HERTFORDSHIRE, England and
PITTSBURGH, Nov. 5, 2019 /PRNewswire/ -- Mylan N.V.
(NASDAQ: MYL) today announced its financial results for the three
and nine months ended September 30, 2019.
Third Quarter 2019 Financial Highlights
- U.S. GAAP diluted earnings per ordinary share ("U.S. GAAP EPS")
of $0.37, up 9% compared to U.S. GAAP
EPS of $0.34 in the prior year period
and adjusted diluted earnings per ordinary share ("adjusted EPS")
of $1.17 compared to $1.25 in the prior year period.
- Total revenues of $2.96 billion,
up 3%, up 6% on a constant currency basis, compared to the prior
year period.
- Revenue Highlights:
-
- North America segment net
sales of $1.09 billion, up 8% on an
actual and constant currency basis.
- Europe segment net sales of
$1.05 billion, up less than 1%, up 6%
on a constant currency basis.
- Rest of World segment net sales of $793.7 million, up 3%, up 4% on a constant
currency basis.
- U.S. GAAP net cash provided by operating activities for the
three months ended September 30, 2019
of $487.8 million, compared to
$653.6 million in the prior year
period, and adjusted free cash flow for the three months ended
September 30, 2019 of $542.1 million, compared to $698.4 million in the prior year period.
- U.S. GAAP net cash provided by operating activities for the
nine months ended September 30, 2019
of $1.12 billion, compared to
$1.71 billion in the prior year
period, and adjusted free cash flow for the nine months ended
September 30, 2019 of $1.29 billion, compared to $2.02 billion in the prior year period, both
driven primarily by the expected increased investment in working
capital to support new product launches.
- Mylan is not providing forward-looking guidance for U.S. GAAP
reported financial measures or a quantitative reconciliation of
forward-looking non-GAAP financial measures. Please see "Non-GAAP
Financial Measures" for additional information.
Mylan CEO Heather Bresch
commented, "Mylan achieved healthy revenue growth across all
segments of our business during the third quarter, supporting solid
year-to-date revenue growth as compared with last year on a
constant currency basis. Also, this quarter, we continued the
purposeful work of transforming our business by applying a highly
disciplined financial lens to further maximize the value of our
asset base. We will continue to execute and remain laser-focused as
we now set our sights on year-end commitments, including the
upcoming launch of our biosimilar to Herceptin®, Ogivri™, and as we continue to make
progress toward a successful deal close with Pfizer's Upjohn
business, which we continue to expect will occur in mid-2020."
Mylan President Rajiv Malik continued, "During the third
quarter, we benefited from continued momentum on key products,
including Yupelri®,
Copaxone®,
Fulphila®
and Wixela™ Inhub™. We also were pleased with the
overall performance of our global key brands and anticipate
continued growth across these areas of our portfolio as we head
into the fourth quarter. We expect to finish the year from a
position of strength as we have reached all of the product
milestones necessary to meet our performance commitments, including
approval on our Ogivri™ product,
which we expect to launch in the coming weeks."
Mylan CFO Ken Parks added,
"During the third quarter, we delivered adjusted free cash flow of
$542 million, bringing total
year-to-date adjusted free cash flow to approximately $1.3 billion,
and are reaffirming our commitment to deliver $1.9 billion to $2.3
billion for the full year 2019. As of the end of the third
quarter, we have repaid approximately $650
million of debt and remain committed to repay at least
$1.1 billion of debt during
2019. Our commitment to
delever and maintain our investment
grade credit rating, while maintaining our financial flexibility to
execute on our business strategies, is supported by our stable and
durable cash flow profile. For the full year 2019, we also are narrowing certain of our
financial guidance range metrics, and now expect total revenues to
be in the range of $11.5 billion to
$12.0 billion, and adjusted EPS to be
in the range of $4.20 to $4.40."
Financial
Summary
|
|
Three Months
Ended
|
|
Nine Months
Ended
|
|
September
30,
|
|
September
30,
|
(Unaudited; in
millions, except per share amounts and %s)
|
2019
|
|
2018
|
|
Percent
Change
|
|
2019
|
|
2018
|
|
Percent
Change
|
Total Revenues
(1)
|
$
|
2,961.7
|
|
|
$
|
2,862.4
|
|
|
3%
|
|
$
|
8,308.7
|
|
|
$
|
8,355.2
|
|
|
(1)%
|
North America Net
Sales
|
1,088.6
|
|
|
1,012.3
|
|
|
8%
|
|
3,035.0
|
|
|
2,998.4
|
|
|
1%
|
Europe Net
Sales
|
1,045.9
|
|
|
1,041.3
|
|
|
—%
|
|
2,930.7
|
|
|
3,070.3
|
|
|
(5)%
|
Rest of World Net
Sales
|
793.7
|
|
|
773.7
|
|
|
3%
|
|
2,241.3
|
|
|
2,164.5
|
|
|
4%
|
Other
Revenues
|
33.5
|
|
|
35.1
|
|
|
(5)%
|
|
101.7
|
|
|
122.0
|
|
|
(17)%
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. GAAP Gross
Profit
|
$
|
1,072.4
|
|
|
$
|
1,039.2
|
|
|
3%
|
|
$
|
2,810.2
|
|
|
$
|
2,986.0
|
|
|
(6)%
|
U.S. GAAP Gross
Margin
|
36.2
|
%
|
|
36.3
|
%
|
|
|
|
33.8
|
%
|
|
35.7
|
%
|
|
|
Adjusted Gross Profit
(2)
|
$
|
1,564.4
|
|
|
$
|
1,584.7
|
|
|
(1)%
|
|
$
|
4,438.2
|
|
|
$
|
4,500.2
|
|
|
(1)%
|
Adjusted Gross Margin
(2)
|
52.8
|
%
|
|
55.4
|
%
|
|
|
|
53.4
|
%
|
|
53.9
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. GAAP Net
Earnings (Loss)
|
$
|
189.8
|
|
|
$
|
176.7
|
|
|
7%
|
|
$
|
(3.7)
|
|
|
$
|
301.3
|
|
|
(101)%
|
U.S. GAAP
EPS
|
$
|
0.37
|
|
|
$
|
0.34
|
|
|
9%
|
|
$
|
(0.01)
|
|
|
$
|
0.58
|
|
|
(102)%
|
Adjusted Net Earnings
(2)
|
$
|
604.4
|
|
|
$
|
648.0
|
|
|
(7)%
|
|
$
|
1,559.1
|
|
|
$
|
1,695.1
|
|
|
(8)%
|
Adjusted EPS
(2)
|
$
|
1.17
|
|
|
$
|
1.25
|
|
|
(6)%
|
|
$
|
3.02
|
|
|
$
|
3.28
|
|
|
(8)%
|
|
|
|
|
|
|
|
|
|
|
|
|
EBITDA
(2)
|
$
|
794.8
|
|
|
$
|
841.6
|
|
|
(6)%
|
|
$
|
1,925.7
|
|
|
$
|
2,188.1
|
|
|
(12)%
|
Adjusted EBITDA
(2)
|
$
|
922.8
|
|
|
$
|
935.9
|
|
|
(1)%
|
|
$
|
2,480.4
|
|
|
$
|
2,616.4
|
|
|
(5)%
|
___________
|
(1)
Amounts exclude
intersegment revenue that eliminates on a consolidated
basis.
|
(2)
Non-GAAP financial
measures. Please see "Non-GAAP Financial Measures" for additional
information.
|
Third Quarter 2019 Financial Results
Total revenues for the three months ended
September 30, 2019 were $2.96
billion, compared to $2.86
billion for the comparable prior year period, representing
an increase of $99.3 million, or 3%.
Total revenues include both net sales and other revenues from third
parties. Net sales for the current quarter were $2.93 billion, compared to $2.83 billion for the comparable prior year
period, representing an increase of $100.9
million, or 4%. Other revenues for the current
quarter were $33.5 million, compared
to $35.1 million for the comparable
prior year period.
The increase in net sales included an increase in the
North America segment of 8% and in
the Rest of World segment of 3%. Net sales in the Europe segment increased less than 1% when
compared to the prior year period. Mylan's net sales were
unfavorably impacted by the effect of foreign currency translation,
primarily reflecting changes in the U.S. Dollar as compared to the
currencies of Mylan's subsidiaries in the European Union and
Australia. The unfavorable impact
of foreign currency translation on current period net sales was
approximately $62.0 million, or 2%.
On a constant currency basis, net sales increased by approximately
$162.9 million, or 6%. This increase
was primarily driven by new product sales, partially offset by a
decrease in net sales from existing products as the impact of lower
pricing exceeded the benefit of higher volumes. Below is a summary
of net sales in each of our segments for the three months ended
September 30, 2019:
- Net sales from North
America segment totaled $1.09
billion in the current quarter, an increase of $76.3 million or 8% when compared to the prior
year period. This increase was primarily driven by new product
sales partially offset by lower sales of existing products due to
lower pricing and lower volumes. New product sales were primarily
driven by sales of the Wixela™
Inhub™ and Yupelri®. Lower sales of existing products
was due to changes in the competitive environment, including the
loss of exclusivity on tadalafil. The impact of foreign currency
translation on current period net sales was insignificant within
North America.
