Conference Call and Webcast Today, May
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 first
quarter ended March 31, 2019, along with a general business
update.
Aerie Highlights
- The Rocklatan® (netarsudil and
latanoprost ophthalmic solution) 0.02%/0.005% U.S. commercial
launch is underway with the sales force actively calling on 14,000
eye care professionals. Upon launch, Rocklatan® had 60% of
commercial lives covered in non-preferred brand Tier 3.
- Rhopressa® (netarsudil ophthalmic
solution) 0.02% generated first quarter net revenues on a U.S. GAAP
(generally accepted accounting principles) basis of $10.9 million,
equivalent to an average of $100 per bottle, lower than prior
quarters as the result of a higher share of Medicare Part D
business. First-quarter 2019 net revenues reflect a higher
proportion of Medicare Part D rebates which are steeper than
commercial rebates, along with the increased level of
government-mandated donut hole funding in 2019 for Medicare Part D
programs.
- Rhopressa® now has preferred brand Tier
2 market access for approximately 75% of lives covered under
Medicare Part D plans. Rhopressa® also has approximately 90% of
lives covered under commercial plans, including 55% in preferred
brand Tier 2 and 35% in Tier 3.
- Rhopressa® shipments to wholesalers,
and from wholesalers to pharmacies, have been achieving record
levels in April and into May 2019. Rhopressa® sales out to
pharmacies totaled over 10,500 bottles for the week ended May 3rd,
compared to less than 9,600 bottles for the week ended March
29th.
- International expansion activities are
progressing. The Rhopressa® Phase 2 clinical trial in Japan
commenced in March 2019 in preparation for subsequent Phase 3
registration trials in Japan. The Rocklatan® Mercury 3 Phase 3
clinical trial continues to progress in Europe.
- Aerie’s retina program continues to
advance with the IND (Investigational New Drug application) for
AR-13503 (Rho kinase and Protein kinase C inhibitor implant)
accepted by the FDA (the U.S. Food and Drug Administration) in
April 2019. Clinical trials for this product candidate are expected
to commence in the second quarter of 2019 for wet age-related
macular degeneration and DME (diabetic macular edema). The AR-1105
(dexamethasone steroid implant) Phase 2 clinical trial commenced in
March 2019 for macular edema due to RVO (retinal vein occlusion).
Safety and efficacy data for AR-1105 will be evaluated at six
months after dosing.
- Net cash burn for the three months
ended March 31, 2019 was approximately $54 million, and cash
and cash equivalents were $148.9 million as of March 31, 2019.
In addition, with the $200 million in undrawn credit facility
capacity available, total liquidity was approximately $350 million
at March 31, 2019. Shares outstanding at March 31, 2019
totaled 45.9 million.
- Aerie reiterated that it expects
full-year 2019 net revenues in the range of $110 million to $120
million on a U.S. GAAP basis for the combined net revenues for
Rhopressa® and Rocklatan®.
- Aerie also reiterated its net cash burn
guidance for full-year 2019 in the range of $130 million to $140
million. This range includes the gross cash burn guidance of $210
million to $220 million, partially offset by estimated full-year
2019 revenue-related net cash inflows of $80 million, which
includes accounts receivable collections and rebate payments.
“We are now uniquely positioned with two very exciting glaucoma
products in the market. With the recent significant gains in
Rhopressa® market access for the Medicare Part D population, we are
proud to report that within only one year of launch we were able to
achieve extensive coverage both for Medicare Part D and
commercially insured lives, which we believe will further stimulate
future volume gains. Though just launched, we are seeing strong
physician interest in Rocklatan®, and we believe, based on its
demonstrated superiority to market-leading latanoprost in clinical
trials, that Rocklatan® will generate a significant presence in the
U.S. market for years to come. Rocklatan® is 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. Further, we continue to make
excellent progress with our expansion efforts in Europe and Japan
and are delighted that by the middle of 2019, we will have our two
retinal implant product candidates in the clinic,” said Vicente
Anido, Jr., Ph.D., Chairman and Chief Executive Officer.
Dr. Anido continued, “We currently have the highest level of
financial liquidity in Aerie history, at approximately $350
million. Based on our current estimates, this is more than we will
need to get to break-even and provides us the flexibility to
continue to support the growth of our pipeline.”
First Quarter 2019 Financial Results
As of March 31, 2019, Aerie had cash and cash equivalents
of $148.9 million. For the first quarter ended March 31, 2019,
Aerie reported net product revenues of $10.9 million related to
sales of Rhopressa®, which was launched in the United States on
April 30, 2018. Aerie reported a U.S. GAAP net loss of $48.0
million, or $1.06 loss per share, for the first quarter of 2019,
compared to a net loss of $40.7 million and $1.05 loss per share
for the first quarter of 2018. The weighted average number of
shares outstanding utilized in the calculation of net loss per
share was 45,270,660 and 38,598,827 for the first quarters of 2019
and 2018, respectively. Total shares outstanding as of
March 31, 2019 were 45,921,976.
The $48.0 million net loss for the first quarter of 2019 is
primarily comprised of $10.5 million of gross profit and $58.6
million in total operating expenses, including $36.3 million in
selling, general and administrative expenses, $4.5 million in
pre-approval commercial manufacturing expenses and $17.9 million in
research and development expenses. Excluding $12.6 million of
stock-based compensation expense, adjusted total operating expenses
for the first quarter of 2019 were $46.0 million, with adjusted
selling, general and administrative expenses of $27.2 million,
adjusted pre-approval commercial manufacturing expenses
of $3.6 million and adjusted research and development expenses
of $15.2 million. Total adjusted net loss for the first quarter of
2019 was $35.3 million, and adjusted net loss per share was
$0.78.
