TARRYTOWN, N.Y., Aug. 5, 2020 /PRNewswire/ --
- Second quarter 2020 revenues increased 24% to $1.95 billion versus second quarter
2019(4)
- Second quarter 2020 EYLEA® U.S. net sales were
$1.11 billion
- Second quarter 2020 Dupixent® global net
sales(2), which are recorded by Sanofi,
were $945 million
- Second quarter 2020 GAAP diluted EPS was $7.61 and non-GAAP diluted
EPS(1) was $7.16
- Initiated Phase 2 and Phase 3 clinical trials of REGN-COV2
for the treatment and prevention of COVID-19
- FDA approved Dupixent for children aged 6 to 11 years with
moderate-to-severe atopic dermatitis
- Dupixent eosinophilic esophagitis trial met co-primary
endpoints and a second confirmatory Phase 3 trial in chronic
obstructive pulmonary disease (COPD) was initiated
- Completed secondary offering of approximately 13 million
shares of common stock held by Sanofi and purchased 9.8 million
shares from Sanofi
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today
announced financial results for the second quarter of 2020 and
provided a business update.
"I'm very proud of how the Regeneron team has continued to drive
important progress for patients, despite the significant challenges
of the COVID-19 pandemic," said Leonard S.
Schleifer, M.D., Ph.D., President and Chief Executive
Officer of Regeneron. "We have advanced REGN-COV2, our antibody
cocktail for COVID-19, into late-stage clinical studies in record
time and are working to ensure supply is available later this year.
We are continuing to drive strong performance with our marketed
medicines, including EYLEA, Dupixent, and Libtayo, while also
advancing research, development, and regulatory progress across a
number of therapeutic areas including cancer, Type 2 inflammatory
diseases, pain, and rare diseases."
"Regeneron's business continues to be resilient during these
times, delivering double digit top- and bottom-line growth in the
second quarter," said Robert E.
Landry, Executive Vice President, Finance and Chief
Financial Officer of Regeneron. "Our strong balance sheet, improved
competitive outlook, increasingly diversified commercial portfolio,
and robust pipeline position Regeneron well for sustained long-term
growth."
Financial Highlights
($ in millions,
except per share data)
|
|
Q2
2020
|
|
Q2
2019
|
|
%
Change
|
Total
revenues(4)
|
|
$
|
1,952
|
|
|
$
|
1,578
|
|
|
24
|
%
|
GAAP net
income
|
|
$
|
897
|
|
|
$
|
193
|
|
|
365
|
%
|
GAAP net income per
share - diluted
|
|
$
|
7.61
|
|
|
$
|
1.68
|
|
|
353
|
%
|
Non-GAAP net
income(1)
|
|
$
|
854
|
|
|
$
|
690
|
|
|
24
|
%
|
Non-GAAP net income
per share - diluted(1)
|
|
$
|
7.16
|
|
|
$
|
6.02
|
|
|
19
|
%
|
Business Highlights
Key Pipeline Progress
Regeneron has more than 20 product candidates in clinical
development, including five marketed products for which it is
investigating additional indications. Updates from the clinical
pipeline include:
EYLEA® (aflibercept) Injection
- Phase 3 studies exploring less frequent dosing intervals using
a high-dose formulation of aflibercept in neovascular age-related
macular degeneration (wet AMD) and diabetic macular edema (DME)
were initiated.
- In April 2020, the European
Commission approved the EYLEA pre-filled syringe.
Dupixent® (dupilumab)
- In May 2020, the U.S. Food and
Drug Administration (FDA) approved Dupixent as the first biologic
medicine for children aged 6 to 11 years with moderate-to-severe
atopic dermatitis.
- In June 2020, the National
Medical Products Administration (NMPA) in China approved Dupixent for adults with
moderate-to-severe atopic dermatitis.
- In May 2020, the Company and
Sanofi announced positive results from Part A of the Phase 3 trial
in patients 12 years and older with eosinophilic esophagitis (EoE).
The trial met both of its co-primary endpoints, as well as all key
secondary endpoints.
- A Phase 3 study in pediatric patients with EoE was
initiated.
- In June 2020, the FDA approved a
300 mg single-dose pre-filled pen for Dupixent.
- An ongoing Phase 3 trial in chronic obstructive pulmonary
disease (COPD) patients with evidence of Type 2 inflammation met a
blinded, stringent early efficacy threshold for continuation. Based
on this result, a second confirmatory Phase 3 trial in COPD was
initiated.
REGN-COV2
- The Company initiated clinical trials of REGN-COV2, its
investigational two-antibody "cocktail" for the treatment and
prevention of COVID-19.
- Following review from the Independent Data Monitoring Committee
(IDMC) of REGN-COV2 Phase 1 safety results, a Phase 3 trial to
evaluate REGN-COV2's ability to prevent infection among uninfected
people who have had close exposure to a COVID-19 patient (such as
the patient's housemate) was initiated and is being run jointly
with the National Institute of Allergy and Infectious Diseases
(NIAID). In addition, REGN-COV2 moved into the Phase 2/3 portion of
two adaptive Phase 1/2/3 trials testing the cocktail's ability to
treat hospitalized and non-hospitalized patients with COVID-19. The
Company plans to report initial virology and biomarker results from
the REGN-COV2 treatment trials in September
2020.
- Two papers were published in Science describing the
creation of REGN-COV2 and highlighting the potential of REGN-COV2
to diminish the risk of viral escape by effectively binding to the
virus's critical spike protein in two separate, non-overlapping
locations.
- Non-human primate data were provided as a pre-review
publication online for REGN-COV2 showing that treatment with this
antibody cocktail can prevent SARS-CoV-2 infection as well as treat
infected animals by accelerating viral elimination.
