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 REPORTS RECORD
OPERATING PERFORMANCE FOR 2005
42% INCREASE IN TOTAL REVENUE FOR 2005 VERSUS PRIOR YEAR
35% ANNUAL INCREASE IN TOTAL PRODUCT SALES FOR 2005
100% INCREASE IN ADJUSTED OPERATING INCOME YEAR-OVER-YEAR
FOURTH QUARTER HIGHLIGHTS:
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o REVLIMID(R) NDA GRANTED FDA APPROVAL FOR MDS DELETION 5q
o REVLIMID sNDA SUBMITTED TO FDA FOR RELAPSED OR REFRACTORY MULTIPLE MYELOMA
o REVLIMID MAA FILING UNDER REVIEW AT EMEA FOR MDS DELETION 5q
o REVLIMID MAA SUBMITTED TO SWITZERLAND FOR MDS DELETION 5q
o MORE THAN 100 ABSTRACTS AT ASH 2005; 23 ORAL PRESENTATIONS INCLUDING
SURVIVAL DATA FOR REVLIMID AND THALOMID(R)
o CELGENE COMPLETED RESPONSE TO THALOMID sNDA APPROVABLE LETTER FOR NEWLY
DIAGNOSED MULTIPLE MYELOMA; FDA ACTION EXPECTED 1H2006
o THALOMID PIVOTAL PHASE III MULTIPLE MYELOMA TRIAL REACHED PRE-SPECIFIED
INTERIM ENDPOINT
2005 FINANCIAL RESULTS:
- -----------------------
o CELGENE REPORTED THIRD CONSECUTIVE FULL-YEAR OF PROFITABILITY
o FULL-YEAR REVENUE INCREASED 42.2% TO $536.9 MILLION VERSUS PRIOR YEAR
o R&D EXPENDITURES INCREASED 18.6% TO $190.8 MILLION SUPPORTING LATE-STAGE
REGULATORY PROGRAMS
o ADJUSTED SELLING, GENERAL AND ADMINISTRATIVE EXPENSES INCREASED 57% TO
$179.3 MILLION INCLUDING $40 MILLION TO SUPPORT REVLIMID PRE-LAUNCH
ACTIVITIES
o ADJUSTED FULL-YEAR EARNINGS PER SHARE INCREASED TO $0.38 PER DILUTED SHARE
EXCLUDING IMPACT OF UNUSUAL AND NON-RECURRING CHARGES OF $4.5 MILLION OR
$0.03 PER DILUTED SHARE
2006 FINANCIAL OUTLOOK:
- -----------------------
o CELGENE FORECASTS STRONG OPERATIONAL PERFORMANCE IN 2006
o RESEARCH AND DEVELOPMENT EXPENSE EXPECTED TO INCREASE APPROXIMATELY 20 TO
25%, YEAR-OVER-YEAR
o SELLING, GENERAL AND ADMINISTRATIVE EXPENSES ARE TARGETED TO INCREASE
APPROXIMATELY 10 TO 15%, YEAR-OVER-YEAR
o INTERNATIONAL SELLING, GENERAL AND ADMINISTRATIVE EXPENSES TARGETED TO A
RANGE OF $30 TO $35 MILLION
o EARNINGS PER SHARE IN 2006 SUBJECT TO REVLIMID(R) U.S. AND EMEA REGULATORY
APPROVALS AND LAUNCH TIMELINES
2006 MILESTONES:
- ----------------
o REVLIMID SUBMISSION TO EMEA FOR RELAPSED OR REFRACTORY MULTIPLE MYELOMA
EXPECTED IN FIRST QUARTER 2006
o EXPAND REVLIMID INTERNATIONAL REGULATORY SUBMISSIONS
o ADVANCE REVLIMID PHASE II NHL TRIALS
o INITIATE REVLIMID CLL REGISTRATION PROGRAM
o ADVANCE REVLIMID NEWLY DIAGNOSED MULTIPLE MYELOMA TRIALS
o CONTINUE REVLIMID BROAD PHASE II HEMATOLOGY AND ONCOLOGY CLINICAL PROGRAMS
o INITIATE POTENTIAL REGULATORY STUDIES IN CC-4047 IN SICKLE CELL ANEMIA AND
MYELOFIBROSIS
o INITIATE AND ADVANCE CC-10004 TRIALS IN PSORIASIS AND OTHER PILOT STUDIES
o COMPLETE CC-11006 PHASE I STUDY; INITIATE CC-10015 PHASE I TRIAL
o ADVANCE JNK-401 CLINICAL PROGRAM
o ADVANCE CELLULAR THERAPEUTICS BIOMATERIALS AND STEM CELL PRODUCTS
o ADVANCE PRE-CLINICAL LIGASE AND KINASE INHIBITOR PROGRAMS
SUMMIT, NJ - (JANUARY 26, 2006) - Celgene Corporation (NASDAQ: CELG) announced
adjusted net income of $68.1 million, or adjusted earnings per diluted share of
$0.38, for the full-year. On a reported basis, under U.S. Generally Accepted
Accounting Principles (GAAP), Celgene reported net income of $63.7 million, or
diluted earnings per share of $0.35, compared to net income of $52.8 million, or
diluted earnings per share of $0.31 in the comparable 2004 period. Total revenue
was a record $536.9 million, an increase of 42% over the same period in 2004.
