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

 


 

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

For the quarterly period ended March 31, 2006

 

¨ 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 0-23155

 


TRIMERIS, INC.

(Exact name of registrant as specified in its charter)

 


 

Delaware   56-1808663

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

3500 Paramount Parkway

Morrisville, North Carolina 27560

(Address of principal executive offices, including zip code)

Registrant’s telephone number, including area code: (919) 419-6050

 


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. x Yes    No ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act.

Large accelerated filer ¨         Accelerated filer x         Non-accelerated filer ¨

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

Yes ¨     No x

The number of shares outstanding of the registrant’s common stock as of May 2, 2006 was 22,102,243.

 



Table of Contents

TRIMERIS, INC.

FORM 10-Q

For the Three Months Ended March 31, 2006

INDEX

 

          Page
PART I.    FINANCIAL INFORMATION   
Item 1.    Financial Statements   
   Balance Sheets as of March 31, 2006 (unaudited) and December 31, 2005    1
   Statements of Operations (unaudited) for the Three Months Ended March 31, 2006 and 2005    2
   Statements of Cash Flows (unaudited) for the Three Months Ended March 31, 2006 and 2005    3
   Notes to Financial Statements (unaudited)    4
Item 2.    Management’s Discussion and Analysis of Financial Condition and Results of Operations    14
Item 3.    Quantitative and Qualitative Disclosures About Market Risk    23
Item 4.    Controls and Procedures    24
PART II.    OTHER INFORMATION   
Item 1.    Legal Proceedings    25
Item 1A.    Risk Factors    25
Item 2.    Unregistered Sales of Equity Securities and Use of Proceeds    26
Item 3.    Defaults Upon Senior Securities    26
Item 4.    Submission of Matters to a Vote of Security Holders    26
Item 5.    Other Information    26
Item 6.    Exhibits    26
Signature Page    27
Exhibit Index    28


Table of Contents

PART I. FINANCIAL INFORMATION

 

Item 1. Financial Statements

TRIMERIS, INC.

BALANCE SHEETS

(in thousands, except par value)

 

     March 31,
2006
    December 31,
2005
 
     (unaudited)        

Assets

    

Current assets:

    

Cash and cash equivalents

   $ 27,518     $ 23,559  

Investment securities-available-for-sale

     13,915       13,330  

Accounts receivable - Roche

     7,068       10,500  

Other receivables

     27       54  

Prepaid expenses

     1,053       1,369  
                

Total current assets

     49,581       48,812  
                

Property, furniture and equipment, net

     2,519       2,640  

Other assets:

    

Patent costs, net

     2,567       2,424  

Advanced payment - Roche

     5,431       5,218  

Deposits and other assets

     791       1,048  
                

Total other assets

     8,789       8,690  
                

Total assets

   $ 60,889     $ 60,142  
                

Liabilities and Stockholders’ Equity

    

Current liabilities:

    

Accounts payable

   $ 989     $ 1,919  

Accrued compensation

     1,950       2,841  

Deferred revenue – Roche

     3,597       1,722  

Accrued expenses

     1,605       1,597  
                

Total current liabilities

     8,141       8,079  

Deferred revenue - Roche

     10,046       10,477  

Accrued marketing costs

     16,699       16,507  

Other liabilities

     708       706  
                

Total liabilities

     35,594       35,769  
                

Stockholders’ equity:

    

Preferred stock at $.001 par value per share, 10,000 shares authorized, zero shares issued and outstanding at March 31, 2006 (unaudited) and December 31, 2005

     —         —    

Common Stock at $.001 par value per share, 60,000 shares authorized, 22,078 and 22,057 shares issued and outstanding at March 31, 2006 (unaudited) and December 31, 2005

     22       22  

Additional paid-in capital

     404,189       404,293  

Accumulated deficit

     (378,898 )     (378,470 )

Deferred compensation

     —         (1,462 )

Accumulated other comprehensive loss

     (18 )     (10 )
                

Total stockholders’ equity

     25,295       24,373  
                

Total liabilities and stockholders’ equity

   $ 60,889     $ 60,142  
                

See accompanying notes to financial statements.

 

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TRIMERIS, INC.

STATEMENTS OF OPERATIONS

(in thousands, except per share data)

(unaudited)

 

     Three Months Ended
March 31,
 
     2006     2005  

Revenue:

    

Milestone revenue

   $ 1,056     $ 431  

Royalty revenue

     2,580       1,761  

Collaboration income (loss)

     3,794       (36 )
                

Total revenue and collaboration income (loss)

     7,430       2,156  
                

Operating expenses:

    

Research and development:

    

Non-cash compensation

     713       109  

Other research and development expense

     4,467       5,347  
                

Total research and development expense

     5,180       5,456  
                

General and administrative:

    

Non-cash compensation

     820       111  

Other general and administrative expense

     2,336       2,200  
                

Total general and administrative expense

     3,156       2,311  
                

Total operating expenses

     8,336       7,767  
                

Operating income (loss)

     (906 )     (5,611 )
                

Other income (expense):

    

Interest income

     418       272  

Interest expense

     (192 )     (183 )
                

Total other income

     226       89  
                

Net loss before cumulative effect of change in accounting principle

   $ (680 )   $ (5,522 )

Cumulative effect of change in accounting principle

   $ 252     $ —    
                

Net loss

   $ (428 )   $ (5,522 )
                

Basic and diluted net loss per share:

    

Before cumulative effect of accounting change

   $ (0.03 )   $ (0.25 )

Accounting change

     0.01       —    
                

Basic and diluted net loss per share

   $ (0.02 )   $ (0.25 )
                

Weighted average shares used in per share computations

     21,858       21,710  
                

See accompanying notes to financial statements.

 

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TRIMERIS, INC.

STATEMENTS OF CASH FLOWS

(in thousands, unaudited)

 

     Three Months Ended
March 31,
 
     2006     2005  

Cash flows from operating activities:

    

Net loss

   $ (428 )   $ (5,522 )

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

    

Depreciation and amortization of property, furniture and equipment

     243       273  

Other amortization

     41       12  

Amortization of deferred revenue – Roche

     (1,056 )     (431 )

Non-cash compensation

     1,533       220  

Cumulative effect of change in accounting principle

     (252 )     —    

Decrease (increase) in assets:

    

Recoverable franchise taxes

     —         144  

Accounts receivable - Roche

     3,432       5,878  

Other receivables

     (1 )     (2 )

Prepaid expenses

     316       352  

Patent costs expensed

     4       34  

Advanced payment - Roche

     (213 )     (419 )

Deposits and other assets

     251       (753 )

Increase (decrease) in liabilities:

    

Accounts payable

     (930 )     (779 )

Accounts payable – Roche

     —         275  

Accrued compensation

     (891 )     (864 )

Accrued expenses

     8       930  

Accrued marketing costs

     192       183  

Deferred revenue - Roche

     2,500       —    

Other liabilities

     2       198  
                

Net cash provided (used) by operating activities

     4,751       (271 )
                

Cash flows from investing activities:

    

Purchases of investment securities - available-for-sale

     (4,008 )     (3,722 )

Maturities of investment securities - available-for-sale

     3,415       7,070  

Purchases of property and equipment

     (127 )     (44 )

Proceeds from the sale of equipment

     33       —    

Patent costs

     (182 )     (129 )
                

Net cash provided (used) by investing activities

     (869 )     3,175  
                

Cash flows from financing activities:

    

Proceeds from exercise of stock options

     77       419  
                

Net cash provided by financing activities

     77       419  
                

Net increase in cash and cash equivalents

     3,959       3,323  

Cash and cash equivalents, beginning of period

     23,559       28,101  
                

Cash and cash equivalents, end of period

   $ 27,518     $ 31,424  
                

See accompanying notes to financial statements.

 

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TRIMERIS, INC.

NOTES TO FINANCIAL STATEMENTS

(unaudited)

1. BASIS OF PRESENTATION

Trimeris, Inc. (the “Company”) was incorporated on January 7, 1993 in Delaware, to discover and develop novel therapeutic agents that block viral infection by inhibiting viral fusion with host cells.

The Company has a worldwide agreement with F. Hoffmann-La Roche Ltd. (“Roche”), to develop and market T-20, marketed as Fuzeon®, whose generic name is enfuvirtide, and T-1249, or a replacement compound. Fuzeon is manufactured and distributed by Roche through Roche’s sales and distribution network throughout the world in countries where regulatory approval has been received. The Company shares gross profits equally from the sale of Fuzeon in the United States and Canada with Roche, and receives a royalty based on net sales of Fuzeon outside the United States and Canada.

The accompanying unaudited financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America and applicable Securities and Exchange Commission (the “SEC”) regulations for interim financial information. Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been condensed or omitted pursuant to the SEC rules and regulations. In the opinion of management, all adjustments (consisting only of normal recurring adjustments) necessary for a fair presentation of financial position and results of operations have been made. Operating results for interim periods are not necessarily indicative of results, which may be expected for a full year. The information included in this Form 10-Q should be read in conjunction with the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections and the 2005 financial statements and notes thereto included in the Company’s 2005 Annual Report on Form 10-K for the year ended December 31, 2005 filed with the SEC on March 10, 2006.

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

The Company has a collaboration agreement with Roche, which accounted for 100% of the Company’s royalty revenue for the three months ended March 31, 2006 and 2005. This agreement with Roche also provides the basis for substantially all of the Company’s results from the collaboration. Substantially all of the accounts receivable at March 31, 2006 and December 31, 2005, are comprised of receivables from Roche.

