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Celgene (CELG) Provides Guidance for 2019, Updates Pipeline

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Celgene Corporation (CELG - Free Report) announced that it has achieved its guidance for 2018 and has issued its financial guidance for 2019. The company also reaffirmed its expected 2020 financial targets.

The preliminary results show that Celgene has achieved guidance for 2018 that it had provided on Oct 25, 2018 (revenues of $15.2 billion and earnings per share of $8.75- $8.80). The company is scheduled to report fourth quarter and 2018 results on Jan 31, 2019.

The company also provided guidance for 2019. Revenues are expected to come between 17.0 billion and $17.2 billion, a 12% year-over-year increase, based on the mid-point of the range. Earnings per share are projected between $1.60 and $1.80.

By 2020, Celgene expects to generate revenues of $19.0-$20.0 billion, while adjusted EPS will exceed $12.50.

Shares of Celgene are up 4.1% in the last six months compared with a 15.6% decline for the overall biotech industry.

 

Celgene is working to expand flagship drug Revlimid’s label. The company expects to get FDA approval for its supplemental New Drug Application (sNDA) for Revlimid in combination with Rituxan for the indication of relapsed/refractory indolent lymphoma.

Data expected from the phase III trial, ROBUST, evaluating Revlimid in combination with Rituxan, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate and prednisone (R-CHOP) in patients with first-line ABC-subtype diffuse large B-cell lymphoma (DLBCL) is also expected in 2019.

The company is also working to expand the label of other drugs. Oncology drug Pomalyst in combination with bortezomib and dexamethasone (PVd) is being evaluated for the treatment of relapsed/refractory multiple myeloma (RRMM) and an approval for the same is expected in Europe and Japan.

The sNDA for plaque psoriasis drug Otezla has been accepted for Behcet’s disease with a Prescription Drug User Fee Act (PDUFA) action date of Jul 21, 2019. The company is expected to submit an sNDA to the FDA for Otezla for a label update for moderate-to-severe scalp psoriasis in the second quarter of 2019.

A decision from the FDA is expected by Mar 12, 2019 on the supplemental Biologics License Application (sBLA) filed by Roche for Tecentriq in combination with Celgene’s Abraxane for the initial treatment of patients with PD-L1-positive, metastatic triple-negative breast cancer.

Celgene plans to submit an NDA to the FDA and a Marketing Authorization Application (MAA) to the EMA for ozanimod for the treatment of relapsing multiple sclerosis in the first quarter of 2019. Regulatory applications for luspatercept, developed in collaboration with Acceleron Pharma (XLRN - Free Report) for transfusion-dependent, lower-risk myelodysplastic syndromes (MDS) with ring sideroblasts (RS+) and transfusion-dependent beta-thalassemia are planned for the first half of 2019.

Data from the TRANSCEND trial on liso-cel in relapsed/refractory DLBCL is expected in 2019 and regulatory applications will be filed in the second half of the year. Celgene is also developing bb2121, an experimental anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cell therapy, with bluebird bio, Inc. (BLUE - Free Report) for the potential treatment of patients with RRMM in the United States.

Data from the KarMMa trial in RRMM are expected in the second half of 2019.

Celgene has been in news since last week due to the recent announcement of a merger agreement by large-cap pharma company, Bristol-Myers Squibb Company (BMY - Free Report) . Shares of Celgene were up on the news. The acquisition is expected to close in the third quarter of 2019. While the pipeline progress is encouraging, Revlimid will lose patent protection

Zacks Rank

Celgene currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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