash bonuses or salary increases for 2009 or 2008.

The Company does not plan to release material, non-public information for the purpose of affecting executive compensation and it does not plan or coordinate grants to existing or new executives around the release of material non public information.

Employment Agreements

The Company maintains employment agreements with key executives principally to define terms under which employment will cease and to provide explicit benefits if termination of employment occurs for certain reasons. These termination benefits are generally comparable to its benchmarked public companies, including IGI, Barrier Therapeutics, PhotoMedex, Antares Pharma, Bentley Pharmaceuticals, Vivus and Palatin Technologies, and have been constructed to provide an orderly transition for the Company if a termination event were to occur.

Material Terms of Employment Agreements

The Company had an employment agreement dated November 1, 1998 with Mr. Massino, as amended effective June 30, 2000, October 31, 2002, January 1, 2003 and April 2006. The agreement and amendments provide for a perpetual three-year term and an annual salary of $340,000 per annum subject to discretionary increases by the Compensation Committee from time to time. Mr. Massino’s base salary was increased from $360,000 to $370,000 as of January 1, 2008. The contract also provides for monthly automobile allowance and reimbursement of related automobile operating expenses. Under the agreement, Mr. Massino is entitled to an annual bonus, to be determined by the Compensation Committee, and is eligible to participate in the Company’s management bonus plan, if any.

Under the terms of the employment agreement, in the event that Mr. Massino’s employment is terminated by the Company (other than for “permanent disability” or “cause”, as such terms are defined in the agreement) or by Mr. Massino for “good reason” (as defined in the agreement), Mr. Massino would become entitled to a lump sum payment equal to the product of multiplying his base salary (and a deemed bonus, if any, as determined in accordance with the agreement) by three (i.e., the number of years remaining under the “evergreen” provisions of his employment agreement). Further, in such circumstance, all unvested and/or unexercisable options held by Mr. Massino would become immediately vested and exercisable. The agreement also provides for payment upon consummation of certain changes of control (as defined below), provided that the Company would not be required, on a change of control, to pay Mr. Massino any amounts that would constitute an “excess parachute

 

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payment” under the Internal Revenue Code. For purposes of the employment agreement with Mr. Massino, a “change of control” would include, among other events set forth in that agreement, (i) a sale, lease or transfer of all or substantially all of its assets, (ii) the adoption by its shareholders of a plan relating to Senetek’s liquidation or dissolution, (iii) Senetek’s merger or consolidation, following which its shareholders immediately prior to such event hold less than 50% of the voting power of the surviving or resulting corporation, (iv) an acquisition by an individual or group of more than 50% of the Company’s voting securities, and (v) a change in the Board of Directors that results in less than a majority of the Board being comprised of directors that have served on the Board of Directors for at least 12 months or who were approved by a majority of the Board at the time of their election or appointment. In connection with the March 2010 Transaction Mr. Massino was terminated without cause as Chief Executive Officer and resigned as Chairman of the Board of Directors (refer to Note 16 to the Consolidated Financial Statements). As a result, Mr. Massino received the lump sum payment described above and his employment agreement was terminated.

The Company had a payment agreement dated March 5, 2007 with Mr. O’Kelly that required the Company to make certain severance payments to Mr. O’Kelly in the event his employment is terminated under certain circumstances. If: (A) following a Change of Control, the Company does not retain Mr. O’Kelly as Chief Financial Officer or he is not offered a position of Equivalent Authority by the Company or a Successor Enterprise or (B) Mr. O’Kelly does not continue his employment with the Company or a Successor Enterprise after a Relocation, then, in either such event, the Company will continue to pay him his base salary as at the date of the Change of Control or Relocation for a period of six months following his separation from the Company or the Successor Enterprise. In connection with the March 2010 Transaction Mr. O’Kelly was terminated without cause as Chief Financial Officer and resigned as Secretary of the Company (refer to Note 16 to the Consolidated Financial Statements). As a result, Mr. O’Kelly received the severance payment described above and his payment agreement was terminated.

The Compensation Committee believes the change in control provisions for the Chief Executive Officer and the Chief Financial Officer are appropriate because neither individual would likely be retained in the event of such a transaction and the provision of change in control benefits serves as an incentive in the best interest of shareholders if such a transaction is under consideration.

Current Equity Holdings and Realization on Equity Holdings

OUTSTANDING EQUITY AWARDS

As at December 31, 2009

 

     Option Awards

Name and Principal Position

   Number of
Securities
Underlying
Unexercised
Options
Exercisable
   Number of
Securities
Underlying
Unexercised
Options
Unexercisable (5)
    Equity
Incentive Plan
Awards:
Number of
Securities
Underlying
Unexercised
Unearned
Options
   Option
Exercise
Price
   Option
Expiration
Date

Frank J. Massino

   183,500    275,250 (1)    —      $ 2.50    01/17/2015

Chairman and Chief Executive

   39,961    41,889 (2)    —      $ 2.50    01/17/2015

Officer (PEO)

   28,516    8,984 (3)    —      $ 1.60    12/17/2013
   75,000    —   (4)    75,000    $ 2.08    06/05/2013

William F. O’Kelly

   23,800    24,950 (2)    —      $ 2.50    01/17/2015

Chief Financial Officer and

   12,500    —   (4)    12,500    $ 2.08    06/05/2013

Secretary (PFO)

             

 

(1) Options vest 20% at issue and 20% on each anniversary date through January 18, 2012
(2) Options vest ratably over 48 months through January 18, 2012

 

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(3) Options vest ratably over 48 months through December 18, 2010
(4) On June 6, 2006, the Compensation committee awarded 150,000 non-qualified options to Mr. Massino and 25,000 non-qualified options to Mr. O’Kelly. The option grants have a term of seven years and were priced at the Company’s share market price at the close of business on the grant date. The option grants vest 25% each with respect to calendar years 2006, 2007, 2008 and 2009 if and only if one of the two conditions (“A” or “B”) described below are satisfied. If neither condition is satisfied with respect to the calendar year, the tranche applicable to that year plus any unvested cumulative tranches from prior years are carried forward to the following year and fully vested if one of the two conditions are met with respect to that year. The criterion for Condition B was met in 2007 and 2006; the shares are 50% vested at December 31, 2009. Neither Condition A or B was met in 2009 or 2008, the shares that would have vested in 2009 and 2008 have been carried forward to 2010.

Condition A

At any time during the calendar year, the closing price of Senetek PLC American Depositary Shares for a consecutive 60 day period averages “X” or higher, as defined below (provided that options shall not vest within the first six months after grant).

Condition B

“Net Operating Income” for the calendar year is greater than or equal to “Y” as defined below. For purposes of this calculation, “Net Operating Income” is defined as Operating Income computed in accordance with U.S. Generally Accepted Accounting Principles plus all operating expenses associated with any program to migrate from a UK legal entity to a US legal entity and operating expenses associated with the evaluation or institution of a share buyback program. Such expenses include, but are not limited to, professional fees, travel and temporary help and specifically exclude imputed value of any CEO or CFO compensation expense except if that compensation expense is directly attributable to the subject programs.

 

Calendar Year

   Condition A: X equals    Condition B: Y equals

2006

   $ 4.00    $ 1,200,000

2007

   $ 5.60    $ 2,040,000

2008

   $ 7.84    $ 2,356,000

2009

   $ 10.96    $ 2,697,000

 

(5) Effective March 10, 2010, in accordance with the Securities Purchase Agreement dated March 4, 2010, between Senetek and DMRJ Group LLC, vesting was accelerated for all options to purchase Ordinary Shares held by the Company’s officers and Directors as of December 1, 2009, the options were extended for five years and the exercise price was re-priced to the greater of $1.25 or the market price on March 10, 2010.

Option Exercises and Stock Vested

An “Option Exercises and Stock Vested” table has not been included as it is not required for Smaller Reporting Companies.

Post Employment Compensation

Disclosures for Pension Benefits and Non-Qualified Deferred Compensation are not included as there were no applicable transactions for the reporting period.

Potential Payments upon Termination or Change in Control

The Company had an employment agreement with Mr. Massino and a payment agreement with Mr. O’Kelly that include severance and change of control provisions. These provisions are fully described in the preceding section titled Material Terms of Employment Agreements. In the event Mr. Massino was to be terminated without cause or in the event of a change in control as described above, Mr. Massino would be entitled to a minimum lump sum payment of $370,000 (his current salary) plus a deemed bonus times three. In addition, all unvested

 

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stock options and restricted stock would immediately vest. In the event Mr. O’Kelly was to be terminated as a result of a change in control or relocation as described above, Mr. O’Kelly would be entitled to a lump sum payment of $107,500.

Senetek and DMRJ Group, LLC, signed a Security Purchase Agreement, a Note and a Warrant Purchase Agreement on March 10, 2010. As a result, Mr. Massino and Mr. O’Kelly were terminated without cause and severance and change of control payments were made to Mr. Massino and Mr. O’Kelly on March 11, 2010 in accordance with their agreements. There are no other employment agreements in place and no claims existed at December 31, 2009 with respect to employment agreements with past employees.

Director Compensation Tables and Narrative Disclosure

DIRECTOR COMPENSATION TABLE

 

Name (1)

   Fees Earned or
Paid in Cash
   Option
Awards
(2) (3)
   Total

Anthony Williams

   $ 12,500    $ 18,901    $ 31,401

Rodger Bogardus

   $ 12,500    $ 13,644    $ 26,144

Kerry Dukes

   $ 12,500    $ 13,643    $ 26,143

 

(1) Mr. Massino is Chairman of the Board. His compensation is discussed in the Executive Compensation tables.
(2) See Note 9 of Notes to the Consolidated Financial Statements for stock compensation computation details.
(3) Mr. Williams holds an aggregate total of 96,250 stock options at December 31, 2009. Mr. Bogardus and Mr. Dukes each hold an aggregate total of 42,500 stock options at December 31, 2009.

Effective January 1, 2008, each non-employee Director receives a $3,125 quarterly cash stipend. New non-employee Directors historically have been granted an option to purchase shares upon joining the Board. There is no established policy requiring such a grant. Subsequent equity grants in the form of stock options, restricted stock or a combination of stock options and restricted stock typically take place annually and are based on each Director’s responsibility, experience, performance and ability to influence the Company’s long-term growth and profitability.

Compensation Committee

Compensation Committee Practices and Procedures

The Compensation Committee of the Board of Directors, comprised solely of independent Directors, has the responsibility and authority to establish the compensation program for the Company’s Executive Officers. The Compensation Committee is comprised of Mr. Kerry Dukes (Chairman) and Dr. Wesley Holland.

In addition, the committee may also request independent compensation survey data and proxy information from companies similar in nature and size for comparative purposes. The Company’s executives may advise the committee but play no role in compensation decisions. The committee reserves the right to also consider other unique factors in setting compensation levels and to adjust or recover for awards of payments if the Company adjusts or restates performance measures in a manner that would reduce the size of an award or payment.

ITEM 12—SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

The following table sets forth certain information regarding the beneficial ownership of Senetek’s outstanding ordinary shares as of March 31, 2010 by (i) each of Senetek’s Directors who is also a stockholder; (ii) its Chief Executive Officer; (iii) its other executive officers currently in office; and (iv) all executive officers and Directors of Senetek as a group. There are no persons believed by Senetek to beneficially own more than 5% of the Company’s outstanding ordinary Shares. The holders listed below have sole voting power and investment

 

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power over the shares beneficially held by them. The address of each of its Directors and executive officers is that of Senetek.

 

Name of Beneficial Owner

   Number  of
Shares
Beneficially
Owned
(1) (2) (3)
   Percentage
of
Class (1)
 

John P. Ryan

   —      —     

Howard Crosby

   —      —     

Anthony Williams

   130,957    1.7

Wesley Holland

   —      —     

Kerry Dukes

   48,750    *   
           

All Directors and Executive Officers as a group

   179,707    1.7
           

 

* Less than one percent
(1) For purposes of this table, a person or a group of persons is deemed to have “beneficial ownership” as of a given date of any shares which that person has the right to acquire within 60 days after that date. For purposes of computing the percentage of outstanding shares held by each person or group of persons named above on a given date, any shares which that person or persons has the right to acquire within 60 days after that date are deemed to be outstanding, but are not deemed to be outstanding for the purpose of computing the percentage ownership of any other person.
(2) Includes the following number of shares issuable upon exercise of options or warrants that currently are exercisable or will become exercisable within 60 days of March 31, 2010: Mr. Williams: 96,250; Mr. Dukes: 42,500
(3) In conjunction with the March 2010 Transaction between Senetek and DMRJ Group LLC, vesting was accelerated for all options to purchase Ordinary Shares held by the Company’s officers and Directors as of December 1, 2009. The options were extended for five years and the exercise price was re-priced to the greater of $1.25 or the market price on March 10, 2010.