- The Company announced an agreement with the Biomedical Advanced
Research and Development Authority (BARDA) of the U.S.
Department of Health and Human Services (HHS) and the U.S.
Department of Defense whereby the Company was awarded a
$450 million contract to manufacture
and supply filled and finished REGN-COV2 to the U.S. Government.
The agreement provides for the Company to manufacture a fixed
number of bulk lots beginning in the summer of 2020 and fill/finish
and storage activities starting in the third quarter of 2020.
Kevzara® (sarilumab)
- The Company and Sanofi reported that the Regeneron-led U.S.
Phase 3 study of Kevzara 400 mg in COVID-19 patients requiring
mechanical ventilation did not meet its primary and key secondary
endpoints. Based on the results, the U.S.-based trial has been
stopped.
Oncology Program
- In April 2020, the Company and
Sanofi announced that the primary endpoint was met in the Phase 3
trial of Libtayo® (cemiplimab) as monotherapy in
first-line non-small cell lung cancer (NSCLC). In May 2020, the Company and Sanofi also announced
that Libtayo demonstrated clinically-meaningful and durable
responses in a pivotal, single-arm, open-label trial in patients
with advanced basal cell carcinoma. The data from these trials will
form the basis of regulatory submissions in the U.S. and European
Union (EU) this year.
- In May 2020, the Company and
Sanofi announced new, longer-term data for Libtayo from a pivotal
Phase 2 trial in advanced cutaneous squamous cell carcinoma (CSCC).
These results demonstrate both longer durability and higher
complete response rates than previously reported. Updated data from
this trial have also been incorporated into the U.S. label.
- A publication in Science Translational Medicine featured
scientific findings highlighting the benefit demonstrated in
preclinical research in combining the Company's novel class of CD28
costimulatory bispecific antibodies with Libtayo. In 2020, the
Company plans to enroll patients in clinical trials investigating
three different CD28 costimulatory bispecific candidates.
Regeneron's first costimulatory bispecific trial, investigating the
combination of PSMAxCD28 (REGN5678) and Libtayo for prostate
cancer, is underway and has treated patients in several
dose-escalation cohorts.
Praluent® (alirocumab)
- The Company submitted a supplemental Biologics License
Application (sBLA) for homozygous familial hypercholesterolemia
(HoFH) in adults.
Evinacumab, an antibody to ANGPTL3
- The Company completed the rolling BLA submission and a
Marketing Authorization Application (MAA) was also submitted for
HoFH.
Fasinumab, an antibody to NGF
- Two Phase 3 trials, FACT OA1 and FACT OA2, achieved the
co-primary endpoints for fasinumab 1 mg monthly, demonstrating
significant improvements in pain and physical function over placebo
at week 16 and week 24, respectively. Fasinumab 1 mg monthly also
showed nominally significant benefits in physical function in both
trials and pain in one trial, when compared to the maximum
FDA-approved prescription doses of non-steroidal anti-inflammatory
drugs for osteoarthritis.
- The FACT OA1 trial included an additional treatment arm,
fasinumab 1 mg every two months, which showed numerical benefit
over placebo, but did not reach statistical significance.
- In initial safety analyses from the Phase 3 trials, there was
an increase in arthropathies reported with fasinumab. In a
sub-group of patients from one Phase 3 long-term safety trial,
there was an increase in joint replacement with fasinumab 1 mg
monthly treatment during the off-drug follow-up period, although
this increase was not seen in the other trials to date. Additional
longer-term safety data from the ongoing trials are being collected
and are expected to be reported early next year.
COVID-19 Business Impact Update
- Regeneron maintains adequate market supply for all
commercialized products. The Company's raw material supplies and
contract manufacturing support have also remained stable.
- The Company continues to evaluate the impact of the COVID-19
pandemic on an individual clinical trial basis and expects
fully-recruited clinical studies to remain generally on track.
After briefly pausing new enrollment in certain studies due to the
pandemic, enrollment in both new and ongoing clinical studies
started to resume as regions relaxed their restrictions and
healthcare resources started to become more available for
non-COVID-19 activities. However, there has been a resurgence of
COVID-19 cases in many regions across the world, and any resurgence
in the regions in which the Company or its collaborators conduct
clinical trials may require the Company to adjust its expectations
relating to the impacted studies.
Corporate and Business Development Update
- The Company and Sanofi entered into an agreement, effective
April 1, 2020, to restructure its
collaboration for Praluent. In the United
States, the Company is now solely responsible for the
development and commercialization of Praluent and records net
product sales. The Company does not owe Sanofi royalties on net
product sales of Praluent in the United
States. Sanofi has sole responsibility for the development
and commercialization of Praluent outside the United States, and pays the Company a 5%
royalty on Praluent net product sales.
- In May 2020, a secondary offering
of approximately 13 million shares of the Company's common stock
held by Sanofi was completed. Concurrent with the secondary
offering, the Company purchased approximately 9.8 million shares
directly from Sanofi for an aggregate purchase amount of
$5 billion. Pursuant to the offering
and purchase, Sanofi disposed of all but 400,000 shares of the
Company's common stock that it retained as of the closing date of
such transactions.
- In May 2020, the Company expanded
its existing collaboration with Intellia Therapeutics, Inc. to
provide the Company with rights to develop products for additional
in vivo CRISPR/Cas9-based therapeutic targets and for the
companies to jointly develop potential products for the treatment
of hemophilia A and B. In addition, the Company also received
non-exclusive rights to independently develop and commercialize
ex vivo gene edited products. In connection with the
agreement, the Company made a $70
million up-front payment and purchased Intellia common stock
for $30 million.
