RVL Pharmaceuticals plc (“RVL” or “the Company”), a specialty
pharmaceutical company focused on the commercialization of UPNEEQ®
(oxymetazoline hydrochloride ophthalmic solution), 0.1%, for the
treatment of acquired blepharoptosis, or droopy eyelid, in adults,
today announced that certain of its U.S. operating subsidiaries,
RevitaLid Pharmaceutical Corp., RVL Pharmaceuticals, Inc. and RVL
Pharmacy, LLC (the “RVL Subsidiaries”), have reached an agreement
with their sole secured lenders, funds managed by Athyrium Capital
Management (“Athyrium”), and other key stakeholders, to effectuate
a change of control transaction through prepackaged bankruptcy
cases commenced in the United States Bankruptcy Court for the
District of Delaware today (the “Reorganization”). The
Reorganization provides a structured pathway for the RVL
Subsidiaries to significantly reduce their debt, while enabling
them to streamline operations, maintain jobs and position
themselves under new ownership. As a result of the Reorganization,
RVL is expected to commence the wind-down of any remaining
operations of the Company and its subsidiaries, other than the RVL
Subsidiaries. RVL’s public equity is expected to be cancelled upon
completion of its wind-down, anticipated to be during 2024, likely
resulting in no recovery to public shareholders.
Under the Reorganization, funds managed by
Athyrium will exchange their outstanding debt into equity of a
newly formed entity that will either (1) directly hold 100% of the
equity interests of Revitalid Pharmaceutical, Corp., which is
currently an indirect wholly owned subsidiary of the Company, or
(2) indirectly hold 100% of the equity interests of RVL
Pharmaceuticals, Inc., which is currently a wholly owned subsidiary
of Revitalid Pharmaceutical, Corp. and the direct parent of RVL
Pharmacy, LLC. In addition, funds managed by Athyrium
are committed to providing incremental financing facilities to
support the RVL Subsidiaries’ operations during the Reorganization
and to support their long-term growth and liquidity. The
Reorganization will enhance the RVL Subsidiaries’ ability to invest
in UPNEEQ, accelerate their strategic initiatives, and allow for
the continued delivery of high-quality, innovative ocular and
aesthetic solutions for patients and healthcare partners. The
Reorganization contemplates that all of RVL Subsidiaries’ vendors,
suppliers, and customers will be unaffected by the Reorganization,
and their employees will remain employed by these entities.
Brian Markison, Chief Executive Officer and
Chairman of the Company’s Board of Directors, commented, “This is a
significant step forward in securing RVL’s future, ensuring we
continue to meet the demands of our patients while also executing
our long-term growth strategy. As we move forward, we remain
committed to realizing the full commercial potential of
UPNEEQ.”
The RVL Subsidiaries are being advised by Ropes
& Gray LLP, Richards, Layton & Finger, P.A., and A&L
Goodbody LLP as legal counsel, Ernst & Young LLP as financial
advisor, and Ducera Partners LLC as investment banker.
Additional Reorganization Information:
The RVL Subsidiaries have filed a series of “First Day Motions”
with the United States Bankruptcy Court for the District of
Delaware. For more information about the Reorganization,
including access to court filings and other documents, please visit
https://restructuring.ra.kroll.com/RVL. Interested parties
who may have questions related to the Reorganization may call the
responsible claims agent at (844) 870-7074 (U.S./Canada, toll-free)
or +1 (646) 651-1184 (international, toll) or email inquiries at
RVLInfo@ra.kroll.com.
For media inquiries, please contact:
Lisa M. WilsonIn-Site Communications, Inc.T: 212-452-2793E:
lwilson@insitecony.com
About the Company
RVL Pharmaceuticals plc is a specialty
pharmaceutical company focused on the commercialization of UPNEEQ®
(oxymetazoline hydrochloride ophthalmic solution), 0.1%, for the
treatment of acquired blepharoptosis, or low-lying eyelid, in
adults. UPNEEQ is the first non-surgical treatment option approved
by the FDA for acquired blepharoptosis.
IMPORTANT SAFETY INFORMATION
INDICATION
UPNEEQ® (oxymetazoline hydrochloride ophthalmic
solution), 0.1%, is indicated for the treatment of acquired
blepharoptosis in adults.
WARNINGS AND PRECAUTIONS
- Ptosis
Association: Ptosis may be associated with neurologic or
orbital diseases such as stroke, cerebral aneurysm, Horner
syndrome, myasthenia gravis, external ophthalmoplegia, orbital
infection, and orbital masses. Consider these conditions in the
presence of ptosis with decreased levator muscle function and/or
other neurologic signs.
