Focalin

Celgene Corporation (NASDAQ: CELG) today announced diluted earnings per share of $0.14 for the quarter ended June 30, 2004, driven by record product sales. Total revenue for the second quarter increased 30.4% to $87.8 million from $67.3 million for the prior-year quarter. THALOMID net sales in the second quarter of 2004 increased 35.9% to $74.6 million from $54.9 million in the second quarter of 2003. Celgene posted second quarter net income of $12.4 million, or $0.14 per diluted share compared to net income of $2.9 million or $0.03 per diluted share in the second quarter of last year. Sequentially, total revenue increased 5.9% to $87.8 million in the second quarter from $82.9 million in the first quarter of 2004, with THALOMID sales rising approximately 7.8% quarter-over-quarter to $74.6 million from $69.2 million.

For the six-month period, total revenue reached a record $170.6 million, an increase of 46.6% over the same period in 2003. THALOMID sales for the six-month period were $143.8 million compared to $100.5 million in 2003, an increase of 43.1% year-over-year. Revenue from the Ritalin® family of drugs totaled approximately $7.0 million for the second quarter of 2004 and approximately $12.7 million for the first six months. ALKERAN sales of $3.1 million in the second quarter were down from first quarter sales of $5.8 million as a result of manufacturing and supply delays from the third party supplier. For the six-month period, Celgene posted net income of $21.1 million or $0.24 per diluted share compared to net income of $3.8 million or $0.05 per share in the comparable 2003 period.

During the quarter, Celgene invested approximately 44 percent of total revenue into R&D. The increased spending in R&D advanced both ongoing pivotal REVLIMID Phase III SPA trials for multiple myeloma and key Phase II regulatory programs for REVLIMID in myelodysplastic syndromes and multiple myeloma. Celgene spent $38.6 million in R&D programs during the second quarter of 2004 representing an increase of 26.6% compared to the year ago quarter. These R&D expenditures support rapid clinical progress in multiple development core programs including; THALOMID®, REVLIMID, ACTIMID™ and our newest IMiD® CC-11006, as well as other high potential investigational compounds including; kinases, benzopyrans, ligases, tubulin inhibitors and placentally-derived stem cell programs.

Celgene reported $736.6 million in cash, cash equivalents and marketable securities, up from $695.3 million reported in the previous quarter.

"Celgene continued to deliver increasing revenue and accelerating profitability while continuing to invest in the R&D that is essential to our future success and maintaining full rights to our core proprietary products," said John W. Jackson, Chairman and Chief Executive Officer of Celgene Corporation. "Furthermore, during the second quarter, THALOMID's potential in hematological and solid tumor cancers was underscored again by more peer-reviewed publications in the Journal of Clinical Oncology and presentations of seminal clinical studies such as the Phase III ECOG (E1A00) at this year's ASCO meetings. We look forward to an eventful second-half of 2004 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:

Based on our strong performance during the second quarter, we are increasing our 2004 earnings target for full-year profitability to a range of $0.50 to $0.60 per diluted share from the previous range of $0.42 to $0.52 per diluted share. Additionally, we are increasing our target for 2004 total revenue to a range of $370 to $390 million from our previous target of $365 to $385 million. THALOMID revenue guidance has been increased to a range of $295 to $305 million from prior guidance of $285 to $295 million. Guidance for SG&A and R&D expense remain unchanged at a range of $115 to $125 million and $160 to $170 million, respectively.

Recent Corporate Developments:

Celgene made progress in our efforts to advance regulatory approval of REVLIMID in our ongoing pivotal Phase III special protocol assessment (SPA) trials that have the potential to result in an FDA marketing approval for REVLIMID in multiple myeloma. In addition to these Phase III trials, there are three ongoing Phase II trials (multiple myeloma, myelodysplastic syndromes (MDS) and 5q minus syndrome) that have completed their target enrollment. These trials may offer the potential to accelerate the approval of REVLIMID if the data are considered compelling by the FDA.

A clinical study, presented at the 157th Annual Meeting of the American Psychiatric Association (APA), demonstrated FOCALIN LA™ capsules (d-MPH-ER) are safe and effective for ADHD in Adults. FOCALIN LA showed significant improvements in ADHD symptoms compared to patients taking placebo and was well tolerated in a double blind, placebo controlled study including 184 adults. Efficacy was measured using the diagnostic and statistical manual-IV (DSM-IV) ADHD rating scale, a standard assessment tool used in ADHD clinical trials. After five weeks, the mean change from baseline on the rating scale total score was significantly greater with all doses of FOCALIN LA than with placebo. Score changes were 7.9 for placebo, 13.7 for patients taking the 20 mg dose of d-MPH (P=.006), 13.4 for patients treated with the 30 mg dose (P=.012) and 16.9 (P < .001) for patients taking the 40 mg dose (all P values vs. placebo). Adverse events associated with d-MPH-ER included headache (23.0 percent), decreased appetite (18.2 percent), dry mouth (15.8 percent) and insomnia (13.9 percent). Withdrawal due to adverse events was similar across treatment groups (7.5 percent for placebo, 10.3 percent for 20 mg, 12.7 percent for 30 mg and 9.1 percent for 40 mg).

A paragraph IV certification for an ANDA for FOCALIN™ (not FOCALIN LA) was filed recently with the FDA. Celgene owns multiple patents, and will vigorously defend our FOCALIN intellectual property estate.

The Medicare Replacement Drug Demonstration Program, mandated under Section 641 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), will cover THALOMID and certain other oral-cancer drugs and biologicals that can be taken by the patient at home and that replace drugs which are currently covered under Medicare Part B when given in a doctor's office. We believe that the real commercial benefit to Celgene and our stakeholders as a result of the MMA will be realized when coverage officially begins starting January 1, 2006.

The Celgene management team was further strengthened during the second quarter with the addition of several experienced industry professionals, including; Mr. Perry Karsen who joined Celgene Corporation as Senior Vice President of Business Development and Dr. Ken Watters who joined Celgene as Vice President, Regulatory Affairs & Clinical Development for Europe. Both executives bring to Celgene broad global experience from the biotech industry.

Celgene will host a conference call to discuss the results and achievements of our second quarter 2004 operating and financial performance on July 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 July 22, 2004 until midnight EDT July 29, 2004. To access the replay, dial 1-800-642-1687 and enter Reservation Number 8661198.

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.

Contact: Robert J. Hugin Senior VP and CFO Celgene Corporation (732) 271-4102 Brian P. Gill Director of PR/IR Celgene Corporation (732) 652-4530