In December 2004, the Financial Accounting Standards Board (“FASB”) issued SFAS No. 123 (revised), “Share-Based Payment” (“SFAS No. 123 (revised)”). SFAS No. 123 (revised) requires that the cost resulting from all share-based payment transactions be recognized as a charge in the financial statements. This statement establishes fair value as the measurement objective in accounting for share-based payment arrangements and requires all entities to apply a fair-value-based measurement method in accounting for share-based payment transactions with employees except for equity instruments held by employee share ownership plans. This statement also establishes fair value as the measurement objective for transactions in which an entity acquires goods or services from non-employees in share-based payment transactions. This statement amends FASB Statement No. 95, Statement of Cash Flows, to require that excess tax benefits be reported as a financing cash inflow rather than as a reduction of taxes paid. This Statement replaces SFAS Statement No. 123, Accounting for Stock-Based Compensation, and supersedes APB Opinion No. 25, Accounting for Stock Issued to Employees.

The Company adopted SFAS No. 123 (revised) as of January 1, 2006, using the modified prospective method. The Company’s financial statements as of and for the three months ended March 31, 2006 reflect the impact of adopting SFAS NO. 123 (revised). In accordance with the modified prospective method, the consolidated financial statements for prior periods have not been restated to reflect, and do not include, the impact of SFAS No. 123 (revised). See Note 6 “Stock Based Compensation” for further details.

Stock-based compensation expense recognized during the period is based on the value of the portion of stock-based payment awards that are ultimately expected to vest. Non-cash compensation expense recognized in the statement of operations during the three months ended March 31, 2006 includes compensation expense for stock-based payment awards granted prior to, but not yet vested, as of December 31, 2005 based on the grant date fair value estimated in accordance with the pro forma provisions of SFAS 148 and compensation expense for the stock-based payment awards granted subsequent to December 31, 2005, based on the grant date

 

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fair value estimated in accordance with SFAS No. 123 (revised). As stock-based compensation expense recognized in the statement of operations for the three months ended March 31, 2006, is based on awards ultimately expected to vest, it has been reduced for estimated forfeitures. SFAS No. 123 (revised) requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. In the pro forma information required under SFAS 148 for the periods prior to 2006, the Company accounted for forfeitures as they occurred.

2. BASIC NET INCOME (LOSS) PER SHARE

In accordance with SFAS No. 128, “Earnings Per Share” (“SFAS No. 128”), basic loss per common share is calculated by dividing net loss by the weighted-average number of common shares outstanding for the period after certain adjustments described below. Diluted net income per common share reflects the maximum dilutive effect of common stock issuable upon exercise of stock options, stock warrants, purchases under the Employee Stock Purchase Plan and conversion of preferred stock. Diluted net loss per common share is not shown, as common equivalent shares from stock options, restricted stock, and stock warrants, would have an anti-dilutive effect. At March 31, 2006, there were 3,479,000 options to purchase common stock, 156,000 restricted stock grants, which become fully vested in 2007, a 50,000 restricted stock grant, which becomes fully vested in 2008, and 362,000 warrants to purchase common stock outstanding. At March 31, 2005, there were 3,271,000 options to purchase common stock, 175,000 restricted stock grants, which become fully vested in 2007, 50,000 restricted stock grants, which become fully vested in 2008 and 362,000 warrants to purchase common stock outstanding.

3. STATEMENTS OF CASH FLOWS

For the three months ended March 31, 2006 and 2005, approximately $192,000 and $183,000, respectively was charged to interest expense for the accretion of the liability resulting from the Company’s share of estimated selling and marketing expenses. The Company recorded a liability of $15.6 million during 2004, as part of collaboration loss, which represents the net present value of the Company’s estimated share of these expenses, based on the expected timing and terms of payment under the amendment to the collaboration agreement dated July 12, 2004. No cash was paid for interest during the three months ended March 31, 2006 and 2005.

Net unrealized losses on investments securities-available-for-sale totaled $8,000 during the three months ended March 31, 2006 and net unrealized losses on short-term investments totaled $3,000 during the three month period ended March 31, 2005. Unrealized gains/losses are reported on the balance sheet as accumulated other comprehensive gain / (loss).

4. ROCHE COLLABORATION

The Development and License Agreement

In July 1999, the Company entered into a worldwide agreement with Roche, to develop and commercialize T-20, currently marketed as Fuzeon®, whose generic name is enfuvirtide, and T-1249, or a replacement compound. While the Company’s development agreement with Roche covers the commercialization of Fuzeon, T-1249 or a replacement product, to date only Fuzeon is commercially available.

This agreement with Roche grants them an exclusive, worldwide license for Fuzeon and T-1249, and certain other compounds. Under this agreement with Roche, a joint management committee consisting of members from Trimeris and Roche oversees the strategy for the collaboration. Roche may terminate its license for a particular country in its sole discretion with advance notice. This agreement with Roche gives Roche significant control over important aspects of the commercialization of Fuzeon and our other drug candidates, including but not limited to pricing, sales force activities, and promotional activities.

Collaboration Income (Loss)

Product sales of Fuzeon began in the United States on March 27, 2003 and are recorded by Roche. Under the collaboration agreement with Roche, the Company shares gross profits equally from the sale of Fuzeon in the United States and Canada with Roche. Collaboration income (loss) is calculated as follows: Total gross sales of Fuzeon in the United States and Canada is reduced by any discounts, returns or rebates resulting in total net sales. Net sales are reduced by costs of goods sold resulting in gross profit. Gross profit is reduced by selling, marketing and other expenses related to the sale of Fuzeon, resulting in operating income or loss. The Company’s share of the operating income or loss is reported as collaboration income or loss as a component of revenue. Total net sales of Fuzeon in the United States and Canada were $27.4 million and $23.3 million during the three months ended March 31, 2006 and 2005, respectively. During the three months ended March 31, 2006, the gross profit from the sale of Fuzeon exceeded the sales, marketing and other expenses resulting in the Company’s share of operating profit from the sale of Fuzeon in the United States of $3.8 million. During the three months ended March 31, 2005, sales, marketing and other expenses exceeded the gross profit from the sale of Fuzeon resulting in the Company’s share of operating loss from the sale of Fuzeon in the United States of $36,000. Revenue is

 

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recognized when Roche ships drug and title and risk of loss passes to wholesalers. Fuzeon is widely available through retail pharmacies and wholesalers across North America.

It is important to recognize that Roche is responsible for the manufacture, sales, marketing and distribution of Fuzeon. Roche is manufacturing bulk quantities of Fuzeon drug substance in its Boulder, Colorado facility and is producing finished drug product from bulk drug substance at another Roche facility. The finished drug product is then shipped to a Roche facility for distribution. Roche’s sales force is responsible for selling Fuzeon. Under the Company’s collaboration agreement with Roche, the Company does not have the ability or rights to co-market this drug or field our own Fuzeon sales force. All third party contracts for manufacturing, distribution, sale, and reimbursement are between Roche and the third party. The Company is not a party to any of the material contracts in these areas. Roche provides the Company with information on manufacturing, sales and distribution of Fuzeon. Roche is responsible for estimating reductions to gross sales for expected returns of expired products, government rebate programs, such as Medicaid reimbursements, and customer incentives, such as cash discounts for prompt payment. The Company reviews these items for accuracy and reasonableness.

Roche prepares estimates for sales returns and allowances, discounts and rebates based primarily on their historical experience with Fuzeon and other anti-HIV drugs and their estimates of the payor mix for Fuzeon, updated for changes in facts and circumstances on a quarterly basis. If actual results differ from these estimates, these estimates will be adjusted which could have an effect on results from operations in the period of adjustment.

Accrued Marketing Costs

The Company and Roche agreed to limit the Company’s actual cash contribution to the Fuzeon selling and marketing expenses in 2004 to approximately $11.2 million, even though Roche spent significantly more on these expenses. If certain cumulative levels of sales for Fuzeon in the United States and Canada are achieved, the Company’s share of the additional expenses incurred by Roche during 2004 will be payable to Roche beginning at a future date over several years from that future date. The Company currently estimates this date to be in 2011. During the year ended December 31, 2004, the Company’s share of selling and marketing expenses exceeded $11.2 million. During 2004, the Company recorded $15.6 million as part of collaboration loss, which represented the net present value of the Company’s estimated share of the expenses that were in excess of approximately $11.2 million. This amount was determined by taking into account the expected timing and terms of payment under the agreement, discounted at a risk free interest rate. The Company is increasing the liability over time to the expected payment amount. For the three months ended March 31, 2006 and 2005, the Company increased the initial recorded liability by $192,000 and $183,000, respectively for accretion of interest. The total liability of $16.7 million and $16.5 million at March 31, 2006 and December 31, 2005, respectively, is reflected on our balance sheet under the caption “Accrued marketing costs.”

For 2005, Roche and Trimeris shared Fuzeon marketing expenses according to the terms of an agreement signed in May 2005. For 2006, Roche and Trimeris will share Fuzeon marketing expenses according to the terms of an agreement signed in March 2006.

Advanced Payment—Roche

In September 2005, the Company entered into a Letter of Amendment (“Manufacturing Amendment”) with Roche setting forth certain rights and responsibilities, that the parties previously agreed to, with respect to the manufacture and sale of Fuzeon. The Company will pay Roche for the Company’s share of the capital invested in Roche’s manufacturing facility over a seven-year period. The Company’s anticipated share of this capital investment is approximately $14.0 million. As a result, the Company recognized an initial payment of $4.0 million at June 2004, and expects to pay approximately $500,000 per quarter through June 2009. As a result, Roche will no longer include the depreciation related to the manufacturing facility in the cost of goods sold. In the event our collaboration agreement is terminated, the Company would not be obligated for any unpaid amounts for capital investment.

