TARRYTOWN, N.Y., Aug. 6,
2019 /PRNewswire/ --
-- Second quarter 2019 revenues increased 20% to $1.93 billion versus second quarter 2018
- EYLEA® U.S. net sales increased 17% to
$1.16 billion versus second quarter
2018
- Dupixent® global net sales, which are
recorded by the Company's collaborator Sanofi, increased 166% to
$557 million versus second quarter
2018
-- For the first time on a quarterly basis, the antibody
collaboration with Sanofi achieved profitability
-- Second quarter 2019 GAAP diluted EPS was $1.68 and second quarter non-GAAP diluted
EPS(1) was $6.02. GAAP diluted EPS includes $3.55 impact related to the Alnylam up-front
payment and unrealized losses on the Alnylam equity
investment.
-- Important regulatory approvals
- FDA approved EYLEA for diabetic retinopathy and Dupixent for
chronic rhinosinusitis with nasal polyposis
- European Commission approved Libtayo® for
metastatic or locally advanced cutaneous squamous cell carcinoma
and Dupixent for adolescents with atopic dermatitis
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today
announced financial results for the second quarter of 2019 and
provided a business update.
"We had a great quarter marked by top- and bottom-line growth as
well as important advances across our innovative R&D engine,"
said Leonard S. Schleifer, M.D.,
Ph.D., President and Chief Executive Officer of Regeneron.
"We are further unlocking EYLEA's potential to help patients with
the recent approval in diabetic retinopathy, and are advancing a
high-dose formulation into the clinic later this year.
Dupixent is growing rapidly in moderate-to-severe atopic dermatitis
and asthma, and we continue to receive new indications in younger
patients and additional Type 2 diseases, including the recent U.S.
approval for chronic rhinosinusitis with nasal polyposis.
Lastly, our immuno-oncology platform, which includes Libtayo and
our portfolio of bispecific antibodies, is progressing well, with
the most advanced bispecific program, REGN1979 (CD20xCD3), entering
a potentially pivotal Phase 2 trial in follicular lymphoma."
Financial
Highlights
|
|
|
|
|
|
|
|
($ in millions,
except per share data)
|
|
Three Months
Ended
June 30,
|
|
|
|
|
2019
|
|
2018
|
|
%
Change
|
Total
revenues
|
|
$
|
1,934
|
|
|
$
|
1,608
|
|
|
20
|
%
|
GAAP net
income
|
|
$
|
193
|
|
|
$
|
551
|
|
|
(65)
|
%
|
GAAP net income per
share - diluted
|
|
$
|
1.68
|
|
|
$
|
4.82
|
|
|
(65)
|
%
|
Non-GAAP net
income(1)
|
|
$
|
690
|
|
|
$
|
624
|
|
|
11
|
%
|
Non-GAAP net income
per share - diluted(1)
|
|
$
|
6.02
|
|
|
$
|
5.45
|
|
|
10
|
%
|
Business Highlights
Key Pipeline Progress
Regeneron has 21 product
candidates in clinical development, including five of the Company's
U.S. Food and Drug Administration (FDA) approved products for which
it is investigating additional indications. Updates from the
clinical pipeline include:
EYLEA® (aflibercept) Injection
- In May 2019, the FDA approved
EYLEA for the treatment of diabetic retinopathy.
- The supplemental Biologics License Application (sBLA) for EYLEA
in a pre-filled syringe has a target action date of August 12, 2019.
Dupixent® (dupilumab)
- In May 2019, the European
Commission (EC) approved Dupixent for use in adults and adolescents
12 years and older as an add-on maintenance treatment for severe
asthma.
- In June 2019, the FDA approved
Dupixent for use with other medicines to treat chronic
rhinosinusitis with nasal polyposis (CRSwNP) in adults whose
disease is not controlled.
- The European Commission approved Dupixent, extending its
approval in the European Union (EU) to include adolescents 12 to 17
years of age with moderate-to-severe atopic dermatitis who are
candidates for systemic therapy.