- Net sales from Europe
segment totaled $1.05 billion in the
current quarter, an increase of $4.6
million, or less than 1%, when compared to the prior year
period. Net sales in the current period were negatively affected by
the unfavorable impact of foreign currency translation of
approximately $53.3 million or 5%,
and to a lesser extent, lower pricing on existing products. The
unfavorable impact of these items was offset by new product sales,
including Hulio™, and higher volumes of existing products. Constant
currency net sales increased by approximately $57.9 million, or 6%, when compared to the prior
year period.
- Net sales from Rest of World segment totaled
$793.7 million in the current
quarter, an increase of $20.0 million
or 3% when compared to the prior year period. This increase was
primarily driven by new product sales in Australia and emerging markets and higher
volumes of existing products primarily driven by products sold in
emerging markets. These increases were partially offset by lower
pricing on existing products and, to a lesser extent, the
unfavorable impact of foreign currency translation. Overall, net
sales from Rest of World were unfavorably impacted by the effect of
foreign currency translation by approximately $8.0 million, or 1%. Constant currency net sales
increased by approximately $28.0
million, or 4% when compared to the prior year period.
U.S. GAAP gross profit was $1.07
billion and $1.04 billion for
the third quarter of 2019 and 2018, respectively. U.S. GAAP
gross margins were 36% in the third quarter of 2019 and 2018.
U.S. GAAP gross margins were negatively impacted as a result of
lower gross profit for sales of existing products, including higher
sales of the authorized generic version of EpiPen®, which has a
lower than company average margin, as well as changes in the
competitive environment on certain products. In addition,
there were certain inventory write-offs, the largest of which is
dated Wixela™ Inhub™ product resulting
from the later than expected approval date. These decreases were
offset by the impact from new product sales and lower site
remediation expenses and restructuring charges related to
activities at the Company's Morgantown plant. Adjusted gross profit
was $1.56 billion and adjusted gross
margins were 53% for the third quarter of 2019 compared to adjusted
gross profit of $1.58 billion and
adjusted gross margins of 55% in the prior year period. Adjusted
gross margins were also negatively impacted by EpiPen® and the
Wixela™ Inhub™, partially offset by the
impact from new product sales.
R&D expense for the three months ended
September 30, 2019 was $167.9
million, compared to $144.1
million for the comparable prior year period, an increase of
$23.8 million. This increase was
primarily due to higher payments in the current year period related
to licensing arrangements for products in development partially
offset by lower expenditures related to the reprioritization of
global programs.
SG&A expense for the three months ended
September 30, 2019 was $632.7
million, compared to $577.3
million for the comparable prior year period, an increase of
$55.4 million. The increase was due
to continued investment in selling and marketing activities. Also
contributing to the increase were higher consulting fees and other
expenses primarily related to the pending Upjohn transaction
totaling approximately $41.2 million
in the current quarter. In addition, the increase included the
impact of the reversal of cumulative expense in the prior year
period related to the Company's One-Time Special Performance-Based
Five-Year Realizable Value Incentive Program that resulted in the
Company recognizing a reduction in share-based compensation expense
of approximately $47.1 million during
the three months ended September 30,
2018. Partially offsetting these items was compensation
expense of $20.0 million recognized
in the prior year period for an additional discretionary bonus for
a certain group of employees and lower restructuring expenses in
the current quarter when compared to the prior year period. None of
the employees who received the 2018 discretionary bonus were named
executive officers.
During the third quarter of 2019, the Company recorded a net
gain of $51.9 million in
Litigation settlements and other contingencies, net compared to
a net gain of $20.4 million in the
comparable prior year period. The favorable litigation settlement
for the three months ended September 30, 2019, consists
primarily of a gain related to the Celgene Corporation settlement
of $62.0 million partially offset by
certain litigation related charges. The net gain recognized in the
prior year period primarily relates to a gain of approximately
$19.3 million for a contingent
consideration fair value adjustment due to changes to assumptions
relating to the timing of product launch along with other
competitive and market factors related to the Wixela™
Inhub™.
U.S. GAAP net earnings increased by $13.1 million to earnings of $189.8 million for the three months ended
September 30, 2019, compared to earnings of $176.7 million for the prior year period and
U.S. GAAP EPS increased from $0.34 in the prior year period to $0.37 in the current quarter. The Company
recognized a U.S. GAAP income tax benefit of
$4.0 million in the current year
period, compared to a U.S. GAAP income tax provision of
$15.5 million for the comparable
prior year period, an increase of $19.5
million. During the current quarter, the Company recorded a
$42.0 million benefit resulting from
refinements to previous estimates in conjunction with the filing of
the Company's 2018 U.S. federal tax return, which revised the
estimated impact of the Company's valuation allowance on its
interest limitation deductions and the estimate of available
foreign tax credits. Also impacting the current year income tax
benefit was the changing mix of income earned in jurisdictions with
differing tax rates. Adjusted net earnings decreased to
$604.4 million compared to
$648.0 million for the prior year
period. Adjusted EPS decreased to $1.17 from $1.25 in
the prior year period.
EBITDA was $794.8
million for the current quarter and $841.6 million for the comparable prior year
period. After adjusting for certain items as further detailed in
the reconciliation below, adjusted EBITDA was $922.8 million for the current quarter and
$935.9 million for the comparable
prior year period.
Nine Months Ended September 30,
2019 Financial Results
Total revenues for the nine months ended
September 30, 2019 were $8.31
billion, compared to $8.36
billion for the comparable prior year period, representing a
decrease of $46.5 million, or 1%.
Total revenues include both net sales and other revenues from third
parties. Net sales for the nine months ended
September 30, 2019 were $8.21
billion, compared to $8.23
billion for the comparable prior year period, representing a
decrease of $26.2 million, or less
than 1%. Other revenues for the nine months ended
September 30, 2019 were $101.7
million, compared to $122.0
million for the comparable prior year period.
The decrease in net sales was primarily the result of a decrease
in net sales in the Europe segment
of 5%, partially offset by an increase in net sales in the Rest of
World segment of 4% and an increase in net sales in the
North America segment of 1%.
Mylan's net sales were unfavorably impacted by the effect of
foreign currency translation, primarily reflecting changes in the
U.S. Dollar as compared to the currencies of Mylan's subsidiaries
in India, Australia, and the European Union. The
unfavorable impact of foreign currency translation on current year
net sales was approximately $287.6
million, or 4%. On a constant currency basis, the increase
in net sales was approximately $261.4
million, or 3% for the nine months ended September 30,
2019. This increase was primarily driven by new product sales,
partially offset by a decrease in net sales from existing products
as a result of lower pricing and volumes. Below is a summary of net
sales in each of our segments for the nine months ended
September 30, 2019:
- Net sales from North
America segment totaled $3.04
billion during the nine months ended September 30, 2019, an increase of $36.6 million or 1% when compared to the prior
year period. This increase was due primarily to new product sales,
including the Wixela™ Inhub™ and
Fulphila® (biosimilar to
Neulasta®). This increase was partially offset by lower pricing and
volumes of existing products, driven by changes in the competitive
environment and the impact of the Morgantown plant remediation activities. The
impact of foreign currency translation on current period net sales
was insignificant within North
America.
- Net sales from Europe
segment totaled $2.93 billion during
the nine months ended September 30,
2019, a decrease of $139.6
million or 5% when compared to the prior year period. This
decrease was primarily the result of the unfavorable impact of
foreign currency translation of approximately $190.4 million or 6%. Sales of existing products
were also negatively impacted by lower pricing. This decrease was
partially offset by new product sales and higher volumes. Constant
currency net sales increased by approximately $50.8 million or 2% when compared to the prior
year period.
- Net sales from Rest of World segment totaled
$2.24 billion during the nine months
ended September 30, 2019, an increase
of $76.8 million or 4% when compared
to the prior year period. This increase was primarily the result of
new product sales, primarily in Australia and emerging markets, and higher
volumes of existing products. Increased volumes of existing
products were primarily driven by
the Company's anti-retroviral therapy franchise. This increase was
partially offset by the unfavorable impact of foreign currency
translation and, to a lesser extent, by lower pricing on existing
products. Overall, net sales from Rest of World were unfavorably
impacted by the effect of foreign currency translation of
approximately $91.7 million, or 4%.
Constant currency net sales increased by approximately $168.5 million or 8% when compared to the prior
year period.
U.S. GAAP gross profit was $2.81
billion and $2.99 billion for
the nine months ended September 30,
2019 and 2018, respectively. U.S. GAAP gross margins
were 34% and 36% for the nine months ended September 30, 2019 and 2018, respectively. U.S.
GAAP gross margins were negatively impacted by lower gross profit
for sales of existing products. In addition, gross margins were
negatively impacted by approximately 65 basis points for higher
site remediation expenses related to activities at the Company's
Morgantown plant, by approximately
10 basis points related to the incremental amortization from
product acquisitions and by approximately 40 basis points for
recall related costs, including inventory write-offs. These items
were partially offset by the impact of new product sales.
Adjusted gross profit was $4.44
billion and adjusted gross margins were 53% for the nine
months ended September 30, 2019
compared to adjusted gross profit of $4.50
billion and adjusted gross margins of 54% in the prior year
period.
R&D expense for the nine months ended
September 30, 2019 was $488.1
million, compared to $555.7
million for the comparable prior year period, a decrease of
$67.6 million. This decrease was
primarily due to lower expenditures related to the reprioritization
of global programs and lower restructuring related costs.
