Aerie Pharmaceuticals Reports Second Quarter 2019 Financial Results, Updates Full-Year 2019 Guidance and Provides Business Update
08/07/2019
Conference Call and Webcast Today,
Aerie Second Quarter Highlights
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The Aerie glaucoma franchise, including Rhopressa® (netarsudil ophthalmic solution) 0.02% and Rocklatan® (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005%, generated second quarter 2019 net revenues on a U.S. GAAP (generally accepted accounting principles) basis of
$15.8 million , equivalent to an average of$94 per bottle. June year-to-date net revenues totaled$26.7 million , equivalent to an average of$96 per bottle. Second quarter 2019 net revenues increased over first quarter 2019 by 46%.
-
Rhopressa® has market access for the majority of lives covered under commercial and
Medicare Part D plans, and Rocklatan® is in the process of generating meaningful coverage gains over the next several months for both commercial andMedicare Part D market access, with the expectation that Rocklatan® will have the majority of lives covered under commercial andMedicare Part D lives by the end of 2019.
-
Net cash burn for the six months ended
June 30, 2019 was approximately$92 million , and cash and cash equivalents were$109.4 million as ofJune 30, 2019 . In addition, with the$200 million in undrawn credit facility capacity available, total liquidity was approximately$309 million atJune 30, 2019 .
-
International clinical development and expansion activities are progressing. Enrollment for the Rhopressa® Phase 2 clinical trial in
Japan is now complete ahead of schedule, and the Rocklatan® Mercury 3 Phase 3 clinical trial inEurope , designed to support commercialization in that region, continues to progress.
-
Aerie’s retina program continues to advance with the AR-1105 (dexamethasone steroid implant) Phase 2 clinical trial having commenced in
March 2019 for macular edema due to RVO (retinal vein occlusion) and the clinical trial for AR-13503 (Rho kinase and Protein kinase C inhibitor implant) set to commence shortly for wet age-related macular degeneration and DME (diabetic macular edema).
Aerie 2019 Guidance Update
-
Based on the U.S. launch trajectory experience year-to-date in 2019, full-year 2019 net revenue guidance has been adjusted to a range of
$70 million to $80 million from the previously reported range of$110 million to $120 million .
-
Net cash burn guidance for full-year 2019 is now at
$160 million to $170 million , compared to the previous guidance of$130 million to $140 million as a result of the updated net revenue guidance.
“The long-term potential of our glaucoma franchise is unchanged, though in the short-term the timing of our expected 2019 uptick in volumes is behind what we originally expected. We are delighted with the initial physician feedback on Rocklatan®’s performance and we fully expect that we will gain Rocklatan® market access during 2019, particularly for
Dr. Anido continued, “We continue to make excellent progress with our expansion efforts in
