HERTFORDSHIRE, England and
PITTSBURGH, March 1, 2017
/PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) today announced
its financial results for the quarter and year ended
December 31, 2016 and provided 2017 guidance.
Fourth Quarter 2016 Financial Highlights
- Total revenues of $3.27 billion,
up 31% compared to the prior year period
- North America segment third
party net sales of $1.57 billion, up
22%
- Europe segment third party net
sales of $927.4 million, up 50%
- Rest of World segment third party net sales of $729.2 million, up 28%
- U.S. GAAP diluted earnings per ordinary share ("U.S. GAAP EPS")
of $0.78, up 105% compared to U.S.
GAAP EPS of $0.38 in the prior year
period
- Adjusted diluted earnings per ordinary share ("adjusted EPS")
of $1.57, up 29% compared to
$1.22 in the prior year period
Full Year 2016 Financial Highlights
- Total revenues of $11.08 billion,
up 18% compared to the prior year
- U.S. GAAP EPS of $0.92, down 46%
compared to $1.70 in the prior
year
- Adjusted EPS of $4.89, up 14%
compared to $4.30 in the prior
year
- U.S. GAAP cash provided by operating activities of $2.05 billion, up 2% compared to the prior
year
Mylan CEO Heather Bresch
commented, "Our strong 2016 results were highlighted by
year-over-year constant-currency total revenue growth of 18% and
adjusted EPS growth of 14%. The fourth quarter capped off the year
with impressive revenue growth of 31% and adjusted EPS growth of
29%. Again, we saw all of our regions contribute to our results for
the year, with double-digit revenue increases in North America, Europe and Rest of World, reflecting the
resilience, differentiation and diversity of our global platform
and our unwavering focus on execution. The diversity of our
business was further demonstrated by our six global therapeutic
franchises that delivered approximately $1
billion or more in revenue: Respiratory and Allergy, CNS and
Anesthesia, Infectious Disease, Cardiovascular, Gastrointestinal,
and Diabetes and Metabolism.
"We look forward in 2017 to delivering yet another strong year
of performance, with anticipated 2017 revenues of $12.25 billion to $13.75 billion and adjusted EPS
of $5.15 to $5.55. We also continue
to advance toward our long-stated 2018 adjusted EPS target of
$6.00."
Mylan President Rajiv Malik said,
"In addition to executing on our core business, we completed during
the year our acquisitions of Meda and the non-sterile,
topicals-focused business of Renaissance Acquisition Holdings,
which further built our scale and breadth from a product and
geographic perspective. We continued the successful integration of
Mylan, bringing these transactions into our One Mylan platform.
Further, we continued executing on the many drivers of our organic
growth, as evidenced, for instance, by the U.S. Food and Drug
Administration's acceptance of our abbreviated new drug application
for Generic Advair Diskus® and our submissions for biosimilars
Pegfilgrastim and Trastuzumab. With regard to the pricing
environment, we continued to see erosion both globally and in U.S.
generics in the mid-single digits which was in line with our
expectations, and we continue to expect a comparable environment in
2017 given the breadth and make-up of our global portfolio."
Mylan CFO Ken Parks added, "In
2016, Mylan once again benefited from the depth and breadth of our
portfolio which drove significant cash flow generation. Our
adjusted free cash flow increased by more than 15% to $2.1 billion. We are positioned well to reduce
debt levels, while also allowing for financial flexibility for
future growth opportunities and maintaining our commitment to our
investment grade credit rating."
Total
Revenues
|
|
|
Three Months
Ended
|
|
Year
Ended
|
|
December
31,
|
|
December
31,
|
(Unaudited; in
millions)
|
2016
|
|
2015
|
|
Percent
Change
|
|
2016
|
|
2015
|
|
Percent
Change
|
Total Revenues
(1)
|
$
|
3,267.8
|
|
|
$
|
2,490.7
|
|
|
31%
|
|
$
|
11,076.9
|
|
|
$
|
9,429.3
|
|
|
18%
|
North America
(2)
|
1,565.0
|
|
|
1,287.9
|
|
|
22%
|
|
5,629.5
|
|
|
5,100.4
|
|
|
10%
|
Europe (1)
(2)
|
927.4
|
|
|
616.4
|
|
|
50%
|
|
2,953.8
|
|
|
2,205.6
|
|
|
34%
|
Rest of World
(2)
|
729.2
|
|
|
570.5
|
|
|
28%
|
|
2,383.8
|
|
|
2,056.6
|
|
|
16%
|
Other
Revenues
|
46.2
|
|
|
15.9
|
|
|
191%
|
|
109.8
|
|
|
66.7
|
|
|
65%
|
(1)
|
For the year ended
December 31, 2015, adjusted third party net sales from Europe
totaled $2.22 billion and adjusted total revenues were $9.45
billion. Adjusted third party net sales from Europe and adjusted
total revenues are non-GAAP financial measures.
|
(2)
|
As a result of our
acquisition of Meda on August 5, 2016 and the integration of our
portfolio across our branded, generics and over-the-counter
platforms in all of our regions, effective October 1, 2016, we
expanded our reportable segments as follows: North America, Europe
and Rest of World. As a result, the amounts previously reported
under the Specialty segment have been recast to North America and
amounts related to Brazil are included in Rest of World for all
periods presented. Segment amounts represent third party net
sales.
|
Fourth Quarter 2016 Financial Results
Total Revenues
Total revenues were $3.27 billion
in 2016, compared to $2.49 billion in
the prior year period. Third party net sales for the current
quarter were $3.22 billion compared
to $2.47 billion for the prior year
period, representing an increase of $746.8
million, or 30%. Other third party revenues for the
current quarter were $46.2 million
compared to $15.9 million in the
prior year period, an increase of $30.3
million as a result of an increase in royalty income,
including the impact of current year acquisitions. Below is a
summary of third party net sales in each of our segments for the
three months ended December 31,
2016:
- Third party net sales from North
America were $1.57 billion
for the quarter, an increase of 22% when compared to the prior year
period. This increase was principally due to net sales from the
acquisitions of Meda AB ("Meda") and the non-sterile,
topicals-focused business of Renaissance Acquisition Holdings, LLC
(the "Topicals Business"), and to a lesser extent, net sales from
new products. Partially offsetting this increase was lower pricing
and volumes on existing products. The impact of foreign currency
translation was insignificant within North America.
- Third party net sales from Europe were $927.4
million for the quarter, an increase of 50% when compared to
the prior year period. This increase was primarily the result of
net sales from the acquisition of Meda, and to a lesser extent, net
sales from new products and higher volumes on existing products,
partially offset by lower pricing. The unfavorable impact of
foreign currency translation on current period third party net
sales was approximately $19.5
million, or 4% within Europe.
