Company Overview
Investor Presentation
August 2020
Important Information
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,AR-13503 and AR-15512, 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. This presentation shall not constitute an offer to sell, nor a solicitation of an offer to buy, any of Aerie's securities.
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. For example, uncertainties around the duration and severity of the current global COVID-19 pandemic including its possible impact on our clinical and commercial operations and our global supply chain could cause our actual results to be materially different than those expressed in our 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, any discussion in this presentation about preclinical activities or opportunities associated with our products or discussions involving the potential for our dry eye product candidate are preliminary and the outcome of any studies may not be predictive of the outcome of later trials and ultimate regulatory approval. 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. Any statements regarding Aerie's future liquidity, cash balances or financing transactions also constitute forward-looking statements. 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 2
Aerie Overview
Aerie IOP-Reducing Products (IP 2030+)
- Rhopressa® and Rocklatan® gaining momentum in the United States
- Aerie franchise ranked #4 in total U.S. prescriptions (April 2020) for branded glaucoma products
- Globalization Plan Under Way - Major decisions upcoming for Japan and Europe
Key Pipeline Activities
- AR-15512TRPM8 agonist for Dry Eye (Phase 2b clinical study expected to commence Q4 2020)
- Sustained-ReleaseImplant Platform:
- Retina AR-13503(First-in-human clinical study commenced Q3 2019) AR-1105 (Positive Topline Phase 2 results reported July 2020)
Rhopressa® has not been approved by any regulatory authorities other than the FDA and EMA and Rocklatan® has 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 | For Investor Use 3 |
development stage product candidates and are not approved by any regulatory agency. |
Aerie's Key Catalysts for 2020
Pipeline:
- AR-15512TRPM8 agonist for Dry Eye Phase 2b clinical study expected to commence Q4 2020
- AR-1105Phase 2 RVO clinical study readout Q3 2020
Globalization:
- Roclanda® Mercury 3 topline readout Q3 2020; Roclanda® EMA approval expected late 2020 / early 2021
- Rhopressa® Phase 3 clinical study in Japan to commence Q4 2020
U.S. Glaucoma Franchise: Focus on continued momentum capitalizing on higher coverage
For Investor Use 4
Aerie Overview
2019 U.S. Glaucoma Market
- ~$3B Market, 36M TRx, 55M bottles
- 55% of unit volume first-line (PGAs)
- 45% of unit volume 2-3X/Day Adjuncts
Estimated Glaucoma Market TRx Mix
Other Government,
11%
Rhopressa, | Lumigan, | |
CAIs, 7% | 1% | 6% |
Travatan Z, | ||
4% | ||
AA, 10% |
Fixed
Combo,
14%
BB, 13% | Latanoprost, |
43% | |
Other PGA, | |
1% | Graph Source: IQVIA 2019 |
CAI: Carbonic Anhydrase Inhibitor | |
AA: Alpha Agonist | |
BB: Beta Blocker |
Medicare Part D &
Medicaid, 57%
Commercial & Cash,
32%
Sources: IQVIA: NPA Rx and NSP Unit data | For Investor Use |
Rhopressa® bottles per Rx year-to-date 2020 were 1.38 (high as 1.43 in recent weeks) compared to same period 2019 of 1.27, reflecting an increase
in 90 days' supply.
5
87% of OPH Offices are Currently Open While a Variety of Mechanisms are Being Deployed
COVID-19 IMPACT ON OFFICES
70%
Offices have limited hours
62%
Offices using telehealth to interact with patients
Fieldwork: April 30 - May 11, 2020 N=225
67%
Offices only seeing "sick" patients
13%
Offices temporary closed
63%
Office staff has been reduced
2%
Business as usual
For Investor Use 6
Ophthalmologists Should Still be Accessible Even if Access Will be Different From the Past
H O W W I L L Y O U I N T E R A C T W I T H P H A R M A C E U T I C A L
S A L E S R E P R E S E N TAT I V E S I N T H E F U T U R E ?