See Item 5 above for information regarding the Company’s equity compensation plans.

ITEM 13—CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE

Anthony Williams, a Director of the Company, is a partner of the law firm DLA Piper US LLP. Mr. Williams was previously a partner of the law firm of Baker & McKenzie LLP from September 2005 through October 2009 and prior to that was a partner of the law firm of Coudert Brothers LLP. Legal fees paid to DLA Piper in 2009 and 2008 were $50,000 and $0, respectively. Legal fees paid to Baker & McKenzie LLP in 2009 and 2008 were $56,000 and $409,000, respectively.

Dr. Brian Clark, Chief Scientist for the Company until January 31, 2010, earned a consulting fee of $108,000 in 2009 and 2008. This amount was accrued and paid in both years.

ITEM 14—PRINCIPAL ACCOUNTING FEES AND SERVICES

The Board of Directors appointed Macias Gini & O’Connell LLP (“Macias Gini”) as independent accountants to examine the Company’s consolidated financial statements for the year ended December 31, 2009 and to render other professional services as required and appointed BDO LLP as its independent accountants to examine the Company’s English accounts and reports.

 

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Aggregate fees billed by the Company’s principal accountants, Macias Gini for 2009 and 2008, for audit services related to the most recent two years, and for other professional services billed in the most recent two fiscal years, were as follows:

 

MACIAS GINI & O’CONNELL LLP—Principal Accountants in the United States:

         

Type of Service

   2009    2008

Audit fees (1)

   $ 132,000    $ 137,000

Other audit-related fees (2)

     —        —  

Tax fees (3)

     —        —  

All other fees (4)

     —        —  
             

Total

   $ 132,000    $ 137,000
             

 

(1) Audit fees: This category consists of fees for professional services rendered by Macias Gini for audits of the Company’s annual financial statements, review of the financial statements included in its quarterly reports on Form 10-Q and services that are normally provided by the independent auditors in connection with regulatory filings or engagements for those fiscal years. This category also includes advice on audit and accounting matters that arose during, or as a result of, the audit or the review of interim financial statements.
(2) Other audit-related fees: None
(3) Tax fees: None
(4) All other fees: None

Aggregate fees billed by the Company’s principal accountants in the United Kingdom, BDO LLP for 2009 and 2008, for audit services related to the most recent two years, and for other professional services billed in the most recent two fiscal years, were as follows:

 

BDO LLP—Principal Accountants in the United Kingdom:

         

Type of Service

   2009    2008

Audit fees (1)

   $ 53,000    $ 74,000

Other audit-related fees (2)

     —        —  

Tax fees (3)

     22,000      26,000

All other fees (4)

     —        —  
             

Total

   $ 75,000    $ 100,000
             

 

(1) Audit fees: This category consists of fees for professional services rendered by BDO LLP for audits of the Company’s annual financial statements and services that are normally provided by the independent auditors in connection with statutory and regulatory filings or engagements for those fiscal years. This category also includes advice on audit and accounting matters that arose during, or as a result of, the audit and statutory audits required by United Kingdom jurisdictions.
(2) Other audit-related fees: None
(3) Tax fees: This category consists of fees for professional services rendered by BDO LLP for United Kingdom tax compliance including tax return preparation, technical tax advice and tax planning.
(4) All other fees: None

The Audit Committee established a policy governing the Company’s use of the Company’s auditors for non-audit services. Under the policy, management may use non-audit services of the auditors that are permitted under SEC rules and regulations, provided that management obtains the Audit Committee’s approval before such services are rendered. In 2009 and 2008, all fees identified above under the captions “Audit Fees”, “Other Audit-Related Fees”, “Tax Fees” and “All Other Fees” were approved by the Audit Committee or the full Board when the Board lacked sufficient non-management Directors to constitute an Audit Committee. The Audit Committee

 

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determined that the rendering of other professional services for audit related matters, tax compliance and tax advice was compatible with these firms maintaining their independence. In 2009 and 2008, no hours were expended on the principal accountant’s engagement to audit the financial statements that were attributable to work performed by persons other than the principal accountant’s full-time, permanent employees.

 

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PART IV

ITEM 15—EXHIBITS, FINANCIAL STATEMENT SCHEDULES

(a) Documents filed as part of this Report

(1) Financial Statements:

 

Report of Independent Registered Public Accounting Firm

   55

Consolidated balance sheets as of December 31, 2009 and 2008

   56

Consolidated statements of operations for the years ended December 31, 2009 and 2008

   57

Consolidated statements of stockholders’ equity and comprehensive loss for the years ended December 31, 2009 and 2008

   58

Consolidated statements of cash flows for the years ended December 31, 2009 and 2008

   59

Notes to consolidated financial statements

   60

(2) The following Exhibits are filed or incorporated by reference as part of this Report on Form 10-K:

 

Exhibit
No.

  

Description

    3.1   

Certificate of Incorporation of Senetek PLC

  

Filed as an Exhibit with corresponding Exhibit Number to Registrant’s Registration Statement on Form F-1, Registration No. 33-3535, and incorporated herein by reference

    3.2   

Memorandum and Articles of Association of Senetek PLC (defining the rights of security holders, subject to the provisions of the United Kingdom Companies Act 1985)

  

Filed as an Exhibit with corresponding Exhibit Number to Registrant’s Registration Statement on Form F-1, Registration No. 33-3535, and incorporated herein by reference

+10.1   

Senetek No. 1 Share Option Scheme for Employees

  

Filed as an Exhibit to Registrant’s Report on Form S-8 on October 8, 1993, Registration No. 33-70136, and incorporated herein by reference

  10.2   

Asset Purchase Agreement dated as of July 31, 1995, between Carme International, Inc. a wholly owned subsidiary of Senetek PLC and Carme Inc.

  

Filed as an Exhibit on Form 8-K, dated October 10, 1995 (as amended), and incorporated herein by reference

+10.3   

Senetek No. 2 Executive Share Option Scheme for Non-Executive Directors and Consultants

  

Filed as an Exhibit to Registrant’s Registration Statement on Form S-8 on October 8, 1993, Registration No. 33-70136, and incorporated herein by reference

  10.4   

Deposit Agreement dated October 3, 2005 between Senetek PLC and The Bank of New York

  

Filed as an Exhibit to Registrant’s Report on Form 10-K for the year ended December 31, 2005 and incorporated herein by reference

+10.14   

Service Agreement dated December 30, 1998 between Senetek PLC and Mr. F. J. Massino

  

Filed as an exhibit to Registrant’s Annual Report on Form 10-K for the year ended December 31, 1998 and incorporated herein by reference

 

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Exhibit
No.

  

Description

10.16    Securities Purchase Agreement dated April 13, 1999 by and among Senetek PLC and certain other parties thereto
  

Filed as an exhibit to Registrant’s Annual Report on Form 10-K for the year ended December 31, 1998 and incorporated herein by reference

10.17   

Securities Purchase Agreement (“Securities Purchase Agreement”) dated April 14, 1999 between Senetek PLC and the various purchasers designated in the agreement

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the quarter ended June 30, 1999 and incorporated herein by reference

10.18   

Form of Senior Secured Note due April 14, 2002 issued by Senetek PLC pursuant to the Securities Purchase Agreement

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the quarter ended June 30, 1999 and incorporated herein by reference

10.19   

Form of Series A Warrant issued by Senetek pursuant to the Securities Purchase Agreement

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the quarter ended June 30, 1999 and incorporated herein by reference

10.20   

Form of Series B Warrant issued by Senetek pursuant to the Securities Purchase Agreement

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the quarter ended June 30, 1999 and incorporated herein by reference

10.21   

Form of Series C Warrant issued by Senetek pursuant to the Securities Purchase Agreement

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the quarter ended June 30, 1999 and incorporated herein by reference

10.22   

Registration Rights Agreement dated as of April 14, 1999 among Senetek PLC and the parties designated therein

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the quarter ended June 30, 1999 and incorporated herein by reference

10.23   

Security Agreement dated as of April 14, 1999 by and between Senetek PLC and the parties designated therein

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the quarter ended June 30, 1999 and incorporated herein by reference

10.24   

Pledge Agreement dated as of April 14, 1999 by and between Senetek PLC and the parties designated therein

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the quarter ended June 30, 1999 and incorporated herein by reference

10.25   

Pledge Agreement dated April 14, 1999 by and between Senetek Drug Delivery Technologies Inc. and the parties designated therein

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the quarter ended June 30, 1999 and incorporated herein by reference

10.26   

Guaranty dated as of April 14, 1999 executed by Senetek Drug Delivery Technologies Inc. and Carme Cosmeceutical Sciences Inc.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the quarter ended June 30, 1999 and incorporated herein by reference

 

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Exhibit
No.

  

Description

10.27   

Patent and Security Agreement dated as of April 14, 1999 between Senetek PLC and the parties designated therein

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the quarter ended June 30, 1999 and incorporated herein by reference

10.28   

Fixed and Floating Security Document dated April 14, 1999 executed by Senetek PLC in favor of the Collateral Agent named therein

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the quarter ended June 30, 1999 and incorporated herein by reference

10.30   

Settlement Agreement dated April 13, 1999 among Senetek PLC and the parties named therein

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the quarter ended June 30, 1999 and incorporated herein by reference

10.31   

Form of Amended Series A Warrant issued by Senetek pursuant to the Securities Purchase Agreement

  

Filed as an exhibit to Amendment No. 1 of Registrant’s Registration Statement on Form
S-3, Registration No. 333-37782, filed on January 23, 2001 and incorporated herein by reference

10.32   

Form of Amended B Warrant issued by Senetek pursuant to the Securities Purchase Agreement

  

Filed as an exhibit to Amendment No. 1 of Registrant’s Registration Statement on Form
S-3, Registration No. 333-37782, filed on January 23, 2001 and incorporated herein by reference

10.33   

Form of Amended C Warrant issued by Senetek pursuant to the Securities Purchase Agreement

  

Filed as an exhibit to Amendment No. 1 of Registrant’s Registration Statement on Form S-3, Registration No. 333-37782, filed on January 23, 2001 and incorporated herein by reference

10.34   

First Amendment to the Securities Purchase Agreement dated as of June 20, 2001 by and among Senetek PLC and the various purchasers designated in the agreement

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the quarter ended June 30, 2001 and incorporated herein by reference

10.35   

Form of Amended and Restated Senior Secured Note due April 14, 2004 issued by Senetek PLC pursuant to the First Amendment to the Securities Purchase Agreement

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the quarter ended June 30, 2001 and incorporated herein by reference

10.36   

Form of Amended and Restated Series A Warrant, issued by Senetek PLC pursuant to the First Amendment to the Securities Purchase Agreement

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the quarter ended June 30, 2001 and incorporated herein by reference

10.37   

Form of Amended and Restated Series B Warrant, issued by Senetek PLC pursuant to the First Amendment to the Securities Purchase Agreement

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the quarter ended June 30, 2001 and incorporated herein by reference

 

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Exhibit
No.

