Exhibit 99.1
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 THIRD QUARTER WITH STRONG
REVENUE AND PROFIT GROWTH
THIRD QUARTER HIGHLIGHTS:
o RECORD REVENUE EXCEEDS $100 MILLION; THIRD QUARTER REVENUE PERFORMANCE
DRIVEN BY 36.7% GROWTH IN THALOMID(R) NET PRODUCT SALES
o QUARTERLY DILUTED EARNINGS PER SHARE INCREASED 383% TO $0.24 (PRE-SPLIT
BASIS) FROM $0.05 (PRE-SPLIT BASIS) IN THE YEAR-AGO QUARTER; 7TH CONSECUTIVE
QUARTER OF INCREASING PROFITABILITY
o CELGENE CORPORATION ACQUIRES THALOMID(R) MANUFACTURING ENTITY IN UK
>> Accretive Transaction Increases Economic Participation in Potential
International Growth of THALOMID
>> Gain Strategic Control of THALOMID Manufacturing
o FOCALIN XR(R) NDA SUBMITTED BY NOVARTIS PHARMA AG TRIGGERING $7.5 MILLION
MILESTONE PAYMENT
o TWO-FOR-ONE STOCK SPLIT APPROVED BY CELGENE BOARD OF DIRECTORS; REPORTING ON
A SPLIT-ADJUSTED BASIS EXPECTED TO START ON OCTOBER 25, 2004
o RAISING 2004 THALOMID REVENUE AND EPS GUIDANCE
>> THALOMID Revenue Target Increased to $305 to $310 Million from $295
to $305
>> Full-Year Profitability Target Increased to $0.60 to $0.65 per Diluted
Share from $0.50 to $0.60 per Diluted Share
o KEY REVLIMID(TM) PHASE III AND ACCELERATED PHASE II REGULATORY PROGRAMS
ADVANCED IN THIRD QUARTER
>> REVLIMID Phase II 5q Minus Data To Support Initial NDA Submission in
First Quarter 2005
>> REVLIMID Multiple Myeloma Pivotal Phase III Special Protocol Assessment
(SPA) Trials and Phase II Trial Fully Enrolled and Remain on Track
WARREN, NJ - (OCTOBER 21, 2004) - Celgene Corporation (NASDAQ: CELG) announced
diluted earnings per share of $0.24 for the quarter ended September 30, 2004,
driven by record product sales. Total revenue for the third quarter increased
36.5% to $101.5 million from $74.3 million for the prior-year quarter. THALOMID
net product sales in the third quarter of 2004 increased 36.7% to $78.7 million
from $57.6 million in the third quarter of 2003. Celgene posted third quarter
net income of $21.3 million, or $0.24 per diluted share (pre-split basis)
compared to net income of $4.3 million or $0.05 per diluted share (pre-split
basis) in the third quarter of last year.
For the nine-month period, total revenue reached a record $272.1 million, an
increase of 42.7% over the same period in 2003. THALOMID sales for the
nine-month period were $222.5 million compared to $158.1 million in 2003, an
increase of 40.8% year-over-year.
Revenue from the Ritalin(R) family of drugs totaled approximately $16.3 million,
for the third quarter and approximately $28.9 million for the nine months,
including a $7.5 million milestone payment for the Focalin XR NDA submission by
Novartis. For the nine-month period, Celgene posted net income of $42.3 million
or $0.48 per diluted share (pre-split basis) compared to net income of $8.1
million or $0.10 per diluted share (pre-split basis) in the comparable 2003
period.
During the quarter, Celgene invested nearly 40 percent of total revenue into
R&D. Our increased spending in R&D, compared to prior periods, advanced both key
Phase II regulatory programs for REVLIMID in 5q minus chromosomal abnormalities
and myelodysplastic syndromes as well as ongoing pivotal REVLIMID Phase III SPA
trials and Phase II trial for multiple myeloma. Celgene spent $40.2 million in
R&D programs during the third quarter of 2004 representing an increase of 22.4%
compared to the year ago quarter. These R&D expenditures support ongoing
clinical progress in multiple development core programs. These investigational
drug development programs include; THALOMID, REVLIMID, ACTIMID(TM), newest
IMiD(R) CC-11006 and lead oral PDE 4 & TNF alpha inhibitor CC-10004, as well as
other promising compounds such as kinases, benzopyrans, ligases, tubulin
inhibitors and placentally-derived stem cell programs.
Celgene reported $798.8 million in cash, cash equivalents and marketable
securities, up 8.5 % from $736.6 million reported in the previous quarter. This
increase includes the addition of seven hundred and eighty-nine thousand shares
of Pharmion common stock resulting from warrants exercised during the third
quarter.
"During the third quarter Celgene achieved key milestones delivering strong
performance through record revenue and earnings, and establishing key regulatory
filing strategies for the potential approval of REVLIMID in multiple
hematological cancers," said John W. Jackson, Chairman and Chief Executive
Officer of Celgene Corporation. "We look forward to an eventful fourth quarter
with key presentations and publications reporting clinical data, at major
medical meetings, that continue to validate our lead investigational
compounds."
