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Q2 2019 Results
July 30, 2019
CHANGING THE COURSE OF
HUMAN HEALTH THROUGH BOLD
PURSUITS IN SCIENCE
Forward-Looking Statements and Adjusted Financial Information
2
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’s current plans, estimates,
assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-
looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements
involve inherent risks and uncertainties, most of which are difficult to predict and 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 our Annual Report on Form 10-K and our other reports filed
with the Securities and Exchange Commission, including factors related to the proposed transaction between Bristol-Myers
Squibb and Celgene, such as, but not limited to, the risks that: management’s time and attention is diverted on transaction
related issues, including the planned divestiture of Otezla; disruption from the transaction makes it more difficult to maintain
business, contractual and operational relationships; any potential litigation instituted against Bristol-Myers Squibb, Celgene or
the combined company could delay or prevent the proposed transaction; and Bristol-Myers Squibb, Celgene or the combined
company is unable to retain key personnel.
In addition to unaudited financial information prepared in accordance with U.S. GAAP, this presentation also contains adjusted
financial measures. Further information relevant to the interpretation of adjusted financial measures, and reconciliations of
these adjusted financial measures to the most comparable GAAP measures, may be found in the Appendix and on our website
at www.Celgene.com in the “Investor Relations” section.
Q2:19 Strong Operating Results & Pipeline Execution
Delivering Excellent Operating Results
− Volume-driven double-digit top- and bottom-line growth
− Raising 2019 total revenue guidance to $17.2B-$17.4B
Advancing Our Pipeline
− Five late-stage assets on-track for U.S. launches anticipated through 2020
− Fedratinib, ozanimod, and luspatercept regulatory filings accepted YTD; liso-cel BLA submission on-track for Q4:19
− On-track to file at least 5 INDs or CTAs for novel assets in 2019
Update on Pending Acquisition by Bristol-Myers Squibb
− Recognizes and unlocks significant value for Celgene shareholders
− Divestiture of Otezla planned; conditioned upon closing of the acquisition
− European Commission unconditional approval granted
− Now expected to close by the end of 2019 or the beginning of 20203
Q2:19 Total Net Product Sales & Adjusted Diluted Earnings Per Share$ M
illio
ns
↑18% ↑20%↑14%
$0
$500
$1,000
$1,500
$2,000
$2,500
$3,000
$3,500
$4,000
$4,500
Q2:18 Volume Price Fx /Hedge
Q2:19
↑15.5%↓1.3%↑11.9%
↑4.9%
Contribution to Q2:19 Adjusted Diluted EPSContribution to Q2:19 Total Net Product Sales Growth
Footnote: Growth Rates = Growth vs. Prior Year Period
$3,808 $4,399
Q2:18 Oper. Income
OIE Tax Rate
Share Count
Q2:19
Do
llars
Per
Sh
are
$2.86$0.63$2.16 $0.01 $0.02$0.04
4
Updated 2019 Guidance
January 2019 July 2019
Total Revenue $17.0B-$17.2B $17.2B-$17.4B
REVLIMID® Net Sales ~$10.8B Unchanged
POMALYST®/IMNOVID® Net Sales ~$2.4B ~$2.5B
OTEZLA® Net Sales ~$1.9B Unchanged
ABRAXANE® Net Sales ~$1.1B ~$1.2B
Adjusted Operating Margin ~57.5% ~58.0%
Adjusted Tax Rate ~17.0% ~16.75%
Adjusted Diluted EPS $10.60-$10.80 $10.65-$10.85
Weighted Average Diluted Shares ~715M ~730M
5
• Full-Year 2019 Total Revenue increase driven by POMALYST® and ABRAXANE® performance
• Full-Year 2019 Adjusted Operating Margin and Adjusted Diluted EPS includes potential collaboration-related expenses of approximately $160 million that may be incurred in the
second half of 2019• Diluted shares outstanding reflects no planned share repurchases in 2019
$185$241
$341$447
$133
$150
$166
$172
Q2:16 Q2:17 Q2:18 Q2:19U.S. ROW
$1,079$1,358
$1,586$1,810
$621
$676
$867
$922
Q2:16 Q2:17 Q2:18 Q2:19U.S. ROW
Current Results & Potential Future Growth Drivers
Q2:19 IMiD® Product Performance and Future Growth Drivers
• REVLIMID® - Q2:19 net sales ~$2.7B, +11% Y/Y
• POMALYST® - Q2:19 net sales $619M, +22% Y/Y
• Strong growth driven primarily by the adoption of triplet therapy resulting in increases in treatment duration and market share
• Clinical development and potential future growth drivers:
– REVLIMID®
• REVLIMID®-based triplet regimens in transplant ineligible NDMM
• Rd-daratumumab1 – FDA approved June 27, 2019
• RVd approved in the EU in May 2019
• R2 in previously treated follicular or marginal zone lymphoma approved by the U.S. FDA in May 2019; EU MAA is currently under review; sNDA submitted to the Japanese PMDA
– POMALYST® / IMNOVID®
• Triplet regimens expected to increase share and duration• PVd in 2L+ MM approved in EU and Japan in May 2019
6
REVLIMID® Net Sales ($M)
1 Daratumumab-Rd sBLA submitted by Janssen Pharmaceutical Companies of Johnson & JohnsonCertain prior year amounts have been rounded +/- $1M to conform to the current year rounding convention.
