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Bank Deutsche	DB strategists: overweight cyclicals - short term risk
Bank Deutsche	for EU Pharma
AG/London
AG/London	Rising US 10-year bond yields and a weakening USD to weigh on relative sector performance

	■	Our sector strategists are overweight cyclicals versus defensives. They see European cyclicals as 10% below the fair-value suggesting that the
		market is already priced for a further sharp growth slowdown. However, they believe such a slowdown is unlikely, as their PMI models project that
		Euro area and global PMI momentum are set to rebound into positive territory over the coming months.
	■	Underweight pharma suggesting short-term downside risk. Our strategists are underweight Pharma which has outperformed the market strongly
		since mid-June, leaving the sector’s price relative meaningfully above the level implied by the historical relationship with US bond yields. They expect
		a rebound in PMI momentum together with shrinking global central bank balance sheets to drive up US bond yields. Combined with their expectations
		for a weaker US$, this points to near-term downside risk for Pharma's relative performance.
	■	12 month market outlook more constructive for defensives but still risks for Pharma. Our strategy team expect the Stoxx 600 to end 2019 at 345,
		~5% below current levels. This view is based on their below consensus projected 2019 EPS growth of 1% (vs consensus 9%) with a target 12.0x
		PE (slightly down from current levels). They expect EPS growth to weaken due to increased headwinds from Euro strength and a slight softening in
		global PMIs. This 12 month outlook would be much more constructive for defensives, particularly given our expectations for EPS growth of ~6% in
		2019 (7% ex dilution from GSK's Tesaro acquisition). However, Euro strength and upward pressure on US bond yields represents the most signiﬁcant
		risk to our more positive fundamental view.

Figure 14 : Our strategists have a below consensus view on market EPS						Figure 15 : European pharma's price relative tends to move inversely to
growth						US 10-year bond yields, but has become disconnected recently
9%											US 10-year bond yield (lhs)
	Factors behind move in Stoxx 600 12-month trailing EPS										Strategy US 10-year bond yield forecast (lhs)
8%	from end-18 to end-19		1.1%				-160				European pharma vs market (rhs)			24%
8%				-5.8%			-160							24%


7%		1.3%				invyields,bondUSinchg6m(bps)	-120							18%	6mmarketvspharmaEuropeanchg (%)
6%	5.5%					invyields,bondUSinchg6m(bps)	-80							12%	6mmarketvspharmaEuropeanchg (%)
6%	5.5%						-80							12%
5%							-40							6%
4%							0							0%
3%							40							-6%
2%					1.3%		80							-12%
1%							120							-18%
0%							160							-24%
	Global growth	Commodities	Bund	EUR TWI	Overall		2004	2006	2008	2010	2012	2014	2016	2018

11Page	Source: Datastream, Haver, Deutsche Bank	Source: Datastream, Deutsche Bank
	Source: Datastream, Haver, Deutsche Bank	Source: Datastream, Deutsche Bank

2018 December 10 Pharmaceuticals Pharmaceuticals European

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Page	What’s changed for our 2019 outlook?
12

	Key forecast, recommendation and TP changes

■Our large cap target prices are generally based on a blend of DCF and target PE. We now use a target PE of 16x our 2020 Core EPS forecasts (rolled forward from 2019).

■For detailed valuation & risk comments for each company please see Appendix B - Price targets and risks

Figure 16 : Summary of earnings estimates and target price changes

Company	2018E	2019E	2020E	2021E	2022E	New Rating	Prev. Rating	TP	TP change	Comments