The $40.7 million net loss for the first quarter of 2018 is
primarily comprised of $40.8 million in total operating expenses,
including $22.9 million in selling, general and administrative
expenses, $4.9 million in pre-approval commercial manufacturing
expenses and $13.0 million in research and development expenses.
Excluding $8.7 million of stock-based compensation expense,
adjusted total operating expenses for the first quarter of 2018
were $32.1 million, with adjusted selling, general and
administrative expenses of $16.7 million, adjusted pre-commercial
manufacturing expenses of $4.4 million and adjusted research and
development expenses of $10.9 million. Total adjusted net loss for
the first quarter of 2018 was $32.1 million, and adjusted net loss
per share was $0.83.
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 6786103. 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 6786103. The telephone replay will be
available until May 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,
has been approved by the FDA and 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 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® or any future product candidates, including the timing,
cost or other aspects of the commercial launch of Rhopressa® and
Rocklatan® or any future product candidates; 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 or additional indications, 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 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 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 future product
candidates; the potential advantages of Rhopressa® and Rocklatan®
or any future product candidates; our plans to pursue development
of additional product candidates and technologies within and beyond
ophthalmology; our plans to explore possible uses of our existing
proprietary compounds beyond glaucoma, including development of our
retina program; our ability to protect our proprietary technology
and enforce our intellectual property rights; and our expectations
regarding strategic operations, including our ability to in-license
or acquire additional ophthalmic products, product candidates or
technologies. 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 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)
MARCH 31, 2019 DECEMBER 31, 2018
Assets Current assets Cash and cash equivalents $ 148,868 $
202,818 Accounts receivable, net 14,758 2,715 Inventory 10,192
10,112 Prepaid expenses and other current assets 6,499 4,530
Total current assets 180,317 220,175 Property, plant and
equipment, net 62,982 60,525 Operating lease right-of-use assets
16,394 — Other assets 3,357 4,344
Total assets
$ 263,050 $ 285,044
Liabilities and
Stockholders’ Equity Current liabilities Accounts payable $
11,121 $ 12,403 Accrued expenses and other current liabilities
35,810 38,381 Operating lease liabilities 5,032 —
Total current liabilities 51,963 50,784 Long-term operating lease
liabilities 12,044 — Other non-current liabilities 6,893
6,454 Total liabilities 70,900 57,238
Stockholders' equity Common stock 46 45 Additional paid-in capital
936,474 924,180 Accumulated deficit (744,370 ) (696,419 ) Total
stockholders’ equity 192,150 227,806
Total
liabilities and stockholders’ equity $ 263,050 $ 285,044
AERIE PHARMACEUTICALS, INC.
Consolidated Statements of
Operations
(Unaudited)
(in thousands, except share and per share
data)
THREE MONTHS ENDEDMARCH
31,
2019 2018 Product revenues, net $ 10,852
$ — Total revenues, net 10,852 — Costs
and expenses: Cost of goods sold 381 — Selling, general and
administrative 36,282 22,930 Pre-approval commercial manufacturing
4,457 4,893 Research and development 17,884 12,972
Total costs and expenses 59,004 40,795 Loss from
operations (48,152 ) (40,795 ) Other income (expense), net 111
96 Loss before income taxes (48,041 ) (40,699 )
Income tax benefit (90 ) — Net loss $ (47,951 ) $ (40,699 )
Net loss per common share—basic and diluted $ (1.06 ) $ (1.05 )
Weighted average number of common shares outstanding—basic and
diluted 45,270,660 38,598,827
AERIE PHARMACEUTICALS, INC.
Reconciliation of GAAP to Non-GAAP
Financial Measures
(Unaudited)
(in thousands)
THREE MONTHS ENDEDMARCH
31,
2019 2018 Net loss (GAAP) $ (47,951 ) $
(40,699 ) Add-back: stock-based compensation expense 12,620
8,719 Adjusted Net loss $ (35,331 ) $ (31,980 )
Selling, general and administrative expenses (GAAP) $ 36,282 $
22,930 Less: stock-based compensation expense (9,121 ) (6,214 )
Adjusted selling, general and administrative expenses $ 27,161
$ 16,716 Pre-approval commercial manufacturing
expenses (GAAP) $ 4,457 $ 4,893 Less: stock-based compensation
expense (849 ) (470 ) Adjusted pre-approval commercial
manufacturing expenses $ 3,608 $ 4,423
Research and development expenses (GAAP) $ 17,884 $ 12,972 Less:
stock-based compensation expense (2,650 ) (2,035 ) Adjusted
research and development expenses $ 15,234 $ 10,937
Total operating expenses (GAAP) $ 58,623 $ 40,795 Less:
stock-based compensation expense (12,620 ) (8,719 ) Adjusted total
operating expenses $ 46,003 $ 32,076
AERIE PHARMACEUTICALS, INC.
Reconciliation of GAAP Net Loss Per
Share to Adjusted Net Loss Per Share
(Unaudited)
THREE MONTHS ENDEDMARCH
31,
2019 2018 Net loss per common share—basic and
diluted (GAAP) $ (1.06 ) $ (1.05 ) Add-back: stock-based
compensation expense 0.28 0.22 Adjusted Net loss per
share—basic and diluted $ (0.78 ) $ (0.83 ) Weighted average number
of common shares outstanding—basic and diluted 45,270,660
38,598,827
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version on businesswire.com: https://www.businesswire.com/news/home/20190507005617/en/
Aerie Pharmaceuticals
Media: Tad Heitmann 949-526-8747;
theitmann@aeriepharma.comInvestors: Ami Bavishi 908-947-3949;
abavishi@aeriepharma.com
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