SG&A expense for the nine months ended
September 30, 2019 was $1.91
billion, compared to $1.81
billion for the comparable prior year period, an increase of
$101.1 million. The increase was due
to continued investment in selling and marketing activities. Also
contributing to the increase were higher consulting fees and other
expenses primarily related to the pending Upjohn transaction
totaling approximately $45.3 million
in the current year period. In addition, the current year period
was impacted by higher share-based compensation expense due to a
reduction of approximately $70.6
million during the nine months ended September 30, 2018
related to certain performance-based awards. Partially offsetting
these increases was a decrease in bad debt expense of
approximately $23.0 million related to a special business
interruption event for one customer in the prior year period and
$20.0 million of compensation expense
for an additional discretionary bonus for a certain group of
employees in the prior year period. None of the employees who
received the 2018 discretionary bonus were named executive
officers.
During the nine months ended September 30, 2019 the Company
recorded a net gain of $30.3 million
in Litigation settlements and other contingencies, net
compared to a net gain of $50.6
million in the comparable prior year period. During the nine
months ended September 30, 2019, the Company recognized a net
gain of approximately $1.4 million
primarily related to a favorable litigation settlement related to
the Celgene matter of $62.0 million
recognized during the nine months ended September 30, 2019 offset by litigation related
charges for settlements reached related to the modafinil antitrust
matter of $18.0 million and the
settlement with the SEC in connection with the SEC staff's
investigation of the Company's public disclosures regarding its
2016 settlement with the Department of Justice concerning the
EpiPen Medicaid Drug Rebate Program of $30.0
million. In addition, a $28.9
million gain was recognized for the reduction of contingent
consideration related to the respiratory delivery platform.
Litigation settlements for the nine months ended September 30,
2018, consisted primarily of a gain of approximately $14.7 million related to a favorable litigation
settlement, which was partially offset by litigation related
charges of approximately $13.3 million related to an antitrust
and a patent infringement matter. In addition, a $49.3 million gain was recognized for the
reduction of contingent consideration related to the respiratory
delivery platform.
U.S. GAAP net (loss) earnings decreased by
$305.0 million to a loss of
$3.7 million for the nine months
ended September 30, 2019, compared to earnings of $301.3 million for the prior year period and
U.S. GAAP EPS decreased from $0.58 in the prior year period to $(0.01) for the nine months ended
September 30, 2019. The Company recognized a U.S. GAAP
income tax provision of $22.9
million, compared to a U.S. GAAP income tax benefit of
$79.9 million for the comparable
prior year period, an increase of $102.8
million. During the nine months ended September 30,
2019, primarily due to the settlement reached with the U.S.
Internal Revenue Service, partially offset by the expiration of
federal and foreign statutes of limitations, the Company increased
its net liability for unrecognized tax benefits by approximately
$50.9 million. Additionally, during
the nine months ended September 30, 2019, the Company recorded
a $42.0 million benefit resulting
from refinements to previous estimates in conjunction with the
filing of the Company's 2018 U.S. federal tax return, which revised
the estimated impact of the Company's valuation allowance on its
interest limitation deductions and the estimate of available
foreign tax credits. In the prior year period, as a result of
federal and state audits and settlements and expirations of certain
state, federal, and foreign statutes of limitations, the Company
reduced its liability for unrecognized tax benefits by
approximately $86.0 million, which
resulted in a net benefit to the income tax provision of
approximately $53.0 million.
Partially offsetting this benefit was an increase in the reserve
for uncertain tax benefits of approximately $18.0
million for certain other matters. Additionally, during
the nine months ended September 30, 2018, income tax
benefits of approximately $30.0 million were recognized
upon revaluations of certain deferred tax items upon statutory rate
changes in certain non-U.S. jurisdictions, $6.9
million of valuation allowance releases in certain
jurisdictions, and a benefit of approximately $6.2
million related to the finalization of previously recorded
2017 tax estimates upon the filing of tax returns. Also impacting
the current year income tax expense was the changing mix of income
earned in jurisdictions with differing tax rates. Adjusted net
earnings decreased to $1.56
billion compared to $1.70
billion for the prior year period. Adjusted EPS
decreased to $3.02 from $3.28 in the prior year period.
EBITDA was $1.93
billion for the nine months ended September 30, 2019,
and $2.19 billion for the comparable
prior year period. After adjusting for certain items as further
detailed in the reconciliation below, adjusted EBITDA was
$2.48 billion for the nine months
ended September 30, 2019 and $2.62
billion for the comparable prior year period.
Cash Flow
U.S. GAAP net cash provided by operating
activities for the three and nine months ended
September 30, 2019 was $487.8
million and $1.12 billion,
compared to $653.6 million and
$1.71 billion in the comparable prior
year periods. Capital expenditures were approximately $42.3 million and $139.6
million for the three and nine months ended
September 30, 2019 compared to approximately $61.5 million and $137.4
million for the comparable prior year periods.
Adjusted net cash provided by operating activities for
the three and nine months ended September 30, 2019 was
$584.4 million and $1.43 billion compared to adjusted net cash
provided by operating activities of $759.9
million and $2.16 billion for
the comparable prior year periods. Adjusted free cash flow,
defined as adjusted net cash provided by operating activities less
capital expenditures, was $542.1
million and $1.29 billion for
the three and nine months ended September 30, 2019, compared
to $698.4 million and $2.02 billion in comparable the prior year
periods.
Updated Full Year 2019 Financial Guidance
Mylan is updating certain of its previous full year 2019
guidance by narrowing certain guidance metric's ranges. As
discussed in the "Non-GAAP Financial Measures" section below, Mylan
is not providing forward looking guidance for U.S. GAAP reported
financial measures or a quantitative reconciliation of
forward-looking non-GAAP financial measures to the most directly
comparable U.S. GAAP measure. For 2019, Mylan continues to expect
to generate $1.9 billion to
$2.3 billion of adjusted free cash
flow. Adjusted EPS for 2019 is now expected to be in the range of
$4.20 to $4.40. Mylan now expects 2019 total revenues in
the range of $11.50 billion to
$12.00 billion.
(In millions,
except for Adjusted EPS)
|
|
2019 Updated
Guidance Range
|
|
2019 Updated
Midpoint
|
Total
Revenues
|
|
$11,500 -
$12,000
|
|
$11,750
|
Adjusted
EPS
|
|
$4.20 -
$4.40
|
|
$4.30
|
Adjusted Free Cash
Flow
|
|
$1,900 -
$2,300
|
|
$2,100
|
Conference Call and Earnings Materials
Mylan N.V. will host a conference call and live webcast, today
at 10:00 a.m. ET, to review the
Company's financial results for the third quarter ended
September 30, 2019. The earnings call
can be accessed live by calling 855.493.3607 or 346.354.0950 for
international callers (ID#: 1519969) or at the following address on
the Company's website: investor.mylan.com. The Q3 2019 "Earnings
Call Presentation", which will be referenced during the call can be
found at investor.mylan.com. A replay of the webcast will also be
available on the website.
Non-GAAP Financial Measures
This press release includes the presentation and discussion of
certain financial information that differs from what is reported
under accounting principles generally accepted in the United States ("U.S. GAAP"). These
non-GAAP financial measures, including, but not limited to,
adjusted EPS, adjusted gross profit, adjusted gross margins,
adjusted net earnings, EBITDA, adjusted EBITDA, adjusted R&D
and as a % of total revenues, adjusted SG&A and as a % of total
revenues, adjusted earnings from operations, adjusted interest
expense, adjusted other income, adjusted effective tax rate,
notional debt to Credit Agreement Adjusted EBITDA leverage ratio,
long term average debt to Credit Agreement Adjusted EBITDA leverage
ratio target, adjusted net cash provided by operating activities,
adjusted free cash flow, constant currency total revenues and
constant currency net sales are presented in order to supplement
investors' and other readers' understanding and assessment of the
financial performance of Mylan N.V. ("Mylan" or the "Company").
Management uses these measures internally for forecasting,
budgeting, measuring its operating performance, and incentive-based
awards. Primarily due to acquisitions and other significant events
which may impact comparability of our periodic operating results,
Mylan believes that an evaluation of its ongoing operations (and
comparisons of its current operations with historical and future
operations) would be difficult if the disclosure of its financial
results was limited to financial measures prepared only in
accordance with U.S. GAAP. We believe that non-GAAP financial
measures are useful supplemental information for our investors and
when considered together with our U.S. GAAP financial measures and
the reconciliation to the most directly comparable U.S. GAAP
financial measure, provide a more complete understanding of the
factors and trends affecting our operations. The financial
performance of the Company is measured by senior management, in
part, using adjusted metrics included herein, along with other
performance metrics. Management's annual incentive compensation is
derived, in part, based on the adjusted EPS metric and the adjusted
free cash flow metric. In addition, the Company believes that
including EBITDA and supplemental adjustments applied in presenting
adjusted EBITDA and Credit Agreement Adjusted EBITDA (as defined
below) pursuant to our Credit Agreement is appropriate to provide
additional information to investors to demonstrate the Company's
ability to comply with financial debt covenants and assess the
Company's ability to incur additional indebtedness. We also report
sales performance using the non-GAAP financial measures of
"constant currency" total revenues and net sales. These measures
provide information on the change in total revenues and net sales
assuming that foreign currency exchange rates had not changed
between the prior and current period. The comparisons presented at
constant currency rates reflect comparative local currency sales at
the prior year's foreign exchange rates. We routinely evaluate our
net sales and total revenues performance at constant currency so
that sales results can be viewed without the impact of foreign
currency exchange rates, thereby facilitating a period-to-period
comparison of our operational activities, and believe that this
presentation also provides useful information to investors for the
same reason. The "Summary of Total Revenues by Segment" table below
compares net sales on an actual and constant currency basis for
each reportable segment for the quarters and year to date periods
ended September 30, 2019 and 2018 as well as for total
revenues. Also, set forth below, Mylan has provided reconciliations
of such non-GAAP financial measures to the most directly comparable
U.S. GAAP financial measures. Investors and other readers are
encouraged to review the related U.S. GAAP financial measures and
the reconciliations of the non-GAAP measures to their most directly
comparable U.S. GAAP measures set forth below, and investors and
other readers should consider non-GAAP measures only as supplements
to, not as substitutes for or as superior measures to, the measures
of financial performance prepared in accordance with U.S. GAAP.
