QUARTERLY INVESTOR UPDATE – MAY 2016
BREAKING NEW
GROUND IN THE US
VICTOZA® SIGNIFICANTLY REDUCES THE RISK OF
MAJOR CARDIOVASCULAR EVENTS IN LEADER TRIAL
FIRST QUARTER OF 2016: OPERATING PROFIT, ADJUSTED,
INCREASED BY 10% IN LOCAL CURRENCIES
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04-05-2016 12:59:35
2016 OFF TO A GOOD START
We are pleased with the results during the first quarter of 2016. Sales increased by 9% in local currencies and by 8%
in Danish kroner to DKK 27.2 billion. All regions contributed to sales growth; however, USA was the main contributor
with 64% share of growth measured in local currencies, followed by International Operations contributing 23%.
Sales growth was realised within both diabetes care and biopharmaceuticals, with the majority of growth originating
from Victoza®, Norditropin®, Levemir® and Tresiba®.
Operating profit decreased by 10% in local currencies and by 11% in Danish kroner to DKK 12.3 billion. Adjusted for
the non-recurring income related to the partial divestment of NNIT and the income related to out-licensing of assets
for inflammatory disorders, both in 2015, operating profit in local currencies increased by 10%.
Within R&D, we announced during the first quarter the positive results from the SWITCH trials which documented
that Tresiba® significantly reduces the risk of hypoglycaemia compared to insulin glargine U100 for people with both
type 1 and type 2 diabetes.
In March, we also announced that Victoza® in the LEADER trial, comprising more than 9,300 people with an average
treatment of approximately four years, significantly reduced the risk of major adverse cardiovascular events.
Finally, in April we also announced that semaglutide, the once-weekly subcutaneously administered GLP-1 analogue,
reduced the risk of major cardiovascular events in the SUSTAIN 6 trial, and with this we have successfully completed
the development programme for semaglutide.
Generally seen, we are very encouraged by the successful outcome of both the SWITCH, LEADER and SUSTAIN trials,
which further strengthens the clinical profile of Tresiba®, Victoza® and semaglutide.
Lars Rebien Sørensen
President and CEO, Novo Nordisk
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VICTOZA® SIGNIFICANTLY REDUCES THE RISK OF MAJOR ADVERSE
CARDIOVASCULAR EVENTS IN LEADER TRIAL
In early March, Novo Nordisk announced
the top-line results from the LEADER trial,
which investigated the cardiovascular safety
of Victoza® (liraglutide) over a period of up
to five years in more than 9,000 adults with
type 2 diabetes at high risk of major adverse
cardiovascular events. The trial compared
the addition of either Victoza® or placebo
to standard of care and met the primary
endpoint of showing non-inferiority as well as
demonstrating superiority, with a statistically
significant reduction in cardiovascular risk. The
primary endpoint of the study was defined as
the composite outcome of the first occurrence
of cardiovascular death, non-fatal myocardial
infarction or non-fatal stroke. The superior
reduction in major adverse cardiovascular events
demonstrated by Victoza® was derived from all
the three components of the endpoint.
The safety profile of Victoza® in LEADER was
generally consistent with previous liraglutide
clinical studies.
”People with type 2 diabetes generally have
a higher risk of experiencing major adverse
cardiovascular events. That’s why we’re very
excited about the results from LEADER, which
showed that Victoza®, in addition to helping
people with type 2 diabetes control their blood
sugar levels, also reduces their risk of major
adverse cardiovascular events,” says Mads
Krogsgaard Thomsen, executive vice president
and chief science officer of Novo Nordisk.
”LEADER is the largest and longest Novo
Nordisk clinical trial to report to date, and we
look forward to sharing the detailed results
with the medical community and to submit
the findings to the regulatory authorities.”
The detailed results will be presented at the 76th
Scientific Sessions of the American Diabetes
Association in June 2016.
