Novartis AG Investor Relations...Fluid is a critical marker for treatment and switching decisions...
Transcript of 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
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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
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
Novartis investor presentation | Beovu® approval | October 8, 20196
Despite advances in therapy significant opportunity exists in wAMD market 1,2
Novartis investor presentation | Beovu® approval | October 8, 20197
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
wAMD = wet Age Related Macular Degeneration
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
Novartis investor presentation | Beovu® approval | October 8, 20198
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.
wAMD = wet Age Related Macular Degeneration
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
Novartis investor presentation | Beovu® approval | October 8, 20199
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.
Novartis investor presentation | Beovu® approval | October 8, 201911
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
Novartis investor presentation | Beovu® approval | October 8, 201912
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
13 Novartis investor presentation | Beovu® approval | October 8, 2019
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
Novartis investor presentation | Beovu® approval | October 8, 201914
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
15 Novartis investor presentation | Beovu® approval | October 8, 2019
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
Novartis investor presentation | Beovu® approval | October 8, 201917
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
Novartis investor presentation | Beovu® approval | October 8, 201918
wAMD = wet Age Related Macular Degeneration
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
Novartis investor presentation | Beovu® approval | October 8, 201920
wAMD = Wet Age Related Macular Degeneration