- In July 2020, HHS exercised its
option under the existing agreement for the treatment of Ebola
virus infection to provide additional funding for the manufacture
and supply of REGN-EB3. REGN-EB3 is currently under priority review
by the FDA, with a target action date of October 25, 2020. Contingent on FDA approval,
Regeneron expects to deliver an established number of treatment
doses over the course of approximately six years.
Second Quarter 2020 Financial Results
Effective January 1, 2020, Regeneron has implemented
changes in the presentation of its financial statements related to
certain reimbursements and other payments for products developed
and commercialized with collaborators. The Company made these
changes in presentation to better reflect the nature of the
Company's costs incurred and revenues earned pursuant to
arrangements with collaborators and to enhance the comparability of
Regeneron's financial statements with industry peers. The change in
presentation has been applied retrospectively. See note (4) below
for further information.
Revenues
Total revenues increased by 24% to $1.952
billion in the second quarter of 2020, compared to
$1.578 billion in the second quarter
of 2019.
EYLEA net product sales in the United
States were $1.114 billion in
the second quarter of 2020, compared to $1.160 billion in the second quarter of 2019.
EYLEA's second quarter 2020 net product sales in the United States were negatively impacted by
the COVID-19 pandemic. Overall distributor inventory levels for
EYLEA in the United States
remained within the Company's one-to-two-week targeted range.
Total revenues also include Sanofi and Bayer collaboration
revenues(2) of $513
million in the second quarter of 2020, compared to
$353 million in the second quarter of
2019. Sanofi collaboration revenue increased primarily due to the
Company's share of profits from commercialization of antibodies,
which increased to $172 million in
the second quarter of 2020 from $39
million in the second quarter of 2019. The change in the
Company's share of profits from collaboration antibodies was
primarily driven by higher Dupixent profits.
Refer to Table 4 for a summary of collaboration revenue.
Other revenues in the second quarter of 2020 include recognition
of revenue in connection with the Company's agreements with BARDA
related to funding of certain development activities for REGN-EB3
for the treatment of Ebola and antibodies for the treatment of
COVID-19.
Operating Expenses
|
|
GAAP
|
|
%
Change
|
|
Non-GAAP(1)
|
|
%
Change
|
($ in
millions)
|
|
Q2
2020
|
|
Q2
2019
|
|
|
Q2
2020
|
|
Q2
2019
|
|
Research and
development (R&D)
|
|
$
|
722
|
|
|
$
|
886
|
|
|
(19)
|
%
|
|
$
|
580
|
|
|
$
|
426
|
|
|
36
|
%
|
Selling, general,
and
administrative
(SG&A)
|
|
$
|
348
|
|
|
$
|
295
|
|
|
18
|
%
|
|
$
|
301
|
|
|
$
|
252
|
|
|
19
|
%
|
Cost of goods sold
(COGS)
|
|
$
|
103
|
|
|
$
|
67
|
|
|
54
|
%
|
|
$
|
93
|
|
|
$
|
58
|
|
|
60
|
%
|
Cost of collaboration
and
contract
manufacturing (COCM)
|
|
$
|
173
|
|
|
$
|
79
|
|
|
119
|
%
|
|
*
|
|
|
*
|
|
|
n/a
|
|
Other operating
(income)
expense, net
|
|
$
|
(50)
|
|
|
$
|
(64)
|
|
|
(22)
|
%
|
|
*
|
|
|
*
|
|
|
n/a
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* GAAP and non-GAAP
amounts are equivalent as no non-GAAP adjustments have been
recorded
|
- GAAP R&D expenses in the second quarter of 2020 included
$85 million in up-front payments in
connection with the collaboration agreement with Intellia. GAAP
R&D expenses in the second quarter of 2019 included a
$400 million up-front payment in
connection with the collaboration agreement with Alnylam
Pharmaceuticals, Inc. Non-GAAP R&D expenses increased in the
second quarter of 2020 principally due to additional costs incurred
in connection with COVID-19 related development activities, higher
headcount and headcount-related costs, and an increase in clinical
manufacturing activities.
- The higher GAAP and non-GAAP SG&A expenses in the second
quarter of 2020 were primarily due to higher headcount-related
costs, higher contributions to independent not-for-profit patient
assistance organizations, and the Company no longer receiving
Praluent-related cost reimbursements from Sanofi.
- The increase in cost of collaboration and contract
manufacturing in the second quarter of 2020 was primarily due to
the recognition of manufacturing costs associated with higher sales
of Dupixent, process validation costs in connection with
manufacturing REGN-EB3 under the BARDA Ebola agreement, and
recognition of costs in connection with manufacturing ex-U.S.
commercial supplies of Praluent for Sanofi under the new
agreement.
- Other operating (income) expense, net, includes recognition of
a portion of amounts previously deferred in connection with
up-front and development milestone payments, as applicable,
received in connection with the Company's collaborative
arrangements.
Other Financial Information
GAAP other income (expense), net, includes the recognition
of net unrealized gains on equity securities of $228 million in the second quarter of 2020,
compared to net unrealized losses of $117
million in the second quarter of 2019. GAAP other income
(expense), net, also includes the recognition of net realized gains
on sales of debt securities.
In the second quarter of 2020, the Company's GAAP effective tax
rate was 2.4%, compared to 14.1% in the second quarter of 2019. The
GAAP effective tax rate for the second quarter of 2020 was
positively impacted, compared to the U.S. federal statutory rate,
primarily by stock-based compensation, and, to a lesser extent,
income earned in foreign jurisdictions with tax rates lower than
the U.S. federal statutory rate and federal tax credits for
research activities. In the second quarter of 2020, the non-GAAP
effective tax rate was 0.9%, compared to 19.1% in the second
quarter of 2019. The Company expects its full year 2020 GAAP
effective tax rate to be 9–11% and its non-GAAP effective tax rate
to be 10–12% (see financial guidance table below).
