On May 4, 2018 Celgene Corporation (NASDAQ:CELG) reported net product sales of $3,531 million for the first quarter of 2018, a 20 percent increase from the same period in 2017 (Press release, Celgene, MAY 4, 2018, View Source [SID1234526130]). Celgene reported first quarter 2018 total revenue of $3,538 million, a 19 percent increase compared to $2,962 million in the first quarter of 2017.
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Based on U.S. GAAP (Generally Accepted Accounting Principles), Celgene reported net income of $846 million and diluted earnings per share (EPS) of $1.10 for the first quarter of 2018. For the first quarter of 2017, GAAP net income was $932 million and diluted EPS was $1.15.
Adjusted net income for the first quarter of 2018 increased 16 percent to $1,572 million compared to $1,355 million in the first quarter of 2017. For the same period, adjusted diluted EPS increased 23 percent to $2.05 (inclusive of approximately $0.05 dilution from the Juno acquisition) from $1.67.
"Strong global demand and excellent commercial execution drove our exceptional first quarter results, leading to improvement in our 2018 financial guidance," said Mark J. Alles, Chairman and Chief Executive Officer of Celgene Corporation. "With multiple catalysts for growth expected over the next 12 to 18 months, we are reaffirming our 2020 outlook."
First Quarter 2018 Financial Highlights
Unless otherwise stated, all comparisons are for the first quarter of 2018 compared to the first quarter of 2017. The adjusted operating expense categories presented below exclude share-based employee compensation expense, research and development asset acquisition expense, collaboration-related upfront expense and a benefit associated with the adjustment to clinical trial and development activity wind-down costs. 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 first quarter increased 19 percent to $2,234 million. Sales growth was primarily volume-driven due to increases in treatment duration and market share. U.S. sales of $1,487 million and international sales of $747 million increased 21 percent and 15 percent year-over-year, respectively.
POMALYST/IMNOVID sales for the first quarter were $453 million, an increase of 24 percent year-over-year. U.S. sales were $300 million and international sales were $153 million, an increase of 39 percent and 3 percent year-over-year, respectively. POMALYST/IMNOVID sales growth was primarily volume-driven due to increases in treatment duration and market share.
OTEZLA sales for the first quarter were $353 million, a 46 percent increase year-over-year. First quarter U.S. sales of $276 million and international sales of $77 million increased 39 percent and 79 percent, year-over-year, respectively. OTEZLA sales in the U.S. were primarily volume-driven due to increasing demand and improved access pull-through in contracted health plans. OTEZLA international sales growth was driven primarily by increasing adoption in key ex-U.S. markets.
ABRAXANE sales for the first quarter were $262 million, an 11 percent increase year-over-year. U.S. sales were $159 million and international sales were $103 million, an increase of 12 percent and 10 percent, year-over-year, respectively. ABRAXANE sales were positively impacted by buying patterns. Growth in Europe was driven by market share gains for ABRAXANE in pancreatic cancer.
In the first quarter, all other product sales, which include IDHIFA, THALOMID, ISTODAX, VIDAZA and an authorized generic version of VIDAZA drug product primarily sold in the U.S., were $229 million compared to $226 million in the first quarter of 2017.
Research and Development (R&D)
On a GAAP basis, R&D expenses were $2,203 million for the first quarter of 2018 versus $995 million for the same period in 2017. The first quarter increase was primarily due to an increase in research and development asset acquisition expense relating to our acquisition of Impact Biomedicines, Inc. (Impact), an increase in share-based compensation expense related to our acquisition of Juno Therapeutics, Inc. (Juno), and increased spending related to clinical trial and other R&D activity, partially offset by a reduction of one-time charges related to wind-down costs associated with the GED-0301 clinical trials in Crohn’s disease and certain development activities.
Adjusted R&D expenses were $694 million for the first quarter of 2018 compared to $595 million for the first quarter of 2017. The first quarter increase was primarily due to increased spending related to clinical trial and other R&D activities.
Selling, General, and Administrative (SG&A)
On a GAAP basis, SG&A expenses were $864 million for the first quarter of 2018 compared to $620 million for the same period in 2017. The first quarter increase was primarily due to an increase in share-based compensation expense related to our acquisition of Juno and an increase in promotional activities and legal expenses.
Adjusted SG&A expenses were $671 million for the first quarter of 2018 compared to $539 million for the first quarter of 2017. The first quarter increase was primarily due to an increase in promotional activities and legal expenses.
