Investor conference call First six months of 2015

Full text

(1)

5,05 4,10 3,50

4,72

Investor conference call

First six months of 2015

(2)

5,05 4,10 3,50

4,72

Agenda

Highlights and key events

By Lars Rebien Sørensen, President and CEO

R&D update

By Mads Krogsgaard Thomsen, CSO

Financials and outlook

By Jesper Brandgaard, CFO

Sales update

By Lars Rebien Sørensen, President and CEO

(3)

5,05 4,10 3,50

4,72

Forward-looking statements

Novo Nordisk’s reports filed with or furnished to the US Securities and Exchange Commission (SEC), including this document as well as the company’s Annual Report 2014 and Form 20-F, both filed with the SEC in February 2015, and written information released, or oral statements made, to the public in the future by or on behalf of Novo Nordisk, may contain forward-looking statements. Words such as ‘believe’, ‘expect’, ‘may’, ‘will’, ‘plan’, ‘strategy’, ‘prospect’, ‘foresee’, ‘estimate’, ‘project’, ‘anticipate’, ‘can’, ‘intend’, ‘target’ and other words and terms of similar meaning in connection with any discussion of future operating or financial performance identify forward-looking statements. Examples of such forward-looking statements include, but are not limited to:

• Statements of targets, plans, objectives or goals for future operations, including those related to Novo Nordisk’s products, product research, product development, product introductions and product approvals as well as cooperation in relation thereto

• Statements containing projections of or targets for revenues, costs, income (or loss), earnings per share, capital expenditures, dividends, capital structure, net financials and other financial measures

• Statements regarding future economic performance, future actions and outcome of contingencies such as legal proceedings, and • Statements regarding the assumptions underlying or relating to such statements.

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 recall, 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 ‘Be aware of the risk’ on p 42-43 of the Annual Report 2014 on the company’s website novonordisk.com.

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.

Important drug information

• Victoza® (liraglutide 1.2 mg & 1.8 mg) is approved for the management of type 2 diabetes only

(4)

5,05 4,10 3,50

4,72

Highlights

– first six months of 2015

Sales development

• Sales increased by 25% in Danish kroner and 9% in local currencies

• North America and International Operations grew by 35% and 26% in Danish kroner, respectively • Victoza® increased by 41% in Danish kroner and continues to drive the growth of the GLP-1 market • Levemir® increased by 28% in Danish kroner and continues to capture market share in the US • Tresiba® continues to perform well in countries with similar reimbursement as insulin glargine

Research and Development

• SUSTAIN® 1, comparing once weekly GLP-1 semaglutide with placebo in people with type 2 diabetes, successfully completed • Encouraging results from phase 3a study with liraglutide in people with type 1 diabetes (ADJUNCT TWO)

• Saxenda® shows sustained weight loss and reduced risk of type 2 diabetes vs placebo after three years in SCALE® trial

Financials

• Operating profit growth of 57% in Danish kroner; adjusted for partial NNIT divestment, growth was 16% in local currency • Diluted earnings per share increased 38% to 7.02 DKK per share and 6.20 DKK when adjusted for partial divestment of NNIT • 2015 financial outlook:

• Sales growth is still expected to be 7-9% in local currencies (around 14% higher as reported)

• Operating profit growth is now expected around 19% in local currencies compared to 17% previously (around 23% higher as reported)

(5)

5,05 4,10 3,50

4,72

Growth analysis – First six months of 2015

North America is the main contributor to growth

Sales as reported – First six months of 2015

Local currencies Growth Share of growth

North America 10% 56%

Europe 4% 10%

International Operations 17% 28%

Region China 3% 3%

Japan & Korea 5% 3%

Total sales 9% 100% International Operations +26% Region China +25%

Japan & Korea +10% North America +35% Europe +5% 51% 20% 14% 10% 5%

Sales of DKK 52.3 billion (+25%)

(6)

5,05 4,10 3,50

4,72

Increased modern insulin penetration Timing of shipments to distributors

Decline in the growth of the overall diabetes care market:

• Cost containment measures in the healthcare system • Restrictions on access to healthcare professionals Intensified competition

Decelerating sales growth

in the first six months of 2015

Key factors impacting sales growth

in the first six months of 2015

Decelerated growth in China reflects timing of shipments,

lower market growth and intensified competition

0% 5% 10% 15% 20% 0.0 0.5 1.0 1.5 2.0 2.5 3.0 Sales as reported bDKK Q2 2015 Q1 2013

MAT quarterly local currency growth

+

÷

÷

÷

(7)

5,05 4,10 3,50

4,72

Local currencies Growth Share of growth

New-generation insulin N/A 10%

Modern insulin 6% 34%

Human insulin 0% 0%

Victoza® 22% 35%

Other diabetes and obesity care1 (2%) (1%)

