Aerie Pharmaceuticals (AERI) 8-K Regulation FD Disclosure

Company Overview

Investor Presentation

January 2018

Exhibit 99.1

2

Important Information

The 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. 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%,

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

®

does

not

guarantee

successful

commercialization

of

Rhopressa

®

or

FDA

approval

of

Roclatan

TM

.

For

more

information

on

Rhopressa

®

,

refer

to

the

full

Rhopressa

®

product

label

at

http://investors.aeriepharma.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

®

does

not

constitute

approval

of

Roclatan

TM

,

and

there

can

be

no

assurance

that

we

will

receive

FDA

approval

for

Roclatan

TM

or

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.

In

addition,

the

preclinical

research

discussed

in

this

presentation

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.

For Investor Use

Aerie  IOP–Lowering Products (IP 2030+)

Pipeline Activities

•

Rhopressa

®

•

24-hour IOP lowering, normal tension glaucoma, disease modification, etc.

•

AR-13503

(ROCK/PKC

inhibitor)

and

AR-1105

(dexamethasone

steroid)

•

Pre-clinical molecules for diseases of the retina

•

Drug

Delivery

–

Focused

on

back

of

the

eye

(e.g.,

PRINT

®

/

DSM)

•

Rhopressa

®

(netarsudil ophthalmic solution) 0.02%

•

Aerie-owned new chemical entity

•

FDA

Approved

December

18,

2017;

in

launch

mode

•

Roclatan™ (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%

•

Two P3’s achieved primary efficacy endpoints

•

NDA

submission

expected

2Q

2018

Aerie:

Building a Major Ophthalmic Pharmaceutical Company

3

Data on file

For Investor Use

4

4

Rhopressa

For Investor Use

-

~$3B Market, 36M TRx, 60M bottles

-

Half of volume first-line (PGAs)

-

Half of volume 2-4X/Day Adjuncts

-

Once-daily dosing directed at site of pathology, the trabecular meshwork

-

Consistent IOP lowering over 12 months and across all IOPs tested, as  

demonstrated in clinical trials     

Rhopressa

®

: Positioning as an Adjunctive Therapy

(8%)

(36%)

(13%)

(16%)

(10%)

(9%)

(8%)

Graph Source: IMS Data

CAI: Carbonic Anhydrase Inhibitor

AA: Alpha Agonist

BB: Beta Blocker

2016 U.S. Glaucoma Market

®

:

Market

Perspective

®

http://investors.aeriepharma.com

Refer to the full  Rhopressa   product  label  at

5

5

Rhopressa

Hired Chief Commercial Officer and VPs of Sales, Marketing,

Market Access,  Commercial Operations, and Medical Affairs in

2016/2017, and Chief Compliance Officer in 2015

Preparing to hire U.S. salesforce of 100 reps; expected to be fully

trained during 2Q 2018

Sales territories finalized and hiring of Sales Regional Directors

and District Managers proceeding                                                                

Market access meetings with top Medicare Part D and Commercial 

Payors under way            

-

Covered

market is ~50/50 Commercial / Part D

-

Part D coverage expected to commence January 2019 

We

believe

awareness

of

Rhopressa

®

is

high

among

ophthalmologists

For Investor Use

Fully Prepared to Execute Launch Plan

®

:

Commercialization

6

Sales

Commercial Operations

Market Access

Marketing

Rhopressa

®

: Launch Plan

Payer Engagement

Field Deployment

Commercial and Med D Strategy

Drive to Preferred Formulary Positioning

Broad Strategy

Brand Planning and Messaging

KOL Engagement

Field Support

For Investor Use

Hire Reps

Sales Training and Deployment

Target 12K Prescribers / 80% of Volume

Success Metrics and Standards

Supply Chain Management

Sales Execution Readiness

Analytics/Reporting

Field Support Programs

2018

2019

U.S. Launch Plan Timeline

January 2020:

Roclatan™

Med D Coverage

Commences

1H-2019: Roclatan™

Commercial Coverage

Commences

December 2017: Rhopressa

®

FDA Approval

2Q/3Q-2018: Rhopressa

®

Sampling and

Initial Commercial Sales

1Q-2018: Begin

Hiring 100

Sales Reps

End of 2018: Rhopressa

®

Commercial Coverage

Majority Preferred

2Q/3Q-2018:

Rhopressa

®

Commercial Coverage

Majority Non-Preferred

1H-2019: Potential

Roclatan

TM

Launch

For Investor Use

January 2019: Rhopressa

®

Med D Coverage

Majority Preferred

All

dates,

except

for

FDA

approval

for

Rhopressa

®

,

are

estimates.

