sidesh0wb0b
17 years ago
Income Statement Get Income Statement for: QDEL
View: Annual Data | Quarterly Data All numbers in thousands
PERIOD ENDING 31-Mar-08 31-Dec-07 30-Sep-07 30-Jun-07
Total Revenue 40,865 37,981 27,570 18,580
Cost of Revenue 14,127 15,146 11,159 9,316
Gross Profit 26,738 22,835 16,411 9,264
Operating Expenses
Research Development 3,067 3,081 3,128 3,282
Selling General and Administrative 8,959 7,248 8,213 7,846
Non Recurring - - - -
Others 1,151 1,342 1,329 1,298
Total Operating Expenses - - - -
Operating Income or Loss 13,561 11,164 3,741 (3,162)
Income from Continuing Operations
Total Other Income/Expenses Net 516 406 440 526
Earnings Before Interest And Taxes 14,077 11,570 4,181 (2,636)
Interest Expense 175 178 182 193
Income Before Tax 13,902 11,392 3,999 (2,829)
Income Tax Expense 5,352 3,286 1,579 (1,117)
Minority Interest - - - -
Net Income From Continuing Ops 8,550 8,106 2,420 (1,712)
Non-recurring Events
Discontinued Operations - - - -
Extraordinary Items - - - -
Effect Of Accounting Changes - - - -
Other Items - - - -
Net Income 8,550 8,106 2,420 (1,712)
Preferred Stock And Other Adjustments - - - -
Net Income Applicable To Common Shares $8,550 $8,106 $2,420 ($1,712)
sidesh0wb0b
17 years ago
Form 10-Q for QUIDEL CORP /DE/
25-Apr-2008
Quarterly Report
ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations
In this quarterly report, all references to "we," "our" and "us" refer to Quidel Corporation and its subsidiaries.
Future Uncertainties and Forward-Looking Statements
This Report on Form 10-Q contains forward-looking statements within the meaning of the federal securities laws that involve material risks, assumptions and uncertainties. Many possible events or factors could affect our future financial results and performance, such that our actual results and performance may differ materially. As a result, no forward-looking statement can be guaranteed. Differences in actual results and performance may arise as a result of a number of factors including, without limitation, seasonality, the timing of onset, length and severity of cold and flu seasons, uncertainty surrounding the detection of novel influenza viruses involving human specimens, adverse changes in the competitive and economic conditions in domestic and international markets, actions of our major distributors, technological changes and uncertainty with research and technology development, including any future molecular-based technology, the reimbursement system currently in place and future changes to that system, manufacturing and production delays or difficulties, adverse actions or delays in product reviews by the U.S. Food and Drug Administration (the "FDA"), intellectual property, product liability, environmental or other litigation, required patent license fee payments not currently reflected in our costs, potential inadequacy of booked reserves and possible impairment of goodwill, and lower-than-anticipated sales or market penetration of our new products. Forward-looking statements typically are identified by the use of terms such as "may," "will," "should," "might," "expect," "anticipate," "estimate," and similar words, although some forward-looking statements are expressed differently. The risks described under "Risk Factors" in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2007, and elsewhere herein and in reports and registration statements that we file with the Securities and Exchange Commission (the "SEC") from time to time, should be carefully considered. You are cautioned not to place undue reliance on these forward-looking statements, which reflect management's analysis only as of the date of this Quarterly Report. The following should be read in conjunction with the Consolidated Financial Statements and notes thereto beginning on page 3 of this Quarterly Report. Except as required by law, we undertake no obligation to publicly release the results of any revision or update of these forward-looking statements.
Overview
We have a leadership position in the development, manufacturing and marketing of rapid diagnostic solutions at the point-of-care ("POC") in infectious diseases and reproductive and women's health. We focus on POC testing solutions specifically developed for the physician office lab and acute care markets globally. We sell our products to professionals for use in physician offices, hospitals, clinical laboratories, retail clinics and wellness screening centers. We market our products in the U.S. through a network of national and regional distributors, supported by a direct sales force. Internationally, we sell and market primarily in Japan and Europe by channeling products through distributor organizations and sales agents.
Our total revenues increased to $40.9 million for the three months ended March 31, 2008 from $33.9 million for the three months ended March 31, 2007. This growth was largely driven by increased domestic sales of our infectious disease products and included the impact of the timing of the 2007/2008 flu season. We continued to focus our efforts to strengthen market and brand leadership in infectious disease and reproductive and women's health by delivering economic and clinical proof through our Quidel Value Build™ ("QVB™") program.
We derive a significant portion of our total revenue from two product categories. For the three months ended March, 31 2008 and 2007, we derived approximately 92% and 88%, respectively, of our total revenue from sales of our infectious disease and reproductive and women's health categories. Additionally, we derive a significant portion of our total revenue from a relatively small number of distributors. Approximately 56% and 52% of our total revenue for the three months ended March 31, 2008 and 2007, respectively, were derived from sales through our four largest distributors.
Outlook
For fiscal year 2008, we anticipate continued year-over-year revenue growth in our infectious disease and reproductive and women's health product lines. We expect gross margins will continue to be positively affected by a more favorable product and geographical mix, increased unit volumes and to a lesser extent overall increased average selling prices. While we experienced significant year-over-year growth of our immunoassay fecal occult blood ("iFOB") test in 2007, we continue to expect a gradual conversion of the fecal occult blood test market from the current guaiac-based test to an immunochemical-based test. Successful conversion of this market requires changing physician behavior through education, focused in part on clinical and economic validation. Additionally, we expect our QuickVue® RSV test for the qualitative detection of respiratory syncytial virus ("RSV") to be a well-received companion test to our QuickVue® Influenza test so that physicians are well prepared to diagnose and appropriately manage patients with influenza and/or RSV. We received Clinical Laboratory Improvement Amendments of 1988 ("CLIA") waiver on our RSV test in February 2008. Internationally, we expect our previously announced global alliance with bioMérieux to increase the reach of our products to markets around the world. Consistent with recent historical periods, the Company has grown operating expenses at a rate less than our revenue growth rate, and we expect this to continue for fiscal 2008.
