Exhibit 99.1
Contact: Robert J. Hugin
Senior VP and CFO
Celgene Corporation
(732) 271-4102
CELGENE CORPORATION REPORTS RECORD OPERATING PERFORMANCE IN THIRD QUARTER AS
TOTAL REVENUE INCREASES 117% AND PROFITS RISE
o THIRD QUARTER PRODUCT SALES INCREASE 112%, VERSUS THE YEAR AGO QUARTER,
DRIVEN BY STRONG THALOMID(R) PERFORMANCE
o QUARTERLY DILUTED EARNINGS PER SHARE OF $0.05 EXCEEDS EARNINGS
CONSENSUS
o PROGRESS IN KEY REVIMID(TM)REGULATORY TRIALS ON-TRACK; ENROLLMENT OF
FIRST COHORT COMPLETED IN PHASE II MDS/5Q MINUS TRIALS
Recent Highlights:
- ------------------
o THALOMID PHASE I/II CLINICAL DATA PRESENTED ON COMBINATION THERAPY FOR
TREATING PROSTATE CANCER
o MAJOR PEER-REVIEWED JOURNAL PUBLICATION OF A CLINICAL STUDY OF THALOMID
PLUS TEMOZOLOMIDE AS ORAL REGIMEN FOR TREATING PATIENTS WITH
ADVANCED-STAGE METASTATIC MELANOMA
o THALOMID IN COMBINATION WITH DEXAMETHASONE INCLUDED AS NEW TREATMENT
OPTIONS IN NCCN MULTIPLE MYELOMA CLINICAL PRACTICE GUIDELINES
o NEWLY ISSUED PATENTS BROADEN STRONG CELGENE JNK INTELLECTUAL PROPERTY
ESTATE
o THALIDOMIDE RECEIVED AUSTRALIAN APPROVAL FOR THE TREATMENT OF RELAPSED
AND REFRACTORY MULTIPLE MYELOMA
WARREN, NJ - (October 23, 2003) - Celgene Corporation (NASDAQ: CELG) today
announced diluted earnings per share of $0.05 driven by record THALOMID(R)
(thalidomide) product sales. Total revenue for the third quarter increased
117.0% to $74.3 million from $34.3 million for the prior-year quarter. THALOMID
sales in the third quarter of 2003 increased 88.7% to $57.6 million from $30.5
million in the third quarter of 2002. Celgene posted third quarter net income of
$4.3 million, or $0.05 per diluted share compared to a net loss of $1.0 million
or ($0.01) per share in the third quarter of last year.
Sequentially, total revenue increased 10.5% to $74.3 million from $67.3 million
in the second quarter of 2003, with THALOMID sales rising 4.9%
quarter-over-quarter to $57.6 million from $54.8 million. Total revenue for the
first nine months of 2003 was a record $190.7 million, an increase of 93.5% over
the same period in 2002. THALOMID(R) sales for the nine-month period ended
September 30, 2003 were $158.1 million, compared to $85.1 million in 2002, up
85.8% year-over-year. Revenue from the Ritalin(R) family of drugs totaled
approximately $5.2 million for the third quarter and approximately $9.9 million
for the first nine months of 2003. Celgene posted net income for the first nine
months of 2003 of $8.1 million or $0.10 per diluted share, compared to a net
loss of $3.6 million or ($0.05) per share in the comparable 2002 period.
As planned, Celgene increased R&D expenditures to accelerate the regulatory
programs for REVIMID(TM) in myelodysplastic syndromes, multiple myeloma and for
the ongoing pivotal Phase III Special Protocol Assessment (SPA) trials for
multiple myeloma and metastatic melanoma. Celgene incurred expenses of $33.3
million in the third quarter of 2003, representing an increase of 61.9% compared
to the year ago quarter. These R&D expenditures supported rapid clinical
progress in multiple development core programs in THALOMID, REVIMID, and
ACTIMID(TM), as well as for high potential SelCID(TM) and kinase programs.
Increased expenditures also enabled accelerated progress in a number of
additional meaningful preclinical and early clinical programs, including
benzopyran, ligase and tubulin inhibitor programs.
Celgene reported $673 million in cash, marketable securities and investments -
including the $12 million Pharmion convertible notes investment - representing
an increase of $10.8 million over the previous quarter.
"This quarter was filled with significant commercial, regulatory and clinical
achievements, including: record THALOMID sales and the initiation of three Phase
II accelerated approval programs for REVIMID in myelodysplastic syndromes, 5Q
minus syndrome and multiple myeloma. Additionally, THALOMID's potential in
cancers and blood disorders was underscored by peer-reviewed publications and
presentations, as well as the approval of thalidomide for multiple myeloma in
Australia through our partner Pharmion," said John W. Jackson, Chairman and
Chief Executive Officer of Celgene Corporation. "We look forward to an eventful
fourth quarter with meaningful milestones such as major presentations and
publications around THALOMID, REVIMID and ACTIMID at upcoming medical meetings,
as well as further advancement of our extensive product pipeline."