GAAP net income per diluted share was $7.61 in the second quarter of 2020, compared to
GAAP net income per diluted share of $1.68 in the second quarter of 2019. Non-GAAP net
income per diluted share was $7.16 in
the second quarter of 2020, compared to non-GAAP net income per
diluted share of $6.02 in the second
quarter of 2019. A reconciliation of the Company's GAAP to non-GAAP
results is included in Table 3 of this press release.
As described above, during the second quarter of 2020, the
Company purchased 9,806,805 shares of Common Stock from Sanofi and
recorded the cost of the shares received, or $5 billion, as Treasury Stock.
The Company generated $943 million
of net cash provided by operating activities in the second quarter
of 2020, compared to $188 million in
the second quarter of 2019, which led to $814 million in free cash flow for the second
quarter of 2020, compared to $94
million for the second quarter of 2019.
2020 Financial
Guidance(3)
The Company's full year 2020 financial guidance consists of the
following components:
|
|
GAAP
|
|
Non-GAAP(1)
|
R&D
|
|
$2.605 billion–$2.725
billion
(previously $2.150 billion–
$2.310 billion)
|
|
$2.270 billion–$2.370
billion
(previously $1.900 billion–
$2.040 billion)
|
SG&A
|
|
$1.400 billion–$1.480
billion
(previously $1.380 billion–
$1.500 billion)
|
|
$1.210 billion–$1.270
billion
(previously $1.190 billion–
$1.290 billion)
|
COGS
|
|
$490 million–$540
million
(previously $350 million–
$420 million)
|
|
$445 million–$485
million
(previously $295 million–
$355 million)
|
COCM(5)
|
|
$600 million–$660
million
(previously $600 million–
$700 million)
|
|
*
|
Other operating
(income)
expense, net
|
|
($180) million–($205)
million
(previously ($175)
million–
($205) million)
|
|
*
|
Capital
expenditures
|
|
$540 million–$590
million
(previously $510
million–
$590 million)
|
|
*
|
Effective tax rate
(ETR)
|
|
9–11%
(previously
10–12%)
|
|
10–12%
(previously
12–14%)
|
|
|
|
|
|
* GAAP and non-GAAP
amounts are equivalent as no non-GAAP adjustments have been or
are
expected to be recorded.
|
A reconciliation of full year 2020 GAAP to Non-GAAP financial
guidance is included below:
|
|
Projected
Range
|
|
(In
millions)
|
|
Low
|
|
High
|
|
GAAP
R&D
|
|
$
|
2,605
|
|
|
$
|
2,725
|
|
|
R&D: Non-cash
share-
based compensation
expense
|
|
(250)
|
|
|
(270)
|
|
|
R&D: Up-front
payments
related to license and
collaboration agreements
|
|
(85)
|
|
|
(85)
|
|
|
Non-GAAP
R&D
|
|
$
|
2,270
|
|
|
$
|
2,370
|
|
|
|
|
|
|
|
|
GAAP
SG&A
|
|
$
|
1,400
|
|
|
$
|
1,480
|
|
|
SG&A: Non-cash
share-
based compensation
expense
|
|
(160)
|
|
|
(180)
|
|
|
SG&A:
Litigation
contingencies and
restructuring-related
expenses
|
|
(30)
|
|
|
(30)
|
|
|
Non-GAAP
SG&A
|
|
$
|
1,210
|
|
|
$
|
1,270
|
|
|
|
|
|
|
|
|
GAAP COGS
|
|
$
|
490
|
|
|
$
|
540
|
|
|
COGS: Non-cash
share-
based compensation
expense
|
|
(44)
|
|
|
(54)
|
|
|
COGS: Other
|
|
(1)
|
|
|
(1)
|
|
|
Non-GAAP
COGS
|
|
$
|
445
|
|
|
$
|
485
|
|
|
|
|
|
|
|
|
GAAP ETR
|
|
9
|
%
|
|
11
|
%
|
|
Income tax effect of
GAAP
to non-GAAP reconciling
items and other
|
|
1
|
%
|
|
1
|
%
|
|
Non-GAAP
ETR
|
|
10
|
%
|
|
12
|
%
|
|
(1)
|
This press release
uses non-GAAP R&D, non-GAAP SG&A, non-GAAP COGS, non-GAAP
other income (expense) net, non-GAAP effective tax rate, non-GAAP
net income, non-GAAP net income per share, and free cash flow,
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/or other items from the related GAAP financial
measure. The Company also includes a non-GAAP adjustment for 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 restructuring-related expenses, including employee
separation costs). 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. With respect to free cash
flows, the Company believes that this non-GAAP measure provides a
further measure of the Company's operations' ability to generate
cash flows. 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. A reconciliation of
the Company's historical GAAP to non-GAAP results is included in
Table 3 of this press release.
|
|
|
(2)
|
The Company's
collaborators provide it with estimates of the collaborators'
respective sales and the Company's share of the profits or losses
from commercialization of products for the most recent fiscal
quarter. The Company's estimates for such quarter are reconciled to
actual results in the subsequent fiscal quarter, and the Company's
share of the profit or loss is adjusted on a prospective basis
accordingly, if necessary.
|
|
|
(3)
|
The Company's 2020
financial guidance does not assume the completion of any
significant business development transactions not completed as of
the date of this press release.