Results of Operations
Total Revenues and Gross Margin
Three months ended March 31, 2008 compared to three months ended March 31, 2007
The following table compares revenues and gross margin for the three months
ended March 31, 2008 and 2007 (in thousands, except percentages):
For the three months
ended March 31,
------------------------- $ increase % increase
2008 2007 (decrease) (decrease)
---------- ---------- ------------ ----------
Net product sales $ 40,614 $ 33,654 $ 6,960 21 %
Royalty income 251 280 (29 ) (10 )%
---------- ---------- ------------ ----------
Total revenues $ 40,865 $ 33,934 $ 6,931 20 %
---------- ---------- ------------ ----------
sidesh0wb0b
17 years ago
Quidel Corporation Q1 2008 Earnings Call Transcript
Quidel Corporation (QDEL)
Q1 2008 Earnings Call
April 23, 2008 5:00 pm ET
Executives
John Radak - CFO
Caren Mason - President and CEO
Analysts
Jeff Frelick - Lazard Capital Markets
Un Kwon-Casado - Pacific Growth Equities
Keay Nakae from Collins Stewart
Zarak Khurshid - Caris & Company
Scott Gleason - Stephens Inc
Steven Crowley - Craig-Hallum
Presentation
Operator
Good day, ladies and gentlemen, and welcome to the Quidel first quarter 2008 conference call. My name is Cynthia, and I will be your operator for today's call. (Operator Instructions) As a reminder, this call is being recorded for replay purposes.
I would now like to turn the call over to your host, Mr. John Radak, Chief Financial Officer. Please proceed.
John Radak
Thank you, and good afternoon to everyone. Thank you for participating in today's call. Joining me today is our President and Chief Executive Officer, Caren Mason. Earlier this afternoon Quidel released financial results for its three months ended March 31, 2008. If you've not received this news release, or if you would like to be added to the Company's distribution list, please call, Rachel Lipsit at Porter Novelli Life Sciences, at 619-849-5378.
Please note that this conference call will include forward-looking statements within the meaning of federal securities laws. It is possible that actual results and performance could differ materially from these stated expectations. For a discussion of risk factors, please review Quidel's Annual Report on Form 10-K and subsequent quarterly reports on Form 10-Q as filed with the SEC.
Furthermore, this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, today, April 23, 2008. Quidel undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call.
Turning to the financial results for the first quarter of 2008. We are very pleased with our business performance this quarter, as our margin expansion continued on double-digit revenue growth. Total revenues for the first quarter were $40.9 million, a 20% increase over the same quarter a year ago. We saw very strong growth in the U.S. market, where revenues increased 26% over Q1 of 2007. As expected, our international revenues declined 13%, largely as a result of continued pricing and reimbursement issues in the Japan flu market.
Excluding Japan flu sales, our international business posted a 48% revenue growth over Q1 of 2007. For the first quarter of 2008, worldwide infectious disease revenues increased 34% to $32.2 million, compared to $24 million in the first quarter of 2007. As we discussed on our previous earnings call, we experienced a shift in normal distribution reorders of our QuickVue influenza test from December of '07 into the first quarter of '08, contributing to record domestic quarterly flu growth of 80%. While a portion of this growth can be attributed to the impact of the late influenza season.
The primary growth drivers also include additional flu test adoption, higher test utilization and increased acute-care market share, all in the U.S. If we compare the '07 and '08 flu season to the '06 to '07 flu season, our domestic test sales increased 44%, and we expect distributor's to have an appropriate level of inventory heading into next year's flu season.
Also contributing to the infectious disease growth was a very solid performance from our RSV test, as a result of gains in the acute-care market. Even though, we received CLIA waiver for our QuickVue RSV test in late February, it was too late in the quarter, for a meaningful contribution from the physician office market. However, we have high expectations for this product next season, as we have already begun to market it to physician offices. In the first quarter of this year, revenues from our reproduct in women's health product family were $5.5 million, compared to $5.9 million, a decline of 6% from the corresponding quarter of 2007. The softness in the first quarter is not unusual given the strong performance of this product category in the fourth quarter of 2007.
Revenues from our other product lines, which include fecal immunochemical test, FIT, for colorectal cancer screening, and our veterinary product line, were $3.1 million in the first quarter of 2008, compared to $4 million in the first quarter of the prior year. The majority of this decline came from our veterinary products that had an exceptionally strong Q1 of 2007. Gross margin came in at 65.4% for the first quarter, a 360 basis point improvement over last year's first quarter, primarily due to higher than normal flu test sales in the quarter.
