Aerie Pharmaceuticals Reports Third Quarter 2019 Financial Results, Updates Full-Year 2019 Guidance and Provides Business Update
11/06/2019
Conference Call and Webcast Today,
Aerie Third Quarter Highlights
-
The Aerie glaucoma franchise, including Rhopressa® (netarsudil ophthalmic solution) 0.02% and Rocklatan® (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005%, generated third quarter 2019 net revenues on a U.S. GAAP (generally accepted accounting principles) basis of
$18.5 million , equivalent to an average of$94 per bottle. September year-to-date net revenues totaled$45.2 million , equivalent to an average of$95 per bottle. Third quarter 2019 net revenues increased over second quarter 2019 by 17.1%. -
Aerie currently expects full-year 2019 net revenues in the range of
$61 to $66 million on a U.S. GAAP basis for the combined net revenues for Rhopressa® and Rocklatan® based on recent volume trends, compared to the previous guidance range of$70 to $80 million . Additionally, Aerie reiterated its net cash burn guidance for full-year 2019 in the range of$160 to $170 million . -
Net cash burn for the nine months ended
September 30, 2019 was approximately$131 million , with$345.8 million in cash and cash equivalents and investments atSeptember 30, 2019 . InSeptember 2019 , the Company issued 1.5% Convertible Senior Notes due 2024 for gross proceeds of$316 million and net proceeds of approximately$275 million . -
Rhopressa® has market access for the majority of lives covered under commercial and
Medicare Part D plans. Rocklatan® now has market access for 80 percent of commercial lives and 36 percent ofMedicare Part D lives. In addition, Rocklatan® has an additional 18 percent of remainingMedicare Part D lives, which, while not yet covered on formulary, have affordable access through U.S. government funded Low Income Subsidy programs through which co-pays are less than$10 per month. -
New data reflecting the topline results of the Rhopressa® Multi-center Open-label Study (“MOST”) Phase 4 study demonstrate positive efficacy and favorable adverse event profiles in both adjunctive and monotherapy real-world clinical settings. In the study, Rhopressa® was equally effective when added to prior prostaglandin analogue (
PGA ) therapy or when added to prior multi-drug therapy, with additional intraocular pressure (IOP) reductions of 4.3 millimeters of mercury (mmHg) and 4.5 mmHg, respectively. When used as monotherapy following a switch from aPGA , Rhopressa® maintained equal IOP-lowering to the priorPGA . The topline results, which covered 260 subjects on an intent to treat basis, will be presented on Aerie’s third-quarter conference call, details for which are included below, and the corresponding presentation is available at http://investors.aeriepharma.com. -
Clinical development and expansion activities related to
Japan are progressing rapidly. The recently released positive topline results from the Rhopressa® Phase 2 clinical trial inJapan set the stage for advancing a number of different activities, including potential partnering discussions, to gain approval and ultimately commercialize our products inJapan . The topline Phase 2 data will be presented on Aerie’s third-quarter conference call, and the corresponding presentation is available at http://investors.aeriepharma.com. -
The European Medicines Agency’s
Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion in September recommending approval of the marketing authorisation application (MAA) for Rhokiinsa® (netarsudil ophthalmic solution) 0.02%. The CHMP positive opinion has been referred to theEuropean Commission for a final decision on the MAA, which is expected in the fourth quarter of 2019. The Rocklatan® Mercury 3 Phase 3 clinical trial inEurope , designed to support commercialization in that region, continues to progress. -
Aerie submitted a Prior Approval Supplement (PAS) to the
U.S. Food and Drug Administration (FDA ) in September to allow commercial production of Rocklatan® in Aerie’s Athlone,Ireland , manufacturing facility. Aerie also plans to file a PAS in the first half of 2020 to obtainFDA approval to manufacture Rhopressa® in Athlone. -
Aerie’s retina program continues to advance. The clinical trial for AR-13503 (Rho kinase and Protein kinase C inhibitor implant) commenced in
August 2019 for wet age-related macular degeneration and DME (diabetic macular edema). The AR-1105 (dexamethasone steroid implant) Phase 2 clinical trial, which commenced inMarch 2019 for macular edema due to RVO (retina vein occlusion) has fully enrolled ahead of schedule.
