Aerie Pharmaceuticals Reports Second Quarter 2018 Financial Results and Provides Business Update
08/08/2018
Conference Call and Webcast Today,
Aerie Highlights
-
The Rhopressa® (netarsudil ophthalmic solution) 0.02% U.S.
commercial launch commenced on
April 30, 2018 , and second quarter net revenues on a U.S. GAAP (generally accepted accounting principles) basis totaled$2.4 million . -
As of
August 1, 2018 , Rhopressa® market access has increased to approximately 80% (up from 70% as last reported) of commercial lives, including 55% in Tier 3 and 25% in preferred brand Tier 2.Medicare Part D coverage is now 12% (up from 10% as last reported) in Tier 2. -
The RoclatanTM (netarsudil/latanoprost ophthalmic solution)
0.02%/0.005% PDUFA (Prescription Drug User Fee Act) date has been set
for
March 14, 2019 , and there are no current expectations for an advisory committee. -
International expansion activities are progressing with the ongoing
RoclatanTM Mercury 3 Phase 3 clinical trial in preparation
for potential regulatory submission in
Europe , and the expected expansion intoJapan with an additional Rhopressa® Phase 2 clinical trial in preparation for 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), and the recently announced expansion of our agreement with DSM opens new opportunities for further advancement of Aerie’s ophthalmic pipeline.
-
Cash burn for the first half of 2018 totaled approximately
$103 million , with$286.1 million in cash, cash equivalents and investments as of June 30, 2018. Shares outstanding at quarter-end totaled 39,839,373 (or 45,208,820 after giving effect to the recently announced issuance of shares to certain entities affiliated withDeerfield Management Company L.P. in connection with the conversion of the convertible notes). -
Aerie reiterated that it expects full year 2018 Rhopressa®
net revenues in the range of
$20 million to $30 million , on a U.S. GAAP basis, and total 2018 cash burn in the range of$200 million to$210 million .
“The physician feedback to date from the Rhopressa® launch
has been quite positive, and we have seen solid uptake in prescription
volumes along with substantial progress in market access. We have
obtained a high degree of access to prescribing physicians, both in
their offices and at educational venues, as they had been anxiously
awaiting the introduction of Rhopressa®, and they are now
experiencing how Rhopressa® performs when taken in
combination with other therapies in a real-world setting. We are also
delighted with the FDA’s response on the RoclatanTM review
process, and we are in the process of refining our RoclatanTM
launch plans,” said
Second Quarter 2018 Financial Results
As of June 30, 2018, Aerie had cash, cash equivalents and investments of
The
The
The higher operating expenses in the second quarter of 2018 as compared to the second quarter 2017 primarily reflect increased activities associated with the expansion of our employee base to support the growth of our operations, and 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 1773437.
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 1773437. The
telephone replay will be available until
About Aerie Pharmaceuticals, Inc.
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, retina diseases and
other diseases of the eye. Aerie's first product, Rhopressa® (netarsudil
ophthalmic solution) 0.02%, a once-daily eyedrop 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 expenses, adjusted selling, general and administrative expenses, 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 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. | ||||||||
| Consolidated Balance Sheets | ||||||||
| (Unaudited) | ||||||||
|
(in thousands) |
||||||||
| JUNE 30, 2018 | DECEMBER 31, 2017 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 270,648 | $ | 197,569 | ||||
| Short-term investments | 15,455 | 52,086 | ||||||
| Accounts receivable, net | 1,125 | — | ||||||
| Inventory | 5,747 | — | ||||||
| Prepaid expenses and other current assets | 2,503 | 4,487 | ||||||
|
Total current assets |
295,478 | 254,142 | ||||||
| Property, plant and equipment, net | 54,879 | 31,932 | ||||||
| Other assets | 2,604 | 4,202 | ||||||
| Total assets | $ | 352,961 | $ | 290,276 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 8,757 | $ | 6,245 | ||||
| Accrued expenses and other current liabilities | 20,016 | 18,939 | ||||||
| Total current liabilities | 28,773 | 25,184 | ||||||
