UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C.  20549

 

Form 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

For the month of July

 

Commission File Number 1-15096

 

Serono S.A.

(Translation of registrant’s name into English)

 

15 bis, Chemin des Mines

Case Postale 54

CH-1211 Geneva 20

Switzerland

(Address of principal executive office)

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F. Form 20-F x  Form 40-F o

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):            

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):            

 

Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.  Yes o  No x

 

If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82-             .

 




 

Media Release

 

 

FOR IMMEDIATE RELEASE

 

SERONO DELIVERS SECOND QUARTER EPS OF $12.92, UP 25.2% ON ADJUSTED* BASIS

- Strong operating margin of 29.0% of revenues -

Geneva, Switzerland, July 26, 2006 – Serono (virt-x: SEO and NYSE: SRA), today reported its second quarter results for the period ended June 30, 2006.

Key Points for Second Quarter 2006

 

·      Record total revenues of $699.2m with product sales of $628.7m

·                  Rebif® worldwide sales up 10.9% (+11.4% in local currencies) to $361.6m

·                  Reported net income of $189.2m up 25.9% on an adjusted* basis

·                  Basic EPS of $12.92 per bearer share and $0.32 per ADS

·                  H1 2006 product sales growth of 8.0% in local currencies, in line with full-year guidance of high single-digit growth

·                  2006 EPS guidance of $45.00 per bearer share reiterated

·                  Decision to move atacicept (TACI-Ig) into Phase 2 in rheumatoid arthritis and preliminary positive Phase 1b results in systemic lupus erythematosus

“We have a solid business platform generating strong cash flow, as well as the financial strength and capability to execute value creating transactions,” said Ernesto Bertarelli, Chief Executive Officer. “We are entering an exciting, new chapter at Serono and I am confident that we will achieve our strategy for growth.”

“Given our financial performance in the first half of 2006, we are on track to achieve our EPS guidance of $45.00,” said Stuart Grant, Chief Financial Officer.  “Our EPS growth is driven by the strength of our operating margin which increased by an impressive eight percentage points in the first half of the year to 29.5% of total revenues.”

 


*                    Non-IFRS financial measures included in order to permit assessment of the performance of the company’s underlying business for the quarter were a $30.0m ($28.5m after-tax) gain on sale of investment in Celgene and a $3.7m write down of investment in CancerVax in Q2 2005.

 

1




 

Financial Performance

Total revenues increased by 3.3%, or 3.9% in local currencies, to $699.2m in the second quarter of 2006 (Q2 2005: $676.8m).  Product sales grew 2.8%, or 3.3% in local currencies, to $628.7m compared to a strong quarter last year (Q2 2005: $611.5m).  Excluding the impact on sales of the Bourn Hall clinic management buyout and the sale of a non-core business, TerraCell S.A., in 2005, as well as the introduction of generics of Novantrone® in early April 2006, sales growth was 7.0% in local currencies in the second quarter of 2006.  Royalty and license income increased by 8.0% to $70.5m (Q2 2005: $65.3m).

Gross margin was strong at 88.2% of product sales (Q2 2005: 87.8%).  Selling, General and Administrative expenses were up 5.1% to $233.7m (Q2 2005: $222.5m).  Research and Development expenses were down 10.6% to $130.3m (Q2 2005: $145.8m) reflecting the completion of a number of Phase 3 trials last year, the transfer of the Serono Genetics Institute and the Bourn Hall clinic management buyout.  Other operating expenses were down 12.2% to $58.2m (Q2 2005: $66.3m), largely due to lower royalty expense related to Novantrone®.

Operating income in the second quarter of 2006 was up 21.1% to $203.0m (Q2 2005: $167.7m) with an operating margin of 29.0% of total revenues (Q2 2005: 24.8% of total revenues).

Financial income was $18.5m (Q2 2005: $43.7m) and financial expense was $6.1m (Q2 2005: $10.0m).  The second quarter of 2005 included an exceptional gain of $30.0m resulting from the sale of an equity holding in Celgene, Inc. and a write-down of $3.7m related to impairment in value of an equity stake in CancerVax.

Net income in the second quarter of 2006 was $189.2m up 8.1% or 25.9% on adjusted* basis (Q2 2005: $175.1m reported, $150.3m adjusted*).  Basic earnings per share in the second quarter of 2006 were up 7.5%, or 25.2% on adjusted* basis, to $12.92 per bearer share (Q2 2005: $12.02, $10.32 adjusted*) and $0.32 per American Depositary Share (Q2 2005: $0.30, $0.26 adjusted*).

For the first six months, net cash flow from operating activities before change in working capital was $495.3m (H1 2005: $354.1m), or $355.3m after change in working capital (H1 2005:  $177.1m).  The company’s liquid financial assets were $1.8 billion at the end of the second quarter 2006.

As of June 30, 2006, there were 14,647,162 outstanding equivalent bearer shares of Serono S.A., net of treasury shares.  The total weighted average number of equivalent bearer shares of Serono S.A. was 14,645,802 for the three months ending June 30, 2006.

Key Product Sales

In the second quarter of 2006, Rebif® had a solid performance with sales of $361.6m, up 10.9%, or 11.4% in local currencies (Q2 2005: $326.0m).  Rebif® continues to be the best-selling therapy for multiple sclerosis outside the US, with sales of $242.5m, growing 5.5%, or 6.0% in local currencies (Q2  2005: $229.8m).  Four years after

 


*                    Non-IFRS financial measures included in order to permit assessment of the performance of the company’s underlying business for the quarter were a $30.0m ($28.5m after-tax) gain on sale of investment in Celgene and a $3.7m write down of investment in CancerVax in Q2 2005.

 

2




 

launch in the US, Rebif® maintains its strong growth and reached US sales of $119.0m, up 23.7% (Q2 2005: $96.2m).

In July 2006, Serono announced that the European Commission has approved an update of the Summary of Product Characteristics of Rebif® in order to align it with current medical practice.  Throughout Europe, Rebif® is now approved for use after the diagnosis of multiple sclerosis has been confirmed based on one attack and subsequent positive magnetic resonance imaging scans.

Sales of Gonal-f® were $139.3m (Q2 2005: $149.9m), in line with the first quarter of 2006.  Global sales of supporting products (Ovidrel®, Cetrotide®, Crinone® and Luveris®) were up 6.9%, or 7.5% in local currencies to $23.8m (Q2 2005: $22.2m).

Saizen® sales were $53.8m (Q2 2005: $53.6m), a growth of 7.6% over the first quarter of 2006.  Serostim® sales were stable at $17.3m (Q2 2005: $17.3m).  In Q2 2006, Serono submitted a Supplemental New Drug Application to the U.S. Food and Drug Administration for recombinant human growth hormone in HIV-associated adipose redistribution syndrome.

Sales of Raptiva®, the only biological therapy specifically developed for  the treatment of psoriasis, were $17.0m in the second quarter 2006 (Q2 2005: $7.4m), a growth of 24.3% over the first quarter of 2006.  The focus for 2006 is on increasing market penetration by leveraging the strong clinical data including the recently published CLEAR study and differentiating Raptiva® from TNF blockers. In July the first large-scale pharmaco-epidemiological study in psoriasis in Europe, CLEARESTTM, was initiated.  This prospective, seven-year study in 7,000 patients with moderate-to-severe plaque psoriasis is further assessing the long-term safety of Raptiva in clinical practice.

Novantrone® sales in the second quarter of 2006 were $5.4m, down 70.4%, consequent to the introduction of generics of mitoxantrone in the US in April 2006 (Q2 2005: $18.3m).

R&D News

In June, favorable results from a Phase 1b clinical trial with atacicept (TACI-Ig) in rheumatoid arthritis were presented at the 7th Annual European Congress of Rheumatology.  Atacicept was well tolerated across the full range of dose levels and schedules tested, and clear biologic effect was observed.  Based on these promising results, Serono and ZymoGenetics expect to begin the Phase 2 clinical program of atacicept in patients with rheumatoid arthritis in the second half of 2006.

In July, preliminary results of two Phase 1b studies in systemic lupus erythematosus indicate that atacicept demonstrated a favorable tolerability profile and that biological activity consistent with the mode of action was observed.  Full results of these studies are planned to be presented at a medical meeting later this year.

Lastly, during the quarter it was announced that the novel fully human anti-CD3 monoclonal antibody, NI-0401, being developed in collaboration with NovImmune, has moved into a proof-of-concept trial in patients suffering from moderate-to-severe Crohn’s Disease.  This study is looking at the safety, tolerability and pharmacokinetics of intravenously administered NI-0401.