For additional information regarding the components and uses of
Non-GAAP financial measures refer to Management's Discussion and
Analysis of Financial Condition and Results of Operations--Use of
Non-GAAP Financial Measures section of Mylan's Quarterly Report on
Form 10-Q for the three months ended September 30, 2019 (the
"Form 10-Q").
Mylan is not providing forward looking guidance for U.S. GAAP
reported financial measures or a quantitative reconciliation of
forward-looking non-GAAP financial measures to the most directly
comparable U.S. GAAP measure because it is unable to predict with
reasonable certainty the ultimate outcome of certain significant
items without unreasonable effort. These items include, but are not
limited to, acquisition-related expenses, including integration,
restructuring expenses, asset impairments, litigation settlements
and other contingencies, including changes to contingent
consideration and certain other gains or losses. These items are
uncertain, depend on various factors, and could have a material
impact on U.S. GAAP reported results for the guidance period.
Reconciliation
of U.S. GAAP Net Earnings to Adjusted Net Earnings and U.S. GAAP
EPS to Adjusted EPS
|
|
Below is a
reconciliation of U.S. GAAP net earnings (loss) and U.S. GAAP EPS
to adjusted net earnings and adjusted EPS for the three and nine
months ended September 30, 2019 compared to the prior year
period:
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
(in millions,
except per share amounts)
|
2019
|
|
2018
|
|
2019
|
|
2018
|
U.S. GAAP net
earnings (loss) and U.S. GAAP
EPS
|
$
|
189.8
|
|
|
$
|
0.37
|
|
|
$
|
176.7
|
|
|
$
|
0.34
|
|
|
$
|
(3.7)
|
|
|
$
|
(0.01)
|
|
|
$
|
301.3
|
|
|
$
|
0.58
|
|
Purchase accounting
related amortization
(primarily included in cost of sales)
|
408.5
|
|
|
|
|
428.7
|
|
|
|
|
1,283.9
|
|
|
|
|
1,282.4
|
|
|
|
Litigation
settlements and other contingencies, net
|
(51.9)
|
|
|
|
|
(20.4)
|
|
|
|
|
(30.3)
|
|
|
|
|
(50.6)
|
|
|
|
Interest expense
(primarily clean energy
investment financing and accretion of contingent
consideration)
|
6.6
|
|
|
|
|
12.1
|
|
|
|
|
20.8
|
|
|
|
|
31.0
|
|
|
|
Clean energy
investments pre-tax loss
|
10.4
|
|
|
|
|
12.6
|
|
|
|
|
43.6
|
|
|
|
|
58.6
|
|
|
|
Acquisition related
costs (primarily included in
SG&A) (a)
|
43.0
|
|
|
|
|
4.9
|
|
|
|
|
56.6
|
|
|
|
|
17.4
|
|
|
|
Restructuring related
costs (b)
|
0.8
|
|
|
|
|
80.8
|
|
|
|
|
78.3
|
|
|
|
|
202.3
|
|
|
|
Share-based
compensation expense (c)
|
16.1
|
|
|
|
|
—
|
|
|
|
|
50.9
|
|
|
|
|
—
|
|
|
|
Other special items
included in:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales
(d)
|
70.9
|
|
|
|
|
65.4
|
|
|
|
|
268.1
|
|
|
|
|
139.4
|
|
|
|
Research and
development expense (e)
|
40.3
|
|
|
|
|
3.2
|
|
|
|
|
100.5
|
|
|
|
|
100.3
|
|
|
|
Selling, general and
administrative expense
|
8.4
|
|
|
|
|
(0.7)
|
|
|
|
|
33.1
|
|
|
|
|
33.2
|
|
|
|
Other expense, net
(f)
|
—
|
|
|
|
|
1.3
|
|
|
|
|
—
|
|
|
|
|
25.5
|
|
|
|
Tax effect of the
above items and other income tax
related items (g)
|
(138.5)
|
|
|
|
|
(116.6)
|
|
|
|
|
(342.7)
|
|
|
|
|
(445.7)
|
|
|
|
Adjusted net earnings
and adjusted EPS
|
$
|
604.4
|
|
|
$
|
1.17
|
|
|
$
|
648.0
|
|
|
$
|
1.25
|
|
|
$
|
1,559.1
|
|
|
$
|
3.02
|
|
|
$
|
1,695.1
|
|
|
$
|
3.28
|
|
Weighted average
diluted ordinary shares
outstanding
|
516.2
|
|
|
|
|
516.5
|
|
|
|
|
516.4
|
|
|
|
|
516.5
|
|
|
|
____________
|
Significant items for
the three and nine months ended September 30, 2019 include the
following:
|
(a)
|
Acquisition related
costs consist primarily of transaction costs including legal and
consulting fees and integration activities. The increase for the
three and nine months ended September 30, 2019 relates to
transaction costs for the pending Upjohn transaction.
|
(b)
|
For the three months
ended September 30, 2019, charges of approximately $11.4
million are included in cost of sales and a net gain of $10.5
million is included in SG&A. For the nine months ended
September 30, 2019, charges of approximately $72.2 million are
included in cost of sales and net charges of approximately $6.1
million are included in SG&A. Refer to Note 17
Restructuring included in Part I, Item 1 of the Form 10-Q
for additional information.
|
(c)
|
Beginning in 2019,
share-based compensation expense is excluded from adjusted net
earnings and adjusted EPS. The full year impact for the year ended
December 31, 2018 was insignificant. As such, the three and nine
months ended September 30, 2018 amounts were not added back to
U.S. GAAP net earnings.
|
(d)
|
Costs incurred during
the three months ended September 30, 2019 primarily relate to
incremental manufacturing variances and site remediation activities
as a result of the activities at the Company's Morgantown plant of
approximately $50.0 million. The nine months ended September 30,
2019 increased $128.7 million primarily due to $54.4 million for
certain incremental manufacturing variances and site remediation
activities as a result of the activities at the Company's
Morgantown plant, approximately $35.1 million for product recall
costs, including inventory write-offs, and charges related to the
cancellation of a contract, each of which were higher during the
nine months ended September 30, 2019 compared to the prior year
period.
|
(e)
|
R&D expense for
the three months ended September 30, 2019 consists primarily
of expenses for product development arrangements of approximately
$39.8 million. Refer to Note 4 Acquisitions and Other
Transactions included in Part I, Item 1 of the Form 10-Q for
additional information. R&D expense for the three months ended
September 30, 2018 includes expenses relating to on-going
collaboration agreements, including Momenta Pharmaceuticals,
Inc.
|
(f)
|
The 2018 amount
primarily related to mark-to-market losses of investments in equity
securities historically accounted for as available-for-sale
securities and the cumulative realized gains on such
investments.
|
(g)
|
The impact of changes
related to uncertain tax positions is excluded from adjusted
earnings.
|
Reconciliation
of U.S. GAAP Net Earnings to EBITDA and Adjusted
EBITDA
|
|
Below is a
reconciliation of U.S. GAAP net earnings (loss) to EBITDA and
adjusted EBITDA for the three and nine months ended
September 30, 2019 compared to the prior year period (in
millions):
|
|
|
Three Months
Ended
|
|
Nine Months
Ended
|
|
September
30,
|
|
September
30,
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
U.S. GAAP net
earnings (loss)
|
$
|
189.8
|
|
|
$
|
176.7
|
|
|
$
|
(3.7)
|
|
|
$
|
301.3
|
|
Add / (deduct)
adjustments:
|
|
|
|
|
|
|
|
Net contribution
attributable to equity method investments
|
10.4
|
|
|
12.6
|
|
|
43.6
|
|
|
58.6
|
|
Income tax (benefit)
provision
|
(4.0)
|
|
|
15.5
|
|
|
22.9
|
|
|
(79.9)
|
|
Interest
expense
|
128.9
|
|
|
136.2
|
|
|
391.3
|
|
|
407.1
|
|
Depreciation and
amortization
|
469.7
|
|
|
500.6
|
|
|
1,471.6
|
|
|
1,501.0
|
|
EBITDA
|
$
|
794.8
|
|
|
$
|
841.6
|
|
|
$
|
1,925.7
|
|
|
$
|
2,188.1
|
|
Add / (deduct)
adjustments:
|
|
|
|
|
|
|
|
Share-based
compensation expense (income)
|
16.1
|
|
|
(29.2)
|
|
|
50.9
|
|
|
(8.6)
|
|
Litigation
settlements and other contingencies, net
|
(51.9)
|
|
|
(20.4)
|
|
|
(30.3)
|
|
|
(50.6)
|
|
Restructuring & other special
items
|
163.8
|
|
|
143.9
|
|
|
534.1
|
|
|
487.5
|
|
Adjusted
EBITDA
|
$
|
922.8
|
|
|
$
|
935.9
|
|
|
$
|
2,480.4
|
|
|
$
|
2,616.4
|
|
About Mylan
Mylan is a global pharmaceutical company committed to setting
new standards in healthcare. Working together around the world to
provide 7 billion people access to high quality medicine, we
innovate to satisfy unmet needs; make reliability and service
excellence a habit; do what's right, not what's easy; and impact
the future through passionate global leadership. We offer a growing
portfolio of more than 7,500 marketed products around the world,
including antiretroviral therapies on which approximately 40% of people being treated
for HIV/AIDS globally depend. We market our products in more than
165 countries and territories. We are one of the world's largest
producers of active pharmaceutical ingredients. Every member of our
approximately 35,000-strong workforce is dedicated to creating
better health for a better world, one person at a time. Learn more
at Mylan.com. We routinely post information that may be important
to investors on our website at investor.mylan.com.
