Q2 2017 Conference Call - s24.q4cdn.com€¦ · Q2 2017 Conference Call Mark Alles, Chief Executive...
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Q2 2017 Conference CallJuly 27, 2017
CHANGING THE COURSE OFHUMAN HEALTH THROUGH BOLD
PURSUITS IN SCIENCE
CHANGING THE COURSE OFHUMAN HEALTH THROUGH BOLD
PURSUITS IN SCIENCE
Q2 2017 Conference CallQ2 2017 Conference Call
Mark Alles, Chief Executive Officer
Terrie Curran, President, I&I
Scott Smith, President & Chief Operating Officer
Q&A
Michael Pehl, President, Hematology/Oncology
Peter Kellogg, Chief Financial Officer
2
Forward Looking Statements and Adjusted Financial InformationForward Looking Statements and Adjusted Financial Information
3
This presentation contains forward-looking statements, which are generally statements that are not historical facts.Forward-looking statements can be identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates,”“plans,” “will,” “outlook,” “targets” and similar expressions. Forward-looking statements are based on management’scurrent plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake noobligation to update any forward-looking statement in light of new information or future events, except as otherwiserequired by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predictand are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in ourAnnual Report on Form 10-K and our other reports filed with the Securities and Exchange Commission.
In addition to unaudited financial information prepared in accordance with U.S. GAAP, this presentation also containsadjusted financial measures. Further information relevant to the interpretation of adjusted financial measures, andreconciliations of these adjusted financial measures to the most comparable GAAP measures, may be found in theAppendix and on our website at www.Celgene.com in the “Investor Relations” section.
Mark AllesChief Executive Officer
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Strong H1 2017 Driven by Execution and Portfolio MomentumStrong H1 2017 Driven by Execution and Portfolio Momentum
Momentum from Commercial and Clinical Portfolio− Operational excellence across functions and geographies− Advanced clinical portfolio; 5 Ph III trials completed enrollment in Q2:17
Significant Pipeline Catalysts in Place− Ozanimod Ph III RMS data presentation in H2:17− Top-line data from 3 Ph III trials by YE:17: AUGMENTTM, RELEVANCE® and apact®
Adding Strategic Opportunities for Growth Beyond 2020− Positive ozanimod Ph III trials in RMS anchors emerging neuroscience platform− Collaboration with BeiGene for BGB-A317 expands and complements existing I/O platform
5
Peter KelloggChief Financial Officer
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Q2 2017 Financial HighlightsQ2 2017 Financial Highlights
Exceptional Operating Results− Q2:17 year-over-year net product sales grew 19% and adjusted diluted EPS grew 26%− Adjusted operating margins improved by 490 bps Y/Y
Strong Execution on Marketed Portfolio− Robust Q2 performance across the portfolio; OTEZLA® up 49% Y/Y, 48% Q/Q− Growth continues from volume; 16 of the 19 percentage points of net product sales growth
Balanced Capital Deployment− $507M in shares repurchased in Q2:17− Expanded oncology focus with BeiGene collaboration
7
2017 Adjusted EPS and Operating Margin Updated− 2017 adjusted diluted EPS raised from $7.15-$7.30 to $7.25-$7.35− Adjusted operating margin raised from ~57% to ~57.5%, +50 bps
Q2 2017 Total Net Product SalesQ2 2017 Total Net Product Sales
Q2:15 Q2:16 Q2:17
$2,254
$2,744
$3,256
$ M
illio
ns
↑22% ↑22% ↑19%
$0
$500
$1,000
$1,500
$2,000
$2,500
$3,000
Q2:16 Volume Price Fx /Hedge
Q2:17
↑18.7%↓0.7%↑15.9% ↑3.5%
Contribution to Q2:17 Total Net Product Sales Growth
$ M
illio
ns
Total Net Product Sales
8Footnote: Growth Rates = Growth vs. Prior Year PeriodCertain prior year amounts have been rounded +/- $1M to conform to the current year rounding convention.
Q2 2017 Adjusted Diluted Earnings Per ShareQ2 2017 Adjusted Diluted Earnings Per Share
$1.23
$1.44
$1.82
Q2:15 Q2:16 Q2:17
↑37% ↑17%
Dol
lars
Per
Sha
re
↑26%
Q2:16 Oper. Income
OIE Tax Rate Share Count
Q2:17
Dol
lars
Per
Sha
re
$1.82$0.46$1.44 ($0.01) ($0.02)($0.05)
9
Contribution to Q2:17 Adjusted Diluted EPSAdjusted Diluted EPS
Footnote: Growth Rates = Growth vs. Prior Year Period
Key P&L Line Items (Adjusted)Key P&L Line Items (Adjusted)
Q2:17 ∆ vs.Q2:16
∆ vs.Q1:17
Product Gross Margin 96.8% ↑50 bps ↑40 bps
R&D expenses% of revenue
$690M21.1% ↓70 bps ↑100 bps
SG&A expenses% of revenue
$532M16.3% ↓360 bps ↓190 bps
Operating Margin 59.5% ↑490 bps ↑140 bps
Effective Tax Rate 16.5% ↑30 bps NC
10
Cash and Marketable SecuritiesCash and Marketable Securities
Cash flow from operations was approximately $1.6B during Q2:17
In Q2:17, purchased $507M of shares– $3.9B remaining under existing stock repurchase program
(in Billions) 6/30/17 12/31/16
Cash and Marketable Securities $10.14 $7.97
11
Return On Invested Capital (ROIC): Focused on Efficient GrowthReturn On Invested Capital (ROIC): Focused on Efficient Growth
0.0%
5.0%
10.0%
15.0%
20.0%
25.0%
30.0%
35.0%
$0.0
$5.0
$10.0
$15.0
$20.0
$25.0
2009 2010 2011 2012 2013 2014 2015 2016 Q2 2017 (TTM)
Capital Base Excluding Cash* Capital Base ROIC Excluding Cash* ROIC
$ B
illio
n
Average Invested Capital
ROIC
*For purposes of this calculation, cash includes cash and cash equivalents and marketable securities available for sale.
