(Source: Business Wire)
Celgene Corporation (NASDAQ:CELG):
2009 Third Quarter Financial Results
Year-Over-Year:
Non-GAAP Total Revenue Increased 18 Percent to $692 Million; GAAP
Total Revenue $695 Million
REVLIMID Net Product Sales Increased 31 Percent to $450 Million
VIDAZA Net Product Sales Increased 62 Percent to $103 Million
THALOMID® Net Product Sales Totaled $110
Million
Non-GAAP Operating Income Increased 30 Percent to $292 Million;
GAAP Operating Income $236 Million
Non-GAAP Net Income Increased 40 Percent to $260 Million; GAAP Net
Income $217 Million
Non-GAAP Earnings Per Share Increased 40 Percent to $0.56 Per
Diluted Share; GAAP Earnings $0.46 Per Diluted Share
Recent Developments And Highlights:
REVLIMID® Reimbursement Approvals In
United Kingdom And Canada
Additional REVLIMID Regulatory Approvals in the Middle East and
Latin America
Lancet Oncology Published Results From ECOG EA403
Phase III Trial, Demonstrating REVLIMID Plus Low-Dose Dexamethasone Is
An Active Regimen For Patients With Newly Diagnosed Multiple Myeloma
(MM)
NHL-001 Study Published In Journal Of Clinical Oncology
Reported REVLIMID Demonstrated Single Agent Activity With Durable
Responses In A Heavily Pretreated Patient Population
Advancing REVLIMID Solid Tumor Program In Prostate Cancer, Renal
Cell Carcinoma, Pancreatic Cancer, and Colorectal Cancer
Journal Of Clinical Oncology Published Two Articles
Highlighting Clinical Potential Of Pomalidomide As Treatment For MM
and Myelofibrosis
VIDAZA® Upgraded By National Comprehensive
Cancer Network (NCCN) To Preferred Therapy Based On Unprecedented
Survival For Intermediate-2 And High-Risk Myelodysplastic Syndromes
(MDS)
VIDAZA Now Listed By NCCN As Low Intensity Treatment Option For
Patients With Acute Myeloid Leukemia
Initiated Phase II Trial Of ACE-011 For Treatment Of Chemotherapy
Induced Anemia In Metastatic Breast Cancer
Completed Enrollment Of Phase I Proof-Of-Principle Study For
Proprietary PDA-001 Placenta-Derived Stem Cells In Crohn's Disease
Celgene Cellular Therapeutics Patent Estate Highlighted
In Nature Biotechnology
2009 Selected Corporate Objectives:
Maximize Global Clinical, Regulatory And Commercial Potential Of
REVLIMID, VIDAZA, Pomalidomide, Apremilast, Amrubicin, ACE-011,
PDA-001 And THALOMID®
Meet With EMEA, FDA and International Regulatory Agencies Regarding
MM-015 Filing Strategy
Commercial Launch of REVLIMID In Australia
Gain Health Canada Regulatory Approval For VIDAZA In High-Risk MDS
Submit REVLIMID Regulatory Filing For Del 5q MDS In Japan
Advance REVLIMID Lymphoma Initiative Through More Than 60 Clinical
Trials Worldwide, Including Novel Combinations In Multiple Patient
Segments
Advance REVLIMID Chronic Lymphocytic Leukemia (CLL) Initiative
Through More Than 40 Clinical Trials Worldwide
Complete Apremilast Phase II Study In Recalcitrant Psoriasis And
Phase IIb Study In Moderate-To-Severe Psoriasis
Complete Enrollment of Amrubicin Phase III Trial In Patients With
Small Cell Lung Cancer
Celgene Corporation (NASDAQ:CELG) announced non-GAAP (Generally Accepted
Accounting Principles) net income of $259.8 million, or non-GAAP
earnings per diluted share of $0.56 for the quarter ended September 30,
2009. Non-GAAP net income for the third quarter of 2008 was $185.9
million, or non-GAAP earnings per diluted share of $0.40. Based on U.S.
GAAP, Celgene reported net income of $216.8 million, or earnings per
diluted share of $0.46 for the quarter ended September 30, 2009. GAAP
net income for the third quarter of 2008 was $136.8 million, or earnings
per diluted share of $0.29.
