-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, BnII/AoMSgYAQD6OmGfdIzurS9NKC+iINvnA8CO3bZGkhlyYSLntFx/1cjG4SKBZ nAjqIY619/4ygIaPn3GZjg== 0001193125-03-073609.txt : 20031106 0001193125-03-073609.hdr.sgml : 20031106 20031105175821 ACCESSION NUMBER: 0001193125-03-073609 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 6 CONFORMED PERIOD OF REPORT: 20030930 FILED AS OF DATE: 20031106 FILER: COMPANY DATA: COMPANY CONFORMED NAME: NEOSE TECHNOLOGIES INC CENTRAL INDEX KEY: 0000877902 STANDARD INDUSTRIAL CLASSIFICATION: MEDICINAL CHEMICALS & BOTANICAL PRODUCTS [2833] IRS NUMBER: 133549286 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 000-27718 FILM NUMBER: 03980502 BUSINESS ADDRESS: STREET 1: 102 WITMER RD CITY: HORSHAM STATE: PA ZIP: 19044 BUSINESS PHONE: 2154415890 MAIL ADDRESS: STREET 1: 102 WITMER ROAD CITY: HORSHAM STATE: PA ZIP: 19044 FORMER COMPANY: FORMER CONFORMED NAME: NEOSE PHARMACEUTICALS INC DATE OF NAME CHANGE: 19950817 10-Q 1 d10q.htm FOR THE QUARTER ENDED SEPTEMBER 30, 2003 FOR THE QUARTER ENDED SEPTEMBER 30, 2003
Table of Contents

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 September 30, 2003.

 

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: 0-27718

 


 

NEOSE TECHNOLOGIES, INC.

(Exact name of registrant as specified in its charter)

 


 

Delaware   13-3549286
(State or other jurisdiction of
incorporation or organization)
  (I.R.S. Employer
Identification No.)
102 Witmer Road
Horsham, Pennsylvania
  19044
(Address of principal executive offices)   (Zip Code)

 

(215) 315-9000

(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 is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act).    Yes  x    No  ¨

 

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date: 19,935,215 shares of common stock, $.01 par value, were outstanding as of October 31, 2003.

 



Table of Contents

NEOSE TECHNOLOGIES, INC.

(a development-stage company)

 

INDEX

 

          Page

PART I.

   FINANCIAL INFORMATION:     

Item 1.

   Financial Statements (unaudited)     

Balance Sheets at December 31, 2002 and September 30, 2003

   3

Statements of Operations for the three and nine months ended September 30, 2002 and 2003, and for the period from inception through September 30, 2003

   4

Statements of Cash Flows for the nine months ended September 30, 2002 and 2003, and for the period from inception through September 30, 2003

   5

Notes to Financial Statements

   6

Item 2.

   Management’s Discussion and Analysis of Financial Condition and Results of Operations    11

Item 3.

   Quantitative and Qualitative Disclosure About Market Risk    20

Item 4.

   Controls and Procedures    21

PART II.

   OTHER INFORMATION:     

Item 6.

   Exhibits and Reports on Form 8-K    22

SIGNATURES

   23

 

2


Table of Contents

PART I. FINANCIAL INFORMATION

 

Item 1.   Financial Statements

 

NEOSE TECHNOLOGIES, INC.

(a development-stage company)

 

BALANCE SHEETS

(unaudited)

(in thousands, except per share amounts)

 

     December 31,
2002


    September 30,
2003


 
Assets                 

Current assets:

                

Cash and cash equivalents

   $ 31,088     $ 41,332  

Marketable securities

     9,952       14,834  

Restricted funds

     977       600  

Prepaid expenses and other current assets

     558       953  
    


 


Total current assets

     42,575       57,719  

Property and equipment, net

     36,508       36,312  

Acquired intellectual property, net

     2,507       2,059  

Other assets

     1,502       889  
    


 


Total assets

   $ 83,092     $ 96,979  
    


 


Liabilities and Stockholders’ Equity                 

Current liabilities:

                

Current portion of long-term debt and capital lease obligations

   $ 1,851     $ 3,123  

Accounts payable

     1,127       1,018  

Accrued compensation

     1,339       2,024  

Accrued expenses

     1,880       1,593  

Deferred revenue

     320       70  
    


 


Total current liabilities

     6,517       7,828  

Long-term debt and capital lease obligations

     5,560       6,728  

Other liabilities

     330       529  
    


 


Total liabilities

     12,407       15,085  
    


 


Stockholders’ equity:

                

Preferred stock, $.01 par value, 5,000 shares authorized, none issued

     —         —    

Common stock, $.01 par value, 30,000 shares authorized; 14,330 and 19,935 shares issued; 14,324 and 19,935 shares outstanding

     143       199  

Additional paid-in capital

     178,945       217,850  

Treasury stock, 6 shares at cost

     (175 )     —    

Deferred compensation

     (170 )     (112 )

Deficit accumulated during the development-stage

     (108,058 )     (136,043 )
    


 


Total stockholders’ equity

     70,685       81,894  
    


 


Total liabilities and stockholders’ equity

   $ 83,092     $ 96,979  
    


 


 

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

 

3


Table of Contents

NEOSE TECHNOLOGIES, INC.

(a development-stage company)

 

STATEMENTS OF OPERATIONS

(unaudited)

(in thousands, except per share amounts)

 

     Three months
ended September 30,


    Nine months
ended September 30,


   

Period from
inception
(January 17, 1989)
to September 30, 2003


 
     2002

    2003

    2002

    2003

   

Revenue from collaborative agreements

   $ 2,187     $ 150     $ 4,519     $ 871     $ 18,317  
    


 


 


 


 


Operating expenses:

                                        

Research and development

     5,285       6,747       16,259       19,031       118,710  

Marketing, general and administrative

     3,197       2,456       9,405       8,657       57,728  
    


 


 


 


 


Total operating expenses

     8,482       9,203       25,664       27,688       176,438  
    


 


 


 


 


Operating loss

     (6,295 )     (9,053 )     (21,145 )     (26,817 )     (158,121 )

Other income

     —         —         —         —         7,773  

Impairment of equity securities

     —         (1,250 )     —         (1,250 )     (1,250 )

Interest income

     378       103       1,225       420       19,198  

Interest expense

     (38 )     (138 )     (120 )     (338 )     (3,643 )
    


 


 


 


 


Net loss

   $ (5,955 )   $ (10,338 )   $ (20,040 )   $ (27,985 )   $ (136,043 )
    


 


 


 


 


Basic and diluted net loss per share

   $ (0.42 )   $ (0.59 )   $ (1.41 )   $ (1.66 )        
    


 


 


 


       

Weighted-average shares outstanding used in computing basic and diluted net loss per share

     14,310       17,437       14,238       16,828          
    


 


 


 


       

 

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

 

4


Table of Contents

NEOSE TECHNOLOGIES, INC.

