Exhibit 99.2
CELGENE
3RD QUARTER 2004 CONFERENCE CALL
OCTOBER 21, 2004
BOB HUGIN:
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THANK YOU. GOOD MORNING, I AM BOB HUGIN, CELGENE'S CHIEF FINANCIAL OFFICER.
THANK YOU FOR JOINING US TODAY. WITH ME THIS MORNING ARE JOHN JACKSON OUR
CHAIRMAN AND CHIEF EXECUTIVE OFFICER AND SOL BARER, CELGENE'S PRESIDENT AND
CHIEF OPERATING OFFICER.
WE WILL DISCUSS OUR THIRD QUARTER OPERATING AND FINANCIAL RESULTS AND REVIEW OUR
2004 FINANCIAL OUTLOOK. BEFORE WE BEGIN, I WILL REVIEW OUR SAFE HARBOR
STATEMENT.
CERTAIN STATEMENTS MADE DURING THIS CONFERENCE CALL MAY BE FORWARD LOOKING AND
ARE MADE PURSUANT TO THE SAFE HARBOR PROVISIONS OF THE SECURITIES AND LITIGATION
REFORM ACT OF 1995.
SUCH STATEMENTS INVOLVE RISKS AND UNCERTAINTIES, AS WELL AS, ESTIMATES AND
PROJECTIONS, WHICH MAY CAUSE RESULTS TO DIFFER MATERIALLY FROM THOSE SET FORTH
IN THESE STATEMENTS.
IN ADDITION, THE ECONOMIC, COMPETITIVE, GOVERNMENTAL, TECHNOLOGICAL, AND OTHER
FACTORS IDENTIFIED IN THE COMPANY'S FILINGS WITH THE SECURITIES AND EXCHANGE
COMMISSION REFERRED TO IN THE PRESS RELEASE ISSUED THIS MORNING COULD AFFECT
SUCH RESULTS.
WE ARE PLEASED TO ANNOUNCE TODAY THAT WE HAVE ACQUIRED ALL OF THE OUTSTANDING
SHARES OF PENN T, THE UK BASED MANUFACTURER OF THALOMID FROM A CONSORTIUM OF
INVESTORS FOR APPROXIMATELY 110 MILLION DOLLARS IN CASH. THIS ACQUISITION
EXPANDS OUR CORPORATE CAPABILITIES AND ENABLES US TO CONTROL MANUFACTURING FOR
THALOMID WORLDWIDE. THROUGH MANUFACTURING CONTRACTS ACQUIRED IN THIS PURCHASE,
WE SIGNIFICANTLY INCREASE OUR PARTICIPATION IN THE POTENTIAL GROWTH OF THALOMID
REVENUE IN KEY INTERNATIONAL MARKETS. WE EXPECT THIS TRANSACTION TO BE 5 TO 10
CENTS ACCRETIVE IN 2005.
NOW, LET ME REVIEW THE FINANCIAL HIGHLIGHTS OF OUR THIRD QUARTER AND UPDATE YOU
ON OUR FINANCIAL OUTLOOK FOR THE REMAINDER OF 2004.
THE RESULTS FOR THE QUARTER WERE EXCELLENT.
TOTAL REVENUE FOR THE THIRD QUARTER WAS 101.5 MILLION DOLLARS, ECLIPSING $100
MILLION FOR THE FIRST TIME, AN INCREASE OF OVER 36 PERCENT COMPARED TO TOTAL
REVENUE IN THE THIRD QUARTER OF 2003. AND AN INCREASE OF 15.6 PERCENT OVER
SECOND QUARTER OF THIS YEAR.
THALOMID SALES CONTRIBUTED SIGNIFICANTLY TO THIS STRONG PERFORMANCE, INCREASING
37 PERCENT OVER THE YEAR AGO QUARTER.
REVENUES WERE ALSO POSITIVELY IMPACTED BY THE RECOGNITION OF THE 7.5 MILLION
DOLLAR MILESTONE FROM NOVARTIS FOR THE SUBMISSION OF THE NEW DRUG APPLICATION
FOR THE LONG ACTING VERSION OF FOCALIN NOW CALLED FOCALIN XR.
DURING THE QUARTER WE INVESTED 40.2 MILLION DOLLARS IN RESEARCH AND DEVELOPMENT
AN AMOUNT THAT REPRESENTS CLOSE TO 40 PERCENT OF TOTAL REVENUE.
