Aerie Pharmaceuticals Reports Third Quarter 2014 Financial Results and Provides Business and Product Development Update
11/11/2014
Focused on Building a
RhopressaTM and RoclatanTM Development Programs Advancing
Conference Call and Webcast Today,
Aerie Highlights
- RhopressaTM Phase 3 registration trials are in progress, with three-month efficacy data expected by mid-2015.
- RoclatanTM Phase 3 enabling activities also are ongoing, and Phase 3 registration trials are expected to commence in mid-2015.
-
Aerie ended the third quarter of 2014 with over
$171 million in cash, cash equivalents and investments. This cash and investment balance is expected to be sufficient to fund development activities and commercialization of Rhopressa™ and Roclatan™ and provides flexibility to pursue potential strategic growth opportunities.
"Aerie continues to make significant progress in advancing its novel
product candidates, which were shown to be highly efficacious in Phase 2
clinical trials for the treatment of patients with glaucoma and ocular
hypertension. Our Phase 3 clinical trials for RhopressaTM are
moving forward at a healthy pace, and Phase 3 preparations for RoclatanTM
continue to point to a mid-2015 commencement of Phase 3 clinical trials.
The strategies we laid out at our
Triple-Action Rhopressa™
Aerie's first-in-class product candidates are all single drop, once-daily medications that are well-tolerated and have shown no systemic drug-related adverse events.
RhopressaTM is a novel triple-action eye drop that we believe, if approved, would become the only once-daily product available that specifically targets the trabecular meshwork (TM), the eye's primary fluid drain and the diseased tissue responsible for elevated intraocular pressure (IOP) in glaucoma. Preclinical results have demonstrated that RhopressaTM also lowers episcleral venous pressure (EVP), which contributes approximately half of IOP in healthy subjects. Further, RhopressaTM provides an additional mechanism that reduces fluid production in the eye and therefore lowers IOP. Biochemically, RhopressaTM is known to inhibit both Rho Kinase (ROCK) and norepinephrine transporter (NET).
In the Company's Phase 2b clinical trial, which was successfully
completed in
In
Quadruple-Action Roclatan™
Roclatan™ is a once-daily eye drop that combines our triple-action
Rhopressa™ with latanoprost, a
A successful 28-day Phase 2b clinical trial for Roclatan™ was completed
in
Third Quarter 2014 Financial Results
As of
The
The
The higher operating expenses in third quarter 2014 as compared to third quarter 2013 primarily reflect increased clinical and non-clinical activities for Rhopressa™, increased non-clinical activities for Roclatan™ and increased activity related to supporting the growth in our operations.
For the nine months ended
The
The
The higher operating expenses 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 the Company'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 20105726.
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
20105726. 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. The Company is conducting two Phase 3 registration trials 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 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.
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| (A Development Stage Company) | ||||||||||||||
| Balance Sheets | ||||||||||||||
| (Unaudited) | ||||||||||||||
| (in thousands, except share and per share data) | ||||||||||||||
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SEPTEMBER 30, |
DECEMBER 31, |
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| 2014 | 2013 | |||||||||||||
| Assets | ||||||||||||||
| Current assets | ||||||||||||||
| Cash and cash equivalents | $ | 148,884 | $ | 69,649 | ||||||||||
| Short-term investments | 22,177 | — | ||||||||||||
| Prepaid expenses and other current assets | 656 | 618 | ||||||||||||
| Total current assets | 171,717 | 70,267 | ||||||||||||
| Furniture, fixtures and equipment, net | 228 | 132 | ||||||||||||
| Other assets, net | 1,338 | 59 | ||||||||||||
| Total assets | $ | 173,283 | $ | 70,458 | ||||||||||
| Liabilities and Stockholders' Equity | ||||||||||||||
| Current liabilities | ||||||||||||||
| Accounts payable and other current liabilities | $ | 6,999 | $ | 3,482 | ||||||||||
