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 STRONG OPERATING,
REGULATORY AND CLINICAL RESULTS WITH
RECORD PRODUCT SALES
THIRD QUARTER HIGHLIGHTS:
- -------------------------
o Total Product Sales for the Third Quarter Reached a Record $113.9 Million,
36% Increase Year-Over-Year
o Commercial Team Finalized Preparations for REVLIMID(R) Launch As First Oral
Targeted Therapy For Low To Intermediate-1-Risk MDS Patients With Deletion 5q
Chromosomal Abnormality
o FDA Oncologic Drugs Advisory Committee Recommended REVLIMID for Full
Approval, by a 10-5 vote, As Oral Targeted Therapy For Low To
Intermediate-1-Risk MDS Patients With Deletion 5q Chromosomal Abnormality;
PDUFA Date Extended to January 7, 2006
o REVLIMID Marketing Authorization Application (MAA) Accepted by the EMEA to
Evaluate REVLIMID as Oral Targeted Therapy for Treatment of Patients with
Myelodysplastic Syndromes (MDS) with Deletion 5q Chromosomal Abnormality
o REVLIMID Phase III Study in Low and Intermediate Risk MDS Patients with
Deletion 5q Chromosomal Abnormality Enrolling Rapidly in Europe
o Significant Number of Presentations on Clinical Data for REVLIMID(R),
THALOMID(R), ACTIMID(TM), ALKERAN(R) as Single Agents and in Combination
Therapies Accepted at The American Society of Hematology 47th Annual Meeting
in Atlanta (December 9-13, 2005)
o REVLIMID First Peer- Reviewed Publication on Newly Diagnosed Multiple Myeloma
in Journal BLOOD
o Celgene Provided Financial Support for Charitable Foundation to Help Patients
Obtain Access to Innovative Therapies
o Celgene 2005 Analyst/Investor Day Event Starting at 8:30 a.m. EST, Access to
Webcast Available at www.celgene.com
o Celgene Management Team Further Strengthened by the Addition of Mr. Aart
Brouwer as President of Celgene International, Sarl
2005 FINANCIAL GUIDANCE UPDATE:
- -------------------------------
o Total Revenue Target Increased to $535 Million Range from $525 Million Range
o SG&A Expenditures Target Increased to $175 Million Range to Include
Approximately $35 Million to Support Pre-Launch Activities for REVLIMID
o R&D Expenditures Target Increased to $200 Million Range from $190 Million
Range to Support Accelerated REVLIMID Global Regulatory and Clinical
Initiatives
o Excluding any potential REVLIMID Revenue and Launch Expenses Expected to
Total Approximately $35 Million in 2005, Adjusted Earnings Per Diluted Share
Target Affirmed to Achieve $0.55 Range
SUMMIT, NJ - (NOVEMBER 3, 2005) - CELGENE CORPORATION (NASDAQ: CELG) announced
adjusted earnings per diluted share of $0.06 for the quarter ended September 30,
2005. On a reported basis, under U.S. Generally Accepted Accounting Principles
(GAAP), Celgene reported net income of $668.0 thousand compared to net income of
$19.0 million, or earnings of $0.11 per diluted share in the third quarter of
the prior year. Total product sales for the third quarter increased 35.9 % to
$113.9 million from $83.8 million for the prior-year quarter. THALOMID(R) net
sales in the third quarter of 2005 increased 25.9% to $99.1 million from $78.7
million in the third quarter of 2004. Celgene posted third quarter adjusted net
income of $10.4 million, or adjusted earnings of $0.06 per diluted share
compared to adjusted net income of $21.2 million or adjusted earnings of $0.12
per diluted share in the third quarter of last year.
For the nine-month period, total product sales reached a record $316.9 million,
an increase of 32.6% over the same period in 2004. THALOMID sales for the
nine-month period were $281.9 million compared to $222.5 million in 2004, an
increase of 26.7% year-over-year. Celgene posted adjusted net income of $60.1
million or adjusted earnings of $0.33 per diluted share, during the nine-month
period, compared to adjusted net income of $42.2 million or adjusted earnings of
$0.24 per diluted share in the comparable 2004 period. During the nine-month
period on a reported basis, Celgene announced GAAP net income of $59.7 million
or earnings of $0.33 per diluted share, compared to GAAP net income of $30.5
million or earnings of $0.17 per diluted share in the nine-months of last year.
