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Aerie Pharmaceuticals OverviewOIS @ ASCRS
May 2019
OIS @ ASCRS 2019; Refer to the full Rhopressa® and Rocklatan ® product labels at www.rhopressa.com and www.rocklatan.com, respectively. AR-13503 and AR-1105 have not been FDA approved. US-CC-NP-0015
2
Important InformationThe information in this presentation does not contain all of the information that a potential investor should review before investing in Aerie shares. The descriptions of Aerie Pharmaceuticals, Inc. (the “Company” or “Aerie”) in this presentation are qualified in their entirety by reference to reports filed with the SEC. Certain information in this presentation has been obtained from outside sources or anecdotal in nature. While such information is believed to be reliable for the purposes used herein, no representations are made as to the accuracy or completeness thereof and we take no responsibility for such information.
Any discussion of the potential use or expected success of Rhopressa® (netarsudil ophthalmic solution) 0.02%, or Rocklatan® (netarsudil and latanoprost ophthalmic solution) 0,02%/0.005%, with respect to foreign approval or additional indications, and our current or any future product candidates is subject to regulatory approval. In addition, any discussion of U.S. Food and Drug Administration (“FDA”) approval of Rhopressa® or Rocklatan® does not guarantee successful commercialization of Rhopressa® or Rocklatan®. For more information on Rhopressa®, or Rocklatan®, including prescribing information, refer to the full Rhopressa® product label at www.rhopressa.com and the full Rocklatan® product label at www.rocklatan.com.
The information in this presentation is current only as of its date and may have changed or may change in the future. We undertake no obligation to update this information in light of new information, future events or otherwise. We are not making any representation or warranty that the information in this presentation is accurate or complete.
Certain statements in this presentation, including any guidance or timelines presented herein, are “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “will,” “should,” “would,” “could,” “believe,” “expects,” “anticipates,” “plans,” “intends,” “estimates,” “targets,” “projects,” “potential” or similar expressions are intended to identify these forward-looking statements. These statements are based on the Company’s current plans and expectations. Known and unknown risks, uncertainties and other factors could cause actual results to differ materially from those contemplated by the statements. In evaluating these statements, you should specifically consider various factors that may cause our actual results to differ materially from any forward-looking statements. In particular, FDA approval of Rhopressa® andRocklatan®, does not guarantee approval of any other product candidates and there can be no assurance that we will receive FDA approval for any future product candidates. Any top line data presented herein is preliminary and based solely on information available to us as of the date of this presentation and additional information about the results may be disclosed at any time. FDA approval of Rhopressa® or Rocklatan® also does not constitute regulatory approval of either product in jurisdictions outside the United States and there can be no assurance that we will receive regulatory approval for Rhopressa® or Rocklatan® in jurisdictions outside the United States. In addition, the preclinical research discussed in this presentation including, without limitation, the development efforts stemming from Aerie’s collaboration with DSM for the treatment of age-related macular degeneration or other ophthalmic uses, is preliminary and the outcome of such preclinical studies may not be predictive of the outcome of later trials. Any future clinical trial results may not demonstrate safety and efficacy sufficient to obtain regulatory approval related to the preclinical research findings discussed in this presentation. These risks and uncertainties are described more fully in the quarterly and annual reports that we file with the SEC, particularly in the sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” Such forward-looking statements only speak as of the date they are made. We undertake no obligation to publicly update or revise any forward-looking statements, whether because of new information, future events or otherwise, except as otherwise required by law.
