Amgen Inc. released its year-end earnings statement, capping a busy span of days that highlighted sections of the company's drug portfolio.
Thousand Oaks, Calif.-based Amgen reported fourth-quarter earnings of $456.4 million, or 34 cents per share, missing consensus estimates by a penny. Those compare to 4Q 2001 earnings of $163 million and 15 cents per share.
Adjusted earnings for the fourth quarter were $471.7 million for the quarter, or 35 cents per share, and for the year were about $1.7 billion, or $1.39 per share. The year-earlier numbers were $320.3 million and 30 cents for the quarter, and $1.3 billion and $1.18 for the year.
When taking the Immunex Corp. merger into account, Amgen reported a loss of $1.4 billion for the year, or $1.21 per share, due to a $3 billion write-off of acquired in-process research and development. That move brought the blockbuster Enbrel in-house.
Total product sales in 2002 were $5 billion, up from $3.5 billion. Total product sales increased 66 percent in the fourth quarter, to $1.6 billion from $974 million. And, as expected, Amgen's trio of blockbusters - Enbrel, Epogen and Neupogen - led the way.
Epogen (epoetin alfa), an anemia therapy for patients on dialysis, and Aranesp (darbepoetin alfa), Amgen's next-generation anemia treatment, brought in combined sales of $827 million. For the year, the two products generated $2.7 billion.
Neupogen (filgrastim), designed to decrease the incidence of infection, and Neulasta (pegfilgrastim), a once-per-cycle product for decreasing infections associated with many types of chemotherapy treatments, sold $541 million in the fourth quarter. For the year, Neupogen and Neulasta generated $1.8 billion in sales.
Enbrel, acquired through the purchase of Immunex, of Seattle, which closed in July for $10.3 billion, had sales of $204 million in the quarter. For the period of 2002 in which Amgen owned Enbrel outright, sales were $362 million, which translates to $802 million for a full year if Amgen had owned Enbrel for all of 2002, it said. Amgen has forecast Enbrel revenues of $1.2 billion to $1.4 billion for 2003.
The company recently announced that its first of two Phase III trials of Enbrel in psoriasis produced positive results, and then it turned around and said it had filed a supplemental biologics license application to expand the drug's reach to include ankylosing spondylitis. (See BioWorld Today, Jan. 21, 2002, and Jan. 23, 2002.)
Although it's clearly Enbrel, Epogen and Neupogen on which Amgen hangs its revenue hat, the company is developing and repositioning the pipeline behind it. It reported that rHu-KGF (recombinant human keratinocyte growth factor) decreased the duration and incidence of severe oral mucositis in a Phase III study of patients undergoing bone marrow transplantation treatment for hematologic malignancies, including lymphoma, multiple myeloma and leukemia. Preliminary results from the double-blind trial were positive on all endpoints and showed a highly significant decrease in duration and incidence of severe mucositis. The company is planning to study KGF in other patients who suffer from mucositis associated with cancer treatments.
Amgen also announced, in coordination with partner Immunomedics Inc., of Morris Plains, N.J., the closure of a Phase III study of AMG 412, or epratuzumab, in patients with low-grade follicular B-cell non-Hodgkin's lymphoma who failed other treatments, including Rituxan (rituximab). Amgen licensed epratuzumab from Immunomedics for North America and Australia.
The study began in 2001 and since then, new agents have been approved for that particular patient population and an unmet medical need has been addressed, the companies said.
However, they are encouraged by results seen in indolent NHL patient trials using AMG 412 and Rituxan (developed by IDEC Pharmaceuticals Corp., of San Diego, and Genentech Inc., of South San Francisco), and that program will continue.
Dropping the AMG 412 program, said Janet Gearlds, analyst and portfolio manager with Private Asset Management, Wells Fargo, is simply a matter of biotechnology efficiency.
"That's just the natural course," she said. "Amgen is going to focus on what is going to bring it success down the line and you can say that with any company."
The AMG 412 and KGF news were released before the market closed Thursday, and the earnings afterward. Amgen's stock (NASDAQ:AMGN) gained $1 Thursday to close at $53.50.