0001193125-15-278671.txt : 20150805 0001193125-15-278671.hdr.sgml : 20150805 20150805160700 ACCESSION NUMBER: 0001193125-15-278671 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20150805 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20150805 DATE AS OF CHANGE: 20150805 FILER: COMPANY DATA: COMPANY CONFORMED NAME: AERIE PHARMACEUTICALS INC CENTRAL INDEX KEY: 0001337553 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 203109565 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36152 FILM NUMBER: 151029031 BUSINESS ADDRESS: STREET 1: 7020 KIT CREEK ROAD STREET 2: SUITE 270 CITY: RESEARCH TRIANGLE PARK STATE: NC ZIP: 27709 BUSINESS PHONE: 919-313-9650 MAIL ADDRESS: STREET 1: 7020 KIT CREEK ROAD STREET 2: SUITE 270 CITY: RESEARCH TRIANGLE PARK STATE: NC ZIP: 27709 8-K 1 d84621d8k.htm FORM 8-K Form 8-K

 

 

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 5, 2015

 

 

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)

2030 Main Street, Suite 1500

Irvine, California 92614

(Address of principal executive offices)(Zip code)

Registrant’s telephone number, including area code: (949) 526-8700

 

 

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 (see General Instruction A.2. below):

 

¨ 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))

 

 

 


Item 2.02. Results of Operations and Financial Condition.

On August 5, 2015, Aerie Pharmaceuticals, Inc. (the “Company”) issued a press release announcing its financial results for the second quarter ended June 30, 2015. A copy of the press release is furnished as Exhibit 99.1 hereto and is hereby incorporated by reference into this Item 2.02.

The information in this Item 2.02 (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as expressly set forth by specific reference in such a filing.


Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

The following exhibit relating to Item 2.02 shall be deemed to be furnished, and not filed:

99.1 Press Release dated August 5, 2015.


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 5, 2015     By:  

/s/ Richard J. Rubino

      Richard J. Rubino
      Chief Financial Officer


EXHIBIT INDEX

 

Exhibit

  

Description

99.1    Press Release dated August 5, 2015.
EX-99.1 2 d84621dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

Aerie Pharmaceuticals Reports Second Quarter 2015 Financial Results and

Provides Business Update

- Company Expects Efficacy Results from RhopressaTM Rocket 2 Trial in September 2015 -

Conference Call and Webcast Today, August 5, at 5:00 p.m. ET

IRVINE, California - (BUSINESS WIRE)—Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with glaucoma and other diseases of the eye, today reported financial results for the second quarter ended June 30, 2015 along with a general business update.

Aerie Highlights

 

  Efficacy results from Aerie’s RhopressaTM Rocket 2 trial, using the primary clinical endpoint range recently modified in consultation with the U.S. Food and Drug Administration, are expected in September 2015.

 

  The fourth RhopressaTM Phase 3 registration trial, known as “Rocket 4,” and the first RoclatanTM Phase 3 registration trial, known as “Mercury 1,” are each expected to commence in the third quarter of 2015.

 

  Announced today a research collaboration and license agreement with GrayBug, Inc. focused on the delivery of Aerie products to both the front and back of the eye.

 

  As of June 30, 2015 Aerie continues to be well-financed, with $163 million in cash, cash equivalents and investments on the balance sheet.

“We expect a number of important clinical activities to take place during the third quarter of this year. Importantly, we anticipate the read-out of 90-day efficacy results for Rocket 2 this September. Additionally, preparations are well under way to launch our two new Phase 3 trials, Rocket 4 for RhopressaTM and Mercury 1 for RoclatanTM, both on track to start during the third quarter,” said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer.

Dr. Anido continued, “We continue to make excellent progress on our preclinical activities associated with the potential disease-modifying and neuroprotective properties of RhopressaTM and our wet AMD preclinical prospect, AR-13154. We expect to report on further findings later this year. Additionally, we remain focused on business development activities, including evaluating new ophthalmic product candidates and technologies to add to our pipeline, and we are very excited about the prospects for our new drug delivery collaboration with GrayBug.”


Second Quarter 2015 Financial Results

As of June 30, 2015, Aerie had cash, cash equivalents and investments of $162.9 million. For the second quarter ended June 30, 2015, Aerie reported a net loss attributable to common stockholders, as measured in accordance with U.S. generally accepted accounting principles (“GAAP”), of $18.8 million, or $0.73 per share, compared to $11.8 million and $0.49 per share for the second quarter 2014. The weighted average number of shares of common stock outstanding utilized in the calculation of net loss per common share was 25,841,530 and 23,893,651 for the second quarters of 2015 and 2014, respectively.