Read more in the company announcement from
4 March at novonordisk.com/newsarchive
FACTS ABOUT LEADER
9,340
patients
Treated for
3.5–5 years
32
countries
410
trial sites
3
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HIGHLIGHTS FOR THE FIRST QUARTER OF 2016
TOTAL DIABETES AND
OBESITY
CARE SALES
INCREASED BY
6%
(Danish kroner)
SALES OF
BIOPHARMACEUTICALS
INCREASED BY
15%
(Danish kroner)
OPERATING PROFIT,
ADJUSTED, INCREASED
BY
10%
(local currencies)
NET PROFIT, ADJUSTED,
INCREASED BY
20%
(Danish kroner)
Novo Nordisk increased operating profit by 10%, adjusted, in local currencies in the first quarter of 2016.
Sales increased by 9% in local currencies.
Sales increased by 9% in local currencies and by 8% in Danish kroner to DKK 27.2 billion.
- Sales of Victoza® increased by 15% (16% in Danish kroner).
- Sales of Levemir® increased by 9% (8% in Danish kroner).
- Sales of Tresiba® increased by 117% (113% in Danish kroner).
- Sales in USA increased by 12% (14% in Danish kroner).
- Sales in International Operations increased by 15% (3% in Danish kroner).
Operating profit decreased by 10% reported in local currencies and by 11% in Danish kroner to DKK 12.3 billion.
Adjusted for the non-recurring income related to the partial divestment of NNIT and the income related to outlicensing of assets for inflammatory disorders, both in 2015, operating profit in local currencies increased by 10%.
Net profit decreased by 4% to DKK 9.5 billion. Diluted earnings per share decreased by 2% to DKK 3.71. Adjusted for
the partial divestment of NNIT, net profit and diluted earnings per share increased by 20% and 23% respectively.
In February, Novo Nordisk announced the successful completion of the SWITCH 1 trial demonstrating the ability of
Tresiba® to lower the rate of hypoglycaemia compared to insulin glargine U100 in people with type 1 diabetes.
On 28 April, Novo Nordisk announced that semaglutide, a once-weekly GLP-1 analogue, significantly reduced the risk
of major adverse cardiovascular events in the SUSTAIN 6 trial. Following the successful completion of the SUSTAIN
programme, Novo Nordisk intends to file for regulatory review in the US and EU in the fourth quarter of 2016.
In March, Novo Nordisk announced that Victoza® in the LEADER trial, comprising more than 9,300 people with an
average treatment of approximately four years, significantly reduced the risk of major adverse cardiovascular events.
For 2016, sales growth is still expected to be 5–9% measured in local currencies. Growth in adjusted operating profit
is also still expected to be 5–9% measured in local currencies.
Read more in the company announcement from 29 April at novonordisk.com/newsarchive
4
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Total sales
Diabetes and obesity care sales
Modern insulin sales
DKK billion
DKK billion
DKK billion
30
30
8%
25
30
25
25
6%
20
20
20
15
15
15
10
10
10
5
5
5
0
Q1
2014
Q1
2015
Q1
2016
0
Q1
2014
Q1
2015
Q1
2016
0
2%
Q1
2014
Q1
2015
Q1
2016
New-generation insulin sales
Victoza® sales
Biopharmcaceutical sales
DKK billion
DKK billion
DKK billion
1.0
5
131%
16%
10
4
8
3
6
2
4
1
2
15%
0.5
0.0
Q1
2014
Q1
2015
Q1
2016
0
Q1
2014
Q1
2015
Q1
2016
0
Q1
2014
Q1
2015
Q1
2016
5
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KEY FIGURES FOR THE FIRST FIRST QUARTER OF 2016
Amounts in DKK million, except number of shares, earnings per share and full-time equivalent employees.
