NN Background

Type 2 diabetes is normally found in people who are overweight as they get older. Although it is sometimes called adult onset diabetes, in some country, such as the United States, more children and young adults are being diagnosed with Type 2 diabetes because they are not getting enough activity. 

About 90 percent of all cases of diabetes are Type 2 diabetes. The difference between Type 1 and Type 2 diabetes is that with Type 2 diabetes the pancreas does not produce enough insulin or the body does not properly use the it.

Type 2 diabetes is sometimes considered a lifestyle disease because it is normally triggered by living a fairly sedentary life, being overweight and not participating in exercise. However, age is a factor as well as heredity. If a parent or sibling develops Type 2 diabetes later in life, a person has greater chances to getting Type 2 diabetes as well.

The third main type of diabetes is gestational diabetes, which is a condition that women can get when they are in the second trimester of pregnancy.  About 4 percent of all pregnant women will develop gestational diabetes.  Unlike Type 1 and Type 2 diabetes, gestational diabetes will disappear after the baby is born.  
       
When a woman has an occurrence of gestational diabetes during pregnancy, she is more likely to have it again in the next pregnancy and puts the woman at a higher risk of developing Type 2 diabetes later in life.  The older a woman is when she is pregnant, the higher the risk of developing gestational diabetes during pregnancy.

There is an emerging global epidemic of diabetes that can be traced back to rapid increases in overweight, obesity and physical inactivity.

387 (only 50% diagnosed, 25% cared, 12,5% achieve targets, 6,25% no compllications) million people have diabetes and by 2035 expected to reach 592 million = one of the fastest growing threats.

Total deaths from diabetes are projected to rise by more than 50% in the next 10 years. Most notably, they are projected to increase by over 80% in upper-middle income countries.

Reports of type 2 diabetes in children - previously rare - have increased worldwide. In some countries, it accounts for almost half of newly diagnosed cases in children and adolescents.

In 2005, 1.1 million people died from diabetes. The full impact is much larger, because although people may live for years with diabetes, their cause of death is often recorded as heart diseases or kidney failure.

80% of diabetes deaths are now occurring in low- and middle-income countries.

Lack of awareness about diabetes, combined with insufficient access to health services, can lead to complications such as blindness, amputation and kidney failure.

Diabetes can be prevented. Thirty minutes of moderate-intensity physical activity on most days and a healthy diet can drastically reduce the risk of developing type 2 diabetes.

Haemophilia is a blood condition that means bleeding does not stop. The bleeding occurs because the blood does not clot.

Approx 500'000 people have ir. If you have hemophilia then the proteins in your blood that make scabs and blood clots are missing. ^[1]A person with a small cut or internal bleed (bruise) could bleed to death. They do not bleed more than a normal person, but they bleed for much longer. The word comes from the Greek words haima "blood" and philia "to love"^[2] To treat this, an affected person can get a blood donation from someone without hemophilia. The donor’s blood has the clotting proteins and can temporarily make a normal scab.

There are 3 types of haemophilia:

• Haemophilia A - about 90% of cases. There is no blood clotting ability.
• Haemophilia B - not as severe, but much less common. There is not enough blood clotting ability.
• Haemophilia C - caused by not one, but two recessive (weak) genes.

Haemophilia A happens in about 1 in 5,000–10,000 male births.^[5] Haemophilia B happens in about 1 in every 20,000–34,000 male births.

The main treatment for hemophilia is called replacement therapy. Concentrates of clotting factor VIII (for hemophilia A) or clotting factor IX (for hemophilia B) are slowly dripped or injected into a vein. These infusions help replace the clotting factor that's missing or low.

Clotting factor concentrates can be made from human blood. The blood is treated to prevent the spread of diseases, such as hepatitis. With the current methods of screening and treating donated blood, the risk of getting an infectious disease from human clotting factors is very small.

To further reduce the risk, you or your child can take clotting factor concentrates that aren't made from human blood. These are called recombinant clotting factors. Clotting factors are easy to store, mix, and use at home—it only takes about 15 minutes to receive the factor.

