Merck reports a Titanic disaster (ongoing)

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Reuters Q3 report

Merck & Co Inc reported disappointing quarterly sales and took an almost $1 billion charge related to a previously disclosed U.S. government probe of its recalled Vioxx arthritis drug, sending its shares 2.1 percent lower.

Merck (MRK.N), like most big U.S. drugmakers in the third quarter, beat profit forecasts on Friday even though its sales fell short, as results were bolstered by cost cuts or other factors. And as with its rivals, investors seemed to pay greater heed to the sales disappointment.

"The third quarter featured slightly lighter revenues, better expenses and better tax rate," said Credit-Suisse analyst Catherine Arnold of Merck's results, describing them as a "low quality beat" because of the sales shortfall.

The earnings report includes an array of drugs and consumer products acquired through the company's purchase last November of New Jersey rival Schering-Plough.

Global revenue almost doubled to $11.12 billion in the quarter. But that was shy of the average Wall Street forecast of $11.24 billion.

Analysts said growth of arthritis drug Remicade, acquired in the Schering-Plough merger, was weaker than expected due in part to price pressures in Europe.

Third-quarter earnings of the combined company fell 89 percent to $372 million, or 11 cents per share, reflecting merger charges and a charge for setting aside a $950 million Vioxx legal reserve.

The charge relates to an ongoing probe by U.S. prosecutors in Massachusetts of how Merck had marketed Vioxx -- Merck's onetime blockbuster arthritis drug that was recalled in 2004 after being linked to heart risks.


Image via WikipediaRelated articles
Merck's Earnings Slump On Cost Of Digesting Schering (forbes.com)

Related articles

• UPDATE 3-Merck sales disappoint, takes big Vioxx charge (reuters.com)
• Merck's Earnings Slump On Cost Of Digesting Schering (forbes.com)
• Summary Box: Large charges cut Merck's 3Q profit (sfgate.com)

Amylin loses the plot

Image via WikipediaByetta producer and Eli Lily partner suffered a drop in its byetta sales , lower by $150 mn for Q3 as its new version of the Byetta regimen, Bydureon was rejected by the FDA for possible Cardiac complications. For FDA it might even have been a simpler case of making a public monkey out of Amylin after Avandia and Glaxo Smithkline was destroyed because of inadequate disclosure on its Cardiac side effects and a recall spanning a loss of $198 mln in September 2010.

Even as diabetes medication comes under the scanner and Pfizer goes ahead with a new sign up with India's Biocon, pecuniary FDA action seems to have triggered an interesting deal mania intth e industry wih Eli Lily rumored to be in the running for using its $5.6 billion in cash to buy up Amylin which is 33% cheaper at $2.5 bln this week or other such niche producers with a pipeline of promising new molecules in its belt.

Related articles

• Amylin, Alkermes crushed by FDA rejection (marketwatch.com)
• Amylin Craters After FDA Asks For More Info On Diabetes Drug (forbes.com)
• Lilly Diabetes Setbacks May Spur Shopping Past Amylin (businessweek.com)

Eli Lilly Rev Recognition needs a relook

Apple got the change done but lilly.com shows up a glaring financial misstatement in the December 2009 for Byetta! 60 doses used over a month and rev rec recognises only $448 million sales over a year against 2009 sales of $796 million!

Byetta

Lilly recognizes in revenue its 50 percent share of Byetta's gross margin in the U.S., 100 percent of Byetta sales outside the U.S., and its sales of Byetta pen delivery devices to its partner, Amylin Pharmaceuticals. For the fourth quarter, Lilly recognized total revenue of $120.5 million for Byetta, an increase of 17 percent.

Worldwide sales of Byetta were $203.6 million in the fourth quarter of 2009, a 9 percent increase compared with the fourth quarter of 2008, driven by growth in international markets. U.S. sales of Byetta increased 1 percent to $163.7 million compared with the fourth quarter of 2008, while sales of Byetta outside the U.S. were $39.9 million.

For the full-year of 2009, worldwide Byetta sales increased 6 percent to $796.5 million. U.S. Byetta sales for 2009 decreased 2 percent to $667.6 million, while sales outside the U.S. increased 77 percent to $128.9 million. For the full-year of 2009, Lilly recognized revenue totaling $448.5 million, representing a 13 percent increase compared with 2008.

Similarily other drugs in partnership:

Erbitux

Lilly recognizes net royalties received from its Erbitux collaboration partners and revenue from manufactured product sold to these partners. For the fourth quarter, Lilly recognized total revenue of $95.0 million for Erbitux. For the full-year of 2009, Lilly recognized total Erbitux revenue of $390.8 million.

Effient(TM)

Worldwide Effient sales were $3.8 million in the fourth quarter of 2009. U.S. Effient sales were $1.4 million. Sales outside the U.S. were $2.4 million. The product is in the early phases of launch in both the U.S. and Europe. Lilly and its partner, Daiichi Sankyo, continue to make good progress in gaining reimbursement and access for the product.

