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Same-Day Analysis

Novo Nordisk Posts 40% Y/Y Increase in 2008 Operating Income, Expects Liraglutide's European Approval by Mid-2009

Published: 29 January 2009
While Novo Nordisk has seen significant improvements to its underlying business in 2008 and expects a similar trend for the year ahead, longer-term prospects are linked to the regulatory success of Type 2 diabetes candidate treatment liraglutide.

IHS Global Insight Perspective

 

Significance

Novo Nordisk has posted a solid set of financial results for 2008. The company's operating profit, as calculated by IHS Global Insight, rose by 40% y/y to 12.1 billion kroner (US$2.1 billion) thanks to decent sales momentum, productivity improvements and lower exceptional charges.

Implications

Novartis has retained its number one position in the insulin market. In the diabetes care franchise, although sales have expanded globally, North America and the international markets have again showed the strongest growth.

Outlook

Novo Nordisk is expecting pharmaceutical sales to grow at around 10% in local currencies and 5% in the reporting currency in 2009. While the company is anticipating its marketed products to still undergo strong market uptake, in 2009, attention will be on the regulatory fate of Novo Nordisk's potential diabetes blockbuster liraglutide. Further delays in liraglutide's approval would be a blow to the company.

Danish pharmaceutical company Novo Nordisk has closed its books on an encouraging set of financial results as the company met its 2008 financial guidance for both sales growth in local currencies and underlying operating profit on an as-reported basis despite a negative currency impact of 0.5 percentage point. In 2008, sales grew by 9% year-on-year (y/y) on an as-reported basis to nearly 45.6 billion Danish kroner (US$8.1 billion). Growth was again driven by the company's North American and international operations, which contributed to 48% and 29% of the sales growth respectively over the full year. In the meantime, Europe and Japan and Oceania, respectively contributed to 21% and 2% of the sales growth over the same period. In the fourth quarter of 2008, sales grew by 15% y/y on an as-reported basis to 12.6 billion kroner.

In 2008, the company's operating profit, as calculated by IHS Global Insight, grew by an impressive 40% y/y to 12.1 billion kroner thanks to sales growth momentum, lower exceptional charges and an effective cost-containment programme. On the expenses front, the cost of goods sold rose by a meagre 3% y/y to 10.1 billion kroner thanks to productivity improvements and a U.S. price increase. Research and development (R&D) expenses contracted by 8% y/y to 7.9 billion kroner thanks to lower non-recurring costs related to the discontinuation of insulin delivery system AERx iDMS and other pulmonary programmes, (see Denmark: 15 January 2008: Novo Nordisk Abandons Development of AERx Insulin Delivery System). In 2008, Novo Nordisk booked 325 million kroner in such charges, a figure that stood at 1.3 billion kroner in 2007. As the discontinuation charges were all booked in the fourth quarter of 2007, Novo Nordisk's operating profit, as calculated by IHS Global Insight, grew by a whopping 219% y/y to 3.3 billion kroner in the fourth quarter of the year. In the meantime, sales and distribution costs rose by 4% y/y to 12.9 billion kroner, partially boosted by the expansion of the company's U.S. sale force. In 2008, Novo Nordisk's operating margin, as calculated by IHS Global Insight was 5.9 percentage points higher than in 2007.

Novo Nordisk: Financial Results, Q4 and FY 2008

 

Q4 2008 (mil. DKK)

% Change Y/Y

FY 2008 (mil. DKK)

% Change Y/Y

Net Sales

12,583

15

45,553

9

Other Revenues

73

-21

286

-11

Cost of Goods Sold

2,536

-2

10,109

3

Marketing and Sales

3,558

10

12,866

4

Research and Development

2,439

-29

7,856

-8

General Administration

749

11

2,635

5

Group Operating Income*

3,301

219

12,087

40

R&D Expenses as Percentage of Total Sales

19.4

11.8 pp lower

17.2

3.2 pp lower

Operating Margin**

26.2

16.8 pp higher

26.5

5.9 pp higher

Group Net Income

2,330

138

9,645

13

Source: Novo Nordisk
* IHS Global Insight estimate: net sales minus R&D, cost of goods sold and SGA expenses (marketing and sales expenses + general and administrative expenses).
** IHS Global Insight estimate: operating income as a percentage of net sales

