2016 Healthcare Outlook

8/19/2019 2016 Healthcare Outlook

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December 17, 2015 Americas: Healthcare

Goldman Sachs Global Investment Research 2

Table of Contents

GIR Americas Healthcare Team 3

PM Summary: Shifting Sands 4 2016 View: What’s Changed 5

Highest Conviction Single Stock Ideas for 2016 6

GS Healthcare Team 2016 Subsector Coverage Views + Key Stock Picks 7

A View from Washington: Marking Time Until the Election 87

Emerging Uncertainties: Key Themes Facing New Challenges 10

Stress Testing the 2016 Pricing Overhang: 6 Key Variables 12

Biopharma Big Picture: 2016 Investable Themes 16

From Launch to Margin: Focus on Expanders 21

Utilization Tug of War: Need For A Product Cycle Overlay 23

The M&A March: Slower, Selective, More Strategic 26

Disclosure Appendix 35


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GIR Americas Healthcare Team

Pharmaceuticals

Jami Rubin 1-212-357-7536 [email protected]

Sector Specialist

Asad Haider, CFA 1-212-902-0691 [email protected]

Medical Technology

David H. Roman 1-212-902-7839 [email protected]

Healthcare Supply ChainRobert P. Jones 1-212-357-3336 [email protected]

Stephan Stewart, CFA 1-212-934-4218 [email protected]

Managed Care & Facilities

Matthew Borsch, CFA 1-212-902-6784 [email protected]

Life Science Tools & Diagnostics

Isaac Ro 1-212-902-6393 [email protected]

Biotechnology

Terence Flynn 1-212-357-5057 [email protected]

Salveen Richter 1-212-934-4204 [email protected]

Specialty & SMID Pharmaceuticals

Gary Nachman 1-212-855-7725 [email protected]

Washington Research

Alec Phillips 1-202-637-3746 [email protected]


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Highest Conviction Single Stock Ideas for 2016

Exhibit 1: Our highest-conviction ideas for 2016GS Healthcare stocks on the Americas Conviction Buy list, bolded companies are recent additions

Source: Factset, Goldman Sachs Global Investment Research.

Ticker Analyst Coverage Group

Price

Target

Price

(12/15/15) Upside GS View

ABBV Jami Rubin Major Pharmaceuticals $80 $56.39 42%Bullish on stability and growth of Humira, growth from the pipeline, and the potential to

increase margins

AMGN Terence Flynn, PhD Large-Cap Biotech $213 $162.62 31%

ew pro uc cyc es , ppe ne rea ou s omo an n erna osm ars w a ow

to replace the potential revenue that could be lost to competition and drive outer-year

rowth

BMY Jami Rubin Major Pharmaceuticals $80 $70.22 14% Bullish on BMY's positioning for Opdivo and larger I-O franchise

HOLX Isaac Ro Diagnostics $49 $38.50 27%Tomo product cycle underappreciated, with execution from management on de-leveraging

and operating improvements

MDT David H. Roman Medical Devices $90 $77.10 17%Strong organic growth with multiple growth drivers for future organic growth and cash

optionality

MYL Jami Rubin Generic Pharmaceuticals $65 $53.99 20%Strong 2016-2018 outlook, dislocated share price and insulation from pricing

pressure

Q Robert P. Jones CROs $86 $68.93 25%

rac ve en ery po n n g o : ec or ea ng oo - o- , suppor ng

accelerating revenue growth, (2) limited client concentration, and (3) growing balance

sheet flexibilit .

TMO Isaac Ro Life Science Tools $158 $137.49 15% Underappreciated growth story with an improving balance sheet which stands to benefitfrom improving fundamentals in Tools' end markets

ZLTQ David H. Roman Medical Devices $44 $27.60 59%Differentiated asset avoiding negative controversies (i.e., drug pricing, util ization

uncertainty) with exposure to new product cycles and consumer spending patterns


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2012, we have seen acquirers across all sectors (except Energy) being rewarded for M&A with aggregate stock

outperformance post deal announcements. However, the magnitude of outperformance has steadily declined over the last

several years with 2015 just barely positive, and we are seeing a gradual reversion to the mean when considering that

acquirers’ stocks underperformed in almost every year in the period 1996-2011. Specifically in healthcare, when comparing

stock performance for acquirers in 2015 vs. 2014 it is clear that 2015 has been a lot more challenging (in biopharma and

managed care acquirers actually underperformed significantly this year).

