October 24, 2008 9:48 AM ET
Celgene: Leerink Swann raising ests on Revlimid strength, Vidaza royalty buyout and tax rate . Leerink Swann notes CELG reported a solid quarter with both Revlimid and Vidaza growth continuing and upside in the bottom line. Firm is impressed with continued strong US growth following Velcade first-line approval and continued OUS volume growth. They are increasing their '09 and '10 estes based on Revlimid strength, lowered tax rate, and improved gross margin as a result of Vidaza royalty buyout.
http://news.moneycentral.msn.com/ticker/article.aspx?Feed=Bcom&Date=20081024&ID=9319144&Symbol=CELG
Celgene International Sàrl
CELG today announced that its cancer drug, VIDAZA® (azacitidine), has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation with:
- Intermediate-2 and high-risk MDS according to the International Prognostic Scoring System (IPSS)
- Chronic myelomonocytic leukaemia (CMML) with 10-29 percent marrow blasts without myeloproliferative disorder
- Acute Myeloid Leukemia (AML) with 20-30 percent blasts and multi-lineage dysplasia, according to World Health Organization (WHO) classification
The positive opinion includes important survival data from the AZA-001 trial in higher-risk MDS patients. The CHMP, which reviews applications for all 27 Member States in the European Union (EU) as well as Norway and Iceland, has recommended approval for azacitidine. The CHMP’s positive opinion will be forwarded to the European Commission, which generally follows the recommendation of the CHMP and typically issues final marketing approval within two to three months.
“The CHMP recommendation is an especially important and positive milestone for Celgene. We are fully committed to deliver VIDAZA to patients in need throughout the EU,” said Philippe Van Holle, President of Celgene Europe. “We are optimistic that VIDAZA will have broad support based on its value to patients and to the healthcare system. Upon approval we are prepared to initiate next steps for pricing, reimbursement and distribution plans for all EU member states.”
http://news.moneycentral.msn.com/ticker/article.aspx?Feed=BW&Date=20081024&ID=9318112&Symbol=CELG
Thu Oct 23, 2008 10:41am EDT
BOSTON (Reuters) - Celgene Corp (CELG.O:
Quote,
Profile, ) said on Thursday its third-quarter earnings rose on higher sales of its cancer drugs and boosted its outlook for 2008, sending its shares up 6 percent.
Net income rose to $136.8 million, or 29 cents a share, from $38 million, or 9 cents a share, a year ago.
Earnings excluding one-time items were 40 cents a share. Analysts on average expected 39 cents a share, according to Reuters Estimates.
Revenue rose nearly 70 percent to $592.5 million, driven by sales of Revlimid.
Sales of Revlimid, a successor to Celgene's cancer drug Thalomid, rose 72 percent to $343 million -- just below the consensus estimate of $347 million.
Celgene executives said on the company's third-quarter earnings call it expects earnings per share in the full year to exceed its previous forecast of $1.50. It expects revenue to exceed its previous forecast of $2.2 billion.
Analysts expect the company to earn $1.53 a share and revenue of $2.25 billion, according to Reuters Estimates.
The company also said it has bought out Pfizer Inc's (PFE.N:
Quote, ) royalty rights to its blood disorder drug Vidaza for $425 million so that it can reap full rewards from the drug.
The company said it expects Vidaza to be approved in Europe imminently.
"Overall we would characterize the quarter as largely in line given the EPS beat and modest upside to revenues, but note that expectations were markedly lower than in previous quarters with many investors expecting a wide Revlimid miss," said Geoffrey Meacham, an analyst at J.P. Morgan.
Product sales of $567 million were higher than Wall Street's expectations of about $563 million.
Celgene's shares rose $3.21 to $56.50 in morning trading on Nasdaq.
http://www.reuters.com/article/hotStocksNews/idUSTRE49M5QV20081023