THIS LEVEL OF R&D SPENDING REFLECTS AN INCREASE OF APPROXIMATELY 22 PERCENT FROM
THE YEAR AGO QUARTER AND DEMONSTRATES OUR CONTINUING COMMITMENT TO DEVELOP OUR
HIGH-POTENTIAL PORTFOLIO OF ASSETS.
FOR THE THIRD QUARTER, WE REPORTED NET INCOME OF 21.3 MILLION DOLLARS OR 24
CENTS PER DILUTED SHARE FOUR CENTS ABOVE CONSENSUS. THIS REPRESENTS OUR SEVENTH
CONSECUTIVE QUARTER OF INCREASING PROFITS, AND WE BELIEVE THAT THESE RESULTS
PROVIDE A SOLID FOUNDATION FOR ACHIEVING OR SURPASSING OUR FULL YEAR 2004
FINANCIAL OBJECTIVES. PLEASE NOTE THAT BEGINNING THIS COMING MONDAY CELGENE
STOCK WILL TRADE ON A TWO-FOR-ONE POST SPLIT BASIS AND ALL FUTURE REPORTS WILL
REFLECT THE STOCK SPLIT.
OUR STRENGTHENED BALANCE SHEET REMAINS A VALUABLE ASSET WITH CASH AND MARKETABLE
SECURITIES TOTALING NEARLY 800 MILLION DOLLARS AT QUARTER END. WITH THE EXERCISE
OF OUR PHARMION WARRANTS IN SEPTEMBER, THIS TOTAL NOW INCLUDES OUR COMPLETE 1.9
MILLION SHARE INVESTMENT IN PHARMION CORPORATION.
WE ARE VERY PLEASED WITH THE RESULTS FOR THE QUARTER AND FOR THE OUTLOOK FOR THE
REMAINDER OF THE YEAR. WITH THIS VERY SUCCESSFUL QUARTER BEHIND US, LET ME NOW
UPDATE YOU ON OUR FINANCIAL OUTLOOK. WE BELIEVE THAT WE ARE ON TRACK TO ACHIEVE
OR EXCEED THE GROWTH IN PROFITABILITY THAT WE OUTLINED LAST QUARTER. IN FACT,
WITH THE POSITIVE BOTTOM LINE RESULTS IN THE QUARTER, WE ARE RAISING OUR FULL
YEAR EARNINGS PER SHARE TARGET TO A RANGE OF 60 TO 65 CENTS PER DILUTED SHARE UP
FROM OUR UPWARDLY REVISED SECOND QUARTER GUIDANCE OF 50 TO 60 CENTS PER DILUTED
SHARE.
BASED ON STRONG THIRD QUARTER THALOMID SALES WE ARE RAISING OUR THALOMID TARGETS
FOR THE YEAR TO 305 TO 310 MILLION DOLLARS FROM PRIOR GUIDANCE OF 295 TO 305
MILLION DOLLARS. WE WILL CONTINUE TO EXAMINE THE POTENTIAL IMPACT OF NEW
CLINICAL DATA PRESENTED AT MAJOR MEDICAL MEETINGS, THE COMPETITIVE LANDSCAPE,
THE PRICING ENVIRONMENT AND OTHER POSSIBLE REVENUE DRIVERS WHEN WE AGAIN REVIEW
OUR TARGETS FOR 2005.
WE BELIEVE THAT WE ARE ON TRACK TO ACHIEVE OUR KEY 2004 FINANCIAL OBJECTIVES AND
ARE NOT MAKING ANY OTHER CHANGES TO OUR FINANCIAL GUIDANCE FOR THE YEAR. LET ME
NOW TURN THE CALL OVER TO SOL FOR HIS PERSPECTIVE ON THESE EXCELLENT RESULTS.
SOL BARER:
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THANKS BOB. THE RESULTS OF THE QUARTER WERE VERY STRONG ACROSS ALL AREAS OF OUR
BUSINESS. TOTAL REVENUE FOR THE QUARTER TOTALED MORE THAN $100 MILLION FOR THE
FIRST TIME DRIVEN IN LARGE PART BY THALOMID SALES AND THE $7.5 MILLION MILESTONE
RECEIVED UPON THE SUBMISSION OF THE NEW DRUG APPLICATION FOR THE LONG ACTING
FOCALIN XR BY NOVARTIS.