Adjusted net income and per share amounts for the three and nine-month periods
ended September 30, 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 a projected cash tax rate of 28.0 percent. Adjusted net
income and per share amounts for the nine-month period ended September 30, 2005,
also excludes the effects of charges recorded for changes in the estimated value
of the Company's investment in EntreMed, Inc. warrants which were exercised on
March 31, 2005.
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 or
non-recurring items 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 clinical development and to advance U.S. and European regulatory
filings, Celgene increased R&D expenditures in REVLIMID(R) regulatory programs
in myelodysplastic syndromes and multiple myeloma. Celgene incurred R&D expenses
of $49.3 million in the third quarter of 2005, representing an increase of 22.9%
compared to the year ago quarter. These R&D expenditures are expected to
increase in the fourth quarter in support of our ongoing global
regulatory filings, late stage clinical trials, clinical progress in multiple
proprietary development programs and related clinical manufacturing costs.
Selling, general and administrative expenses were $46.9 million in the third
quarter of 2005, a 69.2% increase over third quarter last year, driven
primarily by higher marketing and sales expenses related to product launch
activities. Approximately $13 million in marketing and sales expenses, or
approximately $0.07 per diluted share, were spent to support pre-launch
activities for REVLIMID and THALOMID, and headcount growth in commercial
support groups. These marketing and sales expenditures are expected to
increase in the fourth quarter 2005 as Celgene optimizes its commercial
launch preparations.
As of September 30, 2005, Celgene reported $746.0 million in cash and
marketable securities, an increase of $22.3 million versus the prior quarter.
"We are pleased with the progress of our REVLIMID regulatory application for
MDS in the U.S. and Europe achieved during the third quarter," said John W.
Jackson, Chairman and Chief Executive Officer of Celgene Corporation." Our
commercial preparations are being finalized to ensure rapid access to
REVLIMID upon approval."
2005 THIRD QUARTER COMPANY HIGHLIGHTS:
CLINICAL AND REGULATORY ACHIEVEMENTS:
-------------------------------------
o The Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug
Administration (FDA) recommended full 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. The committee based its recommendation on clinical data from
an open label Phase II trial, evaluating REVLIMID(R) in the largest trial
with MDS patients with deletion 5q chromosomal abnormality to date. The
original action date under the Prescription Drug User Fee Act (PDUFA) for the
REVLIMID NDA was extended from October 7, 2005 to January 7, 2006 to allow
more time for completion of review of the REVLIMID risk-management program.
o The European Medicines Agency (EMEA) accepted the Company's Marketing
Authorization Application (MAA) for REVLIMID for review. The application is
based on clinical data from an open-label Phase II trial, evaluating REVLIMID
in the largest clinical trial to date of MDS patients with deletion 5q
chromosomal abnormality. Celgene is seeking authorization 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.
CORPORATE AND COMMERCIAL DEVELOPMENTS:
--------------------------------------
o The Celgene management team was further strengthened by the addition of Mr.
Aart Brouwer as President of Celgene International, Sarl based in Neuchatel,
Switzerland. Aart brings over 30 years of global pharmaceutical and
biotechnology experience building successful major product franchises
throughout Europe. Prior to Celgene, Aart spent 14 years building Amgen's
international business in Europe. His accomplishments included building
subsidiaries in all of Europe, with Sales, Marketing and high quality
Clinical Development organizations.
o Celgene contributed $2 million in financial support to an independent,
non-profit 501(c)(3) charity whose mission is to support the needs of the
underinsured. The foundation provides financial support to eligible patients
suffering from certain diseases. These patients have insurance coverage, but
may not be able to afford the out-of-pocket costs associated with that
coverage, which are necessary to obtain prescription drug therapies critical
to their overall treatment. The foundation, which is not affiliated with
Celgene, assesses patients' eligibility to receive co-payment assistance
based upon its own independent objective eligibility criteria. Celgene has no
involvement or influence over any patient eligibility decisions, and is one
of many donors to the foundation.