(a development-stage company)

 

STATEMENTS OF CASH FLOWS

(unaudited)

(in thousands)

 

     Nine months ended
September 30,


    Period from
inception
(January 17, 1989)
to September 30, 2003


 
     2002

    2003

   

Cash flows from operating activities:

                        

Net loss

   $ (20,040 )   $ (27,985 )   $ (136,043 )

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

                        

Depreciation and amortization

     1,687       3,511       16,620  

Loss on disposition of property and equipment

     —         99       99  

Non-cash compensation

     1,139       129       4,902  

Common stock issued for non-cash and other charges

     —         —         35  

Changes in operating assets and liabilities:

                        

Prepaid expenses and other current and non-current assets

     (1,648 )     (370 )     (1,180 )

Accounts payable

     501       (109 )     1,018  

Accrued compensation

     840       222       1,605  

Accrued expenses

     (1,257 )     (250 )     1,528  

Deferred revenue

     (1,208 )     (250 )     70  

Other liabilities

     45       (220 )     110  
    


 


 


Net cash used in operating activities

     (19,941 )     (25,223 )     (111,236 )
    


 


 


Cash flows from investing activities:

                        

Purchases of property and equipment

     (14,794 )     (2,137 )     (49,245 )

Proceeds from sale-leaseback of equipment

     —         —         1,382  

Purchases of marketable securities

     (68,412 )     (38,568 )     (423,306 )

Proceeds from sales of marketable securities

     —         8,327       19,794  

Proceeds from maturities of and other changes in marketable securities

     31,000       25,500       389,360  

Purchase of acquired technology

     —         —         (4,550 )

Investment in equity securities

     —         —         (1,250 )

Impairment of equity securities

     —         1,250       1,250  
    


 


 


Net cash used in investing activities

     (52,206 )     (5,628 )     (66,565 )
    


 


 


Cash flows from financing activities:

                        

Proceeds from issuance of debt

     —         3,785       18,001  

Repayment of debt

     (1,100 )     (2,132 )     (10,284 )

Restricted cash related to debt

     227       377       (529 )

Proceeds from issuance of preferred stock, net

     —         —         29,497  

Proceeds from issuance of common stock, net

     —         38,893       176,117  

Proceeds from exercise of stock options and warrants

     1,961       172       6,578  

Acquisition of treasury stock

     —         —         (175 )

Dividends paid

     —         —         (72 )
    


 


 


Net cash provided by financing activities

     1,088       41,095       219,133  
    


 


 


Net increase (decrease) in cash and cash equivalents

     (71,059 )     10,244       41,332  

Cash and cash equivalents, beginning of period

     76,245       31,088       —    
    


 


 


Cash and cash equivalents, end of period

   $ 5,186     $ 41,332     $ 41,332  
    


 


 


 

The accompanying notes are an integral part of these financial statements

 

5


Table of Contents

NEOSE TECHNOLOGIES, INC.

(a development-stage company)

 

NOTES TO FINANCIAL STATEMENTS

(unaudited)

 

1. Basis of Presentation

 

We have used accounting principles generally accepted in the United States for interim financial information to prepare our unaudited financial statements:

 

  As of September 30, 2003;

 

  For the three and nine months ended September 30, 2002 and 2003; and

 

  For the period from inception (January 17, 1989) to September 30, 2003.

 

Our unaudited financial statements do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements. In our opinion, the unaudited financial statements include all the normal recurring adjustments that are necessary for a fair presentation of the financial position, results of operations, and cash flows for the periods presented. You should not base your estimate of our results of operations for 2003 solely on our results of operations for the three and nine months ended September 30, 2003. You should read these unaudited financial statements in combination with:

 

  The other Notes in this section;

 

  “Management’s Discussion and Analysis of Financial Condition and Results of Operations” appearing in the following section; and

 

  The Financial Statements, including the Notes to the Financial Statements, included in our Annual Report on Form 10-K for the year ended December 31, 2002.

 

Certain prior year amounts have been reclassified to conform to our current year presentation.

 

2. Stock-based Compensation

 

We apply the intrinsic value method of accounting for all stock-based employee compensation in accordance with APB Opinion No. 25, “Accounting for Stock Issued to Employees” (APB 25), and related interpretations. We record deferred compensation for option grants to employees for the amount, if any, by which the market price per share exceeds the exercise price per share.

 

We have elected to adopt only the disclosure provisions of Statement of Financial Accounting Standards No. 123, “Accounting for Stock-Based Compensation” (SFAS No. 123), as amended by Statement of Financial Accounting Standards No. 148, “Accounting for Stock-Based Compensation – Transition and Disclosure.” The following table illustrates the effect on our net loss and basic and diluted net loss per share if we had recorded compensation expense for the estimated fair value of our stock-based employee compensation, consistent with SFAS No. 123 (in thousands, except per share data):

 

6


Table of Contents
     Three months ended
September 30,


    Nine months ended
September 30,


 
     2002

    2003

    2002

    2003

 

Net loss – as reported

   $ (5,955 )   $ (10,338 )   $ (20,040 )   $ (27,985 )

Add: Stock-based employee compensation expense included in reported net loss

     21       72       141       104  

Deduct: Total stock-based employee compensation expense determined under fair value-based method for all awards

     (4,160 )     (3,159 )     (11,209 )     (9,409 )
    


 


 


 


Net loss – pro forma

   $ (10,094 )   $ (13,425 )   $ (31,108 )   $ (37,290 )
    


 


 


 


Basic and diluted net loss per share – as reported

   $ (0.42 )   $ (0.59 )   $ (1.41 )   $ (1.66 )

Basic and diluted net loss per share – pro forma

   $ (0.71 )   $ (0.77 )   $ (2.18 )   $ (2.22 )

 

3. Revenue Recognition

 

Our revenue from collaborative agreements consists of up-front fees, research and development funding, and milestone payments. We recognize revenues from these agreements consistent with Staff Accounting Bulletin No. 101, “Revenue Recognition in Financial Statements” (SAB 101), issued by the Securities and Exchange Commission. Non-refundable up-front fees are deferred and amortized to revenue over the related performance period. We estimate our performance period based on the specific terms of each collaborative agreement, but the actual performance period may vary. We adjust the performance periods based on available facts and circumstances. Periodic payments for research and development activities are recognized over the period that we perform those activities under the terms of each agreement. Revenue resulting from the achievement of milestone events stipulated in the agreements is recognized when the milestone is achieved. Milestones are based on the occurrence of a substantive element specified in the contract or as a measure of substantive progress towards completion under the contract.

 

In January 2003, the Financial Accounting Standards Board issued Emerging Issues Task Force Issue 00-21, “Revenue Arrangements with Multiple Deliverables” (EITF 00-21). Our existing revenue recognition policy under SAB 101 of recognizing revenue from the achievement of substantive milestone events when such milestones are met complies with EITF 00-21.

 

During the three months ended September 30, 2003, we recognized revenue of $150,000 under a research and development collaboration. During the three months ended June 30, 2003, we completed activities related to our research and development collaboration with Wyeth Nutrition, and recorded as revenue the last scheduled payment for research and development funding of $250,000, which we had received in October 2002. We also recorded revenue of $400,000 under a license agreement during the quarter ended June 30, 2003. During the three months ended March 31, 2003, we recognized revenue of $70,000 under a research and development collaboration.

 

7


Table of Contents

During the three and nine months ended September 30, 2002, we recognized $2,177,000 and $4,458,000, respectively, under two collaborations with Wyeth. Our collaboration with Wyeth Pharmaceuticals was terminated in September 2002. Of the $2,177,000 recognized in the third quarter, $875,000 represented the remaining amortization of a $1,000,000 up-front fee, which we received from Wyeth in 2001. As required under SAB 101, we deferred the up-front fee and began to amortize this amount as revenue over the expected performance period of the Wyeth agreement. Upon termination of the Wyeth agreement in the third quarter of 2002, the unamortized portion of the up-front fee was recognized as revenue.

 

4. Long-term Debt and Capital Lease Obligations

 

In September 2003, we borrowed $831,000 to finance the purchase of equipment and facility improvements, which are collateralizing the amount borrowed. The terms of the financing require us to pay monthly principal and interest payments over 48 months at an interest rate of 8.35%. During the 12 months ending September 30, 2004, 2005, 2006, and 2007, we will be required to make principal repayments totaling $190,000, $224,000, $243,000, and $174,000, respectively, under this agreement.

