new orleans: detailed results from leader study … · the board of directors has decided that an...
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shareQUARTERLY INVESTOR UPDATE – AUGUST 2016
NEW ORLEANS: DETAILED RESULTS FROM LEADER STUDY PRESENTED AT AMERICAN DIABETES ASSOCIATION CONFERENCE
FIRST SIX MONTHS OF 2016: NOVO NORDISK INCREASED ADJUSTED OPERATING PROFIT BY 8% IN LOCAL CURRENCIES
IDEGLIRA RECEIVES POSITIVE 16–0 VOTE IN FAVOUROF APPROVAL FROM FDA ADVISORY COMMITTEE
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Overall, we are satisfied with the performance in the first six months of 2016, during which Victoza® and Tresiba® continued to deliver strong sales growth and Region China improved faster than expected. In the US, the market environment is becoming increasingly challenging, and contract negotiations for 2017 have reflected intensifying price competition. In spite of this, we see significant growth opportunities based on our strong diabetes care portfolio.
Sales increased by 7% measured in local currencies and by 5% in Danish kroner. Sales growth was realised within both diabetes care and biopharmaceuticals, with the majority of growth originating from Victoza®, Tresiba®, Norditropin® and Saxenda®.
Over the first six months of the year, all regions contributed to sales growth; however, the US was the main contributor with 50% share of growth measured in local currencies.
In May, IDegLira – a combination of insulin degludec (Tresiba®) and liraglutide (Victoza®) – received a positive 16–0 vote from FDA’s Advisory Committee recommending the approval of the treatment for adults with type 2 diabetes.
The following month, the detailed results from the LEADER trial, demonstrating that Victoza® (liraglutide) reduced the risk of major cardiovascular events by 13% (statistically significant) versus placebo when added to standard of care, were presented at a symposium hosted by the American Diabetes Association (ADA).
From a financial results perspective, operating profit decreased by 3% reported in local currencies and by 6% in Danish kroner to DKK 24.8 billion. If 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 8%.
For 2016, we now expect sales growth measured in local currencies to be 5–7%, while growth in adjusted operating profit is expected to be 5–8%.
Lars Rebien Sørensen President and CEO, Novo Nordisk
A SATISFACTORY SIX MONTHS
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VICTOZA® SIGNIFICANTLY REDUCED THE RISK OF MAJOR CARDIOVASCULAR EVENTS AND DEATH IN ADULTS WITH TYPE 2 DIABETES IN THE LEADER TRIAL
WHAT IS LEADER?
The LEADER study is the largest and longest Novo Nordisk clinical trial to report to date. It was a randomised double-blind study of 9,340 adults with type 2 diabetes at high risk of heart disease. Half of the participants were given liraglutide and half received placebo, both in addition to the treatment they were already receiving to control their diabetes and associated health problems, such as high blood pressure and high cholesterol.
On 13 June, in a packed auditorium at the American Diabetes Association’s (ADA) conference in New Orleans, investigators unveiled detailed data from the LEADER trial showing that liraglutide (Victoza®) significantly reduced the number of major adverse cardiovascular events in adults with type 2 diabetes.
On the same day, one of the world’s most prestigious medical journals, the New England Journal of Medicine, published the data online in an article about the findings – and the implications for the treatment of the condition.
The results from the LEADER study showed that Victoza® (liraglutide) significantly reduced the risk of the composite primary endpoint of cardiovascular (CV) death, non-fatal myocardial infarction (heart attack) or non-fatal stroke vs placebo, when added to standard of care in 9,340 adults with type 2 diabetes at high CV risk.
At the conference, the magnitude of these reductions was disclosed, which include:• 13% lower overall risk of having major adverse
cardiovascular events • 22% lower risk of death from cardiovascular cause • 15% lower risk of all-cause mortality.
Furthermore, Victoza® was associated with a 22% reduction in the development and progression of kidney disease.
The results are important as, according to the International Diabetes Federation, cardiovascular disease is the number one cause of death for people with type 2 diabetes.
“We’re very excited by the LEADER trial results that demonstrate a significant reduction in major cardiovascular events among type 2 diabetes patients treated with Victoza®, including all-cause death,” says Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “For us, this marks the beginning of a new era where our R&D focus will go beyond glucose control.”
Liraglutide, the active ingredient in Victoza®, is a GLP-1 receptor analogue; it works in the pancreas to stimulate insulin secretion and reduce the production of glucagon in the liver – a hormone which raises the concentration of blood glucose. Liraglutide also works in the brain to reduce appetite and increase satiety – the sensation of feeling full.
