Providing a glimmer of hope for its survival, Trimeris narrowed losses and increased sales in the fourth quarter, due in large part to the profit from the sale of anti-HIV drug Fuzeon and decreased R&D expenses with its partner Roche.
The Durham-based company posted a loss of $15.1 million, or 70 cents per share, compared with a loss of $23.1 million, or $1.09 a share, a year ago. That beats Wall Street estimates, which called for losses of $1.12 a share.
Trimeris (Nasdaq: TRMS) reported earnings after the market closed Tuesday, with shares priced down 25 cents at $16.62. In after-hours trading, shares of TRMS edged up 38 cents to $17. The stock price is near a 52-week low of $16.35 and well removed from its 52-week high of $55.64 achieved soon after Fuzeon was approved by the FDA in March but hit snags over the cost and complexity to administer it.
“2003 was an eventful year for Trimeris with the approval and launch of Fuzeon,” commented Dani Bolognesi, chief executive officer of Trimeris, which says it will launch a nationwide print and Internet promotional campaign of the drug this year. “We will continue to work with our colleagues at Roche to ensure the commercial success of Fuzeon and its broad adoption as a new standard of care in the management of treatment-experienced HIV patients. We look forward to seeing the results of our heightened marketing initiatives on the uptake of Fuzeon during 2004.”
Last month, Trimeris halted clinical trials of another HIV drug, T-1249, due to disappointing results. This move lead to a decline in R&D expenses by more than 50 percent, to $5.6 million from $12.1 million. The company said it was able to defer many costs to Roche under their collaborative research agreement.
For the fourth quarter, global sales of Fuzeon were $17.6 million, compared to $13.1 million last year. But Trimeris reported net revenue of $1.4 million, all in the form of milestone and royalty payments.
The 2003 net loss of $65.7 million was down from the 2002 net loss of $75.7 million. R&D expenses for the year fell to $36.8 million from $51.2 million, while revenue grew to $3.7 million from $1.1 million.
Changing the approach
Trimeris said on Tuesday some 25 percent of patients that receive Fuzeon don’t initiate or temporarily interrupt therapy in the first three months. This can be for a variety of reasons, including not having the go-ahead from physicians, waiting for another complimentary drug or a technique-related issue, such as an unexpected reaction or side effect that stems from a new regimen, but not directly related to Fuzeon.
As a result, Trimeris and Roche said they would implement programs for patient retention, such as nurse and patient education and support prior to and following therapy. The two nursing programs will include a nationwide call center with its own hotline for patients to call or with nurses that call to check up on patients and a program in which nurses would train physicians and patients on the preparation and administration of Fuzeon, which has run into problems for its complexity.
“We believe these adherence and persistency initiatives will — improve patient retention from the very first week of therapy initiation and address some of the problems identified in our field experience to date,” Bolognesi said in a conference call after earning were released. “Roche and Trimeris anticipate expanding Fuzeon distribution through additional specialty distributors with expertise in providing injectible and biologic products. This important expansion in Fuzeon prescription fulfillment should improve both access to and the convenience of obtaining the drug.”
In the conference call, Bolognesi entertained the idea of Trimeris becoming a part of Roche, but said only Roche could decide that. Nevertheless, he reiterated the Swiss pharmaceutical company’s firm commitment to Trimeris and Fuzeon, even amid doubts about the company’s and drug’s future.
“Roche in every way has expressed and will continue to express — their commitment to this product. What it means is that they believe that Fuzeon will establish its rightful place in the treatment of experienced patients–,” he said of Roche. “They believe strongly that they can overcome the issues that are out there in the marketplace in the early phases of this launch at the present time–. A testament to that, obviously, are the efforts they’re putting in on marketing fronts and the continued commitment to the fusion inhibitor franchise that they’ve done with the renewed research agreement and enhancement thereof. So these guys are in it for the long haul — and clearly we’ll stand behind as we go forward.”
Trimeris: www.trimeris.com
Roche: www.roche.com