|
|
|
(4)
|
Applicable amounts
previously reported for the three and six months ended June 30,
2019 and as of December 31, 2019 have been revised to reflect a
change in presentation of cost reimbursements from collaborators
who are not deemed to be the Company's customers from collaboration
revenue to a reduction of the corresponding operating expense. The
Company also changed the presentation of amounts recognized in
connection with up-front and development milestone payments
received from collaboration revenue to Other operating income, as
well as the presentation of the corresponding balance sheet
accounts. The revisions were reclassifications only and had no
impact on the Company's previously reported GAAP and non-GAAP net
income and net income per share. Refer to the Company's Form 10-Q
for the quarterly period ended June 30, 2020 (Note 1 of the Notes
to Condensed Consolidated Financial Statements) for further
details.
|
|
|
(5)
|
Corresponding
reimbursements from collaborators and others for manufacturing of
commercial supplies is recorded within revenues.
|
|
Conference Call Information
Regeneron will host a conference call and simultaneous webcast
to discuss its second quarter 2020 financial and operating results
on Wednesday, August 5, 2020, at 8:30
AM. 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
www.regeneron.com. A replay of the conference call and webcast will
be archived on the Company's website and will be available for at
least 30 days.
About Regeneron Pharmaceuticals, Inc.
Regeneron 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, Regeneron's 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 Regeneron's
laboratories. Regeneron's medicines and pipeline are designed to
help patients with eye diseases, allergic and inflammatory
diseases, cancer, cardiovascular and metabolic diseases, pain,
infectious diseases, and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through its 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.
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, and 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 EYLEA®
(aflibercept) Injection, Dupixent® (dupilumab),
Libtayo® (cemiplimab),
Praluent® (alirocumab),
Kevzara® (sarilumab), fasinumab, evinacumab,
REGN-EB3, garetosmab, pozelimab, REGN-COV2, Regeneron's oncology
programs (including its costimulatory bispecific portfolio),
Regeneron's earlier-stage programs, and the use of human genetics
in Regeneron's research programs; the likelihood and timing of
achieving any of the anticipated milestones described in this press
release; 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; the
likelihood, timing, and scope of possible regulatory approval and
commercial launch of Regeneron's product candidates and new
indications for Regeneron's Products, including without limitation
EYLEA, Dupixent, Libtayo, Praluent, Kevzara, evinacumab, fasinumab,
REGN-COV2, and REGN5678; 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/or lead to
advancement of product candidates to clinical trials, therapeutic
applications, or regulatory approval; ongoing regulatory
obligations and oversight impacting Regeneron's Products (such as
EYLEA, Dupixent, Libtayo, Praluent, and Kevzara), 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, or more cost effective than,
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 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; 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; 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, including GAAP and non-GAAP R&D, GAAP
and non-GAAP SG&A, GAAP and non-GAAP COGS, COCM, other
operating (income) expense, net, capital expenditures, and GAAP and
non-GAAP effective tax rate; 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; 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
EYLEA, Dupixent, and Praluent), other litigation and other
proceedings and government investigations relating to the Company
and/or its operations (including the pending civil litigation
initiated by the U.S. Attorney's Office for the District of
Massachusetts), 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 fiscal year ended
December 31, 2019 and its Form 10-Q
for the quarterly period ended June 30,
2020. 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 and/or the financial results attached to this
press release include amounts that are considered "non-GAAP
financial measures" under SEC rules. As required, Regeneron has
provided reconciliations of such non-GAAP financial measures.
Contact
Information:
|
|
|
|
|
|
Justin
Holko
|
|
Hala Mirza
|
Investor
Relations
|
|
Corporate
Communications
|
914-847-7786
|
|
914-847-3422
|
justin.holko@regeneron.com
|
|
hala.mirza@regeneron.com
|
TABLE 1
|
|
REGENERON
PHARMACEUTICALS, INC.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS (Unaudited)
|
(In
millions)
|
|
|
|
June
30,
|
|
December
31,
|
|
|
2020
|
|
2019*
|
Assets:
|
|
|
|
|
Cash and marketable
securities
|
|
$
|
5,731.8
|
|
|
$
|
6,471.1
|
|
Accounts receivable -
trade, net
|
|
1,991.0
|
|
|
2,100.0
|
|
Accounts receivable -
Sanofi and other
|
|
820.3
|
|
|
685.6
|
|
Inventories
|
|
1,640.9
|
|
|
1,415.5
|
|
Property, plant, and
equipment, net
|
|
3,031.4
|
|
|
2,890.4
|
|
Deferred tax
assets
|
|
774.0
|
|
|
824.2
|
|
Other
assets
|
|
439.3
|
|
|
418.4
|
|
Total
assets
|
|
$
|
14,428.7
|
|
|
$
|
14,805.2
|
|
|
|
|
|
|
Liabilities and
stockholders' equity:
|
|
|
|
|
Accounts payable,
accrued expenses, and other liabilities
|
|
$
|
2,589.1
|
|
|
$
|
2,514.2
|
|
Debt
|
|
1,500.0
|
|
|
—
|
|
Deferred
revenue
|
|
566.3
|
|
|
487.4
|
|
Finance lease
liabilities
|
|
715.9
|
|
|
713.9
|
|
Stockholders'
equity
|
|
9,057.4
|
|
|
11,089.7
|
|
Total liabilities and
stockholders' equity
|
|
$
|
14,428.7
|
|
|
$
|
14,805.2
|
|
|
* Certain revisions
have been made to the previously reported December 31, 2019
amounts. See note (4) above.
|
TABLE 2
|
|
REGENERON
PHARMACEUTICALS, INC.
