2020 Net Revenues of $83.1 Million Increased
19% over 2019
Fourth Quarter Net Revenues of $24.7 Million
or $80 Per Bottle
New Sustained Release Pan-VEGF Inhibitor
Pipeline Candidate Announced Today
Conference Call and Webcast Today, February
25th, 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 fourth
quarter and year ended December 31, 2020 and provided a general
business update.
“Our fourth quarter 2020 net revenues of $24.7 million exceeded
third quarter by nearly 23 percent, reflecting strong sequential
volume growth in our glaucoma franchise and increased net revenue
per bottle. We believe our glaucoma franchise is increasingly
benefiting from broader physician awareness of the two product
profiles and expanded formulary access. We have recently reduced
the fees we pay our wholesalers and continue to refine our payer
rebate contracts, and with that we expect our net revenue per
bottle to continue increasing as we proceed through 2021.
Additionally, we ended 2020 well-funded with cash and investments
of over $240 million reflecting stronger revenues, well-controlled
operating expenses and the Santen upfront payment. While we are not
currently providing full year 2021 financial guidance due to
continuing uncertainties surrounding the impact of the ongoing
pandemic on ophthalmic practices, based on our volume and net
revenue per bottle trajectory, we are comfortable with current
consensus analyst estimates,” said Vicente Anido, Jr., Ph.D.,
Chairman and Chief Executive Officer.
Dr. Anido added, “With our Santen collaboration agreement now
signed and the first Phase 3 trial for Rhopressa® underway in
Japan, we are now receiving inbound interest from multiple
potential collaborators in Europe, now that we have regulatory
approval for both glaucoma products in the region and the positive
topline Mercury 3 results in hand. Turning to our pipeline, we have
announced a new preclinical implant for the potential treatment of
wet age-related macular degeneration and diabetic macular edema,
AR-14034, a sustained-release retinal implant containing the
pan-VEGF inhibitor axitinib formulated in a unique bio-erodible
polymer blend using our exclusive PRINT® technology. We believe,
based on the predictability of our PRINT® platform and the
formulation capabilities provided by our access to a large variety
of polymers, that this preclinical implant may have the potential
to provide up to one year of treatment from a single injection with
potentially better efficacy than currently available products and
product candidates. This is another example of the potential
flexibility of our sustained-release ophthalmic platform, and we
expect there will be other opportunities for this technology well
into the future. Turning to the most advanced product candidates in
our pipeline, the Phase 2b clinical trial of AR-15512, our dry eye
product candidate, is well underway. We also remain excited about
the previously 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.
We are in discussions with both the FDA and EMA to develop a Phase
3 strategy for AR-1105 in the United States and Europe.”
U.S. Glaucoma Franchise Highlights
- Rhopressa® and Rocklatan® generated fourth quarter 2020 net
revenues of $24.7 million, equivalent to an average of $80 per
bottle. Shipments to wholesalers totaled 307,000 during the fourth
quarter of 2020, 18% higher than the 261,000 bottles in the third
quarter of 2020. Net revenues for the year ended December 31, 2020
totaled $83.1 million, compared to $69.9 million for the year ended
December 31, 2019, reflecting a 19% increase.
- Rhopressa® currently has commercial coverage for 90 percent of
lives and market access for 89 percent of lives covered under
Medicare Part D plans. Commercial coverage for Rocklatan®
represents 89 percent of covered 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.
Pipeline and International Highlights
- A new wet age-related macular degeneration (wAMD) / diabetic
macular edema (DME) preclinical implant has been added to Aerie’s
pipeline. AR-14034 represents a sustained-release implant of
axitinib (VEGF A/B/C/D inhibitor) produced with a unique
bio-erodible polymer blend using PRINT® technology that may
potentially necessitate only one injection to treat a wAMD or DME
patient for up to 12 months (refer to the slide presentation posted
today in the Events and Presentations page of
www.aeriepharma.com).
- Aerie continues to expect topline results of COMET-1, Aerie’s
Phase 2b clinical trial for its dry eye product candidate,
AR-15512, in the third quarter of 2021. COMET-1, which was
initiated in October 2020, is powered as a Phase 3 trial.
- Aerie was granted a centralised marketing authorisation in
Europe for Roclanda® (netarsudil and latanoprost ophthalmic
solution) 0.02%/0.005% (marketed as Rocklatan® in the United
States) in January 2021. Aerie continues to prepare for pricing
discussions in Germany while evaluating potential collaboration
opportunities for Europe.
- Aerie and Santen announced in October 2020 that they executed
an exclusive license agreement for the development and
commercialization of Rhopressa® and Rocklatan® in Japan and several
other Asian countries, and the first Phase 3 clinical trial for
Rhopressa® in Japan is underway. The agreement included an upfront
payment to Aerie of $50.0 million, with net cash proceeds after
withholding taxes of $45.0 million received in the fourth quarter
of 2020.
