Aerie Pharmaceuticals Reports First Quarter 2014 Financial Results and Provides Business and Product Development Update
05/12/2014
RoclatanTM Phase 2b Clinical Trial Running Ahead of Schedule
Rhopressa Phase 3 Registration Trials on Track to Begin Soon, with FDA Meetings now Completed
Conference Call and Webcast Today,
Aerie Highlights
-
The RoclatanTM Phase 2b clinical trial is advancing
rapidly, with public release of efficacy data now expected in late
June or early
July 2014 . - The RhopressaTM Phase 3 registration trials are on schedule and planned to commence early third quarter 2014, with efficacy data expected mid-2015, and NDA filing currently projected for mid-2016.
-
Aerie ended the first quarter of 2014 with over
$65 million of cash and short-term investments on its balance sheet. This amount is expected to fund Rhopressa™ Phase 3 development through NDA filing and Roclatan™ development through completion of the Phase 2b trial and including subsequent follow-on Phase 3 preparatory activities.
"This is a very exciting time for Aerie, and we are very pleased with
the progress of our Phase 2b clinical trial for quadruple-action RoclatanTM.
As a result of rapid enrollment in the trial, we have accelerated our
expected public release of data to be in late June or early
Dr. Anido continued, "We expect to initiate partnering discussions for
Product Update
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.
Triple-Action Rhopressa™
Rhopressa™ 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. Furthermore, preclinical results have demonstrated that Rhopressa™ lowers episcleral venous pressure (EVP), which contributes approximately half of IOP in healthy subjects. Moreover, we believe Rhopressa™ provides an additional mechanism which reduces fluid production in the eye and therefore lowers IOP. Biochemically, Rhopressa™ is known to inhibit both Rho Kinase (ROCK) and norepinephrine transporter (NET).
If successful, we expect Rhopressa™ to compete against prostaglandin
analogue (PGA) products as an initial therapy for patients with IOPs of
26 mmHg (millimeters of mercury) or below at the time of diagnosis,
which represents the majority of patients with glaucoma. Additionally,
we believe Rhopressa™ may be used as the add-on product of choice for
patients on
In the Company's Phase 2b clinical trial, which was successfully
completed in
Rhopressa™ is expected to begin two Phase 3 registration trials in
Quadruple-Action Roclatan™
Roclatan™ is a once-daily eye drop that combines our triple-action Rhopressa™ with latanoprost, a prostaglandin analogue that is the most widely prescribed glaucoma drug. If approved, we believe that Roclatan™ would be the first glaucoma product to lower IOP through all known mechanisms: (i) increasing fluid outflow through the TM, the eye's primary drain, (ii) increasing fluid outflow through the uveoscleral pathway, the eye's secondary drain, (iii) reducing fluid production in the eye and (iv) reducing EVP.
The Company believes that Roclatan™, if approved, would be the only
glaucoma product that covers the full spectrum of known IOP-lowering
mechanisms, giving it the potential to provide a greater IOP-lowering
effect than any currently approved glaucoma product. Therefore, we
believe Roclatan™, if approved, could compete in both the
A 28-day Phase 2b clinical trial for Roclatan™ commenced in late
First Quarter 2014 Financial Results
The Company's IPO closed on
The
The
The higher operating expenses in first quarter 2014 as compared to first
quarter 2013 reflect increased clinical preparatory activity for
Rhopressa™, increased clinical activity for Roclatan™, and growth in the
business as a result of having become a public company in
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 32759436.
