EXHIBIT 99.1
Contact: Robert J. Hugin
Senior VP and CFO
Celgene Corporation
(732) 271-4102
CELGENE CORPORATION REPORTS STRONG OPERATING PERFORMANCE IN SECOND QUARTER AS
TOTAL SALES INCREASE 100 PERCENT AND PROFITS RISE
o PRODUCT SALES DRIVEN BY INCREASE OF 93.4 PERCENT, YEAR-OVER-YEAR, IN
THALOMID(R) REVENUES AND REINTRODUCTION OF ALKERAN(R)
o QUARTERLY EARNINGS OF $0.03 PER DILUTED SHARE EXCEEDS EARNINGS CONSENSUS
o 2003 FULL YEAR FINANCIAL GUIDANCE RAISED
o R&D INVESTMENT INCREASED TO ACCELERATE REVIMID(TM) REGULATORY APPROVAL
Recent Highlights:
- ------------------
o ADDITIONAL CLINICAL DATA DEMONSTRATED REVIMID POTENTIAL IN TREATING
o MYELODYSPLASTIC SYNDROMES (MDS) - TWO MDS STUDIES INITIATED
o RESEARCHERS PRESENTED NEW CLINICAL DATA ON THALOMID FROM MORE THAN 150
CLINICAL TRIALS COVERING ALL STAGES OF MULTIPLE MYELOMA AND BROAD RANGE OF
SOLID TUMORS
o FINANCIAL PROFILE STRENGTHENED WITH $400 MILLION 1.75 PERCENT CONVERTIBLE
NOTES OFFERING
o ADDED TOP EXECUTIVES TO EXPAND STRONG SENIOR MANAGEMENT TEAM
WARREN, NJ - (JULY 24, 2003) - Celgene Corporation (NASDAQ: CELG) today
announced earnings per diluted share of $0.03 driven by strong THALOMID(R)
(thalidomide) and ALKERAN(R) (melphalan) Tablets and ALKERAN(R) (melphalan HCl)
for Injection sales. THALOMID sales were approximately $54.8 million up 93.4
percent for the second quarter of 2003 compared to $28.3 million in the second
quarter of 2002. Total revenue was $67.3 million, an increase of 100.1 percent
over the prior-year quarter. Celgene posted net income of $2.9 million, or $0.03
per diluted share compared to a net loss of $1.7 million or ($0.02) per diluted
share year-over-year.
THALOMID sales rose 20.2 percent quarter-over-quarter to $54.8 million from
$45.6 million and total revenues, quarter-over-quarter, increased 37.0 percent
to $67.3 million from $49.0 million. Additionally, to offer more convenience to
patients and prescribers, Celgene launched new 100mg and 200mg strength capsules
of THALOMID in March. We estimate that the launch
of these new formulations contributed approximately $4.0 million in added
revenue in the quarter. It is expected, with the multiple formulations of
THALOMID, that retail pharmacies will maintain higher levels of inventory to
support future sales.
THALOMID sales for the six-month period ended June 30, 2003 were $100.5 million
compared to $54.5 million in 2002, a growth rate of approximately 84.0 percent
year-over-year. Total revenue for the first half of 2003 was a record $116.3
million, an increase of 81.0 percent over the same period in 2002. Celgene
posted net income for the first six months of 2003 of $3.8 million or $0.05 per
diluted share, compared to a net loss of $2.5 million or ($0.03) per diluted
share in the comparable 2002 period.
Celgene increased research and development expenditures to accelerate the
regulatory programs for REVIMID in myelodysplastic syndromes and multiple
myeloma. Celgene spent $30.5 million in the second quarter of 2003, representing
an increase of 59.0 percent compared to the year ago quarter. Additionally,
these research and development expenditures supported rapid clinical progress in
multiple development programs for its THALOMID, REVIMID(TM), and ACTIMID(TM)
products, as well as for its SelCID(TM) and JNK programs. Funding increases also
enabled accelerated progress in a number of additional high potential
preclinical and early clinical programs.