Footnote: Financial performance is based on GAAP operating income adjusted to reflect amortization of certain charges excluded from 2008 calculation and tax impact. Calculation for 2015 includes expenses driven by the Juno Therapeutics and AstraZeneca collaborations and expenses incurred in connection with the acquisition of Receptos as well as the impact of the August 2015 debt issuance on the capital base. Refer to reconciliation tables for complete calculation methodology. Calculation revised in 2015 for all prior periods to reflect amortization of certain charges excluded from 2008 calculation.
12
Updating 2017 GuidanceUpdating 2017 Guidance
Previous Updated
Net Product Sales
REVLIMID® $8.0B-$8.3B Unchanged
POMALYST®/IMNOVID® ~$1.6B Unchanged
OTEZLA® $1.5B-$1.7B Unchanged
ABRAXANE® ~$1.0B Unchanged
Total Revenue $13.0B-$13.4B Unchanged
Adjusted Operating Margin ~57% ~57.5%
Adjusted Diluted EPS $7.15-$7.30 $7.25-$7.35
Weighted Average Diluted Shares ~815M Unchanged13
Michael PehlPresident, Hematology/Oncology
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Q2 2017 Hematology/Oncology Franchise ResultsQ2 2017 Hematology/Oncology Franchise Results
15
Strong Net Product Sales and Operating Momentum− Q2:17 net product sales growth of +16% Y/Y− Sales performance driven by strong uptake in key markets
2017 Growth Drivers On Track− Ongoing REVLIMID® NDMM NSCT launch and increasing use of approved triplets driving share and
duration around the globe− U.S. regulatory decision for IDHIFA® (enasidenib) in IDH2 mutant rrAML expected in August− Ph III data on REVLIMID® in indolent lymphoma and ABRAXANE® in adjuvant PanC by YE:17
Transformational Pipeline Advancing with Future Growth Drivers− Collaboration with BeiGene for BGB-A317 expands immuno-oncology portfolio− Early- and mid-stage pipeline continues to advance with pivotal programs beginning by YE:17
Current Results & Potential Future Growth Drivers
Q2 2017 REVLIMID® Net Sales Summary Q2 2017 REVLIMID® Net Sales Summary
• Q2:17 net sales $2,034M; +20% Y/Y, +8% Q/Q• Ongoing NDMM launch continues to advance
– REVLIMID® NDMM NSCT reimbursed in 22 countries– NDMM NSCT reimbursement in France now expected
in Q3:17• 2017 growth drivers on-track
Maintenance post-ASCT reimbursed in 7 countries; Market share in EU continues to grow
Increased adoption of triplet combinations in RRMM• Potential future growth drivers advancing
– Ph III AUGMENTTM & RELEVANCE® data expected YE:17
– Ph III ROBUST® trial completed enrollment; Data expected in 2018
– U.S. regulatory submission for RVd in 1st line transplant and non-transplant candidates moved to Q1:18
$716$872
$1,079$1,358
$497 $572
$621
$676
Q2:14 Q2:15 Q2:16 Q2:17
U.S. ROW
$1,213
$1,444
$1,700
$2,034
16
Net Sales ($M)
Certain prior year amounts have been rounded +/- $1M to conform to the current year rounding convention.
24%
0%
5%
10%
15%
20%
25%
30%
35%
Q1:15 Q2:15 Q3:15 Q4:15 Q1:16 Q2:16 Q3:16 Q4:16 Q1:17
Source: EU Q2:17 MM Patient Chart tracker topline shares
EU4
EU4 (FR, GER, SP, IT)
1st Line NSCT REVLIMID® New Patient Share –EU4 (France, Germany, Spain, Italy)
1st Line NSCT REVLIMID® New Patient Share –EU4 (France, Germany, Spain, Italy)
Germany Reimbursement
Spain Reimbursement
ItalyReimbursement
France Reimbursement Publication Expected
Q3:17
17
REVLIMID® Continues Uptake in 1st Line Non-Stem Cell Transplant Eligible Patients in EuropeREVLIMID® Continues Uptake in 1st Line Non-Stem Cell Transplant Eligible Patients in Europe
New
Pat
ient
Sha
re
Current Results & Potential Future Growth Drivers
Q2 2017 REVLIMID® Net Sales Summary Q2 2017 REVLIMID® Net Sales Summary
• Q2:17 net sales $2,034M; +20% Y/Y, +8% Q/Q• Ongoing NDMM launch continues to advance
– REVLIMID® NDMM NSCT reimbursed in 22 countries– NDMM NSCT reimbursement in France now expected
in Q3:17• 2017 growth drivers on-track
Maintenance post-ASCT reimbursed in 7 countries; Market share in EU continues to grow
Increased adoption of triplet combinations in RRMM• Potential future growth drivers advancing
– Ph III AUGMENTTM & RELEVANCE® data expected YE:17
– Ph III ROBUST® trial completed enrollment; Data expected in 2018
– U.S. regulatory submission for RVd in 1st line transplant and non-transplant candidates moved to Q1:18
$716$872
$1,079$1,358
$497 $572
$621
$676
Q2:14 Q2:15 Q2:16 Q2:17
U.S. ROW
$1,213
$1,444
$1,700
$2,034
18
Net Sales ($M)
Certain prior year amounts have been rounded +/- $1M to conform to the current year rounding convention.
Current Results & Potential Future Growth Drivers
Q2 2017 POMALYST®/IMNOVID® Net Sales SummaryQ2 2017 POMALYST®/IMNOVID® Net Sales Summary
$104$143
$185$241$57
$91
$133
$150
Q2:14 Q2:15 Q2:16 Q2:17
U.S. ROW
$161
$234
$318
$391
• Q2:17 net sales $391M; +23% Y/Y, +7% Q/Q• POMALYST®/IMNOVID® continues to be a backbone of
therapy in 3rd line+– POMALYST®/IMNOVID® has leading 3rd line share in
U.S. and EU– POMALYST® has leading 3rd line+ share in Japan
• 2017 growth drivers Duration trends increasing across all geographies FDA approval for daratumumab/POMALYST®
combination in RRMM• Potential future growth drivers advancing
Enrollment completed in Ph III OPTIMISMM® trial with POMALYST® in 2nd line+ MM; Data expected in 2018
POMALYST®/IMNOVID® combinations with other novel agents advancing
Net Sales ($M)
19Certain prior year amounts have been rounded +/- $1M to conform to the current year rounding convention.