MULTIPLE ANSWERS ALLOWED, SO TOTAL > 100%
69%
I will limit the number of 'live'
engagements
with reps in the office
15% | 13% | 6% | 3% | |||
Other - mix of | I will only see | I will not be seeing | No live | |||
face-to-face and virtual | reps virtually | any reps in the office | or virtual | |||
We have trained our reps | for the reminder | contact | ||||
(& speakers) to deliver | of 2020 | with reps | ||||
virtual presentations | ||||||
Aerie Fieldwork: April 30 - May 11, 2020 N=225
For Investor Use 7
Comparing April to March, The Aerie Franchise Fared Better Than Key Competitors
Product | Mar-20 | Apr-20 | Chg | % Change↓ |
Rhopressa® | 31,451 | 28,219 | -3,232 | -10.3% |
Rocklatan® | 14,858 | 13,157 | -1,701 | -11.4% |
Lumigan® | 182,875 | 160,907 | -21,968 | -12.0% |
Simbrinza® | 36,412 | 31,875 | -4,537 | -12.5% |
Combigan® | 139,649 | 122,008 | -17,641 | -12.6% |
Travatan Z® | 41,739 | 36,358 | -5,381 | -12.9% |
Alphagan® P | 69,832 | 60,806 | -9,026 | -12.9% |
Zioptan® | 11,186 | 9,611 | -1,575 | -14.1% |
Azopt® | 35,560 | 29,921 | -5,639 | -15.9% |
Vyzulta® | 15,046 | 12,631 | -2,415 | -16.1% |
Cosopt Pf® | 4,450 | 3,659 | -791 | -17.8% |
IQVIA Xponent TRXs Apr'20 vs. Mar'20
For Investor Use | 8 |
COVID-19: How is Aerie Responding?
- Ongoing communication of the MOST Data
- Continued execution of the Pulse Strategy, focused on driving monthly prescribers to weekly prescribers (January to April gain of 700 HCP's to over 4,200 weekly prescribers)
- Increasing share of voice with HCP's to further bolster sales momentum
- Drive benefit from recently increased managed care coverage:
- Rhopressa® 90% Commercial, 88% Med D
- Rocklatan® 88% Commercial, 55% Med D plus 15% Low Income Subsidy
For Investor Use | 9 |
Increasing Share of Voice
Goal: Increase Share of Voice with the 14,000+ targets
- Aeriereps calling on Top 10,000highest prescribers
- Majority to be detailed 2x per month
- Added Contract Sales Organizationto call on next 1,500higher prescribing targets of glaucoma medications
- Added Telesalesteam to call on next 3,000higher prescribing targets
For Investor Use 10
Topline Results from Rhopressa® Phase 4 Multi-centerOpen-label Study (MOST)
- 12-weekMOST study evaluated efficacy, tolerability and safety of Rhopressa® use in 260 patients in a real-world clinical setting
- Use of Rhopressa® as monotherapy or adjunct was at discretion of the physician
- Used adjunctively (n=151, mITT):
- Rhopressa® was similarly effective when added to prior PGA monotherapy or when added to prior multi-drug therapy
- Additional IOP reductions of 4.3 mmHg and 4.5 mmHg, respectively (12 weeks)
- Used as monotherapy (n=91, mITT):
- Rhopressa® maintained IOP levels comparable to prior PGA following switch (n=57)
- Rhopressa® was well tolerated as monotherapy and adjunctive therapy
- No treatment-related serious adverse events (AEs)
- Most common AEs were Conjunctival Hyperemia (20.8%) and Vision Blurred (7.3%)
- 89% of patients reported Rhopressa® was tolerated "well" or better in survey (mITT)
++Data on File | For Investor Use | 11 |
U.S. Glaucoma Franchise Launch Update
Actual Weekly Sales-Out to | IQVIA Weekly Data as of 7/31/2020 | |||
Pharmacies Data as of 8/7/2020 | ||||
24,000 | 18,000 | |||
Franchise Actual Sales-Out to | Franchise IQVIA Bottles | |||
22,000 | Pharmacies - Bottles | 15,864 | ||
16,000 | ||||
Rhopressa® Actual Sales-Out to | Rhopressa® IQVIA Bottles | |||
20,000 | ||||
Pharmacies - Bottles | 18,780 | |||
18,000 | 14,000 | |||
16,000 | 12,000 | |||
14,000 | 12,725 | 10,582 | ||
12,000 | 10,000 |
10,000 | 8,000 |
8,000
6,000
6,000 | 4,000 | ||||||||
4,000 | |||||||||
1/4/2019 | 8/7/2020 | 1/4/2019 | 7/31/2020 | ||||||
Rhopressa® has not been approved by any regulatory authorities other than the FDA and EMA and Rocklatan® has not been | For Investor Use | 12 | |||||||
approved by any regulatory authority other than the FDA. |
Advancing the Pipeline
Drug/Target Indication
Development Stage
Preclinical | Phase 1/2a | Phase 2b |
Front of the Eye
AR-15512 | Dry Eye |
(AVX TRPM8 agonist) |
Back of the Eye
AR-1105 Implant | RVO/DME |
(Dexamethasone) | |
wAMD | |
AR-13503 Implant | DME/DR |
(ROCK, PKC) | |
Glaucoma Neuro- | |
enhancement |
For Investor Use | 13 |
U.S. Dry Eye Market: Under-diagnosed and Under-treated
US 2019 Sales: $1.6B est.
