Aerie Pharmaceuticals Reports First Quarter 2017 Financial Results and Provides Business Update
05/02/2017
Conference Call and Webcast Today,
Aerie Highlights
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All programs for our product candidates remain on track, with the
RhopressaTM (netarsudil ophthalmic solution) 0.02% NDA (new
drug application) resubmitted to the
FDA onFebruary 28, 2017 , and the successful completion of Rocket 4, our six-month safety trial designed for submission to the European regulatory authorities, inApril 2017 . - Topline 90-day efficacy and safety data from Mercury 2, the second Phase 3 registration trial for RoclatanTM (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, are expected in the second quarter of 2017. If both Mercury 1 and Mercury 2 are successful, the RoclatanTM NDA is expected to be submitted in late 2017 or early 2018.
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Mercury 3, a RoclatanTM Phase 3 registration trial to be
conducted in
Europe and designed for European markets, is set to commence in mid-2017. The comparator in this trial will be Ganfort®, a widely prescribed fixed-dose combination of bimatoprost and timolol marketed inEurope . - Preparatory activities for the potential commercialization of RhopressaTM are advancing, including the recent hiring of key executives such as the Vice President of Sales, Vice President of Market Access, and Vice President of Commercial Operations.
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As of
March 31, 2017 , Aerie had$207.9 million in cash, cash equivalents, and investments. Cash burn for the first quarter of 2017 totaled$25.8 million , on track with previously provided full-year 2017 guidance of approximately$100 million .
"With the Phase 3 clinical trials for RhopressaTM behind us,
we are now looking forward to upcoming data that we expect to report
this quarter from our RoclatanTM Mercury 2 trial. Mercury 2
is a 90-day Phase 3 registration trial structured identically to the
successful Mercury 1 trial, but without the 12-month safety component.
The 12-month safety data from Mercury 1 is anticipated this summer.
Looking beyond the
First Quarter 2017 Financial Results
As of
The
The
The higher operating expenses in the first quarter of 2017 as compared to the first quarter of 2016 primarily reflect increased activities associated with the expansion of our employee base to support the growth of our operations and commercialization preparatory activities, including commercial manufacturing costs for RhopressaTM, which are currently included in selling, general and administrative expenses.
Conference Call / Webcast 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 current product candidates are once-daily intraocular
pressure-lowering therapies with novel mechanisms of action to treat
patients with glaucoma or ocular hypertension. The NDA for RhopressaTM
(netarsudil ophthalmic solution) 0.02% was submitted to the
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 and potential future 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 request, 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 selling, 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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| 2017 | 2016 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 139,534 | $ | 197,945 | ||||
| Short-term investments | 68,330 | 35,717 | ||||||
| Prepaid expenses and other current assets | 2,351 | 4,028 | ||||||
| Total current assets | 210,215 | 237,690 | ||||||
| Property, plant and equipment, net | 12,532 | 7,857 | ||||||
| Other assets, net | 2,661 | 2,707 | ||||||
| Total assets | $ | 225,408 | $ | 248,254 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable and other current liabilities | $ | 13,023 | $ | 18,820 | ||||
| Interest payable | 539 | 551 | ||||||
| Total current liabilities | 13,562 | 19,371 | ||||||
| Convertible notes, net of discounts | 123,615 | 123,539 | ||||||
| Other non-current liabilities | 4,115 | — | ||||||
| Total liabilities | 141,292 | 142,910 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' Equity | ||||||||
|
Preferred stock, |
— | — | ||||||
|
Common stock, |
