First Quarter 2021 Net Revenue Per Bottle of
$89, up 11.3% over Fourth Quarter 2020
First Quarter 2021 Net Revenues of $23.0
Million Increased 12.9% over First Quarter 2020
Significant Progress Made Across the
Pipeline
Conference Call and Webcast Today, May 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 first
quarter ended March 31, 2021 and provided a general business
update.
“Our first quarter 2021 results reflect nearly 13 percent growth
in net revenues and 11 percent growth in bottle volumes for our
U.S. glaucoma franchise compared to the first quarter of 2020. Our
franchise has grown from the pre-COVID levels experienced in the
first quarter of 2020 whereas the overall U.S. glaucoma market
prescription volumes have declined six percent for the same period.
Our net revenue per bottle increased to $89 in the first quarter of
2021, the highest level since 2019, with a sequential quarter
increase of $9 per bottle, primarily due to renegotiated wholesaler
fees. We ended the first quarter with $208 million in cash and
investments and our net cash used in operations amounted to $30
million, compared to $42 million in the first quarter of 2020,
reflecting stronger revenues and continued well-controlled
operating expenses. 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 remain
comfortable with current consensus analyst estimates,” said Vicente
Anido, Jr., Ph.D., Chairman and Chief Executive Officer.
Dr. Anido added, “Turning to our pipeline, the COMET-1 Phase 2b
clinical trial of AR-15512, our dry eye product candidate, is now
fully enrolled and we continue to expect to read out topline data
from this clinical trial in the third-quarter of this year.
Regarding our sustained-release retinal implant, AR-1105, we 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.
We continue discussions with both the FDA and EMA to develop a
Phase 3 strategy for AR-1105 in the United States and Europe. Our
IND-enabling preclinical studies are underway for our new
preclinical implant, AR-14034 SR, for the potential treatment of
wet age-related macular degeneration and diabetic macular edema.
AR-14034 SR is 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 AR-14034 SR 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. From a globalization perspective, the first Phase 3
trial for Rhopressa® is well underway in Japan and our
collaboration with Santen remains on track as we prepare for
additional Phase 3 studies in Japan. We continue discussions with
multiple potential collaborators to commercialize our glaucoma
products in Europe and are hoping to announce a new collaboration
by year-end 2021.”
U.S. Glaucoma Franchise Highlights
- Rhopressa® and Rocklatan® generated first quarter 2021 net
revenues of $23.0 million, equivalent to an average of $89 per
bottle. Shipments to wholesalers totaled 257,000 bottles during the
first quarter of 2021.
- 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 59 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.
- Aerie recently announced the publication of a peer-reviewed
paper in eLife, a science journal, entitled, “Antifibrotic activity
of a rho-kinase inhibitor restores outflow function and intraocular
pressure homeostasis” in March 2021. The paper evaluates the
treatment effect of netarsudil, marketed as Rhopressa®, on
steroid-induced ocular hypertension in a mouse model and
steroid-induced glaucoma in humans. In the mouse model, netarsudil
reversed the tissue stiffness and fibrosis at the trabecular
meshwork. The paper also reviews clinical data for Rhopressa® from
retrospective chart reviews of two cohorts of patients with steroid
induced glaucoma whose IOP was not controlled on other medications.
When Rhopressa® was added, usually as a third or fourth medication,
patients achieved an average decrease in IOP of 7 to 8 mmHg
(millimeters of mercury).
Pipeline and Globalization Highlights
- COMET-1, Aerie’s Phase 2b clinical trial for its dry eye
product candidate, AR-15512, continues to progress forward. Aerie
currently expects topline results in the third quarter of 2021.
This now fully enrolled study was initiated in October 2020 and is
powered as a Phase 3 clinical trial.
- In April 2021, Roclanda® received marketing authorisation from
the Medicines and Healthcare Products Regulatory Agency (MHRA) in
Great Britain. Roclanda® was previously granted a marketing
authorisation by the European Commission (EC) in January 2021.
Discussions with potential collaborators in Europe are
ongoing.
- The first Phase 3 clinical trial for Rhopressa® in Japan began
in the fourth quarter of 2020. Aerie expects topline results in the
fourth quarter of 2021.
- 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.
- Investigational New Drug Application (IND)-enabling preclinical
studies are underway for AR-14034 SR, a sustained-release implant
containing the pan-VEGF inhibitor axitinib formulated in a unique
bio-erodible polymer blend using our exclusive PRINT®
technology.
