TARRYTOWN, N.Y., Jan. 7, 2019 /PRNewswire/ -- Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN) will provide a
strategic business update to the investor community today at the
37th Annual J.P. Morgan Healthcare Conference.
Leonard S. Schleifer, M.D., Ph.D.,
President and Chief Executive Officer, and George D. Yancopoulos, M.D., Ph.D., President
and Chief Scientific Officer, will discuss commercial and pipeline
progress across the company's portfolio. Slides and a webcast from
the presentation may be accessed from the "Investors & Media"
page of Regeneron's website
at http://investor.regeneron.com/events.cfm.
"Regeneron continues to advance an innovative, homegrown
portfolio of marketed and investigational therapies for patients
with a range of serious diseases," said Dr. Schleifer. "In 2018, we
saw continued strong growth for EYLEA® (aflibercept)
Injection in retinal diseases and Dupixent® (dupilumab)
Injection in atopic dermatitis, as well as a positive initial
reception to our two new launches – Libtayo®
(cemiplimab-rwlc) Injection for advanced cutaneous squamous
cell carcinoma and Dupixent for asthma. On the development front,
we now have more than 20 investigational candidates in human
clinical trials and look forward to entering several more this
year, as we continue to leverage our cutting-edge science and
technology to bring new hope to patients in need."
EYLEA: Strengthening Market Leadership Position
- EYLEA† achieved $4.07
billion in 2018 U.S. net sales (based on preliminary,
unaudited fourth quarter 2018 U.S. net sales of $1.07 billion), representing approximately 10
percent growth over 2017.(1)
- The U.S. Food and Drug Administration (FDA) has assigned an
action date of May 13, 2019 for a new
EYLEA indication in diabetic retinopathy.
- Regeneron is also advancing next-generation ophthalmology
treatments, such as a high-dose formulation of EYLEA, which is
expected to enter clinical trials in 2019.
Dupixent: Continued Growth and New Indications
- Dupixent*† uptake continues to accelerate
in both its FDA-approved indications with positive trends in
new-to-brand prescriptions following a direct-to-consumer
television campaign for moderate-to-severe atopic dermatitis and
the 2018 asthma launch.
- Additional important regulatory milestones are expected for
Dupixent this year, including a March 11,
2019 FDA action date for adolescent atopic dermatitis (age
12-17), a European Medicines Association (EMA) decision for asthma
and an FDA filing for chronic rhinosinusitis with nasal
polyps.
- In 2019, Regeneron also expects to report results from a Phase
3 study of Dupixent in pediatric patients (age 6-11) with atopic
dermatitis and initiate a Phase 2/3 program in Chronic Obstructive
Pulmonary Disease. Phase 2 studies in grass allergy and peanut
allergy are ongoing, as are combination studies with REGN3500*
(IL-33 antibody) in atopic dermatitis and asthma.
Immuno-Oncology Platform
- Regeneron has seen encouraging early uptake from the U.S.
launch of Libtayo*† for advanced cutaneous
squamous cell carcinoma (CSCC). An EMA decision on Libtayo for
advanced CSCC is expected in the first half of 2019, and pivotal
and earlier studies in other cancers are continuing to enroll.
- Regeneron's CD20xCD3 bispecific antibody, REGN1979, continues
to progress with a potentially pivotal Phase 2 study in Follicular
Lymphoma anticipated to begin in the first half of 2019 and a
potentially pivotal Phase 2 study in Diffuse Large B-Cell Lymphoma
anticipated to begin in the second half of 2019.
- Supported by Regeneron's proprietary science and technology
platforms, the company is advancing a new class of costimulatory
bispecific antibodies for cancer, with two candidates expected to
enter human clinical studies in 2019. These therapies have the
potential to be used in combination with other Regeneron
immuno-oncology therapies to address difficult-to-treat
cancers.
- Earlier today, Regeneron and Sanofi
announced a restructuring of their 2015 Immuno-oncology
Discovery and Development Agreement. Regeneron and Sanofi have
selected two investigational bispecific antibodies (MUC16xCD3 for
mucin16-expressing cancers and BCMAxCD3 for multiple myeloma) for
continued collaborative development. Regeneron will retain
exclusive rights to all its other immuno-oncology programs,
including additional xCD3 bispecifics
and the new class of costimulatory bispecific antibodies. The
bispecific antibody REGN1979 (CD20xCD3) remains exclusively owned
by Regeneron.