RAISING 2004 FINANCIAL OUTLOOK:
-------------------------------
As a result of our strong performance during the third quarter, we are
increasing our 2004 earnings target for full-year profitability to a range
of $0.60 to $0.65 per diluted share (pre-split basis) from the previous
range of $0.50 to $0.60 per diluted share (pre-split basis). THALOMID
revenue guidance has been increased to a range of $305 to $310 million from
prior guidance of $295 to $305 million. Other financial targets remain
unchanged.
CORPORATE HIGHLIGHTS & DEVELOPMENTS:
------------------------------------
o Celgene announced today that it has acquired all of the outstanding shares
of Penn T, the UK based manufacturer of THALOMID for approximately $110
million in cash. This acquisition expands our corporate capabilities and
enables the Company to control manufacturing for THALOMID worldwide. Through
manufacturing contracts acquired in this purchase, Celgene significantly
increases its participation in the potential growth of THALOMID revenue in
key international markets. The transaction is expected to be 5 to 10 cents
accretive in 2005.
o Celgene advanced its efforts for regulatory approval of REVLIMID based on
its ongoing pivotal Phase III special protocol assessment (SPA) trials that
may lead to an FDA marketing approval for REVLIMID in multiple myeloma in
late-2005, assuming positive clinical data. Additionally, as a result of
ongoing discussions with the FDA Celgene plans to submit an initial NDA,
with Phase II data, for the treatment of 5q minus chromosomal abnormalities
in first quarter 2005.
o The Celgene Board of Directors approved a two-for-one stock split, payable
in the form of a 100 percent stock dividend. Stockholders will receive one
additional share for every share they own as of the close of business on
October 15, 2004. The additional shares will be distributed on October 22,
2004. Reporting of the Celgene share price on a split-adjusted basis is
expected to commence on October 25, 2004.
o Clinical investigators from prominent cancer research centers will report
data from recent and on-going clinical trials of THALOMID, REVLIMID, ACTIMID
and ALKERAN in a broad range of cancers at both the Annual Meeting of the
American Society of Hematology (ASH), the largest hematology meeting in the
world, in San Diego, CA from December 3-7, 2004 and CHEMO Symposium meetings
in New York City from November 10-12. Presentations will report information
on potential clinical activity of our compounds in a wide range of
hematological and solid tumor cancers, including; newly diagnosed multiple
myeloma, myelodysplastic syndromes, 5q minus chromosomal abnormalities,
renal cell carcinoma and pancreatic cancer.
Celgene will host a conference call to discuss the results and achievements
of our third quarter 2004 operating and financial performance on October 21,
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
October 21, 2004 until midnight EDT October 29, 2004. To access the replay,
dial 1-800-642-1687 and enter Reservation Number 1365364.
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 NINE MONTH PERIOD ENDED
SEPTEMBER 30, SEPTEMBER 30,
------------------------ ------------------------
2004 2003 2004 2003
--------- --------- --------- ---------
Net product sales $ 83,803 $ 65,445 $ 238,933 $ 173,746
Collaborative agreements and other revenue 10,392 6,208 15,420 9,595
Royalty revenue 7,273 2,679 17,741 7,366
--------- --------- --------- ---------
Total revenue 101,468 74,332 272,094 190,707
Cost of goods sold 15,166 15,932 43,655 36,359
Research and development 40,154 32,804 116,520 88,042
Selling, general and administrative 27,750 24,690 79,408 69,832
--------- --------- --------- ---------
Total costs and expenses 83,070 73,426 239,583 194,233
--------- --------- --------- ---------
Operating income (loss) 18,398 906 32,511 (3,526)
Interest and other income, net 4,831 3,765 13,738 12,388
--------- --------- --------- ---------
Income before taxes 23,229 4,671 46,249 8,862
Income tax provision 1,974 378 3,931 723
--------- --------- --------- ---------
Net income $ 21,255 $ 4,293 $ 42,318 $ 8,139
========= ========= ========= =========
PER COMMON SHARE - BASIC AND DILUTED(1)
- -----------------------------------------------
Net income - basic $ 0.26 $ 0.05 $ 0.52 $ 0.10
========= ========= ========= =========
Net income - diluted $ 0.24 $ 0.05 $ 0.48 $ 0.10
========= ========= ========= =========
Weighted average shares outstanding-basic 82,045 81,047 81,787 80,760
========= ========= ========= =========
Weighted average shares outstanding-diluted 88,531 86,329 88,135 85,214
========= ========= ========= =========
CONSOLIDATED BALANCE SHEET DATA
- -----------------------------------------------
SEPTEMBER 30, DECEMBER 31,
2004 2003
------------- ------------
Cash, cash equivalents & marketable
Securities $ 798,831 $ 666,967
Total assets 941,548 791,336
Convertible notes 400,000 400,000
Stockholders' equity 443,619 310,054
(1) Basic and diluted earnings per share ("EPS") and weighted average shares
outstanding are reported on a pre-split basis. The additional shares
issuable pursuant to the Company's two-for-one stock split will be
distributed on October 22, 2004 and reporting of EPS on a split-adjusted
basis is expected to commence on October 25, 2005.