- Third party net sales from Rest of World were
$729.2 million for the quarter, an
increase of 28% when compared to the prior year period. This
increase was primarily due to net sales from the acquisition of
Meda, and to a lesser extent, net sales from new products. In
addition, net sales from existing products increased slightly, as
higher volumes offset lower pricing throughout the region,
including in our anti-retroviral ("ARV") franchise. The favorable
impact of foreign currency translation on current period third
party net sales was approximately $17.2
million, or 3% within Rest of World.
Total Gross Profit
Gross profit was $1.34 billion and
$1.06 billion for the fourth quarter
of 2016 and 2015, respectively. Gross margins were 41% and 43% in
the fourth quarter of 2016 and 2015, respectively. Gross margins
were negatively impacted in the current quarter due to increased
amortization of intangible assets, the amortization of
acquisition-related inventory fair value adjustments and intangible
asset impairment charges. This negative impact was partially offset
by the positive impact of net sales from new products. Adjusted
gross profit was $1.85 billion and
adjusted gross margins were 57% for the quarter compared to
adjusted gross profit of $1.40
billion and adjusted gross margins of 56% in the prior year
period. Adjusted gross margins were positively impacted in the
current quarter as a result of net sales from new products and the
net impact of acquisitions.
Total Profitability
Earnings from operations decreased $108.1
million from the comparable prior year period primarily due
to the Modafinil antitrust litigation settlement of $165 million, higher amortization expense and
operating expenses related to recent acquisitions.
R&D expense increased from the comparable prior year period
due to the inclusion of Meda and the Topicals Business, expenses
incurred related to the Company's collaboration with Momenta
Pharmaceuticals, Inc. ("Momenta") and the continued development of
our respiratory, insulin and biologics programs. SG&A expense
increased from the comparable prior year period primarily due to
the additional expense related to the acquisitions of Meda and the
Topicals Business as well as restructuring charges incurred in the
current quarter.
U.S. GAAP net earnings attributable to Mylan N.V. ordinary
shareholders ("U.S. GAAP net earnings") increased by $222.9 million to $417.5
million for the quarter ended December 31, 2016,
compared to $194.6 million for the
prior year period. Fourth quarter 2016 U.S. GAAP net earnings were
negatively impacted by the reduction of earnings from operations
and increased non-operating expenses including higher interest
expense. Partially offsetting these decreases were fair value gains
recorded on certain acquisition related contingent consideration
and the recognition of an income tax benefit of $192.6 million in the fourth quarter primarily
due to the mix of earnings between our U.S. and non-U.S.
subsidiaries. U.S. GAAP EPS increased from $0.38 to $0.78 in
the current quarter. Adjusted net earnings increased by
$222.0 million to $842.2 million compared to $620.2 million for the prior year period.
Adjusted EPS increased 29% to $1.57
compared to $1.22 in the prior year
period.
EBITDA, which is defined as net earnings (excluding the
non-controlling interest and losses from equity method investees)
plus income taxes, interest expense, depreciation and amortization,
was $878.5 million for the quarter
ended December 31, 2016, and $657.5
million for the comparable prior year quarter. After
adjusting for certain items as further detailed in the
reconciliation below, adjusted EBITDA was $1.21 billion for the quarter ended
December 31, 2016 and $827.2
million for the comparable prior year quarter.
Year Ended December 31, 2016
Financial Results
Total Revenues
Total revenues were $11.08 billion
in 2016, compared to $9.43 billion in
the prior year. Third party net sales for the current year
were $10.97 billion compared to
$9.36 billion for the prior year,
representing an increase of $1.60
billion, or 17%. Other third party revenues for the
current year were $109.8 million
compared to $66.7 million in the
prior year, an increase of $43.1
million which is consistent with the fourth quarter
increase. Below is a summary of third party net sales in each of
our segments for the year ended December 31,
2016:
- Third party net sales from North
America were $5.63 billion
for the year ended December 31, 2016,
an increase of 10% when compared to the prior year. The increase
was principally due to net sales from the acquisitions of Meda, the
Topicals Business and the incremental sales from the EPD Business,
and to a lesser extent, net sales from new products. These
increases were partially offset by lower volume and pricing on
existing products. As anticipated, the U.S. generics products
experienced price erosion in the mid-single digits. The unfavorable
impact of foreign currency translation on current year third party
net sales was approximately $7
million, or less than 1% within North America.
- Third party net sales from Europe were $2.95
billion for the year ended December
31, 2016, an increase of 34% when compared to the prior
year. This increase was primarily the result of net sales from the
acquisition of Meda and the incremental sales from the EPD
Business, and to a lesser extent, net sales from new products. In
addition, higher volumes on existing products were partially offset
by lower pricing throughout Europe. The unfavorable impact of foreign
currency translation on current year third party net sales was
approximately $30 million, or 1%
within Europe.
- Third party net sales from Rest of World were
$2.38 billion for the year ended
December 31, 2016, an increase of 16%
when compared to the prior year. This increase was primarily driven
by the acquisition of Meda, the incremental sales from the EPD
Business, and to a lesser extent, new products. In addition, higher
sales volumes in Japan,
India, Australia and emerging markets positively
contributed to the sales growth in this segment. These increases
were partially offset by lower pricing throughout the segment,
including the ARV franchise. However, sales within our ARV
franchise increased progressively throughout 2016. The favorable
impact of foreign currency translation on third party net sales was
approximately $21 million, or
1%.
Total Gross Profit
Gross profit was $4.70 billion and
$4.22 billion for the year ended
December 31, 2016 and 2015,
respectively. Gross margins were 42% and 45% for the year ended
December 31, 2016 and 2015,
respectively. Gross margins were negatively impacted in the current
year due to increased amortization of intangible assets and
purchase accounting related items consistent with the fourth
quarter. This negative impact was partially offset by the positive
impact of net sales from new products. Adjusted gross profit was
$6.21 billion and $5.25 billion for the year ended December 31, 2016 and 2015, respectively.
Adjusted gross margins were 56% in both 2016 and 2015. Adjusted
gross margins were positively impacted in the current year as a
result of net sales from new products and the net impact of
acquisitions.
Total Profitability
Earnings from operations were $701.6
million for the year ended December
31, 2016, a decrease of 52% from the comparable prior year.
This decrease was primarily due to an increase in litigation
settlements, higher amortization expense and operating expenses
related to acquisitions completed during 2016.
R&D expense for the year ended December 31, 2016 increased from the comparable
prior year consistent with the fourth quarter drivers.
SG&A expense increased from the comparable prior year period
principally due to the additional expense related to the
acquisition of Meda and the additional two months of expense from
the EPD Business. In addition, we incurred approximately
$113.1 million of restructuring
charges which were offset by lower acquisition related costs in the
current year, including consulting and legal costs.
