TARRYTOWN, N.Y., April 6, 2020 /PRNewswire/ --
Company to Report First Quarter 2020 Results and Host
Conference Call and Webcast on May 5,
2020
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today
announced that the Company has finalized the planned
Praluent® (alirocumab) restructuring with Sanofi.
Regeneron also announced important changes to its accounting
presentation effective January 1,
2020.
The new Praluent agreements, effective April 1, 2020, simplify the antibody
collaboration between the companies, increasing efficiency and
streamlining operations. In the U.S., Regeneron will have sole
responsibility for Praluent and record net product sales. Sanofi
will have sole responsibility outside the U.S. and pay Regeneron a
royalty on Praluent net product sales.
Changes in Accounting Presentation
Effective
January 1, 2020, Regeneron has
implemented changes in the presentation of its consolidated
financial statements related to certain reimbursements and other
payments for products developed and commercialized with
collaborators. Regeneron made these changes to better reflect the
nature of revenues earned and costs incurred pursuant to
arrangements with collaborators. There is no impact from these
changes in presentation to income from operations, income taxes,
net income and net income per share.
Under these changes in accounting, Regeneron will no longer
record reimbursements for research and development (R&D) and
selling, general and administrative (SG&A) expenses from
collaborators as revenue, and these reimbursements will now be
netted against the respective expenses. As a result of the
accounting changes, for the first quarter of 2020, both total
revenue and operating expenses are estimated to be approximately
$300 million lower than with the
previous accounting treatment. A slide presentation outlining
these changes is available on the "Investors and Media" page
of Regeneron's website
at http://investor.regeneron.com/events.cfm.
First Quarter 2020 Conference Call
Information
Regeneron plans to provide financial guidance
for 2020 during its first quarter earnings announcement. The
Company will host a conference call and simultaneous webcast at
8:30 AM Eastern Time on Tuesday May
5, 2020. To access this call, dial (888) 660-6127 (U.S.) or (973)
890-8355 (International). A link to the webcast may be accessed
from the 'Investors and Media' page of Regeneron's website at
http://investor.regeneron.com/events.cfm. A replay of the
conference call and webcast will be archived on the Company's
website for at least 30 days.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading
biotechnology company that invents life-transforming medicines for
people with serious diseases. Founded and led for over 30 years by
physician-scientists, our unique ability to repeatedly and
consistently translate science into medicine has led to seven
FDA-approved treatments and numerous product candidates in
development, all of which were homegrown in our laboratories. Our
medicines and pipeline are designed to help patients with eye
diseases, allergic and inflammatory diseases, cancer,
cardiovascular and metabolic diseases, infectious diseases, pain
and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through our proprietary
VelociSuite® technologies, such as
VelocImmune®, which uses unique
genetically-humanized mice to produce optimized fully-human
antibodies and bispecific antibodies, and through ambitious
research initiatives such as the Regeneron Genetics Center, which
is conducting one of the largest genetics sequencing efforts in the
world.
For additional information about the company, please visit
www.regeneron.com or follow @Regeneron on Twitter.
