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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Aerie Pharmaceuticals Inc | NASDAQ:AERI | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 15.25 | 15.24 | 14.79 | 0 | 01:00:00 |
Year-to-Date Net Revenues of $38.4 Million Increased 44% over 2019
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, August 6th, at 5:00 p.m. ET
Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), 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, today reported financial results for the second quarter ended June 30, 2020 and provided a general business update.
“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 Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer.
Dr. Anido added, “We continue to execute on our goals with our clinical programs and plans, both in the United States and abroad. Our recently announced positive topline results for AR-1105, which indicated up to six months of sustained efficacy, show the broad prospects of our sustained delivery retina platform. In Europe, we expect the Mercury 3 topline readout later in the third quarter, which will highlight Roclanda® intraocular pressure reducing performance compared to Ganfort®. Our most advanced pipeline product candidate, AR-15512, remains on track for a large-scale Phase 2b trial to commence by year-end 2020, and we are excited for its potential in the large dry eye market with significant unmet needs. Finally, we remain well-funded with approximately $242 million of cash and investments as of June 30, 2020, and our second quarter net cash used in operating activities was a relatively low $22.9 million compared to the past several quarters.”
U.S. Glaucoma Franchise Highlights
Pipeline and International Highlights
Net cash used in operating activities for the quarter ended June 30, 2020 on a U.S. GAAP basis totaled approximately $22.9 million, resulting in $241.9 million in cash and cash equivalents and investments as of June 30, 2020.
Second Quarter 2020 Financial Results
As of June 30, 2020, Aerie had cash and cash equivalents and investments of $241.9 million. For the second quarter ended June 30, 2020, Aerie reported net product revenues of $18.0 million related to the combined sales of Rhopressa®, which was launched in the United States in April 2018, and Rocklatan®, which was launched in the United States in May 2019. Aerie reported a U.S. GAAP net loss of $48.2 million, or $1.05 loss per share, for the second quarter of 2020, compared to a net loss of $47.2 million and $1.04 loss per share for the second quarter of 2019. The weighted average number of shares outstanding utilized in the calculation of net loss per share was 45.9 million and 45.4 million for the second quarters of 2020 and 2019, respectively. Total shares outstanding as of June 30, 2020 were 46.5 million.
The $48.2 million net loss for the second quarter of 2020 is primarily comprised of $10.7 million of gross profit, including $7.3 million in cost of goods sold, and $53.3 million in total operating expenses, including $33.2 million in selling, general and administrative expenses, $0.1 million in pre-approval commercial manufacturing expenses and $19.9 million in research and development expenses. The cost of goods sold includes $5.0 million in idle capacity costs resulting from the Athlone manufacturing plant having just recently become operational and not yet reaching full capacity. Excluding $10.2 million of stock-based compensation expense, for the second quarter of 2020 adjusted cost of goods sold was $6.7 million and adjusted total operating expenses were $43.8 million, with adjusted selling, general and administrative expenses of $26.3 million, adjusted pre-approval commercial manufacturing expenses of $0.1 million and adjusted research and development expenses of $17.4 million. Total adjusted net loss for the second quarter of 2020 was $38.0 million, and adjusted net loss per share was $0.83.
The $47.2 million net loss for the second quarter of 2019 was primarily comprised of $61.2 million in total operating expenses, including $34.5 million in selling, general and administrative expenses, $5.8 million in pre-approval commercial manufacturing expenses and $20.9 million in research and development expenses. Excluding $10.7 million of stock-based compensation expense, adjusted total operating expenses for the second quarter of 2019 were $50.5 million, with adjusted selling, general and administrative expenses of $27.4 million, adjusted pre-approval commercial manufacturing expenses of $5.0 million and adjusted research and development expenses of $18.1 million. Total adjusted net loss for the second quarter of 2019 was $36.5 million, and adjusted net loss per share was $0.80.
Conference Call / Webcast Information
Aerie management will host a live conference call and webcast at 5:00 p.m. Eastern Time today to discuss Aerie’s financial results and provide a general business update.
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 7286070. 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 7286070. The telephone replay will be available until August 14, 2020.
About Aerie Pharmaceuticals, Inc.
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 U.S. Food and Drug Administration (FDA) for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, was launched in the United States in April 2018. In clinical trials of Rhopressa®, the most common adverse reactions were conjunctival hyperemia, corneal verticillata, instillation site pain, and conjunctival hemorrhage. More information about Rhopressa®, including the product label, is available at www.rhopressa.com. Aerie’s second product for the reduction of elevated IOP in patients with open-angle glaucoma or ocular hypertension, Rocklatan® (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005%, the first and only fixed-dose combination of Rhopressa® and the widely-prescribed PGA (prostaglandin analog) latanoprost, was launched in the United States in May 2019. In clinical trials of Rocklatan®, the most common adverse reactions were conjunctival hyperemia, corneal verticillata, instillation site pain, and conjunctival hemorrhage. More information about Rocklatan®, including the product label, is available at www.rocklatan.com. Aerie continues to focus on global expansion and the development of additional product candidates and technologies in ophthalmology, including for wet age-related macular degeneration and diabetic macular edema. More information is available at www.aeriepharma.com.