Current Results & Potential Future Growth Drivers
Q2 2017 ABRAXANE® Net Sales SummaryQ2 2017 ABRAXANE® Net Sales Summary
$159 $170 $174 $161
$56 $75 $75 $93
Q2:14 Q2:15 Q2:16 Q2:17
U.S. ROW
$215
$245 $249 $254
Net Sales ($M)
20
• Q2:17 net sales $254M; +2% Y/Y, +8% Q/Q• 2017 growth drivers
Maintain leadership in first-line metastatic pancreatic cancer in U.S.
Continued share gains in metastatic pancreatic in EU• Potential future growth drivers advancing
Ph III apact® data for ABRAXANE® in adjuvant pancreatic cancer by YE:17
I/O combination trials in NSCLC, TNBC in 2018 Ongoing trials in support of potential label expansions in
pancreatic cancer, lung and breast cancer
Certain prior year amounts have been rounded +/- $1M to conform to the current year rounding convention.
BGB-A317 Expands a Robust I/O Portfolio For Hematology and OncologyBGB-A317 Expands a Robust I/O Portfolio For Hematology and Oncology
Hematologic Malignancies
BGB-A317(anti-PD-1)
Bi-Specific T Engager
CAR-TCells
PhagocytosisMacrophage
Immune Modulation
T Cell Checkpoint
Tri-Specific NK Engager
Preclinical Phase II Phase III MarketedPhase I
CC-90002(anti-CD47)
JCAR017(CD19)
bb2121(BCMA)
CC-93269(CD3xBCMA)Novel T-cell
engagers
Selected AML and MM Targets
CC-122CC-220
(CELMoD®)
JTX-2011(anti-ICOS)
OMP-313M32(anti-TIGIT)LYC-55716
(ROR Agonist)
CC-122(CELMoD®)
CC-90002(anti-CD47)
MSC-1(anti-LIF)
Novel Targets
Selected ST Targets
Solid Tumors
CAR-TCells
PhagocytosisMacrophage
Immune Modulation
T Cell Modulation
T Reg Depletion
T Cell Checkpoint
Immune Metabolism
Preclinical Phase II Phase III MarketedPhase I
Celgene has an exclusive option to license JTX-2011, LYC-55716 and OMP-313M32. IMNFINZITM is approved for solid tumors. 21
CC-92480(CELMoD®)
2017 Hematology/Oncology Franchise Outlook2017 Hematology/Oncology Franchise Outlook
22
Commercial Portfolio On Track to Deliver− REVLIMID® continues to show strong uptake and duration trends− POMALYST®/IMNOVID® momentum continues− ABRAXANE® in first-line metastatic PanC is the standard of care
Regulatory Catalysts and Late-Stage Trials Anchor Near-term Growth− REVLIMID® as maintenance therapy post-ASCT approved in U.S. and EU− U.S. regulatory decision for IDHIFA® (enasidenib) in IDH2 mutant rrAML expected in August− On track for Ph III readouts for AUGMENTTM, RELEVANCE® and apact® in H2:17
Mid- and Late-Stage Pipeline Advancing− Completed enrollment in ROBUST®, QUAZAR®, MEDALISTTM and BELIEVETM
− On-track for marizomib, bb2121, JCAR017, CC-122 and durvalumab pivotal programs by YE:17− BeiGene collaboration for solid tumor anti-PD-1
Terrie CurranPresident, I&I
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Q2 2017 I&I Franchise ResultsQ2 2017 I&I Franchise Results
Strong OTEZLA® Performance and Future Growth Drivers Advancing– OTEZLA® adoption increased significantly as global demand and access continue to strengthen– Launches underway in major European markets and Japan – Strengthening of U.S. leadership position in new-to-brand shares for both psoriasis and PsA– Completed enrollment of key lifecycle studies
Ozanimod Moving Forward– Preparing for regulatory submission to the FDA by YE:17– Advancing differentiated efficacy and safety profile– Robust life cycle plan in development
Advancing Development of the I&I Pipeline– Positive results from Ph II ozanimod trial in CD; pivotal trial plans in development– Strong execution of Ph III IBD trials: ozanimod in UC, and GED-0301 in CD
24
$217
$306
$24
$52
Q2:14 Q2:15 Q2:16 Q2:17
U.S. ROW
$90
$241
$358
Q2 2017 OTEZLA® Net Sales Summary Q2 2017 OTEZLA® Net Sales Summary
Net Sales ($M)
25
$85
$5
Current Results & Potential Future Growth Drivers
• Q2:17 net sales $358M; +49% Y/Y, +48% Q/Q• 2017 growth drivers
- Substantial growth in OTEZLA® utilization in the U.S. and international markets
- In France and Japan, uptake surpassing benchmarks• Potential future growth drivers advancing
- Ph III scalp psoriasis trial enrolling- Ph III RELIEF® trial in Behçet's completed enrollment- Ph II POC data in UC expected by YE:17
- 2017 OTEZLA® net sales guidance - $1.5B-$1.7B$5
Certain prior year amounts have been rounded +/- $1M to conform to the current year rounding convention.
