10-Q 1 d10q.htm FORM 10-Q Form 10-Q
Table of Contents

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 10-Q

 

 

(Mark One)

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

For the quarterly period ended June 30, 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 number: 33-20897-D

 

 

HELIX BIOMEDIX, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   91-2099117

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

22118-20th Avenue SE, Suite 204, Bothell, Washington 98021

(Address of principal executive offices)

(425) 402-8400

(Registrant’s telephone number, including area code)

 

 

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 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.

 

Large accelerated filer   ¨    Accelerated filer   ¨
Non-accelerated filer   ¨  (Do not check if a smaller reporting company)    Smaller reporting company   x

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

As of July 30, 2009, 25,653,512 shares of the registrant’s common stock were issued and outstanding.

 

 

 


Table of Contents

HELIX BIOMEDIX, INC.

FORM 10-Q

TABLE OF CONTENTS

 

     Page

PART I - FINANCIAL INFORMATION

  

Item 1. Financial Statements

  

Condensed Balance Sheets (unaudited)

   1

Condensed Statements of Operations (unaudited)

   2

Condensed Statements of Stockholders’ Equity (Deficit) and Total Comprehensive Income (Loss) (unaudited)

   3

Condensed Statements of Cash Flows (unaudited)

   4

Notes to Condensed Financial Statements (unaudited)

   5

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

   17

Item 4. Controls and Procedures

   26

PART II - OTHER INFORMATION

  

Item 1A. Risk Factors

   27

Item 4. Submission of Matters to a Vote of Security Holders

   27

Item 6. Exhibits

   28

Signatures

   29

 


Table of Contents

PART I - FINANCIAL INFORMATION

 

ITEM 1. Financial Statements.

HELIX BIOMEDIX, INC.

CONDENSED BALANCE SHEETS

(Unaudited)

 

     June 30,
2009
    December 31,
2008
 
ASSETS     

Current assets:

    

Cash and cash equivalents

   $ 2,807,024      $ 984,844   

Restricted cash – subscription deposits for convertible debt offering (Note 2)

     —          970,000   

Accounts receivable, net

     108,539        50,467   

Inventory

     163,046        111,411   

Prepaid expenses and other current assets

     54,069        104,706   
                

Total current assets

     3,132,678        2,221,428   

Deposits

     8,522        8,522   

Property and equipment, net

     93,100        120,154   

Intangible assets, net

     315,723        353,603   
                

Total assets

   $ 3,550,023      $ 2,703,707   
                
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)     

Current liabilities:

    

Accounts payable

   $ 67,608      $ 71,824   

Accrued compensation and benefits

     43,023        101,734   

Accrued expenses

     90,516        61,563   

Deferred rent

     927        2,039   

Other current liabilities – subscription deposits for convertible debt offering (Note 2)

     —          970,000   
                

Total current liabilities

     202,074        1,207,160   

Convertible notes payable

     1,301,174        —     

Convertible notes payable, related party

     4,988,844        3,000,000   

Accrued interest on convertible notes payable

     41,485        —     

Accrued interest on convertible notes payable, related party

     394,017        211,069   
                

Total liabilities

     6,927,594        4,418,229   

Commitments and contingencies

    

Stockholders’ equity (deficit):

    

Preferred stock, $0.001 par value, 25,000,000 shares authorized; no shares issued or outstanding

     —          —     

Common stock, $0.001 par value, 100,000,000 shares authorized; 25,653,512 shares outstanding at June 30, 2009, and December 31, 2008

     25,654        25,654   

Additional paid-in capital

     30,622,339        30,342,249   

Accumulated deficit

     (34,025,564     (32,082,425
                

Total stockholders’ equity (deficit)

     (3,377,571     (1,714,522
                

Total liabilities and stockholders’ equity (deficit)

   $ 3,550,023      $ 2,703,707   
                

The accompanying notes are an integral part of the financial statements.

 

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Table of Contents

HELIX BIOMEDIX, INC.

CONDENSED STATEMENTS OF OPERATIONS

(Unaudited)

 

     Three months ended June 30,     Six months ended June 30,  
     2009     2008     2009     2008  

Revenue:

        

Licensing and development fees

   $ 29,795      $ 59,330      $ 64,572      $ 206,392   

Peptide and consumer product sales

     98,441        6,143        140,970        99,451   

Administrative services revenue, related party

     10,251        21,772        20,196        21,772   
                                

Total revenue

     138,487        87,245        225,738        327,615   
                                

Cost of revenue:

        

Cost of peptide and consumer product sales

     82,999        6,085        121,581        75,469   

Cost of administrative service revenue, related party

     10,050        21,772        19,800        21,772   

Other cost of revenue

     —          —          —          38,781   
                                

Total cost of revenue

     93,049        27,857        141,381        136,022   
                                

Gross profit

     45,438        59,388        84,357        191,593   
                                

Operating expenses:

        

Research and development

     239,278        198,238        399,692        393,415   

Marketing and business development

     120,061        89,041        236,034        203,728   

General and administrative

     411,921        586,650        773,789        1,020,019   

Accounting, legal and professional fees

     116,086        159,502        300,811        320,317   

Depreciation and amortization

     32,530        34,901        66,002        69,950   
                                

Total operating expenses

     919,876        1,068,332        1,776,328        2,007,429   
                                

Loss from operations

     (874,438     (1,008,944     (1,691,971     (1,815,836

Other income (expense):

        

Interest income

     3,102        17,074        8,145        35,864   

Interest expense on convertible notes payable

     (27,404     —          (41,485     —     

Interest expense on convertible notes payable, related party

     (101,721     (63,120     (182,948     (93,698

Accretion of discount on convertible notes payable

     (9,079     —          (13,736     —     

Accretion of discount on convertible notes payable, related party

     (13,856     (546,011     (21,144     (831,426

Change in value of derivative instruments, including related party

     —          152,706        —          11,803   

Unrealized loss on marketable securities

     —          —          —          (30,000
                                

Other income (expense), net

     (148,958     (439,351     (251,168     (907,457

Net loss

   $ (1,023,396   $ (1,448,295   $ (1,943,139   $ (2,723,293
                                

Basic and diluted net loss per share

   $ (0.04   $ (0.06   $ (0.08   $ (0.11
                                

Weighted average shares outstanding

     25,653,512        25,653,512        25,653,512        25,653,512   
                                

The accompanying notes are an integral part of the financial statements.

 

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HELIX BIOMEDIX, INC.

CONDENSED STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT) AND TOTAL

COMPREHENSIVE INCOME (LOSS)

For the Year Ended December 31, 2008 and for the Six Months Ended June 30, 2009

(Unaudited)

 

     Common Stock    Additional
Paid-in
Capital
    Accumulated
Deficit
    Accumulated
Other
Comprehensive
Income
    Stockholders’
Equity
(Deficit)
    Total
Comprehensive
Income (Loss)
 
     Number
of Shares
   Amount           

Balance at December 31, 2007

   25,653,512    $ 25,654    $ 29,211,972      $ (27,566,913   $ —        $ 1,670,713      $ —     

Stock-based compensation

   —        —        314,928        —          —          314,928        —     

Reclassification of warrants and options from equity to derivative liabilities

   —        —        (1,255,317     —          —          (1,255,317     —     

Extinguishment of convertible note payable, related party

   —        —        733,317        —          —          733,317        —     

Reclassification of warrants and options from derivative liabilities to equity

   —        —        1,337,349        —          —          1,337,349        —     

Unrealized gain on marketable securities

   —        —        —          —          30,000        30,000        30,000   

Reclassification of realized gain to income due to redemption of marketable securities

   —        —        —          —          (30,000     (30,000     (30,000

Net loss

   —        —        —          (4,515,512     —          (4,515,512     (4,515,512
                                                    

Balance at December 31, 2008

   25,653,512      25,654      30,342,249        (32,082,425     —          (1,714,522     (4,515,512

Stock-based compensation

   —        —        61,228        —          —          61,228        —     

Relative fair value of detachable warrants issued with convertible notes payable

   —        —        218,862        —          —          218,862        —     

Net loss

   —        —        —          (1,943,139     —          (1,943,139     (1,943,139
                                                    

Balance at June 30, 2009

   25,653,512    $ 25,654    $ 30,622,339      $ (34,025,564   $ —        $ (3,377,571   $ (1,943,139
                                                    

The accompanying notes are an integral part of the financial statements.

 

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HELIX BIOMEDIX, INC.

CONDENSED STATEMENTS OF CASH FLOWS

(Unaudited)

 

     Six Months ended June 30,  
     2009     2008  

Cash flows from operating activities

    

Net loss

   $ (1,943,139   $ (2,723,293

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

    

Depreciation and amortization

     66,002        69,950   

Stock-based compensation expense

     61,228        122,721   

Interest expense on convertible notes payable

     41,485        —     

Interest expense on convertible notes payable, related party

     182,948        93,698   

Accretion of discount on convertible notes payable

     13,736        —     

Accretion of discount on convertible notes payable, related party

     21,144        831,426   

Change in valuation of derivative instruments, including related party

     —          (11,803

Unrealized loss on marketable securities

     —          30,000   

Changes in assets and liabilities:

    

Accounts receivable, net

     (58,072     43,356   

Inventory

     (51,635     (12,287

Prepaid expenses and other current assets

     50,637        42,759   

Accounts payable

     (4,216     12,408   

Accrued compensation and benefits

     (58,711     95,316   

Other accrued expenses

     27,841        (18,213

Deferred revenue

     —          (130,000
                

Net cash used in operating activities

     (1,650,752     (1,553,962
                

Cash flows from investing activities

    

Proceeds from sales and redemption of marketable securities

     —          500,000   

Release of restricted cash from convertible debt subscription

     970,000        —     

Purchases of property and equipment

     (1,068     (26,665
                

Net cash provided by investing activities

     968,932        473,335   
                

Cash flows from financing activities

    

Proceeds from issuance of convertible notes payable and detachable warrants

     404,000        —     

Proceeds from issuance of convertible notes payable and detachable warrants, related party

     2,100,000        3,000,000   

Financing costs related to convertible note payable, related party

     —          (5,260
                

Net cash provided by financing activities

     2,504,000        2,994,740   
                

Net increase in cash and cash equivalents

     1,822,180        1,914,113   

Cash and cash equivalents at beginning of period

     984,844        461,290   
                

Cash and cash equivalents at end of period

   $ 2,807,024      $ 2,375,403   
                

Supplemental cash flow information

    

Non-cash investing and financing activities:

    

Reclassification of warrants and options from equity to derivative liabilities

   $ —        $ 1,255,317   
                

Extinguishment of convertible note payable, related party

   $ —        $ 733,317   
                

Reclassification of warrants and options from derivative liabilities to equity

   $ —        $ 1,337,349   
                

Issuance of convertible notes payable in exchange for release of restricted cash

   $ 970,000      $ —     
                

The accompanying notes are an integral part of the financial statements.

 

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HELIX BIOMEDIX, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(Unaudited)

Note 1. Summary of Significant Accounting Policies

Basis of Presentation and Preparation

The accompanying unaudited condensed financial statements of Helix BioMedix, Inc. (the Company) have been prepared in accordance with accounting principles generally accepted in the United States of America (U.S. GAAP) for interim financial reporting and pursuant to the rules and regulations of the Securities and Exchange Commission (SEC). Certain information and footnote disclosures normally included in annual financial statements have been condensed or omitted for interim financial information in accordance with the SEC rules and regulations for quarterly reporting. In accordance with Statement of Financial Accounting Standards (SFAS) No. 165, Subsequent Events (SFAS 165), the Company performed an evaluation of subsequent events for the accompanying financial statements and notes included in Part 1, Item 1of this Quarterly Report through August 6, 2009, the date this Quarterly Report on Form 10-Q was filed with the SEC. In the opinion of management, the accompanying unaudited condensed financial statements reflect all adjustments, consisting of normal recurring adjustments, necessary for a fair presentation of the Company’s financial position and its results of operations and cash flows for the periods indicated. These condensed financial statements should be read in conjunction with the audited financial statements and notes thereto for the year ended December 31, 2008, included in the Company’s Annual Report on Form 10-K filed with the SEC on March 26, 2009.

Use of Estimates

The preparation of the Company’s financial statements in conformity with U.S. GAAP requires the Company’s management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the dates of the balance sheets and the reported amounts of revenue and expenses during the reporting periods. Significant items subject to such estimates and assumptions include, but are not limited to, the carrying amount of investments, property, plant and equipment, and intangibles; valuation allowances for receivables, inventories and deferred income tax assets; and valuation of stock-based compensation, notes payable and obligations related to derivative instruments. Actual results could differ from those estimates.

The results of operations for the three and six months ended June 30, 2009, are not necessarily indicative of the results of operations that may be achieved for the entire year ending December 31, 2009.

Reclassification

Reclassifications of prior years’ balances have been made to conform to the current format. Specifically, in the Condensed Statements of Operations, costs of revenue have been moved from operating expenses and presented separately in the Cost of Revenue section. This reclassification had no impact on the financial results in the periods presented.

