Conference Call and Webcast Today, March 7,
at 5:00 p.m. ET
Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), a clinical-stage
pharmaceutical company focused on the discovery, development, and
commercialization of first-in-class therapies for the treatment of
patients with glaucoma and other diseases of the eye, today
reported financial results for the fourth quarter and full year
ended December 31, 2016, along with a general business update.
Aerie Highlights and Outlook
- Rhopressa™ (netarsudil ophthalmic
solution) 0.02% NDA (new drug application) filing was resubmitted
on February, 28, 2017, with a standard one-year FDA review expected
from the date of resubmission.
- Topline six-month efficacy and safety
data from Rocket 4, the Rhopressa™ Phase 3 clinical trial designed
to provide adequate safety data for European regulatory filings,
are expected in the second quarter of 2017.
- Topline 90-day efficacy and safety data
from the second Phase 3 clinical trial for Roclatan™
(netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, named
Mercury 2, are also expected in the second quarter of 2017. If both
Mercury 1 and Mercury 2 are successful, the Roclatan™ NDA is
expected to be filed in late 2017 or early 2018.
- As of December 31, 2016, Aerie had
$233.7 million in cash, cash equivalents, and investments. For the
full year ended December 31, 2016, cash burn totaled $84.9 million,
in line with our previous guidance of $85 million.
- Cash burn for 2017 is expected to
approximate $100 million and includes the previously announced $16
million in Ireland manufacturing plant capital build-out costs.
Projected operating expenses for 2017 are similar to 2016, with
increased commercialization and scale-up expenses offset by
reductions in clinical spend.
“We are off to a great start in 2017, with over $230 million in
cash and investments, our Rhopressa™ NDA resubmitted, and our
readouts from Rocket 4 and Mercury 2 on track for the second
quarter of this year. We also look forward to commencing our first
European clinical trial for Roclatan™, known as Mercury 3, in
mid-2017,” said Vicente Anido, Jr., Ph.D., Chairman and Chief
Executive Officer.
Dr. Anido continued, “Our strategic initiatives, including our
ongoing review of drug delivery technologies, our progress in
defining our clinical trial path forward in Japan, and the
commencement of build-out of our Ireland manufacturing plant, are
also all proceeding on plan.”
Fourth Quarter 2016 Financial Results
As of December 31, 2016, Aerie had cash, cash equivalents, and
investments of $233.7 million. For the fourth quarter ended
December 31, 2016, Aerie reported a net loss attributable to common
stockholders, as measured in accordance with U.S. generally
accepted accounting principles (“GAAP”), of $29.3 million, or $0.87
per share, compared to $20.4 million and $0.76 per share for the
fourth quarter of 2015. The weighted average number of shares of
common stock outstanding utilized in the calculation of net loss
per common share was 33,613,375 and 26,593,158 for the fourth
quarters of 2016 and 2015, respectively. Total shares outstanding
as of December 31, 2016 were 33,458,607.
The $29.3 million net loss attributable to common stockholders
for the fourth quarter of 2016 includes $28.8 million in operating
expenses, reflecting $14.1 million in research and development
expenses and $14.7 million in general and administrative expenses.
Excluding $5.3 million of non-cash stock-based compensation
expense, adjusted operating expenses for the fourth quarter of 2016
were $23.5 million, with adjusted research and development expenses
of $12.5 million and adjusted general and administrative expenses
of $11.0 million. Total adjusted net loss for the fourth quarter of
2016 was $24.0 million, and adjusted net loss per share was
$0.72.
The $20.4 million net loss attributable to common stockholders
for the fourth quarter of 2015 includes $20.0 million in operating
expenses, reflecting $12.3 million in research and development
expenses and $7.7 million in general and administrative expenses.
Excluding $3.4 million of non-cash stock-based compensation
expense, adjusted operating expenses for the fourth quarter of 2015
were $16.5 million, with adjusted research and development expenses
of $11.5 million and adjusted general and administrative expenses
of $5.0 million. Total adjusted net loss for the fourth quarter of
2015 was $17.0 million, and adjusted net loss per share was
$0.64.
The higher operating expenses in the fourth quarter of 2016 as
compared to the fourth quarter of 2015 primarily reflect the
expansion of our employee base to support the growth of our
operations, including clinical activities related to our Phase 3
programs for our product candidates, and activities associated with
preparing for commercialization efforts.
Conference Call / Web Cast 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 61259874. 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 61259874. The telephone replay will be
available until March 14, 2017.
About Aerie Pharmaceuticals, Inc.