These payments, net of the portion allocated to cost of goods sold, are recorded as an asset presented as “Advanced payment – Roche.” This asset is amortized based on the units of Fuzeon sold during the collaboration period, in order to properly allocate the capital investment to cost of goods sold as the related inventory is sold in future periods. Assuming all payments are made and sales of Fuzeon continue, the Company estimates that this asset has a remaining useful life of approximately 10 years. In addition, other peptide drug candidates discovered under our collaboration with Roche could be manufactured using the same Roche facility. The carrying value of this asset will be evaluated annually for impairment or if a triggering event occurs.

Under the Manufacturing Amendment, the use of Roche owned facilities in Boulder for the manufacture of Fuzeon will result in a credit to the collaboration if used to produce other products for Roche. During the period from January 2006 through March 2006, a key intermediate used in the manufacture of another product was produced using these facilities that resulted in a credit to the collaboration. The Company’s share of this credit is approximately $225,000. During the period from July 2004 through June 2005, we also received a similar credit of which our share was approximately $900,000. These payments have been recorded on the Company’s balance sheet as a reduction to the “Advanced payment – Roche.” This credit offsets variances that would otherwise have been

 

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allocated to Fuzeon if the facility had remained underutilized and will be recognized when the related Fuzeon produced during this period is sold.

Royalty Revenue

The Company receives royalties on sales of Fuzeon in countries outside of the United States and Canada. Roche is responsible for all activities related to Fuzeon outside of the United States and Canada, including regulatory, manufacturing, sales and distribution. These royalties are recognized as revenue when the sales are earned. Royalties of $2.6 million and $1.8 million were recognized as revenue during the three months ended March 31, 2006 and 2005, respectively.

Development Expenses

Under the collaboration agreement, development costs are shared equally. Development typically includes certain clinical and pre-clinical studies performed on a clinical candidate compound, as well as post-marketing commitments related to approved drugs. Both Roche and Trimeris incur development costs for Fuzeon and T-1249. Quarterly, the companies reconcile the amounts expended and one party pays the other party on a 50/50 basis. Roche holds the Investigational New Drug Application, or IND, and the New Drug Application, or NDA, for Fuzeon and is responsible for all regulatory issues, maintenance activities and communications with the Food and Drug Administration or FDA. Development expenses pertaining to the United States and Canada are included on the Company’s Statement of Operations in operating expenses under research and development.

The Research Agreement

Research, or the process of identifying clinical candidates, is generally distinct from the advanced testing of these compounds, a process referred to herein as development (see discussion above “Development Expenses”). In the Company’s collaboration with Roche, the identification of compounds that may become clinical candidates is governed by a separate research agreement and the work by the parties is performed according to an agreed upon research plan. In 2001, the Company entered into the research agreement with Roche to discover, develop and commercialize novel generations of HIV fusion inhibitor peptides. The joint research obligations under the agreement are renewable on an annual basis.

Under this agreement, certain peptides will be treated differently with respect to the sharing of costs and profits of development and commercialization. For example, subject to certain limitations, for peptides discovered after July 1, 1999, and that are covered by the original Trimeris patent estate (“Type II peptides”), Roche and Trimeris will share costs and profits incurred in the U.S. and Canada equally. Trimeris will receive a royalty on the sale of Type II peptides that occur in the rest of the world. With respect to peptides discovered after July 1, 1999, but that are covered by patents outside the original Trimeris patent estate (“Type III peptides”), Roche and Trimeris will share costs and profits equally worldwide.

In December 2005, Roche and Trimeris agreed to an amount to be reimbursed to Trimeris, for research expenses incurred over the course of the year. For 2005, the total reimbursement of research expenses from Roche amounted to $2.0 million and was recorded in the fourth quarter of 2005. In addition, in January 2006, Roche agreed to pay Trimeris $2.5 million for research that was performed outside the research plan during 2005. This payment did not become due until January 2006 upon the next generation peptides passing Roche’s internal review and is distinct from the milestone payments that were made under the collaboration agreement signed in 1999. In February 2006, Trimeris received this payment. This $2.5 million payment will be recognized as a component of revenue during 2006, over the term of the annual 2006 research plan (the period of Trimeris’ continuing involvement).

In January 2006, Roche and Trimeris announced the selection of two next-generation fusion inhibitor peptides for co-development and progression into further pre-clinical studies. The peptides, TRI-1144 and TRI-999, first synthesized at Trimeris, are distinct compounds derived from HR2 sequences of HIV. TRI-1144 and TRI-999 are being developed with the specific goal of achieving durable suppression of HIV by increasing the potency of the molecules and raising their genetic barrier to the development of resistance. Also central to the development program is increased patient convenience via simpler, more patient-friendly administration, with a target of once-weekly dosing.

In the near future, the Company plans to proceed to advanced formulation studies with one or both of these peptides. The results of these studies will determine how rapidly the Company moves toward naming a clinical candidate. These activities are likely to fall under the Company’s research agreement with Roche. At present, the Company is in discussions with Roche to define the research plan and budget for 2006.

5. COMPREHENSIVE INCOME (LOSS)

SFAS No. 130, “Reporting Comprehensive Income”, establishes rules for the reporting and display of comprehensive income or loss and its components. SFAS No. 130 requires that unrealized gains or losses on the Company’s available-to-sale securities be included in other comprehensive income (loss). Comprehensive income (loss) totaled ($436,000) for the three months ended

 

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March 31, 2006, and ($5,519,000) for the three months ended March 31, 2005. For the Company, other comprehensive income (loss) for the three months ended March 31, 2006 consists of our net loss of $428,000 and unrealized losses on investment securities available-for-sale of $8,000.

6. STOCK BASED COMPENSATION

The Company adopted SFAS No. 123 (revised) using the modified prospective transition method beginning January 1, 2006. Accordingly, during the three months ended March 31, 2006, the Company recorded stock-based compensation expense for awards granted prior to, but not yet vested, as of January 1, 2006, and awards granted after January 1, 2006, using the Black-Scholes valuation model. The Company has recognized the compensation expense using a straight-line amortization method. As SFAS No. 123 (revised) requires that stock-based compensation expense be based on awards that are ultimately expected to vest, stock-based compensation for the three months ended March 31, 2006 has been reduced for estimated forfeitures. When estimating forfeitures, the Company considered voluntary termination behaviors as well as trends of actual option forfeitures. As a result of the adoption of SFAS No. 123 (revised), the Company recognized in non-cash compensation expense in its statement of operations approximately $1.3 million relating to the fair value of employee stock options during the three months ended March 31, 2006.

The fair value of common stock options is estimated on the date of grant using the Black-Scholes option-pricing model with the following assumptions used for each year, 2006 and 2005:

 

     2006   2005

Estimated dividend yield

   0.00%   0.00%

Expected stock price volatility

   44.3%   50.0%

Risk-free interest rate

   4.68%   3.50%

Expected life of options (in years)

   4.4-6.8   5

Expected life of employee stock purchase plan options (in years)

   2   2

The Company’s computation of expected volatility for the three months ended March 31, 2006, is based on a combination of historical and market-based implied volatility from traded options on the Company’s stock. The computation of expected life in 2006, was determined based on historical experience of similar awards, giving consideration to the contractual terms of the stock-based awards, vesting schedules and expectations of future employee behavior. The range provided above results from the behavior patterns of separate groups of employees that have similar historical experience. The risk-free interest rate for periods within the contractual term of the share option is based on the U.S. Treasury yield curve in effect at the time of the grant.

The table below presents the Company’s stock based compensation for the three months ended March 31, 2006 and 2005.

 

    

Three months ended

March 31,

 
     2006    2005  

Employee Stock Option Plan *

   $ 1,299    $ —    

Employee Stock Purchase Plan

     24      —    

Restricted stock to employees

     181      232  

Non-employee stock options

     29      (12 )
               

Total stock option expense

   $ 1,533    $ 220  
               

 

* Formally known as the Trimeris, Inc. Amended and Restated Stock Incentive Plan

Employee Stock Option Plan

In 1993, the Company adopted a stock option plan, which allows for the issuance of non-qualified and incentive stock options. During 1996, the Trimeris, Inc. Amended and Restated Stock Incentive Plan (the “Employee Stock Option Plan”) was implemented and replaced the 1993 plan. Under the Employee Stock Option Plan, as amended, the Company may grant non-qualified or incentive

 

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stock options for up to 5,752,941 shares of common stock. The exercise price of each incentive stock option shall not be less than the fair market value of the Company’s common stock on the date of grant and an option’s maximum term is ten years. Outstanding incentive stock options have been issued at prices ranging from $0.34 to $78.50 per share. The vesting period generally occurs over four years. At March 31, 2006, there were approximately 587,000 options remaining available for grant. All incentive stock options which had been granted under the 1993 plan were cancelled at inception of the Employee Stock Option Plan while the non-qualified stock options remain outstanding at an exercise price of $0.43. No more grants will be made under the 1993 plan. The Company has sufficient authorized and unissued shares to make all issuances under its share based compensation plans.