Revenue Recognition

The Company derives its revenue from technology licenses, joint development agreements, sales of peptides and consumer products, and administrative services provided to a related party. Revenue under technology licenses may include up-front payments and royalties from third-party product manufacturing and sales. Revenue associated with joint development agreements primarily consists of payments for completion of development milestones. For agreements with multiple elements, the Company follows Emerging Issues Task Force (EITF) Issue No. 00-21, Revenue Arrangements with Multiple Deliverables, to determine whether each element can be separated into a unit of accounting based on the following criteria: (1) the delivered items have value to the customer on a stand-alone basis; (2) any undelivered items have objective and reliable evidence of fair value; and, (3) delivery or performance of the undelivered items that have a right of return is probable and within the Company’s control. If there is objective and reliable evidence of fair value for all units of accounting in an arrangement, the Company allocates revenue among the separate units of accounting based on their estimated fair values. If the criteria are not met, elements included in an arrangement are accounted for as a single unit of accounting and revenue is deferred until the period in which the final deliverable is provided. When the period of deferral cannot be specifically identified from the agreement, the Company estimates the period based upon other factors contained within the agreement. The Company’s management continually reviews these estimates, which could result in a change in the deferral period and the timing and the amount of revenue recognized.

 

   

Licensing FeesThe Company recognizes up-front payments when persuasive evidence of an agreement exists, delivery has occurred or services have been performed, the price is fixed and determinable and collection is reasonably assured. The Company recognizes royalty revenue in the period the royalty is earned based on reports received from licensees or other information available through the date of issuance of the financial statements. The Company’s management must occasionally make estimates on certain royalty revenue amounts due to the timing of securing information from its customers. While the Company’s management believes it can make reliable estimates for certain royalty revenue, these estimates are inherently subjective. Accordingly, the Company’s estimates of royalty revenue could differ from actual events, thus impacting the Company’s financial position or results of operations.

 

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HELIX BIOMEDIX, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(Unaudited)

 

   

Development Fees. The Company records revenue associated with performance milestones as earned when it has completed the specific milestones as defined in the joint development agreements and there are no uncertainties or contingencies regarding collection of the related payment. Payments received for which the earnings process is not complete are recorded as deferred revenue.

 

   

Peptide and Consumer Product Sales. The Company recognizes revenue from sales of its skin care products and peptides when persuasive evidence of an arrangement exists, delivery has occurred, the price is fixed or determinable and collection is reasonably assured.

 

   

Administrative Services Revenue, Related Party. The Company’s administrative services revenue consists of fees received from DermaVentures, LLC (DermaVentures), a related party, for marketing campaign costs associated with DermaVentures’ product line and other out-of-pocket expenses the Company incurs on DermaVentures’ behalf. Administrative services revenue is invoiced to DermaVentures at or near cost and is recorded as earned when services have been rendered, no obligations remain outstanding and collection is reasonably assured. In accordance with EITF Issue No. 99-19, Reporting Revenue Gross as a Principal versus Net as an Agent, and EITF Issue No. 01-14, Income Statement Characterization of Reimbursements Received for ‘Out-of-Pocket’ Expenses Incurred, fees received from DermaVentures are reported as administrative services revenue, while related costs are included in cost of revenue in the statements of operations.

Derivative Instruments

The Company accounts for its derivative instruments in accordance with the provisions of SFAS No. 133, Accounting for Derivative Instruments and Hedging Activities (SFAS 133), and EITF Issue No. 00-19, Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company’s Own Stock (EITF 00-19), which require derivative instruments to be classified as permanent equity, temporary equity or as assets or liabilities. In general, the Company’s derivative instruments that either require net-cash settlement or are presumed to require net-cash settlement are recorded as assets and liabilities at fair value and the Company’s derivative instruments that require settlement in shares are recorded as equity instruments.

Valuation of Warrants and Stock Options Unrelated to Convertible Note Payable, Related Party, Issued in 2008

In connection with the issuance of the convertible note payable on February 14, 2008 to a related party and the potential contractual obligation to grant the associated warrant, the Company classified the fair value of then outstanding warrants and non-employee stock options (the Other Warrant Liabilities) as derivative liabilities as there was a potential that the Company would not have a sufficient number of authorized common shares available to settle these instruments (see Note 2). The Company valued the Other Warrant Liabilities using a Black-Scholes model and used estimates for an expected dividend yield, a risk-free interest rate, and expected volatility (see Note 6). At each reporting period, as long as the Other Warrant Liabilities were outstanding and there was the potential for an insufficient number of authorized shares available to settle these instruments, the Other Warrant Liabilities were revalued and any difference from the previous valuation date was recognized as a change in fair value in the Company’s statement of operations.

On June 27, 2008, the Company entered into an amendment to the convertible note payable (see Note 2) which effectively extinguished the original convertible note payable and related derivative instruments, including the potential contractual obligation to grant the associated warrant. In accordance with the guidance of EITF Issue No. 96-19, Debtor’s Accounting for a Modification or Exchange of Debt Instruments (EITF 96-19), the Company accounted for this modification as an extinguishment of the original convertible note payable and recorded the amended convertible note payable as new debt. Among other changes, the amended note limits the number of shares issuable under it and therefore eliminates the net-cash settlement requirement for the Other Warrant Liabilities. As a result, the Company is no longer required to account for the Other Warrant Liabilities as derivative liabilities. The June 27, 2008 fair value of the Other Warrant Liabilities was therefore reclassified to additional paid-in capital.

Valuation of Warrant Related to Convertible Note Payable, Related Party, Issued in 2008

In accordance with SFAS 133 and EITF 00-19, the Company classified the fair value of the warrant that may have been granted in connection with the convertible note payable issued to a related party on February 14, 2008 (see Note 2) as a derivative liability as there was a potential that the Company would not have a sufficient number of authorized common shares available to settle this instrument. The Company valued this warrant using a Black-Scholes model and used estimates for an expected dividend yield, a risk-free interest rate, and expected volatility together with management’s estimate of the probability of issuance of the warrant. At each reporting period, as long as the warrant was potentially issuable and there was a potential for an insufficient number of authorized shares available to settle the warrant, the warrant was revalued and any difference from the previous valuation date was recognized as a change in fair value in the Company’s statement of operations.

On June 27, 2008, the Company entered into an amendment to the convertible note payable (see Note 2) which effectively extinguished the original convertible note payable and related derivative instruments, including the potential contractual obligation to grant the associated warrant. The June 27, 2008 fair value of the warrant was reclassified to additional paid-in capital.

 

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HELIX BIOMEDIX, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(Unaudited)

Valuation of Warrants Related to Convertible Notes Payable Issued in 2009

In connection with the convertible notes payable issued in the first quarter of 2009, the Company issued warrants to purchase up to 868,500 shares of the Company’s common stock at an exercise price of $1.00 per share. Since these warrants are legally detachable and are separately exercisable from the debt and its related embedded options, they are considered to be freestanding financial instruments. Pursuant to the guidance in Accounting Principles Board (APB) Opinion 14 (APB 14), Accounting for Convertible Debt and Debt Issued with Stock Purchase Warrants, EITF 00-19, EITF Issue No. 07-5, Determining Whether an Instrument (or Embedded Feature) Is Indexed to an Entity’s Own Stock, and other relevant literature, the Company accounted for these warrants as equity instruments and allocated the value of the warrants based on a relative-fair-value basis between the convertible notes payable issued and the warrants.

Valuation of Conversion Rights Related to Convertible Notes Payable, Including Related Party

In connection with the issuance of the convertible note payable to a related party in February 2008 and under the guidance of SFAS 133, the Company was required to separately account for the fair value of the Company’s right to automatically convert the note payable to equity at the price of equity securities issued in any sale of shares of its equity securities that raised an aggregate amount of at least $5,000,000 on or before June 29, 2008 (see Note 2).

On June 27, 2008, the Company entered into an amendment to the convertible note payable (see Note 2) which effectively extinguished the original convertible note payable, including its embedded derivative instruments. The June 27, 2008 fair value of the separately-accounted-for embedded derivative instruments was credited to additional paid-in capital as part of recording the capital transaction resulting from the extinguishment of the original convertible note payable.

Pursuant to the guidance in SFAS 133, EITF 00-19, EITF 07-5 and other relevant literature, the conversion rights of the amended convertible note payable issued in June 2008 and the convertible notes payable issued in the first quarter of 2009 are not required to be accounted for separately.

Valuation of Call Option Related to Convertible Note Payable, Related Party, Issued in 2008

The convertible note payable issued on February 14, 2008 and subsequently amended on June 27, 2008 includes a call option which gives the holder the right to demand repayment in the case of default. Under the guidance of SFAS 133, the Company is required to separately account for the fair value of the call option. The Company determined that the call option related to the amended note payable had no value at either the issuance date or any of the reporting dates since then based on an analysis of the right and the likelihood of its exercise.

Valuation of Prepayment Right Related to Convertible Note Payable, Related Party, Issued in 2008

The convertible note payable issued on February 14, 2008 and subsequently amended on June 27, 2008 allows the Company to prepay the unpaid balance of the convertible notes and accrued interest at any time and without penalty. Under the guidance of SFAS 133, the Company is required to separately account for the fair value of the prepayment right. The Company determined that this right had no value at either the issuance dates or any of the reporting dates since then based on an analysis of the right and the likelihood of its exercise.

Recent Accounting Pronouncements

In June 2009, the Financial Accounting Standards Board (FASB) issued SFAS No. 168, The FASB Accounting Standards CodificationTM and the Hierarchy of Generally Accepted Accounting Principles (SFAS 168). SFAS 168 represents the last numbered standard to be issued by the FASB under the old (pre-Codification) numbering system, and amends the U.S. GAAP hierarchy. On July 1, 2009, the FASB released The FASB Accounting Standards CodificationTM (Codification) which supersedes all existing non-SEC accounting and reporting standards and becomes the exclusive authoritative U.S. GAAP to be applied by nongovernmental entities for use in financial statements issued for interim and annual periods ending after September 15, 2009. All other non-grandfathered, non-SEC accounting literature not included in the Codification is non-authoritative. The Company does not expect the Codification to have an impact on its financial position, results of operations or cash flows.

        In June 2009, the FASB issued SFAS No. 167, a revision to FASB Interpretation No. 46(R), Consolidation of Variable Interest Entities (SFAS 167), which will change how a company determines when an entity that is insufficiently capitalized or is not controlled through voting (or similar rights) should be consolidated. Under SFAS 167, determining whether a company is required to consolidate an entity will be based on, among other things, an entity’s purpose and design and a company’s ability to direct the activities of the entity that most significantly impact the entity’s economic performance. SFAS 167 is effective at the start of a company’s first fiscal year beginning after November 15, 2009, or January 1, 2010 for companies reporting earnings on a calendar-year basis. The Company is currently evaluating the impact, if any, SFAS 167 will have on its financial position, results of operations or cash flows.

 

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HELIX BIOMEDIX, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(Unaudited)

 

In May 2009, the FASB issued SFAS 165,which sets forth the period after the balance sheet date during which management of a reporting entity should evaluate events or transactions that may occur for potential recognition or disclosure in the financial statements, the circumstances under which an entity should recognize events or transactions occurring after the balance sheet date in its financial statements, and the disclosures that an entity should make about events or transactions that occurred after the balance sheet date. SFAS 165 is effective for interim or annual reporting periods and was effective for the Company beginning April 1, 2009. The adoption of SFAS 165 did not have an impact on the Company’s financial position, results of operations or cash flows. The Company evaluated subsequent events through August 6, 2009, the date the accompanying financial statements were issued.

In April 2009, the FASB issued FASB Staff Position (FSP) No. FAS 157-4, Determining Fair Value When the Volume and Level of Activity for the Asset or Liability Have Significantly Decreased and Identifying Transactions That Are Not Orderly, which provides additional guidance for estimating fair value in accordance with SFAS No. 157, Fair Value Measurements (FSP FAS 157-4). FSP FAS 157-4 supersedes FSP FAS 157-3, Determining the Fair Value of a Financial Asset When the Market for That Asset is not Active, and affirms that in an inactive market, fair value is the price to sell the asset in an orderly transaction and clarifies and includes additional factors for determining inactive markets. FSP FAS 157-4 is effective for interim and annual reporting periods ending after June 15, 2009 and was effective for the Company beginning April 1, 2009. The adoption of FSP FAS 157-4 did not have an impact on the Company’s financial position, results of operations or cash flows.

In April 2009, the FASB issued FSP No. FAS 115-2 and FAS 124-2, Recognition and Presentation of Other-Than-Temporary Impairments (FSP FAS 115-2 and FAS 124-2), which amends the requirements for the recognition and measurement of other-than-temporary impairments for debt securities by modifying the pre-existing “intent and ability” indicator. Under FSP FAS 115-2 and FAS 124-2, an other-than-temporary impairment is triggered when there is an intent to sell the security and it is more likely than not that the security will be required to be sold before recovery, or the security is not expected to recover the entire amortized cost basis of the security. FSP FAS 115-2 and FAS 124-2 requires the presentation of the total other-than-temporary impairment in the statement of earnings for those impairments involving credit losses with an offset for the remainder of the impairment recognized in other comprehensive income. Upon adoption, FSP FAS 115-2 and FAS 124-2 requires a cumulative-effect adjustment in earnings. This FSP does not change existing recognition and measurement guidance related to other-than-temporary impairments of equity securities. FSP FAS 115-2 and FAS 124-2 is effective for interim and annual reporting periods ending after June 15, 2009 and was effective for the Company beginning April 1, 2009. The adoption of FSP FAS 115-2 and FAS 124-2 did not have an impact on the Company’s financial position, results of operations or cash flows.

