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Quotes & Info
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| ICAD > SEC Filings for ICAD > Form 10-Q on 8-Aug-2012 | All Recent SEC Filings |
8-Aug-2012
Quarterly Report
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Certain information included in this Item 2 and elsewhere in this Form 10-Q that are not historical facts contain forward looking statements that involve a number of known and unknown risks, uncertainties and other factors that could cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievement expressed or implied by such forward looking statements. These risks and uncertainties include, but are not limited to, uncertainty of future sales and expense levels, protection of patents and other proprietary rights, the impact of supply and manufacturing constraints or difficulties, regulatory changes and requirements applicable to our products, product market acceptance, possible technological obsolescence of products, increased competition, integration of the acquired businesses, the impact of litigation and/or government regulation, changes in Medicare reimbursement policies, competitive factors, the effects of a decline in the economy in markets served by the Company and other risks detailed in the Company's other filings with the Securities and Exchange Commission. The words "believe", "plan", "intend", "expect", "estimate", "anticipate", "likely", "seek", "should" "would", "could" and similar expressions identify forward-looking statements. Readers are cautioned not to place undue reliance on those forward-looking statements, which speak only as of the date the statement was made.
Results of Operations
Overview
iCAD is an industry-leading provider of advanced image analysis and workflow solutions that enable radiologists and other healthcare professionals to better serve patients by identifying pathologies and pinpointing cancer earlier. iCAD offers a comprehensive range of high-performance, expandable Computer-Aided Detection (CAD) systems and workflow solutions for mammography (film-based, digital radiography (DR) and computed radiography (CR), Magnetic Resonance Imaging (MRI), and Computed Tomography (CT)). iCAD's solutions aid in the early detection of the most prevalent cancers including breast, prostate and colon cancer. Early detection of cancer is the key to better prognosis, less invasive and lower treatment costs, and higher survival rates. Performed as an adjunct to mammography screening, CAD has quickly become the standard of care in breast cancer detection, helping radiologists improve clinical outcomes while enhancing workflow. Computer-enhanced breast and prostate MRI analysis streamlines case interpretation workflow and generates more robust information for more effective patient treatment. CAD for mammography screening is also reimbursable in the U.S. under federal and most third-party insurance programs. Since receiving approval from the FDA for the Company's first breast cancer detection product in January 2002, over 4,000 of iCAD's CAD systems have been placed in mammography practices worldwide. iCAD is the only stand-alone company offering CAD solutions for the early detection of breast cancer.
The Company's CAD systems include proprietary algorithm and other technology together with standard computer and display equipment. CAD systems for the film-based analog mammography market also include a radiographic film digitizer, either manufactured by the Company or others for the digitization of film-based medical images.
The Company intends to apply its core competencies in pattern recognition and algorithm development in disease detection to its future product development efforts. Its focus is on the development and marketing of cancer detection products for disease states where there are established or emerging protocols for screening as a standard of care. iCAD expects to pursue development or acquisition of products for select disease states that demonstrate one or more of the following: it is clinically proven that screening has a significant positive impact on patient outcomes, where there is an opportunity to lower health care costs, where screening is non-invasive or minimally invasive and where public awareness is high. The Company also intends to pursue opportunities beyond CAD through possible strategic acquisitions as part of its growth strategy, as such the Company continues to actively evaluate strategic opportunities in the oncology market that could leverage its opportunities for growth beyond its historic core markets.
iCAD has applied its patented detection technology and algorithms to the development of CAD solutions for use with virtual colonoscopy or CT Colonography (CTC) to improve the detection of colonic polyps. The Company's pattern recognition and image analysis expertise are readily applicable to colonic polyp detection and the Company has developed a CTC CAD solution. Virtual colonoscopy (CTC) is a technology that has evolved rapidly in recent years. Based on the results of the National CT Colonography trial completed in September 2008, the Company expects that the market for virtual colonoscopy will grow along with the procedures for early detection of colon cancer. This trial demonstrated that CTC is highly accurate for the detection of intermediate and large polyps and that the accuracy of CTC is similar to a colonoscopy. CT Colonography or CTC is emerging as an alternative imaging procedure for evaluation of the colon. The Company has developed and commenced marketing Veralook™, a product for computer aided detection of polyps in the colon using CTC and completed the clinical testing of its CTC CAD product in the first quarter of 2009. The Company filed a 510(k) application with the FDA in May 2009 seeking FDA clearance to market Veralook in the U.S and received FDA clearance on August 4, 2010, and is now commercially available. Colorectal cancer has been shown to be highly preventable with early detection and removal of polyps.
In July 2008, the Company acquired pharmaco-kinetic based CAD products that aid in the interpretation of contrast enhanced MRI images of the breast and prostate and began marketing these products in the fourth quarter of 2008. The interpretation of MRI exams also benefits from advanced image analysis and clinical decision support tools. MRI is an excellent tool to detect breast cancer as well as prostate cancer. While MRI is a more expensive option than traditional mammography, it enables physicians to view tumors which may have been missed during routine screenings. MRI uses magnets and radio waves instead of x-rays to produce very detailed, cross-sectional images of the body, and can be used to look specifically at those areas.
