Aerie Pharmaceuticals Reports Fourth Quarter and Full Year 2018 Financial Results, Provides 2019 Cash Burn Guidance and Business Update
02/25/2019
Conference Call and Webcast Today,
Aerie Highlights
-
Rhopressa® (netarsudil ophthalmic solution) 0.02% generated
fourth quarter net revenues on a U.S. GAAP (generally accepted
accounting principles) basis of
$14.5 million , representing$129.53 per bottle. For full-year 2018, net revenues totaled$24.2 million , in line with previous guidance, representing$127.77 per bottle. Year-end 2018 wholesaler inventory levels remained consistent with the end of the third-quarter 2018, at approximately two weeks of demand. -
At the time of this press release, Rhopressa® market access
increased to approximately 90% of commercial lives, including 55% in
preferred brand Tier 2 and 35% in Tier 3, and Medicare Part D Tier 2
coverage currently represents approximately 40% of
Medicare Part D lives. We expect Medicare Part D Tier 2 equivalent coverage to increase to well over 70% within the next few weeks. As we gain more utilization from covered lives, particularly inMedicare Part D , we expect our net revenue per bottle to ultimately decline to approximately$100 during 2019. -
The Rocklatan™ (netarsudil/latanoprost ophthalmic solution)
0.02%/0.005% PDUFA (Prescription Drug User Fee Act) date remains set
for
March 14, 2019 and the related training of our sales force is well underway. -
International expansion activities are progressing with the ongoing
Rocklatan™ Mercury 3 Phase 3 clinical trial in
Europe , and expansion intoJapan with the Rhopressa® Phase 2 clinical trial commencing inMarch 2019 in preparation for potential regulatory submission inJapan . -
Aerie’s retina program continues to advance, with preclinical
candidate AR-1105 (dexamethasone steroid implant) clinical trials
expected to begin in
March 2019 for RVO (retinal vein occlusion). The IND (Investigational New Drug application) for AR-13503 (Rho kinase and Protein kinase C inhibitor implant) is expected to be filed with theFDA (theU.S. Food and Drug Administration ) inMarch 2019 , and, if accepted, we expect to begin clinical trials in the second quarter of 2019 for wet age-related macular degeneration and DME (diabetic macular edema). -
Cash burn for the year ended
December 31, 2018 totaled approximately$215.5 million , consistent with previous guidance, resulting in$202.8 million in cash and cash equivalents as ofDecember 31, 2018 . In addition, we have the$100 million undrawn credit facility available, bringing total liquidity to over$300 million . Shares outstanding atDecember 31, 2018 totaled 45.5 million. -
Guidance for 2019 full-year cash burn is consistent with full-year
2018 actual results, in the range of
$210 million to $220 million .
We plan to communicate full-year 2019 net revenue guidance following the completion of the FDA’s review of the NDA (New Drug Application) for Rocklatan™.
“We are delighted to have achieved the revenue guidance that we
announced a full year ago, well before Rhopressa® launched in
“We are entering 2019 very well financed, with over
Fourth Quarter 2018 Financial Results
As of
The
The
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 7633869.
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 7633869. 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, retinal 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 Rocklatan™ or any future product candidates,
including the timing, cost or other aspects of the commercial launch of
Rhopressa® and Rocklatan™ 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, adjusted pre-approval commercial manufacturing 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) | |||||||||||
DECEMBER 31, | |||||||||||
2018 | 2017 | ||||||||||
Assets | |||||||||||
Current assets | |||||||||||
Cash and cash equivalents | $ | 202,818 | $ | 197,569 | |||||||
Short-term investments | — | 52,086 | |||||||||
Accounts receivable, net | 2,715 | — | |||||||||
Inventory | 10,112 | — | |||||||||
Prepaid expenses and other current assets | 4,530 | 4,487 | |||||||||
Total current assets | 220,175 | 254,142 | |||||||||
Property, plant and equipment, net | 60,525 | 31,932 | |||||||||
Other assets | 4,344 | 4,202 | |||||||||
Total assets | $ | 285,044 | $ | 290,276 | |||||||
Liabilities and Stockholders’ Equity | |||||||||||
Current liabilities | |||||||||||
Accounts payable | $ | 12,403 | $ | 6,245 | |||||||
Accrued expenses and other current liabilities | 38,381 | 18,939 | |||||||||
Total current liabilities | 50,784 | 25,184 | |||||||||
Convertible notes, net | — | 123,845 | |||||||||
Other non-current liabilities | 6,454 | 5,648 | |||||||||
Total liabilities | 57,238 | 154,677 | |||||||||
Stockholders’ equity | |||||||||||
Common stock | 45 | 37 | |||||||||
Additional paid-in capital | 924,180 | 597,318 | |||||||||