Forward-Looking Statements
This release contains "forward-looking statements." Such
forward-looking statements may include, without limitation,
updating our 2019 financial guidance and business outlook; that we
will continue to execute and remain laser-focused as we now set our
sights on year-end commitments, including the upcoming launch of
our biosimilar to Herceptin®, Ogivri™, and as we continue
to make progress toward a successful deal close with Pfizer's
Upjohn business, which we continue to expect will occur in
mid-2020; we were pleased with the overall performance of our
global key brands and anticipate continued growth across these
areas of our portfolio as we head into the fourth quarter; we
expect to finish the year from a position of strength as we have
reached all of the product milestones necessary to meet our
performance commitments, including approval on our Ogivri™ product, which we expect to launch in the
coming weeks; we are reaffirming our commitment to deliver $1.9
billion to $2.3 billion in
adjusted free cash flow for the full year 2019; as of the end of
the third quarter we have repaid approximately $650 million of debt and remain committed to
repay at least $1.1 billion of debt
during 2019; our commitment to delever and maintain our investment
grade credit rating, while maintaining our financial flexibility to
execute on our business strategies, is supported by our stable and
durable cash flow profile; for the full year 2019, we are also
narrowing certain of our financial guidance range metrics, and now
expect total revenues to be in the range of $11.5 billion to $12.0
billion, and adjusted EPS to be in the range of $4.20 to $4.40; and
any other statements about the proposed transaction pursuant to
which Mylan will combine with Pfizer Inc.'s Upjohn Business (the
"Upjohn Business") in a Reverse Morris Trust transaction (the
"Combination"), the expected timetable for completing the
Combination, the benefits and synergies of the Combination, future
opportunities for the combined company and products and any other
statements regarding Mylan's, the Upjohn Business's or the combined
company's future operations, financial or operating results,
capital allocation, dividend policy, debt ratio, anticipated
business levels, future earnings, planned activities, anticipated
growth, market opportunities, strategies, competitions, and other
expectations and targets for future periods. These may often be
identified by the use of words such as "will," "may," "could,"
"should," "would," "project," "believe," "anticipate," "expect,"
"plan," "estimate," "forecast," "potential," "pipeline," "intend,"
"continue," "target," "seek," and variations of these words or
comparable words. Because forward-looking statements inherently
involve risks and uncertainties, actual future results may differ
materially from those expressed or implied by such forward-looking
statements. Factors that could cause or contribute to such
differences include, but are not limited to: with respect to the
Combination, the parties' ability to meet expectations regarding
the timing, completion and accounting and tax treatments of the
Combination, changes in relevant tax and other laws, the parties'
ability to consummate the Combination, the conditions to the
completion of the Combination, including receipt of approval of
Mylan's shareholders, not being satisfied or waived on the
anticipated timeframe or at all, the regulatory approvals required
for the Combination not being obtained on the terms expected or on
the anticipated schedule or at all, the integration of Mylan and
the Upjohn Business being more difficult, time consuming or costly
than expected, Mylan's and the Upjohn Business's failure to achieve
expected or targeted future financial and operating performance and
results, the possibility that the combined company may be unable to
achieve expected benefits, synergies and operating efficiencies in
connection with the Combination within the expected time frames or
at all or to successfully integrate Mylan and the Upjohn Business,
customer loss and business disruption being greater than expected
following the Combination, the retention of key employees being
more difficult following the Combination, changes in third-party
relationships and changes in the economic and financial conditions
of the business of Mylan or the Upjohn Business; actions and
decisions of healthcare and pharmaceutical regulators; failure to
achieve expected or targeted future financial and operating
performance and results; uncertainties regarding future demand,
pricing and reimbursement for our or the Upjohn Business's
products; any regulatory, legal or other impediments to Mylan's or
the Upjohn Business's ability to bring new products to market,
including, but not limited to, where Mylan or the Upjohn Business
uses its business judgment and decides to manufacture, market
and/or sell products, directly or through third parties,
notwithstanding the fact that allegations of patent infringement(s)
have not been finally resolved by the courts (i.e., an "at-risk
launch"); success of clinical trials and Mylan's or the Upjohn
Business's ability to execute on new product opportunities; any
changes in or difficulties with our or the Upjohn Business's
manufacturing facilities, including with respect to remediation and
restructuring activities, supply chain or inventory or the ability
to meet anticipated demand; the scope, timing and outcome of any
ongoing legal proceedings, including government investigations, and
the impact of any such proceedings on our or the Upjohn Business's
financial condition, results of operations and/or cash flows; the
ability to meet expectations regarding the accounting and tax
treatments of acquisitions, including Mylan's acquisition of Mylan
Inc. and Abbott Laboratories' non-U.S. developed markets specialty
and branded generics business; changes in relevant tax and other
laws, including but not limited to changes in the U.S. tax code and
healthcare and pharmaceutical laws and regulations in the U.S. and
abroad; any significant breach of data security or data privacy or
disruptions to our or the Upjohn Business's information technology
systems; the ability to protect intellectual property and preserve
intellectual property rights; the effect of any changes in customer
and supplier relationships and customer purchasing patterns; the
ability to attract and retain key personnel; the impact of
competition; identifying, acquiring, and integrating complementary
or strategic acquisitions of other companies, products, or assets
being more difficult, time-consuming or costly than anticipated;
the possibility that Mylan may be unable to achieve expected
synergies and operating efficiencies in connection with strategic
acquisitions, strategic initiatives or restructuring programs
within the expected time-frames or at all; uncertainties and
matters beyond the control of management, including but not limited
to general political and economic conditions and global exchange
rates; and inherent uncertainties involved in the estimates and
judgments used in the preparation of financial statements, and the
providing of estimates of financial measures, in accordance with
U.S. GAAP and related standards or on an adjusted basis. For more
detailed information on the risks and uncertainties associated with
Mylan's business activities, see the risks described in Mylan's
Annual Report on Form 10-K for the year ended December 31, 2018, as amended, Mylan's Quarterly
Report on Form 10-Q for the quarter ended June 30, 2019 and our other filings with the
Securities and Exchange Commission (the "SEC"). These risks, as
well as other risks associated with Mylan, the Upjohn Business, the
combined company and the Combination are also more fully discussed
in the registration statement on Form S-4 which includes a proxy
statement/prospectus (the "Form S-4"), and Form 10 which includes
an information statement (the "Form 10"), each of which has been
filed by Upjohn Inc. ("Newco") with the SEC on October 25, 2019 (and has not yet been declared
effective) in connection with the Combination. You can access
Pfizer's, Newco's and Mylan's filings with the SEC through the SEC
website at www.sec.gov or through Pfizer's or our website, and
Mylan strongly encourages you to do so. Mylan routinely posts
information that may be important to investors on our website at
investor.mylan.com, and we use this website address as a means of
disclosing material information to the public in a broad,
non-exclusionary manner for purposes of the SEC's Regulation Fair
Disclosure (Reg FD). The contents of our website are not
incorporated into this release. Pfizer, Newco and Mylan undertake
no obligation to update any statements herein for revisions or
changes after the date of this release other than as required by
law.
Additional Information and Where to Find It
This release shall not constitute an offer to sell or the
solicitation of an offer to sell or the solicitation of an offer to
buy any securities, nor shall there be any sale of securities in
any jurisdiction in which such offer, solicitation or sale would be
unlawful prior to registration or qualification under the
securities laws of any such jurisdiction. No offer of securities
shall be made except by means of a prospectus meeting the
requirements of Section 10 of the Securities Act of 1933, as
amended. In connection with the proposed transaction, Newco and
Mylan have filed certain materials with the SEC, including, among
other materials, the Form S-4 and Form 10 filed by Newco. The
registration statements have not yet become effective. After
the Form S-4 is effective, a definitive proxy statement/prospectus
will be sent to the Mylan shareholders seeking approval of the
proposed transaction, and after the Form 10 is effective, a
definitive information statement will be made available to the
Pfizer stockholders relating to the proposed transaction.
