On January 26, 2017 Celgene Corporation (NASDAQ: CELG) reported operating results for the fourth quarter and full-year of 2016 (Press release, Celgene, JAN 26, 2017, View Source [SID1234517573]). 

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For the fourth quarter of 2016, net product sales were $2,977 million, an increase of 17 percent, year-over-year.  Net product sales growth includes a 0.3 percent negative impact from currency exchange effects.  Fourth quarter total revenue increased 16 percent to $2,980 million.
 
Net product sales for the full-year of 2016 were $11,185 million, an increase of 22 percent year-over-year.  Total revenue for the full-year of 2016 was $11,229 million, an increase of 21 percent year-over-year.
 
Based on U.S. GAAP (Generally Accepted Accounting Principles), Celgene reported net income of $429 million and diluted earnings per share (EPS) of $0.53 for the fourth quarter of 2016.  For the fourth quarter of 2015, GAAP net income was $561 million and diluted EPS was $0.69.  The decrease was primarily due to increased research and development (R&D) expenses as a result of the acquisition of Acetylon Pharmaceuticals, Inc. and a fair value adjustment for an equity investment recorded in the fourth quarter of 2016.  Full-year GAAP net income for 2016 was $1,999 million and diluted EPS was $2.49.  Full-year GAAP net income for 2015 was $1,602 million and diluted EPS was $1.94.
 
Adjusted net income for the fourth quarter of 2016 increased 34 percent to $1,290 million compared to $961 million in the fourth quarter of 2015.  For the same period, adjusted diluted EPS increased 36 percent to $1.61 from $1.18.
 
Adjusted net income for the full-year 2016 increased 23 percent to $4,770 million.  Adjusted diluted EPS increased 26 percent to $5.94 from $4.71 for the full-year of 2015.
 
"2016 was an outstanding year of progress strengthening our commercial portfolio and advancing our early-, mid- and late-stage pipeline," said Mark J. Alles, Celgene’s Chief Executive Officer.  "We expect our business momentum and significant near-term catalysts to drive high-growth through 2017 and beyond."
 
Fourth Quarter and Full-year 2016 Financial Highlights
 
Unless otherwise stated, all comparisons are for the fourth quarter and full-year of 2016 compared to the fourth quarter and full-year of 2015.  The adjusted operating expense categories presented below exclude share-based employee compensation expense, collaboration-related upfront expense, research and development asset acquisition expense and a litigation-related loss contingency accrual expense.  Please see the attached Use of Non-GAAP Financial Measures and Reconciliation of GAAP to Adjusted Net Income for further information relevant to the interpretation of adjusted financial measures and reconciliations of these adjusted financial measures to the most comparable GAAP measures, respectively.
 
Net Product Sales Performance
 
·                                          REVLIMID sales for the fourth quarter increased 16 percent to $1,808 million.  Fourth quarter U.S. sales of $1,187 million and international sales of $621 million increased 24 percent and 3 percent, respectively.  Full-year REVLIMID sales were $6,974 million, an increase of 20 percent year-over year.  Sales growth was driven primarily by increased volume as a result of increases in duration and new patients.
 
·                                          POMALYST/IMNOVID sales for the fourth quarter were $378 million, an increase of 29 percent year-over-year.  Fourth quarter U.S. sales of $219 million and international sales of $159 million increased 29 percent and 28 percent, respectively.  Full-year POMALYST/IMNOVID sales were $1,311 million, an increase of 33% year-over-year.  Sales growth was driven primarily by increased volume as a result of increases in duration.
 
·                                          OTEZLA sales in the fourth quarter were $305 million, a 67 percent increase year-over-year.  Fourth quarter U.S. sales of $268 million and international sales of $37 million increased 60 percent and 137 percent, respectively.  Full-year OTEZLA sales were $1,017 million, an increase of 116 percent year-over-year.  OTEZLA uptake and market share gains continued to accelerate in the fourth quarter in the U.S. with increased contribution from early launch countries in Europe.
 