THALOMID CONTINUES TO BE THE MOST WIDELY PRESCRIBED DRUG FOR MULTIPLE MYELOMA
WITH USE IN ALL LINES OF THERAPY INCLUDING MAJOR USE IN THE IMPORTANT NEWLY
DIAGNOSED PATIENT POPULATION WHICH COMPRISES HALF OF ALL MYELOMA PATIENTS. IN
FACT, THIRD PARTY RESEARCH INDICATES THAT THALOMID HAS CONTINUED TO TAKE
INCREASED SHARE IN THE THIRD QUARTER IN THIS IMPORTANT SEGMENT OF PATIENTS.
DURING THE QUARTER WE AGAIN WITNESSED A RECORD NUMBER OF PRESCRIBERS AND
PATIENTS ENROLLED IN OUR PROPRIETARY STEPS PROGRAM.
THALOMID REVENUE CONTINUES TO BENEFIT FROM THE GROWING BODY OF CLINICAL DATA
RESULTING FROM INCREASED NUMBERS OF PEER REVIEWED PUBLICATIONS AND PRESENTATIONS
AT MAJOR MEDICAL MEETINGS: INCLUDING THE INTERIM DATA FROM THE ECOG TRIAL
PRESENTED AT ASCO THAT COMPARED THALOMID AND DEXAMETHASONE VERSUS DEXAMETHASONE
ALONE AS INDUCTION THERAPY FOR NEWLY DIAGNOSED MULTIPLE MYELOMA PATIENTS. THE
INTERIM DATA FOR THIS TRIAL WAS INCLUDED IN OUR SNDA FOR THALOMID. THIS TRIAL
WAS COMPLETED DURING THE QUARTER AND WE ANTICIPATE THAT THIS VERY IMPORTANT
COMPLETE DATA SET WILL BE PRESENTED AT ASH.
WE WILL SOON REACH THE PDUFA DATE FOR THE SNDA FOR THALOMID IN MULTIPLE MYELOMA
AND THE FULL RANGE OF OUTCOMES IS POSSIBLE. GIVEN THE IMPORTANCE OF THE FINAL
VS. THE INTERIM ECOG DATA IN NEWLY DIAGNOSED PATIENTS AND OUR ONGOING
DISCUSSIONS WITH THE FDA IT IS LIKELY THAT WE WILL SHORTLY RECEIVE AN APPROVABLE
LETTER WITH THE EXPECTATION THAT THE EXISTING ECOG INTERIM DATA IN THE FILING BE
AUGMENTED BY THE NOW COMPLETED DATA SET OFFERING THE POTENTIAL FOR THE INCLUSION
OF NEWLY DIAGNOSED MYELOMA IN THE LABEL. ADDITIONALLY THERE WOULD BE A PHASE IV
COMITTMENT TO COMPLETE OUR ONGOING PHASE III SPA THAL TRIAL IN NEWLY DIAGNOSED
PATIENTS. IF THIS WERE TO BE THE CASE, IT WOULD LIKELY ADD APPROXIMATELY SIX TO
NINE MONTHS TO THE APPROVAL TIMELINE. AGAIN WHILE WE HAVE NOT RECEIVED ANY
OFFICIAL GUIDANCE WE WANTED TO GIVE YOU OUR UP TO DATE SENSE OF THE SITUATION.
WE EXPECT IMPORTANT DATA FROM A NUMBER OF TRIALS WILL BE PRESENTED AT THE
CHEMOTHERAPY FOUNDATION MEETING IN EARLY NOVEMBER AND AT ASH IN EARLY DECEMBER.
THE NEW DATA ENCOMPASSES BOTH SOLID TUMORS, HEMATOLOGICAL MALIGNANCIES AND OF
COURSE MULTIPLE MYELOMA INCLUDING THE LANDMARK EUROPEAN ORAL THERAPY STUDY
COMPARING MELPHALAN PREDNISONE THALOMID AND MELPHALAN PREDNISONE IN NEWLY
DIAGNOSED PATIENTS. BASED ON THE NEW DATA COMBINED WITH THE ONGOING TRENDS IT IS
OUR EXPECTATION THAT WE WILL HAVE A STRONG 4TH QUARTER AND A ROBUST 2005 IN
TERMS OF THALOMID REVENUES.