EU major Pharma
AstraZeneca	0.1%	-1.4%	-1.8%	-1.4%	-1.1%	Buy	Buy	6,900	6.2%	Dilution from Synagis deal & impact of Mystic failure; TP rolled forward
Bayer	0.0%	0.0%	0.0%	0.0%	0.0%	Buy	Buy	115	0.0%	Forecast unchanged as these were updated post CMD
GlaxoSmithKline	0.0%	-5.2%	-7.7%	-4.5%	0.1%	Hold	Hold	1,520	-0.3%	Impact from Tesaro acquisition and Horlick's divestment
Novartis	-0.4%	-1.2%	-1.5%	-1.9%	-1.1%	Hold	Hold	96	7.9%	Modest forecast changes. TP roll forward.
Novo Nordisk	-0.1%	-0.3%	-0.3%	-0.3%	-0.3%	Buy	Buy	355	0.0%	Minimal forecast changes
Roche	2.1%	2.2%	2.8%	3.2%	4.7%	Hold	Hold	255	6.3%	Biosimilar erosion rates and assumed cost offsets from Esbriet patent expiry
Sanofi	0.9%	0.5%	0.5%	0.5%	0.6%	Buy	Buy	93	6.9%	Small uplift to BIVV001 forecasts. TP rolled forward
EU mid-cap Pharma
Evotec	0.0%	0.0%	0.0%	0.0%	0.0%	Buy	Buy	22	0.0%
Genmab	-3.8%	-21.4%	-7.3%	28.1%	-1.8%	Buy	Hold	1,250	2.5%	Updated for milestone timing; minimal changes to Darzalex forecasts
Grifols	-0.8%	-2.1%	-2.9%	-3.3%	-2.3%	Hold	Hold	25	8.7%	Reduced near-term margins but increased LT sales growth on albumin/AMBAR
Idorsia	-4.0%	-10.1%	-12.8%	-1.6%	6.5%	Buy	Buy	29	0.0%	Adjusted cashburn spend timing; overall cash runway unchanged
Lundbeck	0.0%	-2.1%	-0.8%	-0.4%	-0.2%	Sell	Sell	225	-6.3%	Fx, Onfi erosion rate. DCF based TP rolled forward.
Merck KGaA	0.0%	0.0%	0.0%	0.0%	0.0%	Hold	Hold	93	0.0%
Morphosys	-4.5%	3.3%	-2.0% -30.0% 71.9%			Buy	Hold	130	8.3%	Updated for milestone timing, minimal underlying changes
Polyphor	0.0%	0.0%	0.0%	0.0%	-53.7%	Buy	Buy	78	5.4%	NPV rolled forward
SOBI	0.0%	0.4%	2.5%	3.0%	5.3%	Buy	Hold	245	22.5%	Increases to Gamifant forecasts post approval
UCB	-0.6%	-4.0%	0.6%	1.4%	7.4%	Buy	Hold	95	26.7%	Increases to long-term pipeline forecasts
Vifor	-0.2%	-7.6%	-7.0%	-9.4%	-10.8%	Hold	Hold	135	-25.0%	Reflecting a more cautious view on the uptake of Veltassa

Source: Deutsche Bank

AG/London Bank Deutsche

2018 December 10 Pharmaceuticals Pharmaceuticals European

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Bank Deutsche	Pricing: Divided congress suggests more bark but
Bank Deutsche	little bite from US pricing in 2019
AG/London
AG/London	Reform of Part B and elimination of rebates most impactful
	Reform of Part B and elimination of rebates most impactful
	■	President Trump's drug pricing blueprint has led to easing fears over detrimental changes to US drug pricing for the industry. The Blueprint
		focused on e orts to reduce high drug list pricing and out of pocket costs by improving competition, negotiating power and reducing perverse
		incentives to maintain high list prices. More damaging measures such as direct government price negotiation in Medicare Part D seem o the table.
		The proposals increase our conﬁdence that the US system is likely to remain supportive of innovation.
	■	Eliminating rebates could lead to disruption but likely neutral overall. The most dramatic proposals in Trump's Blueprint include the possibility of
		reforming the current rebating system, by either eliminating rebates altogether or making these available at the point of sale directly to the consumer. If
		successful we believe this would ultimately be broadly neutral to the Pharma sector. However, it would likely have negative implications for companies
		that have secured dominate positions in categories through aggressive rebating. It creates price transparency and in theory would allow drug utilisation
		decisions to be made on merits of added beneﬁt vs price, aiding products in competitive categories that have previously been 'shut out' of uptake
		in markets due to high rebate barriers.
	■	Medicare Part B proposals suggest any changes are unlikely to be dramatic. High on the agenda for drug price control measures have been e orts
		to reform Medicare Part B which reimburses injectable in-o ce administered drugs. CMS proposals are seeking to test whether using a combination
		of three approaches: 1) an international drug price reference; 2) a change in physician reimbursement from a percentage to a ﬂat fee; and 3) allowing
		private-sector vendors to negotiate will improve quality of care and reduce costs. However, this is planned to be implemented on a test basis which
		would be run in select geographies and phased in over a period of ﬁve years starting from Spring '20. The full proposal will be published in Spring '19.

