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8-K
AERIE PHARMACEUTICALS INC SUITE 270 <span data-hint="Entity false 0001337553 0001337553 2019-08-13 2019-08-13

 

 

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 13, 2019

 

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:

  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))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange

on which registered

Shares of common stock, par value $0.001 per share

 

AERI

 

Nasdaq Global Market

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 13, 2019, 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 2019.


EXHIBIT INDEX

Exhibit

   

Description

         
 

99.1

   

Company Overview Presentation dated August 2019.


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 13, 2019

 

 

By:

 

/s/ Richard J. Rubino

 

 

 

Richard J. Rubino

 

 

 

Chief Financial Officer

EX-99.1
Company Overview
Investor Presentation
August 2019
Exhibit 99.1


2
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 is 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,
including
AR-1105
and
AR-13503,
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
®
,
including
prescribing
information,
refer
to
the
full
Rhopressa
®
product
label
at
www.rhopressa.com.
For
more
information
on
Rocklatan
®
,
including
prescribing
information,
refer
to
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, these statements include any discussion of
potential commercial sales, placement or utilization of Rocklatan or Rhopressa in the United States or any other market. Likewise,  FDA approval of
Rhopressa
®
and
Rocklatan
®
does
not
constitute
approval
of
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
®
and
Rocklatan
®
also
does
not
constitute
regulatory
approval
of
Rhopressa
®
or
Rocklatan
®
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 development work being undertaken for our pipeline and 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.
For Investor Use
Important Information


3
For Investor Use
Aerie Overview
Rhopressa
®
and
Rocklatan
®
have
not
been
approved
by
any
regulatory
authority
other
than
the
FDA.
Additional
potential
Rhopressa
®
indications
are
being
considered for further study and are not labeled indications. AR-13503 and AR-1105 are pre-clinical molecules and have not been approved by FDA.
Aerie IOP–Reducing Products (IP 2030+)
Pipeline Activities
Rhopressa
®
normal
tension
glaucoma,
pseudo
ex
glaucoma,
corneal
healing...
Retina
Program
AR-13503
(IND
accepted
by
FDA
Q2
2019)
and
AR-1105
(Phase 2 clinical study commenced Q1 2019) implants
Sustained-Release Implant Manufacturing Platform
Beyond
Ophthalmology
potential
for
Aerie-owned
molecules
Rhopressa
®
(netarsudil ophthalmic solution) 0.02%
Successful U.S. Launch in 2018
Rocklatan
®
(netarsudil
and
latanoprost
ophthalmic
solution)
0.02%/0.005%
Launched May 1, 2019
Second drug product contract manufacturer approved  for
Rhopressa
®
Aerie Ireland plant expected to be online early 2020
Globalization
Plan
Under
Way
Europe
and
Japan


4
For Investor Use
Glaucoma Market Perspective
-
~$3B Market, 35M TRx, 52M bottles
-
Half of volume first-line (PGAs)
-
Half of volume 2-3X/Day Adjuncts
2018 U.S. Glaucoma Market
Graph Source: IQVIA 2018
CAI: Carbonic Anhydrase Inhibitor
AA: Alpha Agonist
BB: Beta Blocker
Source: IMS/NPA Data R12M May’18-Apr’19 and Aerie company estimates.
Estimated
Glaucoma
Market
TRx
Mix
Lumigan
6%
Travatan
5%
Latanoprost
41%
Other
BB
14%
Fixed
Combo
13%
AA
10%
CAI
7%
Medicare Part D
Commercial
Other Government
Medicaid & Cash
Other Government 8%
Medicaid & Cash 7%
Medicare Part D
51%
Commercial
34%


5
For Investor Use
Rhopressa
®
and Rocklatan
®
Positioning
HCP’s positioning as
concomitant therapy
HCP’s positioning as therapy
for patients requiring maximal
IOP lowering with one drop per
day
Rhopressa
®
Positioning
Rocklatan
®
Positioning 
Efficacy vs. other adjunctive therapies
QD PM dose
Lack of serious and systemic AE’s
Efficacy vs. all other glaucoma therapies
QD PM dose
Lack of serious and systemic AE’s
Refer to the full product labels at www.rhopressa.com and www.rocklatan.com


6
For Investor Use
Rocklatan
®
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%
   14 mmHg
   15 mmHg
   16 mmHg
   17 mmHg
   18 mmHg
IOP on Treatment
Rhopressa  (n=148)
Latanoprost (n=203)
Rocklatan
***
**
®
®
*p<0.05, **p<0.01, ***p<0.0001
++
Data on File
Based on Mercury 1 Interim Analysis 2
Rocklatan
®
has not been approved by any regulatory authority other than the FDA.
*
**
***


