Only a matter of days after the founder and chief executive officer of their company died of a heart attack and less than 12 hours after announcing a yearly loss of $76 million, executives of Triangle Pharmaceuticals huddled by phone with analysts Friday to assure them the company is still on track.

During a conference call the day after Triangle announced its losses for 2001, Triangle President Chris Rallis said plans are on schedule to meet the third quarter-target date for filing new drug application with the Federal Drug Administration (FDA) for the company’s lead drug, HIV inhibitor Coviracil.

Industry analysts remain optimistic despite a number of setbacks over the last year, including the death of Dr. David Barry. But they also said the filing of the NDA will be a critical milestone in the company’s history, as well as the financing for its Phase II programs for amdoxovir and clevudine, other drugs that are in the pipeline.

“The company now is at the NDA stage, and this supports the hope and their ability to translate the original research to something that is commercially viable,” said Dr. Scott Stromatt of C.E. Unterberg, Towbin, an analyst who tracks Triangle closely. “Time will tell.

“Even with the loss of Barry, the clinical research direction is very strong,” he added. “The company is large enough with the intellectual horsepower to move the company where it needs to be.”

Not only was Barry the company’s founder and CEO; he also was one of the world’s leaders in AIDS research.

Succession planning is underway by the executive team to address the management restructuring since Barry’s death of an apparent heart attack while in California for business on Jan. 28, Rallis said. He added that a recommendation would be made to the board of directors “relatively promptly.”

Robert Amundsen, Triangle’s chief financial officer said the two factors of completing financing by end of fourth quarter last year to support the NDA submission process and the full execution of the cost reduction plans have put the company in a strong financial position for 2002.

The company reports a net loss of roughly $76 million for the year ended Dec. 31, 2001, down 30 percent from year ago. Moreover, revenues from its collaborative partner Abbott Laboratories to the company last year were $5.7 million, down 20 percent from 2000. The company also announced it has raised $133 million through private equity funding.

“You’d expect the burn rate to be longer and longer as biotech companies have years with little to no revenue and no profit,” said Dan Allred, vice president of business development for the Center for Entrepreneurial Development (CED). “At some point, you’d expect those losses to shrink.”

Expenses in 2001 for the company were also down significantly versus 2000, to $84.4 million from $124.1 million, due to cost reduction efforts announced last August, says Amundsen. Cutbacks described in the report, included a 35 percent reduction in staff, reduced selling, plus general and administrative cost savings from reduced expenditures related to development of early stage compounds.

“What they are ensuring now (with the cutbacks last fall) is that they have the resources and manpower to ramp up the push for NDA submission,” Allred said. “And, obviously, like any business, they have to be successful at controlling costs. It’s a high-stakes balancing act at this point.”

Allred added the expenditures reported support the magnitude of what the incredible costs are to get through clinical trials and actually make it to NDA stage, but the market potential is there. “It’s a tight gamble, but when you have a scientific technology that can address HIV, the payoff on the other side, if it goes, will be huge.”

Other drug hopefuls

In addition to the first NDA submission for Coviracil, there are two more drug candidates in the pipeline for HIV and hepatitis. Executives confirm the company will continue to make progress with other key drug candidates, including Phase II clinical development programs for amdoxovir and clevudine.

Stromatt said another positive step for Triangle is completing combination studies with other drug manufacturers for the earlier stage compounds (amdoxovir and clevudine.)

“Combination studies set up a clinical trial agreements which could potentially set up a very strong partnership and funding,” he explained.