Diabetes and obesity care 9% 78%

Haemophilia 5% 6%

Norditropin® 15% 12%

Other biopharmaceuticals2 12% 4%

Biopharmaceuticals 9% 22%

Total 9% 100%

Growth is driven by Victoza

®

and modern insulin

Sales as reported – First six months of 2015

Growth analysis – First six months of 2015

1 Predominantly oral antidiabetic products, needles and Saxenda® 2 Predominantly hormone replacement therapy

Other +29% 7% Haemophilia +20% 11% Diabetes and obesity care +24% 79% 3% 79% 11% 7% 3% Norditropin® +30%

Sales of DKK 52.3 billion (+25%)

(8)

5,05 4,10 3,50 4,72 59% 6% 6% 28% 0% 20% 40% 60% 80% 100%

Source: IMS NPA MAT, June 2015

US GLP-1 market development

Source: IMS NPA MAT, June 2015

Victoza

®

maintains leadership in the faster growing US

GLP-1 market

Jun 2015 Jun 2012 2012 Jun Total TRx Growth rate 0% 5% 10% 15% 20% 25% 0 1,000 2,000 3,000 4,000 5,000 6,000 T ho us an ds

US GLP-1 market shares

exenatide Victoza® albiglutide dulaglutide Jun 2015 MAT GLP-1

(9)

5,05 4,10 3,50

4,72

Levemir

®

Novo Nordisk’s modern insulins perform well within their

respective segments in the US

NovoLog

®

Mix

NovoLog

®

Aug

2013 2015 Jul 2013 Aug 2015 Jul 2013 Aug 2015 Jul

TRx volume MS TRx segment volume NBRx volume MS MU MU MU TRx volume MS TRx segment volume NBRx volume MS TRx volume MS TRx segment volume NBRx volume MS 0 200 400 600 800 1,000 1,200 10% 20% 30% 40% 50% 60% 70%

Source: IMS Xponent Plan Trak Weekly and IMS LRx Weekly, July 2015; excludes Medicaid Note: Includes analogue insulins only

0 200 400 600 800 1,000 1,200 10% 20% 30% 40% 50% 60% 70% 0 200 400 600 800 1,000 1,200 10% 20% 30% 40% 50% 60% 70% 0% 0% 0%

(10)

5,05 4,10 3,50

4,72

Key launch observations

Tresiba

®

value share of basal insulin segment

in selected countries

Roll-out of degludec portfolio is progressing

Note: Limited IMS coverage in India Source: IMS Monthly value figures, May 2015

*Tresiba® distribution in Germany to cease by end September 2015 Months from launch

Tresiba®launched in 30 countries

• Tresiba® has shown solid penetration in markets with

similar reimbursement as insulin glargine

• Penetration of Tresiba® remains modest in markets with restricted market access compared to insulin glargine • Tresiba® distribution in Germany to cease by end

September following the negative price negotiation outcome with the German national association of statutory health insurance funds (GKV Spitzenverband)

Ryzodeg®commercially launched in Mexico, India and

Bangladesh

Xultophy®launched in Switzerland as the first country,

followed by Germany and the United Kingdom

30% 5% 11% 8%* 3% 3% 10% 14% 16% 27% 0% 5% 10% 15% 20% 25% 30% 35% 1 3 5 7 9 11 13 15 17 19 21 23 25 27 Mexico Switzerland

Japan India Sweden

Denmark Germany Argentina Brazil

(11)

5,05 4,10 3,50 4,72 6,929 3,882 1,420 1,204 0 2,000 4,000 6,000 8,000 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16

• Encouraging initial Saxenda® uptake

• Positive early feedback from physicians and patients

• Expanding formulary access remains a main priority

• The SCALE® Obesity and Pre-diabetes manuscript was published in the New England Journal of Medicine (NEJM) on 1 July 2015

Note: IMS reporting for new launches may reflect data instability due to small volume and/or supplier reporting

Source: IMS NPA TRx, Weekly data, July 2015

Prescription volume uptake of anti-obesity

medications recently launched in the US

Key launch observations

Encouraging early prescription development for Saxenda

®

TRx volume

Weeks from launch

Saxenda® Lorcaserin Phentermine & topiramate

(12)

5,05 4,10 3,50

4,72

SUSTAIN

®

1 trial design

Headline results

0.5 mg

semaglutide semaglutide Placebo 1.0 mg Change in HbA1c (8.1% baseline) -1.5%* -1.6%* 0.0% Proportion of patients reaching HbA1c target of <7% 74%* 73%* 25%