Newco and Mylan intend to file additional relevant materials with
the SEC in connection with the proposed transaction, including a
proxy statement of Mylan in definitive form. INVESTORS AND
SECURITY HOLDERS ARE URGED TO READ DOCUMENTS FILED WITH THE SEC
CAREFULLY AND IN THEIR ENTIRETY BECAUSE THEY WILL CONTAIN IMPORTANT
INFORMATION ABOUT MYLAN, NEWCO AND THE PROPOSED TRANSACTION. The
documents relating to the proposed transaction (when they are
available) can be obtained free of charge from the SEC's website at
www.sec.gov. These documents (when they are available) can also be
obtained free of charge from Mylan, upon written request to Mylan,
at (724) 514-1813 or investor.relations@mylan.com or from Pfizer on
Pfizer's internet website at
https://investors.Pfizer.com/financials/sec-filings/default.aspx or
by contacting Pfizer's Investor Relations Department at (212)
733-2323, as applicable.
Participants in the Solicitation
This release is not a solicitation of a proxy from any investor
or security holder. However, Pfizer, Mylan, Newco and certain of
their respective directors and executive officers may be deemed to
be participants in the solicitation of proxies in connection with
the proposed transaction under the rules of the SEC. Information
about the directors and executive officers of Pfizer may be found
in its Annual Report on Form 10-K filed with the SEC on
February 28, 2019 and its definitive
proxy statement and additional proxy statement relating to its 2019
Annual Meeting filed with the SEC on March
14, 2019 and on April 2, 2019,
respectively, and Current Report on Form 8-K filed with the SEC on
June 27, 2019. Information about the
directors and executive officers of Mylan may be found in its
amended Annual Report on Form 10-K filed with the SEC on
April 30, 2019, and its definitive
proxy statement relating to its 2019 Annual Meeting filed with the
SEC on May 24, 2019. Additional
information regarding the interests of these participants can also
be found in the Form S-4 and will also be included in the
definitive proxy statement of Mylan in connection with the proposed
transaction when it becomes available. These documents (when
they are available) can be obtained free of charge from the sources
indicated above.
Mylan N.V. and
Subsidiaries
Condensed
Consolidated Statements of Operations
(Unaudited; in
millions, except per share amounts)
|
|
|
Three Months
Ended
|
|
Nine Months
Ended
|
|
September
30,
|
|
September
30,
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
Revenues:
|
|
|
|
|
|
|
|
Net sales
|
$
|
2,928.2
|
|
|
$
|
2,827.3
|
|
|
$
|
8,207.0
|
|
|
$
|
8,233.2
|
|
Other
revenues
|
33.5
|
|
|
35.1
|
|
|
101.7
|
|
|
122.0
|
|
Total
revenues
|
2,961.7
|
|
|
2,862.4
|
|
|
8,308.7
|
|
|
8,355.2
|
|
Cost of
sales
|
1,889.3
|
|
|
1,823.2
|
|
|
5,498.5
|
|
|
5,369.2
|
|
Gross
profit
|
1,072.4
|
|
|
1,039.2
|
|
|
2,810.2
|
|
|
2,986.0
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
167.9
|
|
|
144.1
|
|
|
488.1
|
|
|
555.7
|
|
Selling, general and
administrative
|
632.7
|
|
|
577.3
|
|
|
1,909.2
|
|
|
1,808.1
|
|
Litigation
settlements and other contingencies, net
|
(51.9)
|
|
|
(20.4)
|
|
|
(30.3)
|
|
|
(50.6)
|
|
Total operating
expenses
|
748.7
|
|
|
701.0
|
|
|
2,367.0
|
|
|
2,313.2
|
|
Earnings from
operations
|
323.7
|
|
|
338.2
|
|
|
443.2
|
|
|
672.8
|
|
Interest
expense
|
128.9
|
|
|
136.2
|
|
|
391.3
|
|
|
407.1
|
|
Other expense,
net
|
9.0
|
|
|
9.8
|
|
|
32.7
|
|
|
44.3
|
|
Earnings before
income taxes
|
185.8
|
|
|
192.2
|
|
|
19.2
|
|
|
221.4
|
|
Income tax (benefit)
provision
|
(4.0)
|
|
|
15.5
|
|
|
22.9
|
|
|
(79.9)
|
|
Net earnings
(loss)
|
189.8
|
|
|
176.7
|
|
|
(3.7)
|
|
|
301.3
|
|
Earnings (Loss) per
ordinary share:
|
|
|
|
|
|
|
|
Basic
|
$
|
0.37
|
|
|
$
|
0.34
|
|
|
$
|
(0.01)
|
|
|
$
|
0.59
|
|
Diluted
|
$
|
0.37
|
|
|
$
|
0.34
|
|
|
$
|
(0.01)
|
|
|
$
|
0.58
|
|
Weighted average
ordinary shares outstanding:
|
|
|
|
|
|
|
|
Basic
|
516.0
|
|
|
514.5
|
|
|
515.5
|
|
|
514.4
|
|
Diluted
|
516.2
|
|
|
516.5
|
|
|
515.5
|
|
|
516.5
|
|
Mylan N.V. and
Subsidiaries
Condensed
Consolidated Balance Sheets
(Unaudited; in
millions)
|
|
|
September 30,
2019
|
|
December 31,
2018
|
ASSETS
|
Assets
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
|
358.9
|
|
|
$
|
388.1
|
|
Accounts receivable,
net
|
2,948.0
|
|
|
2,881.0
|
|
Inventories
|
2,763.5
|
|
|
2,580.2
|
|
Prepaid expenses and
other current assets
|
574.7
|
|
|
518.4
|
|
Total current
assets
|
6,645.1
|
|
|
6,367.7
|
|
Intangible assets,
net
|
11,824.3
|
|
|
13,664.6
|
|
Goodwill
|
9,387.1
|
|
|
9,747.8
|
|
Other non-current
assets
|
3,197.0
|
|
|
2,954.8
|
|
Total
assets
|
$
|
31,053.5
|
|
|
$
|
32,734.9
|
|
LIABILITIES AND
EQUITY
|
Liabilities
|
|
|
|
Current portion of
long-term debt and other long-term obligations
|
$
|
605.3
|
|
|
$
|
699.8
|
|
Current
liabilities
|
4,039.7
|
|
|
3,888.0
|
|
Long-term
debt
|
12,460.5
|
|
|
13,161.2
|
|
Other non-current
liabilities
|
2,484.6
|
|
|
2,818.8
|
|
Total
liabilities
|
19,590.1
|
|
|
20,567.8
|
|
Mylan N.V.
shareholders' equity
|
11,463.4
|
|
|
12,167.1
|
|
Total liabilities and
equity
|
$
|
31,053.5
|
|
|
$
|
32,734.9
|
|
Mylan N.V. and
Subsidiaries
Reconciliation of
Non-GAAP Financial Measures
(Unaudited; in
millions)
|
|
Summary of Total
Revenues by Segment
|
|
|
Three Months
Ended
|
|
September
30,
|
(In
millions)
|
2019
|
|
2018
|
|
%
Change
|
|
2019
Currency
Impact (1)
|
|
2019
Constant
Currency
Revenues
|
|
Constant
Currency %
Change (2)
|
Net sales
|
|
|
|
|
|
|
|
|
|
|
|
North
America
|
$
|
1,088.6
|
|
|
$
|
1,012.3
|
|
|
8
|
%
|
|
$
|
0.7
|
|
|
$
|
1,089.3
|
|
|
8
|
%
|
Europe
|
1,045.9
|
|
|
1,041.3
|
|
|
—
|
%
|
|
53.3
|
|
|
1,099.2
|
|
|
6
|
%
|
Rest of
World
|
793.7
|
|
|
773.7
|
|
|
3
|
%
|
|
8.0
|
|
|
801.7
|
|
|
4
|
%
|
Total net
sales
|
2,928.2
|
|
|
2,827.3
|
|
|
4
|
%
|
|
62.0
|
|
|
2,990.2
|
|
|
6
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
Other revenues
(3)
|
33.5
|
|
|
35.1
|
|
|
(5)
|
%
|
|
0.4
|
|
|
33.9
|
|
|
(3)
|
%
|
Consolidated total
revenues (4)
|
$
|
2,961.7
|
|
|
$
|
2,862.4
|
|
|
3
|
%
|
|
$
|
62.4
|
|
|
$
|
3,024.1
|
|
|
6
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months
Ended
|
|
September
30,
|
|
2019
|
|
2018
|
|
%
Change
|
|
2019
Currency
Impact (1)
|
|
2019
Constant
Currency
Revenues
|
|
Constant
Currency %
Change (2)
|
Net sales
|
|
|
|
|
|
|
|
|
|
|
|
North
America
|
$
|
3,035.0
|
|
|
$
|
2,998.4
|
|
|
1
|
%
|
|
$
|
5.5
|
|
|
$
|
3,040.5
|
|
|
1
|
%
|
Europe
|
2,930.7
|
|
|
3,070.3
|
|
|
(5)
|
%
|
|
190.4
|
|
|
3,121.1
|
|
|
2
|
%
|
Rest of
World
|
2,241.3
|
|
|
2,164.5
|
|
|
4
|
%
|
|
91.7
|
|
|
2,333.0
|
|
|
8
|
%
|
Total net
sales
|
8,207.0
|
|
|
8,233.2
|
|
|
—
|
%
|
|
287.6
|
|
|
8,494.6
|
|
|
3
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
Other revenues
(3)
|
101.7
|
|
|
122.0
|
|
|
(17)
|
%
|
|
2.0
|
|
|
103.7
|
|
|
(15)
|
%
|
Consolidated total
revenues (4)
|
$
|
8,308.7
|
|
|
$
|
8,355.2
|
|
|
(1)
|
%
|
|
$
|
289.6
|
|
|
$
|
8,598.3
|
|
|
3
|
%
|
____________
|
(1)
|
Currency impact is
shown as unfavorable (favorable).
