Aerie Pharmaceuticals Reports First Quarter 2018 Financial Results and Provides Business Update
05/08/2018
Conference Call and Webcast Today,
Aerie Highlights
- The Rhopressa® (netarsudil ophthalmic solution) 0.02% U.S. commercial launch is underway, with a seasoned and well-trained field sales force fully deployed and actively calling on 14,000 eye care professionals.
-
Formulary contracts to enable commercial coverage in 2018 and
Medicare Part D coverage in 2019 are being executed. We continue to expect preferred formulary coverage for the majority of commercial plans by the end of 2018, and preferred formulary coverage for the majority ofMedicare Part D plans commencing in 2019. -
Preparation of the RoclatanTM (netarsudil/latanoprost
ophthalmic solution) 0.02%/0.005% NDA (New Drug Application) is
progressing on schedule with an expected submission to the
FDA (U.S. Food and Drug Administration ) this quarter. -
International expansion activities are progressing with the ongoing
Phase 3 clinical trial for RoclatanTM, named Mercury 3, to
prepare for regulatory submission in
Europe , and the ongoing Phase 2 clinical trial for Rhopressa® to prepare for a potential regulatory submission inJapan . - Pre-IND (Investigational New Drug application) activities are well underway for the further advancement of Aerie’s retina program candidates, including AR-13503 (Rho kinase and Protein kinase C inhibitor implant) and AR-1105 (dexamethasone steroid implant).
-
Cash burn for the first quarter of 2018 totaled approximately
$50 million , with$334.0 million in cash, cash equivalents and investments as ofMarch 31, 2018 . Shares outstanding at quarter-end totaled 39,503,110. -
Aerie reiterated that it expects full year 2018 Rhopressa® net
revenues in the range of
$20 million to $30 million , on a U.S. generally accepted accounting principles (GAAP) basis, and total 2018 cash burn in the range of$200 million to $210 million .
“Aerie’s first commercial moment has arrived as we proudly launch
Rhopressa® in
First Quarter 2018 Financial Results
As of
The
The
The higher operating expenses in the first quarter of 2018 as compared to the first quarter 2017 primarily reflect increased activities associated with the expansion of our employee base to support the growth of our operations, and preparatory activities associated with our Rhopressa® commercialization efforts.
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 (U.S.) or (678) 894-3054 (international) to listen to the live
conference call. The conference ID number for the live call is 3992508.
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 3992508. The
telephone replay will be available until
About
Aerie is an ophthalmic pharmaceutical company focused on the discovery,
development and commercialization of first-in-class therapies for the
treatment of patients with open-angle glaucoma and other diseases of the
eye. Aerie's first product, Rhopressa® (netarsudil ophthalmic
solution) 0.02%, for the reduction of elevated intraocular pressure
(IOP) in patients with open-angle glaucoma or ocular hypertension, was
approved by 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: our
expectations regarding the commercialization and manufacturing of
Rhopressa® and RoclatanTM or any future product
candidates, including the timing, cost or other aspects of the
commercial launch of Rhopressa® and RoclatanTM or
any future product candidates; our commercialization, marketing,
manufacturing and supply management capabilities and strategies; the
success, timing and cost of our ongoing and anticipated preclinical
studies and clinical trials for Rhopressa®, with respect to
regulatory approval outside of
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 total operating expenses, adjusted research and development expense, adjusted selling, general and administrative expense, and adjusted net loss per share. For reconciliations of non-GAAP measures to the most directly comparable GAAP measures, please see the “Reconciliation of GAAP to Non-GAAP Financial Measures” 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.
