-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, AInu3bSAGZaUknTCJ9uanm88N9GCcSBMeJEpTmfoouierRxtPsXkCuWgDO9VbnOJ i8zItmvdxeZiDVdVbqiEwg== 0001181431-07-068371.txt : 20071113 0001181431-07-068371.hdr.sgml : 20071112 20071113133443 ACCESSION NUMBER: 0001181431-07-068371 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20071108 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20071113 DATE AS OF CHANGE: 20071113 FILER: COMPANY DATA: COMPANY CONFORMED NAME: TRIMERIS INC CENTRAL INDEX KEY: 0000911326 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 561808663 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-23155 FILM NUMBER: 071236664 BUSINESS ADDRESS: STREET 1: 3500 PARAMOUNT PARKWAY CITY: MORRISVILLE STATE: NC ZIP: 27560 BUSINESS PHONE: (919) 419-6050 MAIL ADDRESS: STREET 1: 3500 PARAMOUNT PARKWAY CITY: MORRISVILLE STATE: NC ZIP: 27560 8-K 1 rrd178148.htm Prepared By R.R. Donnelley Financial -- Form 8-K
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
Form 8-K
 
Current Report
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
 
Date of Report (Date of earliest event reported):  11/08/2007
 
TRIMERIS, INC.
(Exact name of registrant as specified in its charter)
 
Commission File Number:  0-23155
 
DE
  
561808663
(State or other jurisdiction of
  
(IRS Employer
incorporation)
  
Identification No.)
 
3500 Paramount Parkway, Morrisville, NC 27560
(Address of principal executive offices, including zip code)
 
(919) 419-6050
(Registrant’s telephone number, including area code)
 
(Former name or former address, if changed since last report)
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

[  ]   Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

[  ]   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

[  ]   Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

[  ]   Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 

 
Item 2.02.    Results of Operations and Financial Condition
 
On November 8, 2007, Trimeris, Inc. (the "Company") issued a press release announcing financial results for the third quarter ended September 30, 2007. A copy of the press release is attached hereto as Exhibit 99.1.

On November 8, 2007, the Company held a conference call and webcast to discuss the Company's financial results for the third quarter ended September 30, 2007. A transcript of this conference call and webcast is attached hereto as Exhibit 99.2.

The information in this Form 8-K (including Exhibits 99.1 and 99.2) shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 (the "Exchange Act") or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 
 
Item 9.01.    Financial Statements and Exhibits
 
(d) Exhibits

Exhibit 99.1 Press release dated November 8, 2007.

Exhibit 99.2 Third quarter 2007 earnings conference call transcript.

 

 

Signature(s)
 
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 hereunto duly authorized.
 
     
 
TRIMERIS, INC.
 
 
Date: November 13, 2007
     
By:
 
/s/    E. Lawrence Hill, Jr.

               
E. Lawrence Hill, Jr.
               
President and Chief Operating Officer
 
 


 

Exhibit Index
 
Exhibit No.

  
Description

EX-99.1
  
Press release dated November 8, 2007.
EX-99.2
  
Third quarter 2007 earnings conference call transcript.
EX-99.1 2 rrd178148_22321.htm PRESS RELEASE DATED NOVEMBER 8, 2007. DRAFT 1


Exhibit 99.1

 

Contacts:

Andrew Graham

Director of Finance

Trimeris, Inc.

(919) 419-6050

TRIMERIS REPORTS FINANCIAL RESULTS FOR THE THIRD QUARTER 2007

            • Revenues of $10.4 million, a 7 percent increase over revenues of $9.7 million in the third quarter of 2006.
            • U.S. GAAP net income increases to $5.5 million from $3.4 million in the third quarter of 2006.
            • U.S. GAAP earnings per share increases to $0.25 per share from $0.16 per share in the third quarter of 2006.
            • Cash and investments increase to $63.3 million from $48.6 million at December 31, 2006

MORRISVILLE, N.C. - November 8, 2007 - Trimeris, Inc. (Nasdaq: TRMS) today announced financial results for the three months ended September 30, 2007, reporting total revenues of $10.4 million, an increase of 7 percent, compared to the same period last year. This increase was primarily driven by net sales of FUZEON outside of the U.S. and Canada, which reached $43.3 million, an increase of 47 percent over the same period last year. Worldwide sales of FUZEON, reached $73.9 million, an increase of 17 percent over the same period last year. All sales of FUZEON are recorded by F. Hoffmann-La Roche Ltd. ("Roche"), Trimeris' collaborative partner.