In April 2009, the FASB issued FSP No. FAS 107-1 and APB Opinion No. 28-1, Interim Disclosures about Fair Value of Financial Instruments (FSP FAS 107-1 and APB 28-1), which requires disclosures about the fair value of financial instruments as well as the methods and significant assumptions used to estimate the fair value of those financial instruments in the interim reporting periods and in the annual financial statements. FSP FAS 107-1 and APB 28-1 is effective for interim and annual reporting periods ending after June 15, 2009 and was effective for the Company beginning April 1, 2009. The adoption of FSP FAS 107-1 and APB 28-1 did not have an impact on the Company’s financial position, results of operations or cash flows.

Note 2. Debt Financing

2008 Debt Financing

Convertible Note Payable, Related Party, Issued on February 14, 2008

On February 14, 2008, the Company issued to RBFSC, Inc. (RBFSC), a related party, a convertible promissory note (the 2008 Note) in the principal amount of $3,000,000 with an interest rate of 8% per annum, which was subsequently amended on June 27, 2008 (see below). Prior to such amendment, the principal balance and accrued interest of the 2008 Note were due on the earlier of February 14, 2010, or upon an event of default under the 2008 Note, including in the event that the Company files for bankruptcy. In the event that the Company closed an equity financing on or before June 29, 2008, in which the Company sold shares of its equity securities for an aggregate amount of at least $5,000,000, the unpaid balance of the 2008 Note and related accrued interest would have automatically converted into the equity securities issued in the equity financing, at the price of such equity securities issued in the equity financing. In the event the Company did not consummate an equity financing on or before June 29, 2008, the unpaid balance of the 2008 Note and related accrued interest could be converted, at the option of the holder, into common shares at a price equal to 80% of the average per share closing price of the Company’s common stock during the preceding 90-day period, and the Company would have been obligated to issue to RBFSC a warrant (the 2008 Warrant) to purchase that number of shares of its common stock equal to $750,000 divided by the per share closing sale price of the Company’s common stock on the date of issuance.

        Due to the indeterminate number of common shares which might have been issued under the embedded conversion feature of the 2008 Note and the 2008 Warrant, the Company recorded the value of the 2008 Warrant as a derivative liability at its fair value in accordance with SFAS 133 and EITF 00-19, as there was a potential that the Company would not have a sufficient number of authorized shares to settle these obligations. In addition, the Company re-measured the fair value of this derivative liability at the end of each subsequent reporting period. The Company estimated the fair value of the 2008 Warrant to be $280,347 at February 14, 2008. At March 31, 2008, the Company estimated the fair value of this derivative liability had increased to $503,122 and, as a result, recognized the change in value of $222,775 in its statement of operations. At June 27, 2008, the date that the 2008 Note was amended, the Company estimated the fair value of this derivative liability to be $555,674, and as a result, recognized the change in value of

 

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HELIX BIOMEDIX, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(Unaudited)

 

$52,552 in its statement of operations. The fair value of the 2008 Warrant was determined by applying management’s estimate of the probability of issuance of the 2008 Warrant together with the Black-Scholes option pricing model with the following key assumptions:

 

     February 14,
2008
    March 31,
2008
    June 27,
2008
 

Risk-free interest rate

   2.81   2.46   3.36

Expected dividend yield

   0      0      0   

Expected term in years

   5.00      5.00      4.75   

Expected volatility

   98   98   99

The 2008 Note also included embedded features in the form of a call option and put option that were required to be separately accounted for at fair value on the balance sheet with changes in value recognized in the statement of operations under SFAS 133 as the features were not clearly and closely related to the convertible note debt instrument. The embedded call option, which gave the holder the right to demand repayment in the case of default, was determined by management to have no value at February 14, 2008 or March 31, 2008, based on an analysis of the right and the likelihood of its exercise. The embedded put option gave the Company the right to automatically convert the 2008 Note into the equity securities issued in the equity financing. The Company estimated the fair value of the put option associated with the 2008 Note to be $186,512 at February 14, 2008. At March 31, 2008, the Company estimated the fair value of this derivative asset had decreased to $24,170 and, as a result, recognized the change in value of $162,342 in its statement of operations. At June 27, 2008, the Company estimated the fair value of this put option to be $0 as the Company was not intending to exercise the option and, as a result, recognized the change in value of $24,170 in its statement of operations. The fair value of this derivative asset was determined by applying management’s estimate of the probability of the Company’s exercising the put option together with the Black-Scholes option pricing model with the following key assumptions:

 

     February 14,
2008
    March 31,
2008
 

Risk-free interest rate

   2.26   1.32

Expected dividend yield

   0      0   

Expected term in years

   0.37      0.25   

Expected volatility

   79   79

The Company accounted for the 2008 Note in accordance with SFAS No. 150, Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity (SFAS 150), as the conversion feature embedded in the 2008 Note could result in the note principal and related accrued interest being converted to a variable number of the Company’s common shares. The Company determined the value of the 2008 Note at February 14, 2008 to be $2,906,165, which represented the gross proceeds from the debt financing less the fair value of the 2008 Warrant, offset by the fair value of the put option held by the Company. The 2008 Note was being accreted from its carrying value of $2,906,165 at February 14, 2008 to its settlement amount of $3,750,000 at June 29, 2008, the first possible settlement date, through the statement of operations using the effective interest method. As of March 31, 2008, an expense of $285,415 had been recorded as accretion of discount on convertible note payable, related party. As of June 27, 2008, an expense of $831,426 was recorded as accretion of discount on convertible note payable, related party, thereby increasing the carrying value of the 2008 Note to $3,737,591.

Amended Convertible Note Payable, Related Party, Issued on June 27, 2008

On June 27, 2008, the Company entered into a First Amendment to Note and Warrant Purchase Agreement and Convertible Promissory Note with RBFSC pursuant to which the 2008 Note was amended (the 2008 Amended Note) to have a maturity date of July 1, 2011 and to be convertible:

 

  (i) upon the consummation by the Company of an equity financing with proceeds to the Company of at least $7,500,000, whereupon the 2008 Amended Note shall be converted automatically into shares of the Company’s capital stock issued in the equity financing at a price equal to the lesser of the per share price of the securities issued and sold in the equity financing and $1.00;

 

  (ii) upon the consummation of a sale of substantially all of the Company’s assets or a merger or consolidation of the Company in which the Company’s stockholders will hold, in the aggregate, less than 50% of the voting power of the combined entity, whereupon the 2008 Amended Note shall be converted automatically into shares of the Company’s common stock at a price equal to the lesser of the per share price attributed to the Company’s common stock in connection with such transaction and $1.00; or

 

  (iii) voluntarily by RBFSC at and as of the maturity date into shares of the Company’s common stock at a price equal to $1.00 per share.

 

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HELIX BIOMEDIX, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(Unaudited)

 

In addition, the 2008 Warrant was amended and restated in its entirety such that RBFSC shall be entitled to purchase up to 750,000 shares of the Company’s common stock at an exercise price of $1.00 per share (the Restated Warrant), which Restated Warrant was issued by the Company concurrent with the issuance of the 2008 Amended Note.

Under the guidance of EITF 96-19, the Company determined that the terms of the 2008 Amended Note reflect a substantial modification to the 2008 Note based on an analysis of cash flows for the 2008 Amended Note compared to the 2008 Note and, as a result, accounted for this modification as an extinguishment of the 2008 Note. As the 2008 Note was a debt to a related party, the Company recorded the debt extinguishment as a capital transaction under APB Opinion 26, Early Extinguishment of Debt. The 2008 Amended Note was accounted for as new debt and was recorded at its $3,000,000 face value because the estimated June 27, 2008 fair value of the 2008 Amended Note exceeded its face value.

For the three and six months ended June 30, 2009, interest expense resulting from the stated interest rate of 8% related to the 2008 Amended Note was $59,835 and $119,013, respectively.

2009 Debt Financing

Convertible Notes Payable Issued on February 10 and March 5, 2009

As of December 31, 2008, the Company had received a total of $970,000 of subscription deposits toward an offering of unsecured convertible notes payable and warrants (the 2009 Note and Warrant Offering). During the first quarter of 2009, the Company completed the 2009 Note and Warrant Offering and issued convertible promissory notes payable in an aggregate principal amount of $3,474,000 (the 2009 Notes) and warrants to purchase an aggregate of 868,500 shares of the Company’s common stock at an exercise price of $1.00 per share (the 2009 Warrants). The 2009 Notes bear interest at the rate of 8% per annum and are due and payable on July 1, 2011 and are convertible:

 

  (i) upon the consummation by the Company of an equity financing with proceeds to the Company of at least $7,500,000 whereupon the 2009 Notes shall be converted automatically into shares of the Company’s capital stock issued in the equity financing at a price equal to the lesser of the per share price of the securities issued and sold in the equity financing and $1.00;

 

  (ii) upon the consummation of a sale of substantially all of the Company’s assets or a merger or consolidation of the Company in which the Company’s stockholders will hold, in the aggregate, less than 50% of the voting power of the combined entity whereupon the 2009 Notes shall be converted automatically into shares of the Company’s common stock at a price equal to the lesser of the per share price attributed to the Company’s common stock in connection with such transaction and $1.00; or

 

  (iii) voluntarily at and as of the maturity date into shares of the Company’s common stock at a price equal to $1.00 per share.

The Company determined the relative fair value of the 2009 Warrants to be $218,862 and recorded this amount as a discount to the 2009 Notes, with a corresponding credit to additional paid-in capital.

The 2009 Notes are being accreted from their carrying value of $3,255,138 at the issuance dates to their settlement amount of $3,474,000 at July 1, 2011, through the statement of operations using the effective interest method. For the three and six months ended June 30, 2009, the Company recorded $22,935 and $34,880, respectively, as accretion of discount on the 2009 Notes, thereby increasing the carrying value of the 2009 Notes to $3,290,018 as of June 30, 2009. Financing costs associated with the issuance of the 2009 Notes and 2009 Warrants were not material and therefore were expensed as incurred.

For the three and six months ended June 30, 2009, interest expense resulting from the stated interest rate of 8% related to the 2009 Notes was $69,290 and $105,420, respectively. The effective interest rate related to the 2009 Notes for the period from the issuance dates through June 30, 2009, including accretion of discount, was 10.6%.

The 2009 Notes also include a call option, which gives the holders the right to demand repayment in the case of default, and a put option, which allows the Company to prepay the unpaid balance of the 2009 Notes and accrued interest at any time and without penalty. Under the guidance of SFAS 133, the Company determined that these embedded features were clearly and closely related to the debt instruments and therefore were not required to be accounted for separately from the 2009 Notes.

        Participants in the 2009 Note and Warrant Offering included two related parties: 1) a member of the Company’s Board of Directors who purchased a convertible note in the principal amount of $100,000 and received a warrant to purchase up to 25,000 shares of the Company’s common stock, and 2) Cardinal Court LLC which purchased a convertible note in the principal amount of $2,000,000 and received a warrant to purchase up to 500,000 shares of the Company’s common stock. The Vice President and Treasurer of Cardinal Court LLC is Frank T. Nickell, who is also the President and a director of RBSFS. Mr. Nickell beneficially owned approximately 29.5% of the Company’s outstanding common stock as of March 19, 2009.

 

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HELIX BIOMEDIX, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(Unaudited)

 

Note 3. Marketable Securities

At January 1, 2008, the Company had $700,000 of investment in auction rate securities (ARS), classified as current available-for-sale marketable securities. These securities are structured to allow for interest rate resets at approximately every 28 days, but with contractual maturities that are well in excess of ten years. Historically, the carrying value of ARS approximated fair value due to the frequent interest rate resets. Until early February 2008, the ARS market was fairly liquid and the Company was able to auction and sell these securities at par at the end of each reset period or continue to hold them. During the first two months of 2008, the Company liquidated $500,000 of its investment in ARS at par and held the proceeds in cash and cash equivalents.

During February 2008, ARS increasingly failed at auction due to sell orders exceeding buy orders. At March 31, 2008, the Company estimated the fair value of its then remaining $200,000 of ARS to be $170,000, a decline of $30,000 from par value. The Company considered this decline in fair value as other than temporary and, accordingly, recorded an unrealized loss on marketable securities of $30,000 in other non-operating expense in the first quarter of 2008. During the third and fourth quarters of 2008, all the Company’s remaining ARS were sold or redeemed at par, resulting in a realized gain of $30,000. The Company invested the proceeds from these sales and redemption of ARS in cash equivalents.

The Company did not have any ARS or other marketable securities at December 31, 2008 or anytime during the six months ended June 30, 2009.