- Aerie continues to evaluate the clinical and regulatory
pathways for Phase 3 clinical trials for AR-1105 (dexamethasone
steroid implant) in both the U.S. and European markets. This
follows the positive Phase 2 results for macular edema due to
retinal vein occlusion reported in July 2020, which indicated up to
six months of sustained release.
Net cash used in operating activities for the year ended
December 31, 2020 on a GAAP basis totaled approximately $64.7
million, resulting in $240.4 million in cash and cash equivalents
and investments as of December 31, 2020.
Fourth Quarter 2020 Financial Results
As of December 31, 2020, Aerie had cash and cash equivalents and
investments of $240.4 million, including the $45.0 million in net
cash proceeds from the Santen collaboration. For the fourth quarter
ended December 31, 2020, Aerie reported net product revenues of
$24.7 million related to the combined sales of Rhopressa® and
Rocklatan®. Aerie reported a GAAP net loss of $46.1 million, or
$1.00 net loss per share, compared to a net loss of $55.1 million
and $1.21 net loss per share for the fourth quarter of 2019. The
weighted average number of shares outstanding utilized in the
calculation of net loss per share was 46.0 million and 45.6 million
for the fourth quarters of 2020 and 2019, respectively. Total
shares outstanding as of December 31, 2020 were 46.8 million.
The $46.1 million net loss for the fourth quarter of 2020 is
primarily comprised of $18.1 million of gross profit, including
$6.5 million in cost of goods sold, and $53.7 million in total
operating expenses, including $35.0 million in selling, general and
administrative expenses and $18.7 million in research and
development expenses. The cost of goods sold includes $4.6 million
in idle capacity costs resulting from the Athlone manufacturing
plant having just recently become operational and not yet reaching
full capacity. Excluding $9.6 million of stock-based compensation
expense, for the fourth quarter of 2020 adjusted cost of goods sold
was $5.9 million and adjusted total operating expenses for the
fourth quarter of 2020 were $44.8 million, with adjusted selling,
general and administrative expenses of $28.4 million and adjusted
research and development expenses of $16.5 million. Total adjusted
net loss for the fourth quarter of 2020 was $36.5 million and
adjusted net loss per share was $0.79.
The $55.1 million net loss for the fourth quarter of 2019 was
primarily comprised of $23.0 million of gross profit, including
$1.7 million in cost of goods sold, $72.9 million in total
operating expenses, including $35.5 million in selling, general and
administrative expenses, $6.7 million in pre-approval commercial
manufacturing expenses and $30.8 million in research and
development expenses. Excluding $11.2 million of stock-based
compensation expense, adjusted total operating expenses for the
fourth quarter of 2019 were $61.7 million, with adjusted selling,
general and administrative expenses of $28.3 million, adjusted
pre-approval commercial manufacturing expenses of $5.5 million and
adjusted research and development expenses of $28.0 million. Total
adjusted net loss for the fourth quarter of 2019 was $43.9 million
and adjusted net loss per share was $0.96.
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. In addition,
AR-14034 slides will be discussed on the conference call and are
posted to Aerie's website. 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 9047298. 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
9047298. The telephone replay will be available until March 5,
2021.
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 product candidates 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 product candidates 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 product candidates 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 product candidates, preclinical implants 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 product candidates, preclinical
implants or future product candidates; the potential advantages of
Rhopressa® and Rocklatan® or any product candidates 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 expectations for
full year 2021; our ability to protect our proprietary technology
and enforce our intellectual property rights or to develop new
intellectual property; and our expectations regarding strategic
operations, including our ability to in-license or acquire
additional ophthalmic products, product candidates or technologies.
In particular, FDA and European Medicines Agency (EMA) approval of
Rhopressa® and Rocklatan® do not constitute regulatory approval of
Rhopressa® and Rocklatan® in other jurisdictions, and there can be
no assurance that we will receive regulatory approval for
Rhopressa® and Rocklatan® in such other jurisdictions. In addition,
FDA approval of Rhopressa® and Rocklatan® do not constitute FDA
approval of our product candidates or any future product
candidates, and there can be no assurance that we will receive FDA
approval for our product candidates or any future product
candidates. Furthermore, the acceptance of the Investigational New
Drug Applications (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 a New Drug
Application 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 (generally accepted accounting
principles), 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)
DECEMBER 31,
2020
2019
Assets
Current assets
Cash and cash equivalents
$
151,570
$
143,940
Short-term investments
88,794
165,250
Accounts receivable, net
56,022
38,354
Inventory
27,059
21,054
Prepaid expenses and other current
assets
8,310
7,744
Total current assets
331,755
376,342
Property, plant and equipment, net
54,260
58,147
Operating lease right-of-use-assets
14,084
16,523
Other assets
1,946
1,596
Total assets
$
402,045
$
452,608
Liabilities and Stockholders’
Equity
Current liabilities
Accounts payable
$
8,826
$
12,770
Accrued expenses and other current
liabilities
90,723
65,376
Operating lease liabilities
4,923
5,502
Total current liabilities
104,472
83,648
Convertible notes, net
210,373
188,651
Deferred revenue, non-current
50,858
—
Long-term operating lease liabilities
10,206
12,102
Other non-current liabilities
2,168
1,257
Total liabilities
378,077
285,658
Stockholders’ equity
Common stock
47
46
Additional paid-in capital
1,103,074
1,062,996
Accumulated other comprehensive loss
(52)
(92)
Accumulated deficit
(1,079,101)
(896,000)
Total stockholders’ equity
23,968
166,950
Total liabilities and stockholders’
equity
$
402,045
$
452,608
AERIE PHARMACEUTICALS,
INC.