- In August 2019, the Company and
Sanofi announced that the Phase 3 trial to treat severe atopic
dermatitis in children 6 to 11 years of age met its primary and
secondary endpoints.
Libtayo® (cemiplimab)
- In June 2019, the EC granted
conditional marketing authorization for Libtayo for the treatment
of adult patients with metastatic or locally advanced cutaneous
squamous cell carcinoma (CSCC) who are not candidates for curative
surgery or curative radiation.
- A Phase 3 adjuvant study in CSCC was initiated.
REGN1979, a bispecific antibody against CD20 and CD3
- In June 2019, the Company
presented updated positive results from a study in patients with
relapsed or refractory B-cell non-Hodgkin lymphoma at the European
Hematology Association meeting.
- A Phase 2 study in relapsed or refractory follicular lymphoma
(FL) is recruiting patients.
Praluent® (alirocumab)
- In April 2019, based upon data
from the Phase 3 ODYSSEY OUTCOMES trial, the FDA approved a new
indication for Praluent to reduce the risk of heart attack, stroke,
and unstable angina requiring hospitalization in adults with
established cardiovascular disease. The label was also updated to
include data showing that treatment with Praluent was associated
with a reduction in death from any cause.
REGN3500, an antibody to IL-33
- In June 2019, the Company and
Sanofi announced that the Phase 2 study in asthma met the primary
endpoint of improvement in loss of asthma control when comparing
REGN3500 monotherapy to placebo. In the trial, the greatest
improvement was observed in patients with blood eosinophil levels
≥300 cells/microliter. Patients treated with Dupixent monotherapy
did numerically better than REGN3500 across all endpoints. The
combination of REGN3500 and Dupixent did not demonstrate increased
benefit compared to Dupixent monotherapy in this trial.
Second Quarter 2019 Financial Results
Total Revenues: Total revenues increased by 20% to
$1.934 billion in the second quarter
of 2019, compared to $1.608 billion
in the second quarter of 2018.
Net product sales were $1.205
billion in the second quarter of 2019, compared to
$996 million in the second quarter of
2018. EYLEA net product sales in the United States were $1.160 billion in the second quarter of 2019,
compared to $992 million in the
second quarter of 2018. 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(5) of $638
million in the second quarter of 2019, compared to
$501 million in the second quarter of
2018. The Company's Antibody License and Collaboration
Agreement with Sanofi achieved profitability in connection with
commercialization of antibodies in the second quarter of 2019 for
the first time. Consequently, Sanofi collaboration revenue in
the second quarter of 2019 included the Company's share of profits
from collaboration antibodies of $39
million, while Sanofi collaboration revenue in the second
quarter of 2018 included the Company's share of losses from
collaboration antibodies of $69
million. The increase was primarily driven by higher
net product sales of Dupixent.
Refer to Table 4 for a summary of collaboration and other
revenue.
Research and Development (R&D) Expenses: GAAP R&D
expenses were $1.048 billion in the
second quarter of 2019, compared to $529
million in the second quarter of 2018. The higher
R&D expenses in the second quarter of 2019 were principally due
to a $400 million up-front payment in
connection with the collaboration agreement with Alnylam
Pharmaceuticals, Inc. In the second quarter of 2019,
R&D-related non-cash share-based compensation expense was
$59 million, compared to $60 million in the second quarter of 2018.
Selling, General, and Administrative (SG&A) Expenses:
GAAP SG&A expenses were $417
million in the second quarter of 2019, compared to
$365 million in the second quarter of
2018. The higher SG&A expenses in the second quarter of
2019 were primarily due to higher headcount and related costs, and
an increase in commercialization-related expenses for
Dupixent. In the second quarter of 2019, SG&A-related
non-cash share-based compensation expense was $38 million, compared to $41 million in the second quarter of 2018.