Note 4. Fair Value of Financial Instruments

The Company adopted SFAS No. 157, Fair Value Measurements (SFAS 157), effective January 1, 2008. In accordance with SFAS 157, the inputs used to measure fair value are summarized in the three broad levels listed below:

 

   

Level 1 — Quoted prices in active markets for identical securities;

 

   

Level 2 — Other significant observable inputs (including quoted prices in active markets for similar securities); and,

 

   

Level 3 — Significant unobservable inputs (including the Company’s own assumptions in determining fair value of investments).

The inputs or methodology used for valuing securities are not necessarily an indication of the risk associated with investing in those securities. The Company did not hold any marketable securities at either December 31, 2008 or June 30, 2009. At June 30, 2008, there was insufficient observable ARS market information available for the Company to determine the fair value of its investment using level 1 or level 2 inputs. As a result, the Company’s management measured the fair value of its ARS using level 3 inputs and estimated fair value by incorporating assumptions that market participants would use in their estimates of fair value at that time. These assumptions included credit quality, estimates on the probability of the issue being called prior to final maturity and the liquidity of the securities.

The following is a reconciliation of the activities related to the Company’s ARS during the six months ended June 30, 2008:

 

      Six Months
Ended

June 30, 2008
 

Fair value estimates for ARS using significant unobservable inputs (Level 3)

  

Beginning balance at January 1, 2008

   $ 700,000   

Sales of ARS at par value

     (500,000

Unrealized loss recorded in condensed statements of operations

     (30,000

Unrealized gain recorded in accumulated other comprehensive income (loss)

     17,550   
        

Ending balance at June 30, 2008

   $ 187,550   
        

The Company estimated the fair value of its derivative instruments using the Black-Scholes pricing model with the key assumptions summarized in Notes 2 and 6. A reconciliation of the activities of the derivative instruments during the six months ended June 30, 2008 is presented in the tables below. The fair value of derivative instruments was $0 at December 31, 2008 and at each of the reporting dates since then. During the six months ended June 30, 2009, there was no change in the fair value of derivative instruments.

 

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HELIX BIOMEDIX, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(Unaudited)

 

      Six Months
Ended

June 30, 2008
 

Fair value estimates for derivative liabilities using significant unobservable inputs (Level 3)

  

Balance at January 1, 2008

   $ —     

Reclassification of outstanding warrants and options from equity to derivative liabilities at February 14, 2008

     1,255,317   

Derivative liabilities related to issuance of convertible note payable, related party

     280,347   

Change in fair value recorded in condensed statements of operations

     (198,315

Reclassification of outstanding warrants and options from derivative liabilities to equity due to amendment of convertible note payable on June 27, 2008

     (1,337,349
        

Ending balance at June 30, 2008

   $ —     
        
      Six Months
Ended

June 30, 2008
 

Fair value estimates for derivative asset using significant unobservable inputs (Level 3)

  

Beginning balance at January 1, 2008

   $ —     

Derivative asset related to issuance of convertible note payable, related party

     186,512   

Change in fair value recorded in condensed statements of operations

     (186,512
        

Ending balance at June 30, 2008

   $ —     
        

The table below presents the carrying values and estimated fair values for certain of the Company’s financial instruments at June 30, 2009 and December 31, 2008. The carrying amount of the Company’s cash and cash equivalents, accounts receivable, accounts payable, accrued compensation and benefits, and accrued expenses approximated their estimated fair values at June 30, 2009 and December 31, 2008 because of the short-term nature of these instruments. As there is no established market for the Company’s convertible notes, the Company estimated the fair value of its convertible notes payable, including related party, using market-based parameters for the various components of the convertible notes. The fair value of the accrued interest on convertible notes payable, including related party, was estimated as the present value of expected future payments, discounted by an interest rate commensurate with the risk-free interest rate for an equivalent maturity term.

 

     June 30, 2009    December 31, 2008
     Carrying
Value
   Estimated
Fair Value
   Carrying
Value
   Estimated
Fair Value

Liabilities:

           

Convertible notes payable

   $ 1,301,174    $ 1,402,167    $ —      $ —  

Convertible notes payable, related party

     4,988,844      5,204,550      3,000,000      3,168,500

Accrued interest on convertible notes payable

     41,485      40,579      —        —  

Accrued interest on convertible notes payable, related party

     394,017      385,413      211,069      206,496
                           

Total

   $ 6,725,520    $ 7,032,709    $ 3,211,069    $ 3,374,996
                           

Note 5. Stock-Based Compensation

The Helix BioMedix 2000 Stock Option Plan (the 2000 Plan), approved by the Company’s stockholders in 2000, is administered by non-employee directors who are authorized to grant stock options to the Company’s employees, consultants, and directors. Stock options are granted at exercise prices equal to the market value of the Company’s common stock on the date of grant. Stock options granted to employees are typically incentive stock options, as defined and governed by Section 422 of the Internal Revenue Code, and vest at the rate of 1/3 of the total number of shares after one year and monthly thereafter in 24 equal amounts. Options granted to non-employee directors are nonqualified stock options and become exercisable ranging from immediately upon grant to quarterly over one year. All options granted to employees and non-employee directors expire 10 years from the date of grant.

        There were no stock options granted during the three months ended June 30, 2009 or 2008; however, during the three months ended June 30, 2008, the Company modified two option grants. For each of the six months ended June 30, 2009 and 2008, the Company granted to non-employee directors stock options to purchase up to an aggregate of 120,000 shares of the Company’s common stock with a fair value of $0.38 and $0.62 per share, respectively. In determining the fair value of stock option modifications during the three months ended June 30, 2008 and of stock options granted during the six months ended June 30, 2009 and 2008, the following key assumptions were used in the Black-Scholes option pricing model:

 

     Three Months Ended June 30,    Six Months Ended June 30,
     2009    2008    2009    2008

Risk-free interest rate

   —      3.10% – 3.27%    1.89%    2.89% – 3.27%

Expected dividend yield

   —      0    0    0

Expected term in years

   —      3.00 – 5.50    5.50    3.00 – 5.50

Expected volatility

   —      99% – 107%    101%    99% – 107%

 

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HELIX BIOMEDIX, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(Unaudited)

 

The risk-free rate is based on the implied yield available on U.S. Treasury zero–coupon issues with an equivalent remaining term. The Company does not anticipate declaring dividends in the foreseeable future. For the three months ended June 30, 2008 and six months ended June 30, 2009 and 2008, the Company calculated expected volatility based on the annualized daily historical volatility of the Company’s common stock price commensurate with the expected term of the option and other factors, including peer company data. The Company estimates the expected term as the average of the vesting period and the contractual term, as prescribed by the simplified method under Staff Accounting Bulletin (SAB) No. 107, Share-Based Payment, and amended by SAB No. 110. The Company will continue to use the simplified method until it has sufficient historical data to provide reasonable estimates of expected lives of stock options. The determination of the Company’s stock price volatility and option term involves management’s best estimates at that time, both of which impact the fair value of the option calculated under the Black-Scholes pricing model and, ultimately, the expense that will be recognized over the life of the option. SFAS 123R, Share-Based Payment, also requires that the Company recognize compensation expense for only the portion of options that is expected to vest. Therefore, the Company applies an estimated forfeiture rate that is derived from historical employee termination behavior. Forfeiture rates are revised in subsequent periods if actual forfeitures differ from those estimates.

The amount of stock-based compensation expense recognized in the three months ended June 30, 2009 and 2008 related to stock options was $29,616 and $96,292, respectively. For the six months ended June 30, 2009 and 2008, stock-based compensation expense was $61,228 and $122,721, respectively. Stock-based compensation expense for the three and six months ended June 30, 2008 included approximately $65,400 of expense resulting from modification of two option grants. As of June 30, 2009, total unrecognized stock-based compensation related to non-vested stock options was approximately $71,600, which is expected to be recognized over a weighted-average period of approximately one year. A summary of the Company’s stock compensation expense for the three and six months ended June 30, 2009 and 2008 is as follows:

 

     Three Months Ended June 30,    Six Months Ended June 30,
     2009    2008    2009    2008

Research and development

   $ 382    $ —      $ 760    $ —  

Marketing and business development

     5,060      10,348      10,065      15,408

General and administrative

     24,174      85,944      50,403      107,313
                           

Total stock-based compensation

   $ 29,616    $ 96,292    $ 61,228    $ 122,721
                           

A summary of the Company’s stock option activity for the six months ended June 30, 2009 is presented in the following table:

 

     Shares
Subject to
Options
    Weighted
Average
Exercise
Price per
Share
   Weighted
Average
Remaining
Contractual
Life (Years)
   Aggregate
Intrinsic
Value

Outstanding, December 31, 2008

   3,305,194      $ 1.17    4.68    $ —  

Granted

   120,000      $ 0.49    —        —  

Exercised

   —          —      —        —  

Forfeited

   —          —      —        —  

Expired

   (25,000   $ 2.00    —        —  
                        

Outstanding, June 30, 2009

   3,400,194      $ 1.14    4.40    $ 3,900
                        

Exercisable, June 30, 2009

   3,194,915      $ 1.18    4.12    $ 1,392
                        

The aggregate intrinsic value in the table above is based on the Company’s closing stock price of $0.51 on June 30, 2009, which would have been received by the optionees had all of the options with exercise prices less than $0.51 been exercised on that date.

 

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HELIX BIOMEDIX, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(Unaudited)

 

As of June 30, 2009, there were 5,355,000 shares of common stock reserved for issuance pursuant to the 2000 Plan, of which 1,954,806 shares remained available for future grants. Additional information regarding options outstanding as of June 30, 2009, is as follows:

 

   

Options Outstanding

 

Options Exercisable

Range of Exercise

Prices

 

Shares

 

Weighted
Average
Remaining
Contractual
Life (Years)

      Weighted    
Average
Exercise
Price
 

Shares

      Weighted    
Average
Exercise
Price

$0.49 – $0.70

  875,500   7.01   $ 0.58   670,221   $ 0.60

$0.76 – $1.00

  1,149,000   4.86   $ 0.94   1,149,000   $ 0.94

$1.20 – $1.80

  1,241,250   2.19   $ 1.63   1,241,250   $ 1.63

$1.85 – $1.94

  134,444   3.81   $ 1.87   134,444   $ 1.87
                         

$0.49 – $1.94

  3,400,194   4.40   $ 1.14   3,194,915   $ 1.18
                         

Note 6. Stockholders’ Equity

Warrants

During the first six months of 2009, the Company issued warrants to purchase up to 868,500 shares of the Company’s common stock with an exercise price of $1.00 per share in connection with the issuance of convertible promissory notes in the aggregate principal amount of $3,474,000 (see Note 2). As of June 30, 2009, the Company had warrants outstanding to purchase up to 4,289,819 shares of the Company’s common stock with exercise prices ranging from $0.25 to $6.00 per share.

Reclassification of Warrants and Non-Employee Stock Options

The Company’s convertible note payable issued on February 14, 2008, as discussed in Note 2, included a conversion feature and issuable warrant which created the potential for the Company to have an insufficient number of authorized common shares available to settle these instruments. As a result, the Company was required to reclassify, at fair value on February 14, 2008, all outstanding warrants and options subject to the provisions of EITF 00-19 from equity to derivative liabilities at fair value. Awards not subject to EITF 00-19 include grants to employees, officers and non-employee directors for board service as long as these grants have not been modified. The Company estimated the fair value of the outstanding warrants and options subject to EITF 00-19 to be $1,255,317, $1,011,103 and $781,677 at February 14, 2008, March 31, 2008 and June 27, 2008, respectively.

In determining the fair value of these warrants and non-employee stock options, the following key assumptions were used in the Black-Scholes option pricing model:

 

     February 14,
2008
   March 31,
2008
   June 27,
2008

Warrants

        

Risk-free interest rate

   1.93% – 2.81%    1.55% – 2.46%    2.35 – 3.36%

Expected dividend yield

   0    0    0

Expected term in years

   1.14 – 5.29    1.02 – 5.25    0.77 – 5.00

Expected volatility

   98% – 115%    98% – 115%    99% – 107%

Non-Employee Stock Options

        

Risk-free interest rate

   2.05% – 2.34%    1.55% – 1.96%    2.35% – 2.92%

Expected dividend yield

   0    0    0

Expected term in years

   1.50 – 3.63    1.37 – 3.50    0.70 – 3.25

Expected volatility

   102% – 115%    103% – 115%    106% – 107%

At each reporting period, as long as the warrants and non-employee options were outstanding and there was a potential for an insufficient number of authorized shares available to settle these instruments, the outstanding warrants and non-employee options were revalued and any difference from the previous valuation date was recognized as a change in fair value of derivative liabilities and charged or credited to the statement of operations in accordance with SFAS 133 and EITF 00-19. The fair value of these derivative liabilities decreased by $244,214 from February 14, 2008 to March 31, 2008, and further decreased by $229,428 from March 31, 2008 to June 27, 2008.

