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Celgene Reports Strong Third Quarter 2013 Operating And Financial Results

Stocks in this article: CELG

Selling, General, and Administrative (SG&A)

Adjusted SG&A expenses were $405 million for the third quarter of 2013 compared to $323 million for the third quarter of 2012. The increase was primarily due to the IMNOVID ® European launch in relapsed and refractory multiple myeloma (RRMM), the ABRAXANE ® U.S. launch in pancreatic cancer and continued investments in the Company’s Inflammation & Immunology franchise. On a GAAP basis, SG&A expenses were $449 million for the third quarter of 2013 compared to $355 million for the same period in 2012.

Cash, Cash Equivalents, and Marketable Securities

Operating cash flow was $571.1 million in the third quarter of 2013. Celgene purchased approximately 1.5 million shares during the third quarter of 2013 at a total cost of approximately $211 million. Year-to-date, Celgene repurchased approximately $2,048 million of its common stock. Celgene ended the quarter with $5,847 million in cash and marketable securities. During the third quarter of 2013, Celgene issued an aggregate of $1,500 million in senior notes in tranches of five-, ten- and thirty-years.

Product and Pipeline Updates

Hematology

REVLIMID ® (lenalidomide): In July, the Company announced the FIRST ® (Frontline Investigation of REVLIMID ® and Dexamethasone versus Standard Thalidomide) trial (MM-020/IFM 07-01), a phase III trial of REVLIMID ® in combination with dexamethasone in newly-diagnosed multiple myeloma (NDMM), achieved the primary endpoint of progression-free survival (PFS). The MM-020 abstract was accepted for the Plenary Scientific Session on December 8 at the 55 th American Society of Hematology (ASH) annual meeting.

Celgene expects to submit regulatory applications in the U.S. and in Europe for REVLIMID ® in NDMM in the first quarter of 2014 with submissions in additional geographies to follow.

Enrollment in the REMARC trial of REVLIMID ® maintenance versus placebo in patients with diffuse large B-cell lymphoma (DLBCL) responding to R-CHOP is expected to complete in the fourth quarter while enrollment in the phase III RELEVANCE ® trial of REVLIMID ®/rituximab in newly diagnosed follicular lymphoma (FL) continues.

Additional phase III trials evaluating the combination of REVLIMID ®/rituximab compared to rituximab in relapsed or refractory indolent non-Hodgkin’s lymphoma (iNHL) and REVLIMID ® maintenance in post REVLIMID ®/rituximab therapy in relapsed or refractory iNHL are expected to begin enrollment by year end.

POMALYST ®/IMNOVID ® (pomalidomide): In August, the EC granted approval of IMNOVID ® in combination with dexamethasone for the treatment of RRMM in adult patients who have received at least two prior therapies including both lenalidomide and bortezomib and have demonstrated disease progression on the last therapy.

American Society of Hematology Meeting

There were over 150 abstracts across Celgene’s hematology portfolio submitted to the upcoming ASH annual meeting in December. In addition to the MM-020 trial data, Celgene expects presentations on:

  • Meta-analysis of REVLIMID ® maintenance therapy in NDMM
  • Update to the REVLIMID ® maintenance arm in the GIMEMA trial in NDMM
  • Analysis of PFS2 in the MM-015 trial in NDMM
  • Interim data from a phase Ib trial of selective HDAC 6 inhibitor ACY-1215 in combination with REVLIMID ® in RRMM
  • Analysis of patient subtypes in the MM-003 trial comparing POMALYST ®/IMNOVID ® in combination with low-dose dexamethasone to high-dose dexamethasone in RRMM
  • Final phase II results of REVLIMID ® in combination with R-CHOP21 in elderly untreated DLBCL
  • Phase II data of REVLIMID ® and REVLIMID ®/rituximab as maintenance in DLBCL
  • Phase I study of single agent CC-292 in relapsed or refractory chronic lymphocytic leukemia

Oncology

ABRAXANE ® (paclitaxel protein-bound particles for injectable suspension): On September 6, the U.S. FDA approved ABRAXANE ® in combination with gemcitabine as a first-line treatment in patients with metastatic adenocarcinoma of the pancreas. An opinion from the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) is expected in the fourth quarter.

The results of the MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) phase III clinical trial of ABRAXANE ® in combination with gemcitabine were published online in the October 16 th edition of the New England Journal of Medicine.

A phase II/III trial of ABRAXANE ® in triple negative breast cancer began enrolling patients in the third quarter. Additional trials of ABRAXANE ® in solid tumors expected to begin by year-end include a phase III trial of ABRAXANE ® in adjuvant pancreatic cancer and a phase III trial of ABRAXANE ® maintenance after ABRAXANE ®/cisplatin treatment in patients with squamous non-small cell lung cancer. In the fourth quarter, final overall survival data from a phase III clinical trial of ABRAXANE ® in metastatic melanoma are expected.

Inflammation & Immunology

Apremilast: The phase III POSTURE trial of apremilast in active ankylosing spondylitis completed enrollment during the third quarter. The trial randomized approximately 500 patients to receive 20 mg apremilast, 30 mg apremilast, or placebo twice daily. In this 24-week study, the primary endpoint is the proportion of patients achieving an ASAS 20 score at week 16. A number of secondary endpoints will also be evaluated. Top-line data are expected in the first half of 2014.

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