Change in body weight

(92 kg baseline) -3.8 kg* -4.6 kg* -1.0 kg

Discontinuation rate

due to adverse events 6% 5% 2%

Semaglutide shows superior HbA

1c

reduction and weight

loss compared with placebo in SUSTAIN

®

1 trial

1 Inclusion criteria: Type 2 diabetes, treated with diet and exercise at least 30 days before screening,

HbA1c 7.0-10.0% (53 - 86 mmol/mol) (both inclusive) *Statistically significantly greater compared to placebo

Placebo Semaglutide 0.5 mg 0 30 weeks 388 drug-naïve people with type 2 diabetes1 Semaglutide 1.0 mg

(13)

5,05 4,10 3,50

4,72

• Greater improvement in HbA1c between 0.2% and 0.3% for people with type 1 diabetes compared with no improvement for people with type 1 diabetes treated with placebo

• Weight loss of between 2 kg and 5 kg from mean baseline of 84 kg versus stable weight development with placebo

• No difference in severe hypoglycaemia or nocturnal

symptomatic hypoglycaemia for any of the doses. However, a higher rate of symptomatic hypoglycaemia was observed among people treated with liraglutide 1.2 mg compared to people treated with placebo

• Liraglutide appeared to have a safe and well-tolerated profile

• Results of the second and final pivotal phase 3a trial ADJUNCT ONEare expected to be reported shortly

ADJUNCT TWO trial design

1

Headline results

Liraglutide as adjunct to insulin therapy leads to greater

HbA

1c

reduction and weight loss in ADJUNCT TWO trial

26 835 people

with type 1 diabetes2

1 Capped insulin defined as upper limit on total daily insulin dose corresponding to pre-trial average total

daily insulin dose

2 Inclusion criteria: Type 1 diabetes as diagnosed clinically 12 mths or prior to visit 1, 18 years or older,

treatment with basal bolus or Continuous Subcutaneous Insulin Infusion 6 mths or longer prior to visit 1, stable insulin treatment 3 mths or longer prior visit 1, HbA1c 7.0-10.0% (53 - 86 mmol/mol) (both incl.)

0 4 Week

-2 Screening

Liraglutide placebo + capped insulin Liraglutide1.8 mg + capped insulin Liraglutide 1.2 mg + capped insulin Liraglutide 0.6 mg + capped insulin

(14)

5,05 4,10 3,50

4,72

• Approximately 80% reduced risk of developing type 2 diabetes for people treated with Saxenda®3

• Time to onset of type 2 diabetes was 2.6 times longer for the Saxenda® group compared to placebo

• At 160-week, completion rate of 53% and 45% for Saxenda® and placebo respectively

• Saxenda® appeared to have a safe and well tolerated profile with most frequently reported adverse events being

gastrointestinal in nature

1 p<0.0001. 2 p<0.0001

Source: Pi-Sunyer et al. AACE. 2014. Abstract number: 700; Novo Nordisk data on file (NN8022-1839)

Sustained weight loss with Saxenda

®

in

SCALE

®

obesity and prediabetes trial

Saxenda

®

effect on emerging type 2 diabetes

Saxenda

®

shows sustained weight loss and reduced risk of

type 2 diabetes vs placebo after three years in SCALE

®

trial

3p<0.0001

Source: Novo Nordisk data on file (NN8022-1839)

Saxenda® (placebo) 56 weeks1 Saxenda® (placebo) 160 weeks2 Mean weight reduction 8% (3%) 6% (2%) Proportion achieving 5% weight reduction 63% (27%) 50% (23%) Proportion achieving 10% weight reduction 33% (11%) 24% (9%)

(15)

5,05 4,10 3,50

4,72

Key development milestones

DEVOTE trial now expected to be completed mid-2016 compared to previously in the second half of 2016

First phase 1 trial with new oral insulin analogue OI320GT (NN1957) initiated in June 2015

(16)

5,05 4,10 3,50

4,72

Significant news flow from late-stage diabetes and obesity

pipeline

Project Past 6 months Past 3 months Within 3 months In ~3-6 months Oral GLP-1 Phase 2

Faster-acting insulin aspart

LATIN T1D ADJUNCT TWO

Results available In ~6-9 months Semaglutide SUSTAIN® 1 SUSTAIN® 3 SUSTAIN® 2 SUSTAIN® 4 SUSTAIN® 5 Victoza® SUSTAIN® 6 LEADER®

Saxenda® SCALE® ext. data

ONSET® 1 ONSET® 2 Tresiba® SWITCH 1 SWITCH 2

Note: Indicated timeline as of financial release of first six months of 2015 on 06 August

(17)

5,05 4,10 3,50 4,72 DKK million H1 2015 H1 2014 Change Sales 52,259 41,972 25% Gross profit 44,526 34,835 28% Gross margin 85.2% 83.0%