$1,700
$2,034
$2,453$2,732
POMALYST® Net Sales ($M)
$318
$391
$507
$619
Current Results & Potential Future Growth Drivers
Q2:19 ABRAXANE® Performance and Future Growth Drivers
$174 $161 $152
$207
$75 $93 $91
$109
Q2:16 Q2:17 Q2:18 Q2:19
U.S. ROW
$316
$249 $243$254
ABRAXANE® Net Sales ($M)
7
• Q2:19 net sales $316M, +30% Y/Y
• Strong growth driven primarily by increased demand due to IO combinations in non-small cell lung cancer (NSCLC) and triple-negative breast cancer (TNBC)
• Potential future growth drivers:
• Pembrolizumab + ABRAXANE® and carboplatin approved in 1L metastatic squamous NSCLC by FDA on October 30, 20181
• Atezolizumab + ABRAXANE® granted accelerated approval in 1L metastatic TNBC by FDA on March 8, 2019 2
• Upcoming PDUFA date for IO combinations:
− Atezolizumab + ABRAXANE® and carboplatin in 1L metastatic non-squamous NSCLC (Sept 2, 2019) 2
1 Pembrolizumab + ABRAXANE® approval received by Merck & Co. 2 Atezolizumab + ABRAXANE® combinations submitted to FDA by Genentech, a member of the Roche Group
Certain prior year amounts have been rounded +/- $1M to conform to the current year rounding convention.
Q2:19 OTEZLA® Performance and Future Growth Drivers
8
Current Results & Potential Future Growth Drivers
• Q2:19 net sales $493M, +31% Y/Y
• Key performance metrics remain sound
– Strong Q/Q TRx growth in U.S
– Maintaining U.S. new-to-brand leadership1
– Continued strong uptake in key international markets including Japan and France
• Potential future growth drivers for OTEZLA®
– Behҫet’s disease2: U.S. FDA approved on July 19, 2019; EU MAA submitted in Q2:19; anticipate Japanese approval in H2:19
– Scalp psoriasis label enhancement: sNDA submitted to the U.S. FDA in June 2019
– Ph III/IIIb trials in pediatric, genital, and mild to moderate plaque psoriasis
1Source: SHS claims data through April 2019, last updated June 19,2019. includes patients on bridge and PAP for OTEZLA.2Proposed indication: treatment of adult patients with oral ulcers associated with Behҫet’s diseaseCertain prior year amounts have been rounded +/- $1M to conform to the current year rounding convention
$217
$306 $291
$399 $24
$52 $84
$94
Q2:16 Q2:17 Q2:18 Q2:19U.S. ROW
OTEZLA® Net Sales ($M)
$241
$358$375
$493
OTEZLA New to Brand Share in Psoriasis1
(Normalized Patient Equivalents)OTEZLA35.8%
0%
5%
10%
15%
20%
25%
30%
35%
40%
ENBREL STELARA HUMIRA COSENTYX
OTEZLA TALTZ Acitretin Methotrexate
Cyclosporine SILIQ TREMFYA
– Data from pivotal TRANSCEND™ trial in R/R DLBCL expected in Q4:19
– U.S. BLA submission expected in H2:19; approval expected in mid-2020
– Pivotal phase II trial in R/R CLL ongoing
– U.S. NDA for RMS accepted (Mar. 25, 2020 PDUFA date)
– EU MAA for RRMS was accepted for review with approval expected H1:20
– Phase III TRUE NORTH™ UC trial completed enrollment; data expected mid-2020
– U.S. NDA in myelofibrosis granted Priority Review (Sept. 3, 2019 PDUFA date)
– EU MAA submission planned by year-end
– U.S. BLA submission expected in H1:20; approval expected in R/R MM in H2:20
– Clinical program in earlier lines advancing; Phase II NDMM trial planned in H2:19
5 New Late-Stage Products Expected to Launch Through 2020
Liso-cel
(JCAR017)
Ozanimod
Fedratinib
Ide-cel2
(bb2121)
– U.S. BLA for beta-thalassemia granted Priority Review (Dec. 4, 2019 PDUFA date)
– U.S. BLA for MDS accepted (Apr. 4, 2020 PDUFA date)
– EU MAA in beta-thalassemia and MDS was accepted for review
– Phase II myelofibrosis data expected in H2:19
Luspatercept1
1 In collaboration with Acceleron Pharma 2 In collaboration with bluebird bio
9
Q2 2019 Results
July 30, 2019
CHANGING THE COURSE OF
HUMAN HEALTH THROUGH BOLD
PURSUITS IN SCIENCE
Use of Non-GAAP Financial Measures and
Reconciliation Tables
CHANGING THE COURSE OF
HUMAN HEALTH THROUGH BOLD
PURSUITS IN SCIENCE
Use of Non-GAAP Financial Measures
12
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 of performance 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 provide useful and meaningful information to us and investors because they enhance investors’ understanding of the
continuing operating performance of our business and facilitate the comparison of 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, the information prepared in accordance
with U.S. GAAP. When preparing these supplemental non-GAAP financial measures we typically exclude certain GAAP items that management does
not 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 different ways. The following categories of items are excluded from adjusted financial results:
Acquisition/Integration and Divestiture Related Costs: We exclude the impact of certain amounts recorded in connection with business combinations
and divestitures from our adjusted financial results that 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 may include non-cash items such as the amortization of acquired
intangible assets, amortization of purchase accounting adjustments to inventories, intangible asset impairment charges and expense or income related to
