Conference Call and Webcast Today, November
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, retinal diseases and other
diseases of the eye, today reported financial results for the third
quarter ended September 30, 2019 and provided a general business
update.
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 at September 30, 2019. In September
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 of
Medicare Part D lives. In addition, Rocklatan® has an additional 18
percent of remaining Medicare 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 a
PGA, Rhopressa® maintained equal IOP-lowering to the prior PGA. 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 in Japan set the
stage for advancing a number of different activities, including
potential partnering discussions, to gain approval and ultimately
commercialize our products in Japan. 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 the European
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 in Europe, 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 obtain FDA 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 in March
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 $61 to $66 million, reflecting recent volume trends and
our expectations through the upcoming holiday season. As we look at
recent patterns, there have been strong growth weeks interspersed
with weeks of somewhat slower growth. Our previous guidance assumed
more consistent weekly growth. We believe this is a short-term
launch phenomenon. Recent Rocklatan® volume gains are certainly
promising, and we look forward to a meaningful growth trajectory
over the next several years, and the long-term potential of our
glaucoma franchise remains intact. New and impressive data from our
MOST Phase 4 study point to the long-term potential of Rhopressa®
driven by its real-world efficacy in many settings and positive
tolerability profile. The Japan Phase 2 clinical results once again
demonstrate the value proposition for Rhopressa® in Japan while
also being informative as it relates to product performance on the
large population of glaucoma patients on a global basis with
normal-tension glaucoma,” said Vicente Anido, Jr., Ph.D., Chairman
and Chief Executive Officer.
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
Medicare Part D patients. Further, 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 progress we are making in the
clinic with our sustained-release retinal implant product
candidates.”
Third Quarter 2019 Financial Results
As of September 30, 2019, Aerie had cash and cash equivalents
and investments of $345.8 million, reflecting the net proceeds from
the convertible debt offering in September 2019. For the third
quarter ended September 30, 2019, Aerie reported net product
revenues of $18.5 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 $49.4 million, or
$1.09 loss per share, for the third quarter of 2019, compared to a
net loss of $85.4 million and $1.96 loss per share for the third
quarter of 2018. The weighted average number of shares outstanding
utilized in the calculation of net loss per share was 45,448,190
and 43,657,423 for the third quarters of 2019 and 2018,
respectively. Total shares outstanding as of September 30, 2019
were 45,998,956.
The $49.4 million net loss for the third quarter of 2019 is
primarily comprised of $16.5 million of gross profit and $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.
The $85.4 million net loss for the third quarter of 2018 was
primarily comprised of $68.4 million in total operating expenses,
including $32.7 million in selling, general and administrative
expenses, $7.2 million in pre-approval commercial manufacturing
expenses and $28.5 million in research and development expenses.
Excluding $10.0 million of stock-based compensation expense,
adjusted total operating expenses for the third quarter of 2018
were $58.5 million, with adjusted selling, general and
administrative expenses of $26.0 million, adjusted pre-approval
commercial manufacturing expenses of $6.5 million and adjusted
research and development expenses of $25.9 million. Total adjusted
net loss for the third quarter of 2018 was $75.4 million, and
adjusted net loss per share was $1.73.
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
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
November 14, 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 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-1105 or
AR-13503 and the results of such clinical trials; our guidance for
full-year 2019 including expectations through the holiday season;
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 of 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 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 SEPTEMBER
30,
NINE MONTHS ENDED SEPTEMBER
30,
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
outstanding—basic and diluted
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 SEPTEMBER
30,
NINE MONTHS ENDED SEPTEMBER
30,
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 SEPTEMBER
30,
NINE MONTHS ENDED SEPTEMBER
30,
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 and diluted
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/
Aerie Pharmaceuticals Media: Tad
Heitmann 949-526-8747; theitmann@aeriepharma.com Investors: Ami
Bavishi 908-947-3949; abavishi@aeriepharma.com
Aerie Pharmaceuticals (NASDAQ:AERI)
Historical Stock Chart
From Aug 2024 to Sep 2024
Aerie Pharmaceuticals (NASDAQ:AERI)
Historical Stock Chart
From Sep 2023 to Sep 2024