Form 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 9, 2017

 

 

Aerie Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-36152   20-3109565

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification Number)

2030 Main Street, Suite 1500

Irvine, California 92614

(Address of principal executive offices) (Zip code)

Registrant’s telephone number, including area code: (949) 526-8700

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company  ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☒

 

 

 


Item 7.01. Regulation FD Disclosure.

On or after August 9, 2017, representatives of Aerie Pharmaceuticals, Inc. (the “Company”) may present to various investors the information described in the slides attached to this report as Exhibit 99.1 hereto, which is hereby incorporated by reference into this Item 7.01.

The information in this Item 7.01 (including Exhibit 99.1) is being furnished, not filed, pursuant to Regulation FD. Accordingly, the information in this Item 7.01 will not be incorporated by reference into any registration statement filed by the Company under the Securities Act of 1933, as amended, unless specifically identified therein as being incorporated therein by reference. The furnishing of the information in this Item 7.01 is not intended to, and does not, constitute a determination or admission by the Company that this information is material or complete, or that investors should consider this information before making an investment decision with respect to any security of the Company.

 

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

The following exhibit relating to Item 7.01 shall be deemed to be furnished, and not filed:

 

99.1    Company Overview Presentation dated August 2017.


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

    AERIE PHARMACEUTICALS, INC.
Date: August 9, 2017     By:  

/s/ Richard J. Rubino

      Richard J. Rubino
      Chief Financial Officer


EXHIBIT INDEX

 

Exhibit

  

Description

99.1    Company Overview Presentation dated August 2017.
EX-99.1
Company Overview
Investor Presentation
August 2017
Exhibit 99.1


2
Important Information
Any discussion of the potential use or expected success of our product candidates is subject to our product candidates
being approved by regulatory authorities. In addition, any discussion of clinical trial results for Rhopressa™
(netarsudil
ophthalmic solution) 0.02% relate to the results in its first Phase 3 registration trials named Rocket 1 and Rocket 2, or
Rocket 4 which will be used primarily for European regulatory filing purposes, and for Roclatan™ (netarsudil/latanoprost
ophthalmic solution) 0.02%/0.005% relate to the results in its Phase 3 registration trials.
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 the updated guidance 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. Any top line data presented herein is
preliminary and based solely on information available to us as of the date of this document 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


3
Aerie Late Stage IOP–Lowering Products (IP 2030+)
Pipeline Activities
Rhopressa™
Potential for disease modification, 24 hour IOP lowering
AR-13154
Pre-clinical molecule for diseases of the retina
Drug
Delivery
-
Front
and
back
of
the
eye
Rhopressa™ (netarsudil ophthalmic solution) 0.02%
Aerie-owned new chemical entity targeting the diseased tissue
PDUFA goal set for February 28, 2018; entering launch mode
Roclatan™ (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%
Fixed combination of Rhopressa™ and latanoprost
Two P3’s achieved primary efficacy endpoints
NDA preparation underway
Aerie –
Building a Major Ophthalmic
Pharmaceutical Company
Data on file
Product candidates have not been approved by the FDA
For Investor Use


4
Rhopressa™ (netarsudil ophthalmic solution) 0.02%
Roclatan™
(netarsudil/latanoprost ophthalmic solution) 0.02%/0.05%
Positioning as First Line Therapy:
Benefits of Rhopressa™ while also targeting the secondary drain
Achieved statistical superiority to market-leading latanoprost in P3 trials
Potential to become the most efficacious IOP-lowering medication for
glaucoma and ocular hypertension, if approved
Positioning as Adjunctive Therapy:
Once-daily dosing directed at site of pathology, the trabecular meshwork
Consistent IOP lowering over 12 months and across a broad range of
baseline IOPs, as demonstrated in clinical trials
Lowering
of
episcleral
venous
pressure,
among
other
demonstrated
attributes
Aerie’s Lead Glaucoma Therapies
Data on file
Product candidates have not been approved by the FDA
For Investor Use