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
32759436. 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 glaucoma
therapies. The Company is preparing for two Phase 3 registration trials
where the primary efficacy endpoint will be to demonstrate
non-inferiority of IOP lowering for Rhopressa™ (dosed once daily and
twice daily) compared to timolol (dosed twice daily), along with a third
safety-only 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" 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 income (loss), adjusted operating expenses, adjusted research and development expenses, adjusted general and administrative expenses, and adjusted other income (expense). 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" table 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 stock 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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2014 | 2013 | ||||||
Assets | |||||||
Current assets | |||||||
Cash and cash equivalents | $ | 35,843 | $ | 69,649 | |||
Short-term investments | 29,268 | — | |||||
Prepaid expenses and other current assets | 672 | 618 | |||||
Total current assets | 65,783 | 70,267 | |||||
Furniture, fixtures and equipment, net | 146 | 132 | |||||
Other assets, net | 32 | 59 | |||||
Total assets | $ | 65,961 | $ | 70,458 | |||
Liabilities and Stockholders' Equity | |||||||
Current liabilities | |||||||
Accounts payable and other current liabilities | $ | 3,690 | $ | 3,482 | |||
Total current liabilities | 3,690 | 3,482 | |||||
Total liabilities | 3,690 | 3,482 | |||||
Commitments and contingencies | |||||||
Stockholders' Equity | |||||||
Preferred stock, |
— | — | |||||
Common stock, |
23 | 23 | |||||
Additional paid-in capital | 164,008 | 162,021 | |||||
Accumulated other comprehensive loss | (21) | — | |||||
Deficit accumulated during the development stage | (101,739) | (95,068) | |||||
Total stockholders' equity | 62,271 | 66,976 | |||||
Total liabilities and stockholders' equity | $ | 65,961 | $ | 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 | |||||||
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2014 |
2013 |
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Operating expenses | |||||||
General and administrative | $ | (3,612) | $ | (1,466) | |||
Research and development | (5,370) | (3,155) | |||||
Loss from operations | (8,982) | (4,621) | |||||
Other income (expense), net | 2,311 | 831 | |||||
Net loss | $ | (6,671) | $ | (3,790) | |||
Net loss attributable to common stockholders—basic and diluted | $ | (6,671) | $ | (3,927) | |||
Net loss per share attributable to common stockholders—basic and diluted | $ | (0.28) | $ | (4.07) | |||
Weighted average number of common shares outstanding—basic and diluted | 23,717,393 | 965,186 | |||||
Net loss | (6,671) | (3,790) | |||||
Unrealized loss on short-term investments | (21) | — | |||||
Comprehensive loss | $ | (6,692) | $ | (3,790) | |||
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(A Development Stage Company) | |||||||
Reconciliation of GAAP Net Loss to Adjusted Net Loss | |||||||
(Unaudited) | |||||||
(in thousands) | |||||||
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THREE MONTHS ENDED |
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2014 | 2013 | ||||||
Net loss attributable to common stockholders - basic and diluted: | |||||||
Net loss attributable to common stockholders - basic and diluted (GAAP) | $ | (6,671) | $ | (3,927) | |||
Adjustments: | |||||||
Stock-based compensation (a) | 1,922 | 164 | |||||
Change in fair value measurements of warrant liabilities (b) | — | 144 | |||||
Accrued interest and amortization expense related to notes subsequently converted to common equity (c) | — | 293 | |||||
Accretion related to convertible preferred stock (d) | — | 137 | |||||
Adjusted Net loss | $ | (4,749) | $ | (3,189) | |||
Operating expenses: | |||||||
General and administrative expense: | |||||||
General and administrative expense (GAAP) | $ | (3,612) | $ | (1,466) | |||
Adjustments: | |||||||
Stock-based compensation (a) | 1,307 | 142 | |||||
Adjusted general and administrative expense | $ | (2,305) | $ | (1,324) | |||
Research and development expense: | |||||||
Research and development expense (GAAP) | $ | (5,370) | $ | (3,155) | |||
Adjustments: | |||||||
Stock-based compensation (a) | 615 | 22 | |||||
Adjusted research and development expense | $ | (4,755) | $ | (3,133) | |||
Operating expenses (GAAP) | $ | (8,982) | $ | (4,621) | |||
Adjustments: | |||||||
Stock-based compensation (a) | 1,922 | 164 | |||||
Adjusted operating expenses | $ | (7,060) | $ | (4,457) | |||
Other income (expense): | |||||||
Other income (expense) (GAAP) | $ | 2,311 | $ | 831 | |||
Adjustments: | |||||||
Change in fair value measurements of warrant liabilities (b) | — | 144 | |||||
Accrued interest and amortization expense related to notes subsequently converted to common equity (c) | — | 293 | |||||
Adjusted other income (expense) | $ | 2,311 | $ | 1,286 | |||
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) Accrued
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:
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