UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15 (d) OF
THE SECURITIES EXCHANGE ACT OF 1934

 

DATE OF REPORT (Date of earliest event reported):  May 5, 2003

 

COMMISSION FILE NUMBER 333-92383

 

CHARLES RIVER LABORATORIES INTERNATIONAL, INC.

(Exact Name of Registrant as specified in its Charter)

 

DELAWARE

 

06-1397316

(State of Incorporation)

 

(I.R.S. Employer Identification No.)

 

 

 

251 BALLARDVALE STREET, WILMINGTON, MASSACHUSETTS 01887

(Address of Principal Executive Offices) (Zip Code)

 

 

 

978-658-6000

(Registrant’s Telephone Number, Including Area Code)

 

 



 

ITEM 9.  REGULATION FD DISCLOSURE

 

On May 5, 2003, Charles River Laboratories, Inc., wholly-owned subsidiary of the Registrant, posted to its company website an updated investor presentation, a copy of which is filed herewith as Exhibit 99.1.

 

 

EXHIBIT 99.1

 

Investor Presentation

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, we have duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

CHARLES RIVER LABORATORIES INTERNATIONAL, INC.

 

 

Dated: May 5, 2003

 

 

 

 

By:

/s/ Dennis R. Shaughnessy

 

 

 

 

Dennis R. Shaughnessy, Sr. Vice President,

 

Corporate Development, General Counsel

 

and Secretary

 

2


Exhibit 99.1

 

 

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Exhibit 99.1

 

[CHARLES RIVER LABORATORIES LOGO]

 

Contributing to the Search for Healthier LivesTM

 

COMPANY OVERVIEW

 

[GRAPHIC]

 

[LOGO]

 



 

SAFE HARBOR STATEMENT

 

This presentation includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995.  Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “expect,” “estimate,” “plan,” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters.  These statements are based on management’s current expectations, and involve a number of risks and uncertainties that could cause actual results to differ materially from those stated or implied by the forward-looking statements, and the Company expressly does not undertake any duty to update forward-looking statements, which speak only as of the date of this document.  Those risks and uncertainties include, but are not limited to:  a decrease in pre-clinical research and development spending or a decrease in the level of outsourced services; acquisition integration risks; special interest groups; contaminations; industry trends; new displacement technologies; outsourcing trends; USDA and FDA regulations; changes in law; continued availability of products and supplies; loss of key personnel; interest rate and foreign currency exchange rate fluctuations; changes in generally accepted accounting principles; and any changes in business, political, or economic conditions due to the threat of future terrorist activity in the U.S. and other parts of the world, and related U.S. military action overseas.  A further description of these risks, uncertainties, and other matters can be found in the Risk Factors detailed in the Company’s Annual Report on Form 10-K as filed on March 20, 2003, with the Securities an d Exchange Commission.

 

2



 

CONTRIBUTING TO THE SEARCH FOR HEALTHIER LIVES

 

Leading provider of products and services that facilitate drug discovery and development

 

[GRAPHIC]

 

A unique focus on the pre-clinical space

 

3



 

INVESTMENT HIGHLIGHTS

 

      55 years in business

 

      More than 3 decades of consistent growth and profitability

 

      2002 financial results

 

      Revenues - - $555 million

      Operating margin - 22%

 

      5000 employees worldwide

 

      20% have been with Charles River 10 years or more

      Management team average experience — 20 years

 

[GRAPHIC]

 

4



 

INVESTMENT HIGHLIGHTS

 

      Predictable and consistent financial performance

 

      Leading market shares

 

      Longstanding customers

 

      Acquisition track record

 

      Experienced management team

 

      Growth driven by pharma R&D spending

 

      Preclinical outsourcing

 

5



 

[GRAPHIC]

 

80 production and laboratory facilities in 16 countries

 

46 contract staffing locations worldwide

 

6



 

CRITICAL PATH TO DRUG DEVELOPMENT

 

[CHART]

 

7



 

GROWTH IN PHARMA R&D SPENDING

 

Worldwide Pharmaceutical

R&D Spending

($ in billions)

 

[CHART]

 


Sources:  PhRMA Annual Survey 2002; Hambrecht & Quist - Better, Faster, Worldwide Too:

Update On Pharmaceutical Contract Support Organizations, January 1999; Company estimates

 

8



 

Worldwide Pre-Clinical

R&D Spending

($ in billions)

 

[CHART]

 


Sources:  PhRMA Annual Survey 2002; Hambrecht & Quist - Better, Faster, Worldwide Too:

Update On Pharmaceutical Contract Support Organizations, January 1999; Company estimates

 

9



 

BUSINESS SEGMENTS

 

Research Models

 

Biomedical Products & Services

 

[GRAPHIC]

 

10



 

REVENUE COMPOSITION

 