The $18.8 million net loss attributable to common stockholders for the second quarter 2015 includes $18.1 million in operating expenses, reflecting $10.6 million in research and development expenses and $7.5 million in general and administrative expenses. Excluding $3.5 million of non-cash stock-based compensation expense, adjusted operating expenses were $14.6 million, with adjusted research and development expenses of $10.0 million and adjusted general and administrative expenses of $4.6 million. Total adjusted net loss was $15.3 million and adjusted net loss per share was $0.59.

The $11.8 million net loss attributable to common stockholders for the second quarter 2014 reflects research and development expenses of $6.7 million and general and administrative expenses of $5.2 million. Excluding $2.4 million of non-cash stock-based compensation expense, adjusted operating expenses were approximately $9.4 million, reflecting adjusted research and development expenses of $6.4 million and adjusted general and administrative expenses of $3.0 million. Total adjusted net loss was $9.4 million and adjusted net loss per share was $0.39.

The higher operating expenses in second quarter 2015 as compared to second quarter 2014 primarily reflect increased clinical activities for Rhopressa™, increased non-clinical activities for Roclatan™, and the associated growth in our operations.

For the six months ended June 30, 2015, the Company reported a net loss attributable to common stockholders, as measured in accordance with GAAP, of $36.0 million, or $1.43 per share, including $6.2 million of non-cash charges representing stock-based compensation expense included in operating expenses. When stock-based compensation expense is excluded, Aerie’s adjusted net loss was $29.8 million, or $1.18 per share.

Conference Call / Web Cast Information

Aerie management will host a live conference call and webcast at 5:00 p.m. Eastern Time today to discuss Aerie’s financial results and provide a general business update.


The live webcast and a replay may be accessed by visiting Aerie’s website at http://investors.aeriepharma.com. Please connect to Aerie’s website at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. Alternatively, please call (888) 734-0328 (U.S.) or (678) 894-3054 (international) to listen to the live conference call. The conference ID number for the live call is 86313347. Please dial in approximately 10 minutes prior to the call. Telephone replay will be available approximately two hours after the call. To access the replay, please call (855) 859-2056 (U.S.) or (404) 537-3406 (international). The conference ID number for the replay is 86313347. The telephone replay will be available until August 12, 2015.

About Aerie Pharmaceuticals, Inc.

Aerie is a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with glaucoma and other diseases of the eye. Aerie is currently conducting a Phase 3 registration trial in the United States named Rocket 2, where the primary efficacy endpoint is to demonstrate non-inferiority of IOP lowering for RhopressaTM compared to timolol, along with a Phase 3 registration safety-only trial, named Rocket 3, in Canada. Aerie recently completed its initial Phase 3 registration trial, named Rocket 1, the three-month efficacy results of which were initially reported in April 2015, and expects to commence a fourth Phase 3 registration trial, named Rocket 4, in the third quarter of 2015. Aerie also completed in 2014 a Phase 2b clinical trial in which RoclatanTM met the primary efficacy endpoint, demonstrating the statistical superiority of RoclatanTM to each of its components, and plans to commence the first Phase 3 registration trial for RoclatanTM, named Mercury 1, in the third quarter of 2015.

Forward-Looking Statements

This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “exploring,” “pursuing” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the success, timing and cost of our ongoing and anticipated preclinical studies and clinical trials for our current product candidates, including statements regarding the timing of initiation and completion of the studies and trials; our expectations regarding the clinical effectiveness of our product candidates and results of our clinical trials; the timing of and our ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, our product candidates; our expectations regarding the commercialization of our product candidates; our expectations related to the use of proceeds from our initial public offering and the issuance and sale of our senior secured convertible notes and the issuance and sale of shares of our common stock in connection with our “at-the-market” sales agreement; our estimates regarding anticipated capital requirements and our needs for additional financing; the potential advantages of our product candidates; our plans to pursue development of our product candidates for additional indications and other therapeutic opportunities; our plans to explore possible uses of our existing proprietary compounds beyond glaucoma; and our ability to protect our


proprietary technology and enforce our intellectual property rights; and our expectations regarding strategic operations, including our ability to in-license or acquire additional ophthalmic products or product candidates. By their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitive dynamics and industry change, and depend on regulatory approvals and economic circumstances that may or may not occur in the future or may occur on longer or shorter timelines than anticipated. We discuss many of these risks in greater detail under the heading “Risk Factors” in the quarterly and annual reports that we file with the Securities and Exchange Commission. In particular, the preclinical research discussed in this press release is preliminary and the outcome of such preclinical studies may not be predictive of the outcome of later clinical 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 press release. Forward-looking statements are not guarantees of future performance and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Non-GAAP Financial Measures

To supplement our financial statements, which are prepared and presented in accordance with GAAP, we use the following non-GAAP financial measures, some of which are discussed above: adjusted net loss, adjusted operating expenses, adjusted research and development expenses, adjusted general and administrative expenses, adjusted other income (expense) and adjusted net loss per share. For a description of the adjusted calculations and reconciliation to the nearest GAAP measure, please see the “Reconciliation of GAAP Net Loss to Adjusted Net Loss” and “Reconciliation of GAAP Net Loss per Share to Adjusted Net Loss per Share” tables in this press release.

We believe these non-GAAP financial measures provide investors with useful supplemental information about the financial performance of our business, enable comparison of financial results between periods where certain items may vary independent of business performance, and allow for greater transparency with respect to key metrics used by management in operating our business.

The presentation of these financial measures is not intended to be considered in isolation from, or as a substitute for, financial information prepared and presented in accordance with GAAP. Investors are cautioned that there are material limitations associated with the use of non-GAAP financial measures as an analytical tool. In particular, the adjustments to our GAAP financial measures reflect the exclusion of non-cash stock-based compensation expense, which is recurring and will be reflected in our financial results for the foreseeable future. In addition, these measures may be different from non-GAAP financial measures used by other companies, limiting their usefulness for comparison purposes. We compensate for these limitations by providing specific information regarding the GAAP amounts excluded from these non-GAAP financial measures.


AERIE PHARMACEUTICALS, INC.

Consolidated Balance Sheets

(Unaudited)

(in thousands, except share and per share data)

 

     JUNE 30,
2015
    DECEMBER 31,
2014
 

Assets

    

Current assets

    

Cash and cash equivalents

   $ 100,916      $ 85,586   

Short-term investments

     57,873        54,339   

Prepaid expenses and other current assets

     1,118        1,122   
  

 

 

   

 

 

 

Total current assets

     159,907        141,047   

Long-term investments

     4,140        18,275   

Furniture, fixtures and equipment, net

     1,703        240   

Other assets, net

     10,587        1,523   
  

 

 

   

 

 

 

Total assets

   $ 176,337      $ 161,085   
  

 

 

   

 

 

 

Liabilities and Stockholders’ Equity

    

Current liabilities

    

Accounts payable and other current liabilities

   $ 17,710      $ 8,336   

Interest payable

     545        551   
  

 

 

   

 

 

 

Total current liabilities

     18,255        8,887   

Convertible notes, net of discounts

     124,218        124,156   
  

 

 

   

 

 

 

Total liabilities

     142,473        133,043   
  

 

 

   

 

 

 

Commitments and contingencies

    

Stockholders’ Equity

    

Preferred stock, $0.001 par value; 15,000,000 shares authorized as of June 30, 2015 and December 31, 2014; None issued and outstanding

     —          —     

Common stock, $0.001 par value; 150,000,000 shares authorized as of June 30, 2015 and December 31, 2014; 25,499,192 and 24,018,577 shares issued and outstanding as of June 30, 2015 and December 31, 2014, respectively

     25        24   

Additional paid-in capital

     213,106        171,326   

Accumulated other comprehensive loss

     (41     (107

Accumulated deficit

     (179,226     (143,201
  

 

 

   

 

 

 

Total stockholders’ equity

     33,864        28,042   
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 176,337      $ 161,085   
  

 

 

   

 

 

 


AERIE PHARMACEUTICALS, INC.

Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

(in thousands, except share and per share data)

 

     THREE MONTHS ENDED     SIX MONTHS ENDED  
     JUNE 30,     JUNE 30,  
     2015     2014     2015     2014  

Operating expenses

        

General and administrative

   $ (7,502   $ (5,167   $ (15,525   $ (8,779

Research and development

     (10,627     (6,676     (22,245     (12,046
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (18,129     (11,843     (37,770     (20,825

Other income (expense), net

     (505     29        1,897        2,340   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss before income taxes

   $ (18,634   $ (11,814   $ (35,873   $ (18,485

Income tax expense

     (152            (152     —     
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (18,786   $ (11,814   $ (36,025   $ (18,485
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss attributable to common stockholders—basic and diluted

   $ (18,786   $ (11,814   $ (36,025   $ (18,485
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per share attributable to common stockholders—basic and diluted

   $ (0.73   $ (0.49   $ (1.43   $ (0.78
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average number of common shares outstanding—basic and diluted

     25,841,530       23,893,651        25,225,521        23,806,009   

Net loss

   $ (18,786   $ (11,814   $ (36,025   $ (18,485

Unrealized gain (loss) on available-for-sale investments

     17        8        66        (13
  

 

 

   

 

 

   

 

 

   

 

 

 

Comprehensive loss

   $ (18,769   $ (11,806   $ (35,959   $ (18,498
  

 

 

   

 

 

   

 

 

   

 

 

 


Aerie Pharmaceuticals, Inc.

Reconciliation of GAAP Net Loss to Adjusted Net Loss

(Unaudited)

(in thousands)

 

     THREE MONTHS ENDED     SIX MONTHS ENDED  
     JUNE 30,     JUNE 30,  
     2015     2014     2015     2014  

Net loss attributable to common stockholders – basic and diluted:

        

Net loss attributable to common stockholders – basic and diluted (GAAP)

   $ (18,786   $ (11,814   $ (36,025   $ (18,485

Adjustments:

        

Stock-based compensation (a)

     3,476        2,382        6,217        4,304   
  

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted Net loss

   $ (15,310   $ (9,432   $ (29,808   $ (14,181
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating expenses:

        

General and administrative expense:

        

General and administrative expense (GAAP)

   $ (7,502   $ (5,167   $ (15,525   $ (8,779

Adjustments:

        

Stock-based compensation (a)

     2,893        2,145        5,123        3,452   
  

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted general and administrative expense

   $ (4,609   $ (3,022   $ (10,402   $ (5,327
  

 

 

   

 

 

   

 

 

   

 

 

 

Research and development expense:

        

Research and development expense (GAAP)

   $ (10,627   $ (6,676   $ (22,245   $ (12,046

Adjustments:

        

Stock-based compensation (a)

     583        237        1,094        852   
  

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted research and development expense

   $ (10,044   $ (6,439   $ (21,151   $ (11,194
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating expenses (GAAP)

   $ (18,129   $ (11,843   $ (37,770   $ (20,825

Adjustments:

        

Stock-based compensation (a)

     3,476        2,382        6,217        4,304   
  

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted operating expenses

   $ (14,653   $ (9,461   $ (31,553   $ (16,521
  

 

 

   

 

 

   

 

 

   

 

 

 

Other income (expense):

        

Other income (expense) (GAAP)

   $ (505   $ 29      $ 1,897      $ 2,340   

Adjustments:

        
     —          —          —          —     
  

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted other income (expense)

   $ (505   $ 29      $ 1,897      $ 2,340   
  

 

 

   

 

 

   

 

 

   

 

 

 


Aerie Pharmaceuticals, Inc.

Reconciliation of GAAP Net Loss Per Share to Adjusted Net Loss Per Share

(Unaudited)

 

     THREE MONTHS ENDED     SIX MONTHS ENDED  
     JUNE 30,     JUNE 30,  
     2015     2014     2015     2014  

Net loss per share attributable to common stockholders – basic and diluted:

        

Net loss per share attributable to common stockholders – basic and diluted (GAAP)

   $ (0.73   $ (0.49   $ (1.43   $ (0.78

Adjustments:

        

Stock-based compensation (a)

     0.14        0.10        0.25        0.18   
  

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted Net loss per share

   $ (0.59   $ (0.39   $ (1.18   $ (0.60
  

 

 

   

 

 

   

 

 

   

 

 

 
        
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average number of common shares outstanding – basic and diluted

     25,841,530        23,893,651        25,225,521        23,806,009   
  

 

 

   

 

 

   

 

 

   

 

 

 

Aerie is providing adjusted information that excludes certain items because of the nature of these items and the impact they have on the analysis of underlying business performance and trends. Management believes that providing this information enhances investors’ understanding of Aerie’s performance. This information should be considered in addition to, but not in lieu of, information prepared in accordance with GAAP.

Explanation of adjustments:

(a) Stock-based compensation: Exclude the non-cash stock-based compensation.

Contacts

Aerie Pharmaceuticals

Richard Rubino, 908-947-3540

rrubino@aeriepharma.com

or

Burns McClellan, Inc., on behalf of Aerie Pharmaceuticals

Ami Bavishi, 212-213-0006

abavishi@burnsmc.com