A summary of share option activity under the Employee Stock Option Plan as of March 31, 2006 and changes during the quarter then ended is presented below:

 

     Number of
Shares
    Weighted
Average
Exercise
Price
   Weighted
Average
Remaining
Contractual
Life (Years)
   Aggregate
Intrinsic
Value

Outstanding options at January 1, 2006

   3,393,000     $ 23.83      

Granted

   121,000       11.82      

Exercised

   (22,000 )     3.56      

Forfeited

   (14,000 )     14.02      
                        

Options outstanding at March 31, 2006

   3,478,000     $ 23.68    6.57    $ 3,616,000

Options vested or expected to vest at March 31, 2006

   3,392,000     $ 23.92    6.51    $ 3,535,000

Options exercisable at March 31, 2006

   2,366,000     $ 28.28    5.47    $ 2,450,000

The weighted-average grant-date fair value of share options granted during the three months ended March 31, 2006 and 2005 was $5.80 and $6.76, respectively. The total intrinsic value of share options exercised during the three months ended March 31, 2006 and 2005 was $194,000 and $90,000, respectively.

 

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A summary of the status of the Company’s nonvested shares as of March 31, 2006, and changes during the three months ended March 31, 2006, is presented below:

Nonvested Shares Issued Under the Stock Option Plan

 

     Number of
Shares
    Weighted-
Average
Grant-Date
Fair Value

Nonvested at January 1, 2006

   1,098,000     $ 6.86

Granted

   121,000       5.80

Vested

   (94,000 )     9.03

Forfeited

   (13,000 )     6.08
            

Nonvested at March 31, 2006

   1,112,000     $ 6.57
            

As of March 31, 2006, there was approximately $6.1 million of total unrecognized compensation cost related to nonvested share-based compensation arrangements granted under the Plan. That cost is expected to be recognized over a weighted-average period of two years. The total fair value of shares vested during the three months ended March 31, 2006, was $847,000.

Employee Stock Purchase Plan

The Company has an Employee Stock Purchase Plan, which permits eligible employees to purchase newly issued common stock of the Company up to an aggregate of 250,000 shares. Under this plan, employees may purchase from the Company a designated number of shares through payroll deductions at a price per share equal to 85% of the lesser of the fair market value of the Company’s common stock as of the date of the grant or the date the right to purchase is exercised. No shares were issued under this plan in the three months ended March 31, 2006 and 2005. At March 31, 2006, there were 76,000 shares remaining available for issuance. As a result of the adoption of SFAS No. 123 (revised), the Company recognized $24,000 of compensation expense for the three months ended March 31, 2006, related to the fair value of the shares to be purchased under the employee stock purchase plan.

Restricted Stock

In June 2004, an aggregate grant of 191,500 shares of restricted stock was made to substantially all employees. The shares vest 100% after three years. In September 2004, a grant of 50,000 shares of restricted stock was made to the newly appointed Chief Executive Officer (“CEO”). The shares granted to the CEO vest 100% after four years of service. Amortization expense, related to these restricted stock grants, in the amount of $181,000 and $232,000 was charged to non-cash compensation expense for the three months ended March 31, 2006 and 2005, respectively. SFAS No. 123 (revised) requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Prior to the adoption of SFAS No. 123 (revised), the Company recognized actual forfeitures of restricted stock. The cumulative effect of the change in accounting principle relating to this change was $252,000, and is included in the accompanying statement of operations for the three months ended March 31, 2006. As of March 31, 2006, there was approximately $1.0 million of total unrecognized compensation cost related to restricted stock grants.

Prior to the adoption of SFAS No. 123 (revised), the Company’s outstanding restricted stock granted to employees in June 2004 and the CEO in September 2004, were recorded as deferred compensation on the balance sheet as of December 31, 2005. Upon the adoption of SFAS No. 123 (revised) as of January 1, 2006, the unearned deferred compensation balance of approximately $1.5 million was reclassified to additional-paid-in-capital.

 

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A summary of the status of the Company’s nonvested restricted stock shares as of March 31, 2006, and changes during the three months ended March 31, 2006, is presented below:

Nonvested Shares Issued Under the Plan

 

    

Number of

Shares

 

Nonvested at January 1, 2006

   207,000  

Granted

   —    

Vested

   —    

Forfeited

   (1,000 )
      

Nonvested at March 31, 2006

   206,000  
      

Options Granted to Non-employees

Compensation costs for stock options granted to non-employees are accounted for in accordance with SFAS No. 123 (revised) and EITF 96-18, “Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or Services,” which requires that compensation be measured at the end of each reporting period for changes in the fair value of the Company’s common stock until the options are vested.

A change in additional paid–in capital during the three months ended March 31, 2006 was $29,000 related to expense of non-cash compensation charges. A change in additional paid-in capital during the three months ended March 31, 2005 was $12,000 related to expense reversal of non-cash compensation charges. This increase in the expense resulted primarily from the increase in the market price of our stock from December 31, 2005 to March 31, 2006.

Pro forma Information for Periods Prior to the Adoption of SFAS No. 123 (revised)

Prior to the adoption of SFAS No. 123 (revised), the Company provided the disclosures required under SFAS No. 123. Employee stock-based compensation expense was not reflected in our results of operations for the three months ended March 31, 2005 for employee stock option awards as all options were granted with an exercise price equal to the market value of the underlying common stock on the date of grant. Forfeitures of awards were recognized as they occurred. Previously reported amounts have not been restated.

The pro forma amounts for the three months ended March 31, 2005 were as follows (in thousands, except per share data):

 

Net income (loss):

  

As reported

   $ (5,522 )

Compensation cost recorded under APB Opinion No. 25

     232  

Compensation cost resulting from common stock options, restricted stock and employee stock purchase plan

     (1,790 )
        

Pro forma

   $ (7,080 )
        

Basic and diluted loss per share:

  

As reported

   $ (0.25 )

Pro forma

   $ (0.33 )

 

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7. POST-RETIREMENT HEALTH INSURANCE CONTINUATION PLAN

In June 2001, the Company adopted a post-retirement health insurance continuation plan (“the Plan”). Employees who have achieved the eligibility requirements of 60 years of age and 10 years of service are eligible to participate in the Plan. The Plan provides participants the opportunity to continue participating in the Company’s group health plan after their date of retirement. Participants will pay the cost of health insurance premiums for this coverage, less any contributions by the Company. In November 2003, the Plan was amended and the limit on contributions by the Company was changed to 50% of the health insurance premium for the employee and his or her spouse.

The components of net periodic post-retirement benefits cost of the Plan for the three months ended March 31, consisted of the following (in thousands):

 

     Three Months Ended
March 31,
 
     2006     2005  

Service cost

   $ 18     $ 18  

Interest cost

     4       4  

Recognized net actuarial gain (loss)

     (4 )     (4 )

Amortization of prior service costs

     6       6  
                

Total

   $ 24     $ 24  
                

The accumulated post-retirement benefit obligation, or APBO, was determined using a discount rate of 5.75% and 6.00% at December 31, 2005 and 2004, respectively. This rate is determined based on high-quality fixed income investments that match the duration of the expected retiree medical benefits. The Company has typically used the corporate Aa bond rate for this assumption. An assumed annual medical trend rate of 10% was used beginning in 2006, reducing by 1% per year to an ultimate rate of 5% in 2011. A 1% increase in the trend factors would increase the projected APBO by approximately $100,000 and would increase the service and interest cost components by approximately $29,000. A 1% decrease in the trend factors would decrease the projected APBO by approximately $74,000 and would decrease the service and interest cost components by approximately $21,000.

The expected future benefit payments under the plan (in thousands) are as follows:

 

Year(s) ending December 31:

   Amount

2006

   $ —  

2007

     —  

2008

     —  

2009

     1

2010

     2

2011 to 2015

     34
      

Total

   $ 37
      

8. COMMITMENTS AND CONTINGENCIES

The Company is involved in certain claims arising in the ordinary course of business. In the opinion of management, the ultimate disposition of these matters will not have a material adverse effect on the financial position or results of operations of the Company.

As of March 31, 2006, the Company had commitments of approximately $2.0 million to purchase product candidate materials and fund various clinical studies over the next twelve months contingent on delivery of the materials or performance of the services. Substantially all of these expenditures will be shared equally by Roche under the Company’s collaboration agreement with Roche.

 

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Under the collaboration agreement, Trimeris and Roche are obligated to share equally the future development expenses for Fuzeon and T-1249 for the United States and Canada. We also expect to have capital expenditures of approximately $815,000 during 2006 that will not be shared with Roche. We may finance these expenditures with capital or operating leases, debt or working capital.

In 2004, the Company entered into a sublease agreement for its office and laboratory space in Morrisville, North Carolina. The sublease called for the payment of a security deposit for which the Company has accrued $503,000 as of March 31, 2006.

The minimum payments under this lease are as follows (in thousands):

 

Year ending December 31:

    

2006 remaining

     1,131

2007

     1,508

2008

     1,538

2009

     1,569

2010

     1,600

Thereafter

     6,873
      
   $ 14,219
      

 

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

Executive Summary

We are a biopharmaceutical company primarily engaged in the discovery, development and commercialization of a new class of antiviral drug treatments called fusion inhibitors. Fusion inhibitors impair viral fusion, a complex process by which viruses attach to, penetrate and infect host cells. If a virus cannot enter a host cell, the virus cannot replicate. By inhibiting the fusion process of particular types of viruses, like the Human Immunodeficiency Virus (HIV), our first commercial product and our compounds under research offer a novel mechanism of action to treat and potentially prevent the transmission of HIV.

We have a worldwide agreement with F. Hoffmann-La Roche Ltd., or Roche, to develop and market T-20, marketed as Fuzeon, whose generic name is enfuvirtide, and T-1249, or a replacement compound. Fuzeon is manufactured and distributed by Roche through Roche’s sales and distribution network throughout the world in countries where regulatory approval has been received. The Company shares gross profits equally from the sale of Fuzeon in the United States and Canada with Roche, and receives a royalty based on net sales of Fuzeon outside the United States and Canada.