Aerie is a clinical-stage pharmaceutical company focused on the
discovery, development and commercialization of first-in-class
therapies for the treatment of patients with glaucoma and other
diseases of the eye. Aerie's two lead product candidates are
once-daily intraocular pressure lowering therapies with novel
mechanisms of action to treat patients with glaucoma or ocular
hypertension. The NDA filing for Rhopressa™ (netarsudil ophthalmic
solution) 0.02% was resubmitted to the FDA in February 2017.
Aerie’s second product candidate, Roclatan™ (netarsudil/latanoprost
ophthalmic solution) 0.02%/0.005%, is a fixed dose combination of
Rhopressa™ and latanoprost, a widely prescribed prostaglandin
analogue. Roclatan™ currently has two Phase 3 registration trials
underway, named Mercury 1 and Mercury 2. If these trials are
successful, an NDA for Roclatan™ is expected to be filed in late
2017 or early 2018. Aerie is also focused on the development of
additional product candidates and technologies in
ophthalmology.
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: the success, timing
and cost of our ongoing and anticipated preclinical studies and
clinical trials for our current product candidates, including
statements regarding the timing of initiation and completion of the
studies and trials; our expectations regarding the clinical
effectiveness of our product candidates and results of our clinical
trials; the timing of and our ability to obtain and maintain U.S.
Food and Drug Administration or other regulatory authority approval
of, or other action with respect to, our product candidates; our
expectations regarding the commercialization and manufacturing of
our product candidates; our expectations related to the use of
proceeds from our equity and debt financings; our estimates
regarding expected cash burn and expenses, anticipated capital
requirements and our needs for additional financing; the potential
advantages of our product candidates; our plans to pursue
development of our product candidates for additional indications
and other therapeutic opportunities; our plans to explore possible
uses of our existing proprietary compounds beyond glaucoma; 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 or product candidates. By
their nature, forward-looking statements involve risks and
uncertainties because they relate to events, competitive dynamics
and industry change, and depend on regulatory approvals and
economic 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,
the preclinical research discussed in this press release is
preliminary and the outcome of such preclinical studies may not be
predictive of the outcome of later clinical trials. Any future
clinical trial results may not demonstrate safety and efficacy
sufficient to obtain regulatory approval related to the preclinical
research findings discussed in this press release. 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 operating expenses, adjusted research and
development expenses, adjusted general and administrative expenses,
adjusted other income (expense) and adjusted net loss per share.
For a description of the adjusted calculations and reconciliations
to the nearest GAAP measures, please see the “Reconciliation of
GAAP Net Loss to Adjusted Net Loss” 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 non-cash 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 is providing adjusted information
that excludes certain items because of the nature of these items
and the impact they have on the analysis of underlying business
performance and trends. Management believes that providing this
information enhances investors' understanding of the Company's
performance.
This information should be considered in addition to, but not in
lieu of, information prepared in accordance with GAAP. Explanation
of adjustments:
(a) Stock-based compensation: Excludes
non-cash stock-based compensation.
AERIE
PHARMACEUTICALS, INC. Consolidated Balance Sheets
(Unaudited) (in thousands, except share and per share data)
DECEMBER 31, DECEMBER 31, 2016
2015 Assets Current assets Cash and cash equivalents
$ 197,945 $ 91,060 Short-term investments 35,717 45,502 Prepaid
expenses and other current assets 4,028 1,865 Total
current assets 237,690 138,427 Long-term investments - 13,808
Furniture, fixtures and equipment, net 7,857 3,816 Other assets,
net 2,707 3,076 Total assets $ 248,254 $ 159,127
Liabilities and Stockholders’ Equity Current
liabilities Accounts payable and other current liabilities $ 18,820
$ 16,565 Interest payable 551 551 Total current
liabilities 19,371 17,116 Convertible notes, net of discounts
123,539 123,236 Total liabilities 142,910
140,352 Commitments and contingencies Stockholders’ Equity
Preferred stock, $0.001 par value; 15,000,000 shares authorized as
of December 31, 2016 and December 31, 2015; None issued and
outstanding — — Common stock, $0.001 par value; 150,000,000 shares
authorized as of December 31, 2016 and December 31, 2015;
33,458,607 and 26,458,495 shares issued and outstanding as of
December 31, 2016 and December 31, 2015, respectively 33 26
Additional paid-in capital 422,002 236,492 Accumulated other
comprehensive loss (68) (179) Accumulated deficit (316,623)
(217,564) Total stockholders’ equity 105,344
18,775 Total liabilities and stockholders’ equity $ 248,254 $
159,127
AERIE PHARMACEUTICALS, INC.