Brand Fundamentals and Market Growth Driving Pickup of U.S. OTEZLA® SalesBrand Fundamentals and Market Growth Driving Pickup of U.S. OTEZLA® Sales
26
New-to-Brand Share – Psoriasis(Normalized Patient Equivalents)
OTEZLA®
40.3%
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
ENBREL STELARA HUMIRACOSENTYX OTEZLA TALTZAcitretin Methotrexate Cyclosporine
Source: SHS claims data through March 2017, last updated 26 May 2017; Symphony prescriber-level data through June 30, 2017Note: Symphony data subject to restatement; NTB includes patients initiating titration and bridge for OTEZLA®
OTEZLA®
21.7%
0%
5%
10%
15%
20%
25%
30%
35%
40%
Jan-
15Fe
b-15
Mar
-15
Apr-
15M
ay-1
5Ju
n-15
Jul-1
5Au
g-15
Sep-
15O
ct-1
5N
ov-1
5D
ec-1
5Ja
n-16
Feb-
16M
ar-1
6Ap
r-16
May
-16
Jun-
16Ju
l-16
Aug-
16Se
p-16
Oct
-16
Nov
-16
Dec
-16
Jan-
17Fe
b-17
Mar
-17
Apr-
17M
ay-1
7Ju
n-17
ENBREL STELARA HUMIRACOSENTYX OTEZLA TALTZ
U.S. Psoriasis Market Share
OTEZLA® Demonstrating Rapid Uptake in Recently Launched Markets OTEZLA® Demonstrating Rapid Uptake in Recently Launched Markets
France: Launch-Aligned New Patient Starts
1,020
2,115
3,003
0
500
1,000
1,500
2,000
2,500
3,000
3,500
m1 m2 m3 m4 m5 m6 m7
Stelara Taltz Cosentyx Otezla
Japan: New-to-Brand Switch (GP Derm Segment)
Source: Gers; Competitor IMS JPM, Otezla® Ex-W/S data; Apremilast KPI tracking survey, April 2017
69%
8%
7%
8%8%
40%
OTEZLA®
38%
4%
3% 8%8%
OTEZLA®
Launch
Topical Only
TIGASON Others
OTEZLA® NEORAL
Biologics
27
New
Pat
ient
Sta
rts
The Global MS Market is Valued at ~$22B However, Significant Unmet Needs and Opportunity RemainThe Global MS Market is Valued at ~$22B However, Significant Unmet Needs and Opportunity Remain
Injectables52%
Orals37%
Infusions11%
2016 MS Market – G7*
Source: Decision Resources. Pharmacor. 2016, EvaluatePharma, Company Earnings Reports*G7 includes U.S., Germany, France, Spain, Italy, UK and Japan
28
Unmet Needs in RMS
• Improved disease control
• Safe and well-tolerated oral options
• Therapies appropriate for long-term use
• Potential to halt and/or reverse disability
Emerging Ozanimod Profile Targets Significant Unmet Needs in RMSEmerging Ozanimod Profile Targets Significant Unmet Needs in RMS
Ozanimod
Reduction in GdE lesionsReduction in GdE lesions
Favorable Cardiac Profile
(HR, QTc)
Favorable Cardiac Profile
(HR, QTc)
Once-dailyOral DosingOnce-daily
Oral Dosing
Generally Well Tolerated
Generally Well Tolerated
Reduced Annualized
Relapse Rate
Reduced Annualized
Relapse Rate
Favorable HepatotoxFavorable Hepatotox
Disability Progression vs. AVONEX®
Disability Progression vs. AVONEX®
Reduction in Brain AtrophyReduction in
Brain Atrophy
Rapid Lymphocyte
Recovery
Rapid Lymphocyte
Recovery
29Ozanimod is an investigational compound that is not approved for use in any country.
Maximize the OTEZLA® PSOR/PsA Opportunity Strong brand fundamentals to drive continued positive momentum with increasing contribution
from international markets Continue to realize benefits of global access expansion Complete U.S. sNDA filing of QD formulation by YE:17 Accelerate enrollment of OTEZLA® Ph III trial in scalp psoriasis
Optimize the Ozanimod Opportunity File ozanimod U.S. NDA in RMS by YE:17 Continue launch-readiness activities Complete enrollment of Ph III trial in UC Prepare to initiate Ph III in CD
Advance Next Stage of Future Growth Catalysts− Ph II trial readouts from OTEZLA® in UC and GED-0301 in UC by YE:17− Continue to execute on the GED-0301 pivotal program in CD− Advance Ph II development of CC-220 in SLE and CC-90001 in IPF
2017 I&I Franchise Outlook 2017 I&I Franchise Outlook
30
Scott SmithPresident and Chief Operating Officer
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2017 Milestones2017 Milestones
Financial Performance Total Revenue $13.0B-$13.4B REVLIMID® net sales $8.0B-$8.3B POMALYST® net sales ~$1.6B OTEZLA® net sales $1.5B-$1.7B ABRAXANE® net sales ~$1.0B Adj. operating margin ~57.0%1 Adj operating margin ~57.5%2
Adj. EPS $7.15-$7.301 Adj EPS $7.25 to $7.352
Clinical Data Ph III apact® – ABRAXANE® in adjuvant PanC Ph III RELEVANCE® – REVLIMID® in 1st line FL Ph III AUGMENTTM – REVLIMID® in RR FL Ph III Ozanimod in multiple sclerosis (SUNBEAMTM and RADIANCETM)X Ph II CC-486 with fulvestrant in ER+ HER2- mBCX Ph II Demcizumab in NSCLC (DENALI)X Ph II Demcizumab in PanC (YOSEMITE) Ph II OTEZLA® in UC Ph II GED-0301 in UC Ph II STEPSTONETM - Ozanimod in CD Ph I/II Durvalumab in RRMM and 1st Line MDS and AML
Trial Enrollment Complete enrollment in Ph III CD-002 – GED-0301 in CD Complete enrollment in Ph III OPTIMISSM® trial
– POMALYST® in 2nd Line MM Complete enrollment in Ph III ROBUST® - REVLIMID® in DLBCL Complete enrollment in Ph III QUAZAR® - CC-486 in AML Complete enrollment in Ph III MEDALISTTM – Luspatercept in MDS Complete enrollment in Ph III BELIEVETM – Luspatercept in beta-thalassemia Complete enrollment in Ph III RELIEF® – OTEZLA® in Behçet’s Complete enrollment in Ph III TRUE NORTHTM – Ozanimod in UC
Regulatory Submissions/Decisions FDA decision of REVLIMID® in post-ASCT maintenance EU decision of REVLIMID® in post-ASCT maintenance Submit sNDA for RVd in NDMM Moved to Q1:18 FDA decision on IDHIFA® in IDH2-mutated AML Submit sNDA for OTEZLA® once-daily formulation Submit NDA for Ozanimod in RMS
Trial Initiations Initiate pivotal trial with CC-122 in DLBCL Initiate pivotal trial with bb2121 in RRMM Initiate pivotal program with JCAR017 in DLBCL Initiate Ph III trial with OTEZLA® in scalp PSOR Initiate Ph III trial with OTEZLA® in AS Moved to 2018X Initiate Ph III trial with RPC4046 in EoE Initiate pivotal trial with Marizomib in GBM Initiate Ph II trial with Luspatercept in myelofibrosis
R&ED File at least 8 IND’s
321. Updated April 2017 2. Updated July 2017
Strong Momentum. Approaching Inflection Point.Investing to Drive Growth Beyond 2020.Strong Momentum. Approaching Inflection Point.Investing to Drive Growth Beyond 2020.