U.S. GAAP net earnings decreased by $367.6 million to $480.0
million for the year ended December
31, 2016, compared to $847.6
million for the prior year. U.S. GAAP EPS decreased from
$1.70 to $0.92 as a result of the reduction of earnings
from operations and higher non-operating expenses including higher
interest expense as a result of recent acquisition related
borrowings and a higher average share count. Partially offsetting
these items was the recognition of an income tax benefit of
$358.3 million in the current year.
Adjusted net earnings increased by $409.9
million to $2.55 billion for
the year ended December 31, 2016
compared to $2.14 billion for the
prior year period. Adjusted EPS increased 14% to $4.89 for the year ended December 31, 2016 compared to $4.30 in the prior year period.
EBITDA was $2.21 billion for the
year ended December 31, 2016, and
$2.39 billion for the comparable
prior year period. After adjusting for certain items as further
detailed in the reconciliation below, adjusted EBITDA was
$3.68 billion for the year ended
December 31, 2016 and $3.01 billion for the comparable prior year
period.
Cash Flow
Net cash provided by operating activities was $2.05 billion for the year ended
December 31, 2016 compared to $2.01
billion for the prior year. Capital expenditures were
approximately $390.4 million for the
year ended December 31, 2016 compared to approximately
$362.9 million for the comparable
prior year. Adjusted cash provided by operating activities was
$2.52 billion for the year ended
December 31, 2016 compared to $2.22
billion for the prior year. Adjusted free cash flow, defined
as adjusted cash provided by operating activities less capital
expenditures, was $2.13 billion for
the year ended December 31, 2016, compared to $1.85 billion in the prior year.
Guidance
Mylan expects 2017 total revenues in the range of $12.25 billion to $13.75 billion, the midpoint of
which represents an increase of 17% versus 2016. As discussed in
the "Non-GAAP Financial Measures" section below, Mylan is not
otherwise 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. Adjusted EPS is expected to be in the
range of $5.15 to $5.55, the midpoint
of which represents an increase of 9% versus 2016.
The following table provides a summary of Mylan's 2017 full year
guidance ranges, along with significant exchange rates used in
preparing the guidance.
Full Year 2017
Financial Guidance
|
|
(In millions,
except for EPS and %s)
|
|
2017
Guidance
|
Total
Revenues
|
|
$12,250 -
$13,750
|
Gross
Margin*
|
|
54.5% -
56.5%
|
R&D as % of Total
Revenues*
|
|
5.5% -
6.5%
|
SG&A as % of
Total Revenues*
|
|
18.5% -
20.5%
|
EBITDA*
|
|
$4,350 -
$4,750
|
Net
Earnings*
|
|
$2,800 -
$3,000
|
Diluted
EPS*
|
|
$5.15 -
$5.55
|
Cash Provided by
Operating Activities*
|
|
$2,500 -
$2,800
|
Capital
Expenditures
|
|
$400 -
$500
|
Free Cash
Flow*
|
|
$2,000 -
$2,400
|
Effective Tax
Rate*
|
|
16.5% -
18.5%
|
Average Diluted
Shares Outstanding
|
|
535 - 540
|
|
* Adjusted metrics,
see "Non-GAAP Financial Measures" for more information.
|
Key Exchange Rates
Used for 2017 Guidance:
|
|
|
Australian Dollar ($
/ AUD)
|
|
1.32
|
British Pound ($ /
GBP)
|
|
0.76
|
Canadian Dollar ($ /
CAD)
|
|
1.30
|
Euro ($ /
EUR)
|
|
0.90
|
Indian Rupee (INR /
$)
|
|
65.50
|
Japanese Yen (JPY /
$)
|
|
110.00
|
Conference Call
As previously announced on February 3,
2017, Mylan N.V. will host an Investor Day today in
New York City beginning at
1:00 p.m. ET. The presentations will
be broadcast live via webcast. The Company's senior leadership team
will present the financial results for the fourth quarter and year
ended December 31, 2016, financial
guidance for 2017 and an overview of the company's strategic vision
and growth strategy for 2017 and beyond.
To access the live webcast and view the accompanying slide
presentations, visit the Investor Relations section of Mylan's
website, at http://investor.mylan.com, at least 15 minutes before
the presentation is scheduled to begin to register and download or
install any necessary software. If you are unable to view the live
webcast, a replay will be available after the event's conclusion
for a limited period of time. In addition to the webcast, U.S.
callers can access the event, in listen-only mode, at 877.877.1275
or 412.902.6542 for international callers.
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 total revenues, adjusted third party net
sales from Europe, adjusted gross
profit, adjusted gross margins, adjusted net earnings, EBITDA,
adjusted EBITDA, adjusted cash provided by operating activities,
adjusted free cash flow, adjusted SG&A as a percentage of
adjusted total revenues, adjusted R&D as a percentage of
adjusted total revenues and adjusted effective tax rate 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. 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 the adjusted metrics included herein, along with other
performance metrics. Management's annual incentive compensation is
derived, in part, based on the adjusted EPS metric. In addition,
primarily due to acquisitions, 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 were limited to financial
measures prepared only in accordance with U.S. GAAP. In addition,
the Company believes that including EBITDA and supplemental
adjustments applied in presenting adjusted EBITDA pursuant to our
debt agreements is appropriate to provide additional information to
investors to demonstrate the Company's ability to comply with
financial debt covenants (which are calculated using a measure
similar to adjusted EBITDA) and assess the Company's ability to
incur additional indebtedness. We also report sales performance
using the non-GAAP financial measure of "constant currency" total
revenues and third party net sales. This measure provides
information on the change in net sales assuming that foreign
currency exchange rates had not changed between the prior and
current period. The comparisons presented as constant currency
rates reflect comparative local currency sales at the prior year's
foreign exchange rates. We routinely evaluate our third party net
sales 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 we believe that this presentation also
provides useful information to investors for the same reason. The
"Summary of Total Revenues by Segment" table below compares third
party net sales on an actual and constant currency basis for each
reportable segment for the year ended December 31, 2016 and
2015. Also, other than as described, 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 Annual Report on
Form 10-K for the year ended December 31, 2016.
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 those related to
the Meda transaction, 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. With respect to the target of $6.00 in adjusted EPS in 2018, it does not
represent Company guidance and the Company is not providing a U.S.
GAAP target or reconciliation because the Company has not
quantified all future amounts, including U.S. GAAP amounts, related
to this target.