Cost of Goods Sold (COGS): GAAP COGS was $67 million in the second quarter of 2019,
compared to $36 million in the second
quarter of 2018. The increase in COGS was primarily due to
the Company's commercialization of Libtayo in the United States, including royalties to
third parties and the Company's obligation to pay Sanofi its share
of Libtayo gross profits.
Other Income (Expense): GAAP other income (expense), net,
in the second quarter of 2019 and 2018 includes the recognition of
$117 million of net unrealized losses
and $17 million of net unrealized
gains, respectively, on equity securities.
Income Taxes: In the second quarter of 2019, GAAP income
tax expense was $32 million and the
effective tax rate was 14.1%, compared to $105 million and 16.0%, respectively, in the
second quarter of 2018. The effective tax rate for the second
quarter of 2019 was positively impacted, compared to the U.S.
federal statutory rate, primarily by income earned in foreign
jurisdictions with tax rates lower than the U.S. federal statutory
rate, stock-based compensation, and federal tax credits for
research activities.
GAAP and Non-GAAP Net Income(1):
GAAP net income was $193 million, or
$1.77 per basic share and
$1.68 per diluted share, in the
second quarter of 2019, compared to GAAP net income of $551 million, or $5.12 per basic share and $4.82 per diluted share, in the second quarter of
2018.
Non-GAAP net income was $690
million, or $6.32 per basic
share and $6.02 per diluted share, in
the second quarter of 2019, compared to non-GAAP net income of
$624 million, or $5.79 per basic share and $5.45 per diluted share, in the second quarter of
2018.
The difference in GAAP net income and non-GAAP net income in the
second quarter of 2019 was largely impacted by (i) the Alnylam
up-front payment being recognized as GAAP R&D expense during
the period and (ii) unrealized losses recorded in GAAP other income
(expense) related to Alnylam common shares the Company purchased in
connection with the collaboration agreement. A reconciliation
of the Company's GAAP to non-GAAP results is included in Table 3 of
this press release.
2019 Financial
Guidance(2)
The Company's updated full year 2019 financial guidance consists
of the following components:
GAAP Sanofi
collaboration revenue: Sanofi
reimbursement of Regeneron
commercialization-related expenses
|
$500 million–$530
million
(previously $500 million–$535 million)
|
GAAP Unreimbursed
R&D(4)
|
$2.300
billion–$2.380 billion
(previously $2.280
billion–$2.400 billion)
|
Non-GAAP Unreimbursed
R&D(1)(3)
|
$1.650
billion–$1.710 billion
(previously $1.610 billion–$1.710 billion)
|
GAAP
SG&A
|
$1.705
billion–$1.785 billion
(previously $1.695
billion–$1.800 billion)
|
Non-GAAP
SG&A(1)(3)
|
$1.530 billion–$1.580
billion
(previously $1.500 billion–$1.580 billion)
|
GAAP effective tax
rate
|
11%–13%
(reaffirmed)
|
Capital
expenditures
|
$380 million–$420
million
(previously $410 million–$475 million)
|
(1)
|
This press release
uses non-GAAP net income, non-GAAP net income per share, 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. 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. 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 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)
|
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(4)
|
|
$
|
2,300
|
|
|
$
|
2,380
|
|
R&D: Non-cash
share-based compensation expense
|
|
(250)
|
|
|
(270)
|
|
R&D: Up-front
payments related to license and collaboration agreements
|
|
(400)
|
|
|
(400)
|
|
Non-GAAP unreimbursed
R&D
|
|
$
|
1,650
|
|
|
$
|
1,710
|
|
|
|
|
|
|
GAAP
SG&A
|
|
$
|
1,705
|
|
|
$
|
1,785
|
|
SG&A: Non-cash
share-based compensation expense
|
|
(165)
|
|
|
(195)
|
|
SG&A: Litigation
contingencies
|
|
(10)
|
|
|
(10)
|
|
Non-GAAP
SG&A
|
|
$
|
1,530
|
|
|
$
|
1,580
|
|
(4)
|
Unreimbursed R&D
represents R&D expenses reduced by R&D expense
reimbursements from the Company's collaborators and/or
customers.
|
|
|
(5)
|
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.
|
Conference Call Information
Regeneron will host a conference call and simultaneous webcast
to discuss its second quarter 2019 financial and operating results
on Tuesday, August 6, 2019, at 8:30
AM. To access this call, dial (800) 708-4540 (U.S.) or
(847) 619-6397 (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 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 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 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.
