Aerie Pharmaceuticals Reports Third Quarter 2016 Financial Results and Provides Business Update
11/02/2016
- New Data Adds Further Positive Insight into RhopressaTM and RoclatanTM Potential -
- Company Closes the Third Quarter with Over
Conference Call and Webcast Today,
Aerie Highlights
- Recent study data from RhopressaTM (netarsudil ophthalmic solution) 0.02% and RoclatanTM (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005% provide confirmatory insights into how these novel product candidates, if approved, can benefit patients with glaucoma or ocular hypertension.
- In addition to the positive Mercury 1 and Rocket 4 clinical trial results, the results of a recently completed week long 12-patient pilot study demonstrated consistent lowering of intraocular pressure (IOP) for RhopressaTM over a 24-hour period. The study suggests RhopressaTM has the unique potential to provide meaningfully better nocturnal IOP-lowering than currently marketed products.
-
The Company expects to resubmit RhopressaTM New Drug
Application (NDA) in January of 2017 upon notification from finished
product contract manufacturer of their readiness for pre-approval
inspection by the
FDA . -
Strategic plans for RhopressaTM and RoclatanTM
in
Europe andJapan continue to advance, and preclinical studies of AR-13154 for wet AMD, and delivery technology for front and back of the eye are progressing. -
As of
September 30, 2016 , Aerie had$255.6 million in cash, cash equivalents, and investments on the balance sheet, and 33.4 million shares outstanding. For the nine months endedSeptember 30, 2016 , cash burn totaled$62.4 million , on track with current full-year guidance of$85 million .
"We have made significant progress since we closed the second quarter,
including the read-out of the successful Mercury 1 topline results for
RoclatanTM, and most recently the successful Rocket 4 topline
results for RhopressaTM. During the third quarter, we also
significantly added to our financial resources, with over
1. Liu JH, et al. Am J Ophthalmol. 2004; 138:389-395.
2. Gulati V, et al. Arch Ophthalmol. 2012; 130:677-684.
3. Liu JH, et al. Ophthalmology. 2009; 116:449-454.
4. Liu JH, et al. Ophthalmology. 2010; 117:2075-9
5. Fan S et al. J Glaucoma. 2014; 23:276-81
6. Liu JH, et al. Am J Ophthalmol. 2016;169:249-257
Third Quarter 2016 Financial Results
As of
The
The
The higher operating expenses in the third quarter of 2016 as compared to the third 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 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 (
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. Aerie's two lead product candidates are once-daily IOP-lowering
therapies with novel mechanisms of action to treat patients with
glaucoma or ocular hypertension. The NDA filing for RhopressaTM
(netarsudil ophthalmic solution) 0.02% was originally submitted in the
third quarter of 2016 and is expected to be resubmitted 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 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.
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| Consolidated Balance Sheets | ||||||
| (Unaudited) | ||||||
| (in thousands, except share and per share data) | ||||||
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| 2016 | 2015 | |||||
| Assets | ||||||
| Current assets | ||||||
| Cash and cash equivalents | $ | 211,938 | $ | 91,060 | ||
| Short-term investments | 41,694 | 45,502 | ||||
| Prepaid expenses and other current assets | 2,910 | 1,865 | ||||
| Total current assets | 256,542 | 138,427 | ||||
| Long-term investments | 1,970 | 13,808 | ||||
| Furniture, fixtures and equipment, net | 4,607 | 3,816 | ||||
| Other assets, net | 2,799 | 3,076 | ||||
| Total assets | $ | 265,918 | $ | 159,127 | ||
| Liabilities and Stockholders' Equity | ||||||
| Current liabilities | ||||||
| Accounts payable and other current liabilities | $ | 13,547 | $ | 16,565 | ||
| Interest payable | 551 | 551 | ||||
| Total current liabilities | 14,098 | 17,116 | ||||
| Convertible notes, net of discounts | 123,463 | 123,236 | ||||
| Total liabilities | 137,561 | 140,352 | ||||
| Commitments and contingencies | ||||||
| Stockholders' equity | ||||||
|
Preferred stock, |
— | — | ||||
|
Common stock, |
33 | 26 | ||||
| Additional paid-in capital | 415,638 | 236,492 | ||||
| Accumulated other comprehensive loss | (13) | (179) | ||||
| Accumulated deficit | (287,301) | (217,564) | ||||
| Total stockholders' equity | 128,357 | 18,775 | ||||
| Total liabilities and stockholders' equity | $ | 265,918 | $ | 159,127 | ||
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| Consolidated 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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| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| Operating expenses | ||||||||||||||||
