Acquisition Represents Significant
Opportunity for Growth in Prescription Dry Eye Segment
Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye
health company dedicated to helping people see better to live
better, today announced it has entered into a definitive agreement
with Novartis under which Bausch + Lomb will acquire XIIDRA®
(lifitegrast ophthalmic solution) 5%, a non-steroid eye drop
specifically approved to treat the signs and symptoms of dry eye
disease (DED) focusing on inflammation associated with dry eye.
“This acquisition is a prime example of our strategy in action,
as it provides needed scale for the company and transforms our
pharmaceuticals business by making us a leader in ocular surface
diseases,” said Brent Saunders, chairman and CEO, Bausch + Lomb.
“The deal is also expected to accelerate margin expansion through a
larger mix of pharmaceutical products in our portfolio, provide
strong and immediate earnings accretion and presents a clear path
to deleverage, making it financially compelling.”
The strategic acquisition of XIIDRA will complement Bausch +
Lomb’s existing dry eye portfolio that includes eye and contact
lens drops from the company’s consumer brand franchises and its
pharmaceutical business that features MIEBO™ (perfluorohexyloctane
ophthalmic solution), which was recently approved by the U.S Food
and Drug Administration (“FDA”) as the first and only approved eye
drop for DED that directly targets tear evaporation. XIIDRA and
MIEBO work differently to target distinct elements of the DED
cycle.
DED, which is one of the most common ocular surface disorders1,
affects approximately 38 million people in the United States alone
and approximately 739 million people worldwide.2 As lifestyles
change and people are spending more time on digital screens,
research demonstrates the overall prevalence of DED in the United
States has increased in the past decade, including in younger adult
patients (ages 18 to 34).3
“Dry eye disease is multi-factorial and can stem from varying
root causes, which means differing treatment options are needed,”
said Marguerite McDonald, M.D., F.A.C.S., OCLI Vision, Oceanside,
N.Y. “With the acquisition of XIIDRA and recent approval of MIEBO,
Bausch + Lomb enhances its approach to different facets of dry eye
and is well positioned to ensure both medicines reach as many
patients as possible.”
The prescription U.S. DED field is expected to grow at a
double-digit compounded annual growth rate over the next five
years.4 XIIDRA, which generated approximately $487 million in sales
in 2022, is patented through 2033.
As part of the transaction, Bausch + Lomb will also acquire
libvatrep (also known as SAF312), an investigational compound being
studied for the treatment of chronic ocular surface pain, and
AcuStream™ technology, an investigational device that may have the
potential to facilitate precise dosing and accurate delivery of
certain topical ophthalmic medications to the eye.5,6 Libvatrep is
currently in Phase 2b development with study results expected in
the third quarter of 2023.
Transaction Details
Under the terms of the agreement, Bausch + Lomb, through an
affiliate, has agreed to acquire XIIDRA, libvatrep and AcuStream
from Novartis for up to $2.5 billion, including an upfront payment
of $1.75 billion in cash with potential milestone obligations up to
$750 million based on sales thresholds and pipeline
commercialization. Bausch + Lomb will also bring on the sales force
supporting XIIDRA. Bausch + Lomb has obtained fully committed
financing from J.P. Morgan for the transaction and intends to
finance the $1.75 billion upfront cash purchase price with new debt
prior to closing.
The transaction was approved by the Board of Directors at each
of the respective companies and is subject to receipt of regulatory
approval and other customary closing conditions. The transaction is
expected to close by the end of 2023 and will be immediately
accretive. Bausch + Lomb intends to maintain its strong balance
sheet and expects to return to current leverage levels within
approximately 24 months of closing.
J.P. Morgan served as financial advisor to Bausch + Lomb.
Wachtell, Lipton, Rosen & Katz advised on legal matters
relating to the transaction, and Davis Polk & Wardwell advised
on legal matters relating to the financing.
WHAT IS XIIDRA?
XIIDRA (lifitegrast ophthalmic solution) 5% is a prescription
eye drop used to treat the signs and symptoms of dry eye
disease.
IMPORTANT SAFETY INFORMATION
Do not use XIIDRA if you are allergic to any of its ingredients.
Seek medical care immediately if you get any symptoms of an
allergic reaction.
The most common side effects of XIIDRA include eye irritation,
discomfort or blurred vision when the drops are applied to the
eyes, and an unusual taste sensation.
To help avoid eye injury or contamination of the solution, do
not touch the container tip to your eye or any surface. If you wear
contact lenses, remove them before using XIIDRA and wait for at
least 15 minutes before placing them back in your eyes.
It is not known if XIIDRA is safe and effective in children
under 17 years of age.
Click here for full Prescribing Information for
XIIDRA.