For the three months ended September 30, 2007, the Company reported net income of $5.5 million, or $0.25 per share, compared with $3.4 million, or $0.16 per share, for the three months ended September 30, 2006. This result was primarily driven by increased FUZEON sales and decreased operating expenses.

For the nine months ended September 30, 2007, the Company reported net income of $18.4 million, or $0.83 per share, compared with $2.7 million, or $0.12 per share for the nine months ended September 30, 2006.

As previously announced, Roche returned to Trimeris all rights to joint patents and other intellectual property related to next-generation HIV fusion inhibitor peptides including our lead candidate TRI-1144. As a result, the Company accelerated revenue recognition for past milestone payments received from Roche into the first nine months of 2007. Also included in net income for the nine months ended September 30, 2007 are expenses of $4.3 million for the reductions in workforce that occurred during the first nine months of 2007.

For the nine months ended September 30, 2007, the Company reported Non-GAAP net income of approximately $13.3 million, or $0.60 per share, compared with a net loss of $215,000 or a loss of $0.01 per share, for the nine months ended September 30, 2006. Non-GAAP net income for the three months ended September 30, 2007 does not show a significant difference from GAAP net income and therefore is not presented.

Cash, cash equivalents and investment securities available-for-sale totaled $63.3 million at September 30, 2007, compared to $48.6 million at December 31, 2006.

Reconciliations between GAAP and Non-GAAP earnings for the nine months ended September 30, 2007 and 2006 are provided in the following table:

Nine Months Ended

Nine Months Ended

September 30, 2007

[in thousands except per share amounts]

(unaudited)

September 30, 2006

[in thousands except per share amounts]

(unaudited)

Net income (GAAP)

$ 18,366

$ 2,685

Milestone Revenue [1]

(9,369)

(2,900)

Charge related to the reductions in workforce [2]

4,264

--

Net income (loss) excluding milestone revenue and charges related to reduction in workforce (Non- GAAP)

$ 13,261

$ (215)

Diluted net income per share (GAAP)

$ 0.83

$ 0.12

Diluted net income (loss) per share (Non-GAAP)

$ 0.60

$ (0.01)

[1] On March 13, 2007, the Company entered into an agreement with Roche that amended the terms of the Research Agreement. Under this agreement, all rights and joint patents and other intellectual property rights to the next generation fusion inhibitor peptides falling under the Research Agreement, which includes our lead drug candidate, TRI-1144, reverted to Trimeris. As a result of this agreement, the Company accelerated revenue recognition for past milestone payments received from Roche into the first quarter of 2007 because our period of joint development ended. These milestone payments were previously being amortized over the length of the joint research and development period of the next generation fusion inhibitor peptides or through December 2012.

[2] During the nine months ended September 30, 2007, the Company recorded a charge to the Statement of Operations related to the reductions in workforce.

Conference Call

Trimeris will host a live conference call to discuss third quarter 2007 financial results at 5:00 p.m. Eastern Time, today. To access the live call, please dial (800) 399-8403 (U.S.) or (706) 634-6565 (international). The conference ID number is 23609458. Telephone replay is available approximately two hours after the call through 11:59 p.m. Eastern Time, November 22, 2007. To access the replay, please call (800) 642-1687 (U.S.) or (706) 645-9291 (international). The information provided on the teleconference is only accurate at the time of the conference call, and Trimeris will take no responsibility for providing updated information.

Live audio of the conference call will be simultaneously broadcast over the Internet and will be available to members of the news media, investors and the general public. The webcast can be accessed by going to Trimeris' website, www.trimeris.com.

About Trimeris, Inc.

Trimeris, Inc. (Nasdaq: TRMS) is a biopharmaceutical company engaged in the development and commercialization of novel therapeutic agents for the treatment of viral disease. The core technology platform of fusion inhibition is based on blocking viral entry into host cells. FUZEON, approved in the U.S., Canada and European Union, is the first in a new class of anti-HIV drugs called fusion inhibitors. For more information about Trimeris, please visit the Company's website at http://www.trimeris.com.

Non-GAAP Financial Information

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 charge related to the reductions in workforce and the recognition of milestone revenue. The Company believes that the presentation of results excluding the reductions in workforce and recognition of milestone revenue provides meaningful supplemental information regarding our financial results for the nine months ended September 30, 2007 as compared to the nine months ended September 30, 2006 because our financial statements for the nine months ended September 30, 2006 did not include a charge related to a reduction in our workforce or an acceleration of the recognition of milestone revenue. 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 fi nancial 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.

Trimeris Safe Harbor Statement
This document 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 market for HIV therapeutics is very competitive with regular new product entries that could affect the sales of our products; 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 an d 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 16, 2007 and its periodic reports filed with the SEC.

Trimeris, Inc.

Statements of Operations

[in thousands, except per share amounts]

(unaudited)

 

Three Months Ended September 30,

Nine Months Ended September 30,

 

2007

2006

2007

2006

Revenue:

Milestone revenue [1]

$ 78

$ 789

$ 9,369

$ 2,900

Royalty revenue

4,781

3,391

11,862

8,379

Collaboration income [2]

5,518

5,559

15,692

13,168

Total revenue and collaboration income

10,377

9,739

36,923

24,447

Operating expenses:

       

Research and development

3,809

3,840

9,865

13,981

General and administrative

1,674

2,658

10,150

8,741

Total operating expenses [3]

5,483

6,498

20,015

22,722

         

Operating income

4,894

3,241

16,908

1,725

         

Other income (expense)

       

Interest income

815

519

2,212

1,407

Gain on sale of equipment

--

7

7

7

Interest/accretion expense

(115)

(196)

(519)

(582)

Total other income (expense)

700

330

1,700

832

         

Income before taxes and cumulative effect of change in accounting principle

5,594

3,571

18,608

2,557

Income tax provision

54

124

242

124

Income before cumulative effect of change in accounting principle

5,540

3,447

18,366

2,433

Cumulative effect of change in accounting principle [3]

--

--

--

252

         

Net income

$ 5,540

$ 3,447

$ 18,366

$ 2,685

         

Basic net income per share before cumulative effect of accounting change

$ 0.25

$ 0.16

$ 0.83

$ 0.11

Accounting change

--

--

--

0.01

Basic net income per share

$ 0.25

$ 0.16

$ 0.83

$ 0.12

         

Diluted net income per share before cumulative effect of accounting change

$ 0.25

$ 0.16

$ 0.83

$ 0.11

Accounting change

--

--

--

0.01

Diluted net income per share

$ 0.25

$ 0.16

$ 0.83

$ 0.12

         

Weighted average

shares used in basic per share computations

22,108

21,911

22,047

21,889

Weighted average

shares used in diluted per share computations

22,132

22,037

22,068

22,056

 

 

 

Notes:

[1] On March 13, 2007, the Company entered into an agreement with Roche that amended the terms of the Research Agreement. Under this agreement, all rights and joint patents and other intellectual property rights to the next generation fusion inhibitor peptides falling under the Research Agreement, which includes the lead drug candidate, TRI-1144, reverted to Trimeris. As a result of this agreement, the Company accelerated revenue recognition for past milestone payments received from Roche into the first quarter of 2007 because our period of joint development ended. These milestone payments were previously being amortized over the length of the joint research and development period of the next generation fusion inhibitor peptides or through December 2012.

[2] Collaboration income represents our share of the net operating results from the sale of FUZEON in the United States and Canada under our collaboration agreement with Hoffmann-La Roche, Inc., our collaborative partner. These net operating results consist of net sales less cost of goods (gross margin), less selling and marketing expenses and other costs related to the sale of FUZEON.

[3] Included in operating expenses for the three and nine months ended September 30, 2007 are an expense reversal of $90,000 and an expense of $4.3 million, respectively, for the reductions in workforce that occurred during these periods. Excluding these charges, operating expenses for the three and nine months ended September 30, 2007, would have been $5.6 and $15.7 million, respectively.

 

 

 

Trimeris, Inc.

Condensed Balance Sheets

[$ in thousands]

 

September 30,

2007

(unaudited)

December 31,

2006

Assets

   

Cash, cash equivalents and short-term investment securities available-for-sale

$ 57,142

$ 48,035

Other current assets

11,301

14,445

Total current assets

68,443

62,480

Property, furniture and equipment - net

1,801

2,160

Long-term investment securities available-for-sale

6,145

604

Total other assets

9,937

9,659

Total assets

$ 86,326

$ 74,903

Liabilities and Stockholders' Equity

   

Total current liabilities

$ 6,331

$ 8,907

Long term portion of deferred revenue

1,635

9,151

Accrued marketing costs

17,807

17,288

Accrued compensation - long-term

800

1,072

Other liabilities

719

713

Total liabilities

27,292

37,131

     

Total stockholders' equity

59,034

37,772

Total liabilities and stockholders' equity

$ 86,326

$ 74,903

 

 

FUZEON Net Sales

(Recognized by Roche, our collaborative partner)

[$ in millions]

(unaudited)

 

 

Three Months Ended,**

Nine Months

Ended, **

 

September 30,

2007

September 30,

2006

September 30,

2007

September 30,

2006

         

United States and Canada

$ 30.6

$ 33.5

$ 92.8

$ 92.0

Rest of World

43.3

29.5

107.5

83.7

Worldwide Total

$ 73.9

$ 63.0

$ 200.3

$ 175.7

** may not add due to rounding

 

 

 

--end--

EX-99.2 3 rrd178148_22322.htm THIRD QUARTER 2007 EARNINGS CONFERENCE CALL TRANSCRIPT. TRIMERS, INCORPORATED

Exhibit 99.2

TRIMERS, INC.

THIRD QUARTER EARNINGS CONFERENCE CALL

Moderator: Larry Hill

November 8, 2007

4:00 pm CT

Operator:

Good afternoon and welcome to the Trimeris Third Quarter 2007 Earnings conference call. This conference call may contain projections, estimates, and other forward looking statements that involve a number of risks and uncertainties including those discussed in Trimeris' filings with the Securities and Exchange Commission.

Among the factors that could cause actual results to differ materially are the following: there is uncertainty regarding the success of our research and development activities, regulatory authorizations, and product commercialization.

We are dependent on third parties for the sale, marketing, and distribution of our drug candidates. The market for HIV therapeutics is very competitive with regular new product entries that affect the sales of our products.

The results of our products' clinical trials are not necessarily indicative of future clinical trials. Our drug candidates are based upon novel technology, are difficult and expensive to manufacture, and may cause unexpected side effects.

For a complete description of these risks see Trimeris Form 10K filed with the Securities and Exchange Commission on March 16, 2007, and the company's periodic reports filed with the SEC.

Actual manufacturing and commercialization results may differ from previous results and current projections. While the information presented during this call represents managements' current judgment on the future direction of the company's business such risks and uncertainties could cause actual operating results to differ materially from any future performance suggested herein.

Trimeris undertakes no obligation to update these forward looking statements to reflect events or circumstances arising after the date hereof.

I'll now the call over to Mr. Larry Hill, Acting President and Chief Operating Officer.

Larry Hill:

Good afternoon. Thank you for being with us for our third quarter 2007 earnings conference call. Joining me on the call today are several members of the Trimeris senior management team.

There are three key messages that we wanted to convey to you on this call today and we will provide more details surrounding each of them later in the call.

First, we had a good quarter and are very pleased to have reported quarterly earnings of 25 cents per share and quarterly revenues of $10.4 million. Second, we have continued to strengthen our cash position by $14.7 million this year to $63.3 million from $48.6 million at December 31, 2006. And finally, we want to update you on the good progress of our next generation fusion inhibitor program.

I will now give you more details of our financial results. For the third quarter of 2007, we recorded net income of $5.5 million or 25 cents per share compared to $3.4 million or 16 cents per share in the third quarter of 2006. This positive result was primarily driven by an increase in FUZEON sales and a decrease in our operating expenses.

For the first nine months of 2007, we recorded net income of $18.4 million, or 83 cents per share, compared to $2.7 million or 12 cents per share, in the first nine months of 2006.