5
2016 US Glaucoma Market
US
Glaucoma
Market
2016
$2.8B; 36M TRx, Market Share in TRx
PGA: Prostaglandin Analogue; BB: Beta Blocker; AA: Alpha Agonist; CAI: Carbonic Anhydrase Inhibitor
Source: IMS Data         
Non-PGA Market
PGA Market
16%
13%
10%
8%
36%
9%
8%
2 –
4 Times Daily
Once Daily
For Investor Use
36M TRx
approximates
60M units per year
for 1.7 bottles/Rx
Bimatoprost
Travoprost
Latanoprost
Tafluprost
BB
Fixed Combo
AA
CAI
Other


6
**Rhopressa™
achieved non-inferiority to timolol at primary endpoint range                                
of > 20 mmHg to < 25 mmHg
*Rhopressa™
achieved non-inferiority to timolol at pre-specified secondary         
endpoint range of > 20 mmHg to < 24 mmHg; also non-inferior at < 25 mmHg
Rhopressa
Trials Included in NDA
Submission (PDUFA date February 28, 2018)
“Rocket 1”
3 Mo. Safety and
Efficacy* Registration
Trial
U.S.
Rhopressa™ 0.02% QD
202 patients
timolol BID
209 patients
(Total enrollment: 411 patients)
“Rocket 2”
12 Mo. Safety, 3 Mo.
Interim Efficacy**
Registration Trial
U.S.
Rhopressa™ 0.02% QD
251 patients
Rhopressa™ 0.02% BID
254 patients
timolol BID
251 patients
(Total enrollment: 756 patients)
1
Post-hoc analysis
ClinicalTrials.gov Identifier: NCT02207491, NCT02207621
Product candidates have not been approved by the FDA
For Investor Use
TM
1


7
Rhopressa
Phase 3 Trial Data Filed as
Supportive to NDA Filing
ClinicalTrials.gov Identifier: NCT02246764, NCT02558374
Product candidates have not been approved by the FDA
“Rocket 4”
6 Mo. Safety, 3 Mo.
Interim Efficacy* Trial
Rhopressa™ 0.02% QD
351 patients
timolol BID
357 patients
*Rhopressa™
achieved non-inferiority to timolol at primary endpoint range of > 20
mmHg to < 25 mmHg; also non-inferior up to < 30 mmHg; consistent safety results
“Mercury 1”
12 Mo. Safety, 3 Mo.
Interim Efficacy**
Registration Trial
Roclatan™ 0.02%/0.005% QD
238 patients
Rhopressa™ 0.02% QD             244 patients
latanoprost QD
236 patients
**Rhopressa™
achieved non-inferiority to latanoprost at                                        
range of > 20 mmHg to < 25 mmHg
For Investor Use
TM


8
Rocket 2: Safety/Tolerability Overview of
Rhopressa
QD (Interim 12-Month)
Product candidates have not been approved by the FDA
There
were
no
drug-related
systemic
or
serious
adverse
events
The
most
common
adverse
event
was
conjunctival
hyperemia
with
~50%
incidence*,
the
majority
mild
and
sporadic
Other
ocular
AEs
AEs
occurring
in
~5-23%
of
patients
included:
conjunctival
hemorrhage,
cornea
verticillata,
blurry
vision
and
reduced
visual
acuity
For Investor Use
TM


9
9
Rhopressa™ Commercialization Prep
Hired Chief Commercial Officer and VPs of Sales, Market Access, 
Commercial Operations, and Medical Affairs in late 2016 / early
2017, and Chief Compliance Officer in 2015
Expect to hire U.S. salesforce of 100 reps immediately after
approval; fully trained by end of 2Q18                                                           
-
Target top 12,000 prescribers; 80% of Rx’s
Commenced initial scientific market access meetings with top                   
Medicare Part D / Commercial Payors                                                          
Developing launch plan
Product candidates have not been approved by FDA
For Investor Use


10
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
5 Posters, including Enhancing Efficacy
by Continuous Delivery of AR-13154 in
an Animal Model of Proliferative Diabetic
Retinopathy, Carbajal et al.
4 Presentations, including 24 Hour IOP
Lowering of Netarsudil, Peace 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
Data on File