  

Description

10.38   

Form of Amended and Restated Series C Warrant, issued by Senetek PLC pursuant to the First Amendment to the Securities Purchase Agreement

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the quarter ended June 30, 2001 and incorporated herein by reference

10.39   

Amended and Restated Registration Rights Agreement dated as of June 20, 2001 among Senetek PLC and the parties designated therein

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the quarter ended June 30, 2001 and incorporated herein by reference

10.40   

First Amendment to the Security Agreement dated as of June 20, 2001 by and between Senetek PLC and the parties designated therein

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the quarter ended June 30, 2001 and incorporated herein by reference

10.41   

First Amendment to the Pledge Agreement dated as of June 20, 2001 by and between Senetek PLC and the parties designated therein

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the quarter ended June 30, 2001 and incorporated herein by reference

10.42   

First Amendment to the Pledge Agreement dated as of June 20, 2001 by and between Senetek Drug Delivery Technologies, Inc. and the parties designated therein

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the quarter ended June 30, 2001 and incorporated herein by reference

10.43   

First Amendment to the Guaranty dated as of June 20, 2001 executed by Senetek Drug Delivery Technologies, Inc. and Carme Cosmeceutical Sciences, Inc.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the Quarter ended June 30, 2001 and incorporated herein by reference

10.44   

First Amendment to the Patent and Trademark Security Agreement dated as of June 20, 2001 by and between Senetek PLC and the parties designated therein

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the Quarter ended June 30, 2001 and incorporated herein by reference

10.45   

Investment Advice Agreement dated as of June 20, 2001 by and between Senetek PLC and Scorpion Investments, Inc.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the Quarter ended June 30, 2001 and incorporated herein by reference

10.46   

Revolving Credit Agreement dated as of June 20, 2001 by and between Senetek PLC and Wallington Investments, Ltd.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the Quarter ended June 30, 2001 and incorporated herein by reference

10.47   

Form of Revolving Note, issued by Senetek PLC pursuant to the Revolving Credit

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the Quarter ended June 30, 2001 and incorporated herein by reference

 

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Exhibit
No.

  

Description

  10.48   

Distribution Agreement dated as of October 15, 1998, by and between Carme Cosmeceutical Sciences, Inc. and ICN Pharmaceuticals

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the fiscal year ended December 31, 2001 and incorporated herein by reference

  10.49   

License and Supply Agreement dated as of May 26, 2000 by and between Senetek PLC and Buth-Na-Bodhaige, Inc.

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the fiscal year ended December 31, 2001 and incorporated herein by reference

  10.50   

License Agreement dated as of June 8, 2000 between Senetek PLC and Revlon Consumer Products Corporation

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the fiscal year ended December 31, 2001 and incorporated herein by reference

  10.51   

Production and Marketing Agreement dated as of August 15, 2000 between Senetek PLC and Signet Laboratories, Inc.

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the fiscal year ended December 31, 2001 and incorporated herein by reference

  10.52   

Warrant to Purchase 125,000 Ordinary Shares of Senetek PLC issued June 8, 2000 to Revlon Consumer Products Corporation

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the fiscal year ended December 31, 2001 and incorporated herein by reference

  10.53   

Amendment to Agreement dated as of November 30, 2000 by and between Senetek PLC and Buth-Na-Bodhaige

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the Fiscal Year ended December 31, 2001 and incorporated herein by reference

  10.54   

First Amendment to License Agreement dated June 8, 2000 by and between Senetek PLC and Revlon Consumer Products Corporation

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the Fiscal Year ended December 31, 2001 and incorporated herein by reference

*10.55   

Development and Distribution Agreement dated November 12, 2002 by and between Senetek PLC and Douglas Pharmaceuticals Limited

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the Fiscal Year ended December 31, 2002 and incorporated herein by reference

*10.56   

License Agreement dated March 12, 2002 by and between Senetek PLC and Enprani Co., Ltd.

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the Fiscal Year ended December 31, 2002 and incorporated herein by reference

*10.57   

License and Supply Agreement dated November 12, 2002 by and between Senetek PLC and Shaklee Corporation

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the Fiscal Year ended December 31, 2002 and incorporated herein by reference

 

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Exhibit
No.

  

Description

*10.58   

License Agreement dated September 30, 2002 by and between Senetek and Vivier Pharma Inc.

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the Fiscal Year ended December 31, 2002 and incorporated herein by reference

*10.59   

License Agreement dated January 1, 2003 by and between Senetek PLC and Panion & BF Biotech, Inc.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the period ended March 31, 2003 and incorporated herein by reference

+10.60   

Employment contract dated March 3, 2003 between the Company and Bradley D. Holsworth

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the period ended March 31, 2003 and incorporated herein by reference

*10.61   

License Agreement dated March 21, 2003 by and between Senetek PLC and Lavipharm S.A.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the period ended March 31, 2003 and incorporated herein by reference

+10.62   

Employment contract dated April 1, 2003 between the Company and Wade Nichols

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the period ended June 30, 2003 and incorporated herein by reference

  10.63   

Research Collaboration Agreement dated June 10, 2003 by and between Senetek PLC and Beiersdorf A.G.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the period ended June 30, 2003 and incorporated herein by reference

*10.64   

Cooperative Research and Development Agreement dated June 11, 2003 by and between Senetek PLC and Institute of Experimental Botany, Academy of Sciences, Czech Republic

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the period ended June 30, 2003 and incorporated herein by reference

  10.65   

Second Amendment to the Securities Purchase Agreement dated September 4, 2003 by and between Senetek PLC and various purchasers designated in the Agreement

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the period ended September 30, 2003 and incorporated herein by reference

  10.66   

Amendment No. 1 to the Amended and Restated Registration Rights Agreement dated September 4, 2003

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the period ended September 30, 2003 and incorporated herein by reference

  10.67   

Form of Second Amended and Restated Senior Secured Notes Due April 1, 2007 dated September 4, 2003

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the period ended September 30, 2003 and incorporated herein by reference

 

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Exhibit
No.

  

Description

  10.68   

Form of Series D Warrant issued by Senetek PLC pursuant to the Second Amendment to the Securities Purchase Agreement dated September 4, 2003

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the period ended September 30, 2003 and incorporated herein by reference

*10.69   

License Agreement dated August 1, 2003 between ICN Pharmaceuticals, Inc. and Senetek PLC

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the period ended September 30, 2003 and incorporated herein by reference

*10.70   

Amendment #1 dated December 1, 2003 to the license agreement dated August 1, 2003 between Valeant Pharmaceuticals (formerly ICN Pharmaceuticals) and Senetek PLC

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the period ended December 31, 2003 and incorporated herein by reference

  10.71   

Amended License Agreement dated February 1, 2004 by and between Senetek PLC and Panion & BF Biotech, Inc.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the period ended September 30, 2003 and incorporated herein by reference

  10.72   

Deferred Compensation Plan for Company Executives effective January 1, 2004

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the period ended March 31, 2004 and incorporated herein by reference

+10.73   

Deferred Compensation Plan for Directors effective January 1, 2004

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the period ended March 31, 2004 and incorporated herein by reference

*10.74   

Settlement agreement between OMP, Inc. and Senetek PLC dated March 26, 2004

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the period ended March 31, 2004 and incorporated herein by reference

+10.75   

Consulting Agreement with Stewart Slade May 1, 2004

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the year ended December 31, 2005 and incorporated herein by reference

  10.76   

Agreement with Valeant Pharmaceuticals International for Zeatin dated May 4, 2004

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the period ended June 30, 2004 and incorporated herein by reference

*10.77   

Amended License Agreement with Valeant Pharmaceuticals International for Kinetin dated May 4, 2004

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the period ended June 30, 2004 and incorporated herein by reference

  10.78   

Consulting Agreement with Andreas Tobler dated June 1, 2004

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the period ended June 30, 2004 and incorporated herein by reference

  10.79   

License Agreement with Ardana Bioscience Limited dated June 17, 2004

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the period ended June 30, 2004 and incorporated herein by reference

 

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Exhibit
No.

  

Description

*10.80   

Amendment to the License Agreement with Research Foundation for Mental Hygiene, Inc dated May 10, 2004

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the period ended June 30, 2004 and incorporated herein by reference

  10.81   

Agreement with Tri-Artisan Partners LLC dated May 4, 2004

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the period ended September 30, 2004 and incorporated herein by reference

+10.82   

Third Amended and Restated Employment Agreement between Senetek PLC and Frank J. Massino dated as of January 1, 2003

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the year ended December 31, 2005 and incorporated herein by reference

  10.83   

Second Amendment to License Agreement between Senetek PLC and Revlon Consumer Products Corporation dated as of July 1, 2004

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the year ended December 31, 2005 and incorporated herein by reference

  10.84   

Settlement Agreement between Senetek PLC and Eagle-Picher dated September 28, 2004

  

Filed as an exhibit to Registrant’s report on Form 10-K for the fiscal year-ended December 31, 2004 and incorporated herein by reference

  10.85   

3rd Amendment to the Securities Purchase Agreement dated as of September 30, 2004 by and between the Company and the holders of the Company’s Senior Secured Notes, Series A Warrants and Series B Warrants

  

Filed as an exhibit to Registrant’s Report on Form 8-K filed October 5, 2004 and incorporated herein by reference

*10.86   

Letter Agreement dated September 30, 2004 by and between the Company and the holders of the Company’s Series D Warrants

  

Filed as an exhibit to Registrant’s Report on Form 8-K filed October 5, 2004 and incorporated herein by reference

*10.87   

Amendment to License Agreement between Senetek PLC and Valeant Pharmaceuticals International dated as of October 31, 2004

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the year ended December 31, 2005 and incorporated herein by reference

  10.88   

Forbearance Agreement between U.S. International Trading Corporation and Senetek PLC dated November 8, 2004

  

Filed as an exhibit to Registrant’s report on Form 10-K for the fiscal year-ended December 31, 2004, and incorporated herein by reference

*10.89   

License Agreement between the Company and Ferrosan A/S dated December 8, 2004

  

Filed as an exhibit to Registrant’s report on Form 10-K for the fiscal year-ended December 31, 2004, and incorporated herein by reference

*10.90   

Amended and restated agreement between Senetek PLC and Signet Laboratories dated as of January 1, 2005

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the year ended December 31, 2005 and incorporated herein by reference

 

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Exhibit
No.

  

Description

+10.91   

Severance agreement between the Company and Wade H. Nichols dated as of March 23, 2005

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the year ended December 31, 2005 and incorporated herein by reference

+10.92   

Consulting agreement between the Company and Wade H. Nichols dated as of April 1, 2005

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the year ended December 31, 2005 and incorporated herein by reference

*10.93   

License Agreement between Senetek and pH Advantage, LLC dated as of April 30, 2005

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the year ended December 31, 2005 and incorporated herein by reference

*10.94   

Amendment to License Agreement between Senetek PLC and Valeant Pharmaceuticals International dated as of July 15, 2005

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the year ended December 31, 2005 and incorporated herein by reference

*10.95   

License Agreement between Senetek PLC and Ofra Cosmetics dated as of September 15, 2005

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the year ended December 31, 2005 and incorporated herein by reference

  10.96   

Second Amendment to Agreement on Cooperative Research and Development between Senetek PLC and Institute of Experimental Botany dated as of November 10, 2005

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the year ended December 31, 2005 and incorporated herein by reference

*10.97   

License Agreement between Senetek PLC and Plethora Solutions Limited dated as of February 16, 2006

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the year ended December 31, 2005 and incorporated herein by reference

  10.98   

Agreement on Cooperative Research and Development between Senetek PLC, and Dr. Efstathios S. Gonos and Dr. Ioanna Chinou dated as of March 6, 2006

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the year ended December 31, 2005 and incorporated herein by reference

*10.99   

Asset Sale and Purchase Agreement between Senetek PLC and Ranbaxy Pharmaceuticals Inc. dated as of March 15, 2006

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the year ended December 31, 2005 and incorporated herein by reference

  10.100   

Prepayment Agreement between Senetek PLC and the Holders of Senetek’s Senior Secured Notes and Warrants dated as of March 30, 2006

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the year ended December 31, 2005 and incorporated herein by reference

  10.101   

Series E Warrant dated March 31, 2006 issued to Wallington Investment Holdings Ltd.

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the year ended December 31, 2005 and incorporated herein by reference

 

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Exhibit
No.

  

Description

  10.102   

Series E Warrant dated March 31, 2006 issued to Alba Limited

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the year ended December 31, 2005 and incorporated herein by reference

  10.103   

Resignation and Indemnity Consulting Agreement between Senetek PLC and Rani Aliahmad dated as of March 31, 2006

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the year ended December 31, 2005 and incorporated herein by reference

  10.104   

Resignation and Indemnity Agreement Consulting Agreement between Senetek PLC and Michael Khoury dated as of March 31, 2006

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the year ended December 31, 2005 and incorporated herein by reference

  10.105   

Loan and Security Agreement between Senetek PLC and Silicon Valley Bank dated as of March 30, 2006

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the year ended December 31, 2005 and incorporated herein by reference

  10.106   

Intellectual Property Security Agreement between Senetek PLC and Silicon Valley Bank dated as of March 30, 2006

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the year ended December 31, 2005 and incorporated herein by reference

  10.107   

Securities Account Control Agreement between Senetek PLC, U.S. Bank, N.A., SVB Asset Management and Silicon Valley Bank dated as of March 30, 2006

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the year ended December 31, 2005 and incorporated herein by reference

  10.108   

Amendment dated as of May 19, 2006 among Signet Laboratories, Inc., Senetek PLC, Research Foundation for Mental Hygiene and Covance Antibody Services, Inc.