“We are lowering our full-year 2019 net revenue guidance to a range of
Dr. Anido continued, “The key to our long-term growth will be continued gains in physician experience with both Rhopressa® and Rocklatan®, and along with that continued penetration of the available patient base. We currently have nearly 12,000 prescribers of our products out of a target population of 14,000, and nearly 4,000 of the prescribers are writing prescriptions consistently on a weekly basis. When analyzing prescription volumes from the top five prescribers of our glaucoma products, essentially those with the greatest experience with our products, the Aerie share of total prescriptions in their practices ranges from nearly 8 percent to over 26 percent, which we believe is an important indicator of how continued physician experience can drive our market share significantly higher over time. Regarding market access, when including affordable access for Low Income Subsidy patients, Rocklatan® already has affordable copays for the majority of
Third 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 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 (U.S.) or (678) 894-3054 (international) to listen to the live conference call. The conference ID number for the live call is 3884357. 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 3884357. 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 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 total operating expenses, adjusted research and development expenses, adjusted pre-approval commercial manufacturing expenses, 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) |
||||||||
|
|
SEPTEMBER 30, 2019 |
|
DECEMBER 31, 2018 |
||||
Assets |
|
|
|
|
||||
Current assets |
|
|
|
|
||||
Cash and cash equivalents |
|
$ |
248,702 |
|
|
$ |
202,818 |
|
Short-term investments |
|
92,075 |
|
|
— |
|
||
Accounts receivable, net |
|
33,278 |
|
|
2,715 |
|
||
Inventory |
|
14,673 |
|
|
10,112 |
|
||
Prepaid expenses and other current assets |
|
7,940 |
|
|
4,530 |
|
||
Total current assets |
|
396,668 |
|
|
220,175 |
|
||
Long-term investments |
|
5,020 |
|
|
— |
|
||
Property, plant and equipment, net |
|
58,277 |
|
|
60,525 |
|
||
Operating lease right-of-use assets |
|
17,216 |
|
|
— |
|
||
Other assets |
|
2,027 |
|
|
4,344 |
|
||
Total assets |
|
$ |
479,208 |
|
|
$ |
285,044 |
|
|
|
|
|
|
||||
Liabilities and Stockholders’ Equity |
|
|
|
|
||||
Current liabilities |
|
|
|
|
||||
Accounts payable |
|
$ |
11,480 |
|
|
$ |
12,403 |
|
Accrued expenses and other current liabilities |
|
55,728 |
|
|
38,381 |
|
||
Operating lease liabilities |
|
5,802 |
|
|
— |
|
||
Total current liabilities |
|
73,010 |
|
|
50,784 |
|
||
Convertible notes, net |
|
183,553 |
|
|
— |
|
||
Long-term operating lease liabilities |
|
12,235 |
|
|
— |
|
||
Other non-current liabilities |
|
1,206 |
|
|
6,454 |
|
||
Total liabilities |
|
270,004 |
|
|
57,238 |
|
||
Stockholders' equity |
|
|
|
|
||||
Common stock |
|
46 |
|
|
45 |
|
||
Additional paid-in capital |
|
1,050,252 |
|
|
924,180 |
|
||
Accumulated other comprehensive loss |
|
(158 |
) |
|
— |
|
||
Accumulated deficit |
|
(840,936 |
) |
|
(696,419 |
) |
||
Total stockholders’ equity |
|
209,204 |
|
|
227,806 |
|
||
Total liabilities and stockholders’ equity |
|
$ |
479,208 |
|
|
$ |
285,044 |
|
AERIE PHARMACEUTICALS, INC. Consolidated Statements of Operations (Unaudited) (in thousands, except share and per share data) |
|||||||||||||||
|
THREE MONTHS ENDED
|
|
NINE MONTHS ENDED
|
||||||||||||
|
2019 |
|
2018 |
|
2019 |
|
2018 |
||||||||
Product revenues, net |
$ |
18,544 |
|
|
$ |
7,302 |
|
|
$ |
45,231 |
|
|
$ |
9,725 |
|
Total revenues, net |
18,544 |
|
|
7,302 |
|
|
45,231 |
|
|
9,725 |
|
||||
Costs and expenses: |
|
|
|
|
|
|
|
||||||||
Cost of goods sold |
2,063 |
|
|
205 |
|
|
3,149 |
|
|
264 |
|
||||
Selling, general and administrative |
32,171 |
|
|
