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Same-Day Analysis

All Systems Go at Merck & Co and Schering-Plough in Forecast-Beating H1 Results

Published: 25 July 2006
U.S. drug partners Merck & Co and Schering-Plough yesterday presented strong quarterly results that have jointly raised confidence in the pharma sector. Their combined cholesterol joint venture (JV) of Zetia (ezetimibe) and Vytorin (simvastatin/ezetimibe) led the way.

Global Insight Perspective

Significance

Sales growth both from Zetia and Vytorin, as well as other top-line performers at Merck and Schering-Plough, were unexpectedly strong, contradicting analyst fears that they would not be able to withstand the genericisation of Merck’s Zocor (simvastatin) franchise in the United States.

Implications

The second-quarter sales growth at Merck (6%) and Schering-Plough (11%) has allowed significant investment in the companies’ cost base–particularly in R&D (up by 24% and 22% respectively, to account for around 20% of sales on both sides)–without unduly affecting year-to-date operating income, although Merck is the weaker of the two here.

Outlook

The fortunes of Schering-Plough, which can look back on its past misfortunes, and Merck, which is still at the very beginning of its Vioxx (rofecoxib) litigation proceedings, are tied to their JV, though investment in their research base highlights attempts to diversify beyond Vytorin and Zetia. Both are looking towards the biotech industry, and Merck’s quarterly R&D expenditure reflects the acquisition of U.S. antibody firm GlycoFi.

Schering-Plough and Merck: Sharing Wealth and Perks

U.S. Big Pharma firms Merck & Co and Schering-Plough yesterday presented their quarterly results simultaneously, reflecting the prominent position that their cholesterol joint venture (JV) holds within their respective operational performances.

Merck provided a particularly strong package in the second quarter, recording above-expectation sales growth of 6%, to US$5.8 billion. Despite the entry of generic competition to cholesterol blockbuster Zocor (simvastatin) in the United States, domestic sales grew by 17% to US$3.5 billion, while foreign performance was hit primarily by a collapse in Zocor and Fosamax (alendronate; osteoporosis) sales. As the company scaled up preparations for the launch of cervical cancer vaccine Gardasil (human papillomavirus) and spent US$480 million on biotechs GlycoFi and Abmaxis, the quarterly cost base increased significantly; the GlycoFi acquisition included a research expense of US$296.3 million for this quarter. As a result, operating income decreased by 11.8% on a quarterly basis, although if the GlycoFi factor is removed, adjusted operating income would increase by 6.6% year-on-year (y/y) to US$1.7 billion.

Merck & Co: Selected Results, 2006

Q2

H1

US$ mil.

% Change, Y/Y

US$ mil.

% Change, Y/Y

Sales

5,771.7

6

11,181.5

3

Total U.S.

3,536

17

6,783

12

Total Foreign

2,236

-8

4,399

-8

Material & Production Expenses

1,445.2

25

2,787.9

15

Marketing & Administrative

1,734

-1

3,449

3

R&D

1,172.5

24

2,114.5

18

R&D as % of Sales*

20.3

n/m

18.9

n/m

Operating Income*

1,420

-11.8

2,830.1

-12.9

Operating Margin*

24.6

-

25.3

-

Net Income

1,499.3

108.1

3,019.3

44

Source: Merck/Global Insight
*Global Insight calculation

Meanwhile, Schering-Plough sent out all the right signals again, as it reaches the two-thirds mark in the turnaround agenda implemented by CEO Fred Hassan. There are few indicators that do not tell a good story, with sales increasing by 14% y/y in the United States and 10% overseas, leading to overall 11% y/y growth to US$2.8 billion. On a year-to-date (YTD) basis, sales have increased by 10% y/y to US$5.4 billion. Schering-Plough continues to invest aggressively in its cost base, and has opened a major new Latin American subsidiary in Brazil; cost of sales, sales, general and administrative (SGA) spending and R&D expenditure all increased at a double-digit rate for the quarter. This led to a slump in operating income on a quarterly basis, but YTD operating income has increased by 16.4% to US$142 million, although margins remain among the smallest in the industry, as Schering-Plough has only just returned to the black.

