On January 7, 2019 Celgene Corporation (NASDAQ: CELG) reported a business update, including confirmation that the company achieved its guidance for full-year 2018; its financial guidance for 2019; and reaffirmation of its expected 2020 financial targets (Press release, Celgene, JAN 7, 2019, View Source [SID1234532535]).

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Based on a preliminary review of its results for the fourth-quarter ended December 31, 2018, Celgene achieved guidance for the full-year 2018 that it provided on October 25, 2018 and which is summarized in the table below. The company will report its results for the fourth-quarter and full-year 2018 on January 31, 2019.

Celgene today also provides guidance for the full-year 2019, including total revenue expected to be $17.0 billion to $17.2 billion, a 12 percent increase year-over-year, based on the mid-point of the range. Based on Generally Accepted Accounting Principles (GAAP) diluted earnings per share (EPS) for the full-year 2019 is expected to be in the range of $8.48 to $9.17. Adjusted diluted EPS for the full-year 2019 is expected to be in the range of $10.60 to $10.80.

"Our 2019 financial guidance reflects continued strong operating performance and momentum," said Mark J. Alles, Chairman and Chief Executive Officer of Celgene Corporation. "Multiple clinical and regulatory milestones are expected in 2019 to advance our late-stage portfolio and accelerate our early-stage pipeline."

*Year-over-year percentage change based on the mid-point of the range.

**Not meaningful as the 2019 measures exclude the impact of any strategic transactions, impairments, loss contingencies, changes in the fair value of equity investments, costs associated with the Bristol-Myers Squibb Company (Bristol-Myers Squibb) and Celgene transaction and non-operating tax adjustments that have not yet occurred.

Reaffirming Expected 2020 Long-Term Financial Targets*

2020 total revenue range of $19.0 billion to $20.0 billion

Adjusted diluted EPS to exceed $12.50

*At constant currency using an average of December 2018 spot rates

Overview of Key Milestones Expected Over the Next 12 Months

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REVLIMID

Approval expected by the U.S. Food and Drug Administration (FDA) on the supplemental New Drug Application (sNDA) for REVLIMID in combination with rituximab in relapsed/refractory indolent lymphoma (AUGMENT)

Approval expected by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for REVLIMID in combination with bortezomib and dexamethasone (RVd) in newly diagnosed multiple myeloma (NDMM)

Data expected from the phase III ROBUST trial with REVLIMID in combination with rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate and prednisone (R-CHOP) in patients with first-line ABC-subtype diffuse large B-cell lymphoma (DLBCL) (event-driven)

POMALYST/ IMNOVID

Approval expected by the EMA CHMP and Japan Pharmaceuticals and Medical Devices Agency (PMDA) for POMALYST/IMNOVID in combination with bortezomib and dexamethasone (PVd) in relapsed/refractory multiple myeloma (RRMM)

OTEZLA

Approval expected by the U.S. FDA for the sNDA in Behҫet’s disease with a Prescription Drug User Fee Act (PDUFA) action date of July 21, 2019. Approval by the PMDA in Japan is expected in H2:2019

Submission of the sNDA with label update for moderate to severe scalp psoriasis to the U.S. FDA expected in Q2:2019

ABRAXANE

Data from the phase III apact trial with ABRAXANE as adjuvant therapy in patients with surgically resected pancreatic cancer (event-driven)

PDUFA action date of March 12, 2019 for the supplemental Biologics License Application (sBLA) submission filed by Roche of Tecentriq (atezolizumab) in combination with ABRAXANE for the initial treatment of patients with PD-L1-positive, metastatic triple-negative breast cancer

Milestones Expected for Key Pivotal Assets

Ozanimod

U.S. NDA and EU Marketing Authorization Application (MAA) submissions in relapsing multiple sclerosis (RMS) on-track for Q1:2019

Phase III TRUE NORTH trial in ulcerative colitis (UC) expected to complete enrollment in H1:2019

Fedratinib

U.S. FDA approval expected by year-end 2019

EU MAA submission planned in H1:2019

Phase I/II combination trial with luspatercept planned

Luspatercept

U.S. and EU regulatory applications for transfusion-dependent, lower-risk myelodysplastic syndromes (MDS) with ring sideroblasts (RS+) and transfusion-dependent beta-thalassemia planned for H1:2019

Data expected from the phase II myelofibrosis trial in H2:2019

Liso-cel

Data from the pivotal TRANSCEND trial in relapsed/refractory DLBCL expected in 2019

U.S. BLA submission expected in H2:2019

Pivotal phase II trial in relapsed/refractory chronic lymphocytic leukemia (CLL) to be initiated in H1:2019

bb2121

Data from the KarMMa pivotal trial in RRMM expected in H2:2019

Phase II trial in NDMM to be initiated in H2:2019

Key Milestones Expected for Research & Early Development Pipeline

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·Clinical data expected in 2019 from the following assets:

Asset

Indication

Status

CC-92480 (CELMoD)

RRMM

Phase I trial

CC-93269 (BCMA TCE)

RRMM

Phase I trial

CC-220 (CELMoD)

RRMM

Phase I/II trial

bb21217 (BCMA CAR T)

RRMM

Phase I trial

JCARH125 (BCMA CAR T)

RRMM

Phase I trial

CC-90009 (CELMoD)

Relapsed/refractory acute myeloid leukemia (AML)

Phase I trial

CC-90002 (anti-CD47 mAb)

Non-Hodgkin lymphoma (NHL)

Phase I trial