2003 Guidance:
- --------------
Based on strong performance during the first nine months of 2003, we are again
increasing THALOMID revenue guidance to a range of $215-220 million from our
prior guidance of $200-210 million. We are maintaining 2003 target revenue for
the Ritalin(R) family of drugs in a range of $15 million, $40 million and $60
million, in 2003, 2004 and 2005, respectively. Celgene plans 2003 research and
development expenses in a range of $125 - 130 million, an increase of
approximately 50%, year-over-year, as we aggressively accelerate spending to
support multiple pivotal programs and multiple accelerated regulatory approval
programs for REVIMID. Our earnings goal for a record full-year profitability for
2003 is at or slightly above the high end of the previous range of $0.10 to
$0.15 per diluted share.
COMPANY HIGHLIGHTS:
Clinical, Regulatory and Drug Discovery Achievements:
- ----------------------------------------------------
o Celgene announced the results of data presented at the European Cancer
Conference (ECCO) in Copenhagen, Denmark which used THALOMID(R) in
combination with chemotherapy for the treatment of androgen-independent
prostate carcinoma (AIPCa). The Phase I/II study results demonstrated that 18
of 33 (55%) patients who were evaluable for response achieved a 50-79%
decline in PSA and 7 (21%) patients had a > 80% PSA decline.
o To further expand the potential of our lead development compound,
REVIMID(TM), Celgene initiated three Phase II accelerated regulatory approval
clinical programs in the third quarter: a multi-center Phase II trial in
multiple myeloma designed as a single-agent, open label trial to determine
safety and efficacy in relapsed and refractory multiple myeloma patients, and
two multi-center Phase II trials in myelodysplastic syndromes - with or
without an associated 5Q minus cytogenetic abnormality - designed as
single-agent, open-label trials in MDS patients dependent on red blood cell
transfusions. Both MDS trials will evaluate efficacy, based on objectively
determined reduced transfusion needs, hemostatic response and safety. The
accelerated Phase II trials augment the ongoing pivotal Phase III SPA trials
in multiple myeloma and metastatic melanoma. Patient enrollment in these
trials are on or ahead of timelines.
o Celgene announced the results of a clinical study using THALOMID in
combination with temozolomide as an oral regimen for treatment of metastatic
melanoma, published in the September 1, 2003 issue of the Journal of Clinical
Oncology (JCO). This clinical study, initiated by Dr. Wen-Jen Hwu of Memorial
Sloan Kettering Cancer Center, investigated the combination of a low-dose
daily schedule of temozolomide with THALOMID (200 mg - 400 mg) in patients
with advanced-stage metastatic melanoma. This study achieved an overall
objective response rate of 32% and a median survival, in this advanced-stage
patient population, of 9.5 months.
Toxicities associated with the above mentioned studies, included: grade 1-2,
somnolence and fatigue, grade 1 peripheral neuropathy, grade 3/4 DVT, sepsis,
grade 3 lymphopenia, grade 4 leukopenia and neutropenia and grade 4
thrombocytopenia.
o Celgene signed a cooperative research and development agreement (CRADA) with
The National Cancer Institute (NCI) to collaborate on clinical and
preclinical development of CC-8490 and other benzopyran agents that target
the destruction of brain cancer cells. The four-year agreement facilitates
clinical and preclinical evaluation of CC-8490 in biochemical and cell based
assays as well as assays directed at measuring anti-tumor effects. The goals
of this research collaboration are to further examine CC-8490 and other
agents (Celgene's benzopyran class of molecules), both in vitro and in vivo
studies to advance the most promising agents for use in clinical trials and
to assess the efficacy of CC-8490 in the treatment of glioblastoma in humans.
Patient enrollment for the clinical study with CC-8490 has begun.
o Celgene announced that the Australian Drug Evaluation Committee approved
thalidomide for the treatment of both patients with relapsed and refractory
multiple myeloma and for the treatment of cutaneous manifestations of
erythema nodosum leprosum (ENL), a severe and debilitating condition
associated with leprosy. The Australian regulatory authority and our partner,
Pharmion, worked together to finalize the details for registration, labeling
and distribution using our proprietary S.T.E.P.S.(R) program, known as the
Pharmion Risk-Management Program (PRMP) in Australia.
o A new FOCALIN LA(TM) Phase III pivotal study was initiated by Novartis to
evaluate the safety and efficacy of FOCALIN LA at 5-30 mg/day administered
once daily as compared with placebo in pediatric patients 6-17 years of age
who meet DSM-IV criteria for Attention-Deficit/Hyperactivity Disorder (ADHD).
Additionally, Novartis initiated a new Phase III clinical study - known as
G.R.A.C.E. (Girls, Ritalin LA, and ADHD: A Controlled Evaluation) - to
evaluate the efficacy and safety of Ritalin(R) LA (methylphenidate HCL)
extended release capsules in girls aged 12-17. The study is the first
clinical trial to examine the effects of medication specifically in females
with ADHD. A Phase III pivotal trial in FOCALIN LA for adults is ongoing.
Corporate and Commercial Achievements:
-------------------------------------
o Our intellectual property estate for JNK inhibitors was broadened with the
issuance of two fundamental U.S. patents. The newly issued patents, U.S.