Financial Performance Total Revenue $13.0B-$13.4B REVLIMID® net sales $8.0B-$8.3B POMALYST® net sales ~$1.6B OTEZLA® net sales $1.5B-$1.7B ABRAXANE® net sales ~$1.0B Adj. operating margin ~57.0%1 Adj operating margin ~57.5%2
Adj. EPS $7.15-$7.301 Adj EPS $7.25 to $7.352
Clinical Data Ph III apact® – ABRAXANE® in adjuvant PanC Ph III RELEVANCE – REVLIMID® in 1st line FL Ph III AUGMENT® – REVLIMID® in RR FL Ph III Ozanimod in multiple sclerosis (SUNBEAM and RADIANCE)X Ph II CC-486 with fulvestrant in ER+ HER2- mBCX Ph II Demcizumab in NSCLC (DENALI)X Ph II Demcizumab in PanC (YOSEMITE) Ph II OTEZLA® in UC Ph II GED-0301 in UC Ph II STEPSTONE - Ozanimod in CD Ph I/II Durvalumab in RRMM and 1st Line MDS and AML
Trial Enrollment Complete enrollment in Ph III CD-002 – GED-0301 in CD Complete enrollment in Ph III OPTIMISSM® trial
– POMALYST® in 2nd Line MM Complete enrollment in Ph III ROBUST® - REVLIMID® in DLBCL Complete enrollment in Ph III QUAZAR® - CC-486 in AML Complete enrollment in Ph III MEDALISTTM – Luspatercept in MDS Complete enrollment in Ph III BELIEVETM – Luspatercept in beta-thalassemia Complete enrollment in Ph III RELIEF® – OTEZLA® in Behçet’s Complete enrollment in Ph III TRUE NORTH – Ozanimod in UC
Regulatory Submissions/Decisions FDA decision of REVLIMID® in post-ASCT maintenance EU decision of REVLIMID® in post-ASCT maintenance Submit sNDA for RVd in NDMM Moved to Q1:18 FDA decision on IDHIFA® in IDH2-mutated AML Submit sNDA for OTEZLA® once-daily formulation Submit NDA for Ozanimod in RMS
Trial Initiations Initiate pivotal trial with CC-122 in DLBCL Initiate pivotal trial with bb2121 in RRMM Initiate pivotal program with JCAR017 in DLBCL Initiate Ph III trial with OTEZLA® in scalp PSOR Initiate Ph III trial with OTEZLA® in AS Moved to 2018X Initiate Ph III trial with RPC4046 in EoE Initiate pivotal trial with Marizomib in GBM Initiate Ph II trial with Luspatercept in myelofibrosis
R&ED File at least 8 IND’s
331. Updated April 2017 2. Updated July 2017
Increasing Momentum from Commercial Portfolio Volume driven growth across the portfolio REVLIMID® reaches quarterly sales of $2B Strong OTEZLA® performance 2017 Adjusted EPS and operating margin updated to reflect operational excellence
Inflection Points with Multiple Value Drivers Delivering Ozanimod positive top-line data in RMS; Advancing towards FDA filing by YE:17 Data from REVLIMID® lymphoma trials expected by YE:17 Preparing for IDHIFA® launch
Positioned for Growth Beyond 2020 from Distributed Research Model− Strategic collaboration for BeiGene augments I/O platform− Positive data with ozanimod in CD; Pivotal program in development− Pivotal programs for bb2121, JCAR017 and CC-122 advancing
Q2 2017 Conference CallJuly 27, 2017
CHANGING THE COURSE OFHUMAN HEALTH THROUGH BOLD
PURSUITS IN SCIENCE
CHANGING THE COURSE OFHUMAN HEALTH THROUGH BOLD
PURSUITS IN SCIENCE
Reconciliation Tables
CHANGING THE COURSE OFHUMAN HEALTH THROUGH BOLD
PURSUITS IN SCIENCE
CHANGING THE COURSE OFHUMAN HEALTH THROUGH BOLD
PURSUITS IN SCIENCE
Reconciliation TablesReconciliation Tables
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Use of Non-GAAP Financial Measures
In addition to financial information prepared in accordance with U.S. GAAP, this document also contains certain non-GAAP financial measures based on management’s view ofperformance including:
Adjusted research and development expense Adjusted selling, general and administrative expense Adjusted operating margin Adjusted net income Adjusted earnings per share
Management uses such measures internally for planning and forecasting purposes and to measure the performance of the Company. We believe these adjusted financial measures provideuseful and meaningful information to us and investors because they enhance investors’ understanding of the continuing operating performance of our business and facilitate the comparisonof performance between past and future periods. These adjusted financial measures are non-GAAP measures and should be considered in addition to, but not as a substitute for, theinformation prepared in accordance with U.S. GAAP. When preparing these supplemental non-GAAP financial measures we typically exclude certain GAAP items that management doesnot consider to be normal, recurring, cash operating expenses but that may not meet the definition of unusual or non-recurring items. Other companies may define these measures in differentways. The following categories of items are excluded from adjusted financial results:
Acquisition and Divestiture-Related Costs: We exclude the impact of certain amounts recorded in connection with business combinations and divestitures from our adjusted financial resultsthat are either non-cash or not normal, recurring operating expenses due to their nature, variability of amounts, and lack of predictability as to occurrence and/or timing. These amounts mayinclude non-cash items such as the amortization of acquired intangible assets, amortization of purchase accounting adjustments to inventories, intangible asset impairment charges andexpense or income related to changes in the estimated fair value measurement of contingent consideration. We also exclude transaction and certain other cash costs associated with businessacquisitions and divestitures that are not normal recurring operating expenses, including severance costs which are not part of a formal restructuring program.
Share-based Compensation Expense: We exclude share-based compensation from our adjusted financial results because share-based compensation expense, which is non-cash, fluctuatesfrom period to period based on factors that are not within our control, such as our stock price on the dates share-based grants are issued.