OIS @ ASCRS 2019; Refer to the full Rhopressa® and Rocklatan ® product labels at www.rhopressa.com and www.rocklatan.com, respectively. AR-13503 and AR-1105 have not been FDA approved. US-CC-NP-0015
3OIS @ ASCRS 2019; Refer to the full Rhopressa® and Rocklatan ® product labels at www.rhopressa.com and www.rocklatan.com, respectively. AR-13503 and AR-1105 have not been FDA approved. US-CC-NP-0015
Aerie Pharmaceuticals, Inc. at OIS 2014
Building the Next Major Ophthalmic Pharmaceutical Company
4
2014: Building the Next Major Ophthalmic Pharmaceutical Company
Raising $$, Phase 3 (Rhopressa®) and Phase 2 (Rocklatan®) studies
• Completed IPO – raised $68 M (Q4 ‘13)
• Completed Rocklatan® Phase 2b study (Q2 ‘14)
• Initiated Rhopressa® Phase 3 study (Q3 ‘14)
• Additional $125 M financing (Q3 ‘14)
OIS @ ASCRS 2019; Refer to the full Rhopressa® and Rocklatan ® product labels at www.rhopressa.com and www.rocklatan.com, respectively. AR-13503 and AR-1105 have not been FDA approved. US-CC-NP-0015
5
2019:Building the Next Major Ophthalmic Pharmaceutical Company
#1. U.S. glaucoma market – #1 prescription eye drop market: $3 Billion
#2. European glaucoma market – 2nd largest prescription eye drop market: $1 Billion
#3. Japan glaucoma market– 3rd largest prescription eye drop market: $0.8 Billion
#4. Retina market: $9 Billion WW
Expanding Our Product Portfolio and Geographies
OIS @ ASCRS 2019; Refer to the full Rhopressa® and Rocklatan ® product labels at www.rhopressa.com and www.rocklatan.com, respectively. AR-13503 and AR-1105 have not been FDA approved. US-CC-NP-0015
6
Step #1: Enter the $3 billion US Glaucoma Market with Rhopressa® and Rocklatan®
• Rhopressa® (netarsudil ophthalmic solution) 0.02%
– 1st new class of drug in U.S. glaucoma market in 20+ years
• Rocklatan® (netarsudil and latanoprost ophthalmic solution) 0.02% / 0.005%
– 1st combination containing a prostaglandin analog in the U.S.
Rhopressa® U.S.
Rocklatan® U.S.Launch May ‘182018 = $24 MM
Launch May ‘19
Two “First-in-Kind” Products Launched Within 12 Months
OIS @ ASCRS 2019; Refer to the full Rhopressa® and Rocklatan ® product labels at www.rhopressa.com and www.rocklatan.com, respectively. AR-13503 and AR-1105 have not been FDA approved. US-CC-NP-0015
7
0
5,000
10,000
15,000
20,000
25,000
30,000
1 2 3 4 5 6 7 8
Pres
crip
tions
Months Post-Launch
Total Rx’s (TRx) Launch Trajectory
Rhopressa® Results Compare Favorably to the 3 Most
Recent Glaucoma Product Launches
24,155
15,115Rhopressa®
109,006
Product 2
73,400
Product 1
31,345
Dec for
Rhopressa®)
Rhopressa®
1st 8 months TRx$$
Product 3
1st 10 months TRx$$
$29.5¹ MM $17.5 MM
TRx $$ Rhopressa® vs Product 3
¹Last month = $7.0 MM5,920
OIS @ ASCRS 2019; Refer to the full Rhopressa® and Rocklatan ® product labels at www.rhopressa.com and www.rocklatan.com, respectively. AR-13503 and AR-1105 have not been FDA approved. US-CC-NP-0015
Total Rx’s
1st 8
months
8
• 1st combination in the U.S. to contain a prostaglandin analog
• 1st combination anywhere in the world to contain a Rho kinase inhibitor
• 1st combination in the U.S. to require only QD dosing
• 1st product to achieve statistically superior IOP lowering vs latanoprost in U.S. Phase 3 trials
“First-in-Kind” in Many Important Ways
Rocklatan® (netarsudil and latanoprost ophthalmic solution) 0.02% / 0.005%
OIS @ ASCRS 2019; Refer to the full Rhopressa® and Rocklatan ® product labels at www.rhopressa.com and www.rocklatan.com, respectively. AR-13503 and AR-1105 have not been FDA approved. US-CC-NP-0015
9
Over 60% of Rocklatan® Patients Achieved ≥30% Mean IOP Reduction at 3 Months1
1.Data on file, Aerie Pharmaceuticals, Inc.
