Q3 2019 Results · 2019-11-14 · – EU MAA for RRMS was accepted for review with approval...
Transcript of Q3 2019 Results · 2019-11-14 · – EU MAA for RRMS was accepted for review with approval...
Q3 2019 Results
October 31, 2019
CHANGING THE COURSE OF
HUMAN HEALTH THROUGH BOLD
PURSUITS IN SCIENCE
Forward-Looking Statements and Adjusted Financial Information
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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.
Q3:19 Strong Results & Pipeline Execution
Delivering Excellent Operating Results
− Strong volume-driven, double-digit Q3:19 revenue of $4.5B up 16.1% compared to
Q3:18
− Strong Q3:19 adjusted EPS of $2.99 up 31% compared to Q3:18
Advancing Our Pipeline
− INREBIC® approved in myelofibrosis
− Additional late-stage assets on-track for expected U.S. approval through 2020:
luspatercept, ozanimod, liso-cel, and ide-cel; CC-486 regulatory submissions
planned beginning H1:20
Update on Pending Acquisition by Bristol-Myers Squibb
− Amgen to acquire the OTEZLA® product line and related IP for $13.4 billion in cash;
contingent on BMS and Celgene entering into a consent decree with FTC and
closing the BMS/Celgene acquisition
− Expected to close by the end of 2019
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Q3:18 Oper. Income
OIE Tax Rate
Share Count
Q3:19
Q3:19 Total Net Product Sales & Adjusted Diluted Earnings Per Share$ M
illio
ns
↑18% ↑20%↑14%
$0
$500
$1,000
$1,500
$2,000
$2,500
$3,000
$3,500
$4,000
$4,500
$5,000
Q3:18 Volume Price Fx /Hedge
Q3:19
↑16.1%↓0.7%↑15.0%
↑1.8%
Contribution to Q3:19 Adjusted Diluted EPSContribution to Q3:19 Total Net Product Sales Growth
Footnote: Growth Rates = Growth vs. Prior Year Period
$3,890 $4,518
Do
llars
Per
Sh
are
$2.99↑$0.67$2.29 ↑$0.01 ↓$0.04↑$0.06
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$203$268
$357$469
$138
$149
$156
$195
Q3:16 Q3:17 Q3:18 Q3:19U.S. ROW
$1,154$1,361
$1,667$1,902
$738 $720
$782
$868
Q3:16 Q3:17 Q3:18 Q3:19U.S. ROW
Current Results & Potential Future Growth Drivers
Q3:19 IMiD® Product Performance and Future Growth Drivers
• REVLIMID® - Q3:19 net sales ~$2.8B, +13% Y/Y
• POMALYST® - Q3:19 net sales $664M, +29% Y/Y
• Strong growth driven primarily by the adoption of triplet therapy resulting in increases in treatment duration and market share
• Clinical development and potential future growth drivers:
– REVLIMID®
• REVLIMID®-based triplet regimens in transplant ineligible NDMM
• Rd-daratumumab1 – FDA approved June 27, 2019
• RVd approved in the EU in May 2019
• R2 in previously treated follicular or marginal zone lymphoma approved by the U.S. FDA in May 2019; EU MAA is currently under review; sNDA submitted to the Japanese PMDA
– POMALYST® / IMNOVID®
• Triplet regimens expected to increase share and duration• PVd in 2L+ MM approved in EU and Japan in May 2019
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REVLIMID® Net Sales ($M)
1 Daratumumab-Rd approval received by The Janssen Pharmaceutical Companies of Johnson & JohnsonCertain prior year amounts have been rounded +/- $1M to conform to the current year rounding convention.
$1,892$2,081
$2,449
$2,770
POMALYST® Net Sales ($M)
$341$417
$513
$664
Current Results & Potential Future Growth Drivers
Q3:19 ABRAXANE® Performance and Future Growth Drivers
$144 $149 $174
$206
$89 $102
$114
$112
Q3:16 Q3:17 Q3:18 Q3:19
U.S. ROW
$318
$233
$288
$251
ABRAXANE® Net Sales ($M)
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• Q3:19 net sales $318M, +10% Y/Y
• 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 (Dec. 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.
Q3:19 OTEZLA® Performance and Future Growth Drivers
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Current Results & Potential Future Growth Drivers
• Q3:19 net sales $547M, +27% 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: Approved in the U.S. in July 2019; Approved in Japan Sept. 2019; EU MAA submitted in Q2:19
– 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
• Otezla to be acquired by Amgen post the closure of the BMY/CELG merger
1Source: SHS claims data through July 2019, last updated Sept. 26, 2019. includes patients on bridge and PAP for OTEZLA.2 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
$244 $250
$348
$445 $31
$58
$84
$102
Q3:16 Q3:17 Q3:18 Q3:19U.S. ROW
OTEZLA® Net Sales ($M)
$275$308
$432
$547
OTEZLA New to Brand Share in Psoriasis1
(Normalized Patient Equivalents)OTEZLA32.8%
0%
5%
10%
15%
20%
25%
30%
35%
40%
ENBREL STELARA HUMIRA COSENTYX
OTEZLA TALTZ Acitretin Methotrexate
Cyclosporine SILIQ TREMFYA Ilumya
– Data from pivotal TRANSCEND™ trial in R/R DLBCL expected to be presented at ASH 2019
– U.S. BLA submission on-track for Q4:19; FDA 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
– FDA approved for tx of adult pts with intermediate-2 or high-risk primary or secondary
myelofibrosis (August 2019)
– EU MAA submission planned by year-end
– KarMMa™ update expected by year-end; U.S. BLA submission expected in H1:20; FDA
approval expected in R/R MM in H2:20
– Clinical program in earlier lines advancing; NDMM trial planned in Q4:19
Approval of 5 New Late-Stage Products Expected Through 2020
Liso-cel
(JCAR017)
Ozanimod
INREBIC®
(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 to be presented at ASH 2019
luspatercept1
1 In collaboration with Acceleron Pharma 2 In collaboration with bluebird bio
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Q3 2019 Results
October 31, 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
11
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
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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
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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 nine-month periods ended September 30, 2019 and 2018, and for the projected amounts for the twelve-month period ending
December 31, 2019.
Reconciliation Tables
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Reconciliation Tables
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Reconciliation Tables
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