***more at***
http://seekingalpha.com/article/74418-quidel-corporation-q1-2008-earnings-call-transcript?source=yahoo
sidesh0wb0b
17 years ago
QDEL financials
PERIOD ENDING 31-Dec-07 30-Sep-07 30-Jun-07 31-Mar-07
Total Revenue 37,981 27,570 18,580 33,934
Cost of Revenue 15,146 11,159 9,316 12,952
Gross Profit 22,835 16,411 9,264 20,982
Operating Expenses
Research Development 3,081 3,128 3,282 3,364
Selling General and Administrative 7,248 8,213 7,846 8,351
Non Recurring - - - -
Others 1,342 1,329 1,298 1,524
Total Operating Expenses - - - -
Operating Income or Loss 11,164 3,741 (3,162) 7,743
Income from Continuing Operations
Total Other Income/Expenses Net 406 440 526 402
Earnings Before Interest And Taxes 11,570 4,181 (2,636) 8,145
Interest Expense 178 182 193 183
Income Before Tax 11,392 3,999 (2,829) 7,962
Income Tax Expense 3,286 1,579 (1,117) 3,145
Minority Interest - - - -
Net Income From Continuing Ops 8,106 2,420 (1,712) 4,817
Non-recurring Events
Discontinued Operations - - - -
Extraordinary Items - - - -
Effect Of Accounting Changes - - - -
Other Items - - - -
Net Income 8,106 2,420 (1,712) 4,817
Preferred Stock And Other Adjustments - - - -
Net Income Applicable To Common Shares $8,106 $2,420 ($1,712) $4,817
sidesh0wb0b
17 years ago
Form 10-K for QUIDEL CORP /DE/
4-Mar-2008
Annual Report
Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operation
The following discussion of our financial condition and results of operation contains forward-looking statements within the meaning of the federal securities laws that involve material risks and uncertainties. This discussion should be read in conjunction with "A Warning About Forward-Looking Statements" on page 2 and "Risk Factors" under Item 1A of this Annual Report. In addition, our discussion of the financial condition and results of operation of Quidel Corporation in this Item 7 should be read in conjunction with our Consolidated Financial Statements and the related notes included elsewhere in this Annual Report.
Executive Summary
We have a leadership position in the development, manufacturing and marketing of rapid diagnostic solutions at the point-of-care ("POC") in infectious diseases and reproductive and women's health. We focus on POC testing solutions specifically developed for the physician office lab ("POL") and acute care markets globally. We primarily earn revenue from sales of products for use in physician offices, hospitals, clinical laboratories, retail clinics and wellness screening centers. We market our products in the U.S. through a network of national and regional distributors, supported by a direct sales force. Internationally, we sell and market primarily in Japan and Europe by channeling products through distributor organizations and sales agents. Starting in May 2008, bioMerieux S.A. ("bioMerieux") will become our exclusive distributor for all of our current QuickVue® rapid diagnostic tests in all regions except the U.S., Japan and Scandinavia.
A majority of our total revenues relate to three product families. For the years ended December 31, 2007, 2006 and 2005, we derived approximately 81%, 82% and 78%, respectively, of our total revenues from sales of our influenza, Group A Strep and pregnancy tests. Additionally, a significant portion of our total revenue are from a relatively small number of distributors. Approximately 52%, 59% and 63% of our total revenue for the years ended December 31, 2007, 2006 and 2005, respectively, were related to sales through our four largest distributors in each of those periods.
We also develop research products through our Specialty Products Group (the "SPG") with an emphasis on potential future rapid test applications. The SPG is currently responsible for more than 100 of our clinical and research products used worldwide in reference laboratories and in research applications at leading universities and biotechnology companies. The SPG revenues, income and assets are less than 10% of our overall operations.
Our net revenue increased to $118.1 million for the year ended December 31, 2007 from $106.0 million for the year ended December 31, 2006. This was largely driven by increased domestic sales of our infectious disease and reproductive and women's health products as we continued to focus our efforts to strengthen market and brand leadership in infectious disease and reproductive and women's health by delivering economic and clinical proof through our efforts with our Quidel Value Build™ ("QVB™") program. Our POC testing solutions are designed to provide specialized results that meet two important value criteria that we have branded as QVB™:
º •
º Clinical validation: the enabling of rapid patient management decisions leading to improved treatment and outcomes.
º •
º Economic validation: the reduction of overall costs associated with patient testing with emphasis upon critical reimbursement and payer performance criteria.
We focus on ensuring market leadership and providing points of differentiation by specializing in the diagnosis and monitoring of selected disease states. In order to support our value proposition as a company that markets the highest quality products in support of better medical outcomes, we are highlighting our QVB™ through the development of new innovations and the communication of new
solutions in the field of rapid diagnostic testing. Our QVB™ includes significant work in understanding the needs of the end-use customer, building products that meet those needs, providing proof studies to validate rapid diagnostic testing at the point-of-care and leveraging the work of researchers and key opinion leaders studying our tests and technology to help enhance the health and well being of people around the globe. Our marketing strategy includes ensuring each of our key product portfolios is supported by economic and clinical validation that shows hospitals, acute care facilities and POC clinicians that these tests deliver high quality results in a cost-effective manner.
We believe that the trend among healthcare providers to adopt POC testing continues to increase, and demographic changes, reimbursement policies, a shortage of skilled laboratory workers and the availability of clinically valuable tests will increase growth in this diagnostic category. More and more employers, health plans and payers are recognizing that POC testing is a cost-effective means for improving the quality of care and patient satisfaction. Continuous improvements in technologies are resulting in a growing number of new diagnostic tests that combine high levels of accuracy with rapid, easy-to-use product formats. It is our mission to further establish our significant leadership position in POC rapid diagnostics. In order to accomplish this mission, our strategy is to:
º •
º provide clinicians with validated, evidence-based proof which encompasses the clinical efficacy and economic efficiency of our rapid POC tests for the professional market. In conjunction with our QVB™ commitment, we expect to present ongoing information that supports the adoption of rapid POC testing;
º •
º continue to focus on strengthening our market and brand leadership in infectious diseases and reproductive and women's health by acquiring, developing and introducing clinically and economically superior diagnostic solutions;
º •
º drive growth by establishing dedicated distributor partnerships with aggressive performance metrics and expanding our sales organization to assure physician and laboratorian satisfaction through direct relationships with Integrated Delivery Networks and hospitals;
º •
º support payer evaluation of rapid tests and establishment of favorable reimbursement rates;
º •
º as healthcare management continues to move closer to the patient, develop test formats which meet the rigorous requirements for over-the-counter test performance;
º •
º continue creation of strong global alliances to assure leadership in key markets;
º •
º drive profit through further refinement of our manufacturing efficiencies and productivity improvements, with continued focus on profitable products and markets and our effort to create exceptional competency in new product development process management;
º •
º continue to focus our research and development efforts on three areas:
1) new proprietary product platform development, 2) the creation of improved products and new products for existing markets, and
3) products developed under collaborations with other companies for new and existing markets; and
º •
º identify and commercialize new markers, products and collaborations in bone health through the SPG. We believe we can capitalize upon our existing microwell plate platform core competencies and long-standing collaborations with key researchers worldwide, which may assist with identifying, developing and producing unique diagnostic and research products targeted at disease state mastery. We characterize this direction as a dedicated focus on Research to Rapids™. These assays and reagents may be used by customers throughout the continuum-of-care in the diagnosis of disease and monitoring of therapy to the development of novel therapeutics.
