Exhibit 99.1
Contact:
Robert J. Hugin Brian P. Gill
Senior VP and CFO Director of PR/IR
Celgene Corporation Celgene Corporation
(908) 673-9102 (908) 673-9530
CELGENE CORPORATION FIRST QUARTER RESULTS DELIVER
RECORD OPERATING PERFORMANCE AND KEY CLINICAL AND
REGULATORY PROGRESS
Product Sales Drive Record First Quarter Revenue and Profits:
o Total Revenue Increased Approximately 36 Percent Year-Over-Year
o Adjusted Earnings Per Diluted Share More Than Doubled Versus Prior Year
o Company Affirms 2005 Financial Targets
REVLIMID(R)(lenalidomide) Clinical and Regulatory Programs Advanced:
o REVLIMID Pivotal Phase III Special Protocol Assessment (SPA) Multiple
Myeloma (MM) Trials Reported Overwhelming Statistically Significant
Difference (p<0.00001) in Time-To-Progression (TTP) Rate, Exceeding
Pre-Specified Interim Efficacy Endpoint, at 10th International Multiple
Myeloma Workshop
o REVLIMID NDA Submission to FDA, Based on Phase II Studies, Completed for
Treatment of Myelodysplastic Syndromes (MDS) Patients with 5q Deletion
Chromosomal Abnormality
FIRST QUARTER HIGHLIGHTS:
o Total Revenue for the First Quarter Reached a Record $112.4 Million
o 113 Abstracts on Clinical Data for THALOMID(R), REVLIMID, ACTIMID(TM) and
ALKERAN(R) Presented at the 10th International Multiple Myeloma Workshop
o REVLIMID Clinical Data from Interim Analysis of Pivotal Phase III SPA
Trials in Previously Treated Multiple Myeloma Presented at the 10th
International Multiple Myeloma Workshop
o Peer-Reviewed Article on Clinical Data from Initial REVLIMID Study in MDS
Reported in New England Journal of Medicine (February 9, 2005 Issue)
o Celgene Licensed Rights to EntreMed, Inc. for Tubulin Inhibitor Program
o Study Reported Pluripotent Stem Cells Isolated from Non-Controversial
Placental Source at International Stem Cell Meeting
ASCO 2005 PREVIEW:
o 42 Abstracts on Clinical Data for THALOMID(R), REVLIMID(R), ACTIMID(TM),
ALKERAN(R) and FOCALIN(TM) as Single Agents and in Combination Therapies to
be Presented at The American Society of Clinical Oncology (May 12-17, 2005)
o Updated Clinical Data From REVLIMID Pivotal Phase III SPA Trials in
Previously Treated Multiple Myeloma Patients to be Presented at ASCO
Scientific Symposium
o REVLIMID Clinical Data from MDS-003 Trial in Myelodysplastic Syndromes
Patients with 5q Deletion Chromosomal Abnormality to be Presented at
ASCO Plenary Session
o REVLIMID Clinical Data in Chronic Lymphocytic Leukemia to be Presented
o Numerous Abstracts Evaluating THALOMID as Potential Therapy in
Hematological and Solid Tumor Cancers
SUMMIT, NJ - (April 28, 2005) - CELGENE CORPORATION (NASDAQ: CELG) announced
adjusted diluted earnings per share of $0.11 for the quarter ended March 31,
2005, driven by record product sales. On a reported basis, under U.S. Generally
Accepted Accounting Principles (GAAP), Celgene reported earnings per diluted
share of $0.26 in the first quarter of 2005 that included a one-time gain from
the recognition of deferred tax assets previously reserved. Total revenue for
the first quarter increased 35.6% to $112.4 million from $82.9 million for the
prior-year quarter. THALOMID net sales in the first quarter of 2005 increased
27.7% to $88.4 million from $69.2 million in the first quarter of 2004. Celgene
posted first quarter adjusted net income of $19.1 million, or adjusted earnings
of $0.11 per diluted share compared to net income of $8.9 million or $0.05 per
share in the first quarter of last year.
On a reported basis, under GAAP, Celgene reported earnings per diluted share of
$0.26 in the first quarter of 2005, versus $0.05 per diluted share in the same
quarter last year.
Adjusted net income and per share amounts eliminate the effect of first quarter
charges in 2005 relating to a one-time non-cash charge associated with
acceleration of depreciation expense for the Company's corporate headquarters
relocation, exclusion of charges recorded for the change in estimated value of
the Company's investment in EntreMed, Inc. warrants and in-process research and
development relating to our purchase of EntreMed shares as the result of
exercising our warrants offset by the tax effect related to those adjustments,
recognition of deferred tax assets which were previously reserved, and reflects
the projected cash tax rate for the year.
