Aerie Pharmaceuticals Reports Third Quarter 2015 Financial Results and Provides Business Update
11/03/2015
- Based on FDA Meetings, Company Expects to File RhopressaTM NDA in 3Q 2016 -
Conference Call and Webcast Today,
Aerie Highlights
-
Based on multiple discussions with the
FDA , including a recently concluded Type 2 Pre-NDA meeting, Aerie expects to file its NDA for once-daily RhopressaTM in the third quarter of 2016 utilizing the successful Rocket 2 Phase 3 clinical trial results as pivotal, with the Rocket 1 Phase 3 trial results representing supportive data. - Rocket 4, the fourth RhopressaTM Phase 3 clinical trial, is underway and is designed to provide adequate six-month safety data for regulatory filing in the EU, and also provide additional clinical data on this product candidate. The NDA filing in the U.S. is not contingent upon receipt of any Rocket 4 results, including the 90-day efficacy results which are expected in approximately one year.
- Mercury 1, the first Phase 3 registration trial for RoclatanTM, is also underway. RoclatanTM has shown in Phase 2b results to have the potential to be the most efficacious therapy in lowering intraocular pressure.
-
Research collaborations are in full execution mode with
GrayBug, Inc. , focused on drug delivery technology, and with Ramot atTel Aviv University , focused on their preclinical small molecule anti-beta amyloid product candidate for neuroprotection and dry age-related macular degeneration. -
As of
September 30, 2015 , Aerie continues to be well-financed, with$163 million in cash, cash equivalents and investments on the balance sheet.
"We are very pleased with the progress of our ongoing discussions with
the
Third Quarter 2015 Financial Results
As of
The
The
The higher operating expenses in the third quarter of 2015 as compared to the third quarter 2014 primarily reflect increased activities related to our Phase 3 programs for Rhopressa™ and Roclatan™, and the associated growth in our operations.
For the nine months ended
Conference Call / Web Cast Information
Aerie management will host a live conference call and webcast at
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 51129667.
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
51129667. The telephone replay will be available until
About
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 recently reported the successful results of its second Phase
3 registration trial in
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
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 reconciliations to the nearest GAAP measures, 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.
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Consolidated Balance Sheets
(Unaudited) |
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(in thousands, except share and per share data) | |||||||||
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2015 | 2014 | ||||||||
Assets | |||||||||
Current assets | |||||||||
Cash and cash equivalents | $ | 106,946 | $ | 85,586 | |||||
Short-term investments | 48,292 | 54,339 | |||||||
Prepaid expenses and other current assets | 1,348 | 1,122 | |||||||
Total current assets | 156,586 | 141,047 | |||||||
Long-term investments | 7,707 | 18,275 | |||||||
Furniture, fixtures and equipment, net | 2,912 | 240 | |||||||
Other assets, net | 8,034 | 1,523 | |||||||
Total assets | $ | 175,239 | $ | 161,085 | |||||
Liabilities and Stockholders' Equity | |||||||||
Current liabilities | |||||||||
Accounts payable and other current liabilities | $ | 17,961 | $ | 8,336 | |||||
Interest payable | 551 | 551 | |||||||
Total current liabilities | 18,512 | 8,887 | |||||||
Convertible notes, net of discounts | 124,250 | 124,156 | |||||||
Total liabilities | 142,762 | 133,043 | |||||||
Commitments and contingencies | |||||||||
Stockholders' Equity | |||||||||
Preferred stock, |
— | — | |||||||
Common stock, |
26 | 24 | |||||||
Additional paid-in capital | 229,670 | 171,326 | |||||||
Accumulated other comprehensive loss | (32 | ) | (107 | ) | |||||
Accumulated deficit | (197,187 | ) | (143,201 | ) | |||||
Total stockholders' equity | 32,477 | 28,042 | |||||||
Total liabilities and stockholders' equity | $ | 175,239 | $ | 161,085 | |||||
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Consolidated Statements of Operations and Comprehensive Loss | |||||||||||||||||
(Unaudited) | |||||||||||||||||
(in thousands, except share and per share data) | |||||||||||||||||
THREE MONTHS ENDED | NINE MONTHS ENDED | ||||||||||||||||
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2015 | 2014 | 2015 | 2014 | ||||||||||||||
Operating expenses | |||||||||||||||||
