Aerie Pharmaceuticals Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update
02/25/2021
2020 Net Revenues of
Fourth Quarter Net Revenues of
New Sustained Release Pan-VEGF Inhibitor Pipeline Candidate Announced Today
Conference Call and Webcast Today,
“Our fourth quarter 2020 net revenues of
-
Rhopressa® and Rocklatan® generated fourth quarter 2020 net revenues of
$24.7 million , equivalent to an average of$80 per bottle. Shipments to wholesalers totaled 307,000 during the fourth quarter of 2020, 18% higher than the 261,000 bottles in the third quarter of 2020. Net revenues for the year endedDecember 31, 2020 totaled$83.1 million , compared to$69.9 million for the year endedDecember 31, 2019 , reflecting a 19% increase. -
Rhopressa® currently has commercial coverage for 90 percent of lives and market access for 89 percent of lives covered under Medicare Part D plans. Commercial coverage for Rocklatan® represents 89 percent of covered lives. Rocklatan® has market access for 56 percent of Medicare Part D lives and an additional 15 percent of remaining Medicare Part D lives with affordable access through
U.S. government funded Low Income Subsidy programs through which co-pays are less than$10 per month.
Pipeline and International Highlights
- A new wet age-related macular degeneration (wAMD) / diabetic macular edema (DME) preclinical implant has been added to Aerie’s pipeline. AR-14034 represents a sustained-release implant of axitinib (VEGF A/B/C/D inhibitor) produced with a unique bio-erodible polymer blend using PRINT® technology that may potentially necessitate only one injection to treat a wAMD or DME patient for up to 12 months (refer to the slide presentation posted today in the Events and Presentations page of www.aeriepharma.com).
-
Aerie continues to expect topline results of COMET-1, Aerie’s Phase 2b clinical trial for its dry eye product candidate, AR-15512, in the third quarter of 2021. COMET-1, which was initiated in
October 2020 , is powered as a Phase 3 trial. -
Aerie was granted a centralised marketing authorisation in
Europe for Roclanda® (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% (marketed as Rocklatan® inthe United States ) inJanuary 2021 . Aerie continues to prepare for pricing discussions inGermany while evaluating potential collaboration opportunities forEurope . -
Aerie and
Santen announced inOctober 2020 that they executed an exclusive license agreement for the development and commercialization of Rhopressa® and Rocklatan® inJapan and several other Asian countries, and the first Phase 3 clinical trial for Rhopressa® inJapan is underway. The agreement included an upfront payment to Aerie of$50.0 million , with net cash proceeds after withholding taxes of$45.0 million received in the fourth quarter of 2020. -
Aerie continues to evaluate the clinical and regulatory pathways for Phase 3 clinical trials for AR-1105 (dexamethasone steroid implant) in both the
U.S. and European markets. This follows the positive Phase 2 results for macular edema due to retinal vein occlusion reported inJuly 2020 , which indicated up to six months of sustained release.
Net cash used in operating activities for the year ended
Fourth Quarter 2020 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 Aerie’s website at http://investors.aeriepharma.com. In addition, AR-14034 slides will be discussed on the conference call and are posted to Aerie's website. Please connect to Aerie’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 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, ocular surface diseases and retinal diseases. 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: the duration and severity of the coronavirus disease (COVID-19) outbreak, including the impact on our clinical and commercial operations, demand for our products and financial results and condition of our global supply chains; our expectations regarding the commercialization and manufacturing of Rhopressa®, Rocklatan®, Rhokiinsa® and Roclanda® or any product candidates or future product candidates, including the timing, cost or other aspects of their commercial launch; our commercialization, marketing, manufacturing and supply management capabilities and strategies in and outside of
Non-GAAP Financial Measures
To supplement our financial statements, which are prepared and presented in accordance with GAAP (generally accepted accounting principles), we use the following non-GAAP financial measures, some of which are discussed above: adjusted net loss, adjusted cost of goods sold, adjusted selling, general and administrative expenses, adjusted pre-approval commercial manufacturing expenses, adjusted research and development expenses, adjusted total operating 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.