Reconciliation of Adjusted Earnings and Adjusted
EPS
Below is a reconciliation of U.S. GAAP net earnings attributable
to Mylan N.V. and U.S. GAAP EPS to adjusted earnings attributable
to Mylan N.V. and adjusted EPS for the quarter and year ended
December 31, 2016 compared to the prior year period:
|
Three Months Ended
December 31,
|
|
Year Ended
December 31,
|
(In millions,
except per share amounts)
|
2016
|
|
2015
|
|
2016
|
|
2015
|
U.S. GAAP net
earnings attributable to
Mylan N.V. and U.S. GAAP diluted earnings
per share
|
$
|
417.5
|
|
|
$
|
0.78
|
|
|
$
|
194.6
|
|
|
$
|
0.38
|
|
|
$
|
480.0
|
|
|
$
|
0.92
|
|
|
$
|
847.6
|
|
|
$
|
1.70
|
|
Purchase accounting
related amortization (primarily included in cost of sales)
(a)
|
480.5
|
|
|
|
|
291.1
|
|
|
|
|
1,412.3
|
|
|
|
|
900.9
|
|
|
|
Litigation
settlements, net (b)
|
172.1
|
|
|
|
|
(116.5)
|
|
|
|
|
638.5
|
|
|
|
|
(97.4)
|
|
|
|
Interest expense
(primarily related to clean energy investment financing)
|
5.5
|
|
|
|
|
5.7
|
|
|
|
|
24.4
|
|
|
|
|
45.6
|
|
|
|
Accretion of
contingent consideration liability and other fair value adjustments
(c)
|
(45.3)
|
|
|
|
|
9.9
|
|
|
|
|
75.4
|
|
|
|
|
38.4
|
|
|
|
Clean energy
investments pre-tax loss (d)
|
22.9
|
|
|
|
|
24.9
|
|
|
|
|
92.3
|
|
|
|
|
93.2
|
|
|
|
Financing related
costs (included in other expense, net)
|
—
|
|
|
|
|
71.2
|
|
|
|
|
—
|
|
|
|
|
112.0
|
|
|
|
Acquisition related
costs (primarily included in SG&A, other expense, net and
interest expense) (e)
|
5.5
|
|
|
|
|
178.6
|
|
|
|
|
335.3
|
|
|
|
|
419.8
|
|
|
|
Acquisition related
customer incentive (included in third party net sales)
|
—
|
|
|
|
|
—
|
|
|
|
|
—
|
|
|
|
|
17.1
|
|
|
|
Restructuring related
costs (f)
|
110.1
|
|
|
|
|
15.7
|
|
|
|
|
149.7
|
|
|
|
|
18.7
|
|
|
|
Other special items
included in:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of
sales
|
10.6
|
|
|
|
|
16.5
|
|
|
|
|
44.6
|
|
|
|
|
36.3
|
|
|
|
Research and
development expense (g)
|
22.8
|
|
|
|
|
1.8
|
|
|
|
|
121.3
|
|
|
|
|
20.3
|
|
|
|
Selling, general and
administrative expense
|
12.8
|
|
|
|
|
7.0
|
|
|
|
|
35.5
|
|
|
|
|
47.8
|
|
|
|
Other (income)
expense, net (h)
|
(19.8)
|
|
|
|
|
0.3
|
|
|
|
|
(18.5)
|
|
|
|
|
7.2
|
|
|
|
Tax effect of the
above items and other income tax related items
|
(353.0)
|
|
|
|
|
(80.6)
|
|
|
|
|
(843.5)
|
|
|
|
|
(370.1)
|
|
|
|
Adjusted net earnings
attributable to Mylan N.V. and adjusted diluted EPS
|
$
|
842.2
|
|
|
$
|
1.57
|
|
|
$
|
620.2
|
|
|
$
|
1.22
|
|
|
$
|
2,547.3
|
|
|
$
|
4.89
|
|
|
$
|
2,137.4
|
|
|
$
|
4.30
|
|
Weighted average
diluted ordinary shares outstanding
|
536.5
|
|
|
|
|
509.8
|
|
|
|
|
520.5
|
|
|
|
|
497.4
|
|
|
|
|
|
|
|
|
|
Significant items for
the year ended December 31, 2016 include the following:
|
(a)
|
Includes amortization
of the purchase accounting inventory fair value adjustments for
Meda and the Topicals Business totaling approximately $121.3
million, and intangible asset impairment charges totaling
approximately $68.3 million.
|
(b)
|
Includes $465 million
related to the Medicaid Drug Rebate Program Settlement and $165
million settlement related to the Modafinil antitrust
litigation.
|
(c)
|
Includes
approximately $90 million related to the Company's settlement with
Strides Arcolab Limited regarding substantially all outstanding
regulatory, warranty and indemnity claims relate to the acquisition
of Agila Specialties and $55.9 million of fair value gains, net
recognized on contingent consideration. The remaining amount
relates to interest expense for the accretion of contingent
consideration liability.
|
(d)
|
Adjustment represents
exclusion of the pre-tax loss related to Mylan's clean energy
investments and related financing, the activities of which qualify
for income tax credits under Section 45 of the Internal Revenue
Code (the "Code"). The amount is included in other expense, net in
the Consolidated Statements of Operations.
|
(e)
|
Acquisition related
costs primarily relate to acquisition and integration, including
ongoing activities. Included in SG&A is approximately $106.1
million, which primarily related to consulting, professional and
legal costs. Included in interest expense, net is approximately
$30.3 million of interest expense, net of interest income, which
related to the issuance of June 2016 Senior Notes for the period
prior to the completion date of the Meda offer. Such costs included
in other expense, net is approximately $128.6 million of losses
related to the Company's SEK non-designated foreign currency
contracts. Also included in other expense, net is $34.8 million
related to 2016 Bridge Credit Agreement. In addition, other
acquisition related costs are offset by certain mark-to-market
gains, including $30.5 million related to the settlement of the
Meda November offer and the remaining compulsory acquisition
proceeding liability.
|
(f)
|
Of the total amount,
approximately $28.9 million is included in cost of sales, $7.7
million is included in R&D and $113.1 million is included in
SG&A.
|
(g)
|
R&D expense
includes a $45 million upfront payment to Momenta and $15 million
of milestone payments to Theravance Biopharma, Inc. In addition,
included in this amount is approximately $29.2 million of R&D
expense incurred related to the Company's collaboration with
Momenta and approximately $32 million of upfront and milestone
payments related to several smaller collaboration
agreements.
|
(h)
|
Includes a $32
million mark-to-market foreign currency gains on the Euro Notes,
partially offset by the other foreign currency losses.
|
Below is a reconciliation of U.S. GAAP net earnings attributable
to Mylan N.V. to EBITDA and adjusted EBITDA for the quarter and
year ended December 31, 2016 compared to the prior year period
(in millions):
|
Three Months
Ended
|
|
Year
Ended
|
|
December
31,
|
|
December
31,
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
U.S. GAAP net
earnings attributable to Mylan N.V.