·                                          ABRAXANE sales for the fourth quarter were $266 million, a decrease of 1 percent, year-over-year.  U.S. sales were $171 million and international sales were $95 million, a decrease of 5 percent and an increase of 5 percent, respectively.  Full-year ABRAXANE sales were $973 million, an increase of 1 percent, year-over-year.
 
ABRAXANE market shares in pancreatic cancer, first-line advanced non-squamous lung cancer and metastatic breast cancer in the U.S. have remained stable.  Growth in Europe was from market share gains for ABRAXANE in pancreatic cancer.
 
·                                          In the fourth quarter, all other product sales, which include THALOMID, ISTODAX, VIDAZA and an authorized generic version of VIDAZA drug product in the U.S., were $220 million compared to $231 million in the fourth quarter of 2015.  Full-year sales for these products were $910 million compared to $938 million in full-year 2015.
 
Research and Development (R&D)
 
On a GAAP basis, R&D expenses were $1,135 million for the fourth quarter of 2016 versus $777 million for the same period in 2015.  Full-year 2016 R&D expenses were $4,470 million compared to $3,697 million for 2015.  Both the fourth quarter and full-year 2016 increases in R&D expenses on a GAAP basis were primarily due to R&D asset acquisition expenses and early research and clinical trial activity.  The increase in full-year 2016 R&D expenses was partially offset by a decrease in collaboration-related upfront expenses.
 
Adjusted R&D expenses were $673 million for the fourth quarter of 2016 compared to $649 million for the fourth quarter of 2015.  For the full-year 2016, adjusted R&D expenses were $2,508 million compared to $2,044 million for the full-year 2015.  Both the fourth quarter and full-year 2016 increases in adjusted R&D expenses were primarily due to early research and clinical trial activity.  The increase in fourth quarter adjusted R&D expenses was partially offset by a decrease in collaboration-related milestone expenses.
 
Selling, General, and Administrative (SG&A)
 
On a GAAP basis, SG&A expenses were $685 million for the fourth quarter of 2016 compared to $609 million for the same period in 2015.  Full-year SG&A expenses were $2,658 million for 2016 compared to $2,305 million for 2015.  Both the fourth quarter and full-year 2016 increases in SG&A expenses were primarily due to a litigation-related loss contingency accrual expense.
 
Adjusted SG&A expenses were $534 million for the fourth quarter of 2016 compared to $533 million for the fourth quarter of 2015.  For the full-year 2016, adjusted SG&A expenses were $2,139 million versus $2,011 million in 2015.
 
Cash, Cash Equivalents, and Marketable Securities
 
Operating cash flow was $3,976 million for 2016, an increase of 60 percent compared to 2015.  For the full-year 2016, Celgene purchased approximately $2,160 million in shares.  As of December 31, 2016, the Company had $4,731 million remaining under the existing share repurchase program.  The Company ended the year with $7,970 million in cash and marketable securities.
 
Product and Pipeline Updates
 
Hematology/Oncology
 
·                  Celgene advanced regulatory applications with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the expanded indication of REVLIMID as maintenance treatment in patients with newly diagnosed multiple myeloma (NDMM) after receiving an autologous stem-cell transplant (ASCT).  The sNDA was granted Priority Review and the Prescription Drug User Fee Act (PDUFA) date for the submission is February 24, 2017.  A decision on the European Union (EU) application is expected in the first half of 2017.
 
·                  In December 2016, Celgene and collaboration partner Juno Therapeutics, Inc. announced that the FDA granted Breakthrough Therapy designation to investigational drug JCAR017 for the treatment of patients with relapsed and/or refractory aggressive large B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma (DLBCL), not otherwise specified (de novo or transformed from indolent lymphoma), primary mediastinal B-cell lymphoma or grade 3B follicular lymphoma.  In addition, the EMA Committee for Medicinal Products for Human Use (CHMP) and Committee for Advanced Therapies (CAT) granted JCAR017 access to the Priority Medicines (PRIME) scheme for relapsed and/or refractory DLBCL.  A pivotal program for JCAR017 is expected to begin in 2017.  Celgene has license rights to JCAR017 outside of North America and China.
 