- The first-in-human clinical trial for AR-13503 SR (Rho kinase
and protein kinase C inhibitor sustained-release implant),
continues to advance. Aerie currently expects to complete the dose
escalation safety evaluation with the current implant design in the
first quarter of 2022.
Net cash used in operating activities for the first quarter
ended March 31, 2021 on a GAAP basis totaled approximately $30.1
million, resulting in $208.2 million in cash and cash equivalents
and investments as of March 31, 2021.
First Quarter 2021 Financial Results
For the first quarter ended March 31, 2021, Aerie reported net
product revenues of $23.0 million related to the combined sales of
Rhopressa® and Rocklatan®. Aerie reported a GAAP net loss of $42.0
million, or $0.91 net loss per share, for the first quarter of
2021, compared to a net loss of $49.1 million and $1.07 net loss
per share for the first quarter of 2020. The weighted average
number of shares outstanding utilized in the calculation of net
loss per share was 46.1 million and 45.8 million for the first
quarters of 2021 and 2020, respectively. Total shares outstanding
as of March 31, 2021 were 46.9 million. As of March 31, 2021, Aerie
had cash and cash equivalents and investments of $208.2
million.
The $42.0 million net loss for the first quarter of 2021 is
primarily comprised of $16.3 million of gross profit, including
$6.7 million in cost of goods sold, and $50.5 million in total
operating expenses, including $32.6 million in selling, general and
administrative expenses and $17.9 million in research and
development expenses. The cost of goods sold includes $4.4 million
in idle capacity costs resulting from the Athlone manufacturing
plant having commenced operations earlier in 2020 and not having
yet reached full capacity. These idle capacity costs are expected
to decline over time as commercial volumes and clinical supply
requirements increase. Excluding $8.7 million of stock-based
compensation expense, for the first quarter of 2021 adjusted cost
of goods sold was $6.2 million and adjusted total operating
expenses were $42.2 million, with adjusted selling, general and
administrative expenses of $26.3 million and adjusted research and
development expenses of $15.9 million. Total adjusted net loss for
the first quarter of 2021 was $33.2 million and adjusted net loss
per share was $0.72.
The $49.1 million net loss for the first quarter of 2020 was
primarily comprised of $14.2 million of gross profit, including
$6.1 million in cost of goods sold, and $58.2 million in total
operating expenses, including $36.9 million in selling, general and
administrative expenses, $2.1 million in pre-approval commercial
manufacturing expenses and $19.2 million in research and
development expenses. The cost of goods sold includes $3.5 million
in idle capacity costs resulting from the Athlone manufacturing
plant having commenced operations earlier in 2020 and not having
yet reached full capacity. These idle capacity charges commenced
during the first quarter of 2020 and do not represent a full
quarter of activity. Excluding $10.5 million of stock-based
compensation expense, for the first quarter of 2020 adjusted cost
of goods sold was $5.6 million and adjusted total operating
expenses were $48.2 million, with adjusted selling, general and
administrative expenses of $30.0 million, adjusted pre-approval
commercial manufacturing expenses of $1.8 million and adjusted
research and development expenses of $16.3 million. Total adjusted
net loss for the first quarter of 2020 was $38.6 million and
adjusted net loss per share was $0.84.