WE REMAIN COMMITTED TO PROVIDE THALOMID TO THOSE UNABLE TO AFFORD IT. DURING THE
QUARTER WE PROVIDED FREE DRUG TO APPROXIMATELY 17 PERCENT OF ALL PATIENTS. WE
ARE ALSO ASSISTING NEW PATIENTS WHENEVER APPROPRIATE TO ENROLL IN THE MEDICARE
DEMONSTRATION PROGRAM AND ARE READYING OUR PROGRAMS TO ASSIST ALL ELIGIBLE
SENIORS IN ENROLLING IN THE PRESCRIPTION DRUG BENEFIT THAT WILL COME ON LINE IN
JANUARY OF 2006 UNDER THE MEDICARE REFORM ACT OF 2003.
BEFORE MOVING ON, I WANT TO NOTE THAT WE ARE VERY PROUD OF THE PROPRIETARY STEPS
SYSTEM THAT WE CREATED TO ENSURE THE SAFE DISTRIBUTION OF THALOMID. THIS SYSTEM
HAS BECOME THE STANDARD FOR SAFELY DISTRIBUTING THERAPEUTICS THAT OFFER
SIGNIFICANT CLINICAL BENEFIT BUT HAVE A SERIOUS SIDE EFFECT PROFILE. UNDER THE
STEPS PROGRAM OVER THE PAST 6 YEARS, THALOMID HAS BEEN ADMINISTERED TO OVER
100,000 PATIENTS.
S.T.E.P.S. HAS ALSO BEEN CITED AS THE MODEL DISTRIBUTION SYSTEM ON A NUMBER OF
OCCASIONS, INCLUDING AN FDA ADVISORY COMMITTEE. WE ARE NOW IN DISCUSSIONS WITH A
NUMBER OF COMPANIES TO LICENSE OUR STEPS INTELLECTUAL PROPERTY FOR USE WITH
DRUGS THAT REQUIRE CONTROLLED DISTRIBUTION.
THE ACCELERATED DEVELOPMENT OF OUR PROPRIETARY AND UNENCUMBERED PIPELINE, WHICH
WE BELIEVE TO BE AMONG THE MOST PROMISING IN THE BIOTECH INDUSTRY, HAS BEEN AND
CONTINUES TO BE AN IMPORTANT CORPORATE OBJECTIVE, AND WE INTEND TO CONTINUE
COMMITTING THE R&D INVESTMENT NEEDED TO MAKE IT POSSIBLE. THIS PAST QUARTER WE
INVESTED APPROXIMATELY 40 PERCENT OF OUR REVENUE BACK INTO R AND D, TO MAXIMIZE
TO THE GREATEST EXTENT POSSIBLE THE VALUE OF OUR PROMISING PROGRAMS.
THOUGH WE ARE INDEED FORTUNATE TO HAVE MULTIPLE IMPORTANT PROGRAMS, THERE IS NO
HIGHER CORPORATE PRIORITY THAN THE DEVELOPMENT OF REVLIMID. WE BELIEVE THAT THIS
PRODUCT MAY OFFER TRANSFORMING POTENTIAL, HOPEFULLY CHANGING THE STANDARD OF
CARE, FOR PATIENTS WITH BLOOD DISORDERS AND OTHER CANCERS.
LET ME NOW UPDATE YOU ON OUR PROGRESS WITH REVLIMID.
WE HAVE INITIATED 27 CLINICAL TRIALS TO EVALUATE REVLIMID FOR THE TREATMENT OF A
BROAD RANGE OF DISEASES INCLUDING NEWLY DIAGNOSED MULTIPLE MYELOMA,
MYELODYSPLASTIC SYNDROMES, PROSTATE CANCER, NON-SMALL CELL LUNG CANCER,
LYMPHOMA, OVARIAN CANCER, PANCREATIC CANCER, RENAL CELL CARCINOMA,
MYELOFIBROSIS, METASTATIC MELANOMA AND OTHERS.
EXCELLENT PROGRESS IS BEING MADE IN ADVANCING INDEPENDENT STUDIES OF REVLIMID AS
A MONOTHERAPHY OR IN COMBINATION THERAPY AS A POTENTIAL TREATMENT FOR NEWLY
DIAGNOSED MULTIPLE MYELOMA PATIENTS. THESE CLINICAL PROGRAMS ARE LARGE
CONTROLLED RANDOMIZED STUDIES SPONSORED BY THE MAJOR COOPERATIVE ONCOLOGY GROUPS
SUCH AS SOUTHWEST ONCOLOGY GROUP, THE EASTERN COOPERATIVE ONCOLOGY GROUP AND THE
CANCER AND LEUKEMIA GROUP B AND ARE FUNDED BY THE NCI.
