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Form 8-K for TRIMERIS INC
4-May-2010
Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Tran
Item 3.01. Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing.
On May 3, 2010, Trimeris, Inc. (the "Company") received notification from the Nasdaq Office of General Counsel, Hearings that the Company had met the requirements of the decision of the Nasdaq Listing Qualifications Panel (the "Panel") dated March 12, 2010 and all of the applicable requirements for continued listing on The Nasdaq Stock Market, including holding its annual stockholders meeting on or before April 30, 2010. Accordingly, the Panel has determined to continue the listing of the Company's securities on The Nasdaq Stock Market.
Previously, on January 5, 2010, the Company received a letter from the Nasdaq Listing Qualifications Department stating the Company's common stock was subject to delisting since the Company failed to hold the required annual stockholders meeting by December 31, 2009, the end of the Company's fiscal year. The letter stated that unless the Company requested an appeal of this determination, trading of the Company's common stock would be suspended at the opening of business on January 14, 2010, and a Form 25-NSE would be filed with the Securities and Exchange Commission. On January 11, 2010, the Company requested a hearing with the Panel to review the determination contained in the January 5, 2010 letter. The Company's request stayed the delisting until such hearing and determination of the Panel. A hearing with the Panel was held on February 18, 2010.
Item 5.07. Submission of Matters to a Vote of Security Holders.
The Company held its 2009 and 2010 Annual Meeting of Stockholders (the "Annual Meeting") on April 29, 2010. Three proposals were submitted to, and approved by, stockholders at the Annual Meeting. The proposals are described in detail in the Company's proxy statement for the Annual Meeting filed with the Securities and Exchange Commission on March 26, 2010. The final results for the votes regarding each proposal are set forth below.
1. Stockholders elected six directors to the Company's Board of Directors to hold office for a one-year term until the annual meeting of stockholders in 2011 and until their successors are elected and qualified. The votes regarding this proposal were as follows:
NOMINEE FOR WITHHOLD NON VOTES
Felix J. Baker, Ph.D. 17,101,790 697,530 2,553,380
Julian C. Baker 17,101,716 697,604 2,553,380
Stephen R. Davis 15,807,839 1,991,481 2,553,380
Martin A. Mattingly, Pharm. D. 17,084,250 715,070 2,553,380
Barry D. Quart, Pharm. D. 17,102,140 697,180 2,553,380
James R. Thomas 17,085,840 713,480 2,553,380
2. Stockholders ratified and approved the selection of Ernst & Young LLP as the Company's independent registered public accounting firm for the fiscal year ending December 31, 2010. The votes regarding this proposal were as follows:
FOR AGAINST ABSTAIN NON VOTES
20,303,354 36,705 12,641 0
3. Stockholders ratified and approved an amendment to the Company's 2007 Stock Incentive Plan to increase the number of authorized shares issuable under the 2007 Stock Incentive Plan from 1,000,000 to 1,700,000. The votes regarding this proposal were as follows:
FOR AGAINST ABSTAIN NON VOTES
15,294,344 2,494,779 10,197 2,553,380
Trimeris Reports First Quarter 2010 FUZEON® Sales Results
Press Release Source: Trimeris, Inc. On Wednesday April 14, 2010, 5:00 pm EDT
DURHAM, N.C.--(BUSINESS WIRE)--Trimeris, Inc. (Nasdaq: TRMS - News) (“Trimeris”) today announced worldwide net sales of FUZEON for the first quarter of 2010 were $24.4 million, down 12 percent from $27.8 million in the first quarter of 2009, and down 4 percent from $25.5 million in the fourth quarter of 2009. Net sales of FUZEON in the U.S. and Canada for the first quarter of 2010 were $7.2 million, down 28 percent from $10.0 million in the first quarter of 2009, and down 20 percent from $9.0 million in the fourth quarter of 2010. Net sales of FUZEON outside the U.S. and Canada for the first quarter of 2010 were $17.3 million, down 3 percent from $17.8 million in the first quarter of 2009, and up 5 percent from $16.5 million in the fourth quarter of 2009. All sales of FUZEON are recorded by F. Hoffmann-La Roche Ltd., Trimeris' collaborative partner.
Trimeris plans to release its complete financial results for the first quarter of 2010 in early May 2010.
Net FUZEON Sales
The table below presents net FUZEON sales by quarter beginning in the first quarter of 2008:
(millions) 2010
Q1 Q2 Q3 Q4 Total
U.S/Canada Net Sales $ 7.2
Ex. U.S/Canada Net Sales 17.3
Global Net Sales $ 24.4
Brazil Purchase* $ 7.8
2009
Q1 Q2 Q3 Q4 Total
U.S/Canada Net Sales $ 10.0 $ 9.7 $ 10.4 $ 9.0 $ 39.1
Ex. U.S/Canada Net Sales 17.8 19.4 19.4 16.5 73.1
Global Net Sales $ 27.8 $ 29.1 $ 29.8 $ 25.5 $ 112.2
Brazil Purchase* $ 7.1 $ 8.0 $ 7.8 $ 7.6 $ 30.4
2008
Q1 Q2 Q3 Q4 Total
U.S/Canada Net Sales $ 17.0 $ 16.1 $ 14.9 $ 16.1 $ 64.2
Ex. U.S/Canada Net Sales 25.7 22.2 30.6 24.4 102.8
Global Net Sales $ 42.7 $ 38.3 $ 45.5 $ 40.5 $ 167.0
Brazil Purchase* - - $ 11.4 $ 10.0 $ 21.4
(numbers may not add due to rounding)
*included in Ex. U.S/Canada Net Sales and Global Net Sales
Trimeris Announces That Arigene Intends to Terminate Tender Offer
Trimeris, Inc. (Nasdaq
: TRMS) (“Trimeris”) today announced that in connection with the Agreement and Plan of Merger dated October 2, 2009, as amended, by and among Trimeris, Arigene Co., Ltd. and RTM Acquisition Company (“Arigene” and “Purchaser,” respectively) (the “Merger Agreement”), Arigene has informed Trimeris through counsel that Arigene intends to terminate the tender offer for all of Trimeris’ outstanding shares of common stock because Arigene was unable to secure sufficient financing for purposes of funding the tender offer. The tender offer expired on Monday, December 28, 2009
Shortly after entering into the November 17, 2009 amendment to the Merger Agreement which extended the tender offer to December 28, 2009, Trimeris obtained payment of the $12 million reverse termination fee payable to Trimeris under the Merger Agreement. Notwithstanding Arigene’s termination of the tender offer, Trimeris will retain the benefit of the receipt of such fee, net of transaction, advisors’ and legal fees incurred in connection with entering into the Merger Agreement. Trimeris is evaluating its other rights and remedies under the Merger Agreement given the present circumstances
Trimeris intends to continue to actively manage its operations so as to maximize cash flow attributable to its commercial product FUZEON®. FUZEON® is distributed and sold by Trimeris’ commercial partner F. Hoffman La-Roche, Ltd. Trimeris will also seek additional opportunities to enhance shareholder value consistent with its previously elaborated strategy
About Trimeris, Inc. Trimeris, Inc. (Nasdaq: TRMS) is a biopharmaceutical company engaged in the commercialization of 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
Acquisition off: Arigene Co. (067850.KQ), a South Korean maker of medical equipment, terminated its tender offer for the outstanding common stock of biopharmaceutical company Trimeris because it wasn't able to secure sufficient financing. Trimeris shares dropped 20% to $2.55 premarket.
Trimeris Reports Financial Results for the Third Quarter 2009
Press Release
Source: Trimeris, Inc.
On 4:00 pm EST, Thursday November 12, 2009
Companies:Trimeris Inc.
DURHAM, N.C.--(BUSINESS WIRE)--Trimeris, Inc. (Nasdaq: TRMS - News) (“Trimeris” or the “Company”) today announced financial results for the three months ended September 30, 2009, reporting net income of $1.6 million, or $0.07 per share, compared with $3.6 million, or $0.16 per share, for the three months ended September 30, 2008. This result was primarily driven by decreased FUZEON® sales and an increase in tax expense, offset, in part, by lower operating expenses.
For the nine months ended September 30, 2009, the Company reported net income of $5.1 million, or $0.23 per share, compared with $6.5 million, or $0.29 per share for the nine months ended September 30, 2008.
Royalty revenue for the quarter ended September 30, 2009 was $2.1 million compared with $3.4 million for the quarter ended September 30, 2008. This decrease was driven by a decrease in net FUZEON® sales outside the U.S. and Canada. Net sales of FUZEON® outside the U.S. and Canada for the third quarter of 2009 were $19.4 million, down 37 percent from $30.6 million in the third quarter of 2008.
Collaboration income for the quarter ended September 30, 2009 was $1.7 million compared with $1.8 million for the quarter ended September 30, 2008. The decrease was primarily driven by a decrease in net sales of FUZEON® in the U.S and Canada offset, in part, by reduced selling and marketing expenses. Net sales of FUZEON in the U.S. and Canada for the third quarter of 2009 were $10.4 million, down 31 percent from $14.9 million in the third quarter of 2008.
Operating expenses for the quarter ended September 30, 2009 of $1.7 million compared with $1.9 million for the quarter ended September 30, 2008. The decrease was primarily driven by reduced business activities including research and development offset, in part, by increased costs related to the negotiation of the Company’s previously announced agreement and plan of merger with Arigene Co., Ltd. and RTM Acquisition Company as further described below.
The income tax provision for the quarter ended September 30, 2009 was $833,000 compared with $47,000 for the quarter ended September 30, 2008. This increase was driven by an “ownership change” as defined under Section 382 of the Internal Revenue Code of 1986, as amended, which occurred in December 2008. The effects of this ownership change were the imposition of a $457,000 annual limitation on the use of net operating loss carryforwards, tax credits and built-in loss items attributable to periods before the ownership change. Earnings in excess of the annual limitation will now be subject to corporate income taxes.
Cash, cash equivalents and investment securities available-for-sale totaled $35.6 million at September 30, 2009, compared to $31.6 million at December 31, 2008.
As previously announced, the Company has signed an agreement and plan of merger with Arigene Co., Ltd., a Korean corporation (“Arigene”), pursuant to which, upon completion of a tender offer for the outstanding shares of common stock of the Company, the Company will become a wholly-owned subsidiary of Arigene. The Company has previously filed a Schedule 14D-9 Solicitation/Recommendation Statement and amendments thereto with the Securities and Exchange Commission containing additional information regarding the tender offer and merger.
Earnings Conference Call
The Company announced today that it will not be conducting a conference call in connection with this earnings release.
About Trimeris, Inc.
Trimeris, Inc. (Nasdaq: TRMS - News) is a biopharmaceutical company engaged in the commercialization of 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.
