- Expands ophthalmic eye drop portfolio leveraging market
access expertise and newly created US ophthalmic eye drop sales
force
- EYSUVIS complements Systane Preservative-Free by expanding
treatment options for dry eye
Alcon (SIX/NYSE: ALC), the global leader in eye care dedicated
to helping people see brilliantly, today announced it has signed an
agreement to acquire EYSUVIS® (loteprednol etabonate suspension)
0.25% pharmaceutical eye drops from Kala Pharmaceuticals, Inc.
The acquisition will complement Alcon’s existing portfolio in
the large and fast-growing dry eye category. EYSUVIS will
complement the Systane® family of eye drops which includes the
recently launched Systane Preservative-Free formulations now
available in a convenient, multi-dose bottle. While the Systane
family is used for ongoing management of dry eye symptoms, EYSUVIS
will provide Eye Care Professionals (ECPs) with an option for
short-term treatment to mitigate dry eye disease.
Over 30 million people in the United States suffer from dry
eye.1 Alcon research shows that about 20-25% of dry eye patients
experience acute episodes of dry eye on average twice per year.2
EYSUVIS, a corticosteroid, may be prescribed by ECPs during these
episodes of acute dry eye.
EYSUVIS was approved by the U.S. Food & Drug Administration
in January 2021 as the first-and-only corticosteroid indicated for
up to two weeks of treatment of the signs and symptoms of dry eye
disease. The prescription therapy utilizes a proprietary drug
delivery technology known as AMPPLIFY® to enhance penetration of
loteprednol etabonate into targeted tissue on the ocular surface,
helping to prevent flares associated with dry eye disease.
“We will be pleased to add EYSUVIS to our growing pharmaceutical
portfolio,” said Sergio Duplan, President, North America at Alcon.
“EYSUVIS is a natural fit for our newly formed ophthalmic eye drop
sales force in the United States. With our strong expertise in
market access and commercial execution, we are well-positioned to
build the market for acute dry eye treatment.”
As part of the agreement, Alcon will also acquire INVELTYS®
(loteprednol etabonate suspension) 1%, the only corticosteroid for
twice-a-day treatment of post-operative inflammation and pain
following ocular surgery.
Under terms of the agreement, Alcon will pay $60 million in
upfront consideration to Kala Pharmaceuticals, Inc. Alcon may be
required to make additional contingent payments upon achievement of
certain commercial milestones. The transaction is anticipated to
close in Q3 2022, subject to customary closing conditions,
including regulatory approval. Revenues for EYSUVIS and INVELTYS
for full-year 2021 were $6.3 million and $4.9 million,
respectively. Alcon’s full year 2022 guidance is unchanged as a
result of the transaction.
Product Information for
EYSUVIS
For full prescribing information, including approved indications
and important safety information about marketed products, please
visit
https://www.eysuvis-ecp.com/pdf/prescribing-information.pdf
Product Information for
INVELTYS
For full prescribing information, including approved indications
and important safety information about marketed products, please
visit
https://www.inveltys.com/pdf/inveltys-prescribing-information.pdf
Forward-looking
Statements
This press release contains, and our officers and
representatives may from time to time make, certain
“forward-looking statements” within the meaning of the safe harbor
provisions of the US Private Securities Litigation Reform Act of
1995. Forward-looking statements can be identified by words such as
“anticipate,” “intend,” “commitment,” “look forward,” “maintain,”
“plan,” “goal,” “seek,” “target,” “assume,” “believe,” “project,”
“estimate,” “expect,” “strategy,” “future,” “likely,” “may,”
“should,” “will” and similar references to future periods. Examples
of forward-looking statements include, among others, statements we
make regarding our liquidity, revenue, gross margin, operating
margin, effective tax rate, foreign currency exchange movements,
earnings per share, our plans and decisions relating to various
capital expenditures, capital allocation priorities and other
discretionary items, market growth assumptions, and generally, our
expectations concerning our future performance and the effects of
the COVID-19 pandemic on our businesses.
