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QUARTERLY INVESTOR UPDATE – AUGUST 2015
FIRST SIX MONTHS:
OPERATING PROFIT
INCREASED BY 57%
AMONG THE BEST
IN VALUE CREATION
TEAM NOVO NORDISK
TOURED DENMARK
SATISFACTORY SIX MONTHS
We are satisfied with the results of the first six months of 2015. Victoza® and Levemir® continued to drive sales growth
and, in the second quarter, we successfully launched NovoEight® and Saxenda® in the US. Furthermore, we announced
positive results from the first phase 3a trial for semaglutide, our once-weekly GLP-1 analogue.
Sales increased by a ful 25% to DKK 52.3 billion and reflects a considerable appreciation of the US dollar.
Measured in local currencies, sales increased by 9%.
While all our regions contributed to sales growth, North America was the main contributor with 56% share of growth
measured in local currencies, followed by International Operations and Europe contributing 28% and 10% respectively.
Sales growth was realised within both diabetes care and biopharmaceuticals, with the majority of growth originating
from Victoza® and modern insulin.
On the R&D front, we announced in July that we had successfully completed the first phase 3a trial with semaglutide,
a new GLP-1 analogue to be administered subcutaneously once weekly.
We have also completed the first phase 3a trial with liraglutide as adjunct therapy to insulin for people with
type 1 diabetes. We expect to report the results of the second and final pivotal phase 3a trial shortly.
From a financial perspective, operating profit increased by 57% in Danish kroner and by 30% in local currencies to DKK
26.3 billion. Adjusted for the DKK 2.4 billion non-recurring income related to the partial divestment of our IT subsidiary,
NNIT, operating profit in local currencies increased by 16%.
For 2015, we still expect sales growth measured in local currencies to be 7–9%, whereas operating profit growth measured in local currencies is raised by two percentage points and is now expected to be around 19%.
Lars Rebien Sørensen
President and CEO, Novo Nordisk
2
XULTOPHY® ATTRACTS ATTENTION
The annual meeting of the American Diabetes
Association (ADA) drew more than 18,000
doctors, scientists, industry representatives and
patients to Boston from 5 to 8 June. Results
from Novo Nordisk’s research and development
activities were presented in 34 accepted abstracts.
Among the key presentations was an oral presentation of the DUAL® V phase 3b trial for
Xultophy® (a combination of insulin degludec
and liraglutide), which was announced in January 2015. DUAL® V is a 26-week trial comparing
the efficacy and safety of Xultophy® versus
insulin glargine, both in addition to metformin,
in adult patients with type 2 diabetes.
In the study, patients on Xultophy® treatment
achieved a statistically significantly larger mean
reduction in HbA1c of 1.8% compared with a
1.1% reduction achieved by patients who during
the study increased their dose of insulin glargine.
Furthermore, 72% of people treated with
Xultophy® achieved the ADA target HbA1c level
of below 7% compared with 47% in the insulin
glargine group. There was a 57% lower rate
of hypoglycaemia with Xultophy®, and this
group lost an average of 1.4 kg compared with
a weight gain of 1.8 kg in the insulin glargine
group.
BREAKTHROUGH DATA
The data were presented by the study’s lead investigator, Professor John Buse from the University of North Carolina School of Medicine, US.
“The results from the study demonstrated that
IDegLira [Xultophy®] treatment could positively
impact patients who are not in control on their
current basal insulin therapy,” he said.
“IDegLira patients achieved an end-of-trial mean
HbA1c of 6.6% while still experiencing weight
reduction, and had significantly less hypoglycaemia than patients taking a higher dose of insulin
glargine.”
Other key presentations at the annual meeting
included results from a phase 3b trial investigating Victoza® in people with type 2 diabetes
during Ramadan, which were announced in
June 2015, and additional analyses of the
clinical data for Saxenda® from the phase 3a
development programme SCALE®, which were
announced in May 2015.
WHAT IS XULTOPHY®?
Xultophy® is a once-daily single-injection
combination of Tresiba® (insulin degludec)
and Victoza® (liraglutide). It was first
launched in Switzerland in early 2015 and is
now also available in Germany and the UK.