7
For Investor Use
U.S. Glaucoma Franchise Launch Update
Actual Sales-Out to Pharmacies data and
IQVIA data as of 8/2/19
Actual bottles dispensed exceed Rx’s due to extended supply plans (e.g., 90 days’ supply)
Rhopressa
®
and Rocklatan
®
have not been approved by any regulatory authority other than the FDA.
7,362
8,630
9,598
11,294
11,858
14,199
4/13/2018
12/31/2018
8/2/2019
0
3,000
6,000
9,000
12,000
15,000
Franchise Actual Sales-Out to Pharmacies
Rhopressa® Actual Sales-Out to Pharmacies
Franchise IQVIA Bottles
Rhopressa® IQVIA Bottles
Franchise IQVIA Rx
Rhopressa® IQVIA Rx


8
For Investor Use
Gaining Market Access
Access percentages reflect signed contracts, not necessarily implemented underlying formulary coverage.
Rhopressa
®
Access as of August 2019:
Commercial ~ 90%
Medicare Part D ~ 75%
Rocklatan
®
Expected Access by end of September 2019:
Medicare Part D ~ 30%  (Rhopressa
®
~10% in September 2018)


9
For Investor Use
2019 Financial Guidance
Net revenue guidance: $70 to $80 million
Net cash burn guidance: $160 to $170 million


10
For Investor Use
Launch Considerations
Aerie is in the unique position of gaining coverage for Rocklatan
®
while
continuing to grow Rhopressa
®
Underlying formulary coverage is sometimes delayed
Physicians are navigating through the treatment paradigm to optimize patient
care while considering patient costs
Rocklatan
®
samples are being used with excellent results, but without
coverage physicians may add Rhopressa
®
on top of a PGA as an affordable
interim solution
Busy practices may not have patients return for 60 days
Dosing, simplicity and efficacy of Rocklatan
®
is widely recognized and there
appears to be a high willingness for physicians to use it as a first-line agent
Patient access and affordability are key to continued market share gains


11
For Investor Use
Active Engagement at Key Conferences
March 2019: American Glaucoma Society (AGS)
April/May 2019: Association of Research in
Vision and Ophthalmology (ARVO)
May 2019: American Society of Cataract and
Refractive Surgeons (ASCRS)
July 2019: American Society for Retina
Specialists (ASRS)
September 2019: European Society of Cataract
and Refractive Surgeons (ESCRS)
September 2019: Japan Glaucoma Society
(JGS)
October 2019: American Academy of
Ophthalmology (AAO)


12
For Investor Use
Expanding Aerie Franchise: Europe
MAA
accepted
for
Rhokiinsa
®
(Rhopressa
®
)
in
October
2018,
regulatory
decision
expected
by end of 2019
Mercury
3:
6-month
safety
and
90-day
efficacy
registration
trial
comparing
Rocklatan
®
(known
as
Roclanda
®
in
Europe)
for
non-inferiority
to
a
fixed-dose
combo
in
Europe
(Ganfort
®
)
If
Rhokiinsa
®
is
approved,
plan
to
submit
Roclanda
®
MAA
thereafter
(Q1
2020)
Ireland Plant will begin supporting worldwide commercial supply in early 2020
Mercury 3 top-line readout expected in 1H 2020
Aerie expects to commercialize on its own (if approved)
Sources:
IMS
Analytics
Link
at
ex-manufacturer
price
level-
March
2019.
*TRx
calculated
from
IQVIA
unit
data
(1
month
=
1
TRx)


13
For Investor Use
Expanding Aerie Franchise: Japan
Advancing clinical development on our own, established branch office in Tokyo
Phase 1 completed; successful Pilot Phase 2 completed in the U.S. on Japanese and
Japanese-Americans; Phase 2 commenced in Japan, enrollment completed July 2019
Phase 2 Study top-line readout expected in Q4 2019
Phase 3 trials expected to be conducted in Japan
Aerie evaluating commercialization alternatives including partnering
Sources:
IQVIA
Analytics
Link
at
ex-manufacturer
price
level
March
2019.
*TRx
calculated
from
IQVIA
unit
data
(1
month
=
1
TRx)


Advancing the Pipeline
Drug/Target
Indication
Development Stage
Discovery
Preclinical
Phase 1/2a
AR-1105 Implant
(Dexamethasone)
RVO
AR-13503 Implant
(ROCK, PKC)
wAMD
DME/DR
Glaucoma Neuro-
enhancement
AR-xxxxx
Implant
(ROCK/JAK/IKK)
Dry AMD/GA
AR-xxxxx
(JAK, IKKb)
Dry Eye/MGD
AR-xxxxx
(ROCK, JAK, IKKb)
Psoriasis
IND
IND
Evaluating Aerie’s 4,000+ Owned Molecules
For Investor Use
14