34 | 33 | ||||||
| Additional paid-in capital | 426,597 | 422,002 | ||||||
| Accumulated other comprehensive loss | (105) | (68) | ||||||
| Accumulated deficit | (342,410) | (316,623) | ||||||
| Total stockholders' equity | 84,116 | 105,344 | ||||||
| Total liabilities and stockholders' equity | $ | 225,408 | $ | 248,254 | ||||
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||||||
| Consolidated Statements of Operations and Comprehensive Loss | ||||||
| (Unaudited) | ||||||
| (in thousands, except share and per share data) | ||||||
| THREE MONTHS ENDED | ||||||
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| 2017 | 2016 | |||||
| Operating expenses | ||||||
| Selling, general and administrative | $ | (14,475) | $ | (9,801) | ||
| Research and development | (10,954) | (12,309) | ||||
| Loss from operations | (25,429) | (22,110) | ||||
| Other income (expense), net | (312) | (548) | ||||
| Net loss before income taxes | (25,741) | (22,658) | ||||
| Income tax expense | (46) | (46) | ||||
| Net loss | $ | (25,787) | $ | (22,704) | ||
| Net loss attributable to common stockholders—basic and diluted | $ | (25,787) | $ | (22,704) | ||
| Net loss per share attributable to common stockholders—basic and diluted | $ | (0.76) | $ | (0.85) | ||
| Weighted average number of common shares outstanding—basic and diluted | 33,777,395 | 26,723,266 | ||||
| Net loss | (25,787) | (22,704) | ||||
| Unrealized gain (loss) on available-for-sale investments | (37) | 111 | ||||
| Comprehensive loss | $ | (25,824) | $ | (22,593) | ||
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||||||
| Reconciliation of GAAP Net Loss to Adjusted Net Loss | ||||||
| (Unaudited) | ||||||
| (in thousands) | ||||||
| THREE MONTHS ENDED | ||||||
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| 2017 | 2016 | |||||
| Net loss attributable to common stockholders - basic and diluted: | ||||||
| Net loss attributable to common stockholders - basic and diluted (GAAP) | $ | (25,787) | $ | (22,704) | ||
| Adjustments: | ||||||
| Stock-based compensation (a) | 4,850 | 3,534 | ||||
| Adjusted Net loss | $ | (20,937) | $ | (19,170) | ||
| Operating expenses: | ||||||
| Selling, general and administrative expense: | ||||||
| Selling, general and administrative expense (GAAP) | $ | (14,475) | $ | (9,801) | ||
| Adjustments: | ||||||
| Stock-based compensation (a) | 3,786 | 2,822 | ||||
| Adjusted selling, general and administrative expense | $ | (10,689) | $ | (6,979) | ||
| Research and development expense: | ||||||
| Research and development expense (GAAP) | $ | (10,954) | $ | (12,309) | ||
| Adjustments: | ||||||
| Stock-based compensation (a) | 1,064 | 712 | ||||
| Adjusted research and development expense | $ | (9,890) | $ | (11,597) | ||
| Operating expenses (GAAP) | $ | (25,429) | $ | (22,110) | ||
| Adjustments: | ||||||
| Stock-based compensation (a) | 4,850 | 3,534 | ||||
| Adjusted operating expenses | $ | (20,579) | $ | (18,576) | ||
| Other income (expense): | ||||||
| Other income (expense) (GAAP) | $ | (312) | $ | (548) | ||
| Adjustments: | ||||||
| — | — | |||||
| Adjusted other income (expense) | $ | (312) | $ | (548) | ||
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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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| 2017 | 2016 | |||||
| Net loss per share attributable to common stockholders - basic and diluted: | ||||||
| Net loss per share attributable to common stockholders - basic and diluted (GAAP) | $ | (0.76) | $ | (0.85) | ||
| Adjustments: | ||||||
| Stock-based compensation (a) | 0.14 | 0.13 | ||||
| Adjusted Net loss per share | $ | (0.62) | $ | (0.72) | ||
| Weighted average number of common shares outstanding - basic and diluted | 33,777,395 | 26,723,266 | ||||
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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: Excludes non-cash stock-based compensation. | |
View source version on businesswire.com: http://www.businesswire.com/news/home/20170502006299/en/
Richard Rubino, 908-947-3540
rrubino@aeriepharma.com
or
Ami
Bavishi, 212-213-0006
abavishi@burnsmc.com
Source:
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