Q1 2016
Q1 2015
% change Q1 2015
to Q1 2016
Net sales
27,212
25,200
8%
Gross profit
Gross margin
22,978
84.4%
21,326
84.6%
8%
Sales and distribution costs
Percent of sales
6,741
24.8%
6,147
24.4%
10%
Research and development costs
Percent of sales
3,304
12.1%
3,250
12.9%
2%
908
3.3%
854
3.4%
6%
284
-
2,782
2,376
N/A
N/A
12,309
45.2%
13,857
55%
PROFIT AND LOSS
Administrative costs
Percent of sales
Other operating income, net
Non-recurring income from the initial public offering of NNIT A/S
Operating profit
Operating margin
Net financials
(11%)
1
(356)
(1,372)
(74%)
Profit before income taxes
11,953
12,485
(4%)
Income taxes
Effective tax rate
2,498
20.9%
2,609
20.9%
(4%)
Net profit
Net profit margin
9,455
34.7%
9,876
39.2%
(4%)
Depreciation, amortisation and impairment losses
Capital expenditure (tangible assets)
624
1,091
663
764
(6%)
43%
Net cash generated from operating activities
Free cash flow
7,475
6,359
4,106
5,643
82%
13%
Total assets
Equity
Equity ratio
82,368
37,284
45.3%
77,457
32,108
41.5%
6%
16%
Average number of diluted shares outstanding (million)
Diluted earnings per share/ADR (in DKK)
Diluted earnings per share/ADR adjusted for non-recurring income
from NNIT IPO (in DKK)
2,550.1
3.71
2,604.2
3.79
(2%)
(2%)
3.71
3.02
23%
Full-time equivalent employees end of period
41,571
39,062
6%
OTHER KEY NUMBERS
) Adjusted for the non-recurring income related to the partial divestment of NNIT and the income related to
outlicensing of assets for inflammatory disorders, both in 2015, operating profit in local currencies increased by 10%.
1
6
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FORWARD-LOOKING STATEMENTS
This document contains a summary of information made by Novo Nordisk in connection with the issuing
of our company announcement number 34/2016 dated 29 April 2016. The company announcement
contains forward-looking statements with respect to the business, objectives and plans of Novo Nordisk
and its current goals, and expectations relating to its future economic performance. These statements
are based on current plans, estimates and projections. By their very nature, forward-looking statements
involve inherent risks and uncertainties, both general and specific. Novo Nordisk cautions that a number
of important factors, including those described in this document, could cause actual results to differ
materially from those contemplated in any forward-looking statements. Factors that may affect future
results include, but are not limited to, global as well as local political and economic conditions, including
interest rate and currency exchange rate fluctuations, delay or failure of projects related to research and/
or development, unplanned loss of patents, interruptions of supplies and production, product recalls,
unexpected contract breaches or terminations, government-mandated or market-driven price decreases
for Novo Nordisk’s products, introduction of competing products, reliance on information technology,
Novo Nordisk’s ability to successfully market current and new products, exposure to product liability and
legal proceedings and investigations, changes in governmental laws and related interpretation thereof,
including on reimbursement, intellectual property protection and regulatory controls on testing, approval,
manufacturing and marketing, perceived or actual failure to adhere to ethical marketing practices,
investments in and divestitures of domestic and foreign companies, unexpected growth in costs and
expenses, failure to recruit and retain the right employees, and failure to maintain a culture of compliance.
Please also refer to the overview of risk factors in ‘Managing risks’ on pages 42–43 of Annual Report
2015, available at novonordisk.com, and Novo Nordisk’s Form 20-F filed with the US Securities and
Exchange Commission for examples of forward-looking statements and a discussion of certain factors
which could cause actual results to differ materially from those contemplated in any forward-looking
statements.
The forward-looking statements contained in this document are made as of the date of the abovementioned company announcement and, unless required by law, Novo Nordisk is under no duty and
undertakes no obligation to update or revise any forward-looking statement after the distribution of
the company announcement, whether as a result of new information, future events or otherwise.
26.8
MILLION PEOPLE
USE OUR DIABETES
CARE PRODUCTS
NOVO NORDISK’S
SHARE OF THE
GLOBAL DIABETES
MARKET MEASURED
IN VALUE:
27%
WE ARE
41,571
EMPLOYEES
WORLDWIDE
7
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NEW BOARD MEMBER ELECTED AT THE ANNUAL GENERAL MEETING
On 18 March 2016, more than 600 shareholders attended Novo Nordisk’s
Annual General Meeting at Bella Center in Copenhagen, and later
that same afternoon nearly 2,500 shareholders attended the annual
Shareholders’ Meeting, at which Executive Management provided an
informal account of performance in 2015 and took questions from the
large crowd of participants.
Daniels as a new member of the Board for a one-year term and re-elected
all the other current members of the Board up for re-election. Brian
Daniels is a senior advisor with the Boston Consulting Group and has held
various management positions at Bristol-Myers Squibb Pharmaceutical
Group, US, most recently as senior vice president for global development
and medical affairs.