15
For Investor Use
Retinal Eye Diseases –
Aerie’s Next Chapter
Bringing Small Molecule Therapy to Back of the Eye
Most retinal drugs in use and in pipeline are protein therapeutics
Longer half-life allows monthly to bimonthly IVT injections
Protein therapeutics address limited number of extracellular targets
Small molecules address a wider array of therapeutic targets, but are
rapidly cleared from back of the eye
The Solution:
Pair small molecules with a safe and effective sustained delivery
technology
to
enable
IVT
injections
every
4
-
6
months


16
For Investor Use
2018 U.S. Retinal Disease Market
Eylea,
$4.1
Avastin,
$0.04
Lucentis,
$1.7
steroids,
$0.2
others,
$0.02
2018 Sales: $6.0B
2018 Unit Sales: 7.3MM
Eylea, 2.1
Avastin,
3.9
Lucentis,
1.0
steroids,
0.2
others,
0.1
Sources:
Mixture
of
public
information,
IQVIA,
Market-Scope
and
estimates
March
2019        


17
For Investor Use
Aerie’s Innovation in Retinal Disease
Small Molecule Drug
Candidates
Proprietary Drug Delivery
Technology
Bio-erodible,
sustained-release
implant for
intravitreal injection
DSM PEA Polymer
PLGA
PRINT® Mfg
AMD       DME      RVO      Dry AMD/GA      Glaucoma       Others
Aerie Kinase Library
Non-Aerie drug candidates


18
For Investor Use
Retinal Eye Disease: Unmet Needs in AMD and DME
Need new treatments to address disease mechanisms beyond VEGF
Complex pathology cannot be addressed by a single drug class
Anti-VEGFs are used to treat the eye with wet AMD, while the
second eye typically has dry AMD and a high risk of converting to
wet AMD over time. There are no current treatment approaches
to prevent this conversion.
Many patients do not achieve and/or maintain sufficient efficacy
AMD: Anti-VEGF efficacy often lost after 5–7 years of treatment
DME: Anti-VEGF is ineffective for ~1/3 of DME patients
Need treatments that are effective with less frequent intravitreal injections


19
For Investor Use
Aerie’s Lead Retina Product Candidates
AR-1105 (Dexamethasone) Implant
Indications: retinal vein occlusion (RVO) and DME
Target product profile vs. Ozurdex
®
Longer duration of efficacy (6 mo
vs 3 mo)
Improved administration due to smaller needle
Potential for fewer adverse effects due to lower peak drug levels
AR-13503 (ROCK/PKC) Implant
Initial indications: neovascular AMD and DME
Novel MOA: anti-angiogenesis PLUS anti-fibrosis, anti-inflammation
Effective as monotherapy or adjunctive therapy to anti-VEGF
Targeting injection once every 6 months
For
more
information
on
Ozurdex®
please
see
the
product
webpage
https://www.ozurdex.com
AR-1105 and AR-13503 are development stage product candidates and are not approved by any regulatory agency


20
For Investor Use
AR-13503
Synergistic
to
Eylea
®
in
Mouse
Model
of
Proliferative Diabetic Retinopathy
Oxygen-induced retinopathy (OIR) mouse model -
PDR
0%
5%
10%
15%
20%
25%
30%
35%
Vehicle
n=12
Eylea (sub-
optimal dose)
n=12
AR-13503 (sub-
optimal dose)
n=14
Combination
n=8
-40%
*
Administration: Intraperitoneal QD
* :    p<0.01
*** : p<0.0001
-60%
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/
AR-13503 is a development stage product candidate and is not approved by any regulatory agency
***


21
For Investor Use
Summary
Key Priorities
Rhopressa
®
:  Continued successful launch execution
Rocklatan
®
:  Successful launch execution
Globalization Strategy
Europe/Japan clinical path and commercialization strategy
Ireland Manufacturing Facility
Research Initiatives
Rhopressa
®
normal tension glaucoma, pseudoexfoliative
glaucoma, corneal healing    
Retina Program:
-
AR-1105 Phase 2 clinical study commenced in Q1 2019; AR-13503 IND accepted Q2 2019,
to enter clinic in Q3 2019
Broad sustained release ophthalmic implant and manufacturing platform
Evaluating Aerie’s ROCK inhibitors beyond ophthalmology
Well-Financed
$109M cash/investments at 6/30/19; $200M undrawn credit facility