Aerie Pharmaceuticals Reports Fourth Quarter and Full Year 2013 Financial Results and Provides Business and Product Development Update
03/18/2014
Aerie on Track with Both Clinical Programs; Debuts Product Trade Names for Triple-Action and Quadruple-Action Candidates
Conference Call and Webcast Today,
Aerie Highlights
- Proposed trade name for AR-13324 Ophthalmic Solution is "Rhopressa™," for PG324 Ophthalmic Solution is "Roclatan™." Aerie is in the process of filing for trademark protection.
- Based on recent preclinical episcleral venous pressure (EVP) findings, Aerie considers Rhopressa™ a triple-action product and Roclatan™ a quadruple-action product. These products were formerly referred to as "dual action" and "triple action," respectively.
- The Rhopressa™ Phase 3 registration trials are expected to commence early third-quarter 2014, with efficacy data expected mid-2015. The Roclatan™ Phase 2b clinical trial is underway, with efficacy data expected also in early third-quarter 2014.
-
As of
February 28, 2014 , Aerie had$67.6 million of cash and marketable securities on its balance sheet, representing almost the full net proceeds from the initial public offering (IPO) inOctober 2013 . This amount is expected to fund Rhopressa™ Phase 3 development through NDA filing currently projected for mid-2016, and Roclatan™ development through completion of the Phase 2b trial and including subsequent follow-on Phase 3 preparatory activities.
"Aerie is on track with all key clinical activities, and we are
particularly delighted with the recent evidence of our products'
potential effect of reducing EVP. This may represent a breakthrough, and
we view our product candidates as highly differentiated when compared to
currently marketed drugs and those currently under development. If our
product candidates are successful, we believe they may become the
products of choice for a large portion of the population of patients
suffering from glaucoma and ocular hypertension," said
Dr. Anido continued, "We are currently preparing for our triple-action Rhopressa™ Phase 3 registration trials, which are expected to commence early third-quarter 2014. With our Phase 2b clinical trial for quadruple-action Roclatan™ having commenced earlier this year, we expect efficacy data from this study in early third-quarter 2014."
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. Recent preclinical results have demonstrated that Rhopressa™ potentially also lowers EVP, which contributes approximately half of IOP in healthy subjects. Further, 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 and ocular
hypertension. Additionally, we believe Rhopressa™ may be used as the
add-on product of choice for patients on
In our Phase 2b clinical trial, which was successfully completed in
Rhopressa™ is expected to begin two Phase 3 registration trials in early third-quarter 2014, with total expected enrollment of approximately 1,200 patients. The trials will measure efficacy over three months and safety over 12 months. The primary efficacy endpoint of the trials will be to demonstrate non-inferiority of IOP lowering for Rhopressa™ (dosed once daily) compared to timolol (dosed twice daily). Timolol is the most widely used comparator in registration trials for glaucoma, and is also the most widely prescribed add-on therapy to PGAs.
Assuming the trials commence in the early third quarter, three-month efficacy results are expected to be released in mid-2015, and if the trials are successful, we expect to submit our NDA filing in mid-2016.
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 actions: (i) increasing fluid outflow through the TM or primary drain, (ii) increasing fluid outflow through the uveoscleral pathway or secondary drain, (iii) reducing fluid production in the eye and (iv) potentially reducing EVP.
We believe that Roclatan™, if approved, would be the only glaucoma
product that covers the full spectrum of 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
Fourth-Quarter and Full-Year 2013 Financial Results
The Company's IPO closed on
For the quarter ended
The
The
The
The
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 5403263.
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 5403263. 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) compared to timolol (dosed twice daily). The Company is also currently executing a Phase 2b clinical trial where the primary efficacy endpoint is to demonstrate superiority of Roclatan™ to each of its components.