 

3




 

Conference Call and Webcast

Serono will hold a conference call on July 27, 2006, starting at 11:00 am US Eastern Time (17:00 Central European Time) during which Serono Management will present the Company’s Second Quarter 2006 Results.  To join the telephone conference please dial 1 412 858 4600 (from the US), 091 610 5600 (from Switzerland), 0207 107 0611 (from the UK) and +41 91 610 5600 (from elsewhere).  The event will also be relayed by live audio webcast, which interested parties may access via Serono’s Corporate home page, www.serono.com.  A link to the webcast will be provided immediately prior to the event and will be available for replay following the event.  Additionally, the webcast will be available for replay until close of business on August 31, 2006.

###

Forward-looking statements

Some of the statements in this press release are forward looking. Such statements are inherently subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements of Serono S.A. and affiliates to be materially different from those expected or anticipated in the forward-looking statements. Forward-looking statements are based on Serono’s current expectations and assumptions, which may be affected by a number of factors, including those discussed in this press release and more fully described in Serono’s Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on February 28, 2006. These factors include any failure or delay in Serono’s ability to develop new products, any failure to receive anticipated regulatory approvals, any problems in commercializing current products as a result of competition or other factors, our ability to obtain reimbursement coverage for our products, the outcome of any government investigations and litigation.  Serono is providing this information as of the date of this press release, and has no responsibility to update the forward-looking statements contained in this press release to reflect events or circumstances occurring after the date of this press release.

###

 

About Serono

Serono is a global biotechnology leader. The Company has eight biotechnology products, Rebif®, Gonal-f®, Luveris®, Ovidrel®/Ovitrelle®, Serostim®, Saizen®, Zorbtive™ and Raptiva®. In addition to being the world leader in reproductive health, Serono has strong market positions in neurology, metabolism and growth and has recently entered the psoriasis area. The Company’s research programs are focused on growing these businesses and on establishing new therapeutic areas, including oncology and autoimmune diseases.

In 2005, Serono, whose products are sold in over 90 countries, achieved worldwide revenues of US$2,586.4 million. Reported net loss in 2005 was US$106.1 million, reflecting a charge of US$725 million taken relating to the settlement of the US Attorney’s Office investigation of Serostim. Excluding this charge as well as other non-recurring items, adjusted net income grew 28.4% to US$565.3 million in 2005. Bearer shares of Serono S.A., the holding company, are traded on the virt-x (SEO) and its American Depositary Shares are traded on the New York Stock Exchange (SRA).

 

4




 

For more information, please contact:

 

Serono in Geneva, Switzerland:

 

Media Relations:

Investor Relations:

Tel:

+41-22-739 36 00

Tel:

+41-22-739 36 01

Fax:

+41-22-739 30 85

Fax:

+41-22-739 30 22

http://www.serono.com

Reuters: SEO.VX / SRA

 

 

Bloomberg: SEO VX / SRA US

Serono, Inc., Rockland, MA

 

Media Relations:

Investor Relations:

Tel.

+1 781 681 2340

Tel.

+1 781 681 2552

Fax:

+1 781 681 2935

Fax:

+1 781 681 2912

http://www.seronousa.com

 

 

On the following pages, there are:

·                  Tables detailing sales in dollars by therapeutic area, geographic region and the top 10 products for the 3 and 6 months ended June 30, 2006 and 2005.

·                  Consolidated income statements for the 3 and 6 months ended June 30, 2006 and 2005; adjusted net income and adjusted earnings per share for the 3 and 6 months ended June 30, 2006 and 2005; the consolidated balance sheets as of June 30, 2006 and December 31, 2005; the consolidated statements of changes in equity as of June 30, 2006 and 2005; the consolidated statements of cash flows for the 6 months ended June 30, 2006 and 2005; the selected explanatory notes to the consolidated financial statements.  These consolidated financial statements have been prepared on the basis of International Financial Reporting Standards.

5




 

Sales by therapeutic area

 

 

 

Three Months Ended
June 30, 2006

 

 

 

Three Months Ended
June 30, 2005

 

 

 

$ million

 

% of sales

 

% change $

 

$ million

 

% of sales

 

Neurology

 

363.3

 

57.8

%

9.5

%

331.6

 

54.2

%

Reproductive Health

 

170.2

 

27.1

%

(5.4

)%

179.8

 

29.4

%

Growth & Metabolism

 

71.3

 

11.3

%

0.3

%

71.1

 

11.6

%

Dermatology

 

17.0

 

2.7

%

130.3

%

7.4

 

1.2

%

Others

 

7.0

 

1.1

%

(67.6

)%

21.6

 

3.5

%

 

 

 

 

 

 

 

 

 

 

 

 

Total sales (US$ million)

 

$

628.7

 

100

%

2.8

%

$

611.5

 

100

%

 

Sales by geographic region

 

 

 

Three Months Ended
June 30, 2006

 

 

 

Three Months Ended
June 30, 2005

 

 

 

$ million

 

% of sales

 

% change $

 

$ million

 

% of sales

 

Western Europe

 

289.5

 

46.1

%

4.3

%

277.6

 

45.4

%

North America

 

220.0

 

35.0

%

1.6

%

216.6

 

35.4

%

Latin America

 

35.2

 

5.6

%

8.7

%

32.4

 

5.3

%

Others

 

84.0

 

13.3

%

(1.1

)%

85.0

 

13.9

%

 

 

 

 

 

 

 

 

 

 

 

 

Total sales (US$ million)

 

$

628.7

 

100

%

2.8

%

$

611.5

 

100

%

 

Sales by therapeutic area

 

 

 

Six Months Ended
June 30, 2006

 

 

 

Six Months Ended
June 30, 2005

 

 

 

$ million

 

% of sales

 

% change $

 

$ million

 

% of sales

 

Neurology

 

695.8

 

56.9

%

10.5

%

629.4

 

54.1

%

Reproductive Health

 

337.5

 

27.6

%

(2.3

)%

345.3

 

29.7

%

Growth & Metabolism

 

137.3

 

11.2

%

(0.1

)%

137.5

 

11.8

%

Dermatology

 

30.6

 

2.5

%

159.0

%

11.8

 

1.0

%

Others

 

22.4

 

1.8

%

(42.5

)%

38.9

 

3.3

%

 

 

 

 

 

 

 

 

 

 

 

 

Total sales (US$ million)

 

$

1’223.5

 

100

%

5.2

%

$

1’162.9

 

100

%

 

Sales by geographic region

 

 

 

Six Months Ended
June 30, 2006

 

 

 

Six Months Ended
June 30, 2005

 

 

 

$ million

 

% of sales

 

% change $

 

$ million

 

% of sales

 

Western Europe

 

554.9

 

45.4

%

2.3

%

542.5

 

46.6

%

North America

 

434.9

 

35.5

%

8.3

%

401.4

 

34.5

%

Latin America

 

65.7

 

5.4

%

6.3

%

61.9

 

5.3

%

Others

 

168.0

 

13.7

%

6.9

%

157.1

 

13.5

%

 

 

 

 

 

 

 

 

 

 

 

 

Total sales (US$ million)

 

$

1’223.5

 

100

%

5.2

%

$

1’162.9

 

100

%

 

-more-




 

TOP TEN PRODUCTS

 

 

 

 

 

Three Months Ended
June 30, 2006

 

 

 

Three Months Ended
June 30, 2005

 

 

 

* TA

 

$ million

 

% of sales

 

% change $

 

$ million

 

% of sales

 

Rebif®

 

MS

 

361.6

 

57.5

%

10.9

%

326.0

 

53.3

%

Gonal-f®

 

RH

 

139.3

 

22.2

%

(7.1

)%

149.9

 

24.5

%

Saizen®

 

Growth

 

53.8

 

8.6

%

0.4

%

53.6

 

8.8

%

Serostim®

 

Wasting

 

17.3

 

2.8

%

0.4

%

17.3

 

2.8

%

Raptiva®

 

Dermatology

 

17.0

 

2.7

%

130.4

%

7.4

 

1.2

%

Ovidrel®

 

RH

 

7.1

 

1.1

%

11.2

%

6.3

 

1.0

%

Cetrotide®

 

RH

 

6.9

 

1.1

%

11.6

%

6.2

 

1.0

%

Crinone®

 

RH

 

6.9

 

1.1

%

5.5

%

6.5

 

1.1

%

Novantrone®

 

MS/Oncology

 

5.4

 

0.9

%

(70.4

)%

18.3

 

3.0

%

Metrodin-HP®

 

RH

 

3.6

 

0.6

%

(11.8

)%

4.1

 

0.7

%

 

 

 

 

 

Six Months Ended
June 30, 2006

 

 

 

Six Months Ended
June 30, 2005

 