In 2008, Novo Nordisk recorded positive growth in both its diabetes care and biopharmaceuticals franchises. Nevertheless, the bulk of the company's revenues were as usual generated by its diabetes drugs as their collective sales grew by 9% y/y in the reporting currency to 33.4 billion kroner. Sales of modern insulins were up 24% y/y to 17.3 billion kroner, boosted by a 49% y/y hike in Levemir (insulin detemir)-associated revenues. In local currencies, Novo Nordisk diabetes franchise grew by 21% y/y in North America, 6% y/y in Europe, 18% y/y in international markets and 1% y/y in Japan. As a result, in 2008, Novo Nordisk retained its hold on the insulin market with a 52% market share by volume of the total market and 44% of the modern insulin segment. In the United States, the company enjoys a market share of 41% by volume of the total insulin market and a market share of 32% by volume of the modern insulin market. In Europe, the company holds a 55% market share by volume of the total insulin market and a 51% market share by volume of the modern insulin market. In Japan, Novo Nordisk holds a 72% market share by volume of the total insulin market and a 64% market share by volume of the modern insulin market.

In 2008, sales of biopharmaceuticals grew by 7% y/y in the reporting currency to 12.2 billion kroner. NovoSeven pen's sales continued to benefit from its congenital bleeding disorder indication and the launch of room temperature-stable formulation as sales grew by 9% y/y to 6.4 billion kroner. Sales of growth hormone Norditropin grew by 10% y/y in the reporting currency to 3.9 billion kroner. With regards to Novo Nordisk's other biopharmaceuticals products, their performance was hampered by U.S. generic competition on hormone-replacement therapy Activella (estradiol/norethindrone acetate tablets).

Novo Nordisk: Sales by Business Segment, Q4 and FY 2008

 

Q4 2008 (mil. DKK)

% Change Y/Y*

FY 2008 (mil. DKK)

% Change Y/Y*

Modern Insulins (Insulin analogues)

5,028

29

17,317

24

Human Insulin

3,093

-1

11,804

-6

Insulin-Related Sales

477

6

1,844

5

Oral Anti-Diabetic (OAD) Products

602

18

2,391

11

Diabetes Care Total

9,200

15

33,356

9

NovoSeven

1,774

17

6,396

9

Growth Hormone Therapy

1,060

15

3,865

10

Other Products

549

7

1,936

-2

Biopharmaceuticals Total

3,383

14

12,197

7

Total Sales

12,583

15

45,553

9

* Measured on an as-reported basis

Source: Novo Nordisk.

Outlook and Implications

Novo Nordisk is again expecting decent growth for the year ahead. The company foresees pharmaceutical sales growth at around 10% in local currencies and 5% in the reporting currency in 2009. Novo Nordisk has based its forecast on sustained efficiency improvements and market uptake of its products as well as on a stable business environment and currency exchange rates.

Novo Nordisk: 2009 Financial Guidance

Sales growth in local currencies

At the level of 10%

Sales growth in reporting currency

5 percentage points higher

Operating profit growth in local currencies

At the level of 10%

Operating profit growth in reporting currency

9 percentage points higher

Net financial expenses

Around 1.6 billion

Source: Novo Nordisk.

With regards to deriving sales momentum from product launches, Novo Nordisk brought diabetes treatment PrandiMet to the U.S. market in January 2009 (see Denmark: 24 June 2008: Novo Nordisk Secures U.S. Approval for Diabetes Treatment PrandiMet, Enters Collaboration with Emisphere). Further product launches could follow this year as the company also secured U.S. regulatory approval for Norditropin in the treatment of children with short stature. Nevertheless, future growth hangs onto the regulatory success of once-daily GLP1-analogue liraglutide, a diabetes treatment whose potential market is estimated to be worth in excess of US$1 billion per year. While an FDA advisory committee is anticipated to meet on 2 April with regards to the drug's regulatory fate, Novo Nordisk anticipates clinching European approval for the drug by mid-2009. If brought to the market, liraglutide could benefit from the fact that it promotes weight loss rather than weight gain. Novo Nordisk has recently initiated three Phase III trials with the aim to demonstrate its drug's benefits in the management of obesity. In addition, liraglutide could benefit from the fact that it was found superior to competition in a number of head-to-head clinical studies (see  Denmark: 25 September 2008: Novo Nordisk's Liraglutide Shines in Lancet Study and Denmark: 9 June 2008: ADA 2008: Novo Nordisk's Diabetes Drugs Shine in Head-to-Head Trials).
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