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Merck, Schering-Plough's Q2 Results Indicate Challenges Ahead

22 Jul 08

U.S. pharma firms Merck & Co and Schering-Plough have reported sales declines for the second quarter of 2008, with significant challenges looming for both firms.

Global Insight Perspective

 

Significance

Merck's operating and net income have remained afloat, mainly as a result of the company's restructuring efforts. Meanwhile, the charges associated with the acquisition of Organon Biosciences (OBS) have dented Schering-Plough's net income, but its margins remain steady. A Vytorin clinical study has revealed a potential risk of cancer, further dampening efforts to prop up the drug's sales.

Implications

Merck's second-quarter results have mainly reflected gains made through cost-cutting efforts and the performances of key products such as Cozaar, Januvia, and Isentress. Schering-Plough, on the other hand, incorporated sales of OBS, thereby increasing its top-line growth.

Outlook

The two firms have a challenging time ahead, particularly relating to their cholesterol joint venture. Although Merck has refrained from providing any guidance for Vytorin, the assessment of the study is likely to impinge on the product's prospects.

The second quarter of 2008 remained challenging for U.S. firms Merck & Co and Schering-Plough. Merck reported a sales growth dip of 1% year-on-year (y/y), with U.S. sales falling by 10% y/y to US$3.3 billion. Although the firm has been able to reduce its expenditure on material and production and marketing and administrative costs, R&D charges were up by 13%, representing 19.3% of overall sales. Marketing expenses included a provision of US$210 million for Vioxx (rofecoxib) litigation. Restructuring costs were at US$102 million, up by 83% y/y, reflecting primarily on employee separation costs.

Merck: Selected Results, Q2 2008

 

Q2 2008 (US$ mil.)

% Growth Y/Y

Sales

6,051.8

-1.00

U.S. Sales

3,341

-10.00

Foreign Sales

2,711

12.00

Material & Production Expenditure

1,396.5

-10.00

Marketing and Administrative Costs

1,930.2

-7.00

R&D Costs

1,169.3

13.00

R&D as % of Sales

19.3%

3.46 pp higher

Operating Income*

1,555.8

7.67

Operating Margin

25.70

2.06pp higher

Net Income

1,768.3

5.00

Source: Company/Global Insight
*Sales minus material & production, marketing & administrative and R&D costs

Schering-Plough, on the other hand, has received ample support from its acquisition of Organon Biosciences (OBS), widening its portfolio and geographical strengths. The company's consumer healthcare and animal health business also contributed to its top-line growth, growing by 210% y/y. Sales of global pharmaceuticals for the second quarter stood at US$3.7 billion. The acquisition of OBS added US$921 million in net sales. Comparing the cost elements, cost of sales rocketed by 95.2% y/y, while selling, general and administrative (SGA) expenses were up by 37.7%, mainly due to the impact of the acquisition and foreign exchange. R&D spend was also higher due to the inclusion of US$60 million towards upfront payments to licensing transactions. Net income dropped by 19.1% y/y to US$436 million.

Schering-Plough: Selected Results, Q2 2008

 

Q2 2008 (US$ mil.)

% Growth Y/Y

Sales*

4,921

55.0

Prescription Sales (Human)

3,702

47.0

Cost of Sales

1,908

95.2

Selling, General and Administrative (SGA) Expenses

1,870

37.7

R&D Costs

906

30.1

R&D as % of Sales

18.4%

3.49 pp lower

Operating Income**

237

61.2

Operating Margin

4.8

0.18 pp higher

Net Income

436

-19.1

Source: Company/Global Insight *Excluding Vytorin/Zetia JV; **Sales minus cost of sales, SGA and R&D costs

The cardiovascular franchise of the two firms has reported sales of US$1.1 billion, representing a drop of 9% y/y. The two firms hold a 50-50 equity in the joint venture (JV). A clinical study known as the Simvastatin plus Ezetimibe in Aortic Stenosis (SEAS) reported findings that did not support the objective of lowering cholesterol in people with partial blockage of heart valves. Businessweek reported that the results also indicated a statistically significant increase in cancer in patients using Vytorin.

Merck/Schering-Plough Cholesterol JV, Q2 2008

Product

Sales (US$ mil.)