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 the Company’s drug candidates; the market for HIV therapeutics is very competitive with regular new product entries that could affect the sales of the Company’s products; the results of the Company’s previous clinical trials are not necessarily indicative of future clinical trials; and the Company’s 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 13, 2009.
Trimeris, Inc.
Statements of Operations
[in thousands, except per share amounts]
(unaudited)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2009 2008 2009 2008
Revenue:
Milestone revenue $ 67 $ 67 $ 199 $ 199
Royalty revenue 2,141 3,373 6,251 8,663
Collaboration income [1] 1,702 1,756 5,555 6,154
Total revenue and collaboration income 3,910 5,196 12,005 15,016
Operating expenses:
Research and development - 367 - 2,923
General and administrative 1,669 1,519 4,805 5,778
(Gain) loss on disposal of equipment - (10 ) (23 ) 496
Total operating expenses 1,669 1,876 4,782 9,197
Operating income 2,241 3,320 7,223 5,819
Other income (expense)
Interest income 59 397 338 1,756
Gain/(loss) on investments 241 (15 ) 298 (703 )
Interest expense (64 ) (96 ) (192 ) (285 )
Total other income (expense) 236 286 444 768
Income before taxes 2,477 3,606 7,667 6,587
Income tax provision 833 47 2,612 110
Net income $ 1,644 $ 3,559 $ 5,055 $ 6,477
Basic net income per share $ 0.07 $ 0.16 $ 0.23 $ 0.29
Diluted net income per share $ 0.07 $ 0.16 $ 0.23 $ 0.29
Weighted average
shares outstanding – basic
22,320
22,186
22,297
22,180
Weighted average
shares outstanding - diluted
22,320
22,271
22,297
22,270
Dividends declared per common share -- -- -- $ 1.50
Notes:
[1] Collaboration income represents the Company’s share of the net operating results from the sale of FUZEON® in the United States and Canada under the Company’s Development and License Agreement with F.Hoffmann-La Roche, Ltd. (“Roche”), the Company’s collaboration partner. These net operating results consist of net sales less cost of goods (gross margin), less selling and marketing expenses, other costs related to the sale of FUZEON® and development expenses or post marketing commitments.
On January 1, 2009, the Company adopted Financial Accounting Standards Board Emerging Issues Task Force Issue Number 07-1 “Accounting for Collaborative Arrangements,” which falls under the guidance of Accounting Standards Codification Topic 808, "Collaborative Arrangements." As a result, all development expenses generated at Roche related to FUZEON® are included in the Company’s collaboration income. For the three months ended September 30, 2009 and 2008, the Company’s share of the development expenses of $62,000 and $205,000, respectively, was included in the Company’s collaboration income. For the nine months ended September 30, 2009 and 2008, the Company’s share of the development expenses of $594,000 and $716,000, respectively, was included in the Company’s collaboration income. In previous periods, such expenses were included in research and development expenses and have been reclassified to conform to the current presentation.
The Company has entered into negotiations with Roche, in accordance with the Development and License Agreement, related to excess capacity charges and cost of goods sold variances for 2008 and overall cost of goods sold for 2009. Accordingly, the Company cannot accurately determine if cost of goods sold as a percentage of net sales will increase, decrease or remain the same in the future. Although active discussions are on-going, the Company cannot be certain when a final resolution will be reached. Depending upon the resolution of the Company’s negotiations with Roche, cost of goods sold may increase or decrease in future periods.
During 2008, the Company recorded a reserve for 2008 excess capacity charges in the amount of $4.1 million to be shared equally between Roche and the Company. In the first quarter of 2009, Roche informed the Company that actual excess capacity charges for 2008 were $1.9 million. The difference of $2.2 million has been recorded as a credit to cost of goods sold for the first quarter of 2009. The Company’s share of this credit was $1.1 million. The Company is disputing with Roche the remainder of the excess capacity charges for 2008. The resolution of this dispute may result in an additional credit to cost of goods sold for the collaboration in future periods.
Trimeris, Inc.
Condensed Balance Sheets
[$ in thousands]
(unaudited)
September 30,
2009
December 31,
2008
Assets
Cash, cash equivalents and short-term investment securities available-for-sale $ 35,617 $ 28,750
Other current assets 3,185 3,334
Total current assets 38,802 32,084
Long-term investment securities available-for-sale - 2,827
Total other assets 9,427 9,301
Total assets $ 48,229 $ 44,212
Liabilities and Stockholders’ Equity
Total current liabilities $ 1,594 $ 3,541
Long term portion of deferred revenue 1,105 1,304
Accrued marketing costs 18,463 18,271
Accrued compensation – long-term - 74
Total liabilities 21,162 23,190
Total stockholders’ equity 27,067 21,022
Total liabilities and stockholders’ equity $ 48,229 $ 44,212
FUZEON Net Sales
(Recognized by Roche, the Company’s collaborative partner)
[$ in millions]
(unaudited)
Three Months Ended,** Nine Months Ended, **
September 30,
2009
September 30,
2008
September 30,
2009
September 30,
2008
United States and Canada $ 10.4 $ 14.9 $ 30.1 $ 48.0
Rest of World 19.4 30.6 56.6 78.5
Worldwide Total $ 29.8 $ 45.5 $ 86.7 $ 126.5
** may not add due to rounding
Contact:
Trimeris, Inc.Andrew Graham, Chief Financial Officer919-806-4682
Thursday, October 15, 2009, 10:42am EDT
Trimeris: Sales of AIDS drug Fuzeon drop 35%Triangle Business Journal - by Frank Vinluan
Trimeris' earnings fall
Sales of Trimeris' Fuzeon fall 39% in 4Q
New HIV treatments slash into sales of Trimeris' Fuzeon
Slumping sales, end of R&D hurt Trimeris' income
Durham drug company Trimeris, which is being acquired by a South Korean firm, saw sales of its AIDS drug Fuzeon tumble 35 percent in the third quarter compared to the same period a year ago, according to results released Wednesday after the markets closed.
The Durham company’s drug generated $29.8 million in worldwide sales in the third quarter. In North America, third quarter sales were $10.4 million, down 31 percent from $14.9 million a year ago. Outside the United States and Canada, Fuzeon sales reached $19.4 million in the quarter, down 37 percent compared to the third quarter of 2008.
Trimeris (Nasdaq: TRMS) announced on Oct. 5 that it would be acquired by South Korean company Airgene (KOSDAQ: 067850.KQ) for $81 million. Under the deal, Trimeris will become a wholly owned subsidiary of Arigene.
Trimeris co-promotes Fuzeon with Swiss pharmaceutical company Roche. Fuzeon sales have been hurt by drugs from competitors. Trimeris said it plans to release complete financial results for the third quarter in early November.
Arigene Co., Ltd. to Acquire Trimeris, Inc.
Trimeris, Inc. (“Trimeris”) (NASDAQ:TRMS) today announced that it has entered into a merger agreement with Arigene Co., Ltd., a Korean corporation traded on the Korean Securities Dealers Association Quotation System (“Arigene”) (KOSDAQ: 067850) pursuant to which Arigene has agreed to acquire Trimeris for approximately $81 million through a cash tender offer of $3.60 per share, followed by a merger to acquire all remaining outstanding Trimeris shares at the same price per share paid in the tender offer. The tender offer price represents an approximately 55% premium to Trimeris’ average stock price over the last three month period ending on October 1, 2009 and an approximately 40% premium to the closing price of Trimeris’ common stock on October 1, 2009.
Stockholders of Trimeris representing approximately 36% of shares outstanding have executed voting agreements in support of the transaction. The transaction has been approved by the boards of directors of Trimeris and Arigene. The parties expect the tender offer and merger to be completed in the fourth quarter of 2009.
The tender offer will expire at midnight Eastern Time on the 20th business day following and including the tender offer commencement date, unless extended in accordance with the terms of the merger agreement and the applicable rules and regulations of the U.S. Securities and Exchange Commission. Following the tender offer, if successful, RTM Acquisition Company, a wholly owned subsidiary of Arigene, will be merged with and into Trimeris, with Trimeris continuing as the surviving corporation. As a result of the merger, Trimeris will become a wholly-owned subsidiary of Arigene.
The consummation of the tender offer is subject to the satisfaction or waiver of certain conditions, including, among others: (i) a majority of outstanding Trimeris shares having been tendered in response to the offer, (ii) the absence of any injunction or act by any governmental agency prohibiting the transaction, (iii) there not having been a material adverse change with respect to Trimeris, and (iv) other customary conditions. The tender offer is not subject to a financing condition.
Advisors
Wilmer Cutler Pickering Hale and Dorr LLP is acting as legal advisor to Trimeris for this transaction. HCube Advisors, Inc. acted as financial advisor and K&L Gates, LLP is acting as legal advisor to Arigene.
About Trimeris, Inc.
Trimeris, Inc. (Nasdaq: TRMS) is a biopharmaceutical company engaged in the commercialization of 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.
About Arigene Co., Ltd.
Arigene Co., Ltd. (KOSDAQ: 067850) is a developer, manufacturer and marketer of Ubiquitous Healthcare Systems (U-Healthcare) and related medical equipment in Korea. With its planned acquisition of Trimeris, Inc., Arigene is expanding its business to the broader biotechnology industry.
Trimeris Reports Financial Results for the First Quarter 2009
On Friday May 8, 2009, 4:00 pm EDT
DURHAM, N.C.--(BUSINESS WIRE)--Trimeris, Inc. (Nasdaq: TRMS - News) today announced financial results for the quarter ended March 31, 2009, reporting net income of $2.1 million, or $0.10 per share compared with $2.3 million, or $0.10 per share for the quarter ended March 31, 2008. This result was primarily driven by decreased FUZEON® sales and an increase in tax expense offset, in part, by reduced operating expenses and a credit to cost of goods sold included in collaboration income.
Royalty revenue for the quarter ended March 31, 2009 was $2.0 million compared with $2.8 million for the quarter ended March 31, 2008. This decrease was driven by a decrease in net FUZEON® sales outside the U.S. and Canada. Net sales of FUZEON® outside the U.S. and Canada for the first quarter of 2009 were $17.8 million, down 31 percent from $25.7 million in the first quarter of 2008.
Collaboration income for the quarters ended March 31, 2009 and March 31, 2008 was $2.4 million for each quarter. The decrease in net sales of FUZEON® in the U.S and Canada in 2009 was offset primarily by decreased selling and marketing expenses and a credit to cost of goods sold of $1.1 million (see note 1 to the Statement of Operations). Net sales of FUZEON® in the U.S. and Canada for the first quarter of 2009 were $10.0 million, down 41 percent from $17.0 million in the first quarter of 2008.
