-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, NgKBbRB95bnljFzlISsnkZPEUXudWNf/ZJnnn5EbIYcPuRFBN21h1TN/KZFK4P7y dfMOQviURvJ7IiTCGKXl3A== 0001104659-04-001713.txt : 20040126 0001104659-04-001713.hdr.sgml : 20040126 20040126171114 ACCESSION NUMBER: 0001104659-04-001713 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20040126 ITEM INFORMATION: Financial statements and exhibits ITEM INFORMATION: Regulation FD Disclosure FILED AS OF DATE: 20040126 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BIOSITE INC CENTRAL INDEX KEY: 0000834306 STANDARD INDUSTRIAL CLASSIFICATION: IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835] IRS NUMBER: 330288606 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-21873 FILM NUMBER: 04543960 BUSINESS ADDRESS: STREET 1: 11030 ROSELLE ST CITY: SAN DIEGO STATE: CA ZIP: 92121 BUSINESS PHONE: 6194554808 MAIL ADDRESS: STREET 1: 11030 ROSELLE ST CITY: SAN DIEGO STATE: CA ZIP: 92121 FORMER COMPANY: FORMER CONFORMED NAME: BIOSITE DIAGNOSTICS INC DATE OF NAME CHANGE: 19960710 8-K 1 a04-1555_18k.htm 8-K

 

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): January 26, 2004

 

BIOSITE INCORPORATED

(Exact name of registrant as specified in its charter)

 

Delaware

 

000-21873

 

33-0288606

(State or other jurisdiction
of incorporation)

 

(Commission
File Number)

 

(IRS Employer
Identification No.)

 

11030 Roselle Street, San Diego, California 92121

(Address of principal executive offices)     (Zip Code)

 

Registrant’s telephone number, including area code:  (858) 455-4808

 

 



 

ITEM 7                                                        FINANCIAL STATEMENTS AND EXHIBITS.

 

(c)                                                Exhibits.

 

Exhibit 99.1                                    Press release of Biosite Incorporated dated January 26, 2004

ITEM 9                                                        REGULATION FD DISCLOSURE (INFORMATION FURNISHED PURSUANT TO ITEM 12, “DISCLOSURE OF RESULTS OF OPERATIONS AND FINANCIAL CONDITION”).

 

On January 26, 2004, Biosite Incorporated issued an earnings release announcing its financial results for the fourth quarter ended December 31, 2003.  A copy of the earnings release is attached as Exhibit 99.1 to this Form 8-K.

 

The information contained in this Item 9 of this Current Report is being furnished pursuant to “Item 12. Results of Operations and Financial Condition” of Form 8-K in accordance with SEC Release No. 33-8216.

 

The information in this Current Report and attached Exhibit are being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section.  The information in this Current Report and attached Exhibit shall not be deemed incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.

 

2



 

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 hereunto duly authorized.

 

Dated: January 26, 2004

 

 

 

BIOSITE INCORPORATED

 

 

 

 

 

By:

/s/ CHRISTOPHER J. TWOMEY

 

 

 

 

 

Christopher J. Twomey

 

 

Vice President, Finance and

 

 

Chief Financial Officer

 

3



 

INDEX TO EXHIBITS

 

Exhibit
Number

 

Exhibit

 

 

 

Exhibit 99.1

 

Press release of Biosite Incorporated dated January 26, 2004

 

4


EX-99.1 3 a04-1555_1ex99d1.htm EX-99.1

Exhibit 99.1

 

 

Contact:  Nadine Padilla

Vice President, Corporate

& Investor Relations

(858) 455-4808 x3187

npadilla@biosite.com

 

 January 26, 2004

 

 

BIOSITE® INCORPORATED REPORTS

 FOURTH QUARTER 2003 RESULTS

 

SAN DIEGO — Biositeâ Incorporated (Nasdaq:BSTE), a leading provider of novel, rapid diagnostics that improve diagnosis of critical diseases, today reported results for the fourth quarter of 2003.  The quarter was highlighted by a 41 percent year-over-year revenue increase, which contributed to annual revenue growth of 65 percent, and an 85 percent year-over-year increase in net income.  Higher production and selling costs coupled with investments in European sales infrastructure, marketing and new product development unfavorably affected net income and diluted earnings per share in the fourth quarter of 2003.  Citing strong sales performance in the fourth quarter of 2003 and early 2004, the Company reaffirmed its 2004 growth targets of 15 to 25 percent revenue growth and 20 to 30 percent growth in diluted earnings per share.