Celgene posted non-GAAP net income of $681.0 million or non-GAAP
earnings per diluted share of $1.46 during the first nine months of 2009
as compared to non-GAAP net income of $517.9 million and non-GAAP
earnings per diluted share of $1.13 in 2008. On a GAAP basis, Celgene
reported net income of $522.5 million or earnings per diluted share of
$1.12 for the first nine months of 2009, compared to GAAP net loss of
$1.384 billion or a loss per diluted share of $3.17 in 2008, which was
primarily due to an in-process research and development charge
associated with the acquisition of Pharmion Corporation in March 2008.
"All key functional areas -- commercial, clinical, regulatory, and
operations -- executed as planned globally and delivered an exceptional
quarter," said Chairman and Chief Executive Officer Sol J. Barer, Ph.D.
"We are looking forward to sharing significant clinical data with you
across a broad range of Celgene compounds in the fourth quarter that
will demonstrate the extraordinary global potential of our deep and
diverse clinical pipeline."
Product Sales Performance
Non-GAAP total revenue was a record $692.2 million for the quarter ended
September 30, 2009, an increase of 18 percent from 2008. GAAP total
revenue was $695.1 million for the quarter ended September 30, 2009. The
increase in total revenue was driven by global market share gains,
reimbursement approvals, increased duration of therapy of REVLIMID®
and the global growth of VIDAZA®. REVLIMID
net sales were $449.6 million, an increase of 31 percent over the same
period in 2008. THALOMID® net sales (inclusive of
Thalidomide Pharmion and Thalidomide Celgene) were $110.0 million.
VIDAZA net sales were $103.1 million, an increase of 62 percent over
sales in the third quarter of 2008. Revenue from Focalin® and
the Ritalin® family of drugs totaled $25.8 million for the
third quarter of 2009 compared to $23.8 million over the same period
last year.
For the first nine months of 2009, non-GAAP total revenue was a record
$1.919 billion, an increase of 19 percent year-over-year. GAAP total
revenue was $1.929 billion for the nine months ended September 30, 2009.
REVLIMID net sales for the first nine months of 2009 reached $1.209
billion, an increase of 27 percent over $955.2 million for the same
period in 2008. THALOMID net sales for the first nine months of 2009
were $329.2 million. Vidaza net sales for the first nine months of 2009
reached $270.5 million, an increase of 97 percent over the same period
in 2008, which excludes 2008 Vidaza sales prior to the March 7
acquisition of Pharmion.
Research and Development
To support clinical development and to advance global regulatory
filings, the company increased R&D investments in multiple international
clinical programs. For the third quarter of 2009, non-GAAP R&D expenses,
which exclude share-based employee compensation expense, were $178.2
million compared to $149.9 million for the third quarter of 2008. These
R&D expenditures continue to support ongoing clinical progress in
multiple proprietary development programs for REVLIMID®,
pomalidomide and other IMiDs® compounds; VIDAZA®;
amrubicin, our lead compound for small cell lung cancer; apremilast and
our other oral anti-inflammatory compounds; our kinase inhibitor
programs; our Activin inhibitor program with ACE-011 and
placenta-derived stem cell programs. On a GAAP basis, R&D expenses were
$193.4 million for the third quarter of 2009 and $160.9 million for the
same period in 2008.
Selling, General, and Administrative
Non-GAAP selling, general and administrative expenses, which exclude
share-based employee compensation expense, were $172.3 million for the
third quarter of 2009 compared to $152.0 million for the third quarter
of 2008. The increase in expenses was due primarily to unrestricted
donations to non-profit organizations for co-pay assistance. On a GAAP
basis, selling, general and administrative expenses were $192.5 million
for the third quarter of 2009 compared to $168.6 million for the third
quarter of 2008.
Interest and Other Income, Net
For the quarter ended September 30, 2009, interest and other income,
net, was $34.9 million compared to $21.6 million in the same period in
2008.
Cash, Cash Equivalents, and Marketable Securities
Celgene reported $2.764 billion in cash, cash equivalents, and
marketable securities as of September 30, 2009.
Non-GAAP Financial Information
See the attached Reconciliation of GAAP to Non-GAAP Net Income (Loss)
for an explanation of the amounts excluded and included to arrive at
non-GAAP net income and non-GAAP earnings per share amounts for the
three- and nine-month periods ended September 30, 2009 and 2008.
Non-GAAP financial measures provide investors and management with
supplemental measures of operating performance and trends that
facilitate comparisons between periods before and after certain items
that would not otherwise be apparent on a GAAP basis. Certain unusual or
non-recurring items that management does not believe affect the
company's basic operations do not meet the GAAP definition of unusual or
non-recurring items. Non-GAAP net income and non-GAAP earnings per share
are not, and should not be viewed as a substitute for similar GAAP
items. We define non-GAAP diluted earnings per share amounts as non-GAAP
net income divided by the weighted average number of diluted shares
outstanding. Our definition of non-GAAP net income and non-GAAP diluted
earnings per share may differ from similarly named measures used by
others.