Forward-looking statements are neither historical facts nor
assurances of future performance. Instead, they are based only on
our current beliefs, expectations and assumptions regarding the
future of our business, future plans and strategies, and other
future conditions. Because forward-looking statements relate to the
future, they are subject to inherent uncertainties and risks that
are difficult to predict such as: cybersecurity breaches or other
disruptions of our information technology systems; compliance with
data privacy, identity protection and information security laws;
our ability to comply with the US Foreign Corrupt Practices Act of
1977 and other applicable anti-corruption laws, particularly given
that we have entered into a three-year Deferred Prosecution
Agreement with the U.S. Department of Justice; our success in
completing and integrating strategic acquisitions; the impact of a
disruption in our global supply chain or important facilities; the
effect of the COVID-19 pandemic as well as other viral or disease
outbreaks; global and regional economic, financial, legal, tax,
political and social change; Russia’s invasion of Ukraine and the
resulting global response; the commercial success of our products
and our ability to maintain and strengthen our position in our
markets; the success of our research and development efforts,
including our ability to innovate to compete effectively; pricing
pressure from changes in third party payor coverage and
reimbursement methodologies; ongoing industry consolidation; our
ability to properly educate and train healthcare providers on our
products; the impact of unauthorized importation of our products
from countries with lower prices to countries with higher prices;
our reliance on outsourcing key business functions; changes in
inventory levels or buying patterns of our customers; our ability
to attract and retain qualified personnel; our ability to service
our debt obligations; the need for additional financing through the
issuance of debt or equity; our ability to protect our intellectual
property; the effects of litigation, including product liability
lawsuits and governmental investigations; our ability to comply
with all laws to which we may be subject; effect of product recalls
or voluntary market withdrawals; the implementation of our
enterprise resource planning system; the accuracy of our accounting
estimates and assumptions, including pension and other
post-employment benefit plan obligations and the carrying value of
intangible assets; the ability to obtain regulatory clearance and
approval of our products as well as compliance with any
post-approval obligations, including quality control of our
manufacturing; legislative, tax and regulatory reform; the ability
of Alcon Pharmaceuticals Ltd. to comply with its investment tax
incentive agreement with the Swiss State Secretariat for Economic
Affairs in Switzerland and the Canton of Fribourg, Switzerland; our
ability to manage environmental, social and governance matters to
the satisfaction of our many stakeholders, some of which may have
competing interests; the impact of being listed on two stock
exchanges; the ability to declare and pay dividends; the different
rights afforded to our shareholders as a Swiss corporation compared
to a U.S. corporation; and the effect of maintaining or losing our
foreign private issuer status under U.S. securities laws.
Additional factors are discussed in our filings with the United
States Securities and Exchange Commission, including our Form 20-F.
Should one or more of these uncertainties or risks materialize, or
should underlying assumptions prove incorrect, actual results may
vary materially from those anticipated. Therefore, you should not
rely on any of these forward-looking statements. Forward-looking
statements in this press release speak only as of the date of its
filing, and we assume no obligation to update forward-looking
statements as a result of new information, future events or
otherwise.
About Alcon
Alcon helps people see brilliantly. As the global leader in eye
care with a heritage spanning over 75 years, we offer the broadest
portfolio of products to enhance sight and improve people’s lives.
Our Surgical and Vision Care products touch the lives of more than
260 million people in over 140 countries each year living with
conditions like cataracts, glaucoma, retinal diseases and
refractive errors. Our more than 24,000 associates are enhancing
the quality of life through innovative products, partnerships with
Eye Care Professionals and programs that advance access to quality
eye care. Learn more at www.alcon.com.
References
- Tear Film and Ocular Surface Society (TFOS). TFOS DEWS II.
Available at
http://www.tearfilm.org/detreports-tfos_dew_ii_reprot/32_30/eng/
- Alcon Data on File, 2022
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Investor Relations Dan
Cravens + 41 589 112 110 (Geneva) + 1 817 615 2789 (Fort Worth)
investor.relations@alcon.com
Media Relations Steven Smith
+ 41 589 112 111 (Geneva) + 1 817 551 8057 (Fort Worth)
globalmedia.relations@alcon.com
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