Year-to-Date Net Revenues of $58.5 Million
Increased 29% over 2019
Third Quarter Net Revenues of $20.1 Million
or $77 Per Bottle
U.S. Dry Eye Trial Initiated and Japanese
Glaucoma Trial Set to Commence
Conference Call and Webcast Today,
November 5th, 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 third
quarter ended September 30, 2020 and provided a general business
update.
“Our third quarter results demonstrated over 12 percent
sequential growth in our U.S. glaucoma franchise volumes compared
to second quarter, reflecting increased demand for both Rhopressa®
(netarsudil ophthalmic solution) 0.02% and Rocklatan® (netarsudil
and latanoprost ophthalmic solution) 0.02%/0.005%. We believe our
glaucoma franchise is benefitting from heightened prescription
levels reflecting broader physician awareness of the two product
profiles and broad formulary access. In addition, we estimate that
approximately 85 percent of ophthalmologist offices were open in
the third quarter, up from approximately 75 percent in the second
quarter. The value of our glaucoma franchise was further
demonstrated by the recently announced collaboration with Santen
Pharmaceuticals Co., Ltd. (Santen) in Japan and several other
countries in Asia, and we expect to commence the first Phase 3
clinical trial in Japan for Rhopressa® by the end of this year.
Additionally, our recent positive Mercury 3 results and associated
interest from potential collaborators point to the excellent
potential of our glaucoma franchise in Europe,” said Vicente Anido,
Jr., Ph.D., Chairman and Chief Executive Officer.
Dr. Anido added, “Turning to the most advanced product
candidates in our pipeline, we recently commenced the Phase 2b
clinical trial of AR-15512, our dry eye product candidate. We also
remain excited about the recently announced topline Phase 2 results
for AR-1105, which indicated up to six months of sustained efficacy
for patients with macular edema associated with retinal vein
occlusion, a significantly differentiated profile for a retinal
steroid implant. The potential of AR-1105 in the United States and
especially European retina markets could be quite meaningful and we
are evaluating the clinical and regulatory path in both markets.
Finally, we remain well-funded with approximately $218 million of
cash and investments as of September 30, 2020, and our third
quarter net cash used in operating activities was $22.4 million,
slightly better than the $22.9 million reported in the second
quarter and significantly better than prior quarters. Our cash and
investments position of $218 million will be further bolstered with
the $50 million upfront cash payment from the Santen collaboration
expected later this month.”
U.S. Glaucoma Franchise Highlights
- Rhopressa® and Rocklatan® generated third quarter 2020 net
revenues of $20.1 million, compared to $18.5 million in the third
quarter of 2019, equivalent to an average of $77 per bottle,
relatively consistent with the $78 per bottle in the second quarter
of 2020. Shipments to wholesalers totaled 261,000 bottles during
the third quarter of 2020, over 12 percent higher than the 232,500
bottles in the second quarter of 2020. Net revenues for the nine
months ended September 30, 2020 totaled $58.5 million, compared to
$45.2 million for the nine months ended September 30, 2019,
reflecting a 29 percent increase.
- 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 56 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.
- Aerie received approval from the U.S. Food and Drug
Administration (FDA) in September 2020 to manufacture Rhopressa® in
Aerie’s manufacturing plant in Athlone, Ireland for commercial
distribution in the U.S. market. The FDA approved the production of
Rocklatan® in the Athlone manufacturing plant earlier this year and
Aerie began production of commercial supplies of Rocklatan® in the
first quarter of 2020. As volumes produced in the Athlone
manufacturing plant increase over time, idle capacity costs are
expected to decline. Idle capacity costs decreased from $5.0
million in the second quarter of 2020 to $3.8 million in the third
quarter of 2020.
Pipeline and International Highlights
- Aerie and Santen recently announced that they executed an
exclusive license agreement for the development and
commercialization of Rhopressa® and Rocklatan® in Japan and several
other Asian countries. The agreement includes an upfront payment to
Aerie of $50 million. Aerie expects to initiate the first Phase 3
trial in Japan for Rhopressa® by the end of this year.
- Aerie recently initiated COMET-1, its Phase 2b clinical trial
for dry eye product candidate AR-15512. COMET-1 is powered as a
Phase 3 clinical trial, and topline results are expected in the
third quarter of 2021.
- Aerie reported positive topline data from the Rocklatan®
Mercury 3 Phase 3 clinical trial in Europe in September 2020.