WHAT IS MIEBO?
MIEBO™ (perfluorohexyloctane ophthalmic solution) is used to
treat the signs and symptoms of dry eye disease.
IMPORTANT SAFETY INFORMATION
- Patients should remove contact lenses before using MIEBO and
wait for at least 30 minutes before reinserting.
- It is important for patients to use MIEBO exactly as
prescribed.
- It is not known if MIEBO is safe and effective in children
under the age of 18.
- The most common eye side effect seen in studies was blurred
vision (1% to 3% of patients reported blurred vision and eye
redness).
Patients are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088.
Click here for full Prescribing Information for
MIEBO.
About Bausch + Lomb
Bausch + Lomb is dedicated to protecting and enhancing the gift
of sight for millions of people around the world – from the moment
of birth through every phase of life. Its comprehensive portfolio
of more than 400 products includes contact lenses, lens care
products, eye care products, ophthalmic pharmaceuticals,
over-the-counter products and ophthalmic surgical devices and
instruments. Founded in 1853, Bausch + Lomb has a significant
global research and development, manufacturing and commercial
footprint with approximately 13,000 employees and a presence in
nearly 100 countries. Bausch + Lomb is headquartered in Vaughan,
Ontario with corporate offices in Bridgewater, New Jersey. For more
information, visit www.bausch.com and connect with us on Twitter,
LinkedIn, Facebook and Instagram.
Bausch + Lomb Forward-looking Statements
This news release may contain forward-looking statements, which
may generally be identified by the use of the words “anticipates,”
“hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,”
“will,” “may,” “believes,” “estimates,” “potential,” “target,” or
“continue” and variations or similar expressions. These statements
are based upon the current expectations and beliefs of management
and are subject to certain risks and uncertainties that could cause
actual results to differ materially from those described in the
forward-looking statements. These risks and uncertainties include,
but are not limited to, the risks and uncertainties discussed in
Bausch + Lomb’s filings with the U.S. Securities and Exchange
Commission and the Canadian Securities Administrators, which
factors are incorporated herein by reference. In addition, such
risks and uncertainties include, but are not limited to, the
following: uncertainties relating to the timing of the consummation
of the proposed transaction with Novartis (the “Transaction”); the
possibility that any or all of the conditions to the consummation
of the Transaction may not be satisfied or waived, including
failure to receive required regulatory approvals; the effect of the
announcement or pendency of the Transaction on Bausch + Lomb’s
ability to maintain relationships with customers, suppliers, and
other business partners; the impact of the Transaction if
consummated on Bausch + Lomb’s business, financial position and
results of operations, including with respect to expectations
regarding margin expansion, accretion and deleveraging; and risks
relating to potential diversion of management attention away from
Bausch + Lomb’s ongoing business operations. Readers are cautioned
not to place undue reliance on any of these forward-looking
statements. These forward-looking statements speak only as of the
date hereof. Bausch + Lomb undertakes no obligation to update any
of these forward-looking statements to reflect events or
circumstances after the date of this news release or to reflect
actual outcomes, unless required by law.
References 1.
National Eye Institute. Dry Eye. Last updated April 8, 2022.
Accessed May 2, 2023.
https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/dry-eye
2.
Downs P. 2020 Dry Eye Products Market Report: A Global Analysis
for 2019 to 2025. Market Scope; 2020.
3.
Modern technology and a multi-screen lifestyle viewed as
important factors in rising prevalence of dry eye disease. News
release. PR Newswire; October 17, 2016. Accessed October 4, 2022.
https://www.multivu.com/players/English/7893551-shire-dry-eye-disease-awareness/
4.
U.S. dry-eye size including aqueous supplements, secretagogues,
corticosteroids, LFA-1 antagonists, calcineurin inhibitors across
anti-inflammatory and non-anti-inflammatory drug classes. Source:
DRG (12/2022); Expert interviews; Analyst reports.
5.
Quiroz-Mercado H, Ivri E, Gonzalez-Salinas R, et al. Clinical
evaluation of a novel electromechanical topical ocular drug
delivery system: two phase 1 proof of concept studies. Clin
Ophthalmol. 2020;14:139-147.
6.
Data on file. AcuStream repetitive acute and real-time delivery
study. Novartis, 2022.
© 2023 Bausch + Lomb.
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version on businesswire.com: https://www.businesswire.com/news/home/20230630597785/en/
Investor Contacts: George Gadkowski
george.gadkowski@bausch.com
Allison Ryan allison.ryan@bausch.com (877) 354-3705 (toll free)
(908) 927-0735
Media Contacts: T.J. Crawford tj.crawford@bausch.com
(908) 705-2851
Lainie Keller lainie.keller@bausch.com (908) 927-1198
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