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
|
(In millions,
except per share data)
|
|
|
|
Three Months
Ended
June 30,
|
|
Six Months
Ended
June 30,
|
|
|
2020
|
|
2019*
|
|
2020
|
|
2019*
|
Revenues:
|
|
|
|
|
|
|
|
|
Net product
sales
|
|
$
|
1,226.9
|
|
|
$
|
1,205.3
|
|
|
$
|
2,463.6
|
|
|
$
|
2,309.7
|
|
Sanofi collaboration
revenue
|
|
269.1
|
|
|
75.8
|
|
|
516.0
|
|
|
57.8
|
|
Bayer collaboration
revenue
|
|
244.2
|
|
|
277.2
|
|
|
525.6
|
|
|
541.2
|
|
Other
revenue
|
|
211.8
|
|
|
19.5
|
|
|
275.0
|
|
|
41.7
|
|
|
|
1,952.0
|
|
|
1,577.8
|
|
|
3,780.2
|
|
|
2,950.4
|
|
Expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
|
722.0
|
|
|
885.5
|
|
|
1,305.9
|
|
|
1,371.6
|
|
Selling, general, and
administrative
|
|
348.3
|
|
|
294.6
|
|
|
715.6
|
|
|
585.7
|
|
Cost of goods
sold
|
|
102.5
|
|
|
67.0
|
|
|
181.3
|
|
|
137.9
|
|
Cost of collaboration
and contract manufacturing
|
|
173.0
|
|
|
78.8
|
|
|
311.5
|
|
|
180.0
|
|
Other operating
(income) expense, net
|
|
(50.2)
|
|
|
(63.7)
|
|
|
(90.6)
|
|
|
(120.4)
|
|
|
|
1,295.6
|
|
|
1,262.2
|
|
|
2,423.7
|
|
|
2,154.8
|
|
|
|
|
|
|
|
|
|
|
Income from
operations
|
|
656.4
|
|
|
315.6
|
|
|
1,356.5
|
|
|
795.6
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense), net
|
|
262.5
|
|
|
(90.9)
|
|
|
231.0
|
|
|
(24.8)
|
|
|
|
|
|
|
|
|
|
|
Income before income
taxes
|
|
918.9
|
|
|
224.7
|
|
|
1,587.5
|
|
|
770.8
|
|
|
|
|
|
|
|
|
|
|
Income tax
expense
|
|
21.6
|
|
|
31.6
|
|
|
65.6
|
|
|
116.6
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
$
|
897.3
|
|
|
$
|
193.1
|
|
|
$
|
1,521.9
|
|
|
$
|
654.2
|
|
|
|
|
|
|
|
|
|
|
Net income per share
- basic
|
|
$
|
8.19
|
|
|
$
|
1.77
|
|
|
$
|
13.87
|
|
|
$
|
6.00
|
|
Net income per share
- diluted
|
|
$
|
7.61
|
|
|
$
|
1.68
|
|
|
$
|
13.03
|
|
|
$
|
5.69
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding - basic
|
|
109.6
|
|
|
109.2
|
|
|
109.7
|
|
|
109.1
|
|
Weighted average
shares outstanding - diluted
|
|
117.9
|
|
|
114.6
|
|
|
116.8
|
|
|
115.0
|
|
|
|
|
|
|
* Certain revisions
have been made to the previously reported June 30, 2019 amounts.
See note (4) above.
|
TABLE 3
|
|
REGENERON
PHARMACEUTICALS, INC.
|
RECONCILIATION OF
GAAP TO NON-GAAP FINANCIAL INFORMATION (Unaudited)
|
(In millions,
except per share data)
|
|
|
|
Three Months
Ended
June 30,
|
|
Six Months
Ended
June 30,
|
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
GAAP
R&D
|
|
$
|
722.0
|
|
|
$
|
885.5
|
|
|
$
|
1,305.9
|
|
|
$
|
1,371.6
|
|
R&D: Non-cash
share-based compensation expense
|
|
56.9
|
|
|
59.3
|
|
|
113.6
|
|
|
118.0
|
|
R&D: Up-front
payments related to license and collaboration agreements
|
|
85.0
|
|
|
400.0
|
|
|
85.0
|
|
|
400.0
|
|
Non-GAAP
R&D
|
|
$
|
580.1
|
|
|
$
|
426.2
|
|
|
$
|
1,107.3
|
|
|
$
|
853.6
|
|
|
|
|
|
|
|
|
|
|
GAAP
SG&A
|
|
$
|
348.3
|
|
|
$
|
294.6
|
|
|
$
|
715.6
|
|
|
$
|
585.7
|
|
SG&A: Non-cash
share-based compensation expense
|
|
38.2
|
|
|
37.7
|
|
|
78.5
|
|
|
81.5
|
|
SG&A: Litigation
contingencies and restructuring-related expenses
|
|
8.7
|
|
|
5.0
|
|
|
28.9
|
|
|
10.0
|
|
Non-GAAP
SG&A
|
|
$
|
301.4
|
|
|
$
|
251.9
|
|
|
$
|
608.2
|
|
|
$
|
494.2
|
|
|
|
|
|
|
|
|
|
|
GAAP COGS
|
|
$
|
102.5
|
|
|
$
|
67.0
|
|
|
$
|
181.3
|
|
|
$
|
137.9
|
|
COGS: Non-cash
share-based compensation expense
|
|
8.4
|
|
|
8.8
|
|
|
17.2
|
|
|
14.2
|
|
COGS: Other
|
|
0.9
|
|
|
—
|
|
|
0.9
|
|
|
—
|
|
Non-GAAP
COGS
|
|
$