- Cardiovascular
Impact: Alpha-adrenergic agonists as a class may impact
blood pressure. Advise UPNEEQ patients with cardiovascular disease,
orthostatic hypotension, and/or uncontrolled hypertension or
hypotension to seek medical care if their condition worsens.
- Use with Caution:
Use UPNEEQ with caution in patients with cerebral or coronary
insufficiency or Sjögren’s syndrome. Advise patients to seek
medical care if signs and symptoms of potentiation of vascular
insufficiency develop.
- Glaucoma Risk:
UPNEEQ may increase the risk of angle closure glaucoma in patients
with untreated narrow-angle glaucoma. Advise patients to seek
immediate medical care if signs and symptoms of acute narrow-angle
glaucoma develop.
- Container Safety:
Patients should not touch the tip of the single patient-use
container to their eye or to any surface, in order to avoid eye
injury or contamination of the solution.
ADVERSE REACTIONS
Adverse reactions that occurred in 1-5% of
subjects treated with UPNEEQ include punctate keratitis,
conjunctival hyperemia, dry eye, blurred vision, instillation site
pain, eye irritation, and headache.
DRUG INTERACTIONS
- Blood Pressure:
Alpha-adrenergic agonists, as a class, may impact blood pressure.
Exercise caution when using drugs such as beta-blockers,
anti-hypertensives, and/or cardiac glycosides.
- Metabolism:
Caution is advised in patients taking monoamine oxidase inhibitors,
which can affect the metabolism and uptake of circulating
amines.
Cautionary Note Regarding Forward-Looking
Statements
This press release includes statements that
express the Company’s opinions, expectations, beliefs, plans,
objectives, assumptions or projections regarding future events or
future results and therefore are, or may be deemed to be,
“forward-looking statements.” The Company’s actual results may vary
significantly from the results anticipated in these forward-looking
statements, which can generally be identified by the use of
forward-looking terminology, including the terms “believes,”
“expects,” “may,” “will,” “should,” “seeks,” “projects,”
“approximately,” “intends,” “plans,” “targets,” “estimates” or
“anticipates,” or, in each case, their negatives or other
variations or comparable terminology. These forward-looking
statements include all matters that are not historical facts. They
include statements regarding the Company’s intentions, beliefs or
current expectations concerning, among other things, the
Reorganization and the winding down of RVL, its results of
operations, financial condition, liquidity, prospects, financial
guidance, growth plan, strategies, trends and other events,
particularly relating to sales of UPNEEQ, the rollout of Elevate,
our next generation ecommerce portal, and our future marketing mix
shift to consumers, expectations regarding our total addressable
market and consumer awareness, plans to potentially partner with or
acquire companies to support growth and integrate into our
infrastructure and the potential synergies resulting from such
partnership or acquisition, the continuation of historical trends,
its ability to manage costs and service its debt and the
sufficiency of its cash balances and cash generated from operating
and financing activities for future liquidity and capital resource
needs. By their nature, forward-looking statements involve risks
and uncertainties because they relate to events and depend on
circumstances that may or may not occur in the future. The Company
may not achieve the plans, intentions or expectations disclosed in
its forward-looking statements, and you should not place
significant reliance on its forward-looking statements. Actual
results or events could differ materially from the plans,
intentions and expectations disclosed in the forward-looking
statements the Company makes. Important factors that could cause
actual results and events to differ materially from those indicated
in the forward-looking statements include the following: UPNEEQ’s
ability to reach market acceptance by clinicians and patients; the
Company’s ability to successfully commercialize UPNEEQ; customers’
willingness to pay the price the Company charges for UPNEEQ; the
results of the Company’s marketing and sales expenditures; the
Company’s dependence on third-party suppliers and distributors for
UPNEEQ; UPNEEQ’s ability to produce its intended effects; the
impact of legal proceedings; and other risks and uncertainties more
fully described in the “Risk Factors” section of the Company’s
Annual Report on Form 10-K filed on March 20, 2023, its Quarterly
Report on Form 10-Q filed on May 11, 2023, its Quarterly Report on
Form 10-Q filed on August 14, 2023, and other filings that the
Company makes with the Securities and Exchange Commission. These
forward-looking statements speak only as of the time of this press
release and the Company does not undertake to publicly update or
revise them, whether as a result of new information, future events
or otherwise, except as required by law.
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