Aerie Pharmaceuticals Reports Second Quarter 2020 Financial Results and Provides Business Update
08/06/2020
Year-to-Date Net Revenues of
Positive Phase 2 Topline Results for AR-1105 Implant Indicate up to Six-Month Sustained Release
AR-15512 Trial for Dry Eye, COMET-1, Set to Initiate this Year
Conference Call and Webcast Today,
“Our second quarter results highlight the continued demand for both products in our glaucoma franchise, Rhopressa® (netarsudil ophthalmic solution) 0.02% and Rocklatan® (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005%. We are pleased to see that our second quarter volumes slightly exceeded those of first quarter, benefiting from the high levels of coverage we have gained, particularly in Medicare Part D. Strategically, this increase in coverage is an important step, considering the number of retiree lives now with formulary access. We continue to believe our glaucoma franchise is poised for meaningful volume growth as eye care professionals increase the number of patient visits,” said
-
Rhopressa® and Rocklatan® generated second quarter 2020 net revenues of
$18.0 million , compared to$15.8 million in the second quarter of 2019, equivalent to an average of$78 per bottle, reflecting higher Medicare Part D formulary access. Wholesaler shipments totaled 232,000 bottles during the second quarter of 2020, which were slightly higher than the first quarter of 2020. Revenues for the six months endedJune 30, 2020 totaled$38.4 million , compared to$26.7 million for the six months endedJune 30, 2019 , equivalent to an average of$83 per bottle.
-
Rhopressa® currently has market access for 89 percent of lives covered under Medicare Part D plans and commercial coverage for 90 percent of lives. Rocklatan® has market access for 55 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. Commercial coverage for Rocklatan® is at 89 percent of covered lives. Medicare Part D coverage increased substantially from first quarter 2020, which ended with 75 percent and 36 percent coverage for Medicare Part D lives for Rhopressa® and Rocklatan®, respectively.
-
Aerie has filed a Prior Approval Supplement with the
U.S. Food and Drug Administration (FDA) to obtain FDA approval to manufacture Rhopressa® in Aerie’s manufacturing plant in Athlone,Ireland for commercial distribution in the U.S. market. Aerie received approval from the FDA earlier this year to produce Rocklatan® and began production of commercial supplies of Rocklatan® in the first quarter of 2020.
Pipeline and International Highlights
- Dry eye product candidate AR-15512 continues to advance after recent discussions with the FDA. Aerie plans to initiate its Phase 2b clinical trial, named COMET-1, which will be powered as a Phase 3 clinical trial, in the fourth quarter of 2020 after the completion of remaining preclinical activities.
- Aerie recently completed a Phase 2 clinical trial for AR-1105 (dexamethasone steroid implant) for macular edema due to RVO (retinal vein occlusion), which indicates up to six months sustained release.
- The first-in-human clinical trial for AR-13503 (Rho kinase and Protein kinase C inhibitor implant) commenced in the third quarter of 2019 for neovascular age-related macular degeneration and DME (diabetic macular edema) and Aerie currently expects a topline readout in the second half of 2021.
-
Aerie continues to prepare for a Phase 3 clinical trial for Rhopressa® in
Japan following Aerie’s meeting with theJapanese Pharmaceuticals andMedical Devices Agency (PMDA) inApril 2020 to discuss Phase 3 trial designs. Aerie expects to initiate a Rhopressa® Phase 3 clinical trial inJapan in the fourth quarter of 2020, along with continuing to explore a collaboration with a potential partner inJapan to advance Aerie’s clinical development and ultimately commercialize Rhopressa® and Rocklatan® inJapan .
-
Aerie expects an opinion from the European Medicines Agency’s (EMA)
Committee for Medicinal Products for Human Use on the marketing authorisation application (MAA) for Roclanda® (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% (marketed as Rocklatan® inthe United States ) in the fourth quarter of 2020.The European Commission granted a centralised marketing authorisation for Rhokiinsa®(netarsudil ophthalmic solution) 0.02% inNovember 2019 .
-
Topline data from the Rocklatan® Mercury 3 Phase 3 clinical trial in
Europe is expected later in the third quarter of 2020, the results of which will help determine commercial prospects in the region.