Including the $12 million Pharmion convertible notes investment, Celgene
reported more than $662 million in cash, marketable securities and investments
at the end of the second quarter.
"Increasing use of THALOMID in newly diagnosed multiple myeloma patients
contributed to the continued strong results in the second quarter. In addition,
its clinical investigation in a variety of cancers was reported by researchers
in more than 150 studies presented at major international medical meetings,"
said John W. Jackson, Chairman and Chief Executive Officer of Celgene
Corporation. "This was a record quarter, in which we achieved stronger profits
while also advancing key late stage portfolio products like REVIMID, supporting
high potential pipeline programs from our drug discovery engine and further
bolstering our strong financial position."
2003 Full Year Financial Guidance Update
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In light of the results of the first half of the year we are raising our
guidance for 2003. Celgene is raising its THALOMID revenues targets to $200-210
million from prior guidance of $175-185 million. Our new target represents an
increase of approximately 65 to 75 percent over 2002 THALOMID revenues. Based on
sales trends, new data and significant milestones projected in 2004 and 2005, we
maintain our guidance, for the Ritalin(R) product line, approximately $40
million and $60 million, respectively. We are adjusting our target for 2003 to
approximately $15 million from the prior guidance of approximately $20 million.
Celgene is targeting research and development expenses to increase approximately
40 to 45 percent to $120 to 130 million, to support multiple pivotal programs
and an accelerated regulatory approval process for REVIMID. Our goal for
full-year 2003 profitability has been raised to a range of $0.10 to $0.15 per
diluted share from $0.05 to $0.10 per diluted share.
COMPANY HIGHLIGHTS
Clinical, Regulatory and Drug Discovery Achievements
- ----------------------------------------------------
o New clinical data presented at the Seventh International Symposium on
Myelodysplastic Syndromes in Paris, shows that Celgene's lead investigational
IMiD, REVIMID, has potential activity in limiting the number of red cell
transfusions in patients who rely on transfusions as a treatment option. In
addition, REVIMID demonstrated significant cytogenic activity with a 100
percent complete response rate in a 5Q minus patient population, an important
subset of MDS patients.
o REVIMID received fast track designation from the U.S. Food and Drug
Administration (FDA) for the treatment of MDS and multiple myeloma. The FDA
grants fast track designation to compounds that may provide a significant
improvement in the safety or effectiveness of the treatment for a serious or
life-threatening disease. Compounds that receive the designation are also
eligible for priority review, which provides for a six-month review by the
FDA of a new drug application.
o Celgene has also initiated several REVIMID Phase I trials in a range of solid
tumors, based on new studies demonstrating that REVIMID has multiple novel
mechanisms of activity with anti-cancer potential.
o Clinical investigators from leading cancer centers presented promising data
from more than 43 studies on THALOMID in hematologic and solid tumor cancers
at the Annual Meeting of the American Society of Clinical Oncology (ASCO).
Data was presented from clinical trials on THALOMID in combination with IL-2
in Metastatic Renal Cell Carcinoma, in combination with Paclitaxel and
Estramustine in Androgen Independent Prostate Cancer and in combination with
temozolomide in melanoma patients with measurable brain metastasis.
o Clinical investigators presented data from 69 THALOMID and REVIMID clinical
trials at the Ninth International Myeloma Workshop in Salamanca, Spain. The
studies included clinical results for THALOMID used as both a single agent
and in combination therapy in every stage of multiple myeloma. Highlights
included new data on: thalidomide plus dexamethasone as primary therapy for
multiple myeloma of high tumor mass, thalidomide in newly diagnosed patients
with smoldering/indolent multiple myeloma, thalidomide plus dexamethasone
versus conventional chemotherapy in advanced multiple myeloma and thalidomide
plus melphalan versus thalidomide alone in multiple myeloma patients.
o Celgene strengthened its extensive intellectual property estate for the
Company's JNK (c-Jun N-terminal Kinase) program by licensing three European
patents and a pending U.S. patent from Tufts University. The patents and
application cover methods for treating and preventing insulin resistance and
related disorders such as diabetes and obesity.
o A recent study presented at the NIMH 43rd Annual New Drug Evaluation Unit
Meeting in Orlando, Florida demonstrated that Ritalin(R)LA licensed by
Celgene to, and marketed by Novartis provides statistically greater symptom
management compared to Concerta(R) in children with ADHD over the course of
the school day.
Corporate and Commercial Achievements
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o Celgene completed the placement of $400 million of 1.75 percent Convertible
Notes due 2008 to qualified institutional buyers. The notes will be
convertible into Celgene Corporation common stock at a conversion price of
$48.45 per share (reflecting a 50 percent premium, based on the NASDAQ
closing price for Celgene common stock of $32.30 on May 28, 2003.) The net
proceeds of the offering will be used for Celgene general corporate purposes.
o Celgene announced the appointments of Mr. Francis Brown as Senior Vice
President of Sales and Marketing, who brings to Celgene over 20 years of
experience in directing oncology and immunology sales and marketing for
Pharmacia; Dr. Graham Burton as Senior Vice President of Regulatory Affairs,
Pharmacovigilence and Project Management, with over 15 years of strong global
regulatory relationships and a track record of approvals developed during his
successful career at Johnson & Johnson; and Dr. Michael Vander Zwan as Vice
President of Quality Assurance and Compliance, with more than 25 years of
pharmaceutical experience including developing and implementing a global
compliance management function at Pharmacia.
o Celgene's S.T.E.P.S.(R) intellectual property estate for THALOMID was
broadened with the issuance of two fundamental U.S. Patents. The newly issued
patents, U.S. Patents 6,561,976 and 6,561,977, expand the scope of coverage
to include special pharmaceutical distribution programs that do not require
the type of health professional or patient registrations described in prior
patents. Celgene's innovative S.T.E.P.S. includes managed distribution
programs for products or drugs that are either teratogens (causing birth
defects) or have other adverse effects that require contraindication for
certain patients.
Celgene senior management will host a conference call to discuss the results and
achievements of its second quarter operating and financial performance on July
24, 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
July 24, 2003 until midnight EDT July 27, 2003. To access the replay, dial
1-800-633-8284 and enter Reservation Number 21154924.
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 SIX MONTH PERIOD
ENDED JUNE 30, ENDED JUNE 30,
----------------------- -----------------------
2003 2002 2003 2002
---- ---- ---- ----
Product sales $ 62,497 $ 30,359 $ 108,301 $ 57,997
Collaborative agreement and other revenue 2,308 3,262 3,387 6,318
Royalty revenue 2,481 4,686 --
-------- -------- --------- --------
Total revenue 67,286 33,621 116,374 64,315
Cost of goods sold 11,629 4,110 16,291 7,774
Research and development 30,517 19,222 55,238 36,746
Selling, general and administrative 25,905 18,397 49,278 34,695
-------- -------- --------- --------
Total costs and expenses 68,051 41,729 120,807 79,215
-------- -------- --------- --------
Operating loss (765) (8,108) (4,433) (14,900)
Interest and other income, net 3,869 6,393 8,624 12,362
-------- -------- --------- --------
Income (loss) before tax 3,104 (1,715) 4,191 (2,538)
Income tax 210 -- 345 --
-------- -------- --------- --------
Net income (loss) $ 2,894 $ (1,715) $ 3,846 $ (2,538)
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PER COMMON SHARE-BASIC AND DILUTED
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Net income(loss)-basic $ 0.04 $ (0.02) $ 0.05 $ (0.03)
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Net income(loss)-diluted $ 0.03 $ (0.02) $ 0.05 $ (0.03)
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Weighted average shares outstanding-basic 80,839 76,377 80,613 76,003
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Weighted average shares outstanding-diluted 85,134 76,377 84,435 76,003
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CONSOLIDATED BALANCE SHEET DATA
- -------------------------------
JUNE 30, DECEMBER 31,
2003 2002
---- ----
Cash, cash equivalents & marketable
securities $650,111 $261,182
Total assets 758,686 327,287
Convertible notes 400,000 --
Stockholders' equity 292,663 276,698