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the year ended December 31, 2006 and incorporated herein by reference

  10.109   

Contract for Personal Services between Senetek PLC and Brian Clark dated August 1, 2006

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the year ended December 31, 2006 and incorporated herein by reference

*10.110   

Agreement on Cooperative Research and Development dated October 17, 2006 between Senetek PLC and Institute of Bioorganic Chemistry, Polish Academy of Sciences – Phloretamide

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the year ended December 31, 2006 and incorporated herein by reference

*10.111   

Agreement on Cooperative Research and Development dated October 17, 2006 between Senetek PLC and Institute of Bioorganic Chemistry, Polish Academy of Sciences – Plant Nucleic Acids

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the year ended December 31, 2006 and incorporated herein by reference

 

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Exhibit
No.

  

Description

*10.112   

Agreement on Cooperative Research and Development dated October 17, 2006 between Senetek PLC and Institute of Bioorganic Chemistry, Polish Academy of Sciences – Brain Tumor treatment with Interference RNA

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the year ended December 31, 2006 and incorporated herein by reference

*10.113   

Agreement on Cooperative Research and Development dated October 17, 2006 between Senetek PLC and Institute of Bioorganic Chemistry, Polish Academy of Sciences – Furfurylcytosine

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the year ended December 31, 2006 and incorporated herein by reference

+10.114   

Payments in the Event of Certain Changes Agreement between Senetek PLC and William F. O’Kelly dated March 5, 2007

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the year ended December 31, 2006 and incorporated herein by reference

  10.115   

License and Intellectual Property Acquisition Agreement dated March 30, 2007 between Senetek PLC and Valeant Pharmaceuticals North America

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the year ended December 31, 2006 and incorporated herein by reference

  10.116   

License, Supply & Distribution Agreement with Triax Aesthetics LLC dated August 6, 2007

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the period ended March 31, 2007 and incorporated herein by reference

+10.117   

Employment offer letter to Phillip Rose dated May 22, 2008

  

Filed as an exhibit to Registrant’s Report on Form 8-K filed June 16, 2008 and incorporated herein by reference

  10.118   

Settlement Agreement with Triax Aesthetics LLC dated June 27, 2008

  

Filed as an exhibit to Registrant’s Report on Form 8-K filed July 3, 2008 and incorporated herein by reference

  10.119   

Lease Agreement with Fairlawns Partnership dated May 14, 2009

  

Filed as an exhibit to Registrant’s Report on Form 8-K filed May 19, 2009 and incorporated herein by reference

  10.120   

Extension Agreement on Cooperative Research and Development dated June 5, 2009 between Senetek PLC and Czech Republic Institute of Experimental Botany

  

Filed as an exhibit to the Registrant’s Report on Form 8-K filed June 10, 2009 and incorporated herein by reference

  10.121   

Lease Termination Agreement with Fairlawns Partnership dated December 31, 2009

  

Filed as an exhibit to Registrant’s Report on Form 8-K filed January 6, 2010 and incorporated herein by reference

  10.122   

Secured Convertible Promissory Note payable to DMRJ Group, LLC dated March 4, 2010

  

Filed as an exhibit to Registrant’s Report on this Form 10-K filed April 15, 2010

 

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Exhibit
No.

  

Description

10.123   

Warrant Agreement between Senetek Plc and DMRJ Group, LLC dated March 4, 2010

  

Filed as an exhibit to Registrant’s Report on this Form 10-K filed April 15, 2010

10.124   

Securities Purchase Agreement between Senetek Plc and DMRJ Group, LLC dated March 4, 2010

  

Filed as an exhibit to Registrant’s Report on this Form 10-K filed April 15, 2010

10.125   

Collateral Pledge and Security Agreement between Senetek Plc and DMRJ Group LLC dated March 4, 2010

  

Filed as an exhibit to Registrant’s Report on this Form 10-K filed April 15, 2010

10.126   

Trademark License Agreement between Senetek Plc and Skinvera LLC dated March 10, 2010

  

Filed as an exhibit to Registrant’s Report on this Form 10-K filed April 15, 2010

10.127   

Collateral Pledge and Security Agreement between Senetek Plc and Skinvera LLC dated March 10, 2010

  

Filed as an exhibit to Registrant’s Report on this Form 10-K filed April 15, 2010

10.128   

Secured Promissory Note from Skinvera LLC dated March 10, 2010

  

Filed as an exhibit to Registrant’s Report on this Form 10-K filed April 15, 2010

10.129   

Asset Purchase Agreement between Senetek Plc and Skinvera LLC dated March 10, 2010

  

Filed as an exhibit to Registrant’s Report on this Form 10-K filed April 15 2010

21   

Subsidiaries of Senetek PLC

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the Fiscal Year ended December 31, 2001 and incorporated herein by reference

24   

Power of Attorney included on the signature page to this Annual Report on Form 10-K

31.1   

Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

31.2   

Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

32.1   

Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

32.2   

Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

* Confidential treatment has been requested as to certain portions of those exhibits
+ Agreements related to Management Contracts or Compensation Plans

 

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Table of Contents

SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized, in the city of Napa, State of California, on this April 15, 2010.

 

SENETEK PLC
By:   /s/    J. P. RYAN        
  John P. Ryan
 

Chairman of the Board and

Chief Executive Officer

POWER OF ATTORNEY TO SIGN AMENDMENTS

KNOW ALL MEN BY THESE PRESENTS, that each person whose signature appears below does hereby constitute and appoint John P. Ryan and Howard Crosby, and each of them, with full power of substitution and full power to act without the other, his true and lawful attorney-in-fact and agent to act for him in his name, place and stead, in any and all capacities to sign any or all amendments to this Annual Report on Form 10-K, and to file the same, with all exhibits hereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to all intents and purposes, as they or he might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents, or any of them, may lawfully do or cause to be done by virtue hereof.

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed by the following persons in the capacities and on the dates indicated.

 

Signature

  

Title

 

Date

/S/    J. P. RYAN        

John P. Ryan

  

Chairman of the Board and
Chief Executive Officer (Principal Executive Officer)

  April 15, 2010

/S/    H. CROSBY        

Howard Crosby

  

President, Chief Financial Officer and Director (Chief Accounting Officer)

  April 15, 2010

/S/    A. WILLIAMS        

Anthony Williams

  

Corporate Secretary and Director

  April 15, 2010

/S/    W. HOLLAND        

Wesley Holland

  

Director

  April 15, 2010

/S/    K. DUKES        

Kerry Dukes

  

Director

  April 15, 2010

 

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Table of Contents

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To Board of Directors and

Stockholders of Senetek PLC

Napa, California

We have audited the accompanying consolidated balance sheets of Senetek PLC and its subsidiaries (the Company) as of December 31, 2009 and 2008 and the related consolidated statements of operations, stockholders’ equity and comprehensive loss and cash flows for the years then ended. These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these consolidated financial statements based on our audits.

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. Our audits included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. An audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.

In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of Senetek PLC and its subsidiaries at December 31, 2009 and 2008 and the results of their operations and their cash flows for the years then ended in conformity with accounting principles generally accepted in the United States of America.

As discussed in Note 8 to the consolidated financial statements, in 2009 the Company has changed its method of accounting for warrants which are not indexed to its stock due to the adoption of FASB ASC 815 (EITF 07-5, Determining Whether an Instrument (or embedded feature) is Indexed to an Entity’s Own Stock).

 

/s/    MACIAS GINI & O’CONNELL LLP        
Macias Gini & O’Connell LLP

Sacramento, California

April 15, 2010

 

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Table of Contents

SENETEK PLC

CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share amounts)

 

     December 31  
     2009     2008  

ASSETS

    

Current assets

    

Cash and cash equivalents

   $ 4,232      $ 5,833   

Short-term investments

     6,500        10,143   

Trade receivables (net of allowances of $5 in 2009 and $187 in 2008)

     311        148   

Non-trade receivables

     122        159   

Tax receivable

     9        352   

Inventory

     312        165   

Prepaid expenses and deposits

     154        140   

Prepaid tax

     2        59   
                

Total current assets

     11,642        16,999   

Property and equipment—net

     44        98   
                

Total assets

   $ 11,686      $ 17,097   
                

LIABILITIES AND STOCKHOLDERS’ EQUITY

    

Current liabilities

    

Accounts payable

   $ 696      $ 772   

Accrued liabilities

     442        855   

Deferred revenue and license fees

     174        178   

Other liabilities

     53        —     
                

Total current liabilities

     1,365        1,805   
                

Long term liabilities

    

Deferred license fees

     416        588   
                

Commitments, contingencies and subsequent events

     —          —     

Stockholders’ equity

    

Ordinary shares

    

Authorized shares: 100,000,000; $0.65 (40 pence) par value; 7,645,802 shares issued and outstanding at December 31, 2009 and 2008

     4,940        4,940   

Share premium

     85,546        85,700   

Accumulated deficit

     (80,627     (75,969

Accumulated other comprehensive income—translation adjustments

     46        33   
                

Total stockholders’ equity

     9,905        14,704   
                

Total liabilities and stockholders’ equity

   $ 11,686      $ 17,097   
                

See accompanying notes to the consolidated financial statements.

 

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Table of Contents

SENETEK PLC

CONSOLIDATED STATEMENTS OF OPERATIONS

 

    Year Ended December 31  
        2009             2008      
    (in thousands, except per
share data)
 

Revenue

   

Royalties and licensing fees

  $ 1,541      $ 1,485   

Product sales

    366        360   
               

Total revenue

    1,907        1,845   
               

Cost of sales

   

Royalties and licensing

    670        636   

Product sales

    35        117   
               

Total cost of sales

    705        753   
               

Gross profit

    1,202        1,092   
               

Operating expenses

   

Research and development

    1,275        1,141   

Administration, sales and marketing

    5,154        5,778   
               

Total operating expenses

    6,429        6,919   
               

Operating loss

    (5,227     (5,827

Interest income

    124        499   

Interest expense

    (1     (1

Other (expense) income, net

    2        1,267   
               

Loss before income taxes

    (5,102     (4,062

(Provision) benefit for income taxes

    (3     303   
               

Net Loss

  $ (5,105   $ (3,759
               

Basic and diluted loss per share

  $ (0.67   $ (0.49

Weighted average basic and diluted ordinary shares outstanding

    7,646        7,646   

See accompanying notes to the consolidated financial statements

 

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SENETEK PLC

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY AND

COMPREHENSIVE LOSS

(in thousands, except share data)

 

     Shares    Amount    Share
Premium
    Accumulated
Deficit
    Accumulated
Other
Comprehensive
Income-
Currency

Translation
    Stockholders’
Equity
 

Balances January 1, 2008

   7,645,802    $ 4,940    $ 85,050      $ (72,210   $ 43      $ 17,823   
                                            

Stock-based compensation expense related to employee and director stock options

   —        —        650        —          —          650   

Comprehensive loss:

              

Net loss

   —        —        —          (3,759     —          (3,759

Translation adjustments

   —        —        —          —          (10     (10
                    

Total comprehensive loss

   —        —        —          —          —          (3,769
                                            

Balances December 31, 2008

   7,645,802      4,940      85,700        (75,969     33        14,704   
                                            

Cumulative effect of adjustments for the fair value of warrants ASC 815 (EITF 07-5)

   —        —        (500     447        —          (53
                                            

Balance January 1, 2009 (restated)

   7,645,802      4,940      85,200        (75,522     33        14,651   
                                            

Stock-based compensation expense related to employee and director stock options

   —        —        346        —          —          346   

Comprehensive loss:

              

Net loss

   —        —        —          (5,105     —          (5,105

Translation adjustments

   —        —        —          —          13        13   
                    

Total comprehensive loss

   —        —        —          —          —          (5,092
                                            

Balances December 31, 2009

   7,645,802    $ 4,940    $ 85,546      $ (80,627   $ 46      $ 9,905   
                                            

See accompanying notes to consolidated financial statements.