On June 27, 2008, the Company entered into an amendment to the convertible note payable (See Note 2) which effectively extinguished the original convertible note payable and related derivative instruments. In accordance with the guidance of EITF No. 96-19, the Company accounted for this modification as an extinguishment of the original convertible note payable. As a result of the modification, outstanding warrants and non-employee options were no longer considered to include a “net cash settlement” provision within the meaning of EITF 00-19, and, therefore, the Company reclassified their fair value from derivative liabilities to equity.

 

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HELIX BIOMEDIX, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(Unaudited)

 

Note 7. Net Loss per Share

Net loss per share has been computed by dividing net loss by the weighted-average number of shares outstanding during the period. Diluted per share amounts reflect potential dilution from the exercise or conversion of securities into common stock. The Company’s capital structure includes common stock options and common stock warrants, all of which have been excluded from net loss per share calculations as they are antidilutive, as follows:

 

     Three Months Ended June 30,    Six Months Ended June 30,
     2009    2008    2009    2008

Weighted average outstanding options

   3,400,194    3,015,194    3,386,824    2,991,513

Weighted average outstanding warrants

   4,300,317    2,725,269    4,105,463    2,712,907

Note 8. Property and Equipment

Property and equipment consisted of the following as of June 30, 2009 and December 31, 2008:

 

     June 30,
2009
    December 31,
2008
 

Machinery and equipment

   $ 548,535      $ 548,535   

Website

     36,000        36,000   

Furniture and fixtures

     55,614        54,546   

Leasehold improvements

     43,993        43,993   
                
     684,142        683,074   

Less accumulated depreciation

     (591,042     (562,920
                

Property and equipment, net

   $ 93,100      $ 120,154   
                

Aggregate depreciation expense for property and equipment during the three months ended June 30, 2009 and 2008 was $14,369 and $15,181, respectively, and was $28,122 and $30,511 during the six months ended June 30, 2009 and 2008, respectively.

Note 9. Intangible Assets

Identifiable intangible assets consisted of the following as of June 30, 2009 and December 31, 2008:

 

     June 30,
2009
    December 31,
2008
 

Antimicrobial technology

   $ 222,187      $ 222,187   

Licensing agreements

     61,391        61,391   

Patents, pending and approved

     834,301        834,301   
                

Total intangible assets

     1,117,879        1,117,879   

Less accumulated amortization

     (802,156     (764,276
                

Intangible assets, net

   $ 315,723      $ 353,603   
                

Amortization expense for intangible assets during the three months ended June 30, 2009 and 2008 was $18,161 and $19,720, respectively, and was $37,880 and $39,439 during the six months ended June 30, 2009 and 2008, respectively.

Note 10. Total Comprehensive Income (Loss)

Total comprehensive loss for the three months ended June 30, 2009 was $1,023,396 compared to $1,430,745 for the same period in 2008. For the six months ended June 30, 2009 and 2008, total comprehensive loss was $1,943,139 and $2,705,743, respectively. For the three and six months ended June 30, 2009, there was no difference between net loss as reported and total comprehensive loss. For the three and six months ended June 30, 2008, the difference between net loss as reported and total comprehensive loss of $17,550 was the unrealized gain on the Company’s marketable securities.

Note 11. Liquidity and Capital Resources

        For the six months ended June 30, 2009, the Company incurred a net loss of $1,943,139. At June 30, 2009, the Company had approximately $2,807,000 in cash and cash equivalents. For the six months ended June 30, 2009, cash used in operations was $1,650,752, cash provided by investing activities was $968,932, primarily representing the release of the restricted cash from convertible debt subscription following the completion of the 2009 Note and Warrant Offering in March 2009, and cash provided by financing activities was $2,504,000, which was comprised of net proceeds from the issuance of the 2009 Notes and 2009 Warrants.

 

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HELIX BIOMEDIX, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(Unaudited)

 

Based on the current status of the Company’s operating and product commercialization development plans, the Company estimates that its existing cash and cash equivalents will be sufficient to fund its operations, begin initial work towards its Rx product development and support the continued expansion of its consumer programs through the remainder of 2009. The Company will need substantial additional capital in order to maintain the current level of operations beyond 2009, continue commercialization of its technology and advance its pharmaceutical programs. Accordingly, the Company will need to raise additional funding, which may include debt and/or equity financing. However, there is no assurance that additional funding will be available on favorable terms, if at all. If the Company is unable to obtain the necessary additional funding, it would be required to severely reduce the scope of its operations, which would significantly impede its ability to proceed with current operational plans and could lead to the discontinuation of its business.

The amount of capital the Company will need in the future will depend on many factors, including capital expenditures and hiring plans to accommodate future growth, research and development plans, future demand for the Company’s products and technology, and general economic conditions.

Note 12. Concentration of Risks

The Company maintains its cash balances in one financial institution, which at times may exceed federally insured limits. As of June 30, 2009, the Company maintained approximately $2,342,000 at a major financial institution in a money market account insured by the Securities Investor Protection Corporation up to $500,000 per account. The Company has not experienced any losses in such account and believes it is not exposed to any significant credit risk on cash.

A significant portion of the Company’s revenue is concentrated with a limited number of customers. The following individual customers accounted for 10% or more of revenue for the three and six months ended June 30, 2009 and 2008:

 

     Three Months Ended
June 30,
    Six Months Ended
June 30,
 
     2009     2008     2009     2008  

Customer A

   80   40   79   23

Customer B

   *      23   *      18

Customer C

   *      25   10   *   

Customer D

   —        —        —        40

Customer E

   —        11   —        *   
 
  * Sales were less than 10%

Note 13. Commitments and Contingencies

Purchase Commitment

In August 2007, the Company entered into an agreement with Peptisyntha, Inc. for the purchase of a certain peptide over a period of eighteen months from the agreement date. The aggregate purchase requirement under this agreement over the eighteen-month period was $234,000. As of December 31, 2008, the Company had placed orders totaling approximately $131,200 under this agreement. In the first quarter of 2009, the Company placed an order of approximately $102,800 and thereby fulfilled the entire purchase obligation under this agreement. As of June 30, 2009, the Company did not have any material purchase commitments outstanding.

Operating Lease

The Company leases office and laboratory space located in Bothell, Washington, under an operating lease expiring in November 2009. On July 29, 2009, the Company renewed the operating lease for its current office and laboratory space. The new lease agreement, which begins on December 1, 2009, has a term of five years and 7 months and expires on June 30, 2015. Future minimum rental payments required under this lease agreement are as follows:

 

     2010    2011    2012    2013    Thereafter    Total

Operating lease

   $ 37,446    $ 76,947    $ 79,256    $ 81,634    $ 127,277    $ 402,560

 

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ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

Forward-Looking Statements

Our disclosure and analysis in this Quarterly Report contain forward-looking statements, which provide our current expectations or forecasts of future events. Forward-looking statements include, without limitation:

 

   

statements concerning possible or assumed future results of operations, trends in financial results and business plans, including those relating to earnings growth and revenue growth;

 

   

statements about our product development schedule;

 

   

statements about our future capital requirements and the sufficiency of our cash, cash equivalents, investments, and any other sources to meet these requirements;

 

   

statements about our plans, objectives, expectations, and intentions; and,

 

   

other statements that are not historical facts.

Words such as “may,” “should,” “expect,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “could,” “future,” “target,” and similar expressions may identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. Our actual results could differ materially from those anticipated in the forward-looking statements for many reasons, including the factors described in Part II, Item 1A, “Risk Factors” in this Quarterly Report and in Part I, Item 1A, “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2008. You should carefully consider these factors in evaluating our forward-looking statements.

You should not unduly rely on these forward-looking statements, which speak only as of the date of this Quarterly Report. Except as required by law, we undertake no obligation to publicly revise any forward-looking statement to reflect circumstances or events after the date of this Quarterly Report or to reflect the occurrence of unanticipated events. You should, however, review the factors and risks we describe in the reports we file from time to time with the Securities and Exchange Commission (SEC) after the date of this Quarterly Report.

This information should be read in conjunction with the condensed financial statements and the notes included in Item 1 of Part I of this Quarterly Report and the audited financial statements and notes and Management’s Discussion and Analysis of Financial Condition and Results of Operations contained in our Annual Report on Form 10-K for the year ended December 31, 2008.

Business Overview

Helix BioMedix, Inc. is a biopharmaceutical company with an extensive library of structurally diverse bioactive peptides and patents covering hundreds of thousands of peptide sequences. Our mission is to enrich clinical practice and the patient/consumer experience by developing and commercializing topically applied products which offer the benefits of our advanced bioactive small molecule peptide technology. Our vision is to be recognized as the world leader in the identification, qualification and commercialization of natural and synthetic peptides. We have a proprietary library containing a broad array of these synthetic bioactive peptides. Our business strategy is to develop and out-license to third parties the rights to use these proprietary peptides in diverse fields of application and to commercialize our own branded products. We have developed numerous peptides with unique sequences in the following two broad areas of application:

 

   

Consumer (skin care) — we have developed a number of peptides capable of stimulating certain aspects of the skin’s innate ability to regenerate and are marketing these peptides as innovative ingredients for cosmetic use.

 

   

Pharmaceutical — certain of our peptides have demonstrated promising results in the areas of topical anti-infectives and wound healing and are being developed for Rx applications.

Our objective is also to increase our focus on our pharmaceutical programs and initiate clinical development of our lead drug candidates. Due to the pre-clinical stage of development of each of our peptide sequences in our pharmaceutical programs, we are unable to estimate the total costs and timing to complete development, and we do not separately track these costs due to the cost burden associated with accounting at such levels of detail and our limited resources. However, the majority of our research and development spending is on the two areas of application discussed above. Further development of our pharmaceutical programs will require additional funding to support these programs.

We generate revenue through license agreements with skin care product manufacturers and through collaborative development agreements, as well as by selling proprietary branded skin care products through distribution channels in the United States.

        We make available on our website at www.helixbiomedix.com, free of charge, copies of our Annual Reports on Forms 10-K and 10-KSB, Quarterly Reports on Forms 10-Q and 10-QSB, Current Reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended, as soon as reasonably practicable after filing or furnishing the information to the SEC. Information contained on our website is not part of, and is not incorporated into, this Quarterly Report. Our filings with the SEC are also available to the public at the SEC’s website at www.sec.gov.

 

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Critical Accounting Policies and Estimates

The preparation of our financial statements requires us to make estimates and assumptions that affect the reported amounts of liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. On an ongoing basis, our management evaluates its estimates and judgments, including those related to revenue recognition, research and development costs, capitalized patent costs and valuation of stock options and warrants. We base our estimates and judgments on historical experience and on various other factors that are believed to be reasonable under the circumstances. Actual results may differ from these estimates under different assumptions or conditions.

Revenue Recognition. We derive our revenue from technology licenses, joint development agreements, sales of peptides and consumer products, and administrative services provided to a related party. Revenue under technology licenses may include up-front payments and royalties from third-party product manufacturing and sales. Revenue associated with joint development agreements primarily consists of payments for completion of development milestones. For agreements with multiple elements, we follow the Emerging Issues Task Force (EITF) Issue No. 00-21, Revenue Arrangements with Multiple Deliverables, to determine whether each element can be separated into a unit of accounting based on the following criteria: (1) the delivered items have value to the customer on a stand-alone basis; (2) any undelivered items have objective and reliable evidence of fair value; and, (3) delivery or performance of the undelivered items that have a right of return is probable and within our control. If there is objective and reliable evidence of fair value for all units of accounting in an arrangement, we allocate revenue among the separate units of accounting based on their estimated fair values. If the criteria are not met, elements included in an arrangement are accounted for as a single unit of accounting and revenue is deferred until the period in which the final deliverable is provided. When the period of deferral cannot be specifically identified from the agreement, we estimate the period based upon other factors contained within the agreement. Our management continually reviews these estimates, which could result in a change in the deferral period and the timing and the amount of revenue recognized.

 

   

Licensing Fees. We recognize up-front license payments at the point when persuasive evidence of an agreement exists, delivery has occurred or services have been performed, the price is fixed and determinable and collection is reasonably assured. We recognize royalty revenue in the period royalty is earned based on reports received from licensees or other information available through the date of issuance of the financial statements. We must occasionally make estimates on certain royalty revenue amounts due to the timing of securing information from our customers. While we believe we can make reliable estimates for certain royalty revenue, these estimates are inherently subjective. Accordingly, our estimates for royalty revenue could differ from actual events, thus impacting our financial position and results of operations.

 

   

Development Fees. We record revenue associated with performance milestones as earned when we have completed the specific milestones as defined in the joint development agreements and there are no uncertainties or contingencies regarding collection of the related payment. Payments received for which the earnings process is not complete are recorded as deferred revenue.

 

   

Peptide and Consumer Product Sales. We recognize revenue from sales of our skin care products and peptides when persuasive evidence of an arrangement exists, delivery has occurred, the price is fixed or determinable and collection is reasonably assured.