AERIE PHARMACEUTICALS, INC. |
||||||||||
MARCH 31, | DECEMBER 31, | |||||||||
2018 | 2017 | |||||||||
Assets | ||||||||||
Current assets | ||||||||||
Cash and cash equivalents | $ | 249,501 | $ | 197,569 | ||||||
Short-term investments | 84,476 | 52,086 | ||||||||
Inventory | 1,062 | — | ||||||||
Prepaid expenses and other current assets | 6,115 | 4,487 | ||||||||
Total current assets | 341,154 | 254,142 | ||||||||
Property, plant and equipment, net | 47,810 | 31,932 | ||||||||
Other assets | 2,079 | 4,202 | ||||||||
Total assets | $ | 391,043 | $ | 290,276 | ||||||
Liabilities and Stockholders’ Equity | ||||||||||
Current liabilities | ||||||||||
Accounts payable | $ | 6,066 | $ | 6,245 | ||||||
Accrued expenses and other current liabilities | 19,070 | 18,939 | ||||||||
Total current liabilities | 25,136 | 25,184 | ||||||||
Convertible notes, net | 123,922 | 123,845 | ||||||||
Other non-current liabilities | 5,714 | 5,648 | ||||||||
Total liabilities | 154,772 | 154,677 | ||||||||
Stockholders' equity | ||||||||||
Common stock | 40 | 37 | ||||||||
Additional paid-in capital | 740,952 | 597,318 | ||||||||
Accumulated other comprehensive loss | (157 | ) | (28 | ) | ||||||
Accumulated deficit | (504,564 | ) | (461,728 | ) | ||||||
Total stockholders’ equity | 236,271 | 135,599 | ||||||||
Total liabilities and stockholders’ equity | $ | 391,043 | $ | 290,276 | ||||||
AERIE PHARMACEUTICALS, INC. Consolidated Statements of Operations (Unaudited) (in thousands, except share and per share data) |
||||||||||
THREE MONTHS ENDED | ||||||||||
MARCH 31, | ||||||||||
2018 | 2017 | |||||||||
Operating expenses | ||||||||||
Selling, general and administrative | $ | 27,823 | $ | 14,475 | ||||||
Research and development | 12,972 | 10,954 | ||||||||
Total operating expenses | 40,795 | 25,429 | ||||||||
Loss from operations | (40,795 | ) | (25,429 | ) | ||||||
Other income (expense), net | 96 | (312 | ) | |||||||
Net loss before income taxes | (40,699 | ) | (25,741 | ) | ||||||
Income tax expense | - |
46 |
|
|||||||
Net loss | $ | (40,699 | ) | $ | (25,787 | ) | ||||
Net loss per common share—basic and diluted | $ | (1.05 | ) | $ | (0.76 | ) | ||||
Weighted average number of common shares outstanding—basic and diluted | 38,598,827 | 33,777,395 | ||||||||
AERIE PHARMACEUTICALS, INC. |
|||||||||
THREE MONTHS ENDED | |||||||||
MARCH 31, | |||||||||
2018 | 2017 | ||||||||
Net loss (GAAP) | $ | (40,699 | ) | $ | (25,787 | ) | |||
Add-back: non-cash stock-based compensation expense | 8,719 | 4,850 | |||||||
Adjusted Net loss | $ | (31,980 | ) | $ | (20,937 | ) | |||
Selling, general and administrative expense (GAAP) | $ | 27,823 | $ | 14,475 | |||||
Less: non-cash stock-based compensation expense | (6,684 | ) | (3,786 | ) | |||||
Adjusted selling, general and administrative expense | $ | 21,139 | $ | 10,689 | |||||
Research and development expense (GAAP) | $ | 12,972 | $ | 10,954 | |||||
Less: non-cash stock-based compensation expense | (2,035 | ) | (1,064 | ) | |||||
Adjusted research and development expense | $ | 10,937 | $ | 9,890 | |||||
Total operating expenses (GAAP) | $ | 40,795 | $ | 25,429 | |||||
Less: non-cash stock-based compensation expense | (8,719 | ) | (4,850 | ) | |||||
Adjusted total operating expenses | $ | 32,076 | $ | 20,579 | |||||
AERIE PHARMACEUTICALS, INC. |
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THREE MONTHS ENDED | ||||||||||
MARCH 31, | ||||||||||
2018 | 2017 | |||||||||
Net loss per common share—basic and diluted (GAAP) | $ | (1.05 | ) | $ | (0.76 | ) | ||||
Add-back: Non-cash stock-based compensation expense | 0.22 | 0.14 | ||||||||
Adjusted Net loss per share—basic and diluted | $ | (0.83 | ) | $ | (0.62 | ) | ||||
Weighted average number of common shares outstanding—basic and diluted | 38,598,827 | 33,777,395 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20180508005211/en/
Source:
Aerie Pharmaceuticals
Media:
Tad
Heitmann, 949-526-8747
theitmann@aeriepharma.com
or
Investors:
Richard
Rubino, 908-947-3540
rrubino@aeriepharma.com
or
Burns
McClellan, Inc., on behalf of Aerie Pharmaceuticals
Media:
Justin
Jackson, 212-213-0006
jjackson@burnsmc.com
or
Investors:
Ami
Bavishi, 212-213-0006
abavishi@burnsmc.com