changes in the estimated fair value measurement of contingent consideration and success payments. We also exclude transaction and certain other cash
costs associated with business acquisitions and divestitures that are not normal, recurring operating expenses, including severance costs which are not
part of a formal restructuring program as well as integration preparation costs associated with our merger with Bristol -Myers Squibb.
Use of Non-GAAP Financial Measures
13
Share-Based Compensation Expense: We exclude share-based compensation from our adjusted financial results because share-based compensation
expense, which is non-cash, fluctuates from 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.
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 are made 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 with respect to particular programs. The variability of amounts
and lack of predictability of collaboration-related upfront expenses makes the identification of trends in our ongoing research and development
activities more difficult. We believe the presentation of adjusted research and development, which does not include collaboration-related upfront
expenses, provides useful and meaningful information about our ongoing research and development activities by enhancing investors’
understanding of our normal, recurring operating research and development expenses and facilitates comparisons between periods and with respect
to projected performance. All expenses incurred subsequent to the initiation of the collaboration arrangement, such as research and development
cost-sharing expenses/reimbursements and milestone payments up to the point of regulatory approval are 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 to be normal, recurring operating expenses due to their nature, variability of amounts, and lack of predictability as to
occurrence and/or timing. Research and development asset acquisition expenses includes expenses to acquire rights to pre-commercial compounds
from a collaboration partner when there will be no further participation from the collaboration partner or other parties. The variability of amounts
and lack of predictability of research and development asset acquisition expenses makes the identification of trends in our ongoing research and
development activities more difficult. We believe the presentation of adjusted research and development, which does not include research and
development asset acquisition expenses, provides useful and meaningful information about our ongoing research and development activities by
enhancing investors’ understanding of our normal, recurring operating research and development expenses and facilitates comparisons between
periods and with respect to projected performance.
Use of Non-GAAP Financial Measures
14
Restructuring Costs: We exclude costs associated with restructuring initiatives from our adjusted financial results. These costs include amounts
associated with facilities to be closed, employee separation costs and costs to move operations from one location to another. We do not frequently
undertake restructuring initiatives and therefore do not consider such 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 financial results. 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 result of 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 significant items excluded from adjusted financial results would be: significant litigation-related
loss contingency accruals and expenses to settle other disputed matters and, effective for fiscal year 2018, changes in the fair value of our equity securities
upon the adoption of ASU 2016-01 (Financial Instruments-Overall: Recognition and Measurement of Financial Assets and Financial Liabilities).
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 net income 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 law and the statutory tax rate in the tax jurisdiction where the adjustment was incurred.
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 are not normal, recurring operating expenses (or benefits), including adjustments related to acquisitions, divestitures, collaborations,
certain adjustments to the amount of unrecognized tax benefits related to prior year tax positions, the impact of tax reform legislation commonly referred
to as the Tax Cuts and Jobs Act (2017 Tax Act), and other similar items. We also exclude excess tax benefits and tax deficiencies that arise upon vesting or
exercise of share-based payments recognized as income tax benefits or expenses due to their nature, variability of amounts, and lack of predictability as to
occurrence 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 the three- and six-month periods ended June 30, 2019 and 2018, and for the projected amounts for the twelve-month period ending December
31, 2019.
Reconciliation Tables
15
Reconciliation Tables
16
Reconciliation Tables
17