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 clinical trials and anticipated Phase 3 clinical trials for our
current product candidates, including statements regarding the timing of
initiation and completion of the 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 (in thousands, except share and per share data) |
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| 2013 | 2012 | |||||||||
| Assets | ||||||||||
| Current assets | ||||||||||
| Cash and cash equivalents | $ | 69,649 | $ | 2,925 | ||||||
| Prepaid expenses and other current assets | 618 | 113 | ||||||||
| Total current assets | 70,267 | 3,038 | ||||||||
| Furniture, fixtures and equipment, net | 132 | 133 | ||||||||
| Other assets, net | 59 | 48 | ||||||||
| Total assets | $ | 70,458 | $ | 3,219 | ||||||
| Liabilities, Convertible Preferred Stock and Stockholders' Equity (Deficit) | ||||||||||
| Current liabilities | ||||||||||
| Accounts payable and other current liabilities | $ | 3,482 | $ | 1,437 | ||||||
| Notes payable, net of discount—related parties | — | 2,331 | ||||||||
| Interest payable—related parties | — | 16 | ||||||||
| Total current liabilities | 3,482 | 3,784 | ||||||||
| Warrants liability—related parties | — | 2,456 | ||||||||
| Total liabilities | 3,482 | 6,240 | ||||||||
| Commitments and contingencies | ||||||||||
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Convertible preferred stock, |
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Series A-1—Zero and 400,000 shares authorized as of |
— | 1,000 | ||||||||
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Series A-2—Zero and 2,002,006 shares authorized as of |
— | 10,000 | ||||||||
|
Series A-3—Zero and 4,495,895 shares authorized as of |
— | 20,979 | ||||||||
|
Series A-4—Zero and 1,136,681 shares authorized as of |
— | 4,606 | ||||||||
|
Series B—Zero and 8,500,000 shares authorized as of |
— | 24,313 | ||||||||
| Total convertible preferred stock | — | 60,898 | ||||||||
| Stockholders' Equity (deficit) | ||||||||||
|
Preferred stock, |
— | — | ||||||||
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Common stock, |
23 | 1 | ||||||||
| Additional paid-in capital | 162,021 | — | ||||||||
| Deficit accumulated during the development stage | (95,068 | ) | (63,920 | ) | ||||||
| Total stockholders' equity (deficit) | 66,976 | (63,919 | ) | |||||||
| Total liabilities, convertible preferred stock and stockholders' equity (deficit) | $ | 70,458 | $ | 3,219 | ||||||
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| 2013 | 2012 | 2013 | 2012 | |||||||||||||||||
| (unaudited) | ||||||||||||||||||||
| Operating expenses | ||||||||||||||||||||
| General and administrative | $ | (3,594 | ) | $ | (1,319 | ) | $ | (10,287 | ) | $ | (5,020 | ) | ||||||||
| Research and development | (3,156 | ) | (1,968 | ) | (11,883 | ) | (9,273 | ) | ||||||||||||
| Loss from operations | (6,750 | ) | (3,287 | ) | (22,170 | ) | (14,293 | ) | ||||||||||||
| Other income (expense), net | (3,532 | ) | (258 | ) | (8,978 | ) | (685 | ) | ||||||||||||
| Net loss | $ | (10,282 | ) | $ | (3,545 | ) | $ | (31,148 | ) | $ | (14,978 | ) | ||||||||
| Comprehensive loss | $ | (10,282 | ) | $ | (3,545 | ) | $ | (31,148 | ) | $ | (14,978 | ) | ||||||||
| Net loss attributable to common stockholders—basic and diluted | $ | (10,319 | ) | $ | (3,804 | ) | $ | (31,598 | ) | $ | (15,643 | ) | ||||||||
| Net loss per share attributable to common stockholders—basic and diluted | $ | (0.62 | ) | $ | (4.01 | ) | $ | (6.38 | ) | $ | (16.39 | ) | ||||||||