|
93.2
|
|
|
$
|
58.2
|
|
|
$
|
163.2
|
|
|
$
|
123.7
|
|
|
|
|
|
|
|
|
|
|
GAAP other income
(expense), net
|
|
$
|
262.5
|
|
|
$
|
(90.9)
|
|
|
$
|
231.0
|
|
|
$
|
(24.8)
|
|
Other income/expense:
(Gains) losses on investments
|
|
(256.1)
|
|
|
116.9
|
|
|
(199.3)
|
|
|
74.1
|
|
Interest expense:
Other
|
|
1.5
|
|
|
—
|
|
|
1.5
|
|
|
—
|
|
Non-GAAP other income
(expense), net
|
|
$
|
7.9
|
|
|
$
|
26.0
|
|
|
$
|
33.2
|
|
|
$
|
49.3
|
|
|
|
|
|
|
|
|
|
|
GAAP net
income
|
|
$
|
897.3
|
|
|
$
|
193.1
|
|
|
$
|
1,521.9
|
|
|
$
|
654.2
|
|
Total of GAAP to
non-GAAP reconciling items above
|
|
(56.5)
|
|
|
627.7
|
|
|
126.3
|
|
|
697.8
|
|
Income tax effect of
GAAP to non-GAAP reconciling items
|
|
13.6
|
|
|
(130.8)
|
|
|
(23.2)
|
|
|
(144.3)
|
|
Non-GAAP net
income
|
|
$
|
854.4
|
|
|
$
|
690.0
|
|
|
$
|
1,625.0
|
|
|
$
|
1,207.7
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP net income
per share - basic
|
|
$
|
7.80
|
|
|
$
|
6.32
|
|
|
$
|
14.81
|
|
|
$
|
11.07
|
|
Non-GAAP net income
per share - diluted
|
|
$
|
7.16
|
|
|
$
|
6.02
|
|
|
$
|
13.70
|
|
|
$
|
10.50
|
|
|
|
|
|
|
|
|
|
|
Shares used in
calculating:
|
|
|
|
|
|
|
|
|
Non-GAAP net income
per share - basic
|
|
109.6
|
|
|
109.2
|
|
|
109.7
|
|
|
109.1
|
|
Non-GAAP net income
per share - diluted
|
|
119.3
|
|
|
114.6
|
|
|
118.6
|
|
|
115.0
|
|
|
|
|
|
|
|
|
|
|
Effective tax rate
reconciliation:
|
|
|
|
|
|
|
|
|
GAAP effective tax
rate
|
|
2.4
|
%
|
|
14.1
|
%
|
|
4.1
|
%
|
|
15.1
|
%
|
Income tax effect of
GAAP to non-GAAP reconciling items
|
|
(1.5)
|
%
|
|
5.0
|
%
|
|
1.1
|
%
|
|
2.7
|
%
|
Non-GAAP effective
tax rate
|
|
0.9
|
%
|
|
19.1
|
%
|
|
5.2
|
%
|
|
17.8
|
%
|
|
|
|
|
|
|
|
|
|
Free cash flow
reconciliation:
|
|
|
|
|
|
|
|
|
Net cash provided by
operating activities
|
|
$
|
943.4
|
|
|
$
|
188.3
|
|
|
$
|
1,641.4
|
|
|
$
|
1,085.3
|
|
Capital
expenditures
|
|
(129.9)
|
|
|
(94.6)
|
|
|
(300.0)
|
|
|
(168.9)
|
|
|
|
$
|
813.5
|
|
|
$
|
93.7
|
|
|
$
|
1,341.4
|
|
|
$
|
916.4
|
|
TABLE 4
|
|
REGENERON
PHARMACEUTICALS, INC.
|
COLLABORATION
REVENUE (Unaudited)
|
(In
millions)
|
|
|
|
Three Months
Ended
June 30,
|
|
Six Months
Ended
June 30,
|
|
|
2020
|
|
2019*
|
|
2020
|
|
2019*
|
Sanofi
collaboration revenue:
|
|
|
|
|
|
|
|
|
Antibody:
|
|
|
|
|
|
|
|
|
Regeneron's share of
profits in connection with commercialization of
antibodies
|
|
$
|
171.9
|
|
|
$
|
38.8
|
|
|
$
|
342.8
|
|
|
$
|
11.0
|
|
Reimbursement for
manufacturing of commercial supplies
|
|
100.6
|
|
|
43.9
|
|
|
180.7
|
|
|
58.4
|
|
Immuno-oncology:
|
|
|
|
|
|
|
|
|
Regeneron's share of
losses in connection with commercialization of Libtayo outside the
United States
|
|
(6.4)
|
|
|
(6.9)
|
|
|
(12.6)
|
|
|
(11.6)
|
|
Reimbursement for
manufacturing of commercial supplies
|
|
3.0
|
|
|
—
|
|
|
5.1
|
|
|
—
|
|
Total Sanofi
collaboration revenue
|
|
$
|
269.1
|
|
|
$
|
75.8
|
|
|
$
|
516.0
|
|
|
$
|
57.8
|
|
|
|
|
|
|
|
|
|
|
Bayer
collaboration revenue:
|
|
|
|
|
|
|
|
|
Regeneron's net profit
in connection with commercialization of EYLEA outside the United
States
|
|
$
|
230.9
|
|
|
$
|
269.0
|
|
|
$
|
484.7
|
|
|
$
|
518.3
|
|
Reimbursement for
manufacturing of commercial supplies
|
|
13.3
|
|
|
8.2
|
|
|
40.9
|
|
|
22.9
|
|
Total Bayer
collaboration revenue
|
|
$
|
244.2
|
|
|
$
|
277.2
|
|
|
$
|
525.6
|
|
|
$
|
541.2
|
|
|
|
|
|
|
* Certain revisions
have been made to the previously reported June 30, 2019 amounts.