 

Following are financial highlights for the fourth quarter and year ending December 31, 2003:

 

($in 000’s)

 

Three months ended

 

Year Ended

 

 

 

12/31/03

 

12/31/02

 

Chg.

 

12/31/03

 

12/31/02

 

Chg.

 

Triage® BNP sales

 

$

28,910

 

$

16,074

 

80

%

$

103,224

 

$

38,127

 

171

%

Total product sales

 

45,015

 

31,816

 

41

%

169,298

 

100,830

 

68

%

Total revenue

 

45,955

 

32,697

 

41

%

173,364

 

105,226

 

65

%

Net income

 

5,152

 

4,968

 

4

%

24,763

 

13,394

 

85

%

Earnings per share (Diluted)

 

$

.32

 

$

.31

 

1

%

$

1.50

 

$

.86

 

74

%

Gross margin on product sales

 

63

%

69

%

 

 

65

%

69

%

 

 

Operating margin

 

17

%

22

%

 

 

22

%

19

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

December 31, 2003

 

 

 

December 31, 2002

 

Chg.

 

Cash and marketable securities balance

 

$

53,934

 

 

 

 

 

$

71,165

 

 

 

(24

%)

 



 

-                    Sales of the Triage BNP Test surpassed expectations in the fourth quarter of 2003, increasing 19 percent from the third quarter.  The increase was attributed to increases in customer adoptions, and higher utilization by customers, which the Company believes may have been driven in part by seasonal factors, such as increased visits to emergency departments by patients with breathing difficulty during the flu season.  The Company has continued to experience favorable sales in January.

 

At December 31, 2003 the Triage BNP Test was in use in 2,335 acute care hospitals and 144 physician offices.

 

-                    As anticipated, Biosite’s gross margin declined on a year-over-year and sequential basis in the fourth quarter of 2003, but to a greater degree than expected.  The Company attributed this primarily to higher per kit overhead costs as production slowed during the quarter in an effort to reach targeted inventory levels.  As a result, overhead costs were spread over a smaller production volume.  The Company believes margins could improve in future quarters as production increases, provided sales remain strong.

 

-                    Due to acceleration in customer demand of the Triage BNP Test in December, distributor inventory levels of certain of the Company’s products were below targeted stocking levels at December 31, 2003.  The Company believes it has sufficient manufacturing capacity to restore distributor inventories to targeted stocking levels, which are used to maintain an efficient flow of product to the distributor’s customers.

 

-                    Selling, general and administrative expenses in the fourth quarter of 2003 totaled 32 percent of revenues, compared with 35 percent of revenues for the like period of 2003.  Sales commissions, marketing expenses related to anticipated product launches and investments in direct marketing efforts in Europe contributed to higher than expected expense.  Within the last six months, Biosite has launched direct sales efforts in France, Germany, the United Kingdom, Belgium and Luxemburg, as part of a strategy aimed at improving sales growth and profitability.

 

-                    Research and development expenses, primarily related to product development and improvements as well as clinical trials, totaled 15 percent of revenues, moderately higher than the fourth quarter of 2002.  The higher expenses reflect the Company’s expanding research and development efforts, which are currently supporting development of seven potential new products expected to launch over the next four years.  The Company is also investing significantly in two clinical trials related to existing products.

 

-                    Biosite’s cash and marketable securities balance declined $17.2 million since December 2002, largely due to the purchase of land for the Company’s new corporate facility, which is currently under construction, manufacturing capacity expansion, and existing facilities improvements to meet increases in BNP product demand.  The Company has expended $35 million to date on its new facility.

