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巴克莱-美股-生物制药业-美国生物制药:下周有何期待?-14-26页.pdf
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Equity Research
4 January 2019
CORE
Barclays Capital Inc. and/or one of its affiliates does and seeks to do business with
companies covered in its research reports. As a result, investors should be aware that the
firm may have a conflict of interest that could affect the objectivity of this report. Investors
should consider this report as only a single factor in making their investment decision.
PLEASE SEE ANALYST CERTIFICATION(S) AND IMPORTANT DISCLOSURES BEGINNING ON PAGE 20.
U.S. Biopharmaceuticals
What To Expect Next Week in SF
Focus on catalyst-rich year and overall sentiment heading into 2019. The 2019
healthcare conference season kicks off next week in San Francisco, and we anticipate
much of the commentary to focus on overall expectations looking ahead to FY2019
given what we’d characterize as a tough end to 2018 (NBI -9%; DRG +4%; S&P -6%).
Broadly speaking, we think the general tone will be largely conservative in large cap
Biopharma after an uninspiring 3Q18 and low growth expectations, though could be
more bullish in SMid cap Biotech given the pace of innovation poised to accelerate this
year. In our view, the modest expectations and negative sentiment heading into the
year set the group up well for a modest re-rating in 2019, and we maintain our positive
outlook on the sector; see The 2019 Outlook Global Pharma Outlook and Company
Profiles – A Focus on 2019, both published on 1/3/2019. While we do not anticipate
any major data disclosures at the conference, we could be provided with incremental
updates on the numerous catalysts expected near-term across biotech (i.e. Gilead’s
NASH program, Biogen’s Alzheimer’s assets, Celgene’s luspatercept/bb2121, Alexion’s
Ultomiris, and Vertex’s CF franchise).
Potential 4Q18 pre-announcements: Unlike in past years, Celgene is not expected to
release 2018 financial results given what was characterized on the 3Q earnings call as
“tight timelines between year-end and the conference” but with the pending Bristol
deal, it is less relevant. Additionally, we suspect Regeneron could announce 4Q18 US
Eylea sales—we forecast $1.028B vs. consensus at $1.035B—as well as some guidance
metrics (e.g., unreimbursed R&D, SG&A, Sanofi reimbursement of commercialization
expenses and tax rate). Lastly, we suspect that Vertex could provide 4Q CF sales details
but the main focus is on the clinical development side.
Potential 2019 and longer-term guidance updates: Several of the major pharmas
have already provided initial 2019 guidance in conjunction with 3Q18 earnings. While
AbbVie has given preliminary growth expectations for 2019 EPS, we think management
may provide us with a more concrete range for the year. Additionally, we look for
Celgene to provide 2019 guidance (total revs, EPS, and product sales). We also
anticipate Vertex will provide 2019 CF revenue guidance (unlikely broken out on a
product-by-product basis) and non-GAAP R&D/SG&A expense guidance.
Regulatory and commercial updates: While we expect minimal late-stage pipeline
updates, despite a catalyst-heavy 1H19/mid-2019, we may be provided incremental
regulatory and commercial updates. Namely, we expect interest in the BMY/CELG deal
that was announced yesterday to be a topic that is widely brought up at the conference
(see BMY/CELG - Top 20 Questions for BMY/CELG deal; BMY/CELG - Additional
Thoughts on Bristol / Celgene Deal; and BMY/CELG - Initial Thoughts on Bristol /
Celgene, 1/03/19).
INDUSTRY UPDATE
U.S. Biopharmaceuticals
POSITIVE
Unchanged
U.S. Biopharmaceuticals
Geoff Meacham, Ph.D.