As a business in a highly regulated and competitive industry, we face many risks and challenges and we also have opportunities. There are many economic and industry factors that affect our business; some of the more important factors are outlined below:
º •
º sales of our infectious disease products, which have collectively accounted for approximately 64%, 65% and 59% of total revenue for the years ended December 31, 2007, 2006 and 2005, respectively, are subject to and significantly affected by the seasonal demands of the cold and flu seasons;
º •
º sales of our products can be affected significantly by many competitive factors, including convenience, price and product performance as well as the distribution, advertising, promotion and brand name recognition of the marketer;
º •
º intellectual property protection of our products is crucial to our business;
º •
º the testing, manufacture and commercialization of our products are subject to regulation by numerous governmental authorities, principally the FDA and corresponding state and foreign regulatory agencies;
º •
º the production processes for POC tests are complex, highly regulated and vary widely from product to product;
º •
º to successfully compete for business in our industry, we believe our POC testing solutions must be designed to provide specific results for clinical and economic validation; and
º •
º there has been a trend toward industry consolidation in our markets over the last several years.
We have entered into an agreement to form a long-term global alliance with bioMerieux in the area of rapid clinical diagnostics for the point-of-care. Starting in May 2008, bioMerieux will become our primary distributor for our current QuickVue® rapid diagnostic tests in all regions except the U.S., Japan and Scandinavia.
In September 2007, we entered an exclusive partnership to provide Roche Pharma AG with the QuickVue® Influenza A+B rapid diagnostic test for marketing activities related to its Tamiflu® (Oseltamivir) antiviral drug for the 2007-2008 influenza season in Germany. The agreement will leverage the strength and speed of the QuickVue® rapid test to help characterize influenza infection along with the Tamiflu® treatment to improve patient recovery time. Subsequently, we also launched a pilot program with Roche in the U.S. for the 2007-08 flu season, which complements the collaboration already underway in Germany.
Outlook
For fiscal year 2008, we anticipate continued year-over-year revenue growth in our infectious disease and reproductive and women's health product lines. We expect gross margins will continue to be positively affected by a more favorable product and geographical mix, increased unit volumes and to a lesser extent increased average selling prices. While we experienced significant year-over-year growth of our immunoassay fecal occult blood test ("iFOB") in 2007, we continue to expect a gradual conversion of the fecal occult blood test market from the current guaiac-based test to an immunochemical-based test. Successful conversion of this market requires changing physician behavior through education, focused in part on clinical and economic validation. Additionally, we expect our respiratory syncytial virus ("RSV") product to be a well-received companion test to our QuickVue® Influenza test so that physicians are well prepared to diagnose and appropriately manage patients with influenza and/or RSV. We received Clinical Laboratory Improvement Amendments of 1988 ("CLIA") waiver on our RSV test in February 2008. Internationally, we expect our global alliance with bioMerieux to increase the reach of our products to markets around the world. Over recent historical
periods, the company has grown operating expenses at a rate less than our revenue growth rate, and we expect this to continue for fiscal 2008.
You should also refer to the discussion in Item 1A, "Risk Factors" in Part I of this Annual Report for further discussion of risks related to our business.
Results of Operations
Comparison of years ended December 31, 2007 and 2006
Total Revenues
The following table compares total revenues for the years ended December 31, 2007 and 2006 (in thousands, except percentages):
For the year ended
December 31, Increase (decrease)
---------------------- -----------------------
2007 2006 $ %
---------- --------- --------------- ----
Net product sales $ 116,890 $ 104,732 $ 12,158 12 %
Royalty income and license fees 1,175 1,283 (108 ) (8 )%
---------- --------- ---------------
Total revenues $ 118,065 $ 106,015 $ 12,050 11 %
---------- --------- ---------------
Greencake
17 years ago
Tue 6:01am QDEL QUIDEL CORP /DE/ Files SEC form 10-K, Annual Report - EDGAR Online
Mar-2008
Annual Report
Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operation
The following discussion of our financial condition and results of operation contains forward-looking statements within the meaning of the federal securities laws that involve material risks and uncertainties. This discussion should be read in conjunction with "A Warning About Forward-Looking Statements" on page 2 and "Risk Factors" under Item 1A of this Annual Report. In addition, our discussion of the financial condition and results of operation of Quidel Corporation in this Item 7 should be read in conjunction with our Consolidated Financial Statements and the related notes included elsewhere in this Annual Report.
Executive Summary
We have a leadership position in the development, manufacturing and marketing of rapid diagnostic solutions at the point-of-care ("POC") in infectious diseases and reproductive and women's health. We focus on POC testing solutions specifically developed for the physician office lab ("POL") and acute care markets globally. We primarily earn revenue from sales of products for use in physician offices, hospitals, clinical laboratories, retail clinics and wellness screening centers. We market our products in the U.S. through a network of national and regional distributors, supported by a direct sales force. Internationally, we sell and market primarily in Japan and Europe by channeling products through distributor organizations and sales agents. Starting in May 2008, bioMerieux S.A. ("bioMerieux") will become our exclusive distributor for all of our current QuickVue® rapid diagnostic tests in all regions except the U.S., Japan and Scandinavia.