 



 

“In 2003, we set out to deliver record growth and establish the infrastructure to ensure the long-term expansion of our business, and succeeded in doing so,” said Kim Blickenstaff, Biosite president and chief executive officer.  “Entering 2004, we are intent on:

 

-                    growing the BNP business through our arrangement with Beckman Coulter, new market efforts in physician offices and growth from existing acute hospital business;

-                    building in significant European markets where we have established direct sales and marketing efforts;

-                    executing worldwide commercialization of  Triage Cardio ProfilER SOB (Shortness of Breath) Panel and the Triage CardioRisk ACS Panel, and launching our stroke diagnostic in Europe, and

-                    increasing profitability.

 

While the year holds several challenges, we believe we can drive progress in these key areas and advance toward our growth objectives in 2004.”

 

In addition to announcing financial results, Biosite also reported on research and development progress:

 

-                    Management reported that it has enrolled nine centers for its stroke diagnostic clinical study, which is scheduled to commence in the first quarter of 2004.  Approximately 20 centers worldwide are expected to participate in the study that is intended to generate data to be submitted to the FDA for approval to market the first rapid blood test for the early diagnosis of stroke in the United States.  The Company intends to launch the diagnostic panel in Europe in the fourth quarter of 2004.

 

-                    Biosite reported that is has embarked on a platform development program intended to miniaturize the Triage MeterPlus Platform currently used to run many of the Company’s tests.  The program is intended to yield a state-of-the-art testing platform with enhanced speed, accuracy and precision.

 

About Biosite

A leader in the drive to advance diagnosis, Biosite Incorporated is a research-based company dedicated to the discovery and development of novel protein-based diagnostic tests that improve a physician’s ability to diagnose debilitating and life-threatening diseases.  Through combined expertise in diagnostic discovery and commercialization, the Company is able to access potential markers of disease, identify proteins with high diagnostic utility, develop and commercialize products and educate the medical community on new diagnostic approaches, thereby benefiting patients.  Biosite’s Triage® rapid diagnostics are used in approximately 50 percent of U.S. hospitals and in over 50 international markets for toxicology screening and diagnosis of infectious and cardiovascular disease.  Information on Biosite can be found at www.biosite.com.

 

Investor Conference Call

Biosite’s investor conference call will take place today, January 26, 2004, at 2:30 p.m. (Pacific).  A live web cast of the call can be accessed via the Internet at www.biosite.com.  The phone number for the call is (706) 643-1834.  The call will be archived on the Biosite web site for

 



 

at least 21 days.  A telephone replay of the call will also be available by calling (800) 642-1687.  International callers, please dial (706) 645-9291.  Please reference the conference call number 4684373.

 

Except for the historical information presented herein, matters discussed in this press release are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Statements that are not historical facts, such as financial targets and growth objectives and also including but not limited to statements that are preceded by, followed by, or that include the words “will”; “believes”; “should”; “intend”;  “anticipates”; “plans”; “expects”; “estimates”; or similar statements are forward-looking statements.  Risks and uncertainties include risks associated with Biosite’s ability to market and sell a BNP test that runs on the Beckman Coulter family of immunoassay systems, the expansion of business through direct sales in certain European countries, Biosite’s ability to obtain a monitoring claim for the Triage BNP Test, the continued growth of the BNP market, the implementation of automated and semi-automated manufacturing methods that maintain or improve product quality and manufacturing efficiency, costs and expenses that the Company may incur in transitioning from a distributor sales model to a direct sales model in selected international markets, Biosite’s ability to effectively promote the Triage BNP Test, either directly or through distributors, and acceptance of the Triage BNP Test in the physician office market, Biosite’s ability to initiate and complete clinical trials for its stroke diagnostic in the manner and in the timeframe expected, the Company’s ability to obtain regulatory approvals and complete other clinical and pre-market activities needed to launch new products as currently planned, including the Triage Cardio ProfilER SOB Panel and the Triage CardioRisk ACS Panel, and the stroke diagnostic, the Company’s ability to obtain a CLIA waiver for the Triage BNP Test and the risks associated with the efforts to miniaturize the Triage MeterPlus Platform. Other risks that should be considered include risks associated with changing market conditions, sales, profitability, and the extent to which our other products and products under development are successfully developed and gain market acceptance, risks associated with the introduction of competitive products from companies with greater capital and resources, and risks and expenses associated with litigation, contract disputes, patent conflicts, product recalls, manufacturing constraints, backlog, delays or inefficiencies, shipment problems, seasonal customer demand, the timing of significant orders, uncertainties or delays, changes in reimbursement policies, regulatory changes, competitive pressures on average selling prices, changes in the mix of products sold, and the other risks detailed in the Company’s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other SEC filings. The Company disclaims, however, any intent or obligation to update these forward-looking statements. Copies of the Company’s public disclosure filings are available from the Investor Relations department.