Synthetic human growth hormone was developed in 1985 and approved by the FDA for specific uses in children and adults. In children, HGH injections are approved for treating short stature of unknown cause as well as poor growth due to a number of medical causes, including:

• Turner's syndrome, a genetic disorder that affects a girl's development
• Prader-Willi syndrome, an uncommon genetic disorder causing poor muscle tone, low levels of sex hormones, and a constant feeling of hunger
• Chronic kidney insufficiency
• HGH deficiency or insufficiency
• Children born small for gestational age

In adults, approved uses of HGH include:

• Short bowel syndrome, a condition in which nutrients are not properly absorbed due to severe intestinal disease or the surgical removal of a large portion of the small intestine
• HGH deficiency due to rare pituitary tumors or their treatment
• Muscle-wasting disease associated with HIV/AIDS

Overweight and obesity are defined as "abnormal or excessive fat accumulation that may impair health

In 2008, more than 1.4 billion adults were overweight and more than half a billion were obese. At least 2.8 million people each year die as a result of being overweight or obese. The prevalence of obesity has nearly doubled between 1980 and 2008. Once associated with high-income countries, obesity is now also prevalent in low- and middle-income countries.

Childhood obesity is one of the most serious public health challenges of the 21st century. Overweight children are likely to become obese adults. They are more likely than non-overweight children to develop diabetes and cardiovascular diseases at a younger age, which in turn are associated with a higher chance of premature death and disability.

65% of the world's population live in a country where overweight and obesity kills more people than underweight. This includes all high-income and middle-income countries. Globally, 44% of diabetes, 23% of ischaemic heart disease and 7–41% of certain cancers are attributable to overweight and obesity.

HRT (also known as hormone therapy, menopausal hormone therapy, and estrogen replacement therapy) uses female hormones -- estrogenand progesterone -- to treat common symptoms of menopause and aging. Doctors can prescribe it during or after menopause.

After your period stops, your hormone levels fall, causing uncomfortable symptoms like hot flashes and vaginal dryness, and sometimes conditions like osteoporosis. HRT replaces hormones your body no longer makes. It’s the most effective treatment for menopause symptoms.

Q4: 28,876 million Danish kroner

Annual: 107,927 million Danish kroner = 15,811.3$ (0.146516 DKK/USD) = 14,463.22 EUR (0.91475 USD/EUR)

Diabetes and obesity care 22,942 million Danish kroner
Biopharmaceuticals 5,934 million Danish kroner

North America 15,662 million Danish kroner
Europe 5,399 million Danish kroner
International Operations 3,992 million Danish kroner
Region China 2,325 million Danish kroner
Japan & Korea 1,498 million Danish kroner

24,400,000

The Novo Nordisk Foundation is Novo Nordisk’s main shareholder. The foundation’s purpose is to provide a stable basis for the commercial and research activities of the Novo Group of companies, and also to support scientific and humanitarian projects. This unique ownership structure protects Novo Nordisk against hostile takeovers, enables long-term planning and ensures that the company remains in Danish ownership. 

Novo Nordisk Foundation

The Novo Nordisk Foundation is a non-profit institution, whose formal purpose is to provide a stable basis for its company's operations and to make contributions to scientific, humanitarian and social progress.
 

Novo A/S

Novo A/S is an unlisted Danish public limited liability company, owned by the Novo Nordisk Foundation and established to manage the Foundation's funds and to invest actively in other companies. All A and B shares in Novo Nordisk A/S, previously held by the Novo Nordisk Foundation, were transferred to Novo A/S on 31 December 1999.
 

The Novo Group

Novo A/S is the major shareholder in the Novo Group’s two publicly listed companies, Novo Nordisk A/S and Novozymes A/S.

Codes and regulations

As an international company listed on Nasdaq Copenhagen and the New York Stock Exchange, Novo Nordisk is in compliance with Danish and - as a foreign listed private issuer - US securities laws including the US Sarbanes-Oxley Act.

Further Novo Nordisk is in compliance with the majority (44 out of 47) of the Danish Corporate Governance Recommendations (2013). Also, Novo Nordisk is - as a foreign listed private issuer - in compliance with corporate governance standards on New York Stock Exchange (2013).