THE SWOG STUDY IS A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED TRIAL
COMPARING DEXAMETHASONE TO THE COMBINATION OF DEXAMETHASONE PLUS REVLIMID IN
PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA. THIS TRIAL IS EXPECTED TO ENROLL
APPROXIMATELY 500 PATIENTS AND SHOULD BEGIN IN NOVEMBER.
THE ECOG STUDY IS A RANDOMIZED PHASE III STUDY OF REVLIMID PLUS DEXAMETHASONE
VERSUS REVLIMID PLUS LOW DOSE DEXAMETHASONE IN MULTIPLE MYELOMA WITH
THALOMID/DEXAMETHASONE SALVAGE THERAPY FOR NON-RESPONDERS. PATIENTS WHO DO NOT
RESPOND TO THE REVLIMID/DEXAMETHASONE COMBINATION WILL BE GIVEN
THALOMID/DEXAMETHASONE SALVAGE THERAPY. THIS TRIAL WILL HOPEFULLY DETERMINE AN
OPTIMAL DOSE OF DEXAMETHASONE THAT CAN BE USED IN NEWLY DIAGNOSED MULTIPLE
MYELOMA AS WELL AS DETERMINING WHETHER THALOMID CAN BE USED AS A SALVAGE
TREATMENT FOR REVLIMID FAILURES. THIS TRIAL IS EXPECTED TO ENROLL MORE THAN 400
PATIENTS AND TO BEGIN SHORTLY.
THE CANCER AND LEUKEMIA GROUP B (CALGB) STUDY IS A PHASE III RANDOMIZED,
DOUBLE-BLIND, PLACEBO CONTROLLED STUDY OF MAINTENANCE THERAPY WITH REVLIMID OR
PLACEBO FOLLOWING AUTOLOGUS STEM CELL TRANSPLANTATION FOR MULTIPLE MYELOMA THIS
TRIAL IS EXPECTED TO ENROLL MORE THAN 600 PATIENTS AND IS EXPECTED TO BEGIN END
OF OCTOBER. SHOULD THE RESULTS BE POSITIVE THIS STUDY MAY BROADEN THE LONG-TERM
USE OF REVLIMID.
ADDITIONALLY, CLINICAL INVESTIGATORS FROM LEADING CANCER RESEARCH CENTERS WILL
REPORT DATA FROM RECENT AND ON-GOING CLINICAL TRIALS OF THALOMID, REVLIMID,
ACTIMID AND ALKERAN IN A BROAD RANGE OF CANCERS AT BOTH THE
ANNUAL MEETING OF THE AMERICAN SOCIETY OF HEMATOLOGY (ASH), THE LARGEST
HEMATOLOGY MEETING IN THE WORLD, IN EARLY DECEMBER AND THE CHEMOTHERAPY
FOUNDATION SYMPOSIUM IN NOVEMBER. THE PRESENTATIONS WILL REPORT INFORMATION ON
POTENTIAL CLINICAL ACTIVITY OF OUR COMPOUNDS IN A WIDE RANGE OF HEMATOLOGICAL
AND SOLID TUMOR CANCERS, INCLUDING; NEWLY DIAGNOSED MULTIPLE MYELOMA,
MYELODYSPLASTIC SYNDROMES, 5Q MINUS CHROMOSOMAL ABNORMALITIES, RENAL CELL
CARCINOMA AND PANCREATIC CANCER.
I'LL NOW PROVIDE AN UPDATE OF THE STATUS OF OUR REGULATORY EFFORTS FOR REVLIMID.
LET ME START WITH OUR PHASE III PIVOTAL SPECIAL PROTOCOL ASSESSMENT MULTIPLE
MYELOMA PROGRAM WHICH IS THE BACKBONE OF OUR REGULATORY STRATEGY. THIS PROGRAM
WITH OVER 600 PATIENTS EVALUATES REVLIMID PLUS DEXAMETHASONE VERSUS
DEXAMETHASONE ALONE FOR THE TREATMENT OF RELAPSED OR REFRACTORY MYELOMA PATIENTS
IN THE U.S. AND EUROPE.
