Aerie Pharmaceuticals Announces Full-Year 2019 Net Revenue and Net Cash Burn Guidance
March 12 2019 - 6:30PM
Business Wire
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20190312005936/en/
Media: Tad Heitmann 949-526-8747; theitmann@aeriepharma.comInvestors: Ami Bavishi
908-947-3949; abavishi@aeriepharma.com
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