Aerie Pharmaceuticals Reports Fourth Quarter and Full Year 2019 Financial Results, Provides 2020 Guidance and Business Update
02/20/2020
Conference Call and Webcast Today,
Aerie Highlights
-
The Aerie glaucoma franchise, including Rhopressa® (netarsudil ophthalmic solution) 0.02% and Rocklatan® (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005%, generated fourth quarter 2019 net revenues on a U.S. GAAP (generally accepted accounting principles) basis of
$24.7 million , representing an average of$120 per bottle. For full-year 2019, net revenues totaling$69.9 million exceeded the upper end of previous guidance of$61 to $66 million , representing an average of$103 per bottle. Net revenue benefited from a lower than expected fourth-quarter 2019Medicare Part D coverage gap invoice. -
Rhopressa® has market access for the majority of lives covered under commercial and
Medicare Part D plans. Rocklatan® now has market access for 82 percent of commercial lives and 36 percent ofMedicare Part D lives. In addition, Rocklatan® has an additional 18 percent of market access for patients covered underMedicare Part D that are not covered on formulary but have affordable access through U.S. government funded Low Income Subsidy programs through which co-pays are less than$10 per month. -
Net cash used in operating activities for the year ended
December 31, 2019 on a U.S. GAAP basis totaled approximately$150.4 million , resulting in$309.2 million in cash and cash equivalents and investments as ofDecember 31, 2019 . - Aerie recently acquired Avizorex Pharma S.L. (Avizorex), a Spanish ophthalmic pharmaceutical company, developing therapeutics for the treatment of dry eye disease. Avizorex completed a Phase 2a study in dry eye subjects in 2019 with its lead product candidate AVX-012. Aerie plans to initiate a larger Phase 2b study in late 2020.
-
Aerie’s retina program continues to advance. The clinical trial for AR-13503 (Rho kinase and Protein kinase C inhibitor implant) commenced in the third quarter of 2019 for wet age-related macular degeneration and DME (diabetic macular edema). The AR-1105 (dexamethasone steroid implant) Phase 2 clinical trial, which commenced in
March 2019 for macular edema due to RVO (retina vein occlusion) has fully enrolled ahead of schedule inOctober 2019 with topline data expected later in 2020. -
Aerie expects to move forward with plans for Rhopressa® Phase 3 clinical trial initiation in
Japan , along with exploring a collaboration with a potential partner inJapan to advance our clinical development and ultimately commercialize Rhopressa® and Rocklatan® inJapan . -
Aerie received approval from the
U.S. Food and Drug Administration (FDA ) in January to produce Rocklatan® for commercial distribution in the U.S. market in Aerie’s Athlone,Ireland , manufacturing facility. Aerie also plans to file a Prior Approval Supplement with theFDA in the first half of 2020 to obtainFDA approval to manufacture Rhopressa® in Athlone for commercial distribution in the U.S. market. -
The European Commission granted a marketing authorisation for Rhokiinsa® (netarsudil ophthalmic solution) 0.02%.The European Medicines Agency (EMA) has accepted for review the marketing authorisation application (MAA) for Roclanda® (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005%. An opinion from the EMA’sCommittee for Medicinal Products for Human Use on the MAA for Roclanda® is expected in late 2020. Topline data from the Rocklatan® Mercury 3 Phase 3 clinical trial inEurope is expected in the second half of 2020, the results of which will help determine commercial prospects in the region.
2020 Guidance
-
Aerie currently expects full-year 2020 net revenues to be in the range of
$100 to $110 million on a U.S. GAAP basis for Rhopressa® and Rocklatan® combined. Aerie also currently expects full-year 2020 net cash used in operating activities to be in the range of$110 million to $120 million , on a U.S. GAAP basis, with operating expenses in full-year 2020 remaining consistent with full-year 2019.
