Novartis AG Investor Relations...Fluid is a critical marker for treatment and switching decisions...

Beovu® FDA ApprovalOctober 8, 2019

Novartis AG

Investor Relations

Disclaimer

2 Novartis investor presentation | Beovu® approval | October 8, 2019

This presentation contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995 that can generally

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similar expressions, or by express or implied discussions regarding Beovu and other approved and potential new products, potential new indications, approvals

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Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this presentation as of this date and does not

undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.

Marie-France TschudinPresident of Novartis Pharmaceuticals

Paul SpittleHead of Global Product &

Portfolio Strategy Pharma

Retina Rare diseases Ocular surface disease/ refractive disorders Regenerative medicines (glaucoma)

Novartis - #1 pharma company in Ophthalmology1 with strong pipeline, commercial portfolio and global footprint

More than 70 brands across front and back of the eye

Reaching ~150M patients in 125 countries every year

Strong innovation track record in small molecules, biologics, and cell & gene therapy

1. Ranking based on IMS 2018 sales. Source: Patient Reach Brand Dashboard Period Feb 2019; FY2018. 2. Ex-US only. 3. Beovu has been approved in the US for wAMD. It has not received marketing authorization or regulatory approval in

any other jurisdiction. 4. Novartis Global Drug Development Pipeline. The safety and efficacy of these compounds have not been evaluated by any regulatory authorities and they have not received regulatory approval in any jurisdiction. 5. Ex-

EU only.

wAMD = wet Age Related Macular Degeneration

2

3

2

LKA651macular edema 4

CPK850gene therapy for retinitis pigmentosa4

ECF843Adry eye4,5

SAF312chronic ocular surface pain 4

UNR844presbyopia 4

Novartis investor presentation | Beovu® approval | October 8, 20195

https://www.google.com/url?sa=i&source=images&cd=&ved=2ahUKEwjL3vfV0f7kAhWMjqQKHZg8Df0QjRx6BAgBEAQ&url=https%3A%2F%2Fwww.durezolhcp.com%2F&psig=AOvVaw3t_v069_px1pntmGjvKa3g&ust=1570142195518876

Fluid is a critical marker for treatment and switching decisions

For ~90% of survey participants fluid on OCT is

THE major driver of re-treatment in wAMD

Among responders, insufficient fluid resolution

is the key reason to switch anti-VEGF therapy

Source: 21st annual American Society of Retina Specialists (ASRS) PAT 2019 annual membership survey; ASRS 2019, Chicago, IL.

OCT = Optical Coherence Tomography; wAMD = wet Age Related Macular Degeneration; VEGF = Vascular Endothelial Growth Factor; PAT = Preferences and Trends


Despite advances in therapy significant opportunity exists in wAMD market 1,2


Source: 1. 1. Novartis analysis of IQVIA medical claims data with US nAMD patients on anti-VEGF therapies; January 2014 – July 2017; 2. 21st annual American Society of Retina Specialists (ASRS) PAT 2019 annual membership

survey; ASRS 2019, Chicago, IL. 3. Varano M, et al. Current barriers to treatment for wet age-related macular degeneration (wAMD): findings from the wAMD patient and caregiver survey. Clin Ophthalmol. 2015;9:2243–2250. 4. Gohil R, et al.

Caregiver Burden in Patients Receiving Ranibizumab Therapy for Neovascular Age Related Macular Degeneration. PLoS ONE. 2015;10(6):e0129361


Frequent injections can overwhelm

patients – many stop therapy, which

could result in vision loss3,4

~30% of wAMD patients drop off

therapy each year1

>50% retina specialists believe patients

are being undertreated with current

available therapy2

Beovu® - addressing unmet need and principle treatment objective with greater fluid control1


Unmet need Beovu®

Less retinal fluid ▶ Greater fluid resolution1

Poor adherence and sub-optimal

outcomes related to injection burden▶ Longer treatment intervals achievable4

wAMD remains leading cause of

severe & irreversible vision loss2,3▶ Robust vision gains

1. At Week 48, demonstrated superiority in three secondary endpoints considered key markers of wAMD in clinical practice: central subfield retinal thickness, retinal fluid (intraretinal fluid and/or subretinal fluid) and disease activity; advantages

maintained at Week 96. 2.Schmidt-Erfurth U, et al. Br J Ophthalmol. 2014;98:1144-67. 3. Wong WL, et al. Lancet Glob Health. 2014;2:e106-e116. 4. At Week 48, the majority of patients (56% and 51%) were maintained on q12w injection

interval in Hawk and Harrier respectively with remaining patients on q8w regimen (key secondary endpoints); greater than 75% of these patients continued on q12w dosing up to Week 96.