Reconciliation TablesReconciliation Tables
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Collaboration-related Upfront Expenses: We exclude collaboration-related upfront expenses from our adjusted financial results because we do not consider them to be normal,recurring operating expenses due to their nature, variability of amounts, and lack of predictability as to occurrence and/or timing. Upfront payments to collaboration partners aremade at the commencement of a relationship anticipated to continue for a multi-year period and provide us with intellectual property rights, option rights and other rights withrespect to particular programs. The variability of amounts and lack of predictability of collaboration-related upfront expenses makes the identification of trends in our ongoingresearch and development activities more difficult. We believe the presentation of adjusted research and development, which does not include collaboration-related upfrontexpenses, provides useful and meaningful information about our ongoing research and development activities by enhancing investors’ understanding of our normal, recurringoperating research and development expenses and facilitates comparisons between periods and with respect to projected performance. All expenses incurred subsequent to theinitiation of the collaboration arrangement, such as research and development cost-sharing expenses/reimbursements and milestone payments up to the point of regulatory approvalare considered to be normal, recurring operating expenses and are included in our adjusted financial results.
Research and Development Asset Acquisition Expense: We exclude costs associated with acquiring rights to pre-commercial compounds because we do not consider such costs tobe normal, recurring operating expenses due to their nature, variability of amounts, and lack of predictability as to occurrence and/or timing. Research and development assetacquisition expenses includes expenses to acquire rights to pre-commercial compounds from a collaboration partner when there will be no further participation from thecollaboration partner or other parties. The variability of amounts and lack of predictability of research and development asset acquisition expenses makes the identification oftrends in our ongoing research and development activities more difficult. We believe the presentation of adjusted research and development, which does not include research anddevelopment asset acquisition expenses, provides useful and meaningful information about our ongoing research and development activities by enhancing investors’ understandingof our normal, recurring operating research and development expenses and facilitates comparisons between periods and with respect to projected performance.
Restructuring Costs: We exclude costs associated with restructuring initiatives from our adjusted financial results. These costs include amounts associated with facilities to beclosed, employee separation costs and costs to move operations from one location to another. We do not frequently undertake restructuring initiatives and therefore do not considersuch costs to be normal, recurring operating expenses.
Certain Other Items: We exclude certain other significant items that may occur occasionally and are not normal, recurring, cash operating expenses from our adjusted financialresults. Such items are evaluated on an individual basis based on both the quantitative and the qualitative aspect of their nature and generally represent items that, either as a resultof their nature or magnitude, we would not anticipate occurring as part of our normal business on a regular basis. While not all-inclusive, examples of certain other significantitems excluded from adjusted financial results would be: expenses for significant fair value adjustments to equity investments, significant litigation-related loss contingencyaccruals and expenses to settle other disputed matters.
Estimated Tax Impact From Above Adjustments: We exclude the net income tax impact of the non-tax adjustments described above from our adjusted financial results. The netincome tax impact of the non-tax adjustments includes the impact on both current and deferred income taxes and is based on the taxability of the adjustment under local tax lawand the statutory tax rate in the tax jurisdiction where the adjustment was incurred.
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Non-Operating Tax Adjustments: We exclude the net income tax impact of certain other significant income tax items, which are not associated with our normal,recurring operations (“Non-Operating Tax Items”), from our adjusted financial results. Non-Operating Tax Items include items which may occur occasionally and arenot normal, recurring operating expenses (or benefits), including adjustments related to acquisitions, divestitures, collaborations, certain adjustments to the amount ofunrecognized tax benefits related to prior year tax positions, and other similar items. We also exclude excess tax benefits and tax deficiencies that arise upon vestingor exercise of share-based payments recognized as income tax benefits or expenses due to their nature, variability of amounts, and lack of predictability as tooccurrence and/or timing.