Operating expenses for the quarter ended March 31, 2009 were $1.4 million compared with $2.7 million for the quarter ended March 31, 2008. This decrease was primarily driven by a decrease in research and development expenses as the Company no longer staffs any research and development functions.
The income tax provision for the quarter ended March 31, 2009 was $1.0 million compared with $257,000 for the quarter ended March 31, 2008. This increase was driven by an ownership change under Section 382 of the Internal Revenue Code of 1986, as amended, which occurred in December 2008. The effects of this ownership change were the imposition of a $457,000 annual limitation on the use of net operating loss carryforwards, tax credits and built-in loss items attributable to periods before the change. Earnings over the annual limitation will now be subject to corporate income taxes.
Cash, cash equivalents and investment securities available-for-sale totaled $33.1 million at March 31, 2009, compared to $31.6 million at December 31, 2008.
Wholesaler Inventory
Historically in the U.S. the Company has observed that wholesaler inventory levels of FUZEON® generally increase at the end of the fourth quarter; that is wholesaler inventory levels generally are above the average wholesaler inventory of approximately 25 days.
Based on information provided by Roche, our collaboration partner, we believe average wholesaler inventory at the end of 2008 was approximately 53 days but that by March 31, 2009 the wholesaler inventory had returned to the average of 25 days. The Company believes that the decrease in wholesaler inventory impacted sales for the first quarter of 2009.
2009 Guidance
The Company updated its guidance that it expects its total operating expenses in 2009 to be in the range of $4.5 million to $6.0 million.
Earnings Conference Call
The Company announced today that it will not be conducting a conference call in connection with this earnings release.
Trimeris Has Further to Fall
Tuesday August 19, 12:41 pm ET
By Grant Zeng, CFA
Sales of Trimeris, Inc.'s (NasdaqGM: TRMS - News) lead drug Fuzeon -- its first-generation fusion inhibitor for HIV -- has been declining dramatically since 1Q08 due to fierce competition from Selzentry and Isentress. The collaboration amendment with Roche and several management changes further cast a shadow on the company's future. We maintain our Sell rating on Trimeris with a $3.50 price target.
U.S. sales of Fuzeon came in at only $16.1 million in the second quarter of 2008, down 51 percent year-over-year. Ex-U.S. sales of Fuzeon were $22.2 million, down 23.8 percent year-over-year. As a result, Trimeris booked only $4.7 million in revenue in 2Q08, a decline of 48% year-over-year. Net income in 2Q08 was $2.5 million ($0.11 per share) on an adjusted basis compared to net income of $4.6 million ($0.21 per share) one year ago.
The Biojector 2000 was expected to be approved in 2008. The device was expected to make Fuzeon more convenient for intake and drive the drug s sales. However, in October 2007, Trimeris and Roche announced the withdrawal of the supplemental New Drug Application (sNDA) for Biojector 2000 due to a significant delay in receiving approval of Biojector 2000.
Further, we don't think the dividend and the share repurchase program will create value to shareholders unless the company acquires meaningful late-stage drug candidates. We remain clueless as to how the management will drive topline growth in the coming years.
Trimeris Reports Second Quarter 2008 FUZEON(R) Sales Results
Monday July 21, 9:00 am ET
DURHAM, N.C.--(BUSINESS WIRE)--Trimeris, Inc. (NASDAQ:TRMS - News) today announced worldwide net sales of FUZEON for the second quarter of 2008 were $38.3 million, down 38 percent from $62.0 million in the second quarter of 2007. Net sales of FUZEON in the U.S. and Canada for the second quarter of 2008 were $16.1 million, down 51 percent from $32.9 million in the second quarter of 2007. Net sales of FUZEON outside the U.S. and Canada for the second quarter of 2008 were $22.2 million, down 24 percent from $29.2 million in the second quarter of 2007. All sales of FUZEON are recorded by F. Hoffmann-La Roche Ltd, ("Roche"), Trimeris' collaborative partner.
Net sales of FUZEON for the first half of 2008 were $81.0 million, a decrease of 36 percent from $126.3 million in the first half of 2007. Net sales of FUZEON in the U.S. and Canada for the first half of 2008 were $33.1 million, a decrease of 47 percent from $62.2 million in the first half of 2007. Net sales of FUZEON outside the U.S. and Canada for the first half of 2008 were $47.9 million, a decrease of 25 percent from $64.1 million in the first half of 2007.
The release of complete financial results for the second quarter of 2008 will take place in early August 2008.
Net Fuzeon Sales
The table below presents net FUZEON sales by quarter beginning in the first quarter of 2006:
(millions)
2008
Q1 Q2 Q3 Q4 Total
U.S/Canada Net Sales $ 17.0 $ 16.1 - - $ 33.1
Ex. U.S/Canada Net Sales 25.7 22.2 - - 47.9
Global Net Sales $ 42.7 $ 38.3 - - $ 81.0
Brazil Purchase - - - - -
2007
Q1 Q2 Q3 Q4 Total
U.S/Canada Net Sales $ 29.3 $ 32.9 $ 30.6 $ 31.5 $ 124.3
Ex. U.S/Canada Net Sales 35.0 29.2 43.3 35.0 142.5
Global Net Sales $ 64.3 $ 62.0 $ 73.9 $ 66.5 $ 266.8
Brazil Purchase $ 6.0 - $ 13.8 $ 7.3 $ 27.1
2006
Q1 Q2 Q3 Q4 Total
U.S/Canada Net Sales $ 27.4 $ 31.1 $ 33.5 $ 42.2 $ 134.2
Ex. U.S/Canada Net Sales 28.0 26.2 29.5 31.1 114.8
Global Net Sales $ 55.4 $ 57.2 $ 63.0 $ 73.3 $ 249.0
Brazil Purchase $ 5.3 - $ 4.4 $ 4.7 $ 14.3
(numbers may not add due to rounding)
About Trimeris, Inc.
Trimeris, Inc. (NASDAQ:TRMS - News) 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.
Form 8-K for TRIMERIS INC
9-Jul-2008
Other Events
Item 8.01. Other Events
On July 7, 2008, the Company was informed by its collaborative partner, Hoffmann-La Roche, Ltd. ("Roche") that, effective July 7, 2008, Roche had increased the wholesale acquisition cost of a one-year supply of FUZEON by 6%. Under the Company's collaboration agreement with Roche, Roche retains sole responsibility for the pricing of FUZEON.
Anyone notice the buyins.com release listing TRMS and several other stocks new to the Reg Sho list. The ex-dividend date has passed and I wonder if the there will be any further upside action in the near future considering the company plans to buy back 17 million shrs?
Trimeris Reports Financial Results for the First Quarter 2008
Thursday May 8, 4:13 pm ET
-- Company reports earnings of $0.10 per share for the first quarter of 2008
-- Cash and investments increase to $80.0 million up from $69.6 million at December 31, 2007
-- Company announces special cash dividend and share repurchase program
MORRISVILLE, N.C.--(BUSINESS WIRE)--Trimeris, Inc. (Nasdaq: TRMS - News) today announced financial results for the quarter ended March 31, 2008, reporting net income of $2.3 million, or $0.10 per share. This compares to adjusted net income for the quarter ended March 31, 2007 of $3.8 million, or $0.17 per share, excluding the impact of two non-recurring events in the first quarter of 2007, or $8.2 million, or $0.37 per share on a GAAP basis, including these events. As previously reported, Trimeris recognized two one-time events in the first quarter of 2007, the acceleration of $8.7 million of revenue for past milestone payments received from Roche and a $4.3 million charge for a reduction-in-force. A reconciliation and explanation of the differences between GAAP and adjusted earnings is detailed in the table below.
Total revenue and collaboration income for the quarter ended March 31, 2008 totaled $5.6 million. In the first quarter of 2007, total revenue and collaboration income, excluding the non-recurring acceleration of milestone revenues, was $8.7 million. This decrease was primarily driven by lower worldwide FUZEON® sales. Total revenue and collaboration income in the first quarter of 2007, including the one-time acceleration of milestone revenues from Roche, was $17.4 million.
Total operating expenses for the quarter ended March 31, 2008 were $3.0 million compared with $9.6 million in the first quarter of 2007, which included a $4.3 million charge for the reduction-in-force recorded during the first quarter of 2007. First quarter 2008 operating expenses have further declined as a result of the Company’s 2008 strategic plan which significantly reduced personnel levels at Trimeris compared to the first quarter of 2007.
Cash, cash equivalents and investment securities available-for-sale totaled $80.0 million at March 31, 2008, compared to $69.6 million at December 31, 2007. As previously reported, in the first quarter of 2008, the Company received approximately $4.7 million from Roche related to a credit derived from collaboration calculations of costs of goods sold. This amount was included in our other current assets as of December 31, 2007.
In addition, based on a preliminary analysis of changes in our common stock ownership, the Company believes that the threshold for an "ownership change" under Section 382 of the Internal Revenue Code has been surpassed. If an ownership change has occurred, this would limit our utilization of NOL's generated prior to such ownership change. These financial statements included for the first quarter of 2008 have been prepared based on an assumption that an ownership change occurred during the first quarter of 2008.
Special Cash Dividend and Stock Repurchase Program
As part of its plan to return up to $50 million to shareholders by the end of 2008, the Board of Directors has declared a one-time special cash dividend of $1.50 per share of common stock to stockholders of record on May 22, 2008. The aggregate dividend payment will total approximately $33 million based on the number of shares of common stock currently outstanding. The dividend will be paid on June 6, 2008.
As a further step in this plan, the Board of Directors authorized a share repurchase program to purchase up to $17.0 million of Trimeris common stock from time to time on the open market, in block trades or otherwise.
The timing of repurchases and the amount of any shares repurchased will be determined by Trimeris management based on its evaluation of market conditions and other factors. The repurchase program may be suspended or discontinued at any time. Any repurchased shares will be available for use in connection with Trimeris stock plans and for other corporate purposes.
Both the special cash dividend and any repurchases under the stock repurchase program will be funded using Trimeris working capital. As of March 31, 2008, Trimeris had cash, cash equivalents and investment securities available-for-sale of approximately $80.0 million and approximately 22.2 million shares of common stock outstanding.
2008 and 2009 Guidance
As a convenience to investors, Trimeris is providing its outlook for 2008. This outlook is based upon numerous assumptions, all of which are subject to certain risks and uncertainties. For a discussion of the risks and uncertainties associated with these forward-looking statements, please see the Trimeris Safe Harbor Statement below.
The Company reiterates its previous guidance that total operating expenses are expected to be in the range of $10.0 million to $14.0 million in 2008, down from $24.0 million in 2007. The Company expects total operating expenses in 2009 to be in the range of $5.0 million to $10.0 million.