| General and administrative | $ | (10,627 | ) | $ | (7,462 | ) | $ | (29,814 | ) | $ | (22,987 | ) | ||||
| Research and development | (12,688 | ) | (9,904 | ) | (38,301 | ) | (32,149 | ) | ||||||||
| Loss from operations | (23,315 | ) | (17,366 | ) | (68,115 | ) | (55,136 | ) | ||||||||
| Other income (expense), net | (460 | ) | (523 | ) | (1,490 | ) | 1,374 | |||||||||
| Net loss before income taxes | $ | (23,775 | ) | $ | (17,889 | ) | $ | (69,605 | ) | $ | (53,762 | ) | ||||
| Income tax expense | (39 | ) | (72 | ) | (132 | ) | (224 | ) | ||||||||
| Net loss attributable to common stockholders—basic and diluted | $ | (23,814 | ) | $ | (17,961 | ) | $ | (69,737 | ) | $ | (53,986 | ) | ||||
| Net loss per share attributable to common stockholders—basic and diluted | $ | (0.81 | ) | $ | (0.69 | ) | $ | (2.52 | ) | $ | (2.12 | ) | ||||
| Weighted average number of common shares outstanding—basic and diluted | 29,380,453 | 26,061,993 | 27,632,090 | 25,507,409 | ||||||||||||
| Net loss | $ | (23,814 | ) | $ | (17,961 | ) | $ | (69,737 | ) | $ | (53,986 | ) | ||||
| Unrealized (loss) gain on available-for-sale investments | (3 | ) | 9 | 166 | 75 | |||||||||||
| Comprehensive loss | $ | (23,817 | ) | $ | (17,952 | ) | $ | (69,571 | ) | $ | (53,911 | ) | ||||
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| Reconciliation of GAAP Net Loss to Adjusted Net Loss | ||||||||||||||||
| (Unaudited) | ||||||||||||||||
| (in thousands) | ||||||||||||||||
| THREE MONTHS ENDED | NINE MONTHS ENDED | |||||||||||||||
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| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| Net loss attributable to common stockholders - basic and diluted: | ||||||||||||||||
| Net loss attributable to common stockholders - basic and diluted (GAAP) | $ | (23,814 | ) | $ | (17,961 | ) | $ | (69,737 | ) | $ | (53,986 | ) | ||||
| Adjustments: | ||||||||||||||||
| Stock-based compensation (a) | 4,099 | 3,316 | 11,514 | 9,533 | ||||||||||||
| Adjusted Net loss | $ | (19,715 | ) | $ | (14,645 | ) | $ | (58,223 | ) | $ | (44,453 | ) | ||||
| Operating expenses: | ||||||||||||||||
| General and administrative expense: | ||||||||||||||||
| General and administrative expense (GAAP) | $ | (10,627 | ) | $ | (7,462 | ) | $ | (29,814 | ) | $ | (22,987 | ) | ||||
| Adjustments: | ||||||||||||||||
| Stock-based compensation (a) | 3,406 | 2,719 | 9,295 | 7,842 | ||||||||||||
| Adjusted general and administrative expense | $ | (7,221 | ) | $ | (4,743 | ) | $ | (20,519 | ) | $ | (15,145 | ) | ||||
| Research and development expense: | ||||||||||||||||
| Research and development expense (GAAP) | $ | (12,688 | ) | $ | (9,904 | ) | $ | (38,301 | ) | $ | (32,149 | ) | ||||
| Adjustments: | ||||||||||||||||
| Stock-based compensation (a) | 693 | 597 | 2,219 | 1,691 | ||||||||||||
| Adjusted research and development expense | $ | (11,995 | ) | $ | (9,307 | ) | $ | (36,082 | ) | $ | (30,458 | ) | ||||
| Operating expenses (GAAP) | $ | (23,315 | ) | $ | (17,366 | ) | $ | (68,115 | ) | $ | (55,136 | ) | ||||
| Adjustments: | ||||||||||||||||
| Stock-based compensation (a) | 4,099 | 3,316 | 11,514 | 9,533 | ||||||||||||
| Adjusted operating expenses | $ | (19,216 | ) | $ | (14,050 | ) | $ | (56,601 | ) | $ | (45,603 | ) | ||||
| Other income (expense): | ||||||||||||||||
| Other income (expense) (GAAP) | $ | (460 | ) | $ | (523 | ) | $ | (1,490 | ) | $ | 1,374 | |||||
| Adjustments: | ||||||||||||||||
| — | — | — | — | |||||||||||||
| Adjusted other income (expense) | $ | (460 | ) | $ | (523 | ) | $ | (1,490 | ) | $ | 1,374 | |||||
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| Reconciliation of GAAP Net Loss Per Share to Adjusted Net Loss Per Share | ||||||||||||||||
| (Unaudited) | ||||||||||||||||
| THREE MONTHS ENDED | NINE MONTHS ENDED | |||||||||||||||
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| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| Net loss per share attributable to common stockholders - basic and diluted: | ||||||||||||||||
| Net loss per share attributable to common stockholders - basic and diluted (GAAP) | $ | (0.81 | ) | $ | (0.69 | ) | $ | (2.52 | ) | $ | (2.12 | ) | ||||
| Adjustments: | ||||||||||||||||
| Stock-based compensation (a) | 0.14 | 0.13 | 0.42 | 0.38 | ||||||||||||
| Adjusted Net loss per share | $ | (0.67 | ) | $ | (0.56 | ) | $ | (2.10 | ) | $ | (1.74 | ) | ||||
| Weighted average number of common shares outstanding - basic and diluted | 29,380,453 | 26,061,993 | 27,632,090 | 25,507,409 | ||||||||||||
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. |
View source version on businesswire.com: http://www.businesswire.com/news/home/20161102006170/en/
Richard Rubino, 908-947-3540
rrubino@aeriepharma.com
or
Ami
Bavishi, 212-213-0006
abavishi@burnsmc.com
Source:
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