Effective January 1, 2006, the Company adopted Statement of Financial Accounting Standards No. 123 (revised) which requires that the cost resulting from all share-based payment transactions be recognized as a charge in the financial statements. For the first quarter of 2006, the Company recognized an additional $1.3 million in employee stock option expenses when compared to the results for the first quarter of 2005. After employee stock option expense, for the first quarter of 2006, the Company recorded a loss of $428,000 or ($0.02) per share. Before employee stock option expense, for the first quarter of 2006 the Company recorded its second consecutive quarter of profitability of $643,000 compared to a net loss of $5.5 million in the first quarter of 2005. This result was primarily driven by the following factors:

 

    Profitability of the collaboration - profitability of the collaboration increased to $3.8 million in the first quarter of 2006 compared to a loss of $36,000 in the first quarter of 2005. This result was primarily driven by an increase in Fuzeon sales in North America to $27.4 million in the first quarter of 2006 from $23.3 million in the first quarter of 2005, a growth of 17%, and lower selling and marketing and other expenses in the first quarter of 2006 compared to the first quarter of 2005.

 

    Royalty revenues – royalty revenue from sales of Fuzeon outside of United States and Canada increased to $2.6 million in the first quarter of 2006 from $1.8 million in the first quarter of 2005. This was driven by an increase in Fuzeon sales outside of United States and Canada to $28.0 million in the first quarter of 2006 from $19.1 million in the first quarter of 2005, a growth of 47%.

 

    Milestone revenue – milestone revenue increased to $1.1 million in the first quarter of 2006 from $431,000 in the first quarter of 2005. The increase in milestone revenue was driven by the payment of $2.5 million in February 2006 from Roche for research that was performed outside the research plan during 2005. This payment is being recognized over the term of the annual 2006 research plan (the period of our continuing involvement).

 

    Operating Expenses – operating expenses, before employee stock option expense, decreased to $7.0 million in the first quarter of 2006 from $7.8 million in the first quarter of 2005. The decrease was primarily driven by a reduction in research and development expenses.

Our research agreement with Roche to co-develop a novel, next generation fusion inhibitor with the goal of durable HIV suppression and once weekly dosing continues to make progress. Both of our compounds are advancing into large scale chemical synthesis to support advanced formulation work and pre-clinical testing. We expect to begin our first time in man studies with one of these compounds in 2007. Currently we are in the final stages of agreeing to the development plan and budget for 2006 with our partner Roche.

In June 2005, we entered into a drug discovery and development agreement with ChemBridge Research Laboratories, Inc., or CRL. Under the terms of the agreement, Trimeris and CRL have worked together to discover and develop small molecule inhibitors of HIV. Specifically, pursuant to the agreement, we have worked with CRL to identify small molecule inhibitor compounds against two HIV entry targets. In April 2006, Trimeris notified CRL that we would not be supplying any additional funding support of any CRL research related to the collaboration. While the agreement remains in effect, there are no current research efforts being conducted other than some activities associated with the winding down of projects.

Management’s Discussion and Analysis in this Form 10-Q should be read in conjunction with our Form 10-K as filed with the Securities and Exchange Commission on March 10, 2006.

This Management’s Discussion and Analysis contains certain non-GAAP financial measures. See “Non-GAAP Financial Measures” for additional information.

 

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RESULTS OF OPERATIONS

Comparison Of Three Months Ended March 31, 2006 and 2005

Revenues

The table below presents our revenue sources for the three months ended March 31, 2006 compared to the three months ended March 31, 2005.

 

      Three Months Ended
March 31,
    Increase
(Decrease)

(in thousands)

   2006    2005    

Milestone revenue

   $ 1,056    $ 431     $ 625

Royalty revenue

     2,580      1,761       819

Collaboration income (loss)

     3,794      (36 )     3,830
                     

Total revenue and collaboration income (loss)

   $ 7,430    $ 2,156     $ 5,274
                     

Milestone revenue: Total milestone revenue represents the amortization of achieved milestones under our collaboration with Roche.

The table below presents our achieved milestones from Roche as of March 31, 2006. We are recognizing these milestones on a straight-line basis over the estimated development period, or estimated commercial period, as appropriate.

 

(in thousands)

  

Milestone

Total

    Date Achieved    Total Revenue
Recognized
Through March 31,
2006
   Revenue for the
Three Months Ended
March 31, 2006
   End of Recognition
Period
   $ 4,600 *   July    1999    $ 3,598    $ 37    December 2012
     2,000     October    2000      1,436      21    December 2012
     8,000     March    2003      3,283      175    December 2012
     5,000     May    2003      1,908      114    December 2012
     2,500     June    2003      702      63    June 2013
     750     June    2004      155      21    June 2013
     2,500     Jan    2006      625      625    December 2006
                              

Total

   $ 25,350           $ 11,707    $ 1,056   
                              

* Roche made a nonrefundable initial cash payment to the Company of $10 million during 1999. In July 1999, the Company granted Roche a warrant to purchase 362,000 shares of common stock at a purchase price of $20.72 per share. The fair value of the warrant of $5.4 million was credited to additional paid-in capital in 1999, and as a reduction of the $10 million up-front payment received from Roche. We have deferred $4.6 million, the net of the $10 million up-front payment and the $5.4 million for the warrant, over the research and development period.

In 2006, we will recognize $2.5 million more in milestone revenue when compared to 2005. In January 2006, Roche agreed to pay Trimeris $2.5 million for research that was performed outside the research plan during 2005. This payment did not become due until January 2006 upon the next generation peptides passing Roche’s internal review and is distinct from the milestone payments that were made under the collaboration agreement signed in 1999. In February 2006, Trimeris received this payment. This $2.5 million payment will be recognized as a component of revenue during 2006, over the term of the annual 2006 research plan (the period of Trimeris’ continuing involvement).

 

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Royalty revenue: Royalty revenue represents the royalty payment earned from Roche based on total net sales of Fuzeon outside the United States and Canada. Sales of Fuzeon outside the United States and Canada began in June 2003. To calculate the royalty revenue, an 8% distribution charge is deducted from Roche’s reported net sales, from which Trimeris received a 10% royalty. Royalty revenue has been increasing period over period as sales in new countries are initiated. In 2006, we expect sales outside the US and Canada to continue to increase, but not at the same percentage growth rate as seen from 2004 to 2005.

Collaboration Income (Loss): The table below presents our collaboration income (loss) (United States and Canada) for the three months ended March 31, 2006 compared to the three months ended March 31, 2005. Collaboration income (loss) is reported on our Statement of Operations as a component of revenue. Under our collaboration agreement with Roche, we share gross profits equally from the sale of Fuzeon in the United States and Canada. Fuzeon was launched in March 2003.

 

     

Three Months Ended

March 31,

   

Increase

(Decrease)

 

(in thousands)

   2006     2005    

Gross Fuzeon sales by Roche

   $ 32,205     $ 27,054     $ 5,151  

Less sales adjustments

     (4,827 )     (3,742 )     (1,085 )

Sales adjustments as a % of Gross Sales

     15 %     14 %  
                        

Net sales

     27,378       23,312       4,066  

Cost of goods sold

     (9,509 )     (10,390 )     881  

Cost of goods sold as a % of Net Sales

     35 %     45 %  
                        

Gross profit

     17,869       12,922       4,947  

Gross profit as a % of Net Sales

     65 %     55 %  

Selling and marketing expenses

     (9,977 )     (11,541 )     1,564  

Other costs

     (667 )     (2,428 )     1,761  
                        

Total shared profit (loss)

     7,225       (1,047 )     8,272  

Trimeris share *

     4,019       166       3,853  

Costs exclusive to Trimeris Inc.

     (225 )     (202 )     (23 )
                        

Net income (loss) from collaboration

   $ 3,794     $ (36 )   $ 3,830  
                        

 

* Trimeris contribution to selling and marketing expenses is limited in 2006 and 2005. As a result, Trimeris’ and Roche’s share of the collaboration income and loss are not equal.

Gross Fuzeon sales by Roche: Revenue is recognized when Roche ships drug and title and risk of loss passes to wholesalers.

The table below presents the number of kits shipped to wholesalers in the U.S. and Canada during 2006 and 2005.

 

Kits Shipped

   2006    2005

Q1

   17,100    15,000

Q2

      16,900

Q3

      18,500

Q4

      21,600
         

Total

   17,100    72,000
         

 

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Sales adjustments: Sales adjustments are recorded by Roche based on their experience with selling Fuzeon. There were no material revisions to Roche’s recorded estimates related to total sales adjustments compared to net sales for the three months ended March 31, 2005.

Cost of goods sold: Cost of goods sold decreased for the three months ended March 31, 2006 as compared to the three months ended March 31, 2005 as Roche is now selling Fuzeon inventory manufactured at lower costs due to manufacturing efficiencies. We expect that our cost of goods sold as a percentage of sales for the remainder of 2006 will average approximately 40%.

Gross profit: Gross profit as a percentage of net sales increased for the three months ended March 31, 2006 compared to the three months ended March 31, 2005 as a result of improving cost of goods sold as discussed above.

Selling and marketing expenses: Selling and marketing expenses decreased for the three months ended March 31, 2006 compared to the three months ended March 31, 2005 as a result of differences in the timing and phasing of certain programs. Overall selling and marketing expenses for 2006 are expected to be similar to those for 2005.

Other costs: Other costs for the three months ended March 31, 2006 and March 31, 2005 includes general and administrative and distribution charges. Also included in other costs for the three months ended March 31, 2005 are equipment write offs at the Boulder manufacturing facility. Trimeris is responsible for 50% of these costs under the collaboration agreement.