 

 

* TA

 

$ million

 

% of sales

 

% change $

 

$ million

 

% of sales

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Rebif®

 

MS

 

688.5

 

56.3

%

11.2

%

618.9

 

53.2

%

Gonal-f®

 

RH

 

278.4

 

22.8

%

(3.3

)%

287.9

 

24.8

%

Saizen®

 

Growth

 

103.7

 

8.5

%

2.3

%

101.4

 

8.7

%

Serostim®

 

Wasting

 

33.1

 

2.7

%

(6.8

)%

35.5

 

3.1

%

Raptiva®

 

Dermatology

 

30.6

 

2.5

%

159.0

%

11.8

 

1.0

%

Novantrone®

 

MS/Oncology

 

22.8

 

1.9

%

(33.4

)%

34.3

 

2.9

%

Ovidrel®

 

RH

 

13.9

 

1.1

%

15.5

%

12.1

 

1.0

%

Cetrotide®

 

RH

 

13.6

 

1.1

%

9.5

%

12.4

 

1.1

%

Crinone®

 

RH

 

12.9

 

1.1

%

6.6

%

12.1

 

1.0

%

Metrodin-HP®

 

RH

 

6.3

 

0.5

%

(14.1

)%

7.3

 

0.6

%

 

 

* Therapeutic Areas

 

RH

= Reproductive Health

Wasting

= AIDS Wasting

 

 

MS

= Multiple Sclerosis

Growth

= Growth Retardation

 

 

Oncology

= Oncology

Dermatology

= Dermatology

 

 




 

Second Quarter Consolidated Income Statements (unaudited)

Three months ended June 30

 

2006

 

% of
Revenues

 

% change

 

2005

 

% of
Revenues

 

 

 

US$’000

 

 

 

 

 

US$’000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenues

 

 

 

 

 

 

 

 

 

 

 

Product sales

 

628,681

 

 

 

2.8

%

611,487

 

 

 

Royalty and license income

 

70,493

 

 

 

8.0

%

65,269

 

 

 

Total Revenues

 

699,174

 

100.0

%

3.3

%

676,756

 

100.0

%

Operating Expenses

 

 

 

 

 

 

 

 

 

 

 

Cost of product sales

 

(73,877

)

 

 

 

 

(74,525

)

 

 

% of Sales

 

11.8

%

 

 

 

 

12.2

%

 

 

Selling, general and administrative

 

(233,747

)

33.4

%

5.1

%

(222,466

)

32.9

%

Research and development

 

(130,334

)

18.6

%

(10.6

)%

(145,785

)

21.5

%

Other operating expense, net

 

(58,244

)

8.3

%

(12.2

)%

(66,312

)

9.8

%

Total Operating Expenses

 

(496,202

)

71.0

%

(2.5

)%

(509,088

)

75.2

%

Operating Income

 

202,972

 

29.0

%

21.1

%

167,668

 

24.8

%

Financial income

 

18,533

 

 

 

 

 

43,749

 

 

 

Financial expense

 

(6,091

)

 

 

 

 

(9,973

)

 

 

Foreign currency (loss) / gain, net

 

(2,443

)

 

 

 

 

1,478

 

 

 

Share of (loss) / profit of associates

 

(413

)

 

 

 

 

15

 

 

 

Income Before Taxes

 

212,558

 

30.4

%

4.7

%

202,937

 

30.0

%

Taxes

 

(23,271

)

 

 

 

 

(27,626

)

 

 

Net Income

 

189,287

 

27.1

%

8.0

%

175,311

 

25.9

%

Attributable to:

 

 

 

 

 

 

 

 

 

 

 

Minority interest

 

59

 

 

 

 

 

187

 

 

 

Equity holders of Serono S.A.

 

189,228

 

27.1

%

8.1

%

175,124

 

25.9

%

 

Three months ended June 30

 

2006

 

 

 

% change

 

2005

 

 

 

 

 

US$

 

 

 

 

 

US$

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic Earnings per Share

 

 

 

 

 

 

 

 

 

 

 

- Bearer shares

 

12.92

 

 

 

7.5

%

12.02

 

 

 

- Registered shares

 

5.17

 

 

 

7.5

%

4.81

 

 

 

- American depositary shares

 

0.32

 

 

 

7.5

%

0.30

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Diluted Earnings per Share

 

 

 

 

 

 

 

 

 

 

 

- Bearer shares

 

12.78

 

 

 

7.3

%

11.90

 

 

 

- Registered shares

 

5.11

 

 

 

7.3

%

4.76

 

 

 

- American depositary shares

 

0.32

 

 

 

7.3

%

0.30

 

 

 

 

Quarterly Basic Earnings per Share is calculated in accordance with IAS 33 - “Earnings per Share” by dividing the Net Income attributable to bearer equity holders of Serono S.A., $132.3 million for the three months ended June 30, 2006 (June 30, 2005: $122.2 million), by the weighted average number of shares outstanding during the period presented. This is 10,240,586 bearer shares (2005: 10,161,095) and 11,013,040 registered shares (2005: 11,013,040). The total weighted average number of bearer shares is 14,645,802 (June 30, 2005: 14,566,311) for the three months ended June 30, 2006. As each American depositary share represents ownership interest in one fortieth of bearer share, Basic and Diluted Earnings per American depositary share is calculated as one fortieth of the Basic and Diluted Earnings per bearer share.

For quarterly Diluted Earnings per Share, the weighted average number of bearer shares outstanding is adjusted to assume conversion of all potential dilutive shares arising from outstanding stock options and the convertible bond. The number of bearer shares used to calculate the Diluted Earnings per Share for the three months ended June 30, 2006 was 10,685,403 (June 30, 2005: 10,609,689).

The accompanying selected explanatory notes form an integral part of these financial statements.




 

Consolidated Income Statements (unaudited)

 

 

 

 

% of

 

 

 

 

 

% of

 

Six months ended June 30

 

2006

 

Revenues

 

% change

 

2005

 

Revenues

 

 

 

US$’000

 

 

 

 

 

US$’000

 

 

 

Revenues

 

 

 

 

 

 

 

 

 

 

 

Product sales

 

1,223,532

 

 

 

5.2

%

1,162,900

 

 

 

Royalty and license income

 

143,110

 

 

 

24.2

%

115,237

 

 

 

Total Revenues

 

1,366,642

 

100.0

%

6.9

%

1,278,137

 

100.0

%

 

 

 

 

 

 

 

 

 

 

 

 

Operating Expenses

 

 

 

 

 

 

 

 

 

 

 

Cost of product sales

 

(142,631

)

 

 

 

 

(133,995

)

 

 

% of Sales

 

11.7

%

 

 

 

 

11.5

%

 

 

Selling, general and administrative

 

(445,236

)

32.6

%

1.9

%

(437,115

)

34.2

%

Research and development

 

(253,278

)

18.5

%

(16.1

)%

(302,059

)

23.6

%

Other operating expense, net

 

(122,515

)

9.0

%

(85.7

)%

(854,735

)

66.9

%

Total Operating Expenses

 

(963,660

)

70.5

%

(44.2

)%

(1,727,904

)

135.2

%

Operating Income / (Loss)

 

402,982

 

29.5

%

189.6

%

(449,767

)

(35.2

)%

 

 

 

 

 

 

 

 

 

 

 

 

Financial income

 

42,423

 

 

 

 

 

55,791

 

 

 

Financial expense

 

(12,418

)

 

 

 

 

(20,597

)

 

 

Foreign currency (loss) / gain, net

 

(3,489

)

 

 

 

 

2,247

 

 

 

Share of (loss) / profit of associates

 

(585

)

 

 

 

 

26

 

 

 

Income / (Loss) Before Taxes

 

428,913

 

31.4

%

204.0

%

(412,300

)

(32.3

)%

Taxes

 

(59,619

)

 

 

 

 

20,434

 

 

 

Net Income / (Loss)

 

369,294

 

27.0

%

194.2

%

(391,866

)

(30.7

)%

Attributable to:

 

 

 

 

 

 

 

 

 

 

 

Minority interest

 

119

 

 

 

 

 

759

 

 

 

Equity holders of Serono S.A.

