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JP 摩根-美股-医疗保健行业-美国生命科学工具与诊断:摩根大通医疗会议要点-121-59页.pdf
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JP 摩根-美股-医疗保健行业-美国生命科学工具与诊断:摩根大通医疗会议要点-121-59页.pdf
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North America Equity Research
21 January 2020
Life Science Tools &
Diagnostics
Final Takeaways From J.P. Morgan Healthcare
Conference
Life Science Tools & Diagnostics
Tycho W. Peterson
AC
(1-212) 622-6568
Bloomberg JPMA PETERSON <GO>
Tejas Savant
(1-212) 622-5650
Julia Qin, CFA
(1-212) 622-9253
Eleni Apostolatos
(1-212) 622-0136
J.P. Morgan Securities LLC
See page 56 for analyst
certification and important disclosures.
J.P. Morgan does and seeks to do business with companies covered in its research reports. As a result, investors should be aw
are that the
firm may have a conflict of interest that could affect the objectivity of thi
s report. Investors should consider this report as only a single factor in
making their investment decision.
www.jpmorganmarkets.com
Following the J.P. Morgan Healthcare Conference last week, we wanted to pass
along key takeaways from the meeting for the life science tools, diagnostics,
CRO/CDMO and med tech group, as well as for the 35 companies in our coverage
universe that presented.
Core tools companies generally sounded positive… Tools companies across
the board highlighted a stable end market outlook, sustained biopharma
momentum and unchanged industrial trends. Looking closer, Danaher (DHR)
pre-announced 4Q core growth of +5.5%, 100 bps above guidance, despite
difficult comps, driven by Life Sciences (in particular, PLL Biotech) and
Diagnostics (in particular, CPHD, with flu tailwinds, but also broad-based
strength), while E&A remained solid. Thermo Fisher Scientific (TMO) did
not provide an update on 4Q, although management noted no significant end
market changes, with biopharma (40% of revenues) remaining strong, while
industrial comps ease in 2H20. Agilent (A), which previously guided to +4-5%
core growth for FY20, highlighted a growing biopharma portfolio (~12% of
sales, growing +DD), including cell analysis, NGS and NASD, spanning
upstream R&D and downstream manufacturing, with management also noting
abundant opportunities within ACG (portfolio expansion) to enhance growth
and margin expansion.
... albeit with some incremental conservatism baked into guidance, by some.
As noted Agilent (A) previously guided to +4-5% core growth in FY20 (vs.
expectations for +4.5-5.5% at the time), which conservatively assumes flat core
growth in LSAG and +MSD growth in China, with potential upside from Food
and C&E. For the new NASD facility ($100M incremental run-rate capacity),
management noted that $50M is in the ballpark (assuming a linear ramp during
the year). Bruker (BRKR) now expects 2019 full-year revenues at or near the
high end of guidance of +4.5-5.5% organic, implying 4Q revenue growth of
+5% (+2% ex-NMR), while for 2020, management continues to have muted
expectations for China, given the recent order slowdown and paperwork delays.
Mettler Toledo (MTD) previously guided to +4% LC growth in 2020 (below
the long-term model of 5% organic), which factors in difficult comps (especially
for Industrial) and macro conservatism, although management noted no change
in target markets, other than continued weakness in Food Retail and CPG. The
2020 outlook for MTD assumes +MSD growth in Lab, +LSD in Core Industrial,
+LSD-MSD in PI (CPG companies are not expected to resume capex) and
+LSD in Food Retail (on easy comps, although 1H could see a slight decline).
China is expected to moderate to +MSD in 2020, reflecting conservatism on the
Industrial side. Finally, PerkinElmer (PKI) did not reaffirm the prior target of
+HSD organic growth in 2020, but noted it feels confident in achieving above-
market growth (market growing 4-6%) in the mid to long term, although
management would not confirm in the breakout whether this implies potential
guidance for +MSD growth (or something higher) in 2020.