|
$
|
417.5
|
|
|
$
|
194.6
|
|
|
$
|
480.0
|
|
|
$
|
847.6
|
|
Add/(deduct)
adjustments:
|
|
|
|
|
|
|
|
Net contribution
attributable to the noncontrolling interest and
equity method investments
|
27.2
|
|
|
27.6
|
|
|
112.8
|
|
|
105.2
|
|
Income tax (benefit)
provision
|
(192.6)
|
|
|
23.7
|
|
|
(358.3)
|
|
|
67.7
|
|
Interest
expense
|
149.8
|
|
|
70.9
|
|
|
454.8
|
|
|
339.4
|
|
Depreciation and
amortization
|
476.6
|
|
|
340.7
|
|
|
1,523.0
|
|
|
1,032.1
|
|
EBITDA
|
$
|
878.5
|
|
|
$
|
657.5
|
|
|
$
|
2,212.3
|
|
|
$
|
2,392.0
|
|
Add/(deduct)
adjustments:
|
|
|
|
|
|
|
|
Share-based
compensation expense
|
17.8
|
|
|
26.4
|
|
|
88.9
|
|
|
92.8
|
|
Litigation
settlements and other contingencies, net
|
116.1
|
|
|
(116.5)
|
|
|
672.5
|
|
|
(97.4)
|
|
Restructuring & other special
items
|
199.5
|
|
|
259.8
|
|
|
704.4
|
|
|
624.7
|
|
Adjusted
EBITDA
|
$
|
1,211.9
|
|
|
$
|
827.2
|
|
|
$
|
3,678.1
|
|
|
$
|
3,012.1
|
|
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 approximately 7,500 marketed products around the
world, including antiretroviral therapies on which approximately
50% of people being treated for HIV/AIDS in the developing world
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 more than
35,000-strong workforce is dedicated to creating better health for
a better world, one person at a time. Learn more at mylan.com.
FORWARD-LOOKING STATEMENTS
This release contains "forward-looking statements." These
statements are made pursuant to the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995. Such
forward-looking statements may include, without limitation, 2017
financial guidance and statements that Mylan looks forward in 2017
to delivering yet another strong year of performance and continues
to advance toward its long-stated 2018 adjusted EPS target of
$6.00; Mylan continues to expect a
comparable pricing environment in 2017 given the breadth and
make-up of its global portfolio; and that Mylan is positioned well
to reduce debt levels, while also allowing for financial
flexibility for future growth opportunities and maintaining its
commitment to its investment grade credit rating. 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," "intend," "continue,"
"target" 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: the ability to meet expectations regarding
the accounting and tax treatments of Mylan's acquisition (the "EPD
Transaction") of Mylan Inc. and Abbott Laboratories' non-U.S.
developed markets specialty and branded generics business (the "EPD
Business") and the Meda Transaction; 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; actions and decisions of healthcare and
pharmaceutical regulators; the integration of the EPD Business and
Meda being more difficult, time-consuming, or costly than expected;
operating costs, customer loss, and business disruption (including,
without limitation, difficulties in maintaining relationships with
employees, customers, clients, or suppliers) being greater than
expected following the EPD Transaction and the Meda Transaction;
the retention of certain key employees of the EPD Business and Meda
being difficult; the possibility that Mylan may be unable to
achieve expected synergies and operating efficiencies in connection
with the EPD Transaction, the Meda Transaction, and the
December 2016 announced restructuring
program in certain locations, within the expected time-frames or at
all and to successfully integrate the EPD Business and Meda; with
respect to a settlement with the U.S. Department of Justice and
other government agencies related to the classification of the
EpiPen® Auto-Injector and EpiPen Jr® Auto-Injector (collectively,
"EpiPen® Auto-Injector") for purposes of the Medicaid Drug Rebate
Program (the "Medicaid Drug Rebate Program Settlement"), the
inability or unwillingness on the part of any of the parties to
agree to a final settlement, any legal or regulatory challenges to
the settlement, and any failure by third parties to comply with
their contractual obligations; expected or targeted future
financial and operating performance and results; the capacity to
bring new products to market, including but not limited to where
Mylan 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"); any regulatory, legal, or other impediments to Mylan's
ability to bring new products to market; success of clinical trials
and Mylan's ability to execute on new product opportunities; any
changes in or difficulties with our inventory of, and our ability
to manufacture and distribute, the EpiPen® Auto-Injector to meet
anticipated demand; the potential impact of any change in patient
access to the EpiPen® Auto-Injector and the introduction of a
generic version of the EpiPen® Auto-Injector; the scope, timing,
and outcome of any ongoing legal proceedings, including government
investigations, and the impact of any such proceedings on financial
condition, results of operations, and/or cash flows; 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; changes in third-party
relationships; the impact of competition; changes in the economic
and financial conditions of the businesses of Mylan; the inherent
challenges, risks, and costs in identifying, acquiring, and
integrating complementary or strategic acquisitions of other
companies, products, or assets and in achieving anticipated
synergies; uncertainties and matters beyond the control of
management; 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, 2015, as amended, Mylan's Quarterly
Report on Form 10-Q for the quarter ended March 31, 2016, Mylan's Quarterly Report on Form
10-Q for the quarter ended September 30,
2016, and our other filings with the Securities and Exchange
Commission (the "SEC"). You can access Mylan's filings with the SEC
through the SEC website at www.sec.gov, and Mylan strongly
encourages you to do so. Mylan undertakes no obligation to update
any statements herein for revisions or changes after the date of
this release.