 

369,175

 

27.0

%

194.0

%

(392,625

)

(30.7

)%

 

Six months ended June 30

 

2006

 

 

 

% change

 

2005

 

 

 

 

 

US$

 

 

 

 

 

US$

 

 

 

Basic Earnings / (Loss) per Share

 

 

 

 

 

 

 

 

 

 

 

- Bearer shares

 

25.21

 

 

 

193.5

%

(26.96

)

 

 

- Registered shares

 

10.09

 

 

 

193.5

%

(10.78

)

 

 

- American depositary shares

 

0.63

 

 

 

193.5

%

(0.67

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Diluted Earnings / (Loss) per Share

 

 

 

 

 

 

 

 

 

 

 

- Bearer shares

 

24.90

 

 

 

192.4

%

(26.96

)

 

 

- Registered shares

 

9.96

 

 

 

192.4

%

(10.78

)

 

 

- American depositary shares

 

0.62

 

 

 

192.4

%

(0.67

)

 

 

 

Basic Earnings / (Loss) per Share is calculated in accordance with IAS 33 - “Earnings per Share” by dividing the Net Income / (Loss) attributable to bearer equity holders of Serono S.A., $258.1 million for the six months ended June 30, 2006 (June 30, 2005: net loss of $273.9 million), by the weighted average number of shares outstanding during the period presented, being 10,237,254 bearer shares (2005: 10,158,113) and 11,013,040 registered shares (2005: 11,013,040). The total weighted average number of bearer shares is 14,642,470 (June 30, 2005: 14,563,329) for the six months ended June 30, 2006. As each American depositary share represents ownership interest in one fortieth of bearer share, Basic and Diluted Earnings / (Loss) per American depositary share is calculated as one fortieth of the Basic and Diluted Earnings / (Loss) per bearer share.

For Diluted Earnings / (Loss) per Share, the weighted average number of bearer shares outstanding is adjusted to assume conversion of all potential dilutive shares arising from outstanding stock options and the convertible bond. The number of bearer shares used to calculate the Diluted Earnings per Share for the six months ended June 30, 2006 was 10,699,936. The effect of outstanding stock options and the convertible bond were excluded from the calculation of Diluted Loss per Share for the six months ended June 30, 2005 as they were anti-dilutive.

The accompanying selected explanatory notes form an integral part of these financial statements.




 

Adjusted net income and adjusted earnings per share

 

 

 

 

% of

 

 

 

 

 

% of

 

Six months ended June 30

 

2006

 

Revenues

 

% change

 

2005

 

Revenues

 

 

 

US$’000

 

 

 

 

 

US$’000

 

 

 

Net Income / (Loss) as reported

 

369,294

 

27.0

%

194.2

%

(391,866

)

(30.7

)%

Gain on sale of investment in Zymogenetics

 

(8,365

)

 

 

 

 

 

 

 

Litigation expense and related costs

 

 

 

 

 

 

725,000

 

 

 

Tax impact on litigation expense and related costs

 

 

 

 

 

 

(64,525

)

 

 

Gain on sale of investment in Celgene

 

 

 

 

 

 

(29,963

)

 

 

Tax impact on gain on sale of investment in Celgene

 

 

 

 

 

 

1,439

 

 

 

Impairment loss on investment in CancerVax

 

 

 

 

 

 

8,440

 

 

 

Adjusted Net Income

 

360,929

 

26.4

%

45.2

%

248,525

 

19.4

%

Attributable to:

 

 

 

 

 

 

 

 

 

 

 

Minority interest

 

119

 

 

 

 

 

759

 

 

 

Equity holders of Serono S.A.

 

360,810

 

26.4

%

45.6

%

247,766

 

19.4

%

 

 

 

 

 

 

 

Adjusted basis

 

 

 

 

 

Six months ended June 30

 

Adjusted basis 2006

 

 

 

% change

 

Adjsuted basis 2005

 

 

 

 

 

US$

 

 

 

 

 

US$

 

 

 

Basic Earnings per Share

 

 

 

 

 

 

 

 

 

 

 

- Bearer shares

 

24.64

 

 

 

44.8

%

17.01

 

 

 

- Registered shares

 

9.86

 

 

 

44.8

%

6.81

 

 

 

- American depositary shares

 

0.62

 

 

 

44.8

%

0.43

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Diluted Earnings per Share

 

 

 

 

 

 

 

 

 

 

 

- Bearer shares

 

24.35

 

 

 

43.4

%

16.99

 

 

 

- Registered shares

 

9.74

 

 

 

43.4

%

6.79

 

 

 

- American depositary shares

 

0.61

 

 

 

43.4

%

0.42

 

 

 

 

 

 

 

 

% of

 

 

 

 

 

% of

 

Three months ended June 30

 

2006

 

Revenues

 

% change

 

2005

 

Revenues

 

 

 

US$’000

 

 

 

 

 

US$’000

 

 

 

Net Income / (Loss) as reported

 

189,287

 

27.1

%

8.0

%

175,311

 

25.9

%

Gain on sale of investment in Celgene

 

 

 

 

 

 

(29,963

)

 

 

Tax impact on gain on sale of investment in Celgene

 

 

 

 

 

 

1,439

 

 

 

Impairment loss on investment in CancerVax

 

 

 

 

 

 

3,740

 

 

 

Adjusted Net Income

 

189,287

 

27.1

%

25.7

%

150,527

 

22.2

%

Attributable to:

 

 

 

 

 

 

 

 

 

 

 

Minority interest

 

59

 

 

 

 

 

187

 

 

 

Equity holders of Serono S.A.

 

189,228

 

27.1

%

25.9

%

150,340

 

22.2

%

 

 

 

 

 

 

 

Adjusted basis

 

 

 

 

 

Three months ended June 30

 

Adjusted basis 2006

 

 

 

% change

 

Adjsuted basis 2005

 

 

 

 

 

US$

 

 

 

 

 

US$

 

 

 

Basic Earnings per Share

 

 

 

 

 

 

 

 

 

 

 

- Bearer shares

 

12.92

 

 

 

25.2

%

10.32

 

 

 

- Registered shares

 

5.17

 

 

 

25.2

%

4.13

 

 

 

- American depositary shares

 

0.32

 

 

 

25.2

%

0.26

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Diluted Earnings per Share

 

 

 

 

 

 

 

 

 

 

 

- Bearer shares

 

12.78

 

 

 

24.6

%

10.25

 

 

 

- Registered shares

 

5.11

 

 

 

24.6

%

4.10

 

 

 

- American depositary shares

 

0.32

 

 

 

24.6

%

0.26

 

 

 

 

Adjusted net income and adjusted earnings per share are Non-IFRS financial measures and are not and should not be viewed as a substitute for IFRS reported net income and earnings per share. Non-IFRS financial measures are not standardized by IFRS and, therefore, have limits in its usefulness to investors and may not be comparable with the calculation of similar measures for other companies. Adjusted net income and adjusted earnings per share are an alternative view of performance used by management as they exclude those non-recurring, non-operational activities and transactions that are not necessarily relevant to understand the comparative operating performance of the company’s underlying business for the period.




 

Consolidated Balance Sheets (unaudited)

As of

 

June 30, 2006

 

December 31, 2005

 

 

 

US$’000

 

US$’000

 

Assets

 

 

 

 

 

Current Assets

 

 

 

 

 

Cash and cash equivalents

 

1,022,894

 

358,853

 

Short-term available-for-sale financial assets

 

393,240

 

565,545

 

Trade accounts receivable

 

462,308

 

402,358

 

Inventories

 

259,247

 

248,476

 

Prepaid expenses and other current assets

 

249,855

 

199,189

 

Total Current Assets

 

2,387,544

 

1,774,421

 

 

 

 

 

 

 

Non-Current Assets

 

 

 

 

 

Tangible fixed assets

 

795,692

 

746,430

 

Intangible assets

 

327,728

 

341,382

 

Deferred tax assets

 

224,385

 

224,779

 

Investments in associates

 

5,254

 

5,446

 

Long-term available-for-sale financial assets

 

530,229

 

736,543

 

Other long-term assets

 

73,852

 

92,234

 

Total Non-Current Assets

 

1,957,140

 

2,146,814

 

Non-current assets classified as held for sale

 

12,725

 

 

Total Assets

 

4,357,409

 

3,921,235

 

 

 

 

 

 

 

Liabilities

 

 

 

 

 

Current Liabilities

 

 

 

 

 

Trade and other payables

 

326,614

 

343,525

 

Short-term financial debts

 

254,354

 

28,604

 

Income taxes

 

106,303

 

97,797

 

Deferred income - current

 

26,198

 

34,111

 

Provisions - current

 

24,402

 

29,291

 

Other current liabilities

 

159,215

 

183,396

 

Total Current Liabilities

 

897,086

 

716,724

 

 

 

 

 

 

 

Non-Current Liabilities

 

 

 

 

 

Long-term financial debts

 

503,507

 

635,039

 

Deferred tax liabilities

 

19,054

 

18,316

 

Deferred income - non-current

 

115,621

 

123,142

 

Provisions - non-current

 

127,406

 

108,607

 

Other long-term liabilities

 

130,343

 

148,465

 

Total Non-Current Liabilities

 

895,931

 

1,033,569

 

Total Liabilities

 

1,793,017

 

1,750,293

 

 

 

 

 

 

 

Shareholders’ Equity

 

 

 

 

 

Share capital

 

236,444

 

235,555

 

Share premium

 

526,166

 

500,605

 

Treasury shares

 

(370,018

)

(372,724

)

Retained earnings

 

2,085,755

 

1,803,929

 

Fair value and other reserves

 

54,396

 

14,654

 

Cumulative foreign currency translation adjustments

 

30,742

 

(11,988

)

Total Shareholders’ Equity attributable to equity holders of Serono S.A.