THALOMID(R) net sales for the full-year were $387.8 million, compared to $308.6
million in 2004, an increase of 25% year-over-year. Revenue from the Ritalin(R)
family of drugs totaled $72.8 million for the year, including a milestone
payment of $20 million, an increase of 89% versus prior year.
Total revenue for the fourth quarter increased 42% to $149.3 million from $105.4
million for the prior-year quarter. THALOMID net sales in the fourth quarter of
2005 increased 23% to $105.8 million from $86.1 million in the fourth quarter of
2004. Celgene posted fourth quarter adjusted net income of $8.0 million, or
adjusted earnings per diluted share of $0.04 compared to adjusted net income of
$17.4 million or adjusted earnings per diluted share of $0.10 in the fourth
quarter of 2004. Sequentially, total revenue increased approximately 15% to
$149.3 million in the fourth quarter from $129.5 million in the third quarter of
2005, with THALOMID sales rising approximately 7% quarter-over-quarter to $105.8
million from $99.1 million. On a reported basis, under U.S. GAAP, Celgene
reported earnings per diluted share of $0.02 in the fourth quarter of 2005
versus $0.13 in the same quarter of 2004.
Adjusted net income and per share amounts for the three and twelve-month periods
ended December 31, 2005, eliminate the effects of charges for accelerated
depreciation expense related to the Company's corporate headquarters relocation,
charges to record our share of equity losses in EntreMed, Inc. and to adjust the
income tax provision to reflect cash taxes. Adjusted net income and per share
amounts for the twelve-month period ended December 31, 2005 also excludes a
charge recorded for changes in the estimated value of our investment in
EntreMed, Inc. warrants prior to our March 31, 2005 exercise. Adjusted net
income and per share amounts for the three and twelve-month periods ended
December 31, 2004 excludes charges recorded for changes in the estimated value
of our investment in EntreMed, Inc. warrants and to adjust the income tax
provision to reflect cash taxes.
To further accelerate the progress of key late-stage regulatory programs,
Celgene increased R&D expenditures in REVLIMID(R) Phase II and Phase III
regulatory programs in myelodysplastic syndromes and multiple myeloma, including
the ongoing pivotal Phase III MDS deletion 5q trial to support the Company's MAA
seeking approval to market REVLIMID in Europe. Celgene incurred R&D expenses of
$52.4 million in the fourth quarter of 2005, representing an increase of 19%
compared to the year ago quarter. These R&D expenditures continue to support
ongoing clinical progress in multiple proprietary development programs for
THALOMID(R), REVLIMID, and for other immunomodulatory drugs such as CC-4047,
CC-11006 and CC-10050, as well as in the TNF alpha, kinase and ligase inhibitor
programs and stem cell program.
Celgene reported $724.3 million in cash and marketable securities as of December
31, 2005.
"In 2005, we made great strides across all areas of Celgene, and in 2006, we
will continue to prepare for an incredibly promising future," said Celgene
Chairman and Chief Executive Officer John W. Jackson. " We believe that the
REVLIMID transformation is well on its way."
2005 COMPANY HIGHLIGHTS:
CLINICAL, REGULATORY AND DRUG DISCOVERY ACHIEVEMENTS:
- -----------------------------------------------------
o The U.S. Food and Drug Administration (FDA) granted approval of REVLIMID
for the treatment of patients with transfusion-dependent anemia due to low-
or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a
deletion 5q cytogenetic abnormality with or without additional cytogenetic
abnormalities. REVLIMID is now available through an Education and
Prescribing Safety Program, called RevAssist(SM) via specialty pharmacies.
o The FDA granted approval for FOCALIN XR (dexmethylphenidate HCl)
extended-release capsules for the treatment of
Attention-Deficit/Hyperactivity Disorder (ADHD) in adults, adolescents and
children. The approval of FOCALIN XR for the treatment of ADHD was based on
efficacy and safety data from clinical trials involving approximately 320
adults, adolescents and children diagnosed with ADHD.