NOVO NORDISK TO
CEASE DISTRIBUTION
OF TRESIBA® IN
GERMANY
On 1 July 2015, Novo Nordisk announced the
decision to cease distribution of its oncedaily basal insulin Tresiba® (insulin degludec)
in Germany, following the negative outcome
of price negotiations with the GKV-Spitzenverband, the German national association
of statutory health insurance funds. In order
to ensure the safe switch to an alternative
insulin treatment for the 40,000 people with
diabetes currently using Tresiba®, Novo
Nordisk will continue supplying the product
until the end of September 2015.
“We’re very dissapointed that it has not
been possible to reach a price agreement
with the insurance fund,” says Jakob Riis,
executive vice president of China, Pacific &
Marketing.
Tresiba® has been launched in 30 countries.
The decision to cease distribution of
Tresiba® in Germany has no implications for
the other countries where the product is
available.
Read more in the press release from 1 July at
novonordisk.com/newsarchive.
3
HIGHLIGHTS FOR THE FIRST SIX MONTHS
OPERATING PROFIT
INCREASED BY
57%
(Danish kroner)
NET PROFIT
INCREASED BY
35%
Novo Nordisk increased operating profit in Danish kroner by 57% in the first six months of 2015 to
DKK 26.3 billion. 16% local currency operating profit growth adjusted for the NNIT divestment
Sales increased by 25% in Danish kroner and by 9% in local currencies to DKK 52.3 billion.
- Sales of Victoza® increased by 41% (22% in local currencies).
- Sales of Levemir® increased by 28% (10% in local currencies).
- Sales in North America increased by 35% (10% in local currencies).
- Sales in International Operations increased by 26% (17% in local currencies).
- Sales in Region China increased by 25% (3% in local currencies).
(Danish kroner)
Gross margin improved by 2.2 percentage points in Danish kroner to 85.2%, driven by a positive currency impact and
product mix.
TOTAL DIABETES
CARE SALES
INCREASED BY
Operating profit increased by 57% in Danish kroner and by 30% in local currencies to DKK 26.3 billion. Adjusted for
the DKK 2.4 billion non-recurring income related to the partial divestment of NNIT, operating profit in local currencies
increased by 16%.
24%
Net profit increased by 35% to DKK 18.2 billion. Diluted earnings per share increased by 38% to DKK 7.02. Adjusted
for the partial divestment of NNIT, net profit and diluted earnings per share increased by 20% and 22% respectively.
(Danish kroner)
SALES OF
INSULIN
INCREASED BY
22%
(Danish kroner)
In July, Novo Nordisk announced the successful completion of the first phase 3a trial with semaglutide, a new GLP-1
analogue to be administered subcutaneously once weekly.
Novo Nordisk successfully completed the first phase 3a trial with liraglutide as adjunct therapy to insulin for people
with type 1 diabetes, in July.
For 2015, sales growth measured in local currencies is still expected to be 7–9%, whereas operating profit growth
measured in local currencies is raised by two percentage points and is now expected to be around 19%.
Read more in the company announcement from 6 August at novonordisk.com/newsarchive.
4
Total sales
Diabetes care sales
DKK billion
DKK billion
60
60
25%
50
50
50
60
40
60
40
60
40
50
30
50
30
50
30
40
20
40
20
30
10
20
0
10
25%
DKK billion
60
60
50
50
60
40
60
40
50
24%
60
30
10
30
10
30
10
20
0
20
0
20
0
20
0
10
10
0
0
10
40
20
30
10
30
10
30
10
30
10
20
0
20
0
20
0
20
0
10
10
0
10
41%
Victoza sales
0
10
41%
10
24%
40
20
H1
2013
H1
102014
0
60
40
40
20
40
20
0
10
50
24%
60
40
20
40
20
®
50
50
30
50
30
H1
2015
10
50
24%
60
50
30
50
30
H1
2014
60
40
50
30
25%
60
40
40
25%
60
25%
25%
H1
2013 10
0
10
60
60
Modern insulin sales
0
10
24%
H1
2015
10
24%
50
30
40
20
30
8
8
8
8 billion
DKK
8
8
8
10
10
10
10
10
10
10
10
10
6
6
6
41%
6
6
41%
6
6
6
6
8
8
8
4
4
6
6
2
2
4
4
0
0
2
2
2
0
0
0
8
8
4
4
6
6
2
2
4
4
0
0
2
2
0
H1
2013
0
H1
2014
H1
2015
16%
8
4
6
4
0
H1
2013
16%
8
4
4
6
6
16%
2
16%
16%
8
6
6
4
30%
4
16%
2
4
4
0
0
2
2
2
2
0
0
0
H1
2014
H1
2014
H1
2015
8
30%
4
4
2
0
22%
Norditropin® sales
8 billion
DKK
41%
H1
2013
10
41%
NovoSeven sales
22%
22%
10
22%
0
10
®
8
DKK
billion
22%
22%
H1
2015
2
2
0
30%
30%
30%
30%
0
H1
2013
H1
2014
H1
2015
5
KEY FIGURES FOR THE FIRST SIX MONTHS OF 2015
Amounts in DKK million, except number of shares, earnings per share and full-time equivalent employees.