At the Annual General Meeting, the Board proposed an increase in
dividend from DKK 5.00 per share for 2014 to DKK 6.40 per share for
2015. The proposal was approved by the shareholders.
Two board members, Eivind Kolding and Thomas Paul Koestler, did not
seek re-election.
Moreover, the shareholders approved the Board’s proposal to elect Brian
The complete overview of resolutions from the Annual General Meeting
can be found at novonordisk.com/newsarchive
Chairman of the Board Göran Ando and the rest of Executive Management on stage at the Shareholders’ Meeting in March.
8
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TRESIBA® SHOWS SIGNIFICANTLY LOWER RATE OF HYPOGLYCAEMIA
THAN INSULIN GLARGINE U100 IN SWITCH TRIALS
During the first quarter of 2016, Novo Nordisk announced the headline
results from both SWITCH 1 and SWITCH 2, 64-weeks randomised,
double-blind, cross-over, treat-to-target trials comparing the safety and
efficacy of Tresiba® (insulin degludec) and Lantus® (insulin glargine U100) in
type 1 and type 2 diabetes respectively.
The overall purpose of the two trials was to compare the hypoglycaemia
occurrence in people with type 1 or type 2 diabetes treated with Tresiba®
or insulin glargine. Both trials showed non-inferiority in HbA1c reduction
for Tresiba® compared to insulin glargine, thus fulfilling the requirements for
objectively comparing hypoglycaemia rates between the two treatments.
U100,” says Mads Krogsgaard Thomsen, executive vice president and chief
science officer of Novo Nordisk. ”We expect to initiate filing of the data
from the SWITCH trials with regulatory authorities in Q3 2016, with the
aim of updating the label for Tresiba®.”
Read more about the SWITCH trials at novonordisk.com/newsarchive
SEMAGLUTIDE SIGNIFICANTLY REDUCES THE RISK
OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN
THE SUSTAIN 6 TRIAL
In late April Novo Nordisk announced the top-line results from the
sixth and last global phase 3a trial, SUSTAIN 6, for semaglutide.
Both SWITCH 1 and SWITCH 2 demonstrated a statistically significantly lower
rate of severe or blood glucose-confirmed symptomatic hypoglycaemia in
the maintenance period of Tresiba® compared to insulin glargine of 11% and
30% respectively. Similarly, the trials demonstrated a statistically significant
reduction in the rate of severe or blood glucose-confirmed symptomatic
nocturnal hypoglycaemia during the maintenance period of 36% and 42%
respectively.
Finally, SWITCH 1 demonstrated a statistically significant reduction
in the proportion of subjects with type 1 diabetes experiencing severe
hypoglycaemia, while SWITCH 2 demonstrated a numerical reduction
among patients with type 2 diabetes for this endpoint.
”We’re very excited about these trial results, which document that Tresiba®
significantly reduces the risk of hypoglycaemia compared to insulin glargine
The trial achieved its primary endpoint of showing non-inferiority of
major cardiovascular events (MACE) with semaglutide compared with
placebo, and further documented a statistically significant reduction
in cardiovascular risk. In the trial, around 250 MACE were accrued.
The primary endpoint of the study was, as the LEADER trial for
Victoza®, defined as the composite outcome of the first occurrence
of cardiovascular death, non-fatal myocardial infarction or non-fatal
stroke.
The safety profile of semaglutide in SUSTAIN 6 was as expected and
consistent with previous semaglutide clinical studies.
Based on the now concluded SUSTAIN trials, Novo Nordisk expects to
file semaglutide for regulatory review in the US and EU in the fourth
quarter of 2016.
9
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BREAKING GROUND ON 2 BILLION US DOLLAR PRODUCTION FACILITY
On 29 March, Novo Nordisk broke ground on its new production facility in
Clayton, North Carolina. The facility represents an expected investment of
around 2 billion US dollars.
The facility will produce active pharmaceutical ingredients for a range of
Novo Nordisk’s current and future GLP-1 and insulin products. Once fully
operational in 2020, Clayton will provide production capacity for diabetes
care products in the US for the following decade.