Cash, Cash Equivalents, Marketable Debt Securities and Publicly-Traded Equity Securities
Operating cash flow was $(325) million in the first quarter of 2018, compared to $853 million for the first quarter of 2017, which was primarily impacted by the $1.1 billion upfront cash payment to acquire Impact Biomedicines (fedratinib).
In the first quarter, Celgene completed two strategic acquisitions for over $10 billion. We repurchased approximately 29.0 million shares at a total cost of approximately $2.7 billion. Celgene raised $4.5 billion in a debt offering to finance a portion of the acquisition of Juno. Celgene ended the quarter with approximately $4.7 billion in cash, cash equivalents, marketable debt securities and publicly-traded equity securities.
Product and Pipeline Updates
Hematology & Oncology
At the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June, data presentations are expected to include:
Updated durability and safety data from the pivotal TRANSCEND NHL-001 trial evaluating liso-cel (JCAR017) in patients with relapsed or refractory aggressive non-Hodgkin lymphoma (NHL). In addition, the pivotal TRANSCEND NHL-001 trial completed enrollment in April.
In collaboration with partner bluebird bio, updated data from the CRB-401 phase I trial evaluating bb2121 in patients with relapsed and/or refractory multiple myeloma (RRMM).
Results from the phase III OPTIMISMM trial evaluating POMALYST in combination with bortezomib and dexamethasone (PVd) in patients with second-line multiple myeloma.
Results from the phase III RELEVANCE trial with REVLIMID in combination with rituximab (R²) in patients with previously untreated follicular lymphoma (FL).
Primary progression-free survival (PFS) and safety analysis from the Genentech-sponsored phase III IMpower131 trial evaluating atezolizumab plus chemotherapy (carboplatin and ABRAXANE) as first-line treatment in patients with advanced squamous non-small cell lung cancer (NSCLC).
In April, Celgene initiated the pivotal TRANSCEND WORLD trial evaluating liso-cel in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in the EU and Japan. These data are expected to support international registration submissions for liso-cel in DLBCL.
The phase I TRANSCEND CLL-004 trial evaluating liso-cel in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) initiated in the first quarter.
The phase I EVOLVE trial evaluating JCARH125, a chimeric antigen receptor (CAR) T cell therapy targeting B-cell maturation antigen (BCMA), in patients with RRMM initiated in the first quarter.
Celgene’s partner BeiGene initiated the phase III trial evaluating BGB-A317 (tislelizumab) versus sorafenib in patients with previously untreated advanced hepatocellular carcinoma (HCC) in the first quarter. In addition, a phase II trial evaluating tislelizumab in patients with previously treated advanced HCC was initiated.
Inflammation & Immunology
In February, Celgene announced it received a Refusal To File (RTF) letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for ozanimod in relapsing multiple sclerosis (RMS). Following a Type A meeting with the FDA in early April, Celgene expects to resubmit the NDA in the first quarter of 2019.
Following a meeting with European regulatory authorities, Celgene expects to submit a Marketing Authorization Application (MAA) for ozanimod in RMS in the first quarter of 2019.
At the 2018 American Academy of Neurology (AAN) Annual meeting in April, data from new analyses of both pivotal phase III SUNBEAM and RADIANCE Part B trials evaluating ozanimod in RMS were presented. These new analyses show dose-dependent effects of ozanimod on annualized relapse rate (ARR) versus interferon beta-1a (Avonex) across subgroups, including baseline disability and prior exposure to disease-modifying therapies, that were consistent with the overall ARR primary endpoint. In addition, data presentations of exploratory endpoints showed reductions in cortical grey matter and thalamic volume loss consistent with the reductions in whole brain volume loss seen in SUNBEAM at one year and RADIANCE Part B at two years for ozanimod compared with Avonex. The overall safety and tolerability profile for ozanimod has been consistent across the RADIANCE Part A, SUNBEAM and RADIANCE Part B studies.
In February, data from the phase II randomized, double-blind, placebo-controlled proof of concept study evaluating OTEZLA in patients with ulcerative colitis (UC) were presented at the 13th Congress of the European Crohn’s and Colitis Organization (ECCO). In addition, these phase II data have also been accepted for an encore presentation at the Digestive Disease Week (DDW) meeting in June. Celgene plans to initiate the pivotal program with OTEZLA in UC in 2018.
Business Updates
In March, Celgene announced that it completed the acquisition of Juno, a biopharmaceutical company focused on developing innovative cellular immunotherapies for the treatment of cancer. The Juno acquisition positions Celgene as a global cellular immunotherapy company by adding a novel scientific platform and scalable manufacturing capabilities, in addition to liso-cel, an investigational CD19-directed CAR T currently in a clinical development program for relapsed and/or refractory DLBCL.