A majority of our total revenues relate to three product families. For the years ended December 31, 2007, 2006 and 2005, we derived approximately 81%, 82% and 78%, respectively, of our total revenues from sales of our influenza, Group A Strep and pregnancy tests. Additionally, a significant portion of our total revenue are from a relatively small number of distributors. Approximately 52%, 59% and 63% of our total revenue for the years ended December 31, 2007, 2006 and 2005, respectively, were related to sales through our four largest distributors in each of those periods.
We also develop research products through our Specialty Products Group (the "SPG") with an emphasis on potential future rapid test applications. The SPG is currently responsible for more than 100 of our clinical and research products used worldwide in reference laboratories and in research applications at leading universities and biotechnology companies. The SPG revenues, income and assets are less than 10% of our overall operations.
Our net revenue increased to $118.1 million for the year ended December 31, 2007 from $106.0 million for the year ended December 31, 2006. This was largely driven by increased domestic sales of our infectious disease and reproductive and women's health products as we continued to focus our efforts to strengthen market and brand leadership in infectious disease and reproductive and women's health by delivering economic and clinical proof through our efforts with our Quidel Value Build™ ("QVB™") program. Our POC testing solutions are designed to provide specialized results that meet two important value criteria that we have branded as QVB™:
º •
º Clinical validation: the enabling of rapid patient management decisions leading to improved treatment and outcomes.
º •
º Economic validation: the reduction of overall costs associated with patient testing with emphasis upon critical reimbursement and payer performance criteria.
We focus on ensuring market leadership and providing points of differentiation by specializing in the diagnosis and monitoring of selected disease states. In order to support our value proposition as a company that markets the highest quality products in support of better medical outcomes, we are highlighting our QVB™ through the development of new innovations and the communication of new
--------------------------------------------------------------------------------
solutions in the field of rapid diagnostic testing. Our QVB™ includes significant work in understanding the needs of the end-use customer, building products that meet those needs, providing proof studies to validate rapid diagnostic testing at the point-of-care and leveraging the work of researchers and key opinion leaders studying our tests and technology to help enhance the health and well being of people around the globe. Our marketing strategy includes ensuring each of our key product portfolios is supported by economic and clinical validation that shows hospitals, acute care facilities and POC clinicians that these tests deliver high quality results in a cost-effective manner.
We believe that the trend among healthcare providers to adopt POC testing continues to increase, and demographic changes, reimbursement policies, a shortage of skilled laboratory workers and the availability of clinically valuable tests will increase growth in this diagnostic category. More and more employers, health plans and payers are recognizing that POC testing is a cost-effective means for improving the quality of care and patient satisfaction. Continuous improvements in technologies are resulting in a growing number of new diagnostic tests that combine high levels of accuracy with rapid, easy-to-use product formats. It is our mission to further establish our significant leadership position in POC rapid diagnostics. In order to accomplish this mission, our strategy is to:
º •
º provide clinicians with validated, evidence-based proof which encompasses the clinical efficacy and economic efficiency of our rapid POC tests for the professional market. In conjunction with our QVB™ commitment, we expect to present ongoing information that supports the adoption of rapid POC testing;
º •
º continue to focus on strengthening our market and brand leadership in infectious diseases and reproductive and women's health by acquiring, developing and introducing clinically and economically superior diagnostic solutions;
º •
º drive growth by establishing dedicated distributor partnerships with aggressive performance metrics and expanding our sales organization to assure physician and laboratorian satisfaction through direct relationships with Integrated Delivery Networks and hospitals;
º •
º support payer evaluation of rapid tests and establishment of favorable reimbursement rates;
º •
º as healthcare management continues to move closer to the patient, develop test formats which meet the rigorous requirements for over-the-counter test performance;
º •
º continue creation of strong global alliances to assure leadership in key markets;
º •
º drive profit through further refinement of our manufacturing efficiencies and productivity improvements, with continued focus on profitable products and markets and our effort to create exceptional competency in new product development process management;
º •
º continue to focus our research and development efforts on three areas:
1) new proprietary product platform development, 2) the creation of improved products and new products for existing markets, and
3) products developed under collaborations with other companies for new and existing markets; and
º •
º identify and commercialize new markers, products and collaborations in bone health through the SPG. We believe we can capitalize upon our existing microwell plate platform core competencies and long-standing collaborations with key researchers worldwide, which may assist with identifying, developing and producing unique diagnostic and research products targeted at disease state mastery. We characterize this direction as a dedicated focus on Research to Rapids™. These assays and reagents may be used by customers throughout the continuum-of-care in the diagnosis of disease and monitoring of therapy to the development of novel therapeutics.
--------------------------------------------------------------------------------
As a business in a highly regulated and competitive industry, we face many risks and challenges and we also have opportunities. There are many economic and industry factors that affect our business; some of the more important factors are outlined below:
º •
º sales of our infectious disease products, which have collectively accounted for approximately 64%, 65% and 59% of total revenue for the years ended December 31, 2007, 2006 and 2005, respectively, are subject to and significantly affected by the seasonal demands of the cold and flu seasons;
º •
º sales of our products can be affected significantly by many competitive factors, including convenience, price and product performance as well as the distribution, advertising, promotion and brand name recognition of the marketer;
º •
º intellectual property protection of our products is crucial to our business;
º •
º the testing, manufacture and commercialization of our products are subject to regulation by numerous governmental authorities, principally the FDA and corresponding state and foreign regulatory agencies;
º •
º the production processes for POC tests are complex, highly regulated and vary widely from product to product;
º •
º to successfully compete for business in our industry, we believe our POC testing solutions must be designed to provide specific results for clinical and economic validation; and
º •
º there has been a trend toward industry consolidation in our markets over the last several years.