For the full-year of 2009, worldwide Effient sales were $27.0 million. U.S. Effient sales for 2009 were $22.5 million. Sales outside the U.S. were $4.5 million.

Meanwhile Forteo sales and other local Lilly productions scoot on harder ground except for forex translations

Humulin

Worldwide Humulin sales increased 4 percent in the fourth quarter of 2009, to $273.0 million. U.S. sales increased 1 percent to $102.5 million. Sales outside the U.S. increased 6 percent, to $170.5 million, driven by increased demand and the favorable impact of foreign exchange rates, partially offset by lower prices.

For the full-year of 2009, worldwide Humulin sales decreased 4 percent to $1.022 billion. U.S. Humulin sales for 2009 were $402.4 million, a 6 percent increase driven by higher prices, partially offset by lower demand. Humulin sales outside the U.S. were $619.6 million, a 9 percent decrease driven by the unfavorable impact of foreign exchange rates and, to a lesser extent, lower prices, partially offset by increased demand.

Forteo

Fourth-quarter sales of Forteo were $212.8 million, a 9 percent increase compared with the fourth quarter of 2008. U.S. sales of Forteo increased 3 percent, to $129.4 million, driven by higher prices, partially offset by lower demand. Sales outside the U.S. increased 20 percent, to $83.5 million, due to higher prices and the favorable impact of foreign exchange rates.

For the full-year of 2009, worldwide Forteo sales increased 5 percent to $816.7 million. U.S. Forteo sales for 2009 were $518.3 million, a 6 percent increase driven by higher prices, partially offset by lower demand. Forteo sales outside the U.S. were $298.4 million, a 3 percent increase driven by increased demand and increased prices, partially offset by the unfavorable impact of foreign exchange rates.

Pfizer, Roche disappoint street

Pfizer results include Wyeth Labs for the first time but street expected mrore from the combined topline, profits

Marketwatch

Pfizer Inc. reported higher fourth-quarter earnings Wednesday, with its top line boosted by recent the drugmaker's merger with Wyeth as profit also benefited from the absence of a major year-ago charge related to its recalled pain reliever Bextra.

Pfizer (PFE 18.59, -0.65, -3.38%) also issued a financial forecast that fell below analysts' estimates for earnings. Shares of Pfizer, part of the Dow Jones Industrial Average, traded down 2% to $18.68 shortly after the opening bell.

For the December quarter, Pfizer posted net income of $767 million, or 10 cents a share, up from $266 million, or 4 cents, earned in the final three months of 2008.

The year-ago quarter saw the New York-based company take $2.3 billion in charges related to resolution of investigations into Bextra and certain other products.

Stock float rose to 7.85 billion shares up by 1.1 billion shares, with Quarterly topline at $16.54 billion agst 12.5 billion standalone a year back. The $65 billion revenue megalith was shaky about 2010 prospects with 2010 earnings adj to $2.10 to $2.20 (topline of 67-69 b) scaling back its own estimates. they shd just making forward staements till they have an idea. 2012 forecasts for a similar topline/ revenue promise cost controls with EPS of $2.25-2.35 from 66-68billion sales

Analysts were somehow expecting $2.27 for 2010 and $2.22 in 2012 Dividend for the 1st quarter at 18c is back from 16c but is down from 32 c before cash was saved up for Wyeth

ROCHE's 'honeymoon' with the flu is over as Tamiflu sales recede from here

Roche Holding on Wednesday reported a 4% rise in second-half profit, buoyed by sales of flu medication Tamiflu and eye-disease drug Lucentis as sales growth slowed toward the end of the year.

Though the company didn't provide second-half results, MarketWatch calculated Roche's (CH:ROG 179.20, -1.40, -0.78%) profit rose to 4.31 billion Swiss francs ($4 billion) from 4.15 billion francs, while sales rose to 25.05 billion francs from 23.61 billion francs.

During the fourth quarter, total sales rose just 3%, as sales of its top selling drug, Avastin, slowed to 9% on a constant-currency basis, with MabThera sales flat and Herceptin sales up just 2%. All three are cancer medications.

The company expects 2010 sales to grow in a mid-single-digit range at constant currencies -- excluding Tamiflu sales -- compared to 10% growth by that measure in 2009, and Roche sees core earnings per share up by a double-digit level compared to 20% growth in 2009.

Tamiflu sales are seen falling to 1.2 billion francs from 3.2 billion francs as worries over pandemic flu recede.

GAVI Alliance

With Novartis staying away from pro bono giveaways of its vaccination and social health products, GAVI's ten years of existence have a special proud moment for it. The Global Alliance for Vaccines and Immunization including WHO , UNICEF and the Gates Foundation was launched at the WEF in January 2000

When GAVI was publicly launched at the World Economic Forum in January 2000, immunisation rates in the world’s poorest countries were in decline and there was slow progress in introducing new vaccines against Hepatitis B and Yellow Fever.

