[CELGENE GRAPHIC OMITTED]
Contact:
Robert J. Hugin Brian P. Gill
Senior VP and CFO Director of PR/IR
Celgene Corporation Celgene Corporation
(732) 271-4102 (732) 652-4530
CELGENE CORPORATION REPORTS RECORD OPERATING
PERFORMANCE IN FIRST QUARTER WITH STRONG
REVENUE GROWTH AND PROFITS
First Quarter Results:
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o FIRSTo QUARTER REVENUES INCREASED 68.8% VERSUS THE YEAR AGO QUARTER,
DRIVEN BY STRONG THALOMID(R) AND ALKERAN(R) PERFORMANCE
o QUARTERLY DILUTED EARNINGS PER SHARE INCREASED TO $0.10 FROM $0.01 IN
THE YEAR-AGO QUARTER.
o KEY REVLIMID(TM) MULTIPLE MYELOMA REGULATORY TRIAL ENROLLMENT
ACCELERATED
o ACCELERATED PHASE II TRIAL TARGET ENROLLMENT COMPLETED
o PIVOTAL PHASE III SPA TRIAL TARGET ENROLLMENT AHEAD OF SCHEDULE
o RAISING 2004 REVENUE AND EARNINGS TARGETS
Recent Highlights:
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o KEY REVLIMID REGULATORY TRIALS COMPLETED TARGET ENROLLMENT IN PIVOTAL
PHASE III MELANOMA TRIALS, AND IN ACCELERATED PHASE II MYELODYSPLASTIC
SYNDROMES (MDS) TRIALS
o THALOMID SUPPLEMENTAL NEW DRUG APPLICATION (SNDA) ACCEPTED BY FDA FOR
REVIEW AS TREATMENT FOR MULTIPLE MYELOMA
o REVLIMID RECEIVED ORPHAN DRUG DESIGNATION FROM THE EUROPEAN COMMISSION
FOR MULTIPLE MYELOMA AND MYELODYSPLASTIC SYNDROMES
WARREN, NJ - (APRIL 22, 2004) - Celgene Corporation (NASDAQ: CELG) today
announced diluted earnings per share of $0.10 for the quarter ended March 31,
2004, driven by record product sales. Total revenue for the first quarter
increased more than 68.8% to $82.9 million from $49.1 million for the prior-year
quarter. THALOMID net sales in the first quarter of 2004 increased 51.7% to
$69.2 million from $45.6 million in the first quarter of 2003. Celgene posted
first quarter net income of $8.6 million, or $0.10 per diluted share compared to
net income of
$952 thousand or $0.01 per diluted share in the first quarter of last year.
Sequentially, total revenue increased 2.6% to $82.9 million in the first quarter
from $80.8 million in the fourth quarter of 2003, with THALOMID(TM) sales rising
approximately 5.5% quarter-over-quarter to $69.2 million from $65.6 million.
During the quarter, Celgene invested more than 45 percent of total revenues into
accelerating R&D spending with the immediate focus on the approval and
commercialization of our lead investigational drug REVLIMID(TM). The increased
investments in R&D advanced ongoing pivotal REVLIMID Phase III Special Protocol
Assessment (SPA) trials for multiple myeloma and malignant metastatic melanoma,
and continued to accelerate key regulatory programs for REVLIMID in
myelodysplastic syndromes and multiple myeloma. Celgene spent $37.7 million in
R&D programs during the first quarter of 2004 representing an increase of 52.6%
compared to the year ago quarter. These R&D expenditures support rapid clinical
progress in multiple development core programs including; THALOMID, REVLIMID,
ACTIMID(TM), and our newest IMiD(TM) CC-11006, as well as other high potential
investigational compounds including; SelCID(TM), kinase, benzopyran, ligase,
tubulin inhibitors and stem cell programs.
Celgene reported $695.4 million in cash, cash equivalents and marketable
securities, an increase from $667 million reported at year-end.
"Celgene delivered growing profitability, strong product performance and
significant progress across all key regulatory programs this quarter, a
reflection of the extraordinary efforts of our people," said John W. Jackson,
Chairman and Chief Executive Officer of Celgene Corporation. "We will continue
to accelerate our investments in R&D that are essential to our future success.
We look forward to an eventful year with meaningful milestones including;
regulatory announcements, key presentations and publications reporting new
clinical data on our lead products at major medical meetings, as well as further
advancement of our rich product pipeline."