 

In September 2003, we entered into a capital lease obligation for equipment with a book value of $354,000, which was calculated using an assumed incremental annual borrowing rate of 7.96%. The terms of the lease required us to make an initial payment of $90,000 followed by monthly payments through September 2006. During the 12 months ending September 30, 2004, 2005, and 2006, we will be required to make principal repayments totaling $81,000, $88,000, and $95,000, respectively, under this agreement. We also entered into a capital lease obligation during September 2003 for software with a fair value of $60,000. The terms of the lease require us to make monthly payments through September 2008. During the 12 months ending September 30, 2004, 2005, 2006, 2007, and 2008, we will be required to make principal repayments totaling $9,000, $11,000, $12,000, $13,000, and $15,000, respectively, under this agreement.

 

During the quarter ended June 30, 2003, we entered into various capital lease obligations for equipment and software with an aggregate book value of $373,000, which was calculated using an assumed incremental annual borrowing rate of 8.35%. We are required to make monthly payments on each lease. The leases have expiration dates ranging from April 2006 to June 2006. During the 12 months ending September 30, 2004, 2005, and 2006, we will be required to make principal repayments totaling $108,000, $121,000, and $77,000, respectively, under these agreements.

 

In March 2003, we borrowed $2,954,000 secured by laboratory equipment. We are required to make monthly principal and interest payments at an annual rate of 8.35% through October 2006. During the 12 months ending September 30, 2004, 2005, 2006, and 2007, we will be required to make principal repayments totaling $785,000, $853,000, $927,000, and $81,000, respectively, under this agreement.

 

8


Table of Contents

5. Stockholders’ Equity

 

In September 2003, we sold 2,655,557 shares of common stock in a registered offering to a group of institutional and individual investors at a price of $9.00 per share, generating net proceeds of $22,377,000. In February 2003, we sold 2,866,763 shares of common stock in a private placement to a group of institutional and individual investors at a price of $6.00 per share, generating net proceeds of $16,320,000.

 

During the nine months ended September 30, 2003, options to purchase 62,780 shares of our common stock were exercised at an aggregate exercise price of $172,000. In addition, during the nine months ended September 30, 2003, employees participating in our employee stock purchase plan purchased 25,836 shares of common stock at a total purchase price of $196,000. In connection with the employee stock purchases, we reissued 6,000 shares of treasury stock, which were originally acquired in 2001 for $175,000.

 

6. Separation and Retirement Agreements

 

In March 2002, we entered into a Separation and Consulting Agreement with our former Chief Executive Officer, Stephen A. Roth. Under this agreement, we agreed to provide medical benefits to Dr. Roth and to pay him $39,622 per month for 12 months. During the quarter ended March 31, 2002, we recorded severance expense related to this agreement of $309,000, which represented the present value of his future benefit payments, which has been included in marketing, general and administrative expenses in our statements of operations.

 

Prior to March 29, 2003, Dr. Roth had the right to extend his non-competition and non-solicitation commitments for two additional years by entering into a separate non-competition agreement. Dr. Roth extended his commitments in March 2003 and, therefore, we will pay him $39,622 per month for 24 additional months and, should he leave our board of directors during the additional two-year period, we will continue his stock option vesting and exercisability. During the quarter ended March 31, 2003, we recorded a liability of $882,000, which represented the present value of the future payments, and a corresponding asset for the value of the non-competition commitment. The asset will be amortized to marketing, general and administrative expense in our statements of operations over the two-year term of the agreement.

 

In January 2002, we entered into a retirement agreement with our Vice President, Research. Under the agreement, he terminated his employment effective June 30, 2002. We have committed to pay a retirement benefit over a five-year period. We will continue to provide Dr. McGuire health insurance benefits through December 31, 2003. During the quarter ended March 31, 2002, we recorded severance expense related to this agreement of $516,000, which represented the present value of his future retirement benefit. In addition, we extended the period during which he may exercise his stock options and recorded a non-cash severance charge of $1,608,000 associated with this option modification.

 

7. Other Assets

 

In 2000, we made an investment of $1,250,000 in Series A convertible preferred stock of Neuronyx, Inc., and entered into a research and development collaboration with Neuronyx for the discovery and development of drugs for treating Parkinson’s disease and other neurological diseases. We recorded the equity investment at cost. In October 2003, Neuronyx informed us that they were nearing completion of a Series C equity financing, under which Series C and Series B Neuronyx investors would have an

 

9


Table of Contents

aggregate liquidation preference that is senior to the Series A liquidation preference and exceeds the assumed post-money valuation of Neuronyx. As a result, we reduced the carrying value of our equity investment to zero as of September 30, 2003 by recording a non-cash charge, which is reflected as an impairment of equity securities in our statements of operations.

 

8. Net Loss Per Share

 

Basic and diluted net loss per share are presented in conformity with Statement of Financial Accounting Standards No. 128, “Earnings Per Share.” Basic net loss per share is computed by dividing net loss by the weighted-average number of common shares outstanding for the period. Diluted net loss per share reflects the potential dilution from the exercise or conversion of securities into common stock. For the three and nine months ended September 30, 2002 and 2003, the effects of the exercise of outstanding stock options and warrants to purchase 3,713,319 and 4,323,234 shares, respectively, were antidilutive; accordingly, they were excluded from the calculation of diluted net loss per share.

 

9. Supplemental Disclosure of Cash Flow Information

 

The following table contains additional cash flow information for the periods reported.

 

    

Nine months

ended
September 30,


    Period from
inception
(January 17, 1989)
to September 30, 2003


     2002

   2003

   

Supplemental disclosure of cash flow information:

                     

Cash paid for interest

   $ 86    $ 352     $ 3,797
    

  


 

Non-compete agreement

   $ —      $ 882     $ 882
    

  


 

Non-cash investing activities:

                     

Increase / (decrease) in accrued property and equipment

   $ —      $ (37 )   $ 65
    

  


 

Non-cash financing activities:

                     

Issuance of common stock for dividends

   $ —      $ —       $ 90
    

  


 

Issuance of common stock to employees in lieu of cash compensation

   $ —      $ —       $ 44
    

  


 

 

10. New Accounting Pronouncements

 

In April 2003, the Financial Accounting Standards Board (“FASB”) issued Statement of Financial Accounting Standard No. 149, “Amendment of Statement 133 on Derivative Instruments and Hedging Activities” (SFAS No. 149). This Statement amends and clarifies accounting for derivative instruments, including certain derivative instruments embedded in other contracts, and for hedging activities under SFAS No. 133. SFAS No. 149 is effective for contracts entered into or modified after June 30, 2003, for hedging relationships designated after June 30, 2003, and to certain preexisting contracts. We do not expect the adoption of SFAS No. 149 to have a material impact on our financial statements.

 

In May 2003, the FASB issued Statement of Financial Accounting Standard No. 150, “Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity” (SFAS No. 150). This Statement establishes standards for how an issuer classifies and measures certain financial instruments with characteristics of both liabilities and equity. SFAS No. 150 is effective for financial instruments entered into or modified after May 31, 2003, and is otherwise effective July 1, 2003. We do not expect the adoption of SFAS No. 150 to have a material impact on our financial statements.

 

10


Table of Contents

In November 2002, the FASB issued Interpretation No. 45, “Guarantor’s Accounting and Disclosure Requirement for Guarantees, Including Indirect Guarantees of Indebtedness to Others, an Interpretation of FASB Statements No. 5, 57 and 107 and a Rescission of FASB Interpretation No. 34.” This Interpretation elaborates on the disclosures to be made by a guarantor in its interim and annual financial statements about its obligations under guarantees issued. The Interpretation also clarifies that a guarantor is required to recognize, at inception of a guarantee, a liability for the fair value of the obligation undertaken. The initial recognition and measurement provisions of the Interpretation are applicable to guarantees issued or modified after December 31, 2002, and did not have a material effect on our financial statements.