Schering-Plough: Selected Results, 2006

Q2

H1

US$ mil.

% Change, Y/Y

US$ mil.

% Change, Y/Y

Sales

2,818

11

5,369

10

U.S.

1,103

14

2,102

13

International

1,715

10

3,267

8

Prescription

2,230

13

4,263

12

U.S.

718

18

1,375

19

International

1,512

11

2,888

8

Consumer Health

349

5

659

0

Animal Health

239

6

447

7

Cost of Sales

1,004

16

1,897

8

Selling, General & Administrative (SGA) Expenses

1,224

10

2,310

5

R&D

539

22

1,020

24

R&D as % of Sales*

19.1

n/m

19.0

n/m

Operating Income*

51

-52.3

142

16.4

Operating Margin*

1.8

-

2.6

-

Net Income

237

n/m

587

n/m

Source: Schering-Plough/Global Insight
*Global Insight calculation

The two companies' sales were heavily driven by their Zetia (ezetimibe) and Vytorin (simvastatin/ezetimibe) franchise. Zetia sales grew by 50% y/y during the second quarter, and by 37% during the first half, and the continuation of these growth rates would enable it to reach half-yearly blockbuster status in 2007. Vytorin has entirely shrugged off market uncertainty, and has again proved itself to be in a stronger position than statins to absorb the impact of generic simvastatin, due to clearer clinical differentiation. Vytorin sales increased by 143% y/y for the quarter to US$491 million, pushing up the global JV cholesterol franchise by 86% y/y, to US$965 million. On a YTD basis, the JV has grown by 70% y/y to US$1.8 billion.

Merck & Co: Product Sales, Q2 2006

Total

U.S.

Foreign

US$ mil.

% Change, Y/Y

US$ mil.

% Change, Y/Y

US$ mil.

% Change, Y/Y

Cozaar / Hyzaar

784

-

271

4

513

-2

Fosamax

821

-4

516

8

305

-19

Singulair

950

30

679

39

270

12

Zocor

990

-14

742

-9

247

-27

Aggrastat

23

-

-

-

23

-

Arcoxia

66

32

-

-

66

32

Cancidas

124

-12

47

-37

77

18

Cosopt / Trusopt

175

14

77

30

98

4

Crixivan / Stocrin

74

-16

5

-52

69

-12

Emend

32

63

25

49

7

n/m

Invanz

34

52

21

48

13

60

Maxalt

97

15

64

21

33

7

Primaxin

172

-5

49

-4

123

-6

Propecia

85

23

37

19

47

27

Proscar

183

-3

89

-5

94

-1

Timoptic / Timoptic XE

33

-10

2

-19

31

-9

Vasotec / Vaseretic

140

-14

-

-

140

-14

Hepatitis Vaccines

59

28

49

45

11

-16

Viral Vaccines

223

55

204

56

19

45

Other Vaccines

67

17

53

44

14

-32

Source: Merck

Merck & Co’s story also tells of greater-than-expected Zocor sales, which decreased by 14% to US$990 million despite the entry of generic competition, which has gained 63% of the market share for the product. Similarly, sales of urology drug Propecia (finasteride) have not yet been unduly decimated by new generic competition; sales decreased by 3% to US$183 million. In addition to this, sales of asthma drug Singulair (montelukast) were strong, up by 30% in total on the back of near-40% growth in the United States. Elsewhere, Merck’s vaccines franchise grew across the board, providing a telling indicator of things to come.

Schering-Plough: Product Sales, Q2 2006

Total

U.S.

International

US$ mil.

% Change, Y/Y

US$ mil.

% Change, Y/Y

US$ mil.