Consolidated Balance Sheets (Unaudited) (in thousands) |
|||||||
|
|
||||||
|
2020 |
|
2019 |
||||
Assets |
|
|
|
||||
Current assets |
|
|
|
||||
Cash and cash equivalents |
$ |
151,570 |
|
|
$ |
143,940 |
|
Short-term investments |
88,794 |
|
|
165,250 |
|
||
Accounts receivable, net |
56,022 |
|
|
38,354 |
|
||
Inventory |
27,059 |
|
|
21,054 |
|
||
Prepaid expenses and other current assets |
8,310 |
|
|
7,744 |
|
||
Total current assets |
331,755 |
|
|
376,342 |
|
||
Property, plant and equipment, net |
54,260 |
|
|
58,147 |
|
||
Operating lease right-of-use-assets |
14,084 |
|
|
16,523 |
|
||
Other assets |
1,946 |
|
|
1,596 |
|
||
Total assets |
$ |
402,045 |
|
|
$ |
452,608 |
|
Liabilities and Stockholders’ Equity |
|
|
|
||||
Current liabilities |
|
|
|
||||
Accounts payable |
$ |
8,826 |
|
|
$ |
12,770 |
|
Accrued expenses and other current liabilities |
90,723 |
|
|
65,376 |
|
||
Operating lease liabilities |
4,923 |
|
|
5,502 |
|
||
Total current liabilities |
104,472 |
|
|
83,648 |
|
||
Convertible notes, net |
210,373 |
|
|
188,651 |
|
||
Deferred revenue, non-current |
50,858 |
|
|
— |
|
||
Long-term operating lease liabilities |
10,206 |
|
|
12,102 |
|
||
Other non-current liabilities |
2,168 |
|
|
1,257 |
|
||
Total liabilities |
378,077 |
|
|
285,658 |
|
||
Stockholders’ equity |
|
|
|
||||
Common stock |
47 |
|
|
46 |
|
||
Additional paid-in capital |
1,103,074 |
|
|
1,062,996 |
|
||
Accumulated other comprehensive loss |
(52) |
|
|
(92) |
|
||
Accumulated deficit |
(1,079,101) |
|
|
(896,000) |
|
||
Total stockholders’ equity |
23,968 |
|
|
166,950 |
|
||
Total liabilities and stockholders’ equity |
$ |
402,045 |
|
|
$ |
452,608 |
|
Consolidated Statements of Operations (Unaudited) (in thousands, except share and per share data) |
|||||||||||||||
|
THREE MONTHS ENDED
|
|
TWELVE MONTHS ENDED
|
||||||||||||
|
2020 |
|
2019 |
|
2020 |
|
2019 |
||||||||
Product revenues, net |
$ |
24,683 |
|
|
$ |
24,657 |
|
|
$ |
83,138 |
|
|
$ |
69,888 |
|
Total revenues, net |
24,683 |
|
|
24,657 |
|
|
83,138 |
|
|
69,888 |
|
||||
Costs and expenses: |
|
|
|
|
|
|
|
||||||||
Cost of goods sold |
6,534 |
|
|
1,684 |
|
|
25,333 |
|
|
4,833 |
|
||||
Selling, general and administrative |
35,016 |
|
|
35,467 |
|
|
137,184 |
|
|
138,402 |
|
||||
Pre-approval commercial manufacturing |
— |
|
|
6,650 |
|
|
2,304 |
|
|
22,767 |
|
||||
Research and development |
18,726 |
|
|
30,794 |
|
|
74,007 |
|
|
91,378 |
|
||||
Total costs and expenses |
60,276 |
|
|
74,595 |
|
|
238,828 |
|
|
257,380 |
|
||||
Loss from operations |
(35,593) |
|
|
(49,938) |
|
|
(155,690) |
|
|
(187,492) |
|
||||
Other (expense) income, net |
(5,266) |
|
|
(5,126) |
|
|
(22,166) |
|
|
(12,179) |
|
||||
Loss before income taxes |
(40,859) |
|
|
(55,064) |
|
|
(177,856) |
|
|
(199,671) |
|
||||
Income tax expense (benefit) |
5,278 |
|
|
— |
|
|
5,245 |
|
|
(90) |
|
||||
Net loss |
$ |
(46,137) |
|
|
$ |
(55,064) |
|
|
$ |
(183,101) |
|
|
$ |
(199,581) |
|
Net loss per common share—basic and diluted |
$ |
(1.00) |
|
|
$ |
(1.21) |
|
|
$ |
(3.99) |
|
|
$ |