| Total current liabilities | 6,999 | 3,482 | ||||||||||||
| Convertible notes, net of discounts | 124,125 | — | ||||||||||||
| Total liabilities | 131,124 | 3,482 | ||||||||||||
| Commitments and contingencies | ||||||||||||||
| Stockholders' Equity | ||||||||||||||
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Preferred stock, |
— | — | ||||||||||||
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Common stock, |
24 | 23 | ||||||||||||
| Additional paid-in capital | 168,844 | 162,021 | ||||||||||||
| Accumulated other comprehensive loss | (9 | ) | — | |||||||||||
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Deficit accumulated during the development stage |
(126,700 | ) | (95,068 | ) | ||||||||||
| Total stockholders' equity | 42,159 | 66,976 | ||||||||||||
| Total liabilities and stockholders' equity | $ | 173,283 | $ | 70,458 | ||||||||||
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| (A Development Stage Company) | |||||||||||||||||||||||
| 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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| 2014 | 2013 | 2014 | 2013 | ||||||||||||||||||||
| Operating expenses | |||||||||||||||||||||||
| General and administrative | $ | (4,944 | ) | $ | (3,287 | ) | $ | (13,723 | ) | $ | (6,693 | ) | |||||||||||
| Research and development | (8,230 | ) | (2,399 | ) | (20,276 | ) | (8,727 | ) | |||||||||||||||
| Loss from operations | (13,174 | ) | (5,686 | ) | (33,999 | ) | (15,420 | ) | |||||||||||||||
| Other income (expense), net | 27 | (5,062 | ) | 2,367 | (5,446 | ) | |||||||||||||||||
| Net loss | $ | (13,147 | ) | $ | (10,748 | ) | $ | (31,632 | ) | $ | (20,866 | ) | |||||||||||
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Net loss attributable to common stockholders—basic and diluted |
$ | (13,147 | ) | $ | (10,887 | ) | $ | (31,632 | ) | $ | (21,279 | ) | |||||||||||
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Net loss per share attributable to common stockholders—basic and diluted |
$ | (0.54 | ) | $ | (10.81 | ) | $ | (1.32 | ) | $ | (21.61 | ) | |||||||||||
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Weighted average number of common shares outstanding—basic and diluted |
24,325,166 | 1,006,893 | 23,980,963 | 984,727 | |||||||||||||||||||
| Net loss | $ | (13,147 | ) | $ | (10,748 | ) | $ | (31,632 | ) | $ | (20,866 | ) | |||||||||||
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Unrealized gain (loss) on available-for-sale investments |
4 | — | (9 | ) | — | ||||||||||||||||||
| Comprehensive loss | $ | (13,143 | ) | $ | (10,748 | ) | $ | (31,641 | ) | $ | (20,866 | ) | |||||||||||
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| (A Development Stage Company) | |||||||||||||||||||||||
| Reconciliation of GAAP Net Loss to Adjusted Net Loss | |||||||||||||||||||||||
| and GAAP Net Loss per Share to Adjusted Net Loss per Share | |||||||||||||||||||||||
| Reconciliation of GAAP Net Loss to Adjusted Net Loss | |||||||||||||||||||||||
| (Unaudited) | |||||||||||||||||||||||
| (in thousands) | |||||||||||||||||||||||
| THREE MONTHS ENDED | NINE MONTHS ENDED | ||||||||||||||||||||||
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| 2014 | 2013 | 2014 | 2013 | ||||||||||||||||||||
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Net loss attributable to common stockholders - basic and diluted: |
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Net loss attributable to common stockholders - basic and diluted (GAAP) |
$ | (13,147 | ) | $ | (10,887 | ) | $ | (31,632 | ) | $ | (21,279 | ) | |||||||||||
| Adjustments: | |||||||||||||||||||||||
| Stock-based compensation (a) | 2,392 | 1,130 | 6,696 | 1,531 | |||||||||||||||||||
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Change in fair value measurements of warrant liabilities (b) |
— | 3,585 | — | 3,850 | |||||||||||||||||||
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Interest and amortization expense related to notes subsequently converted to common equity (c) |
— | 1,477 | — | 2,865 | |||||||||||||||||||
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Accretion related to convertible preferred stock (d) |
— | 139 | — | 413 | |||||||||||||||||||
| Adjusted Net loss | $ | (10,755 | ) | $ | (4,556 | ) | $ | (24,936 | ) | $ | (12,620 | ) | |||||||||||