Six months 2015
Six months 2014
% change H1 2014
PROFIT AND LOSS
to H1 2015
Net
sales
52,259
41,972
25%
Gross profit
Gross margin
44,526 34,835
85.2%83.0%
28%
Sales and distribution costs
Percent of sales
13,322
10,645
25.5%25.4%
25%
Research and development costs
Percent of sales
6,285
6,243
12.0%14.9%
1%
Administrative costs
Percent of sales
1,741
1,600
3.3%3.8%
9%
Other operating income, net
Non-recurring income from the initial public offering of NNIT A/S
3,161
2,376
N/A
N/A
419
-
Operating profit
Operating margin
26,339
50.4% 16,76657%
39.9% Net financials
(3,306)
524
N/A
Profit before income taxes
23,033
17,290
33%
Income taxes
Effective tax rate
4,8143,838 25%
20.9%
22.2%
Net profit
Net profit margin
18,219
13,45235%
34.9%32.0%
OTHER KEY NUMBERS
Depreciation, amortisation and impairment losses
Capital expenditure (tangible assets)
1,311
1,782 1,324
1,495 (1%)
19%
Net cash generated from operating activities
Free cash flow
16,080
16,473
12,194 10,522 32%
57%
Total assets
Equity
Equity ratio
81,313 63,681 28%
39,11136,661 (7%)
48.1%
57.6% Average number of diluted shares outstanding (million)
2,594.1
2,645.2
(2%)
Diluted earnings per share/ADR (in DKK)
7.02
5.09
38%
Diluted earnings per share/ADR adjusted for non-recurring income
from NNIT IPO (in DKK)6.20
5.0922%
Full-time equivalent employees end of period1
1. Full-time equivalent employees in H1 2014 in NNIT A/S was 2,277.
6
39,658
40,226 (1%)
FORWARD-LOOKING STATEMENTS
This document 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 ‘Risks to be aware of’ on pages 42–43 of Novo Nordisk’s Annual Report 2014, 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 Novo Nordisk’s
half-year report 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 this document, whether as a
result of new information, future events or otherwise.
24.4
MILLION PEOPLE
USE OUR DIABETES
CARE PRODUCTS
GLOBAL
VALUE MARKET
SHARE OF
28%
39,658
EMPLOYEES
WORLDWIDE
7
AMONG THE BEST
IN VALUE CREATION
CFO Jesper Brandgaard believes that
Novo Nordisk’s foundation-based ownership
ownership
structure
theto deliver
structure has
helped has
the helped
company
company
to deliver
high
high shareholder
returns.
value creation.
Novo Nordisk shareholders have during the last five years benefited from the
fact that the company has been among the best in the world in value creation.
That is calculated in an analysis among the largest listed companies in the world
produced by Boston Consulting Group.
With a score of 34 points in the analysis, Novo Nordisk is ranked seventh on the
global list of large-cap value creators. According to Chief Financial Officer
Jesper Brandgaard, the company’s long-term focus and founda­tion-based
ownership structure makes a positive difference:
“I believe the good performance in the ranking reflects Novo Nordisk’s ownership
structure with a major shareholder focused on the long-term perspectives and not
just the next quarter. This enables us to make long-term business decisions which
in return create long-term value for our shareholders.”
Boston Consulting Group’s analysis ranks companies by total shareholder
return, an indicator of their total value creation based on sales and earnings
growth, multiple change, dividends, share issues and net debt change.