We have entered into an agreement to form a long-term global alliance with bioMerieux in the area of rapid clinical diagnostics for the point-of-care. Starting in May 2008, bioMerieux will become our primary distributor for our current QuickVue® rapid diagnostic tests in all regions except the U.S., Japan and Scandinavia.
In September 2007, we entered an exclusive partnership to provide Roche Pharma AG with the QuickVue® Influenza A+B rapid diagnostic test for marketing activities related to its Tamiflu® (Oseltamivir) antiviral drug for the 2007-2008 influenza season in Germany. The agreement will leverage the strength and speed of the QuickVue® rapid test to help characterize influenza infection along with the Tamiflu® treatment to improve patient recovery time. Subsequently, we also launched a pilot program with Roche in the U.S. for the 2007-08 flu season, which complements the collaboration already underway in Germany.
Outlook
For fiscal year 2008, we anticipate continued year-over-year revenue growth in our infectious disease and reproductive and women's health product lines. We expect gross margins will continue to be positively affected by a more favorable product and geographical mix, increased unit volumes and to a lesser extent increased average selling prices. While we experienced significant year-over-year growth of our immunoassay fecal occult blood test ("iFOB") in 2007, we continue to expect a gradual conversion of the fecal occult blood test market from the current guaiac-based test to an immunochemical-based test. Successful conversion of this market requires changing physician behavior through education, focused in part on clinical and economic validation. Additionally, we expect our respiratory syncytial virus ("RSV") product to be a well-received companion test to our QuickVue® Influenza test so that physicians are well prepared to diagnose and appropriately manage patients with influenza and/or RSV. We received Clinical Laboratory Improvement Amendments of 1988 ("CLIA") waiver on our RSV test in February 2008. Internationally, we expect our global alliance with bioMerieux to increase the reach of our products to markets around the world. Over recent historical
--------------------------------------------------------------------------------
periods, the company has grown operating expenses at a rate less than our revenue growth rate, and we expect this to continue for fiscal 2008.
You should also refer to the discussion in Item 1A, "Risk Factors" in Part I of this Annual Report for further discussion of risks related to our business.
Results of Operations
Comparison of years ended December 31, 2007 and 2006
Total Revenues
The following table compares total revenues for the years ended December 31, 2007 and 2006 (in thousands, except percentages):
For the year ended
December 31, Increase (decrease)
---------------------- -----------------------
2007 2006 $ %
---------- --------- --------------- ----
Net product sales $ 116,890 $ 104,732 $ 12,158 12 %
Royalty income and license fees 1,175 1,283 (108 ) (8 )%
---------- --------- ---------------
Total revenues $ 118,065 $ 106,015 $ 12,050 11 %
---------- --------- ---------------
The increase was largely driven by an increase in sales of our infectious disease and reproductive and women's health products of $7.3 million and $2.4 million, respectively. The overall increase was partially offset by an expected decrease of our influenza product revenues in our Japanese market. We believe the increase in total revenue from these product groups was due to successes related to our QVB™ programs, which have resulted in strengthened customer relationships and preferred partnership programs. We believe that sales of our influenza products continue to increase as a result of increased market awareness, greater utilization and the demonstrated quality of our test. We believe our average selling price in the U.S. has continued to increase largely as a result of our clinical proof claims and product quality, while we have experienced downward pressure in the Japanese market as a result of reimbursement changes and increased competition. Sales of our infectious disease and reproductive and women's health products accounted for 88% and 89% of our total revenue for the years ended December 31, 2007 and 2006, respectively.
The revenue from royalty income and license fees for all periods primarily relate to royalty payments earned on patented technologies of ours utilized by third parties.
Cost of Sales
Cost of sales increased 8% to $48.6 million, or 41% of total revenue, for the year ended December 31, 2007 compared to $44.8 million, or 42% of total revenues, for the year ended December 31, 2006. The absolute dollar increase was primarily related to the increase in direct costs (material and labor) associated with the 11% increase in total revenues. The percentage decrease in cost of sales to revenue was primarily due to a more favorable product and geographic mix and the leveraging of fixed costs associated with higher unit volume and increased average selling prices.
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Operating Expenses
The following table compares operating expenses for the years ended
December 31, 2007 and 2006 (in thousands, except percentages):
For the year ended December 31,
-------------------------------------------------- Increase
2007 2006 (decrease)
----------------------- ------------------------ ----------------
As a % of As a % of
Operating total Operating total
expenses revenues expenses revenues $ %
----------- --------- ------------ --------- --------- --
Research and development $ 12,855 11 % $ 13,047 12 % $ (192 ) (1 )%
Sales and marketing 18,491 16 % 16,966 16 % 1,525 9 %
General and administrative 13,167 11 % 12,770 12 % 397 3 %
Amortization of intangible assets 5,493 5 % 4,580 4 % 913 20 %
Research and Development Expense
Our research and development expenses were relatively constant. While we may experience some fluctuation in our research and development activities associated with the timing of certain projects, the primary components of research and development expense are personnel and material costs associated with development of potential new technologies and processes and with products under development. In addition, we continue to incur costs related to intellectual property, clinical activity as well as our overall efforts under our QVB™ programs.
Sales and Marketing Expense
The increase in sales and marketing expense was primarily related to an overall increase in sales personnel and related programs and expenses, which support our leadership position and strategies to capitalize further on opportunities in POC diagnostics. Other key components of this expense relate to continued investment in assessing future product extensions and enhancements, market research (including voice of customer surveys), programs aimed at distribution partners and end-user customers and reimbursement-related activities and product shipment costs.