2
North America
Equity Research
21 January 2020
Tycho W. Peterson
(1-212) 622-6568
Illumina (ILMN) had a relatively quiet conference, although its dominance
within NGS remains unchallenged. In addition to an in-line 4Q (led by
sequencing consumables +20% y/y and IVD growth, offset by lower sequencing
system and DTC sales), ILMN guided for top-line growth of +9-11%
(bracketing JPMe of 10.6%, but below the Street at 12%), driven by sequencing
consumables growth of ~17% (sequencing revenues are expected to grow ~14%,
with fewer NovaSeq shipments y/y), offset by a continued decline in arrays (-
15% y/y), due to DTC weakness, although given the easy array comp, the latter
appears conservative. Following a string of popseq delays that hamstrung
performance in 2019, ILMN also shared more color on assumptions in guidance
around key projects, including 200K whole genomes from UKBB, ~60K whole
genomes (starting mid-2020) from All of Us, and ~20K whole genomes from
GeL/NHS (starting mid-2020). In terms of linearity, ILMN expects a softer start
to 2020 (similar to 2017) due to the new NextSeq launches, popseq ramp
timelines, DTC softness (eliminating the possibility of a 1Q seasonality benefit)
and an expected q/q decline in NovaSeq placements. This year was also busier
for ILMN on the innovation front (although the new launches are unlikely to
move the needle in the near term). Specifically, driven by innovations in flow
cell density (leveraging new blue/green SBS chemistry and super resolution
optics which together drive a >30x increase in data density vs. NextSeq 550),
ILMN announced the NextSeq 1000/2000 platforms. The $335K NextSeq 2000
(which runs both 120 Gb P2 and 300 Gb P3 flow cells) will ship in limited
quantities in 1Q20 (with P2 available with launch and P3 available by 4Q20),
while the $210K NextSeq 1000 (which runs the P2 flow cell) will ship in 4Q20.
Compared to NextSeq 550, NextSeq 2000 with a P3 flow cell delivers a 2.5x
increase in output, 50% reduction in operating costs, with a 4x reduction in
footprint and 6x faster secondary analysis (enabled by an integrated DRAGEN
Bio-IT platform on board). Other highlights included a 15-year IVD partnership
with Roche to accelerate adoption of distributable NGS-based testing in
oncology, plans to launch an IVD version of NovaSeq (2022) and an IVD
version of VeriSeq (TruSight NIPT, no timelines specified) and a TruSight
Software Suite to enable sample-to-reports for genetic diseases (2Q20). Finally,
following official termination of the merger with Pacific Biosciences (PACB),
ILMN noted that it does not expect to pursue large transactions with a focus on
tuck-ins and collaborations, including the possibility of one with PACB.
The CRO/CDMO market remains healthy, supported by Smid-cap biotech
spending, increasing outsourcing penetration rates and significant
advantages to scale. Biotech funding trends remain supportive of R&D
spending, driven not just by financing via capital markets, but also large
biopharma companies, with Catalent (CTLT) highlighting biologics
manufacturing and cell & gene therapy as key growth drivers. Furthermore,
while there is some degree of concern around the impact of biopharma
consolidation in light of the string of recent M&A announcements and related
deal synergies (although the JPM conference this year saw almost nothing on the
biopharma M&A front, as opposed to prior years), CROs remain unanimous in
the view that while there is some risk of near-term disruptions and elongated
decision timelines, the customers’ focus on pipelines (vs. purely realizing cost
synergies) should cushion any impact, while low levels of customer
concentration provide further insulation. In terms of year-ahead
outlooks, Catalent (CTLT), which sounded extremely positive at the conference
(aided by the growing biologics/cell & gene therapy segment) kept FY20
guidance unchanged, despite the F1Q beat (implying a healthy degree of
conservatism embedded in the outlook), while Syneos (SYNH) and Icon
(ICLR) both provided in-line 2020 guidance, which was received positively.
3
North America
Equity Research
21 January 2020
Tycho W. Peterson
(1-212) 622-6568
For SYNH, the weakness in Commercialization services also appears to be in
the rearview mirror, with management expecting +2.8-6.7% growth in the
business in 2020, while IQVIA (IQV), which was not at the conference, also
noted a sustained return to growth for CSMS on the 3Q19 call. Looking ahead,
consolidation in the fragmented industry (both in the preclinical and clinical
market) is expected to continue, driven by significant advantages to scale, as
standalone assets look to keep up with larger/merged competitors such as IQV
(Quintiles/IMS), LH (LabCorp/Covance/Chiltern), SYNH (INCR/inVentiv),
CRL (Charles River Labs/MPI/WIL) and Envigo (Huntingdon/Harlan), further
fueled by chatter around another possible large-scale transaction in the horizon.