11
**Roclatan™
achieved statistical superiority to components at primary endpoint
range of > 20 mmHg to < 36 mmHg, similar to Mercury 1
*Roclatan™
achieved statistical superiority to components at primary endpoint
range of > 20 mmHg to < 36 mmHg
Roclatan
U.S. Registration Trial Results
“Mercury 1”
12 Mo. Safety, 3 Mo.
Interim Efficacy*
Registration Trial
Roclatan™ 0.02%/0.005% QD
238 patients
Rhopressa™
0.02%
QD
244 patients
latanoprost QD                          236 patients
“Mercury 2”
3 Mo. Safety and
Efficacy** 
Registration Trial
Same structure as Mercury 1, except 3 months
Roclatan™ 0.02%/0.005% QD
245 patients
Rhopressa™
0.02% QD
255 patients
latanoprost QD
250 patients
ClinicalTrials.gov Identifier: NCT02558400, NCT02674854        Product candidates have not been approved by the FDA
For Investor Use
TM


12
12
Roclatan
Maintained Superior Efficacy Over
Individual Components for 12 Months
Mean IOP at Each Time Point  (ITT)
Roclatan™ statistically superior to latanoprost and Rhopressa™ at all
time points
Roclatan™ IOP-lowering 1-3 mmHg greater than monotherapy through
Month 12
++
Data on File
Based on Mercury 1 Topline 12-month
Product candidates have not approved by the FDA
For Investor Use
TM


13
13
Roclatan
Maintained Superior Efficacy Over
Individual Components for 12 Months
Mean Diurnal IOP at Each Visit (ITT)
p<0.0001 at All Visits vs. Latanoprost and Rhopressa
++
Data on File
Based on Mercury 1 Topline 12-month
Product candidates have not approved by the FDA
For Investor Use
TM


14
Roclatan
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 Topline 12-month
Product candidates have not approved by the FDA
For Investor Use
TM
16%
26%
37%
49%49%
57%
12%
22%
35%
66%
27%
43%
60%
72%
82%
0%
20%
40%
60%
80%
100%
<
14 mmHg
<
15 mmHg
<
16 mmHg
<
17 mmHg
<
18 mmHg
Rhopressa™ (n=148)
Latanoprost (n=203)
Roclatan™ (n=158)
***
**
IOP on Treatment


15
Mercury 1: Safety/Tolerability Overview of
Roclatan
QD Topline 12 Month
There were no drug-related systemic or serious adverse events
The most common adverse event was conjunctival hyperemia with
~60% incidence, scored as mild on biomicroscopy for ~70% of these
patients and sporadic
Other ocular AEs
AEs occurring in ~5-18% of subjects receiving Roclatan™ 
included: cornea verticillata, conjunctival hemorrhage, eye
pruritus, lacrimation increased, visual acuity reduced, blepharitis
and punctate keratitis.
++
Data on File
Based on Mercury 1 Topline 12-month
Product candidates have not approved by the FDA
For Investor Use
TM


16
Roclatan
Next Steps
Roclatan
NDA filing expected 1H 2018
-
Pre-NDA meeting expected 2H 2017
-
Final stability data on critical path
Aerie Ireland plant and 2 contract manufacturers are
expected to support Roclatan™ U.S. commercial activities
Mercury 3 expected to commence in Europe 3Q 2017; 
regulatory submission in Europe expected in 2H 2019 
Product candidates have not been approved by FDA
For Investor Use
TM


17
Expanding Aerie Franchise to Europe and
Japan
Europe (‘16 Glaucoma Market: 128M monthly units, >2X U.S.)
Expect to file EU MAA for Rhopressa™ in 2018
Current clinical plan expected to satisfy EU 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
®
) expected to start 3Q 2017. Approximately 250 patients per arm.
Commenced construction of Ireland Plant to support worldwide commercial
supply
Japan (‘16 Glaucoma Market: 52M monthly units)
Preparing to advance clinical development on our own
Phases 1 and 2 to be conducted in U.S. on Japanese / Japanese Americans
Phase 3 trials expected to be conducted in Japan commencing 2H 2018
For Investor Use