| Convertible notes, net | 123,999 | 123,845 | ||||||
| Other non-current liabilities | 5,309 | 5,648 | ||||||
| Total liabilities | 158,081 | 154,677 | ||||||
| Stockholders' equity | ||||||||
| Common stock | 40 | 37 | ||||||
| Additional paid-in capital | 754,437 | 597,318 | ||||||
| Accumulated other comprehensive loss | (9 | ) | (28 | ) | ||||
| Accumulated deficit | (559,588 | ) | (461,728 | ) | ||||
| Total stockholders’ equity | 194,880 | 135,599 | ||||||
| Total liabilities and stockholders’ equity | $ | 352,961 | $ | 290,276 | ||||
| AERIE PHARMACEUTICALS, INC. | ||||||||||||||||
| Consolidated Statements of Operations | ||||||||||||||||
| (Unaudited) | ||||||||||||||||
|
(in thousands, except share and per share data) |
||||||||||||||||
|
THREE MONTHS ENDED |
SIX MONTHS ENDED |
|||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| Product revenues, net | $ | 2,423 | $ | — | $ | 2,423 | $ | — | ||||||||
| Total revenues, net | 2,423 | — | 2,423 | — | ||||||||||||
| Costs and expenses: | ||||||||||||||||
| Cost of goods sold | 59 | — | 59 | — | ||||||||||||
| Selling, general and administrative | 39,891 | 17,153 | 67,714 | 31,628 | ||||||||||||
| Research and development | 18,157 | 10,615 | 31,129 | 21,569 | ||||||||||||
| Total costs and expenses | 58,107 | 27,768 | 98,902 | 53,197 | ||||||||||||
| Loss from operations | (55,684 | ) | (27,768 | ) | (96,479 | ) | (53,197 | ) | ||||||||
| Other income (expense), net | 663 | (618 | ) | 759 | (930 | ) | ||||||||||
| Loss before income taxes | (55,021 | ) | (28,386 | ) | (95,720 | ) | (54,127 | ) | ||||||||
| Income tax expense | 3 | 47 | 3 | 93 | ||||||||||||
| Net loss | $ | (55,024 | ) | $ | (28,433 | ) | $ | (95,723 | ) | $ | (54,220 | ) | ||||
| Net loss per common share—basic and diluted | $ | (1.40 | ) | $ | (0.82 | ) | $ | (2.46 | ) | $ | (1.58 | ) | ||||
| Weighted average number of common shares outstanding—basic and diluted | 39,204,762 | 34,783,195 | 38,903,469 | 34,283,073 | ||||||||||||
| AERIE PHARMACEUTICALS, INC. | ||||||||||||||||
| Reconciliation of GAAP to Non-GAAP Financial Measures | ||||||||||||||||
| (Unaudited) | ||||||||||||||||
|
(in thousands) |
||||||||||||||||
|
THREE MONTHS ENDED |
SIX MONTHS ENDED |
|||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| Net loss (GAAP) | $ | (55,024 | ) | $ | (28,433 | ) | $ (95,723 | ) | $ (54,220 | ) | ||||||
| Add-back: stock-based compensation expense | 10,318 | 6,665 | 19,037 | 11,515 | ||||||||||||
| Adjusted Net loss | $ | (44,706 | ) | $ | (21,768 | ) | $ | (76,686 | ) | $ | (42,705 | ) | ||||
| Selling, general and administrative expenses (GAAP) | $ | 39,891 | $ | 17,153 | $ | 67,714 | $ | 31,628 | ||||||||
| Less: stock-based compensation expense | (7,760 | ) | (5,251 | ) | (14,444 | ) | (9,037 | ) | ||||||||
| Adjusted selling, general and administrative expenses | $ | 32,131 | $ | 11,902 | $ | 53,270 | $ | 22,591 | ||||||||
| Research and development expenses (GAAP) | $ | 18,157 | $ | 10,615 | $ | 31,129 | $ | 21,569 | ||||||||
| Less: stock-based compensation expense | (2,558 | ) | (1,414 | ) | (4,593 | ) | (2,478 | ) | ||||||||
| Adjusted research and development expenses | $ | 15,599 | $ | 9,201 | $ | 26,536 | $ | 19,091 | ||||||||
| Total operating expenses (GAAP) | $ | 58,048 | $ | 27,768 | $ | 98,843 | $ | 53,197 | ||||||||
| Less: stock-based compensation expense | (10,318 | ) | (6,665 | ) | (19,037 | ) | (11,515 | ) | ||||||||
| Adjusted total operating expenses | $ | 47,730 | $ | 21,103 | $ | 79,806 | $ | 41,682 | ||||||||
| AERIE PHARMACEUTICALS, INC. | ||||||||||||||||
| Reconciliation of GAAP Net Loss Per Share to Adjusted Net Loss Per Share | ||||||||||||||||
|
(Unaudited) |
||||||||||||||||
|
THREE MONTHS ENDED |
SIX MONTHS ENDED |
|||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| Net loss per common share—basic and diluted (GAAP) | $ | (1.40 | ) | $ | (0.82 | ) | $ | (2.46 | ) | $ | (1.58 | ) | ||||
| Add-back: stock-based compensation expense | 0.26 | 0.19 | 0.49 | 0.34 | ||||||||||||
| Adjusted Net loss per share—basic and diluted | $ | (1.14 | ) | $ | (0.63 | ) | $ | (1.97 | ) | $ | (1.24 | ) | ||||
| Weighted average number of common shares outstanding—basic and diluted | 39,204,762 | 34,783,195 | 38,903,469 | 34,283,073 | ||||||||||||
View source version on businesswire.com: https://www.businesswire.com/news/home/20180808005013/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
Investors:
Ami
Bavishi, 212-213-0006
abavishi@burnsmc.com
