Celgene (CELG) Tops Q1 EPS by 1c

Celgene (NASDAQ: CELG) reported Q1 EPS of $1.07, $0.01 better than the analyst estimate of $1.06. Revenue for the quarter came in at $2.08 billion versus the consensus estimate of $2.11 billion.

Product and Pipeline Updates

Hematology

REVLIMID^®: In February, the U.S. Food and Drug Administration expanded the approved indication for REVLIMID^® to include the treatment of patients with newly diagnosed multiple myeloma (NDMM), in combination with dexamethasone. Also in February, the European Commission (EC) approved REVLIMID^® for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. Celgene is actively involved in reimbursement discussions and launch activities across Europe.

At the American Society of Clinical Oncology (ASCO) Annual Meeting beginning in May, updated overall survival data from the FIRST^® trial as well as data on REVLIMID^® in combination with novel compounds in multiple myeloma are expected to be presented. Also, results from the Follicular Lymphoma Analysis of Surrogacy Hypothesis (FLASH) in first-line follicular lymphoma will be presented. Celgene is sponsoring five phase III trials with REVLIMID^® in lymphoma with data expected beginning in early 2017.

POMALYST^®: In March, Japan’s Ministry of Health, Labour and Welfare approved POMALYST^® for the treatment of relapsed and refractory multiple myeloma. Reimbursement is expected mid-year.

Luspatercept and Sotatercept: Celgene, in collaboration with partner Acceleron, is presenting additional phase II data on sotatercept in lower-risk myelodysplastic syndromes (MDS) and luspatercept in MDS at the 13th International Symposium on Myelodysplastic Syndromes. The companies plan to initiate a phase III program with luspatercept in beta-thalassemia and MDS by year-end 2015.

In April, Celgene announced that it had entered into a strategic collaboration with AstraZeneca to develop and commercialize MEDI4736, an anti-PD-L1 monoclonal antibody, for hematologic malignancies including multiple myeloma, non-Hodgkin’s lymphoma and myeloid diseases. The agreement provides a negotiation period to expand the agreement for other immuno-therapeutics.

Oncology

ABRAXANE^®: In March, Celgene announced that the EC approved ABRAXANE^® in combination with carboplatin for the first-line treatment of non-small cell lung cancer (NSCLC) in adult patients who are not candidates for potentially curative surgery and/or radiation therapy. Celgene is actively involved in reimbursement discussions and launch activities across Europe.

Demcizumab: Celgene’s collaboration partner, OncoMed, has begun enrollment in phase II trials of demcizumab in first-line advanced-stage NSCLC and pancreatic cancer. In April, data from a phase Ib trial of demcizumab in NSCLC were presented at the European Lung Cancer Conference. At ASCO, phase I data on demcizumab in pancreatic cancer and NSCLC will be presented.

Inflammation & Immunology (I&I)

OTEZLA^®: In January, Celgene announced that the EC granted marketing authorization for OTEZLA^® for moderate-to-severe chronic plaque psoriasis and the treatment of active psoriatic arthritis. Celgene is actively involved in reimbursement discussions and launch activities across Europe.

At the 73rd Annual Meeting of the American Academy of Dermatology in March, data were presented on the phase III LIBERATE^TM (PSOR-010) trial which evaluated the clinical efficacy and safety of oral OTEZLA^® or weekly subcutaneous etanercept compared with placebo at week 16. A post-hoc analysis revealed no significant difference between OTEZLA^® and etanercept (P=0.2565) in PASI-75 at week 16. LIBERATE^TM was not designed or powered to directly compare OTEZLA^® to etanercept. Among patients who switched from etanercept to OTEZLA^® at week 16, more patients achieved a PASI-75 response at week 32 than at week 16 [61 percent (n=51/83) vs. 48 percent (n=40/83), respectively].

Results from a multicenter, randomized, placebo-controlled phase II trial (BCT-001) of OTEZLA^® in patients with Behçet’s disease were published in the April 16 issue of The New England Journal of Medicine. Behçet’s disease is a rare, chronic inflammatory disorder characterized by recurrent oral and genital ulcers, which are considered a hallmark of the disease. Joint inflammation and recurrent skin and eye lesions may also occur. Based on the phase II results, Celgene has filed with regulatory authorities in Turkey and has initiated a global phase III trial.

GED-0301 (mongersen): Results from a double-blind, placebo-controlled, multicenter phase II trial of GED-0301 in patients with active Crohn's disease were published in the March 19 issue of The New England Journal of Medicine.

A randomized, double-blind registration-enabling endoscopy trial with GED-0301 has initiated. The primary endpoint of the 52-week trial is the change in Simplified Endoscopic Activity Score for Crohn's disease (SES-CD Score) at twelve weeks and secondary endpoints include Crohn’s Disease Activity Index (CDAI) remission. Phase III trials with GED-0301 in Crohn’s disease will begin enrollment in mid-2015. A phase II trial of GED-0301 in ulcerative colitis will begin enrollment in late 2015.

At the Digestive Disease Week Annual Meeting in May, data on patient reported outcomes (PRO2) and the impact of severity and duration of active Crohn’s disease efficacy from the phase II trial of GED-0301 in Crohn’s disease will be presented.

For earnings history and earnings-related data on Celgene (CELG) click here.

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