Novo Nordisk is now preparing to submit the LEADER data to regulatory authorities in the US, Europe and elsewhere later this year, with the aim of having the Victoza® label updated to reflect the cardiovascular benefits.
Read more in the press release from 13 June at novonordisk.com/media.
9,340patients
countries32
trial sites410
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Sales increased by 7% in local currencies and by 5% in Danish kroner to DKK 54.7 billion. - Sales of Victoza® increased by 14% (13% in Danish kroner). - Sales of Tresiba® increased by 167% (161% in Danish kroner). - Sales in US increased by 7% (7% in Danish kroner). - Sales in International Operations increased by 11% (decreased by 2% in Danish kroner). - Sales in Region China increased by 10% (5% in Danish kroner).
Operating profit decreased by 3% reported in local currencies and by 6% in Danish kroner to DKK 24.8 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 8%.
Net profit increased by 7% to DKK 19.4 billion. Diluted earnings per share increased by 9% to DKK 7.63. Adjusted for the partial divestment of NNIT, net profit and diluted earnings per share increased by 22% and 23% respectively.
In May, IDegLira – the combination of insulin degludec (Tresiba®) and liraglutide (Victoza®) – received a positive 16-0 vote from FDA’s Advisory Committee recommending the approval of the treatment for adults with type 2 diabetes.
In June, at a symposium hosted by the American Diabetes Association (ADA), hosted symposium the detailed results from the LEADER trial were presented, demonstrating that Victoza® (liraglutide) significantly reduced the risk of major cardiovascular events by 13% versus placebo when added to standard of care in 9,340 adults with type 2 diabetes at high cardiovascular risk.
The Board of Directors has decided that an interim dividend for 2016 of DKK 3.00 per share of DKK 0.20 will be paid in August 2016.
For 2016, sales growth is now expected to be 5–8% whereas growth in adjusted operating profit is still expected to be 5–9%, both measured in local currencies. For 2017, Novo Nordisk has completed the majority of formulary negotiations in the US and average prices after rebates are expected to be moderately lower, while the market access for Novo Nordisk’s key products is expected to remain largely unchanged.
Read more in the company announcement from 5 August at novonordisk.com/media.
Novo Nordisk increased adjusted operating profit by 8% in local currencies in the first six months of 2016. Sales increased by 7% in local currencies.
HIGHLIGHTS FROM THE FIRST SIX MONTHS OF 2016
7%TOTAL DIABETES AND OBESITY CARE SALES GREW BY
8%TOTAL BIOPHARMA-CEUTICALS SALES INCREASED BY
7%NET PROFIT INCREASED BY
(local currencies)
(local currencies)
(local currencies)
(Danish kroner)
8%ADJUSTED OPERATING PROFIT INCREASED BY
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13% 6%New-generation insulin salesDKK billion
Victoza® salesDKK billion
Biopharmaceutical salesDKK billion
Diabetes and obesity care salesDKK billion
Modern insulin salesDKK billion
6M2014
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Total sales DKK billion
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KEY FIGURES FOR THE FIRST SIX MONTHS OF 2016
1 Adjusted for the non-recurring income related to the partial divestment of NNIT (2,376 m. kr.) and the income related to out- licensing of assets for inflammatory disorders (449 m. kr.), both in 2015, operating profit in local currencies increased by 10%.
Amounts in DKK million, except number of shares, earnings per share and full-time equivalent employees. H1 2016 H1 2015 % change H1 2015
INCOME STATEMENT to H1 2016 Net sales 54,671 52,259 5% Gross profit 46,392 44,526 4%Gross margin 84.9% 85.2%
Sales and distribution costs 13,608 13,322 2%Percent of sales 24.9% 25.5%
Research and development costs 6,635 6,285 6%Percent of sales 12.1% 12.0%
Administrative costs 1,781 1,741 2% Percent of sales 3.3% 3.3%
Other operating income, net 438 3,161 (86%)Non-recurring income from the initial public offering of NNIT A/S - 2,376 N/A
Operating profit 24,806 26,339 (6%)1
Operating margin 45.4% 50.4%
Net financials (251) (3,306) (92%)
Profit before income taxes 24,555 23,033 7%
Income taxes 5,132 4,814 7% Effective tax rate 20.9% 20.9%
Net profit 19,423 18,219 7% Net profit margin 35.5% 34.9%
OTHER KEY NUMBERS
Depreciation, amortisation and impairment losses 1,341 1,311 2% Capital expenditure (tangible assets) 2,775 1,782 56%
Net cash generated from operating activities 21,972 16,080 37% Free cash flow 19,102 16,473 16%
Total assets 88,269 81,313 9% Equity 42,585 39,111 9%Equity ratio 48.2% 48.1%
Average number of shares outstanding, diluted (million) 2,545.4 2,594.1 (2%)Diluted earnings per share/ADR (in DKK) 7.63 7.02 9%Diluted earnings per share/ADR adjusted for non-recurring income from NNIT IPO (in DKK) 7.63 6.20 23%
Full-time equivalent employees end of period 42,265 39,658 7%
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27%
FORWARD-LOOKING STATEMENTS
This document contains a summary of information made by Novo Nordisk in connection with the issuing of our company announcement number 55/2016 dated 5 August 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 above- mentioned 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
42,265
MILLION PEOPLEUSE OUR DIABETES CARE PRODUCTS
NOVO NORDISK’S SHARE OF THE GLOBAL DIABETES MARKET MEASURED IN VALUE:
EMPLOYEES WORLDWIDE
WE ARE
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In May, Novo Nordisk filed nonacog beta pegol for regulatory approval in the US. Nonacog beta pegol is a new long-acting factor IX treatment for people living with haemophilia B.