 

2,563,485

 

2,170,031

 

Minority Interests

 

907

 

911

 

Total Shareholders’ Equity

 

2,564,392

 

2,170,942

 

 

 

 

 

 

 

Total Liabilities and Shareholders’ Equity

 

4,357,409

 

3,921,235

 

 

The accompanying selected explanatory notes form an integral part of these financial statements.




 

Consolidated Statements of Changes in Equity (unaudited)

 

 

Share
capital

 

Share
premium

 

Treasury
shares

 

Retained
earnings

 

Fair value
and other
reserves

 

Cumulative
foreign
currency
translation
adjustments

 

Total
Shareholders’
Equity
attributable
to equity
holders of
Serono S.A.

 

Minority
interests

 

Total
Shareholders’
Equity

 

 

 

US$’000

 

US$’000

 

US$’000

 

US$’000

 

US$’000

 

US$’000

 

US$’000

 

US$’000

 

US$’000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance as of January 1, 2005

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

As previously reported

 

254,420

 

1,023,125

 

(987,489

)

2,064,499

 

23,482

 

69,841

 

2,447,878

 

3,343

 

2,451,221

 

Effect of adopting revised IAS 39 - “Financial Instruments: Recognition and Measurement”

 

 

 

 

(28,547

)

33,347

 

(2,245

)

2,555

 

 

2,555

 

Effect of adopting IFRS 2 - “Share-Based Payment”

 

 

15,875

 

 

(15,527

)

 

(348

)

 

 

 

Balance as of January 1, 2005 as restated

 

254,420

 

1,039,000

 

(987,489

)

2,020,425

 

56,829

 

67,248

 

2,450,433

 

3,343

 

2,453,776

 

Fair value adjustments on available-for-sale investments taken to equity

 

 

 

 

 

(22,073

)

 

(22,073

)

 

(22,073

)

Transferred to income statement on sale of available-for-sale investments

 

 

 

 

 

(29,871

)

 

(29,871

)

 

(29,871

)

Transferred to income statement for impairment of available-for-sale investments

 

 

 

 

 

8,486

 

 

8,486

 

 

8,486

 

Fair value adjustments on cash flow hedge taken to equity

 

 

 

 

 

(5,775

)

 

(5,775

)

 

(5,775

)

Transferred to income statements on fair value loss on interest rate swaps

 

 

 

 

 

62

 

 

62

 

 

62

 

Serono share of equity recognized by associated companies

 

 

 

 

 

 

 

 

 

 

Foreign currency translation effect

 

 

 

 

 

 

(59,731

)

(59,731

)

 

(59,731

)

Net (loss) / income recognized directly in equity

 

 

 

 

 

(49,171

)

(59,731

)

(108,902

)

 

(108,902

)

Net (loss) / income

 

 

 

 

(392,625

)

 

 

(392,625

)

759

 

(391,866

)

Total recognized income and expense

 

 

 

 

(392,625

)

(49,171

)

(59,731

)

(501,527

)

759

 

(500,768

)

Issue of share capital

 

638

 

19,036

 

3,063

 

 

 

 

22,737

 

 

22,737

 

Issue of call options on Serono shares

 

 

94

 

 

 

 

 

94

 

 

94

 

Share-based compensation

 

 

8,631

 

 

 

 

 

8,631

 

 

8,631

 

Dividend - bearer shares

 

 

 

 

(76,992

)

 

 

(76,992

)

 

(76,992

)

Dividend - registered shares

 

 

 

 

(33,390

)

 

 

(33,390

)

 

(33,390

)

Purchase of minorities

 

 

 

 

 

 

 

 

(3,147

)

(3,147

)

Balance as of June 30, 2005

 

255,058

 

1,066,761

 

(984,426

)

1,517,418

 

7,658

 

7,517

 

1,869,986

 

955

 

1,870,941

 

 

The accompanying selected explanatory notes form an integral part of these financial statements.

 




 

 

 

Share
capital

 

Share
premium

 

Treasury
shares

 

Retained
earnings

 

Fair value
and other
reserves

 

Cumulative
foreign
currency
translation
adjustments

 

Total
Shareholders’
Equity
attributable
to equity
holders of
Serono S.A.

 

Minority
interests

 

Total
Shareholders’
Equity

 

 

 

US$’000

 

US$’000

 

US$’000

 

US$’000

 

US$’000

 

US$’000

 

US$’000

 

US$’000

 

US$’000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance as of January 1, 2006

 

235,555

 

500,605

 

(372,724

)

1,803,929

 

14,654

 

(11,988

)

2,170,031

 

911

 

2,170,942

 

Fair value adjustments on available-for-sale investments taken to equity

 

 

 

 

 

37,840

 

 

37,840

 

 

37,840

 

Transferred to income statement on sale of available-for-sale investments

 

 

 

 

 

(8,582

)

 

(8,582

)

 

(8,582

)

Transferred to income statement for impairment of available-for-sale investments

 

 

 

 

 

313

 

 

313

 

 

313

 

Fair value adjustments on cash flow hedge taken to equity

 

 

 

 

 

10,228

 

 

10,228

 

 

10,228

 

Transferred to income statements on fair value gain on interest rate swaps

 

 

 

 

 

(59

)

 

(59

)

 

(59

)

Serono share of equity recognized by associated companies

 

 

 

 

 

2

 

 

2

 

 

2

 

Foreign currency translation effect

 

 

 

 

 

 

42,730

 

42,730

 

 

42,730

 

Net income recognized directly in equity

 

 

 

 

 

39,742

 

42,730

 

82,472

 

 

82,472

 

Net income

 

 

 

 

369,175

 

 

 

369,175

 

119

 

369,294

 

Total recognized income and expense

 

 

 

 

369,175

 

39,742

 

42,730

 

451,647

 

119

 

451,766

 

Issue of share capital

 

889

 

25,561

 

2,706

 

 

 

 

29,156

 

 

29,156

 

Share-based compensation

 

 

 

 

29,737

 

 

 

29,737

 

 

29,737

 

Dividend - bearer shares

 

 

 

 

(35,224

)

 

 

(35,224

)

 

(35,224

)

Dividend - registered shares

 

 

 

 

(81,862

)

 

 

(81,862

)

 

(81,862

)

Purchase of minorities

 

 

 

 

 

 

 

 

(123

)

(123

)

Balance as of June 30, 2006

 

236,444

 

526,166

 

(370,018

)

2,085,755

 

54,396

 

30,742

 

2,563,485

 

907

 

2,564,392

 

 

The accompanying selected explanatory notes form an integral part of these financial statements.




 

Consolidated Statements of Cash Flows (unaudited)

Six months ended June 30

 

2006

 

2005

 

 

 

US$’000

 

US$’000

 

 

 

 

 

 

 

Net Income / (Loss)

 

369,294

 

(391,866

)

Reversal of non-cash items

 

 

 

 

 

Taxes

 

59,619

 

(20,434

)

Depreciation and amortization

 

64,074

 

68,093

 

Interest income

 

(33,695

)

(25,906

)

Interest expense

 

8,236

 

8,779

 

Unrealized foreign currency exchange results

 

(7,461

)

7,230

 

Legal provision

 

 

725,000

 

Share of loss / (profit) of associates

 

585

 

(26

)

Other non-cash items

 

34,608

 

(16,820

)

Operating Cash Flows Before Working Capital Changes

 

495,260

 

354,050

 

 

 

 

 

 

 

Working capital changes

 

 

 

 

 

Trade and other payables, other current liabilities and deferred income

 

(34,881

)

(73,180

)

Trade accounts receivable and other receivables

 

(31,261

)

(18,180

)

Inventories

 

21,097

 

4,739

 

Prepaid expenses and other current assets

 

(44,655

)

(14,289

)

Taxes paid

 

(50,215

)

(76,029

)

Net Cash Flows From Operating Activities

 

355,345

 

177,111

 

 

 

 

 

 

 

Purchase of tangible fixed assets

 

(74,780

)

(76,267

)