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; the likelihood and timing of achieving any
of the anticipated milestones described in this press release;
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® (aflibercept) Injection,
Dupixent® (dupilumab) Injection,
Praluent® (alirocumab) Injection,
Kevzara® (sarilumab) Injection,
Libtayo® (cemiplimab) Injection, fasinumab,
evinacumab, REGN1979, and REGN3500; 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 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; coverage and reimbursement determinations by
third-party payers, including Medicare and Medicaid; 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 without limitation those
relating to Sanofi reimbursement of Regeneron
commercialization-related expenses, GAAP and non-GAAP unreimbursed
R&D, GAAP and non-GAAP SG&A, GAAP effective tax rate, and
capital expenditures; 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, the ultimate outcome of any such
proceedings, 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, 2018
and its Form 10-Q for the quarterly period ended June 30, 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).
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,
|
|
|
2019
|
|
2018
|
Assets:
|
|
|
|
|
Cash and marketable
securities
|
|
$
|
5,554.3
|
|
|
$
|
4,564.9
|
|
Accounts receivable -
trade, net
|
|
1,920.2
|
|
|
1,723.7
|
|
Accounts receivable
from Sanofi and Bayer
|
|
535.7
|
|
|
519.5
|
|
Inventories
|
|
1,317.2
|
|
|
1,151.2
|
|
Property, plant, and
equipment, net
|
|
2,676.6
|
|
|
2,575.8
|
|
Deferred tax
assets
|
|
821.6
|
|
|
828.7
|
|
Other
assets
|
|
348.0
|
|
|
370.7
|
|
Total
assets
|
|
$
|
13,173.6
|
|
|
$
|
11,734.5
|
|
|
|
|
|
|
Liabilities and
stockholders' equity:
|
|
|
|
|
Accounts payable,
accrued expenses, and other liabilities
|
|
$
|
1,388.6
|
|
|
$
|
1,352.0
|
|
Deferred
revenue
|
|
1,317.8
|
|
|
916.7
|
|
Finance lease
liabilities
|
|
711.3
|
|
|
708.5
|
|
Stockholders'
equity
|
|
9,755.9
|
|
|
8,757.3
|
|
Total liabilities and
stockholders' equity
|
|
$
|
13,173.6
|
|
|
$
|
11,734.5
|
|
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,
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
Revenues:
|
|
|
|
|
|
|
|
|
Net product
sales
|
|
$
|
1,205.3
|
|
|
$
|
996.4
|
|
|
$
|
2,309.7
|
|
|
$
|
1,984.3
|
|
Sanofi collaboration
revenue
|
|
349.1
|
|
|
237.8
|
|
|
595.5
|
|
|
427.2
|
|
Bayer collaboration
revenue
|
|
289.0
|
|
|
262.9
|
|
|
565.2
|
|
|
510.8
|
|
Other
revenue
|
|
90.3
|
|
|
110.9
|
|
|
175.1
|
|