Consolidated Statements of Operations and Comprehensive Loss
(Unaudited) (in thousands, except share and per share data)
THREE MONTHS ENDED TWELVE MONTHS ENDED DECEMBER
31, DECEMBER 31, 2016 2015 2016
2015 Operating expenses General and administrative $
(14,664) $ (7,648) $ (44,478) $ (30,635) Research and development
(14,093) (12,302) (52,394) (44,451)
Loss from operations (28,757) (19,950) (96,872) (75,086) Other
income (expense), net (504) (512) (1,994)
862 Net loss before income taxes (29,261) (20,462) (98,866)
(74,224) Income tax expense (61) 85 (193)
(139) Net loss $ (29,322) $ (20,377) $ (99,059) $ (74,363)
Net loss attributable to common stockholders—basic and
diluted $ (29,322) $ (20,377) $ (99,059) $ (74,363) Net loss
per share attributable to common stockholders—basic and diluted $
(0.87) $ (0.76) $ (3.40) $ (2.88) Weighted average number of
common shares outstanding—basic and diluted 33,613,375
26,593,158 29,135,583 25,781,230 Net
loss (29,322) (20,377) (99,059) (74,363) Unrealized (loss) gain on
available-for-sale investments (55) (147) 111
(72) Comprehensive loss $ (29,377) $ (20,524) $ (98,948) $
(74,435)
Aerie Pharmaceuticals,
Inc. Reconciliation of GAAP Net Loss to Adjusted Net
Loss (Unaudited) (in thousands)
THREE MONTHS ENDED TWELVE MONTHS ENDED
DECEMBER 31, DECEMBER 31, 2016 2015
2016 2015 Net loss attributable to common
stockholders – basic and diluted: Net loss attributable to
common stockholders – basic and diluted (GAAP) $ (29,322) $
(20,377) $ (99,059) $ (74,363)
Adjustments: Stock-based
compensation (a) 5,280 3,412 16,794 12,945
Adjusted Net loss
$ (24,042) $ (16,965) $ (82,265) $
(61,418) Operating expenses: General and
administrative expense: General and administrative expense
(GAAP) $ (14,664) $ (7,648) $ (44,478) $ (30,635)
Adjustments: Stock-based compensation (a) 3,718 2,603 13,013
10,445
Adjusted general and administrative expense $
(10,946) $ (5,045) $ (31,465) $ (20,190)
Research and development expense: Research and
development expense (GAAP) $ (14,093) $ (12,302) $ (52,394) $
(44,451)
Adjustments: Stock-based compensation (a) 1,562 809
3,781 2,500
Adjusted research and development expense $
(12,531) $ (11,493) $ (48,613) $ (41,951)
Operating expenses (GAAP) $ (28,757) $ (19,950) $ (96,872) $
(75,086)
Adjustments: Stock-based compensation (a) 5,280
3,412 16,794 12,945
Adjusted operating expenses $
(23,477) $ (16,538) $ (80,078) $ (62,141)
Other income (expense): Other income (expense) (GAAP)
$ (504) $ (512) $ (1,994) $ 862
Adjustments: — — — —
Adjusted other income (expense) $ (504) $
(512) $ (1,994) $ 862
Aerie Pharmaceuticals, Inc. Reconciliation of GAAP Net
Loss Per Share to Adjusted Net Loss Per Share
(Unaudited) THREE MONTHS
ENDED TWELVE MONTHS ENDED DECEMBER 31,
DECEMBER 31, 2016 2015 2016 2015
Net loss per share attributable to common stockholders – basic
and diluted: Net loss per share attributable to common
stockholders – basic and diluted (GAAP) $ (0.87) $ (0.76) $ (3.40)
$ (2.88)
Adjustments: Stock-based compensation (a) 0.15 0.12
0.58 0.50
Adjusted Net loss per share $ (0.72) $
(0.64) $ (2.82) $ (2.38)
Weighted average number of common shares outstanding –
basic and diluted 33,613,375 26,593,158
29,135,583 25,781,230 Aerie is providing
adjusted information that excludes certain items because of the
nature of these items and the impact they have on the analysis of
underlying business performance and trends. Management believes
that providing this information enhances investors' understanding
of the Company's performance. This information should be considered
in addition to, but not in lieu of, information prepared in
accordance with GAAP. Explanation of adjustments:
(a)
Stock-based compensation: Exclude the non-cash stock-based
compensation.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170307005200/en/
Aerie PharmaceuticalsRichard
Rubino, 908-947-3540rrubino@aeriepharma.comorBurns McClellan,
Inc., on behalf of Aerie PharmaceuticalsAmi
Bavishi, 212-213-0006abavishi@burnsmc.com
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