Novo Nordisk’s share capital is DKK 520,000,000, which is divided into an A share capital of nominally DKK 107,487,200 and a B share capital of nominally DKK 412,512,800.

Each A share of DKK 0.01 carries 10 votes, whereas each B share of DKK 0.01 carries one vote. Thus, each B share of DKK 0.2 (the present denomination of the company's shares) carries 20 votes and each A share of DKK 0.2 carries 200 votes.

On 2 January 2014 the B shares were split in a five-for-one ratio and the trading unit of the B shares listed on Nasdaq Copenhagen was changed from DKK 1 to DKK 0.2. On 9 January 2014, each of Novo Nordisk’s American Depository Receipts (ADRs) listed on New York Stock Exchange was also split in a five-for-one ratio. Hence, the ratio of B shares to ADRs listed on the New York Stock Exchange remains 1:1.

Special rights attached to A shares include pre-emptive subscription rights in case of an increase of the A share capital, pre-emptive purchase rights in case of a sale of A shares and priority dividend if dividend is below 0.5%. B shares take priority for dividend between 0.5% and 5%, and B shares take priority for liquidation proceedings. However, in practice, A shares and B shares receive the same amount of dividend per share of DKK 0.01.

The Board may issue new shares or buy back shares in accordance with authorisations granted by the general meeting and recorded in the meeting minutes.

In March 2015, the Annual General Meeting of the company approved a reduction of the company's B share capital from DKK 422,512,800 to DKK 412,512,800 by cancellation of 50,000,000 B shares of DKK 0.20 each from the company's own holdings of B shares at a nominal value of DKK 10,000,000, equal to 1.9% of the total share capital. The reduction of the company's B share capital was implemented on 22 April 2015.

All A shares are held by Novo A/S, a Danish public limited liability company fully owned by the Danish self-governing foundation, the Novo Nordisk Foundation. The A shares are not listed but are in principle transferable. However, according to the Articles of Association of the Foundation, the A shares cannot be divested by Novo A/S or the Foundation.

The B shares are listed on Nasdaq Copenhagen and on the New York Stock Exchange as American Depository Receipts (ADRs) under the symbol NVO, and there are no transferability restrictions on the B shares.

• Tresiba® (insulin degludec) – our new-generation long-acting
insulin – was approved in the US in September and launched in
January 2016 for the treatment of type 1 and type 2 diabetes.

Xultophy® – the combination of insulin degludec and liraglutide for
type 2 diabetes – was launched in the first European countries and
filed for approval in the US.

Following successful completion of the phase 3a studies, we filed
for regulatory approval of faster-acting insulin aspart in both the
EU and the US for the management of blood glucose around
meals for both type 1 and 2 diabetes patients.

Injectable semaglutide – a once-weekly GLP-1-analogue for type 2
diabetes – showed superior efficacy over the comparator products
in four phase 3 trials announced during the year.

• A once-daily oral formulation of semaglutide showed very
encouraging results in a proof-of-concept phase 2 trial, and we
subsequently decided to take this product into phase 3
development.

In 2015, we found ourselves in increasingly tougher negotiations with
payers in the US to get our products onto their formularies. In Europe,
China, Japan and many other countries, we are experiencing continued
strong pressure on prices and reimbursement restrictions for new
products. In one case, for Tresiba® in Germany, we had to make the
difficult decision to discontinue the product following the negative
outcome of price negotiations with the statutory health insurance
funds. We were offered a price at the level of ordinary human insulin,
a product which was launched in the 1980s. If we were to accept this
price, we would undermine our ability to research and develop medical
innovations for people with diabetes.

This is an extreme case, but it serves as an example of what could
become an unsustainable future for research-based pharmaceutical
companies if payers and producers cannot find common ground when
determining the value of a medicinal product.

see image

see image

Sales increased by 22% in Danish kroner and
by 8% measured in local currencies. North
America was the main contributor with 62%
share of growth measured in local currencies,
followed by International Operations with
26%. Sales growth was realised within both
diabetes care and biopharmaceuticals, with
the majority of growth originating from
modern insulin and Victoza®.

Novo Nordisk is the world
leader in diabetes care and holds a global
value market share of 28%, compared to
27% at the same time last year.