 

   

Administrative Services Revenue, Related Party. Administrative services revenue consists of fees received from DermaVentures LLC (DermaVentures), a related party, for marketing campaign costs associated with DermaVentures’ product line and other out-of-pocket expenses we incur on DermaVentures’ behalf. Administrative services revenue is invoiced to DermaVentures at or near cost and is recorded as earned when services have been rendered, no obligations remain outstanding and collection is reasonably assured. In accordance with EITF Issue No. 99-19, Reporting Revenue Gross as a Principal versus Net as an Agent, and EITF Issue No. 01-14, Income Statement Characterization of Reimbursements Received for ‘Out-of-Pocket’ Expenses Incurred, fees received from DermaVentures are reported as administrative services revenue, while related costs are included in cost of revenue in the statements of operations.

Research and Development Costs. Our research and development costs are expensed as incurred. Research and development expenses include, but are not limited to, payroll and benefit expenses, lab supplies and expenses, and external trials and studies. In instances where we enter into agreements with third parties for research and development activities, which may include personnel costs, supplies and other costs associated with such collaborative agreements, we expense these items as incurred.

Capitalization of Patent Costs. We capitalize the third-party costs associated with patents that have been issued. Our policy for the capitalization of patent costs is to begin amortization of these costs at the time they are incurred. We periodically review our patent portfolio to determine whether any such costs have been impaired and are no longer being used in our research and development activities. To the extent we no longer use certain patents, the associated costs will be written-off at that time.

        Valuation of Stock Options Granted to Employees, Officers and Non-Employee Directors for Board Service. The fair value of each option granted to employees, officers and non-employee directors for board service is estimated on the date of grant using the Black-Scholes option valuation model. The assumptions used to calculate the fair value of options granted are evaluated and revised, as necessary, to reflect market conditions and our experience. Options granted are valued using the single option valuation approach, and the resulting expense is recognized using the cliff, straight-line attribution method, consistent with the single option valuation approach. Compensation expense is recognized only for those options expected to vest.

 

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Valuation of Warrants and Non-Employee Stock Options Unrelated to Convertible Note Payable, Related Party, Issued in 2008. We account for our warrants and non-employee stock options in accordance with the provisions of SFAS No. 133, Accounting for Derivative Instruments and Hedging Activities (SFAS 133), EITF Issue No. 00-19, Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company’s Own Stock (EITF 00-19), EITF Issue No. 07-5, Determining Whether an Instrument (or an Embedded Feature) is Indexed to an Entity’s Own Stock (EITF 07-5), and EITF Issue No. 96-18, Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or Services (EITF 96-18), which require these instruments to be classified as permanent equity, temporary equity or as assets or liabilities. In general, warrants and non-employee stock options that either require net-cash settlement or are presumed to require net-cash settlement are recorded as assets and liabilities at fair value, and warrants that require settlement in shares are recorded as equity instruments.

We estimate the fair value of these derivative liabilities and equity instruments using a Black-Scholes model and use estimates for an expected dividend yield, a risk-free interest rate, and expected volatility. At each reporting period, as long as the derivative liabilities were outstanding and there was a potential for an insufficient number of authorized shares available to settle these instruments, they were revalued and any difference from the previous valuation date would be recognized as a change in fair value in our statement of operations.

Valuation of Warrant Related to Convertible Note Payable, Related Party, Issued in 2008. In connection with the convertible note payable to a related party issued in February 2008 and amended in June 2008, we issued warrants to purchase up to 750,000 shares of our common stock at an exercise price of $1.00 per share. Pursuant to the guidance in EITF 00-19 and EITF 07-5, we accounted for these warrants as an equity instrument.

Valuation of Warrants Related to Convertible Notes Payable Issued in 2009. In connection with the convertible notes payable issued in the first quarter of 2009, we issued warrants to purchase up to 868,500 shares of our common stock at an exercise price of $1.00 per share. Because these warrants are legally detachable and are separately exercisable from the debt and its related embedded options, they are considered to be freestanding financial instruments from these convertible notes payable. Pursuant to the guidance in Accounting Principles Board (APB) Opinion 14 (APB 14), Accounting for Convertible Debt and Debt Issued with Stock Purchase Warrants, EITF 00-19, EITF 07-5 and other relevant literature, we accounted for these warrants as an equity instrument and allocated the value of the warrants based on a relative-fair-value basis between the convertible notes payable issued and the warrants.

Valuation of Conversion Features Related to Convertible Notes Payable, Including Related Party. In connection with the issuance of the convertible note payable to a related party in February 2008 and under the guidance of SFAS 133, we were required to separately account for the fair value of our right to automatically convert the note payable to equity at the price of equity securities issued in any sale of shares of our equity securities that raised an aggregate amount of at least $5,000,000 on or before June 29, 2008 (see Note 2 of our Notes to Condensed Financial Statements).

On June 27, 2008, we entered into an amendment to the convertible note payable which effectively extinguished the original convertible note payable, including its embedded derivative instruments. The June 27, 2008 fair value of the separately-accounted-for embedded derivative instruments was credited to additional paid-in capital as part of recording the capital transaction resulting from the extinguishment of the original convertible note payable.

Pursuant to the guidance in SFAS 133, EITF 00-19, EITF 07-5 and other relevant literature, the conversion rights of the amended convertible note payable issued in June 2008 and the convertible notes payable issued in the first quarter of 2009 are not required to be accounted for separately.

Valuation of Call Option Related to Convertible Note Payable, Related Party, Issued in 2008. The convertible note payable issued on February 14, 2008 and subsequently amended on June 27, 2008 includes a call option which gives the holder the right to demand repayment in the case of default. Under the guidance of SFAS 133, we are required to separately account for the fair value of the embedded call option. We determined that the call option related to this convertible note payable had no value at either the issuance date or any of the reporting dates since then, based on an analysis of the right and the likelihood of its exercise.

Valuation of Prepayment Right Related to Convertible Note Payable, Related Party, Issued in 2008. The convertible note payable issued on February 14, 2008 and subsequently amended on June 27, 2008 allows us to prepay the unpaid balance of the convertible note and accrued interest at any time and without penalty. Under the guidance of SFAS 133, we are required to separately account for the fair value of the prepayment right. We determined that this prepayment right had no value at either the issuance date or any of the reporting dates since then, based on an analysis of the right and the likelihood of its exercise.

Results of Operations

        As of June 30, 2009, our accumulated deficit was approximately $34,025,600. We may continue to incur substantial operating losses over the next several years, due principally to the costs associated with our current level of operations, continued commercialization of our technology, and initiation of our Rx programs. Our net loss for the three months ended June 30, 2009 was approximately $1,023,400, or $0.04 per share, reflecting a decrease of approximately $424,900 compared to a net loss of approximately $1,448,300, or $0.06 per share, for the same period in 2008. The decrease in net loss for the second quarter of 2009

 

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compared to the same period in 2008 was primarily due to decreases in operating expenses of approximately $148,500 and non-operating expenses of approximately $290,400, partially offset by a decrease in gross profit of approximately $14,000. Our net loss for the six months ended June 30, 2009 was approximately $1,943,100, or $0.08 per share, representing a decrease of $780,200 compared to a net loss of approximately $2,723,300, or $0.11 per share, for the same period in 2008. The decrease in net loss for the first six months of 2009 compared to the same period in 2008 was primarily due to decreases in operating expenses of approximately $231,100 and non-operating expenses of approximately $656,300, partially offset by a decrease in gross profit of approximately $107,200.

For the three and six months ended June 30, 2009 compared the same periods in 2008, the decrease in operating expenses was primarily attributable to decreases in compensation and benefit expense due to a net reduction of headcount, stock-based compensation and general corporate expenses, partially offset by an increase in consulting fees; the decrease in non-operating expenses was due primarily to decreases in accretion of debt discount and change in fair value of derivative instruments related to our convertible notes payable, partially offset by an increase in interest expense associated with the outstanding convertible notes payable.

Revenue

Revenue in the three and six months ended June 30, 2009 and 2008 consisted primarily of license fees, development fees, peptide sales, consumer product sales and administrative services revenue as summarized in the table below.

 

     Three Months Ended
June 30,
         Six Months Ended
June 30,
      
     2009    2008    Change     2009    2008    Change  

License and development fees

   $ 29,795    $ 59,330    (49.8 )%    $ 64,572    $ 206,392    (68.7 )% 

Peptide and consumer product sales

     98,441      6,143    1502.5     140,970      99,451    41.7

Administrative services revenue, related party

     10,251      21,772    (52.9 )%      20,196      21,772    (7.2 )% 
                                        

Total revenue

   $ 138,487    $ 87,245    58.7   $ 225,738    $ 327,615    (31.1 )% 
                                        

Revenue, excluding administrative services revenue from DermaVentures, a related party, increased by approximately $62,800, or 95.9%, in the three months ended June 30, 2009 from approximately $65,500 in the three months ended June 30, 2008, and decreased by approximately $100,300, or 32.8%, in the six months ended June 30, 2009 from approximately $305,800 in the six months ended June 30, 2008.

For the three months ended June 30, 2009, license and development fees decreased by approximately $29,500, or 49.8%, compared to the three months ended June 30, 2008. For the six months ended June 30, 2009, license and development fees decreased by approximately $141,800, or 68.7%, compared to the same period in 2008. The decrease in license and development fees for both the three and six months ended June 30, 2009, reflected decreases in both development fees and license fees. The fluctuation in development fees was attributable to the timing of the achievement of certain milestones under applicable development agreements. The decrease in license fees was due primarily to the timing and volume of the manufacturing and sales of products containing our peptides from third-party licensees.

For the three months ended June 30, 2009, peptide and consumer product sales increased by approximately $92,300, or 1502.5%, compared to the three months ended June 30, 2008. For the six months ended June 30, 2009, peptide and consumer product sales increased by approximately $41,500, or 41.7%, compared to the same period in 2008. The increase in peptide and consumer product sales during the three and six months ended June 30, 2009 was principally due to an increase in repeat sales to our existing customers. Sales of consumer products for the three and six months ended June 30, 2009 were approximately 8.2% and 6.2% of total revenue for the respective periods. As these new products were launched in the fourth quarter of 2008, we expect consumer product sales will increase in the future.

For the three months ended June 30, 2009, administrative services revenue decreased by approximately $11,500, or 52.9%, compared to the three months ended June 30, 2008. For the six months ended June 30, 2009, administrative services revenue decreased by approximately $1,600, or 7.2%, compared to the same period in 2008. Administrative services revenue, which consists of revenue received from DermaVentures, a related party, for marketing costs associated with DermaVentures’ product line and other out-of-pocket expenses we incurred on DermaVentures’ behalf, is typically invoiced to DermaVentures at or near cost and therefore has no material net effect on our gross profit or net loss. As of June 30, 2009, we were in the process of concluding our relationship with DermaVentures, and, therefore, we expect no future administrative services revenue from DermaVentures.

Cost of Revenue and Gross Margin

        Cost of revenue consists of (1) cost of peptides and materials associated with consumer products, (2) cost of administrative services revenue from DermaVentures, a related party, which includes primarily marketing campaign costs associated with DermaVentures’ product line and other out-of-pocket expenses we incur on DermaVentures’ behalf, and (3) other cost of revenue, which includes cost of materials associated with development activities as well as professional fees incurred related to development agreements. Gross profit is the difference between revenue and cost of revenue, and gross margin is gross profit expressed as a percentage of total revenue. Revenue mix affects our gross margin because our margins from license and development fees are higher than our margins from peptide sales and administrative services revenue.

 

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Cost of revenue and gross margin for the three and six months ended June 30, 2009 and 2008 are summarized in the table below.

 

     Three Months Ended June 30,           Six Months Ended June 30,        
     2009     2008     Change     2009     2008     Change  

Cost of peptides and consumer product sales

   $ 82,999      $ 6,085      1264.0   $ 121,581      $ 75,469      61.1

Percentage of total revenue

     59.9     7.0       53.9     23.0  

Percentage of related revenue

     84.3     99.1       86.2     75.9  

Cost of administrative services revenue, related party

   $ 10,050      $ 21,772      (53.8 )%    $ 19,800      $ 21,772      (9.1 )% 

Percentage of total revenue

     7.3     25.0       8.8     6.6  

Percentage of related revenue

     98.0     100.0       98.0     100.0  

Other cost of revenue

     —          —        *      $ —        $ 38,781      *   

Percentage of total revenue

     —          —            —          11.8  

Percentage of related revenue

     —          —            —          18.8  

 

* Percentage not meaningful

For the three months ended June 30, 2009, cost of peptide and consumer product sales increased by approximately $76,900, or 1264.0%, compared to the three months ended June 30, 2008. Peptides and consumer products sold in the second quarter of 2009 resulted in 15.7% margin compared to less than 1% margin for the same period in 2008. For the six months ended June 30, 2009, cost of peptide and consumer product sales increased by approximately $46,100, or 61.1%, compared to the same period in 2008. For the first six months of 2009, peptides and consumer products sole resulted in 13.8% margin compared to 24.1% margin for the same period in 2008. The fluctuation in gross margin related to peptide and consumer product sales for the three and six months ended June 30, 2009 was due primarily to the customer mix for peptide sales as peptides are sold at a lower margin to certain customers based on the terms of respective licensing arrangements. Sales of our consumer products generate a higher gross margin compared to sales of peptides; however, as our consumer products are still fairly new in the market, the sale volume for these products has not reached a level that would make a significant contribution to the gross margin.