WEBCAST
Celgene will webcast its third quarter 2005 operating and financial results
on November 3, 2005 starting at 8:00 a.m. EST, and its 2005 Analyst/Investor
Day program starting at 8:30 a.m. EST. The webcast will be available at
www.celgene.com. A replay of the event will be available from noon EDT
November 4, 2005 until midnight EDT November 18, 2005. To access the audio
replay, dial 1-888-286-8010 and enter Reservation Number 22719360.
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 FORWARD-LOOKING STATEMENTS WHICH ARE SUBJECT TO 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 EXPRESSED OR 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 OTHER FACTORS DESCRIBED IN THE COMPANY'S FILINGS
WITH THE SECURITIES AND EXCHANGE COMMISSION SUCH AS OUR 10-K, 10-Q AND 8-K
REPORTS.
# # #
CELGENE CORPORATION
CONSOLIDATED STATEMENT OF OPERATIONS
THREE MONTHS ENDED
(UNAUDITED)
(IN THOUSANDS, EXCEPT PER SHARE DATA)
SEPTEMBER 30, 2005 SEPTEMBER 30, 2004
GAAP ADJUSTMENTS "ADJUSTED" GAAP ADJUSTMENTS "ADJUSTED"
----------- ----------- ---------- ---------- ----------- ----------
Net product sales $ 113,900 $ -- $ 113,900 $ 83,803 $ -- $ 83,803
Collaborative agreements and other revenue 4,879 -- 4,879 10,392 -- 10,392
Royalty revenue 10,727 -- 10,727 7,273 -- 7,273
----------- ----------- ---------- ---------- ----------- ----------
Total revenue 129,506 -- 129,506 101,468 -- 101,468
Cost of goods sold 23,199 176 (2) 23,375 15,166 -- 15,166
Research and development 49,348 -- 49,348 40,154 -- 40,154
Selling, general and administrative 46,941 (111)(1) 46,830 27,750 27,750
----------- ----------- ---------- ---------- ----------- ----------
Total costs and expenses 119,488 65 119,553 83,070 -- 83,070
----------- ----------- ---------- ---------- ----------- ----------
Operating income 10,018 (65) 9,953 18,398 -- 18,398
Equity in losses of associated company 980 (980)(2) -- -- -- --
Interest and other income (expense), net 4,605 4,605 2,584 2,246(3) 4,830
----------- ----------- ---------- ---------- ---------- ----------
Income before taxes 13,643 915 14,558 20,982 2,246 23,228
Income tax provision (benefit) 12,975 (8,899)(4) 4,076 1,974 47(4) 2,021
----------- ----------- ---------- ---------- ----------- ----------
Net income $ 668 $ 9,814 10,482 $ 19,008 $ 2,199 21,207
=========== =========== ========== ========== =========== ==========
PER COMMON SHARE -- BASIC AND DILUTED
- ---------------------------------------
Net income -- basic $ -- $ 0.06 $ 0.06 $ 0.12 $ 0.01 $ 0.13
=========== =========== ========== ========== =========== ==========
Net income -- diluted $ -- $ 0.05 $ 0.06 $ 0.11 $ 0.01 $ 0.12
=========== =========== ========== ========== =========== ==========
Weighted average shares outstanding-basic 168,298 168,298 168,298 164,091 164,091 164,091
=========== =========== ========== ========== =========== ==========
Weighted average shares outstanding-diluted 179,862 179,862 179,862 177,064 193,576 193,576(5)
=========== =========== ========== ========== =========== ==========
CELGENE CORPORATION
NOTES TO RECONCILIATION OF GAAP EARNINGS TO "ADJUSTED" EARNINGS
THREE MONTHS ENDED SEPTEMBER 30, 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 a projected cash tax rate of 28.0%
and 8.7% in 2005 and 2004, respectively. The projected cash tax rate
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 use of net operating losses that
arose from employee stock option deductions that reduce cash taxes, but not
the tax provision, (iii) the exercise of employee stock options in the
current year that reduce cash taxes, but not the tax provision, and (iv)
the payment in the current year of prior year taxes, that increase cash
taxes, but not the tax provision
(5) For the three-month period ended September 30, 2004, the Company's
convertible debt was anti-dilutive on a GAAP basis but dilutive on an
adjusted basis. Accordingly, the weighted-average shares used to compute
the adjusted diluted earnings includes the additional common shares
assuming conversion of the convertible debt.