See the attached Reconciliations of GAAP to Adjusted Net Income for explanations of the amounts excluded and included to arrive at the adjusted measures for thethree- and six-month periods ended June 30, 2017 and 2016, and for the projected amounts for the twelve-month period ending December 31, 2017.
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Reconciliation TablesReconciliation Tables
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Reconciliation TablesReconciliation Tables
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Reconciliation TablesReconciliation Tables
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Return on Invested Capital CalculationReturn on Invested Capital Calculation
44
Appendix
CHANGING THE COURSE OFHUMAN HEALTH THROUGH BOLD
PURSUITS IN SCIENCE
CHANGING THE COURSE OFHUMAN HEALTH THROUGH BOLD
PURSUITS IN SCIENCE
Advancing a High Quality Pipeline with Significant PotentialAdvancing a High Quality Pipeline with Significant Potential
REVLIMID®
Del 5q MDS
VIDAZA®
MDS, AML
IDHIFA®
IDH2 AML
LuspaterceptMDS, Beta-thalassemia
CC-486 MDS, AML
IMFINZI™ MDS, AML
CC-90002AML
CC-90009AML
FT-1101MDS, AML
MyeloidDisease
9
MarizomibGBM
CC-486NSCLC, mBC
CC-122HCC
CC-90002Solid Tumors
CC-90011Solid Tumors
ABRAXANE®
PanC, NSCLC, mBC
AG-881Glioma
SolidTumors
12
OMP-313M32Solid Tumors
NavicixizumabSolid Tumors
RosmantuzumabSolid Tumors
LYC-55716Solid Tumors
JTX-2011Solid Tumors
Inflammation& Immunology
12OzanimodIBD, MS
OTEZLA®
PSOR, PSAOTEZLA®
Behçet's, ASScalp PSOR
GED-0301IBD
RPC-4046EoE
OTEZLA®
UCCC-220
SLE
CC-90001 IPF
CC-90006PSOR
FT-4101NASH
LYC-30937UC, PSOR
ABX-1431Neuro, Pain
MarketPh I
L E G E N D
Celgene has an exclusive option to license JTX-2011, LYC-55716, LYC-30937, rosmantuzumab, navicixizumab, OMP-313M32 and FT-1101
REVLIMID®
MCL
ISTODAX®
PTCL, CTCL
REVLIMID®
NHL
CC-122NHL, CLL
JCAR017NHL
IMFINZI™ NHL, CLL
CC-486NHL
Lymphoma& Leukemia
7
REVLIMID®
NDMM, RRMM
POMALYST®
RRMM
THALOMID®
NDMM, RRMM
CC-122RRMM
CC-220RRMM
IMFINZI™ NDMM, RRMM
bb2121RRMM
MarizomibRRMM
ACY-241RRMM
CC-486RRMM
MultipleMyeloma
11
46
LuspaterceptMF
CC-90002NHL
REVLIMID® Multiple Myeloma Late Stage ProgramsREVLIMID® Multiple Myeloma Late Stage Programs
Patient Population Induction and Maintenance in ASCT EligibleTrial Name MYELOMA XI
Phase III
Target Enrollment 4,420
Design
Arm A: Cyclophosphamide (500mg) D1,8,15; THALOMID® (100mg) D1-21 then 200mg daily; Dexamethasone (40mg) D1-4,12-15 for minimum of 4 21-day cycle
Arm B: REVLIMID® (25mg) D1-21; Cyclophosphamide (500mg) D1,8; Dexamethasone (40mg) D1-4,12-15 for minimum of 4 28-day cycles
Arm C: Cyclophosphamide (500mg) D1,8; Carfilzomib (20 mg/m2) D1,2 cycle 1 then (36 mg/m2) D1,2,8,9,15,16; REVLIMID® (25mg) D1-21; Dexamethasone (40mg) D1-4,8,9,15,16 for 4 21-day cycles
Patients with no change, progressive disease, PR or MR randomized to:Arm A: Bortezomib (1.3mg/m2) D1,4,8,11; Cyclophosphamide (500mg) D1,8,15; Dexamethasone (20mg)
D1,2,4,5,8,9,11,12 for max of 8 21-day cyclesArm B: No treatmentAll patients go to SCT
After SCT randomization to:Arm A: REVLIMID® (10mg) D1-21 for 28-day cycle to disease progression
Arm B: No maintenance
Primary Endpoint Overall Survival and Progression Free Survival
Status Interim data presented at ASH 2016
47
POMALYST®/IMNOVID® Multiple Myeloma Late Stage ProgramsPOMALYST®/IMNOVID® Multiple Myeloma Late Stage Programs
Patient Population RRMM
Trial NameMM-007
OPTIMISMM®
Phase III
Target Enrollment 558
Design
Arm A: POMALYST®/IMNOVID® (4mg); Bortezomib (1.3 mg/m2 IV); Low-dose dexamethasone to disease
progressionArm B: Bortezomib (1.3 mg/m2 IV); Low-dose
dexamethasone to disease progression
Primary Endpoint Progression Free Survival
StatusEnrollment complete
Data in 2018E
48
MDS/AML/MF Late Stage ProgramsMDS/AML/MF Late Stage Programs
Patient Population Low risk/INT-1 transfusion-dependent MDS Post induction AML Maintenance
MoleculeCC-486
(Oral Azacitidine)CC-486
(oral azacitidine)
Trial Name AZA-MDS-003 CC-486-AML-001
Phase III III
Target Enrollment 386 460
DesignArm A: CC-486 (150mg or 200mg)
Arm B: PlaceboArm A: CC-486 (150mg or 200mg)
Arm B: Best Supportive Care
Primary Endpoint RBC-transfusion independence for more than 12 weeks Overall Survival
Status Trial enrollingEnrollment complete
Data expected in 2018E
49
MDS/AML/MF Late Stage ProgramsMDS/AML/MF Late Stage Programs
Patient Population Anemia in to Very Low-, Low-, or Intermediate-Risk MDS
Red Blood Cell Transfusion Dependent Beta-Thalassemia
Molecule Luspatercept Luspatercept
Trial Name MEDALISTTM BELIEVETM
Phase III III
Target Enrollment 210 335
DesignArm A: Luspatercept (starting dose of 1.0 mg/kg
subcutaneous injection every 3 weeks)Arm B: Placebo (subcutaneous injection every 3
weeks)
Arm A: Luspatercept (1mg/kg plus Best Supportive Care)
Arm B: Placebo plus Best Supportive Care
Primary Endpoint Red Blood Cell Transfusion Independence (RBC-TI) ≥ 8 weeks
Proportion of subjects with hematological improvement from Week 13 to Week 24 compared
to 12-week prior to randomizationHematological improvement from Week 13 to Week
24 compared to the 12-week.