Trimeris to give shareholders most of its cash:
http://triangle.bizjournals.com/triangle/stories/2008/05/05/daily37.html?ana=yfcpc
Zacks.com
Sell Trimeris to $5 Level
Thursday April 17, 2:37 pm ET
By Grant Zeng, CFA
Trimeris, Inc. (NasdaqGM: TRMS - News) develops therapeutic agents for the treatment of viral diseases based on its fusion inhibition technology that blocks viral entry into host cells. The collaboration amendment with Roche and several management changes have cast a shadow on the company's future.
The company registered a 34 percent year-over-year decline in Fuzeon sales for the first quarter of 2008. We attribute the decline to the withdrawal of the sNDA for Biojector 2000 along with approvals of competitors Selzentry and Isentress. The decline may be steeper going forward.
With the company's top-line shrinking by 27 percent by 2011, we maintain our Sell rating on Trimeris with a $5.00 price target. At this point, it's very difficult to value the stock. We believe qualitative factors prevail currently. There are many uncertainties about Trimeris due to the management change and collaboration amendment with Roche.
As such, we maintain our Sell rating on Trimeris given the lack of visibility on the company's long-term growth prospects. Our $5.00 price target corresponds to a P/E ratio of 21.8x to our 2010 EPS of $0.33, discounted back at 20 percent for 2 years. This is a huge discount to biotech peers, but it is warranted due to the recent corporate developments and changes in the competitive landscape.
Trimeris Reports First Quarter 2008 FUZEON(R) Sales Results
Trimeris, Inc. (Nasdaq: TRMS) today announced worldwide net sales of FUZEON for the first quarter of 2008 were $42.7 million, down 34 percent from $64.3 million in the first quarter of 2007. Net sales of FUZEON in the U.S. and Canada for the first quarter of 2008 were $17.0 million, down 42 percent from $29.3 million in the first quarter of 2007. Net sales of FUZEON outside the U.S. and Canada for the first quarter of 2008 were $25.7 million, down 26 percent from $35.0 million in the first quarter of 2007. All sales of FUZEON are recorded by F. Hoffmann-La Roche Ltd, ("Roche"), Trimeris' collaborative partner.
The release of complete financial results for the first quarter of 2008 will take place in early May 2008.
Net Fuzeon Sales
The table below presents net FUZEON sales by quarter beginning in the first quarter of 2006:
(millions)
2008
Q1 Q2 Q3 Q4 Total
U.S/Canada Net Sales $ 17.0 - - - $ 17.0
Ex. U.S/Canada Net Sales 25.7 - - - 25.7
Global Net Sales $ 42.7 - - - $ 42.7
Brazil Purchase - - - - -
2007
Q1 Q2 Q3 Q4 Total
U.S/Canada Net Sales $ 29.3 $ 32.9 $ 30.6 $ 31.5 $ 124.3
Ex. U.S/Canada Net Sales 35.0 29.2 43.3 35.0 142.5
Global Net Sales $ 64.3 $ 62.0 $ 73.9 $ 66.5 $ 266.8
Brazil Purchase $ 6.0 - $ 13.8 $ 7.3 $ 27.1
2006
Q1 Q2 Q3 Q4 Total
U.S/Canada Net Sales $ 27.4 $ 31.1 $ 33.5 $ 42.2 $ 134.2
Ex. U.S/Canada Net Sales 28.0 26.2 29.5 31.1 114.8
Global Net Sales $ 55.4 $ 57.2 $ 63.0 $ 73.3 $ 249.0
Brazil Purchase $ 5.3 - $ 4.4 $ 4.7 $ 14.3
(numbers may not add due to rounding)
About Trimeris, Inc.
4:03PM Trimeris misses by $0.02, beats on revs (TRMS) 5.96 unch : Reports Q4 (Dec) earnings of $0.18 per share, excluding non-recurring items, $0.02 worse than the First Call consensus of $0.20; revenues fell 0.6% year/year to $12.5 mln vs the $9.6 mln consensus. After June 30, 2008, the Company expects that it will no longer staff any research or development functions. As a result, total operating expenses are expected to be in the range of $10.0 mln to $14.0 mln in 2008 down from $24.0 mln in 2007. The Company expects total operating expenses in 2009 to be in the range of $5.0 mln to $10.0 mln.
Trimeris shareholder HealthCor urges co. to consider sale
Mon Feb 4, 2008 1:15pm EST
Feb 4 (Reuters) - Trimeris Inc (TRMS.O: Quote, Profile, Research) shareholder HealthCor Management urged it to consider sale of the company and proposed representation for two of its members on the board.
In a letter to the Trimeris management dated Feb 1, HealthCor, which holds a 17.77 percent stake in the company, also said Trimeris should not pursue acquisitions and should return its excess cash to the shareholders. (Reporting by Esha Dey in Bangalore; Editing by Anupama Dwivedi)
Trimeris Reports 2007 FUZEON(R) Sales Results
Tuesday January 29, 4:05 pm ET
MORRISVILLE, N.C.--(BUSINESS WIRE)--Trimeris, Inc. (NASDAQ:TRMS - News) today announced worldwide net sales of FUZEON for the year were $266.8 million, an increase of 7 percent from $249.0 million in 2006. Net sales of FUZEON in the U.S. and Canada for 2007 were $124.3 million, down 7 percent from $134.2 million in 2006. Net sales of FUZEON outside the U.S. and Canada for 2007 were $142.5 million, up 24 percent from $114.8 million in 2006. All sales of FUZEON are recorded by F. Hoffmann-La Roche Ltd, ("Roche"), Trimeris' collaborative partner.
For the fourth quarter of 2007, worldwide net sales of FUZEON were $66.5 million, down 9 percent from $73.3 million in the fourth quarter of 2006. Net sales of FUZEON in the U.S. and Canada were $31.5 million, down 25 percent from $42.2 million in the fourth quarter of 2006. Net sales of FUZEON outside the U.S. and Canada were $35.0 million, up 13 percent from $31.1 million in the fourth quarter of 2006.
The release of complete financial results for 2007 will take place in early March 2008.
Net FUZEON Sales
The table below presents net FUZEON sales by quarter beginning in the first quarter of 2005:
(millions)
2007
Q1 Q2 Q3 Q4 Total
U.S/Canada Net Sales $ 29.3 $ 32.9 $ 30.6 $ 31.5 $ 124.3
Ex. U.S/Canada Net Sales 35.0 29.2 43.3 35.0 142.5
Global Net Sales $ 64.3 $ 62.0 $ 73.9 $ 66.5 $ 266.8
Brazil Purchase $ 6.0 - $ 13.8 $ 7.3 $ 27.1
2006
Q1 Q2 Q3 Q4 Total
U.S/Canada Net Sales $ 27.4 $ 31.1 $ 33.5 $ 42.2 $ 134.2
Ex. U.S/Canada Net Sales 28.0 26.2 29.5 31.1 114.8
Global Net Sales $ 55.4 $ 57.2 $ 63.0 $ 73.3 $ 249.0
Brazil Purchase $ 5.3 - $ 4.4 $ 4.7 $ 14.3
2005
Q1 Q2 Q3 Q4 Total
U.S/Canada Net Sales $ 23.3 $ 25.2 $ 28.4 $ 35.8 $ 112.7
Ex. U.S/Canada Net Sales 19.1 28.7 20.5 27.1 95.5
Global Net Sales $ 42.5 $ 53.9 $ 48.9 $ 62.9 $ 208.2
Brazil Purchase - $ 7.3 - $ 5.5 $ 12.8
(numbers may not add due to rounding)
http://biz.yahoo.com/bw/080129/20080129006312.html?.v=1
Trimeris Announces 2008 Strategic Plan
Monday December 10, 4:00 pm ET
-- The Strategic Plan is Designed to Maximize Cash Flows from FUZEON(R), While Also Advancing TRI-1144 to a Value-Creating Milestone
-- Research and Development Functions to be Eliminated
MORRISVILLE, N.C.--(BUSINESS WIRE)--Trimeris, Inc. (NASDAQ: TRMS - News) today announced its strategic plan for 2008 that is designed to maximize cash flows from FUZEON while also advancing TRI-1144 to a value-creating milestone.
The Company plans to file an Investigational New Drug application (“IND”) for TRI-1144, the Company’s next-generation fusion inhibitor, as well as plans to initiate and complete a single ascending dose (SAD) Phase I clinical trial for TRI-1144 in the first half of the year.
In connection with the 2008 plan, Trimeris has immediately implemented a program to reduce the Company’s workforce. Following the completion of the Phase I SAD study for TRI-1144, the Company expects that it will no longer staff any research or development functions. As a result, total operating expenses, excluding restructuring costs, are expected to be in the range of $10.0 million to $14.0 million in 2008, down from approximately $21.0 to $23.0 million in 2007.
"While market conditions and the significant risks involved in research and development have required the company to shift strategic direction, Trimeris still possesses significant financial assets that include substantial cash and revenue streams from the sale of FUZEON in collaboration with Roche,” said Martin Mattingly, Chief Executive Officer of Trimeris.
“In addition, we believe that TRI-1144 has the potential to be a valuable product for the treatment of HIV. We look forward to generating human data by filing an IND in the first quarter of 2008 followed shortly by a Phase I clinical trial. During this transition period we will evaluate a full range of options for maximizing shareholder value, including strategic transactions
http://biz.yahoo.com/bw/071210/20071210006073.html?.v=1
Nice fund buying of TRMS stock over the past few weeks:
http://www.form4oracle.com/company?cik=0000911326&ticker=TRMS
Trimeris Appoints Martin A. Mattingly as Chief Executive Officer
Thursday November 15, 9:00 am ET
MORRISVILLE, N.C.--(BUSINESS WIRE)--Trimeris, Inc. (NASDAQ:TRMS - News) today announced the appointment of Martin A. Mattingly, Pharm.D. as Chief Executive Officer, effective immediately. Dr. Mattingly will also join the Company's board of directors.
“The Trimeris Board is extremely excited by Martin’s decision to join the Company. Martin’s hands-on experience in commercializing HIV products in crowded markets and in maximizing the value of these products as they mature is an ideal fit for Trimeris. During his tenure at Agouron and Pfizer, Martin was actively involved in both the successful launch of VIRACEPT® (nelfinavir mesylate) and its life-cycle management as numerous competitors entered the market,” said Julian Baker, member of the Company’s board of directors.
Dr. Mattingly brings significant experience as a biotechnology and pharmaceutical executive. He was most recently President and Chief Executive Officer of Ambrx Pharmaceuticals. Prior to that, Dr. Mattingly served as Executive Vice President and Chief Operating Officer at CancerVax. From 1996 to 2003, he provided senior leadership in various management positions at Agouron Pharmaceuticals and Pfizer. These assignments included General Manager for the Agouron HIV division; Vice President, Product Development Group; and Vice President, Global Marketing Planning. From 1983 to 1996, Dr. Mattingly held various positions in oncology marketing and sales management at Eli Lilly and Company. He holds a Doctor of Pharmacy degree from the University of Kentucky.