Cequa (Sun),
$46
Xiidra (TAK /
NVS), $409
Restasis (AGN),
$1,138
- Estimated 30 million dry eye sufferers in the United States; less than 3 million treated
- Dry eye related symptoms are one of the most common reasons for patients to visit an eye care professional
- Represents a significant health care burden, contributing to approximately 25% of visits to ophthalmic clinics
- Current pharmaceutical therapies are anti-inflammatories, often with poor maintenance on therapy and poor tolerability
- DED affects quality of life and interferes with reading, driving ability, computer use, work productivity and is associated with increased anxiety, stress and depression
- Unmet need for different MOAs, better tolerability, and treatment of symptoms
Sources: Mixture of public information, IQVIA , Market Scope and estimates - Feb 2020; Gayton JL. Clin Ophthalmol. 2009; 3:405-412.; | For Investor Use | 14 |
Stonecipher KG et al. Ther Clin Risk Manag. 2013; Asrini Noor N. W J Opthalmol & Vision Res 2018. |
AR-15512 for Dry Eye
- Novel Mechanism of Action - Modulation of Corneal TRPM8 receptors
- Topical eye drop
- TRPM8 receptor is a cold thermoreceptor ion channel located on corneal nerve endings
- Reduced corneal temperature triggered by tear evaporation activates TRPM8 which leads to:
- Increased basal tear production (sign for DED)
- A cooling sensation leading to reduction in discomfort / ocular pain (symptom for DED)
- This dual mechanism of action is different than those of current prescription dry eye products and supports use as monotherapy as well in conjunction with approved products
- Basal tearing depending on TRPM8 stimulation is independent of pain-evolved reflex tearing
Data on file. | For Investor Use | 15 |
AR-15512 is a development stage product candidate and is not approved by any regulatory agency | ||
AR-15512 (TRPM8 Agonist) for Dry Eye
How AR-15512
works
AR-15512
Ophthalmic
Solution
For Investor Use16
AR-15512 for Dry Eye
- Avizorex completed a Phase 2a study in early 2019 in 109 subjects
- One concentration (0.0014%) and two dosing regimens (BID/TID) for 4 weeks were evaluated
- Primary endpoint: % of patients ≥ 20 points change in symptoms questionnaire (SANDE)
- Secondary endpoints:
- Schirmer's test (tear production)
- Tear film break-up-time (TBUT)
- Corneal staining
- Key findings:
- BID dosing demonstrated greater separation from vehicle, especially in subjects with higher symptoms at baseline
- Statistical differences from vehicle observed in BID dosing≥ arm in symptoms (severe subjects) and Schirmer's change 3 mm
Data on file. | For Investor Use | 17 |
AR-15512 is a development stage product candidate and is not approved by any regulatory agency | ||
AVX-012(AR-15512) Dry Eye Clinical Trial Highlights
- Significant efficacy achieved for sign and symptoms with BID dosing of 0.0014% (50µM) AVX-012(AR-15512) over 28 days
Symptoms: SANDE Score
Percentage of patients improving ≥20 score
p=0.021
p=0.1
• Graph on the right represents primary endpoint with a | |||
subset of more severe symptoms | |||
++Data on File | • Demonstrated statistical significance | For Investor Use | 18 |
AVX-012(AR-15512) Dry Eye Clinical Trial Highlights
- Significant efficacy achieved for sign and symptoms with BID dosing of 0.0014% (50µM) AVX-012(AR-15512) over 28 days
Sign: Schirmer Evaluation
Percentage of patients improving ≥3mm
++Data on File | 19 |
For Investor Use |
Dry Eye Program: AR-15512
- Target symptoms: significant step in addressing the symptoms of dry eye patients and providing a cooling sensation