When considering healthcare M&A overall, we believe investors have most soured on deals that have been primarily for

financial engineering purposes (e.g., acquiring mature assets and driving accretion largely through price increases and/or

cost synergies, tax inversions, etc.). Where we expect companies to be more focused with their M&A going forward is on

strategic deals that add new products or technologies that have very good durability, and that will be significant

contributors to long-term organic growth even if they are less accretive in the very near term.

Many companies within healthcare continue to have significant firepower on their balance sheets despite the substantial

amount of deal making over the last few years. Average net leverage ratios across all of healthcare have been continuing to

climb, but are still at a reasonable level in our view at roughly 1.4x. There are some concerns that a higher interest rate

environment may impede future deals, but what we have seen in the past is that higher rates are typically associated with a

growing economy and with higher consumer and business confidence that ultimately drives greater M&A activity. As such,

we do not believe a higher interest rate environment in and of itself would necessarily change the level of M&A in

healthcare. If borrowing costs do end up going higher, stock deals could also potentially be a trend that continues to

increase going forward.


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Exhibit 3: Assessing the impact of a dual eligible step up to Biopharma 2015 EPSImpact on EPS evaluated based on a 23% rebate to estimated Medicare Part D Exposure

Source: Goldman Sachs Global Investment Research

Exhibit 4: Government exposure as a % of 2014 revenue in PharmaBased on GS estimates if company data not available

Exhibit 5: Government exposure as a % of 2014 revenue in BiotechBased on GS estimates if company data not available

Source: Company data, Goldman Sachs Global Investment Research. Source: Company data, Goldman Sachs Global Investment Research.

6.8%

4.9%

2.2% 1.9%1.5% 1.2%

0.3%

2.5% 1.8% 1.6%1.2%

0.0% 0.0% -0%

-2%

-4%

-6%

-8%

-10%

-12%

-14%

-16%

-18%

-20%

$0.00

$2.00

$4.00

$6.00

$8.00

$10.00

$12.00

$14.00

$16.00

$18.00

BMY LLY ABBV MRK JNJ PFE BXLT GILD CELG BIIB AMGN ALXN REGN

Pharma Biotech*

2015E EPS EPS Impact EPS Impact (%)

*Non-GAAP EPS for ALXN, AMGN, BIIB, CELG, GILD, and REGN

Exposure as a % of Revenue

Company Medicare

Part B

Medicare

Part D

ABBV 12% 1% 11%

BMY 36% 10% 26%

BXLT 24% 22% 1%JNJ 12% 5% 7%

LLY 26% 9% 17%

MRK 16% 5% 11%

PFE 23% 15% 8%

AGN 25% 1% 24%

ABBV: based on Humira sales Medicare Part B/D breakdown estimated based on molecule type

AGN: based on proforma estimates (excluding generic sales)

LLY and MRK: based on 2013 figures

Total

Medicare/Medicaid

ExposureTotal Government

ExposureMedicaid Medicare

Medicare

Part D

Medicare

Part B

ALXN 7% 6% 1% 0% 1%

AMGN 30% 4% 27% 5% 22%

BIIB 18% 2% 16% 8% 9%CELG 35% 3% 32% 32% 0%

GILD 44% 26% 18% 18% 0%

REGN 44% 2% 42% 0% 42%

VRTX 9% 9% 0% 0% 0%

Exposure (as a % of 2014 Revenue)


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December 17 2015 Americas: Healthcare


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BIIB’s Aducanumab (a-beta antibody) Ph3 AD program is under way and we expect data in 2019/2020. But in 2016

we could get two updates from the initial Ph1b trial – data from the titration arm as well as from the rollover, open-

label extension portion (beyond one year). However, we do not view these as upside drivers given BIIB has already

designed the Aducanumab Ph3 program to incorporate dose titration and the Ph1b open-label extension lacks a

control arm. With respect to additional assets in BIIB’s AD portfolio, we expect updates on Eisai’s BAN2401 (a-beta

antibody) and E2609 (BACE inhibitor) in 2016. For BAN2401 the Ph2 data will be fairly robust (N=650 patients over arange of doses) and will include cognition data (novel composite endpoint called ADCOMS), 65% of the components

come from CDR-sb and hence might be generally comparable to Aducanumab Ph1b. Whereas the E2609 data will be

primarily focused on safety/tolerability.