The filing was based on the results from the paradigm clinical trial programme, which involved 115 patients with severe or moderately
severe haemophilia B. Nonacog beta pegol was found to be efficacious in routine prophylaxis, treatment of bleeding episodes and surgery for adults, adolescents and children. Furthermore, the product appeared to be well tolerated and no safety concerns were identified.
Novo Nordisk’s long-acting factor IX has a five times longer half-life compared to standard factor IX products, and the phase 3 trials showed that patients using the product had a higher level of factor IX in their blood despite less frequent dosing. Furthermore, these patients reported a significant improvement in quality of life during the trial.
“With the regulatory filings in 2016 of our long-acting factor IX, people with haemophilia B in both the EU and the US are one step closer to having a new treatment option,” says Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “With its high factor activity level, less frequent dosing and reduced bleeding rate, nonacog beta pegol has the potential to improve quality of life for both patients and their families.”
Read more in the company announcement from 16 May at novonordisk.com/media.
NEW HAEMOPHILIA B TREATMENT FILED FOR REGULATORY APPROVAL IN THE US
Connor Jones, from Bristol, UK, has haemophilia B
ABOUT THE PARADIGM CLINICAL PROGRAMMEThe paradigm clinical trial programme for nonacog beta pegol enrolled children and adults with severe or moderately severe haemophilia B. It involved a total of 115 previously treated patients with a total of more than 10,625 exposure days for up to 3.3 years of treatment.
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BREXIT – WHAT DOES IT MEAN FOR NOVO NORDISK?
Global financial markets plunged in late-June after the UK voted to leave the European Union, with financial analysts warning that the decision could have big implications for the pharmaceutical industry.
But exactly how will the UK’s withdrawal from the EU affect Novo Nordisk? According to Novo Nordisk’s chief financial officer, Jesper Brandgaard, it is hard to predict as the conditions and timeline for an exit are still unknown.
“One thing is pretty certain, though,” Jesper Brandgaard explains. “When the British pound drops against the euro and the Danish krone, cash flows from our UK business are affected negatively. Not in the short term, because we have hedged incomes in British pounds for the next 12 months, but in the longer term we’ll feel the impact unless we can increase our prices to make up for the shortfall. We do not know at the moment whether that is possible.”
He adds that it is unlikely that there will be any major short-term implications for the activities of Novo Nordisk’s UK affiliate or the company’s ongoing collaborations with British academic institutions, such as Oxford University.
“Our first commitment is always to the patients we serve,” he stresses. “As long as they need our products, and as long as British researchers can help us in our quest to find and develop even better medicines for our patients, Britain will remain an important country for Novo Nordisk.”
Jesper Brandgaard’s sentiments are echoed by
Jurek Gruhn, executive vice president and head of Novo Nordisk’s European region. “Brexit does not change our commitment to British patients,” he confirms. “It just adds some uncertainty and complexity that we will need to figure out how to handle once we have a clearer picture of the process, timelines and conditions for Britain’s exit from the EU.”
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On 25 May, the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the US Food and Drug Administration (FDA) voted 16–0, recommending the approval of IDegLira for the treatment of adults with type 2 diabetes. IDegLira is a once-daily, single-injection fixed combination of insulin degludec (Tresiba®) and liraglutide (Victoza®) for the treatment of adults with type 2 diabetes.
Based on the data contained in the New Drug Application (NDA) for IDegLira, the FDA had asked the panel members to discuss whether Novo Nordisk had provided adequate evidence to establish the efficacy and safety profile of IDegLira for the treatment of adults with type 2 diabetes.