Patents 6,610,505 and 6,610,523, contain broad claims to methods utilized for
screening and developing novel small molecule therapies to modulate the JNK
signaling pathway and covers polypeptides of mitogen-activated protein kinase
kinases (MKKs) that are involved in the c-Jun N-terminal kinase (JNK)
pathways, respectively. Importantly, the JNK gene regulation pathway has been
shown to play a pivotal role in the onset and progression of several
significant human diseases.
o During the quarter our drug discovery operations were strengthened by the
addition of David Webb, Ph.D., who joined Celgene San Diego as Vice President
of Research. Dr. Webb's distinguished career is underscored by the breadth
and depth of his experience in product development and senior management
positions in several biotechnology and pharmaceutical companies where he
developed and led drug discovery programs focused on inflammation, asthma,
cancer and diabetes. Moreover, Dr. Webb has held several distinguished
academic positions, including: Consulting Professor of Cancer Biology at
Stanford University, member of the Department of Cell Biology at the Roche
Institute, and Adjunct Professor of Human Genetics at Columbia University
College of Physicians and Surgeons.
o We are very pleased to announce that Eve E. Slater, M.D., former US Assistant
Secretary for Health and Senior Vice President of Merck Research
Laboratories, has been retained by Celgene Cellular Therapeutics, as a Senior
Advisor. Dr. Slater will advise Celgene Cellular Therapeutics on key
governmental, academic and clinical development initiatives.
Celgene senior management will host a conference call to discuss the results and
achievements of its third quarter operating and financial performance on October
23, 2003 at 9:00 a.m. EDT. The conference call will be available by webcast at
www.celgene.com. An audio replay of the call will be available from noon EDT
October 23, 2003 until midnight EDT October 30, 2003. To access the replay, dial
1-800-642-1687 and enter Reservation Number 3232927.
Celgene Corporation, headquartered in Warren, New Jersey, is an integrated
biopharmaceutical company engaged primarily in the discovery, development and
commercialization of novel therapies for the treatment of cancer and
inflammatory diseases through gene and protein regulation. For more information,
please visit the Company's website at www.celgene.com.
This release contains certain forward-looking statements which involve known and
unknown risks, delays, uncertainties and other factors not under the Company's
control, which may cause actual results, performance or achievements of the
Company to be materially different from the results, performance or other
expectations implied by these forward-looking statements. These factors include
results of current or pending research and development activities, actions by
the FDA and other regulatory authorities, and those factors detailed in the
Company's filings with the Securities and Exchange Commission such as 10K, 10Q
and 8K reports.
# # #
CELGENE CORPORATION
CONSOLIDATED FINANCIAL RESULTS
(UNAUDITED)
(IN THOUSANDS, EXCEPT PER SHARE DATA)
CONSOLIDATED STATEMENT OF OPERATIONS DATA
- -----------------------------------------
THREE MONTH PERIOD NINE MONTH PERIOD
ENDED SEPTEMBER 30, ENDED SEPTEMBER 30,
---------------------- ----------------------
2003 2002 2003 2002
---- ---- ---- ----
Product sales $ 65,587 $ 30,896 $ 173,888 $ 88,893
Collaborative agreement and other revenue 6,066 1,556 9,453 6,442
Royalty revenue 2,679 1,806 7,366 3,238
--------- --------- --------- ---------
Total revenue 74,332 34,258 190,707 98,573
Cost of goods sold 13,639 4,429 29,909 12,203
Research and development 33,270 20,549 89,095 57,584
Selling, general and administrative 26,517 15,738 75,229 50,154
--------- --------- --------- ---------
Total costs and expenses 73,426 40,716 194,233 119,941
--------- --------- --------- ---------
Operating profit (loss) 906 (6,458) (3,526) (21,368)
Interest and other income, net 3,765 5,421 12,388 17,794
--------- --------- --------- ---------
Income (loss) before tax 4,671 (1,037) 8,862 (3,574)
Income tax 378 -- 723 --
--------- --------- --------- ---------
Net income (loss) $ 4,293 $ (1,037) $ 8,139 $ (3,574)
========= ========= ========= =========
PER COMMON SHARE-BASIC AND DILUTED
- -------------------------
Net income(loss)-basic $ 0.05 $ (0.01) $ 0.10 $ (0.05)
========= ========= ========= =========
Net income(loss)-diluted $ 0.05 $ (0.01) $ 0.10 $ (0.05)
========= ========= ========= =========
Weighted average shares outstanding-basic 81,047 78,583 80,760 76,872
========= ========= ========= =========
Weighted average shares outstanding-diluted 86,329 78,583 85,214 76,872
========= ========= ========= =========
CONSOLIDATED BALANCE SHEET DATA
- -------------------------------
SEPTEMBER 30, DECEMBER 31,
2003 2002
---- ----
Cash, cash equivalents & marketable
securities $660,875 $261,182
Total assets 772,931 327,287
Convertible notes 400,000 --
Stockholders' equity 300,327 276,698