Conference Call and Webcast Information
Celgene will host a conference call to discuss the results and
achievements of its third quarter 2009 and its operating and financial
performance on October 22, 2009, at 9 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 October 22,
2009, until midnight EDT October 29, 2009. To access the replay, in the
U.S. dial 888-203-1112; outside the U.S. dial 719-457-0820; and enter
reservation number 9504107. The Company's fourth quarter 2009 financial
and operational results will be reported on January 28, 2010.
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 Web site 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 and Subsidiaries
Condensed Consolidated Statements of Operations
(Unaudited)
(In thousands, except per share data)
Three Months EndedSeptember 30, Nine Months EndedSeptember 30,
2009 2008 2009 2008
Net product sales $ 667,967 $ 567,017 $ 1,842,353 $ 1,541,556
Collaborative agreements and other revenue 2,381 2,402 6,979 9,960
Royalty revenue 24,789 23,046 79,524 75,011
Total revenue 695,137 592,465 1,928,856 1,626,527
Cost of goods sold (excluding amortization of acquired intangible assets) 52,058 70,534 167,259 190,452
Research and development 193,362 160,911 593,109 462,650
Selling, general and administrative 192,512 168,607 542,264 485,345
Amortization of acquired intangible assets 21,111 32,833 67,403 77,842
Acquired in-process research and development - - - 1,740,000
Total costs and expenses 459,043 432,885 1,370,035 2,956,289
Operating income (loss) 236,094 159,580 558,821 (1,329,762 )
Equity in losses of affiliated companies 329 2,338 944 8,761
Interest and other income, net 34,937 21,630 113,257 70,270
Income (loss) before income taxes 270,702 178,872 671,134 (1,268,253 )
Income tax provision 53,887 42,058 148,602 116,138
Net income (loss) $ 216,815 $ 136,814 $ 522,532 $ (1,384,391 )
Per common share:
Net income (loss) - basic $ 0.47 $ 0.30 $ 1.14 $ (3.17 )
Net income (loss) - diluted $ 0.46 $ 0.29 $ 1.12 $ (3.17 )
Weighted average shares - basic 458,834 456,509 459,332 437,206
Weighted average shares - diluted 467,057 468,891 467,469 437,206
September30,2009 December31,2008
Balance sheet items:
Cash, cash equivalents & marketable securities $ 2,764,448 $ 2,222,091
Total assets 5,082,286 4,445,270
Stockholders' equity 4,109,099 3,491,328
Celgene Corporation and Subsidiaries
Reconciliation of GAAP to Non-GAAP Net Income (Loss)
(In thousands, except per share data)
Three Months EndedSeptember30, Nine Months EndedSeptember 30,
2009 2008 2009 2008
Net income (loss) - GAAP $ 216,815 $ 136,814 $ 522,532 $ (1,384,391 )
Before tax adjustments:
Net product sales:
Pharmion products to be divested (1) (2,902 ) (5,725 ) (9,367 ) (12,153 )
Cost of goods sold (excluding amortization of acquired intangible assets):
Share-based compensation expense (2) 1,331 668 3,304 1,829
Pharmion inventory step-up (3) - 7,545 354 18,668
Pharmion products to be divested (1) 1,127 2,450 5,395 5,014
EntreMed intercompany royalty (4) (197 ) (398 ) (197 ) (398 )
Research and development:
Share-based compensation expense (2) 15,178 10,964 44,841 32,264
Upfront collaboration payments (5) - - 34,500 45,000
Selling, general and administrative:
Share-based compensation expense (2) 20,167 16,596 56,384 41,557
Amortization of acquired intangible assets (6) 21,111 32,833 67,403 77,842
Acquired in-process research and development (7) - - - 1,740,000
Equity in losses of affiliated companies:
Equity in losses of EntreMed (8) 321 763 980 2,821
Net income tax adjustments (9) (13,115 ) (16,638 ) (45,119 ) (50,191 )
Net income - non-GAAP $ 259,836 $ 185,872 $ 681,010 $ 517,862
Per common share -non-GAAP:
Net income - basic $ 0.57 $ 0.41 $ 1.48 $ 1.18
Net income - diluted (10) $ 0.56 $ 0.40 $ 1.46 $ 1.13
Explanation of adjustments: A service of YellowBrix, Inc.