·                  At the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2016, data were presented on Celgene’s marketed and pipeline hematology assets.  Data presented included:
 
·                  Results from the large randomized, open-label phase III Myeloma XI trial that included a comparison of REVLIMID maintenance treatment versus no maintenance for patients with NDMM were presented.  The study included both transplant-eligible (TE) and transplant non-eligible (TNE) patients.
 
·                  Results from the phase III BMT CTN 0702 StaMINA trial were presented.  The trial randomized TE patients following transplant between three arms to receive either four cycles of REVLIMID in combination with bortezomib and dexamethasone consolidation, tandem melphalan autologous stem cell transplant consolidation or no consolidation.
 
·                  Results from an analysis of three phase I/II studies evaluating CC-486 in patients with myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia and acute myeloid leukemia (AML) who had received prior hypomethylating agents.  Phase III trials evaluating CC-486 in MDS and AML maintenance are enrolling with enrollment in the AML trial expected to complete in 2017.
 
·                  In collaboration with our partner Acceleron Pharma, Inc., results from phase II trials with luspatercept in MDS and beta-thalassemia and sotatercept in myelofibrosis were presented.  Phase III trials with luspatercept in MDS and beta-thalassemia are expected to complete enrollment in the second half of 2017.  A phase II trial evaluating luspatercept in myelofibrosis is expected to initiate in 2017.
 
·                  At the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Molecular Targets and Cancer Therapeutics Symposium ("Triple Meeting") in November 2016, interim data were presented from a phase I trial with anti-BCMA CAR-T cell product candidate bb2121 in patients with relapsed and/refractory multiple myeloma (RRMM).  Celgene is developing bb2121 in collaboration with partner bluebird bio.
 
·                  In the fourth quarter of 2016, enrollment completed in the phase III AUGMENT trial evaluating REVLIMID in combination with rituximab in patients with relapsed or refractory follicular lymphoma or marginal zone lymphoma.  Top-line data from the event-driven trial is expected by year-end 2017.
 
Inflammation & Immunology
 
·                  In December 2016, Japan’s Ministry of Health, Labor and Welfare (MHLW) granted full marketing authorization to OTEZLA for the treatment of adult patients with plaque psoriasis with an inadequate response to topical therapies, as well as adult patients with psoriatic arthritis.  Reimbursement for OTEZLA in Japan is expected in the first quarter of 2017.
 
·                  At the American College of Rheumatology (ACR) meeting in November 2016, data were presented from the phase IIIb ACTIVE trial evaluating OTEZLA versus placebo in patients with active psoriatic arthritis who have not previously been treated with a biologic therapy.
 
·                  Data from part 1 of a phase IIa trial evaluating CC-220 for systemic lupus erythematosus were presented at the Lupus 2016 Meeting in Armonk, NY in September 2016 and at the 10th European Lupus Meeting in Venice in October 2016.  The second part of the phase IIa trial evaluating improvement in skin manifestations and improvement in the Cutaneous Lupus Area and Severity Index (CLASI) score is enrolling.
 
·                  In October 2016, data from the phase Ib trial evaluating the effects of oral GED-0301 (mongersen) on both endoscopic and clinical outcomes in patients with active Crohn’s disease were presented at the United European Gastroenterology Week (UEGW) and at the American College of Gastroenterology (ACG) meetings.  The phase III REVOLVE and DEFINE registration trials with GED-0301 in patients with active Crohn’s disease are enrolling with data expected in 2018.  Data from a proof-of-concept phase II trial evaluating GED-0301 in ulcerative colitis is expected in 2017.
 
·                  In October 2016, phase II data from the TOUCHSTONE trial evaluating ozanimod as induction and maintenance in patients with ulcerative colitis were presented at the UEGW and at the ACG meetings.  The phase III TRUE NORTH registration trial with ozanimod in patients with ulcerative colitis is enrolling with data expected in 2018.  Data from a proof of concept phase II trial ozanimod in patients with Crohn’s disease are expected in 2017.
 