87
75
62
43
31
53
37
24
14
6
75
56
33
17
9
0
10
20
30
40
50
60
70
80
90
100
≥20% ≥25% ≥30% ≥35% ≥40%
PATI
ENTS
, %
IOP REDUCTION FROM BASELINE, %
*
Pooled MERCURY Studies: Proportion of Patients Achieving Prespecified Percentage of Mean Diurnal IOP Reduction at Month 3 (ITT Pop)
Latanoprost (n=458)Rocklatan® (n=421) Rhopressa® (n=426)
*
*
*
*
OIS @ ASCRS 2019; Refer to the full Rhopressa® and Rocklatan ® product labels at www.rhopressa.com and www.rocklatan.com, respectively. AR-13503 and AR-1105 have not been FDA approved. US-CC-NP-0015
10
Majority of Rocklatan® Ocular AEs Were Mild and Similar to the Individual Components1
1. Bacharach et al. 13th Biennial Meeting of the European Glaucoma Society 2018. Poster #P4.048.
Ocular Adverse Events Reported in ≥5% of Patients In Pooled MERCURY Studies
ROCKLATAN®
(N=482), %RHOPRESSA®
(N=498), %LATANOPROST
(N=488), %
Eye disorders
Conjunctival hyperemia 58.7 47.0 22.1
Cornea verticillata 15.4 11.6 0
Conjunctival hemorrhage 10.8 14.5 1.0
Eye pruritus 7.7 4.6 1.0
Visual acuity reduced 5.2 4.2 1.8
Lacrimation increased 5.2 5.6 0.2
Punctate keratitis 3.5 5.4 2.9
General disorders and administration site conditions
Instillation site pain 20.1 16.7 6.8
Instillation site discomfort 5.2 4.6 1.0
OIS @ ASCRS 2019; Refer to the full Rhopressa® and Rocklatan ® product labels at www.rhopressa.com and www.rocklatan.com, respectively. AR-13503 and AR-1105 have not been FDA approved. US-CC-NP-0015
11
Step #2 & #3: Enter Europe and Japan with Our Glaucoma Franchise
Rhopressa® U.S.
Rocklatan® U.S.Launch May ‘182018 = $25 MM
Launch May ‘19
MAA¹ filedQ3 ’18
MAA¹ to fileQ1 ‘20
P2 FPFT ²Q1 ’19
U.S.Glaucoma
EuropeGlaucoma
JapanGlaucoma
OIS @ ASCRS 2019; Refer to the full Rhopressa® and Rocklatan ® product labels at www.rhopressa.com and www.rocklatan.com, respectively. AR-13503 and AR-1105 have not been FDA approved. US-CC-NP-0015
Rhopressa® EU (Rhokiinsa®)
Rocklatan® EU(Roclanda™)
Rhopressa® Jp
Rocklatan® Jp
Top Ophthalmic MarketTop 3 Geographies
1. MAA = Marketing Authorization Application2. FPFT = First Patient First Treatment
Post ApprovalOf Rhopressa®
12
Step #2: Enter the $1 Billion Europe Glaucoma Market
• MAA accepted for Rhokiinsa® (Rhopressa®) in Oct ‘18
• Plan to submit Rocklatan® MAA post-Rhokiinsa® approval
• Mercury 3: 6-month safety and 90-day efficacy registration trial comparing
Rocklatan® for non-inferiority to a fixed-dose combo in Europe (Ganfort®)
• Hired Chief Commercial Officer, Europe on April 1, ‘19
• 70 employees (Manufacturing, Clinical, Medical Affairs, Commercial, Regulatory,
Quality) in Europe
• Ireland Plant in process to support worldwide commercial supply in 1H ‘20
OIS @ ASCRS 2019; Refer to the full Rhopressa® and Rocklatan ® product labels at www.rhopressa.com and www.rocklatan.com, respectively. AR-13503 and AR-1105 have not been FDA approved. US-CC-NP-0015
Progress in Europe; Filings, Studies, Employees and a Plant
13
Step #3: Enter the $0.8 Billion Japan Glaucoma Market
• Established office in Tokyo with 4 employees
• Phase 1 and pilot Phase 2 completed in the U.S. on Japanese and Japanese-Americans
• Phase 2 initiated in Japan (Q1 ‘19)
• Phase 3 trials expected to be conducted in Japan
OIS @ ASCRS 2019; Refer to the full Rhopressa® and Rocklatan ® product labels at www.rhopressa.com and www.rocklatan.com, respectively. AR-13503 and AR-1105 have not been FDA approved. US-CC-NP-0015
Progress in Japan; Filings, Employees and Studies
14
Step #4: Enter the $9 billion WW Retina Market
Rhopressa® U.S.
