Aerie Pharmaceuticals Reports Second Quarter 2021 Financial Results and Provides Business Update
08/04/2021
Second Quarter 2021 Net Revenues of
Second Quarter 2021 Net Revenue Per Bottle of
Phase 2b Topline Results for AR-15512 (COMET-1) Expected in the Third Quarter of 2021
Conference Call and Webcast Today,
“Our second quarter 2021 results reflect nearly 51 percent growth in net revenues and 31 percent growth in bottle volumes for our
-
Rhopressa® and Rocklatan® generated second quarter 2021 net revenues of
$27.2 million , equivalent to an average of$89 per bottle. Shipments to wholesalers totaled 306,000 bottles during the second quarter of 2021. Rhopressa® currently has market access for 92 percent of lives covered under Medicare Part D plans and commercial coverage for 77 percent of covered lives. Rocklatan® has market access for 74 percent of Medicare Part D lives and an additional 10 percent of remaining Medicare Part D lives with affordable access throughU.S. government funded Low Income Subsidy programs through which co-pays are less than$10 per month. Commercial coverage for Rocklatan® represents 75 percent of covered lives. Commercial coverage shows a decline due to unemployment remaining higher than pre-pandemic levels as well as commercial payors seeking money-saving opportunities such as moving to generic-only formulary configurations. Aerie’s commercial business accounted for 24 percent of the Company’s total revenue during the second quarter of 2021, having consistently decreased since launch.
Pipeline and Globalization Highlights
-
Aerie expects to report topline results for COMET-1, Aerie’s Phase 2b clinical trial for its dry eye product candidate, AR-15512, in the third quarter of 2021. The study, which was initiated in
October 2020 and fully enrolled inApril 2021 , is powered as a Phase 3 clinical trial.
-
The first Phase 3 clinical trial for Rhopressa® in
Japan began in the fourth quarter of 2020 and is now fully enrolled. Aerie expects the Phase 3 trial to be completed by the end of 2021 with topline results to be reported shortly thereafter.
-
Discussions with potential collaborators in
Europe and potentially beyond are ongoing and we expect to announce a new collaboration agreement by year-end 2021.
- Investigational New Drug Application (IND)-enabling preclinical studies are underway for AR-6121, a ROCK inhibitor-linked steroid. Aerie expects to file the IND application for AR-6121 in the second half of 2022.
- IND-enabling preclinical studies are ongoing for AR-14034 SR, a sustained-release implant containing the pan-VEGF inhibitor axitinib formulated in a unique bio-erodible polymer blend using Aerie’s exclusive PRINT® technology. Aerie expects to file the IND application for AR-14034 SR in the second half of 2022.
- The first-in-human clinical trial for AR-13503 SR (Rho kinase and protein kinase C inhibitor sustained-release implant), continues to progress. Aerie currently expects to complete the dose escalation safety evaluation with the current implant design in the first quarter of 2022.
Corporate Update
-
Following the resignation of
Richard J. Rubino , Chief Financial Officer at Aerie, effectiveJuly 30, 2021 , Aerie has appointedChristopher Staten , Aerie’s Vice President of Finance, as interim Chief Financial Officer. Mr. Staten’s appointment is effective fromJuly 30, 2021 and he will serve as interim Chief Financial Officer until a permanent replacement is announced.
Net cash used in operating activities for the second quarter ended
Second Quarter 2021 Financial Results
For the second quarter ended
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 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) |
||||||||||
|
|
|
|
|
||||||
Assets |
|
|
|
|
||||||
Current assets |
|
|
|
|
||||||
Cash and cash equivalents |
|
$ |
79,956 |
|
|
|
$ |
151,570 |
|
|
Short-term investments |
|
108,331 |
|
|
|
88,794 |
|
|
||
Accounts receivable, net |
|
59,151 |
|
|
|
56,022 |
|
|
||
Inventory |
|
30,704 |
|
|
|
27,059 |
|
|
||
Prepaid expenses and other current assets |
|
10,876 |
|
|
|
8,310 |
|
|
||
Total current assets |
|
289,018 |
|
|
|
331,755 |
|
|
||
Property, plant and equipment, net |
|
52,715 |
|
|
|
54,260 |
|
|
||
Operating lease right-of-use assets |
|
12,830 |
|
|
|
14,084 |
|
|
||
Other assets |
|
965 |
|
|
|
1,946 |
|
|
||
Total assets |
|
$ |
355,528 |
|
|
|
$ |
402,045 |
|
|
|
|
|
|
|
||||||
Liabilities and Stockholders’ (Deficit) Equity |