2002 Sales: $555 million

 

[CHART]

 

   Customers include all major pharmaceutical and biotech companies

   No commercial customer accounts for > 3% of revenues

 

11



 

ANIMAL RESEARCH MODELS:  40% OF REVENUES

 

              More than 165 genetically and virally defined research models

 

              Movement towards disease models — Diabetes, Alzheimer’s, Cardiovascular

 

              Mandated by FDA and global regulatory agencies

 

[GRAPHIC]

 

12



 

UNIQUE COMPETITIVE ADVANTAGES

 

      Global reach

 

      Long-standing customer relationships

 

      Scientific depth

 

      Biosecurity

 

[GRAPHIC]

 

13



 

MARKET SHARE LEADER

 

2002 Worldwide Market Opportunity: $475+ million

 

[CHART]

 

Charles River is 4x larger than its next competitor

 


Source:  Company estimates

 

14



 

NEW DEVELOPMENTS

 

STRATEGIC PARTNERSHIP WITH THE JACKSON LABORATORIES

 

      Premier mammalian genetic research institution

 

      Hundreds of unique mouse models

 

      Exclusive distribution in Europe and Japan

 

[GRAPHIC]

 

15



 

CAPACITY EXPANSION

 

      New production facility in Canada

 

      Added 25% more space

 

      Massachusetts production facility

 

      Added 40% more space

 

      California production facility

 

      Added 33% more space

 

[GRAPHIC]

 

16



 

BIOMEDICAL PRODUCTS AND SERVICES: 60% OF REVENUES

 

      Focus on high-growth areas of drug discovery and development

 

      Discovery Services

      Development Services

      in vitro Technologies

      Vaccine Support Services

 

      Enables customers to outsource required drug development procedures

 

17



 

WORLDWIDE MARKET OPPORTUNITY

 

$4+ billion

 

[CHART]

 

Charles River is #1 in all major markets

 


Sources:  PhRMA Annual Survey 2002; Hambrecht & Quist - Better, Faster, Worldwide Too:

Update On Pharmaceutical Contract Support Organizations, January 1999; Company estimates

 

18



 

DISCOVERY SERVICES

 

      Transgenic Services

 

      Facilities in US, France, Japan

 

      Laboratory and Research Services

 

      Genetic testing

      Infectious disease testing

      Drug efficacy testing

 

      Contract Site Management

 

      Approximately 800 employees in the US and Europe

 

[GRAPHIC]

 

19



 

NEW DEVELOPMENTS

 

DISCOVERY SERVICES

 

      Growth of Transgenic Services business

 

      New facility in Wilmington, MA added 70,000 sq ft — 50% occupied, 50% expansion space

      Expansion in San Diego, CA

      Growth in

 

      Lyon, France

      Tokyo, Japan

 

[GRAPHIC]

 

20



 

FULL RANGE OF DEVELOPMENT SERVICES

 

Entire range of services to take molecule from discovery to FDA filing

 

      Drug Safety Assessment

 

      Pharmacokinetics / Metabolism

 

      Bioanalytical Chemistry

 

      Surgery / Pharmacology

 

      Biosafety Testing

 

      Pathology Services

 

[GRAPHIC]

 

21



 

NEW DEVELOPMENTS

 

DEVELOPMENT SERVICES

 

      Lower demand for drug safety testing

 

      Pharma’s “barbell” focus

      Biotech’s clinical focus

      Pharma budgets solidified end of Q1

      Some potential outsourcing business staying in-house

      Waiting until last minute to commit to expensive studies

      Increased capacity

      Price pressure

 

22



 

MAJOR ACQUISITIONS

 

BIOLABS – June 2002

 

Description

Privately held pre-clinical outsourcing services in western Ireland

 

Performs bioassay, animal health, and medical device support

 

 

2001 Revenue

$10 million

 

 

Rationale

Established a base for expansion of our services portfolio in Europe

 

 

EPS Impact

Accretive

 

[GRAPHIC]

 

[BIOLOGICAL LABORATORIES EUROPE LTD. LOGO]

 

23



 

SPRINGBORN LABORATORIES — October 2002

 

Description

Privately held Ohio-based general and specialty toxicology services

 

 

LTM Revenue

$15 million

 

 

Rationale

Expanded geographic base and customer base to medium and small biopharmaceutical customers

 

 

EPS Impact

Accretive

 

[GRAPHIC]

 

[SPRINGBORN LABORATORIES LOGO]

 

24



 

JOINT VENTURE

 

CHARLES RIVER PROTEOMICS SERVICES – Opened April 2003

 

80/20 joint venture between Charles River and Proteome Systems Ltd provides leading-edge proteomics testing and analysis to enable researchers to rapidly identify proteins that may have commercial value as drug targets, biomarkers, or as the basis for diagnostic tests