Proceeds from disposal of tangible fixed assets

 

1,004

 

2,203

 

Purchase of intangible assets

 

(12,277

)

(47,686

)

Proceeds from disposal of intangibles

 

400

 

 

Purchase of available-for-sale financial assets

 

 

(167,077

)

Proceeds from sale of available-for-sale financial assets

 

409,726

 

607,453

 

Purchase of investments in associates

 

 

(4,748

)

Interest received

 

42,376

 

59,084

 

Net Cash Flows From Investing Activities

 

366,449

 

372,962

 

 

 

 

 

 

 

Proceeds from issue of Serono shares

 

11,218

 

11,055

 

Proceeds from exercise of options on Serono shares

 

12,377

 

4,534

 

Proceeds from issue of call options on Serono shares

 

 

263

 

Proceeds from issue of financial debts

 

58,451

 

32,694

 

Repayments of financial debt

 

(19,143

)

(4,728

)

Other non-current liabilities

 

(2,240

)

(7,942

)

Interest paid

 

(2,814

)

(2,062

)

Dividends paid

 

(117,086

)

(110,382

)

Net Cash Flows Used For Financing Activities

 

(59,237

)

(76,568

)

Effect of Exchange Rate Changes on Cash and Cash Equivalents

 

1,484

 

(1,740

)

Net Increase in Cash and Cash Equivalents

 

664,041

 

471,765

 

 

 

 

 

 

 

Cash and Cash Equivalents at the Beginning of Period

 

358,853

 

275,979

 

Cash and Cash Equivalents at the End of Period

 

1,022,894

 

747,744

 

 

The accompanying selected explanatory notes form an integral part of these financial statements.




 

Selected explanatory notes to the interim financial report for the six months ended June 30, 2006 (unaudited)

1.                              Basis of Preparation

This unaudited interim financial report of the Serono group (“group” or “Serono”) has been prepared in accordance with IAS 34 - “Interim Financial Reporting” and in accordance with the accounting policies set out in the Serono 2005 Annual Report, with the exception of the following new International Financial Reporting Standards adopted by the group:

IAS 19 (Amended), “Employee Benefits – Actuarial Gains and Losses, Group Plans and Disclosures” The group has adopted the amendments to IAS 19, which introduces the option of an alternative recognition approach for actuarial gains and losses for defined benefit pension plans. The group has elected not to apply the option of recognizing actuarial gains and losses arising on its defined benefit plans in full in the statement of recognized income and expense and continues to recognize the amortization of actuarial gains and losses outside the corridor in the income statement.

The following amendments have been adopted by the group and have had no effect on these consolidated financial statements: IAS 39 (Amended), “Cash Flow Hedge Accounting of Forecast Intragroup Transactions”; IAS 39 (Amended), “The Fair Value Option”; IAS 39 and IFRS 4 (Amended), and “Financial Guarantee Contracts”.

These consolidated financial statements were approved for issuance on July 25, 2006 by Serono S.A.’s Board of Directors.

2.                              Segment information – geographical segments

Six months ended June 30, 2006

 

Western
Europe

 

North
America

 

Middle East,
Africa and 
Eastern
Europe

 

Asia-Pacific,
Oceania
and Japan

 

Latin
America

 

Unallocated

 

Total

 

 

 

US$000

 

US$000

 

US$000

 

US$000

 

US$000

 

US$000

 

US$000

 

Product sales to third parties

 

554,891

 

434,926

 

100,080

 

67,887

 

65,748

 

 

1,223,532

 

Royalty and license income

 

113,661

 

1,957

 

27,492

 

 

 

 

143,110

 

Total revenues

 

668,552

 

436,883

 

127,572

 

67,887

 

65,748

 

 

1,366,642

 

Operating income

 

385,625

 

222,198

 

38,017

 

23,500

 

38,140

 

(110,863

)

596,617

 

Impairment losses on tangible and intangible assets

 

(1,480

)

 

 

 

 

 

(1,480

)

Corporate research and development expenses

 

 

 

 

 

 

 

 

 

 

 

(192,155

)

(192,155

)

Operating income

 

 

 

 

 

 

 

 

 

 

 

 

 

402,982

 

 




 

 

 

 

 

 

 

Middle East,

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Africa and

 

Asia-Pacific,

 

 

 

 

 

 

 

 

 

Western

 

North

 

Eastern

 

Oceania

 

Latin

 

 

 

 

 

Six months ended June 30, 2005

 

Europe

 

America

 

Europe

 

and Japan

 

America

 

Unallocated

 

Total

 

 

 

US$000

 

US$000

 

US$000

 

US$000

 

US$000

 

US$000

 

US$000

 

Product sales to third parties

 

542,476

 

401,430

 

93,680

 

63,447

 

61,867

 

 

1,162,900

 

Royalty and license income

 

96,599

 

902

 

17,736

 

 

 

 

115,237

 

Total revenues

 

639,075

 

402,332

 

111,416

 

63,447

 

61,867

 

-

 

1,278,137

 

Operating (loss) / income

 

(448,189

)

206,418

 

24,860

 

17,681

 

33,574

 

(52,813

)

(218,469

)

Corporate research and development expenses

 

 

 

 

 

 

(231,298

)

(231,298

)

Operating loss

 

 

 

 

 

 

 

 

 

 

 

 

 

(449,767

)

 

Unallocated items represent income and expenses of corporate coordination functions, which are not directly attributable to specific geographical segments. Product sales to third parties are allocated to the geographical segments based on the country in which the customer is located. Royalty and license income is allocated to the geographical segments based on the country that receives the royalty. Operating income / (loss) is allocated to the geographical segments as recorded by the legal entities in the respective regions. There are no sales or other transactions between the geographical segments.

3.                              Financial income and expense

Six months ended June 30

 

 

2006

 

2005

 

 

 

US$000

 

US$000

 

Interest income

 

33,695

 

25,906

 

Other financial income

 

87

 

14

 

Fair value gain on interest rate swaps

 

59

 

 

Realized gains on disposal of available-for-sale financial assets

 

8,582

 

29,871

 

Financial income

 

42,423

 

55,791

 

 

Six months ended June 30

 

 

2006

 

2005

 

 

 

US$000

 

US$000

 

Interest expense

 

(8,236

)

(8,779

)

Other financial expense

 

(3,869

)

(3,270

)

Fair value loss on interest rate swaps

 

 

(62

)

Impairment losses on available-for-sale financial assets

 

(313

)

(8,486

)

Financial expense

 

(12,418

)

(20,597

)

 

During the six months ended June 30, 2006, the group recognized a realized gain of $8.4 million (2005: $30.0 million) on partial disposal of an available-for-sale equity investment and impairment losses of $0.3 million (2005: $8.4 million) on its available-for-sale equity investments.

4.                              Taxes

The effective income tax rate for the six months ended June 30, 2006 is 12.5% (2005: 12.4%). The effective income tax rate is calculated by dividing the income tax expense by the income / (loss) before taxes reduced by capital and




 

other taxes, both without the tax impact of the litigation and related costs. Taxes recognized for the six months ended June 30, 2005 included $64.5 million in deferred tax income from the recognition of the litigation expense and related costs as disclosed in note 11 concerning legal proceedings.

Six months ended June 30

 

 

2006

 

2005

 

 

 

US$000

 

US$000

 

Income tax expense without tax impact for the litigation expense and related costs

 

52,830

 

37,927

 

Capital and other taxes

 

6,789

 

6,164

 

Total tax expense

 

59,619

 

44,091

 

Deferred tax income from litigation expense and related costs

 

 

64,525

 

Total taxes

 

59,619

 

(20,434

)

 

5.                              Earnings / (loss) per share

Basic earnings / (loss) per share

Basic earnings / (loss) per share is calculated by dividing the net income /(loss) attributable to equity holders of Serono S.A. by the weighted average number of shares outstanding during the period presented. The number of outstanding shares is calculated by deducting the average number of shares purchased and held as treasury shares from the total number of issued shares.

Six months ended June 30

 

 

2006

 

2005

 

 

 

US$000

 

US$000

 

Net income / (loss) attributable to bearer equity holders of Serono S.A.

 

258,108

 

(273,861

)

Net income / (loss) attributable to registered equity holders of Serono S.A.

 

111,067

 

(118,764

)

Total net income / (loss) attributable to the equity holders of Serono S.A.

