Actionable news
0
All posts from Actionable news
Actionable news in NVO: NOVO-NORDISK A/S,

Report of foreign issuer [Rules 13a-16 and 15d-16]

STYLE="font: 10pt Times New Roman, Times, Serif">

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

________________

FORM 6-K

________________

REPORT OF FOREIGN PRIVATE ISSUER

Pursuant to Rule 13a-16 or 15d-16

of the Securities Exchange Act of 1934

October 29, 2015

________________

NOVO NORDISK A/S

(Exact name of Registrant as specified in its charter)

Novo Allé

DK- 2880, Bagsvaerd

Denmark

(Address of principal executive offices)

________________

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F

Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.

If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g-32(b):82-________

Financial report for the period 1 January 2015 to 30 September 2015

Novo Nordisk increased operating profit by 51% in the first nine months of 2015 to DKK 38.3 billion

16% local currency operating profit growth adjusted for the NNIT divestment

Sales increased by 23% in Danish kroner and by 9% in local currencies to DKK 79.1 billion.

Gross margin improved by 1.8 percentage points in Danish kroner to 85.4% driven by a positive currency impact.

Operating profit increased by 51% in Danish kroner and by 26% in local currencies to DKK 38.3 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%.

Net profit increased by 33% to DKK 26.6 billion. Diluted earnings per share increased by 36% to DKK 10.28. Adjusted for the partial divestment of NNIT, net profit and diluted earnings per share increased by 22% and 24% respectively.

In September, Novo Nordisk announced the US FDA approval of Tresiba ® and Ryzodeg ® 70/30 after the review of the class II resubmission of the New Drug Applications.

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 1 percentage point and now expected to be around 20%.

The preliminary outlook for 2016 in local currencies indicates mid to high single-digit growth in sales and mid to high single-digit growth in operating profit adjusted for the non-recurring impact of the partial divestment of NNIT and the income related to the out-licensing of assets for inflammatory disorders, both in 2015.

Lars Rebien Sørensen, president and CEO: “We are satisfied with the results of the first nine months of 2015. Sales growth was primarily driven by Victoza ® aided by the high growth of the GLP-1 market. In the third quarter, a significant milestone was achieved with the US FDA approval of Tresiba ® , and we look forward to launching Tresiba ® early 2016.”

ABOUT NOVO NORDISK

Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 40,300 people in 75 countries, and markets its products in more than 180 countries. Novo Nordisk’s B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, vi sit novonordisk.com

CONFERENCE CALL DETAILS

On 29 October 2015 at 13.00 CET, corresponding to 8.00 am EDT, a conference call will be held. Investors will be able to listen in via a link on novonordisk.com, which can be found under ‘Investors ’. Presentation material for the conference call will be available approximately one hour before on the same page.

WEBCAST DETAILS

On 30 October 2015 at 12.30 CET, corresponding to 7.30 am EDT, management will give a presentation to institutional investors and sell-side analysts in London. A webcast of the presentation can be followed via a link on novonordisk.com, which can be found under ‘Investors’. Presentation material for the webcast will be made available on the same page.

FINANCIAL CALENDAR

CONTACTS FOR FURTHER INFORMATION

Fur ther information about Novo Nordisk is available on novonordisk.com.

FINANCIAL PERFORMANCE

CONSOLIDATED FINANCIAL STATEMENT FOR THE FIRST NINE MONTHS OF 2015

These unaudited consolidated financial statements for the first nine months of 2015 have been prepared in accordance with IAS 34 ‘Interim Financial Reporting’ and on the basis of the same accounting policies as were applied in the Annual Report 2014 of Novo Nordisk, amended with accounting policy regarding associated companies as described in appendix 9 in the company announcement No 31/2015 – Financial report for the period 1 January 2015 to 31 March 2015. Furthermore, the financial report including the consolidated financial statements for the first nine months of 2015 and Management’s review have been prepared in accordance with additional Danish disclosure requirements for interim reports of listed companies. Novo Nordisk has adopted all new, amended or revised accounting standards and interpretations (‘IFRSs’) as published by the IASB, and also those that are endorsed by the EU effective for the accounting period beginning on 1 January 2015. These IFRSs have not had a significant impact on the consolidated financial statements for the first nine months of 2015.

Amounts in DKK million, except number of shares, earnings per share and full-time equivalent employees.

1) Full-time equivalent employees in 9M 2014 in NNIT A/S was 2,351

SALES DEVELOPMENT

Sales increased by 23% measured in Danish kroner and by 9% in local currencies. While all 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 27% and 8% respectively. Sales growth was realised within both diabetes care and biopharmaceuticals, with the majority of growth originating from Victoza ® and modern insulin.

1) Comprises Tresiba®, Ryzodeg® and Xultophy®.

2) Primarily NovoNorm®, needles and Saxenda®.

3) Primarily Vagifem® and Activelle®.

Please refer to appendix 6 for further details on sales in the first nine months of 2015.

In the following sections, unless otherwise noted, market data are based on moving annual total (MAT) from August 2015 and August 2014 provided by the independent data provider IMS Health.

DIABETES AND OBESITY CARE, SALES DEVELOPMENT

Sales of diabetes and obesity care products increased by 24% measured in Danish kroner and by 9% in local currencies to DKK 62,648 million. Novo Nordisk is the world leader in diabetes care with a global value market share of 28%.

Insulin

Sales of insulin increased by 20% measured in Danish kroner and by 6% in local currencies to DKK 46,032 million. Measured in local currencies, sales growth was driven by International Operations and North America. Novo Nordisk is the global leader with 47% of the total insulin market and 46% of the market for modern insulin and new- generation insulin, both measured in volume.

Sales of new-generation insulin (Tresiba ® , Ryzodeg ® and Xultophy ® ) reached DKK 977 million compared with DKK 396 million in 2014.

The roll-out of Tresiba ® (insulin degludec), the once-daily new-generation insulin with an ultra-long duration of action, continues and the product has now been launched in 36 countries. In Japan, where Tresiba ® was launched in March 2013 with the same level of reimbursement as insulin glargine, its share of the basal insulin market has grown steadily, and Tresiba ® has now captured 31% of the basal insulin market measured in monthly value market share. Similarly, Tresiba ® has shown solid penetration in other markets with reimbursement at a similar level to insulin glargine, whereas penetration remains modest in markets with restricted market access compared with insulin glargine. In September 2015, Novo Nordisk announced the FDA approval of Tresiba ® in the US; Novo Nordisk expects to launch Tresiba ® in the beginning of 2016.

Ryzodeg ® , a soluble formulation of insulin degludec and insulin aspart, has been marketed in Mexico, India and Bangladesh. Feedback from the countries is positive.

Xultophy ® , a once-daily single-injection combination of insulin degludec (Tresiba ® ) and liraglutide (Victoza ® ), marketed in Switzerland, Germany and the UK, has now also been launched in Sweden. Launch activities are progressing as planned, and the early feedback from patients and prescribers is encouraging.

Sales of modern insulin increased by 21% in Danish kroner and by 6% in local currencies to DKK 36,602 million. North America accounted for 56% of the growth, followed by International Operations and Region China. Sales of modern insulin and new-generation insulin now constitute 82% of Novo Nordisk’s sales of insulin measured in value.

Source: IMS, August 2015 data. *: Data for 13 selected markets representing approximately 70% of Novo Nordisk’s diabetes sales in the region. **: Data for mainland China, excluding Hong Kong and Taiwan.

North America

Sales of insulin in North America increased by 27% in Danish kroner and by 5% in local currencies. Sales growth is driven by the continued market share gains for Levemir ® and NovoLog ® as well as a positive contribution from the...


More