Costs exclusive to Trimeris: Costs exclusive to Trimeris includes license fees, based on net sales of Fuzeon, for certain technology paid to a third party.

Research And Development Expenses

The table below presents our research and development expenses for the three months ended March 31, 2006 compared to the three months ended March 31, 2005.

 

     

Three Months Ended

March 31,

  

Increase

(Decrease)

 

(in thousands)

   2006    2005   

Non-cash compensation

   $ 713    $ 109    $ 604  

Other research and development expense

     4,467      5,347      (880 )
                      

Total research and development expense

   $ 5,180    $ 5,456    $ (276 )
                      

Total other research and development expense includes:

 

    Development expenses for Fuzeon and T-1249, which we share equally with Roche, and

 

    Research expenses for the preclinical development of the next generation of fusion inhibitors, which we did not share equally with Roche in 2005. The Company also conducts non-partnered research outside of the agreements with Roche.

Non-cash compensation: Effective January 1, 2006, the Company adopted SFAS No. 123 (revised) which requires that the cost resulting from all share-based payment transactions be recognized as a charge in the financial statements. For the first quarter of 2006, the Company recognized an additional $593,000 in employee stock option expenses when compared to the results for the first quarter of 2005. Also included in non-cash compensation expense for the three months ended March 31, 2006 and 2005, is the amortization expense for restricted stock issued to employees in June 2004 and expense for stock options granted to non-employees. The restricted stock grants vest 100% after the third year of service and are being amortized on a straight-line basis over the three-year period.

In 2006, we expect a significant increase in non-cash compensation when compared to 2005, due to the adoption of SFAS No. 123 (revised), “Share-Based Payment.” Prior to the adoption of this statement, the majority of share-based payments were disclosed in the footnotes to the financial statements.

Other research and development expense: Total other research and development expense decreased during the three months ended March 31, 2006 compared to the three months ended March 31, 2005, primarily as a result of the following:

 

    decreased costs associated with ongoing clinical trial costs for Fuzeon and T-1249,

 

    an increase in the reimbursement from Roche for our research expenses related to the next generation fusion inhibitor peptides, and

 

    decreased facilities costs as a result of combining our facilities into one location.

 

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These expense reductions were offset, in part, by the following:

 

    an increase in supplies purchases during the first quarter of 2006, and

 

    an increase in research and related expense conducted with a third party.

We expect research and development expenses, net of the reimbursements for Fuzeon, T-1249 and the next generation development costs from Roche, to be higher in 2006, as compared to 2005, as a result of increased costs related to the development of the next generation peptides offset, in part, by decreased costs associated with ongoing clinical trial costs for Fuzeon and T-1249.

General and Administrative Expenses

The table below presents our general and administrative expenses for the three months ended March 31, 2006 compared to the three months ended March 31, 2005.

 

     

Three Months Ended

March 31,

  

Increase

(Decrease)

(in thousands)

   2006    2005   

Non-cash compensation

   $ 820    $ 111    $ 709

Other general and administrative expense

     2,336      2,200      136
                    

Total general and administrative expense

   $ 3,156    $ 2,311    $ 845
                    

Non-cash compensation: Effective January 1, 2006, the Company adopted Statement of Financial Accounting Standards No. 123 (revised) which requires that the cost resulting from all share-based payment transactions be recognized as a charge in the financial statements. For the first quarter of 2006, the Company recognized an additional $730,000 in employee stock option expenses when compared to the results for the first quarter of 2005. Also included in non-cash compensation expense for the three months ended March 31, 2006 and 2005, is the amortization expense for restricted stock issued to employees in June 2004 and to the newly appointed CEO in September 2004. These restricted stock grants vest 100% after the third year of service for employees and after the fourth year of service for the CEO and are being amortized on a straight-line basis over the three-year and four-year period, respectively.

In 2006, we expect a significant increase in non-cash compensation when compared to 2005, due to the adoption of SFAS No. 123 (revised), “Share-Based Payment.” Prior to the adoption of this statement, the majority of share-based payments were disclosed in the footnotes to the financial statements.

Other general and administrative expense: Other general and administrative expenses were comparable for the three months ended March 31, 2006 compared to the three months ended March 31, 2005.

We expect other general and administrative expenses to increase modestly in 2006, when compared to 2005, as the business grows.

Other Income (Expense): The table below presents our other income (expense) for the three months ending March 31, 2006 and 2005.

 

     

Three Months Ended

March 31,

   

Increase

(Decrease)

 
      2006     2005    

Interest income

   $ 418     $ 272     $ 146  

Interest expense

     (192 )     (183 )     (9 )
                        

Total other income, net

   $ 226     $ 89     $ 137  
                        

Other income (expense) consists of interest income and accretion of interest. The increase in interest income for the three months ended March 31, 2006 was primarily due to the favorable interest rate environment. Interest expense increased for the three months ended March 31, 2006 as compared to the three months ended March 31, 2005 as a result of accreting the excess marketing expenses recorded on the balance sheet as “Accrued marketing costs.” Our actual cash contribution to certain selling and marketing expenses for Fuzeon in 2004 was limited, even though Roche spent significantly more on these expenses. If certain cumulative levels of sales for Fuzeon in the United States and Canada are achieved, our share of any additional expenses incurred by Roche during 2004 will be payable to Roche beginning at a future date over several years from that future date. We are increasing the liability over time to the expected payment amount.

 

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LIQUIDITY AND CAPITAL RESOURCES

The table below presents our cash flows for the three months ended March 31, 2006 as compared to the three months ended March 31, 2005.

 

      Three Months Ended
March 31,
 

(in thousands)

   2006     2005  

Net cash provided (used) by operating activities

   $ 4,751     $ (271 )

Net cash provided (used) by investing activities

     (869 )     3,175  

Net cash provided by financing activities

     77       419  
                

Net increase in cash and cash equivalents

     3,959       3,323  

Cash and cash equivalents, beginning of period

     23,559       28,101  
                

Cash and cash equivalents, end of period

   $ 27,518     $ 31,424  
                

Operating Activities. Since inception, we have financed our operations primarily through private placements and public offerings of common stock, equipment lease financing and payments under our collaboration agreement with Roche.

For the three months ended March 31, 2006, cash provided by operating activities resulted from the reduced net loss and increased payments from Roche for the collaboration activities. We also received $4.5 million from Roche during the quarter for payment of our 2005 research expenses. We use our cash primarily to fund research and development relating to Fuzeon, T-1249 and other product candidates and costs for the commercialization of Fuzeon. The amount used by operating activities decreased for the three months ended March 31, 2006 primarily due to the reduced net loss and the increase in the amount received from Roche for the collaboration.

In 2006, cash provided by (used in) operating activities will depend on several factors including the sales, cost of sales and commercialization expenses related to the sale of Fuzeon (profitability of the collaboration with Roche) and the amount of money we deploy into developing our research pipeline and post marketing commitments for Fuzeon (development expenses), offset by any cash payments we receive from Roche related to the research of our next generation fusion inhibitors.

Investing Activities. The amount used by investing activities for the three months ended March 31, 2006 resulted from the net purchase of investment securities-available-for-sale, purchase of property, and equipment and patent costs. The amount provided by investing activities for the three months ended March 31, 2005 resulted from the net maturities of investment securities-available-for-sale offset, in part, by the purchase of property, and equipment and patent costs. The purchase and maturity of investment securities-available-for-sale was due to the normal maturity and repurchase of investments.

In 2006, cash provided by investing activities will depend primarily on the net maturities of investments. We expect spending on the purchase of property, furniture and equipment and patent costs in 2006 to approximate the spending in 2005.

Financing Activities. The amount provided by financing activities for the three months ended March 31, 2006 and 2005 resulted from proceeds from the exercise of stock options.

Total Cash, Cash Equivalents and Investment Securities-Available-for-Sales. As of March 31, 2006, we had $41.4 million in cash and cash equivalents and short-term-investments, compared to $36.9 million as of December 31, 2005.

Future Capital Requirements. Depending on Fuzeon sales, the level of expenses and other factors, we may not be able to generate sufficient positive cash flows to fund our operations in the foreseeable future. Although we expect to share the future development costs for Fuzeon and our other potential drug candidates for the United States and Canada equally with Roche, we have expended, and expect to continue to expend in the future, substantial funds to pursue our drug candidates and compound discovery and development efforts, including:

 

    expenditures for commercialization activities related to Fuzeon,

 

    research and development and preclinical testing of other product candidates,

 

    the development of our proprietary technology platform, and

 

    possible acquisitions and in licensing of research programs, clinical stage products and marketed products.

 

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Under the current operating environment, excluding any extraordinary items, based on expected sales levels of Fuzeon, we expect that our existing capital resources, together with the interest earned thereon, will be adequate to fund our current programs for at least the next 24 months. However, any reduction in Fuzeon sales below currently expected levels or increase in expenditures beyond currently expected levels would increase our capital requirements substantially beyond our current expectations. If we require additional funds and such funds are not available through debt or equity financings, or collaboration arrangements, we will be required to delay, scale-back or eliminate certain preclinical testing, clinical trials and research and development programs, including our collaborative efforts with Roche. In the event Roche becomes unable or unwilling to share future development expenses for Fuzeon, T-1249 or our other potential drug candidates, our capital requirements would increase substantially beyond our current expectations.