"Over the last few years, we've made excellent progress with our
immuno-oncology portfolio, which includes Libtayo, the first and
only approved treatment for advanced cutaneous squamous cell
carcinoma, as well as our first clinical-stage bispecific antibody,
REGN1979," said Dr. Yancopoulos. "Regeneron now has one approved
and five clinical-stage immuno-oncology therapies for a range of
targets and modalities, which have the opportunity to be used as
monotherapy or in combination with other agents. We're particularly
encouraged to be entering two new therapies into the clinic this
year from our costimulatory bispecific portfolio. Building on our
deep antibody engineering expertise, this new class of bispecific
agents has the promise to treat certain cancers where other classes
of immunotherapy have proven inadequate."
Additional Research and Development Updates
- In 2018, Regeneron entered four new molecules into the clinic:
REGN4018, a MUC16xCD3 bispecific antibody for cancer; REGN4461, a
leptin receptor (LEPR) agonist for lipodystrophy and obesity;
REGN4659, a CTLA-4 antibody for cancer; and REGN5069, a GFRa3
antibody for pain.
- In 2019, four to six new molecules are expected to enter
clinical development, including REGN5458, the BCMAxCD3 bispecific
antibody which has already initiated a Phase 1 study, as well as
two costimulatory bispecific antibodies for cancer.
- The Regeneron Genetics Center (RGC) continues to make important
discoveries, including validating the genetic role of IL-33 in
asthma and identifying a new genetic variant that protects against
chronic liver disease. The RGC has now sequenced over 500,000 human
exomes linked to detailed patient electronic health records and
anticipates sequencing up to 500,000 more exomes in 2019.
2019 Financial Guidance(2)
Sanofi
Collaboration Revenue
Reimbursement of
Regeneron
Commercialization-Related Expenses
|
$510 – 560
Million
|
Non-GAAP Unreimbursed
R&D(3)(4)
|
$1,590 – 1,710
Million
|
Non-GAAP
SG&A(3)(4)
|
$1,500 – 1,600
Million
|
Effective Tax
Rate
|
14 –
16%
|
Capital
Expenditures
|
$410 – 490
Million
|
(1)
|
Regeneron records net
product sales of EYLEA in the United States. Outside the United
States, EYLEA net product sales comprise sales by Bayer in
countries other than Japan and sales by Santen Pharmaceutical Co.,
Ltd. in Japan under a co-promotion agreement with an affiliate of
Bayer. The Company recognizes its share of the profits (including a
percentage on sales in Japan) from EYLEA sales outside the United
States within "Bayer collaboration revenue" in its Statements of
Operations.
|
|
|
(2)
|
The Company's 2019
financial guidance does not assume the completion of any
significant business development transactions not completed as of
the date of this press release.
|
|
|
(3)
|
This press release
uses non-GAAP unreimbursed R&D and non-GAAP SG&A, which are
financial measures that are not calculated in accordance with U.S.
Generally Accepted Accounting Principles ("GAAP"). These non-GAAP
financial measures are computed by excluding certain non-cash and
other items from the related GAAP financial measure. Non-GAAP
adjustments also include the estimated income tax effect of
reconciling items.
The Company makes
such adjustments for items the Company does not view as useful in
evaluating its operating performance. For example, adjustments may
be made for items that fluctuate from period to period based on
factors that are not within the Company's control (such as the
Company's stock price on the dates share-based grants are issued or
changes in the fair value of the Company's equity investments) or
items that are not associated with normal, recurring operations
(such as changes in applicable laws and regulations). Management
uses these non-GAAP measures for planning, budgeting, forecasting,
assessing historical performance, and making financial and
operational decisions, and also provides forecasts to investors on
this basis. Additionally, such non-GAAP measures provide investors
with an enhanced understanding of the financial performance of the
Company's core business operations. However, there are limitations
in the use of these and other non-GAAP financial measures as they
exclude certain expenses that are recurring in nature.
Furthermore, the Company's non-GAAP financial measures may not be
comparable with non-GAAP information provided by other companies.
