Aerie Pharmaceuticals Reports First Quarter 2015 Financial Results and Provides Business and Strategic Update
05/07/2015
Conference Call and Webcast Today,
Company to Review Additional Findings from Initial Rhopressa™ Phase 3 Registration Trial on Conference Call
Aerie Highlights
-
At
5:00 p.m. Eastern Time today, the Company will discuss additional analyses of the Rocket 1 results and provide updates on its second RhopressaTM Phase 3 registration trial, "Rocket 2," prospects for an additional RhopressaTM trial and the Roclatan™ Phase 3 clinical trials. -
As of
March 31, 2015 , the Company had$179.3 million in cash, cash equivalents and investments.
"We have been gaining valuable insights into the recently reported
Rocket 1 results and plan to conduct further analyses over the next
several weeks. We are in the process of defining our path forward for
both RhopressaTM and RoclatanTM and will discuss
our perspective on our call today," said
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).
There are three Phase 3 registration trials for RhopressaTM,
"Rocket 1," a 90-day efficacy trial, the results of which were initially
reported on
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
First Quarter 2015 Financial Results
As of
The
The
The higher operating expenses in the first quarter of 2015 as compared to the first quarter of 2014 primarily reflect increased clinical activities for Rhopressa™, increased non-clinical activities for Roclatan™ and increased activity related to supporting the growth in our operations.
Conference Call / Web Cast Information
The Company will host a live conference call and webcast at
The live webcast and a replay may be accessed by visiting the Company'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 1639305.
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
1639305. 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 a 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 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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Consolidated Balance Sheets |
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(in thousands, except share and per share data) |
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| Assets | (unaudited) | |||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 113,450 | $ | 85,586 | ||||
| Short-term investments | 56,286 | 54,339 | ||||||
| Prepaid expenses and other current assets | 1,219 | 1,122 | ||||||
| Total current assets | 170,955 | 141,047 | ||||||
| Long-term investments | 9,574 | 18,275 | ||||||
| Furniture, fixtures and equipment, net | 796 | 240 | ||||||
| Other assets, net | 13,872 | 1,523 | ||||||
| Total assets | $ | 195,197 | $ | 161,085 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable and other current liabilities | $ | 21,852 | $ | 8,336 | ||||
| Interest payable | 539 | 551 | ||||||
| Total current liabilities | 22,391 | 8,887 | ||||||
| Convertible notes, net of discounts | 124,187 | 124,156 | ||||||
| Total liabilities | 146,578 | 133,043 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' Equity | ||||||||
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Preferred stock, |
— | — | ||||||
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Common stock, |
25 | 24 | ||||||
| Additional paid-in capital | 209,092 | 171,326 | ||||||
| Accumulated other comprehensive loss | (58 | ) | (107 | ) | ||||
| Accumulated deficit | (160,440 | ) | (143,201 | ) | ||||
| Total stockholders' equity | 48,619 | 28,042 | ||||||
| Total liabilities and stockholders' equity | $ | 195,197 | $ | 161,085 | ||||
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| Consolidated Statements of Operations and Comprehensive Loss | ||||||||
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(Unaudited) |
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(in thousands, except share and per share data) |
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THREE MONTHS ENDED |
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| 2015 | 2014 | |||||||
| Operating expenses | ||||||||
| General and administrative | $ | (8,023 | ) | $ | (3,612 | ) | ||
| Research and development | (11,618 | ) | (5,370 | ) | ||||
| Loss from operations | (19,641 | ) | (8,982 | ) | ||||
| Other income (expense), net | 2,402 | 2,311 | ||||||
| Net loss | $ | (17,239 | ) | $ | (6,671 | ) | ||
| Net loss attributable to common stockholders—basic and diluted | $ | (17,239 | ) | $ | (6,671 | ) | ||
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Net loss per share attributable to common stockholders—basic and |
$ | (0.70 | ) | $ | (0.28 | ) | ||
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Weighted average number of common shares outstanding—basic and |
24,602,668 | 23,717,393 | ||||||
| Net loss | (17,239 | ) | (6,671 | ) | ||||
| Unrealized loss on available-for-sale investments | 49 | (21 | ) | |||||
| Comprehensive loss | $ | (17,190 | ) | $ | (6,692 | ) | ||
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| Reconciliation of GAAP Net Loss to Adjusted Net Loss | ||||||||
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THREE MONTHS ENDED |
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| 2015 | 2014 | |||||||
| Net loss attributable to common stockholders - basic and diluted: | ||||||||
| Net loss attributable to common stockholders - basic and diluted (GAAP) | $ | (17,239 | ) | $ | (6,671 | ) | ||
| Adjustments: | ||||||||
| Stock-based compensation (a) | 2,741 | 1,922 | ||||||
| Adjusted Net loss | $ | (14,498 | ) | $ | (4,749 | ) | ||
| Operating expenses: | ||||||||
| General and administrative expense: | ||||||||
| General and administrative expense (GAAP) | $ | (8,023 | ) | $ | (3,612 | ) | ||
| Adjustments: | ||||||||
| Stock-based compensation (a) | 2,230 | 1,307 | ||||||
| Adjusted general and administrative expense | $ | (5,793 | ) | $ | (2,305 | ) | ||
| Research and development expense: | ||||||||
| Research and development expense (GAAP) | $ | (11,618 | ) | $ | (5,370 | ) | ||
| Adjustments: | ||||||||
| Stock-based compensation (a) | 511 | 615 | ||||||
| Adjusted research and development expense | $ | (11,107 | ) | $ | (4,755 | ) | ||
| Operating expenses (GAAP) | $ | (19,641 | ) | $ | (8,982 | ) | ||
| Adjustments: | ||||||||
| Stock-based compensation (a) | 2,741 | 1,922 | ||||||
| Adjusted operating expenses | $ | (16,900 | ) | $ | (7,060 | ) | ||
| Other income (expense): | ||||||||
| Other income (expense) (GAAP) | $ | 2,402 | $ | 2,311 | ||||
| Adjustments: | ||||||||
| — | — | |||||||
| Adjusted other income (expense) | $ | 2,402 | $ | 2,311 | ||||
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| Reconciliation of GAAP Net Loss Per Share to Adjusted Net Loss Per Share | ||||||||
| (Unaudited) | ||||||||
| THREE MONTHS ENDED | ||||||||
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| 2015 | 2014 | |||||||
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Net loss per share attributable to common stockholders - basic
and |
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Net loss per share attributable to common stockholders - basic and
diluted |
$ | (0.70 | ) | $ | (0.28 | ) | ||
| Adjustments: | ||||||||
| Stock-based compensation (a) | 0.11 | 0.08 | ||||||
| Adjusted Net loss per share | $ | (0.59 | ) | $ | (0.20 | ) | ||
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Weighted average number of common shares outstanding - basic and |
24,602,668 | 23,717,393 | ||||||
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.
Richard Rubino, 908-947-3540
rrubino@aeriepharma.com
or
Ami
Bavishi, 212-213-0006
abavishi@burnsmc.com
Source:
News Provided by Acquire Media