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 the United States; the success, timing and cost of our ongoing and anticipated preclinical studies and clinical trials for Rhopressa® and Rocklatan®, with respect to regulatory approval outside of the United States, and any current or future product candidates, including statements regarding the timing of initiation and completion of the studies and trials, such as statements in this press release regarding any expected clinical trials for AR-15512 (formerly AVX-012), AR-1105 or AR-13503 and the results of such clinical trials; our expectations regarding the effectiveness of Rhopressa®, Rocklatan®, Rhokiinsa®, Roclanda® or any current or future product candidates; the timing of and our ability to request, obtain and maintain FDA or other regulatory authority approval of, or other action with respect to, as applicable, Rhopressa®, Rocklatan® or any current or future product candidates, including the expected timing of, and timing of regulatory and/or other review of, filings for, as applicable, Rhopressa®, Rocklatan® or any current or future product candidates; the potential advantages of Rhopressa® and Rocklatan® or any current or future product candidates; our plans to pursue development of additional product candidates and technologies; our plans to explore possible uses of our existing proprietary compounds beyond glaucoma, including development of our retina program; our ability to protect our proprietary technology and enforce our intellectual property rights; and our expectations regarding strategic operations, including our ability to in-license or acquire additional ophthalmic products, product candidates or technologies. In particular, FDA approval of Rhopressa® and Rocklatan® and EMA approval of Rhokiinsa® do not constitute regulatory approval of Rhopressa® and Rocklatan® in other jurisdictions, including EMA approval of Roclanda®, and there can be no assurance that we will receive regulatory approval for Rhopressa® and Rocklatan® in such other jurisdictions, including EMA approval of Roclanda®. In addition, FDA approval of Rhopressa® and Rocklatan® do not constitute FDA approval of our current or any future product candidates, and there can be no assurance that we will receive FDA approval for our current or any future product candidates. Furthermore, EMA acceptance of the MAA for Roclanda® does not constitute EMA approval of Roclanda®, and there can be no assurance that we will receive EMA approval of Roclanda®. In addition, the acceptance of the INDs by the FDA for AR-15512, AR-1105 and AR-13503 do not constitute FDA approval of AR-15512, AR-1105 or AR-13503 and the outcomes of later clinical trials for AR-15512, AR-1105 or AR-13503 may not be sufficient to submit an NDA with the FDA or to receive FDA approval. The topline data presented herein is preliminary and additional information about the results may be disclosed at any time. By their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitive dynamics, industry change and other factors beyond our control, and depend on regulatory approvals and economic and other environmental circumstances that may or may not occur in the future or may occur on longer or shorter timelines than anticipated. We discuss many of these risks in greater detail under the heading “Risk Factors” in the quarterly and annual reports that we file with the Securities and Exchange Commission (SEC). Forward-looking statements are not guarantees of future performance and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
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.
AERIE PHARMACEUTICALS, INC.
Consolidated Balance Sheets
(Unaudited)
(in thousands)
JUNE 30, 2020
DECEMBER 31, 2019
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
AERIE PHARMACEUTICALS, INC.
Consolidated Statements of Operations
(Unaudited)
(in thousands, except share and per share data)
THREE MONTHS ENDED
JUNE 30,
SIX MONTHS ENDED
JUNE 30,
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 outstanding—basic and diluted
45,876,106
45,397,024
45,834,305
45,334,191
AERIE PHARMACEUTICALS, INC.
Reconciliation of GAAP to Non-GAAP Financial Measures
(Unaudited)
(in thousands)
THREE MONTHS ENDED
JUNE 30,
SIX MONTHS ENDED
JUNE 30,
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
AERIE PHARMACEUTICALS, INC.
Reconciliation of GAAP Net Loss Per Share to Adjusted Net Loss Per Share
(Unaudited)
THREE MONTHS ENDED
JUNE 30,
SIX MONTHS ENDED
JUNE 30,
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
View source version on businesswire.com: https://www.businesswire.com/news/home/20200806005849/en/
Aerie Pharmaceuticals Media: Tad Heitmann 949-526-8747; theitmann@aeriepharma.com Investors: Ami Bavishi 908-947-3949; abavishi@aeriepharma.com
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