On the last conference call, I mentioned two one time events that impacted our results for the first quarter. Those one time events were the acceleration of revenue recognition for past milestones payments received from Roche and the recording of a one time expense associated with the reduction in force. Excluding milestone revenue and reduction in force expenses, we would have recorded net income of $13.3 million or 60 cents per share, compared to a loss of $215,000 or a loss of one cent per share, in the first nine months of 2006.

Worldwide net sales of FUZEON for the third quarter of 2007 were $73.9 million, an increase of 17% from the $63 million in the third quarter of 2006. Net sales of FUZEON in the US and Canada for the third quarter of 2007 were $30.6 million, down 9% from $33.5 million in the third quarter of 2006.

Net sales of FUZEON outside the US and Canada for the third quarter of 2007 were $43.3 million, an increase of 47% from $29.5 million in the third quarter of 2006. Worldwide net sales of FUZEON for the first nine months of 2007 were $200.3 million, an increase of 14% from $175.7 million in the first nine months of 2006.

Net sales of FUZEON in the US and Canada for the first nine months of 2007 were $92.8 million, up 1% from $92 million in the first nine months of 2006. Net sales of FUZON outside the US and Canada for the first nine months of 2007 were $107.5 million, an increase of 28% from $83.7 million in the first nine months of 2006.

Our cash position increased by $14.7 million to $63.3 million as of September 3 - excuse me - September 30, 2007 compared to $48.6 million at December 31, 2006.

Turning to our next generation HIV Fusion inhibitor, or NGFI, program we're pleased with the progress of TRI-1144 and the positive attributes that it continues to show.

In pre-clinical studies TRI-1144 has demonstrated excellent antiviral pharmacokinetics, safety, and physical properties. The preclinical safety program is progressing well and thus far in animal studies injection site reactions with TRI-1144 have been minimal.

Thus TRI-1144 remains on track to achieve a profile of a convenient, low volume, once daily injection delivered by a pre-filled auto-injector with minimal- to no- injection site reactions.

In addition, the target profile for TRI1144 seeks to retain the excellent, systemic safety profile of FUZEON and to date this continues to be borne out in the preclinical safety studies.

The program is on track. We're filing an IND in the first half of next year followed shortly by a focused Phase I study in healthy volunteers and a Phase I/II study in HIV one infected patients.

Each of these studies is being designed to provide for an early go/no go decision regarding continued development of TRI-1144 and could provide key data impacting decisions to consider less frequent dosing options.

And lastly, as a convenience to our investors, we would again like to comment on our outlook for 2007. Our outlook is based on a number of factors which are subject to certain risks and assumptions that are more fully described in our filings with the Securities and Exchange Commission. For a discussion of the risks and uncertainties associated with these forward looking statements please refer to the Trimeris safe harbor statement that was read at the beginning of this call.

At this time, we reiterate our previous outlook that total worldwide net sales of FUZEON will show modest top line growth in 2007 compared to 2006. Also, Trimeris forecasts its 2007 total operating expenses will be less than those incurred in 2006.

In summary, we are pleased with our financial performance this quarter. Thank you for listening and I will now take your questions.

Operator:

At this time, I would like to remind everyone, if you would like to ask a question simply press star, then the number 1, on your telephone keypad. That is star then, the number 1, to ask your question.

We will pause for just a moment to compile the Q&A roster.

Your first question comes from the line of Matthew Eckman. Sir, your line is open.

Matthew Eckman:

Hi gentlemen. Thanks for providing the update. I was wondering if you could give us some color on the - any options expense this quarter.

Larry Hill:

Andrew?

Andrew Graham:

Sure. Option expense this quarter was around $700,000.

Matthew Eckman:

And how did that split out between R&D and...

Andrew Graham:

It's roughly an equal split out between R&D and G&A.

Matthew Eckman:

Okay thank you.

Operator:

And again, if you would like to ask a question it is simply star then 1 on your telephone keypad.

Gentlemen, there are no further questions at this time. Do you have any closing remarks?

Larry Hill:

Yes. Thank you for participating on our third quarter 2007 earnings conference call.

Operator:

This concludes today's conference. You may now disconnect.

 

END

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