Mylan N.V. and
Subsidiaries
|
Consolidated
Statements of Operations
|
(Unaudited; in
millions, except per share amounts)
|
|
|
Three Months
Ended
|
|
Year
Ended
|
|
December
31,
|
|
December
31,
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
Revenues:
|
|
|
|
|
|
|
|
Net sales
|
$
|
3,221.6
|
|
|
$
|
2,474.8
|
|
|
$
|
10,967.1
|
|
|
$
|
9,362.6
|
|
Other
revenues
|
46.2
|
|
|
15.9
|
|
|
109.8
|
|
|
66.7
|
|
Total
revenues
|
3,267.8
|
|
|
2,490.7
|
|
|
11,076.9
|
|
|
9,429.3
|
|
Cost of
sales
|
1,932.8
|
|
|
1,428.1
|
|
|
6,379.9
|
|
|
5,213.2
|
|
Gross
profit
|
1,335.0
|
|
|
1,062.6
|
|
|
4,697.0
|
|
|
4,216.1
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
194.6
|
|
|
159.0
|
|
|
826.8
|
|
|
671.9
|
|
Selling, general and
administrative
|
708.5
|
|
|
596.2
|
|
|
2,496.1
|
|
|
2,180.7
|
|
Litigation
settlements and other contingencies, net
|
116.1
|
|
|
(116.5)
|
|
|
672.5
|
|
|
(97.4)
|
|
Total operating
expenses
|
1,019.2
|
|
|
638.7
|
|
|
3,995.4
|
|
|
2,755.2
|
|
Earnings from
operations
|
315.8
|
|
|
423.9
|
|
|
701.6
|
|
|
1,460.9
|
|
Interest
expense
|
149.8
|
|
|
70.9
|
|
|
454.8
|
|
|
339.4
|
|
Other expense,
net
|
(58.9)
|
|
|
134.7
|
|
|
125.1
|
|
|
206.1
|
|
Earnings before
income taxes and noncontrolling interest
|
224.9
|
|
|
218.3
|
|
|
121.7
|
|
|
915.4
|
|
Income tax (benefit)
provision
|
(192.6)
|
|
|
23.7
|
|
|
(358.3)
|
|
|
67.7
|
|
Net
earnings
|
417.5
|
|
|
194.6
|
|
|
480.0
|
|
|
847.7
|
|
Net earnings
attributable to the noncontrolling interest
|
—
|
|
|
—
|
|
|
—
|
|
|
(0.1)
|
|
Net earnings
attributable to Mylan N.V. ordinary shareholders
|
$
|
417.5
|
|
|
$
|
194.6
|
|
|
$
|
480.0
|
|
|
$
|
847.6
|
|
Earnings per ordinary
share attributable to Mylan N.V. ordinary shareholders:
|
|
|
|
|
|
|
|
Basic
|
$
|
0.78
|
|
|
$
|
0.40
|
|
|
$
|
0.94
|
|
|
$
|
1.80
|
|
Diluted
|
$
|
0.78
|
|
|
$
|
0.38
|
|
|
$
|
0.92
|
|
|
$
|
1.70
|
|
Weighted average
ordinary shares outstanding:
|
|
|
|
|
|
|
|
Basic
|
534.1
|
|
|
490.2
|
|
|
513.0
|
|
|
472.2
|
|
Diluted
|
536.5
|
|
|
509.8
|
|
|
520.5
|
|
|
497.4
|
|
Mylan N.V. and
Subsidiaries
|
Condensed
Consolidated Balance Sheets
|
(Unaudited; in
millions)
|
|
|
December 31,
2016
|
|
December 31,
2015
|
ASSETS
|
Assets
|
|
|
|
Current
assets
|
|
|
|
Cash and cash
equivalents
|
$
|
998.8
|
|
|
$
|
1,236.0
|
|
Accounts receivable,
net
|
3,310.9
|
|
|
2,689.1
|
|
Inventories
|
2,456.4
|
|
|
1,951.0
|
|
Prepaid expenses and
other current assets
|
756.4
|
|
|
596.6
|
|
Total current
assets
|
7,522.5
|
|
|
6,472.7
|
|
Intangible assets,
net
|
14,447.8
|
|
|
7,221.9
|
|
Goodwill
|
9,231.9
|
|
|
5,380.1
|
|
Other non-current
assets
|
3,524.0
|
|
|
3,193.0
|
|
Total
assets
|
$
|
34,726.2
|
|
|
$
|
22,267.7
|
|
LIABILITIES AND
EQUITY
|
Liabilities
|
|
|
|
Current portion of
long-term debt and other long-term obligations
|
$
|
290.0
|
|
|
$
|
1,077.0
|
|
Other current
liabilities
|
4,750.7
|
|
|
3,045.2
|
|
Long-term debt
|
15,202.9
|
|
|
6,295.6
|
|
Other non-current
liabilities
|
3,365.0
|
|
|
2,084.1
|
|
Total
liabilities
|
23,608.6
|
|
|
12,501.9
|
|
Noncontrolling
interest
|
1.4
|
|
|
1.4
|
|
Mylan N.V.
shareholders' equity
|
11,116.2
|
|
|
9,764.4
|
|
Total liabilities and
equity
|
$
|
34,726.2
|
|
|
$
|
22,267.7
|
|
Mylan N.V. and
Subsidiaries
|
Reconciliation of
Non-GAAP Financial Measures
|
(Unaudited; in
millions)
|
|
Summary of Total
Revenues by Segment
|
|
|
Three Months
Ended
|
|
December
31,
|
|
2016
|
|
2015
|
|
%
Change
|
|
2016
Currency
Impact (1)
|
|
2016
Constant
Currency
Revenues
|
|
Constant
Currency %
Change (2)
|
Third party net
sales
|
|
|
|
|
|
|
|
|
|
|
|
North America
(3)
|
$
|
1,565.0
|
|
|
$
|
1,287.9
|
|
|
22
|
%
|
|
$
|
0.3
|
|
|
$
|
1,565.3
|
|
|
22
|
%
|
Europe
(3)
|
927.4
|
|
|
616.4
|
|
|
50
|
%
|
|
19.5
|
|
|
946.9
|
|
|
54
|
%
|
Rest of World
(3)
|
729.2
|
|
|
570.5
|
|
|
28
|
%
|
|
(17.2)
|
|
|
712.0
|
|
|
25
|
%
|
Total third party net
sales (3)
|
3,221.6
|
|
|
2,474.8
|
|
|
17
|
%
|
|
2.6
|
|
|
3,224.2
|
|
|
30
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
Other third party
revenues
|
46.2
|
|
|
15.9
|
|
|
191
|
%
|
|
0.5
|
|
|
46.7
|
|
|
194
|
%
|
Consolidated total
revenues
|
$
|
3,267.8
|
|
|
$
|
2,490.7
|
|
|
31
|
%
|
|
$
|
3.1
|
|
|
$
|
3,270.9
|
|
|
31
|
%
|
|
|
|
|
|
Year
Ended
|
|
December
31,
|
|
2016
|
|
2015
|
|
%
Change
|
|
2016
Currency
Impact (1)
|
|
2016 Constant
Currency Revenues
|
|
Constant Currency
% Change (2)
|
Third party net
sales
|
|
|
|
|
|
|
|
|
|
|
|
North America
(3)
|
$
|
5,629.5
|
|
|
$
|
5,100.4
|
|
|
10
|
%
|
|
$
|
6.9
|
|
|
$
|
5,636.4
|
|
|
11
|
%
|
Europe
(3)(4)
|
2,953.8
|
|
|
2,205.6
|
|
|
34
|
%
|
|
30.1
|
|
|
2,983.9
|
|
|
35
|
%
|
Rest of World
(3)
|
2,383.8
|
|
|
2,056.6
|
|
|
16
|
%
|
|
(21.3)
|
|
|
2,362.5
|
|
|
15
|
%
|
Total third party net
sales (3)(4)
|
10,967.1
|
|
|
9,362.6
|
|
|
17
|
%
|
|
15.7
|
|
|
10,982.8
|
|
|
17
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
Other third party
revenues
|
109.8
|
|
|
66.7
|
|
|
65
|
%
|
|
0.8
|
|
|
110.6
|
|
|
66
|
%
|
Consolidated total
revenues (4)
|
$
|
11,076.9
|
|
|
$
|
9,429.3
|
|
|
18
|
%
|
|
$
|
16.5
|
|
|
$
|
11,093.4
|
|
|
18
|
%
|
|
|
|
|
Summary of
Adjusted Total Revenues by Segment
|
|
|
|
Year
Ended
|
|
December
31,
|
|
2016
|
|
2015
|
|
%
Change
|
|
2016
Currency
Impact (1)
|
|
2016 Constant
Currency Revenues
|
|
Constant Currency
% Change (2)
|
Third party net
sales
|
|
|
|
|
|
|
|
|
|
|
|
North America
(3)
|
$
|
5,629.5
|
|
|
$
|
5,100.4
|
|
|
10
|
%
|
|
$
|
6.9
|
|
|
$
|
5,636.4
|
|
|
11
|
%
|
Europe
(3)(4)
|
2,953.8
|
|
|
2,222.7
|
|
|
33
|
%
|
|
30.1
|
|
|
2,983.9
|
|
|
34
|
%
|
Rest of World
(3)
|
2,383.8
|
|
|
2,056.6
|
|
|
16
|
%
|
|
(21.3)
|
|
|
2,362.5
|
|
|
15
|
%
|
Total third party net
sales (3)(4)
|
10,967.1
|
|
|
9,379.7
|
|
|
17
|
%
|
|
15.7
|
|
|
10,982.8
|
|
|
17
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
Other third party
revenues
|
109.8
|
|
|
66.7
|
|
|
65
|
%
|
|
0.8
|
|
|
110.6
|
|
|
66
|
%
|
Consolidated total
revenues (4)
|
$
|
11,076.9
|
|
|
$
|
9,446.4
|
|
|
17
|
%
|
|
$
|
16.5
|
|
|
$
|
11,093.4
|
|
|
17
|
%
|
|
|
|
|
|
|
|
|
|
|
(1)
|
Currency impact is
shown as unfavorable (favorable).