o The European Medicines Agency (EMEA) accepted for review the Company's
Marketing Authorization Application (MAA) for REVLIMID. The application is
based on the same
clinical data, from an open-label Phase II trial, evaluated by the FDA to
support its decision to approve REVLIMID as a treatment for
transfusion-dependent anemia due to low- or intermediate-1-risk
myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic
abnormality with or without additional cytogenetic abnormalities.
o Celgene submitted its Supplemental New Drug Application (sNDA) for REVLIMID
to the Division of Oncology Drug Products at the FDA seeking approval to
market REVLIMID as a treatment for relapsed or refractory multiple myeloma.
o Celgene submitted its MAA for REVLIMID to the Swiss Intercantonal Medicines
Control Office seeking approval to market REVLIMID as a treatment for
transfusion-dependent anemia due to low- or intermediate-1-risk
myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic
abnormality with or without additional cytogenetic abnormalities.
o The FDA issued an approvable letter in response to the Company's sNDA
seeking approval to market THALOMID as a treatment for multiple myeloma
(MM). The FDA requested revised product labeling with the specific
indication of newly diagnosed multiple myeloma and updated safety
information, as well as some additional patient information to finalize its
review. The Company has completed its response, and anticipates an action
by the FDA in the first half of 2006.
o The Company announced that an external Independent Data Monitoring
Committee analysis of the multi-centered, randomized, placebo-controlled
phase III study (MM-003) evaluating combination thalidomide plus
dexamethasone versus dexamethasone alone as induction therapy for
previously untreated multiple myeloma met the pre-specified p<0.0015 value
for stopping the trial. The IDMC found time to disease progression - the
primary endpoint of this Phase III trial - of 75.7 weeks versus 27.9 weeks
(p=0.000065), plus progression-free survival of 55.7 weeks versus 24.3
weeks (p=0.0003) in patients receiving THALOMID plus dexamethasone compared
to patients receiving dexamethasone alone.
o At THE 47TH AMERICAN SOCIETY OF HEMATOLOGY MEETING (ASH), clinical
investigators from leading cancer research centers presented data from
recent and on-going clinical trials of THALOMID, and REVLIMID in broad
indications, including survival data in multiple myeloma. The presentations
included 30 abstracts clinically evaluating REVLIMID in both oral and
poster sessions, including a plenary session, across a broad range of
disease indications, as well as 77 abstracts clinically evaluating THALOMID
in both oral and poster sessions.
o At the ASH plenary session, updated clinical data were presented on two
Phase III pivotal studies evaluating REVLIMID plus dexamethasone in
previously treated multiple myeloma patients. The updated clinical data
from the pivotal International Phase III trial (MM-010), demonstrated that
the combination of REVLIMID plus dexamethasone led to a statistically
significant improvement in median time to disease progression (p=0.001).
The updated clinical data from the pivotal North American Phase III trial
(MM-009), reported that the combination of REVLIMID(R) plus dexamethasone
led to a statistically significant improvement in overall survival in
addition to a statistically significant improvement in
median time to disease progression. As of June 2005, median overall
survival in patients treated with REVLIMID plus dexamethasone has not been
reached as compared to 104 weeks with dexamethasone plus placebo (p=0.013).
o At ASH, clinical data from two phase III studies evaluating oral
combination THALOMID(R) reported survival advantage for elderly newly
diagnosed multiple myeloma patients. The Italian study reported a
statistically significant difference in event-free survival of 68 percent
versus 32 percent (p<0.001) after twenty-six months of treatment with
melphalan, prednisone and thalidomide (MPT) versus melphalan and prednisone
(MP) alone. The French study reported a significant difference in
progression-free survival of 73 percent versus 55 percent (p=0.0001) after
treatment with MPT versus melphalan and autologous stem cell transplant.
Importantly, the study reported a significant difference in overall
survival that has not been reached after 55 months.
o At the XXIII Chemotherapy Foundation Symposium, preliminary clinical data
evaluating THALOMID as an oral combination therapy for the treatment of
recurrent epithelial ovarian cancer in patients who had received prior
treatments reported 50% of patients achieved overall response in median
progression free survival.
2005 CORPORATE AND COMMERCIAL ACHIEVEMENTS:
- -------------------------------------------
o Celgene announced that its Chairman and Chief Executive Officer John W.