Global anti-VEGF market estimated to reach USD 13.3bn in 2024, driven by aging and diabetic prevalence

2018 2024E

wet AMD Other Indications

10.9bn1

1. 2018 aflibercept and ranibizumab actuals, Evaluate Pharma. 2. Estimated growth rate, Decision Resources Group, 2018.

AMD = Age Related Macular Degeneration; VEGF = Vascular Endothelial Growth Factor

13.3bn

4%

CAGR2


Branded anti-VEGF marketUSD billion

Dirk SauerGlobal Development Unit Head Ophthalmology

HAWK & HARRIER showed robust vision gains and greater reduction in fluid with fewer injections

Brolucizumab provided robust vision gains, similar to

aflibercept1

Brolucizumab demonstrated greater reduction in retinal

fluid and central retinal thickness vs aflibercept2

Majority of patients maintained on a q12W dosing

immediately after loading and through week 48, and most

of these patients continued on a q12w interval to week 963

The overall safety profile was comparable to aflibercept

Non-inferiority study of

Brolucizumab 3 mg

(HAWK) and 6 mg (HAWK

& HARRIER) administered

q8w or q12w (after loading

doses) vs. Aflibercept 2 mg

administered q8w (after

loading doses)

BCVA = best corrected visual acuity; CST = central subfield thickness; IRF = intraretinal fluid; q12w = every 12 weeks; SRF = subretinal fluid; VEGF = vascular endothelial growth factor.

Notes based on HAWK & HARRIER: 1. Met primary efficacy endpoint of noninferiority to aflibercept in mean change in BCVA at Week 48 with comparable safety to aflibercept; vision gains comparable to aflibercept up to Week 96.

2. At Week 48, demonstrated superiority in three secondary endpoints considered key markers of nAMD in clinical practice: central subfield retinal thickness, retinal fluid (intraretinal fluid and/or subretinal fluid) and disease activity; advantages

maintained at Week 96; 3. At Week 48, the majority of patients (56% and 51%) were maintained on q12w injection interval in Hawk and Harrier respectively with remaining patients on q8w regimen (key secondary endpoints); Of patients on the

q12w interval at Week 48, greater than 75% of these patients continued on q12w dosing up to Week 96.


The recommended dose for BEOVU is 6 mg (0.05 mL of 120

mg/mL solution) administered by intravitreal injection monthly

(approximately every 25-31 days) for the first three doses,

followed by 6 mg (0.05 mL) by intravitreal injection

once every 8-12 weeks

Beovu® US label – flexible dosing without compromising efficacy

BEOVU is indicated for the treatment of Neovascular

(Wet) Age-related Macular Degeneration (AMD)

Indication statement1

Dosage and administration1

The only anti-VEGF

recommended to start eligible

patients on q12w intervals

immediately after loading

Same loading regimen as

other anti-VEGFs

Flexible dosing without

compromising efficacy at

indicated frequencies


1. BEOVU [prescribing information] East Hanover, NJ. Novartis: 2019

AMD = Age Related Macular Degeneration; VEGF = Vascular Endothelial Growth Factor; q12w = every 12 weeks

Beovu® US label – uncompromised vision, fewer injections, less retinal fluid


Efficacy1, 2 In both studies, after three initial monthly doses (Week 0, 4 and 8), treating physicians decided whether to

treat each individual patient on an every 8 week or 12 week dosing interval guided by visual and

anatomical measures of disease activity, although the utility of these measures has not been

established.

In both studies, Beovu® treated patients had a similar mean change from baseline in BCVA as the

patients treated with aflibercept 2 mg (fixed every 8 weeks).

Through Week 48, 56% (HAWK) and 51% (HARRIER) of patients remained on Beovu® every 12

weeks.

Pharmaco-

dynamics1, 2

Leakage of blood and fluid from choroidal neovascularization (CNV) may cause retinal thickening or

edema. Reductions in central retinal subfield thickness (CST) were observed across all treatment

arms.