THE PRIMARY ENDPOINT OF THESE TRIALS IS TIME TO DISEASE PROGRESSION. BASED ON
THIS END POINT, WE EXPECT TRIAL COMPLETION IN THE SECOND QUARTER OF 2005. THE
FDA HAS GRANTED REVLIMID FAST TRACK DESIGNATION IN MULTIPLE MYELOMA, WHICH
SHOULD RESULT IN A SIX-MONTH REVIEW ASSUMING OF COURSE POSITIVE DATA.
THOUGH THE PHASE III SPA MYELOMA TRIAL REMAINS THE KEY REGULATORY TRACK FOR
REVLIMID, WE ARE ADVANCING OUR PHASE II TRIALS THAT MAY HAVE THE POTENTIAL TO
LEAD TO EARLIER REGULATORY APPROVAL. WE HAVE FULLY ENROLLED IMPORTANT PHASE II
TRIALS IN RELAPSED/REFRACTORY MYELOMA, IN MYELODYSPLASTIC SYNDROMES INCLUDING A
TRIAL EXAMINING REVLIMID IN MDS PATIENTS WITH 5Q MINUS CHROMOSOMAL
ABNORMALITIES.
WE ANNOUNCED IN SEPTEMBER THAT BASED ON CONSTRUCTIVE AND ONGOING DISCUSSIONS
WITH THE FDA, WE INTEND TO SUBMIT A NEW DRUG APPLICATION BASED ON THE RESULTS OF
THE 5Q MINUS TRIAL. THIS TRIAL ENROLLED MORE THAN 140 TRANSFUSION DEPENDENT
PATIENTS WITH THE 5Q MINUS CHROMOSOME INDICATION AND WILL INCLUDE DATA FROM THE
APPROXIMATELY 210 PATIENTS IN THE GENERAL MDS TRIAL. WE ARE ALSO FINALIZING THE
DETAILS WITH THE FDA OF THE SPECIFIC SAFETY DATA TO BE INCLUDED IN THE
SUBMISSION. BASED ON THE DATA THAT WE EXPECT TO INCLUDE IN THE PACKAGE, WE
ESTIMATE THE SUBMISSION OF THE FILING WILL BE COMPLETED SOME TIME IN THE FIRST
QUARTER. THOUGH WE ARE VERY ENCOURAGED BY THE CLINICAL RESULTS, THE
ACCEPTABILITY OF THIS DATA FROM PHASE II OPEN LABEL TRIALS AS A BASIS OF AN NDA
WILL DEPEND ON THE FDA'S FINAL JUDGMENT AS TO COMPELLING NATURE OF THE DATA.
AT ASH WE WILL PROVIDE AN UPDATE ON OUR OVERALL PROGRESS WITH REVLIMID. WE
EXPECT PRESENTATIONS ON THE USE OF REVLIMID IN NEWLY DIAGNOSED AS WELL AS
RELAPSED AND REFRACTORY MULTIPLE MYELOMA AND OTHER HEMATOLOGICAL CONDITIONS,
WHICH MAY INCLUDE OF COURSE TOP-LINE DATA ON THE REVLIMID MYELODYSPLASTIC
SYNDROME TRIALS.
WE ARE ALSO MAKING PROGRESS REGARDING OUR EUROPEAN STRATEGY FOR REVLIMID IN
DISCUSSIONS WITH THE EUROPEAN AND JAPANESE REGULATORY AUTHORITIES INCLUDING THE
DESIGN AND INITIATION OF ANY ADDITIONAL TRIALS. AS THE REGULATORY TIMELINE IS
IDENTIFIED WE WILL OUTLINE OUR COMMERCIAL STRATEGY IN ACCESSING MARKETS OUTSIDE
THE U.S.
OUR EARLIER STAGE PIPELINE ALSO INCLUDES A NUMBER OF INNOVATIVE PROGRAMS THAT
CONTINUE TO MAKE SIGNIFICANT PROGRESS. OUR LEAD PDE4/TNF ALPHA INHIBITOR
CC-10004 IS IN A PHASE II RANDOMIZED CONTROLLED TRIAL FOR EXERCISE INDUCED
ASTHMA AND SHORTLY WILL BE IN A PHASE II TRIAL FOR PSORIASIS. OUR STRATEGY IS TO
EVALUATE THIS COMPOUND IN A NUMBER OF INDICATIONS IN WHICH TNF ALPHA AND PDE 4
INHIBITORS HAVE SHOWN ACTIVITY.