General and Administrative Expense
The increase in general and administrative expenses was primary driven by increased stock compensation expense and costs associated with the departure of our former Chief Financial Officer and hiring a new Chief Financial Officer.
Amortization of Intangible Assets
The increase in the amortization of intangible assets was primarily due to a license agreement entered into during late 2006 and an additional license agreement entered into during 2007.
Other Income (Expense)
Interest income was $1.9 million and $1.4 million for the years ended December 31, 2007 and 2006, respectively. The increase in interest income was largely related to the increase in our average cash balance as well as more favorable interest rates for the year ended December 31, 2007 as compared to the prior year. Interest expense was relatively constant at $0.7 million for both of the years ended December 31, 2007 and 2006. Interest expense relates to interest paid on obligations under capital leases, primarily associated with our San Diego facility.
--------------------------------------------------------------------------------
Income Taxes
We recognized income tax expense of $6.9 million for the year ended December 31, 2007 versus a tax benefit of $5.9 million for the year ended December 31, 2006. Income tax expense for 2007 includes a reduction of $0.7 million for the completion of a research and development tax credit study for prior years. For 2006, we recorded a tax benefit which was primarily related to a decrease in the deferred tax valuation allowance during the fourth quarter ended December 31, 2006 and recognizes the deferred tax asset amount considered by management, more likely than not, to be realized.
Comparison of years ended December 31, 2006 and 2005
Total Revenues
The following table compares total revenues for the years ended December 31, 2006 and 2005 (in thousands, except percentages):
For the year ended
December 31, Increase (decrease)
----------------------- ------------------------
2006 2005 $ %
---------- --------- -------------- ------
Net product sales $ 104,732 $ 88,731 $ 16,001 18 %
Research contracts, license fees and 1,283 3,568 (2,285 ) (64 )%
royalty income
---------- --------- --------------
Total revenues $ 106,015 $ 92,299 $ 13,716 15 %
---------- --------- --------------
The increase in total revenue was largely driven by an increase in sales of our infectious disease products of $14.3 million. The overall increase was partially offset by a decrease of influenza product revenues in our Japanese market. For the year ended December 31, 2006, we believe revenue from these products continued to increase due to successes related to our QVB™ programs, which have resulted in strengthened customer relationships and preferred partnership programs. We believe that sales of our infectious disease products continued to increase as a result of increased market awareness and the demonstrated quality of our test. We believe our average selling price in the U.S. continued to increase largely as a result of our clinical proof claims and product quality, while we experienced downward pressure in the Japanese market as a result of reimbursement changes and increased competition. This product line collectively accounted for 65% and 59% of our total revenue for the years ended December 31, 2006 and 2005, respectively.
Research Contracts, License Fees and Royalty Income
The decrease for the year ended December 31, 2006 was primarily related to research contract revenue that we earned during the year ended December 31, 2005 in connection with achieving certain milestones under a joint development agreement with another company. During the second quarter of 2005, the joint development agreement was terminated. The balance of this revenue for all periods primarily relates to royalty payments earned on patented technologies of ours utilized by third parties.
Cost of Sales
Cost of sales increased 21% to $44.8 million, or 42% of total revenue for the year ended December 31, 2006 compared to $37.1 million, or 40% of total revenues for the year ended December 31, 2005. The absolute dollar increase was primarily related to the increase in direct costs (material and labor) associated with the 15% increase in total revenues. The percentage increase in cost of sales to revenue was primarily due to the 8.5% royalty we began paying on the majority of our products during the second quarter of 2005 related to the patent litigation settlement with Inverness Medical Innovations, Inc. ("IMA") and strategic investments in our operational infrastructure, partially
--------------------------------------------------------------------------------
offset by a more favorable product and geographic mix, higher unit volume and increased average selling prices.
In connection with the patent litigation settlement entered into during the second quarter of 2005, we were required, as of May 2005, to pay an 8.5% royalty on net sales of our current influenza, Group A Strep, pregnancy, H. pylori, mononucleosis, Chlamydia, iFOB, RSV and veterinary products. These product sales accounted for 92% of total revenue for the year ended December 31, 2006 and 88% for the year ended December 31, 2005. Also for the year ended December 31, 2006, the cost of sales as a percentage of total revenues was favorably impacted compared to 2005 as we fulfilled the terms of an agreement with another party related to the development of our influenza product during the first quarter of 2005. We are no longer required to pay this party a 6% royalty on sales of our influenza product.
Operating Expenses
The following table compares operating expenses for the years ended
December 31, 2006 and 2005 (in thousands, except percentages):
For the year ended December 31,
------------------------------------------------- Increase
2006 2005 (decrease)
----------------------- ----------------------- -------------
As a % of As a % of
Operating total Operating total
expenses revenues expenses revenues $ %
----------- --------- ----------- --------- ------- ---
Research and development $ 13,047 12 % $ 12,829 14 % $ 218 2 %
Sales and marketing 16,966 16 % 16,121 17 % 845 5 %
General and administrative 12,770 12 % 13,062 14 % (292 ) (2 )%
Amortization of intangible assets 4,580 4 % 1,476 2 % 3,104 210 %
Research and Development Expense
Our research and development expenses were relatively constant. The primary components of this expense are personnel and material costs associated with development of potential new technologies and processes and with products under development. In addition, we continued to incur substantial costs related to clinical trials as well as our overall effort under our QVB™ programs.
Sales and Marketing Expense
The primary components of this expense relate to continued investment in assessing future product extensions and enhancements, market research (including voice of customer surveys), programs aimed at distribution partners and end-user customers and reimbursement-related activities and product shipment costs. We also increased our sales force to further support our leadership position and seek to take advantage of further opportunities in POC diagnostics.
