Novo Nordisk A/S (NVO)

[TREND1]

DEW
How did this turn out ?
................................

FDA extends NDA review of NVO’s Tresiba (a/k/a degludec) long-acting insulin by three months:

http://in.reuters.com/article/2012/06/08/us-novonordisk-degludec-fda-idINBRE85709520120608

The extension also affects the FDA’s concurrent review of Ryzodeg (a/k/a degludecplus), which is a combination of degludec and NVO’s NovoLog mealtime insulin. The new PDUFA date for both products is 10/29/12.

[TREND1]

Novo is studying the injected drug - already on the market as a treatment for type-2 diabetes under the brand name Victoza

- as a therapy for the seriously obese, with pivotal clinical trial results due in the first half of next year 2013.

Do not know how this turned out.

[a surfer]

Share buyback started Feb 1st. Also just did a 6 for 1 split. Plenty in the works as well.
This will find a slow climb if the market plays nice, just as it has for the last 10 years.

[Ichauway]

Final push before reversal IMO.

[a surfer]

Agreed but I do see this eventually higher. But a correction may be imminent.

[Ichauway]

Looks like a good day to take some profits.

[a surfer]

This thing is a monster!! Share buy back in full swing!

[Ichauway]

diabetes market to be $58 billion by 2018

LOL , all that cash on something that can be cured by diet within a few months.

[investora2z]

A recent article on insidermonkey makes an interesting read. It reveals statistics about diabetes which indicate great growth prospects for companies like Novo Nordisk which specialize in the field. The number of people in the world suffering from diabetes is likely to increase by 50% from 366 million in 2011 to 552 million in 2030. Type 2 diabetes represents more than 90% of the cases. Urbanization, changing diets and the rise of sedentary lifestyles have all contributed to the increase. 80% of total diabetes cases are from the not so affluent countries. China, India, and Indonesia are the high potential markets. China has more than 93 million patients now, and the number is going to increase to nearly 130 million in 2030. India is expected to have 101.2 million by that year, and the US nearly 30 million patients. Novo has a good market share in China, while Merck (MRK) is making inroads into the Indian, Brazilian and Chinese market with its diabetes drugs. S&P predicts the diabetes market to be $58 billion by 2018 (65% over 2012's figure of $35 billion). Companies like Sanofi (SNY) and Johnson & Johnson (JNJ) are also getting more aggressive in the market. Considering these statistics, the major players in this sector like Novo Nordisk are going to benefit from the growth story. However, the high potential segment is likely to get more competitive over time. Even smaller players like Chromadex Corporation (CDXC) are actively researching on innovative molecules for diabetes / obesity management. Chromadex has recently launched a vitamin derivative which is useful in diabetes / obesity management. Novo has done well over the years on the back of improvement in fundamentals. There are hopes from Tresiba, and the R&D pipeline looks healthy with several products at the filing or the phase 3 stage.

[DewDiligence]

Great company, but the valuation is a little on the high side, IMO.

[investora2z]

Novo is a good growth story as far as the fundamentals are concerned. The stock has delivered decent returns for the investors. Revenues have increased by 53% since 2009, and the net income has more than doubled during the same period. Though there were some sequential declines in the last quarter, the yoy performance was not bad. The revenues and the net income increased by 8.5% and 29% respectively. Tresiba has been launched in the UK, Denmark and Japan, and progress is expected in the US as the company is in discussions with the FDA to address their concerns. Its R&D pipeline comprises of several products at the filing or the phase 3 stage. For 2013, sales growth measured in local currencies is expected to be 9-11%, whereas operating profit growth is expected to be around 10%. The trailing P/E is around 23, while the forward P/E is ~20.5, which reflects moderate expectations of growth. The price to sales and price to book are a little high at 6.3 and 15 respectively. These metrics indicate that the stock has priced in a lot of the future positives already. However, the high profit margin of 28% and liquidity position are difficult to ignore. More appreciation is possible if the company is able to beat the guidance, or deliver some positive surprises by launch of new products. Diabetes management has numerous sub-segments with several pharmaceutical giants competing for market share. Even smaller players like Chromadex Corporation (CDXC) are actively researching on innovative molecules for diabetes / obesity management. Novo Nordisk commands nearly 50% market share in the insulin market world-wide, and is expected to strengthen its strong position with new launches over the next few years. In countries like China the market share in insulin market is as high as 60%. It can leverage its commanding position to increase the growth rate. That will translate into better returns for investors.

[Wildbilly]

Novo bets on high-price niche for obesity drug

LONDON | Tue Dec 11, 2012

(Reuters) - Denmark's Novo Nordisk is sizing up a high-price niche market for its drug liraglutide as a weight-loss treatment, with the United States the prime opportunity.

The premium-price approach could turn it into a multibillion-dollar-a-year product, the company believes.

Novo is studying the injected drug - already on the market as a treatment for type-2 diabetes under the brand name Victoza - as a therapy for the seriously obese, with pivotal clinical trial results due in the first half of next year.

While some in the industry are sceptical about using so-called GLP-1 diabetes drugs such as liraglutide to fight obesity, Novo's Chief Science Officer Mads Krogsgaard Thomsen believes the approach can offer cost-effective benefits.

Glucagon-like peptide-1, or GLP-1, drugs work by stimulating insulin release when glucose levels become too high. Their ability to induce weight loss is an added benefit, since type-2 diabetes is linked to obesity.

What is more, the willingness of the U.S. Food and Drug Administration to license new obesity pills from Vivus and Arena Pharmaceuticals last summer shows the door is open to such new medicines, Thomsen said.

"It's positive. More physicians are now knowledgeable that pharmacotherapy can make a difference and the political establishment in the U.S. now knows that behavior change alone is not enough," he said in an interview in London.

More than a third of American adults, or some 100 million people, are obese and the figure is rising fast, posing a growing threat to the nation's health.

Among this population group, liraglutide may help the severely obese, including those with related problems like interrupted breathing during sleep and pre-diabetes, who might otherwise receive stomach surgery.

"We are not going out to treat the 100 million ... We see this as solving a problem in a niche of maybe a few million patients," Thomsen said.

"If you took one million patients and gave them liraglutide at 3.0 milligrams (a day) at the U.S. price that would be a $6 billion market."

When used in diabetes as Victoza, liraglutide is given at daily doses of either 1.2 or 1.8 mg. Novo is betting on a higher dose to produce greater weight-loss in the obese. A key unknown is whether this will produce unacceptable side effects - and Thomsen admits this makes it something of a "joker" in the company's line-up of new products.

The main adverse effect of Victoza is nausea in some patients, although this is not strong enough in itself to account for the weight loss seen with the drug and Thomsen does not see nausea as a hurdle to regulatory approval.

More worrying, would be any evidence that high-dose liraglutide is linked to pancreatitis.

Given the high safety bar required for a new obesity drug, analysts are currently divided as to whether liraglutide will make it for weight loss - especially given past disappointments with diet drugs such as Sanofi's Acomplia.

If all goes according to plan, however, Novo aims to file for approval at the end of next year, implying a potential U.S. launch in late 2014 or early 2015 for a product that would add a new string to the bow of the world's biggest maker of insulin.

[DewDiligence]

FDA extends NDA review of NVO’s degludec and degludecplus by three months:

#msg-76408031

The new PDUFA date is 10/29/12.