General and administrative | $ | (7,462 | ) | $ | (4,944 | ) | $ | (22,987 | ) | $ | (13,723 | ) | |||||
Research and development | (9,904 | ) | (8,230 | ) | (32,149 | ) | (20,276 | ) | |||||||||
Loss from operations | (17,366 | ) | (13,174 | ) | (55,136 | ) | (33,999 | ) | |||||||||
Other income (expense), net | (523 | ) | 27 | 1,374 | 2,367 | ||||||||||||
Net loss before income taxes | (17,889 | ) | (13,147 | ) | (53,762 | ) | (31,632 | ) | |||||||||
Income tax expense | (72 | ) | — | (224 | ) | — | |||||||||||
Net loss | $ | (17,961 | ) | $ | (13,147 | ) | $ | (53,986 | ) | $ | (31,632 | ) | |||||
Net loss attributable to common stockholders—basic and diluted | $ | (17,961 | ) | $ | (13,147 | ) | $ | (53,986 | ) | $ | (31,632 | ) | |||||
Net loss per share attributable to common stockholders—basic and diluted | $ | (0.69 | ) | $ | (0.54 | ) | $ | (2.12 | ) | $ | (1.32 | ) | |||||
Weighted average number of common shares outstanding—basic and diluted | 26,061,993 | 24,325,166 | 25,507,409 | 23,980,963 | |||||||||||||
Net loss | $ | (17,961 | ) | $ | (13,147 | ) | $ | (53,986 | ) | $ | (31,632 | ) | |||||
Unrealized loss on available-for-sale investments | 9 | 4 | 75 | (9 | ) | ||||||||||||
Comprehensive loss | $ | (17,952 | ) | $ | (13,143 | ) | $ | (53,911 | ) | $ | (31,641 | ) | |||||
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Reconciliation of GAAP Net Loss to Adjusted Net Loss | |||||||||||||||||
(Unaudited) | |||||||||||||||||
(in thousands) | |||||||||||||||||
THREE MONTHS ENDED | NINE MONTHS ENDED | ||||||||||||||||
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2015 | 2014 | 2015 | 2014 | ||||||||||||||
Net loss attributable to common stockholders - basic and diluted: | |||||||||||||||||
Net loss attributable to common stockholders - basic and diluted (GAAP) | $ | (17,961 | ) | $ | (13,147 | ) | $ | (53,986 | ) | $ | (31,632 | ) | |||||
Adjustments: | |||||||||||||||||
Stock-based compensation (a) | 3,316 | 2,392 | 9,533 | 6,696 | |||||||||||||
Adjusted Net loss | $ | (14,645 | ) | $ | (10,755 | ) | $ | (44,453 | ) | $ | (24,936 | ) | |||||
Operating expenses: | |||||||||||||||||
General and administrative expense: | |||||||||||||||||
General and administrative expense (GAAP) | $ | (7,462 | ) | $ | (4,944 | ) | $ | (22,987 | ) | $ | (13,723 | ) | |||||
Adjustments: | |||||||||||||||||
Stock-based compensation (a) | 2,719 | 2,172 | 7,842 | 5,624 | |||||||||||||
Adjusted general and administrative expense | $ | (4,743 | ) | $ | (2,772 | ) | $ | (15,145 | ) | $ | (8,099 | ) | |||||
Research and development expense: | |||||||||||||||||
Research and development expense (GAAP) | $ | (9,904 | ) | $ | (8,230 | ) | $ | (32,149 | ) | $ | (20,276 | ) | |||||
Adjustments: | |||||||||||||||||
Stock-based compensation (a) | 597 | 220 | 1,691 | 1,072 | |||||||||||||
Adjusted research and development expense | $ | (9,307 | ) | $ | (8,010 | ) | $ | (30,458 | ) | $ | (19,204 | ) | |||||
Operating expenses (GAAP) | $ | (17,366 | ) | $ | (13,174 | ) | $ | (55,136 | ) | $ | (33,999 | ) | |||||
Adjustments: | |||||||||||||||||
Stock-based compensation (a) | 3,316 | 2,392 | 9,533 | 6,696 | |||||||||||||
Adjusted operating expenses | $ | (14,050 | ) | $ | (10,782 | ) | $ | (45,603 | ) | $ | (27,303 | ) | |||||
Other income (expense): | |||||||||||||||||
Other income (expense) (GAAP) | $ | (523 | ) | $ | 27 | $ | 1,374 | $ | 2,367 | ||||||||
Adjustments: | |||||||||||||||||
— | — | — | — | ||||||||||||||
Adjusted other income (expense) | $ | (523 | ) | $ | 27 | $ | 1,374 | $ | 2,367 | ||||||||
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Reconciliation of GAAP Net Loss Per Share to Adjusted Net Loss Per Share | |||||||||||||||||
(Unaudited)
(in thousands, except share and per share data) |
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THREE MONTHS ENDED | NINE MONTHS ENDED | |||||||||||||||
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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) | $ | (0.69 | ) | $ | (0.54 | ) | $ | (2.12 | ) | $ | (1.32 | ) | |||||
Adjustments: | |||||||||||||||||
Stock-based compensation (a) | 0.13 | 0.10 | 0.38 | 0.28 | |||||||||||||
Adjusted Net loss per share | $ | (0.56 | ) | $ | (0.44 | ) | $ | (1.74 | ) | $ | (1.04 | ) | |||||
Weighted average number of common shares outstanding - basic and diluted | 26,061,993 | 24,325,166 | 25,507,409 | 23,980,963 |
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 non-cash stock-based compensation expense.
View source version on businesswire.com: http://www.businesswire.com/news/home/20151103006640/en/
Richard Rubino, 908-947-3540
rrubino@aeriepharma.com
or
Ami
Bavishi, 212-213-0006
abavishi@burnsmc.com
Source:
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