Rocklatan® (known as Roclanda® in Europe) achieved non-inferiority
to a fixed-dose combination in Europe (Ganfort®) and has received
early interest from potential collaborators.
- 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® in the United States) in the fourth quarter of 2020. The
European Commission granted a centralised marketing authorisation
for Rhokiinsa® (netarsudil ophthalmic solution) 0.02% in November
2019.
- Aerie completed a Phase 2 clinical trial for AR-1105
(dexamethasone steroid implant) for macular edema due to retinal
vein occlusion in July 2020, which indicates up to six months
sustained release, and is evaluating the clinical and regulatory
pathway for both the U.S. and European markets.
Net cash used in operating activities for the quarter ended
September 30, 2020 on a U.S. GAAP basis totaled approximately $22.4
million, resulting in $218.4 million in cash and cash equivalents
and investments as of September 30, 2020.
Third Quarter 2020 Financial Results
As of September 30, 2020, Aerie had cash and cash equivalents
and investments of $218.4 million. For the third quarter ended
September 30, 2020, Aerie reported net product revenues of $20.1
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 $39.6 million, or $0.86 loss per share, for
the third quarter of 2020, compared to a net loss of $49.4 million
and $1.09 loss per share for the third 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 third quarters of 2020 and 2019, respectively. Total shares
outstanding as of September 30, 2020 were 46.8 million.
The $39.6 million net loss for the third quarter of 2020 is
primarily comprised of $14.7 million of gross profit, including
$5.4 million in cost of goods sold, and $48.3 million in total
operating expenses, including $32.0 million in selling, general and
administrative expenses, $0.1 million in pre-approval commercial
manufacturing expenses and $16.2 million in research and
development expenses. The cost of goods sold includes $3.8 million
in idle capacity costs resulting from the Athlone manufacturing
plant having just recently become operational and not yet reaching
full capacity. Excluding $9.8 million of stock-based compensation
expense, for the third quarter of 2020 adjusted cost of goods sold
was $4.9 million and adjusted total operating expenses were $39.0
million, with adjusted selling, general and administrative expenses
of $25.3 million, adjusted pre-approval commercial manufacturing
expenses of $0.1 million and adjusted research and development
expenses of $13.6 million. Total adjusted net loss for the third
quarter of 2020 was $29.8 million, and adjusted net loss per share
was $0.65.
The $49.4 million net loss for the third quarter of 2019 was
primarily comprised of $59.8 million in total operating expenses,
including $32.2 million in selling, general and administrative
expenses, $5.8 million in pre-approval commercial manufacturing
expenses and $21.8 million in research and development expenses.
Excluding $10.6 million of stock-based compensation expense,
adjusted total operating expenses for the third quarter of 2019
were $49.2 million, with adjusted selling, general and
administrative expenses of $25.1 million, adjusted pre-approval
commercial manufacturing expenses of $5.0 million and adjusted
research and development expenses of $19.0 million. Total adjusted
net loss for the third quarter of 2019 was $38.8 million, and
adjusted net loss per share was $0.86.
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
6776445. 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 6776445. The telephone replay will be available until
November 13, 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; 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. 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)
SEPTEMBER 30, 2020
DECEMBER 31, 2019
Assets
Current assets
Cash and cash equivalents
$
129,787
$
143,940
Short-term investments
88,645
165,250
Accounts receivable, net
46,848
38,354
Inventory
20,842
21,054
Prepaid expenses and other current
assets
9,091
7,744
Total current assets
295,213
376,342
Property, plant and equipment, net
55,293
58,147
Operating lease right-of-use assets
15,041
16,523
Other assets
1,139
1,596
Total assets
$
366,686
$
452,608
Liabilities and Stockholders’
Equity
Current liabilities
Accounts payable
$
4,536
$
12,770
Accrued expenses and other current
liabilities
78,806
65,376
Operating lease liabilities
5,303
5,502
Total current liabilities
88,645
83,648
Convertible notes, net
204,688
188,651
Long-term operating lease liabilities
10,759
12,102
Other non-current liabilities
2,497
1,257
Total liabilities
306,589
285,658
Stockholders’ equity
Common stock
47
46
Additional paid-in capital
1,093,026
1,062,996
Accumulated other comprehensive income
(loss)
(12)
(92)
Accumulated deficit
(1,032,964)
(896,000)
Total stockholders’ equity
60,097
166,950
Total liabilities and stockholders’
equity
$
366,686
$
452,608
AERIE PHARMACEUTICALS, INC.