The cost of goods sold increased by 11% to
DKK 16,188 million, resulting in a gross
margin of 85.0%, compared with 83.6% in
2014. This reflects a positive currency impact
of 1.5 percentage points and a positive
impact from the product mix, primarily due
to increased sales of Victoza® and modern
insulin

Sales and distribution costs increased by
22% in Danish kroner and by 9% in local
currencies to DKK 28,312 million. The
increase in costs is driven by US launch costs
related to Saxenda® and NovoEight® and by
preparations for the Tresiba® launch in the
US, sales force investments in selected
countries in International Operations as well
as adjustments to legal provisions.

Research and development costs decreased
by 1% in Danish kroner and by 6% in local
currencies to DKK 13,608 million. Excluding
all costs related to inflammatory disorders,
an area which Novo Nordisk exited in
September 2014, research and development
costs increased by 8% compared to 2014.

Administration costs increased by 9% in
Danish kroner and by 4% in local currencies
to DKK 3,857 million.

Other operating income (net) was DKK
3,482 million, compared with DKK 770
million in 2014. The increase is driven by the
DKK 2,376 million non-recurring income
from the partial divestment of NNIT A/S, an
IT service and consultancy company, in
connection with the Initial Public Offering
on Nasdaq Copenhagen

Operating profit increased by 43% in Danish
kroner to DKK 49,444 million. In local
currencies the growth was 21%, which is
slightly higher than the latest guidance for
operating profit growth measured in local
currencies for 2015 of ‘around 20%’.

Net financials showed a net loss of DKK
5,961 million, compared with a net loss of
DKK 396 million in 2014. The reported net
financial loss in 2015 is larger than the latest
guidance of ‘around DKK 5.6 billion’,
primarily reflecting higher than expected
losses on commercial balances following the
depreciation of the Argentine peso in
December 2015 as well as an effect from
the depreciation of the Russian rouble and
the Brazilian real during the fourth quarter
of 2015.

In line with Novo Nordisk’s treasury policy,
the most significant foreign exchange risks
for the Group have been hedged, primarily
through foreign exchange forward contracts.
The foreign exchange result was a loss of
DKK 5,898 million compared with a loss of
DKK 381 million in 2014. This development
reflects losses on foreign exchange hedging
involving especially the US dollar due to its
appreciation versus the Danish krone compared
with the prevailing exchange rates in
2014

Net capital expenditure for property, plant
and equipment was DKK 5.2 billion, compared
with DKK 4.0 billion in 2014, which is in line
with the latest guidance of ‘around DKK 5.0
billion’. Net capital expenditure was primarily
related to investments in additional insulin
filling capacity, expansion of the manufacturing
capacity for biopharmaceutical products
and the construction of new research
facilities.
Free cash flow was DKK 34.2 billion, compared
with DKK 27.4 billion in 2014, which
is in line with the latest guidance of ’DKK
33–35 billion’. The increase of 25% compared
with 2014 primarily reflects the
increased cash flow from operating activities
as well as the non-recurring proceeds from
the partial divestment of NNIT A/S.

see image

According to the International Diabetes Federation,
415 million people worldwide are
living with diabetes, and it is predicted that
by 2040 more than 10% of the world’s adult
population – 642 million people worldwide
– will have diabetes.1
The global market for diabetes care products
amounts to 353 billion Danish kroner, of
which Novo Nordisk products account for
approximately 27%. The market
has grown
by around 10% annually in the last decade,
and all indications are that it will continue to
grow as a result of the increasing number of
people with diabetes and the need for
better treatments. Of this global market,
insulin accounts for 56%, oral diabetes
products (tablet-based medications)
account
for 37% and GLP-1 products account for
7%, measured in value.

Obesity is known to be a major risk factor in
developing serious diseases such as type 2
diabetes and, as such, is a natural therapeutic
area for Novo Nordisk to enter. Obesity has
reached pandemic proportions, with more
than 600 million adults having clinical
obesity (defined as having a Body Mass
Index of 30 or above).2 However, currently
there are few pharmaceutical treatment
options available to treat obesity, and
reimbursement for these medications is
limited. The global pharmaceutical market
for obesity products currently amounts to
around 10 billion kroner.