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巴克莱-美股-制药业-美国专业制药行业深度研究-6-714页.pdf
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Equity Research
10 June 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 346.
Restricted - Internal
U.S. Specialty Pharmaceuticals
O Fortuna velut Luna: Initiating on U.S. Specialty
We launch coverage of U.S. Specialty Pharmaceuticals with a Neutral industry view,
covering 20 companies (11 OWs) including Specialty, Generics and Animal Health.
After a somewhat remarkable rise, the US Specialty Generics sector has had a torrid
time in the last four years, with fundamentals deteriorating, legal risks expanding
and weak market sentiment. From our coverage, 10 companies have lost a total of
$300B+ in market cap (~80%+ from mid-2015 levels). So, relying on value as a
strong investment argument is tempting at current valuations, with a few other
stocks at 5- to 20-year lows. We say resist the temptation. We place importance
upon cash flows and companies’ ability to manage leverage and improve balance
sheets. Hence, our valuation methodologies give priority to innovation, cash
generation, sustainability, and return metrics.
In our U.S. Specialty subset of 17 companies, we highlight JAZZ, BHC, CHRS: We are
unlikely to see the return of pricing as a lever for both Specialty and Generics in the near
term. That said, we do see a strong growth outlook for differentiated and innovative
Specialty products and in Biosimilars, where we expect a 15-fold rise in the next 7 years.
Thus, we are OW on mix of developmental and commercial stage companies with
unique products & segments: JAZZ, BHC, CHRS, RVNC, FOMX, PCRX, AMAG and OSMT
(with this report, we transfer coverage of BHC and OSMT). We are EW on LGND, UW on
AGN and EOLS. In Generics, despite deceleration in Gx deflation and compelling
valuations, we are highly selective, preferring growth visibility; balanced global exposure
and limited regulatory risk. Hence, we are OW on MYL, EW on AMRX, ENDP, RDY &
MNK, and UW on TEVA. Though managements have commented on Gx stabilization,
we believe a difficult payer landscape and potential legal risks will delay future cash
flow generation and recovery.
We are OW on ZTS and KIN in the US Animal Health sector on solid megatrends: The
sector offers revenue and earnings growth led primarily by positive megatrends in pet
care. Our positive outlook is based on a continuously improving basket of products,
including highly profitable Biologics that address unmet pet needs, regulations and capex
that are less demanding, and global exposure. We are OW on ZTS and KIN, and UW on
PAHC due to issues affecting the livestock industry and weak margin outlook.
Risks to Thesis and Valuation: With stocks at 1-2 standard deviations below mean,
valuations look undemanding. We believe there is still potential for significant downside
and multiple risks that may pose a challenge to projected cash flows, including specialty
competitive dynamics, worsening pricing outlook. competition in Generics, rigid payer
landscape, and legal risks around Opioids and Generics price fixing charges. What
would make us more constructive? Resolution of legal and regulatory risks. Upside
risks to our views come from improvement in business quality in Specialty and
Generics, normalized pricing environment for Generics, pipeline progress in Specialty,
and rapid economic growth for animal health.
INITIATING COVERAGE
U.S. Specialty Pharmaceuticals
NEUTRAL
from N/A
For a full list of our ratings, price target and
earnings changes in this report, please see
table on page 2.