Our future capital requirements and the adequacy of available funds will depend on many factors, including the level of market acceptance and sales levels achieved by Fuzeon; expenses related to the sale of Fuzeon; the condition of the capital markets; the progress and scope of our product development programs; the magnitude of these programs; the results of preclinical testing and clinical trials; the need for additional facilities based on the results of these clinical trials and other product development programs; changes in the focus and direction of our product development programs; the costs involved in preparing, filing, processing, maintaining, protecting and enforcing patent claims and other intellectual property rights; competitive factors and technological advances; the cost, timing and outcome of regulatory reviews; changes in the requirements of the FDA; administrative and legal expenses; evaluation of the commercial viability of potential product candidates and compounds; the establishment of capacity, either internally or through relationships with third parties, for manufacturing, sales, marketing and distribution functions; the results of our business development activities, including in-licensing and merger and acquisition opportunities; and other factors, many of which are outside of our control.

Since our initial public offering in 1997, we have obtained the majority of our funding through public or private offerings of our common stock. We expect to continue to obtain our funding through public or private offerings of our common stock or other equity like instruments, such as convertible preferred stock or convertible debt, until such time, if ever, as we are able to generate significant funds from operations.

We may have difficulty raising additional funds by selling equity. If we fail to meet the clinical and financial expectations of securities analysts and investors, it could have a material adverse effect on the market price of our common stock and restrict or eliminate our ability to raise additional funds by selling equity. The public capital markets in which shares of our common stock are traded have been extremely volatile. Therefore, even if we do achieve positive clinical or financial results that meet or exceed the expectations of securities analysts and investors, the state of the public equity markets in general and particularly the public equity market for biotechnology companies may prohibit us from raising funds in the equity markets on acceptable terms or at all. Even if we are able to obtain additional funding through an equity financing, the terms of this financing could be highly dilutive to current stockholders.

We may also attempt to obtain additional funding through debt and debt-like financings such as convertible debt and/or arrangements with new or existing collaborative partners. Any debt financings may contain restrictive terms that limit our operating flexibility. Arrangements with collaborative partners may require us to relinquish rights to our technologies or product candidates or to reduce our share of potential profits. This could have a material adverse effect on our business, financial condition or results of operations.

Contractual Obligations. The following table summarizes our material contractual commitments at March 31, 2006 for the remainder of 2006 and subsequent years (in thousands):

 

Contractual Obligation

   2006    2007    2008    2009    2010    Thereafter    Total

Operating leases*

   $ 1,131    $ 1,508    $ 1,538    $ 1,569    $ 1,600    $ 6,873      14,219

Other contractual obligations**

     3,479      2,000      2,000      1,000      —        —        8,479

Other long-term liabilities reflected on the Balance Sheet ***

     —        —        —        —        —        16,699      16,699
                                                

Total

   $ 4,610    $ 3,508    $ 3,538    $ 2,569    $ 1,600    $ 23,572    $ 39,397
                                                

* Includes payments due under a sublease signed during June 2004, which commenced on January 1, 2005, on an existing office and laboratory building.

 

**

We are making advance payments to Roche for our share of the cost of the capital improvements made at Roche’s Boulder facility where Fuzeon drug substance is produced. We reached an agreement with Roche whereby we will pay Roche for our

 

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share of the capital invested in Roche’s manufacturing facility over a seven-year period. Our share of this capital investment is approximately $14.0 million. At March 31, 2006, we have capitalized costs of $7.5 million, and expect to pay approximately $500,000 per quarter through June 2009. This amount, net of charges to cost of goods sold as the related inventory is sold, is recorded as an asset on our Balance Sheet under the caption “Advanced payment—Roche.” In the event our collaboration agreement is terminated, we would not be obligated for any unpaid amounts for capital investment. The 2006 amount also includes $2.0 million for contracts to purchase product candidate material and fund various clinical studies contingent on delivery of the materials or performance of the services. Substantially all of these costs will be shared equally with Roche.

 

*** Our actual cash contribution to the selling and marketing expenses for Fuzeon in 2004 was limited to approximately $11.2 million, even though Roche spent significantly more on these expenses. If certain cumulative levels of sales for Fuzeon in the United States and Canada are achieved, our share of these additional expenses incurred by Roche during 2004 will be payable to Roche beginning at a future date over several years from that future date. We currently estimate this date to be in 2011. During the year ended December 31, 2004, we reached the $11.2 million limitation for the year. We recorded a liability of approximately $15.6 million as part of collaboration loss during the year ended December 31, 2004. This represents the net present value of our estimated share of the additional expenses, discounted at a risk-free interest rate from the expected payment date based on achievement of the sales milestones in the agreement. We are increasing the liability over time to the expected payment amount. In 2005 and 2004, we increased this liability by $746,000 and $154,000, respectively, for accretion of interest. During the three months ended March 31, 2006, we increased this liability by $192,000. The total liability of $16.7 million at March 31, 2006, is reflected on our balance sheet under the caption “Accrued marketing costs.”

Off-Balance Sheet Arrangements

We do not have any off-balance sheet arrangements other than operating leases for our properties. In the past we have entered into derivative transactions that represented call options sold on our stock to a third party financial institution and were entered into in order to generate cash from the option premiums and provide us with the opportunity to raise capital at prices significantly in excess of the market price at the time of the transaction. All of these options have expired unexercised. In the event these options were exercised, we expect they would have been settled by issuing shares of our stock. We may enter into similar transactions in the future, subject to market conditions. We enter into these transactions as a potential method to raise capital and not to speculate on the future market price of our stock. We have no subsidiaries or other unconsolidated limited purpose entities, and we have not guaranteed or otherwise supported the obligations of any other entity.

Accounting and Other Matters

The FASB issues exposure drafts for proposed statements of financial accounting standards. Such exposure drafts are subject to comment from the public, to revisions by the FASB and to final issuance by the FASB as statements of financial accounting standards. Management considers the effect of the proposed statements on our financial statements and monitors the status of changes to issued exposure drafts and to proposed effective dates.

Net Operating Loss Carryforwards

As of December 31, 2005, we had a net operating loss carryforward for federal tax purposes of approximately $343.6 million. We have recognized a valuation allowance equal to the deferred asset represented by this net operating loss carryforward and other deferred tax assets, net of deferred tax liabilities, and therefore recognized no tax benefit. Our ability to utilize these net operating loss carryforwards may be subject to an annual limitation in future periods pursuant to the “change in ownership rules” under Section 382 of the Internal Revenue Code of 1986, as amended.

Critical Accounting Policies

Reference is made to “Critical Accounting Policies” included in our Annual Report on Form 10-K for the year ended December 31, 2005. As of the date of the filing of this Quarterly Report, the Company has not identified any significant changes to the critical accounting policies discussed in our Annual Report for the year ended December 31, 2005 except as follows.

Stock-based Compensation

In December 2004, the Financial Accounting Standards Board (FASB) issued SFAS No. 123 (revised), a revision of SFAS No. 123, Accounting for Stock-Based Compensation (SFAS 123), which requires that all share-based payments to employees and directors,

 

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including grants of stock options be recognized in the income statement based on their fair values. SFAS No. 123 (revised) supersedes Accounting Principles Board Opinion No. 25, Accounting for Stock Issued to Employees (APB 25) and amends SFAS No. 95, Statement of Cash Flows. On January 1, 2006, we adopted SFAS No. 123 (revised) using the modified prospective method of adoption as permitted under SFAS No. 123 (revised) which requires that compensation expense be recorded for all non-vested stock options and other stock-based awards as of the beginning of the first quarter of adoption. In accordance with the modified prospective method, no prior period amounts have been restated to reflect the provisions of SFAS No. 123 (revised).

Prior to the adoption of SFAS No. 123 (revised), in accordance with the provisions of SFAS 123, we elected to follow APB 25 “Accounting for Stock Issued to Employees” in accounting for our employee stock-based plans. Under APB 25, if the exercise price of Trimeris’s employee and director stock options was equal to or greater than the fair value of the underlying stock on the date of grant, no compensation expense was recognized. However, as required by SFAS 123, the pro forma impact of expensing the fair value of our stock option awards and employee stock purchase plan was disclosed in the notes to our financial statements.

In connection with our adoption of SFAS No. 123 (revised), we refined our valuation assumptions and the methodologies used to derive those assumptions; however, we elected to continue using the Black-Scholes option valuation model. Concurrent with our adoption of SFAS No. 123 (revised), we determined that a blend of historical volatility along with implied volatility for traded options on Trimeris’s stock is an appropriate measure of market conditions and expected volatility. We estimate the weighted-average expected life of our stock-option awards based on historical cancellation and exercise data related to our stock-based awards as well as the contractual term and vesting terms of the awards. We are allocating stock-based compensation expense using a straight-line expense attribution approach for stock-based awards. We currently believe that the straight-line expense attribution approach better reflects the level of service to be provided over the vesting period of our awards. Stock-based compensation expense related to stock options is recognized net of estimated forfeitures. We estimated forfeitures based on our historical experience.

During the quarter ended March 31, 2006, we recognized stock-based compensation expense related to employee stock options of $1.3 million. As of March 31, 2006, we had unrecognized stock-based compensation of $6.1 million related to non-vested stock options awards, which is expected to be recognized over an estimated weighted average period of two years.

Non-GAAP Financial Measures

In addition to disclosing financial results calculated in accordance with Generally Accepted Accounting Principles (“GAAP”), we have included certain non-GAAP financial measures that exclude the effect of non-cash stock compensation expense as a result of the Company’s adoption of SFAS No. 123 (revised). The Company believes that the presentation of results excluding non-cash stock compensation expense provides meaningful supplemental information regarding our financial results for the three months ended March 31, 2006 as compared to the same period in 2005 since our financial statements issued prior to January 1, 2006 did not change as a result of adopting SFAS No. 123 (revised). We believe that this financial information is useful to management and investors in assessing our historical performance and results. The Company will use these non-GAAP financial measures when evaluating its financial results, as well as for internal planning and forecasting purposes. The non-GAAP financial measures disclosed by the Company should not be considered a substitute for or superior to financial measures calculated in accordance with GAAP, and the financial results calculated in accordance with GAAP and reconciliations to those financial statements should be carefully evaluated. The non-GAAP financial measures used by the Company may be calculated differently from, and therefore may not be comparable to, similarly titled measures used by other companies.