(4.39) |
|
Weighted average number of common shares outstanding—basic and diluted |
45,973,297 |
|
|
45,589,014 |
|
|
45,897,255 |
|
|
45,427,154 |
|
Reconciliation of GAAP to Non-GAAP Financial Measures (Unaudited) (in thousands) |
|||||||||||||||
|
THREE MONTHS ENDED
|
|
TWELVE MONTHS ENDED
|
||||||||||||
|
2020 |
|
2019 |
|
2020 |
|
2019 |
||||||||
Net loss (GAAP) |
$ |
(46,137) |
|
|
$ |
(55,064) |
|
|
$ |
(183,101) |
|
|
$ |
(199,581) |
|
Add-back: stock-based compensation expense |
9,590 |
|
|
11,172 |
|
|
40,095 |
|
|
45,093 |
|
||||
Adjusted Net loss |
$ |
(36,547) |
|
|
$ |
(43,892) |
|
|
$ |
(143,006) |
|
|
$ |
(154,488) |
|
|
|
|
|
|
|
|
|
||||||||
Cost of goods sold (GAAP) |
$ |
6,534 |
|
|
$ |
1,684 |
|
|
$ |
25,333 |
|
|
$ |
4,833 |
|
Less: stock-based compensation expense |
$ |
(675) |
|
|
$ |
— |
|
|
$ |
(2,353) |
|
|
$ |
— |
|
Adjusted cost of goods sold |
$ |
5,859 |
|
|
$ |
1,684 |
|
|
$ |
22,980 |
|
|
$ |
4,833 |
|
|
|
|
|
|
|
|
|
||||||||
Selling, general and administrative expenses (GAAP) |
$ |
35,016 |
|
|
$ |
35,467 |
|
|
$ |
137,184 |
|
|
$ |
138,402 |
|
Less: stock-based compensation expense |
(6,652) |
|
|
(7,210) |
|
|
(27,176) |
|
|
(30,463) |
|
||||
Adjusted selling, general and administrative expenses |
$ |
28,364 |
|
|
$ |
28,257 |
|
|
$ |
110,008 |
|
|
$ |
107,939 |
|
|
|
|
|
|
|
|
|
||||||||
Pre-approval commercial manufacturing expenses (GAAP) |
$ |
— |
|
|
$ |
6,650 |
|
|
$ |
2,304 |
|
|
$ |
22,767 |
|
Less: stock-based compensation expense |
— |
|
|
(1,144) |
|
|
(344) |
|
|
(3,634) |
|
||||
Adjusted pre-approval commercial manufacturing expenses |
$ |
— |
|
|
$ |
5,506 |
|
|
$ |
1,960 |
|
|
$ |
19,133 |
|
|
|
|
|
|
|
|
|
||||||||
Research and development expenses (GAAP) |
$ |
18,726 |
|
|
$ |
30,794 |
|
|
$ |
74,007 |
|
|
$ |
91,378 |
|
Less: stock-based compensation expense |
(2,263) |
|
|
(2,818) |
|
|
(10,222) |
|
|
(10,996) |
|
||||
Adjusted research and development expenses |
$ |
16,463 |
|
|
$ |
27,976 |
|
|
$ |
63,785 |
|
|
$ |
80,382 |
|
|
|
|
|
|
|
|
|
||||||||
Total operating expenses (GAAP) |
$ |
53,742 |
|
|
$ |
72,911 |
|
|
$ |
213,495 |
|
|
$ |
252,547 |
|
Less: stock-based compensation expense |
(8,915) |
|
|
(11,172) |
|
|
(37,742) |
|
|
(45,093) |
|
||||
Adjusted total operating expenses |
$ |
44,827 |
|
|
$ |
61,739 |
|
|
$ |
175,753 |
|
|
$ |
207,454 |
|
Reconciliation of GAAP Net Loss Per Share to Adjusted Net Loss Per Share (Unaudited) |
|||||||||||||||
|
THREE MONTHS ENDED
|
|
TWELVE MONTHS ENDED
|
||||||||||||
|
2020 |
|
2019 |
|
2020 |
|
2019 |
||||||||
Net loss per common share—basic and diluted (GAAP) |
$ |
(1.00) |
|
|
$ |
(1.21) |
|
|
$ |
(3.99) |
|
|
$ |
(4.39) |
|
Add-back: stock-based compensation expense |
0.21 |
|
|
0.25 |
|
|
0.87 |
|
|
0.99 |
|
||||
Adjusted Net loss per share—basic and diluted |
$ |
(0.79) |
|
|
$ |
(0.96) |
|
|
$ |
(3.12) |
|
|
$ |
(3.40) |
|
Weighted average number of common shares outstanding—basic and diluted |
45,973,297 |
|
|
45,589,014 |
|
|
45,897,255 |
|
|
45,427,154 |
|
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