Regeneron Forward-Looking Statements and Use of Digital
Media
This press release includes
forward-looking statements that involve risks and uncertainties
relating to future events and the future performance of Regeneron
Pharmaceuticals, Inc. ("Regeneron" or the "Company"), and actual
events or results may differ materially from these forward-looking
statements. Words such as "anticipate," "expect," "intend," "plan,"
"believe" "seek," "estimate," variations of such words, and similar
expressions are intended to identify such forward-looking
statements, although not all forward-looking statements contain
these identifying words. These statements concern, and these
risks and uncertainties include, among others, the impact of
SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on
Regeneron's business and its employees, collaborators, suppliers,
and other third parties on which Regeneron relies, Regeneron's and
its collaborators' ability to continue to conduct research and
clinical programs, Regeneron's ability to manage its supply chain,
net product sales of products marketed by Regeneron and/or its
collaborators (collectively, "Regeneron's Products"), and the
global economy; the nature, timing, and possible success and
therapeutic applications of Regeneron's Products and Regeneron's
product candidates and research and clinical programs now underway
or planned, including without limitation Praluent®
(alirocumab); the potential for any license or collaboration
agreement, including Regeneron's agreements with Sanofi (such as
the antibody license and collaboration agreement, as amended from
time to time), Bayer, and Teva Pharmaceutical Industries Ltd. (or
their respective affiliated companies, as applicable), to be
cancelled or terminated without any further product success; the
impact of the restructuring of the antibody collaboration with
Sanofi in respect of Praluent discussed in this press release on
Regeneron's business, operating results, and financial condition;
the extent to which the results from the research and development
programs conducted by Regeneron and/or its collaborators may be
replicated in other studies and lead to therapeutic applications;
the likelihood, timing, and scope of possible regulatory approval
and commercial launch of Regeneron's product candidates and new
indications for Regeneron's Products; unforeseen safety issues
resulting from the administration of Regeneron's Products and
product candidates in patients, including serious complications or
side effects in connection with the use of Regeneron's Products and
product candidates in clinical trials; determinations by regulatory
and administrative governmental authorities which may delay or
restrict Regeneron's ability to continue to develop or
commercialize Regeneron's Products and product candidates; ongoing
regulatory obligations and oversight impacting Regeneron's
Products, research and clinical programs, and business, including
those relating to patient privacy; uncertainty of market acceptance
and commercial success of Regeneron's Products and product
candidates and the impact of studies (whether conducted by
Regeneron or others and whether mandated or voluntary) on the
commercial success of Regeneron's Products and product candidates;
the availability and extent of reimbursement of Regeneron's
Products from third-party payers, including private payer
healthcare and insurance programs, health maintenance
organizations, pharmacy benefit management companies, and
government programs such as Medicare and Medicaid; coverage and
reimbursement determinations by such payers and new policies and
procedures adopted by such payers; competing drugs and product
candidates that may be superior to Regeneron's Products and product
candidates; the ability of Regeneron to manufacture and manage
supply chains for multiple products and product candidates; the
ability of Regeneron's collaborators, suppliers, or other third
parties (as applicable) to perform manufacturing, filling,
finishing, packaging, labeling, distribution, and other steps
related to Regeneron's Products and product candidates;
unanticipated expenses; the costs of developing, producing, and
selling products; the ability of Regeneron to meet any of its
financial projections or guidance and changes to the assumptions
underlying those projections or guidance; and risks associated with
intellectual property of other parties and pending or future
litigation relating thereto (including without limitation the
patent litigation and other related proceedings relating to
Dupixent® (dupilumab) and Praluent), other litigation
and other proceedings and government investigations relating to the
Company and/or its operations, the ultimate outcome of any such
proceedings and investigations, and the impact any of the foregoing
may have on Regeneron's business, prospects, operating results, and
financial condition. A more complete description of these and other
material risks can be found in Regeneron's filings with the U.S.
Securities and Exchange Commission, including its Form 10-K for the
year ended December 31,
2019. Any forward-looking statements are made based on
management's current beliefs and judgment, and the reader is
cautioned not to rely on any forward-looking statements made by
Regeneron. Regeneron does not undertake any obligation to update
publicly any forward-looking statement, including without
limitation any financial projection or guidance, whether as a
result of new information, future events, or otherwise.
Regeneron uses its media and investor relations website and
social media outlets to publish important information about the
Company, including information that may be deemed material to
investors. Financial and other information about Regeneron is
routinely posted and is accessible on Regeneron's media and
investor relations website (http://newsroom.regeneron.com) and its
Twitter feed (http://twitter.com/regeneron).
Regeneron
Contacts:
Media
Relations
Hala Mirza
Tel: +1 (914)
847-3422
Hala.Mirza@regeneron.com
|
Investor
Relations
Justin
Holko
Tel: +1 (914)
847-7786
Justin.Holko@regeneron.com
|
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SOURCE Regeneron Pharmaceuticals, Inc.