“I am very pleased and excited to be a member of the Trimeris team,” said Dr. Mattingly. “The Company has significant assets, including the breakthrough HIV/AIDS treatment FUZEON. I look forward to working with the management team to maximize shareholder value".
also 10-Q out
http://biz.yahoo.com/e/071109/trms10-q.html
http://biz.yahoo.com/zacks/071029/9968.html?.v=1
Downgrading TRMS from Hold to Sell
Monday October 29, 5:07 pm ET
By Zacks Equity Research
Zacks senior pharmaceutical analyst Grant Zeng, CFA has decided to downgrade the shares of healthcare company Trimeris, Inc. (NasdaqGM: TRMS - News) from a Hold to Sell. Here we bring you some of the reasons behind his argument:
ADVERTISEMENT
\'Trimeris, Inc. develops a new class of therapeutic agents for the treatment of viral diseases based on its fusion inhibition technology that blocks viral entry into host cells. We are concerned about the decline in the U.S. sales of Fuzeon. Additionally, withdrawal of the supplemental New Drug Application (sNDA) for Biojector 2000 together with approvals of competitors Selzentry and Isentress are expected to adversely impact Fuzeon sales going forward.
\'We downgrade the shares of Trimeris from Hold to Sell with a target price of $5.50 based on the management change in March 2007, collaboration amendment with Roche (Other OTC: RHHBY.PK - News), withdrawal of the sNDA application for Biojector 2000 and declining U.S. sales of Fuzeon. To add to the company's woes, the impressive growth in ex-U.S. sales of Fuzeon is being driven by the bulk orders placed by the Brazilian government.
\'We remain concerned about the competition especially from Pfizer's (NYSE: PFE - News) Selzentry and Merck's (NYSE: MRK - News) Isentress. Selzentry has been approved in both the U.S. and European markets while Isentress received FDA approval in October 2007.
\'At this point, it's very difficult to value the stock. We believe qualitative factors prevail currently. There are many uncertainties about Trimeris due to the management change and collaboration amendment with Roche. As such, we downgrade Trimeris from Hold to Sell given the lack of visibility on the company's long-term growth prospects.
\'EPS should decline to $0.14 in 2009 from $0.67 in 2007. Our $5.50 price target corresponds to a P/E ratio of 8.2x to our 2007 EPS of $0.67 and 39 x our estimated EPS of $0.14 in 2009. This is a huge discount to biotech peers, but it is warranted due to the recent corporate developments and changes in the competitive landscape.\
October 15, 2007 - 3:02 PM EST
Trimeris Reports Third Quarter 2007 FUZEON(R) Sales Results
* Global sales in the third quarter grew 17 percent over 2006
* U.S/Canada sales in the third quarter declined 9 percent over 2006
* Ex U.S/Canada sales in the third quarter grew 47 percent over 2006
Trimeris, Inc. (Nasdaq: TRMS) today announced worldwide net sales of FUZEON for the third quarter of 2007 were $73.9 million, an increase of 17 percent from $63.0 million in the third quarter of 2006. Net sales of FUZEON in the U.S. and Canada for the third quarter of 2007 were $30.6 million, a decrease of 9 percent from $33.5 million in the third quarter of 2006. Net sales of FUZEON outside the U.S. and Canada for the third quarter of 2007 were $43.3 million, an increase of 47 percent from $29.5 million in the third quarter of 2006. All sales of FUZEON are recorded by F. Hoffmann-La Roche Ltd. ("Roche"), Trimeris' collaborative partner.
Worldwide net sales of FUZEON for the first nine months of 2007 were $200.3 million, an increase of 14 percent from $175.7 million in the first nine months of 2006. Net sales of FUZEON in the U.S. and Canada for the first nine months of 2007 were $92.8 million, an increase of 1 percent from $92.0 million in the first nine months of 2006. Net sales of FUZEON outside the U.S. and Canada for the first nine months of 2007 were $107.5 million, an increase of 28 percent from $83.7 million in the first nine months of 2006.
The release of complete financial results for the third quarter of 2007 will take place in early November, 2007.
Net Fuzeon Sales
The table below presents net FUZEON sales by quarter beginning in the first quarter of 2005:
(millions)
2007
Q1 Q2 Q3 Q4 Total 9mth
U.S/Canada Net Sales $29.3 $32.9 $30.6 $92.8 $92.8
Ex. U.S/Canada Net Sales 35.0 29.2 43.3 107.5 107.5
Global Net Sales $64.3 $62.0 $73.9 $200.3 $200.3
Brazil Purchase $6.0 - $13.8 $19.8 $19.8
2006
Q1 Q2 Q3 Q4 Total 9mth
U.S/Canada Net Sales $27.4 $31.1 $33.5 $42.2 $134.2 $92.0
Ex. U.S/Canada Net Sales 28.0 26.2 29.5 31.1 114.8 83.7
Global Net Sales $55.4 $57.2 $63.0 $73.3 $249.0 $175.7
Brazil Purchase $5.3 - $4.4 $4.7 $14.3 $9.6
2005
Q1 Q2 Q3 Q4 Total 9mth
U.S/Canada Net Sales $23.3 $25.2 $28.4 $35.8 $112.7 $76.9
Ex. U.S/Canada Net Sales 19.1 28.7 20.5 27.1 95.5 68.4
Global Net Sales $42.5 $53.9 $48.9 $62.9 $208.2 $145.3
Brazil Purchase - $7.3 - $5.5 $12.8 $7.3
(numbers may not add due to rounding)
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.
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 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 16, 2007 and its periodic reports filed with the SEC.
Trimeris, Inc.
Andrew Graham, Director of Finance, 919-419-6050
Source: Business Wire (October 15, 2007 - 3:02 PM EST)
News by QuoteMedia
www.quotemedia.com
Trimeris sets departure date for leaders
Thursday October 11, 4:45 pm ET
Trimeris' top executives, temporary consultants brought on to turn around the drug company after its previous executives left, will leave the Morrisville concern Jan. 2.
E. Lawrence Hill, president and chief operating officer, and Daniel Ratto, chief financial officer, joined Trimeris earlier this year after former CEO and co-founder Dani Bolognesi and CFO Robert Bonczek were asked to resign from the company, which has developed an AIDS drug known as Fuzeon.
Hill and Ratto are consultants employed by California firm Hickey and Hill. Their job at Trimeris was to prepare the company for human studies of its next-generation AIDS drug, T-1144, said Andrew Graham, the company's director of finance. Trimeris plans to file for permission to start human trials on the drug in the first half of 2008.
"They were hired to do a specific job, and that was to put us in a position to file an (Investigational New Drug Application) for 1144, which they've done," Graham said. "... It's nearing the end of the time when they can add value to the company."
Still at question is whether any development can add value to Trimeris at this point.
Bolognesi and Bonczek left the company at the end of a trying 12 months that saw sales of Fuzeon come in below expectations. Also leaving were dozens of employees, who lost their jobs as a cost-cutting measure.
At the same time, the company lost the support of its drug development partner, Swiss company Roche, for T-1144.
Meanwhile, Pfizer won U.S. regulatory approval for a new AIDS drug known as Selzentry. And Merck is seeking this week approval of an AIDS treatment called Isentress. Both could take market share away from Fuzeon, which must be adminstered through painful injections.
Finally, New York investment firm HealthCor has bought nearly 19 percent of Trimeris' shares and has demanded changes. In particular, it wants Trimeris to seriously reconsider plans to develop T-1144, a course of action it calls "too expensive, lengthy and risky," and look into selling the company.
Graham said Trimeris has been in contact with HealthCor.
"The company has had communication, as it would with any large shareholder," he said. "But I'm not going to comment beyond that."
He also said Trimeris has made no decision on who will lead the company after Jan. 2.
"We're taking it one step at a time," he said. "... Right now the board's confident that we have the correct management team in place."
Isn't it interesting that Health Cor comes out pumping the company should be sold and then this news hits!
Is the fat lady preparing to sing for TRMS?
It's time for Roche to take over.
katie...
Roche and Trimeris Provide Update on Development of Alternative Administration Options for Delivery of FUZEON(R)
Companies withdraw application to market Biojector® 2000 device for use with FUZEON
Roche and Trimeris, Inc. (Nasdaq: TRMS) today provided an update on our efforts to offer a needle-free device which has been investigated for use with FUZEON® (enfuvirtide). Based on comprehensive assessment of the clinical program, as well a significant delay in achieving U.S. regulatory approval due to the time required to generate additional data, Roche and Trimeris are withdrawing a supplemental application for approval to market the Biojector® 2000 device (known as “B2000” and manufactured by Bioject Medical Technologies, Inc.) for use with FUZEON.
Importantly, Roche and Trimeris believe that patients who are currently administering FUZEON with the device through an existing program or clinical trial may continue to do so, provided that the precautions in the current FUZEON label regarding use with B2000 are followed. We recognize that B2000 is commercially available for general use.
“As part of our efforts to find administration alternatives, Roche and Trimeris have invested considerable resources to leverage the benefits of the B2000 device for use with FUZEON. While the device has shown potential benefit for some patients, we don’t believe it’s the ideal alternative delivery option for all treatment-experienced patients. We continue to review other options for administering FUZEON,” said Michelle Zupancic, Vice President, HIV, Roche. “In addition, we continue to offer Nurse Connections, a free support program that provides patients in the U.S. with personalized, in-home instruction from a highly-trained nurse.”
Facts About FUZEON
Administered via one 90 mg injection twice-daily, FUZEON is the first and only fusion inhibitor for the treatment of HIV. Unlike other HIV drugs that work after HIV has entered the human immune cell, FUZEON works outside the CD4 cell, blocking HIV from entering the cell. For this reason, FUZEON is effective in treatment-experienced patients who have developed resistance to other anti-HIV drugs, though patients may still develop resistance to FUZEON. FUZEON was granted accelerated approval by the U.S. Food and Drug Administration (FDA) in March 2003 on the basis of 24-week data, and was granted traditional (full) approval on Oct. 15, 2004 on the basis of long-term 48-week data.
FUZEON is indicated for use in combination with other antiretroviral agents for the treatment of HIV in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy.
Injection Site Reactions (ISRs): ISRs are the most common adverse events associated with FUZEON. ISRs occurred in 98% of patients studied and 4% discontinued FUZEON due to ISRs. Signs/symptoms may include pain and discomfort, hardened skin, redness, bumps, itching and swelling. Eleven percent of patients had local reactions that required analgesics or limited usual activities.
