Conference Call and Webcast Today, August
7th, 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, retinal
diseases and other diseases of the eye, today reported financial
results for the second quarter ended June 30, 2019, updated
full-year 2019 guidance and provided a general business update.
Aerie Second 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 second
quarter 2019 net revenues on a U.S. GAAP (generally accepted
accounting principles) basis of $15.8 million, equivalent to an
average of $94 per bottle. June year-to-date net revenues totaled
$26.7 million, equivalent to an average of $96 per bottle. Second
quarter 2019 net revenues increased over first quarter 2019 by
46%.
- Rhopressa® has market access for the majority of lives covered
under commercial and Medicare Part D plans, and Rocklatan® is in
the process of generating meaningful coverage gains over the next
several months for both commercial and Medicare Part D market
access, with the expectation that Rocklatan® will have the majority
of lives covered under commercial and Medicare Part D lives by the
end of 2019.
- Net cash burn for the six months ended June 30, 2019 was
approximately $92 million, and cash and cash equivalents were
$109.4 million as of June 30, 2019. In addition, with the $200
million in undrawn credit facility capacity available, total
liquidity was approximately $309 million at June 30, 2019.
- International clinical development and expansion activities are
progressing. Enrollment for the Rhopressa® Phase 2 clinical trial
in Japan is now complete ahead of schedule, and the Rocklatan®
Mercury 3 Phase 3 clinical trial in Europe, designed to support
commercialization in that region, continues to progress.
- Aerie’s retina program continues to advance with the AR-1105
(dexamethasone steroid implant) Phase 2 clinical trial having
commenced in March 2019 for macular edema due to RVO (retinal vein
occlusion) and the clinical trial for AR-13503 (Rho kinase and
Protein kinase C inhibitor implant) set to commence shortly for wet
age-related macular degeneration and DME (diabetic macular
edema).
Aerie 2019 Guidance Update
- Based on the U.S. launch trajectory experience year-to-date in
2019, full-year 2019 net revenue guidance has been adjusted to a
range of $70 million to $80 million from the previously reported
range of $110 million to $120 million.
- Net cash burn guidance for full-year 2019 is now at $160
million to $170 million, compared to the previous guidance of $130
million to $140 million as a result of the updated net revenue
guidance.
“The long-term potential of our glaucoma franchise is unchanged,
though in the short-term the timing of our expected 2019 uptick in
volumes is behind what we originally expected. We are delighted
with the initial physician feedback on Rocklatan®’s performance and
we fully expect that we will gain Rocklatan® market access during
2019, particularly for Medicare Part D, at a more rapid pace than
we experienced for Rhopressa® following its commercial launch.
Aerie is in the unique position of gaining coverage for Rocklatan®
while continuing to grow Rhopressa® and physicians are navigating
through the treatment paradigm to optimize patient care while
considering patient costs. Over time, as physicians continue to
gather experience with both products and as formulary access is
gained and penetrated, we believe our long-term growth prospects
are very strong. This all points to great promise for Rocklatan®,
the first and only fixed-dose combination product in the United
States for the reduction of intraocular pressure that includes a
prostaglandin, and the only fixed-dose combination product
available in the United States that is dosed once daily,” said
Vicente Anido, Jr., Ph.D., Chairman and Chief Executive
Officer.
Dr. Anido continued, “We continue to make excellent progress
with our expansion efforts in Europe and Japan, great strides as we
prepare our plant in Ireland for production in early 2020, and we
are delighted by the advances we are making with our
sustained-release retinal implant product candidates.”
Second Quarter 2019 Financial Results
As of June 30, 2019, Aerie had cash and cash equivalents of
$109.4 million. For the second quarter ended June 30, 2019, Aerie
reported net product revenues of $15.8 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 on May 1, 2019. Aerie reported a U.S. GAAP net loss
of $47.2 million, or $1.04 loss per share, for the second quarter
of 2019, compared to a net loss of $55.0 million and $1.40 loss per
share for the second quarter of 2018. The weighted average number
of shares outstanding utilized in the calculation of net loss per
share was 45,397,024 and 39,204,762 for the second quarters of 2019
and 2018, respectively. Total shares outstanding as of June 30,
2019 were 45,949,418.
The $47.2 million net loss for the second quarter of 2019 is
primarily comprised of $15.1 million of gross profit and $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.
The $55.0 million net loss for the second quarter of 2018 is
primarily comprised of $58.0 million in total operating expenses,
including $33.1 million in selling, general and administrative
expenses, $6.8 million in pre-approval commercial manufacturing
expenses and $18.2 million in research and development expenses.
Excluding $10.3 million of stock-based compensation expense,
adjusted total operating expenses for the second quarter of 2018
were $47.7 million, with adjusted selling, general and
administrative expenses of $26.0 million, adjusted pre-approval
commercial manufacturing expenses of $6.1 million and adjusted
research and development expenses of $15.6 million. Total adjusted
net loss for the second quarter of 2018 was $44.7 million, and
adjusted net loss per share was $1.14.
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 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
9487267. 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 9487267. The telephone replay will be available until
August 15, 2019.