|
(2)
|
The constant currency
percentage change is derived by translating net sales or revenues
for the current period at prior year comparative period exchange
rates, and in doing so shows the percentage change from 2019
constant currency net sales or revenues to the corresponding amount
in the prior year.
|
(3)
|
For the three months
ended September 30, 2019, other revenues in North America,
Europe, and Rest of World were approximately $17.6 million, $3.8
million, and $12.1 million, respectively. For the nine months ended
September 30, 2019, other revenues in North America, Europe, and
Rest of World were approximately $58.8 million, $12.3 million, and
$30.6 million, respectively.
|
(4)
|
Amounts exclude
intersegment revenue that eliminates on a consolidated
basis.
|
Reconciliation of
Income Statement Line Items
|
|
|
Three Months
Ended
|
|
Nine Months
Ended
|
|
September
30,
|
|
September
30,
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
U.S. GAAP cost of
sales
|
$
|
1,889.3
|
|
|
$
|
1,823.2
|
|
|
$
|
5,498.5
|
|
|
$
|
5,369.2
|
|
Deduct:
|
|
|
|
|
|
|
|
Purchase accounting
amortization and other related items
|
(408.6)
|
|
|
(426.9)
|
|
|
(1,284.0)
|
|
|
(1,275.2)
|
|
Acquisition related
items
|
(0.8)
|
|
|
(1.4)
|
|
|
(2.9)
|
|
|
(2.4)
|
|
Restructuring and
related costs
|
(11.4)
|
|
|
(51.8)
|
|
|
(72.2)
|
|
|
(97.2)
|
|
Share-based
compensation expense
|
(0.3)
|
|
|
—
|
|
|
(0.8)
|
|
|
—
|
|
Other special
items
|
(70.9)
|
|
|
(65.4)
|
|
|
(268.1)
|
|
|
(139.4)
|
|
Adjusted cost of
sales
|
$
|
1,397.3
|
|
|
$
|
1,277.7
|
|
|
$
|
3,870.5
|
|
|
$
|
3,855.0
|
|
|
|
|
|
|
|
|
|
Adjusted gross profit
(a)
|
$
|
1,564.4
|
|
|
$
|
1,584.7
|
|
|
$
|
4,438.2
|
|
|
$
|
4,500.2
|
|
|
|
|
|
|
|
|
|
Adjusted gross margin
(a)
|
53
|
%
|
|
55
|
%
|
|
53
|
%
|
|
54
|
%
|
|
|
Three Months
Ended
|
|
Nine Months
Ended
|
|
September
30,
|
|
September
30,
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
U.S. GAAP
R&D
|
$
|
167.9
|
|
|
$
|
144.1
|
|
|
$
|
488.1
|
|
|
$
|
555.7
|
|
Add /
(Deduct):
|
|
|
|
|
|
|
|
Acquisition related
costs
|
(0.3)
|
|
|
(0.2)
|
|
|
(0.6)
|
|
|
(0.7)
|
|
Restructuring and
related costs
|
0.1
|
|
|
(0.3)
|
|
|
—
|
|
|
(17.0)
|
|
Purchase accounting
amortization and other related items
|
—
|
|
|
(0.1)
|
|
|
—
|
|
|
(0.2)
|
|
Share-based
compensation expense
|
(0.6)
|
|
|
—
|
|
|
(1.6)
|
|
|
—
|
|
Other special
items
|
(40.3)
|
|
|
(3.2)
|
|
|
(100.5)
|
|
|
(100.3)
|
|
Adjusted
R&D
|
$
|
126.8
|
|
|
$
|
140.3
|
|
|
$
|
385.4
|
|
|
$
|
437.5
|
|
|
|
|
|
|
|
|
|
Adjusted R&D as %
of total revenues
|
4
|
%
|
|
5
|
%
|
|
5
|
%
|
|
5
|
%
|
|
|
Three Months
Ended
|
|
Nine Months
Ended
|
|
September
30,
|
|
September
30,
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
U.S. GAAP
SG&A
|
$
|
632.7
|
|
|
$
|
577.3
|
|
|
$
|
1,909.2
|
|
|
$
|
1,808.1
|
|
Add /
(Deduct):
|
|
|
|
|
|
|
|
Acquisition related
costs
|
(41.9)
|
|
|
(3.2)
|
|
|
(53.1)
|
|
|
(14.3)
|
|
Restructuring and
related costs
|
10.5
|
|
|
(28.7)
|
|
|
(6.1)
|
|
|
(88.4)
|
|
Purchase accounting
amortization and other related items
|
0.1
|
|
|
(1.7)
|
|
|
0.1
|
|
|
(7.0)
|
|
Share-based
compensation expense
|
(15.2)
|
|
|
—
|
|
|
(48.5)
|
|
|
—
|
|
Other special
items
|
(8.4)
|
|
|
0.7
|
|
|
(33.1)
|
|
|
(33.2)
|
|
Adjusted
SG&A
|
$
|
577.8
|
|
|
$
|
544.4
|
|
|
$
|
1,768.5
|
|
|
$
|
1,665.2
|
|
|
|
|
|
|
|
|
|
Adjusted SG&A as
% of total revenues
|
20
|
%
|
|
19
|
%
|
|
21
|
%
|
|
20
|
%
|
|
|
Three Months
Ended
|
|
Nine Months
Ended
|
|
September
30,
|
|
September
30,
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
U.S. GAAP total
operating expenses
|
$
|
748.7
|
|
|
$
|
701.0
|
|
|
$
|
2,367.0
|
|
|
$
|
2,313.2
|
|
Add /
(Deduct):
|
|
|
|
|
|
|
|
Litigation
settlements and other contingencies, net
|
51.9
|
|
|
20.4
|
|
|
30.3
|
|
|
50.6
|
|
R&D
adjustments
|
(41.1)
|
|
|
(3.8)
|
|
|
(102.7)
|
|
|
(118.2)
|
|
SG&A
adjustments
|
(54.9)
|
|
|
(32.9)
|
|
|
(140.7)
|
|
|
(142.9)
|
|
Adjusted total
operating expenses
|
$
|
704.6
|
|
|
$
|
684.7
|
|
|
$
|
2,153.9
|
|
|
$
|
2,102.7
|
|
|
|
|
|
|
|
|
|
Adjusted earnings
from operations (b)
|
$
|
859.8
|
|
|
$
|
900.0
|
|
|
$
|
2,284.3
|
|
|
$
|
2,397.5
|
|
|
|
Three Months
Ended
|
|
Nine Months
Ended
|
|
September
30,
|
|
September
30,
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
U.S. GAAP interest
expense
|
$
|
128.9
|
|
|
$
|
136.2
|
|
|
$
|
391.3
|
|
|
$
|
407.1
|
|
Deduct:
|
|
|
|
|
|
|
|
Interest expense
related to clean energy investments
|
(1.4)
|
|
|
(2.1)
|
|
|
(4.6)
|
|
|
(6.5)
|
|
Accretion of
contingent consideration liability
|
(3.8)
|
|
|
(5.3)
|
|
|
(12.0)
|
|
|
(16.3)
|
|
Other special
items
|
(1.4)
|
|
|
(4.7)
|
|
|
(4.2)
|
|
|
(8.2)
|
|
Adjusted interest
expense
|
$
|
122.3
|
|
|
$
|
124.1
|
|
|
$
|
370.5
|
|
|
$
|
376.1
|
|
|
|
Three Months
Ended
|
|
Nine Months
Ended
|
|
September
30,
|
|
September
30,
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
U.S. GAAP other
expense, net
|
$
|
9.0
|
|
|
$
|
9.8
|
|
|
$
|
32.7
|
|
|
$
|
44.3
|
|
Add /
(Deduct):
|
|
|
|
|
|
|
|
Clean energy
investments pre-tax loss (c)
|
(10.4)
|
|
|
(12.6)
|
|
|
(43.6)
|
|
|
(58.6)
|
|
Restructuring and
related costs
|
—
|
|
|
—
|
|
|
—
|
|
|
0.3
|
|
Other items
(d)
|
—
|
|
|
(1.3)
|
|
|
—
|
|
|
(25.5)
|
|
Adjusted other
income
|
$
|
(1.4)
|
|
|
$
|
(4.1)
|
|
|
$
|
(10.9)
|
|
|
$
|
(39.5)
|
|
|
|
Three Months
Ended
|
|
Nine Months
Ended
|
|
September
30,
|
|
September
30,
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
U.S. GAAP earnings
before income taxes
|
$
|
185.8
|
|
|
$
|
192.2
|
|
|
$
|
19.2
|
|
|
$
|
221.4
|
|
Total pre-tax
non-GAAP adjustments
|
553.0
|
|
|
587.8
|
|
|
1,905.6
|
|
|
1,839.5
|
|
Adjusted earnings
before income taxes
|
$
|
738.8
|
|
|
$
|
780.0
|
|
|
$
|
1,924.8
|
|
|
$
|
2,060.9
|
|
|
|
|
|
|
|
|
|
U.S. GAAP income
tax (benefit) provision
|
$
|
(4.0)
|
|
|
$
|
15.5
|
|
|
$
|
22.9
|
|
|
$
|
(79.9)
|
|
Adjusted tax
expense
|
138.4
|
|
|
116.5
|
|
|
342.8
|
|
|
445.7
|
|
Adjusted income tax
provision
|
$
|
134.4
|
|
|
$
|
132.0
|
|
|
$
|
365.7
|
|
|
$
|
365.8
|
|
|
|
|
|
|
|
|
|
Adjusted effective
tax rate
|
18.2
|
%
|
|
16.9
|
%
|
|
19.0
|
%
|
|
17.7
|
%
|
|
|
Three Months
Ended
|
|
Nine Months
Ended
|
|
September
30,
|
|
September
30,
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
U.S. GAAP net cash