See note (4) above.
|
TABLE 5
|
|
REGENERON
PHARMACEUTICALS, INC.
|
NET PRODUCT SALES
OF REGENERON-DISCOVERED PRODUCTS (Unaudited)
|
(In
millions)
|
|
|
|
Net Product
Sales
Recorded
by
Regeneron
|
|
Three Months
Ended
June 30,
|
|
|
|
|
|
2020
|
|
2019
|
|
%
Change
|
|
|
|
U.S.
|
|
ROW
|
|
Total
|
|
U.S.
|
|
ROW
|
|
Total
|
|
(Total
Sales)
|
EYLEA(a)
|
|
U.S.
|
|
$
|
1,113.7
|
|
|
$
|
641.0
|
|
|
$
|
1,754.7
|
|
|
$
|
1,160.3
|
|
|
$
|
715.3
|
|
|
$
|
1,875.6
|
|
|
(6)
|
%
|
Dupixent
|
|
(b)
|
|
$
|
770.4
|
|
|
$
|
174.6
|
|
|
$
|
945.0
|
|
|
$
|
454.7
|
|
|
$
|
102.6
|
|
|
$
|
557.3
|
|
|
70
|
%
|
Libtayo(b)
|
|
U.S.
|
|
$
|
63.3
|
|
|
$
|
16.7
|
|
|
$
|
80.0
|
|
|
$
|
40.8
|
|
|
—
|
|
|
$
|
40.8
|
|
|
96
|
%
|
Praluent(c)
|
|
U.S.
|
|
$
|
47.2
|
|
|
$
|
39.4
|
|
|
$
|
86.6
|
|
|
$
|
26.5
|
|
|
$
|
47.2
|
|
|
$
|
73.7
|
|
|
18
|
%
|
Kevzara
|
|
(b)
|
|
$
|
36.5
|
|
|
$
|
31.8
|
|
|
$
|
68.3
|
|
|
$
|
34.2
|
|
|
$
|
24.3
|
|
|
$
|
58.5
|
|
|
17
|
%
|
ZALTRAP
|
|
(b)
|
|
$
|
1.7
|
|
|
$
|
25.0
|
|
|
$
|
26.7
|
|
|
$
|
1.3
|
|
|
$
|
25.3
|
|
|
$
|
26.6
|
|
|
—
|
%
|
ARCALYST
|
|
U.S.
|
|
$
|
2.7
|
|
|
—
|
|
|
$
|
2.7
|
|
|
$
|
4.2
|
|
|
—
|
|
|
$
|
4.2
|
|
|
(36)
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Product Sales
Recorded by Regeneron
|
|
Six Months
Ended
June 30,
|
|
|
|
|
|
2020
|
|
2019
|
|
%
Change
|
|
|
|
U.S.
|
|
ROW
|
|
Total
|
|
U.S.
|
|
ROW
|
|
Total
|
|
(Total
Sales)
|
EYLEA(a)
|
|
U.S.
|
|
$
|
2,285.7
|
|
|
$
|
1,322.7
|
|
|
$
|
3,608.4
|
|
|
$
|
2,234.4
|
|
|
$
|
1,384.7
|
|
|
$
|
3,619.1
|
|
|
—
|
%
|
Dupixent
|
|
(b)
|
|
$
|
1,449.4
|
|
|
$
|
350.8
|
|
|
$
|
1,800.2
|
|
|
$
|
757.7
|
|
|
$
|
173.3
|
|
|
$
|
931.0
|
|
|
93
|
%
|
Libtayo(b)
|
|
U.S.
|
|
$
|
125.0
|
|
|
$
|
29.8
|
|
|
$
|
154.8
|
|
|
$
|
67.6
|
|
|
—
|
|
|
$
|
67.6
|
|
|
129
|
%
|
Praluent(c)
|
|
U.S.
|
|
$
|
82.3
|
|
|
$
|
84.1
|
|
|
$
|
166.4
|
|
|
$
|
49.4
|
|
|
$
|
88.2
|
|
|
$
|
137.6
|
|
|
21
|
%
|
Kevzara
|
|
(b)
|
|
$
|
71.8
|
|
|
$
|
56.6
|
|
|
$
|
128.4
|
|
|
$
|
54.9
|
|
|
$
|
37.3
|
|
|
$
|
92.2
|
|
|
39
|
%
|
ZALTRAP
|
|
(b)
|
|
$
|
3.2
|
|
|
$
|
51.5
|
|
|
$
|
54.7
|
|
|
$
|
1.8
|
|
|
$
|
49.3
|
|
|
$
|
51.1
|
|
|
7
|
%
|
ARCALYST
|
|
U.S.
|
|
$
|
5.7
|
|
|
—
|
|
|
$
|
5.7
|
|
|
$
|
7.7
|
|
|
—
|
|
|
$
|
7.7
|
|
|
(26)
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a) Regeneron records net product
sales of EYLEA in the United States. Bayer records net product
sales of EYLEA outside the United States. The Company records its
share of profits/losses in connection with sales of EYLEA outside
the United States.
|
(b) Regeneron records net product
sales of Libtayo in the United States. Sanofi records net product
sales of Libtayo outside the United States and global net product
sales of Dupixent, Kevzara, and ZALTRAP. The Company records its
share of profits/losses in connection with (i) sales of Libtayo
outside the United States, and (ii) global sales of Dupixent and
Kevzara, within collaboration revenue (see Table 4). Sanofi pays
the Company a percentage of net sales of ZALTRAP.
|
(c) Effective April 1, 2020,
Regeneron records net product sales of Praluent in the United
States. Also effective April 1, 2020, Sanofi records net product
sales of Praluent outside the United States and pays the Company a
royalty on such sales. Previously, Sanofi recorded global net
product sales of Praluent and the Company recorded its share of
profits/losses in connection with such sales. Refer to "Business
Development Update" section above for further details.
|
View original
content:http://www.prnewswire.com/news-releases/regeneron-reports-second-quarter-2020-financial-and-operating-results-301106192.html
SOURCE Regeneron Pharmaceuticals