 

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Table of Contents

SENETEK PLC

CONSOLIDATED STATEMENTS OF CASH FLOWS

 

     Year Ended December 31  
         2009             2008      
     (in thousands)  

CASH FLOWS FROM OPERATING ACTIVITIES:

    

Net loss

   $ (5,105   $ (3,759

Adjustments to reconcile net loss to net cash used by operating activities:

    

Loss on retirement/sale of assets

     24        —     

Depreciation

     72        76   

Bad debt expense

     (8     7   

Stock-based compensation

     346        650   

Changes in operating assets and liabilities:

    

Trade receivables

     (155     19   

Non-trade receivables

     37        (40

Tax receivable

     343        (352

Inventory

     (147     (30

Prepaid expenses and deposits

     (14     18   

Prepaid tax

     57        (59

Accounts payable

     (76     21   

Accrued liabilities

     (413     (303

Deferred revenue and license fees

     (176     (181

Income taxes

     —          (38
                

Net cash used by operating activities

     (5,215     (3,971

CASH FLOWS FROM INVESTING ACTIVITIES:

    

Proceeds from (purchases of) short-term investments

     3,643        (10,143

Purchase of property and equipment

     (42     (22
                

Net cash provided (used) by investing activities

     3,601        (10,165
                

Effect of exchange rate on cash and cash equivalents

     13        (10

NET CHANGE IN CASH AND CASH EQUIVALENTS

     (1,601     (14,146

Cash and cash equivalents at the beginning of the year

     5,833        19,979   
                

Cash and cash equivalents at the end of the year

   $ 4,232      $ 5,833   
                

Supplemental disclosures of cash flow information

    

Income taxes paid

   $ 6      $ 314   

Interest paid

   $ 1      $ 1   

Initial valuation of derivative liability (other liability)

   $ 53      $ —     

See accompanying notes to consolidated financial statements

 

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1. Business

Senetek PLC is a life sciences company engaged in the development of technologies that target the science of healthy aging.

Senetek PLC, together with its subsidiaries (the “Company” which may be referred to as “Senetek”), is a public limited company organized under the laws of England in 1983. Senetek has three wholly-owned subsidiaries, Senetek Drug Delivery Technologies Inc. (“SSDT”) and Carmé Cosmeceutical Sciences Inc. (“CCSI”), both Delaware corporations and Senetek Denmark ApS, formed by Senetek under the laws of Denmark.

 

2. Principal Accounting Policies

(a) Basis of Presentation

The consolidated financial statements incorporate the accounts of Senetek PLC and its wholly owned subsidiaries. All significant inter-company balances and transactions have been eliminated in consolidation. The accounts have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”).

(b) Use of Estimates

The preparation of financial statements in conformity with generally accepted accounting principles requires management to make complex and subjective estimates and assumptions that affect the reported amounts in the Company’s financial statements and notes thereto. On a regular basis, management evaluates these estimates and assumptions. Actual results may differ materially from these estimates.

Examples of significant estimates and assumptions made by management involve revenue recognition, the establishment of provisions for bad debt, sales returns and inventory realization, the determination of fair value of stock compensation awards, realizability of deferred tax assets, valuation of derivatives, and impairment of long lived assets.

The Company believes the estimates used are reasonable and appropriate based on current facts and circumstances. It is possible, however, that other parties applying reasonable judgment to the same facts and circumstances could develop different estimates. Additionally, changes in actual experience or changes in other qualitative factors could cause our estimates to fluctuate, particularly those associated with newly launched products.

(c) Cash and Cash Equivalents

For the purposes of the statements of cash flows and balance sheets, the Company considers any highly liquid investments purchased with a maturity of three months or less to be cash equivalents.

At times, cash balances may be in excess of FDIC insurance limits. The Company has not experienced any losses with respect to bank balances in excess of government provided insurance. At December 31, 2009 and 2008, the Company held $69,000 and $5,594,000, respectively, in bank balances in excess of the insurance limits.

(d) Short-Term Investments

The Company’s short-term investments are classified as held-to-maturity securities. Held-to-maturity securities are measured at amortized cost as it is the Company’s intent to hold these securities to maturity. Interest earned on these securities is included in interest income.

 

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(e) Revenue, Deferred Revenue and Accounts Receivable

The Company recognizes revenue when (i) persuasive evidence of an arrangement exists, (ii) shipment of products has occurred, (iii) the sales price charged is fixed or determinable, and (iv) collection is reasonably assured. The Company’s shipment terms are FOB shipping point.

The Company recognizes revenue from skincare product sales in the physician channel of distribution when the product is shipped. For sales of skin care products the Company provides no return right to its customers.

For its other channel of distribution, the Company has a 30-day return policy. Therefore, revenue associated with this channel is deferred for 30 days following the sale. Revenue recognized for the years ended December 31, 2009 and 2008 in this channel was $17,000 and $0, respectively. Deferred revenue as of December 31, 2009 and 2008 was $2,000 and $0, respectively.

Included in revenue are fees charged to customers for shipping and handling. Such revenue amounted to $1,000 and $500 for the years December 31, 2009 and 2008, respectively. Shipping and handling costs incurred in a sales transaction to ship products to customers are included as a component of cost of sales.

Remittances received from the Company’s marketer, Covance Antibody Services, Inc. (“Covance”) on its sales of monoclonal antibodies are recognized based upon a percentage of actual Covance sales pursuant to the contract terms. Upfront license fees received from the licensing of manufacturing and distribution rights for the Company’s skincare products where the Company has substantive continuing obligations are deferred and recognized as revenue is earned, which is generally on a straight-line basis over the life of the contract. When the Company does not have substantive continuing obligations, such license fees are recognized as revenue. Royalties from the Company’s skincare licensees are recognized based on sales reports from the licensees that calculate the per item or percentage due on products sold by the licensees. The Company receives sales reports from the licensee and based upon this information, plus subsequent cash receipts, records royalty revenue.

The Company performs periodic credit evaluations of the financial condition of its customers, monitors collections and payments from customers, and generally does not require collateral. Receivables are generally due within 30 days. The Company provides for the possible inability to collect accounts receivable by recording an allowance for doubtful accounts. The Company writes off an account when it is considered to be uncollectible. The Company estimates its allowance for doubtful accounts based on historical experience, aging of accounts receivable, and information regarding the creditworthiness of its customers. To date, losses have been within the range of management’s expectations.

(f) Inventories and Inventory Reserves

Inventories, consisting of raw materials, work in process and finished goods, are stated at standard cost. Inventories are valued at the lower of cost or market using the first in, first out method.

(g) Property and Equipment

Property and equipment are stated at cost less accumulated depreciation. Depreciation is calculated on a straight line basis using the following estimated useful lives:

 

   

Office furniture fixtures and equipment: 3 to 15 years

 

   

Plant and laboratory equipment: 5 years

 

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Leasehold improvements are amortized over the estimated useful lives of the assets or the related lease term, whichever is the shorter.

(h) Impairment of Long-Lived Assets

The Company reviews the carrying value of its property and equipment and intangible assets for impairment in value whenever events or changes in circumstances indicate that the carrying amount of assets may not be recoverable.

(i) Research and Development

Expenditures on research and development are expensed as incurred.

(j) Foreign Exchange

All assets and liabilities in the balance sheets of foreign branches and subsidiaries whose functional currency is other than U.S. dollars are translated at period-end exchange rates. All income and expenditure items in the profit and loss account of foreign branches and subsidiaries whose functional currency is other than U.S. dollars are translated at average annual exchange rates. Translation gains and losses arising from the translation of the financial statements of foreign branches and subsidiaries whose functional currency is other than the U.S. dollar are not included in determining net income but are accumulated in a separate component of stockholders’ equity as a component of comprehensive income. Foreign currency transaction gains and losses are included in the determination of net income in the period in which they occur. The functional currency of the Company’s United Kingdom and Denmark operations is the Pound Sterling and Danish Kroner, respectively.

(k) Calculation of the Number of Shares and Net Income per Share

Basic earnings per share are computed using the weighted average number of ordinary shares outstanding during the period. Diluted earnings per share incorporate the incremental shares issuable upon the assumed exercise of dilutive stock options and warrants using the treasury stock method. The following is a reconciliation of the numerators and denominators of the basic and fully diluted earnings per share computation.

 

     December 31  
     2009     2008  
     (in thousands)  

Numerator:

    

Net loss

   $ (5,105   $ (3,759
                

Denominator:

    

Basic weighted average ordinary shares outstanding

     7,646        7,646   

Potentially dilutive common stock equivalents

     —          —     
                

Diluted weighted average ordinary shares outstanding

     7,646        7,646   
                

Options and warrants to purchase stock totaling 1,414,000 and 1,567,000 shares were outstanding at December 31, 2009 and 2008, respectively, but were excluded from the calculation of diluted earnings per share as their effect would have been antidilutive.

(l) Financial Instruments

The carrying values of cash, short-term investments, receivables, inventory, accounts payable and accrued liabilities approximate their fair values due to the short-term nature of these items. Fair value is the price that

 

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would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date.

(m) Income Taxes

The Company recognizes deferred tax liabilities and assets for the expected future tax consequences of events that have been included in the financial statements or tax returns. Accordingly, deferred tax liabilities and assets are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted rules in effect for the year in which differences are expected to reverse. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date.

A valuation allowance is established to reduce the deferred tax assets when the Company determines it is more likely than not that the related tax benefits will not be realized. The Company periodically reviews the valuation of deferred tax assets in light of expected future operating results.

(n) Stock Compensation Expense

The Company accounts for stock-based compensation under the provisions of Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) 718 (Statement of Financial Accounting Standards No. 123 (revised 2004), Share-Based Payment), which requires the Company to measure the stock-based compensation costs of share-based compensation arrangements based on the grant date fair value and generally recognizes the costs in the financial statements over the employee’s requisite service period. Stock-based compensation expense for all stock-based compensation awards granted was based on the grant date fair value estimated in accordance with the provisions of FASB ASC 178.

(o) Advertising Expenses

The Company’s policy is to expense advertising costs as incurred. Advertising expenses for the 2009 and 2008 were $108,000 and $0, respectively.

(p) Shipping and handling costs

The Company records shipping and handling fees billed to customers as revenue included in product sales. Costs associated with shipping and handling activities are comprised of outbound freight and are recorded in cost of sales. Shipping revenue was $1,000 and $500 in the years ended December 31, 2009 and 2008, respectively. Shipping costs incurred were $5,000 and $2,000 in the years ended December 31, 2009 and 2008, respectively.

(q) Recent accounting pronouncements

The FASB implemented the FASB Accounting Standards Codification (the “Codification”) effective July 1, 2009. The Codification has become the source of authoritative GAAP recognized by FASB to be applied to nongovernmental entities. Rules and interpretive releases of the SEC under authority of federal securities law are also sources of authoritative GAAP for SEC registrants, including the Company. On the effective date of the Codification, the Codification superseded all then-existing non-SEC accounting and reporting standards. All other non-grand-fathered non-SEC accounting literature not included in the Codification has become non-authoritative.

Following the effective date of the Codification, FASB will not release new standards in the form of Statements, FASB Staff Positions, or Emerging Issues Task Force abstracts, but instead will issue Accounting

 

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Standards Updates (“ASU’s”). ASU’s will not be considered authoritative in their own right, but will serve only to update the Codification, provide background information about the guidance in the Codification, and provide the basis for the conclusions on the changes in the Codification.

In March 2008, the Financial Accounting Standards Board (“FASB”) issued FASB ASC 815-10-50; 815-10-65-1 (Statement of Financial Accounting Standards No. 161, Disclosures about Derivative Instruments and Hedging Activities, an Amendment of FASB Statement No. 133). ASC 815-10-50; 815-10-65-1 (SFAS No. 161) requires enhanced disclosures about a company’s derivative and hedging activities. For Senetek, ASC 815-10-50; 815-10-65-1 (SFAS No. 161) is effective for financial statements issued for the fiscal year beginning January 1, 2009. The Company’s adoption of FASB ASC 815-10-50; 815-10-65-1 (SFAS No. 161) did not have a material impact on results of operations, cash flows or financial position.