Business Update Summary
 
·                  In January 2017, Celgene entered into an agreement to acquire Delinia, Inc., a privately-held biotechnology company, for an initial payment of $300 million as well as contingent payments of $475 million that may be achieved upon development, regulatory, and commercial advances related to Delinia’s lead program, DEL-106.  DEL-106 is a novel IL-2 mutein Fc fusion protein designed to preferentially upregulate regulatory T cells (Tregs), immune cells that are critical to maintaining natural self-tolerance and immune system homeostasis and is expected to go into the clinic next year.  The acquisition will expand Celgene’s pipeline of potential medicines for the treatment of patients with autoimmune disorders.  The transaction is expected to close in the first quarter of 2017.
  
·                  In January 2017, an exclusive global research collaboration with Anokion SA, a privately held biopharmaceutical company developing novel tolerance-inducing therapeutics for autoimmune diseases, was announced.  Anokion is advancing its antigen-specific immune tolerance platform to develop therapeutics for multiple autoimmune indications.  Under the terms of the collaboration agreement, Anokion received a $45 million upfront payment and is eligible to receive a future payment of an additional $10 million based on certain preclinical development achievements.  As part of the strategic collaboration agreement, Celgene obtained an equity interest in Anokion and the exclusive right to acquire Anokion at pre-specified option exercise points.
 
·                  In December 2016, Celgene Corporation, Dana-Farber Cancer Institute and the University of Arkansas for Medical Sciences announced the creation of the Myeloma Genome Project, a collaborative initiative aimed at compiling the largest dataset of high-quality genomic and clinical data to identify distinct molecular disease segments within multiple myeloma to advance diagnosis, prognosis and treatment of multiple myeloma patients.  The initiative seeks to develop clinically relevant tests.
 
·                  In December 2016, Celgene acquired Acetylon Pharmaceuticals, Inc. including worldwide rights to Acetylon’s selective HDAC6 inhibitor programs and intellectual property in oncology, neurodegeneration, and autoimmune disease, including its lead drug candidates citarinostat (ACY-241) and ricolinostat (ACY-1215).  The transaction resulted in a $226.1 million research and development asset acquisition expense.  In addition, the sellers of Acetylon are eligible to receive contingent regulatory and commercial milestone payments.
 
·                  In December 2016, Celgene and German company, Evotec AG entered into a strategic drug discovery and development collaboration to identify disease-modifying therapeutics for a broad range of neurodegenerative diseases.  Initial disease areas of focus will include amyotrophic lateral sclerosis, Alzheimer’s disease, Parkinson’s disease, and multiple other neurodegenerative disorders.  Under the terms of the agreement, Evotec received an upfront payment of $45 million and is eligible to receive up to $250 million in milestones as well as up to low double-digit royalties on programs Celgene in-licenses.
 
·                  In November 2016, Celgene acquired marizomib from privately-held Triphase Accelerator L.P.  Marizomib is in development for glioblastoma and RRMM.  Phase I data with marizomib in patients with glioblastoma were presented at the Society for Neuro-Oncology (SNO) conference in November 2016.  The transaction resulted in a $43.5 million research and development asset acquisition expense.  In addition, the sellers of Triphase are eligible to receive contingent development, regulatory and commercial milestone payments.
 
Celgene Expects Strong Product Sales and Earnings Growth in 2017
 
  2017 Guidance Year-over-Year
Change*
Total Revenue Approximately $13.0B to $13.4B 18%
REVLIMID Net Sales Approximately $8.0B to $8.3B 17%
POMALYST/ IMNOVID Net Sales Approximately $1.6B 22%
OTEZLA Net Sales Approximately $1.5B to $1.7B 57%
ABRAXANE Net Sales Approximately $1.0B 3%
GAAP diluted EPS $5.85 to $6.21 NM**
Adjusted diluted EPS $7.10 to $7.25 21%
GAAP operating margin Approximately 45.5% NM**
Adjusted operating margin Approximately 56.5% +150 bps
Weighted average diluted shares Approximately 815M +12M***
 
*Year-over-year percentage change based on the mid-point of the range.
 
** Not meaningful as the 2017 measures exclude the impact of any strategic transactions, impairments and loss contingencies that have not yet occurred.
 
***Reflects accounting standard change effective 1/1/2017 which eliminates a favorable adjustment currently provided in diluted share count under existing accounting guidance. (Accounting Standards Update 2016-09)