Beyond large-scale M&A, companies remain focused on tuck-ins in patient
engagement/access, real world evidence, enhanced data services and exposure to
niche geographic and therapeutic areas, as noted in particular by CRL and ICLR.
During the conference, Charles River Labs (CRL) also provided color on the
recent $380M HemaCare acquisition (closed January 3
rd
), which should add at
least $50M to 2020 revenues (30%+ growth annually over the next five years),
while being neutral to 2020 adjusted EPS and accretive thereafter.
Our top Smid-cap picks also sounded good, albeit without much
incremental news…
1) 10x Genomics (TXG): In addition to continued momentum for Chromium
(1,500+ instruments placed to date vs. an installed base of 50K real-time
PCR systems worldwide, suggesting a strong launch, but also ample
runway for growth), Chromium Connect (targeted at biopharma customers)
is expected to start shipping imminently, which should help increase pull-
through from current levels of ~$150K per box. Turning to Visium,
management noted that initial interest has exceeded internal forecasts post
commercial launch in late November, while going forward, TXG plans to
introduce capabilities to perform immunohistochemistry and Visium gene
expression from the same tissue sample at the same time. To address the
fact that IHC cannot scale beyond one or two protein marker targets, TXG
is also introducing ultra-high-plex protein analysis by bringing feature
barcoding (via oligo-tagged antibodies) to the Visium platform. Finally,
while acknowledging that Visium was not initially designed to deal with
FFPE samples, following significant interest from translational and clinical
users (who need FFPE sample capabilities, since that is how most patient
samples are stored), TXG has now internally developed an FFPE-
compatible Visium solution, albeit with no commercial timelines provided
at this point (could come at AGBT next month). In terms of other pipeline
products, TXG is also developing a solution that will directly link
epigenetic programming (using ATAC-seq) and output (RNA gene
expression) across tens of thousands of cells in the same experiment, while
also working on two new capabilities to make single cell experiments less
expensive and more flexible: first, via targeted transcriptome sequencing
applications and second, via multiplexing reagents. Over the next two years,
TXG aims to enable 1M cell experiments, eventually getting to 10M cells.
As noted, we expect further color on the new launches and timelines at
AGBT next month.
4
North America
Equity Research
21 January 2020
Tycho W. Peterson
(1-212) 622-6568
2) Adaptive Biotechnologies (ADPT): While there were no new
announcements from ADPT, management sounded a bullish tone, outlining
key targets for this year including launching the new immunoSEQ RUO kit
in 1Q20, achieving CMS coverage in CLL and launching clonoSEQ for
CLL in blood, while filing with FDA for ALL in blood, and submitting the
first indication for immunoSEQ Dx to FDA and generating a second clinical
diagnostic signal. Finally, Roche (Genentech) is expected to file an IND for
the first shared product in 2020. Subsequent to the conference, the company
also announced the publication of a paper in Nature Cancer highlighting the
potential use of immunoSEQ to predict which primary melanoma patients
are at risk for cancer recurrence based on a quantitative, molecular count of
T cells.
3) Guardant Health (GH): We also came away favorably impressed
following GH's presentation and breakout, with management noting that it
expects a significant impact from the Medicare pan-cancer LCD (finalized
in December), starting in February 2020, while the company is also seeing a
greater-than-expected jump in the fraction of Medicare test volumes
reimbursed following LCD finalization. Private payors are also starting to
lean towards copying the Medicare coverage policy, with total lives covered
increasing from 115M a year ago to 170M today. Moreover, the NILE study
publication (comparing tissue vs. G360 testing in a 282 patient NSCLC
cohort) in 2019 is also driving an inflection in liquid biopsy testing via the
shift towards a “blood first” paradigm. Turning to LUNAR 1, ahead of the
conference, GH announced the launch of a 1,400 patient CRC trial (called
COBRA) with NRG Oncology (NCI) using LUNAR to select stage 2 CRC
patients who would benefit from adjuvant chemotherapy vs. active
surveillance alone, to establish clinical utility of the assay in early stage
colon cancer. Regarding LUNAR 2 for early detection, following
encouraging data at AACR, GH launched the ECLIPSE 10K average risk
CRC screening study (to compare LUNAR vs screening colonoscopy),
noting that the effort has now ramped to ~100 sites in the U.S., with the
majority now enrolling patients, with a readout expected in the 2022
timeframe.