|
(2)
|
The constant currency
percentage change is derived by translating third party net sales
or revenues for the current period at prior year comparative period
exchange rates, and in doing so shows the percentage change from
2016 constant currency third party net sales or revenues to the
corresponding amount in the prior year.
|
(3)
|
Effective October 1,
2016, the Company expanded its reportable segments as follows:
North America, Europe and Rest of World. As a result, the amounts
previously reported under the Specialty segment have been recast to
North America and amounts related to Brazil are included in Rest of
World for all periods presented.
|
(4)
|
For the year ended
December 31, 2015, adjusted third party net sales from Europe
totaled $2.22 billion, adjusted third party net sales were $9.38
billion and adjusted total revenues were $9.45 billion. Adjusted
third party net sales from Europe, adjusted third party net sales
and adjusted total revenues are non-GAAP financial
measures.
|
|
Three Months
Ended
|
|
Year
Ended
|
|
December
31,
|
|
December
31,
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
U.S. GAAP third
party net sales from Europe
|
$
|
927.4
|
|
|
$
|
616.4
|
|
|
$
|
2,953.8
|
|
|
$
|
2,205.6
|
|
Add:
|
|
|
|
|
|
|
|
Acquisition related
customer incentive
|
—
|
|
|
—
|
|
|
—
|
|
|
17.1
|
|
Adjusted third party
net sales from Europe
|
$
|
927.4
|
|
|
$
|
616.4
|
|
|
$
|
2,953.8
|
|
|
$
|
2,222.7
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Year
Ended
|
|
December
31,
|
|
December
31,
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
U.S. GAAP third
party net sales
|
$
|
3,221.6
|
|
|
$
|
2,474.8
|
|
|
$
|
10,967.1
|
|
|
$
|
9,362.6
|
|
Add:
|
|
|
|
|
|
|
|
Acquisition related
customer incentive
|
—
|
|
|
—
|
|
|
—
|
|
|
17.1
|
|
Adjusted third party
net sales
|
$
|
3,221.6
|
|
|
$
|
2,474.8
|
|
|
$
|
10,967.1
|
|
|
$
|
9,379.7
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Year
Ended
|
|
December
31,
|
|
December
31,
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
U.S. GAAP total
revenues
|
$
|
3,267.8
|
|
|
$
|
2,490.7
|
|
|
$
|
11,076.9
|
|
|
$
|
9,429.3
|
|
Add:
|
|
|
|
|
|
|
|
Acquisition related
customer incentive
|
—
|
|
|
—
|
|
|
—
|
|
|
17.1
|
|
Adjusted total
revenues
|
$
|
3,267.8
|
|
|
$
|
2,490.7
|
|
|
$
|
11,076.9
|
|
|
$
|
9,446.4
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Year
Ended
|
|
December
31,
|
|
December
31,
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
U.S. GAAP cost of
sales
|
$
|
1,932.8
|
|
|
$
|
1,428.1
|
|
|
$
|
6,379.9
|
|
|
$
|
5,213.2
|
|
Deduct:
|
|
|
|
|
|
|
|
Purchase accounting
amortization and other related items
|
(474.5)
|
|
|
(287.2)
|
|
|
(1,389.3)
|
|
|
(885.5)
|
|
Acquisition related
costs
|
(12.9)
|
|
|
(34.8)
|
|
|
(52.7)
|
|
|
(98.3)
|
|
Restructuring related
items
|
(15.1)
|
|
|
—
|
|
|
(28.9)
|
|
|
(0.2)
|
|
Other special
items
|
(10.6)
|
|
|
(16.5)
|
|
|
(44.6)
|
|
|
(36.3)
|
|
Adjusted cost of
sales
|
$
|
1,419.7
|
|
|
$
|
1,089.6
|
|
|
$
|
4,864.4
|
|
|
$
|
4,192.9
|
|
|
|
|
|
|
|
|
|
Adjusted gross profit
(a)
|
$
|
1,848.1
|
|
|
$
|
1,401.1
|
|
|
$
|
6,212.5
|
|
|
$
|
5,253.5
|
|
|
|
|
|
|
|
|
|
Adjusted gross margin
(a)
|
57
|
%
|
|
56
|
%
|
|
56
|
%
|
|
56
|
%
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Year
Ended
|
|
December
31,
|
|
December
31,
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
U.S. GAAP
R&D
|
$
|
194.6
|
|
|
$
|
159.0
|
|
|
$
|
826.8
|
|
|
$
|
671.9
|
|
Deduct:
|
|
|
|
|
|
|
|
Acquisition related
costs
|
(1.4)
|
|
|
(0.9)
|
|
|
(1.8)
|
|
|
(2.1)
|
|
Restructuring related
items
|
(7.4)
|
|
|
—
|
|
|
(7.7)
|
|
|
—
|
|
Other special
items
|
(22.8)
|
|
|
(1.8)
|
|
|
(121.3)
|
|
|
(20.3)
|
|
Adjusted
R&D
|
$
|
163.0
|
|
|
$
|
156.3
|
|
|
$
|
696.0
|
|
|
$
|
649.5
|
|
|
|
|
|
|
|
|
|
Adjusted R&D as %
of adjusted total revenues
|
5
|
%
|
|
6
|
%
|
|
6
|
%
|
|
7
|
%
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Year
Ended
|
|
December
31,
|
|
December
31,
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
U.S. GAAP
SG&A
|
$
|
708.5
|
|
|
$
|
596.2
|
|
|
$
|
2,496.1
|
|
|
$
|
2,180.7
|
|
Deduct:
|
|
|
|
|
|
|
|
Acquisition related
costs
|
(20.7)
|
|
|
(75.3)
|
|
|
(106.1)
|
|
|
(209.4)
|
|
Restructuring related
items
|
(87.5)
|
|
|
(15.7)
|
|
|
(113.1)
|
|
|
(18.5)
|
|
Purchase accounting
amortization and other related items
|
(0.3)
|
|
|
—
|
|
|
(0.3)
|
|
|
—
|
|
Other special
items
|
(12.8)
|
|
|
(7.0)
|
|
|
(35.5)
|
|
|
(47.8)
|
|