 

In January 2003, the FASB issued Interpretation No. 46, “Consolidation Of Variable Interest Entities, and An Interpretation Of ARB No. 51.” This Interpretation addresses the consolidation by business enterprises of variable interest entities as defined in the Interpretation. This Interpretation applies immediately to variable interests in variable interest entities created after January 31, 2003, and in the first fiscal year or interim period ending after December 15, 2003 to variable interests in variable interest entities created prior January 31, 2003. The Company does not believe that it has any variable interest entities.

 

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

 

CAUTIONARY STATEMENT PURSUANT TO SAFE HARBOR PROVISIONS OF THE PRIVATE SECURITIES LITIGATION ACT OF 1995:

 

This report and the documents incorporated by reference herein contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this report and the documents incorporated herein by reference, the words “anticipate,” “believe,” “estimate,” “may,” “expect,” “intend,” and similar expressions are generally intended to identify forward-looking statements. These forward-looking statements include, among others, the statements in Management’s Discussion and Analysis of Financial Condition and Results of Operations about our:

 

    estimate of the length of time that our existing cash, cash equivalents and marketable securities, expected revenue, and interest income will be adequate to finance our operating and capital requirements;

 

    expected losses;

 

    expectations for future capital requirements;

 

    expectations for increases in operating expenses;

 

    expectations for increases in research and development, and marketing, general and administrative expenses in order to develop products, manufacture commercial quantities of reagents and products, and commercialize our technology;

 

    expectations for the development of an improved EPO, G-CSF, and subsequent proprietary drug candidates;

 

11


Table of Contents
    expectations for incurring additional capital expenditures for renovations of our facilities;

 

    expectations for generating revenue;

 

    ability to enter into new or expanded collaboration agreements and the ability of our existing collaboration partners to develop and commercialize products incorporating our technologies.

 

Our actual results could differ materially from the results expressed in, or implied by, these forward-looking statements. Potential risks and uncertainties that could affect our actual results include the following:

 

    our ability to obtain the funds necessary for our operations;

 

    our ability to renovate our facilities as required for our operations;

 

    our ability to develop and commercialize any therapeutic proteins or to commercialize our technologies;

 

    our ability to develop commercial-scale manufacturing processes;

 

    our ability to enter into and maintain collaborative arrangements;

 

    our ability to obtain adequate sources of proteins and reagents;

 

    our ability to expand and protect our intellectual property and to operate without infringing the rights of others;

 

    our ability to compete successfully in an intensely competitive field;

 

    our ability to attract and retain key personnel; and

 

    general economic conditions.

 

These and other risks and uncertainties that could affect our actual results are discussed in this report and in our other filings with the Securities and Exchange Commission, particularly the section entitled “Risk Factors” of our Registration Statement on Form S-3 dated June 20, 2003. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, events, levels of activity, performance, or achievements. We do not assume responsibility for the accuracy and completeness of the forward-looking statements other than as required by applicable law.

 

We do not undertake any duty to update after the date of this report any of the forward-looking statements in this report to conform them to actual results.

 

You should read this section in combination with the Management’s Discussion and Analysis of Financial Condition and Results of Operations for the year ended December 31, 2002, included in our Annual Report on Form 10-K and in our 2002 Annual Report to Stockholders.

 

12


Table of Contents

Overview

 

We are a biopharmaceutical company focused on improving protein therapeutics using our proprietary technologies. Most therapeutic proteins in development or on the market today are glycoproteins – proteins with carbohydrate structures attached. These carbohydrates are important to the proper functioning of the proteins. The process by which carbohydrates are attached to proteins is called “glycosylation.” Manufacturing protein drugs often results in the problem of incomplete glycosylation or the lack of glycosylation. We are using our GlycoAdvance and GlycoPEGylation technologies to develop improved versions of currently marketed drugs with proven efficacy and to improve the therapeutic profiles of glycoproteins in development. We do this by completing the carbohydrate chains on glycosylated proteins or initiating and extending glycosylation on non-glycosylated proteins. As a final step, we typically attach a sugar molecule linked to polyethylene glycol (PEG). Our goal is to offer next-generation proteins with significant advantages over first-generation drugs that are now on the market, such as less frequent dosing and improved safety and efficacy. In addition to developing our own products or co-developing products with others, we expect to enter into strategic partnerships utilizing our technologies for the product design and manufacturing processes of other biotechnology and pharmaceutical companies. In addition to protein drug development, our technologies offer multiple opportunities to participate in the evolving therapeutic protein market by addressing other challenges, such as manufacturing efficiency, manufacturing consistency, and the use of non-mammalian cell expression systems.

 

As of September 30, 2003, we had an accumulated deficit of approximately $136.0 million. We expect additional losses in 2003 and over the next several years as we expand product research and development efforts and increase manufacturing scale-up activities.

 

Liquidity and Capital Resources

 

Overview

 

We have incurred operating losses each year since our inception. As of September 30, 2003, we had an accumulated deficit of $136,043,000. We have financed our operations primarily through proceeds from private and public placements of equity securities. We have also funded our operations to a lesser extent from interest earned on investments, proceeds from property and equipment financings, revenues from corporate collaborations and gains from the sale of investments. We had $56,166,000 in cash, cash equivalents and marketable securities as of September 30, 2003, compared to $41,040,000 in cash, cash equivalents and marketable securities as of December 31, 2002. The increase during 2003 was primarily attributable to the net proceeds from our February 2003 and September 2003 equity financings as discussed below, offset by the use of cash to fund our operating losses and capital expenditures.

 

In September 2003, we sold 2,655,557 shares of common stock in a registered offering to a group of institutional and individual investors, generating net proceeds of $22,377,000. In February 2003, we sold 2,866,763 shares of common stock in a private placement to a group of institutional and individual investors, generating net proceeds of $16,320,000. We believe that our existing cash, cash equivalents and marketable securities, expected revenue from collaborations and license arrangements, and interest income should be sufficient to meet our operating and capital requirements at least through 2004, although changes in our collaborative relationships or our business, whether or not initiated by us, may cause us to deplete our cash

 

13


Table of Contents

and marketable securities sooner than the above estimate. The timing and amount of our future capital requirements and the adequacy of available funds will depend on many factors, including the risks and uncertainties listed and referenced above.

 

During 2002, we focused our business on the development of next generation proprietary protein therapeutics, which we plan to pursue both independently and in collaboration with selected partners. This development and commercialization will require substantial investments by us and our collaborators. Most of our 2002 revenues were derived from agreements that have been terminated or were fully performed early in 2003. As a result, our revenues for the remainder of 2003 are difficult to project and will be largely dependent on entering into new collaborations and on the financial terms of any new collaborations. Other than revenues from any future collaborations, we expect to generate no significant revenues until such time as products incorporating our technologies are commercialized, which is not expected during the next several years. We expect an additional several years to elapse before we can expect to generate sufficient cash flow from operations to fund our operating and capital requirements. Accordingly, we will need to raise substantial additional funds to continue our business activities and fund our operations beyond 2004.

 

Capital Expenditures

 

During the nine months ended September 30, 2003, we invested $2,137,000 in property, equipment, and building improvements. We anticipate additional capital expenditures during 2003 of approximately $1.5 million, which excludes the impact of resuming the facility renovations described below. We may finance some or all of our capital expenditures through the issuance of new debt or equity. If we issue new debt, we may be required to maintain a minimum cash and investments balance, or to transfer cash into an escrow account to collateralize some portion of the debt, or both.

 

We entered into a lease agreement in 2002 for a 40,000 square foot building, which we intended to convert into laboratory and office space. Later in 2002, we suspended work on these renovations. We are now making plans to resume work on a portion of this space. Our property and equipment at September 30, 2003 included approximately $4,056,000 in renovations to this facility. If we were to determine that the partially completed renovations are of no future use to us, we would be required to recognize an impairment loss in our statement of operations. If we were to resume and fully complete the entire project at this time, the additional cost would be approximately $8.5 million.