OUR NEWEST IMID, CC-11006 (A POTENT TNF ALPHA INHIBITOR) IS COMPLETING ITS
INITIAL PHASE I DOSE-ESCALATING STUDY IN HEALTHY HUMAN VOLUNTEERS IN THE U.K. WE
EXPECT CC-11006 TO TARGET ANTI-INFLAMMATORY INDICATIONS BASED ON OUR
STRUCTURE-ACTIVITY RELATIONSHIP STUDIES AND PRECLINICAL MODELS. FOLLOWING THE
SUCCESSFUL COMPLETION OF THIS PHASE I CLINICAL STUDY, A SECOND PHASE I
MULTI-DOSE STUDY WILL BE PERFORMED.
CC-8490 OUR LEAD INVESTIGATIONAL COMPOUND FROM OUR BENZOPYRAN PROGRAM IS
PROGRESSING IN THE CLINIC IN A PHASE I/II GLIOBLASTOMA TRIAL AT THE NATIONAL
CANCER INSTITUTE. WE EXPECT DATA FROM THE TRIAL IN THE SECOND HALF OF 2005.
EXCELLENT PROGRESS CONTINUES TO BE MADE WITH OUR KINASE, LIGASE AND TUBULIN
INHIBITOR PROGRAMS AS WELL AS IN THE IDENTIFICATION OF NEW IMIDS TO COMPLEMENT
REVLIMID, ACTIMID AND CC-11006.
FINALLY, AS YOU MAY KNOW, CELGENE IS ALSO A LEADER IN THE EXCITING AREA OF
PLACENTAL STEM CELL RESEARCH. THESE ARE STEM CELLS, HARVESTED FROM A
NON-CONTROVERSIAL SOURCE. RESEARCH ON OUR CELLS IS PROCEEDING OR BEING INITIATED
WITH LEADING INSTITUTIONS SUCH AS THE HUTCHINSON CANCER RESEARCH CENTER AND THE
TEXAS HEART INSTITUTE IN THE AREAS OF CARDIAC REPAIR, WOUND HEALING, SPINAL CORD
INJURY, REGENERATIVE INDICATIONS, SICKLE CELL ANEMIA AND OF COURSE HEMATOPOIETIC
RECONSTITUTION. ADDITIONALLY IMPORTANT RESEARCH IS BEING PERFORMED INTO THE
BIOLOGY, IMMUNOLOGY, SIGNALING AND EXPANSION OF STEM CELLS TO ESTABLISH THE
SOLID SCIENTIFIC AND INTELLECTUAL PROPERTY FOUNDATION FOR US TO BECOME THE
LEADER IN THIS AREA.
I AM VERY PLEASED WITH THE PROGRESS THAT WE MADE IN ALL AREAS OF OUR COMPANY
DURING THE QUARTER. LET ME NOW TURN THE CALL OVER TO JOHN.
JOHN JACKSON:
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JOHN JACKSON: THANK YOU, SOL AND GOOD MORNING EVERYONE. WE ARE PLEASED WITH
THE EXCELLENT PROGRESS ACHIEVED DURING THE THIRD QUARTER. OUR COMMERCIAL
FRANCHISE CONTINUES TO PRODUCE SUPERIOR FINANCIAL RESULTS ENABLING US TO INVEST
IN THE DEVELOPMENT OF OUR KEY PIPELINE PROGRAMS. I AM PLEASED THAT WE HAVE
ACHIEVED OUR SEVENTH CONSECUTIVE QUARTER OF INCREASING PROFITABILITY.
THERE CONTINUES TO BE MULTIPLE OPPORTUNITIES THAT OFFER THE POTENTIAL FOR
SUBSTANTIAL ADDITIONAL REVENUE GROWTH. DURING THE FOURTH QUARTER WE EXPECT THAT
NEW DATA HIGHLIGHTING OUR LEAD PRODUCTS THALOMID, REVLIMID, ACTIMID AND ALKERAN
WILL BE PRESENTED AT UPCOMING MAJOR MEDICAL MEETINGS. IMPORTANTLY, THESE STUDIES
WILL INCLUDE MATURE DATA FROM THE ECOG PHASE III THALOMID/DEXAMETHASONE STUDY IN
NEWLY DIAGNOSED MULTIPLE MYELOMA, WHERE INTERIM DATA WAS PRESENTED AT ASCO THIS
PAST JUNE, AS WELL AS OTHER CLINICAL STUDIES REPORTING RESULTS WITH OUR PRODUCTS
IN NEWLY DIAGNOSED MULTIPLE MYELOMA.
