Imclone Systems Inc. reports earnings for the fiscal fourth-quarter and full-year on Thursday. The following is a summary of key developments and analyst opinion related to the period.
OVERVIEW: Billionaire investor Carl Icahn won his battle for control of Imclone during the quarter after the board named him chairman in October. He was elected to the board during the third quarter and had been fighting to make several executive changes. Interim chief executive Joseph L. Fischer resigned immediately following Icahn's election victory.
Icahn previously said one of his top priorities is finding a new CEO.
In November, the company reported mixed results from two late-stage studies of its cancer treatment Erbitux, which is also its only marketed drug. The drug is approved to treat colon cancer and head and neck cancer.
In January, results from one study adding the drug to standard chemotherapy increased the survival rate of colon cancer patients. Imclone and its partner Bristol-Myers Squibb plan to file for approval of Erbitux as a first-line treatment for colon and pancreatic cancer.
BY THE NUMBERS: Analysts polled by Thomson Financial expect Imclone to earn 43 cents per share on revenue of $155.9 million during the fourth-quarter. For the full-year, analysts expect profit of $2.94 per share on revenue of $701.4 million.
ANALYST TAKE: Analysts expect sales of Erbitux to either meet or miss Wall Street expectations, with several citing the competition from Amgen's Vectibix as a factor in lost market share. Analysts are generally staying on the sidelines, taking a wait-and-see approach based on Erbitux numbers and management strategy.
"Vectibix-driven share erosion is inevitable, but to date, there has only been limited market growth," said Morgan Stanley analyst Steven Harr, in a note earlier this month.
The long-term potential of Erbitux, said Citigroup analyst Dr. Yaron Werber, could rely on the recent outcome of two late-stage trials. One study, called the Crystal study, showed Erbitux improved survival rates when added to chemotherapy. The drug could be able to capture between 10 percent and 20 percent of the first-line market, but would be going up against Genentech's Avastin.
Werber expects sales of Erbitux during the fourth quarter to reach about $170 million, below both Citigroup and Wall Street estimates.
WHAT'S AHEAD: The company is still without a CEO and Icahn has said finding one is a top priority. Several other executive positions, including the chief financial officer spot, also have to be filled.
On Thursday rival Amgen is set to release data from its study testing Vectibix with Avastin as a treatment. The results of that study could put more pressure on Erbitux as could the launch of Vectibix in Europe later this year.
Also, data on a study testing Erbitux as a pancreatic cancer treatment is expected later in the quarter.
STOCK PERFORMANCE: Shares of Imclone shed 5.7 percent during the quarter, opening Oct. 2 at $28.38 and closing at $26.76 Dec. 29. The stock hit a 52-week low of $26.28 on Dec. 27.
OVERVIEW: Billionaire investor Carl Icahn won his battle for control of Imclone during the quarter after the board named him chairman in October. He was elected to the board during the third quarter and had been fighting to make several executive changes. Interim chief executive Joseph L. Fischer resigned immediately following Icahn's election victory.
Icahn previously said one of his top priorities is finding a new CEO.
In November, the company reported mixed results from two late-stage studies of its cancer treatment Erbitux, which is also its only marketed drug. The drug is approved to treat colon cancer and head and neck cancer.
In January, results from one study adding the drug to standard chemotherapy increased the survival rate of colon cancer patients. Imclone and its partner Bristol-Myers Squibb plan to file for approval of Erbitux as a first-line treatment for colon and pancreatic cancer.
BY THE NUMBERS: Analysts polled by Thomson Financial expect Imclone to earn 43 cents per share on revenue of $155.9 million during the fourth-quarter. For the full-year, analysts expect profit of $2.94 per share on revenue of $701.4 million.
ANALYST TAKE: Analysts expect sales of Erbitux to either meet or miss Wall Street expectations, with several citing the competition from Amgen's Vectibix as a factor in lost market share. Analysts are generally staying on the sidelines, taking a wait-and-see approach based on Erbitux numbers and management strategy.
"Vectibix-driven share erosion is inevitable, but to date, there has only been limited market growth," said Morgan Stanley analyst Steven Harr, in a note earlier this month.
The long-term potential of Erbitux, said Citigroup analyst Dr. Yaron Werber, could rely on the recent outcome of two late-stage trials. One study, called the Crystal study, showed Erbitux improved survival rates when added to chemotherapy. The drug could be able to capture between 10 percent and 20 percent of the first-line market, but would be going up against Genentech's Avastin.
Werber expects sales of Erbitux during the fourth quarter to reach about $170 million, below both Citigroup and Wall Street estimates.
WHAT'S AHEAD: The company is still without a CEO and Icahn has said finding one is a top priority. Several other executive positions, including the chief financial officer spot, also have to be filled.
On Thursday rival Amgen is set to release data from its study testing Vectibix with Avastin as a treatment. The results of that study could put more pressure on Erbitux as could the launch of Vectibix in Europe later this year.
Also, data on a study testing Erbitux as a pancreatic cancer treatment is expected later in the quarter.
STOCK PERFORMANCE: Shares of Imclone shed 5.7 percent during the quarter, opening Oct. 2 at $28.38 and closing at $26.76 Dec. 29. The stock hit a 52-week low of $26.28 on Dec. 27.
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