- Impact basal tear production: production of natural tears and not just an acute reflex tear
- Safe for long-term use
- Other approved products on the market:
- Xiidra®: only approved product for the treatment of signs and symptoms
- Restasis®, Cequa™ and TrueTear®: approved for increase in tear production
For Investor Use | 20 |
AR-15512 Development Update
- 3-monthtoxicity studies ongoing
- FDA meeting held in June 2020
- Clinical Trial Series named "COMET" = Cold Thermoreceptor Modulation as an Effective Treatment
- Phase 2b study will evaluate efficacy and safety of 0.0014% and 0.003% BID
- First patient enrolled Q4 2020
- 360 patients (1:1:1) for 3 months
- Environmental and Controlled Adverse Environment (CAE) conditions
- Primary endpoints: ocular discomfort (symptom) and tear production (Sign)
-
Secondary endpoints include: SANDE, staining TBUT, changes post
CAE
COMET-1 Phase 2b topline results expected Q3 2021
For Investor Use | 21 |
2019 U.S. Retinal Disease Market
2019 Sales: $6.8B | 2019 Unit Sales: 8.1MM | ||||
Beovu, | steroids, | others, | Beovu, | steroids, | others, |
$0.21 | 0.3 | 0.1 | |||
$0.04 | 0.03 | ||||
$0.02 | |||||
Lucentis,
1.1
Lucentis, | |
$1.8 | Eylea, 3.3 |
Eylea,
$4.6
Avastin,
$0.04
Avastin,
3.3
Sources: Mixture of public information, IQVIA, Market-Scope and estimates - Feb 2020 | For Investor Use | 22 |
Aerie's Lead Implant Product Candidates
AR-1105 (Dexamethasone) Implant (Phase 2 Topline reported July 2020)
- Indications under development: retinal vein occlusion (RVO)
- Target product profile vs. Ozurdex®
- Designed for longer duration of efficacy (6 mo vs 3 mo)
- Designed for improved administration due to smaller needle
- Potential for fewer adverse effects due to lower peak drug levels
AR-13503 (ROCK/PKC) Implant (Topline data expected H2 2021)
- Initial indications under development: neovascular AMD and DME
- Novel MOA: anti-angiogenesis PLUS anti-fibrosis,anti-inflammation
- Designed to be 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 | For Investor Use 23 |
AR-1105 and AR-13503 are development stage product candidates and are not approved by any regulatory agency |
AR-1105: Phase 2 Topline Summary
- The Phase 2 clinical trial (AR-1105-CS201) was conducted at 19 centers in the United States. A total of 49 patients completed the study.
- The objective of the Phase 2 clinical trial was to evaluate two formulations of AR-1105, clinical formulation #1 (CF-1) and clinical formulation #2 (CF-2) with different steroid release profiles. The clinical trial was conducted in two stages.
In the initial safety stage, five patients were enrolled in a single cohort to receive CF-1, delivering a 340µg dose of dexamethasone in a single intravitreal injection. In stage 2, 44 patients were randomized 1:1 to receive either CF-1 or CF-2. - The results demonstrated positive and sustained treatment effects with both formulations as shown by increases in best corrected visual acuity and reductions in macular edema. Peak efficacy was observed earlier with CF-1, while CF-2 demonstrated a longer overall duration of effect of up to six months.
- Both formulations, CF-1 and CF-2, were well tolerated with no unexpected safety findings. Adverse events were consistent with other corticosteroid treatments and intravitreal injection procedures.
The profiles of the different cohorts demonstrate the flexibility of the
PRINT® sustained release technology platform in enhancing the management
and durability of treatment effects. Further details will be provided at an
upcoming ophthalmology conference.