|
197.2
|
|
|
|
1,933.7
|
|
|
1,608.0
|
|
|
3,645.5
|
|
|
3,119.5
|
|
Expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
|
1,048.3
|
|
|
529.3
|
|
|
1,690.1
|
|
|
1,027.9
|
|
Selling, general, and
administrative
|
|
417.3
|
|
|
364.8
|
|
|
828.1
|
|
|
695.6
|
|
Cost of goods
sold
|
|
67.0
|
|
|
36.0
|
|
|
137.9
|
|
|
105.2
|
|
Cost of collaboration
and contract manufacturing
|
|
85.5
|
|
|
55.7
|
|
|
193.8
|
|
|
101.4
|
|
|
|
1,618.1
|
|
|
985.8
|
|
|
2,849.9
|
|
|
1,930.1
|
|
|
|
|
|
|
|
|
|
|
Income from
operations
|
|
315.6
|
|
|
622.2
|
|
|
795.6
|
|
|
1,189.4
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense), net
|
|
(90.9)
|
|
|
33.9
|
|
|
(24.8)
|
|
|
52.1
|
|
|
|
|
|
|
|
|
|
|
Income before income
taxes
|
|
224.7
|
|
|
656.1
|
|
|
770.8
|
|
|
1,241.5
|
|
|
|
|
|
|
|
|
|
|
Income tax
expense
|
|
(31.6)
|
|
|
(104.7)
|
|
|
(116.6)
|
|
|
(212.1)
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
$
|
193.1
|
|
|
$
|
551.4
|
|
|
$
|
654.2
|
|
|
$
|
1,029.4
|
|
|
|
|
|
|
|
|
|
|
Net income per share
- basic
|
|
$
|
1.77
|
|
|
$
|
5.12
|
|
|
$
|
6.00
|
|
|
$
|
9.56
|
|
Net income per share
- diluted
|
|
$
|
1.68
|
|
|
$
|
4.82
|
|
|
$
|
5.69
|
|
|
$
|
8.97
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding - basic
|
|
109.2
|
|
|
107.8
|
|
|
109.1
|
|
|
107.7
|
|
Weighted average
shares outstanding - diluted
|
|
114.6
|
|
|
114.5
|
|
|
115.0
|
|
|
114.7
|
|
TABLE 3
|
|
REGENERON
PHARMACEUTICALS, INC. RECONCILIATION OF GAAP NET INCOME
TO NON-GAAP NET INCOME (Unaudited) (In millions,
except per share data)
|
|
|
|
Three Months
Ended
June 30,
|
|
Six Months
Ended
June 30,
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
GAAP net
income
|
|
$
|
193.1
|
|
|
$
|
551.4
|
|
|
$
|
654.2
|
|
|
$
|
1,029.4
|
|
Adjustments:
|
|
|
|
|
|
|
|
|
R&D: Non-cash
share-based compensation expense
|
|
59.3
|
|
|
59.6
|
|
|
118.0
|
|
|
100.4
|
|
R&D: Up-front
payments related to license and
collaboration agreements
|
|
400.0
|
|
|
—
|
|
|
400.0
|
|
|
—
|
|
SG&A: Non-cash
share-based compensation expense
|
|
37.7
|
|
|
40.5
|
|
|
81.5
|
|
|
75.5
|
|
SG&A: Litigation
contingencies
|
|
5.0
|
|
|
—
|
|
|
10.0
|
|
|
—
|
|
COGS and COCM:
Non-cash share-based
compensation expense
|
|
8.8
|
|
|
6.7
|
|
|
14.2
|
|
|
13.3
|
|
Other income/expense:
Losses (gains) on investments
in equity securities
|
|
116.9
|
|
|
(16.5)
|
|
|
74.1
|
|
|
(25.9)
|
|
Income tax effect of
reconciling items above
|
|
(130.8)
|
|
|
(18.0)
|
|
|
(144.3)
|
|
|
(32.3)
|
|
Non-GAAP net
income
|
|
$
|
690.0
|
|
|
$
|