Second Quarter 2019Financial 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 9487267. 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 9487267. 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 eye drop 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 in this release 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®, including the timing, cost or other aspects of the commercial launch of Rhopressa® and Rocklatan®; 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® and Rocklatan®, 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 pre-approval commercial manufacturing, 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, 2019 |
|
DECEMBER 31, 2018 |
||||||
Assets |
|
|
|
|
||||||
Current assets |
|
|
|
|
||||||
Cash and cash equivalents |
|
$ |
109,363 |
|
|
$ |
202,818 |
|
||
Accounts receivable, net |
|
25,650 |
|
|
2,715 |
|
||||
Inventory |
|
10,419 |
|
|
10,112 |
|
||||
Prepaid expenses and other current assets |
|
8,678 |
|
|
4,530 |
|
||||
Total current assets |
|
154,110 |
|
|
220,175 |
|
||||
Property, plant and equipment, net |
|
58,595 |
|
|
60,525 |
|
||||
Operating lease right-of-use assets |
|
17,882 |
|
|
— |
|
||||
Other assets |
|
3,554 |
|
|
4,344 |
|
||||
Total assets |
|
$ |
234,141 |
|
|
$ |
285,044 |
|
||
|
|
|
|
|
||||||
Liabilities and Stockholders’ Equity |
|
|
|
|
||||||
Current liabilities |
|
|
|
|
||||||
Accounts payable |
|
$ |
9,098 |
|
|
$ |
12,403 |
|
||
Accrued expenses and other current liabilities |
|
46,523 |
|
|
38,381 |
|
||||
Operating lease liabilities |
|
5,494 |
|
|
— |
|
||||
Total current liabilities |
|
61,115 |
|
|
50,784 |
|
||||
Long-term operating lease liabilities |
|
13,238 |
|
|
— |
|
||||
Other non-current liabilities |
|
4,030 |
|
|
6,454 |
|
||||
Total liabilities |
|
78,383 |
|
|
57,238 |
|
||||
Stockholders' equity |
|
|
|
|
||||||
Common stock |
|
46 |
|
|
45 |
|
||||
Additional paid-in capital |
|
947,246 |
|
|
924,180 |
|
||||
Accumulated deficit |
|
(791,534 |
) |
|
(696,419 |
) |
||||
Total stockholders’ equity |
|
155,758 |
|
|
227,806 |
|
||||
Total liabilities and stockholders’ equity |
|
$ |
234,141 |
|
|
$ |
285,044 |
|
AERIE PHARMACEUTICALS, INC. Consolidated Statements of Operations (Unaudited) (in thousands, except share and per share data) |
||||||||||||||||||
|
THREE MONTHS ENDED JUNE 30, |
|
SIX MONTHS ENDED JUNE 30, |
|||||||||||||||
|
2019 |
|
2018 |
|
2019 |
|
2018 |
|||||||||||
Product revenues, net |
$ |
15,835 |
|
|
$ |
2,423 |
|
|
$ |
26,687 |
|
|
$ |
2,423 |
|
|||
Total revenues, net |
15,835 |
|
|
2,423 |
|
|
26,687 |
|
|
2,423 |
|
|||||||
Costs and expenses: |
|
|
|
|
|
|
|
|||||||||||
Cost of goods sold |
705 |
|
|
59 |
|
|
1,086 |
|
|
59 |
|
|||||||
Selling, general and administrative |
34,482 |
|
|
33,112 |
|
|
70,764 |
|
|
56,042 |
|
|||||||
Pre-approval commercial manufacturing |
5,819 |
|
|
6,779 |
|
|
10,276 |
|
|
11,672 |
|
|||||||
Research and development |
20,904 |
|
|
18,157 |
|
|
38,788 |
|
|
31,129 |
|
|||||||
Total costs and expenses |
61,910 |
|
|
58,107 |
|
|
120,914 |
|
|
98,902 |
|
|||||||
Loss from operations |
(46,075 |
) |
|
(55,684 |
) |
|
(94,227 |
) |
|
(96,479 |
) |
|||||||
Other (expense) income, net |
(1,089 |
) |
|
663 |
|
|
(978 |
) |
|
759 |
|
|||||||
Loss before income taxes |
(47,164 |
) |
|
(55,021 |
) |
|
(95,205 |
) |
|
(95,720 |
) |
|||||||
Income tax expense (benefit) |
— |
|
|
3 |
|
|
(90 |
) |
|
3 |
|
|||||||
Net loss |
$ |
(47,164 |
) |
|
$ |
(55,024 |
) |
|
$ |
(95,115 |
) |
|
$ |