 

[GRAPHIC]

 

25



 

IN VITRO (NON-ANIMAL) TECHNOLOGIES

 

      Only FDA-approved alternative to animal testing

 

      Endotoxin testing for injectable drug / medical device lot release

 

[GRAPHIC]

 

26



 

NEW DEVELOPMENTS

 

EXPANDED MARKET OPPORTUNITIES

 

      In Vitro Pyrogen Test

 

      Aimed at $50 million market for lot-release testing of products derived from human blood and biologicals

 

[GRAPHIC]

 

27



 

EXPANDED MARKET OPPORTUNITIES

 

      Portable LAL Device

 

      Allows endotoxin testing in the workplace in real time

      Developed in house

      Technology leader

      FDA approval in process

      Once approved, doubles the market opportunity

 

[GRAPHIC]

 

28



 

VACCINE SUPPORT PRODUCTS

 

      SPF Chicken Eggs

 

      Poultry and Human Vaccine Production

 

[GRAPHIC]

 

29



 

GROWTH - MORE SALES TO SAME CUSTOMERS

 

[CHART]

 


Note:  Results are not to scale.

 

30



 

GROWTH THROUGH STRATEGIC ACQUISITIONS

 

      21 acquisitions and alliances since 1994

 

      Stringent criteria for acquisitions

 

      Non-dilutive

      20% operating margin

      15%+ top-line growth

      Leading player

      Scientific leadership

      Leverage worldwide infrastructure

 

31



 

FINANCIAL REVIEW

 

32



 

FINANCIAL HIGHLIGHTS

 

Net Sales

 

Research Models 4-Year CAGR:

 

12

%

Biomedical Products & Services 4-Year CAGR:

 

39

%

($ in millions)

 

[CHART]

 

33



 

[CHART]

 

34



 

Operating Income(1)

 

[CHART]

 


(1)   Excludes unallocated corporate overhead

 

35



 

EBITDA

 

[CHART]

 

36



 

Return on Invested Capital

 

[CHART]

 

37



 

Return on Net Operating Assets

 

[CHART]

 

38



 

SOLID FINANCIAL PERFORMANCE

 

Adjusted Earnings per Share

 

[CHART]

 

39



 

STRONG CAPITALIZATION

 

 

 

As of
Mar. 29, 2003

 

As of
Dec. 28, 2002

 

($ in millions)

 

Actual

 

Actual

 

Cash & Cash Equivalents

 

$

119.0

 

$

127.5

 

 

 

 

 

 

 

Other Debt

 

7.6

 

10.8

 

Senior Convertible Debentures

 

185.0

 

185.0

 

Total Debt

 

$

192.6

 

$

195.8

 

 

 

 

 

 

 

Shareholder’s Equity

 

380.3

 

357.4

 

Total Capitalization

 

$

572.9

 

$

553.2

 

Net Debt / Total Capitalization

 

12.8

%

12.3

%

 


(1)   Adjusted for subsequent retirements of Senior Subordinated Notes and the Senior Convertible Debenture offering.

 

40



 

2003 GUIDANCE

 

 

 

2003

 

Q2

 

Net Sales

 

 

 

 

 

Research Models

 

11-14%

 

 

 

Biomedical Products & Services

 

11-14%

 

 

 

Total

 

11-14%

 

12-14%

 

 

 

 

 

 

 

Diluted EPS

 

$1.63-$1.68

 

$0.40-$ 0.42

 

Operating Cash Flow

 

$110-$115 M

 

 

 

CAPEX

 

$40 M

 

 

 

Free Cash Flow

 

$70-$75 M

 

 

 

 

41



 

[CHARLES RIVER LABORATORIES LOGO]

 

Contributing to the Search for Healthier LivesTM

 

Ticker: CRL

 

42



 

CHARLES RIVER LABORATORIES INTERNATIONAL, INC.

RECONCILIATION OF GAAP SALES TO NON-GAAP SALES EXCLUDING FOREIGN EXCHANGE

(dollars in thousands)

 

 

 

Three Months Ended

 

 

 

 

 

March 29, 2003

 

March 30, 2002

 

%
Increase

 

 

 

 

 

 

 

 

 

North American Research Model Sales

 

 

 

 

 

 

 

North American Research Model Sales

 

$

27,539

 

$

24,991

 

10.2

%

 

 

 

 

 

 

 

 

Foreign exchange impact

 

(119

)

 

 

 

North American Research Model Sales at prior year rates

 

$

27,420

 

$

24,991

 

9.7

%

 

 

 

 

 

 

 

 

European Research Model Sales

 

 

 

 

 

 

 

European Research Model Sales

 

$

18,714

 

$

14,503

 

29.0

%

 

 

 

 

 

 

 

 

Foreign exchange impact

 

