EX-99.1 2 a07-12135_1ex99d1.htm EX-99.1

Exhibit 99.1

Contact:
Nadine Padilla
VP, Corporate & Investor Relations
858-805-2820
npadilla@biosite.com
April 24, 2007

BIOSITE INCORPORATED ANNOUNCES
FIRST QUARTER 2007 RESULTS

Cash & Marketable Securities Up 54 Percent Sequentially;
 Revenue Grows 6 Percent Year-Over-Year

SAN DIEGO — Biosite Incorporated (Nasdaq:BSTE) today reported financial results for the first quarter of 2007 highlighted by increases in revenue and cash. The Company also provided an update on clinical trials for several potential new products.

Key Financial Results

·                  Cash generated from operations was $32.3 million in the first quarter of 2007, raising Biosite’s cash and marketable securities balance to $98.9 million, a 54 percent increase over its cash and marketable securities balance at December 31, 2006.

·                  Revenues for the first quarter of 2007 totaled $83.7 million, a 6 percent increase from $79.3 million in the comparable period of 2006. As expected, growth resulted primarily from sales of Biosite’s non-BNP cardiovascular products and international sales, which increased 43 percent and 33 percent, respectively, on a year-over-year basis.

Year-over-year sales of the Triage® BNP Test products decreased 1 percent in the quarter. The decrease resulted from an anticipated decline in U.S. hospital sales of the product partially offset by growth in international and physician office sales, which increased 40 percent and 12 percent, respectively. The Company attributed the decline in U.S. hospital sales to an expected decline in the average price of the product.

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BIOSITE ANNOUNCES Q1 2007 EARNINGS                                                                                                                           -2-2-2-

·                  For the first quarter of 2007, GAAP diluted earnings per share was $0.66, compared with $0.68 for the first quarter of 2006. As previously reported, Biosite’s 2006 first quarter earnings per share was favorably affected by the resolution of certain tax contingencies amounting to $0.05 per diluted share following the completion of an Internal Revenue Service audit of certain prior years.

·                  GAAP operating income for the first quarter of 2007 was $18.1 million. In the comparable period of 2006, GAAP operating income was $18.5 million.

Following are financial highlights pertaining to revenues and cash flow for the three months ended March 31, 2007 and 2006:

($ in 000’s)

 

Three months ended

 

 

 

3/31/07

 

3/31/06

 

Change

 

Triage BNP Test sales

 

$

51,965

 

$

52,564

 

(1

%)

Other cardiovascular product sales

 

17,362

 

12,106

 

43

%

Other product sales

 

13,153

 

13,487

 

(2

%)

Total product sales

 

82,480

 

78,157

 

6

%

Total revenues

 

83,749

 

79,332

 

6

%

 

 

 

 

 

 

 

 

Cash flow from operations

 

$

32,296

 

$

31,025

 

 

 

Cash used for stock repurchases

 

$

 

30,000

 

 

 

 

 

3/31/07

 

12/31/06

 

Change

 

Cash and marketable securities balance

 

$

98,857

 

$

64,229

 

54

%

 

“The year is off to a sound start driven by 81 percent combined year-over-year growth in sales of our Triage Profiler Panel products and Triage D-Dimer Test along with strong results in physician office and international markets,” said Kim Blickenstaff, Biosite’s chairman and chief executive officer. “We believe this reflects efforts to diversify our revenue base and to capitalize on opportunities that exist for newer tests addressing important areas of cardiovascular medicine, such as acute coronary syndromes and pulmonary embolism.”

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BIOSITE ANNOUNCES Q1 2007 EARNINGS                                                                                                                           -3-3-3-

Research and Development

In the area of research and development, Biosite continued to advance several projects related to products currently under development:

·                  Activities relating to the clinical validation studies for the Triage MPO Test and a next generation Triage CardioProfiler® Panel continued to progress in the first quarter of 2007. The Company expects to file a Premarket Notification 510(k) submission with the U.S. Food and Drug Administration early in the third quarter of 2007 for the prognostic use of myeloperoxidase (MPO.) Plans aimed at international commercialization of the next generation Triage CardioProfiler Panel are also underway. The Company’s objective is to obtain CE marking for the product by mid-year 2007 and to immediately launch a post-market evaluation study to support future clinical publications.

The next generation Triage CardioProfiler Panel is designed to combine the cardiovascular markers on the present test panel with MPO and to incorporate Biosite’s MultiMarker Index™ Value algorithm.  MPO is believed to be useful as an aid in the early diagnosis of myocardial infarction and could signal risk for heart disease or heart attack in patients with chest pain or acute coronary syndromes.

·                  Biosite also confirmed that the training study for its Triage NGAL Test was launched in the first quarter of 2007.  The Company intends to file for CE marking of that product early in the third quarter of 2007. The Triage NGAL Test is being developed as an aid in the prognosis of kidney injury following cardiovascular surgery.