Exhibit 8: Timeline for AD catalysts2016 is a major year for Alzheimer’s

Source: clinicaltrials.gov

2020 202120192014 2015 2016 2017 2018

DataRelease

Data

Release

Eli Lilly

BACE Inhibitor (LY3314814) AMARANTH

Eisai / Biogen

BACE Inhibitor Phase 1/2

Eisai / Biogen

BACE Inhibitor (BAN2401) Phase 2Eisai / Biogen

aducanumab (BIIB037)Phase 1b

Eisai / Biogen

BIIB037 Phase 3 Alzheimer's Data

Eli Lilly

solanezumab EXPEDITION 3Primary

Completion S t u d y

C o m p l e t e

PrimaryCompletion

S t u d y

C o m p l e t e

Merck

BACE inhibitor verubecestat (MK-8931) EPOCH Mild to Mod, no PET scan S t u d y

C o m p l e t e

PrimaryCompletion

Merck

BACE inhibitor verubecestat (MK-8931) APECS, Prodromal, w/PET scanPrimary

Completion

Roche

gantenerumab, Mild w/PET scanPrimary

Completion

S t u d y

C o m p l e t e

S t u d y

C o m p l e t e

PrimaryCompletion

December 17 2015 Americas: Healthcare


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Beyond AD, we expect a high degree of focus on BIIB’s anti-Lingo Ph2 MS data. While not a pivotal trial, it has the potential

to significantly impact BIIB’s multiple give the target profile of this drug (remyelination for MS). Earlier this year reported

data from the first Ph2 trial of the drug in AON. In our view the data were mixed as while there appears to be a signal of

activity on the primary endpoint – recovery of optic nerve latency (time for a signal to travel from the retina to the visual

cortex), as measured by full field visual evoked potential (FF-VEP), relative to placebo – the study showed no effect on

secondary endpoints. We were looking for a signal of activity across multiple measures. Hence, we expect definitive proof-of-concept for anti-Lingo to remain an outstanding question until we see data in a second Ph2 trial in MS in 2016.

3. Outside of cancer and CNS within large-cap biotech we see several additional important pipeline catalysts including

AMGN/REGN PCSK9 Ph3 CV outcomes data, AMGN’s Romo Ph3 osteoporosis data, REGN’s Dupi Ph3 atopic dermatitis data,

CELG’s Revlimid Ph3 REMARC trial and GILD’s Simtuzumab Ph2 IPF and NASH data. In our view expectations are highest

for PCSK9 outcomes data (given robust cholesterol reductions and genetic support) and lowest for Simtuzumab (given prior

failures in cancer).

4. Gaining leverage to the overall biopharma innovation cycle through the CROs. The CRO group has experienced high-single

digit backlog growth on average through 2015, which has contributed to an acceleration of trailing 12-month book-to-bills

well above normalized levels. In our view, record biotech funding and a continued focus by large pharma in investing in

their late-stage pipelines (which grew 8% on an annualized basis through the first nine months of the year) have been the

key drivers of this recent backlog strength – we expect these trends to continue. As a result, we expect 2016 to deliver

accelerating sales growth across the group, helping drive margin expansion and generate greater levels of cash flow for

capital allocation.



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Exhibit 9: Risk/Reward for select Ph3 pipeline catalysts

Source: Company data, Goldman Sachs Global Investment Research

LLY/SolanezumabAlzheimers

ABBV/ElagolixEndometriosis

BMY/Opdivo-New indications

MRK/Keytruda

New indications

JNJ/Sirukumab-RA

TEVA/AuspexTardive dyskinesia

ALXN/Soliris-MG

AMGN/RepathaCV outcomes

AMGN/Romoosteoporosis

REGN/DupiAtopic derm/asthma

FGEN/Roxa-CKD China

OPHT/Fovista-Wet AMD

ALKS/5461Depression

BLUE/Lenti-D-CCALD

BMRN/PEG-PALPKU

BMRN/BMN 190-Batten

KITE/KTE-C19DLBCL

INCY/JakafiPancreatic cancer

INCY/Baricitinib-RA JUNO/JCAR015-ALL

SGEN/AdcetrisCTCL-frontline

Pharma Large‐cap Biotech Smid‐cap Biotech

H i g h e r R e w a r

d

L o w e r R e w a r d

Lower

Risk Higher

Risk


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Exhibit 10: Margin expansion expected to continue through pharma and biotech names2015-18E margin expansion vs. 2016 P/E