Top 2 Ophthalmic MarketsTop 3 Geographies
Rocklatan® U.S.Launch May ‘182018 = $25 MM
Launch May ‘19
MAA¹ filedQ3 ’18
MAA¹ to fileQ1 ‘20
P2 FPFT²Q1 ’19
U.S.Glaucoma
EuropeGlaucoma
JapanGlaucoma
OIS @ ASCRS 2019; Refer to the full Rhopressa® and Rocklatan ® product labels at www.rhopressa.com and www.rocklatan.com, respectively. AR-13503 and AR-1105 have not been FDA approved. US-CC-NP-0015
Rhopressa® Jp
Rocklatan® Jp
AR - 13503
AR - 1105
FPFT² Q1 ‘19
FPFT² Q2 ‘19
Retina
1. MAA = Marketing Authorization Application2. FPFT = First Patient First Treatment
Post ApprovalOf Rhopressa®
Rhopressa® EU (Rhokiinsa®)
Rocklatan® EU(Roclanda™)
15
Aerie Retina Assets
AR-1105 (Dexamethasone) Implant• RVO and DME• Target: 6 months of efficacy
AR-13503 (ROCKi / PKCi) Implant• Neovascular AMD and DME• Novel MOA: anti-angiogenesis PLUS anti-
fibrosis, anti-inflammation• Active as monotherapy or adjunctive therapy• Target: 6 months of efficacy
DSM • Bio-erodible, sustained-release implants
PRINT® manufacturing technology• In our cGMP facility in RTP
OIS @ ASCRS 2019; Refer to the full Rhopressa® and Rocklatan ® product labels at www.rhopressa.com and www.rocklatan.com, respectively. AR-13503 and AR-1105 have not been FDA approved. US-CC-NP-0015
Investigational Retina Products and Technologies
Product Candidates Enabling Technologies
16
Oxygen-induced retinopathy (OIR) mouse model - PDR
Administration: Intraperitoneal QD
Preclinical AR-13503 Provides Efficacy Similar to Eylea®
in a Proliferative Diabetic Retinopathy Model
• Data on File• For more information on Eylea® please see the product webpage https://www.eylea.us/
Vehicle (n=14)
1.25 mg/kg AR-13503 (n=16)
1 mg/kg Eylea(n=14)
OIS @ ASCRS 2019; Refer to the full Rhopressa® and Rocklatan ® product labels at www.rhopressa.com and www.rocklatan.com, respectively. AR-13503 and AR-1105 have not been FDA approved. US-CC-NP-0015
17
AR-13503 Synergistic to Eylea® in Mouse Model of Proliferative Diabetic Retinopathy
• Data on File• Sub-optimal dose levels selected in the study to provide less than maximal efficacy• For more information on Eylea® please see the product webpage https://www.eylea.us/
Oxygen-induced retinopathy (OIR) mouse model - PDR
0%
5%
10%
15%
20%
25%
30%
35%
Vehiclen=12
Eylea (sub-optimal dose)
n=12
AR-13503 (sub-optimal dose)
n=14
Combinationn=8
-40%
****
Administration: Intraperitoneal QD
* : p<0.01*** : p<0.0001
-60%% o
f Tot
al A
rea
Neovascular Area (+SEM)
OIS @ ASCRS 2019; Refer to the full Rhopressa® and Rocklatan ® product labels at www.rhopressa.com and www.rocklatan.com, respectively. AR-13503 and AR-1105 have not been FDA approved. US-CC-NP-0015
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