Raising 2004 Financial Outlook:
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Based on strong performance during the first three months, we are increasing our
2004 earnings per share target for full-year profitability to a range of $0.42
to $0.52 per diluted share from previous range of $0.40 to $0.50 per diluted
share. Additionally, we are increasing our target for 2004 total revenue to be
in the range of $365 to $385 million from our initial target of $360 to $380
million. THALOMID revenue guidance has been increased to a range of $285-295
million from our prior guidance of $280-290 million. We are maintaining 2004
target revenue for the Ritalin(R) family of drugs in a range $40 million, which
includes a milestone payment for filing a NDA for Focalin LA(TM). Investment in
research and development spending, is expected to be in the range of $160 to
$170 million, representing more than 45% of total revenue and an increase of
approximately 34%, year-over-year.
2004 COMPANY HIGHLIGHTS:
CLINICAL, REGULATORY AND DRUG DISCOVERY ACHIEVEMENTS:
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o The Division of Oncology Drug Products at the U.S. Food and Drug
Administration (FDA) accepted for review Celgene's Supplemental New Drug
Application (sNDA) seeking approval to market THALOMID(TM) for the
treatment of multiple myeloma. Multiple myeloma is the second most common
blood cancer in the United States affecting approximately 50,000 people.
About 14,600 new cases of multiple myeloma are diagnosed each year and
about 11,000 Americans are expected to die each year of multiple myeloma.
FDA review is expected to be completed by late October of this year.
o REVLIMID(TM) was granted orphan drug designation for multiple myeloma and
myelodysplastic syndromes by the European Commission (EC) following the
favorable opinion of the European Agency for the Evaluation of Medicinal
Products (EMEA). REVLIMID is our lead development compound of a new class
of novel immunomodulatory drugs, or IMiDs (TM). Clinical trials, ongoing or
soon to be initiated, are evaluating REVLIMID in the treatment of a broad
range of conditions, including; myelodysplastic syndromes, multiple
myeloma, myelofibrosis, metastatic melanoma, renal cell carcinoma and
ovarian cancer.
RECENT CORPORATE DEVELOPMENTS:
- ------------------------------
o The Celgene management team was further strengthened with the addition of
several experienced industry professionals. Mr. Mark Alles joined Celgene
Corporation as Vice President of Marketing. Mark served as Vice President
of the Oncology Division for Aventis Oncology USA. Dr. Michael Needle
joined Celgene Corporation as Vice President of Clinical R&D, Oncology.
Most recently, Michael served as the Medical Affairs Officer & VP, Clinical
Affairs responsible for Corporate-wide Medical & Clinical Affairs for
Imclone Systems Incorporated. And Dr. Janice Smiell joined Celgene
Corporation as Executive Director, Clinical R&D. Prior to joining Celgene
Janice was Sr. Director, Clinical R&D responsible for Global Clinical R&D
for various products including Epoetin(R)and Regranex(R)for Johnson &
Johnson PRD.
Celgene will host a conference call to discuss the results and achievements of
its first quarter 2004 operating and financial performance on April 22, 2004 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
April 22, 2004 until midnight EDT April 29, 2004. To access the replay, dial
1-800-642-1687 and enter Reservation Number 4810377.
ABOUT CELGENE:
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 ENDED
MARCH 31,
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2004 2003
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Net product sales $ 76,120 $ 45,804
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Collaborative agreements and other revenue 2,133 1,079
Royalty revenue 4,620 2,206
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Total revenue 82,873 49,089
Cost of goods sold 14,395 6,553
Research and development 37,728 24,721
Selling, general and administrative 25,936 21,482
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Total costs and expenses 78,059 52,756
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Operating income (loss) 4,814 (3,667)
Interest and other income, net 4,607 4,754
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Income before taxes 9,421 1,087
Income tax provision 801 135
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Net income $ 8,620 $ 952
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PER COMMON SHARE - BASIC AND DILUTED
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Net income - basic $ 0.11 $ 0.01
======================
Net income - diluted $ 0.10 $ 0.01
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Weighted average shares outstanding-basic 81,475 80,384
=======================
Weighted average shares outstanding-diluted 87,263 83,940
=======================
CONSOLIDATED BALANCE SHEET DATA
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MARCH 31, DECEMBER 31,
2004 2003
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Cash, cash equivalents & marketable
securities $ 695,443 $ 666,967
Total assets 822,127 791,336
Convertible notes 400,000 400,000
Stockholders' equity 340,899 310,054