Adjusted or Non-GAAP financial measures provide investors and management with
supplemental measures of operating performance and trends that facilitate
comparisons between periods before, during and after certain items that would
not otherwise be apparent on a GAAP basis because certain unusual and one-time
or non-recurring charges that do not affect the Company's basic operations also
do not meet the GAAP definition of unusual non-recurring items. Adjusted
earnings are not, and should not be, viewed as a substitute for GAAP net income.
Our definition of adjusted earnings may differ from others.
To support accelerated clinical development and to advance regulatory filings,
Celgene increased R&D expenditures in REVLIMID(R) Phase II regulatory programs
in myelodysplastic syndromes and the ongoing pivotal Phase III SPA trials for
multiple myeloma. Celgene incurred R&D expenses of $40.0 million in the first
quarter of 2005, representing an increase of 6.1% compared to the year ago
quarter. These R&D expenditures continue to support ongoing clinical progress in
multiple proprietary development programs.
Celgene reported $701.3 million in cash, marketable securities and investments
as of March 31, 2005.
"Celgene continues to achieve excellent performance and significant progress
across all key regulatory programs and business units." said John W. Jackson,
Chairman and Chief Executive Officer of Celgene Corporation. "As we work to
improve people's lives, we are building a highly profitable global
biopharmaceutical company focused on delivering innovative therapies for unmet
medical needs in cancer and immune-inflammatory diseases."
AFFIRMS 2005 FINANCIAL OUTLOOK:
The Company today affirmed its 2005 financial targets, announced on January 27,
2005. 2005 financial guidance anticipates total revenue in a $525 million range,
with THALOMID(R) revenue targeted to reach the $400 million range. We are
maintaining our revenue forecast for the Ritalin(R) family of drugs at
approximately $60 million in 2005, which includes a significant milestone
payment for the anticipated approval of FOCALIN XR(TM). Research and development
expenses are expected to be in the range of $190 million, and selling, general
and administrative expenses are targeted to reach a range of $140 million.
Adjusted diluted earnings per share for the full-year are expected to be in the
$0.55 range.
2005 FIRST QUARTER COMPANY HIGHLIGHTS:
CLINICAL, REGULATORY AND DRUG DISCOVERY ACHIEVEMENTS:
o The Company announced that it completed the rolling submission of its New
Drug Application (NDA) for REVLIMID, an investigational drug, to the
Division of Oncology Drug Products at the U.S. Food and Drug Administration
(FDA) for review. Our NDA is seeking approval to market REVLIMID(R) as a
treatment for transfusion-dependent patients with myelodysplastic syndromes
(MDS) and with a 5q deletion chromosomal abnormality.
o The Company announced that external Independent Data Monitoring Committee
analyses of both REVLIMID Phase III SPA multiple myeloma trials exceeded
the pre-specified stopping rule of p<0.0015 statistical significance for
the trials. This Independent Committee found a statistically significant
improvement in time to disease progression, the primary endpoint of these
Phase III trials, in patients receiving REVLIMID plus dexamethasone
compared to patients receiving dexamethasone alone. Celgene is in ongoing
discussions with the FDA and international regulatory authorities regarding
the submission of these data for potential marketing approval.
o At the 10th International Multiple Myeloma Workshop held in Sydney,
Australia, clinical results from our Pivotal Phase III SPA trials using
REVLIMID as a new approach in the treatment of previously treated multiple
myeloma patients were presented. The studies reported an overwhelming
statistically significant difference (p<0.00001) in the TTP, the primary
endpoint of the two trials. At the time of the interim analysis, the median
TTP for the combination therapy arms had not been reached both for the U.S.
trial at fifteen months and for the international trial at more than eleven
months. This is in contrast to the TTP for the dexamethasone only treated
arms of both trials in which the median TTP was five months.
o The New England Journal of Medicine published in February a peer-reviewed
article on a Phase I/II trial that evaluated REVLIMID therapy for patients
with myelodysplastic syndromes (MDS). This study conducted at the
University of Arizona by Alan List, M.D., Professor of Medicine and Program
Leader Hematologic Malignancies at the H. Lee Moffitt Cancer Center, Tampa,
Florida. REVLIMID has received both orphan drug status and fast track
designation from the U.S. Food and Drug Administration (FDA) and orphan
drug status from the European Agency for the Evaluation of Medicinal
Products for the treatment of MDS.
o At an oral presentation at a recent International Conference on Stem Cell
Research and Therapeutics in San Diego, Celgene announced that human
placenta-derived stem cells that are "pluripotent", or have the ability to
become multiple different types of tissue, can be isolated with a
proprietary perfusion technology from placentas, a non-controversial source
of stem cells.