CELGENE CORPORATION
CONSOLIDATED STATEMENT OF OPERATIONS
NINE MONTHS ENDED
(UNAUDITED)
(IN THOUSANDS, EXCEPT PER SHARE DATA)
SEPTEMBER 30, 2005 SEPTEMBER 30, 2004
GAAP ADJUSTMENTS "ADJUSTED" GAAP ADJUSTMENTS "ADJUSTED"
----------- ----------- ---------- ---------- ----------- ----------
Net product sales $ 316,928 $ -- $ 316,928 $ 238,933 $ -- $ 238,933
Collaborative agreements and other revenue 35,829 -- 35,829 15,420 -- 15,420
Royalty revenue 34,846 -- 34,846 17,741 -- 17,741
----------- ----------- ---------- ---------- ----------- ----------
Total revenue 387,603 -- 387,603 272,094 -- 272,094
Cost of goods sold 53,999 176 (2) 54,175 43,655 -- 43,655
Research and development 138,413 -- 138,413 116,520 -- 116,520
Selling, general and administrative 126,114 (2,355)(1) 123,759 79,408 -- 79,408
----------- ----------- ---------- ---------- ----------- ----------
Total costs and expenses 318,526 (2,179) 316,347 239,583 -- 239,583
----------- ----------- ---------- ---------- ----------- ----------
Operating income 69,077 2,179 71,256 32,511 -- 32,511
Equity in losses of associated company 5,975 (5,975)(2) -- -- -- -
Interest and other income (expense), net 5,396 6,875 (3) 12,271 1,937 11,801(3) 13,738
----------- ----------- ---------- ---------- ----------- ----------
Income before taxes 68,498 15,029 83,527 34,448 11,801 46,249
Income tax provision (benefit) 8,770 14,617 (4) 23,387 3,931 93(4) 4,024
----------- ----------- ---------- ---------- ----------- ----------
Net income $ 59,728 $ 412 60,140 $ 30,517 $ 11,708 42,225
=========== =========== ========== ========== =========== ==========
PER COMMON SHARE-- BASIC AND DILUTED
- ---------------------------------------
Net income -- basic $ 0.36 $ 0.00 $ 0.36 $ 0.19 $ 0.07 $ 0.26
=========== =========== ========== ========== =========== ==========
Net income -- diluted $ 0.33 $ -- $ 0.33 $ 0.17 $ 0.07 $ 0.24
=========== =========== ========== ========== =========== ==========
Weighted average shares outstanding-basic 167,027 167,027 167,027 163,574 163,574 163,574
=========== =========== ========== ========== =========== ==========
Weighted average shares outstanding-diluted 195,002 195,002 195,002 176,273 176,273 176,273
=========== =========== ========== ========== =========== ==========
CELGENE CORPORATION
NOTES TO RECONCILIATION OF GAAP EARNINGS TO "ADJUSTED" EARNINGS
NINE MONTHS ENDED SEPTEMBER 30, 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 a projected cash tax rate of 28.0%
and 8.7% in 2005 and 2004, respectively. The projected cash tax rate
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 use of net operating losses that
arose from employee stock option deductions that reduce cash taxes, but not
the tax provision, (iii) the exercise of employee stock options in the
current year that reduce cash taxes, but not the tax provision, and (iv)
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)
SEPTEMBER 30, DECEMBER 31,
2005 2004
------------ ------------
Cash, cash equivalents & marketable securities $ 745,990 $ 748,537
Total assets 1,213,455 1,107,293
Convertible notes 399,992 400,000
Stockholders' equity 583,232 477,444