Celgene acquired all the outstanding shares of common stock of Juno through a tender offer for $87 per share in cash, or an aggregate of approximately $9.1 billion. The transaction was funded through a combination of existing cash, cash equivalents, debt securities available-for-sale and new debt.
In February, Celgene completed the acquisition of Impact, a privately-held biotechnology company developing fedratinib, a highly selective Janus kinase 2 (JAK2) inhibitor, for myelofibrosis. This acquisition strengthens Celgene’s commitment to myelofibrosis, a disease with high unmet medical need, and expands strategic development options within Celgene’s myeloid portfolio of assets.
Under the terms of the agreement, Celgene paid approximately $1.1 billion upfront, contingent consideration based upon regulatory approvals of up to $1.4 billion (including $1.25 billion for myelofibrosis), and contingent consideration of up to $4.5 billion based upon the achievement of sales in any four consecutive calendar quarters between $1.0 billion and $5.0 billion.
In March, Celgene and Prothena Corporation (Prothena) announced a global collaboration to develop new therapies for a broad range of neurodegenerative diseases. The multi-year research and development collaboration is focused on three proteins implicated in the pathogenesis of several neurodegenerative diseases, including tau, TDP-43 and an undisclosed target. For each of the programs, Celgene has an exclusive right to license clinical candidates in the U.S. at Investigational New Drug (IND) filing, and if exercised, would also have a right to expand the license to global rights at the completion of phase I.
Under the terms of the collaboration, Prothena received a $150 million upfront payment (which includes an equity investment) plus future potential exercise payments and regulatory and commercial milestones for each licensed program. Prothena will also receive additional royalties on net sales of any resulting marketed products.
In March, Celgene and Vividion Therapeutics Inc., (Vividion) announced a multi-year strategic research collaboration focused on the identification and development of unique small molecules against targets for a range of oncology, inflammatory and neurodegenerative indications. The collaboration utilizes Vividion’s platform to identify ligands and discover drug candidates against a selected list of high-value, difficult-to-drug targets.
Under the terms of the collaboration, Vividion received an upfront payment of $101 million (which includes an equity investment). Celgene will have the right to opt in to programs at IND acceptance and Celgene will receive exclusive worldwide rights for certain programs, including the first program. In addition, other programs will allow for Celgene and Vividion to share equally either U.S. or worldwide development costs and commercialization profits and losses.
In early March, Celgene’s partner bluebird bio opted in on their right to co-develop and co-promote bb2121, an investigational anti-BCMA CAR T cell therapy for the treatment of patients with RRMM in the United States. The companies originally entered into a broad, global strategic research collaboration in 2013 to discover, develop and commercialize novel therapies in oncology, which included bb2121. Celgene and bluebird bio amended and restated the collaboration agreement in 2015 to focus on developing product candidates targeting BCMA.
Organizational Updates
Celgene recently announced the election of Hans Bishop, Patricia "Pat" Hemingway Hall and John Weiland to the Board of Directors.
Mr. Bishop is a 30-year industry veteran and pioneer in the field of cellular immunotherapy whose expertise will help Celgene lead in this extremely promising area of science. He was most recently President and CEO of Juno, a cellular immunotherapy company that he co-founded in 2013 and led until Juno was acquired by Celgene in March 2018.
Ms. Hemingway Hall has more than 30 years of experience with a focus on the U.S. health insurance market and deep understanding of the U.S. market access landscape which will help to shape Celgene’s strategy in an increasingly complex environment. She most recently was CEO of Health Care Service Corporation (HCSC), the nation’s largest mutual health insurance company, which operates as Blue Cross and Blue Shield in Illinois, Montana, New Mexico, Oklahoma and Texas, from 2008 until her retirement in 2015.
Mr. Weiland has over 30 years in the healthcare industry with significant expertise and experience across therapeutic areas and geographies. His leadership and insight will help to inform and direct Celgene’s long-term growth strategy. He was most recently the President and Chief Operating Officer of C. R. Bard, Inc. (Bard), with worldwide responsibility for all of Bard’s business operations prior to it being acquired by Becton, Dickinson and Company (BD) in December 2017.
First Quarter 2018 Conference Call and Webcast Information
Celgene will host a conference call to discuss the first quarter of 2018 operational and financial performance on Friday, May 4, 2018, at 9 a.m. ET. The conference call will be available by webcast at www.celgene.com. An audio replay of the call will be available from noon May 4, 2018, until midnight ET May 11, 2018. To access the replay in the U.S., dial (855) 859-2056; outside the U.S. dial (404) 537-3406. The participant passcode is 6196716.