 

Long-term Debt

 

Montgomery County (Pennsylvania) IDA Bonds

 

In 1997, we issued, through the Montgomery County (Pennsylvania) Industrial Development Authority, $9,400,000 of taxable and tax-exempt bonds, of which $3,900,000 remained outstanding as of September 30, 2003. The bonds were issued to finance the purchase of our headquarters building and the construction of a pilot-scale manufacturing facility within our building. The bonds are supported by an AA-rated letter of credit, and a reimbursement agreement between our bank and the letter of credit issuer. The interest rate on the bonds will vary weekly, depending on market rates for AA-rated taxable and tax-exempt obligations, respectively. During the nine months ended September 30, 2003, the weighted-average, effective interest rate was 2.4% per year, including letter-of-credit and other fees. The terms of the bond

 

14


Table of Contents

issuance provide for monthly, interest-only payments and a single repayment of principal at the end of the twenty-year life of the bonds. However, under our agreement with our bank, we are making monthly payments to an escrow account to provide for an annual prepayment of principal. As of September 30, 2003, we had restricted funds relating to the bonds of $600,000, which consisted of our monthly payments to an escrow account plus interest revenue on the balance of the escrow account. During the next 12 months, we will be required to make payments of $650,000 into the escrow account.

 

To provide credit support for this arrangement, we have given a first mortgage on the land, building, improvements, and certain machinery and equipment to our bank. We have also agreed to maintain a minimum required cash and short-term investments balance of at least two times the outstanding loan balance. If we fail to comply with this requirement, we are required to deposit with the lender cash collateral up to, but not more than, the unpaid balance of the loan. At September 30, 2003, we were required to maintain $7,800,000 of cash and short-term investments.

 

Equipment Loans

 

In September 2003, we borrowed $831,000 to finance the purchase of equipment and facility improvements, which are collateralizing the amount borrowed. The terms of the financing require us to pay monthly principal and interest payments over 48 months at an interest rate of 8.35%. During the 12 months ending September 30, 2004, 2005, 2006, and 2007, we will be required to make principal and interest payments totaling $214,000, $269,000, $269,000, and $182,000, respectively, under this agreement.

 

In March 2003, we borrowed $2,954,000 to finance the purchase of equipment, which is collateralizing the amount borrowed. The terms of the financing require us to pay monthly principal and interest payments over 42 months at an interest rate of 8.35%. During the 12 months ending September 30, 2004, 2005, and 2006, we will be required to make principal and interest payments totaling $976,000, $976,000, $976,000, and $81,000, respectively, under this agreement.

 

In December 2002, we borrowed $2,261,000 to finance the purchase of equipment, which is collateralizing the amount borrowed. The terms of the financing require us to pay monthly principal and interest payments over 36 months at an interest rate of 8.0%. During the 12 months ending September 30, 2004, 2005, and 2006, we will be required to make principal and interest payments totaling $850,000, $850,000, and $283,000, respectively, under this agreement.

 

Capital Lease Obligations

 

In September 2003, we entered into a capital lease for $354,000 of equipment. The terms of the lease required us to make an initial payment of $90,000 followed by monthly payments through September 2006. Under this agreement, we will be required to make lease payments totaling $99,000 during each of the 12 months ending September 30, 2004, 2005, and 2006. We also entered into a capital lease obligation during September 2003 for $60,000 of software. The terms of the lease require us to make monthly payments through September 2008. Under this agreement, we will be required to make lease payments totaling $16,000 during each of the 12 months ending September 30, 2004, 2005, 2006, 2007, and 2008.

 

15


Table of Contents

In June 2003, we entered into a capital lease for $119,000 of equipment. The terms of the lease required us to make an initial payment of $31,000 followed by monthly payments through June 2006. During the 12 months ending September 30, 2004, 2005, and 2006, we will be required to make lease payments totaling $34,000, $37,000, and $28,000, respectively, under this agreement.

 

In April and May 2003, we entered into capital leases for $254,000 of equipment. The terms of the leases require us to make monthly payments through April 2006. During the 12 months ending September 30, 2004, 2005, and 2006, we will be required to make lease payments totaling $96,000, $96,000, and $51,000, respectively, under these agreements.

 

In November 2002, we entered into a capital lease for $50,000 of equipment. The terms of the lease require us to make monthly payments through November 2005. During the 12 months ending September 30, 2004, 2005, and 2006, we will be required to make lease payments totaling $19,000, $19,000, and $5,000, respectively, under this agreement.

 

Summary of Contractual Obligations

 

A summary of our obligations to make future payments under contracts existing as of December 31, 2002 is included in Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations, of our Annual Report on Form 10-K for the year ended December 31, 2002. The Liquidity and Capital Resources section of this Form 10-Q describes additional obligations from contracts entered into during the nine months ended September 30, 2003.

 

Off-Balance Sheet Arrangements

 

We do not have any off-balance sheet arrangements that have or are reasonably likely to have a material future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures, or capital resources.

 

Critical Accounting Policies

 

A discussion of our critical accounting policies is included in Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations, of our Annual Report on Form 10-K for the year ended December 31, 2002. There have not been any changes or additions to our significant accounting policies during the nine months ended September 30, 2003.

 

Results of Operations

 

Our net loss for the three and nine months ended September 30, 2003 was $10,338,000 and $27,985,000, respectively, compared to $5,955,000 and $20,040,000 for the corresponding periods in 2002. The following section explains the changes between the reporting periods in each component of net loss.

 

16


Table of Contents

Revenue from Collaborative Agreements

 

Revenues from collaborative agreements for the three and nine months ended September 30, 2003 were $150,000 and $871,000, respectively, compared to $2,187,000 and $4,519,000 for the corresponding periods in 2002.

 

During the three months ended September 30, 2003, we recognized revenue of $150,000 under a research and development collaboration. During the three months ended June 30, 2003, we completed activities related to our research and development collaboration with Wyeth Nutrition, and recorded as revenue the last scheduled payment for research and development funding of $250,000, which we received in October 2002. During the quarter ended June 30, 2003, we also recognized revenue of $400,000 under a license agreement. During the three months ended March 31, 2003, we recognized revenue of $70,000 under a research and development collaboration.

 

During the three and nine months ended September 30, 2002, we recognized $2,177,000 and $4,458,000, respectively, under two collaborations with Wyeth. Our collaboration with Wyeth Pharmaceuticals was terminated in September 2002. Of the $2,177,000 recognized in the third quarter, $875,000 represented the remaining amortization of a $1,000,000 up-front fee received from Wyeth in 2001. As required under SAB 101, we deferred the up-front fee and began to amortize this amount as revenue over the expected performance period of the Wyeth agreement. Upon termination of the Wyeth agreement in the third quarter of 2002, the unamortized portion of the up-front fee was recognized as revenue.

 

Research and Development Expense

 

In January 2003, we announced the selection of an improved erythropoietin (EPO) as the target for our first proprietary drug development project. EPO is prescribed to stimulate production of red blood cells, and is approved for sale in major markets around the world for the treatment of anemia associated with oncology chemotherapy, end stage renal disease, and chronic renal insufficiency. Based on proof-of-concept data, we believe it is feasible to develop a long acting EPO through GlycoPEGylation. We are planning to conduct various preclinical development activities during 2003 and the first half of 2004, with the goal of submitting an investigational new drug application during the third quarter of 2004.

 

In October 2003, we announced the selection of an improved granulocyte colony stimulating factor (G-CSF) as the target for our second proprietary drug development project. G-CSF is prescribed to stimulate production of white blood cells, and is approved for sale in major markets around the world for treatment of neutropenia associated with oncology chemotherapy. Based on proof-of-concept data, we believe it is feasible to develop a long acting G-CSF through GlycoPEGylation. We are planning to conduct various preclinical development activities during 2003 and 2004, with the goal of submitting an investigational new drug application during the middle of 2005.