The following is a reconciliation of our GAAP and non-GAAP net income.

 

    

Three Months Ended
March 31, 2006

[in thousands except

per share amounts]
(unaudited)

 

Net loss (GAAP)

   $ (428 )

Cumulative effect of change in accounting principle*

     (252 )

Employee stock option expense:

  

Research and development

     593  

General and administrative

     730  
        

Net income (Non- GAAP)

   $ 643  
        

Basic and diluted net income per share excluding employee stock option expense and cumulative effect of change in account principle (Non -GAAP)

   $ 0.03  
        

Weighted average shares outstanding

     21,858  
        

 

* The cumulative effect of change in accounting principle relates to the difference in accounting for the restricted stock grants under SFAS No. 123 (revised). Under SFAS No. 123 (revised) we are required to estimate a forfeiture rate for the restricted stock grants and apply that forfeiture rate from the date of grant. Prior to SFAS No. 123 (revised), we did not estimate forfeitures and only accounted for forfeitures as they occurred. The difference in these two methods results in the cumulative effect of change in accounting principle.

 

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The following is a reconciliation of our GAAP and non GAAP operating expenses:

 

    

Three months ended
March 31, 2006

(in thousands)

 

Total operating expenses (GAAP)

   $ 8,336  

Employee stock option expense:

  

Research and development

     (593 )

General and administrative

     (730 )
        

Total operating expenses (Non-GAAP)

   $ 7,013  
        

Cautionary Statements Regarding Forward Looking Statements

This Form 10-Q and any attachments may contain forward-looking information about the Company’s financial results and business prospects that involve substantial risks and uncertainties. These statements can be identified by the fact that they use words such as “expect,” “project,” “intend,” “plan,” “believe” and other words and terms of similar meaning. Among the factors that could cause actual results to differ materially are the following: there is uncertainty regarding the success of research and development activities, regulatory authorizations and product commercializations; we are dependent on third parties for the sale, marketing and distribution of our drug candidates; the results of our previous clinical trials are not necessarily indicative of future clinical trials; and our drug candidates are based upon novel technology, are difficult and expensive to manufacture and may cause unexpected side effects. For a detailed description of these factors, see Trimeris’ Form 10-K filed with the Securities and Exchange Commission on March 10, 2006 and its periodic reports filed with the SEC.

Undue reliance should not be placed on these forward-looking statements, which are current only as of the date of this report. We disclaim any current intention or obligation to update any forward-looking statements or an y of the factors that may affect actual results. See “Risk Factors,” in Part II -Item 1A or our Report on Form 10-K for the fiscal year ended December 31, 2005, for a further discussion regarding some of the reasons that actual result may be materially different from those that we anticipate.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

Our exposure to market risk is primarily in our investment portfolio. We do not use derivative financial instruments for speculative or trading purposes. Substantially all of our contracts are denominated in US dollars; therefore, we have no material foreign currency risk. We have an investment policy that sets minimum credit quality standards for our investments. The policy also limits the amount of money we can invest in any one issue, issuer or type of instrument. We have not experienced any material loss in our investment portfolio, and we believe the market risk exposure in our investment portfolio has remained consistent over this period.

 

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The table below presents the carrying value, which is approximately equal to fair market value, and related weighted-average interest rates for our investment portfolio at March 31, 2006. Fair market value is based on actively quoted market prices. Our investments are generally most vulnerable to changes in short-term interest rates in the United States. Substantially all of our investments mature in twelve months or less, and have been given a rating of A1 or higher by a nationally recognized statistical rating organization or are the debt obligations of a federal agency and, therefore, we believe that the risk of material loss of principal due to changes in interest rates is minimal.

 

     Carrying
Amount
   Average
Interest Rate
 
     (thousands)       

Cash equivalents—fixed rate

   $ 27,226    4.60 %

Investment securities—available-for-sale-fixed rate

     13,915    4.62 %

Overnight cash investments—fixed rate

     292    3.84 %
             

Total investment securities

   $ 41,433    4.60 %
             

 

Item 4. Controls and Procedures

Our Chief Executive Officer and Chief Financial Officer reviewed and evaluated the effectiveness of our disclosure controls and procedures, with the participation of the Company’s management, as of March 31, 2006. Disclosure controls and procedures are controls and procedures that are designed to ensure that information required to be disclosed in our reports filed or submitted under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of March 31, 2006, our Chief Executive Officer and Chief Financial Officer have each concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.

No change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Securities and Exchange Act of 1934) occurred during the fiscal quarter ended March 31, 2006 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 1. Legal Proceedings

None.

 

Item 1A. Risk Factors

Our business activities involve various elements of risk. We consider the following issues to be some of the critical risks to the success of our business:

 

    that if Fuzeon does not maintain or increase its market acceptance, our business will be materially harmed;

 

    that we rely on our collaborative partner Roche to fulfill its contractual obligations regarding research and development, manufacturing and financial reporting. If Roche is unable or unwilling to fulfill its obligations to us, our business could be significantly harmed;

 

    that if Roche does not re-new or agree to amendments of our current research agreement to discover, develop and commercialize novel peptide fusion inhibitors, we may not be able to proceed with the development of our most promising drug candidates;

 

    that newly approved HIV drugs may displace or significantly reduce the use and market share of Fuzeon;

 

    that our business may require substantial additional capital, which we may not be able to obtain on commercially reasonable terms, we could be required to cut back or stop certain operations if we are unable to raise or obtain needed funding;

 

    that in order to be profitable over an extended period, we will need to maintain arrangements with third parties for the sale, marketing and distribution of our current and future drug candidates or expend significant resources to develop these capabilities

 

    that if sufficient amounts of Fuzeon and or any other drugs we attempt to bring to market cannot be manufactured on a cost-effective basis, our financial condition and results of operations will be materially and adversely affected;

 

    that we face intense competition in our efforts to develop commercially successful drugs in the biopharmaceutical industry and if we are unable to compete successfully, our business will suffer;

 

    that we may not receive all necessary regulatory approvals for future drug candidates or approvals may be delayed;

 

    that HIV is likely to develop resistance to Fuzeon and our future drug candidates, which could adversely affect demand for those drug candidates and harm our competitive position;

 

    that our business is based on a novel technology called fusion inhibition, and unexpected side effects or other characteristics of this technology may delay or otherwise adversely affect the development, regulatory approval and/or commercialization of our drug candidates;

 

    that our internal research programs and our efforts to obtain rights to new products from third parties may not yield potential products for clinical development, which would adversely affect any future revenues;

 

    that we depend on patents and proprietary rights, which may offer only limited exclusive protection and do not protect against infringement, and if we are unable to protect our patents and proprietary rights, our assets and business could be materially harmed;

 

    that the intellectual property of our competitors or other third parties may prevent us from developing or commercializing our drug candidates;

 

    that uncertainty relating to third-party reimbursement and health care reform measures could limit the amount we will be able to charge for our drugs and adversely affect our results of operations;

 

    that Roche has significant inventory of both finished product and raw materials on hand, if Fuzeon sales do not increase we could face the risk of significant write-offs;

 

    that any additional financing we obtain may result in dilution to our stockholders, restrictions on our operating flexibility, or the transfer of particular rights to our technologies or drug candidates.
   

 

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There were no material changes to the risk factors described in our 2005 Annual Report on Form 10-K. See “Item 1A-Risk Factors.” in Form 10-K filed by Trimeris on March 10, 2006.

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

 

  (a) Not applicable.

 

  (b) Not applicable.

 

  (c) Not applicable

 

Item 3. Defaults Upon Senior Securities

Not applicable.

 

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

Not applicable

 

Item 5. Other Information

None

 

Item 6. Exhibits

 

  (a) Exhibits

 

       The exhibits filed as part of this Quarterly Report on Form 10-Q are listed on the Exhibit Index and such list is incorporated herein by reference.

 

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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.

 

   

Trimeris, Inc.

(Registrant)

May 10, 2006     By:   /s/ STEVEN D. SKOLSKY
      Steven D. Skolsky
      Chief Executive Officer
May 10, 2006     By:   /s/ ROBERT R. BONCZEK
      Robert R. Bonczek
     

Chief Financial Officer

(Principal Financial Officer)

May 10, 2006     By:   /s/ ANDREW L. GRAHAM
        Andrew L. Graham
       

Director of Finance and Secretary

(Principal Accounting Officer)

 

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EXHIBIT INDEX

 

Number   

Description

10.1*    Letter Agreement between Trimeris, Inc. and Roche Laboratories Inc., dated March 14, 2006.(1)
31.1    Rule 13a-14(a) Certification by Steven D. Skolsky as Chief Executive Officer.
31.2    Rule 13a-14(a) Certification by Robert R. Bonczek as Chief Financial Officer.
32.1    Section 1350 Certification by Steven D. Skolsky as Chief Executive Officer.
32.2    Section 1350 Certification by Robert R. Bonczek as Chief Financial Officer.

 

(1) Filed as an exhibit to Registrant’s Current Report on Form 8-K filed with the SEC on March 14, 2006, and incorporated herein by reference.

 

* Confidential treatment has been requested as to certain portions of the exhibit. Such portions have been omitted and filed separately with the Securities and Exchange Commission.

 

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