“We are delighted to have exceeded the revenue guidance that we announced in our third quarter 2019 release. The net revenue and net revenue per bottle exceeded our expectations largely as the result of having received a lower than expected fourth quarter 2019 coverage gap invoice for our
“We are entering 2020 with approximately
Fourth Quarter 2019 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 6595386. 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 6595386. 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, dry eye, 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®, 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 total operating expenses, adjusted selling, general and administrative expenses, adjusted pre-approval commercial manufacturing expenses, adjusted research and development expenses and adjusted net loss and 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, |
||||||
|
2019 |
|
2018 |
||||
Assets |
|
|
|
||||
Current assets |
|
|
|
||||
Cash and cash equivalents |
$ |
143,940 |
|
|
$ |
202,818 |
|
Short-term investments |
165,250 |
|
|
— |
|
||
Accounts receivable, net |
38,354 |
|
|
2,715 |
|
||
Inventory |
21,054 |
|
|
10,112 |
|
||
Prepaid expenses and other current assets |
7,744 |
|
|
4,530 |
|
||
Total current assets |
376,342 |
|
|
220,175 |
|
||
Property, plant and equipment, net |
58,147 |
|
|
60,525 |
|
||
Operating lease right-of-use-assets |
16,523 |
|
|
— |
|
||
Other assets |
1,596 |
|
|
4,344 |
|
||
Total assets |
$ |
452,608 |
|
|
$ |
285,044 |
|
Liabilities and Stockholders’ Equity |
|
|
|
||||
Current liabilities |
|
|
|
||||
Accounts payable |
$ |
12,770 |
|
|
$ |
12,403 |
|
Accrued expenses and other current liabilities |
65,376 |
|
|
38,381 |
|
||
Operating lease liabilities |
5,502 |
|
|
— |
|
||
Total current liabilities |
83,648 |
|
|
50,784 |
|
||
Convertible notes, net |
188,651 |
|
|
— |
|
||
Long-term operating lease liabilities |
12,102 |
|
|
— |
|
||
Other non-current liabilities |
1,257 |
|
|
6,454 |
|
||
Total liabilities |
285,658 |
|
|
57,238 |
|
||
Stockholders’ equity |
|
|
|
||||
Common stock |
46 |
|
|
45 |
|
||
Additional paid-in capital |
1,062,996 |
|
|
924,180 |
|
||
Accumulated other comprehensive loss |
(92 |
) |
|
— |
|
||
Accumulated deficit |
(896,000 |
) |
|
(696,419 |
) |
||
Total stockholders’ equity |
166,950 |
|
|
227,806 |
|
||
Total liabilities and stockholders’ equity |
$ |
452,608 |
|
|
$ |
285,044 |
|
AERIE PHARMACEUTICALS, INC. |
|||||||||||||||
Consolidated Statements of Operations |
|||||||||||||||
(Unaudited) |
|||||||||||||||
(in thousands, except share and per share data) |
|||||||||||||||
|
THREE MONTHS ENDED
|
|
TWELVE MONTHS ENDED
|
||||||||||||
|
2019 |
|
2018 |
|
2019 |
|
2018 |
||||||||
Product revenues, net |
$ |
24,657 |
|
|
$ |
14,456 |
|
|
$ |
69,888 |
|
|
$ |
24,181 |
|
Total revenues, net |
24,657 |
|
|
14,456 |
|
|
69,888 |
|
|
24,181 |
|
||||
Costs and expenses: |
|
|
|
|
|
|
|
||||||||
Cost of goods sold |
1,684 |
|
|
377 |
|
|
4,833 |
|
|
641 |
|
||||
Selling, general and administrative |
35,467 |
|
|
31,887 |
|
|
138,402 |
|
|
120,614 |
|
||||
Pre-approval commercial manufacturing |
6,650 |
|
|
7,625 |
|
|
22,767 |
|
|
26,545 |
|
||||
Research and development |
30,794 |
|
|
26,492 |
|
|
91,378 |
|
|
86,123 |
|
||||
Total costs and expenses |
74,595 |
|
|
66,381 |
|
|
257,380 |
|
|
233,923 |
|
||||
Loss from operations |
(49,938 |
) |
|
(51,925 |
) |
|
(187,492 |
) |
|
(209,742 |
) |
||||
Other (expense) income, net |
(5,126 |
) |
|
467 |
|
|