Pneumonia: An increased rate of bacterial pneumonia was observed in subjects treated with FUZEON in the Phase III clinical trials compared to the control arm. It is unclear if the increased incidence of pneumonia is related to FUZEON use. Patients with HIV infection should be carefully monitored for signs and symptoms of pneumonia. Risk factors for pneumonia included low initial CD4 cell count, high initial viral load, intravenous drug use, smoking and a prior history of lung disease.
Hypersensitivity Reactions: Systemic hypersensitivity reactions have been associated with FUZEON therapy and may recur on rechallenge. Hypersensitivity reactions have included individually and in combination: rash, fever, nausea and vomiting, chills, rigors, hypotension and elevated serum liver transaminases. Other adverse events that may be immune mediated and have been reported in subjects receiving FUZEON include primary immune complexreaction, respiratory distress, glomerulonephritis and Guillain-Barre syndrome.
Administration with Biojector®2000: Nerve pain (neuralgia and/or parethesia) lasting up to six months associated with administration at anatomical sites where large nerves course close to the skin, bruising and hematomas have occurred with the use of the Biojector 2000 needle-free device for administration of FUZEON. Patients receiving anticoagulants or persons with hemophilia, or other coagulation disorders, may have a higher risk of post-injection bleeding.
Other Adverse Events: The events most frequently reported in patients receiving FUZEON plus an optimized background regimen were diarrhea (32%), nausea (23%) and fatigue (20%). These events were seen at a lower incidence in patients taking a FUZEON-based regimen compared to those receiving an optimized background regimen without FUZEON when taking into account the uneven number of patients in each arm and the length of time they are in that arm. As measured in number per 100 patient years, the incidence was: diarrhea (38 per 100 patient-years in subjects receiving FUZEON-based regimens vs. 73 per 100 patient-years in patients who did not receive FUZEON), nausea (27 vs. 50, respectively) and fatigue (24 vs. 38, respectively).
Roche in HIV
Roche is at the forefront of efforts to combat HIV infection and AIDS, committe
Zacks.com
Questions on Trimeris\' Outlook
Monday August 20, 12:15 pm ET
By Zacks Equity Research
Though it has been trading down significantly over the past few months, Trimeris (NasdaqGM: TRMS - News) shares should continue to trade at a discount, according to the latest release from Zacks senior biotech analyst Grant Zemg, CFA:
Trimeris, Inc. develops a new class of therapeutic agents for the treatment of viral diseases based on its fusion inhibition technology that blocks viral entry into host cells. The most significant outcome of this anti-viral fusion technology is the development of Fuzeon for the treatment of HIV. Fuzeon sales have been relatively strong in the past few quarters, and the launch of the needle free device in 2008 will further boost the Fuzeon franchise.
However, the recent collaboration amendment with Roche and management change cast a shadow on the company\'s future. Therefore, we maintain our Hold rating on Trimeris with an $8.00 price target.
At this point, it\'s very difficult to value the stock. We believe qualitative factors prevail currently. There are lots of uncertainties about Trimeris. We would like to remain on the sidelines now until we gain more visibility about the company. Our $8.00 price target corresponds to a P/E [price-to-earnings] ratio of 8.8x to our 2007 EPS [earnings per share] of $0.91. This is a huge discount to biotech peers, but it\'s warranted due to the recent corporate developments and change of competitive landscape.
Trimeris shareholder adviser asks company to consider sale
Tue Aug 14, 2007 8:17AM EDT
Aug 14 (Reuters) - HealthCor Management L.P., an investment adviser to funds that own shares of biotechnology company Trimeris Inc. (TRMS.O: Quote, Profile, Research), today asked the company to seek strategic alternatives, such as a sale.
In a filing with the U.S. Securities and Exchange Commission, HealthCor said Trimeris' plan to continue development of next generation fusion inhibitors -- drugs that target HIV -- will continue to depress its value.
HealthCor also increased its stake in the company to 15.04 percent from 9.43 percent. (Reporting by Varsha Tickoo in Bangalore)
Trimeris Reports Financial Results for the Second Quarter 2007
* Revenues of $9.1 Million, a 25 Percent Increase over Revenues of $7.3 Million in the Second Quarter of 2006
* U.S. GAAP Net Income Increases to $4.7 Million from a Loss of 334,000 in the Second Quarter of 2006
* U.S. GAAP Earnings Per Share Increases to $0.21 Per Share from a Loss of $0.02 Per Share in the Second Quarter of 2006
* Cash and Investments Increase to $58.9 Million from $48.6 Million at December 31, 2006
* Trimeris Elaborates on the Target Product Profile for TRI-1144
August 9, 2007 - 3:01 PM EST
Trimeris, Inc. (NASDAQ: TRMS) today announced financial results for the three months ended June 30, 2007, reporting total revenues of $9.1 million, an increase of 25 percent, compared to the same period last year. This increase was primarily driven by worldwide sales of FUZEON, which reached $62.0 million, a growth of 8 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 June 30, 2007, the Company reported net income of $4.7 million, or $0.21 per share, compared with a net loss of $334,000, or ($0.02 per share), for the three months ended June 30, 2006. This result was primarily driven by increased FUZEON sales and decreased operating expenses resulting in a significant improvement in the Company’s operating income.
For the six months ended June 30, 2007, the Company reported net income of $12.8 million, or $0.58 per share, compared with a net loss of $762,000, or ($0.04 per share) for the six months ended June 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 half of 2007. Also included in net income for the six months ended June 30, 2007 are expenses of $4.4 million for the reduction in workforce that occurred during the first half of 2007.
For the six months ended June 30, 2007, the Company reported Non-GAAP net income of approximately $8.0 million, or $0.36 per share, compared with a net loss of $2.9 million, or ($0.13 per share), for the six months ended June 30, 2006. Non-GAAP net income for the three months ended June 30, 2007 is not presented as it does not show a significant difference from GAAP net income.
Cash, cash equivalents and investment securities available-for-sale totaled $58.9 million at June 30, 2007, compared to $48.6 million at December 31, 2006.
Reconciliations between GAAP and Non-GAAP earnings for the six months ended June 30, 2007 and 2006 are provided in the following table:
Six Months Ended Six Months Ended
June 30, 2007
[in thousands except per share amounts]
(unaudited)
June 30, 2006
[in thousands except per share amounts]
(unaudited)
Net income (loss) (GAAP) $ 12,826 $ (762 )
Milestone Revenue [1] (9,291 ) (2,111 )
Charge related to the reduction in workforce [2] 4,421 --
Net income (loss) excluding milestone revenue and charges related to reduction in workforce (Non- GAAP) $ 7,956 $ (2,873 )
Diluted net income (loss) per share (GAAP) $ 0.58 $ (0.04 )
Diluted net income (loss) per share (Non-GAAP) $ 0.36 $ (0.13 )
[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 six months ended June 30, 2007, the Company recorded a charge to the Statement of Operations related to a reduction in workforce.
Target Product Profile for TRI-1144
In preclinical studies, TRI-1144 has demonstrated excellent antiviral, pharmacokinetic, safety and physical properties. The Company has adopted a target product profile of a convenient, low-volume, once per day injection, delivered by a pre-filled auto-injector with minimal to no injection site reactions. In addition the target product profile for TRI-1144 seeks to retain the excellent systemic safety profile of FUZEON. Future line extensions or modifications to the current target product profile could include less frequent than once per day dosing.
The TRI-1144 preclinical safety program is ongoing with an IND filing planned for the first half of next year followed shortly by a comprehensive Phase I/II clinical study that we anticipate will provide key data to support our target product profile.
Conference Call
Trimeris will host a live conference call to discuss second 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 12098374. Telephone replay is available approximately two hours after the call through 11:59 p.m. Eastern Time, August 23, 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 reduction in workforce and the recognition of milestone revenue. The Company believes that the presentation of results excluding the reduction in workforce and recognition of milestone revenue provides meaningful supplemental information regarding our financial results for the six months ended June 30, 2007 as compared to the six months ended June 30, 2006 because our financial statements for the six months ended June 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 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.
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 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 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 June 30,
Six Months Ended June 30,
2007 2006 2007 2006
Revenue:
Milestone revenue [1] $ 83 $ 1,055 $ 9,291 $ 2,111
Royalty revenue 3,219 2,408 7,081 4,988
Collaboration income [2] 5,806 3,815 10,174 7,609
Total revenue and collaboration income 9,108 7,278 26,546 14,708
Operating expenses:
Research and development 2,959 4,961 6,056 10,141
General and administrative 1,937 2,927 8,476 6,083
Total operating expenses [3] 4,896 7,888 14,532 16,224
Operating income (loss) 4,212 (610 ) 12,014 (1,516 )
Other income (expense)
Interest income 727 470 1,397 888
Gain on sale of equipment 5 7
Interest/accretion expense (203 ) (194 ) (404 ) (386 )
Total other income (expense) 529 276 1,000 502
Income (loss) before taxes and cumulative effect of change in accounting principle 4,741 (334 ) 13,014 (1,014 )
Income tax provision 66 188
Income (loss) before cumulative effect of change in accounting principle 4,675 (334 ) 12,826 (1,014 )
Cumulative effect of change in accounting principle [3] -- -- -- 252
Net income (loss) $ 4,675 $ (334 ) $ 12,826 $ (762 )
Basic net income (loss) per share before cumulative effect of accounting change $ 0.21 $ (0.02 ) $ 0.58 $ (0.05 )
Accounting change -- -- -- 0.01
Basic net income (loss) per share $ 0.21 $ (0.02 ) $ 0.58 $ (0.04 )
Diluted net income (loss) per share before cumulative effect of accounting change $ 0.21 $ (0.02 ) $ 0.58 $ (0.05 )
Accounting change -- -- -- 0.01
Diluted net income (loss) per share $ 0.21 $ (0.02 ) $ 0.58 $ (0.04 )
Weighted average
shares used in basic per share computations
22,043
21,896
22,036
21,877
Weighted average
shares used in diluted per share computations
22,184
21,896
22,096
21,877
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 six months ended June 30, 2007 are expenses of $77,000 and $4.4 million, respectively, for the reductions in workforce that occurred during these periods. Excluding these charges, operating expenses for the three and six months ended June 30, 2007, would have been $4.8 and $10.1 million, respectively.
Trimeris, Inc.