Net cash used in operating activities for the quarter ended
Second 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. 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 current 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, 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) |
||||||||
|
|
|
|
|
||||
Assets |
|
|
|
|
||||
Current assets |
|
|
|
|
||||
Cash and cash equivalents |
|
$ |
151,299 |
|
|
$ |
143,940 |
|
Short-term investments |
|
90,619 |
|
|
165,250 |
|
||
Accounts receivable, net |
|
43,078 |
|
|
38,354 |
|
||
Inventory |
|
19,092 |
|
|
21,054 |
|
||
Prepaid expenses and other current assets |
|
8,991 |
|
|
7,744 |
|
||
Total current assets |
|
313,079 |
|
|
376,342 |
|
||
Property, plant and equipment, net |
|
56,177 |
|
|
58,147 |
|
||
Operating lease right-of-use assets |
|
14,906 |
|
|
16,523 |
|
||
Other assets |
|
1,093 |
|
|
1,596 |
|
||
Total assets |
|
$ |
385,255 |
|
|
$ |
452,608 |
|
|
|
|
|
|
||||
Liabilities and Stockholders’ Equity |
|
|
|
|
||||
Current liabilities |
|
|
|
|
||||
Accounts payable |
|
$ |
6,661 |
|
|
$ |
12,770 |
|
Accrued expenses and other current liabilities |
|
71,886 |
|
|
65,376 |
|
||
Operating lease liabilities |
|
5,314 |
|
|
5,502 |
|
||
Total current liabilities |
|
83,861 |
|
|
83,648 |
|
||
Convertible notes, net |
|
199,157 |
|
|
188,651 |
|
||
Long-term operating lease liabilities |
|
10,501 |
|
|
12,102 |
|
||
Other non-current liabilities |
|
1,924 |
|
|
1,257 |
|
||
Total liabilities |
|
295,443 |
|
|
285,658 |
|
||
Stockholders’ equity |
|
|
|
|
||||
Common stock |
|
47 |
|
|
46 |
|
||
Additional paid-in capital |
|
1,082,964 |
|
|
1,062,996 |
|
||
Accumulated other comprehensive income (loss) |
|
117 |
|
|
(92) |
|
||
Accumulated deficit |
|
(993,316) |
|
|
(896,000) |
|
||
Total stockholders’ equity |
|
89,812 |
|
|
166,950 |
|
||
Total liabilities and stockholders’ equity |
|
$ |
385,255 |
|
|
$ |
452,608 |
|
Consolidated Statements of Operations (Unaudited) (in thousands, except share and per share data) |
|||||||||||||||
|
THREE MONTHS ENDED
|
|
SIX MONTHS ENDED
|
||||||||||||
|
2020 |
|
2019 |
|
2020 |
|
2019 |
||||||||
Product revenues, net |
$ |
18,033 |
|
|
$ |
15,835 |
|
|
$ |
38,374 |
|
|
$ |
26,687 |
|
Total revenues, net |
18,033 |
|
|
15,835 |
|
|
38,374 |
|
|
26,687 |
|
||||
Costs and expenses: |
|
|
|
|
|
|
|
||||||||
Cost of goods sold |
7,326 |
|
|
705 |
|
|
13,418 |
|
|
1,086 |
|
||||
Selling, general and administrative |
33,237 |
|
|
34,482 |
|
|
70,139 |
|
|
70,764 |
|
||||
Pre-approval commercial manufacturing |
80 |
|
|
5,819 |
|
|
2,194 |
|
|
10,276 |
|
||||
Research and development |
19,943 |
|
|
20,904 |
|
|
39,116 |
|
|
38,788 |
|
||||
Total costs and expenses |
60,586 |
|
|
61,910 |
|
|
124,867 |
|
|
120,914 |
|
||||
Loss from operations |
(42,553) |
|
|
(46,075) |
|
|
(86,493) |
|
|
(94,227) |
|
||||
Other (expense) income, net |
(5,634) |
|
|
(1,089) |
|
|
(10,856) |
|
|
(978) |
|
||||
Loss before income taxes |
(48,187) |
|
|
(47,164) |
|
|
(97,349) |
|
|
(95,205) |
|
||||
Income tax benefit |
— |
|
|
— |
|
|
(33) |
|
|
(90) |
|
||||
Net loss |
$ |
(48,187) |
|
|
$ |
(47,164) |
|
|
$ |
(97,316) |
|
|
$ |
(95,115) |
