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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): November 13, 2018

 

 

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)

4301 Emperor Boulevard, Suite 400

Durham, North Carolina 27703

(Address of principal executive offices) (Zip code)

Registrant’s telephone number, including area code: (919) 237-5300

 

 

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 November 13, 2018, 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 November 2018.


EXHIBIT INDEX

 

Exhibit

  

Description

99.1    Company Overview Presentation dated November 2018.


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: November 13, 2018     By:  

/s/ Richard J. Rubino

      Richard J. Rubino
      Chief Financial Officer
EX-99.1
Company Overview
Investor Presentation
November 2018
Exhibit 99.1


2
Important Information
For Investor Use
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 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%, 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 Rocklatan™. For more information on
Rhopressa
®
, including prescribing information, refer to the full Rhopressa  
®
product label at  www.rhopressa.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 Rocklatan™, and there can be no assurance that we will receive FDA
approval for Rocklatan™ 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 particular, FDA approval of Rhopressa
®
does not
constitute FDA approval of Rocklatan™, and there can be no assurance that we will receive FDA approval for Rocklatan™ or any future product candidates. FDA
approval of Rhopressa
®
also does not constitute regulatory approval of Rhopressa
®
in jurisdictions outside the United States and there can be no assurance that
we will receive regulatory approval for Rhopressa
®
in jurisdictions outside the United States. Our receipt of a Prescription Drug User Fee Act (“PDUFA”) goal date
notification for Rocklatan™ does not constitute FDA approval of the Rocklatan™ New Drug Application (“NDA”), and there can be no assurance that the FDA will
complete its review by the PDUFA goal date of March 14, 2019, that the FDA will not require changes or additional data that must be made or received before it
will approve the NDA, if ever, or that the FDA will approve the NDA.  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.


3
Aerie IOP–Reducing Products (IP 2030+)
Pipeline Activities
Rhopressa
®
24-hour IOP reduction, normal tension glaucoma, etc.
Retina
Program
AR-13503
and
AR-1105
implants
Sustained Release / Implant Manufacturing Platform
Beyond
Ophthalmology
potential
for
Aerie-owned
molecules
Rhopressa
®
(netarsudil ophthalmic solution) 0.02%
Successfully launched in U.S. April 30, 2018
Rocklatan™ (netarsudil / latanoprost ophthalmic solution) 0.02% / 0.005%
U.S. NDA accepted, PDUFA set for March 14, 2019
Aerie Overview
Data on file
For Investor Use
Globalization
Plan
Under
Way
Europe
and
Japan


4
4
Rhopressa
®
: Market Perspective
Refer
to
the
full
Rhopressa
®
product
label
at
www.rhopressa.com
For Investor Use
-
~$3B Market, 37M TRx, 61M bottles
-
Half of volume first-line (PGAs)
-
Half of volume 2-3X/Day Adjuncts
-
New drug class per drug databases
-
Once-daily dosing directed at site of pathology, the trabecular meshwork
-
Consistent IOP reduction over 12 months and across all IOPs tested, as  
demonstrated in clinical trials     
2017 U.S. Glaucoma Market
Rhopressa
®
: HCP’s Positioning as Concomitant Therapy
Graph
Source:
IQVIA
TRx
Data
CAI: Carbonic Anhydrase Inhibitor
AA: Alpha Agonist
BB: Beta Blocker
Fixed
Combo
15%
AA
10%
Lumigan
8% 
Travatan
7%
Latanoprost
37%
BB 13%
CAI
10%


5
5
Rhopressa
®
Formulary Coverage Increasing
For Investor Use
25%
40%
12%
40%
55%
45%
Preferred Tier
Non-preferred Tier
As of 10/01/18:
~85% of Commercial Lives Covered
~40% Medicare Part D Lives Covered
------------Commercial-------------
-----------Medicare Part D---------
9/01/18                    10/01/18                    9/01/18                  10/01/18


6
Rhopressa
®
U.S. Launch Update
Weekly IQVIA Total Rx’s and Extended Units:
For Investor Use
Week 30: 11/2/18
*Actual
bottles
dispensed
exceed
TRx’s
due
to
extended
supply
plans
(e.g.,
90
days’
supply)
Rhopressa
®
has
not
been
approved
by
any
regulatory
authority
other
than
the
FDA.
5,850
4,726
Week Ending 11/9/18:
Wholesaler Shipments
to Pharmacies = 7,263


7
Rhopressa
®
U.S. Launch Update
For Investor Use
Rhopressa
®
has not been approved by any regulatory authority other than the FDA.
Strong Net Sales and Volume Growth:
$136 net sales
per unit
$122 net sales
per unit