provided by operating activities
|
$
|
487.8
|
|
|
$
|
653.6
|
|
|
$
|
1,117.0
|
|
|
$
|
1,705.6
|
|
Add /
(Deduct):
|
|
|
|
|
|
|
|
Restructuring and
related costs (e)
|
58.4
|
|
|
75.8
|
|
|
198.6
|
|
|
203.2
|
|
Financing related
expense
|
—
|
|
|
—
|
|
|
—
|
|
|
2.6
|
|
Corporate
contingencies
|
(43.5)
|
|
|
5.5
|
|
|
(50.1)
|
|
|
115.7
|
|
Acquisition related
costs
|
22.2
|
|
|
—
|
|
|
22.2
|
|
|
3.7
|
|
R&D
expense
|
59.5
|
|
|
25.0
|
|
|
125.5
|
|
|
125.0
|
|
Other
|
—
|
|
|
—
|
|
|
19.2
|
|
|
5.0
|
|
Adjusted net cash
provided by operating activities
|
$
|
584.4
|
|
|
$
|
759.9
|
|
|
$
|
1,432.4
|
|
|
$
|
2,160.8
|
|
|
|
|
|
|
|
|
|
Deduct:
|
|
|
|
|
|
|
|
Capital
expenditures
|
(42.3)
|
|
|
(61.5)
|
|
|
(139.6)
|
|
|
(137.4)
|
|
Adjusted free cash
flow
|
$
|
542.1
|
|
|
$
|
698.4
|
|
|
$
|
1,292.8
|
|
|
$
|
2,023.4
|
|
___________
|
(a)
|
U.S. GAAP gross
profit is calculated as total revenues less U.S. GAAP cost of
sales. U.S. GAAP gross margin is calculated as U.S. GAAP gross
profit divided by total revenues. Adjusted gross profit is
calculated as total revenues less adjusted cost of sales. Adjusted
gross margin is calculated as adjusted gross profit divided by
total revenues.
|
(b)
|
U.S. GAAP earnings
from operations is calculated as U.S. GAAP gross profit less U.S.
GAAP total operating expenses. Adjusted earnings from operations is
calculated as adjusted gross profit less adjusted total operating
expenses.
|
(c)
|
Adjustment represents
exclusion of activity related to Mylan's clean energy investments,
the activities of which qualify for income tax credits under
section 45 of the U.S. Internal Revenue Code of 1986, as
amended.
|
(d)
|
2018 adjustment
primarily related to mark-to-market losses of investments in equity
securities historically accounted for as available-for-sale
securities and the cumulative realized gains on such
investments.
|
(e)
|
For the three and
nine months ended September 30, 2019 includes approximately
$46.4 million and $147.2 million, respectively, of certain
incremental manufacturing variances and site remediation expenses
as a result of the activities at the Company's Morgantown
plant.
|
Reconciliation of
EBITDA and Adjusted EBITDA
|
|
Below is a
reconciliation of U.S. GAAP net earnings to EBITDA and adjusted
EBITDA for the respective quarterly periods:
|
|
|
Three Months
Ended
|
|
December 31,
2018
|
|
March 31,
2019
|
|
June 30,
2019
|
|
September 30,
2019
|
U.S. GAAP net
earnings (loss)
|
$
|
51.2
|
|
|
$
|
(25.0)
|
|
|
$
|
(168.5)
|
|
|
$
|
189.8
|
|
Add / (deduct)
adjustments:
|
|
|
|
|
|
|
|
Net contribution
attributable to equity method investments
|
20.1
|
|
|
17.0
|
|
|
16.2
|
|
|
10.4
|
|
Income tax provision
(benefit)
|
25.8
|
|
|
(89.5)
|
|
|
116.4
|
|
|
(4.0)
|
|
Interest
expense
|
135.2
|
|
|
131.2
|
|
|
131.2
|
|
|
128.9
|
|
Depreciation and
amortization
|
608.9
|
|
|
500.5
|
|
|
501.4
|
|
|
469.7
|
|
EBITDA
|
$
|
841.2
|
|
|
$
|
534.2
|
|
|
$
|
596.7
|
|
|
$
|
794.8
|
|
Add / (deduct)
adjustments:
|
|
|
|
|
|
|
|
Share-based
compensation expense
|
5.3
|
|
|
18.0
|
|
|
16.8
|
|
|
16.1
|
|
Litigation
settlements and other contingencies, net
|
1.1
|
|
|
0.7
|
|
|
20.9
|
|
|
(51.9)
|
|
Restructuring & other special
items
|
158.9
|
|
|
157.3
|
|
|
213.0
|
|
|
163.8
|
|
Adjusted
EBITDA
|
$
|
1,006.5
|
|
|
$
|
710.2
|
|
|
$
|
847.4
|
|
|
$
|
922.8
|
|
September 30,
2019 Notional Debt to Twelve Months Ended September 30, 2019
Mylan N.V. Adjusted EBITDA as calculated under our Credit Agreement
("Credit Agreement Adjusted EBITDA") Leverage Ratio
|
|
The stated non-GAAP
financial measure September 30, 2019 notional debt to twelve
months ended September 30, 2019 Credit Agreement Adjusted
EBITDA leverage ratio is based on the sum of (i) Mylan's adjusted
EBITDA for the quarters ended December 31, 2018,
March 31, 2019, June 30, 2019 and September 30, 2019
and (ii) certain adjustments permitted to be included in Credit
Agreement Adjusted EBITDA as of September 30, 2019 pursuant to
the revolving credit facility dated as of July 27, 2018 (as
amended, supplemented or otherwise modified from time to time),
among Mylan Inc., as borrower, the Company, as guarantor, certain
affiliates and subsidiaries of the Company from time to time party
thereto as guarantors, each lender from time to time party thereto
and Bank of America, N.A., as administrative agent as compared to
Mylan's September 30, 2019 total debt and other current
obligations at notional amounts.
|
|
|
Three Months
Ended
|
|
Twelve
Months Ended
|
|
December 31,
2018
|
|
March 31,
2019
|
|
June 30,
2019
|
|
September 30,
2019
|
|
September 30,
2019
|
Mylan N.V. Adjusted
EBITDA
|
$
|
1,006.5
|
|
|
$
|
710.2
|
|
|
$
|
847.4
|
|
|
$
|
922.8
|
|
|
$
|
3,486.9
|
|
Add: other
adjustments including estimated
synergies
|
|
|
|
|
|
|
|
|
20.8
|
|
Credit Agreement
Adjusted EBITDA
|
|
|
|
|
|
|
|
|
$
|
3,507.7
|
|
|
|
|
|
|
|
|
|
|
|
Reported debt
balances:
|
|
|
|
|
|
|
|
|
|
Long-term debt,
including current portion
|
|
|
|
|
|
|
|
|
$
|
13,015.0
|
|
Short-term borrowings
and other current
obligations
|
|
|
|
|
|
|
|
|
161.8
|
|
Total
|
|
|
|
|
|
|
|
|
$
|
13,176.8
|
|
Add /
(deduct):
|
|
|
|
|
|
|
|
|
|
Net discount on
various debt issuances
|
|
|
|
|
|
|
|
|
32.3
|
|
Deferred financing
fees
|
|
|
|
|
|
|
|
|
64.3
|
|
Fair value adjustment
for hedged debt
|
|
|
|
|
|
|
|
|
(27.4)
|
|
Total debt at
notional amounts
|
|
|
|
|
|
|
|
|
$
|
13,246.0
|
|
|
|
|
|
|
|
|
|
|
|
Notional debt to
Credit Agreement Adjusted
EBITDA Leverage Ratio
|
|
|
|
|
|
|
|
|
3.8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term average debt to Credit Agreement Adjusted EBITDA
leverage ratio target of ~3.0x
The stated forward-looking non-GAAP financial measure, targeted
long term average leverage of ~3.0x debt-to-Credit Agreement
Adjusted EBITDA, is based on the ratio of (i) targeted long-term
average debt, and (ii) targeted long-term Credit Agreement Adjusted
EBITDA. However, the Company has not quantified future amounts to
develop the target but has stated its goal to manage long-term
average debt and adjusted earnings and EBITDA over time in order to
generally maintain the target. This target does not reflect Company
guidance.
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SOURCE Mylan N.V.