Consolidated Statements of
Operations
(Unaudited)
(in thousands, except share and
per share data)
THREE MONTHS ENDED DECEMBER
31,
TWELVE MONTHS ENDED DECEMBER
31,
2020
2019
2020
2019
Product revenues, net
$
24,683
$
24,657
$
83,138
$
69,888
Total revenues, net
24,683
24,657
83,138
69,888
Costs and expenses:
Cost of goods sold
6,534
1,684
25,333
4,833
Selling, general and administrative
35,016
35,467
137,184
138,402
Pre-approval commercial manufacturing
—
6,650
2,304
22,767
Research and development
18,726
30,794
74,007
91,378
Total costs and expenses
60,276
74,595
238,828
257,380
Loss from operations
(35,593)
(49,938)
(155,690)
(187,492)
Other (expense) income, net
(5,266)
(5,126)
(22,166)
(12,179)
Loss before income taxes
(40,859)
(55,064)
(177,856)
(199,671)
Income tax expense (benefit)
5,278
—
5,245
(90)
Net loss
$
(46,137)
$
(55,064)
$
(183,101)
$
(199,581)
Net loss per common share—basic and
diluted
$
(1.00)
$
(1.21)
$
(3.99)
$
(4.39)
Weighted average number of common shares
outstanding—basic and diluted
45,973,297
45,589,014
45,897,255
45,427,154
AERIE PHARMACEUTICALS,
INC.
Reconciliation of GAAP to
Non-GAAP Financial Measures
(Unaudited)
(in thousands)
THREE MONTHS ENDED DECEMBER
31,
TWELVE MONTHS ENDED DECEMBER
31,
2020
2019
2020
2019
Net loss (GAAP)
$
(46,137)
$
(55,064)
$
(183,101)
$
(199,581)
Add-back: stock-based compensation
expense
9,590
11,172
40,095
45,093
Adjusted Net loss
$
(36,547)
$
(43,892)
$
(143,006)
$
(154,488)
Cost of goods sold (GAAP)
$
6,534
$
1,684
$
25,333
$
4,833
Less: stock-based compensation expense
$
(675)
$
—
$
(2,353)
$
—
Adjusted cost of goods sold
$
5,859
$
1,684
$
22,980
$
4,833
Selling, general and administrative
expenses (GAAP)
$
35,016
$
35,467
$
137,184
$
138,402
Less: stock-based compensation expense
(6,652)
(7,210)
(27,176)
(30,463)
Adjusted selling, general and
administrative expenses
$
28,364
$
28,257
$
110,008
$
107,939
Pre-approval commercial manufacturing
expenses (GAAP)
$
—
$
6,650
$
2,304
$
22,767
Less: stock-based compensation expense
—
(1,144)
(344)
(3,634)
Adjusted pre-approval commercial
manufacturing expenses
$
—
$
5,506
$
1,960
$
19,133
Research and development expenses
(GAAP)
$
18,726
$
30,794
$
74,007
$
91,378
Less: stock-based compensation expense
(2,263)
(2,818)
(10,222)
(10,996)
Adjusted research and development
expenses
$
16,463
$
27,976
$
63,785
$
80,382
Total operating expenses (GAAP)
$
53,742
$
72,911
$
213,495
$
252,547
Less: stock-based compensation expense
(8,915)
(11,172)
(37,742)
(45,093)
Adjusted total operating expenses
$
44,827
$
61,739
$
175,753
$
207,454
AERIE PHARMACEUTICALS,
INC.
Reconciliation of GAAP Net
Loss Per Share to Adjusted Net Loss Per Share
(Unaudited)
THREE MONTHS ENDED
DECEMBER 31,
TWELVE MONTHS ENDED
DECEMBER 31,
2020
2019
2020
2019
Net loss per common share—basic and
diluted (GAAP)
$
(1.00)
$
(1.21)
$
(3.99)
$
(4.39)
Add-back: stock-based compensation
expense
0.21
0.25
0.87
0.99
Adjusted Net loss per share—basic and
diluted
$
(0.79)
$
(0.96)
$
(3.12)
$
(3.40)
Weighted average number of common shares
outstanding—basic and diluted
45,973,297
45,589,014
45,897,255
45,427,154
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version on businesswire.com: https://www.businesswire.com/news/home/20210225005810/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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