Company on Track to File NDA in 3Q 2016 for Rhopressa™ (netarsudil ophthalmic solution) 0.02%
Mercury 1 Phase 3 Topline Readout for Roclatan™ (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005% Also Expected in 3Q 2016
Conference Call and Webcast Today,
- Aerie remains well positioned to file its NDA for RhopressaTM (netarsudil ophthalmic solution) 0.02% in the third quarter of 2016.
- The first Phase 3 clinical trial for RoclatanTM (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, Mercury 1, is nearly completely enrolled, and its 90-day topline interim efficacy readout remains on track for the third quarter of 2016. Mercury 2, the second Phase 3 clinical trial for RoclatanTM which commenced in March of 2016, is enrolling on schedule.
- Rocket 4, the Phase 3 clinical trial for RhopressaTM designed to provide adequate safety data for approval by European regulatory authorities, also remains on schedule for topline 90-day efficacy readout in the fourth quarter of 2016.
New preclinical research being presented at the Annual Meeting of
ARVO( Association for Research in Vision and Ophthalmology) provides further valuable insights into RhopressaTM, including its potential to reverse fibrosis in trabecular meshwork cells as well as important in vivo research on the potential of RhopressaTM to increase trabecular meshwork outflow.
March 31, 2016, Aerie had $130.8 millionin cash, cash equivalents, and investments on the balance sheet. For the first quarter of 2016, net cash burn totaled $19.7 million, on track with the full-year guidance provided earlier this year.
"We are rapidly approaching two very important milestones with our
upcoming NDA filing for RhopressaTM and the readout of
Mercury 1 topline Phase 3 data for RoclatanTM, both expected
in the third quarter of this year. Ophthalmologist responses to the
efficacy and safety profiles of our product candidates have been very
positive and appear to be fully aligned with our expected market
positioning of both product candidates. We also continue to observe
promising evidence of the disease modification and neuroprotective
potential of RhopressaTM in preclinical studies, and we have
commenced research to evaluate sustained release formulation
technologies that could have the capability of delivering RhopressaTM
over several months to the front of the eye for glaucoma," said
First Quarter 2016 Financial Results
The higher operating expenses in the first quarter of 2016 as compared to the first quarter 2015 primarily reflect increased activities associated with the expansion of our employee base to support the growth of our operations, including clinical activities related to our Phase 3 programs for our product candidates, and preparatory activities associated with our commercialization efforts.
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
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's two lead product candidates are once-daiIy IOP-lowering
therapies with novel mechanisms of action to treat patients with
glaucoma or ocular hypertension. It is expected that the NDA filing for
RhopressaTM (netarsudil ophthalmic solution) 0.02% will take
place in the third quarter of 2016. The second product candidate,
RoclatanTM (netarsudil/latanoprost ophthalmic solution)
0.02%/0.005%, which is a fixed dose combination of RhopressaTM
and widely prescribed
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.
|Cash and cash equivalents||$||74,266||$||91,060|
|Prepaid expenses and other current assets||1,402||1,865|
|Total current assets||120,691||138,427|
|Furniture, fixtures and equipment, net||3,993||3,816|
|Other assets, net||3,037||3,076|
|Liabilities and Stockholders' (Deficit) Equity|
|Accounts payable and other current liabilities||$||15,501||$||16,565|
|Total current liabilities||16,046||17,116|
|Convertible notes, net of discounts||123,310||123,236|
|Commitments and contingencies|
|Stockholders' (deficit) equity|
|Additional paid-in capital||240,154||236,492|
|Accumulated other comprehensive loss||(68||)||(179||)|
|Total stockholders' (deficit) equity||(155||)||18,775|
|Total liabilities and stockholders' (deficit) equity||$||139,201||$||159,127|
THREE MONTHS ENDED
|General and administrative||$||(9,801||)||$||(8,023||)|
|Research and development||(12,309||)||(11,618||)|
|Loss from operations||(22,110||)||(19,641||)|
|Other income (expense), net||(548||)||2,402|
|Net loss before income taxes||(22,658||)||(17,239||)|
|Income tax expense||(46||)||—|
Net loss attributable to common stockholders—basic and diluted
Net loss per share attributable to common stockholders—basic and diluted
Weighted average number of common shares outstanding—basic and diluted
|Unrealized gain on available-for-sale investments||111||49|
THREE MONTHS ENDED
Net loss attributable to common stockholders - basic and diluted:
Net loss attributable to common stockholders - basic and diluted (GAAP)
|Stock-based compensation (a)||3,534||2,741|
|Adjusted Net loss||$||(19,170||)||$||(14,498||)|
|General and administrative expense:|
|General and administrative expense (GAAP)||$||(9,801||)||$||(8,023||)|
|Stock-based compensation (a)||2,822||2,230|
|Adjusted general and administrative expense||$||(6,979||)||$||(5,793||)|
|Research and development expense:|
|Research and development expense (GAAP)||$||(12,309||)||$||(11,618||)|
|Stock-based compensation (a)||712||511|
|Adjusted research and development expense||$||(11,597||)||$||(11,107||)|
|Operating expenses (GAAP)||$||(22,110||)||$||(19,641||)|
|Stock-based compensation (a)||3,534||2,741|
|Adjusted operating expenses||$||(18,576||)||$||(16,900||)|
|Other income (expense):|
|Other income (expense) (GAAP)||$||(548||)||$||2,402|
|Adjusted other income (expense)||$||(548||)||$||2,402|
THREE MONTHS ENDED
Net loss per share attributable to common stockholders -
Net loss per share attributable to common stockholders - basic
|Stock-based compensation (a)||0.13||0.11|
|Adjusted Net loss per share||$||(0.72||)||$||(0.59||)|
Weighted average number of common shares outstanding -
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.
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