SAN DIEGO, April 24 /PRNewswire-FirstCall/ -- Biosite Incorporated 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(R) 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. * 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.”
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(R) 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(TM) 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.
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(R) Triage(R) 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 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(R), Cardio Profiler(R), Triage(R) and New Dimensions in Diagnosis(R) are registered trademarks of Biosite Incorporated. MultiMarker Index(TM) 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(R) 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
Biosite Incorporated
CONTACT: Nadine Padilla, VP, Corporate & Investor Relations of BiositeIncorporated, +1-858-805-2820, npadilla@biosite.com
Web site: http://www.biosite.com/
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