(3,236

)

 

 

 

European Research Model Sales at prior year rates

 

$

15,478

 

$

14,503

 

6.7

%

 

 

 

 

 

 

 

 

Japan Research Model Sales

 

 

 

 

 

 

 

Japan Research Model Sales

 

$

12,990

 

$

11,867

 

9.5

%

 

 

 

 

 

 

 

 

Foreign exchange impact

 

(1,327

)

 

 

 

Japan Research Model Sales at prior year rates

 

$

11,663

 

$

11,867

 

-1.7

%

 

 

 

 

 

 

 

 

Large Model Sales

 

 

 

 

 

 

 

Large Model Sales

 

$

5,884

 

$

5,538

 

6.2

%

 

 

 

 

 

 

 

 

Total Research Model Sales

 

 

 

 

 

 

 

Total Research Model Sales

 

$

65,127

 

$

56,899

 

14.5

%

 

 

 

 

 

 

 

 

Foreign exchange impact

 

(4,682

)

 

 

 

Total Research Model Sales at prior year rates

 

$

60,445

 

$

56,899

 

6.2

%

 

43



 

May 5, 2003

 

CHARLES RIVER LABORATORIES INTERNATIONAL, INC.

RECONCILIATION OF GAAP TO NON-GAAP EBITDA

(dollars in thousands)

 

 

 

Three Months Ended

 

 

 

March 29, 2003

 

March 30, 2002

 

 

 

 

 

 

 

EBITDA

 

 

 

 

 

 

 

 

 

 

 

Operating Earning

 

$

33,848

 

$

28,410

 

 

 

 

 

 

 

Depreciation and amortization

 

6,925

 

5,434

 

EBITDA

 

$

40,773

 

$

33,844

 

 

 

 

 

 

 

Total Net Sales

 

$

152,125

 

$

133,820

 

 

 

 

 

 

 

EBITDA as a percent of net sales

 

26.8

%

25.3

%

 

44



 

CHARLES RIVER LABORATORIES INTERNATIONAL, INC.

RECONCILIATION OF GAAP EPS TO NON-GAAP EPS

(dollars in thousands, except for per share data)

 

 

 

Three Months Ended

 

 

 

March 31, 2001

 

June 30, 2001

 

September 29, 2001

 

December 29, 2001

 

March 30, 2002

 

June 29, 2002

 

September 28, 2002

 

December 28, 2002

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net Income (loss)

 

$

6,951

 

$

9,018

 

$

10,521

 

$

8,917

 

(2,232

)

16,328

 

18,531

 

17,505

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Add Back:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss on debt retirement

 

365

 

2,435

 

1,975

 

3,291

 

27,479

 

1,790

 

613

 

 

Non-GAAP impact on provision for income taxes

 

(128

)

(852

)

(691

)

(1,152

)

(10,717

)

(698

)

(236

)

 

Non-GAAP net income

 

$

7,188

 

$

10,601

 

$

11,805

 

$

11,056

 

$

14,530

 

$

17,420

 

$

18,908

 

$

17,505

 

After tax equivalent Interest Expense

 

28

 

27

 

27

 

27

 

$

714

 

$

996

 

$

995

 

$

996

 

Non-GAAP net income for calculation of fully diluted earnings per share

 

$

7,216

 

$

10,628

 

$

11,832

 

$

11,083

 

$

15,244

 

$

18,416

 

$

19,903

 

$

18,501

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-GAAP Earnings per common share

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

0.20

 

$

0.26

 

$

0.27

 

$

0.25

 

$

0.33

 

$

0.39

 

$

0.42

 

$

0.39

 

Diluted

 

$

0.18

 

$

0.24

 

$

0.26

 

$

0.24

 

$

0.31

 

$

0.36

 

$

0.39

 

$

0.36

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-GAAP Weighted average number of common shares outstanding

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

36,582,532

 

40,175,630

 

43,054,478

 

44,133,268

 

44,254,895

 

44,557,027

 

44,836,974

 

45,077,506

 

3.5% senior convertible debentures

 

 

 

 

 

 

 

 

 

3,401,024

 

4,759,455

 

4,759,455

 

4,759,455

 

Stock options

 

985,782

 

1,036,294

 

1,089,075

 

1,101,873

 

990,494

 

1,076,211

 

1,242,543

 

1,198,628

 

Warrants

 

2,718,731

 

2,711,927

 

1,407,259

 

1,034,810

 

855,707

 

659,682

 

523,291

 

483,054

 

2% Convertible notes

 

 

128,315

 

128,315

 

128,315

 

35,251

 

 

 

 

Non-GAAP Diluted

 

40,287,045

 

44,052,166

 

45,679,127

 

46,398,266

 

49,537,371

 

51,052,375

 

51,362,263

 

51,518,643

 

 

45