(95,723 |
) |
|||
Net loss per common share—basic and diluted |
$ |
(1.04 |
) |
|
$ |
(1.40 |
) |
|
$ |
(2.10 |
) |
|
$ |
(2.46 |
) |
|||
Weighted average number of common shares outstanding—basic and diluted |
45,397,024 |
|
|
39,204,762 |
|
|
45,334,191 |
|
|
38,903,469 |
|
AERIE PHARMACEUTICALS, INC. Reconciliation of GAAP to Non-GAAP Financial Measures (Unaudited) (in thousands) |
||||||||||||||||||
|
|
THREE MONTHS ENDED JUNE 30, |
|
SIX MONTHS ENDED JUNE 30, |
||||||||||||||
|
|
|
|
2019 |
|
2018 |
|
2019 |
|
2018 |
||||||||
Net loss (GAAP) |
|
$ |
(47,164 |
) |
|
$ |
(55,024 |
) |
|
$ |
(95,115 |
) |
|
$ |
(95,723 |
) |
||
Add-back: stock-based compensation expense |
|
10,695 |
|
|
10,318 |
|
|
23,315 |
|
|
19,037 |
|
||||||
Adjusted Net loss |
|
$ |
(36,469 |
) |
|
$ |
(44,706 |
) |
|
$ |
(71,800 |
) |
|
$ |
(76,686 |
) |
||
|
|
|
|
|
|
|
|
|
||||||||||
Selling, general and administrative expenses (GAAP) |
|
$ |
34,482 |
|
|
$ |
33,112 |
|
|
$ |
70,764 |
|
|
$ |
56,042 |
|
||
Less: stock-based compensation expense |
|
(7,091 |
) |
|
(7,126 |
) |
|
(16,212 |
) |
|
(13,340 |
) |
||||||
Adjusted selling, general and administrative expenses |
|
$ |
27,391 |
|
|
$ |
25,986 |
|
|
$ |
54,552 |
|
|
$ |
42,702 |
|
||
|
|
|
|
|
|
|
|
|
||||||||||
Pre-approval commercial manufacturing expenses (GAAP) |
|
$ |
5,819 |
|
|
$ |
6,779 |
|
|
$ |
10,276 |
|
|
$ |
11,672 |
|
||
Less: stock-based compensation expense |
|
(834 |
) |
|
(634 |
) |
|
(1,683 |
) |
|
(1,104 |
) |
||||||
Adjusted pre-approval commercial manufacturing expenses |
|
$ |
4,985 |
|
|
$ |
6,145 |
|
|
$ |
8,593 |
|
|
$ |
10,568 |
|
||
|
|
|
|
|
|
|
|
|
||||||||||
Research and development expenses (GAAP) |
|
$ |
20,904 |
|
|
$ |
18,157 |
|
|
$ |
38,788 |
|
|
$ |
31,129 |
|
||
Less: stock-based compensation expense |
|
(2,770 |
) |
|
(2,558 |
) |
|
(5,420 |
) |
|
(4,593 |
) |
||||||
Adjusted research and development expenses |
|
$ |
18,134 |
|
|
$ |
15,599 |
|
|
$ |
33,368 |
|
|
$ |
26,536 |
|
||
|
|
|
|
|
|
|
|
|
||||||||||
Total operating expenses (GAAP) |
|
$ |
61,205 |
|
|
$ |
58,048 |
|
|
$ |
119,828 |
|
|
$ |
98,843 |
|
||
Less: stock-based compensation expense |
|
(10,695 |
) |
|
(10,318 |
) |
|
(23,315 |
) |
|
(19,037 |
) |
||||||
Adjusted total operating expenses |
|
$ |
50,510 |
|
|
$ |
47,730 |
|
|
$ |
96,513 |
|
|
$ |
79,806 |
|
AERIE PHARMACEUTICALS, INC. Reconciliation of GAAP Net Loss Per Share to Adjusted Net Loss Per Share (Unaudited) |
||||||||||||||||
|
|
THREE MONTHS ENDED JUNE 30, |
|
SIX MONTHS ENDED JUNE 30, |
||||||||||||
|
|
2019 |
|
2018 |
|
2019 |
|
2018 |
||||||||
Net loss per common share—basic and diluted (GAAP) |
|
$ |
(1.04 |
) |
|
$ |
(1.40 |
) |
|
$ |
(2.10 |
) |
|
$ |
(2.46 |
) |
Add-back: stock-based compensation expense |
|
0.24 |
|
|
0.26 |
|
|
0.51 |
|
|
0.49 |
|
||||
Adjusted Net loss per share—basic and diluted |
|
$ |
(0.80 |
) |
|
$ |
(1.14 |
) |
|
$ |
(1.59 |
) |
|
$ |
(1.97 |
) |
Weighted average number of common shares outstanding—basic and diluted |
|
45,397,024 |
|
|
39,204,762 |
|
|
45,334,191 |
|
|
38,903,469 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20190807005455/en/
Source:
Aerie Pharmaceuticals
Media: Tad Heitmann 949-526-8747; theitmann@aeriepharma.com
Investors: Ami Bavishi 908-947-3949; abavishi@aeriepharma.com