Jackson will retire as Chief Executive Officer on May 1, 2006. Mr. Jackson
will continue as Chairman of the Board of Directors and stand for
re-election at the Company's annual meeting on June 15, 2006. On May 1st,
Sol J. Barer will assume responsibility as the Company's Chief Executive
Officer. At the same time, Robert J. Hugin will assume Dr. Barer's current
role as President and Chief Operating Officer.
o The Board of Directors of Celgene approved a two-for-one stock split,
payable in the form of a 100 percent stock dividend. The stock split is
subject to stockholder's approval to increase the number of authorized
shares of common stock from 280,000,000 to 580,000,000, an action that will
be voted on at a Special Meeting of the Stockholders on February 16, 2006.
o Celgene expanded its international infrastructure through investments in
ongoing commercial, manufacturing, clinical and regulatory activities in
Europe to support the potential launch of REVLIMID for the treatment of MDS
associated with a deletion 5q cytogenetic abnormality, as well as
preparations for the potential launch of REVLIMID as a treatment for
relapsed or refractory multiple myeloma.
o Celgene was added to the Nasdaq-100 Index(R), and included in the
Nasdaq-100 Index Tracking Stock (NASDAQ: QQQQ). In 2005, Celgene was
reported as the best performing stock in the Nasdaq-100.
WEBCAST
Celgene will host a conference call to discuss the results and achievements of
its fourth quarter and 2005 fiscal year operating and financial performance on
January 26, 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 January 26, 2006 until
midnight EDT February 3, 2006. To access the replay, dial 1-800-642-1687 and
enter Reservation Number 4306926.
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 10K, 10Q
AND 8K REPORTS.
# # #
CELGENE CORPORATION
Consolidated Statement of Operations
Three Months Ended
(Unaudited)
(In thousands, except per share data)
DECEMBER 31, 2005 DECEMBER 31, 2004
GAAP ADJUSTMENTS "ADJUSTED" GAAP ADJUSTMENTS "ADJUSTED"
-------- ----------------- ---------- -------- ----------------- ----------
Net product sales $128,697 $ -- $128,697 $ 91,638 $ -- $ 91,638
Collaborative agreements and other revenue 5,505 -- 5,505 4,592 -- 4,592
Royalty revenue 15,136 -- 15,136 9,178 -- 9,178
-------- ------- -------- -------- --------- --------
Total revenue 149,338 -- 149,338 105,408 -- 105,408
Cost of goods sold 26,728 511 (2) 27,239 16,071 -- 16,071
Research and development 52,421 -- 52,421 44,332 -- 44,332
Selling, general and administrative 55,682 (101)(1) 55,581 34,788 34,788
-------- ------- -------- -------- --------- --------
Total costs and expenses 134,831 410 135,241 95,191 -- 95,191
-------- ------- -------- -------- --------- --------
Operating income 14,507 (410) 14,097 10,217 -- 10,217
Equity in losses of associated company 948 (948)(2) -- -- -- --
Interest and other income (expense), net 2,155 -- 2,155 18,506 (9,879)(3) 8,627
-------- ------- -------- -------- --------- --------
Income before taxes 15,714 538 16,252 28,723 (9,879) 18,844
Income tax provision 11,786 (3,515)(4) 8,271 6,484 (5,018)(4) 1,466
-------- ------- -------- -------- --------- --------
Net income $ 3,928 $ 4,053 $ 7,981 $ 22,239 $ (4,861) $ 17,378
======== ======= ======== ======== ========= ========
PER COMMON SHARE - BASIC AND DILUTED
- ------------------------------------
Net income - basic $ 0.02 $ 0.03 $ 0.05 $ 0.13 $ (0.03) $ 0.10
======== ======= ======== ======== ========= ========
Net income - diluted $ 0.02 $ 0.02 $ 0.04 $ 0.13 $ (0.03) $ 0.10
======== ======= ======== ======== ========= ========
Weighted average shares outstanding-basic 169,919 169,919 169,919 164,749 164,749 164,749
======== ======= ======== ======== ========= ========
Weighted average shares outstanding-diluted 179,999 179,999 179,999 173,669 173,669 173,669
======== ======= ======== ======== ========= ========
CELGENE CORPORATION
NOTES TO RECONCILIATION OF GAAP EARNINGS TO "ADJUSTED" EARNINGS
THREE MONTHS ENDED DECEMBER 31, 2005 AND 2004
(UNAUDITED)
(IN THOUSANDS, EXCEPT PER SHARE DATA)
(1) To exclude accelerated depreciation expense related to the relocation of
the Company's corporate headquarters.
(2) To exclude the Company's share of equity losses in EntreMed, Inc. and to
adjust for our share of THALOMID royalties payable to EntreMed, Inc.
(3) To exclude the charge recorded for changes in the estimated value of the
Company's investment in EntreMed, Inc. warrants prior to our March 31, 2005
exercise.