In June 2008, FASB ASC 815-40; 815-10-65-3 (Emerging Issues Task Force Issue No. 07-5, Determining Whether an Instrument (or Embedded Feature) Is Indexed to an Entity’s Own Stock) was issued. ASC 815-40; 815-10-65-3 (EITF 07-5) addresses the determination of whether an instrument (or an embedded feature) is indexed to an entity’s own stock and establishes a two-step approach with which to make the determination. ASC 815-40; 815-10-65-3 (EITF 07-5) is effective for financial statements issued for fiscal years after December 15, 2008 and interim periods within those fiscal years. See Note 8 for additional information.

In April 2009, FASB issued FASB ASC 825-10-65-1 (FSP 107-1 and APB 28-1, Interim Disclosures about Fair Value of Financial Instruments) which increases the frequency of fair value disclosures to a quarterly instead of an annual basis. The guidance relates to fair value disclosures for any financial instruments that are not currently reflected on an entity’s balance sheet at fair value. ASC 825-10-65-1 is effective for interim and annual periods ending after June 15, 2009, but may be adopted for interim and annual periods ending after March 15, 2009. The adoption of ASC 825-10-65-1 did not have a material impact on results of operations, cash flows or financial position.

In October 2009, FASB issued Accounting Standard Update (ASU) 2009-13 Revenue Recognition (Topic 605). ASU 2009-13 provides accounting and financial reporting disclosure amendments for multiple-deliverable revenue arrangements. ASU 2009-13 is effective prospectively for revenue arrangements entered into or materially modified in fiscal years beginning on or after June 15, 2010. Early adoption is allowed. The new guidance states that if vendor specific objective evidence or third party evidence for deliverables in an arrangement cannot be determined, companies will be required to develop a best estimate of the selling price to separate deliverables and allocate arrangement consideration using the relative selling price method. Under the previous guidance, if the fair value of all of the elements in an arrangement was not determinable, then revenue was deferred until all of the items were delivered or fair value was determined. The adoption of ASU 2009-13 is not anticipated to have a material impact on the Company’s results of operations, cash flows, or financial position.

In January 2010, FASB issued ASU 2010-06 Fair Value Measurements and Disclosures (Topic 820): Improving Disclosures about Fair Value Measurements which requires new disclosures about transfers into and out of Level 1 and 2 of the fair value hierarchy and separate disclosures about purchases, sales, issuances, and settlements relating to Level 3 measurements. Specifically, for assets and liabilities that are measured at fair value on a recurring basis in periods after initial recognition. This ASU also includes conforming amendments to the guidance on employers’ disclosures about postretirement benefit plan assets (Subtopic 715-20) which include a change in terminology from major categories of assets to classes of assets and a cross-reference to the guidance in Subtopic 820-10 on how to determine appropriate classes to present fair value disclosures. Effective for interim and annual reporting periods beginning after December 15, 2009, except for the separate disclosures about purchases, sales, issuances, and settlements in the roll forward of activity in Level 3 fair value

 

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measurements. Those disclosures are effective for fiscal years beginning after December 15, 2010, and for interim periods within those fiscal years.

(r) Reclassification

Certain 2008 amounts have been reclassified to conform to the 2009 presentation.

 

3. Concentration of Risk

The Company’s customers are located principally in the United States. One customer in the skincare segment and one customer in the pharmaceutical segment accounted for approximately 9% and 72% of net revenue, respectively, and 0% and 96% of net receivables, respectively, in 2009. In 2008, one customer in the skincare segment and one customer in the pharmaceutical segment accounted for approximately 71% and 13% of net revenue, respectively, and 90% and 0% of net receivables, respectively.

Concentration of credit risk with respect to other trade receivables is limited due to the number of customers comprising the Company’s customer base and their dispersion across different geographic regions.

 

4. Short-Term Investments

Short-term investments represent certificates of deposit (CDARS) with various financial institutions totaling $6,500,000 and $10,143,000 at December 31, 2009 and 2008, respectively. Each CDAR has a principal balance of approximately $99,000 and is outstanding for a period of six months. At December 31, 2009 and 2008, the Company classified all of its investments as held-to-maturity. The fair market value approximates the cost and it is the intent of the Company to hold these investments until they mature.

 

5. Inventory

Inventory consists of the following:

 

     December 31,
2009
   December  31,
2008
     (in thousands)

Raw materials

   $ 175    $ 119

Work in process

     3      7

Finished goods

     134      39
             

Total inventory

   $ 312    $ 165
             

 

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6. Property and Equipment

Property and equipment are summarized as follows:

 

     December 31,
2009
   December  31,
2008
     (in thousands)

Cost:

     

Office furniture, fixtures and equipment

   $ 138    $ 140

Plant and laboratory equipment

     179      176

Leasehold improvements

     100      99
             
     417      415
             

Accumulated depreciation:

     

Office furniture and fixtures

     119      121

Plant and laboratory equipment

     158      120

Leasehold improvements

     96      76
             
     373      317
             

Net carrying value

   $ 44    $ 98
             

Depreciation expense for the years ended December 31, 2009 and 2008 was $72,000 and $76,000, respectively.

 

7. Accrued Liabilities

Accrued liabilities comprise the following:

 

     December 31,
2009
   December  31,
2008
     (in thousands)

Accrued salaries and benefits

   $ 82    $ 236

Legal and professional fees

     100      168

Audit and tax fees

     150      212

Accountancy fees

     10      30

Other liabilities and accruals

     100      209
             
   $ 442    $ 855
             

 

8. Other Liabilities

On January 1, 2009, the Company recorded the value of its outstanding warrants as a liability in accordance with FASB ASC 815-40; 815-10-65-3 (Emerging Issues Task Force Issue No. 07-5, Determining Whether an Instrument (or Embedded Feature) Is Indexed to an Entity’s Own Stock).

Below is the cumulative effect of recording the warrant liability:

 

     Other
Liability
   Share
Premium
    Accumulated
Deficit
 
    

(in thousands)

Increase/(decrease)

 

January 1, 2009 derivative instrument liability related to warrants

   $ 53    $ —        $ 53   

Reversal of prior accounting related to warrants

     —        (500     (500
                       
   $ 53    $ (500   $ (447
                       

 

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Derivative Liabilities

The Company currently does not use derivative instruments to manage its exposures to currency risk or interest rates. The Company evaluates all of its financial instruments to determine if such instruments are derivatives or contain features that qualify as embedded derivatives. All derivative financial instruments are recognized in the balance sheet at fair value. Changes in fair value are recognized in earnings if they are not eligible for hedge accounting or other comprehensive income if they qualify for cash flow hedge accounting.

A Black-Scholes option-pricing model was used to estimate the fair value, using Level 3 inputs, of the Company’s warrants using the following assumptions at December 31, 2009:

 

   

Number of
Shares

 

Dividend

Yield

 

Volatility

 

Risk-Free Rate

 

Expected Life

(in years)

 

Stock price

Warrant

  375,000   None   48.6%   0.47%   1.172   $1.22

The Company determined that the change in estimated fair value of the warrants from January 1, 2009 was not significant.

The fair value of outstanding derivative instruments not designed as hedging instruments on the accompanying Consolidated Balance Sheet was as follows:

 

Derivative Instruments

 

Balance Sheet Location

 

December 31, 2009

 

December 31, 2008

        (in thousands)    

Warrant

  Other liabilities   $ 53   $ —

There was no change in the recorded balance and no income or expense associated with changes in derivative instrument fair values recorded in the accompanying Consolidated Statements of Operations for the years ended December 31, 2009 and 2008.

 

9. Stock Option Plans

The Company has three share-based plans under which non-qualified stock options have been granted to employees, non-employees and board members. The Company is also authorized, under its Articles of Association and applicable laws and rules, to grant equity-based incentives such as stock options or restricted stock, outside of shareholder approved plans by action of its Board of Directors.

In December 1985, Senetek adopted a share option plan (the “No. 1 Plan”) for employees with shareholder approval. Under the No. 1 Plan, options to purchase ordinary shares are granted by the Board of Directors, subject to the exercise price of the option being not less than the market value of an ordinary share on the grant date. After the first twelve months following the date of the grant, options are exercisable at the rate of 25 percent, for each full year of employment. In the event the optionee’s employment is terminated, the option may not be exercised unless the Board of Directors so permits. The options expire seven years from the date of the grant. On May 16, 1997, shareholders approved the extension of the No. 1 Plan until December 1, 2005 and an increase in the number of shares available for grant to 750,000. The No. 1 Plan expired by its terms in December 2005. During 2009, all remaining options in Plan 1 expired.

 

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NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

 

The following table summarizes option transactions under the No. 1 Plan for the two years ended December 31, 2009:

 

     Number of
Options
    Weighted
Average
Exercise  price

Outstanding at December 31, 2007

   121,875      $ 6.89

Expired

   —          —  
        

Outstanding at December 31, 2008

   121,875        6.89

Expired

   (121,875     6.89
        

Outstanding at December 31, 2009

   —          —  
        

In May 1987, the Company adopted a share option plan (“the No. 2 Plan”) for non-executive directors and consultants with shareholder approval. Under the No. 2 Plan, options to purchase ordinary shares were granted by the Board of Directors, subject to the exercise price being not less than the market value of an ordinary share on the grant date. Options granted under this plan are exercisable in their entirety one year after the date of grant. In the event the optionee ceases to be a non-executive Director or consultant, the option may not be exercised unless the Board of Directors so permits. The options expire seven years from the date of grant. In 1997, shareholders approved an extension of the Plan until December 1, 2005 and an increase in the number of shares available for grant to 500,000. The No. 2 Plan expired by its terms in December 2005.

The following table summarizes option transactions under the No. 2 Plan for the two years ended December 31, 2009:

 

     Number of
Options
    Weighted
Average
Exercise  price
   Weighted
Average
Remaining
Contractual
Life

(in years)
   Aggregate
Intrinsic
Value

(in  thousands)

Outstanding at December 31, 2007

   75,000      $ 6.01    2.23    —  

Expired

   (12,500     15.00      
              

Outstanding at December 31, 2008

   62,500        4.22    1.52   

Expired

       —        
                

Outstanding at December 31, 2009

   62,500      $ 4.22    0.52    —  
                

Vested or expected to vest at December 31, 2009

   62,500      $ 4.22    0.52    —  
                

Exercisable at December 31, 2009

   62,500      $ 4.22    0.52    —  
                

In May 2006, the Company adopted the Senetek Equity Plan providing for issuance of non-qualified options and restricted stock to employees, non-employees and board members. Options are granted at the discretion of the Compensation Committee of the Board of Directors. The options will generally become exercisable for 25% of the option shares one year from the date of grant and then ratably over the following 36 months. The Compensation Committee of the Board of Directors has the discretion to use a different vesting schedule.

 

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On December 10, 2007, Senetek’s stockholders approved an amendment to the Senetek Equity Plan to increase the maximum shares from 625,000 to 937,500, representing an increase of 312,500 shares.

 

Options Granted in

   Number of
Shares
Granted
   Exercise
Price
(1)
   Average
Fair
Value

June 2009

   27,000    $ 1.28    $ 0.83

September 2009

   1,000    $ 1.19    $ 0.77

January 2008

   458,750    $ 2.50    $ 1.59

January 2008

   238,600    $ 2.50    $ 1.66

June 2008

   40,000    $ 1.55    $ 1.00

 

(1) Exercise Price represents the closing stock price on the grant date

A total of 976,662 stock options and 25,781 restricted shares have been granted to date, net of forfeitures. These totals include 64,943 stock options issued outside of the shareholder approved plan.

The following tables summarize option and restricted stock transactions under the Senetek Equity Plan:

 

     Number of
Shares
Available
for Grant
    Number of
Options Issued
Outside of
Shareholder
Approved Plan
    Number of
Options and
Restricted
Stock
Outstanding
(1)
 

Balance at December 31, 2007

   633,595      —        303,905   

Granted

   (633,907   (103,443   737,350   

Expired

   312      8,000      (8,312
                  

Balance at December 31, 2008

   —        (95,443   1,032,943   

Granted

   —        (28,000   28,000   

Expired

   —        58,500      (58,500
                  

Balance at December 31, 2009

   —        (64,943   1,002,443   
                  

 

(1) Includes 25,781 shares of Restricted Stock issued in December 2007.