 

We are continuing to generate internal data on other potential proprietary drug candidates, and we expect to announce additional drug development projects at appropriate times in the future based on emerging data and market conditions. Concurrently, we are continuing to invest in the development of our core technologies, particularly new applications of our GlycoPEGylation and GlycoConjugation technologies.

 

17


Table of Contents

Our current research and development projects are divided between two categories: (i) GlycoAdvance, GlycoPEGylation, and GlycoConjugation and (ii) Other Glycotechnology Programs, which includes projects investigating other applications of our intellectual property. We are exploring the most cost-effective means of continuing some of the projects classified as Other Glycotechnology Programs. The following chart sets forth our projects in each of these categories and the stage to which each has been developed:

 

     Development Stage

   Status

GlycoAdvance, GlycoPEGylation and GlycoConjugation

         

Improved erythropoietin

   Preclinical    Active

Improved granulocyte colony stimulating factor

   Preclinical    Active

Other protein projects

   Research    Active

Other Glycotechnology Programs

         

Non-protein therapeutic applications

   Research    Active

Nutritional applications

   N/A    Evaluating
Outlicensing
Opportunities

 

For each of our research and development projects, we incur both direct and indirect expenses. Direct expenses include salaries and other costs of personnel, raw materials, and supplies for each project. We may also incur third party costs related to these projects, such as contract research, consulting and preclinical development costs. Indirect expenses include the costs of operating and maintaining our facilities, property, and equipment, to the extent used for our research and development projects, as well as the costs of general management of our research and development projects.

 

Our research and development expenses were $6,747,000 and $19,031,000 for the three and nine months ended September 30, 2003, respectively, and $5,285,000 and $16,259,000 for the comparable 2002 periods. The following table illustrates research and development expenses incurred in each period for our significant groups of research and development projects (in thousands).

 

    

Three months ended

September 30,


   Nine months ended
September 30,


     2002

   2003

   2002

   2003

GlycoAdvance, GlycoPEGylation and GlycoConjugation

   $ 2,013    $ 2,535    $ 5,093    $ 6,854

Other Glycotechnology Programs

     608      84      1,629      468

Indirect expenses

     2,664      4,128      9,537      11,709
    

  

  

  

     $ 5,285    $ 6,747    $ 16,259    $ 19,031
    

  

  

  

 

18


Table of Contents

GlycoAdvance, GlycoPEGylation and GlycoConjugation

 

Our GlycoAdvance, GlycoPEGylation and GlycoConjugation research and development expenses increased during the 2003 periods, compared to 2002, primarily due to increased purchases of supplies and outside services, including preclinical studies, hiring of employees, and the reallocation of resources from our Other Glycotechnology Programs.

 

Other Glycotechnology Programs

 

Research and development expenses related to our Other Glycotechnology Programs decreased during the 2003 periods, compared to 2002, consistent with our decision during 2002 to focus our resources on our GlycoAdvance, GlycoPEGylation and GlycoConjugation programs.

 

Indirect expenses

 

Our indirect research and development expenses increased during the 2003 periods, compared to 2002, primarily due to increases related to depreciation of our recently completed pilot manufacturing facility, additional personnel, and the purchase of more supplies and outside services. Substantially offsetting the increases during the comparable nine-month period was a reduction in severance expense of $2,124,000, of which $1,608,000 was a non-cash charge, related to an agreement entered into during the first quarter of 2002 with one of our former executive officers.

 

The process of bringing drugs from the preclinical research and development stage through Phase I, Phase II, and Phase III clinical trials and FDA approval is a time consuming and expensive process. Because our announced product candidates are currently in the preclinical stage and there are a variety of potential intermediate clinical outcomes that are inherent in drug development, we cannot reasonably estimate the timing and costs we will incur to complete these research and development projects. In addition, the timing and costs to complete our research and development projects will be affected by the timing and nature of any collaboration agreements we may enter into with a third party, neither of which we can currently estimate.

 

Material cash inflows from proprietary drug development projects are highly uncertain, and we cannot reasonably estimate the period in which we will begin to receive material net cash inflows from our major research and development projects. Cash inflows from development stage products are dependent on several factors, including entering into collaborative agreements, the achievement of certain milestones, and regulatory approvals. We may not receive milestone payments from any existing or future collaborations if a development stage product fails to meet technical or performance targets or fails to obtain the required regulatory approvals. Further, our revenues from collaborations will be affected by the level of effort committed and made by our collaborative partners. Even if we achieve technical success in developing drug candidates, our collaborative partners may not devote the resources necessary to complete development and commence marketing of these products or they may not successfully market potential products.

 

Marketing, General and Administrative Expense

 

Marketing, general and administrative expenses for the three and nine months ended September 30, 2003 were $2,456,000 and $8,657,000, respectively, compared to $3,197,000 and $9,405,000 for the corresponding periods in 2002. The 2002 periods included expenses associated with recruiting and relocating executives, as well as severance expense related to an

 

19


Table of Contents

agreement entered into with one of our former executive officers. The 2002 periods also included consulting costs incurred in the development of the Company’s strategic plan. Offsetting the decrease in those expenses in the 2003 periods were increased salary expense related to additional executive personnel and higher insurance premiums than in the 2002 periods.

 

Impairment of Equity Securities, Interest Income and Interest Expense

 

Impairment of equity securities for the three and nine months ended September 30, 2003 was $1,250,000, and consists of a non-cash impairment charge relating to our investment in Series A convertible preferred stock of Neuronyx, Inc. We recorded the equity investment, which was made in 2000, at cost. In October 2003, Neuronyx informed us that they were nearing completion of a Series C equity financing, under which Series C and Series B Neuronyx investors would have an aggregate liquidation preference that is senior to the Series A liquidation preference and exceeds the assumed post-money valuation of Neuronyx. As a result, we reduced the carrying value of our equity investment to zero as of September 30, 2003 by recording the non-cash impairment charge.

 

Interest income for the three and nine months ended September 30, 2003 was $103,000 and $420,000, respectively, compared to $378,000 and $1,225,000 for the corresponding periods in 2002. The decreases during the 2003 periods were due to lower average cash, cash equivalents and marketable securities balances as well as lower interest rates.

 

Interest expense for the three and nine months ended September 30, 2003 was $138,000 and $338,000, respectively, compared to $38,000 and $120,000 for the corresponding periods in 2002. The increases in the 2003 periods were due to higher average debt balances and a reduction in capitalized interest due to the completion of improvements to our cGMP facility. During the 2002 period, our investment in improvements to our cGMP facility and other facility improvements, as discussed in the Liquidity and Capital Resources section, was significant enough to require the capitalization of related interest costs. Since we completed construction of the improvements to our cGMP facility in December 2002, we have not capitalized any interest expense.

 

Item 3.   Quantitative and Qualitative Disclosure About Market Risk

 

Our holdings of financial instruments are comprised primarily of government agency securities. All such instruments are classified as securities held to maturity. We seek reasonable assuredness of the safety of principal and market liquidity by investing in rated fixed income securities, while at the same time seeking to achieve a favorable rate of return. Our market risk exposure consists principally of exposure to changes in interest rates. Our holdings are also exposed to the risks of changes in the credit quality of issuers. We typically invest in the shorter-end of the maturity spectrum. As of September 30, 2003, we held $14.8 million in an obligation of a U.S. government agency with an original maturity of 347 days. The balance of our investment portfolio was held in money market securities and in obligations of U.S. government agencies with original maturities of three months or less. The approximate principal amount of our investment portfolio as of September 30, 2003 was $56.1 million. The annualized weighted-average interest rate for the nine months ended September 30, 2003 was approximately 1.3%.