|
Net loss per common share—basic and diluted |
$ |
(1.05) |
|
|
$ |
(1.04) |
|
|
$ |
(2.12) |
|
|
$ |
(2.10) |
|
Weighted average number of common shares
|
45,876,106 |
|
|
45,397,024 |
|
|
45,834,305 |
|
|
45,334,191 |
|
Reconciliation of GAAP to Non-GAAP Financial Measures (Unaudited) (in thousands) |
||||||||||||||||
|
|
THREE MONTHS ENDED
|
|
SIX MONTHS ENDED
|
||||||||||||
|
|
2020 |
|
2019 |
|
2020 |
|
2019 |
||||||||
Net loss (GAAP) |
|
$ |
(48,187) |
|
|
$ |
(47,164) |
|
|
$ |
(97,316) |
|
|
$ |
(95,115) |
|
Add-back: stock-based compensation expense |
|
10,176 |
|
|
10,695 |
|
|
20,705 |
|
|
23,315 |
|
||||
Adjusted Net loss |
|
$ |
(38,011) |
|
|
$ |
(36,469) |
|
|
$ |
(76,611) |
|
|
$ |
(71,800) |
|
|
|
|
|
|
|
|
|
|
||||||||
Cost of goods sold (GAAP) |
|
$ |
7,326 |
|
|
$ |
705 |
|
|
$ |
13,418 |
|
|
$ |
1,086 |
|
Less: stock-based compensation expense |
|
(670) |
|
|
— |
|
|
(1,167) |
|
|
— |
|
||||
Adjusted cost of goods sold |
|
$ |
6,656 |
|
|
$ |
705 |
|
|
$ |
12,251 |
|
|
$ |
1,086 |
|
|
|
|
|
|
|
|
|
|
||||||||
Selling, general and administrative expenses (GAAP) |
|
$ |
33,237 |
|
|
$ |
34,482 |
|
|
$ |
70,139 |
|
|
$ |
70,764 |
|
Less: stock-based compensation expense |
|
(6,900) |
|
|
(7,091) |
|
|
(13,808) |
|
|
(16,212) |
|
||||
Adjusted selling, general and administrative expenses |
|
$ |
26,337 |
|
|
$ |
27,391 |
|
|
$ |
56,331 |
|
|
$ |
54,552 |
|
|
|
|
|
|
|
|
|
|
||||||||
Pre-approval commercial manufacturing expenses (GAAP) |
|
$ |
80 |
|
|
$ |
5,819 |
|
|
$ |
2,194 |
|
|
$ |
10,276 |
|
Less: stock-based compensation expense |
|
(22) |
|
|
(834) |
|
|
(316) |
|
|
(1,683) |
|
||||
Adjusted pre-approval commercial manufacturing expenses |
|
$ |
58 |
|
|
$ |
4,985 |
|
|
$ |
1,878 |
|
|
$ |
8,593 |
|
|
|
|
|
|
|
|
|
|
||||||||
Research and development expenses (GAAP) |
|
$ |
19,943 |
|
|
$ |
20,904 |
|
|
$ |
39,116 |
|
|
$ |
38,788 |
|
Less: stock-based compensation expense |
|
(2,584) |
|
|
(2,770) |
|
|
(5,414) |
|
|
(5,420) |
|
||||
Adjusted research and development expenses |
|
$ |
17,359 |
|
|
$ |
18,134 |
|
|
$ |
33,702 |
|
|
$ |
33,368 |
|
|
|
|
|
|
|
|
|
|
||||||||
Total operating expenses (GAAP) |
|
$ |
53,260 |
|
|
$ |
61,205 |
|
|
$ |
111,449 |
|
|
$ |
119,828 |
|
Less: stock-based compensation expense |
|
(9,506) |
|
|
(10,695) |
|
|
(19,538) |
|
|
(23,315) |
|
||||
Adjusted total operating expenses |
|
$ |
43,754 |
|
|
$ |
50,510 |
|
|
$ |
91,911 |
|
|
$ |
96,513 |
|
Reconciliation of GAAP Net Loss Per Share to Adjusted Net Loss Per Share (Unaudited) |
||||||||||||||||
|
|
THREE MONTHS ENDED
|
|
SIX MONTHS ENDED
|
||||||||||||
|
|
2020 |
|
2019 |
|
2020 |
|
2019 |
||||||||
Net loss per common share—basic and diluted (GAAP) |
|
$ |
(1.05) |
|
|
$ |
(1.04) |
|
|
$ |
(2.12) |
|
|
$ |
(2.10) |
|
Add-back: stock-based compensation expense |
|
0.22 |
|
|
0.24 |
|
|
0.45 |
|
|
0.51 |
|
||||
Adjusted Net loss per share—basic and diluted |
|
$ |
(0.83) |
|
|
$ |
(0.80) |
|
|
$ |
(1.67) |
|
|
$ |
(1.59) |
|
Weighted average number of common shares outstanding—basic and diluted |
|
45,876,106 |
|
|
45,397,024 |
|
|
45,834,305 |
|
|
45,334,191 |
|
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