 

     Number of
Options and
Restricted
Stock
Outstanding
(1)
    Weighted
Average
Exercise  price
   Weighted
Average
Remaining
Contractual
Life

(in years)
   Aggregate
Intrinsic
Value

(in  thousands)

Outstanding at December 31, 2007

   303,905      $ 2.01    5.50    $ 149,476

Granted

   737,350      $ 2.45      

Expired

   (8,312   $ 2.48      
                  

Outstanding at December 31, 2008

   1,032,943      $ 2.31    5.64      —  

Granted

   28,000      $ 1.28      

Expired

   (58,500   $ 1.46      
                  

Outstanding at December 31, 2009

   1,002,443      $ 2.33    4.62      —  
                  

Vested or expected to vest at December 31, 2009

   478,036      $ 2.27    4.33      —  
                  

Exercisable at December 31, 2009

   478,036      $ 2.27    4.33      —  
                  

 

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10. Stock Compensation Expense

The Company records compensation expense for all awards granted after the date of adoption, and for the unvested portion of previously granted awards that remain outstanding. After assessing alternative valuation models and amortization assumptions, the Company has selected the Black-Scholes-Merton option-pricing formula and straight-line amortization of compensation expense over the requisite service period of the grant. The Company will reconsider use of this model if additional information becomes available in the future that indicates another model would be more appropriate, or if grants issued in future periods have characteristics that cannot be reasonably estimated using this model.

Assumptions used to value the stock-based compensation grants were as follows:

 

Average

   2009      2008

Expected volatility

   75.4%-75.5%      77.8%-78.2%

Expected dividends

   0%      0%

Expected term (in years)

   7      7

Risk-free rate

   3.07%-3.31%      3.2%-3.73%

The following table summarizes stock-based compensation expense related to employee and Director stock options for 2009 and 2008, which was allocated as follows (in thousands):

 

     2009    2008

Administration, sales and marketing

   $ 345    $ 648

Research and development

     1      2
             

Stock-based compensation expense included in operating expenses and net income (loss)

   $ 346    $ 650
             

As of December 31, 2009, the unrecorded deferred stock-based compensation balance related to stock options was $278,000 and is expected to be recognized over a weighted average period of 1.61 years. As of December 31, 2008, the unrecorded deferred stock-based compensation balance related to stock options was $601,000 and was expected to be recognized over a weighted average period of 2.61 years.

Effective March 10, 2010, in accordance with the transaction between Senetek and DMRJ Group LLC, vesting was accelerated for all options. See Subsequent Events (Note 16) for additional information.

 

11. Stockholders’ Equity

The following warrants were outstanding at December 31, 2009:

 

Warrant

Type

   Warrants
Issued and
Unexercised
   Exercise
Price
   Expiration
Date

Series E

   375,000    $ 2.00    March 2011

The series E warrants were issued in association with the retirement of senior secured notes in March 2006. The warrants entitled the holder to purchase ordinary shares convertible into American Depositary Receipts of the Company at the purchase prices referred to above at any time commencing 90 days from the date of subscription and prior to the expiration date. The offer and sale of the warrants was made in compliance with and in reliance upon the provision of Regulation S under the United States Securities Act of 1933, as amended. Warrants for 12,500 ordinary shares with an exercise price of $4.96 expired in September 2008.

 

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12. Taxation

Income taxes are determined using an annual effective tax rate, which generally differs from the U.S. Federal statutory rate, primarily because of state and local income taxes, the treatment of share-based payments that are not designed to normally result in tax deductions, various expenses that are not deductible for tax purposes, and differences in tax rates in certain non-U.S. jurisdictions. Senetek’s effective tax rate may be subject to fluctuations during the year as new information is obtained which may affect the assumptions used to estimate the annual effective tax rate.

The Company accounts for income taxes under FASB ASC 740-10. Under the asset and liability method of ASC 740-10, deferred income tax assets and liabilities are recognized for the future tax consequences attributable to differences between financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. Under ASC 740 the effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date.

In assessing the realizability of deferred tax assets, the Company considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. The Company considers the historical and projected future taxable income and tax planning strategies in making this assessment. The Company will continue to maintain a full valuation allowance, since negative evidence outweighs positive evidence.

Senetek is incorporated in England with branch operations in the U.S. along with two U.S. subsidiaries and a Danish subsidiary. The Company is subject to United Kingdom corporation tax on a worldwide basis with relief for foreign taxes in cases where double taxation relief agreements have been established. The U.S. branch and U.S. subsidiaries are subject to United States tax only. U.K. tax law presently allows excess current year trading losses to be offset against trading profits of the prior year, without limit; and £50,000 of trading losses against trading profits in the two years preceding that. Since there are no taxable profits to offset in the preceding three years, for which relief is available, it will not be possible to carry-back U.K. tax losses arising in the 2009 period. The full amount will therefore be carried forward.

Per IRC Section 56(d), the Company may carry-back 100% of its 2008 or 2009 AMT net operating losses back three, four or five years under IRC Section 172(b)(1)(h). The company may file a carry-back claim back to its 2005, 2006 and 2007 tax years for a potential refund of $365,000. However, there is no certainty that the carry-back claim will be accepted. A benefit has not been recorded for the refund claim in the 2009 provision. The benefit will be recorded when the claim is filed and cash is received.

 

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     Year ended December 31  
         2009             2008      
     (in thousands)  

Loss from operations before income taxes included the following:

    

U.S. loss

   $ (4,397   $ (3,387

Foreign loss

     (708     (675
                

Total loss

   $ (5,105   $ (4,062
                
     Year ended December 31  
     2009     2008  
     (in thousands)  

Income tax provision (benefit) is comprised of the following:

    

Current federal taxes

   $ —        $ (21

Current state and local taxes

     3        (65

Current foreign taxes

     —          (217
                

Total tax provision (benefit)

   $ 3      $ (303
                

Income tax provision or benefit differed from the amounts computed by applying the U.S. federal income tax rate of 34% to pretax loss from continuing operations as a result of the following:

 

         2009             2008      

Computed expected tax benefit

   34   34

State tax rate, net of federal benefit

   5   6

Permanent differences

   —        (1 )% 

Utilization of tax loss carryforward

   —        —     

Timing differences and losses for which no benefit has been recognized

   (33 )%    (33 )% 

Credits and other

   (6 )%    1
            
   —        7
            

The components of deferred tax assets and liabilities are as follows (1):

 

     December 31  
     2009     2008  
     (in thousands)  

Net operating loss carryforwards

   $ 20,177      $ 18,141   

Reserves and accruals

     280        434   

Stock-based compensation

     1,010        1,331   

Organization costs

     4        —     

Depreciation and amortization

     332        266   

State tax

     1        1   

Tax credits

     228        228   
                

Gross deferred tax asset

   $ 22,032      $ 20,401   

Valuation allowance

     (22,032     (20,401
                

Net deferred tax asset

   $ —        $ —     
                

 

(1) No deferred tax liability at December 31, 2009 or 2008

 

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Included in Senetek’s net operating loss carryforwards are provisional tax losses available to the Company in the U.K., estimated to be approximately $44,323,000 at the end of fiscal year 2009. The U.K. tax loss carryforwards are available indefinitely against profits from the same trade carried on in the U.K. The U.K. tax loss carryforwards could be limited if there was a greater than 50% change in ownership in any three year period.

At December 31, 2009, the Company has federal net operating loss carryforwards of approximately $21,633,000. Federal net operating losses expire at varying dates from 2010 through 2029. At December 31, 2009, California net operating losses are estimated to be $7,644,000. California net operating losses expire at varying dates from 2010 through 2019. The Company is considered a loss corporation per Internal Revenue Code Section 382. The Company has not experienced an ownership change as defined in Section 382 and therefore is not limited in its utilization of U.S. NOL carryovers and other tax attributes at December 31, 2009. As a result of the March 2010 transaction described in Subsequent Events (Note 16) below, the Company has yet to perform an analysis of any ownership change and the potential effect on its NOLs.

The Company adopted the provisions of accounting for uncertain tax positions in accordance with ASC 740, Income Taxes, topic on December 31, 2007, and accordingly, performed a comprehensive review of the Company’s uncertain tax positions as of that date. In this regard, an uncertain tax position represents its expected treatment of a tax position taken in a filed tax return, or planned to be taken in a future tax return, that has not been reflected in measuring income tax expense for financial reporting purposes. For the years ended December 31, 2009 and 2008, the Company had no unrecognized tax benefits. The Company does not expect there to be any material changes to the assessment of uncertain tax positions over the next twelve months.

The liability for uncertain tax positions is recorded in accrued expenses in the Company’s consolidated balance sheet. During 2009 and 2008, the Company had no uncertain tax positions. The Company recognizes interest and penalties related to uncertain tax positions in the income tax provision. Interest and penalties are computed based upon the difference between its uncertain tax positions under ASC 740 and the amount deducted or expected to be deducted in its tax returns. During 2009 and 2008, the Company did not accrue or pay for any interest and penalties.

The Company is subject to routine corporate income tax audits in the U.S. and the U.K. The statute of limitations for the Company’s 2005 through 2008 tax years remain open for U.S. purposes. The statute of limitations for the Company’s 2008 tax year remains open for U.K. purposes. NOL carryforwards generated in 1994 through 2008 remain open to examination by the major domestic taxing jurisdictions.

At December 31, 2009 and 2008, management did not consider it more likely than not that it’s net deferred tax assets would be realizable and, as a result, the Company has established a 100% valuation allowance against such assets. The net change in the total valuation allowance for the years ended December 31, 2009 and 2008 was increases of $1,631,000 and $729,000, respectively. The change in the valuation allowance is primarily related to changes in the Company’s NOLs.

In assessing the realizability of deferred tax assets, the Company considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. The Company considers the historical and projected future taxable income and tax planning strategies in making this assessment. The Company will continue to maintain a full valuation allowance, since negative evidence outweighs positive evidence.

 

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13. Segment Reporting

Senetek is a life sciences company engaged in the development and commercialization of technologies that target the science of healthy aging. Senetek is comprised of two business segments: dermatological branded products and compounds addressing photoaging and other skincare needs (“Skincare”); and pharmaceuticals, currently principally those addressing sales of monoclonal antibodies, erectile dysfunction and drug delivery of liquid injectable products (automatic injectors) (“Pharmaceutical”). The Company’s organization is structured in a functional manner.

Financial information regarding the operating segments was as follows (in thousands):

 

     2009     2008  
     Skincare     Pharmaceutical     Total     Skincare     Pharmaceutical     Total  

Revenue

   $ 539      $ 1,368      $ 1,907      $ 532      $ 1,313      $ 1,845   

Cost of sales

     35        670        705        124        629        753   
                                                

Gross profit

   $ 504      $ 698      $ 1,202      $ 408      $ 684      $ 1,092   
                                                

Gross profit percentage

     94     51     63     77     52     59

Unallocated operating expenses

         6,429            6,919   
                        

Operating loss

       $ (5,227       $ (5,827
                        

The Company’s customers are principally in the United States.

 

Geographic Areas

   2009    2008
     (in thousands)

Net revenue

     

United States

   $ 1,903    $ 1,813

Other foreign countries

     4      32
             

Total consolidated

   $ 1,907    $ 1,845
             

Long-lived assets

     

United States

   $ 22    $ 12

United Kingdom and Denmark

     22      86
             

Total long-lived assets

   $ 44    $ 98
             

The Company’s registered office is located in the United Kingdom. The majority of its employees are based in the United States from where it liaises with the U.S. investing public and from where the primary sales and development of skincare activities are directed.

 

14. Commitments and Contingencies

(a) Research and Commercial Agreements

An agreement with the Institute of Experimental Botany (the “Institute”) was extended in the second quarter 2009 for an additional six years through December 31, 2014. Under this agreement Senetek is committed to pay $100,000 in 2009, $80,000 in 2010 and $75,000 in each of the years 2011 through 2014 to support the Institute’s continued research on certain cytokinins. This agreement provides exclusive global licenses for all applications to any cytokinin developed, in-licensed or otherwise acquired by the Institute and the right to co-exploit with the Institute any cytokinins that Senetek does not elect to in-license. Senetek also has a right of first refusal before

 

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the Institute can license any of its non-cytokinin compounds to any third party for cosmeceutical or anti-aging dermatological applications. In addition, a new group of compounds, “supercytokinin plus”, has been added to the agreement. The Institute will also perform enhanced research activities in the areas of pre-selective assay, development of analytical methods, stability testing, large scale synthesis and molecular mechanism of action. The 2009 commitment of $100,000 was paid in the second quarter of 2009. As part of the March 2010, Asset Purchase Agreement between Senetek and Skinvera, the liability for this agreement was transferred to Skinvera as described in the Subsequent Events (Note 16).

