Millennium CFO Marsha Fanucci says the company is "doggedly" working toward its goal of reaching profitability in 2006.
"It's in the crosshair and we're on track," she says of putting the company into the black. "I think we've demonstrated to the outside world that we've put together a loss profile [to reach profitability] and we're delivering on that."
Wall Street is looking for Millennium to lose $175 million this year, $107 million in 2005, and earn $8 million in 2006. On an earnings-per-share basis, that works out to a net loss of 55 cents and 36 cents in 2004 and 2005, respectively, and earnings of 2 cents in 2006.
Velcade was approved in May 2003 as a first-in-class treatment for multiple myeloma patients who had failed three or more previous therapies. Sales in 2003 totaled $59 million and are expected to reach about $140 million in 2004, but that's only the low end of the company's $140 million-$160 million guidance for the year.
Fanucci says the company is pleased with Velcade's performance this year. "When you launch a new product, there are all kinds of vagaries to making guidance," she said. "Our guidance for Velcade sales was $140 million to $160 million, so we feel good about falling into that range."
One of the keys to reinvigorating the Millennium story will be to expand the use of Velcade. First, the company is working on moving the drug's use up the so-called treatment ladder in multiple myeloma. An application for second-line use in multiple myeloma already has been filed with the FDA, with an affirmative approval decision widely expected next year.
At last week's meeting of the American Society of Hematology, the company presented positive data from midstage studies of Velcade in front-line, or newly diagnosed, multiple myeloma. Pivotal phase III studies in this indication, the most commercially lucrative in multiple myeloma, will be started by year-end or early 2005, says David Schenkein, Millennium's vice president of clinical oncology development.