U.S. Specialty Pharmaceuticals
Balaji Prasad, MD
+1 212 526 4160
balaji.prasad@barclays.com
BCI, US
Stephen Ragard, CFA
+1 212 526 5080
stephen.ragard@barclays.com
BCI, US
Ann-Hunter Van Kirk
+1 212 526 2279
Ann-Hunter.VanKi[email protected]m
BCI, US
Barclays | U.S. Specialty Pharmaceuticals
10 June 2019 2
Summary of our Ratings, Price Targets and Earnings Changes in this Report (all changes are shown in bold)
Company
Rating
Price
Price Target
EPS FY1 (E)
EPS FY2 (E)
Old
New
07-Jun-19
Old
New
%Chg
Old
New
%Chg
Old
New
%Chg
U.S. Specialty Pharmaceuticals
NR
Neu
Allergan plc (AGN)
N/A
UW
127.13
N/A
133.00
-
N/A
16.95
-
N/A
17.30
-
AMAG Pharmaceuticals (AMAG)
N/A
OW
9.69
N/A
19.00
-
N/A
-2.17
-
N/A
-0.26
-
Amneal Pharmaceuticals (AMRX)
N/A
EW
7.65
N/A
9.00
-
N/A
1.04
-
N/A
1.29
-
Bausch Health Companies (BHC)
OW
OW
21.24
31.00
28.00
-10
4.05
4.21
4
4.25
4.41
4
Coherus Biosciences Inc. (CHRS)
N/A
OW
17.91
N/A
30.00
-
N/A
-1.28
-
N/A
-0.26
-
Dr. Reddy's Laboratories Ltd. (RDY)
N/A
EW
37.67
N/A
39.00
-
N/A
2.05
-
N/A
2.25
-
Endo International PLC (ENDP)
N/A
EW
4.89
N/A
6.00
-
N/A
2.25
-
N/A
2.28
-
Evolus Inc. (EOLS)
N/A
UW
14.49
N/A
13.00
-
N/A
-1.03
-
N/A
-1.58
-
Foamix Pharmaceuticals Ltd. (FOMX)
N/A
OW
2.50
N/A
10.00
-
N/A
-1.11
-
N/A
-0.96
-
Jazz Pharmaceuticals PLC (JAZZ)
N/A
OW
130.97
N/A
164.00
-
N/A
14.74
-
N/A
16.64
-
Kindred Biosciences Inc. (KIN)
N/A
OW
8.01
N/A
13.00
-
N/A
-1.16
-
N/A
-0.34
-
Ligand Pharmaceuticals Inc. (LGND)
N/A
EW
113.56
N/A
131.00
-
N/A
3.21
-
N/A
3.15
-
Mallinckrodt (MNK)
N/A
EW
9.29
N/A
11.00
-
N/A
8.25
-
N/A
8.13
-
Mylan NV (MYL)
N/A
OW
17.40
N/A
26.00
-
N/A
4.53
-
N/A
4.79
-
Osmotica Pharmaceuticals (OSMT)
OW
OW
2.36
14.00
11.00
-21
-0.33
-0.41
-24
N/A
-0.30
-
Pacira BioSciences (PCRX)
N/A
OW
44.24
N/A
52.00
-
N/A
1.53
-
N/A
2.19
-
Phibro Animal Health Corp. (PAHC)
N/A
UW
29.96
N/A
25.00
-
N/A
1.50
-
N/A
1.82
-
Revance Therapeutics Inc. (RVNC)
N/A
OW
10.83
N/A
28.00
-
N/A
-3.44
-
N/A
-2.40
-
Teva Pharmaceutical Industries (TEVA)
N/A
UW
9.26
N/A
8.00
-
N/A
2.28
-
N/A
2.34
-
Zoetis Inc. (ZTS)
N/A
OW
110.06
N/A
120.00
-
N/A
3.52
-
N/A
3.78
-
Source: Barclays Research. Share prices and target prices are shown in the primary listing currency and EPS estimates are shown in the reporting currency.
FY1(E): Current fiscal year estimates by Barclays Research. FY2(E): Next fiscal year estimates by Barclays Research.
Stock Rating: OW: Overweight; EW: Equal Weight; UW: Underweight; RS: Rating Suspended
Industry View: Pos: Positive; Neu: Neutral; Neg: Negative
Barclays | U.S. Specialty Pharmaceuticals
10 June 2019 3
EXEC SUMMARY: INITIATING ON U.S. SPECIALTY PHARMA
O Fortuna
velut luna
statu variabilis,
semper crescis
aut decrescis
O Fortuna is a medieval Latin poem from the Carmina Burana manuscript of poems.