Roclatan

TM

has

not

been

approved

by

the

FDA.

The

NDA

for

Roclatan

TM

is

expected

to

be

submitted

in

2Q

2018

7

2Q-2018: Rhopressa

®

Commercial Launch

Over 1,500

Experienced

Applicants      

To Date

S

A

L

E

S

A

C

C

E

S

S

8

Building a World Class Medical Affairs Team

•

Hired highly-experienced, successful and recognized leaders in Medical

Affairs, Medical Science, Field Medical Affairs and Professional Affairs

•

Communicating the key medical scientific messages

•

Responding to technical questions from practitioners and managed care

decision makers

•

Placing speakers at national, regional and local scientific meetings

•

Active presence at major ophthalmic conferences, including a Medical

Affairs Booth

Medical Affairs

For Investor Use

9

American Society of Cataract Refractive

Surgeons (ASCRS) May 2017

World Glaucoma Congress

Helsinki June 2017

Association of Research in Vision and

Ophthalmology (ARVO) May 2017

American Glaucoma Society (AGS)

March 2017

Building Aerie’s Presence in the Medical Community:

19 Podium Presentations at Major Eyecare Meetings

4 Presentations, including 24-Hour IOP

Lowering of Netarsudil, Peace et al.

5 Posters, including Enhancing Efficacy

by Continuous Delivery of AR-13154 in

an Animal Model of Proliferative Diabetic

Retinopathy, Carbajal et al.

3 Presentations, including 3-Month

Interim Results of Mercury 1, Asrani

et

al., and Aqueous Humor Dynamics of

Netarsudil Ophthalmic Solution 0.02% in

Healthy Volunteers, Sit et al.

Aerie Medical

Affairs Booth

highlighted, in

addition to

presentation

For Investor Use

10

Roclatan

TM

(netarsudil/latanoprost

ophthalmic

solution)

0.02%/0.005%

Positioning as First Line Therapy:

•

Benefits

of

Rhopressa

®

while

also

targeting

the

secondary

drain

•

Achieved statistical superiority to market-leading latanoprost in two

P3 trials

•

Potential to become the most efficacious IOP-lowering medication

for glaucoma or ocular hypertension, if approved

Roclatan

TM

Combination

Product

Candidate

Data on file

Roclatan

TM

has

not

been

approved

by

the

FDA

For Investor Use

NDA Submission Expected 2Q 2018

11

Roclatan

TM

Efficacy

and

Safety

Efficacy:

•

Roclatan

TM

demonstrated

statistical

superiority

over

its

components

(market-

leading PGA latanoprost and Rhopressa

®

) in Mercury 1 and 2 Phase 3 trials, at

all measured time points

•

Consistent incremental IOP-lowering over latanoprost and Rhopressa

®

in the

range of 1 to 3 mmHg

Safety:

•

No treatment-related serious adverse events and minimal evidence of

treatment-related systemic effects. The most common adverse event is

conjunctival hyperemia with ~60% incidence, majority mild and sporadic and

present in 20% of subjects at baseline

•

Other

ocular

AEs

occurring

in

~5-15%

of

subjects

receiving

Roclatan

TM

included: cornea verticillata, conjunctival hemorrhage, eye pruritus, lacrimation

increased, visual acuity reduced, blepharitis and punctate keratitis 

Data on file                                                                                                                  

For Investor Use

12

Roclatan

TM

Phase 3 Month 12 Responder Analysis:

Goal is to Achieve Lowest IOP Possible

At Month 12:  % of Patients

with IOP Reduced to 18 mmHg or Lower

*p<0.05, **p<0.01, ***p<0.0001

++

Data on File

Based on Mercury 1 Interim Analysis 2

For Investor Use

®

16%

26%

37%

49%

57%

12%

22%

35%

49%

66%

27%

43%

60%

72%

82%

0%

20%

40%

60%

80%

100%

14 mmHg

15 mmHg

16 mmHg

17 mmHg

18 mmHg

IOP on Treatment

Latanoprost (n=203)

Roclatan

(n=158)

Rhopressa

(n=148)

™

13

Roclatan™ Next Steps

•

Roclatan

TM

NDA submission expected 2Q 2018

•

Aerie Ireland plant and 2 contract manufacturers are

expected to support Roclatan

TM

U.S. commercial activities

•

Mercury 3 commenced in Europe 3Q 2017 

-

Trial conducted in U.K., France, Germany, Italy, Spain, Belgium and    

Austria   

-

Marketing Authorization Application (MAA) in Europe expected in           

2H 2019 

For Investor Use

14

Expanding Aerie Franchise: Europe and Japan

•

Europe (2016 Europe “Big 5” Glaucoma Market: 90M units per year, 1.5X

U.S. units)

•

Expect to file MAA for Rhopressa

®

in 2H 2018

•

Current clinical plan expected to satisfy European regulatory requirements

(including Rocket 4 for Rhopressa

®

and Mercury 3 for Roclatan

)

•

Mercury 3: 6-month safety and 90-day efficacy registration trial for Europe,

comparing Roclatan

for non-inferiority to a fixed-dose combo in Europe

(Ganfort

®

) started 3Q 2017. Approximately 250 patients per arm.

•

Construction of Ireland Plant in process to support worldwide commercial

supply

•

Japan (2016 Glaucoma Market: 52M units per year)

•

Plan to advance clinical development on our own

•

Phases 1 and 2 under way in the U.S. on Japanese and Japanese-

Americans, initiated 4Q 2017

•

Phase 3 trials expected to be conducted in Japan

For Investor Use

TM

TM

15

Europe Glaucoma Market:

Aerie Expects to Commercialize on Its Own (if approved)

“Big

5”

Europe

Glaucoma

Market

–

2016

$1.0B; 90M TRx*

PGA: Prostaglandin Analogue; BB: Beta Blocker; AA: Alpha Agonist; CAI: Carbonic Anhydrase Inhibitor

Sources:

IMS

Analytics

Link

at

ex-manufacturer

price

level.

*TRx

calculated

from

IMS

unit

data

(1

month

=

1

TRx)

Non-PGA Market (47%)

PGA Market (53%)

Bimatoprost

Travoprost

Latanoprost

PGA Fixed

Combo

BB

Non-PGA

Fixed Combo

AA

CAI

17%

12%

12%

4%

19%

10%

6%

2 -

4 Times Daily

Once Daily

17%

Others

3%

For Investor Use

Tafluprost

2%

16

Japan Glaucoma Market:

Aerie Expects to Partner for Commercialization (if approved)

PGA: Prostaglandin Analogue; BB: Beta Blocker; AA: Alpha Agonist; CAI: Carbonic Anhydrase Inhibitor

Sources: IMS Analytics Link at ex-manufacturer price level.  *Monthly Units calculated from IMS SU Data

Non-PGA Market (48%)

PGA Market (52%)

Unoprostone

Bimatoprost

Travoprost

Latanoprost

Tafluprost

BB

Non-PGA

Fixed Combo

AA

CAI

ROCK

Inhibitors

Others

12%

10%

9%

12%

20%

6%

6%

2 -

4 Times Daily

Once Daily

(Unoprostone is bid)

9%

Japan

Glaucoma

Market

–

2016

$0.8B; 52M Units Annually

9%

4%

3%

For Investor Use

PGA Fixed

Combo

17

Advancing the Pipeline

AR-13503 and AR-1105 are preclinical stage molecules and have not been approved by the FDA

•

Rhopressa

®

•

Potential for disease modification in glaucoma

•

24-hour IOP lowering

•

Retina Program Opportunities:

AR-13503* (ROCK/PKC inhibitor) potentially for AMD and DME

AR-1105 (dexamethasone steroid) potentially for DME

•

Drug Delivery

•

Focused

on

implants

for

retinal

diseases

(DSM

/

PRINT

®

)

For Investor Use

* Active metabolite of AR-13154

18

Netarsudil* Causes Expansion of TM Tissue,

Opening Spaces for Increased Outflow

Control

+ Netarsudil

TM: Trabecular Meshwork

SC: Schlemm’s

Canal

Control = buffered saline solution

Increasing Trabecular Outflow, Reducing Fibrosis Could Stop

Degeneration of Outflow Tissues in Glaucoma

Increasing Trabecular Outflow, Reducing Fibrosis Could Stop

Degeneration of Outflow Tissues in Glaucoma

*Active ingredient of Rhopressa

®

Source: Ren R et al.  Invest Ophthalmol

Vis Sci. 2016; 57(14):6197-6209.

For Investor

Use

200um

19

Rhopressa

®

24-hour IOP Pilot Study

Demonstrates Effective Nocturnal Efficacy

Netarsudil

(n=8)

Baseline

(n=8)

**

**

**

***

**

**

***

***

**

p<0.01

***

p<0.001

•

Netarsudil (active ingredient of Rhopressa

®

) equally effective during

nocturnal and diurnal periods

•

Current glaucoma medications either have no efficacy at night (beta

blockers,

alpha

agonists)

or

reduced

efficacy

at

night

(PGAs,

CAIs)

1

-

6

AR-13324-CS204

1.

Liu JH, et al. Am J Ophthalmol. 2004; 138:389-395.  2. Gulati V, et al.  Arch Ophthalmol. 2012; 130:677-684. 3.  Liu JH, et al. Ophthalmology. 2009; 116:449-

454.  4. Liu JH, et al. Ophthalmology. 2010; 117:2075-9.  5. Fan S et al. J Glaucoma.  2014; 23:276-81.  6. Liu JH, et al. Am J Ophthalmol. 2016;169:249-257.

For

Investor

Use

Pre-dose

Post-dose (Day 8/9)

20

20

Retinal Diseases –

Aerie’s Next Chapter

The market for retina eye diseases is twice that of glaucoma with $4.9

billion in the U.S. and $9 billion worldwide per IMS

Current treatments for retina eye diseases lose efficacy over time, some

have very serious side effects and there are limited surgical options

The majority of current treatments for retina eye diseases require repeated

injections into the patient’s eye

Aerie has two preclinical molecules for the treatment of retinal disease:

-

AR-13503 (ROCK/PKC Inhibitor) for AMD/DME

-

AR-1105 (dexamethasone steroid) for DME

Aerie also has access to bio-erodible implant technology through DSM

collaboration, and also has ophthalmic rights to PRINT

®

technology, a fully

scalable manufacturing platform for implants

For Investor Use

21

21

2016 U.S. Retina Market

For Investor Use

Eylea,

$3.3

Avastin,

$0.02

Lucentis,

$1.4

steroids,

$0.1

others,

$0.03

2016 Sales: $4.9B

U.S. Unit Sales: 6.5M

Eylea, 2.3

Avastin,

3.0

Lucentis,

0.9

steroids,

0.2

others,

0.1

Source: IMS Data         

22

AR-13503: A First-in-Class ROCK/PKC Inhibitor for the

Treatment of Wet AMD and Diabetic Retinopathy

•

Active metabolite of AR-13154 and netarsudil

•

Potential to improve outcomes by targeting multiple

disease processes

•

Monotherapy shows strong efficacy in preclinical models

•

Effective as adjunct to anti-VEGF therapy in preclinical

models

•

Expect durable treatment effect with injection frequency

of once every 4 –

6 months

For Investor Use

23

Aerie Preclinical Molecule Provides Additive Efficacy to

Eylea

®

in a Proliferative Diabetic Retinopathy Model

0%

20%

40%

60%

80%

100%

120%

Vehicle Control

(n=55)

AR-13154(S)

topical

(n=28)

Eylea

1mg/kg IP (n=26)

AR-13154(S) +

Eylea (n=18)

Total Neovascular Area

-37%

-34%

-57%

**

***

***

***

Oxygen-induced retinopathy model of PDR (mouse)

AR-13154(S) is a precursor molecule to AR-13503

Confirms potential as monotherapy and as adjunct to anti-VEGF

therapies; not yet tested in humans

Data

on

file;

Carbajal,

KS

et

al.,

Enhancing

Efficacy

by

Continuous

Delivery

of

AR-13154(S)

in an Animal Model of Proliferative Diabetic Retinopathy, ARVO 2017, Poster B0481.