The recommendation for approval was based on data from clinical trials of IDegLira, including the DUAL phase 3 clinical trial programme, which involved more than 3,000 adults with type 2 diabetes. In addition to the DUAL clinical trial programme, both insulin degludec and liraglutide have been studied extensively in separate clinical trial programmes and the products are commercially available across the globe.
“The unanimous recommendation from the Advisory Committee marks an important step towards making IDegLira available to adults with type 2 diabetes in the US,” explains Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “We look forward to working with the FDA as they complete their review of IDegLira.”
The NDA for IDegLira was submitted to the FDA in September 2015 under the FDA’s Prescription Drug User Fee Act V (PDUFA V) regulation. Novo Nordisk expects the FDA to complete its review of IDegLira in the third quarter of this year.
In Europe, IDegLira was approved in September 2014 and is marketed under the brand name Xultophy®.
Read more in the company announcement from 25 May at novonordisk.com/media.
IDEGLIRA RECEIVES POSITIVE 16–0 VOTE IN FAVOUR OF APPROVAL FROM FDA ADVISORY COMMITTEE
NOVO NORDISK INVESTS DKK 400 MILLION IN EXPANSION OF KALUNDBORG PRODUCTION PLANT
Novo Nordisk is investing 400 million Danish kroner in a 500 m2 extension of the world’s largest insulin production plant in Kalundborg, Denmark.
“The expansion of our production plant highlights our ambition to continue strengthening our presence in Kalundborg,” says Michael Hallgren, senior vice president and head of production at Kalundborg. “The new facilities will give us greater flexibility and enable the installation of equipment that will enhance efficiency and increase the long-term production capacity of the plant.”
Established in 1969, the Kalundborg production site today covers a total area of 1.1 million square metres. With 3,400 employees, the plant is a cornerstone of Novo Nordisk’s global production capacity and produces 50% of the world’s insulin as well as a range of biopharmaceutical products.
Groundbreaking for the plant expansion took place in early July, and construction is expected to be completed by the end of 2018.
WHAT IS IDEGLIRA?IDegLira is a once-daily, single-injection fixed combination product, consisting of Tresiba® (insulin degludec), a once-daily basal insulin analogue with an ultra-long duration of action, and Victoza® (liraglutide), a once-daily human GLP-1 analogue.
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WHY HAVING DIABETES WHEN PREGNANT IS A SERIOUS MATTER
Chaya Nayak experienced complications during pregnancy as a result of gestational diabetes.
Every mother-to-be wants a trouble-free pregnancy, a normal birth and a healthy child. But diabetes in pregnancy, also known as gestational diabetes, can change all that.
In fact, gestational diabetes can not only lead to complications during pregnancy which can result in premature labour and stillbirth, it can also affect the health of both mother and child by increasing the risk of developing conditions including type 2 diabetes, obesity and cardiovascular diseases.
One woman who has experienced the challenges of gestational diabetes first hand is Chaya Nayak, who lives in Madhya Pradesh in India. When she was expecting her second child, tragedy struck.
“My second child was stillborn,” says Chaya. “Later, when I was pregnant with my third child, I also experienced complications.”
Globally, one in seven births – around 18 million each year – are affected by gestational diabetes. And it is not only in low- and
middle-income countries that women need to be aware of their blood sugar levels. In Denmark, for example, 3–4% of all pregnant women develop gestational diabetes, and this number has been slowly increasing since 2000.
Of the women who develop gestational diabetes, 50% will develop diabetes within five years. Children born to women with gestational diabetes are up to eight times more likely to develop type 2 diabetes and obesity in their teens or early adulthood.
Statistics like these are why Novo Nordisk is working to improve maternal health through its Changing Diabetes® in Pregnancy programme. In mid-May, the company engaged with maternal health experts at the Women Deliver conference in Copenhagen, highlighting the urgent need for action to tackle the growing problem of gestational diabetes.
You can read more about Novo Nordisk’s Changing Diabetes in Pregnancy® initiative at novonordisk.com/cdip.
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Novo Nordisk A/SCorporate Communications, Novo Allé, 2880 Bagsværd, Tel +45 4444 8888 Share Magazineis distributed three times a year to share holders Editorial staff Chris MossTel +45 4443 5677, cms@novo nordisk. com Editor-in-chiefMike Rulis Translation, copy-editing and layoutCorporate CommunicationsPrinting and distribution Bording A/S, CopenhagenCirculation 12,000 Danish 2,000 English Investor contact Hanna ÖgrenTel +45 3079 8519, [email protected] names Not all products mentioned in Share have been introduced worldwide. Trade names may vary from country to country.
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