·                  As previously reported, preliminary data related to the Triage Sepsis Panel were presented at the 27th International Symposium on Intensive Care and Emergency Medicine. The data showed that the panel, made up of the biomarkers neutrophil gelatinase-associated lipocalin (NGAL), c-reactive protein (CRP) and macrophage inflammatory protein-3 (MIP-3), may be a clinically useful tool in the assessment of risk of sepsis progression within 72 hours of patients presenting to the emergency department and meeting the diagnostic criteria for sepsis.

·                  Biosite said that patient enrollment for the Triage Sepsis Panel validation study is on track to commence in May 2007. The study is aimed at generating data to support a U.S. regulatory submission. A filing for CE marking of the product is expected to be submitted in the third quarter of 2007.

·                  The pilot feasibility trial for a Triage BNP Test fingerstick device has been successfully completed and the validation study is anticipated to start later this year, following completion of development.

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BIOSITE ANNOUNCES Q1 2007 EARNINGS                                                                                                                           -4-4-4-

About Biosite Incorporated

Biosite Incorporated is a leading bio-medical company commercializing proteomics discoveries for the advancement of medical diagnosis. The Company’s products contribute to improvements in medical care by aiding physicians in the diagnosis of critical diseases and health conditions. The Biosite® Triage® rapid diagnostic tests are used in more than 70 percent of U.S. hospitals and in more than 60 international markets. Information on Biosite can be found at www.biosite.com.

Investor Conference Call

Biosite will host an investor conference call to discuss financial results and research and development progress. The call will take place today, April 24, 2007, at 1:30 p.m. Pacific. A live webcast of the call can be accessed via the Internet at www.biosite.com. The phone number is (617) 213-8832. The conference call code for the live call is 60807471. The call will be archived on the Biosite website for at least 21 days. The phone replay number is (888) 286-8010. International callers, please dial (617) 801-6888. Please reference the conference call code 50964236.

Forward Looking Statements

This press release contains 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. Examples of forward-looking statements are financial targets and growth objectives and also include but are 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. Forward-looking statements in this press release include statements regarding the Company’s expected financial performance for the 2007 fiscal year, such as anticipated revenues, operating margins and earnings per share, the Company’s ability to achieve growth targets in the international and physician office markets, the Company’s ability to maintain market share for cardiovascular testing, the Company’s plans to initiate and complete  proposed studies for the Triage MPO Test, the next generation Triage CardioProfiler Panel, the Triage NGAL Test, the Triage Sepsis Panel and the Triage BNP fingerstick device, as well as the Company’s plans to submit United States and foreign regulatory filings for those potential new products when expected. Risks and uncertainties include risks associated with Biosite’s ability to commence and complete clinical trials as currently planned, Biosite’s ability to obtain regulatory approvals and complete other pre-market activities needed to launch new products as currently planned, Biosite’s ability to manufacture new products on a commercial scale and in accordance with acceptable quality standards, Biosite’s ability to effectively promote and market acceptance of any new products, the continued growth of the BNP market generally, including the physician office market, the Company’s ability to effectively expand sales activities outside the United States, and other risks associated with changing market conditions and the effect of

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BIOSITE ANNOUNCES Q1 2007 EARNINGS                                                                                                                           -5-5-5-

competition from companies with greater capital and resources, including the impact on market pricing for BNP testing generally. Other risks that should be considered are detailed in the Company’s most recent Annual Report on Form 10-K and subsequent SEC filings. The Company disclaims, however, any intent or obligation to update these forward-looking statements. Copies of the Company’s SEC filings are available from the Investor Relations department or from the Company’s website.

###

Biosite®, Cardio Profiler®, Triage® and New Dimensions in Diagnosis® are registered trademarks of Biosite Incorporated. MultiMarker Index is a trademark of Biosite Incorporated.

 




Biosite Incorporated

Unaudited Statements of Income Data - GAAP

(In thousands, except per share data and margins)

 

 

 

Three months ended
March 31,

 

 

 

2007

 

2006

 

% Change

 

Total revenues:

 

 

 

 

 

 

 

Product sales

 

$

82,480

 

$

78,157

 

6

%

Contract revenue

 

1,269

 

1,175

 

8

%

Total revenues

 

83,749

 

79,332

 

6

%

 

 

 

 

 

 

 

 

Gross margin on product sales

 

69

%

70

%

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

Cost of product sales

 

25,565

 

23,105

 

11

%

Selling, general and administrative

 

26,552

 

23,966

 

11

%

Research and development

 

13,568

 

13,698

 

(1

%)

License and patent disputes

 

 

41

 

(100

%)

Total operating expenses

 

65,685

 

60,810

 

8

%

 

 

 

 

 

 

 

 

Operating income

 

18,064

 

18,522

 

(2

%)

 

 

 

 

 

 

 

 

Operating income as % of total revenue

 