General and Administrative Expense
The decrease in general and administrative expenses for the year ended December 31, 2006 was primarily due to decreased legal fees of $2.3 million associated primarily with the settlement of our intellectual property litigation with IMA during 2005, partially offset by increases in personnel costs associated with stock-based compensation and management incentive plans.
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Patent Litigation Settlement
As previously disclosed, during the second quarter of 2005 we entered into an agreement to settle certain patent litigation with IMA and recorded a charge of $17.0 million in the first quarter of 2005, which amount was paid in April 2005.
Amortization of Intangible Assets
The increase in amortization of intangible assets for the year ended December 31, 2006 was primarily due to the amortization of intellectual property related to two license agreements entered into during late 2005 and an additional license agreement entered into during late 2006.
Other Income (Expense)
Interest income was $1.4 million and $0.7 million for the years ended December 31, 2006 and 2005, respectively, and relates primarily to interest earned on our cash and cash equivalents balance. Interest expense was $0.8 million for both of the years ended December 31, 2006 and 2005 and relates to interest paid on obligations under capital leases, which are primarily related to our San Diego facility. Other income increased to $0.5 million for the year ended December 31, 2006 from $0.1 million for the year ended . . .
Greencake
17 years ago
Is Quidel's Drop a Random Flu-ke?
Many investors in Quidel Corporation (Nasdaq: QDEL) appear to have caught the short-sighted flu following Thursday’s release of disappointing fourth-quarter results and tossed the stock aside like a used Kleenex.
Shares of the San Diego-based health-care-testing maker plummeted 12% in after-hours trading to $16 on heavy volume Thursday. The stock didn’t fare much better Friday, opening at $16.24 and ending the day at $16.55.
The headline numbers culled from the Quidel press release made many investors ill: net income for the quarter ended Dec. 31, 2007 dropped to $8.1 million, or $0.25 per share, from $18.3 million, or $0.54 per share, the year before. Quarterly revenue also declined slightly, to just under $38 million from $38.8 million in the final quarter of 2006.
The diagnosis: a delay in the flu season cut into sales of Quidel’s test kits.
The consensus estimate of analysts polled by Thomson Financial had expected Quidel to post earnings of $0.27 a share, and revenue of $44.8 million.
While not a miss of epidemic proportions, it does leave Quidel investors wondering if this signals serious problems. Ahead of the release, Thomson Financial showed that two analysts rated Quidel a “buy,” one had it a “strong buy” and another had it at “hold.”
Still, it’s unlikely that analysts are going to significantly alter their view of Quidel going forward because of its failure to accurately calculate when the flu was going to strike hardest. Flu-test sales missing from last quarter are likely to show up in the current one, after the Centers for Disease Control reported Friday that the flu is “widespread” in 49 states.
Quidel’s specialty is rapid-diagnostic products at the point of care for infectious diseases and reproductive health. The company has developed a line of testing kits for the professional and consumer markets, including pregnancy, influenza, strep and Chlamydia, with many sold under its QuickVue brand. The Quidel products also are used in oncology and in testing for inflammatory diseases and bone health.
Quidel began in 1979, launching its first products in 1984 — dipstick-style pregnancy tests. Quidel, a public company for 25 years, saw its shares peak at an all-time high of $21.07 on Oct. 30; its 52-week low of $10.12 was hit last March 5.
Of note when comparing the final quarter of 2007 with the year before, the 2006 period included a tax benefit contributing a one-time net boost of $5.9 million, or $0.17 a share.
The flu season doesn’t follow the calendar and Quidel’s expectations based on historical patterns failed to materialize in the quarter. The flu season’s deepest impact fled into early 2008, and Quidel says it’s ready to meet late-blooming demand for its flu tests.
On Thursday’s conference call with analysts, CEO Caren Mason said that Quidel entered the fourth quarter “with great momentum.”
Mason told analysts that “The company was poised to generate several million dollars in additional revenue from our influenza line domestically. … We were all very surprised, that for the first time since we began selling our influenza tests, influenza incidence for the last month of the year … did not materialize in the United States."
“Many of our investors and our analysts have become armchair prognosticators regarding influenza seasons and severity,” she said. “…We expected a strong flu season this year based on what was reported in the Southern Hemisphere — a more severe flu season than what had been seen for several years.”
Just wait, Mason said. “Although there was a seven-week delay in the season, we are experiencing very strong demand for our flu tests, and we are well-positioned to capitalize on our readiness and our market-leading positions.”
While much of Quidel’s business depends on the seasonal impact of influenza, this is not a one-trick pony. For all of 2007, Quidel reported its infectious-disease revenue (including flu tests) increased 24%, while revenue from reproductive-health products grew 11%.
Full-year operating income increased 41% to $19.5 million, or 17% of total revenue. Full-year earnings fell to $13.6 million, or $0.41 a share, compared with $21.7 million, or $0.63 a share, the year before. Revenue grew to $118.1 million from $106 million in 2006.
To lessen the flu bug’s seasonal impact, Quidel has taken such steps as entering into a strategic alliance with BioMerieux Inc. [EPA: BIM], which will distribute QuickVue products outside the United States and help give the brand a stronger global presence. The company has alliances in place with Abbott Laboratories (NYSE: ABT) and Swiss giant Roche Holding AG [Xetra: RHO.DE], with the latter teaming up Quidel’s test with Tamiflu in Germany and in U.S. testing.
The tone of analysts who participated in last week’s conference call did not reveal any alarm over the late flu season. Analyst Jeffrey Frelick of Lazard Capital Markets on Friday reiterated his “buy” rating on Quidel. Frelick had initiated coverage in November with a $27 price target. The recent Thomson Financial median price target was $22.50.
The late flu season did interrupt Quidel’s (QDEL) momentum — but it could present investors with a buying opportunity.
(source:) http://seekingalpha.com/article/66041-is-quidel-s-drop-a-random-flu-ke?source=yahoo
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