8
8
Early Rhopressa
®
Feedback
Physician Examples:
End-stage glaucoma patient at brink of needing surgery. Patient on
maximal medical therapy (PGA/Combo/CAI) with IOP of 18 mmHg.
Added Rhopressa
®
and IOP dropped to 13 mmHg, avoiding surgery.
Patient on maximal drug therapy and inadequately controlled at 16
mmHg, with patient requiring surgery as next step. Patient IOP reduced
to 12 mmHg with Rhopressa
®
and surgery canceled.
Physician added Rhopressa
®
to a patient on two medications, and
Rhopressa
®
reduced IOP from 42 mmHg to 9 mmHg.
Patient on first-line and adjunct, physician replaced previous adjunct with
Rhopressa
®
and reduced IOP from 24 mmHg to 15 mmHg.
For Investor Use
Observations on file are anecdotal, do not reflect the results of clinical trials, and are not necessarily
indicative of the entire population


9
Active Engagement at Key Conferences
American Glaucoma Society
(AGS)
March 2018
American Society of Cataract and
Refractive Surgeons (ASCRS)
April 2018
Association of Research
in Vision and
Ophthalmology (ARVO)              
April 2018
European Glaucoma Society
(EGS)
Florence, May 2018
European Society of Cataract
and Refractive Surgeons
(ESCRS)
Vienna, September 2018
For Investor Use
American Academy of
Ophthalmology (AAO)
October 2018


10
Rocklatan
(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
-
At each of nine time points in each of the two Phase 3 trials
We
believe
it
may
have
the
potential
to
become
the
most
efficacious
IOP-reducing
medication
for
glaucoma
or
ocular
hypertension,
if
approved
Rocklatan
Combination Product Candidate
Data
on
file
Rocklatan
has
not
been
approved
by
the
FDA
For Investor Use
PDUFA Date Set for March 14, 2019
TM
TM
TM


11
Rocklatan
Efficacy
and
Safety
Rocklatan
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-reduction over latanoprost and Rhopressa
®
in the
range of 1 to 3 mmHg
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
Rocklatan
included: cornea verticillata, conjunctival hemorrhage, eye pruritus, lacrimation
increased, visual acuity reduced, blepharitis and punctate keratitis 
Data on file                                                                                                                  
For Investor Use
TM
TM
Safety:
Efficacy:
TM


12
Rocklatan
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


13
Rocklatan
Next Steps
Rocklatan
NDA submission accepted, with March 14,
2019 PDUFA
Current
U.S.
sales
force
will
be
trained
on
Rocklatan
in advance of PDUFA
Commercial formulary access expected to be finalized
post-approval
Medicare Part D formulary submission to payers expected
in April 2019
For Investor Use
TM
TM
TM


14
Expanding Aerie Franchise: Europe and Japan
Europe (2017 Europe “Big 5” Glaucoma Market: 91M units per year, 1.5X U.S.
units)
MAA accepted for Rhokiinsa
®
(Rhopressa
®
) in October 2018, expect 12-month
review
Mercury 3: 6-month safety and 90-day efficacy registration trial comparing
Rocklatan
for
non-inferiority
to
a
fixed-dose
combo
in
Europe
(Ganfort
®
)
If
Rhokiinsa
®
is
approved,
plan
to
submit
Rocklatan
MAA
thereafter
Construction of Ireland Plant in process to support worldwide commercial
supply
Japan (2017 Glaucoma Market: 54M units per year)
Advancing clinical development on our own, established branch office in Tokyo
Phase 1 completed and Phase 2 under way in the U.S. on Japanese and
Japanese-Americans; additional Phase 2 to commence in Japan
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
2017
$1.0B; 91M TRx*, Market Share in TRx
PGA: Prostaglandin Analogue; BB: Beta Blocker; AA: Alpha Agonist; CAI: Carbonic Anhydrase Inhibitor
Sources:
IQVIA
Analytics
Link
at
ex-manufacturer
price
level.
*TRx
calculated
from
IQVIA
unit
data
(1
month
=
1
TRx)
Non-PGA Market (47%)
PGA Market (53%)
17%
11%
13%
4%
19%
10%
5%
2 -
4 Times Daily
Once Daily
17%
Others
2%
For Investor Use
CAI
AA
Non-PGA
Fixed Combo
BB
PGA Fixed
Combo
Tafluprost
1%
Latanoprost
Travoprost
Bimatoprost


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:
IQVIA
Analytics
Link
at
ex-manufacturer
price
level.
*TRx
calculated
from
IQVIA
unit
data
(1
month
=
1
TRx)
Japan
Glaucoma
Market
2017
$0.8B; 54M TRx*, Market Share in TRx
For Investor Use
Non-PGA Market (48%)
PGA Market (52%)
13%
9%
9%
12%
19%
6%
5%
2 -
4 Times Daily
Once Daily
(Unoprostone
is bid)
11%
8%
4%
2%


17
Advancing the Pipeline
AR-13503 and AR-1105 are preclinical stage molecules and have not been approved by the FDA
Additional potential Rhopressa
®
indications are being considered for further study and are not labeled indications.
Rhopressa
®
Research
Targets
24-hour IOP reduction
Potential in normal tension glaucoma
pressure)
Pseudoexfoliative
glaucoma
Corneal healing
Retina Program Opportunities:
AR-1105 (dexamethasone steroid) potentially for DME
AR-13503 (ROCK/PKC inhibitor) potentially for AMD and DME
Drug Delivery Platform
Focused on ophthalmic sustained release                         
technologies
(DSM
/
PRINT
®
)
For Investor Use
Aqueous humor dynamics (trabecular outflow, episcleral venous