For the three months ended June 30, 2009, cost of administrative services revenue decreased by approximately $11,700, or 53.8%, compared to the three months ended June 30, 2008. For the six months ended June 30, 2009, cost of administrative services revenue decreased by approximately $2,000, or 9.1%, compared to the same period in 2008. Cost of administrative services revenue may fluctuate from period to period due to actual expenses incurred. As administrative services revenue is invoiced at or near cost, the margin related to this revenue is insignificant for all periods presented.

For the three months ended June 30, 2009 and 2008, other cost of revenue was $0. For the six months ended June 30, 2009, other cost of revenue was $0 compared to approximately $38,800 for the same period in 2008. Other cost of revenue for the six months ended June 30, 2008 consisted primarily of professional fees for services performed in connection with a joint development agreement.

We expect that our gross margin will fluctuate in the future due to customer mix and product mix.

Research and Development Expenses

Research and development (R&D) expenses consist primarily of compensation and benefit expenses, stock-based compensation expense, cost of external studies and trials, and contract and other outside service fees related to our R&D efforts. R&D expenses for the three and six months ended June 30, 2009 and 2008 are summarized in the table below.

 

     Three Months Ended June 30,           Six Months Ended June 30,        
     2009     2008     Change     2009     2008     Change  

Research and development

   $ 239,278      $ 198,238      20.7   $ 399,692      $ 393,415      1.6

Percentage of total revenue

     172.8     227.2       177.1     120.1  

For the three months ended June 30, 2009, R&D expenses increased by approximately $41,000, or 20.7%, compared to the three months ended in June 30, 2008. For the six months ended June 30, 2009, R&D expenses increased by approximately $6,300, or 1.6%, compared to the same period in 2008. The increase in R&D expenses for the three and six months ended June 30, 2009 was primarily attributable to an increase in spending on external trials and studies, partially offset by a decrease in compensation and benefit expenses due to a reduction of R&D headcount. We anticipate R&D expenses to increase in absolute dollars for the remainder of 2009 as we expect to incur expenses on external testing and studies related to the development of our new consumer products as a well as our Rx programs.

 

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Marketing and Business Development Expenses

Marketing and business development (M&BD) expenses consist primarily of compensation and benefit expenses, stock-based compensation expense, consulting fees and various marketing costs. M&BD expenses for the three and six months ended June 30, 2009 and 2008 are summarized in the table below.

 

     Three Months Ended
June 30,
          Six Months Ended
June 30,
       
     2009     2008     Change     2009     2008     Change  

Marketing and business development

   $ 120,061      $ 89,041      34.8   $ 236,034      $ 203,728      15.9

Percentage of total revenue

     86.7     102.1       104.6     62.2  

For the three months ended June 30, 2009, M&BD expenses increased by approximately $31,000, or 34.8%, compared to the three months ended June 30, 2008. The increase was primarily attributable to increases in compensation and benefit expenses due to a headcount addition, partially offset by decreases in marketing expenses and stock-based compensation expense. For the six months ended June 30, 2009, M&BD expenses increased by approximately by $32,300, or 15.9%, compared to the same period in 2008, primarily due to an increase in compensation and benefit expenses, partially offset by decreases in consulting fees and stock-based compensation expense. We anticipate M&BD expenses to increase in absolute dollars for the remainder of 2009 as we expect to incur expenses on market testing and promotions related to the introduction of our new consumer products.

General and Administrative Expenses

General and administrative (G&A) expenses consist primarily of salaries and benefit expenses, stock-based compensation expense, consulting fees and general corporate expenditures. G&A expenses for the three and six months ended June 30, 2009 and 2008 are summarized in the table below.

 

     Three Months Ended
June 30,
          Six Months Ended
June 30,
       
     2009     2008     Change     2009     2008     Change  

General and administrative

   $ 411,921      $ 586,650      (29.8 )%    $ 773,789      $ 1,020,019      (24.1 )% 

Percentage of total revenue

     297.4     672.4       342.8     311.3  

For the three months ended June 30, 2009, G&A expenses decreased by approximately $174,700, or 29.8%, compared to the three months ended June 30, 2008. For the six months ended June 30, 2009, G&A expenses decreased by approximately $246,200, or 24.1%, compared to the same period in 2008. The decrease in G&A expenses for the three and six months ended June 30, 2009 was primarily due to decreases in compensation and benefit expenses resulting from a reduction in G&A headcount as well as decreases in stock-based compensation and general corporate expenses, partially offset by an increase in consulting fees. We anticipate G&A expenses for the remainder of 2009 to increase compared to the first six months of 2009 as we expect to incur additional expenses related to compliance with the Sarbanes-Oxley Act of 2002.

Accounting, Legal and Professional Fees Expenses

Accounting, legal and professional fees expenses for the three and six months ended June 30, 2009 and 2008 are summarized in the table below.

 

     Three Months Ended
June 30,
          Six Months Ended
June 30,
       
     2009     2008     Change     2009     2008     Change  

Accounting, legal and professional fees

   $ 116,086      $ 159,502      (27.2 )%    $ 300,811      $ 320,317      (6.1 )% 

Percentage of total revenue

     83.8     182.8       133.3     97.8  

For the three months ended June 30, 2009, accounting, legal and professional fees expenses decreased by approximately $43,400, or 27.2%, compared to the three months ended June 30, 2008. For the six months ended June 30, 2009, accounting, legal and professional fees expenses decreased by approximately $19,500, or 6.1%, compared to the same period in 2008. The decrease for the three and six months ended June 30, 2009 was primarily due to decreases in accounting and legal services associated with general corporate matters.

For the remainder of 2009, we anticipate accounting, legal and professional fees to increase compared to the first six months of 2009 as we expect to incur additional expenses related to compliance with the Sarbanes-Oxley Act of 2002 with respect to applicable auditor attestation requirements.

 

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Depreciation and Amortization Expenses

Depreciation and amortization expenses for the three and six months ended June 30, 2009 and 2008 are summarized in the table below.

 

     Three Months Ended
June 30,
          Six Months Ended
June 30,
       
     2009     2008     Change     2009     2008     Change  

Depreciation and amortization

   $ 32,530      $ 34,901      (6.8 )%    $ 66,002      $ 69,950      (5.6 )% 

Percentage of total revenue

     23.5     40.0       29.2     21.4  

For the three months ended June 30, 2009, depreciation and amortization expenses decreased by approximately $2,400, or 6.8%, compared to the three months ended June 30, 2008. For the six months ended June 30, 2009, depreciation and amortization expenses decreased by approximately $3,900, or 5.6%, compared to the six months ended June 30, 2008. The decrease for the three and six months ended June 30, 2009 was primarily due to reduced depreciation from assets becoming fully depreciated and from intangible assets becoming fully amortized. For the remainder of 2009, we expect depreciation and amortization expenses on a quarterly basis to increase slightly from the levels experienced during the three months ended June 30, 2009 due to our plan to purchase additional capital assets for operating activities.

Other Income (Expense)

Other income (expense) consists of interest income, interest expense related to the outstanding convertible notes payable, accretion of discount on the outstanding convertible notes payable, change in valuation of derivative instruments and unrealized loss related to ARS deemed to be other than temporary. Other income (expense), net for the three and six months ended June 30, 2009 and 2008 is summarized in the table below.

 

     Three Months Ended
June 30,
          Six Months Ended
June 30,
       
     2009     2008     Change     2009     2008     Change  

Interest income

   $ 3,102      $ 17,074      (81.8 )%    $ 8,145      $ 35,864      (77.3 )% 

Interest expense on convertible note payable

     (27,404     —        *        (41,485     —        *   

Interest expense on convertible note payable, related party

     (101,721     (63,120   61.2     (182,948     (93,698   95.3

Accretion of discount on convertible note payable

     (9,079     —        *        (13,736     —        *   

Accretion of discount on convertible note payable, related party

     (13,856     (546,011   (97.5 )%      (21,144     (831,426   (97.5 )% 

Change in value of derivative instruments, including related party

     —          152,706      *        —          11,803      *   

Unrealized loss of marketable securities

     —          —        *        —          (30,000   *   
                                            

Other income (expense), net

   $ (148,958   $ (439,351   (66.1 )%    $ (251,168   $ (907,457   (72.3 )% 
                                            

 

* percentage not meaningful

Interest Income. For the three months ended June 30, 2009, interest income decreased by approximately $14,000, or 81.8%, compared to the three months ended June 30, 2008. For the six months ended June 30, 2009, interest income decreased by approximately $27,700, or 77.3%, compared to the same period in 2008. The decreases were due primarily to lower prevailing interest rates. For the remainder of 2009, we expect interest income to decrease due to our decreasing balance in cash and cash equivalents.

Interest Expense, Including Related Party. For the three months ended June 30, 2009, interest expense related to our outstanding convertible notes payable, including related party, increased by approximately $66,000, or 104.6%, to approximately $129,100 from approximately $63,100 for the same period in 2008. For the six months ended June 30, 2009, interest expense related to our outstanding convertible notes payable, including related party, increased by approximately $130,700, or 139.5%, to approximately $224,400 from approximately $93,700 for the same period in 2008. Interest expense in the three and six months ended June 30, 2009 was significantly higher due to interest expense incurred from additional convertible notes payable issued during the first quarter of 2009. We anticipate future quarterly interest expense associated with our outstanding convertible notes payable to be consistent with the levels experienced in the second quarter of 2009.

Accretion of Discount on Convertible Notes Payable, Including Related Party. For the three and six months ended June 30, 2009, accretion of discount on the convertible notes payable, including related party, issued in the first quarter of 2009 (see Note 2 of the Notes to our Condensed Financial Statements) was approximately $22,900 and $34,900, respectively, which represented the increase

 

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in carrying value of these convertible notes from the issuance dates through June 30, 2009. We anticipate future quarterly accretion of discount on the 2009 Notes to be consistent with the level experienced in the second quarter of 2009 for as long as the 2009 Notes remain outstanding. For the three and six months ended June 30, 2008, accretion of discount on the convertible note payable issued to a related party in February 2008 was approximately $546,000 and $831,400, respectively, which represented the increase in carrying value of that convertible note from the issuance date of February 14, 2008 through June 27, 2008. On June 27, 2008, the convertible note payable issued in February 2008 was effectively extinguished and replaced by an amended convertible note payable (see Note 2 of the Notes to our Condensed Financial Statements). As a result, we incurred no further accretion of discount on this convertible note payable.

Change in Value of Derivative Instruments. For the three and six months ended June 30, 2009, there was no change in fair value of the derivative instruments related to the outstanding convertible notes payable. For the period from April 1, 2008 to June 27, 2008, the change in fair value of derivative instruments resulted in a net gain of approximately $152,700, comprised of a decrease of approximately $229,500 in the fair value of outstanding warrants and non-employee stock options, partially offset by a decrease of approximately $24,200 in the fair value of the put option and an increase of $52,600 in the fair value of the warrant related to the original convertible note payable. For the period from February 14, 2008 to June 27, 2008, the change in fair value of the derivative instruments resulted in a net gain of approximately $11,800, comprised of a decrease of approximately $473,700 in the fair value of outstanding warrants and non-employee stock options, partially offset by a decrease of $186,500 in the fair value of the put option and an increase of approximately $275,400 in the fair value of the warrant related to the original convertible note payable. At the amendment of the convertible note payable on June 27, 2008, in accordance with EITF 96-19, we recorded an extinguishment of the original convertible note payable and reclassified the fair value of the then outstanding derivative instruments to equity (see Note 2 of the Notes to our Condensed Financial Statements).

Unrealized Loss and Realized Gain on Marketable Securities. During the first six months of 2009, we did not hold any marketable securities and therefore did not experience any realized or unrealized gain or loss on investments. During the six months ended June 30, 2008, we recognized an unrealized loss of $30,000 on our investment in ARS due to the deemed lack of liquidity associated with these investments at that time.

Liquidity and Capital Resources

Since inception, we have financed our operations primarily through the private sale of debt and equity securities. Our principal sources of liquidity are cash and cash equivalents. As of June 30, 2009, we had approximately $2,807,000 in cash and cash equivalents, compared to approximately $985,000 in cash and cash equivalents at December 31, 2008. The increase in cash and cash equivalents from December 31, 2008, was primarily attributable to the proceeds of $3,474,000, including the release of restricted cash of $970,000, from our issuance of convertible notes payable in February and March 2009, partially offset by cash used in operations of approximately $1,650,800 and purchase of capital assets of approximately $1,100.

Cash Flows from Operating Activities

Cash used in operating activities for the six months ended June 30, 2009 and 2008 was approximately $1,650,800 and $1,554,000, respectively, in each case derived primarily from the net loss for the period plus the net effect of non-cash expenses. We continue to experience negative cash flows from operating activities due to the cash requirements to support our current level of operations while expanding our revenue base. Working capital uses of cash for the six months ended June 30, 2009 were primarily due to increases in accounts receivable and inventory as well as a decrease in accrued compensation and benefits, partially offset by a decrease in prepaid expenses and other current assets and an increase in accrued expenses. Working capital uses of cash for the six months ended June 30, 2008 were primarily due to an increase in inventory and decreases in deferred revenue and accrued expenses, partially offset by decreases in prepaid assets and increases in accrued compensation and other expenses.