The Goliard poets who penned this poem complain about the ever-changing nature
of Fortune; its fickleness compared to the waxing and waning of the Moon. This
perhaps also best describes our thoughts on US Specialty Pharma, a sector that has
seen a meteoric rise and a rather dramatic decline within this decade.
The U.S. Specialty Pharma sector offers investors a contradiction of sorts. While Specialty
Drugs are expected to be the fastest growth components of US Pharma, our outlook on the
Specialty sector is divergent. We see strong cash flow outlook for companies that are
differentiated, likely to bring innovative products to the market, while a section of our
coverage struggles with cash flows, competition and legal risks.
Ten firms from our Specialty coverage alone have lost more than 80% of their market
cap in the last 4 years. Few stocks trade at 5-20 year lows and at valuations which would
have sounded far-fetched few years ago. Yet, we believe that relying heavily on Value as an
investment criterion under the current environment is challenging. Our investment
framework places heavy emphasis on visibility of growth, balanced global exposure and free
cash flow generation. We also steer clear of stocks with significant legal and regulatory
risks, as the likelihood of material cash outflow may be high, and lack of available data
makes it hard to reliably formulate estimates at this point.
That said, significant investment opportunities with strong cash flow potential or future
cash flow capabilities exist within our coverage. We highlight a mix of developmental and
commercial stage companies with unique products / segments: JAZZ, CHRS, RVNC, BHC,
FOMX, PCRX, AMAG, MYL and OSMT as our Overweight-rated stocks. Within Animal
Health, we rate ZTS and KIN as Overweight.
The Generics industry has saved the US Healthcare system around $293B in 2018 alone, as
per the Association of Accessible Medicines. The market value for Generics is perhaps not
reflective of the socio-economic value the sector brings. Nevertheless, we are highly
selective in rating any predominantly Generic stocks OW given the quantum of risks
surrounding them. The year has been marked by multiple managements speaking about
stabilization in the Generics industry after 3-4 years of Generic deflation. While this is cause
for cheer for the Generics industry, an ongoing multi-state investigation into drug price
collusion charges naming most of the leaders in Generics is highly concerning. We see
limited potential for a re-rating despite improving fundamentals, till the legal and regulatory
clouds clear away. Wait and watch is perhaps the best investment policy in the current
setup.
We are positive on the Animal Health industry, which rides on a couple of strong global
Macro trends: First, stable demographic trends translating into a rising demand for pets,
greater willingness to spend on pets and enough potential for growth as unmet health
needs for pets still abound. Regulatory and capex needs are relatively undemanding,
development cycles are shorter and it is mostly a cash pay market with high profitability.
Second, on the livestock side, a 3B+ emerging market population is enjoying rising affluence
and greater protein consumption, even as protein consumption is declining in developed
markets. This cycle is unlikely to change for 1-2 decades, setting the scene for a healthy
long-term outlook for the livestock segment. Despite such attractive industry dynamics,
competitive intensity is still healthy, with the industry mostly consolidated and
genericization trends fairly benign.
We present brief investment summaries for our Overweight-rated stocks below.
O Fortune,
like the moon
you are changeable,
ever waxing
ever waning
Our OW-rated stocks: JAZZ,
CHRS, RVNC, BHC, FOMX,
PCRX, AMAG, MYL, OSMT,
ZTS, KIN
Barclays | U.S. Specialty Pharmaceuticals
10 June 2019 4
OW-rated stocks: Investment summaries
We like JAZZ for its dominance in the CNS-Sleep franchise and believe its cash flows are
undervalued, especially as most of the past concerns with Xyrem have been addressed.
We like CHRS as a play on the Biosimilars theme, where we are positive and believe that the
next decade will see steady emergence of the US Biosimilar market, which is currently less
than a billion dollars. Legal, regulatory and commercial visibility is increasing.