Any non-GAAP financial measure presented by Regeneron should be
considered supplemental to, and not a substitute for, measures of
financial performance prepared in accordance with GAAP.
|
|
|
(4)
|
A reconciliation of
full year 2019 non-GAAP to GAAP financial guidance is included
below:
|
|
|
Projected
Range
|
(In
millions)
|
|
Low
|
|
High
|
GAAP unreimbursed
R&D (5)
|
|
$
|
1,855
|
|
|
$
|
2,000
|
|
R&D: Non-cash
share-based compensation expense
|
|
(265)
|
|
|
(290)
|
|
Non-GAAP unreimbursed
R&D
|
|
$
|
1,590
|
|
|
$
|
1,710
|
|
|
|
|
|
|
GAAP
SG&A
|
|
$
|
1,700
|
|
|
$
|
1,830
|
|
SG&A: Non-cash
share-based compensation expense
|
|
(200)
|
|
|
(230)
|
|
Non-GAAP
SG&A
|
|
$
|
1,500
|
|
|
$
|
1,600
|
|
|
|
|
|
|
|
|
|
|
(5)
|
Unreimbursed R&D
represents R&D expenses reduced by R&D expense
reimbursements from the Company's collaborators and/or
customers.
|
About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company
that invents life-transforming medicines for people with serious
diseases. Founded and led for 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, neuromuscular
diseases, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through our
proprietary VelociSuite® technologies,
such as VelocImmune® which produces
optimized fully-human antibodies, and 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 nature, timing,
and possible success and therapeutic applications of Regeneron's
products, product candidates, and research and clinical programs
now underway or planned, including without limitation
EYLEA® (aflibercept) Injection, Dupixent®
(dupilumab) Injection, Praluent® (alirocumab) Injection,
Kevzara® (sarilumab) Injection, Libtayo®
(cemiplimab-rwlc) Injection, fasinumab, evinacumab, Regeneron's
immuno-oncology programs (including its costimulatory bispecific
portfolio), Regeneron's earlier-stage product candidates, and the
use of human genetics in Regeneron's research programs; the extent
to which the results from Regeneron's research programs or
preclinical testing may lead to advancement of product candidates
to clinical trials or therapeutic applications; unforeseen safety
issues resulting from the administration of products and product
candidates in patients, including serious complications or side
effects in connection with the use of Regeneron's product
candidates in clinical trials; the likelihood and timing of
possible regulatory approval and commercial launch of Regeneron's
late-stage product candidates and new indications for marketed
products, including without limitation EYLEA, Dupixent, Praluent,
Kevzara, Libtayo, fasinumab, and evinacumab; the likelihood and
timing of achieving any of the anticipated milestones described in
this press release; the extent to which the results from the
research and development programs conducted by Regeneron or its
collaborators may be replicated in other studies and lead to
therapeutic applications; ongoing regulatory obligations and
oversight impacting Regeneron's marketed products (such as EYLEA,
Dupixent, Praluent, Kevzara, and Libtayo), research and clinical
programs, and business, including those relating to patient
privacy; 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; competing drugs and product
candidates that may be superior to Regeneron's products and product
candidates; 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 the Company'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; 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 to perform 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 sales or other
financial projections or guidance and changes to the assumptions
underlying those projections or guidance, including financial
guidance relating to Sanofi collaboration revenue, non-GAAP
unreimbursed R&D, non-GAAP SG&A, effective tax rate, and
capital expenditures; risks associated with intellectual property
of other parties and pending or future litigation relating thereto,
including without limitation the patent litigation proceedings
relating to EYLEA, Dupixent, and Praluent, the ultimate outcome of
any such litigation proceeding, and the impact any of the foregoing
may have on Regeneron's business, prospects, operating results, and
financial condition; and the potential for any license or
collaboration agreement, including Regeneron's agreements with
Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd. (or their
respective affiliated companies, as applicable), to be cancelled or
terminated without any further product success. 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 fiscal year ended
December 31, 2017 and its Form 10-Q
for the quarterly period ended September 30,
2018, including in each case in the section thereof
captioned "Item 1A. Risk Factors." 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).
Non-GAAP Financial Measures
This press
release includes amounts that are considered non-GAAP financial
measures under U.S. Securities and Exchange Commission rules.
Please refer to important information about these measures, as well
as a reconciliation of the non-GAAP financial measures included in
this press release to the most directly comparable GAAP measures,
in the notes above.
Media
Relations
Hala Mirza
Tel: +1 (914)
847-3422
hala.mirza@regeneron.com
Investor
Relations
Mark Hudson
Tel: +1 (914)
847-3482
mark.hudson@regeneron.com
[*] Collaboration program with
Sanofi
[†] See full prescribing information
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SOURCE Regeneron Pharmaceuticals, Inc.