Condensed Balance Sheets
[$ in thousands]
June 30,
2007
(unaudited)
December 31,
2006
Assets
Cash, cash equivalents and short-term investment securities available-for-sale
$
55,769
$
48,035
Other current assets 9,439 14,445
Total current assets 65,208 62,480
Property, furniture and equipment – net 1,972 2,160
Long-term investment securities available-for-sale 3,120 604
Total other assets 10,310 9,659
Total assets $ 80,610 $ 74,903
Liabilities and Stockholders’ Equity
Total current liabilities $ 6,167 $ 8,907
Long term portion of deferred revenue 1,645 9,151
Accrued marketing costs 17,692 17,288
Accrued compensation – long-term 1,597 1,072
Other liabilities 717 713
Total liabilities 27,818 37,131
Total stockholders’ equity 52,792 37,772
Total liabilities and stockholders’ equity $ 80,610 $ 74,903
FUZEON Net Sales
(Recognized by Roche, our collaborative partner)
[$ in millions]
(unaudited)
Three Months
Ended,(a)
Six Months
Ended,(a)
June 30,
2007
June 30,
2006
June 30,
2007
June 30,
2006
United States and Canada $ 32.9 $ 31.1 $ 62.2 $ 58.5
Rest of World 29.2 26.2 64.1 54.2
Worldwide Total $ 62.0 $ 57.2 $ 126.3 $ 112.7
(a) may not add due to rounding
Trimeris, Inc.
Andrew Graham, 919-419-6050
Director of Finance
Source: Business Wire (August 9, 2007 - 3:01 PM EST)
News by QuoteMedia
www.quotemedia.com
New Interim Results Demonstrate High Response Rate With FUZEON(R) Plus Darunavir Regardless of Existing Protease Inhibitor Resistance
NUTLEY, N.J. and MORRISVILLE, N.C., July 20 /PRNewswire-FirstCall/ -- Roche and Trimeris, Inc. (Nasdaq: TRMS) today announced interim results from BLQ (Below the Level of Quantification), an ongoing study evaluating the use of FUZEON(R) (enfuvirtide) with the most recently-approved boosted protease inhibitor, darunavir/ritonavir (r), in combination with other anti-HIV drugs. The data, which are being presented at the 4th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention in Sydney, Australia, show that almost two-thirds (64 percent) of three-class, treatment-experienced patients achieved undetectable HIV (less than 50 copies per mL of blood) at 24 weeks, and that baseline sensitivity to darunavir (the amount of resistance to this protease inhibitor prior to the study) did not appear to influence patient response to the regimen.
FUZEON, co-developed by Roche and Trimeris, is the first and only fusion inhibitor available for the treatment of HIV, while darunavir (Prezista(R)) is a commercially available, ritonavir-boosted protease inhibitor, marketed by Tibotec Therapeutics. The BLQ study is sponsored by Roche and Trimeris; patients received darunavir predominantly through co-enrollment in the darunavir compassionate use program.
'Previous studies had provided encouraging -- but limited -- information on the use of enfuvirtide in combination with darunavir/r,' said Edwin DeJesus, M.D., Medical Director, Orlando Immunology Center, Florida. 'Given that attaining undetectable HIV of less than 50 copies has become the standard of care even in treatment-experienced patients, it is encouraging that so many patients can achieve this result with enfuvirtide and darunavir/r -- two agents widely available to patients and physicians today. Even patients with significant resistance to darunavir responded well to this combination.'
About the BLQ Study Results (Poster WEPEB039)
The BLQ study is a prospective, open-label, 24-week, single-arm, multicenter, cohort study conducted in the United States and Australia. The trial was designed to explore the impact of baseline variables -- including darunavir phenotypic sensitivity (prior resistance) -- on virologic responses in highly treatment-experienced patients receiving regimens containing FUZEON and darunavir/r. Patients received the approved dosages of FUZEON and darunavir/r, along with other anti-HIV drugs selected on the basis of treatment history and resistance testing. This protocol-defined interim analysis was conducted when the first half of total enrolled patients completed their week 24 assessments.
Of 63 eligible patients enrolled, 62 had at least one dose of trial medication and a safety follow-up at day seven and were included in the safety analysis. A total of 58 patients who received at least one dose of trial medication and received at least one post-baseline efficacy assessment at week 4 were included in the intent-to-treat (ITT) efficacy analysis. Of the 58 patients in the ITT population, results for 52 patients were available for evaluation of phenotypic resistance to darunavir.
Key results:
-- 64 percent of patients achieved undetectable HIV of less than 50 copies
per mL of blood; 78 percent of patients achieved undetectable HIV of
less than 400 copies per mL of blood; and 86 percent of patients
achieved a viral load reduction of at least 1 log10
-- The mean reduction in HIV levels was -2.39 log10
-- When virologic response was analyzed as a function of patients'
baseline phenotypic sensitivity to darunavir, the percentages of
patients achieving less 50 than copies per of mL blood were similar in
the three groups of patients: 67 percent undetectable for patients with
a low levels of resistance (fold change of less than 10); 70 percent
undetectable for patients with medium levels of resistance (fold change
of 10 or greater and less than or equal to 40); and 67 percent
undetectable for patients with high levels of resistance (fold change
greater than 40)
-- Treatment with FUZEON and darunavir/r with other anti-HIV drugs was
generally well tolerated. A total of 11 serious adverse events were
reported in seven patients. Two of these patients discontinued therapy
due to their adverse events. An additional patient discontinued
therapy due to an adverse event not considered to be serious. One death
(unrelated to study drug) was reported in a patient with sepsis,
worsening anemia, and worsening renal insufficiency.
Facts About FUZEON
Administered via one 90 mg injection twice-daily, FUZEON is the first and only fusion inhibitor for the treatment of HIV. Unlike other HIV drugs that work after HIV has entered the human immune cell, FUZEON works outside the CD4 cell, blocking HIV from entering the cell. For this reason, FUZEON is effective in treatment-experienced patients who have developed resistance to other anti-HIV drugs, though patients may still develop resistance to FUZEON. FUZEON was granted accelerated approval by the U.S. Food and Drug Administration (FDA) in March 2003 on the basis of 24-week data, and was granted traditional (full) approval on Oct. 15, 2004 on the basis of long-term 48-week data.
FUZEON is indicated for use in combination with other antiretroviral agents for the treatment of HIV in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy.
Injection Site Reactions (ISRs): ISRs are the most common adverse events associated with FUZEON. ISRs occurred in 98% of patients studied and 4% discontinued FUZEON due to ISRs. Signs/symptoms may include pain and discomfort, hardened skin, redness, bumps, itching and swelling. Eleven percent of patients had local reactions that required analgesics or limited usual activities.
Pneumonia: An increased rate of bacterial pneumonia was observed in subjects treated with FUZEON in the Phase III clinical trials compared to the control arm. It is unclear if the increased incidence of pneumonia is related to FUZEON use. Patients with HIV infection should be carefully monitored for signs and symptoms of pneumonia. Risk factors for pneumonia included low initial CD4 cell count, high initial viral load, intravenous drug use, smoking and a prior history of lung disease.
Hypersensitivity Reactions: Systemic hypersensitivity reactions have been associated with FUZEON therapy and may recur on rechallenge. Hypersensitivity reactions have included individually and in combination: rash, fever, nausea and vomiting, chills, rigors, hypotension and elevated serum liver transaminases. Other adverse events that may be immune mediated and have been reported in subjects receiving FUZEON include primary immune complexreaction, respiratory distress, glomerulonephritis and Guillain-Barre syndrome.
Administration with Biojector(R)2000: Nerve pain (neuralgia and/or parethesia) lasting up to six months associated with administration at anatomical sites where large nerves course close to the skin, bruising and hematomas have occurred with the use of the Biojector 2000 needle-free device for administration of FUZEON. Patients receiving anticoagulants or persons with hemophilia, or other coagulation disorders, may have a higher risk of post-injection bleeding.
Other Adverse Events: The events most frequently reported in patients receiving FUZEON plus an optimized background regimen were diarrhea (32%), nausea (23%) and fatigue (20%). These events were seen at a lower incidence in patients taking a FUZEON-based regimen compared to those receiving an optimized background regimen without FUZEON when taking into account the uneven number of patients in each arm and the length of time they are in that arm. As measured in number per 100 patient years, the incidence was: diarrhea (38 per 100 patient-years in subjects receiving FUZEON-based regimens vs. 73 per 100 patient-years in patients who did not receive FUZEON), nausea (27 vs. 50, respectively) and fatigue (24 vs. 38, respectively).
Roche in HIV
Roche is at the forefront of efforts to combat HIV infection and AIDS, committed for more than 15 years to groundbreaking research and development of new drugs and diagnostic technology. The objective is to provide tailored treatment solutions and an improved standard of care worldwide for those people living with HIV.
About Roche
Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. pharmaceuticals headquarters of the Roche Group, one of the world's leading research-oriented healthcare groups with core businesses in pharmaceuticals and diagnostics. For more than 100 years, the Roche Group has been committed to developing innovative products and services that address prevention, diagnosis and treatment of diseases, thus enhancing people's health and quality of life. An employer of choice, in 2006, Roche was named one of the Top 20 Employers (Science magazine), ranked the No. 1 Company to Sell For (Selling Power), and one of AARP's Top Companies for Older Workers, and in 2005, Roche was named one of Fortune magazine's Best Companies to Work For in America. For additional information about the U.S. pharmaceuticals business, visit our websites: http://www.rocheusa.com or http://www.roche.us.
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.
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 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 16, 2007 and its periodic reports filed with the SEC.
SOURCE Roche; Trimeris, Inc.
Trimeris to Release Third Quarter 2006 Financial Results on Tuesday November 7, 2006
Wednesday November 1, 4:00 pm ET
MORRISVILLE, N.C.--(BUSINESS WIRE)--Trimeris, Inc. (NASDAQ:TRMS - News) today announced that it will release its financial results for the third quarter of 2006 on Tuesday, November 7, 2006 at 4:00 p.m. Eastern Time. Trimeris' announcement will be followed by a conference call at 5:00 p.m., led by Steven D. Skolsky, Chief Executive Officer, and other members of senior management.
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.
New Data Show Unprecedented Undetectable Rates of over 90 Percent in HIV Patients Receiving FUZEON(R) and Investigational Integrase Inhibitor MK-0518
Thursday October 5, 6:01 pm ET
New data presented at the 46th annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Francisco indicate that nearly all treatment-experienced HIV patients who initiated therapy with FUZEON® (enfuvirtide) and the investigational integrase inhibitor MK-0518 in a clinical trial achieved undetectable levels of HIV (less than 400 copies per mL of blood). Such response rates have never been attained in clinical trials of HIV patients living with drug-resistant virus. FUZEON, co-developed by Roche and Trimeris (NASDAQ: TRMS - News), is the first and only fusion inhibitor available for the treatment of HIV. MK-0518 is a novel investigational integrase inhibitor being developed by Merck & Co., Inc.
