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Trimeris today announced financial results for the three months ended June 30, 2008, reporting net income of $590,000, or $0.03 per share compared with $4.7 million, or $0.21 per share for the three months ended June 30, 2007
Durham, NC, USA | August 7, 2008 | Trimeris, Inc. (NASDAQ:TRMS) today announced financial results for the three months ended June 30, 2008, reporting net income of $590,000, or $0.03 per share compared with $4.7 million, or $0.21 per share for the three months ended June 30, 2007. This result was primarily driven by decreased FUZEON(R) sales and two one-time events recorded during the second quarter of 2008.
For the six months ended June 30, 2008, the Company reported net income of $2.9 million, or $0.13 per share, compared with $12.8 million, or $0.58 per share for the six months ended June 30, 2007.
In the second quarter of 2008, the Company relocated its corporate offices and shut-down its existing research facility and therefore recognized an associated one-time restructuring charge of $1.9 million. Excluding the impact of this charge, for the three months ended June 30, 2008, the Company reported adjusted net income of approximately $2.5 million, or $0.11 per share. For the six months ended June 30, 2008, the Company reported adjusted net income of approximately $4.7 million, or $0.21 per share. A reconciliation and explanation of the differences between GAAP and adjusted earnings is detailed in the table below.
Cash, cash equivalents and investment securities available-for-sale totaled $49.7 million at June 30, 2008, compared to $69.6 million at December 31, 2007. As previously announced, on June 6, 2008, the Company paid a $33.3 million special dividend to stockholders.
The financial statements for the first quarter of 2008 were prepared based on the assumption that an "ownership change" occurred under Section 382 of the Internal Revenue Code during the first quarter of 2008. Based on a subsequent analysis of changes in the Company's common stock ownership this position has been reversed. As a result, the Company believes that the utilization of its net operating losses is not limited at this time.
Preliminary Results from the Phase 1 Clinical Study of TRI-1144
Trimeris also today announced preliminary results from study TRI-1144-101, a Phase 1 study of the next-generation HIV fusion inhibitor, TRI-1144. Results of the study indicate TRI-1144 was well tolerated at all doses tested. Plasma concentrations at 24 hours suggested that a dose of approximately 25 mg of TRI-1144 could be sufficient for a convenient, once-daily, low-volume injection. In addition, this dose produced no injection-site reactions (ISRs) in this study.
"We are very pleased with the results from this first-in-human study of TRI-1144," said Martin Mattingly, CEO of Trimeris, Inc. "The initial safety and pharmacokinetic results from this study, together with the excellent solution stability of TRI-1144, continue to suggest that this peptide will meet the target profile of a safe and convenient once-daily fusion inhibitor. As previously communicated, we are no longer funding research and development at Trimeris and are seeking a licensor to develop this promising candidate."
Conducted in 24 healthy subjects, study TRI 1144-101 was a placebo-controlled, double-blind, single-dose trial that explored the safety, tolerability and pharmacokinetics of four doses of TRI-1144. A total of 18 subjects received TRI-1144, ranging from 25 mg to 250 mg while 6 subjects received placebo. Pharmacokinetic analyses showed that the plasma half-life ranged from 13 to 20 hours depending on the dose administered, with a time to maximal exposure ranging from 10 to 13 hours.
There were no serious adverse events observed during the trial. Eight subjects experienced a total of 13 adverse events. Of these eight subjects, five were in the TRI-1144 group (5/18 or 28%) while three subjects were in the placebo group (3/6 or 50%). With respect to the events observed in the TRI-1144 group, five were considered mild (5/6 or 83%) and one was moderate (1/6 or 17%) (backache; unrelated). With respect to adverse events observed in the placebo group, five events were considered mild (5/7 or 71%) and two were moderate in intensity (2/7 or 29%). No serious injection-site reactions (ISRs) were observed. Two out of 6 (33%) and 15/18 (83%) of subjects receiving placebo or TRI-1144, respectively, experienced mild or moderate ISRs. No ISRs were experienced in the TRI-1144 25 mg group. Erythema and pain/discomfort were the most frequent signs/symptoms observed and most ISRs resolved by 96 hours. No ISRs were experienced in the 25 mg group. Full data from the trial will be presented at an upcoming medical conference.
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 revises total operating expenses guidance. Operating expenses are expected to be in the range of $10.0 million to $12.0 million in 2008 down from previous guidance of $10.0 million to $14.0 million. The Company expects total operating expenses in 2009 to be in the range of $5.0 million to $10.0 million.
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.
SOURCE: Trimeris, Inc. |