22

%

23

%

 

 

 

 

 

 

 

 

 

 

Interest and other income, net

 

693

 

1,248

 

(44

%)

 

 

 

 

 

 

 

 

Income before provision for income taxes

 

18,757

 

19,770

 

(5

%)

 

 

 

 

 

 

 

 

Provision for income taxes

 

(7,472

)

(7,213

)

4

%

 

 

 

 

 

 

 

 

Net income

 

$

11,285

 

$

12,557

 

(10

%)

 

 

 

 

 

 

 

 

Diluted earnings per share

 

$

0.66

 

$

0.68

 

(3

%)

 

 

 

 

 

 

 

 

Diluted shares used in calculating per share amounts

 

17,060

 

18,601

 

 

 

 

Share-based compensation expense for stock options and the employee stock purchase plan recorded in accordance with FAS 123R for continuing operations:

 

Cost of product sales

 

$

773

 

$

222

 

248

%

Selling, general and administrative

 

3,069

 

4,022

 

(24

%)

Research and development

 

1,565

 

1,810

 

(14

%)

Subtotal

 

$

5,407

 

$

6,054

 

(11

%)

Tax benefit

 

(1,736

)

(1,639

)

6

%

Total

 

$

3,671

 

$

4,415

 

(17

%)

 




Biosite Incorporated

Selected Product Data

(In thousands, except margins and %’s)

 

Sales by Product:

 

 

 

 

 

 

 

 

 

 

 

 

 

Q1 2006

 

Q2 2006

 

Q3 2006

 

Q4 2006

 

Q1 2007

 

Triage® Drugs of Abuse Products

 

$

11,547

 

$

10,464

 

$

11,444

 

$

10,836

 

$

10,783

 

Triage Cardiac Panel

 

6,616

 

7,188

 

6,902

 

7,606

 

7,440

 

Triage BNP Tests

 

52,564

 

50,678

 

45,531

 

47,620

 

51,965

 

Triage Profiler Products

 

4,036

 

4,598

 

5,735

 

5,743

 

7,748

 

Triage D-Dimer Test

 

1,417

 

1,450

 

1,616

 

1,852

 

2,133

 

Triage Parasite Panel

 

286

 

337

 

377

 

360

 

320

 

Triage C. difficile Panel

 

1,029

 

1,088

 

1,022

 

977

 

1,272

 

Triage Meters

 

625

 

539

 

458

 

602

 

778

 

Triage Stroke Panel (EU)

 

37

 

30

 

26

 

25

 

41

 

Total Product Sales

 

$

78,157

 

$

76,372

 

$

73,111

 

$

75,621

 

$

82,480

 

 

International Sales:

 

 

 

 

 

 

 

 

 

 

 

 

 

Q1 2006

 

Q2 2006

 

Q3 2006

 

Q4 2006

 

Q1 2007

 

International Sales as % of Product Sales

 

14

%

15

%

14

%

16

%

18

%

BNP International Sales as % of BNP Total Sales

 

11

%

11

%

10

%

13

%

15

%

 

Margin by Product Type (a), (b):

 

 

 

 

 

 

 

 

 

 

 

 

 

Q1 2006

 

Q2 2006

 

Q3 2006

 

Q4 2006

 

Q1 2007

 

Triage Drugs of Abuse Product Line

 

79

%

77

%

73

%

78

%

78

%

Triage Cardiovascular Product Line (incl. BNP)

 

71

%

70

%

68

%

69

%

70

%


(a) These margins do not include all products.  The Triage Meters, Triage Micro Product Line and Triage Stroke Panel are not included.

(b) Includes the impact of FAS 123R, which relates to the expensing of non-cash stock-based compensation, beginning the first quarter of 2006




Biosite Incorporated

Unaudited Balance Sheet Data - GAAP

(In thousands)

 

 

 

March 31, 2007

 

December 31, 2006

 

 

 

Unaudited

 

 

 

Assets

 

 

 

 

 

Cash, cash equivalents & marketable securities

 

$

98,857

 

$

64,229

 

Accounts receivable

 

33,157

 

33,613

 

Inventories

 

32,729

 

33,154

 

Other current assets

 

13,700

 

14,603

 

Total current assets

 

178,443

 

145,599

 

 

 

 

 

 

 

Property, equipment and leasehold improvements, net

 

157,658

 

157,945

 

Patents and license rights, net

 

8,873

 

9,399

 

Other assets

 

15,307

 

13,644

 

Total assets

 

$

360,281

 

$

326,587

 

 

 

 

 

 

 

Liabilities and Stockholders' Equity

 

 

 

 

 

Current liabilities

 

$

39,793

 

$

34,669

 

Long-term liabilities

 

13,474

 

11,763

 

Stockholders' equity

 

307,014

 

280,155

 

Total liabilities and stockholders' equity

 

$

360,281

 

$

326,587