Data on file. | For Investor Use | 24 |
Expanding Aerie Franchise: Japan
- Phase 2 study successful topline results released in November 2019
- Phase 3 trials expected to commence in Japan Q4 2020
Aerie currently exploringva uatingpartneringopportunities
Sources: IMS Analytics link at ex-manufacturer price level and Unit-April 2020. *TRx calculated from IQVIA unit data (1 month = 1 TRx) | For Investor Use | 25 |
AR-13324-CS208 Japan Phase 2 Study Topline Results
- 28-dayprospective, double-masked,placebo-controlled,dose-ranging study of netarsudil efficacy and safety in Japanese subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT)
- Netarsudil 0.01%, 0.02% and 0.04% were efficacious, met primary endpoint of superiority to placebo in mean diurnal IOP at Week 41, were safe and generally well tolerated
- Baseline mean diurnal IOPs 20-21 mmHg across study arms2 (Japanese IOPs ~3 - 4 mmHg lower than in the U.S.)
- Week 4 mean diurnal IOP was 16.3 (-4.1), 15.4 (-4.8), 16.2 (-4.8) and 19.3 (-1.7) mmHg in the netarsudil 0.01%, 0.02%, 0.04%, and placebo groups, respectively2
- No serious adverse events
- Netarsudil 0.02% (concentration of Rhopressa® in the U.S) provided best balance of efficacy and safety
- Most common AE was Conjunctival Hyperemia (37.0%), discontinuation rate was 1.9%, all lower than in US trials3-5
Netarsudil generated up to 4.8 mmHg reduction in IOP
from baseline
1. ANCOVA with MCMC imputation. 2. Observed data. 3. Bacharach J, et al. Ophthalmology. 2015 Feb;122(2):302-7. 4. Serle JB, et al. Am J Ophthalmol. 2018 Feb;186:116-127. 5. Khouri AS, et al. Am J Ophthalmol. 2019 Aug;204:97-104.
For Investor Use | 26 |
AR-13324-CS208 Japan Phase 2 Study Topline Results
Mean Diurnal IOP (ITT, Observed Data) | ||||||
24 | ||||||
23 | ||||||
22 | 21.1 | |||||
20.5 | 20.8 | |||||
21 | 20.3 | |||||
SEM | 20 | 19.8 19.3 | 19.3 | Baseline | ||
+ | 19 | |||||
mmHg | 18 | Week 1 | ||||
Week 2 | ||||||
IOP | 17 | |||||
16.3 | 15.9 | 15.7 15.7 16.2 | Week 4 | |||
16.215.9 | ||||||
16 | 15.6 15.4 | |||||
15 | ||||||
14 | ||||||
13 | Placebo | Netarsudil 0.01% | Netarsudil 0.02% | Netarsudil 0.04% | ||
(n=55) | (n=55) | (n=54) | (n=51) |
• P<0.0001 vs. placebo at Week 4 for all dose levels1
• 0.02% achieved lowest mean diurnal IOP at Week 4 | 27 |
1. ANCOVA with MCMC imputation | For Investor Use |
Expanding Aerie Franchise: Europe
- Marketing authorisation granted for Rhokiinsa® (Rhopressa®) in November 2019; Roclanda® (Rocklatan®) MAA accepted for review in December 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®).
- Ireland Plant approved for U.S. production
Mercury 3 topline readout in Q3 2020;
Results will inform commercialization strategy
Sources: IQVIA Midas data at ex-manufacturer price level and Unit-April 2020. *TRx calculated from IQVIA unit data (1 month = 1 TRx) | For Investor Use | 28 |
Summary
- Key Priorities
- Rhopressa® and Rocklatan® gaining momentum in the United States
- Globalization Strategy
- Europe/Japan clinical path and commercialization strategy
- Ireland Manufacturing Facility
- Research Initiatives
- TRPM8 agonist for dry eye
- Retina Program
- Well-Financed
- $241.9M cash/investments at 6/30/20
- Relatively low net cash used in operations of $22.9M for second-quarter 2020
For Investor Use | 29 |
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Aerie Pharmaceuticals Inc. published this content on 12 August 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 12 August 2020 10:37:17 UTC