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| 8-K - FORM 8-K - AERIE PHARMACEUTICALS INC | d601472d8k.htm |
 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 |