Accumulated other comprehensive loss | — | (28 | ) | ||||||||
Accumulated deficit | (696,419 | ) | (461,728 | ) | |||||||
Total stockholders’ equity | 227,806 | 135,599 | |||||||||
Total liabilities and stockholders’ equity | $ | 285,044 | $ | 290,276 | |||||||
AERIE PHARMACEUTICALS, INC. | |||||||||||||||||||||
Consolidated Statements of Operations | |||||||||||||||||||||
(Unaudited) | |||||||||||||||||||||
(in thousands, except share and per share data) | |||||||||||||||||||||
THREE MONTHS ENDED |
TWELVE MONTHS ENDED |
||||||||||||||||||||
2018 | 2017 | 2018 | 2017 | ||||||||||||||||||
Product revenues, net | $ | 14,456 | $ | — | $ | 24,181 | $ | — | |||||||||||||
Total revenues, net | 14,456 | — | 24,181 | — | |||||||||||||||||
Costs and expenses: | |||||||||||||||||||||
Cost of goods sold | 377 | — | 641 | — | |||||||||||||||||
Selling, general and administrative | 31,887 | 18,471 | 120,614 | 56,905 | |||||||||||||||||
Pre-approval commercial manufacturing | 7,625 | 3,742 | 26,545 | 16,710 | |||||||||||||||||
Research and development | 26,492 | 38,101 | 86,123 | 72,078 | |||||||||||||||||
Total costs and expenses | 66,381 | 60,314 | 233,923 | 145,693 | |||||||||||||||||
Loss from operations | (51,925 | ) | (60,314 | ) | (209,742 | ) | (145,693 | ) | |||||||||||||
Other income (expense), net | 467 | (99 | ) | (22,824 | ) | (1,170 | ) | ||||||||||||||
Loss before income taxes | (51,458 | ) | (60,413 | ) | (232,566 | ) | (146,863 | ) | |||||||||||||
Income tax expense (benefit) | — | (1,900 | ) | 3 | (1,758 | ) | |||||||||||||||
Net loss | $ | (51,458 | ) | $ | (58,513 | ) | $ | (232,569 | ) | $ | (145,105 | ) | |||||||||
Net loss per common share—basic and diluted | $ | (1.14 | ) | $ | (1.60 | ) | $ | (5.58 | ) | $ | (4.11 | ) | |||||||||
Weighted average number of common shares outstanding—basic and diluted | 45,101,458 | 36,487,669 | 41,663,958 | 35,324,472 | |||||||||||||||||
AERIE PHARMACEUTICALS, INC. | |||||||||||||||||||||
Reconciliation of GAAP to Non-GAAP Financial Measures | |||||||||||||||||||||
(Unaudited) | |||||||||||||||||||||
(in thousands) | |||||||||||||||||||||
THREE MONTHS ENDED |
TWELVE MONTHS ENDED |
||||||||||||||||||||
2018 | 2017 | 2018 | 2017 | ||||||||||||||||||
Net loss (GAAP) | $ | (51,458 | ) | $ | (58,513 | ) | $ | (232,569 | ) | $ | (145,105 | ) | |||||||||
Add-back: stock-based compensation expense | 9,713 | 8,006 | 38,728 | 26,078 | |||||||||||||||||
Adjusted Net loss | $ | (41,745 | ) | $ | (50,507 | ) | $ | (193,841 | ) | $ | (119,027 | ) | |||||||||
Selling, general and administrative expenses (GAAP) | $ | 31,887 | $ | 18,471 | $ | 120,614 | $ | 56,905 | |||||||||||||
Less: stock-based compensation expense | (6,410 | ) | (5,458 | ) | (26,432 | ) | (18,613 | ) | |||||||||||||
Adjusted selling, general and administrative expenses | $ | 25,477 | $ | 13,013 | $ | 94,182 | $ | 38,292 | |||||||||||||
Pre-approval commercial manufacturing expenses (GAAP) | $ | 7,625 | $ | 3,742 | $ | 26,545 | $ | 16,710 | |||||||||||||
Less: stock-based compensation expense | (818 | ) | (482 | ) | (2,622 | ) | (1,359 | ) | |||||||||||||
Adjusted pre-approval commercial manufacturing expenses | $ | 6,807 | $ | 3,260 | $ | 23,923 | $ | 15,351 | |||||||||||||
Research and development expenses (GAAP) | $ | 26,492 | $ | 38,101 | $ | 86,123 | $ | 72,078 | |||||||||||||
Less: stock-based compensation expense | (2,485 | ) | (2,066 | ) | (9,674 | ) | (6,106 | ) | |||||||||||||
Adjusted research and development expenses | $ | 24,007 | $ | 36,035 | $ | 76,449 | $ | 65,972 | |||||||||||||
Total operating expenses (GAAP) | $ | 66,004 | $ | 60,314 | $ | 233,282 | $ | 145,693 | |||||||||||||
Less: stock-based compensation expense | (9,713 | ) | (8,006 | ) | (38,728 | ) | (26,078 | ) | |||||||||||||
Adjusted total operating expenses | $ | 56,291 | $ | 52,308 | $ | 194,554 | $ | 119,615 | |||||||||||||
AERIE PHARMACEUTICALS, INC. | |||||||||||||||||||||
Reconciliation of GAAP Net Loss Per Share to Adjusted Net Loss Per Share | |||||||||||||||||||||
(Unaudited) | |||||||||||||||||||||
THREE MONTHS ENDED |
TWELVE MONTHS ENDED |
||||||||||||||||||||
2018 | 2017 | 2018 | 2017 | ||||||||||||||||||
Net loss per common share—basic and diluted (GAAP) | $ | (1.14 | ) | $ | (1.60 | ) | $ | (5.58 | ) | $ | (4.11 | ) | |||||||||
Add-back: stock-based compensation expense | 0.22 | 0.22 | 0.93 | 0.74 | |||||||||||||||||
Adjusted Net loss per share—basic and diluted | $ | (0.92 | ) | $ | (1.38 | ) | $ | (4.65 | ) | $ | (3.37 | ) | |||||||||
Weighted average number of common shares outstanding—basic and diluted | 45,101,458 | 36,487,669 | 41,663,958 | 35,324,472 | |||||||||||||||||
View source version on businesswire.com: https://www.businesswire.com/news/home/20190225005907/en/
Source:
Aerie Pharmaceuticals
Media: Tad
Heitmann 949-526-8747; theitmann@aeriepharma.com
Investors:
Ami Bavishi 908-947-3949; abavishi@aeriepharma.com