 

We have exposure to changing interest rates on our taxable and tax-exempt bonds, and we are currently not engaged in hedging activities. Interest on approximately $3.9 million of

 

20


Table of Contents

outstanding indebtedness is at an interest rate that varies weekly, depending on the market rates for AA-rated taxable and tax-exempt obligations. During the nine months ended September 30, 2003, the annualized weighted-average, effective interest rate was approximately 2.4%.

 

Item 4.   Controls and Procedures

 

We carried out an evaluation, under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures as such term is defined under Rule 13a-15(e) promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), for financial reporting as of September 30, 2003. Based on that evaluation, our principal executive officer and principal financial officer concluded that these controls and procedures are effective to ensure that information required to be disclosed by the Company in reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported as specified in Securities and Exchange Commission rules and forms. There were no changes in these controls or procedures identified in connection with the evaluation of such controls or procedures that occurred during our last fiscal quarter, or in other factors that have materially affected, or are reasonably likely to materially affect, these controls or procedures.

 

Our disclosure controls and procedures are designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the rules and forms of the Securities and Exchange Commission. These disclosure controls and procedures include, among other things, controls and procedures designed to ensure that information required to be disclosed by us in the reports that we file under the Exchange Act is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure. Our internal controls and procedures for financial reporting are designed to provide reasonable assurance, and management believes that they provide such reasonable assurance, that our transactions are properly authorized, our assets are safeguarded against unauthorized or improper use, and our transactions are properly recorded and reported, in order to permit the preparation of our financial statements in conformity with generally accepted accounting principles.

 

Our management group, including our principal executive officer and principal financial officer, does not expect that our disclosure controls and internal controls and related procedures will prevent all error and all fraud. A control system, no matter how well designed and implemented, can provide only reasonable assurance that the objectives of the control system are met. In addition, the design and implementation of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered in relation to their costs. The design of any system of controls is based, in part, upon certain assumptions about the likelihood of future events, which may prove to be incorrect. Due to the limitations of all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within an organization have been detected or prevented.

 

21


Table of Contents

PART II. OTHER INFORMATION

 

Item 6.   Exhibits and Reports on Form 8-K.

 

(a)

   List of Exhibits:
     10.1 Promissory Note of the Company to General Electric Capital Corporation, dated September 17, 2003.
     31.1 Certification by Chief Executive Officer pursuant to Rule 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
     31.2 Certification by Chief Financial Officer pursuant to Rule 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
     32.1 Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
     32.2 Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

(b)

   Reports on Form 8-K:
     On August 7, 2003, we filed a Current Report on Form 8-K announcing our second quarter financial results.
     On September 22 and 23, 2003, we filed Current Reports on Form 8-K announcing our agreement to sell registered shares of the Company’s Common Stock for approximately $23 million.

 

22


Table of Contents

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.

 

       

NEOSE TECHNOLOGIES, INC.

Date: November 5, 2003

     

By:

 

/s/ Robert I. Kriebel

         
               

Robert I. Kriebel

               

Senior Vice President and Chief Financial Officer

               

(Principal Financial Officer and Duly Authorized

Signatory)

 

23

EX-10.1 3 dex101.htm PROMISSORY NOTE OF THE COMPANY TO GENERAL ELECTRIC CAPITAL CORPORATION PROMISSORY NOTE OF THE COMPANY TO GENERAL ELECTRIC CAPITAL CORPORATION

Exhibit 10.1

 

PROMISSORY NOTE

 

            September 17, 2003            

(Date)

 

FOR VALUE RECEIVED, Neose Technologies, Inc. a corporation located at the address stated below (“Maker”) promises, jointly and severally if more than one, to pay to the order of General Electric Capital Corporation or any subsequent holder hereof (each, a “Payee”) at its office located at 401 Merritt 7 Suite 23, Norwalk, CT 06851-1177 or at such other place as Payee or the holder hereof may designate, the principal sum of Eight Hundred Thirty-One Thousand One Hundred Fifty-Eight and 82/100 Dollars ($831,158.82), with interest on the unpaid principal balance, from the date hereof through and including the dates of payment, at a fixed interest rate of Eight and Twenty-Nine percent (8.35%) per annum, to be paid in lawful money of the United States, in Forty -Eight (48) consecutive monthly installments of principal and interest as follows:

 

Periodic

Installment


   Amount

Thirty-Six (36)

   $ 22,430.62

Eleven (11)

   $ 13,320.48

 

each (“Periodic Installment”) and a final installment which shall be in the amount of the total outstanding principal and interest. The first Periodic Installment shall be due and payable on             11/1/03             and the following Periodic Installments and the final installment shall be due and payable on the same day of each succeeding month (each, a “Payment Date”). Such installments have been calculated on the basis of a 360 day year of twelve 30-day months. Each payment may, at the option of the Payee, be calculated and applied on an assumption that such payment would be made on its due date.

 

The acceptance by Payee of any payment which is less than payment in full of all amounts due and owing at such time shall not constitute a waiver of Payee’s right to receive payment in full at such time or at any prior or subsequent time.

 

The Maker hereby expressly authorizes the Payee to insert the date value is actually given in the blank space on the face hereof and on all related documents pertaining hereto.

 

This Note may be secured by a security agreement, chattel mortgage, pledge agreement or like instrument (each of which is hereinafter called a “Security Agreement”).

 

Time is of the essence hereof. If any installment or any other sum due under this Note or any Security Agreement is not received within ten (10) days after its due date, the Maker agrees to pay, in addition to the amount of each such installment or other sum, a late payment charge of five percent (5%) of the amount of said installment or other sum, but not exceeding any lawful maximum. If (i) Maker fails to make payment of any amount due hereunder within ten (10) days after the same becomes due and payable; or (ii) Maker is in default under, or fails to perform under any term or condition contained in any Security Agreement, then the entire principal sum remaining unpaid, together with all accrued interest thereon and any other sum payable under this Note or any Security Agreement, at the election of Payee, shall immediately become due and payable, with interest thereon at the lesser of eighteen percent (18%) per annum or the highest rate not prohibited by applicable law from the date of such accelerated maturity until paid (both before and after any judgment).

 

Notwithstanding anything to the contrary contained herein or in the Security Agreement, Maker may not prepay in full or in part any indebtedness hereunder without the express written consent of Payee in its sole discretion.

 

It is the intention of the parties hereto to comply with the applicable usury laws; accordingly, it is agreed that, notwithstanding any provision to the contrary in this Note or any Security Agreement, in no event shall this Note or any Security Agreement require the payment or permit the collection of interest in excess of the maximum amount permitted by applicable law. If any such excess interest is contracted for, charged or received under this Note or any Security Agreement, or if all of the principal balance shall be prepaid, so that under any of such circumstances the amount of interest contracted for, charged or received under this Note or any Security Agreement on the principal balance shall exceed the maximum amount of interest permitted by applicable law, then in such event (a) the provisions of this paragraph shall govern and control, (b) neither Maker nor any other person or entity now or hereafter liable for the payment hereof shall be


obligated to pay the amount of such interest to the extent that it is in excess of the maximum amount of interest permitted by applicable law, (c) any such excess which may have been collected shall be either applied as a credit against the then unpaid principal balance or refunded to Maker, at the option of the Payee, and (d) the effective rate of interest shall be automatically reduced to the maximum lawful contract rate allowed under applicable law as now or hereafter construed by the courts having jurisdiction thereof. It is further agreed that without limitation of the foregoing, all calculations of the rate of interest contracted for, charged or received under this Note or any Security Agreement which are made for the purpose of determining whether such rate exceeds the maximum lawful contract rate, shall be made, to the extent permitted by applicable law, by amortizing, prorating, allocating and spreading in equal parts during the period of the full stated term of the indebtedness evidenced hereby, all interest at any time contracted for, charged or received from Maker or otherwise by Payee in connection with such indebtedness; provided, however, that if any applicable state law is amended or the law of the United States of America preempts any applicable state law, so that it becomes lawful for the Payee to receive a greater interest per annum rate than is presently allowed, the Maker agrees that, on the effective date of such amendment or preemption, as the case may be, the lawful maximum hereunder shall be increased to the maximum interest per annum rate allowed by the amended state law or the law of the United States of America.