Safety1, 2 Most common adverse reactions (≥5%): Vision blurred, cataract, conjunctival hemorrhage, eye pain,

vitreous floaters.

The overall safety profile was comparable to aflibercept.

1. BEOVU [prescribing information] East Hanover, NJ. Novartis: 2019. 2. Dugel P, at al. HAWK and HARRIER: Phase 3, multicenter, randomized, double-masked trials of brolucizumab for neovascular age-related macular degeneration

[published online ahead of print]. Ophthalmology. 2019.

BCVA = Best Corrected Visual Acuity; CNV = choroidal neovascularization; CST = Central Retinal Subfield Thickness

BLA approval

Oct 7, 2019

MAA validated

CHMP opinion

expected

Q4 2019

“Procedure with

prior notification”

granted

Feb 2019

submission

Decision expected

Q1 2020

Feb 2019

submission

Decision expected

Q1 2020

March 2019

submission

Decision expected

Q1 2020

April 2019

submission

Decision expected

Q1/Q2 2020

Beovu® submissions completed in key markets with regulatory action dates throughout 2019 and 2020

Selected submission for Beovu® in wAMD


wAMD = Wet Age Related Macular Degeneration; BLA = Biologics License Application; CHMP = Committee for Medicinal Products for Human Use; MAA = Marketing Authorization Application

Beovu® clinical trial programs on track to explore potential new indications and gather additional evidence


DME RVO PDRAMD

A head-to-head superiority study

vs aflibercept evaluating treatment

interval duration in an identical

Treat-to-Control regimen Phase 3 head-to-head non-inferiority

studies vs aflibercept to support global

registration

CONDOR

Phase 3 non-inferiority study vs

aflibercept to support global

registration

20212 ≥20232 ≥20232,32019-20201

A head-to-head non-inferiority study

vs aflibercept evaluating the efficacy

and safety of q4w treatment

1. First expected approval date. 2. first planned submission. 3. Study name pending approval

AMD = Age related macular degeneration, DME = Diabetic Macular Edema, RVO = Retinal vein occlusion, PDR = Proliferative diabetic retinopathy; q4w = every 4 weeks

PCV studyRandomized, open-label, multicenter

study assessing the safety & efficacy

of two different dosing regimens of

brolucizumab 6 mg in patients with

symptomatic macular PCV

A head-to-head non-inferiority study

vs aflibercept evaluating the efficacy

and safety of q4w treatment

Phase 3 non-inferiority studies of

brolucizumab q12w/ q8w vs

aflibercept to support global

registration

Patrick MooneyVice President and US Franchise Head

Novartis Pharmaceuticals Corporation

Branded US anti-VEGF market represents ~50%

of WW value

Market expected to reach USD 7bn by 20281

700k wAMD patients, 200k newly diagnosed p.a.

~30% of wAMD patients drop off therapy each

year2

Branded anti-VEGF market growing rapidly in US –wAMD largest segment1,2


3,596

4,256

4,7505,139

5,773

20182014 2015 2016 2017

+13%

Source: 1. Evaluate Pharma; 2. Novartis analysis of IQVIA medical claims data with US nAMD patients on anti-VEGF therapies; January 2014 – July 2017

VGEF = Vascular Endothelial Growth Factor; AMD = Age Related Macular Degeneration; WW = Worldwide

Branded US anti-VEGF salesUSD million

Beovu® - ready for launch in US immediately upon approval

Fully staffed & trained Sales, Reimbursement and Medical teams with deep

experience in the US Retina market

Differentiated product and dosing profile at competitive price per vial (USD 1,850)

Competitive programs to support broad patient access

Product available from specialty distributors same week of approval

Innovative patient access program with real time benefit response for

majority of wAMD patients available at launch

Comprehensive patient and caregiver support program available at launch



Marie-France TschudinPresident of Novartis Pharmaceuticals

Conclusion

Beovu® addresses major unmet need of under-treatment in wAMD

and associated vision loss

Differentiated based on greater drying properties, fewer injections

and uncompromised vision

Ready to launch in US, solidifying Novartis leadership in ophthalmology

Additional wAMD submissions throughout 2019 and 2020. Potential

new indications on track for submission from 2021 onwards


wAMD = Wet Age Related Macular Degeneration

Novartis AG Investor Relations...Fluid is a critical marker for treatment and switching decisions...

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