For Investor Use

For more information on Eylea®

please see the product webpage

https://www.eylea.us/

24

DSM Collaboration –

Implant Delivery Technology

•

Intravitreal sustained-release, bio-erodible implant technology

•

Potential for treatment of Wet AMD and Diabetic Retinopathy

•

Promising results from ongoing feasibility study

•

Evaluating AR-13503 (ROCK/PKC inhibitor) and related Aerie compounds

•

Linear sustained elution rates over several months

•

Achieved target retinal drug concentrations

•

Executed collaboration/licensing agreement

•

Continue prototype evaluations and IND-enabling activities

For Investor Use

Data on File

25

PRINT

®

Technology for Ophthalmology

Best in class control over particle size, shape and formulation

Micropatterned

Template

Mold formation

Mold Filling

(e.g. drug/polymer)

Particle Array

PRINT= Particle Replication In Non-wetting Templates

Aerie recently acquired the rights to use this technology for ophthalmic

applications

Proprietary technology capable of creating precisely engineered sustained-release

products using fully scalable manufacturing processes

Expected to accelerate development of Aerie’s retinal disease program, including

pre-clinical AR-13503 and AR-1105

For Investor Use

26

Evaluating Aerie’s 3,000+ Owned Molecules

ROCK

•

Commencing screening for

additional indications beyond

ophthalmology

•

ROCK inhibition has

potential in:

•

Pulmonary health,

including pulmonary

fibrosis and bronchial

asthma

•

Dermatology indications

•

Cancer

•

Others

Relationship tree of human kinases.  TK, TKL, STE, CK1, AGC, CAMK, CMGC, Other: Kinase superfamilies

For Investor Use

Aerie molecules inhibit

both ROCK1

and ROCK2

27

Summary

•

Lead Product Priorities

•

Rhopressa

®

:  Successful launch execution expected in 2Q 2018                               

•

Roclatan™:

•

Research Initiatives

•

Rhopressa

®

24-hour IOP lowering, normal tension glaucoma, disease modification    

•

AR-13503 (ROCK/PKC inhibitor) and AR-1105 (dexamethasone steroid)                          

with potential for retinal diseases

•

Evaluating Aerie’s 3,000+ proprietary Rho kinase molecules

–

beyond ophthalmology

•

Business Development and Expansion Opportunities

•

Drug delivery opportunities focused on back of the eye (e.g., PRINT

®

/ DSM)

•

EU/JP clinical path and commercialization strategy

•

Ireland Manufacturing Facility

For Investor Use

Mercury 3 commenced 3Q 2017 (EU)

U.S. NDA submission expected in 2Q 2018

2017

2018

Key Product-Related Milestones

1H-2019: Roclatan™

Potential U.S. Approval and Launch

2Q-2018: Roclatan™

NDA Submission Expected

Q1-2017: Rhopressa

®

NDA Resubmitted

2Q-2018: Rhopressa

®

U.S. Launch Expected

Q2-2017: Rhopressa

®

Rocket 4 Topline safety (6 mos)

Q3-2017: Roclatan™

P3 Mercury 1

12-month Safety

Q2-2017: Roclatan™

P3

Mercury

2

Topline Efficacy (3 mos)

2H-2018: Rhopressa®

Potential EU MAA Filing

For Investor Use

Q3-2017: Roclatan™

P3 Mercury 3 (EU)

Initiation (6 mos)

2018 and 2019 dates are estimates. Roclatan

TM

has not been approved by the FDA.

28

December 2017: Rhopressa

®

FDA Approval