 

###

 

Biosite® and Triage® and New Dimensions in Diagnosis® are registered trademarks of Biosite Incorporated.  The Company’s logo is a trademark of Biosite Incorporated.

 



 

Biosite Incorporated

Unaudited Statements of Income Data

(in thousands, except per share data)

 

 

 

Three months ended
December 31,

 

Year ended
December 31,

 

 

 

2003

 

2002

 

% Change

 

2003

 

2002

 

% Change

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

Product sales

 

$

45,015

 

$

31,816

 

41

%

$

169,298

 

$

100,830

 

68

%

Contract revenue

 

940

 

$

881

 

7

%

4,066

 

4,396

 

(8

)%

Total revenues

 

45,955

 

32,697

 

41

%

173,364

 

105,226

 

65

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Gross margin on product sales

 

63

%

69

%

(6

)%

65

%

69

%

(4

)%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of product sales

 

16,602

 

9,830

 

69

%

58,567

 

31,312

 

87

%

Selling, general, and administrative

 

14,506

 

11,330

 

28

%

51,944

 

34,208

 

52

%

Research and development

 

6,975

 

4,214

 

66

%

24,474

 

16,160

 

51

%

License & patent disputes

 

0

 

0

 

NA

 

0

 

4,043

 

(100

)%

Total operating expenses

 

38,083

 

25,374

 

50

%

134,985

 

85,723

 

57

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating income

 

7,872

 

7,323

 

7

%

38,379

 

19,503

 

97

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating income as % of total revenue

 

17

%

22

%

 

 

22

%

19

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest and other income, net

 

274

 

500

 

(45

)%

1,436

 

1,971

 

(27

)%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Income before provision for income taxes

 

8,146

 

7,823

 

4

%

39,815

 

21,474

 

85

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Provision for income taxes

 

(2,994

)

(2,855

)

5

%

(15,052

)

(8,080

)

86

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income

 

$

5,152

 

$

4,968

 

4

%

$

24,763

 

$

13,394

 

85

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Diluted net income per share

 

$

0.32

 

$

0.31

 

1

%

$

1.50

 

$

0.86

 

74

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Diluted shares used in calculating per share amounts

 

16,191

 

15,814

 

 

 

16,497

 

15,512

 

 

 

 



 

Biosite Incorporated

Balance Sheet Data

(in thousands)

 

 

 

December 31, 2003

 

December 31, 2002

 

 

 

 

 

 

 

Assets

 

 

 

 

 

Cash, cash equivalents & marketable securities

 

$

53,934

 

$

71,165

 

Accounts receivable

 

23,755

 

10,996

 

Inventories

 

27,780

 

12,295

 

Other current assets

 

9,534

 

4,574

 

Total current assets

 

115,003

 

99,030

 

 

 

 

 

 

 

Property, equipment and leasehold improvements, net

 

71,408

 

19,864

 

Patents and license rights, net

 

6,771

 

7,899

 

Other assets

 

1,442

 

4,461

 

Total assets

 

$

194,624

 

$

131,254

 

 

 

 

 

 

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

Current liabilities

 

$

24,128

 

$

18,060

 

Long-term liabilities

 

17,593

 

5,253

 

Stockholders’ equity

 

152,903

 

107,941

 

Total liabilities and stockholders’ equity

 

$

194,624

 

$

131,254

 

 


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