Consolidated Statements of Operations (Unaudited) (in
thousands, except share and per share data)
THREE MONTHS ENDED SEPTEMBER
30,
NINE MONTHS ENDED SEPTEMBER
30,
2020
2019
2020
2019
Product revenues, net
$
20,081
$
18,544
$
58,455
$
45,231
Total revenues, net
20,081
18,544
58,455
45,231
Costs and expenses:
Cost of goods sold
5,381
2,063
18,799
3,149
Selling, general and administrative
32,029
32,171
102,168
102,935
Pre-approval commercial manufacturing
110
5,841
2,304
16,117
Research and development
16,165
21,796
55,281
60,584
Total costs and expenses
53,685
61,871
178,552
182,785
Loss from operations
(33,604)
(43,327)
(120,097)
(137,554)
Other (expense) income, net
(6,044)
(6,075)
(16,900)
(7,053)
Loss before income taxes
(39,648)
(49,402)
(136,997)
(144,607)
Income tax benefit
—
—
(33)
(90)
Net loss
$
(39,648)
$
(49,402)
$
(136,964)
$
(144,517)
Net loss per common share—basic and
diluted
$
(0.86)
$
(1.09)
$
(2.99)
$
(3.19)
Weighted average number of common shares
outstanding—basic and diluted
45,945,745
45,448,190
45,871,723
45,372,608
AERIE PHARMACEUTICALS, INC.
Reconciliation of GAAP to Non-GAAP Financial Measures
(Unaudited) (in thousands)
THREE MONTHS ENDED SEPTEMBER
30,
NINE MONTHS ENDED SEPTEMBER
30,
2020
2019
2020
2019
Net loss (GAAP)
$
(39,648)
$
(49,402)
$
(136,964)
$
(144,517)
Add-back: stock-based compensation
expense
9,800
10,606
30,505
33,921
Adjusted Net loss
$
(29,848)
$
(38,796)
$
(106,459)
$
(110,596)
Cost of goods sold (GAAP)
$
5,381
$
2,063
$
18,799
$
3,149
Less: stock-based compensation expense
(511)
—
(1,678)
—
Adjusted cost of goods sold
$
4,870
$
2,063
$
17,121
$
3,149
Selling, general and administrative
expenses (GAAP)
$
32,029
$
32,171
$
102,168
$
102,935
Less: stock-based compensation expense
(6,716)
(7,041)
(20,524)
(23,253)
Adjusted selling, general and
administrative expenses
$
25,313
$
25,130
$
81,644
$
79,682
Pre-approval commercial manufacturing
expenses (GAAP)
$
110
$
5,841
$
2,304
$
16,117
Less: stock-based compensation expense
(28)
(807)
(344)
(2,490)
Adjusted pre-approval commercial
manufacturing expenses
$
82
$
5,034
$
1,960
$
13,627
Research and development expenses
(GAAP)
$
16,165
$
21,796
$
55,281
$
60,584
Less: stock-based compensation expense
(2,545)
(2,758)
(7,959)
(8,178)
Adjusted research and development
expenses
$
13,620
$
19,038
$
47,322
$
52,406
Total operating expenses (GAAP)
$
48,304
$
59,808
$
159,753
$
179,636
Less: stock-based compensation expense
(9,289)
(10,606)
(28,827)
(33,921)
Adjusted total operating expenses
$
39,015
$
49,202
$
130,926
$
145,715
AERIE PHARMACEUTICALS, INC.
Reconciliation of GAAP Net Loss Per Share to Adjusted Net Loss
Per Share (Unaudited)
THREE MONTHS ENDED SEPTEMBER
30,
NINE MONTHS ENDED SEPTEMBER
30,
2020
2019
2020
2019
Net loss per common share—basic and
diluted (GAAP)
$
(0.86)
$
(1.09)
$
(2.99)
$
(3.19)
Add-back: stock-based compensation
expense
0.21
0.23
0.67
0.75
Adjusted Net loss per share—basic and
diluted
$
(0.65)
$
(0.86)
$
(2.32)
$
(2.44)
Weighted average number of common shares
outstanding—basic and diluted
45,945,745
45,448,190
45,871,723
45,372,608
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201105005952/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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