FIRST PHASE 3A TRIAL INVESTIGATING LIRAGLUTIDE FOR TYPE 1 DIABETES SUCCESSFULLY COMPLETED
8
In July 2015, Novo Nordisk completed the first phase 3a trial with liraglutide as adjunct to insulin therapy in people with type 1 diabetes.
ADJUNCT TWO is a randomised, double-blinded placebo-controlled trial
investigating the efficacy and safety of daily doses of 0.6 mg, 1.2 mg or
1.8 mg liraglutide compared with placebo as adjunct to insulin treatment.
The trial involved 835 people with type 1 diabetes and ran for 26 weeks.
greater improvement in HbA1c of between 0.2% and 0.3% compared
with 0.0% for people treated with placebo.
From a mean baseline HbA1c of around 8.1%, people treated with
liraglutide as adjunct to insulin therapy achieved a statistically significant
The results of the second and final pivotal phase 3a trial ADJUNCT ONE
are expected to be reported shortly.
Furthermore, people treated with liraglutide as adjunct to insulin therapy
experienced a statistically significant greater weight loss of between 2 kg
and 5 kg. whereas people treated with placebo had no weight change.
1.5 BILLION DANISH KRONER INVESTMENT IN NEW
HAEMOPHILIA PRODUCTION
In May, Novo Nordisk announced that the company is investing 1.5 billion
Danish kroner in a new 7,500 m2 facility in Kalundborg, Denmark. The facility
will produce active pharmaceutical ingredients for NovoSeven® and future
products for treating haemophilia. It is estimated that the investment will create 100 new jobs in Kalundborg,
where Novo Nordisk currently employs more than 2,800 people.
“The investment in Kalundborg underscores our long-term ambition to create and maintain jobs in Denmark. This year alone, we expect Novo Nordisk
to create about 250 new jobs in Kalundborg, and we’re always on the lookout for capable and highly skilled employees,” says Henrik Wulff, executive
vice president of Product Supply.
Established in 1969, Kalundborg is Novo Nordisk’s largest production site,
with a total area of 1,000,000 m2.
Read more in the press release from 4 May at novonordisk.com/newsarchive.
This is what the new haemophilia facility in
Kalundborg will look like.
FIRST PHASE 3A TRIAL WITH
SEMAGLUTIDE SUCCESSFULLY COMPLETED
On 10 July, Novo Nordisk announced the headline results from
SUSTAIN 1, the first phase 3a trial for semaglutide, a new GLP-1 analogue
to be administered subcutaneously once weekly. The trial investigated the
efficacy and safety of 0.5 mg and 1.0 mg semaglutide as monotherapy
over 30 weeks of treatment compared with placebo in 388 people with
type 2 diabetes previously on diet and exercise.
The trial achieved its primary objective by demonstrating that, from a
mean baseline HbA1c of 8.1%, people treated with doses of 0.5 mg and
1.0 mg semaglutide achieved superior improvements in HbA1c of 1.5%
and 1.6% respectively, compared with no change in HbA1c in the placebo
group.
“We’re excited about these results, which confirm that semaglutide has
the potential to help people with type 2 diabetes achieve both good glycaemic control and a significant weight loss with one weekly injection,”
says Mads Krogsgaard Thomsen, chief science officer. “We look forward
to further results from the SUSTAIN clinical development programme.”
Novo Nordisk expects to announce headline results for the five remaining SUSTAIN trials within the next nine months.
Read more in the company announcement from 10 July at
novonordisk.com/newsarchive.
9
From 4 to 8 August Team Novo Nordisk was
back in Denmark for its third appearance in
Post Danmark Rundt.
TEAM NOVO NORDISK
TOURED DENMARK
SPONSORSHIP RENEWED
At the beginning of August, Team Novo Nordisk, the world’s first all-diabetes professional cycling team, returned to Denmark for its third appearance
at the six-stage Post Danmark Rundt, which took place from 4 to 8 August.
Team Novo Nordisk will continue to race under the Changing Diabetes®
banner for at least another two years, after securing an extension of its
sponsorship deal with Novo Nordisk in May. The original three-year
agreement was due to expire later this year, but now Novo Nordisk will
continue to sponsor the team until 2017.