% Growth Y/Y

Zetia/Ezetrol

560.4

-2.96

Vytorin/Inegy

592.1

-13.73

Total

1,152.5

-9.00

In terms of product performance, Merck's Cozaar/Hyzaar, Arcoxia, Isentress, and Januvia contributed with higher growth. Worldwide sales of Fosamax were hampered by generic competition, with a drop of 48%. Vaccine sales were up, mainly due to Zostavax and Rotateq, which contributed US$66 million and US$178 million, respectively while Gardasil reported drops of 9% and 11% in global and U.S. sales, respectively. For Schering-Plough, Remicade, Nasonex, Temodar, and Claritin represented higher growth.

Merck: Product Breakdown, Q2 2008

Product

Global Sales (US$ mil.)

% Growth Y/Y

U.S. Sales (US$ mil.)

% Growth Y/Y

Cozaar/Hyzaar

941

11

315

5

Fosamax

411

-48

123

-76

Singulair

1,082

-1

710

-8

Zocor

177

-1

19

*

Vaccines:

 

 

 

 

Gardasil

326

-9

255

-11

Rotateq

178

49

166

46

Zostavax

66

41

66

41

Other Viral Vaccines

318

-7

291

-11

Hepatitis Vaccines

38

-52

29

-58

Other Vaccines

69

-28

33

-52

Other Reported Products:

 

 

 

 

Arcoxia

104

17

-

N/A

Cancidas

161

20

26

-25

Cosopt/Trusopt

217

13

87

3

Crixivan/Stocrin

79

5

3

-39

Emend

65

39

41

27

Invanz

71

53

34

30

Isentress

77

*

45

*

Januvia

344

*

262

91

Janumet

72

*

67

*

Maxalt

130

20

86

18

Primaxin

201

8

41

-19

Propecia

108

10

38

-3

Proscar

86

-24

3

-83

Timoptic/Timoptic XE

32

4

2

-16

Vasotec/Vaseretic

94

-27

-

N/A

Zolinza

3

-

3

-7

Source: Company
*100% or over

Schering-Plough: Product Breakdown, Q2 2008

Product

 (US$ mil.)

% Growth Y/Y

Remicade

557

41

Nasonex

311

6

Temodar

251

16

Clarinex/Aerius

240

-4

Pegintron

229

-2

Follistim/Puregon

162

-

Nuvaring

116

-

Claritin

111

8

Integrilin

78

-

Caelyx

78

20

Rebetol

70

-5

Zemuron

67

-

Avelox

67

-12

Subutex/Suboxone

62

18

Remeron

61

-

Intron A

61

10

Asmanex

48

16

Noxafil

38

91

Other Pharmaceuticals

755

72

Consumer Health

401

2

-OTC

181

-1

Animal Health

818

210

Consolidated GAPP Net Sales

4,921

55

Source: Company

Outlook and Implications

The performance of the two firms relates pressure on new product growth. Merck's vaccine franchise as well as its Singulair and Cozaar revenues will continue to lead the table. Gardasil sales are under pressure as rival firm GlaxoSmithKline's (GSK; U.K.) Cervarix gains reimbursement from five European nations. In terms of costs, the company's restructuring efforts will be higher as manufacturing site closures and employee layoffs continue. Schering-Plough, on the other hand, will step ahead with the integration of OBS. The company has announced initiation of Phase III studies of boceprevir in patients who are chronically infected with genotype hepatitis C virus 1. Furthermore, the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) is expected to recommend sugammadex for marketing approval shortly.

Merck: Forecast, 2008 (US$)

Singulair

4.4-4.6 bil

Cozaar/Hyzaar

3.5-3.7 bil.

Gardasil

1.4-1.6 bill.

Other Vaccines (as recorded by Merck)

2.7-2.9 bil.

Fosamax

1.4-1.7 bil.

Other Reported Products

7.8-8.2 bil.

AstraZeneca Royalties

1.3-1.5 bil.

Marketing & Administrative expenses

7.5-7.7 bil.

R&D Expenditure

4.7-4.9 bil.

Product Gross Margin

77.5%-78.5%

Costs related to restructuring

200-300 mil.

Source: Company

The two firms have a challenging time ahead, particularly in the cardiovascular therapeutic area. Vytorin and Zetia have already caused concern over the drugs' benefit profile, and the firms are facing consumer concerns. The clinical study has further dashed hopes to continue to prop up the product as a blockbuster. The findings will invoke further assessment from the two firms over the prospects of the product, which is under pressure.
 
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