Sales and distribution costs 13,322 10,645 25%

Percentage of sales 25.5% 25.4%

Research and development costs 6,285 6,243 1%

Percentage of sales 12.0% 14.9%

Administration costs 1,741 1,600 9%

Percentage of sales 3.3% 3.8%

Other operating income, net 3,161 419 N/A

Non-recurring income from the IPO of NNIT 2,376

Operating profit 26,339 16,766 57%

Net financials (3,306) 524 N/A

Profit before income tax 23,033 17,290 33%

Tax 4,814 3,838 25%

Effective tax rate 20.9% 22.2%

Net profit 18,219 13,452 35%

Diluted earnings per share (DKK) 7.02 5.09 38%

Diluted earnings per share (DKK) adjusted for NNIT IPO 6.20 5.09 22%

(18)

5,05 4,10 3,50 4,72 1 2 3 4 1 2 40 60 80 100 120 140 90 95 100 105 110 115 120 125 130 135

Appreciation of key currencies against the Danish krone

drive significant positive currency impact in 2015

H ed g ed cu rr en ci es In d ex ( 1 J an 2 0 1 4 = 1 0 0

) USD/DKK CNY/DKK JPY/DKK

No n -h ed g ed cu rr en ci es In d ex ( 1 J an 2 0 1 4 = 1 0 0 ) 2014 CAD/DKK GBP/DKK

1 DKK per 100; 2As of 04 August 2015;3 Operating profit in DKK million per annum; 4 USD used

as proxy; 5 Operating profit impact of one of the non-hedged currencies fluctuating 5% is in the

range of DKK -15 to +25 million

Hedged

Currencies average 2014 average2015 2 rateSpot 2 Impact of a 5% move3 Hedging (months)

USD1 562 671 680 1,675 11 CNY1 91.2 107.8 109.5 270 104 JPY1 5.32 5.55 5.48 115 13 GBP1 925 1,025 1,062 80 11 CAD1 509 539 518 60 11 Non-hedged

Currencies5 average 2014 average2015 2 rateSpot 2

RUB1 14.8 11.7 10.8 INR1 9.20 10.65 10.7 ARS1 0.69 0.75 0.74 BRL1 239 223 198 TRY1 257 259 245 INR/DKK ARS/DKK RUB/DKK BRL/DKK TRY/DKK 2015

(19)

5,05 4,10 3,50

4,72

Financial outlook for 2015

The financial outlook is based on an assumption of a continuation of the current business environment and given the current scope of business activities and has been prepared assuming that currency exchange rates remain at the level as of 04 August 2015

Sales growth - local currencies Sales growth - reported

Operating profit growth - local currencies

Operating profit growth - reported Net financials

Effective tax rate Capital expenditure

Free cash flow

Expectations 6 August 2015

7-9%

Around 14 percentage points higher Around 19%

Around 23 percentage points higher Loss of around DKK 5.7 billion

Around 21% Around DKK 5.0 billion Around DKK 3.0 billion Around DKK 33-35 billion Previous expectations 30 April 2015

Depreciation, amortisation and impairment losses

7-9%

Around 16 percentage points higher Around 17%

Around 25 percentage points higher Loss of around DKK 6 billion

Around 21% Around DKK 5.0 billion Around DKK 3.0 billion Around DKK 32-34 billion

(20)

5,05 4,10 3,50

4,72

Source: IMS MAT May 2015 volume and value (DKK) figures

Solid market performance

Promising pipeline

Closing remarks

> >

The only company with a full portfolio of novel insulin products

GLP-1 portfolio offers expansion opportunity within type 1 and 2 diabetes

Xultophy® supports promising outlook for insulin and GLP-1 combination therapy

Saxenda® holds potential within obesity

Promising pipeline within haemophilia and growth

hormone disorders

≥10% annual diabetes care market growth driven

by diabetes prevalence

28% market share in diabetes care and solid leadership position

47% insulin volume market share with leadership

position across all regions

46% modern and new-generation insulin volume

c market share

71% GLP-1 value market share with strong global

(21)

5,05 4,10 3,50

4,72

Share information

Investor Relations contacts

Investor contact information

Novo Nordisk’s B shares are listed on the stock exchange in Copenhagen under the symbol ‘NOVO B’. Its ADRs are listed on the New York Stock Exchange under the symbol ‘NVO’. For further company information, visit Novo Nordisk on the internet at: novonordisk.com

Kasper Roseeuw Poulsen +45 3079 4303 krop@novonordisk.com

Daniel Bohsen +45 3079 6376 dabo@novonordisk.com

Melanie Raouzeos +45 3075 3479 mrz@novonordisk.com

In North America:

Frank Daniel Mersebach +1 609 235 8567 fdni@novonordisk.com Novo Nordisk A/S

Investor Relations

Novo Allé, DK-2880 Bagsværd

29 Oct 2015 Financial statement for the first nine months of 2015 03 Feb 2016 Financial statement for 2015

Figure

Updating...

References

Updating...

Related subjects :