CORPORATE AND COMMERCIAL ACHIEVEMENTS:
o In advance of potential product launches, the Celgene management team was
further strengthened by the addition of Shawn Tomasello as Vice President
of Sales. Prior to joining Celgene, Shawn spent sixteen years with
Genentech, Inc. In her most recent position, Shawn led the National Sales
Force responsible for Rituxan(R), the number one selling Oncology Product
in the U.S.
o Celgene announced a licensing agreement with EntreMed, Inc., whereby
EntreMed has been granted rights to develop and commercialize the Company's
tubulin inhibitor compounds, a class of orally available,
anti-proliferative agents that have demonstrated, in preclinical models,
activity against drug-resistant cancer cells, inhibition of inflammatory
cytokines and anti-angiogenic activity.
o As part of our long-term collaboration with Slone Epidemiology Center at
Boston University, Celgene and Slone have initiated the development of
Multiple Myeloma and Myelodysplastic Syndromes registries. These
outcomes-based registries are expected to open in 2006, and are designed to
increase the healthcare community's understanding of effective MDS and MM
disease management strategies.
Webcast
Celgene will host a conference call to discuss the results and achievements of
its first quarter 2005 operating and financial performance on April 28, 2005 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 28, 2005 until midnight EDT May 5, 2005. To access the replay, dial
1-800-642-1687 and enter Reservation Number 5702223.
ABOUT CELGENE
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated
global 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 FORM 10-K,
10-Q AND 8-K REPORTS.
# # #
CELGENE CORPORATION
CONSOLIDATED FINANCIAL RESULTS
(UNAUDITED)
(IN THOUSANDS, EXCEPT PER SHARE DATA)
CONSOLIDATED STATEMENT OF OPERATIONS DATA
- -----------------------------------------
THREE MONTHS ENDED MARCH 31, 2005 THREE MONTHS ENDED
GAAP ADJUSTMENTS "ADJUSTED" MARCH 31, 2004
------------------- ------------------- ---------------- ---------------------
Net product sales $ 97,645 $ -- $ 97,645 $ 76,120
Collaborative agreements and other revenue 5,229 -- 5,229 2,133
Royalty revenue 9,522 -- 9,522 4,620
------------------- ------------------- ---------------- ---------------------
Total revenue 112,396 -- 112,396 82,873
Cost of goods sold 12,604 -- 12,604 14,395
Research and development 40,037 -- 40,037 37,728
Selling, general and administrative 37,806 (1,216)(1) 36,590 25,936
------------------- ------------------- ---------------- ---------------------
Total costs and expenses 90,447 (1,216) 89,231 78,059
------------------- ------------------- ---------------- ---------------------
Operating income 21,949 1,216 23,165 4,814
Equity in losses of associated company 4,355 (4,355)(2) -- --
Interest and other income, net (3,552) 6,875(3) 3,323 4,901
------------------- ------------------- ---------------- ---------------------
Income before taxes 14,042 12,446 26,488 9,715
Income tax provision (benefit) (34,172) 41,589(4) 7,417 801
------------------- ------------------- ---------------- ---------------------
Net income $ 48,214 $ (29,143) 19,071 $ 8,914
=================== =================== ================ =====================
PER COMMON SHARE - BASIC AND DILUTED (1)
- ----------------------------------------
Net income - basic $ 0.29 $ (0.18) $ 0.12 $ 0.05
=================== =================== ================ =====================
Net income - diluted $ 0.26 $ (0.15) $ 0.11 $ 0.05
=================== =================== ================ =====================
Weighted average shares outstanding-basic 165,613 165,613 165,613 162,950
=================== =================== ================ =====================
Weighted average shares outstanding-diluted 191,108 191,108 191,108 174,526
=================== =================== ================ =====================
CONSOLIDATED BALANCE SHEET DATA
- ----------------------------------------
MARCH 31, DECEMBER 31,
2005 2004
---------------------------------------
Cash, cash equivalents & marketable
securities $ 701,283 $ 748,537
Total assets 1,125,636 1,107,293
Convertible notes 400,000 400,000
Stockholders' equity 534,706 477,444
CELGENE CORPORATION
NOTES TO RECONCILIATION OF GAAP EARNINGS TO "ADJUSTED" EARNINGS
(UNAUDITED)
(IN THOUSANDS, EXCEPT PER SHARE DATA)
(1) To exclude the one-time non-cash expense associated with acceleration of
depreciation expense related to the Company's corporate headquarters relocation.
(2) To exclude the charge for in-process research and development related to the
Company's equity method investment in EntreMed, Inc.
(3) To exclude the charge recorded for changes in estimated value of the
Company's investment in EntreMed, Inc. warrants.
(4) The adjusted income tax provision reflects the projected cash tax rate of
28.0% for 2005, including $8.5 million of benefit for book/cash tax differences,
and excluding $42.6 million of benefit for the deferred tax asset recognition
and $7.5 million of benefit for the tax effect of the above adjustments.