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,
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 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 the second
quarter of 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: 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; 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 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-1105 or
AR-13503 and the results of such clinical trials; our guidance for
full-year 2019; our estimates regarding expected net revenues,
expected cash burn, anticipated capital requirements and our needs
for additional financing; our expectations regarding the
effectiveness of Rhopressa®, Rocklatan® 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. 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). In particular, FDA approval of
Rhopressa® and Rocklatan® do not constitute FDA approval of
AR-1105, AR-13503 or any future product candidates, and there can
be no assurance that we will receive FDA approval for AR-1105,
AR-13503 or any future product candidates. FDA approval of
Rhopressa® and Rocklatan® also do not constitute regulatory
approval of Rhopressa® and Rocklatan® in jurisdictions outside the
United States and there can be no assurance that we will receive
regulatory approval for Rhopressa® and Rocklatan® in jurisdictions
outside the United States. In addition, the acceptance of the INDs
by the FDA for AR-1105 and AR-13503 does not constitute FDA
approval of AR-1105 or AR-13503 and the outcome of later clinical
trials for AR-1105 or AR-13503 may not be sufficient to submit an
NDA with the FDA or to receive FDA approval. 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 total operating expenses, adjusted research and
development expenses, adjusted pre-approval commercial
manufacturing, 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)
JUNE 30, 2019
DECEMBER 31, 2018
Assets
Current assets
Cash and cash equivalents
$
109,363
$
202,818
Accounts receivable, net
25,650
2,715
Inventory
10,419
10,112
Prepaid expenses and other current
assets
8,678
4,530
Total current assets
154,110
220,175
Property, plant and equipment, net
58,595
60,525
Operating lease right-of-use assets
17,882
—
Other assets
3,554
4,344
Total assets
$
234,141
$
285,044
Liabilities and Stockholders’
Equity
Current liabilities
Accounts payable
$
9,098
$
12,403
Accrued expenses and other current
liabilities
46,523
38,381
Operating lease liabilities
5,494
—
Total current liabilities
61,115
50,784
Long-term operating lease liabilities
13,238
—
Other non-current liabilities
4,030
6,454
Total liabilities
78,383
57,238
Stockholders' equity
Common stock
46
45
Additional paid-in capital
947,246
924,180
Accumulated deficit
(791,534
)
(696,419
)
Total stockholders’ equity
155,758
227,806
Total liabilities and stockholders’
equity
$
234,141
$
285,044
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,
2019
2018
2019
2018
Product revenues, net
$
15,835
$
2,423
$
26,687
$
2,423
Total revenues, net
15,835
2,423
26,687
2,423
Costs and expenses:
Cost of goods sold
705
59
1,086
59
Selling, general and administrative
34,482
33,112
70,764
56,042
Pre-approval commercial manufacturing
5,819
6,779
10,276
11,672
Research and development
20,904
18,157
38,788
31,129
Total costs and expenses
61,910
58,107
120,914
98,902
Loss from operations
(46,075
)
(55,684
)
(94,227
)
(96,479
)
Other (expense) income, net
(1,089
)
663
(978
)
759
Loss before income taxes
(47,164
)
(55,021
)
(95,205
)
(95,720
)
Income tax expense (benefit)
—
3
(90
)
3
Net loss
$
(47,164
)
$
(55,024
)
$
(95,115
)
$
(95,723
)
Net loss per common share—basic and
diluted
$
(1.04
)
$
(1.40
)
$
(2.10
)
$
(2.46
)
Weighted average number of common
shares
outstanding—basic and diluted
45,397,024
39,204,762
45,334,191
38,903,469
AERIE PHARMACEUTICALS,
INC.
Reconciliation of GAAP to
Non-GAAP Financial Measures
(Unaudited)
(in thousands)
THREE MONTHS ENDED JUNE
30,
SIX MONTHS ENDED JUNE
30,
2019
2018
2019
2018
Net loss (GAAP)
$
(47,164
)
$
(55,024
)
$
(95,115
)
$
(95,723
)
Add-back: stock-based compensation
expense
10,695
10,318
23,315
19,037
Adjusted Net loss
$
(36,469
)
$
(44,706
)
$
(71,800
)
$
(76,686
)
Selling, general and administrative
expenses (GAAP)
$
34,482
$
33,112
$
70,764
$
56,042
Less: stock-based compensation expense
(7,091
)
(7,126
)
(16,212
)
(13,340
)
Adjusted selling, general and
administrative expenses
$
27,391
$
25,986
$
54,552
$
42,702
Pre-approval commercial manufacturing
expenses (GAAP)
$
5,819
$
6,779
$
10,276
$
11,672
Less: stock-based compensation expense
(834
)
(634
)
(1,683
)
(1,104
)
Adjusted pre-approval commercial
manufacturing expenses
$
4,985
$
6,145
$
8,593
$
10,568
Research and development expenses
(GAAP)
$
20,904
$
18,157
$
38,788
$
31,129
Less: stock-based compensation expense
(2,770
)
(2,558
)
(5,420
)
(4,593
)
Adjusted research and development
expenses
$
18,134
$
15,599
$
33,368
$
26,536
Total operating expenses (GAAP)
$
61,205
$
58,048
$
119,828
$
98,843
Less: stock-based compensation expense
(10,695
)
(10,318
)
(23,315
)
(19,037
)
Adjusted total operating expenses
$
50,510
$
47,730
$
96,513
$
79,806
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,
2019
2018
2019
2018
Net loss per common share—basic and
diluted (GAAP)
$
(1.04
)
$
(1.40
)
$
(2.10
)
$
(2.46
)
Add-back: stock-based compensation
expense
0.24
0.26
0.51
0.49
Adjusted Net loss per share—basic and
diluted
$
(0.80
)
$
(1.14
)
$
(1.59
)
$
(1.97
)
Weighted average number of common shares
outstanding—basic and diluted
45,397,024
39,204,762
45,334,191
38,903,469
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190807005455/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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