THE MANY CLINICAL TRIALS STUDYING THALOMID'S POTENTIAL USEFULNESS IN A WIDE
RANGE OF INDICATIONS REFLECTS OUR COMMITMENT TO FULLY UNDERSTAND THE
LONG-TERM GLOBAL POTENTIAL OF THALOMID. ASSUMING AN APPROVABLE LETTER FROM THE
FDA WE ARE HOPEFUL WE WILL HAVE LABEL EXPANSION TO INCLUDE MULTIPLE MYELOMA
BASED ON THE ECOG TRIAL IN NEWLY DIAGNOSED PATIENTS.
I AM, OF COURSE, DELIGHTED THAT WE HAVE ANNOUNCED THIS MORNING THE ACQUISITION
OF THE PENN T OPERATION IN WALES. THIS TRANSACTION ACCOMPLISHES BOTH STRATEGIC
AND FINANCIAL GOALS. WE ARE BROADENING CORPORATE CAPABILITIES AND GAINING
STRATEGIC CONTROL OVER THE SUPPLY OF OUR LEAD COMMERCIAL PRODUCT. THIS OWNERSHIP
ENABLES US TO INCREASE OUR PARTICIPATION IN THE POTENTIAL GROWTH OF THALOMID
OVERSEAS AND IS EXPECTED TO BE ACCRETIVE TO EARNINGS.
WE ARE READYING OUR COMPANY TO TAKE FULL ADVANTAGE OF THE POTENTIAL OF REVLIMID,
LEVERAGING OUR COMMERCIAL ORGANIZATION, ADVANCING OUR STRATEGIES FOR
INTERNATIONAL COMMERCIALIZATION AND DEVELOPING CLINICAL PROGRAMS TO FULLY
SUPPORT A GLOBAL PRODUCT LAUNCH. OUR REGULATORY TEAM IS WORKING DILIGENTLY TO
SUPPORT ALL APPROVAL STRATEGIES BOTH IN THE U.S. AND INTERNATIONALLY.
OUR REVLIMID SPECIAL PROTOCOL ASSESSMENT PHASE III PIVOTAL PROGRAM IN MULTIPLE
MYELOMA REMAINS THE KEY COMPONENT OF OUR U.S. REGULATORY STRATEGY FOR POTENTIAL
APPROVAL IN LATE 2005, BUT WE PLAN TO BE FULLY PREPARED TO ADVANCE COMMERCIAL
TIMELINES IF WE ARE FORTUNATE TO HAVE APPROVAL ACCELERATED THROUGH OUR MDS 5 Q
MINUS FILING STRATEGY.
WE ARE OPTIMISTIC THAT CELGENE WILL CONTINUE THE COMMERCIAL, OPERATIONAL AND
REGULATORY MOMENTUM NEEDED TO ACCOMPLISH OUR MISSION, NAMELY, TO BECOME A HIGHLY
PROFITABLE, MULTI-NATIONAL COMPANY ADDRESSING MAJOR UNMET MEDICAL NEEDS IN THE
FIELDS OF CANCER AND INFLAMMATORY DISEASE.
WE BELIEVE THAT CELGENE IS WELL POSITIONED FOR SUCCESS AND THAT OUR REVENUE
GROWTH WILL ENABLE US TO DRIVE DEVELOPMENT OF OUR MULTIPLE COMPOUNDS WITH
PROMISING CLINICAL AND GLOBAL COMMERCIAL POTENTIAL. TO SUPPORT THIS ON-GOING
EFFORT, WE HAVE AN EXCEPTIONALLY ABLE AND EXPERIENCED TEAM. WE LOOK FORWARD TO
UPDATING YOU ON OUR CONTINUED PROGRESS. WE VALUE YOUR CONTINUING INTEREST AND
SUPPORT DURING THIS EXCITING TIME FOR CELGENE.
THANK YOU - OPERATOR PLEASE OPEN THE CALL TO QUESTIONS.