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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): September 19, 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 September 19, 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 September 2018.


EXHIBIT INDEX

 

Exhibit

  

Description

99.1    Company Overview Presentation dated September 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: September 19, 2018   By:  

/s/ Richard J. Rubino

    Richard J. Rubino
    Chief Financial Officer
EX-99.1
Company Overview
Ophthalmology Futures European Forum
Vienna, Austria
Presenter: Richard Rubino, Aerie Chief Financial Officer
September 20, 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
Roclatan™.
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
Roclatan™,
and
there
can
be
no assurance
that
we
will
receive
FDA
approval
for
Roclatan™ 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
Roclatan™,
and
there
can
be
no
assurance
that
we
will
receive
FDA
approval
for
Roclatan™
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
Roclatan™
does
not
constitute
FDA
approval
of
the
Roclatan™
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
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
Roclatan™ (netarsudil / latanoprost ophthalmic solution) 0.02% / 0.005%
U.S. NDA accepted, PDUFA set for March 14, 2019
Aerie Overview
Data on file.       Rhopressa
®
has not been approved by any regulatory authority other than the FDA.
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.
Rhopressa
®
has not been approved by any regulatory authority other than the FDA.
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
Travatan
7%
BB 13%
Fixed
Combo
15%
Lumigan
8%
Latanoprost
37%
CAI
10%
AA
10%


5
5
Rhopressa
:
U.S.
Commercialization
Status
Full Commercial Team on board
Medical Affairs and Compliance Teams in place
Adequate product in inventory and supply chain
Market Access contracts with top Medicare Part D and
Commercial Payers rapidly advancing 
-
Covered Market is ~50/50 Commercial / Part D
-
Part D coverage generally commences January 2019; for those
uncovered,
prior
authorization
success
rate
for
Rhopressa
®
of
~80%
~80% of Commercial lives covered:
~25% Tier 2 (preferred brand tier) + ~55% Tier 3
~12% of Medicare Part D lives already covered in Tier 2
More to come in early Q4
Rhopressa
®
has not been approved by any regulatory authority other than the FDA.
®
For Investor Use


6
Rhopressa
®
U.S. Launch Update
Weekly IQVIA Total Rx’s and Extended Units:
0
500
1000
1500
2000
2500
3000
3500
4000
4500
1
2
3
4
5
6
7
8*
9
10
11
12
13*
14
15
16
17
18
19
20
21
Bottles**
TRx's
For Investor Use
Week 21: 8/31/18
*Holiday Weeks
**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.


7
7
Examples
of
Early
Rhopressa
®
Feedback
Product Performance:
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 already on four medications,
and Rhopressa
®
reduced IOP from 33 mmHg to 19 mmHg.
Physician’s first experience with Rhopressa
®
, patient’s IOP was cut in
half from 30 mmHg to 15 mmHg.
For Investor Use
Observations on file are anecdotal and not necessarily indicative of the entire population.
Rhopressa
®
has not been approved by any regulatory authority other than the FDA.


8
Roclatan™
(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
Potential
to
become
the
most
efficacious
IOP-reducing
medication
for
glaucoma or ocular hypertension, if approved
Roclatan™
Combination Product Candidate
Data on file
Roclatan™ has not been approved by any regulatory authority.
For Investor Use
PDUFA Date Set for March 14, 2019


9
Roclatan™ Efficacy and Safety
Efficacy:
Roclatan™ 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
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™ 
included: cornea verticillata, conjunctival hemorrhage, eye pruritus, lacrimation
increased, visual acuity reduced, blepharitis and punctate keratitis 
Data on file          Rhopressa
®
has not been approved by any regulatory authority other than the FDA.                                                        
Roclatan™ has not been approved by any regulatory authority.                                                                   For Investor Use


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
16%
26%
37%
49%49%
57%
12%
22%
35%
66%
27%
43%
60%
72%
82%
0%
20%
40%
60%
80%
100%
IOP on Treatment
Rhopressa® (n=148)
Latanoprost (n=203)
Roclatan™ (n=158)
***
**
*p<0.05, **p<0.01, ***p<0.0001
*
**
***
++
Data on File
Based on Mercury 1 Interim Analysis 2
Roclatan™ has not been approved by any regulatory authority.     For Investor Use
14 mmHg
15 mmHg
16 mmHg
17 mmHg
18 mmHg


11
Roclatan™
Next
Steps
Roclatan
NDA
submission
accepted,
with
March
14,
2019
PDUFA
Current
U.S.
sales
force
will
be
trained
on
Roclatan
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
Roclatan
has
not
been
approved
by
any
regulatory
authority.
TM
TM
TM


12
Expanding Aerie Franchise: Europe and Japan
Europe (2017 Europe “Big 5” Glaucoma Market: 91M 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 comparing
Roclatan™ for non-inferiority to a fixed-dose combo in Europe (Ganfort
®
)
Construction of Ireland Plant in process to support worldwide commercial
supply
Japan (2017 Glaucoma Market: 54M units per year)
Plan to advance clinical development on our own, establish 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


13
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%)
Bimatoprost
Travoprost
Latanoprost
Tafluprost
1%
PGA Fixed
Combo
BB
Non-PGA
Fixed Combo
AA
CAI
17%
11%
13%
4%
19%
10%
5%
2
-
4
Times
Daily
Once Daily
17%
Others
2%
For Investor Use


14
Rhopressa
®
24-hour IOP reduction
Potential in normal tension glaucoma
Aqueous
humor
dynamics
(trabecular
outflow,
episcleral
venous
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
®
)
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
®
has not been approved by any regulatory authority other than the FDA.
For Investor Use