(4) To adjust the income tax provision to cash taxes, net of federal refunds
and payments. The projected cash taxes differs from the GAAP provision due
primarily to (i) The recognition of deferred tax assets in the first
quarter of 2005 that decreased the tax provision but not cash taxes, (ii)
the exercise of employee stock options in the current year that reduce cash
taxes, but not the tax provision, and (iii) the payment in the current year
of prior year taxes, that increase cash taxes, but not the tax provision.
CELGENE CORPORATION
Consolidated Statement of Operations
Twelve Months Ended
(Unaudited)
(In thousands, except per share data)
DECEMBER 31, 2005 DECEMBER 31, 2004
GAAP ADJUSTMENTS "ADJUSTED" GAAP ADJUSTMENTS "ADJUSTED"
-------- ----------------- ---------- -------- ----------------- ----------
Net product sales $ 445,625 $ -- $ 445,625 $ 330,571 $ -- $ 330,571
Collaborative agreements and other revenue 41,334 -- 41,334 20,012 -- 20,012
Royalty revenue 49,982 -- 49,982 26,919 -- 26,919
--------- --------- --------- --------- --------- ---------
Total revenue 536,941 -- 536,941 377,502 -- 377,502
Cost of goods sold 80,727 687 (2) 81,414 59,726 -- 59,726
Research and development 190,834 -- 190,834 160,852 -- 160,852
Selling, general and administrative 181,796 (2,456)(1) 179,340 114,196 -- 114,196
--------- --------- --------- --------- --------- ---------
Total costs and expenses 453,357 (1,769) 451,588 334,774 -- 334,774
--------- --------- --------- --------- --------- ---------
Operating income 83,584 1,769 85,353 42,728 -- 42,728
Equity in losses of associated company 6,923 (6,923)(2) -- -- -- --
Interest and other income (expense), net 7,551 6,875 (3) 14,426 20,443 1,922 (3) 22,365
--------- --------- --------- --------- --------- ---------
Income before taxes 84,212 15,567 99,779 63,171 1,922 65,093
Income tax provision 20,556 11,102 (4) 31,658 10,415 (4,925)(4) 5,490
--------- --------- --------- --------- --------- ---------
Net income $ 63,656 $ 4,465 $ 68,121 $ 52,756 $ 6,847 $ 59,603
========= ========= ========= ========= ========= =========
PER COMMON SHARE - BASIC AND DILUTED
Net income - basic $ 0.38 $ 0.03 $ 0.41 $ 0.32 $ 0.04 $ 0.36
========= ========= ========= ========= ========= =========
Net income - diluted $ 0.35 $ 0.03 $ 0.38 $ 0.31 $ 0.03 $ 0.34
========= ========= ========= ========= ========= =========
Weighted average shares outstanding-basic 167,756 167,756 167,756 163,869 163,869 163,869
========= ========= ========= ========= ========= =========
Weighted average shares outstanding-diluted 195,292 195,292 195,292 172,855 172,855 172,855
========= ========= ========= ========= ========= =========
CELGENE CORPORATION
NOTES TO RECONCILIATION OF GAAP EARNINGS TO "ADJUSTED" EARNINGS
TWELVE MONTHS ENDED DECEMBER 31, 2005 AND 2004
(UNAUDITED)
(IN THOUSANDS, EXCEPT PER SHARE DATA)
(1) To exclude accelerated depreciation expense related to the relocation of
the Company's corporate headquarters.
(2) To exclude the Company's share of equity losses in EntreMed, Inc. and to
adjust for our share of THALOMID royalties payable to EntreMed, Inc.
(3) To exclude the charge recorded for changes in the estimated value of the
Company's investment in EntreMed, Inc. warrants prior to our March 31, 2005
exercise.
(4) To adjust the income tax provision to cash taxes, net of federal refunds
and payments. The projected cash taxes differs from the GAAP provision due
primarily to (i) The recognition of deferred tax assets in the first
quarter of 2005 that decreased the tax provision but not cash taxes, (ii)
the exercise of employee stock options in the current year that reduce cash
taxes, but not the tax provision, and (iii) the payment in the current year
of prior year taxes, that increase cash taxes, but not the tax provision.
CELGENE CORPORATION
CONSOLIDATED BALANCE SHEET DATA
(UNAUDITED)
(IN THOUSANDS, EXCEPT PER SHARE DATA)
DECEMBER 31, DECEMBER 31,
2005 2004
----------- -----------
Cash, cash equivalents & marketable
securities $ 724,260 $ 748,537
Total assets 1,246,637 1,107,293
Convertible notes 399,984 400,000
Stockholders' equity 635,775 477,444