|
|
|
|
||||||
Current liabilities |
|
|
|
|
||||||
Accounts payable |
|
$ |
7,437 |
|
|
|
$ |
8,826 |
|
|
Accrued expenses and other current liabilities |
|
96,761 |
|
|
|
90,723 |
|
|
||
Operating lease liabilities |
|
3,888 |
|
|
|
4,923 |
|
|
||
Total current liabilities |
|
108,086 |
|
|
|
104,472 |
|
|
||
Convertible notes, net |
|
222,023 |
|
|
|
210,373 |
|
|
||
Deferred revenue, non-current |
|
52,829 |
|
|
|
50,858 |
|
|
||
Long-term operating lease liabilities |
|
10,031 |
|
|
|
10,206 |
|
|
||
Other non-current liabilities |
|
2,173 |
|
|
|
2,168 |
|
|
||
Total liabilities |
|
395,142 |
|
|
|
378,077 |
|
|
||
Stockholders’ (deficit) equity |
|
|
|
|
||||||
Common stock |
|
47 |
|
|
|
47 |
|
|
||
Additional paid-in capital |
|
1,120,153 |
|
|
|
1,103,074 |
|
|
||
Accumulated other comprehensive loss |
|
(61 |
) |
|
|
(52 |
) |
|
||
Accumulated deficit |
|
(1,159,753 |
) |
|
|
(1,079,101 |
) |
|
||
Total stockholders’ (deficit) equity |
|
(39,614 |
) |
|
|
23,968 |
|
|
||
Total liabilities and stockholders’ (deficit) equity |
|
$ |
355,528 |
|
|
|
$ |
402,045 |
|
|
Consolidated Statements of Operations (Unaudited) (in thousands, except share and per share data) |
|||||||||
|
THREE MONTHS ENDED |
||||||||
|
2021 |
|
|
2020 |
|
||||
Product revenues, net |
$ |
27,185 |
|
|
|
$ |
18,033 |
|
|
Total revenues, net |
27,185 |
|
|
|
18,033 |
|
|
||
Costs and expenses: |
|
|
|
||||||
Cost of goods sold |
6,177 |
|
|
|
7,326 |
|
|
||
Selling, general and administrative |
34,542 |
|
|
|
33,237 |
|
|
||
Pre-approval commercial manufacturing |
— |
|
|
|
80 |
|
|
||
Research and development |
17,967 |
|
|
|
19,943 |
|
|
||
Total costs and expenses |
58,686 |
|
|
|
60,586 |
|
|
||
Loss from operations |
(31,501 |
) |
|
|
(42,553 |
) |
|
||
Other (expense) income, net |
(7,169 |
) |
|
|
(5,634 |
) |
|
||
Loss before income taxes |
(38,670 |
) |
|
|
(48,187 |
) |
|
||
Income tax expense (benefit) |
18 |
|
|
|
— |
|
|
||
Net loss |
$ |
(38,688 |
) |
|
|
$ |
(48,187 |
) |
|
Net loss per common share—basic and diluted |
$ |
(0.84 |
) |
|
|
$ |
(1.05 |
) |
|
Weighted average number of common shares outstanding—basic and diluted |
46,197,656 |
|
|
|
45,876,106 |
|
|
Reconciliation of GAAP to Non-GAAP Financial Measures (Unaudited) (in thousands) |
||||||||||
|
|
THREE MONTHS ENDED |
||||||||
|
|
2021 |
|
|
2020 |
|
||||
Net loss (GAAP) |
|
$ |
(38,688 |
) |
|
|
$ |
(48,187 |
) |
|
Add-back: stock-based compensation expense |
|
7,996 |
|
|
|
10,176 |
|
|
||
Adjusted Net loss |
|
$ |
(30,692 |
) |
|
|
$ |
(38,011 |
) |
|
|
|
|
|
|
||||||
Cost of goods sold (GAAP) |
|
$ |
6,177 |
|
|
|
$ |
7,326 |
|
|
Less: stock-based compensation expense |
|
(431 |
) |
|
|
(670 |
) |
|
||
Adjusted cost of goods sold |
|
$ |
5,746 |
|
|
|
$ |
6,656 |
|
|
|
|
|
|
|
||||||
Selling, general and administrative expenses (GAAP) |
|
$ |
34,542 |
|
|
|
$ |
33,237 |
|
|
Less: stock-based compensation expense |
|
(5,598 |
) |
|
|
(6,900 |
) |
|
||
Adjusted selling, general and administrative expenses |
|
$ |
28,944 |
|
|
|
$ |
26,337 |
|
|
|
|
|
|
|
||||||
Pre-approval commercial manufacturing expenses (GAAP) |
|
$ |
— |
|
|
|
$ |
80 |
|
|
Less: stock-based compensation expense |
|
— |
|
|
|
(22 |
) |
|
||
Adjusted pre-approval commercial manufacturing expenses |
|
$ |
— |
|
|
|
$ |
58 |
|
|
|
|
|
|
|
||||||
Research and development expenses (GAAP) |
|
$ |
17,967 |
|
|
|
$ |
19,943 |
|
|
Less: stock-based compensation expense |
|
(1,967 |
) |
|
|
(2,584 |
) |
|
||
Adjusted research and development expenses |
|
$ |
16,000 |
|
|
|
$ |
17,359 |
|
|
|
|
|
|
|
||||||
Total operating expenses (GAAP) |
|
$ |
52,509 |
|
|
|
$ |
53,260 |
|
|
Less: stock-based compensation expense |
|
(7,565 |
) |
|
|
(9,506 |
) |
|
||
Adjusted total operating expenses |
|
$ |
44,944 |
|
|
|
$ |
43,754 |
|
|
Reconciliation of GAAP Net Loss Per Share to Adjusted Net Loss Per Share (Unaudited) |
||||||||||
|
|
THREE MONTHS ENDED |
||||||||
|
|
2021 |
|
|
2020 |
|
||||
Net loss per common share—basic and diluted (GAAP) |
|
$ |
(0.84 |
) |
|
|
$ |
(1.05 |
) |
|
Add-back: stock-based compensation expense |
|
0.17 |
|
|
|
0.22 |
|
|
||
Adjusted Net loss per share—basic and diluted |
|
$ |
(0.67 |
) |
|
|
$ |
(0.83 |
) |
|
Weighted average number of common shares outstanding—basic and diluted |
|
46,197,656 |
|
|
|
45,876,106 |
|
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20210804005757/en/
Source: