DURHAM, N.C.--(BUSINESS WIRE)--Mar. 12, 2019--
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
announced full-year 2019 net revenue and net cash burn guidance.
Aerie Guidance Highlights
-
With the recently announced FDA approval of RocklatanTM
(netarsudil and latanoprost ophthalmic solution) 0.02%/0.005%, the
Company announced full-year 2019 net revenue guidance in the range of
$110 million to $120 million. This guidance includes the combined net
revenues for Rhopressa® (netarsudil ophthalmic solution)
0.02% and RocklatanTM. As previously announced, the Company
does not intend to provide separate guidance for each product.
-
Net cash burn guidance for full-year 2019 is estimated in the range of
$130 million to $140 million. This range includes the gross cash burn
guidance previously provided 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.
Including the $100 million undrawn credit facility available to the
Company, year-end 2019 total liquidity is estimated to be in the range
of $160 million to $170 million based on the net cash burn guidance
range above.
“Now that we have RocklatanTM approved, and the Rhopressa®
launch is well underway, we are delighted to provide full-year
2019 net revenue guidance in the range of $110 million to $120 million.
We expect to launch RocklatanTM in early May 2019 and hope to
gain meaningful RocklatanTM market access for commercial and
Medicare Part D plans as the year progresses. Since we anticipate
significant gains in preferred tier equivalent market access for
Rhopressa® in second-quarter 2019 and RocklatanTM was
just approved, the large majority of our 2019 net revenue guidance is
expected to be achieved later in the year. In addition to normal first
quarter variability in wholesaler ordering patterns, there may also be
an impact from the anticipated RocklatanTM launch. Lastly,
our full-year 2019 net cash burn guidance, which includes the partially
offsetting effect of revenue-related collections, points to our
well-financed position,” said Vicente Anido, Jr., Ph.D., Chairman and
Chief Executive Officer.
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 eyedrop 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, 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 is expected to be launched in the United States
in the second quarter of 2019. 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; our net revenue and net cash burn
guidance for the full-year 2019; 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.
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190312005936/en/
Source: Aerie Pharmaceuticals, Inc.
Media: Tad Heitmann 949-526-8747; theitmann@aeriepharma.com
Investors:
Ami Bavishi 908-947-3949; abavishi@aeriepharma.com