18
18
Retinal Eye Diseases –
Aerie’s Next Chapter
The retinal disease market is twice that of glaucoma with $4.9 billion in
the U.S. and $9 billion worldwide per IQVIA
Current treatments lose efficacy over time, some have very serious
side effects and there are limited surgical options
The majority of current treatments require repeated injections into the
patient’s eye
Aerie has two preclinical molecules for the treatment of retinal disease:
-
AR-1105 (dexamethasone steroid) for DME
-
AR-13503 (ROCK/PKC Inhibitor) for AMD/DME
Aerie also has implant and associated manufacturing platform
technologies
For Investor Use
AR-1105 and AR-13503 are preclinical stage molecules and have not been approved by the FDA


19
19
2017 U.S. Retinal Disease Market
For Investor Use
2017 Sales: $5.3B
Unit Sales: 6.8M
Sources: Mix of public information, IQVIA and estimates         
Eylea
,
$3.70
Avastin
,
$0.02
Lucentis
,
$1.44
steroids
,
$0.15
others
,
$0.02
Eylea
,
2.61
Avastin
,
3.03
Lucentis
,
0.86
steroids
,
0.23
others,
0.11


20
20
AR-1105: Dexamethasone Implant
Target indications
Macular edema due to diabetic retinopathy (DME)
Macular edema due to retinal vein occlusion (RVO)
Unmet need
First line anti-VEGF agents often not sufficient even with monthly intravitreal
(IVT) injections
Current second-line steroid treatments have limitations due to side effects
and/or injection frequency
For Investor Use
Data on File
AR-1105 may have the potential to lower treatment burden
and improve outcomes
2x sustained efficacy: injections every 6 months vs. every 3 months
Safety: Better control of drug elution, lower exposure of non-target
tissues
Improved IVT delivery: applicator has smaller needle (25G)
AR-1105 is a preclinical stage molecule and has not been approved by the FDA


21
AR-13503: A First-in-Class ROCK/PKC Inhibitor for the
Treatment of Wet AMD and DME
Active metabolite of 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
AR-13503 is a preclinical stage molecule and has not been approved by the FDA


22
Oxygen-induced retinopathy (OIR) mouse model -
PDR
Administration: Intraperitoneal QD
For Investor Use
Preclinical
AR-13503
Provides
Efficacy
Similar
to
Eylea
®
in a Proliferative Diabetic Retinopathy Model
Vehicle
(n=14)
1.25 mg/kg AR-13503
(n=16)
1 mg/kg Eylea
(n=14)
Data on File
For
more
information
on
Eylea®
please
see
the
product
webpage
https://www.eylea.us/


23
AR-13503 Synergistic to Eylea
®
in Mouse Model of
Proliferative Diabetic Retinopathy
Oxygen-induced retinopathy (OIR) mouse model -
PDR
Administration: Intraperitoneal QD
* :    p<0.01
*** : p<0.0001
For Investor Use
Neovascular Area (+SEM)
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/


24
DSM Collaboration –
Implant Delivery Technology
Bio-erodible implant technology
Aerie now has a worldwide exclusive license for all ophthalmic indications
Broad sustained release platform for treatment of Wet AMD and DME, as well
as glaucoma
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
Aerie also has access to DSM’s preclinical stage latanoprost implant for
glaucoma
For Investor Use
Data on File


25
PRINT
®
Technology for Ophthalmology
Micropatterned
Template
Mold formation
Mold Filling
(e.g. drug/polymer)
Particle Array
PRINT= Particle Replication In Non-wetting Templates
Aerie has 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, and other ophthalmic indications
For Investor Use
Excellent Control Over Particle Size, Shape and Formulation:
Aerie’s Ophthalmic Implant Manufacturing Platform


26
Evaluating Aerie’s 3,500+ Owned Molecules
ROCK
Commencing screening for
additional indications beyond
ophthalmology
ROCK inhibition should have
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
Key Priorities
Rhopressa
®
:  Successful launch execution
Rocklatan
TM
:   U.S. PDUFA set for March 14, 2019                                                            
Globalization Strategy
Europe/Japan clinical path and commercialization strategy
Ireland Manufacturing Facility
Research Initiatives
Rhopressa
®
24-hour IOP reduction, normal tension glaucoma,
aqueous humor dynamics, pseudoexfoliative
glaucoma, corneal healing    
Retina Program:
-
File IND for AR-1105 in 4Q 2018 and AR-13503 in 1H 2019, enter clinic in 2019
Broad sustained release ophthalmic implant and manufacturing platform
Evaluating Aerie’s ROCK inhibitors beyond ophthalmology
Well-Financed
$236M cash/investments at 9/30/18; $100M undrawn credit facility
For Investor Use