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8-K
AERIE PHARMACEUTICALS INC false 0001337553 0001337553 2019-11-06 2019-11-06

 

 

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): November 6, 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 November 6, 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

   

AR-13324-CS208 Japan Phase 2 Study Topline Results presentation.

         
 

104

   

Cover Page Interactive Data File (embedded within the Inline XBRL document)


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: November 6, 2019

 

By:

 

/s/ Richard J. Rubino

 

 

Richard J. Rubino

 

 

Chief Financial Officer

EX-99.1

Slide 1

AR-13324-CS208 Japan Phase 2 Study Topline Results November 6, 2019 Exhibit 99.1


Slide 1

Important Information The information in this presentation is current only as of its date and may have changed or may change in the future. We are not making any representation or warranty that the information in this presentation is accurate or complete. Certain statements in this presentation 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. The results generated by the studies discussed herein are not predictors of future results or outcomes of any ongoing or future studies conducted by the Company pertaining to any of our products or product candidates. 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. 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.” In particular, the topline AR-13324-CS208 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. 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


Slide 3

Japan Phase 2 Executive Summary 28-day prospective, 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 and met primary endpoint of superiority to placebo in mean diurnal IOP at Week 41 Baseline mean diurnal IOPs 20-21 mmHg across study arms2 (Japanese IOPs ~3 – 4 mmHg lower than in Caucasians) 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 Netarsudil 0.01%, 0.02% and 0.04% were safe and generally well tolerated in Japanese subjects No serious adverse events Netarsudil 0.02% provided optimal efficacy and safety profile Most common AEs were Conjunctival Hyperemia (37.0%) and Eye Irritation (9.3%) Discontinuations rate was 1.9% (1/54 subjects) Hyperemia and discontinuation rates lower than in US trials3-5 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


Slide 4

Primary Endpoints Efficacy: Mean diurnal IOP at Week 4 Safety: Ocular/Systemic safety during a 4-week treatment period Japanese patients with Open Angle Glaucoma (OAG) with IOP (unmedicated) ≥ 15 mmHg and < 35 mmHg   or Ocular Hypertension (OHT) with IOP (unmedicated) ≥ 22 mmHg and < 35 mmHg N = 215 subjects randomized (1:1:1:1) Netarsudil 0.02% QD (PM) Placebo QD (PM) Netarsudil 0.04% QD (PM) Study Design Netarsudil 0.01% QD (PM) For Investor Use


Slide 5

Efficacy – Mean IOP at Each Time Point For Investor Use


Slide 6

Primary Endpoint – Mean Diurnal IOP P<0.0001 vs. placebo at Week 4 for all dose levels1 0.02% achieved lowest mean diurnal IOP at Week 4 1. ANCOVA with MCMC imputation For Investor Use


Slide 7

Any TEAEs ≥ 2% System Organ Class Preferred Term Netarsudil 0.01% QD (N=55) n (%) Netarsudil 0.02% QD (N=54) n (%) Netarsudil 0.04% QD (N=51) n (%) Placebo (N=55) n (%) Eye Disorders 16 ( 29.1) 22 ( 40.7) 32 ( 62.7) 3 ( 5.5) Conjunctival hyperemia 13 ( 23.6) 20 ( 37.0) 29 ( 56.9) 1 ( 1.8) Eye irritation 3 ( 5.5) 5 ( 9.3) 2 ( 3.9) 0 Conjunctival hemorrhage 0 3 ( 5.6) 3 ( 5.9) 0 Eye discharge 1 ( 1.8) 1 ( 1.9) 1 ( 2.0) 0 Vision blurred 1 ( 1.8) 1 ( 1.9) 1 ( 2.0) 0 Visual acuity reduced 0 1 ( 1.9) 1 ( 2.0) 0 Conjunctival follicles 0 0 1 ( 2.0) 0 Dry eye 0 0 1 ( 2.0) 0 Eye pain 0 0 1 ( 2.0) 0 Keratitis 0 0 1 ( 2.0) 0 Vernal keratoconjunctivitis 0 0 1 ( 2.0) 0 General disorders/admin site conditions 0 2 ( 3.7) 1 ( 2.0) 0 Instillation site irritation 0 1 ( 1.9) 1 ( 2.0) 0 Infections and Infestations 1 ( 1.8) 0 2 ( 3.9) 0 Conjunctivitis 1 ( 1.8) 0 2 ( 3.9) 0 Safety Summary There were no serious adverse events 6 of 215 subjects (1 each in netarsudil 0.01% and 0.02%, and 4 in netarsudil 0.04%) had early discontinuation due to an AE For Investor Use


Slide 8

Japan Phase 2 Executive Summary Netarsudil 0.01%, 0.02% and 0.04% were efficacious and met primary endpoint of superiority to placebo in mean diurnal IOP1 Baseline mean diurnal IOPs were 20 - 21 mmHg across study arms2 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 Netarsudil 0.01%, 0.02% and 0.04% were safe and generally well tolerated in Japanese subjects Netarsudil 0.02% provided optimal efficacy and safety profile Most common AEs were Conjunctival Hyperemia (37.0%) and Eye Irritation (9.3%) Discontinuations rate was 1.9% (1/54 subjects) Hyperemia and discontinuation rates lower than in US trials3-5 Efficacy at low baseline IOPs predicts efficacy in Normal Tension Glaucoma Meeting with PMDA in 1H’20 and expect start of P3 trials in 2H ‘20 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