Over the past 10 years, the Alliance has played a catalytic role in reversing these trends. Drawing on the specialized skills and knowledge of the leading public and private stakeholders in immunisation, from UNICEF and WHO to the Vaccine Industry and the World Bank, GAVI has:

- Funded the delivery of life-saving vaccines to 250 million children
- Averted five million future deaths
- Helped push immunisation rates in poor counties to an unprecedented 80% average
- Reduced the time lag between introducing new vaccines like Haemophilus influenzae type b (Hib) and Hepatitis B, into poorer countries

In Nov 2006, the International Finance Facility for Immunizations issued the first vaccine bonds and claim to serve billions thru innovative financing and not millions.

Gates Foundation on Emerging Markets

VACCINATION PROGRAM

Endorsing vaccines as the world’s most cost-effective public health measure, Bill and Melinda Gates said Friday that their foundation would more than double its spending on them over the next decade, to at least $10 billion.

The change could save the lives of as many as eight million children by 2020, Mr. Gates calculated. He said he hoped his gift would inspire other charities and donor nations to do the same.

The commitment is the largest ever made by a foundation, according to the Chronicle of Philanthropy, which noted that $10 billion is slightly more than the total worth of the Ford Foundation, the country’s second largest. The Gates Foundation, created in 1999 with the fortune that Mr. Gates made from Microsoft, has about $34 billion in assets; it has already spent $4.5 billion on vaccines.

“Vaccines are a real success story,” Mr. Gates said in an interview before the announcement, which he made at the World Economic Forum in Davos, Switzerland. “The cost is tiny, and yet it saves more lives than any other component of a health care system.”

Novartis December 2009 results

Great work by NVS, but it is still overpaying for Alcon while in a very infortunate attempt, mistreating the remaining minority interest in Alcon. Nestle walks away with close to $40 bn for ALCON

Novartis has already paid $11billion to Nestle last year for 25% and has agreed to pay another $28billion for 52% in Alcon still with Nestle. Hwvr, the remianing minority shareholders want the same or a fair deal while NVS expects a deep discount on the remaining

Results for December from the NY times

Drug maker Novartis (NYSE:NVS) AG on Tuesday reported a 54 percent rise in fourth-quarter net profit to $2.32 billion on strong sales and favorable exchange rates, and announced the appointment of Joe Jimenez as its new chief executive.

Earnings per share rose 53 percent to $1.01 from $0.66 in the same quarter of 2008, when Novartis posted a net profit of $1.51 billion, the company said.

Sales of its products, which include the hypertension drug Diovan and anticancer drug Glivec -- known as Gleevec in the United States, rose 28 percent to $12.93 billion in the September-December period from $10.08 billion the previous year.

"The fourth quarter has been especially strong," outgoing CEO Daniel Vasella told reporters in a conference call, noting that Novartis benefited from better exchange rates and the shipment of large orders of swine flu vaccine in the final three months of 2009.

Interestingly, as mentioned otherwise as well, NVS did pursue a patent centric strategy and lost much blood in India/elsewhere. In the vaccines market also it refuses to get into emerging market specific pricing like GSK giving away free vaccines etc.

Also its $3.5 billion Diovan (2005) runs out of patent in 2012 . It has been creating Hypertension / BP reducing extensions, esp one with Pfizer..It also has a vaccine coy purchase from 2005. It expects Galvus to give $2 b in sales by then in the Type 2 Diabetes market. Indian drugmakers and others have also marked down NVS' Gleevec for patent challenges. Gleevec is its high volume drug in Cancer with another $3b in sales

Novartis is also going after the diabetes market with Galvus, a once-daily oral treatment for type 2 diabetes. Analysts project that the drug, filed in March, could hit $2.1 billion in sales by 2012, as it competes with Merck’s Januvia.

The biggest drug approval news for Novartis came from the generic division, which received clearance in the U.S. and EU for Omnitrope, which is not a biogeneric, but a ‘follow-on version of a previously approved recombinant biotechnology drug.’ That approval may open the door to a new era of follow-on biologics, as more of the pioneer biodrugs show their age.

ACQUISITIONS

Target: Chiron Corp.
Price: $5.4 billion
Announced: May 2006

Target: NeuTec Pharma
Price: $569 million
Announced: June 2006
More Vax

In September 2005, Novartis bid to acquire beleaguered biopharma/vaccine/blood testing company Chiron for approximately $5.1 billion, a sum representing the 58% of shares that Novartis didn’t already own. The deal finally closed at $5.4 billion, giving Novartis a position in the vaccines field, a $10.8 billion market that analysts project will grow at an annual 20% clip in the next five years.