Source: Company data, FactSet, Goldman Sachs Global Investment Research

ABBV

BMY

LLY

JNJ

MRKPFE AMGN

BIIB

CELG

GILD

0x

5x

10x

15x

20x

25x

30x

35x

-10% -5% 0% 5% 10% 15%

2 0 1 6

P / E

2015E - 2018E Margin Expansion


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Exhibit 11: The economic cycle and healthcare spending trendsCommercial medical cost trend relative to the timing of the economic cycle since 1982

Source: Company data, industry surveys, CMS, Goldman Sachs Global Investment Research.

0.0%

2.0%

4.0%

6.0%

8.0%

10.0%

12.0%

14.0%

16.0%

1 9 8 2

1 9 8 3

1 9 8 4

1 9 8 5

1 9 8 6

1 9 8 7

1 9 8 8

1 9 8 9

1 9 9 0

1 9 9 1

1 9 9 2

1 9 9 3

1 9 9 4

1 9 9 5

1 9 9 6

1 9 9 7

1 9 9 8

1 9 9 9

2 0 0 0

2 0 0 1

2 0 0 2

2 0 0 3

2 0 0 4

2 0 0 5

2 0 0 6

2 0 0 7

2 0 0 8

2 0 0 9

2 0 1 0

2 0 1 1

2 0 1 2

2 0 1 3

2 0 1 4

2 0 1 5 E

Recession Recession RecessionRecession

?



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Lateral read and cross sector data points

Hospitals: Same-store admissions growth peaked in 1Q15 and has decelerated sequentially in both 2Q and 3Q15, reflecting

diminished contribution from ACA coverage expansion. That said, the most recent (3Q) volume growth was still strong for

most companies and we expect sequential acceleration into 4Q. In 2016, we are assuming no contribution from the ACA to

volumes beyond roughly maintaining the level of coverage expansion achieved through this year. However, we are

expecting core (non-ACA) volumes will continue to be a key driver.

Labs: After 3 quarters of sequential volume acceleration (4Q14-3Q15), volume growth decelerated in 3Q15. On a two-year

basis volume growth, the rate of acceleration slowed in 3Q15 following a robust 2Q15 and trend appears to be normalizing

at a low-single-digit rate.

Medical Devices: Since 4Q14 organic growth has stabilized across various MedTech end markets (orthopaedics, supplies).

That said, the rate of acceleration has moderated as the industry laps tough comps from 2H14. Overall, multi-year trend

appears to be improving albeit at a slower pace.

Prescription drug volumes: We expect a gradual acceleration in Rx growth for 2016 on modest improvement in same-storevolumes against easy compares. While the deceleration in Rx volumes in 2015 is worth noting, we think it was largely due

to cycling the uplift from ACA the prior year. The two-year stack has remained relatively stable throughout 2015, and we

expect that once ACA comparisons are cycled, we should see y/y Rx growth accelerate.



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The M&A March: Slower, Selective, More Strategic

1. We expect the pace of M&A going forward to slow given that acquirers’ stocks have been starting to underperform

again after deals are announced. Since 2012, we have seen acquirers across all sectors (with the exception of Energy)

being rewarded for M&A with aggregate stock outperformance two days post deal announcements (Exhibit 12). However,

the magnitude of outperformance has steadily declined over the last several years with 2015 just barely positive, and we are

seeing a gradual reversion to the mean when considering that acquirers’ stocks underperformed in almost every year in the

period 1996-2011. Specifically in healthcare (Exhibits 13-14), when comparing stock performance for acquirers in 2015 vs.

2014 it is clear that 2015 has been a lot more challenging. In 2015, acquirers have outperformed to a much lesser extent

than in 2014 in the two days following deal announcements across all subsectors of healthcare, and when looking at

performance through the end of the year the difference was even more dramatic (in biopharma and managed care

acquirers actually underperformed significantly this year). With M&A losing some of its appeal and acquirers getting much

less credit by investors for deals, we expect the pace of M&A to slow down somewhat going forward.