”As the prevalence of diabetes has grown in the US, so too has the
demand for effective treatments,” said Lars Rebien Sørensen, president
and chief executive officer of Novo Nordisk. ”It gives me great pride
to break ground on our new facility site in Clayton, where we have an
existing, strong organisation. This site will play a vital role in enabling us to
meet the needs of people living with diabetes in the US for years to come.”
The new site is situated adjacent to Novo Nordisk’s existing 42,000 m2
facility, which assembles and packages FlexPen® and FlexTouch® pre-filled
devices for the US market. The expansion is expected to create close to 700
new jobs, and Novo Nordisk expects to create a significant employment
effect during the construction period, with up to 2,500 people working on
the project at its peak.
10
President and CEO Lars Rebien Sørensen (third from
left) took part in the ground-breaking event.
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Diabetes is ranked sixth among the top 10 leading causes of death in Johannesburg.
The city is now part of the Cities Changing Diabetes programme.
JOHANNESBURG JOINS CITIES
CHANGING DIABETES
On 8 April, the city of Johannesburg joined the Cities Changing Diabetes
programme and became the first African city to join the global initiative.
The addition of the largest city in South Africa as a partner city means Cities
Changing Diabetes now unites six cities across four continents in the fight
against urban diabetes.
Johannesburg City Member of the Mayoral Council on Health and Social
Development Ms Nonceba Molwele says: “Diabetes is ranked sixth among the
top 10 leading causes of death in Johannesburg and represents a significant
public health challenge here. Joining Cities Changing Diabetes is an exciting
opportunity for us to learn more about what we can do to combat this
growing condition. We look forward to learning from the experiences of other
cities around the world, so that we can create a more liveable and healthy
Johannesburg with fewer people at risk of developing diabetes.”
Cities Changing Diabetes was established in 2014 by founding partners
Novo Nordisk, University College London and Steno Diabetes Center.
The programme aims to tackle the rise of diabetes in cities through
three distinct but interconnecting phases: mapping the challenges,
sharing the learnings among the cities and stakeholders,
and taking action on these learnings.
Read more in the press release from 8 April at novonordisk.com/newsarchive
or at citieschangingdiabetes.com
FOCUS ON URBAN DIABETES
Read more about why Novo Nordisk focuses on urban
diabetes in the latest sustainability magazine TBL Quarterly
at novonordisk.com/tblquarterly
11
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SHAREHOLDER INFORMATION
Follow Novo Nordisk on novonordisk.com
and on social media:
facebook.com/novonordisk
FINANCIAL CALENDAR
3 August 2016
twitter.com/novonordisk
28 October 2016
linkedin.com/company/novo-nordisk
2 February 2017
pinterest.com/novonordisk
FIRST THREE
QUARTERS OF 2016
HALF YEAR 2016
Share price performance
Price development and monthly turnover
N
are
res
off Novo
Nordisk B shares
vo Nordisk share
sh
hare price
pri and indexed peers
Novo
No
o Nordisk
sk
Novo
OM
M
A
OMXC20
CAP
youtube.com/novonordisk
FULL YEAR 2016
Pha
a
Pharmaceutical
industry peers*
Turn
Tu
Turnover
of B shares (left)
Nov Nordisk’s B share
Novo
clo
los
closing
prices (right)
DKK
430
DKK Billion
30
400
390
25
320
350
20
160
10
270
0
240
15
310
80
5
May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr
2015
2016
* Pharma peers comprise AstraZeneca, Bistrol-Myers Squibb, Eli Lilly, GlaxoSmithKline,
Lundbeck, Merck, Novartis, Pfizer, Roche and Sanofi.
0
May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr
2015
2016
0
Novo Nordisk A/S
Corporate Communications, Novo Allé, 2880 Bagsværd,
Tel +45 4444 8888
Share Magazine
is distributed three times a year to shareholders
Editorial staff
Christina Weber-Villumsen
Tel +45 3079 6321, cwev@novonordisk.com
Editor-in-chief
Mike Rulis
Translation, copy-editing and layout
Corporate Communications
Printing and distribution
Bording A/S, Copenhagen
Circulation
12,000 Danish
2,000 English
Investor contact
Hanna Ögren
Tel +45 3079 8519, haeo@novonordisk.com
Product names
Not all products mentioned in Share have been introduced
worldwide. Trade names may vary from country to country.
Photos
Novo Nordisk
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