623.7
|
|
|
$
|
1,207.7
|
|
|
$
|
1,160.4
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP net income
per share - basic
|
|
$
|
6.32
|
|
|
$
|
5.79
|
|
|
$
|
11.07
|
|
|
$
|
10.77
|
|
Non-GAAP net income
per share - diluted
|
|
$
|
6.02
|
|
|
$
|
5.45
|
|
|
$
|
10.50
|
|
|
$
|
10.12
|
|
|
|
|
|
|
|
|
|
|
Shares used in
calculating:
|
|
|
|
|
|
|
|
|
Non-GAAP net income
per share - basic
|
|
109.2
|
|
|
107.8
|
|
|
109.1
|
|
|
107.7
|
|
Non-GAAP net income
per share - diluted
|
|
114.6
|
|
|
114.5
|
|
|
115.0
|
|
|
114.7
|
|
TABLE 4
|
|
REGENERON
PHARMACEUTICALS, INC. COLLABORATION AND OTHER REVENUE
(Unaudited) (In millions)
|
|
|
|
Three Months
Ended
June 30,
|
|
Six Months
Ended
June 30,
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
Sanofi
collaboration revenue:
|
|
|
|
|
|
|
|
|
Reimbursement of
Regeneron research and development expenses
|
|
$
|
118.3
|
|
|
$
|
141.6
|
|
|
$
|
239.2
|
|
|
$
|
275.8
|
|
Reimbursement of
Regeneron commercialization-related expenses
|
|
122.8
|
|
|
105.7
|
|
|
241.7
|
|
|
192.3
|
|
Regeneron's share of
profits (losses) in connection with
commercialization of antibodies
|
|
38.8
|
|
|
(68.8)
|
|
|
11.0
|
|
|
(143.7)
|
|
Other
|
|
69.2
|
|
|
59.3
|
|
|
103.6
|
|
|
102.8
|
|
Total Sanofi
collaboration revenue
|
|
349.1
|
|
|
237.8
|
|
|
595.5
|
|
|
427.2
|
|
|
|
|
|
|
|
|
|
|
Bayer
collaboration revenue:
|
|
|
|
|
|
|
|
|
Regeneron's net
profit in connection with commercialization of
EYLEA outside the United States
|
|
269.0
|
|
|
246.3
|
|
|
518.3
|
|
|
478.4
|
|
Reimbursement of
Regeneron development expenses
|
|
8.0
|
|
|
3.9
|
|
|
10.6
|
|
|
7.8
|
|
Other
|
|
12.0
|
|
|
12.7
|
|
|
36.3
|
|
|
24.6
|
|
Total Bayer
collaboration revenue
|
|
289.0
|
|
|
262.9
|
|
|
565.2
|
|
|
510.8
|
|
|
|
|
|
|
|
|
|
|
Total Sanofi and
Bayer collaboration revenue
|
|
$
|
638.1
|
|
|
$
|
500.7
|
|
|
$
|
1,160.7
|
|
|
$
|
938.0
|
|
|
|
|
|
|
|
|
|
|
Other
revenue:
|
|
|
|
|
|
|
|
|
Reimbursement of
Regeneron research and development expenses -
Teva
|
|
$
|
36.5
|
|
|
$
|
34.3
|
|
|
$
|
68.7
|
|
|
$
|
73.4
|
|
Reimbursement of
Regeneron research and development expenses -
other
|
|
3.7
|
|
|
3.9
|
|
|
12.1
|
|
|
6.6
|
|
Other
|
|
50.1
|
|
|
72.7
|
|
|
94.3
|
|
|
117.2
|
|
Total other
revenue
|
|
$
|
90.3
|
|
|
$
|
110.9
|
|
|
$
|
175.1
|
|
|
$
|
197.2
|
|
TABLE 5
|
|
REGENERON
PHARMACEUTICALS, INC. NET PRODUCT SALES OF
REGENERON-DISCOVERED PRODUCTS (Unaudited) (In
millions)
|
|
|
|
Three Months
Ended
June 30,
|
|
|
2019
|
|
2018
|
|
|
U.S.
|
|
ROW
|
|
Total
|
|
U.S.