Figure 17 : The Trump administration has focused on the growing gap					Figure 18 : Medicare Part B reform has also been a political focus
between list and net drug prices
370				35%		16%
370				35%
						14%
330				33%		12%
USDBN					RevenueTotal	12%
USDBN					RevenueTotal	10%
290				31%
						8%
250				29%		6%
250				29%
					%	4%
210				27%		2%
						2%
						0%
170				25%		Astra	Bayer	GSK	Novartis	Novo	Roche	Sanofi
2013	2014	2015	2016	2017
								Medicare Part B (% Total Revenue)

Page		RETAIL GROSS	RETAIL NET	GROSS TO NET DISCOUNT (%)
		RETAIL GROSS	RETAIL NET	GROSS TO NET DISCOUNT (%)
	Source: American Patients First. The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs; Medicine				Source: Deutsche Bank, Company data
					Source: Deutsche Bank, Company data
13	Use and Spending in the U.S.; A Review of 2017 and Outlook to 2022. April 19, 2018

2018 December 10 Pharmaceuticals Pharmaceuticals European

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Page	Biosimilars: uptake a key political target; Roche at
14	risk but delays cannot be ruled out
	risk but delays cannot be ruled out

Biologic drugs make up 25% of global drug spend = $200bn

■Pressure on healthcare costs means biosimilar approvals and utilisation are a key political focus. The FDA has taken a pragmatic approach to biosimilar ﬁlings with multiple major approvals in place (Enbrel, Remicade, Avastin and Humira). The FDA also recently published its Biosimilar Action plan, which seeks to facilitate robust and timely market competition. In addition, the Trump administration's Pricing Blueprint highlights biosimilar adoption as a strategic priority. However, impact of biosimilars has been moderated in the US by ongoing legal battles over patents and di culty for new entrants to overcome existing rebate contracts.

■Driving biosimilar uptake in Medicare Part B and eliminating rebate trap key to savings. Thus far, US biosimilars that are reimbursed via Medicare Part D have been able to gain meaningful share. However, for drugs such as Remicade (primarily Medicare Part B) uptake has been muted. This likely reﬂects a 'rebate trap', with incumbents leveraging 'all or nothing' discount schemes that limit penetration of new competition. This is particularly pertinent for Remicade as physicians are unlikely to actively switch existing patients. This limits willingness of hospitals to stock biosimilars when there is uncertainty over likely volume use. We expect these barriers to biosimilar uptake to be a key focus for legislators during 2019.

■Roche has the largest uncertainties in 2019. With broad approvals for biosimilars of Herceptin, Avastin and soon expected Rituxan by the FDA, further pressures on Roche's oncology sales are imminent (patents expire in late '18 and mid '19). Biosimilar launches in Europe have thus far had a greater impact than initially anticipated. However, the impact of US launches remains a major uncertainty. In contrast to Remicade, Roche's cancer drugs are generally shorter duration treatments meaning higher patient turnover and thus lower economic barriers for payors to o er biosimilars. We note that Roche is also continuing to defend its patent estate covering each of the big three drugs. These legal cases could signiﬁcantly delay erosion of these franchises relative to consensus forecasts.

Figure 19 : Biosimilar erosion to constrain Roche sales growth		Figure 20 : EU company exposure to biosimilar risk (2018-2023)

		8								48			50%
		8								48
BankDeutsche	salesProduct(CHFbn)	7								46	groupTotalsales (CHFbn)	of%2018E group sales	40%
BankDeutsche	salesProduct(CHFbn)	1				Rituxan (consensus)				34	groupTotalsales (CHFbn)	of%2018E group sales
		6								44
													30%
		5								42
		4								40			20%
		4								40
		3								38			10%
													10%
		2				Avastin (consensus)				36
						Herceptin (consensus)							0%
													0%
AG/London						Total pharma sales (DBe)							Astra	Bayer	GSK	Novartis	Novo	Roche	Sanofi
AG/London		0								32						Sector Average
		0								32
		2015A	2016A	2017A	2018E	2019E	2020E	2021E	2022E	2023E
		2015A	2016A	2017A	2018E	2019E	2020E	2021E	2022E	2023E
	Source: Deutsche Bank, FactSet Consensus											Source: Deutsche Bank