 

The Maker and all sureties, endorsers, guarantors or any others (each such person, other than the Maker, an “Obligor”) who may at any time become liable for the payment hereof jointly and severally consent hereby to any and all extensions of time, renewals, waivers or modifications of, and all substitutions or releases of, security or of any party primarily or secondarily liable on this Note or any Security Agreement or any term and provision of either, which may be made, granted or consented to by Payee, and agree that suit may be brought and maintained against any one or more of them, at the election of Payee without joinder of any other as a party thereto, and that Payee shall not be required first to foreclose, proceed against, or exhaust any security hereof in order to enforce payment of this Note. The Maker and each Obligor hereby waives presentment, demand for payment, notice of nonpayment, protest, notice of protest, notice of dishonor, and all other notices in connection herewith, as well as filing of suit (if permitted by law) and diligence in collecting this Note or enforcing any of the security hereof, and agrees to pay (if permitted by law) all expenses incurred in collection, including Payee’s actual attorneys’ fees. Maker and each Obligor agrees that fees not in excess of twenty percent (20%) of the amount then due shall be deemed reasonable.

 

Maker hereby irrevocably authorizes and empowers the Prothonotary or Clerk, or any attorney for any Court of record to appear for Maker in such Courts, at any time, and confess a judgement against Maker, without process, in favor of any holder hereof, without the filing of a declaration of default, with release of errors, without stay of execution, for such amount as may appear from the face hereof to be due hereunder (or, if such attorney so elects, for the amount which may be due hereon as evidenced by an affidavit signed by a representative of holder setting forth the amount then due) together with charges, attorney’s fees and costs as herein provided, and Maker hereby waives and releases all benefits and relief from any and all appraisement, stay or exemption laws of any state, now in force or hereafter to be passed. If a copy hereof, verified by an affidavit, shall have been filed in said proceeding, it shall not be necessary to file the original as a warrant of attorney. No single exercise of the foregoing warrant and power to confess judgement shall be deemed to exhaust the power, whether or not such exercise shall be held by any Court to be invalid, voidable, or void, but the power shall continue undiminished and may be exercised from time to time as often as the holder hereof shall elect, until all sums payable or that may become payable hereunder by Maker have been paid in full.

 

THE MAKER HEREBY UNCONDITIONALLY WAIVES ITS RIGHTS TO A JURY TRIAL OF ANY CLAIM OR CAUSE OF ACTION BASED UPON OR ARISING OUT OF, DIRECTLY OR INDIRECTLY, THIS NOTE, ANY OF THE RELATED DOCUMENTS, ANY DEALINGS BETWEEN MAKER AND PAYEE RELATING TO THE SUBJECT MATTER OF THIS TRANSACTION OR ANY RELATED TRANSACTIONS, AND/OR THE RELATIONSHIP THAT IS BEING ESTABLISHED BETWEEN MAKER AND PAYEE. THE SCOPE OF THIS WAIVER IS INTENDED TO BE ALL ENCOMPASSING OF ANY AND ALL DISPUTES THAT MAY BE FILED IN ANY COURT (INCLUDING, WITHOUT LIMITATION, CONTRACT CLAIMS, TORT CLAIMS, BREACH OF DUTY CLAIMS, AND ALL OTHER COMMON LAW AND STATUTORY CLAIMS.) THIS WAIVER IS IRREVOCABLE MEANING THAT IT MAY NOT BE MODIFIED EITHER ORALLY OR IN WRITING, AND THE WAIVER SHALL APPLY TO ANY SUBSEQUENT AMENDMENTS, RENEWALS, SUPPLEMENTS OR MODIFICATIONS TO THIS NOTE, ANY RELATED DOCUMENTS, OR TO ANY OTHER DOCUMENTS OR AGREEMENTS RELATING TO THIS TRANSACTION OR ANY RELATED TRANSACTION. IN THE EVENT OF LITIGATION, THIS NOTE MAY BE FILED AS A WRITTEN CONSENT TO A TRIAL BY THE COURT.

 

This Note and any Security Agreement constitute the entire agreement of the Maker and Payee with respect to the subject matter hereof and supercedes all prior understandings, agreements and representations, express or implied.

 

No variation or modification of this Note, or any waiver of any of its provisions or conditions, shall be valid unless in writing and signed by an authorized representative of Maker and Payee. Any such waiver, consent, modification or change shall be effective only in the specific instance and for the specific purpose given.


Any provision in this Note or any Security Agreement which is in conflict with any statute, law or applicable rule shall be deemed omitted, modified or altered to conform thereto.

 

    Neose Technologies, Inc.

/s/ Monica Klos


 

By:

 

/s/ A. Brian Davis


(Witness)

 

Name:

 

A. Brian Davis

Monica Klos

 

Title:

 

Vice President, Finance

(Print name)

 

Federal Tax ID #: 13-3549286

102 Witmer Road, Horsham, PA 19044

 

Address:

 

102 Witmer Rd, Horsham, Montgomery County, PA 19044

(Address)

       
EX-31.1 4 dex311.htm SECTION 302 CEO CERTIFICATION SECTION 302 CEO CERTIFICATION

Exhibit 31.1

 

CERTIFICATION OF CHIEF EXECUTIVE OFFICER

 

I, C. Boyd Clarke, certify that:

 

1. I have reviewed this quarterly report on Form 10-Q of Neose Technologies, Inc.

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have:

 

a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

b) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

c) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and


b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

November 5, 2003

Date

 

/s/ C. Boyd Clarke


   

C. Boyd Clarke

   

President and Chief Executive Officer

EX-31.2 5 dex312.htm SECTION 302 CFO CERTIFICATION SECTION 302 CFO CERTIFICATION

Exhibit 31.2

 

CERTIFICATION OF CHIEF FINANCIAL OFFICER

 

I, Robert I. Kriebel, certify that:

 

1. I have reviewed this quarterly report on Form 10-Q of Neose Technologies, Inc.

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have:

 

a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

b) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

c) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and


b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

November 5, 2003

Date

 

/s/ Robert I. Kriebel


   

Robert I. Kriebel

   

Senior Vice President and Chief Financial Officer

 

2

EX-32.1 6 dex321.htm SECTION 906 CEO CERTIFICATION SECTION 906 CEO CERTIFICATION

Exhibit 32.1

 

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

In connection with the Quarterly Report of Neose Technologies, Inc. (the “Company”) on Form 10-Q for the period ending September 30, 2003 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, C. Boyd Clarke, President and Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:

 

(1) The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

/s/ C. Boyd Clarke


C. Boyd Clarke

President and Chief Executive Officer

November 5, 2003

EX-32.2 7 dex322.htm SECTION 906 CFO CERTIFICATION SECTION 906 CFO CERTIFICATION

Exhibit 32.2

 

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

In connection with the Quarterly Report of Neose Technologies, Inc. (the “Company”) on Form 10-Q for the period ending September 30, 2003 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Robert I. Kriebel, Principal Financial Officer of the Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:

 

(1) The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

/s/ Robert I. Kriebel


Robert I. Kriebel

Principal Financial Officer

November 5, 2003

-----END PRIVACY-ENHANCED MESSAGE-----