BHC stands out on the litigation front, with less legal risk than many of its peers, most legal
issues having been resolved. Business fundamentals are improving steadily with cash flow
generation picking up.
RVNC is likely to bring in the first innovation in the $3B toxin market, nearly three decades
since market leader AGN introduced Botox in 1989. We believe that its long-acting toxin
DAXI is likely to be a game changer in Aesthetics and especially, the Therapeutic side.
While the Opioid litigations impacts a few companies in our coverage, the flip side is a large
market opportunity for products that address this situation. We like PCRX as a strong play
on this opportunity, and see a multi-year growth platform for the company.
We like AMAG for its specialty products focused on women health and potentially two
innovative products addressing female hyposexual disorder and severe pre-eclampsia, for
which currently there are no effective treatments.
MYL is the only stock involved in both the Generic & Opioid litigations that we rate as
Overweight. The stock fits our investment framework of strong FCF generation, balanced
global exposure and one of the broadest Biosimilars pipelines that could carry it on a growth
mode through most of next decade.
FOMX is potentially on the verge of being a commercial stage company with a first-of-its-
kind, topical Minocycline product for acne and rosacea.
OSMT offers asymmetric return potential. While its current generics segment is generating
cash, two products could help transition it to the Specialty segment – RVL-120 for Ptosis
(where an effective solution today is Surgical) and Ontinua ER for spasticity in multiple
sclerosis.
Shifting to Animal Health, we like ZTS as another stock which fits our investment
framework neatly – strong cash generation which will likely be sustained for next couple of
years at least, diverse global exposure, leadership across species and drug category with
continued innovations.
Lastly, we like KIN as potentially the first Biologics focused pure pet care company. With
numerous Biologic drugs in its pipeline, KIN has the potential to address many unmet needs
in pet care; the fastest growth segment in Animal Health.
Barclays | U.S. Specialty Pharmaceuticals
10 June 2019 5
Why read this report? Key topics discussed
1. Use of FCF generation to analyze the 80% market cap destruction in Specialty and
Generics and future FCF potential to predict extent of possible market cap recovery.
2. An in-depth look at four different segments: US Specialty Pharmaceuticals, US &
Global Generics, US Biosimilars and US & Global Animal Health
3. Biosimilars in Humans and Biologics in Animals: Our positive view on Biosimilars
potential starting to be realized and also a look into veterinary Biologics pipeline.
4. Our take on global revenue exposure, in Animal Health and Generics and relevance of
these markets for risk diversification in our coverage.
5. Views on current legal and regulatory risks facing the sector –Opioid and Generic
price collusion litigation.
6. Overview of different markets, including:
o Biosimilars in the US
o Global Neurotoxin market and shifting dynamics in market share
o Migraine market and shift in Rx paradigm
o Acne and Rosacea markets
o Narcolepsy and EDS markets
o Pain management market
7. Valuations: Making the case for large cap multiples to stay compressed
8. On an individual stock basis:
o Highlighted names: JAZZ, RVNC, CHRS, KIN show that innovation and
differentiation is likely the best way to generate shareholder returns in today’s
Specialty Pharma world.
o We are less excited about most of the larger Specialty and Generics stocks –
AGN, TEVA, RDY, ENDP, MNK.
o Unique opportunities in small-cap stocks like FOMX, OSMT
o Lastly, we highlight our preference for industry leaders in Animal Health – ZTS
& ELAN – as secular dynamics unique to Animal Health help these companies.
9. Interesting read through from from my Barclays colleagues:
o US Biopharma analyst – Geoff Meacham’s work on Migraine Rx paradigm and
call on Biosimilars with an industry expert
o US HC Services analyst – Steve Valiquette’s call on Generics price fixing &
Opioid litigation outlook with a legal expert
o US Agribusiness analyst – Ben Theurer’s report on Greenhouse Gas emissions
and our takeaways for global Protein production trends and structural growth
drivers for Animal health industry.
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