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
2748249. 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 2748249. The telephone replay will be available until May
13, 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®, and MHRA authorisation of Roclanda® do
not constitute regulatory approval of Rhopressa®, Rocklatan® or
Roclanda® in other jurisdictions, and there can be no assurance
that we will receive regulatory approval for Rhopressa®, Rocklatan®
or Roclanda® 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 INDs by the FDA for AR-15512, AR-1105, AR-14034
and AR-13503 do not constitute FDA approval of AR-15512, AR-1105,
AR-14034 or AR-13503 and the outcomes of later clinical trials for
AR-15512, AR-1105, AR-14034 or AR-13503 may not be sufficient to
submit a New Drug Application (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 (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)
MARCH 31, 2021
DECEMBER 31, 2020
Assets
Current assets
Cash and cash equivalents
$
122,695
$
151,570
Short-term investments
85,509
88,794
Accounts receivable, net
46,150
56,022
Inventory
28,324
27,059
Prepaid expenses and other current
assets
10,899
8,310
Total current assets
293,577
331,755
Property, plant and equipment, net
53,283
54,260
Operating lease right-of-use assets
13,241
14,084
Other assets
2,627
1,946
Total assets
$
362,728
$
402,045
Liabilities and Stockholders’ (Deficit)
Equity
Current liabilities
Accounts payable
$
6,520
$
8,826
Accrued expenses and other current
liabilities
82,792
90,723
Operating lease liabilities
4,052
4,923
Total current liabilities
93,364
104,472
Convertible notes, net
216,088
210,373
Deferred revenue, non-current
51,605
50,858
Long-term operating lease liabilities
9,914
10,206
Other non-current liabilities
2,125
2,168
Total liabilities
373,096
378,077
Stockholders’ (deficit) equity
Common stock
47
47
Additional paid-in capital
1,110,714
1,103,074
Accumulated other comprehensive loss
(64
)
(52
)
Accumulated deficit
(1,121,065
)
(1,079,101
)
Total stockholders’ (deficit) equity
(10,368
)
23,968
Total liabilities and stockholders’
(deficit) equity
$
362,728
$
402,045
AERIE PHARMACEUTICALS,
INC. Consolidated Statements of Operations
(Unaudited) (in thousands, except share and per share
data)
THREE MONTHS ENDED MARCH
31,
2021
2020
Product revenues, net
$
22,970
$
20,341
Total revenues, net
22,970
20,341
Costs and expenses:
Cost of goods sold
6,700
6,092
Selling, general and administrative
32,598
36,902
Pre-approval commercial manufacturing
—
2,114
Research and development
17,891
19,173
Total costs and expenses
57,189
64,281
Loss from operations
(34,219
)
(43,940
)
Other (expense) income, net
(7,714
)
(5,222
)
Loss before income taxes
(41,933
)
(49,162
)
Income tax expense (benefit)
31
(33
)
Net loss
$
(41,964
)
$
(49,129
)
Net loss per common share—basic and
diluted
$
(0.91
)
$
(1.07
)
Weighted average number of common shares
outstanding—basic and diluted
46,109,080
45,792,504
AERIE PHARMACEUTICALS, INC.
Reconciliation of GAAP to Non-GAAP Financial Measures
(Unaudited) (in thousands)
THREE MONTHS ENDED MARCH
31,
2021
2020
Net loss (GAAP)
$
(41,964
)
$
(49,129
)
Add-back: stock-based compensation
expense
8,749
10,529
Adjusted Net loss
$
(33,215
)
$
(38,600
)
Cost of goods sold (GAAP)
$
6,700
$
6,092
Less: stock-based compensation expense
(507
)
(497
)
Adjusted cost of goods sold
$
6,193
$
5,595
Selling, general and administrative
expenses (GAAP)
$
32,598
$
36,902
Less: stock-based compensation expense
(6,255
)
(6,908
)
Adjusted selling, general and
administrative expenses
$
26,343
$
29,994
Pre-approval commercial manufacturing
expenses (GAAP)
$
—
$
2,114
Less: stock-based compensation expense
—
(294
)
Adjusted pre-approval commercial
manufacturing expenses
$
—
$
1,820
Research and development expenses
(GAAP)
$
17,891
$
19,173
Less: stock-based compensation expense
(1,987
)
(2,830
)
Adjusted research and development
expenses
$
15,904
$
16,343
Total operating expenses (GAAP)
$
50,489
$
58,189
Less: stock-based compensation expense
(8,242
)
(10,032
)
Adjusted total operating expenses
$
42,247
$
48,157
AERIE PHARMACEUTICALS,
INC. Reconciliation of GAAP Net Loss Per Share to Adjusted
Net Loss Per Share (Unaudited)
THREE MONTHS ENDED MARCH
31,
2021
2020
Net loss per common share—basic and
diluted (GAAP)
$
(0.91
)
$
(1.07
)
Add-back: stock-based compensation
expense
0.19
0.23
Adjusted Net loss per share—basic and
diluted
$
(0.72
)
$
(0.84
)
Weighted average number of common shares
outstanding—basic and diluted
46,109,080
45,792,504
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210505005852/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 Apr 2024 to May 2024
Aerie Pharmaceuticals (NASDAQ:AERI)
Historical Stock Chart
From May 2023 to May 2024