StatusEnrollment complete
Data expected in 2018EEnrollment complete
Data expected in 2018E
50
MDS/AML/MF Late Stage ProgramsMDS/AML/MF Late Stage Programs
Patient Population IDH2 Mutant AML
Molecule IDHIFA® (enasidenib, AG-221)
Trial Name IDHENTIFYTM
Phase III
Target Enrollment 280
Design Arm A: IDHIFA® (100 mg daily) 28-day cycle; Best Supportive Care
Arm B: Best Supportive Care
Primary Endpoint Overall survival
Status Trial enrolling
51
REVLIMID® Lymphoma Late Stage ProgramsREVLIMID® Lymphoma Late Stage Programs
Patient Population Relapsed or Refractory Follicular Lymphoma
Newly Diagnosed Follicular Lymphoma
Untreated Activated B-Cell DLBCL
Trial NameAUGMENTTM
NHL-007RELEVANCE®
ROBUST®
DLC-002
Phase III III III
Target Enrollment 357 1,031 560
Design
Arm A: REVLIMID® (10-20mg) D1-21; Rituximab 375 mg/m2 weekly for cycle 1 then D1 of cycles 2-5 for 5 28-day
cyclesArm B: Placebo d1-21; Rituximab 375 mg/m2 weekly for cycle 1 then D1 of
cycles 2-5 for 5 28-day cycles
Arm A: REVLIMID® (starting dose 20mg)
D2-22 for up to 18 28-day cycles; Rituximab (starting dose 375 mg/m2)
weekly for up to 12 28-day cyclesArm B: Physician’s choice of
Rituximab-CHOP, Rituximab-CVP or Rituximab-bendamustine
Arm a: REVLIMID® (15mg) D1-14; R-CHOP21 for 6 21-day cycles
Arm B: Placebo; R-CHOP21 for 6 cycles
Primary Endpoint Progression Free Survival Complete Response Rate and Progression Free Survival Progression Free Survival
StatusEnrollment complete
Data in 2017EEnrollment complete
Data in 2017ETrial enrollingData in 2018E
52
REVLIMID® Lymphoma Late Stage ProgramsREVLIMID® Lymphoma Late Stage Programs
Patient Population Relapsed or Refractory Indolent Lymphoma
Trial NameMAGNIFYTM
NHL-008
Phase III
Target Enrollment 278
Design
Arm A: REVLIMID® (10-20mg) D1-21; Rituximab 375 mg/m2 weekly for cycle 1 then D of cycles 3, 5,7,9 and 11 for 12 28-day cycles followed by REVLIMID® (10mg) D1-21; Rituximab 375 mg/m2 D1 of cycles 13,15,17,19,21,23,25,27 and 29 for 18 28-day cycles followed by REVLIMID® (10mg) D1-
21 until disease progression; 28 day cycleArm B: REVLIMID® (10-20mg) D1-21; Rituximab 375 mg/m2 weekly for cycle 1 then D1 of cycles 3, 5,7,9 and 11 for 12 28-day cycles followed by REVLIMID® (10mg) D1-21; Rituximab 375 mg/m2 D1
of cycles 13,15,17,19,21,23,25,27 and 29 for 18 28-day cycles
Primary Endpoint Progression Free Survival
StatusTrial enrollingData in 2020E
53
ABRAXANE® Solid Tumor Late Stage ProgramsABRAXANE® Solid Tumor Late Stage Programs
Patient Population Adjuvant Therapy in Surgically Resected Pancreatic Cancer
Trial NamePANC-003
apact®
Phase III
Target Enrollment 866
DesignArm A: ABRAXANE® (125 mg/m2); Gemcitabine (1000
mg/m2) D1,8,15 for 6 28-day cyclesArm B: Gemcitabine (1000 mg/m2) D1,8,15 for 6 28-
day cycles
Primary Endpoint Disease Free Survival
StatusEnrollment complete
Data in 2017E
54
I&I Late Stage ProgramsI&I Late Stage Programs
Patient Population Active Behçet’s Disease Scalp Psoriasis
Molecule OTEZLA® OTEZLA®
Trial NameBCT-002RELIEF®
SPSO-001STYLETM
Phase III III
Target Enrollment 207 300
DesignArm A: Placebo for 12 weeks followed by 30mg
OTEZLA® twice daily for 52 weeksArm B: 30mg OTEZLA® twice daily for 64
weeks
Arm A: Placebo for 16 weeks followed by 30mg OTEZLA® twice daily for 16 weeks
Arm B: Placebo for 32 weeks
Primary Endpoint Area under the curve (AUC) for the number of oral ulcers from baseline through week 12
Proportion of subjects with ScPGA score of clear (0) or almost clear (1) with at least a 2-
point reduction from baseline at Week 16
StatusEnrollment complete
Data in 2017EInitiated; Not yet enrolling
55
I&I Late Stage ProgramsI&I Late Stage Programs
Patient Population Active Crohn’s Disease Active Crohn’s Disease
Molecule GED-0301 GED-0301
Trial Name CD-002 CD-004
Phase III III
Target Enrollment 1,300 1,300
Design
Arm A: GED-0301 (160mg) daily for 12 weeks followed by GED-0301 (40mg) daily for 40 weeks
Arm B: GED-0301 (160mg) daily for 12 weeks followed by GED-0301 (40mg) daily for 4 weeks
on/4 weeks off for 40 weeksArm C: GED-0301 (160mg) daily for 12 weeks
followed by GED-0301 (160mg) daily for 4 weeks on/4 weeks off for 40 weeks
Arm A: GED-0301 (160mg) daily for 12 weeks followed by GED-0301 (40mg) daily for 40 weeks
Arm B: GED-0301 (160mg) daily for 12 weeks followed by GED-0301 (40mg) daily for 4 weeks
on/4 weeks off for 40 weeksArm C: GED-0301 (160mg) daily for 12 weeks
followed by GED-0301 (160mg) daily for 4 weeks on/4 weeks off for 40 weeks
Primary Endpoint Clinical remission defined by Crohn's Disease Activity Index (CDAI) Safety
StatusEnrolling
Data in 2018EEnrolling
56
I&I Late Stage ProgramsI&I Late Stage Programs
Patient Population Active Crohn’s Disease Moderate to Severe Ulcerative Colitis
Molecule GED-0301 Ozanimod
Trial Name CD-003 TRUE NORTHTM
Phase III III
Target Enrollment 799 900
DesignArm A: GED-0301 (160mg) dailyArm B: GED-0301 (4x40mg) daily
Arm C: Placebo
Arm A: Ozanimod (1mg) daily for induction and maintenance
Arm B: Placebo induction and maintenance
Primary Endpoint Proportion of subjects achieving clinical remission at Week 12
Clinical remission assessed by Mayo component sub-scores at week 10
Clinical remission assessed by Mayo component sub-scores at week 52
StatusInitiated
Not yet enrollingEnrolling
Data in 2018E
57
I&I Late Stage ProgramsI&I Late Stage Programs
Patient Population Relapsing Multiple Sclerosis Relapsing Multiple Sclerosis
Molecule Ozanimod Ozanimod
Trial Name SUNBEAMTM RADIANCETM
Phase III II/III
Target Enrollment ~1300 ~1300
Design
Arm A: Ozanimod (0.5mg) daily; Placebo IM weeklyArm B: Ozanimod (1mg) daily; Placebo IM weekly
Arm C: Oral placebo daily; Beta-interferon IM weekly
Phase IIArm A: Ozanimod (0.5mg) dailyArm B: Ozanimod (1mg) daily
Arm C: Placebo dailyPhase III
Arm A: Ozanimod (0.5mg) daily; Placebo IM weeklyArm B: Ozanimod (1mg) daily; Placebo IM weekly
Arm C: Oral placebo daily; Beta-interferon IM weekly
Primary Endpoint Annualized relapse rate at month 12 Annualized relapse rate at month 24
StatusData top-lined
Full data expected in H2:17Data top-lined
Full data expected in H2:17
58