In April 2005, the Company entered into an amendment of the agreement with RFMH, under which the licenses on all existing monoclonal antibody cell lines and any new cell lines were extended through July 10, 2011 with a minimum guaranty of royalty receipts to RFMH of $430,000 per year (on a pro rata basis) through the new term of the license.

(b) Commitments under Operating Leases

Minimum future lease payments and operating expense reimbursements under non-cancelable leases are as follows:

 

Years Ending

December 31

   Future Minimum
Payments
     (in thousands)

2010

   $ 37

2011

     2
      
   $ 39
      

Rent expense was approximately $293,000 and $272,000 in 2009 and 2008, respectively. The Napa, CA lease for office space currently expires on June 30, 2010.

(c) Litigation

On June 27, 2008, Senetek reached an agreement to terminate its co-marketing agreement for Pyratine-6™, the terms of which include settlement payments totaling $1,125,000, return of all intellectual property, product inventory and promotional materials, access and ownership of all accounts opened, remittance of all proceeds of product sales through the agreement termination date, rights to use the Lumeris brand name for one year in conjunction with sales of existing packaged product inventory; and a non-competition agreement from the co-marketer prohibiting their sale of any topical non monograph products used for antiaging purpose and/or in connection with acne rosacea for a period of two years. The settlement was recorded as other income in the second quarter of 2008.

(d) Employment Contracts and Deferred Compensation Plans

The Company has an employment agreement with Mr. Frank J. Massino, the Company’s Chairman and CEO, most recently amended as of April 2006. The agreement and amendments, which were approved by the Compensation Committee of the Board of Directors, provide for a perpetual three-year term and an annual salary of $340,000 per annum subject to annual increases (salary was $360,000 for 2007 and increased to $370,000 effective January 1, 2008). The contract also provides for an automobile allowance and reimbursement of related automobile operating expenses. Under the agreement, Mr. Massino is entitled to an annual bonus, to be determined by the Compensation Committee, and is eligible to participate in the Company’s management bonus plan, if any. In the event that Mr. Massino’s employment is terminated by the Company (other than for

 

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“permanent disability” or “cause”, as such terms are defined in the agreement) or by Mr. Massino for “good reason” (as defined in the agreement), Mr. Massino would become entitled to a lump sum payment equal to the product of multiplying his base salary (and a deemed bonus, if any, as determined in accordance with the agreement) by three (i.e., the number of years remaining under the “evergreen” provisions of his employment agreement). Further, in such circumstance, all unvested and/or unexercisable options held by Mr. Massino would become immediately vested and exercisable. The agreement also provides for payment of three years’ worth of additional compensation upon consummation of certain changes of control (as defined in the agreement), provided that the Company would not be required, on a change of control, to pay Mr. Massino any amounts that would constitute an “excess parachute payment” under the Internal Revenue Code.

The Company has a payment agreement dated March 5, 2007 with Mr. William O’Kelly, the Company’s Chief Financial Officer that requires the Company to make certain severance payments to Mr. O’Kelly in the event his employment is terminated under certain circumstances. If: (A) following a Change of Control, the Company does not retain Mr. O’Kelly as Chief Financial Officer or he is not offered a position of Equivalent Authority by the Company or a Successor Enterprise or (B) Mr. O’Kelly does not continue his employment with the Company or a Successor Enterprise after a Relocation, then, in either such event, the Company will continue to pay his base salary as at the date of the Change of Control or Relocation for a period of six months following his separation from the Company or the Successor Enterprise.

In conjunction with the Transaction (Note 16) entered into by the Company in March 2010, Mr. Massino and Mr. O’Kelly were terminated without cause. Severance and change of control payments of $1,287,000 and $111,000 were made to Mr. Massino and Mr. O’Kelly, respectively, on March 11, 2010 in accordance with their agreements. There are no other employment agreements in place and no claims existed at December 31, 2009 with respect to employment agreements with past employees.

In conjunction with the Transaction, vesting was accelerated on March 10, 2010, the effective date, for all options to purchase Ordinary Shares held by the Company’s officers and Directors as of December 1, 2009. The options were extended for five years and the exercise price was re-priced to the greater of $1.25 or the market price on March 10, 2010. See Subsequent Events (Note 16) for additional information.

(e) Indemnifications

Under its Articles of Association, the Company is required to indemnify its officers and Directors for all costs, losses and liabilities they may incur as a result of the officer or Director’s serving in such capacity subject to statutory restrictions. The term of the indemnification period is for the officer’s or Director’s lifetime.

The maximum potential amount of future payments the Company could be required to make under the indemnification provisions contained in its Articles of Association is unlimited except as provided by applicable law. However, the Company has a Director and Officers liability insurance policy that limits its exposure and enables it to recover all or a portion of any future amounts paid by the Company to indemnify a Director or officer. As a result of its insurance policy coverage, management believes the estimated fair value of these indemnification obligations is minimal and has no liabilities recorded for these agreements as of December 31, 2009.

The Company enters into indemnification provisions under its agreements with other companies in its ordinary course of business, typically with licensees, research institutes at which studies are conducted, landlords, investment bankers and financial advisers. Under these provisions the Company generally indemnifies and holds harmless the indemnified party for losses suffered or incurred by the indemnified party as a result of their performance of such agreements except in cases of their negligence or default. These indemnification

 

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provisions often include indemnifications relating to representations made by the Company, including those with regard to intellectual property rights. These indemnification provisions generally survive termination of the underlying agreement. In some cases, the Company has obtained insurance providing coverage for losses such as these, against which the Company has agreed to indemnify a third party. The maximum potential amount of future payments the Company could be required to make under these indemnification provisions generally is limited. The Company has not incurred material costs in connection with defending these indemnification agreements. As a result, management believes the estimated fair value of these obligations is minimal. Accordingly, the Company has no liabilities recorded for these agreements as of December 31, 2009.

 

15. Related Party Transactions

Mr. Anthony Williams, a Director of the Company, has been a partner of the law firm DLA Piper US, LLP since November 2009 and prior to that was a partner of the law firm Baker & McKenzie LLP. Both law firms have rendered legal services to the Company. 2009 and 2008 legal fees paid to Baker & McKenzie LLP totaled $56,000 and $409,000, respectively. No fees were paid in 2009 or 2008 to DLA Piper US, LLP.

Dr. Brian Clark, Chief Scientist for the Company until January 31, 2010, earned a consulting fee of $108,000 in 2009 and 2008. This amount was accrued and paid in both years.

 

16. Subsequent Events

In March 2010, Senetek and DMRJ Group, LLC, effected a Security Purchase Agreement, a Note and a Warrant Purchase Agreement (“Transaction”). DMRJ Group, LLC is a Delaware limited liability company affiliated with Platinum Partners Value Arbitrage Fund L.P., an accredited institutional investor with its investment manager headquartered in New York, New York.

In conjunction with the Transaction, the Company issued a Secured Convertible Promissory Note to DMRJ in the principal amount of $3.0 million, which bears no interest and is convertible at a price of $1.25 per share at any time from inception to the fifth anniversary of the Note, at which time conversion is mandatory. Except in the event of default, the Note is not repayable in cash. In addition, the Company issued a five-year warrant to purchase 1.8 million of the Company’s ordinary shares at an exercise price of $1.75 per share. As a result of these transactions, DMRJ has effective control of Senetek and its subsidiaries.

In connection with the Transaction, Frank J. Massino was terminated without cause as Chief Executive Officer and resigned as Chairman of the Board of Directors. Mr. Massino has been retained as a part-time consultant for a three year period to assist in management of certain of the Company’s existing investments and interests, for which he was paid $360,000. Also, William F. O’Kelly was terminated without cause as Chief Financial Officer and Mr. Rodger Bogardus resigned from the Board of Directors. In addition on March 10, 2010, the effective date of the Transaction, all options to purchase Ordinary Shares held by the Company’s officers and directors as of December 1, 2009 became immediately vested and were extended for five years with re-pricing of the exercise price to $1.25 per share or the Market Price on the date of the Transaction, whichever is greater. No additional incremental expense is expected to be recognized as a result of this transaction.

John P. Ryan has been appointed to succeed Mr. Massino as Chief Executive Officer and Chairman of the Board of Directors. In addition, Mr. Howard Crosby has been appointed to succeed Mr. O’Kelly as the Chief Financial Officer and to the Board of Directors and Dr. Wesley Holland has been appointed to the Board of Directors.

 

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The Company developed, in consultation with its strategic advisor, Miller Tabak + Co., LLC, a new business strategy to bring revenue, profits and a positive opportunity for Company shareholders. As part of that strategy, the Company decided to divest itself of its skincare business. In conjunction with the Transaction, the Company executed an Asset Purchase Agreement and a Note with Skinvera LLC, a company wholly owned by Frank J. Massino, former Chairman and Chief Executive Officer of the Company, whereby Skinvera purchased all assets and assumed all existing liabilities of the Company’s skincare business (except for assets and liabilities related to Kinetin and Zeatin) and received $1.8 million in cash in return for a $1.8 million Secured Promissory Note which bears interest at 6% per annum and is due on the seventh anniversary of the Note. The Asset Purchase Agreement includes provisions for royalty payments to the Company from Skinvera based on 5% of net direct sales of skincare products and 10% of net skincare royalties; up to a maximum of $5 million. The Company and Mr. Massino have agreed to amend the Asset Purchase Agreement such that in the event of a near-term transaction resulting in (i) the change of control, directly or indirectly, of at least 50% of the equity interests in the Purchaser (as defined in the Asset Purchase Agreement), other than a transfer to a certain affiliate of the Purchaser, or (ii) the sale of substantially all of the Assets (as defined in the Asset Purchase Agreement), the Company shall be entitled to receive (i) 50% of the after-tax purchase price paid to the Purchaser if such sale occurs on or before March 10, 2011 or (ii) 25% of the after-tax purchase price paid to the Purchaser if such sale occurs between March 10, 2011 and March 10, 2012. The loss on the Transaction has not been finalized but is expected to be no less than $331,000 and will be recorded in the first quarter of 2010. The Company is evaluating the collectability of the $1.8 million note and may establish a reserve if necessary.

The Company has determined that the skincare segment does not meet the criteria for classification as discontinued operations at December 31, 2009 because the company did not make a decision or have a plan to sell the assets at December 31, 2009. The Company has determined that a sale has occurred during the first quarter of 2010 that will require classification as discontinued operations.

On April 1, 2010, Senetek consummated the purchase for $5.0 million from a partnership that is majority owned by Platinum Partners Value Arbitrage Fund (“Seller”) of the interest in $7.0 million of amounts owed to Seller pursuant to outstanding notes (the “Notes”) and contractual rights (the “Rights”, together with the Notes the “Seller Claims”). The amounts are owed to Seller from an entity (the “Debtor”) focused in the area of natural resources which has filed a petition in the United States Bankruptcy Court. The debtor is a company called Firstgold Corporation and the main asset of Firstgold is the Relief Canyon Mine located near Lovelock, Nevada. Further information on Firstgold and Relief Canyon Mine can be obtained at the website www.firstgoldcorp.com. As disclosed above, on March 10, 2010, Senetek consummated a $3.0 million convertible note financing pursuant to a Securities Purchase Agreement, dated March 4, 2010, with DMRJ Group, LLC, a Delaware limited liability company, an entity affiliated with Platinum Partners Value Arbitrage Fund L.P and the Seller. The purchase amount for the Seller Claims was determined based upon arms length negotiations between the parties. Senetek received only the following representations from the Seller in substantially the following form: (i) Seller has good and valid title to the Notes and has not pledged or transferred the Notes, or any of the Claims, to any third party, and (ii) upon acquisition of Senetek’s interest in the Seller Claims as contemplated hereby, Senetek will acquire such interest free and clear of any liens or encumbrances made by or through Seller; (iii) Debtor has not in its bankruptcy action, as of the date hereof, contested the validity, perfection or priority of any security interest in collateral securing the Seller Claims and (iv) no consent or filing with the court having jurisdiction in the bankruptcy action is necessary or required in connection with the sale of the Senetek interest in the Seller Claims.

 

 

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