Exhibit 12: Acquirers have been outperforming around large ($1.5bn+) M&A deal announcements, except in Energy

Source: Company data, Goldman Sachs Global Investment Research.

(6.3%)

1.8%

(3.0%)

(2.0%)

(4.4%)

(2.0%)

0.4%

(1.0%)

(3.5%)

0.2%

(2.5%)

(0.9%)

(3.3%)

(5.2%)

(1.6%)

(0.5%)

4.6%

3.3%

1.3%

0.7%

-8%

-6%

-4%

-2%

0%

2%

4%

6%

1 9 9 6

1 9 9 7

1 9 9 8

1 9 9 9

2 0 0 0

2 0 0 1

2 0 0 2

2 0 0 3

2 0 0 4

2 0 0 5

2 0 0 6

2 0 0 7

2 0 0 8

2 0 0 9

2 0 1 0

2 0 1 1

2 0 1 2

2 0 1 3

2 0 1 4

2 0 1 5

-6%

-4%

-2%

0%

2%

4%

6%

8%

Across these sectors, acquirers have outperformed for two-thirds of the $1.5bn+ deal announcements since 2012

The hit rate ofoutperformance is

lower for Utilities (50%)and Energy (30%)

Acquirer stocks

starting to

underperform


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Exhibit 15: Aggregate balance sheet “firepower” by Health Care subsector

Source: Company data, Goldman Sachs Global Investment Research.

3. Higher interest rates probably will not change the dynamics for M&A that much, including a trend towards more

stock deals. Interestingly, there is a very strong correlation between the Federal funds rate and the 10 year Treasury rates

with the US M&A volumes over the last ten years (Exhibit 16). What we have seen in the past is that higher rates are

typically associated with a growing economy with higher consumer and business confidence that ultimately drives greater

M&A activity. As such, we do not believe a higher interest rate environment in and of itself would necessarily change the

level of M&A in healthcare. However, the level of accretion from such deals could certainly decrease with a higher cost of

debt. As an example in Specialty Pharma with ENDP’s deal for Par that closed on September 28, 2015, based on our

estimates the deal is likely to be accretive to EPS by 18-21% in 2016. We ran a sensitivity analysis and for every incremental

100bps in interest rate (actual rate for deal was 5.25-6%) that would have reduced the accretion by only ~1-2% (with ~$25mn

of additional synergies needed to offset that). So even if interest rates went up 200-300bp we do not think that would have

been a deal-breaker for ENDP. A noticeable trend within healthcare has been the increased use of stock in deals which has

gone up significantly over the last two years (Exhibit 17). All cash deals have represented only 25% of the overall healthcare

M&A volume YTD in 2015, well below the 20-year average of 47%. If borrowing costs end up going higher, stock deals

could potentially be a trend that continues to increase going forward.

0

50

100

150

200

250

300

0

50

100

150

200

250

300

2012 2015 2012 2015 2012 2015 2012 2015 2012 2015

A g g r e

g a t e F i r e p o w e r ( $ ,

b i l l i o n s )

A g g r

e g a t e F i r e p o w e r ( $ ,

b i l l i o n s )

2012 - Firepower at 4x




Pharma Biotech HC Providers & Svcs HC Tech & Equip Life Sc Tools & Dx

Rising interest rates

unlikely to be aheadwind



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Exhibit 16: Correlation with US M&A Volumes as percentage of market cap (1995 – 2014)

Source: Federal Reserve, Dealogic, Bloomberg, FactSet, iBoxx, Goldman Sachs Global Investment Research

78%72%

64% 61% 59%53% 51%

-7%-17%

-22% -23%

-55%



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Exhibit 17: Health Care announced M&A volumes by payment type

Source: Dealogic, Goldman Sachs Global Investment Research. As of November 30, 2015.

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

0

100

200

300

400

500

600

Stock Only Cash / Stock & Other Cash Only Cash Only (%, RHS) 20yr Avg. ('95-'14)

2015TD, All-Cash

deals represent just25% of total

volumes, well below20-year average

levels (47%).