The team included seven professional riders who during the race were
backed by fans and Novo Nordisk employees along the routes. Team Novo
Nordisk ended just outside top 10 and especially French rider Charles Planet
draw attention when he was part of the breakaway at the race’s sixth and
final stage.
Speaking after the announcement, Jakob Riis, executive vice president of
China, Pacific & Marketing, said that the company was proud to pledge its
continued support for the world’s first all-diabetes pro cycling team.
Team Novo Nordisk is one of the most followed cycling team on social media.
You can follow them on facebook.com/teamnovonordisk or read more at
teamnovonordisk.com.
10
“As a global leader in diabetes care, Novo Nordisk has a responsibility not
only to provide innovative products to tackle the diabetes pandemic, but
also to invest in initiatives that support the diabetes community,” he said.
BREAKING A SWEAT AT SPORTSCAMP
Young dancers, handballers, badminton players
and American footballers are among those
who attended the Novo Nordisk SportsCamp
this summer. In total, 162 children aged 11 to
15 had their heart rates raised as high as their
spirits when they participated in a week-long
camp offering eight different sporting programmes and lots of social activities.
very good at talking with their room-mates
about their diabetes.
and was partly staffed by volunteers from Novo
Nordisk.
The Novo Nordisk SportsCamp was held at various locations in Denmark over the summer,
Read more at sportscamp.dk.
“I think it’s really fun. You meet loads of great
people, make new friends, and there are lots
and lots of fun activities, also in the evenings,”
says 13-year-old Johanne Larsen, who spent the
week playing badminton.
TOUGH CHILDREN WITH DIABETES
Johanne is one of 12 children with diabetes
who attended the SportsCamp, for which Novo
Nordisk has been the main sponsor since 2004.
The attendees also included two nurses, who
kept a check on the children’s blood sugar
levels, ensuring that they were always in good
hands. Other than that, these children did not
need to be given any special consideration.
“They are incredibly tough and much better at
coping with their diabetes than many adults.
Obviously, though, we keep an eye on them and
make sure that nothing happens,” says nurse
Anne Lundgreen, adding that the children were
There are eight different sports programmes at the Novo Nordisk SportsCamp. Here, a group of boys are doing American football training.
11
SHAREHOLDER INFORMATION
Follow Novo Nordisk on novonordisk.com
and on social media:
facebook.com/novonordisk
FINANCIAL CALENDAR
twitter.com/novonordisk
29 October 2015
linkedin.com/company/novo-nordisk
3 February 2016
pinterest.com/novonordisk
FIRST NINE
MONTHS OF 2015
er
FULL YEAR 2015
Share price performance
Price development and monthly turnover
of Novo Nordisk B shares
Novo Nordisk share price and indexed peers
Novo Nordisk
Pharmaceutical industry peers*
youtube.com/novonordisk
OMXC20 CAP
DKK

Turnover of B shares (left)
Novo Nordisk’s B share
closing prices (right)
400
430
DKK billion
25
400
320
390
20
320
240
350
15
240
160
310
10
160
80
270
5
80
0
0
0
Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul
Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun
2014
2014
2015
* Pharma peers comprise AstraZeneca, Bristol-Myers Squibb, Eli Lilly,
GlaxoSmithKline, Lundbeck, Merck, Novartis, Pfizer, Roche and Sanofi.
2015
Jul
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
Share
price Weber-Villumsen
performance
Tel +45share
3079
6321,
Novo Nordisk
price
and cwev@novo­
indexed peersnordisk.­­com
Editor-in-chief
Novo Nordisk
Pharmaceutical industry peers*
OMXC20 CAP
Mike Rulis
Translation,
copy-editing
and
layout
DKK
Corporate Communications
430
Printing and distribution
390 Bording A/S, Copenhagen
Circulation
350 12,000 Danish
2,000 English
310
Investor contact
270 Kasper Veje
Tel +45 3079 8519, [email protected]
Product names
NotSep
all products
Share
introduced
Aug
Oct Nov mentioned
Dec Jan Feb inMar
Aprhave
May been
Jun Jul
worldwide. Trade names
2014
2015may vary from country to country.
* PharmaPhotos
peers comprise AstraZeneca, Bristol-Myers Squibb, Eli Lilly,
GlaxoSmithKline, Lundbeck, Merck, Novartis, Pfizer, Roche and Sanofi.
Novo Nordisk