Once oral dialysis drugs like Amgen's Sensipar, used to treat hyperparathyroidism, are included in the dialysis payment bundle, it is unlikely that the inevitable drop in sales will match what the biotech firm has seen from its anemia drugs. Although the company said in its most recent conference call on fourth quarter earnings that it controls 95% of the U.S. anemia drug market, the sales of Epogen and Aranesp have declined so heavily in the last couple of years partly because the ESRD payment bundle was released alongside FDA warnings that changed the way nephrologists treat anemia in dialysis patients.
But Amgen's heavy lobbying to delay the inclusion of oral drugs like Sensipar in the ESRD bundle signals that the biotech company is anticipating somewhat of a drop in sales. So how important is Sensipar to Amgen?
The company recently reported a 16% drop in fourth-quarter profit. Much of this drop is the result of a 9% increase in research and development costs; the company has four drug programs advancing into Phase III. Amgen executives said in a conference call that they are also increasing direct to consumer marketing for some of its drugs. Revenues for the quarter were actually up 11%.
- Sensipar (cinacalcet) sales increased 19% for the fourth quarter of 2012 versus the fourth quarter of 2011 and 18% for the full year due to unit growth and price increases. Sales of Sensipar reached more than $250 million globally.
- Enbrel sales for the fourth quarter of 2012 increased 23%. "Enbrel remains, in value terms, the leading biologic in the fast-growing rheumatology and dermatology segments," said Chief Financial Officer Jonathan Peacock.
- Combined sales of cancer drugs Vectibix (panitumumab) and Nplate (romiplostim) increased 15% for the fourth quarter of 2012 versus the fourth quarter of 2011 and 17% for the full year.
- Sales of Xgeva, which is used to prevent skeletal problems in cancer patients, increased 7% on a sequential basis and 113% for the full year.
- Sales of osteoporosis drug Prolia increased 40% on a sequential basis and 133% for the full year.
- Epogen sales decreased 2%, which Amgen executives attributed to competition. "However, the impact of competition continues to be modest, and primarily in the form of pilot programs," Tony Hooper, V.P. of global commercial operations. "Dialysis providers continue to recognize the value of Epogen based on their long term experience." Epogen doses have stabilized and Amgen has not seen a dramatic change on the anemia market in some time now, Hooper said.
- Aranesp sales globally were down 9% for the year. "However, sales were down just 2% sequentially," Peacock said. He estimated that 65% of Aranesp sales are outside the United States and the actual market "in terms of usage or dosage appears to be fairly stable."
- Sales of Neulasta and Neupogen, drugs that fight infection in chemotherapy patients, were down 1% in the fourth quarter, and 3% for the full year. Executives said they believe more direct to consumer advertising will help sales in this market.
Overall, Amgen's business is growing. They have a strong pipeline with late-stage drugs, and they recently acquired deCODE Genetics, which executives said in the conference call will help them become the industry leader in using human genetics. Business outside the Unites States grew 14% in 2012. And, according to the conference call, they still own 95% of the dialysis anemia market in the United States.