Accounts receivable increased by approximately $58,100 during the first six months of 2009, compared to a decrease of $43,400 for the same period in 2008. The fluctuations were primarily attributable to the timing of peptide shipments, royalty reports received from our licensees and the achievement of certain milestones under applicable license and development agreements.

Inventory, comprised of peptides held for resale and products from our proprietary branded skin care line, increased by approximately $51,600 and $12,300 for the six months ended June 30, 2009 and 2008, respectively. The increase in the six months of 2009 was due primarily to our purchase of peptides to fulfill a purchase agreement entered in August 2007, and the increase in the first six months of 2008 was due to the timing of peptide sales.

Accrued compensation and benefits decreased by approximately $58,700 in the first six months of 2009 due primarily to payments related to retroactive salary increases for two executives, compared to an increase of approximately $95,300 for the same period in 2008 due primarily to an accrual for severance related to the departure of our Chief Financial Officer in June 2008.

Deferred revenue decreased by $130,000 during the first six months of 2008 due to the achievement of certain milestones under applicable license and development agreements. There was no change in deferred revenue in the first six months of 2009.

 

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Cash Flows from Investing Activities

As of December 31, 2008, we had received an aggregate of $970,000 of subscription deposits for our 2009 convertible promissory note and warrant offering, which we classified as restricted cash until the completion of this offering. Following the closing of the offering in the first quarter of 2009, the restrictions on the restricted cash were removed and we reclassified the $970,000 to cash and cash equivalents.

For the six months ended June 30, 2008, cash provided by investing activities was approximately $473,300, consisting of proceeds from the sales of marketable securities of $500,000, partially offset by purchases of capital equipment of approximately $26,700.

For the remainder of 2009, we expect to invest approximately $10,000 in capital assets related to system upgrades.

Cash Flows from Financing Activities

For the six months ended June 30, 2009, cash provided by financing activities was $2,504,000, which reflected the aggregate proceeds of $3,474,000 from our recent convertible note and warrant offering less $970,000 of cash deposits already received as of December 31, 2008.

For the six months ended June 30, 2008, cash provided by financing activities was approximately $2,994,700, which consisted of net proceeds from the issuance of a convertible note payable and warrant to a related party.

Based on the current status of our operating plans and product commercialization development, we estimate that our existing cash and cash equivalents will be sufficient to fund our operations and support the continued expansion of our consumer programs at least through the remainder of 2009. We will need substantial additional capital in order to maintain our current level of operations beyond 2009, continue commercialization of our technology and advance our pharmaceutical programs. Accordingly, we will need to raise additional funding, which may include debt and/or equity financing. However, there is no assurance that additional funding will be available to us on favorable terms, if at all. If we are unable to obtain the necessary additional funding, among other things, we would be required to severely reduce the scope of our operations, which would significantly impede our ability to proceed with current operational plans and could lead to the discontinuation of our business.

The amount of capital we will need in the future will depend on many factors, including capital expenditures and hiring plans to accommodate future growth, research and development plans, future demand for our products and technology, and general economic conditions.

Contractual Obligations

The following table summarizes our contractual obligations and the effect such obligations are expected to have on liquidity in future periods as of June 30, 2009:

 

Contractual Obligations    Remainder
of 2009
   2010    2011    2012    Thereafter    Total

Operating lease

   $ 32,165    $ 37,446    $ 76,947    $ 79,256    $ 208,911    $ 434,725

Convertible notes payable and related accrued interest to date (1)

     —        —        6,909,502      —        —        6,909,502
                                         

Total contractual obligations

   $ 32,165    $ 37,446    $ 6,986,449    $ 79,256    $ 208,911    $ 7,344,227
                                         

 

(1) Interest is accrued at the rate of 8% per annum and is due and payable on the earlier of July 1, 2011, or when called by the note holders upon an event of default, including in the event we file for bankruptcy. Assuming no principal prepayments on these convertible notes payable and no conversion into equity before July 1, 2011, we would incur approximately $1.47 million of total interest on all outstanding notes payable.

Recent Accounting Pronouncements

In June 2009, the FASB issued SFAS No. 168, The FASB Accounting Standards CodificationTM and the Hierarchy of Generally Accepted Accounting Principles (SFAS 168). SFAS 168 represents the last numbered standard to be issued by the FASB under the old (pre-Codification) numbering system, and amends the GAAP hierarchy. On July 1, 2009, the FASB released The FASB Accounting Standards CodificationTM (Codification) which supersedes all existing non-SEC accounting and reporting standards and becomes the exclusive authoritative U.S. GAAP to be applied by nongovernmental entities for use in financial statements issued for interim and annual periods ending after September 15, 2009. All other non-grandfathered, non-SEC accounting literature not included in the Codification is non-authoritative. We do not expect the Codification to have an impact on our financial position, results of operations or cash flows.

        In June 2009, the FASB issued SFAS No. 167, a revision to FASB Interpretation No. 46(R), Consolidation of Variable Interest Entities (SFAS 167), which will change how a company determines when an entity that is insufficiently capitalized or is not controlled through voting (or similar rights) should be consolidated. Under SFAS 167, determining whether a company is required to consolidate an entity will be based on, among other things, an entity’s purpose and design and a company’s ability to direct the activities of the

 

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entity that most significantly impact the entity’s economic performance. SFAS 167 is effective at the start of a company’s first fiscal year beginning after November 15, 2009, or January 1, 2010 for companies reporting earnings on a calendar-year basis. We are currently evaluating the impact, if any, SFAS 167 will have on our financial position, results of operations or cash flows.

In May 2009, the FASB issued SFAS No. 165, Subsequent Events (SFAS 165), which sets forth the period after the balance sheet date during which management of a reporting entity should evaluate events or transactions that may occur for potential recognition or disclosure in the financial statements, the circumstances under which an entity should recognize events or transactions occurring after the balance sheet date in its financial statements, and the disclosures that an entity should make about events or transactions that occurred after the balance sheet date. SFAS 165 is effective for interim or annual reporting periods and was effective for us beginning April 1, 2009. The adoption of SFAS 165 did not have an impact on our financial position, results of operations or cash flows. We evaluated subsequent events through August 6, 2009, the date the accompanying financial statements were issued.

In April 2009, the FASB issued FASB Staff Position (FSP) No. FAS 157-4, Determining Fair Value When the Volume and Level of Activity for the Asset or Liability Have Significantly Decreased and Identifying Transactions That Are Not Orderly, which provides additional guidance for estimating fair value in accordance with SFAS No. 157, Fair Value Measurements (FSP FAS 157-4). FSP FAS 157-4 supersedes FSP FAS 157-3, Determining the Fair Value of a Financial Asset When the Market for That Asset is not Active, and affirms that in an inactive market, fair value is the price to sell the asset in an orderly transaction and clarifies and includes additional factors for determining inactive markets. FSP FAS 157-4 is effective for interim and annual reporting periods ending after June 15, 2009 and was effective for us beginning April 1, 2009. The adoption of FSP FAS 157-4 did not have an impact on our financial position, results of operations or cash flows.

In April 2009, the FASB issued FSP No. FAS 115-2 and FAS 124-2, Recognition and Presentation of Other-Than-Temporary Impairments (FSP FAS 115-2 and FAS 124-2), which amends the requirements for the recognition and measurement of other-than-temporary impairments for debt securities by modifying the pre-existing “intent and ability” indicator. Under FSP FAS 115-2 and FAS 124-2, an other-than-temporary impairment is triggered when there is an intent to sell the security and it is more likely than not that the security will be required to be sold before recovery, or the security is not expected to recover the entire amortized cost basis of the security. FSP FAS 115-2 and FAS 124-2 require the presentation of the total other-than-temporary impairment in the statement of earnings for those impairments involving credit losses with an offset for the remainder of the impairment recognized in other comprehensive income. Upon adoption, FSP FAS 115-2 and FAS 124-2 requires a cumulative-effect adjustment in earnings. This FSP does not change existing recognition and measurement guidance related to other-than-temporary impairments of equity securities. FSP FAS 115-2 and FAS 124-2 is effective for interim and annual reporting periods ending after June 15, 2009 and was effective for us beginning April 1, 2009. The adoption of FSP FAS 115-2 and FAS 124-2 did not have an impact on our financial position, results of operations or cash flows.

In April 2009, the FASB issued FSP No. FAS 107-1 and Accounting Principles Board (APB) Opinion No. 28-1, Interim Disclosures about Fair Value of Financial Instruments (FSP FAS 107-1 and APB 28-1), which requires disclosures about the fair value of financial instruments as well as the methods and significant assumptions used to estimate the fair value of those financial instruments in the interim reporting periods and in the annual financial statements. FSP FAS 107-1 and APB 28-1 is effective for interim and annual reporting periods ending after June 15, 2009 and was effective for us beginning April 1, 2009. The adoption of FSP FAS 107-1 and APB 28-1 did not have an impact on our financial position, results of operations or cash flows.

 

ITEM 4. Controls and Procedures.

We carried out an evaluation, under the supervision and with the participation of our senior management, including our Chief Executive Officer and Acting Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended) as of the end of the period covered by this report. Based upon that evaluation, our Chief Executive Officer and Acting Chief Financial Officer concluded that our disclosure controls and procedures are effective in timely alerting him to material information required to be included in our periodic SEC filings.

There has been no change in our internal control over financial reporting during the quarter that ended June 30, 2009 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

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PART II – OTHER INFORMATION

 

ITEM 1A. Risk Factors.

There are numerous factors that affect our business and results of operations, many of which are beyond our control. Please see our Annual Report on Form 10-K for the year ended December 31, 2008 for a description of some of the risks and uncertainties that we face. There have been no material changes in our risk factors from those described in that Annual Report. If any of those risks were to occur, our business, operating results and financial condition could be seriously harmed.

 

ITEM 4. Submission of Matters to a Vote of Security Holders.

Our Annual Meeting of Stockholders was held on May 14, 2009, at which there were two matters submitted to a vote of security holders:

 

  1. To elect two Class III directors to serve until the 2012 Annual Meeting of Stockholders or until such directors’ successors are elected and qualified:

 

Nominee

  

For

  

Withheld

R. Stephen Beatty

   16,262,259    169,656

John F. Clifford

   16,324,037    107,872

 

  2. To ratify the appointment of KPMG LLP as our independent registered public accounting firm for the fiscal year ending December 31, 2009:

 

      For      

  

Against

  

Abstain

16,199,409

   39,716    192,790

 

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ITEM 6. Exhibits.

 

Exhibit Number

(Referenced to
Item 601 of
Regulation S-K)

  

Exhibit Description

  2.1

   Proposal for Approval of Reincorporation of Helix BioMedix, Inc., a Colorado corporation, from Colorado to Delaware (incorporated by reference to Exhibit 2 to the Company’s Annual Report on Form 10-KSB filed with the Securities and Exchange Commission on April 16, 2001)

  3.1

   Certificate of Ownership and Merger of Helix BioMedix, Inc. a Delaware corporation and Helix BioMedix, Inc., a Louisiana corporation (incorporated by reference to Exhibit 3.1 to the Company’s Annual Report on Form 10-KSB filed with the Securities and Exchange Commission on April 16, 2001)

  3.2

   Certificate of Incorporation of Helix BioMedix, Inc. (incorporated by reference to Exhibit 3-A to the Company’s Annual Report on Form 10-KSB/A filed with the Securities and Exchange Commission on April 30, 2003)

  3.3

   Certificate of Amendment to the Certificate of Incorporation of Helix BioMedix, Inc. (incorporated by reference to Exhibit 3.3 to the Company’s Annual Report on Form 10-KSB/A filed with the Securities and Exchange Commission on April 30, 2003)

  3.4

   Bylaws of Helix BioMedix, Inc. (incorporated by reference to Exhibit 3-B to the Company’s Annual Report on Form 10-KSB filed with the Securities and Exchange Commission on April 16, 2001)

  4.1

   Rights Agreement dated August 21, 2003 (incorporated by reference to Exhibit 10.27 to the Company’s Annual Report on Form 10-KSB filed with the Securities and Exchange Commission on March 26, 2004)

  4.2

   Acceptance and Acknowledgement of Appointment dated January 4, 2004 (incorporated by reference to Exhibit 10.28 to the Company’s Annual Report on Form 10-KSB filed with the Securities and Exchange Commission on March 26, 2004)

31.1

   Certification of the Company’s principal executive officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934

31.2

   Certification of the Company’s principal financial officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934

32.1

   Certification of the Company’s principal executive officer pursuant to 18 U.S.C. Section 1350

32.2

   Certification of the Company’s principal financial officer pursuant to 18 U.S.C. Section 1350

 

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SIGNATURES

Pursuant to the requirements 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.

August 6, 2009

 

HELIX BIOMEDIX, INC.

            (Registrant)

By:  

/s/    R. Stephen Beatty

 

R. Stephen Beatty

President and Chief Executive Officer and

Acting Chief Financial Officer

(Principal Executive Officer and

Acting Principal Financial Officer)

 

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