+1 212 526 2795
geoffrey.meacham@barclays.com
BCI, US
Olivia Brayer
+1 212-526-5914
olivia.brayer@barclays.com
BCI, US
Scott Puckhaber, MD
+1 212 526 5157
scott.puckhaber@barclays.com
BCI, US
Jason Zemansky, PhD
+1 212 526 6608
jason.zemansky@barclays.com
BCI, US
Greg Harrison, CFA
+1 212 526 1544
greg.harrison@barclays.com
BCI, US
Barclays | U.S. Biopharmaceuticals
4 January 2019 2
CONTENTS
Johnson & Johnson ......................................................................................................................................... 3
Pfizer ................................................................................................................................................................... 4
Merck & Co. ...................................................................................................................................................... 5
Amgen ............................................................................................................................................................... 6
Gilead ................................................................................................................................................................. 7
AbbVie ............................................................................................................................................................... 8
Bristol-Myers Squibb ..................................................................................................................................... 9
Celgene ........................................................................................................................................................... 10
Eli Lilly ............................................................................................................................................................. 11
Biogen ............................................................................................................................................................. 12
Regeneron ..................................................................................................................................................... 13
Alexion ............................................................................................................................................................ 14
Vertex .............................................................................................................................................................. 15
Incyte .............................................................................................................................................................. 16
Seattle Genetics............................................................................................................................................ 17
United Therapeutics .................................................................................................................................... 18
Neurocrine Biosciences .............................................................................................................................. 19
Barclays | U.S. Biopharmaceuticals
4 January 2019 3
Johnson & Johnson
What We Expect to Hear
High level comments on market growth rates in 2019 and general expectations given
the overall uncertain macroeconomic outlook
Comments addressing the potential 2019 impact of drug pricing reform rhetoric from
the current administration
Litigation positioning/strategy given the ongoing talcum powder concerns following
last month’s Reuters report
What We Don’t Expect to Hear
Detailed commentary on Remicade IP litigation/generic Zytiga launches (in 4Q18)
Our Take
As in prior years, we expect JNJ to set the tone for the healthcare sector in 2019 at JPM with
commentary on macroeconomic themes affecting the overall space. While we view the
recent weakness in shares (-8% vs. DRG +4% in 2018) from talc litigation concerns as
overdone, we expect it to remain a major overhang at least for 1H19. Fundamentally, we
think 2019 could be more of a challenging year for JNJ particularly in Pharma given multiple
generic launches, the biggest of which will be Zytiga (4Q18 generic launches); indeed
consensus Pharma growth in 2019 could trough at 3.1%, (vs. 11.7% in 2018e and 5.6% in
2020). In our view, the Medical Device (-1%) and Consumer (+2.5%) segments are not
enough of an offset and neither are in an acceleration phase to positively impact growth,
hence, we suspect that JNJ shares are unlikely to see multiple expansion in 2019. While
valuation isn’t high at current levels, it isn’t attractive enough to change our EW thesis and
in our view, the growth profile in Pharma in 2020 looks more compelling relative to 2019.
FIGURE 1
JNJ Presentation Expectations and 4Q18 and 2019 Consensus vs. Barclays Estimates
Source: Barclays Research, company reports, Refinitiv, First Order Analytics.
$ million except for EPS 4Q18 Results 2019 Guidance Cons. Barclays Cons. Barclays
Remicade No No $1,214 $1,241 $4,438 $4,648
Stelara No No 1,298 1,292 5,678 5,675
Tremfya No No 138 194 712 836
Darzalex No No 549 531 2,801 2,674
Imbruvica No No 677 686 3,174 2,988
Zytiga No No 726 888 2,525 2,507
PAH No No 644 656 2,741 2,788
Invokana No No 200 192 766 807
Xarelto No No 715 656 2,916 2,778
Pharmaceuticals No No 9,966 10,056 41,781 41,377
Orthopedics No No 2,233 2,148 8,868 8,742
Surgery No No 2,537 2,357 9,824 9,656
Medical Devices No No 6,706 6,575 26,753 27,291
Consumer No No 3,550 3,429 14,222 14,043
Revenue No No $20,147 $20,058 $82,757 $82,712
EPS No No $1.95 $1.95 $8.62 $8.60
Pre-Announcements
4Q18E
2019E
JNJ
Stock Rating
EQUAL WEIGHT
Industry View
POSITIVE
Price Target
USD 137.00
Price (03-Jan-2019)
USD 125.72
Potential Upside/Downside
+9.0%
Barclays | U.S. Biopharmaceuticals
4 January 2019 4
Pfizer
What We Expect to Hear
General commentary regarding capital allocation including the potential for a near-term
acquisition and the outlook for shareholder return (share repurchases and dividends)
Details on the JV Consumer Health decision and its financial implications
Outlook for new/key Innovative Health products; updates of ongoing I/O combo studies
What We Don’t Expect to Hear
Commentary regarding 2018 guidance, which the company has historically provided
during the 4Q call (scheduled for Jan 29, 2019)
Detailed color on potential acquisition targets
Our Take
PFE shares were among the best performers in Pharma in 2018 (+21% vs. the DRG index
+4%), largely driven by increased consensus expectations and multiple expansion.
Admittedly, we agree that fundamentals are on much more solid footing versus the
previous five years, but we’d argue that this is broadly reflected in the multiple at current
levels and we’d expect upside to be more incremental in 2019. With top-line growth to
remain driven by Innovative Health (continued headwinds facing Essential Health given
LOEs and pricing pressures), we expect management to reassure investors on the outlook
for operational performance/commercial execution looking forward to 2019—with updated
outlooks for key drivers (Prevnar, Ibrance, Eliquis). We think the conversation will largely
remain centered on revenue growth and pipeline expansion/execution, however, unlike in
recent years, we anticipate focus will begin to move away from transformational deals/large
restructuring. We don’t believe incoming CEO Albert Bourla is in the market for a large-
scale, transformational deal; instead, it seems to us that Bourla’s overall strategy going
forward will be one of fine-tuning, with smaller-scale deals that are more product-specific
or R&D-centric and not necessarily yielding cost savings or having significant operational
synergies. Next week’s presentation is also likely to include commentary on the recent
Consumer Health decision to form a JV with GSK—which we think is viewed favorably by
investors and makes sense from a strategic point of view for both companies—as well as
high-level plans for capital deployment. With regards to financial performance, we do not
anticipate any insights into the outlook for 2019, with management likely to wait until the
4Q18 call (scheduled for Jan 29
th
).