32,685 |
|
|
102,935 |
|
|
88,727 |
|
||||
Pre-approval commercial manufacturing |
5,841 |
|
|
7,248 |
|
|
16,117 |
|
|
18,920 |
|
||||
Research and development |
21,796 |
|
|
28,502 |
|
|
60,584 |
|
|
59,631 |
|
||||
Total costs and expenses |
61,871 |
|
|
68,640 |
|
|
182,785 |
|
|
167,542 |
|
||||
Loss from operations |
(43,327 |
) |
|
(61,338 |
) |
|
(137,554 |
) |
|
(157,817 |
) |
||||
Other (expense) income, net |
(6,075 |
) |
|
(24,050 |
) |
|
(7,053 |
) |
|
(23,291 |
) |
||||
Loss before income taxes |
(49,402 |
) |
|
(85,388 |
) |
|
(144,607 |
) |
|
(181,108 |
) |
||||
Income tax (benefit) expense |
— |
|
|
— |
|
|
(90 |
) |
|
3 |
|
||||
Net loss |
$ |
(49,402 |
) |
|
$ |
(85,388 |
) |
|
$ |
(144,517 |
) |
|
$ |
(181,111 |
) |
Net loss per common share—basic and diluted |
$ |
(1.09 |
) |
|
$ |
(1.96 |
) |
|
$ |
(3.19 |
) |
|
$ |
(4.47 |
) |
Weighted average number of common shares
|
45,448,190 |
|
|
43,657,423 |
|
|
45,372,608 |
|
|
40,505,534 |
|
AERIE PHARMACEUTICALS, INC. Reconciliation of GAAP to Non-GAAP Financial Measures (Unaudited) (in thousands) |
||||||||||||||||
|
|
THREE MONTHS ENDED
|
|
NINE MONTHS ENDED
|
||||||||||||
|
|
2019 |
|
2018 |
|
2019 |
|
2018 |
||||||||
Net loss (GAAP) |
|
$ |
(49,402 |
) |
|
$ |
(85,388 |
) |
|
$ |
(144,517 |
) |
|
$ |
(181,111 |
) |
Add-back: stock-based compensation expense |
|
10,606 |
|
|
9,978 |
|
|
33,921 |
|
|
29,015 |
|
||||
Adjusted Net loss |
|
$ |
(38,796 |
) |
|
$ |
(75,410 |
) |
|
$ |
(110,596 |
) |
|
$ |
(152,096 |
) |
|
|
|
|
|
|
|
|
|
||||||||
Selling, general and administrative expenses (GAAP) |
|
$ |
32,171 |
|
|
$ |
32,685 |
|
|
$ |
102,935 |
|
|
$ |
88,727 |
|
Less: stock-based compensation expense |
|
(7,041 |
) |
|
(6,682 |
) |
|
(23,253 |
) |
|
(20,022 |
) |
||||
Adjusted selling, general and administrative expenses |
|
$ |
25,130 |
|
|
$ |
26,003 |
|
|
$ |
79,682 |
|
|
$ |
68,705 |
|
|
|
|
|
|
|
|
|
|
||||||||
Pre-approval commercial manufacturing expenses (GAAP) |
|
$ |
5,841 |
|
|
$ |
7,248 |
|
|
$ |
16,117 |
|
|
$ |
18,920 |
|
Less: stock-based compensation expense |
|
(807 |
) |
|
(700 |
) |
|
(2,490 |
) |
|
(1,804 |
) |
||||
Adjusted pre-approval commercial manufacturing expenses |
|
$ |
5,034 |
|
|
$ |
6,548 |
|
|
$ |
13,627 |
|
|
$ |
17,116 |
|
|
|
|
|
|
|
|
|
|
||||||||
Research and development expenses (GAAP) |
|
$ |
21,796 |
|
|
$ |
28,502 |
|
|
$ |
60,584 |
|
|
$ |
59,631 |
|
Less: stock-based compensation expense |
|
(2,758 |
) |
|
(2,596 |
) |
|
(8,178 |
) |
|
(7,189 |
) |
||||
Adjusted research and development expenses |
|
$ |
19,038 |
|
|
$ |
25,906 |
|
|
$ |
52,406 |
|
|
$ |
52,442 |
|
|
|
|
|
|
|
|
|
|
||||||||
Total operating expenses (GAAP) |
|
$ |
59,808 |
|
|
$ |
68,435 |
|
|
$ |
179,636 |
|
|
$ |
167,278 |
|
Less: stock-based compensation expense |
|
(10,606 |
) |
|
(9,978 |
) |
|
(33,921 |
) |
|
(29,015 |
) |
||||
Adjusted total operating expenses |
|
$ |
49,202 |
|
|
$ |
58,457 |
|
|
$ |
145,715 |
|
|
$ |
138,263 |
|
AERIE PHARMACEUTICALS, INC. Reconciliation of GAAP Net Loss Per Share to Adjusted Net Loss Per Share (Unaudited) |
||||||||||||||||
|
|
THREE MONTHS ENDED
|
|
NINE MONTHS ENDED
|
||||||||||||
|
|
2019 |
|
2018 |
|
2019 |
|
2018 |
||||||||
Net loss per common share—basic and diluted (GAAP) |
|
$ |
(1.09 |
) |
|
$ |
(1.96 |
) |
|
$ |
(3.19 |
) |
|
$ |
(4.47 |
) |
Add-back: stock-based compensation expense |
|
0.23 |
|
|
0.23 |
|
|
0.75 |
|
|
0.72 |
|
||||
Adjusted Net loss per share—basic and diluted |
|
$ |
(0.86 |
) |
|
$ |
(1.73 |
) |
|
$ |
(2.44 |
) |
|
$ |
(3.75 |
) |
Weighted average number of common shares outstanding—basic
|
|
45,448,190 |
|
|
43,657,423 |
|
|
45,372,608 |
|
|
40,505,534 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20191106005738/en/
Source:
Aerie Pharmaceuticals
Media: Tad Heitmann 949-526-8747; theitmann@aeriepharma.com
Investors: Ami Bavishi 908-947-3949; abavishi@aeriepharma.com