| Operating expenses: | |||||||||||||||||||||||
| General and administrative expense: | |||||||||||||||||||||||
| General and administrative expense (GAAP) | $ | (4,944 | ) | $ | (3,287 | ) | $ | (13,723 | ) | $ | (6,693 | ) | |||||||||||
| Adjustments: | |||||||||||||||||||||||
| Stock-based compensation (a) | 2,172 | 1,068 | 5,624 | 1426 | |||||||||||||||||||
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Adjusted general and administrative expense |
$ | (2,772 | ) | $ | (2,219 | ) | $ | (8,099 | ) | $ | (5,267 | ) | |||||||||||
| Research and development expense: | |||||||||||||||||||||||
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Research and development expense (GAAP) |
$ | (8,230 | ) | $ | (2,399 | ) | $ | (20,276 | ) | $ | (8,727 | ) | |||||||||||
| Adjustments: | |||||||||||||||||||||||
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Stock-based compensation (a) |
220 | 62 | 1,072 | 105 | |||||||||||||||||||
| Adjusted research and development expense | $ | (8,010 | ) | $ | (2,337 | ) | $ | (19,204 | ) | $ | (8,622 | ) | |||||||||||
| Operating expenses (GAAP) | $ | (13,174 | ) | $ | (5,686 | ) | $ | (33,999 | ) | $ | (15,420 | ) | |||||||||||
| Adjustments: | |||||||||||||||||||||||
| Stock-based compensation (a) | 2,392 | 1,130 | 6,696 | 1,531 | |||||||||||||||||||
| Adjusted operating expenses | $ | (10,782 | ) | $ | (4,556 | ) | $ | (27,303 | ) | $ | (13,889 | ) | |||||||||||
| Other income (expense): | |||||||||||||||||||||||
| Other income (expense) (GAAP) | $ | 27 | $ | (5,062 | ) | $ | 2,367 | $ | (5,446 | ) | |||||||||||||
| Adjustments: | |||||||||||||||||||||||
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Change in fair value measurements of warrant liabilities (b) |
— | 3,585 | — | 3,850 | |||||||||||||||||||
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Interest and amortization expense related to notes subsequently converted to common equity (c) |
— | 1,477 | — | 2,865 | |||||||||||||||||||
| Adjusted other income (expense) | $ | 27 | $ | — | $ | 2,367 | $ | 1,269 | |||||||||||||||
| Reconciliation of GAAP Net Loss Per Share to Adjusted Net Loss Per Share | |||||||||||||||||||||||
| (Unaudited) | |||||||||||||||||||||||
| THREE MONTHS ENDED | NINE MONTHS ENDED | ||||||||||||||||||||||
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| 2014 | 2013 | 2014 | 2013 | ||||||||||||||||||||
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Net loss per share attributable to common stockholders - basic and diluted: |
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Net loss per share attributable to common stockholders - basic and diluted (GAAP) |
$ | (0.54 | ) | $ | (10.81 | ) | $ | (1.32 | ) | $ | (21.61 | ) | |||||||||||
| Adjustments: | |||||||||||||||||||||||
| Stock-based compensation (a) | 0.10 | 1.12 | 0.28 | 1.55 | |||||||||||||||||||
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Change in fair value measurements of warrant liabilities (b) |
— | 3.56 | — | 3.91 | |||||||||||||||||||
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Interest and amortization expense related to notes subsequently converted to common equity (c) |
— | 1.47 | — | 2.91 | |||||||||||||||||||
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Accretion related to convertible preferred stock (d) |
— | 0.14 | — | 0.42 | |||||||||||||||||||
| Adjusted Net loss per share | $ | (0.44 | ) | $ | (4.52 | ) | $ | (1.04 | ) | $ | (12.82 | ) | |||||||||||
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Weighted average number of common shares outstanding - basic and diluted |
24,325,166 | 1,006,893 | 23,980,963 | 984,727 | |||||||||||||||||||
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 the Company'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.
(b) Change in fair
value measurements of warrant liabilities: Exclude the non-cash
change in fair value.
(c) Interest and amortization expense
related to notes subsequently converted to common equity: Exclude
the non-cash interest and amortization expense.
(d) Accretion
related to convertible preferred stock: Exclude the accretion
related to convertible preferred stock.
Richard Rubino, 908-470-4320
rrubino@aeriepharma.com
or
Angeli
Kolhatkar, 212-213-0006
akolhatkar@burnsmc.com
Source:
News Provided by Acquire Media