Investigators reported results of a 24-week, Phase IIB, Merck-sponsored study of MK-0518 in patients with resistance to protease inhibitors, nucleoside analogues and non-nucleoside analogues. Patients received one of three doses of MK-0518 (200 mg, 400 mg or 600 mg) twice-daily in combination with an optimized regimen of anti-HIV drugs. In the subset of patients who received FUZEON for the first time in their drug regimen along with MK-0518, approximately 90 to 95 percent of 32 subjects achieved undetectable HIV, compared to approximately 60 to 70 percent of 82 subjects who received MK-0518 without FUZEON. Overall, FUZEON increased response rates in the study by approximately 50 percent.
These findings are consistent with the recent HIV treatment guidelines, which emphasize undetectability as the goal of therapy in treatment-experienced patients, as well as the need to initiate multiple active anti-HIV agents simultaneously in order to achieve this goal.
"These exciting data with enfuvirtide and MK-0518 show that when agents from two new classes of anti-HIV drugs are used together, we can expect to achieve high response rates which have only previously been observed in the most successful trials with treatment-naive patients," said Richard Haubrich, Professor of Medicine, Division of Infectious Diseases, University of California at San Diego. "If these data are confirmed in larger groups of patients, the availability of enfuvirtide and novel agents such as MK-0518, now available in expanded access programs, will provide treatment-experienced patients with an excellent opportunity to achieve undetectable HIV-RNA values."
According to a Merck press release on the study, the most commonly reported study therapy-related side effects (occurring in at least five percent of patients in at least one treatment group) were diarrhea, nausea, fatigue, headache and itching. Four patients discontinued treatment due to adverse experiences.
New Treatment Guidelines Support Use of FUZEON(R) to Achieve Undetectable HIV in Treatment-Experienced Patients
Monday August 14, 10:59 am ET
TORONTO--(BUSINESS WIRE)--Aug. 14, 2006--Newly updated HIV/AIDS treatment guidelines, issued by the International AIDS Society-USA and published in this week's edition of the Journal of the American Medical Association, support important changes for the management of treatment-experienced patients. They recommend for the first time that the goal of therapy in heavily treatment-experienced patients should be to achieve undetectable levels of HIV (less than 50 copies/mL), and highlight the results from several pivotal studies with newer anti-HIV treatments, such as darunavir and tipranavir, in which concomitant use of FUZEON was associated with a significantly greater likelihood of achieving this result. FUZEON, the first and only fusion inhibitor available for the treatment of HIV, was co-developed by Roche and Trimeris (Nasdaq: TRMS - News). The revised IAS-USA guidelines were released in a news conference at the XVI International AIDS Conference, being held this week in Toronto.
"Maintaining undetectable viral load is the best way to achieve long-term treatment success in HIV," said Dr. Julio S.G. Montaner, president-elect of the International AIDS Society and a member of the IAS-USA panel that drafted the updated guidelines. "Today using FUZEON with darunavir or tipranavir, we have the right drugs to help us achieve this goal for treatment-experienced patients. The new IAS-USA guidelines clearly support this approach."
Detectable HIV can lead to drug resistance, and recent research shows 66 percent of HIV patients in the U.S. have detectable viral levels. In order to combat these rates of resistance and improve the chances of reaching undetectable - which has been shown to improve clinical outcomes - the newly-issued guidelines recognize that patients need the full potency of at least two fully active drugs, such as FUZEON and a newer boosted protease inhibitor. Prior to the simultaneous availability of these drugs which retain activity against drug-resistant virus, achieving undetectable in a significant number of heavily treatment-experienced patients was not possible.
"This concept of the significance of getting HIV to under 50 copies/mL is not complicated. If viral load is over 50 copies/mL, resistance can develop, leading to a deterioration in immune function and eventually resulting in disease progression," said Jules Levin, founder and Executive Director, National AIDS Treatment Advocacy Project (NATAP). "Now that the IAS-USA guidelines have been updated, doctors must aim for an undetectable viral load if they have the drugs available - none of us should be complacent."
better than expected.....
Excluding employee stock option expense, its earned $643,000,
or 3 cents per share, in the latest quarter.
--For the latest quarter, eight analysts on average had
expected the company to lose 7 cents a share, excluding any
exceptional items, according to Reuters Estimates.
(Reporting by Tuhin Kar in Bangalore)
trimeris at morgan stanley conference today...
05/05/06 8:45 a.m. ET
Trimeris, Inc. at Morgan Stanley Global Healthcare Unplugged Conference
Trimeris, Inc. Earnings Conference Call (Q1 2006)
Scheduled to start Wed, May 10, 2006, 5:00 pm Eastern
Short Interest
3,413,915.000
there a lot of shares to cover and very little availability.
i want to see a covering rally to say the least.
Hi there RSox....no I have not listened to the CC, however, I believe the stock will at least triple again in the next two years if their new fusion inhibitors show promise in the clinic. I'm eager to learn more about the Roche/TRMS development strategy on these new compounds. I think institutions own roughly 90% of TRMS, paper is scarce on this stock.
TRMS ALWAYS hosts quarterly CCs whether the news is good or bad!
katie...
another periodical with the fuzeon affect...i believe the fuzeon affect is being recognized as seen in the increasing sales of fuzeon...once bioejector 2000 is approved more will be accepting of this drug.
http://www.medicalnewstoday.com/medicalnews.php?newsid=35252
there is an internet address towards the middle of this page that leads to the guidelines of the dhhs with regards efuzeon
DHHS guidelines - clear recommendations for FUZEON use with
boosted PIs
The importance of FUZEON in the management of HIV has been
recognised by the US Department of Health and Human Services (DHHS).
Their newly updated HIV/AIDS treatment guidelines support the use of
FUZEON with an active boosted PI for the management of treatment
experienced patients. The guidelines state that adding a drug with
activity against drug-resistant virus (e.g. a boosted PI such as
TMC114/r) and a drug with a new mechanism of action (e.g. an HIV
entry inhibitor such as FUZEON) can provide significant
antiretroviral activity.
These data come at a pivotal time as Tibotec has launched this
month an international expanded access programme for TMC114/r. This
will enable patients that are rapidly running out of new treatment
options early access to this investigational agent, which has been
seen to be highly promising when used in combination with FUZEON.
The updated DHHS guidelines (October 6, 2005) are available at
online: http://aidsinfo.nih.gov/guidelines/. <<<<<<<<<<<<<<<<<<<<<
TMC114 is an investigational product
Growing Body of Evidence, RESIST 1&2 / POWER 1&2 / TORO 1&2 -
Collectively the data from all six studies, in over 2,500 patients,
establish a new paradigm in the management of triple
class-experienced patients.
continued from previous post...
This adds to the growing body of evidence for the powerful "FUZEON
effect" which has been seen across the RESIST 1 & 2, POWER 1 & 2 and
TORO 1 & 2 studies, where adding FUZEON was seen to almost double the
number of patients reaching undetectable, when combined with one of
the latest boosted PIs such as lopinavir/r, tipranavir/r or TMC
114/r.
Doctors underestimate significant "FUZEON effect"
Surprisingly, of the 560 doctors surveyed onsite this week at the
IAS conference, three quarters (75%) underestimated the "FUZEON
effect" seen in both RESIST(2) and POWER(3) studies.
Latest data adds to growing Body of Evidence - Latest Boosted
Protease Inhibitors (lopinavir/r, tipranavir/r and TMC 114/r) all
work best in combination with FUZEON
RESIST Phase III tipranavir trials
- Over 24 weeks, almost double the proportion of patients who
received FUZEON plus tipranavir/r showed a 90% drop in viral load
compared with patients not receiving FUZEON
POWER Phase II TMC114 dosing trials
- Over 24 weeks in the combined TMC114 trials, almost double the
proportion of patients who received FUZEON plus TMC114/r achieved a
viral load below 50 copies/ml compared with patients not receiving
FUZEON
- A remarkable 67% of the patients receiving FUZEON plus TMC114/r
reached an undetectable viral load
TORO Phase III FUZEON trials
- Over 24 weeks, double the proportion of patients who received
FUZEON plus lopinavir/r achieved an undetectable viral load (<50
copies/ml) compared with patients not receiving FUZEON
Collectively the data from all six studies, in over 2,500
patients, establish a new paradigm in the management of triple
class-experienced patients.
Why FUZEON is effective in face of HIV resistance
FUZEON is still the first and only anti-retroviral drug to work
outside the human immune cell (CD4), blocking the HIV virus from
entering. All other currently available HIV drugs fight the HIV virus
once it has entered the cell. FUZEON's unique mode of action means
that FUZEON has no cross-resistance with currently available drugs
and that it is an effective treatment, in combination with other
anti-HIV drugs, for patients facing resistance.
New combination improves quality of life
Spike, a 48 year old person living with HIV from London, whose
blood levels of HIV reached undetectable within six months of taking
FUZEON and boosted tipranavir and has remained undetectable ever
since, explains "This new combination of treatments has really
improved my quality of life. Getting back to undetectable and seeing
my CD4 count increase from 20 to 268 has changed my outlook on life.
I believe I can plan for the future, which I didn't even consider
doing before starting this regimen. I have much more energy now than
I had before, which is exhilarating since I have been held back for
so long." Spike has been living with HIV since it was detected in his
body in 1986 and works as a freelance designer and night-club
promoter.
The use of FUZEON is continuing to grow, despite initial
reluctance from patients and physicians to using an injection, and
more patients are now successfully starting and remaining on
treatment. Roche continues to roll out educational initiatives to
support patients and physicians with the administration and use of
FUZEON.
References:
(1) Grinsztejn B et al. IAS 2005 Abstract WePe 16.7B07
(2) Cooper D et al. CROI 2005 Abstract 560
(3) Katlama C et al. CROI 2005 Abstract 164LB
ots Originaltext: Roche Pharmaceuticals
Im Interne
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http://www.trimeris.com/
http://www.synageva.com/
http://finance.yahoo.com/q/ks?s=GEVA
http://finance.yahoo.com/q/ks?s=TRMS
http://www.form4oracle.com/company?cik=0000911326&ticker=TRMS
Trimeris, Inc., a biopharmaceutical company, engages in the discovery, development, and commercialization of therapeutic agents for the treatment of viral disease in the United States and Canada. It provides a class of antiviral drug treatments, known as fusion inhibitors. Fusion inhibitors impair viral fusion, a process by which viruses attach to, penetrate, and infect host cells. The company offers FUZEON, is a 36-amino acid synthetic peptide that binds to a key region of an HIV surface protein called gp41. FUZEON blocks HIV viral fusion by interfering with certain structural rearrangements within gp41 that are required for HIV to fuse to and enter a host cell. It has a collaboration agreement with F. Hoffmann-La Roche, Ltd. to develop and market Fuzeon and T-1249, a replacement compound. The company was founded in 1993 and is based in Morrisville, North Carolina.
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