4) Nanostring (NSTG): The company pre-announced a 4Q beat and GeoMx
orders (n=20) above guidance (10-15), which showed accelerating q/q
momentum and leaves year-end backlog at 55 DSP orders (vs. 50
previously expected). The planned launch of an NGS readout this year will
also expand the addressable market into discovery labs and should
accelerate placement momentum, with management considering the TXG
Chromium ramp as a good benchmark and noting that GeoMx’s progress in
peer-reviewed publications and the order book is also tracking in line with
Chromium. Last, but not least, NSTG also announced a roadmap for the
NGS readout, with the initial menu covering the cancer transcriptome
(1,800 genes) this year, followed by a broader menu covering the whole
transcriptome (18K genes) in 2021, which should broader adoption of
GeoMx among the discovery research market in 2021+, as it addresses a
key concern around the limitations of a targeted menu. We expect more
color at AGBT next month.
5
North America
Equity Research
21 January 2020
Tycho W. Peterson
(1-212) 622-6568
Meanwhile, there was no significant update on QGEN, although recent
news reports suggest talks have resumed. As expected, Qiagen (QGEN) did
not provide an update on 4Q, but did provide a brief recap of the previous
strategic review process. In sum, there were multiple interested acquirers, and
the reason for walking away from each discussion is different (price, deal close
timing and uncertainty, implications for stakeholders including employees), with
management noting that stakeholder value (not just shareholder value) was an
important part of consideration (our current assumption is that while QGEN may
have had an acceptable offer in the ~$45 range it was a hell-or-high water
provision that broke up the talks). That said, the company remains open to
strategic opportunities, as long as they “make sense”, and news reports over the
weekend (see New York Times article) suggest that QGEN has resumed talks
with (at least) one strategic buyer, which revives the prospect of a takeout.
Barring a takeout in the near term, however, the search for a permanent CEO is
still underway and will conclude by the end of 1H20, at the latest. The guidance
philosophy going forward will be “realistically ambitious”, while +HSD growth
still viewed as achievable in medium term. For 2020, management expects to
build in enough conservatism on the top-line growth to reflect delays in QIAstat
menu expansion and ongoing China Dx headwinds (recovery will take several
quarters) and to look to beat its own guidance, while on the bottom line,
management will focus on delivering profitability through financial discipline.
Over the medium term, management still believes a +HSD growth profile is
achievable based on the underlying assets in the portfolio.
Lastly, in med tech, ISRG and HOLX both closed the year on a strong note.
Against the backdrop of investor concerns around a procedure slowdown in
4Q19, Intuitive Surgical (ISRG) pre-announced revenues of $1,278M, above
consensus ($1,216M) and JPMe ($1,179M), driven by strong procedure growth
(+19% vs. JPMe +17%) and healthy system placements (336 vs. JPMe 338). For
the year, ISRG posted procedure growth of +18%, or 1,229K procedures,
including 282K U.S. GYN (+6% y/y), 138K U.S. urology (+8% y/y), 421K U.S.
general surgery (+29% y/y), 42K other U.S. procedures (+20% y/y) and 346K
OUS procedures (+21% y/y). Moving to systems, ISRG shipped 336 da Vinci
systems in 4Q including 272 Xi systems and 53 X systems, in addition to 6 SP
units (vs. 4 in 3Q19). Along with the preannouncement, ISRG also provided
initial 2020 procedure growth guidance of +13-16% vs. JPMe of +16%,
although we note that it is not atypical for ISRG to start the year guiding
conservatively (started 2019 at +13-17% before posting beat and raises
throughout the year and ending at +18%, with a similar story in 2018 and 2017).
As expected, the company is starting the year with a relatively wide guidance
range due to, in our view, somewhat limited visibility on a few key variables,
including cadence of orders and timing of placements from the new quota and
Xi approval in China, in addition to the SP ramp (installed base now at 44) and
early Ion commercial launch underway (ten systems sold to date, with the
PRECISE study set to come out later this year). Turning to Hologic (HOLX),
the company pre-announced a F1Q20 revenue beat with the bulk of the upside
driven by Diagnostics and (encouragingly) GYN Surgical, with in-line sales
across other divisions (excluding the now-divested CYNO business), while
looking ahead, following the CYNO divestiture, the company has a renewed
focus on core strengths (Breast Health, Diagnostics and GYN Surgical), as it
continues to build a broader ecosystem around key platforms.
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