2018 December 10 Pharmaceuticals Pharmaceuticals European

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Bank Deutsche	Competitive categories: Limited new exclusions,
Bank Deutsche	more benign on insulins, HIV at risk?
AG/London
AG/London	Pricing in competitive categories in the US is here to stay
	Pricing in competitive categories in the US is here to stay
	■	Consolidation amongst US payors, slowing patent expiries and increasing new approvals have combined to put pressure on drug budgets and
		increase buyer purchasing power. As a result, payors have been increasing use of formulary exclusions and exclusive contracts to control cost
		inﬂation. This has led to increased pressure in categories with multiple competitors and low therapeutic di erentiation. However, total drug spend
		growth in the US has slowed from a peak in 2014, a fact we believe will continue to alleviate pressure to manage pricing.
	■	2019 will likely see minimal changes in excluded drug lists by major US formularies. Exclusion changes impacting our coverage include Eloctate
		(excluded from Express) and Symbicort (added back to Caremark) impacting Sanoﬁ/AZN.
	■	Pressures on insulins to continue but more benign than expected. Basal insulin pricing pressure triggered by launch of Lilly's biosimilar Basaglar
		has been a major drag for both Sanoﬁ and Novo in recent years. However, Merck recently terminated its Lantus biosimilar collaboration with Samsung
		Bioepis choosing not to launch its biosimilar, quoting the expected pricing and cost of production. While we expect continued price erosion in the
		segment the decision suggests pricing may be reaching somewhat of a ﬂoor and implies a more benign outlook than originally envisioned.
	■	More active management of costs a risk in HIV. Major pharmacy beneﬁt manager Express Scripts recently announced it will exclude Gilead's HIV
		drug Atripla from its formulary in 2019 in favour of Mylan's generic formulation Symﬁ (efavirenz/3TC/TDF). In addition, UnitedHeallth has introduced
		a cost saving measure to encourage utilisation of Mylan's generic Cimduo. We believe these e orts could signal a trend of more active management
		of HIV costs and price pressure in the category, which may be negative for GSK's franchise in the long term.

Figure 21 : EU company revenue exposure to competitive drug		Figure 22 : Slowdown in total drug spend increases in the US market
categories
	100%		500	20%
	90%		450	15%
	80%		450	15%
2018Eofgroup sales	80%	Spending($bn)			changeAnnual(%)
2018Eofgroup sales	30%	Spending($bn)			changeAnnual(%)
	70%		400	10%
	60%
	50%		350	5%
	50%
	40%		300	0%
%	20%		250	-5%
	20%
	10%		200	-10%
			200	-10%
	0%			2007A 2008A 2009A 2010A 2011A 2012A 2013A 2014A 2015A 2016A 2017A
	0%

Astra

Bayer

GSK

Novartis

Novo

Roche

Sanofi

Net Spending $bn (lhs)

Gross to Net Discount $bn (lhs)

Sector Average

Page

Invoice Spending Growth % (rhs)

Net Spending Growth % (rhs)

Source: Deutsche Bank estimates; Competitive categories deﬁned as % of 2018E Group sales from at risk segments i.e. Diabetes,

Source: IQVIA, National Sales Perspectives, Dec 2016; IQVIA Institute of Human Data Science

Respiratory, Cardio-metabolic, Haemophilia, HIV & genericised categories

2018 December 10 Pharmaceuticals Pharmaceuticals European

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Page	R&D productivity: Record year for new approvals but
16	pace of innovation has a catch
	pace of innovation has a catch

A record year expected for new drug approvals

■FDA approvals expected to reach a record high in 2018. Thus far the FDA has approved 55 NME/BLA’s. This is well above the 2000-2009 average of 19 and exceeds the previous record in 2017. With a further 5 novel agents still under review, the total could exceed the all time record year of 1996. We continue to believe the industry is in the middle of a super cycle of innovation driven by improved understanding of the biology of disease.