 

369,175

 

(392,625

)

Weighted average number of bearer shares outstanding

 

10,237,254

 

10,158,113

 

Weighted average number of registered shares outstanding

 

11,013,040

 

11,013,040

 

 

Six months ended June 30

 

 

2006

 

2005

 

 

 

US$

 

US$

 

Basic earnings / (loss) per share

 

 

 

 

 

Bearer shares

 

25.21

 

(26.96

)

Registered shares

 

10.09

 

(10.78

)

American depositary shares

 

0.63

 

(0.67

)

 

Basis earnings per share for the three months ended June 30, 2006 was $12.92 compared to $12.02 for the three months ended June 30, 2005.

Diluted earnings / (loss) per share

For diluted earnings / (loss) per share, the weighted average number of bearer shares outstanding is adjusted to assume conversion of all potential dilutive shares arising from outstanding stock options and the convertible bond. For stock options, a calculation is made to determine the number of shares that could have been acquired at fair value based on proceeds from the exercise of stock options. The number of shares calculated as above is compared with the number of shares that would have been issued assuming the exercise of the stock options. The difference is added to the denominator as additional shares for no consideration. There is no adjustment made to the numerator. For the convertible bond, the number of shares into which the bond is assumed to be fully convertible is added to the denominator. The numerator is increased by eliminating the interest expense, net of tax that would not be incurred if




 

the bond were converted. The effect of the convertible bond and the effect of the outstanding stock options were excluded from the calculation of diluted earning per share for the six months ended June 30, 2005, as they were anti-dilutive.

Six months ended June 30

 

2006

 

2005

 

 

 

US$000

 

US$000

 

Net income / (loss) attributable to the equity holders of Serono S.A. for basic earnings / (loss) per share

 

369,175

 

(392,625

)

Interest expense on convertible bond

 

7,005

 

 

Net income / (loss) attributable to the equity holders of Serono S.A. for dilutive earnings / (loss) per share

 

376,180

 

(392,625

)

 

 

 

 

 

 

Weighted average number of bearer shares outstanding for basic earnings / (loss) per share

 

10,237,254

 

10,158,113

 

Adjustment for dilutive stock options

 

38,686

 

 

Adjustment for assumed conversion of convertible bond

 

423,996

 

 

Weighted average number of bearer shares outstanding for dilutive earnings / (loss) per share

 

10,699,936

 

10,158,113

 

 

Six months ended June 30

 

 

2006

 

2005

 

 

 

US$

 

US$

 

Diluted earnings / (loss) per share

 

 

 

 

 

Bearer shares

 

24.90

 

(26.96

)

Registered shares

 

9.96

 

(10.78

)

American depositary shares

 

0.62

 

(0.67

)

 

Fully diluted earnings per share for the three months ended June 30, 2006 was $12.78 compared to $11.90 for the three months ended June 30, 2005. Fully diluted earnings per share for the three months ended June 30, 2006 and 2005 includes the dilutive impact of outstanding stock options and the conversion of the convertible bond that would result in the issuance of an additional 444,817 bearer shares (2005: 448,595).

6.                              Share capital

 

 

As of June 30, 2006

 

Class of shares

 

Number of shares

 

Nominal value

 

CHF000

 

US$000

 

Issued and fully paid share capital

 

 

 

 

 

 

 

 

 

Registered

 

11,013,040

 

CHF10

 

110,130

 

68,785

 

Bearer

 

10,877,992

 

CHF25

 

271,950

 

167,659

 

Total

 

 

 

 

 

382,080

 

236,444

 

Authorized share capital – bearer

 

9,018,860

 

CHF25

 

225,472

 

183,444

 

Conditional share capital – bearer for options and/or convertible bonds

 

1,452,000

 

CHF25

 

36,300

 

29,534

 

Conditional share capital – bearer for stock options

 

624,399

 

CHF25

 

15,610

 

12,700

 

 




 

 

 

As of December 31, 2005

 

Class of shares

 

Number of shares

 

Nominal value

 

CHF000

 

US$000

 

Issued and fully paid share capital

 

 

 

 

 

 

 

 

 

Registered

 

11,013,040

 

CHF10

 

110,130

 

68,785

 

Bearer

 

10,832,507

 

CHF25

 

270,813

 

166,770

 

Total

 

 

 

 

 

380,943

 

235,555

 

 

 

 

 

 

 

 

 

 

 

Authorized share capital – bearer

 

1,400,000

 

CHF25

 

35,000

 

26,553

 

Conditional share capital – bearer for options and/or convertible bonds

 

1,452,000

 

CHF25

 

36,300

 

27,540

 

Conditional share capital – bearer for stock options

 

669,884

 

CHF25

 

16,747

 

12,705

 

 

Registered shares have a nominal value of CHF10 each and bearer shares have a nominal value of CHF25 each. Registered and bearer shares participate in dividends in proportion to their nominal value. Each share entitles the holder to one vote. The authorized share capital may be used by Serono S.A. or its affiliates to finance research and development projects and acquire interests in other companies.

The shareholders at the Annual General Meeting of Shareholders on April 25, 2006 authorized an increase in share capital by a maximum amount of CHF190,471,500 through the issuance of a maximum of 7,618,860 new bearer shares, each with a par value of CHF25, until April 25, 2008. The Board of Directors may proceed to increase the share capital all at once or in installments.

7.                              Treasury shares

There were 641,470 treasury shares held by the group as of January 1, 2006. During the six months ended June 30, 2006, no additional treasury shares were acquired (none in 2005). During the six months ended June 30, 2006, 5,395 treasury shares were granted to employees (5,766 shares in 2005) as part of the Employee Share Purchase Plan. In addition, 29 treasury shares were issued as part of the Stock Grant Plan and no additional treasury shares (988 shares in 2005) were issued upon the exercise of stock options as part of the Director Stock Option Plan.  The total number of treasury shares held as of June 30, 2006 is 636,046.

8.                              Distribution of earnings

The proposed gross dividend in respect of 2005 of CHF4.00 gross (2005: CHF3.60) per registered share, CHF10.00 gross (2005: CHF9.00) per bearer share or CHF0.25 gross (2004: CHF0.23) per American depositary share, was approved by shareholders at the Serono Annual General Meeting held on April 25, 2006.  The dividend equivalent to $117.1 million was subsequently paid on April 28, 2006 and has been accounted for as an appropriation of retained earnings in the six months ended June 30, 2006.

9.                              Equity compensation plans

Employee Stock Option Plan

Stock options are granted to senior management members of Serono S.A. and its affiliates. Each stock option gives the holder the right to purchase one bearer share or one American depositary share (“ADS”) of Serono S.A. stock, depending on which affiliate employs the holder. Stock options are granted every plan year and vest as follows: 25% one year after date of grant, 50% after two years, 75% after three years and 100% after four years. Options expire six years after the fourth and final vesting date such that each option has a 10-year duration. The exercise price is equal to the fair market value of the underlying Serono S.A. bearer share or American depositary shares on the date of grant.




 

Movements in the number of employee bearer stock options and ADS stock options outstanding are as follows:

 

 

2006

 

2005

 

 

 

 

 

Weighted

 

 

 

Weighted

 

 

 

 

 

average

 

 

 

average

 

 

 

Bearer

 

exercise

 

Bearer

 

exercise

 

 

 

options

 

price CHF

 

options

 

price CHF

 

Outstanding as of January 1

 

382,692

 

984

 

346,486

 

995

 

Granted

 

100,420

 

919

 

91,465

 

859

 

Exercised

 

(20,249

)

722

 

(7,885

)

615

 

Cancelled

 

(21,680

)

1,092

 

(11,830

)

1,112

 

Outstanding as of June 30

 

441,183

 

976

 

418,236

 

968

 

 

 

 

2006

 

2005

 

 

 

 

 

Weighted

 

 

 

Weighted

 

 

 

 

 

average

 

 

 

average

 

 

 

ADS

 

exercise

 

ADS

 

exercise

 

 

 

options

 

price US$

 

options

 

price US$

 

Outstanding as of January 1

 

1,791,150

 

16.52

 

1,066,800

 

15.54

 

Granted

 

902,720

 

17.49

 

834,200

 

17.73

 

Exercised

 

(61,300

)

15.53

 

(5,550

)

15.55

 

Cancelled

 

(168,390

)

17.06

 

(140,050

)

15.83

 

Outstanding as of June 30

 

2,464,180

 

16.86

 

1,755,400

 

16.51

 

 

During the six months ended June 30, 2006, 20,249 bearer stock options (2005: 7,885 bearer stock options) were exercised yielding proceeds of CHF14.6 million or $11.4 million (2005: CHF4.9 million or $3.9 million) and 61,300 ADS options (2005: 5,550 options) were exercised yielding proceeds of $1.0 million (2005: $0.1 million). Bearer and ADS stock options cancelled in all years since inception of the plan are the result of options forfeited by participants upon their departure from the group. The total number of bearer and ADS stock options available for grant as of June 30, 2006 is 95,571 options (2005: 210,566 options).

