 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
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 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
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 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
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 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 |