|
|
ROW
|
|
Total
|
|
EYLEA*
|
|
$
|
1,160.3
|
|
|
$
|
715.3
|
|
|
$
|
1,875.6
|
|
|
$
|
992.0
|
|
|
$
|
665.9
|
|
|
$
|
1,657.9
|
|
|
Libtayo
|
|
40.8
|
|
|
—
|
|
|
40.8
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
ARCALYST
|
|
4.2
|
|
|
—
|
|
|
4.2
|
|
|
4.4
|
|
|
—
|
|
|
4.4
|
|
|
Net product sales
recorded by
Regeneron
|
|
$
|
1,205.3
|
|
|
|
|
|
|
$
|
996.4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product sales
recorded by Sanofi*:
|
|
|
|
|
|
|
|
|
|
Dupixent
|
|
$
|
454.7
|
|
|
$
|
102.6
|
|
|
$
|
557.3
|
|
|
$
|
180.9
|
|
|
$
|
28.3
|
|
|
$
|
209.2
|
|
|
Praluent
|
|
$
|
26.5
|
|
|
$
|
47.2
|
|
|
$
|
73.7
|
|
|
$
|
41.4
|
|
|
$
|
32.1
|
|
|
$
|
73.5
|
|
|
Kevzara
|
|
$
|
34.2
|
|
|
$
|
24.3
|
|
|
$
|
58.5
|
|
|
$
|
18.8
|
|
|
$
|
5.3
|
|
|
$
|
24.1
|
|
|
ZALTRAP
|
|
$
|
1.3
|
|
|
$
|
25.3
|
|
|
$
|
26.6
|
|
|
$
|
2.7
|
|
|
$
|
25.7
|
|
|
$
|
28.4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months
Ended
June 30,
|
|
|
2019
|
|
2018
|
|
|
U.S.
|
|
ROW
|
|
Total
|
|
U.S.
|
|
ROW
|
|
Total
|
|
EYLEA*
|
|
$
|
2,234.4
|
|
|
$
|
1,384.7
|
|
|
$
|
3,619.1
|
|
|
$
|
1,976.0
|
|
|
$
|
1,289.9
|
|
|
$
|
3,265.9
|
|
|
Libtayo
|
|
67.6
|
|
|
—
|
|
|
67.6
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
ARCALYST
|
|
7.7
|
|
|
—
|
|
|
7.7
|
|
|
8.3
|
|
|
—
|
|
|
8.3
|
|
|
Net product sales
recorded by
Regeneron
|
|
$
|
2,309.7
|
|
|
|
|
|
|
$
|
1,984.3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product sales
recorded by Sanofi*:
|
|
|
|
|
|
|
|
|
|
Dupixent
|
|
$
|
757.7
|
|
|
$
|
173.3
|
|
|
$
|
931.0
|
|
|
$
|
298.1
|
|
|
$
|
42.5
|
|
|
$
|
340.6
|
|
|
Praluent
|
|
$
|
49.4
|
|
|
$
|
88.2
|
|
|
$
|
137.6
|
|
|
$
|
73.2
|
|
|
$
|
60.2
|
|
|
$
|
133.4
|
|
|
Kevzara
|
|
$
|
54.9
|
|
|
$
|
37.3
|
|
|
$
|
92.2
|
|
|
$
|
28.2
|
|
|
$
|
8.3
|
|
|
$
|
36.5
|
|
|
ZALTRAP
|
|
$
|
1.8
|
|
|
$
|
49.3
|
|
|
$
|
51.1
|
|
|
$
|
5.1
|
|
|
$
|
49.6
|
|
|
$
|
54.7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* Bayer records net product sales of
EYLEA outside the United States and Sanofi records global net
product sales
of Dupixent, Praluent, Kevzara, and ZALTRAP. Refer to Table 4
for the Company's share of profits/losses recorded
in connection with sales of EYLEA outside the United States and
global sales of Dupixent, Praluent, and Kevzara.
Sanofi pays the Company a percentage of aggregate net sales of
ZALTRAP.
|
View original
content:http://www.prnewswire.com/news-releases/regeneron-reports-second-quarter-2019-financial-and-operating-results-300896721.html
SOURCE Regeneron Pharmaceuticals, Inc.