Adjusted
SG&A
|
$
|
587.2
|
|
|
$
|
498.2
|
|
|
$
|
2,241.1
|
|
|
$
|
1,905.0
|
|
|
|
|
|
|
|
|
|
Adjusted SG&A as
% of adjusted total revenues
|
18
|
%
|
|
20
|
%
|
|
20
|
%
|
|
20
|
%
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Year
Ended
|
|
December
31,
|
|
December
31,
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
U.S. GAAP total
operating expenses
|
$
|
1,019.2
|
|
|
$
|
638.7
|
|
|
$
|
3,995.4
|
|
|
$
|
2,755.2
|
|
(Deduct) /
Add:
|
|
|
|
|
|
|
|
Litigation
settlements and other contingencies, net
|
(116.2)
|
|
|
116.5
|
|
|
(672.6)
|
|
|
97.4
|
|
R&D
adjustments
|
(31.6)
|
|
|
(2.7)
|
|
|
(130.8)
|
|
|
(22.4)
|
|
SG&A
adjustments
|
(121.3)
|
|
|
(98.0)
|
|
|
(255.0)
|
|
|
(275.7)
|
|
Adjusted total
operating expenses
|
$
|
750.1
|
|
|
$
|
654.5
|
|
|
$
|
2,937.0
|
|
|
$
|
2,554.5
|
|
|
|
|
|
|
|
|
|
Adjusted earnings
from operations (b)
|
$
|
1,098.0
|
|
|
$
|
746.6
|
|
|
$
|
3,275.5
|
|
|
$
|
2,699.0
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Year
Ended
|
|
December
31,
|
|
December
31,
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
U.S. GAAP interest
expense
|
$
|
149.8
|
|
|
$
|
70.9
|
|
|
$
|
454.8
|
|
|
$
|
339.4
|
|
Deduct:
|
|
|
|
|
|
|
|
Interest expense
related to clean energy investments (c)
|
(3.4)
|
|
|
(3.9)
|
|
|
(14.4)
|
|
|
(16.4)
|
|
Accretion of
contingent consideration liability
|
(10.6)
|
|
|
(9.9)
|
|
|
(41.3)
|
|
|
(38.4)
|
|
Acquisition related
costs
|
(0.5)
|
|
|
(1.8)
|
|
|
(46.1)
|
|
|
(29.2)
|
|
Other special
items
|
(2.0)
|
|
|
(14.6)
|
|
|
(10.0)
|
|
|
(56.9)
|
|
Adjusted interest
expense
|
$
|
133.3
|
|
|
$
|
40.7
|
|
|
$
|
343.0
|
|
|
$
|
198.5
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Year
Ended
|
|
December
31,
|
|
December
31,
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
U.S. GAAP other
expense, net
|
$
|
(58.9)
|
|
|
$
|
134.7
|
|
|
$
|
125.1
|
|
|
$
|
206.1
|
|
(Add) /
Deduct:
|
|
|
|
|
|
|
|
Clean energy
investments pre-tax loss
|
(22.9)
|
|
|
(24.9)
|
|
|
(92.3)
|
|
|
(93.2)
|
|
Purchase accounting
related amortization
|
(5.7)
|
|
|
(3.9)
|
|
|
(22.6)
|
|
|
(15.4)
|
|
Acquisition related
costs
|
30.0
|
|
|
(53.2)
|
|
|
(128.6)
|
|
|
(53.2)
|
|
Financing related
costs
|
—
|
|
|
(71.2)
|
|
|
—
|
|
|
(112.0)
|
|
Other
items
|
19.8
|
|
|
(0.3)
|
|
|
18.5
|
|
|
(7.2)
|
|
Adjusted other
income
|
$
|
(37.7)
|
|
|
$
|
(18.8)
|
|
|
$
|
(99.9)
|
|
|
$
|
(74.9)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year
ended
|
|
|
|
|
|
|
|
|
|
December
31,
|
|
|
|
|
|
|
|
|
|
2016
|
|
2015
|
U.S. GAAP net cash
provided by operating activities
|
|
|
|
|
|
|
|
|
$
|
2,047.2
|
|
|
$
|
2,008.5
|
|
Add /
(Deduct):
|
|
|
|
|
|
|
|
|
|
|
|
Payment / (receipt)
of litigation settlements
|
|
|
|
|
|
|
|
|
68.5
|
|
|
(113.0)
|
|
Financing related
expenses
|
|
|
|
|
|
|
|
|
66.9
|
|
|
137.4
|
|
Acquisition related
costs
|
|
|
|
|
|
|
|
|
244.4
|
|
|
190.5
|
|
R&D
expense
|
|
|
|
|
|
|
|
|
123.2
|
|
|
12.0
|
|
Income tax
items
|
|
|
|
|
|
|
|
|
(25.8)
|
|
|
(22.0)
|
|
Other
|
|
|
|
|
|
|
|
|
—
|
|
|
3.9
|
|
Adjusted cash
provided by operating activities
|
|
|
|
|
|
|
|
|
$
|
2,524.4
|
|
|
$
|
2,217.3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deduct:
|
|
|
|
|
|
|
|
|
|
|
|
Capital
expenditures
|
|
|
|
|
|
|
|
|
(390.4)
|
|
|
(362.9)
|
|
Adjusted free cash
flow
|
|
|
|
|
|
|
|
|
$
|
2,134.0
|
|
|
$
|
1,854.4
|
|
|
|
|
|
|
|
|
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(a)
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U.S. GAAP gross
profit is calculated as U.S. GAAP total revenues less U.S. GAAP
cost of sales. U.S. GAAP gross margin is calculated as U.S. GAAP
gross profit divided by U.S. GAAP total revenues. Adjusted gross
profit is calculated as total revenues (adjusted total revenues for
2015) less adjusted cost of sales. Adjusted gross margin is
calculated as adjusted gross profit divided by total revenues
(adjusted total revenues for 2015).
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(b)
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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.
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(c)
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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 Code.
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To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/mylan-reports-fourth-quarter-and-full-year-2016-results-and-provides-2017-guidance-300415611.html
SOURCE Mylan N.V.