■EU Pharma approvals remain solid; outlook for '19 strong. Thus far in 2018, EU Pharma has had 9 new drug approvals that are expected to contribute close to $5bn to outer year sales, including AZN's Lumoxiti and Lokelma, Shire's Takhzyro, Roche's Xoﬂuza and Novartis' Aimovig and Lutathera, and Bayer's Vitrakvi. In addition, major new approvals for AstraZeneca's Tagrisso (1L EGFRm lung cancer) and Imﬁnzi (unresectable stage III lung cancer) have added multi-blockbuster sales in new indications. We see potential for a further 15 major new drug approvals in late '18 or '19, including three blockbusters from Novartis including AVXS-101, siponimod and RTH258. In addition, we see an early approval of Novo's oral semaglutide as possible if it utilises its priority review voucher. These drugs contribute a total of >$15bn to outer year sales.

■Rapid pace of innovation has a catch: Lifecycles getting squeezed by fast followers and serial innovation. We maintain our positive view over the pace of sector innovation. However, we note a concentrated industry focus on limited drug classes. This is highlighted by the crowded nature of certain novel drug categories (such as PARP, PD-1/PD-L1, ALKi & CDKi). This and the fast pace of obsolescence through serial innovation is squeezing the lifecycles of new drugs in some circumstances, as evidenced by fast followers in the ALK inhibitor category. As such, increasing thought needs to be given to peak sales assumptions and terminal values for drugs in high research intensity categories.

Figure 23 : Another record year for new drug approvals		Figure 24 : Onset of competition is rapid and truncates peak sales
		potential

	70															3,500
	60														(USDm)	3,000
	60
													48	59		2,500
	50										35		48			2,500
											35

	38						41	41		41		41			Sales	2,000
	38		35		36				36		45		46		Sales	2,000
	40		35	34	36				36	41	45		46
				34
		26						39							Worldwide	1,500
Deutsche		26						39								1,500
Deutsche	30					23
						23	30									1,000
							30		27							1,000
	20			24	26				27
					26
		22				21						22				500
	20	22										22
			18


	10															-
																-
Bank	0															2013A	2014A	2015A	2016A	2017A	2018E	2019E	2020E	2021E	2022E	2023E
Bank

	2005	2006	2007	2008	2009	2010	2011	2012	2013	2014	2015	2016	2017	2018*		Xalkori (crizotinib) - Pfizer						Zykadia (ceritinib) - Novartis
																Xalkori (crizotinib) - Pfizer						Zykadia (ceritinib) - Novartis
AG/London		NME/new BLA Approvals					NME/BLA Filings				Average Approvals					Alecensa (alectinib) - Roche/Chugai						Alunbrig (brigatinib) - Takeda
		NME/new BLA Approvals					NME/BLA Filings				Average Approvals
											(2005-2018)					Lorbrena (lorlatinib) - Pfizer						entrectinib - Roche/Chugai
	Source: Deutsche Bank, FDA *DB estimate														Source: Evaluate Pharma

2018 December 10 Pharmaceuticals Pharmaceuticals European

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Bank Deutsche	New launches in 2019 key for Novartis and Roche

	Drugs to be launched in '19 should add >$15bn to outer year sales
AG/London		specialty launches have continued to meet or beat expectations as highlighted by strong launches of AZN's Imﬁnzi, Tagrisso and Fasenra in key
	■	Given a tougher US payor environment the pace of new drug launches has been a sector debate, with disappointing launches in cardiovascular
		disease (Novarts’ Entresto; Sanoﬁ’s Praluent) weighing on sentiment and impacting share prices in past years. However, oncology and innovative
		indications during 2018. Even PD-1's/PD-L1's have beat initial expectations, but unfortunately not Roche's Tecentriq.
	■	>12 major new drug launches expected in 2019, with potential to deliver >$15bn in peak sales. This rate of portfolio rejuvenation for the sector
		is above the rate we believe is required for the sector to derive a positive rate of return on investment. New launches include AVXS-101 (spinal
		muscular atrophy; Novartis), RTH258 (wet AMD; Novartis), siponimod (secondary progressive multiple sclerosis; Novartis), polatuzumab (DLBCL;
		Roche), potentially risdiplam (spinal muscular atrophy; Roche) and oral-semaglutide (diabetes; Novo Nordisk). We expect these new drugs to go on
		to deliver >$15bn in sales. We see Novartis as most sensitive to the performance of expected new launches in 2019.
	■	New product sales underpin our expectations for an acceleration in EPS growth DBe '18-23E EPS CAGR of 7%. We expect new product sales to
		drive a 5% CAGR in revenues over '18-23E, more than o setting relatively modest impact from patent expiries and erosion of legacy portfolios from
		biosimilars over this period.
	■	~ 75% of new products sales from oncology/innovative/specialty segments. Importantly, only a minor proportion of forecasts for new product sales
		within the sector are derived from segments where access is more challenging or where price competition is intense (cardiovascular/diabetes/primary
		care/respiratory).