% Change, Y/Y

Remicade

307

31

-

-

307

31

Nasonex

242

21

144

25

98

16

PEG-Intron

226

25

57

50

169

18

Clarinex / Aerius

226

10

97

8

129

11

Temodar

171

18

72

12

99

24

Claritin Rx

104

4

-

-

104

4

Rebetol

86

-5

-

-

84

-6

Integrilin

82

0

78

0

4

0

Intron A

64

-15

33

-10

31

-19

Avelox

58

26

58

26

-

-

Caelyx

53

15

-

-

53

15

Subutex

53

0

-

-

53

0

Elocon

38

0

1

-48

37

2

Cipro

34

-6

34

-6

-

-

Source: Schering-Plough

Schering-Plough, meanwhile, shows stronger growth among its top products, including arthritis drug Remicade (infliximab; up 31% to US$307 million), allergy drug Nasonex (mometasone furoate; up 21% to US$242 million) and hepatitis drug PEG-Intron (peginterferon; up 25% to US$226 million). This provides a solid base for Schering-Plough's performance, and the company is no longer held down by a long tail of drugs; the acquisition of U.S. rights to Bayer (Germany) products is bringing some–albeit modest–growth here. Equity income from the JV with Merck stood at US$355 million, significantly above market expectations, although during the conference call, management noted modest stocking for Zetia and Vytorin in the second quarter.

Company Joint Ventures (US$ mil.)

Q2 2006

Q2 2005

H1 2006

H1 2005

Sanofi Pasteur-MSD

Hepatitis vaccines

17.4

23.0

36.5

44.9

Viral Vaccines

23.0

21.8

44.7

38.6

Other Vaccines

136.7

151.3

268.6

282.4

Total

177.1

196.1

349.8

365.9

Merial (Merck & Co Animal Health)

Total

586.4

512.3

1,172.1

1,007.0

Merck / Schering-Plough (as Reported by Merck)

Vytorin

497.4

192.6

875.8

372.0

Zetia

476.0

314.3

890.8

646.0

Total

973.4

506.9

1,766.6

1,018.0

Merck / Schering-Plough (as Reported by Schering-Plough)

Q2 2006

% Change, Y/Y

H1 2006

% Change, Y/Y

Zetia

474

50

889

37

U.S.

363

51

679

33

International

111

43

210

51

Vytorin

491

143

862

127

U.S.

421

143

740

124

International

70

139

122

146

Global Cholesterol

965

86

1,751

70

U.S.

784

90

1,419

69

International

181

70

332

76

Source: Merck / Schering-Plough

Outlook and Implications

Vioxx and All That

Significantly, both Schering-Plough (up 22%) and Merck (up 24%) invested heavily in research expenditure during the second quarter; as a percentage of sales, R&D stood at 19% and 20% respectively–unusually high for Big Pharma companies. This reflects movement into the biotech field, via the purchase of GlycoFi and Abmaxis by Merck and the licensing of Phase III Remicade follow-up golimumab by Schering-Plough. Merck clearly has stronger potential in its pipeline, and its vaccines business has cleared all significant regulatory hurdles so far; its DPP-IV inhibitor has also speeded to filing status. With an attractive pricing package for Gardasil already in the bag, the near-term outlook for new products looks strong here. In addition, while the significant overhang from Vioxx persists, the outlook here is brightening as well, following the highly unexpected win in the most recent New Jersey case, which involved a long-term user. Management commented during the conference call that two cases in New Jersey that were due to be heard in September have been dismissed; federal courts have already dismissed over 300 cases.

Guidance

As a result of Zocor's strong sales performance, backed up by a competitive pricing strategy, Merck has raised its guidance for the product by US$300 million to US$2.6-2.9 billion. Merck has also raised its full-year earnings-per share forecast.

Merck & Co: Guidance

2006 Forecast

Minimum % Change Y/Y

Singulair

US$3.3-3.6 bil.

11

Cozaar/Hyzaar

US$2.9-3.2 bil.

-4

Fosamax

US$2.8-3.1 bil.

-12

Zocor

US$2.6-2.9 bil.

-47

Other Products

US$6.3-6.6 bil.

n/a

AstraZeneca Royalties

US$1.5-1.7 bil.

n/a

Marketing & Administrative expenses

mid single-digit increase

3-6

R&D Expenditure

low single-digit increase

0-3

Reported Earnings-per-Share (EPS)

US$2.40-2.48

n/a

Source: Company/Global Insight

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