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Fi i l b li t C i ith th hi h t IRR


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Financial buyer list: Companies with the highest IRRs

In addition to our analyst-driven Healthcare Strategic Assets basket, we provide a list of companies in our US Healthcare coverage

universe with IRRs over 15% based on our quantitative standardized departmental LBO model.

Assumptions: As a base case, this purely quantitative model (applicable to our non-financial coverage) assumes a five-year holding

period, a 20% premium, initial leverage based on S&P GICS Level 1 sector-specific debt/EBITDA multiples (median plus 1 standarddeviation; and rent-adjusted for Retail companies), a 7% weighted average cost of debt, and an exit multiple based on a company’s

three-year historical EV/EBITDA. 2016 is year 1. Operational assumptions for sales growth, EBITDA margin and capex growth are

taken from our analyst forecasts, extrapolated when required.

Taking size into consideration, we exclude any companies with a market cap of over $15 bn (and under $200 mn), those who already

operate with high leverage and Managed Care names. In addition, we exclude relatively recent IPOs (those priced since January 1,

2013).

Given the variety of qualitative and industry-specific factors that go into a leveraged buyout, we do not necessarily believe that each

of the companies with IRRs greater than 15%, is a viable buyout candidate. However, a high IRR, at the very least, serves as apositive valuation signpost.

This list includes all stocks under our coverage irrespective of our analysts’ ratings.

Exhibit 21: Healthcare companies with IRRs of 15% or moreIRRs based on our standardized departmental LBO model (IRRs and pricing as of the market close of December 15, 2015

M&A rank definitions are provided in the M&A framework section on page 3.

Source: Goldman Sachs Global Investment Research.

Ticker Company name IRR Market Cap Sector Rating Last Price

Target

Price

Upside To

Price Target

($, mn) ($) ($) Target PeriodTMH Team Health Holdings 21.7% 3,256 Providers Neutral 44.94 63.00 40% 12 months

JAZZ Jazz Pharmaceuticals 19.9% 8,516 Specialty & SMID Pharma Neutral 138.47 154.00 11% 12 months

AMSG Amsurg Corp. 18.7% 4,048 Providers Buy 83.55 101.00 21% 12 months

IPXL Impax Laboratories Inc. 16.1% 2,949 Specialty & SMID Pharma Neutral 41.82 40.00 -4% 12 monthsLPNT LifePoint Health Inc. 15.4% 3,015 Hospitals Buy 69.28 84.00 21% 12 months


Rating and pricing information


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Rating and pricing information

AbbVie Inc. (B/A, $57.63), Adeptus Health Inc. (B/A, $52.01), Alere Inc. (B/N, $39.70), Alexion Pharmaceuticals Inc. (N/N, $188.91),

Amgen Inc. (B/N, $164.58), Baxter International Inc. (B/N, $37.83), Boston Scientific Corp. (B/A, $18.88), Bristol-Myers Squibb Co. (B/A,

$70.71), Cardinal Health Inc. (B/N, $88.22), Cerner Corp. (B/N, $61.16), Cigna Corp. (B/N, $141.19), Dimension Therapeutics (B/N,

$9.98), Endo International Plc (B/A, $62.03), Envision Healthcare Holdings (B/N, $24.02), Evolent Health Inc. (B/N, $13.39), FibroGen

Inc. (B/N, $30.78), Hologic Inc. (B/N, $38.99), Horizon Pharma Plc (B/A, $21.15), INC Research Holdings (B/A, $48.00), Intuitive Surgical

Inc. (B/A, $545.13), McKesson Corp. (B/N, $190.72), Medtronic plc (B/A, $78.57), Mylan NV (B/A, $54.39), Quintiles Transnational

Holdings (B/A, $68.73), Regeneron Pharmaceuticals Inc. (B/N, $559.67), Stryker Corp. (B/A, $93.93), Teva Pharmaceuticals (B/A,

$65.87), Thermo Fisher Scientific Inc. (B/A, $140.45), VWR Corp. (B/A, $26.40) and ZELTIQ Aesthetics Inc. (B/A, $28.25).

Equity basket disclosure

The ability to trade the basket(s) discussed in this research will depend upon market conditions, including liquidity and borrow

constraints at the time of trade.


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Documents

2016 Healthcare Outlook