18
Advancing the Pipeline
Product candidates have not been approved by FDA
Rhopressa™
Potential for disease modification
24-hour IOP lowering
AR-13154
(and related compounds)
Significant lesion size reduction in wet AMD models
Drug Delivery
Front of the eye implants for glaucoma
Back of the eye implants for retinal diseases
For Investor Use


19
Netarsudil* Blocks TGF-beta-Induced Expression of
Fibrosis Proteins in Cultured Human TM Cells
TGF-beta Levels are Elevated in the Aqueous Humor of    
Patients with Glaucoma
TGF
2: Transforming growth factor
2; SMA: Smooth muscle actin; FSP1: Fibroblast-specific protein 1
Lin, C-W et. al., J. Ocul
Pharmacol
Ther
(2017) –
in press
For
Investor
Use
*Active ingredient of
Rhopressa™
Data on File
Control                   TGF
2 (8ng/ml)
TGF
2 (8 ng/ml) +
Netarsudil
(500nM)


20
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
*Active ingredient of Rhopressa™
Source: Ren R et al.  Invest Ophthalmol
Vis Sci. 2016; 57(14):6197-6209.
For Investor
Use


21
Rhopressa™ 24-hour IOP Pilot Study
Demonstrates Effective Nocturnal Efficacy
**
**
**
***
**
**
***
***
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)
Netarsudil
(n=8)
Baseline
(n=8)
**
p<0.01
***
p<0.001


22
Retina Program: AR-13154 Efficacy Driven
Primarily by ROCK, PKC Inhibition
Retinal tissue harvested
from OIR mouse model
AR-13154 effectively
converted to active
metabolite by esterases
Active metabolite keeps
ROCK, PKC activity,
loses PDGFR, JAK
activity
ROCK/PKC Action:
Vascular Dysfunction
and Fibrosis
ROCK Action:
Inflammation
Retinal
Esterases
ROCK
PKC
X
AR-13154
Active
Inactive
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.
ROCK  JAK
PKC PDGFR
182 Aerie compounds
screened against 469
human kinases
AR-13154 identified as
potent lead compound
For Investor Use
Data on File


23
Topical AR-13154(S) Provides Additive Efficacy to
Eylea® in Proliferative Diabetic Retinopathy Model
Oxygen-induced
retinopathy model of
PDR (mouse)
0.06% AR-13154(S)
delivered topically
from P12 to P17
Eylea
®
delivered IP
Confirms AR-13154(S)
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
-37%
-34%
-57%
**
***
***
***
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


24
Bioerodible
implant technology using polyester amide (PEA) polymers
Promising results from ongoing feasibility study
Evaluating AR-13154 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
DSM Collaboration –
Implant Delivery Technology
For Investor Use


25
Evaluating Aerie’s 3,000+ Owned Molecules
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
ROCK


26
Summary
Key Clinical Priorities
Rhopressa: PDUFA date set for February 28, 2018                               
Roclatan:    Mercury 3 expected to commence 3Q 2017 (EU)
U.S. NDA filing expected in 1H 2018
Research Initiatives
Rhopressa
disease modification, 24-hour IOP lowering, sustained release    
AR-13154 and related compounds with potential for retinal diseases
Evaluating Aerie’s 3,000+ proprietary Rho kinase molecules
Business Development and Expansion Opportunities
Drug delivery opportunities for front and back of the eye (e.g., DSM)
EU/JP clinical path and commercialization strategy
Ireland Manufacturing Facility
Well-Financed: $308M cash and investments at 6/30/17
For Investor Use


Rhopressa
and Roclatan
Key Milestones
1H-2019: Roclatan™
Potential U.S. Approval and Launch
1H-2018: Roclatan™
NDA Submission Expected
Q1-2017: Rhopressa™
NDA Resubmitted
1H-2018: Rhopressa™
Potential U.S. Approval and Launch
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
2H-2018: Rhopressa™
Potential P3 Commencement in Japan
Q3-2017: Roclatan™
P3 Mercury 3 (EU)
Initiation (6 mos)
Product candidates have not been approved by the FDA
27
2017
2018
TM
TM