(12,179 |
) |
|
(22,824 |
) |
||||
Loss before income taxes |
(55,064 |
) |
|
(51,458 |
) |
|
(199,671 |
) |
|
(232,566 |
) |
||||
Income tax (benefit) expense |
— |
|
|
— |
|
|
(90 |
) |
|
3 |
|
||||
Net loss |
$ |
(55,064 |
) |
|
$ |
(51,458 |
) |
|
$ |
(199,581 |
) |
|
$ |
(232,569 |
) |
Net loss per common share—basic and diluted |
$ |
(1.21 |
) |
|
$ |
(1.14 |
) |
|
$ |
(4.39 |
) |
|
$ |
(5.58 |
) |
Weighted average number of common shares outstanding—basic and diluted |
45,589,014 |
|
|
45,101,458 |
|
|
45,427,154 |
|
|
41,663,958 |
|
AERIE PHARMACEUTICALS, INC. |
|||||||||||||||
Reconciliation of GAAP to Non-GAAP Financial Measures |
|||||||||||||||
(Unaudited) |
|||||||||||||||
(in thousands) |
|||||||||||||||
|
THREE MONTHS ENDED
|
|
TWELVE MONTHS ENDED
|
||||||||||||
|
2019 |
|
2018 |
|
2019 |
|
2018 |
||||||||
Net loss (GAAP) |
$ |
(55,064 |
) |
|
$ |
(51,458 |
) |
|
$ |
(199,581 |
) |
|
$ |
(232,569 |
) |
Add-back: stock-based compensation expense |
11,172 |
|
|
9,713 |
|
|
45,093 |
|
|
38,728 |
|
||||
Adjusted Net loss |
$ |
(43,892 |
) |
|
$ |
(41,745 |
) |
|
$ |
(154,488 |
) |
|
$ |
(193,841 |
) |
|
|
|
|
|
|
|
|
||||||||
Selling, general and administrative expenses (GAAP) |
$ |
35,467 |
|
|
$ |
31,887 |
|
|
$ |
138,402 |
|
|
$ |
120,614 |
|
Less: stock-based compensation expense |
(7,210 |
) |
|
(6,410 |
) |
|
(30,463 |
) |
|
(26,432 |
) |
||||
Adjusted selling, general and administrative expenses |
$ |
28,257 |
|
|
$ |
25,477 |
|
|
$ |
107,939 |
|
|
$ |
94,182 |
|
|
|
|
|
|
|
|
|
||||||||
Pre-approval commercial manufacturing expenses (GAAP) |
$ |
6,650 |
|
|
$ |
7,625 |
|
|
$ |
22,767 |
|
|
$ |
26,545 |
|
Less: stock-based compensation expense |
(1,144 |
) |
|
(818 |
) |
|
(3,634 |
) |
|
(2,622 |
) |
||||
Adjusted pre-approval commercial manufacturing expenses |
$ |
5,506 |
|
|
$ |
6,807 |
|
|
$ |
19,133 |
|
|
$ |
23,923 |
|
|
|
|
|
|
|
|
|
||||||||
Research and development expenses (GAAP) |
$ |
30,794 |
|
|
$ |
26,492 |
|
|
$ |
91,378 |
|
|
$ |
86,123 |
|
Less: stock-based compensation expense |
(2,818 |
) |
|
(2,485 |
) |
|
(10,996 |
) |
|
(9,674 |
) |
||||
Adjusted research and development expenses |
$ |
27,976 |
|
|
$ |
24,007 |
|
|
$ |
80,382 |
|
|
$ |
76,449 |
|
|
|
|
|
|
|
|
|
||||||||
Total operating expenses (GAAP) |
$ |
72,911 |
|
|
$ |
66,004 |
|
|
$ |
252,547 |
|
|
$ |
233,282 |
|
Less: stock-based compensation expense |
(11,172 |
) |
|
(9,713 |
) |
|
(45,093 |
) |
|
(38,728 |
) |
||||
Adjusted total operating expenses |
$ |
61,739 |
|
|
$ |
56,291 |
|
|
$ |
207,454 |
|
|
$ |
194,554 |
|
AERIE PHARMACEUTICALS, INC. |
|||||||||||||||
Reconciliation of GAAP Net Loss Per Share to Adjusted Net Loss Per Share |
|||||||||||||||
(Unaudited) |
|||||||||||||||
|
THREE MONTHS ENDED
|
|
TWELVE MONTHS ENDED
|
||||||||||||
|
2019 |
|
2018 |
|
2019 |
|
2018 |
||||||||
Net loss per common share—basic and diluted (GAAP) |
$ |
(1.21 |
) |
|
$ |
(1.14 |
) |
|
$ |
(4.39 |
) |
|
$ |
(5.58 |
) |
Add-back: stock-based compensation expense |
0.25 |
|
|
0.22 |
|
|
0.99 |
|
|
0.93 |
|
||||
Adjusted Net loss per share—basic and diluted |
$ |
(0.96 |
) |
|
$ |
(0.92 |
) |
|
$ |
(3.40 |
) |
|
$ |
(4.65 |
) |
Weighted average number of common shares outstanding—basic and diluted |
45,589,014 |
|
|
45,101,458 |
|
|
45,427,154 |
|
|
41,663,958 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20200220005540/en/
Source:
Aerie Pharmaceuticals
Media: Tad Heitmann 949-526-8747; theitmann@aeriepharma.com
Investors: Ami Bavishi 908-947-3949; abavishi@aeriepharma.com