	Figure 25 : Key new drug launches in 2019 ($m)		Figure 26 : New product launches in 2019 to add ~$14bn sales by
			2024E, all new launches since 2015 reaching >$70bn.

Drug	Indication	Company	DB 2024E	Consensus		90,000									45%
			($m)	2024E ($m)		90,000									45%
			($m)	2024E ($m)
						80,000									40%
Oral semaglutide	Diabetes	Novo Nordisk	4,587	2,600		70,000									35%
Siponimod (BAF312)	SPMS	Novartis	2,150	841		70,000									35%
Siponimod (BAF312)	SPMS	Novartis	2,150	841
Brolucizumab (RTH258)	wet AMD	Novartis	1,890	1,062		60,000									30%
AVXS-101	SMA	Novartis	1,750	1,370	USDM	50,000									25%
Risdiplam	SMA	Roche	900	151		50,000									25%


Alpelisib	PIK3Am breast cancer	Novartis	700	127		40,000									20%
Polatuzumab	DLBCL	Roche	630	458		30,000									15%
Sotagliflozin	Type I diabetes	Sanofi	592	767		30,000									15%
Sotagliflozin	Type I diabetes	Sanofi	592	767
Larotrectinib	TRK/ROS1m lung cancer	Bayer	546	484		20,000									10%
Isatuximab	Multiple myeloma	Sanofi	531	479		10,000									5%
Entrectinib	TRK/ROS1m lung cancer	Roche	380	377		10,000									5%
Entrectinib	TRK/ROS1m lung cancer	Roche	380	377
						-									0%
						2015A	2016A	2017A	2018E	2019E	2020E	2021E	2022E	2023E	2024E

		LAUNCHES IN 2019	RECENT LAUNCHES	AS % OF SECTOR REVENUES (RHS)
		LAUNCHES IN 2019	RECENT LAUNCHES	AS % OF SECTOR REVENUES (RHS)
Source: Deutsche Bank	Source: Deutsche Bank, Company data. Recent launches deﬁned as product launches in 2015 - 2018. Sector revenues deﬁned as
Source: Deutsche Bank
17Page	Pharmaceuticals & Vaccines revenues for our European large cap coverage, excluding Shire.

2018 December 10 Pharmaceuticals Pharmaceuticals European

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Page	Consensus forecasts for growth products are
18	favourable
	favourable

Key growth drivers have relatively undemanding consensus expectations

Figure 27 : Tagrisso (AZN)

Figure 28 : Ocrevus (Roche)

900

$50m/$50m per quarter

1,200

CHF55m/CHF100m per

800

quarter required to meet

1,000

consensus/DB forecasts

700

(USDm)

600

$65m per quarter

(CHFm)

800

added to sales

CHF80m per quarter

500

600

added to sales

sales

400

sales

Global

300

Global

400

200

100

4Q17A

1Q18A

2Q18A

3Q18A

4Q18E

1Q19E

2Q19E

3Q19E

4Q19E

4Q17A

1Q18A

2Q18A

3Q18A

4Q18E

1Q19E

2Q19E

3Q19E

4Q19E

Consensus (FactSet)

Deutsche Bank

Consensus (FactSet)

Deutsche Bank

Source: Deutsche Bank, FactSet

Figure 29 : Cosentyx (Novartis)

Figure 30 : Dupixent (Sanoﬁ)

1,200

$25m/$60m per quarter

600

€30m/€75m per quarter

required to meet

1,000

consensus/DB forecasts

500

required to meet

consensus/DB forecasts

(USDm)salesGlobal

$50m per quarter

(EURm)salesGlobal

800

added to sales

400

600

300

€40m per quarter

400

200

added to sales

Deutsche

200

100

4Q17A

1Q18A

2Q18A

3Q18A

4Q18E

1Q19E

2Q19E

3Q19E

4Q19E

4Q17A

1Q18A

2Q18A

3Q18A

4Q18E

1Q19E

2Q19E

3Q19E

4Q19E

Consensus (FactSet)

Deutsche Bank

Consensus (FactSet)

Deutsche Bank

AG/London Bank

Source: Deutsche Bank, FactSet

2018 December 10 Pharmaceuticals Pharmaceuticals European

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Bank Deutsche	2019 large cap catalysts: most optionality at AZN &
	2019 large cap catalysts: most optionality at AZN &
	Novartis
AG/London
AG/London	Phase III readouts expected from ~18 major programmes in '19

	■	$15bn in future new sales on the table in '19 Most upside optionality likely at AZN and Novartis. We expect Phase III de-risking data to report on
		~18 major programmes during 2019. Collectively, these drugs could in theory deliver ~$15bn in future sales potential. We see greatest potential for
		swings to investor expectations for AZN and Novartis. For AZN, focus will be on an integrated safety analysis of trials of roxadustat in 1Q19 and from
		trials of Lynparza in new potential indications. For Novartis, results of subcut CD20 antibody ofatumumab in relapsing remitting multiple sclerosis
		and trials of fevipiprant in severe asthma could open up a major opportunities.

	Figure 31 : Key Phase III readouts in 2019
	Company	Timing	Sales	Current DB	Cons '23E	Drug	Indication	DB comment
			potential*	'23E	(USDm)
				(USDm)

	AZN	2019	>$1bn	$2,500m	$2,134m	Lynparza	1L BRCAm pancreatic cancer (POLO-1), 1L	Positive data fom PAOLO-1 in unselected ovarian cancer repesents a >$2bn
							ovarian cancer (PAOLA-1) and 2L prostate	opportunity
							cancer (PROFOUND)
	AZN	2019	>$1bn	$3,204m	$3,575m	Imfinzi	1L SCCHN (KESTREL), 1L SCLC (CASPIAN), 1L	Smaller opportunities but potential to expand utility outside of core Stage III NSCLC
							bladder cancer (DANUBE)	indication
	AZN	1H19	$1-3bn	$991m	$704m	Roxadustat	Anaemia in kidney disease	Cardiovascular outcomes analysis in 1Q19 is key to differentiation and market
								potential
	AZN	1H19	$500m+	$2,041m	$2,186m	Brilinta	THEMIS - type 2 diabetes with previous
							MI/stroke
	AZN	2H19	>$1bn	$1,482m	$1,232m	Calquence	Chronic lymphocytic leukaemia	Positive data would enable potential approval in the multi-blockbuster CLL
								indication. However, data from head-to-head trials with Imbruvica will likely be
								required to achieve meaningful market share.
	Bayer	1Q19	$500m	$136m	$271m	Aliqopa	2L+ Non-Hodgkin's lymphoma
	Bayer	1H19	>$1bn	$376m	$450m	Daralutamide	Castration resistant prostate cancer	Presentation of detailed data in 1H19 could be share price moving if it demonstrates
								an efficacy advantage or clear safety benefit vs already launched competitors
	GSK	1H19	<$500m	$1,079m	$953m	Trelegy	Asthma	Incremental opportunity (<$500m) given modest current use of LAMAs in asthma
								treatment
	GSK	1H19	$500m	$489m	$250m	BCMA-ADC	4L r/r multiple myeloma (P2 pivotal)	GSK's most promising pipeline asset but likely to be entering a competitive field of
								BCMA targetting therapies and in an initially limited 4L setting.
	Novartis	2H19	>$1bn	$1,200m	$900m	Ofatumumab	Multiple sclerosis	Potential to compete with Roche's blockbuster Ocrevus with the advantage of
						subcut		monthly subcut dosing and faster immune reconstitution
	Novartis	2H19	>$1bn	$500m	$405m	Fevipiprant	Moderate/severe asthma	Efficacy profile requires characterisation in Phase III trials to evaluate positioning in
								the treatment paradigm
	Novartis	2H19	$500m	$0m	$150m	Spartalizumab	1L metastatic melanoma, combo with Tafinlar & Launching in a competitive field of PD-1 inhibitors
							Mekinist
	Roche	1H19	$600m	$2,275m	$3,854m	Tecentriq	1L TNBC combo with paclitaxel (IMpassion131), TNBC represents a ~$600m opportunity but data from Merck's Keynote-355 trial of
							1L neo-adj breast cancer combo with nab-pac	pembrolizumab in a similar setting is expected in 2019
							(IMpassion031)
	Roche	2H19	$500m	$1,425m	$1,297m	Kadcyla	KAITLIN - operable HER2+ breast cancer
	Sanofi	1Q19	$500m	$393m	$0m	Isatuximab	ICARIA - r/r multiple myeloma	First Phase III data of Darzalex fast follower
Page	Sanofi	2H19	>$1bn	$0m	$0m	Fitusiran	Haemophilia A & B with/without inhibitors	Favourable safety profile required to allay concerns over pro-thrombotic risks
	Source: Deutsche Bank, * - peak sales potential includes sales across all indications

19
19

2018 December 10 Pharmaceuticals Pharmaceuticals European

vk.com/id446425943

Page	Mid cap coverage: More Bullish on mid cap catalysts
20	in 2019
	in 2019

We are more bullish on the pipelines of our mid cap coverage in 2019

■We have previously been cautious on much of our mid cap coverage. This reﬂected both high valuations and structural challenges with immature pipelines. However, valuation appear more reasonable in 2019 and we expect to see Genmab's early stage pipeline begin to mature and key Phase III readouts from Idorsia (clazosentan/ponesimod), UCB (bimekizumab) and Genmab/Novartis (subcut ofatumumab).

■Detailed Phase II data for UCB's FcRn inhibitor rozanolixizumab at American Academy of Neurology should increase confidence in blockbuster potential. Early clinical data suggest FcRn inhibition is e ective in reducing pathogenic IgG levels and thus improving disease outcomes in various autoantibody driven autoimmune diseases. We see strong proof-of-concept and mechanistic rationale in the treatment of myasthenia gravis (MG), immune thrombocytopenia (ITP) and pemphigus vulgaris (PV). We believe these settings have ~$3bn in sales potential, with upside to $7bn if planned Phase II trials in chronic inﬂammatory demyelinating polyneuropathy (CIDP) report positively in 2020. We expect data from UCB's Phase II trial to be presented at the AAN conference in May to conﬁrm its competitiveness in this potential multi-blockbuster class.

	Figure 32 : Mid-cap catalysts 2019				Figure 33 : FcRn drug class market potential
	Company	Drug	Timing	Description
	Genmab	Darzalex	Mid-19	Approval for 1L MM based on MAIA data	Pemphigus
	Genmab	Ofatumumab	2H19	Phase III data in multiple sclerosis	Pemphigus
	Genmab	Ofatumumab	2H19	Phase III data in multiple sclerosis	504	Myasthenia Gravis
	Genmab	Tisotumab vedotin	2019	Data from Phase I/II trials in multiple solid tumours	504	Myasthenia Gravis
	Genmab	Tisotumab vedotin	2019	Data from Phase I/II trials in multiple solid tumours		1188
						1188
	Genmab	DuoBody-CD3xCD20	2019	First clinical data from Phase I/II study in B-cell cancer
	Genmab	HexaBody DR5/DR5	2019	First clinical data from Phase I/II study in solid tumors
	Genmab	HuMax-AXL-ADC	2019	First clinical data from Phase I/II study in solid tumors
	Idorsia	Clazosentan	1Q19	Results of Phase III in SAH in Japan
	Idorsia	Ponesimod	Mid-19	Phase III data in multiple sclerosis
	Lundbeck	Rexulti	1H19	Phase III data in bipolar disorder
	Lundbeck	Foliglurax	1H19	Results of Phase II AMBLED study in Parkinson's		ITP
	SOBI	Gamifant	2019	Performance of US launch		ITP
	SOBI	Gamifant	2019	Performance of US launch		1197.504
	UCB	Evenity	1H19	FDA approval decision in osteoporosis		1197.504
	UCB	Evenity	1H19	FDA approval decision in osteoporosis
	UCB	Rozanolixizumab	May-19	Publication of data at AAN conf. from Phase II trial in MG
	UCB	Bimekizumab	2H19	Phase III data from psoriasis programme
					CIDP
					4032
AG/LondonBankDeutsche	Source: Deutsche Bank				Source: Deutsche Bank
AG/LondonBankDeutsche

2018 December 10 Pharmaceuticals Pharmaceuticals European

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