Director Stock Option Plan

Stock options are granted to members of the Board of Directors of Serono S.A. Each stock option gives the holder the right to purchase one bearer share of Serono S.A. stock. Stock options are granted every plan year and vest beginning one year after their grant rateably over four years. Each option has a 10-year duration. The exercise price is equal to the fair market value of the underlying Serono S.A. bearer share on the date of grant. There were 5,200 options granted (2005: 5,200) to directors during the six months ended June 30, 2006. No director stock options were cancelled or exercised (1,320 option were exercised in 2005, yielding total proceeds of CHF0.7 million) during the six months ended June 30, 2006. There are 27,000 director stock options outstanding as of June 30, 2006 (2005: 24,600 director stock options) with a weighted average exercise price of CHF798 (2005: CHF770).

A total compensation expense of $10.7 million (2005: $8.8 million) has been recognized for the six months ended June 30, 2006 arising on share-based payment transactions related to stock options. The compensation expense in 2006 has been charged to the appropriate income statement headings as follows: cost of product sales $0.8 million, selling, general and administrative $5.7 million and research and development $4.2 million.

Employee Share Purchase Plan

The group has an Employee Share Purchase Plan (“ESPP”) covering substantially all of its employees. The ESPP is designed to allow employees to purchase every calendar year bearer shares or American depositary shares at 85% of the lower of the average market values in the 10 days preceding the beginning and end of the calendar year. Shares purchased under the ESPP are granted in January of the following calendar year. Purchases under the ESPP are subject to certain restrictions and may not exceed 15% of the employee’s annual salary. During the six months ended




 

June 30, 2006, 21,904 bearer shares (2005: 20,940 bearer shares) were issued to employees at a price of CHF630 per share (2005: CHF630 per share). As of June 30, 2006, a total of $5.8 million (2005: $5.6 million) in contributions was held by the group to be used to purchase bearer and American depositary shares on behalf of employees in January 2007.

Shares purchased under the ESPP that are held for one calendar year after the purchase date entitle each participant to receive, on a one-time basis in early January of each year, one matching share for every three shares purchased and held. In January 2006, 5,437 bearer shares (2005: 5,766 bearer shares) were distributed to employees.

The total compensation expense of $2.7 million (2005: $3.8 million) has been recognized for the six months ended June 30, 2006 arising on share-based payment transactions related to the ESPP discount and matching shares. The compensation expense in 2006 has been charged to the appropriate income statement headings as follows: cost of product sales $0.5 million, selling, general and administrative $1.5 million and research and development $0.7 million.

Director Share Purchase Plan

The group has a share purchase plan reserved for its Board of Directors (the “DSPP”). The DSPP allows board members to purchase Serono S.A. bearer shares through allocation of 50% or 100% of their gross yearly fees. Each cycle commences on the first business day following the Annual General Meeting of Shareholders (the “AGM”) and concludes on the day of the next AGM. Directors must elect to participate in the DSPP at the beginning of each cycle. The purchase price per share is 85% of the fair market value of the share on the fifth business day following the AGM. Shares are purchased at the end of each cycle. There were 1,800 bearer shares issued to the directors that participate in the plan during the first six months of 2006 (1,348 in 2005).

Restricted Share Plan

The group has a Restricted Share Plan whereby employees may be granted restricted share awards as a result of an award based on certain performance criteria.  Shares granted under this plan generally have a three-year vesting period.  No shares were granted to employees during the first six months of 2006 and 2005.

Stock Grant Plan

The group adopted a new Stock Grant Plan effective January 1, 2006, whereby selected employees may be granted restricted share awards at the absolute discretion of the Board of Directors. Shares granted under this plan will vest in three annual installments on the first, second and third anniversaries of the grant date subject to continuous employment from the grant date to the vesting dates. There were 29,917 bearer shares and 856,430 American depositary shares granted to selected employees during the first six months of 2006. The compensation expense in 2006 of $8.8 million has been charged to the appropriate income statement headings as follows: cost of product sales $0.6 million, selling, general and administrative $5.3 million and research and development $2.9 million.

10.  Principal shareholders

As of June 30, 2006, Bertarelli Biotech S.A., a corporation with its principal offices at Chéserex (Vaud), Switzerland, held 57.01% of the capital and 66.93% of the voting rights in Serono S.A. Ernesto Bertarelli controls Bertarelli Biotech S.A. On the same date, Maria-Iris Bertarelli, Ernesto Bertarelli and Donata Bertarelli Späth owned in the aggregate 4.77% of the capital and 8.58% of the voting rights of Serono S.A.

11.  Legal proceedings

Serono’s principal US subsidiary, Serono Inc., received a subpoena in 2001 from the US Attorney’s office in Boston, Massachusetts requesting that it produce documents for the period from 1992 forward relating to Serostim. During 2002, Serono Inc. also received subpoenas from the states of California, Florida, Maryland and New York, which mirror the requests in the US Attorney’s subpoena.  Other pharmaceutical companies have received similar subpoenas as part of an ongoing, industry-wide investigation by the states and the federal government into sales, marketing and other practices. These investigations seek to determine whether such practices violated any laws, including the




 

Federal False Claims Act or the US Food, Drug and Cosmetic Act or constituted fraud in connection with Medicare and/or Medicaid reimbursement to third parties. Serono cooperated fully with the investigation and agreed to settle this dispute in October 2005. Under the terms of the settlement agreement, approximately $724.9 million was paid as a comprehensive settlement with federal and state governments and to cover related costs. Serono’s US holding company, Serono Holding Inc., also entered into a Corporate Integrity Agreement with the Office of Inspector General of the US Department of Human Health Services in connection with the investigation.

In September 2005, the Government Employees Hospital Association (“GEHA”), a health insurance plan, filed a purported class action on behalf of third party payors and individual consumers against Serono Inc. and Serono International S.A. alleging that Serono Inc. and Serono International S.A. inflated the average wholesale price (AWP) of certain products, and that this inflation caused GEHA to overpay for those products. In November 2005, GEHA filed an amended complaint alleging, in addition to its average wholesale price claims, that Serono illegally promoted and marketed Serostim. On February 22, 2006, GEHA requested (and Serono consented to) permission from the court to file a Second Amended Class Action Complaint which adds another plaintiff, District Council 37 Health & Security Plan Trust (alleged to be a third party payor of prescriptions for its members), does not contain any AWP claims, adds Serono Laboratories, Inc. as a defendant, alleges that Serono illegally promoted and marketed Serostim, and alleges that Serono used improper and inappropriate sales and marketing practices to increase the sales of other Serono products, including Cetrotide, Crinone, Gonal-F, Fertinex, Ovidrel, Pergonal, Profasi, Rebif, and Saizen. The allegations in the Second Amended Complaint concerning Serostim are drawn from the government investigation of Serostim discussed above. The Second Amended Complaint alleges eight counts: (1) violation of 18 U.S.C. § 1962(C) (civil RICO); (2) violation of 18 U.S.C. § 1962(C) (civil RICO); (3) violation of 18 U.S.C. § 1962(D) (civil RICO conspiracy); (4) civil conspiracy; (5) violation of the Massachusetts Consumer Protection Act; (6) violation of consumer protection statutes of 44 states and the District of Columbia; (7) common law fraud; and (8) unjust enrichment. The parties are still engaged in preliminary motion practice and the Serono Defendants have not yet filed an answer. The Serono Defendants intend to vigorously defend the lawsuit. The final settlement or adjudication of this matter could have a material adverse effect on the operations or financial condition of the company. The company cannot predict the timing of the resolution of this matter or ultimate outcome.

On April 7, 2006, Eugene Francis filed a purported class action on behalf of all persons or entities that paid a portion of the purchase price for Serostim against Serono Inc., Serono Laboratories, Inc., and certain other parties. The allegations of the complaint concern only the sales and marketing of Serostim, and are substantially similar to the allegations concerning Serostim made in the GEHA matter described above. The complaint contains the same eight counts as the GEHA Second Amended Complaint described above. The parties are still engaged in preliminary motion practice, and the Serono Defendants have not yet filed an answer. The case has be consolidated with the GEHA case. The Serono Defendants intend to vigorously defend this case. The final settlement or adjudication of this case could have a material adverse effect on the operations or financial condition of the company. The company cannot predict the timing of the resolution of these cases or ultimate outcome.

- end -




 

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

SERONO S.A.,

 

 

 

a Swiss corporation

 

 

(Registrant)

 

 

 

Date

July 26, 2006

 

 

By:  /s/ Stuart Grant

 

 

Name: Stuart Grant

 

 

Title: Chief Financial Officer