FIGURE 2
Pfizer Presentation Expectations and 4Q18 and 2019 Consensus vs. Barclays Estimates
Source: Barclays Research, company reports, Refinitiv, First Order Analytics
$ million except for EPS 4Q18 Results 2019 Guidance Cons. Barclays Cons. Barclays
Lyrica No No $1,140 $1,172 $2,890 $3,049
Prevnar No No $1,482 $1,540 $5,812 $5,840
Ibrance No No $1,127 $1,093 $4,784 $4,657
Xtandi No No $201 $219 $896 $903
Revenue No No $13,948 $13,934 $54,502 $54,596
EPS No No $0.64 $0.65 $3.08 $3.06
Pre-Announcements
4Q18E
2019E
PFE
Stock Rating
EQUAL WEIGHT
Industry View
POSITIVE
Price Target
USD 40.00
Price (03-Jan-2019)
USD 42.04
Potential Upside/Downside
-4.9%
Barclays | U.S. Biopharmaceuticals
4 January 2019 5
Merck & Co.
What We Expect to Hear
Keytruda growth should remain strong in 2019 with increasing PD-L1 testing, deeper
penetration in 1L NSCLC, geographic expansion, and other indications to drive sales
Non-Keytruda immuno-oncology pipeline assets continue to progress, with some
potential earlier-stage readouts in 2019
Business development remains a priority but bolt-on acquisitions are still preferred over
transformative deals
What We Don’t Expect to Hear
Details on the timing for KEYNOTE-426 (1L RCC) or KEYNOTE-522 (TNBC)
Insights into the KEYNOTE-042 approval (months ahead of delayed April 2019 PDUFA)
Our Take
MRK shares took longer than expected to undergo a significant re-rating in 2018 (based
mostly on phase 3 wins for Keytruda) but finished the year as a strong performer (+36% vs.
DRG +4%). Looking to 2019, we think sentiment around the stock is positive, which should
continue as Keytruda’s dominance across I/O becomes more pronounced over 2019.
Investors are looking to see how dominant Keytruda can really be in lung and across I/O in
general (i.e., RCC and melanoma) in 2019, and while we recognize that we won’t see an
initial bolus of patients from recent label expansions, there is increasing emphasis in the
magnitude of Keytruda upside each quarter. Indeed, we saw weakness in MRK shares after
3Q18 earnings from not beating expectations by $100-150M. Keytruda has mostly
exceeded Street expectations in 2017-2018, but it has yet to dramatically beat consensus
despite robust 1L results/line extensions in the large NSCLC market. In our view, this should
play out by mid-2019 given a greater contribution from OUS sales on top of consistent
market share gains in NSCLC in the US and, as a result, we are maintaining our bullish
outlook on Merck in 2019. We suspect Merck will position 2019 as a growth year at the
conference, with the I/O franchise poised to deliver robust growth as the year progresses.
While it is evident that MRK needs to broaden product mix diversity away from oncology, in
our view share performance will be primarily driven by the Keytruda franchise over the
course of 2019. Outside of Keytruda, we think investors will closely watch Gardasil/Gardasil
9’s market position (consensus: +14% growth in 2019) given recent line-
extension/transition to the 2-dose regimen, along with Lynparza for metastatic breast
cancer following a recent positive string of results (consensus: +63% in 2019).
FIGURE 3
Merck Presentation Expectations and 4Q18 and 2019 Consensus vs. Barclays Estimates
Source: Barclays Research, company reports, Refinitiv, First Order Analytics.
$ million except for EPS 4Q18 Results 2019 Guidance Cons. Barclays Cons. Barclays
Keytruda No No $2,073 $2,105 $9,600 $8,850
Januvia/Janumet No No 1,508 1,525 5,803 5,666
Gardasil No No 791 929 3,491 3,579
Zepatier No No 88 115 256 400
Revenue No No $10,993 $11,327 $44,531 $45,094
EPS No No $1.05 $1.06 $4.71 $4.70
Pre-Announcements
4Q18E
2019E
MRK
Stock Rating
OVERWEIGHT
Industry View
POSITIVE
Price Target
USD 78.00
Price (03-Jan-2019)
USD 74.04
Potential Upside/Downside
+5.3%
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