| Weighted average number of common shares outstanding—basic and diluted | 16,739,367 | 947,623 | 4,955,760 | 954,695 | ||||||||||||||||
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| 2013 | 2012 | 2013 | 2012 | |||||||||||||||
| Net loss attributable to common stockholders—basic and diluted: | ||||||||||||||||||
| Net loss attributable to common stockholders—basic and diluted (GAAP) | $ (10,319 | ) | $ (3,804 | ) | $ (31,598 | ) | $ | (15,643 | ) | |||||||||
| Adjustments: | ||||||||||||||||||
| Stock-based compensation (a) | 1,327 | 138 | 2,858 | 430 | ||||||||||||||
| Change in fair value measurements of warrant liabilities (b) | (133 | ) | 189 | 3,717 | 630 | |||||||||||||
| Accrued interest and amortization expense related to notes subsequently converted to common equity (c) | 930 | 60 | 3,795 | 75 | ||||||||||||||
| Accretion related to convertible preferred stock (d) | 37 | 138 | 450 | 544 | ||||||||||||||
| Loss on conversion of notes payable to related parties (e) | 2,737 | — | 2,737 | — | ||||||||||||||
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— | 121 | — | 121 | ||||||||||||||
| Adjusted net loss | $ (5,421 | ) | $ (3,158 | ) | $ (18,041 | ) | $ | (13,843 | ) | |||||||||
| Operating expenses: | ||||||||||||||||||
| General and administrative expense: | ||||||||||||||||||
| General and administrative expense (GAAP) | $ (3,594 | ) | $ (1,319 | ) | $ (10,287 | ) | $ | (5,020 | ) | |||||||||
| Adjustments: | ||||||||||||||||||
| Stock-based compensation (a) | 1,211 | 115 | 2,636 | 341 | ||||||||||||||
| Adjusted general and administrative expense | $ (2,383 | ) | $ (1,204 | ) | $ (7,651 | ) | $ | (4,679 | ) | |||||||||
| Research and development expense: | ||||||||||||||||||
| Research and development expense (GAAP) | $ (3,156 | ) | $ (1,968 | ) | $ (11,883 | ) | $ | (9,273 | ) | |||||||||
| Adjustments: | ||||||||||||||||||
| Stock-based compensation (a) | 116 | 23 | 222 | 89 | ||||||||||||||
| Adjusted research and development expense | $ (3,040 | ) | $ (1,945 | ) | $ (11,661 | ) | $ | (9,184 | ) | |||||||||
| Operating expenses (GAAP) | $ (6,750 | ) | $ (3,287 | ) | $ (22,170 | ) | $ | (14,293 | ) | |||||||||
| Adjustments: | ||||||||||||||||||
| Stock-based compensation (a) | 1,327 | 138 | 2,858 | 430 | ||||||||||||||
| Adjusted operating expenses | $ (5,423 | ) | $ (3,149 | ) | $ (19,312 | ) | $ | (13,863 | ) | |||||||||
| Other income (expense), net: | ||||||||||||||||||
| Other income (expense), net (GAAP) | $ (3,532 | ) | $ (258 | ) | $ (8,978 | ) | $ | (685 | ) | |||||||||
| Adjustments: | ||||||||||||||||||
| Change in fair value measurements of warrant liabilities (b) | (133 | ) | 189 | 3,717 | 630 | |||||||||||||
| Accrued interest and amortization expense related to notes subsequently converted to common equity (c) | 930 | 60 | 3,795 | 75 | ||||||||||||||
| Loss on conversion of notes payable to related parties (e) | 2,737 | — | 2,737 | — | ||||||||||||||
| Adjusted other income (expense), net |
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$ (9 | ) |
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$ | 20 | ||||||||||||
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.
(e) Loss on conversion
of notes payable to related parties: Exclude the non-cash
extinguishment loss on conversion of notes payable to related parties.
(f)
* In 2012, Aerie's Board of Directors declared a dividend and
distributed 100% of the equity interests in
rrubino@aeriepharma.com
or
akolhatkar@burnsmc.com
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