The acquisition of Xoft Inc. ("Xoft"), in December 2010, brought an isotope-free cancer treatment platform technology to the Company's product line. Xoft designs, develops, manufactures, markets and sells electronic brachytherapy (eBx) products for the treatment of breast and other cancers, used in a broad range of clinical settings. The portable Axxent System which delivers electronically controlled radiation therapy directly to cancer sites with minimal radiation exposure to surrounding healthy tissue is FDA-cleared. Electronic Brachytherapy (eBx™) is a type of
brachytherapy that utilizes a miniaturized high dose rate X-ray source to apply radiation directly to the cancerous site. The goal is to direct the radiation dose to the size and shape of the cancerous area, sparing healthy tissue and organs. The Xoft technology delivers similar clinical dose rates to traditional radio-active systems. Electronic Brachytherapy can be delivered during an operative procedure and may be used as a primary or secondary modality over a course of days. This technology enables radiation oncology departments in hospitals, clinics and physician offices to perform traditional radiotherapy treatments and offer advanced treatments such as Intra-Operative Radiation Therapy (IORT). Current customers for the Xoft eBx system include university research and community hospitals, private and governmental institutions, doctors' offices and cancer care clinics.
The Company's headquarters are located in Nashua, New Hampshire, with manufacturing and contract manufacturing facilities in New Hampshire and Massachusetts, a research and development facility in Ohio and, with its acquisition of Xoft, an operation, research, development, manufacturing and warehousing facility in Sunnyvale, California.
Critical Accounting Policies
The Company's discussion and analysis of its financial condition, results of operations, and cash flows are based on the Company's consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On an on-going basis, the Company evaluates these estimates, including those related to accounts receivable allowance, inventory valuation and obsolescence, intangible assets, income taxes, warranty obligations, contingencies and litigation. Additionally, the Company uses assumptions and estimates in calculations to determine stock-based compensation. The Company bases its estimates on historical experience and on various other assumptions that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. For a comprehensive list of the Company's critical accounting policies, reference should be made to the Annual Report on Form 10-K for the year ended December 31, 2011 filed on March 9, 2012.
Three months ended June 30, 2012 compared to the three months ended June 30, 2011
Revenue:
Three months ended June 30:
Total revenue for the three month period ended June 30, 2012 was $5.9 million compared with revenue of $6.6 million for the three month period ended June 30, 2011, a decrease of $0.7 million or 10.8%. The decrease in revenue was primarily due to a reduction in digital, MRI and film based revenues offset by increases from the electronic brachytherapy products and increases in service and supply revenue.
Three months ended June 30,
2012 2011 Change % Change
Digital & MRI revenue $ 2,321 $ 3,197 $ (876 ) (27.4 )%
Film based revenue 365 537 (172 ) (32.0 )%
Electronic Brachytherapy 889 760 129 17.0 %
Service & supply revenue 2,356 2,152 204 9.5 %
Total revenue $ 5,931 $ 6,646 $ (715 ) (10.8 )%
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Our Digital and MRI CAD revenue for three month period ended June 30, 2012 decreased $0.9 million or 27.4%, to $2.3 million compared to revenue of $3.2 million in the three month period ended June 30, 2011. This decrease was due primarily to a decrease in market share by our customers which led to decreased demand for our systems.
Revenue from iCAD's film based products decreased 32.0% or $172,000, to $365,000 in the three month period ended June 30, 2012 from $537,000 in the three month period ended June 30, 2011. This decrease was primarily attributed to the decline in sales of our TotalLook MammoAdvantage. The TotalLook MammoAdvantage product is used for digitizing film based prior mammography exams for comparative reading and is sold to further optimize workflow in a digital mammography environment. This decrease continues to reflect the expected decrease in demand for film-based products and accessories as the marketplace continues to transition to digital technologies.
Revenue from our Axxent Electronic Brachytherapy System and accessories, was $889,000 in the three month period ended June 30, 2012 an increase of 17.0% from $760,000 for the three month period ended June 30, 2011. Demand for the Axxent Electronic Brachytherapy System improved during the quarter, with sales increases for the controllers as well as the related accessories. We believe that there is continued momentum for the Axxent Electronic Brachytherapy System driven primarily for its use in the intra-operative radiation therapy ("IORT") market, particularly breast IORT.
Service and supply revenue increased 9.5% or $204,000 in the three month period ended June 30, 2012, to $2.4 million compared to $2.2 million in three months ended June 30, 2011. Service and supply revenue relating to our digital CAD and TotalLookMammoAdvantage systems was approximately $1.7 million for the three month period ended June 30, 2012 and remained flat as compared to the three months ended June 30, 2011. Service and supply revenue in the first quarter of 2012 included approximately $610,000 related to the Axxent Electronic Brachytherapy
products, which represented an increase of $203,000 or 50.0% as compared to $407,000 in the three months ended June 30, 2011. Service and supply revenue related to our Electronic Brachytherapy products increased primarily due to increases in service and source agreements related to sales of the Electronic Brachytherapy system. We expect service and supply revenue for our Electronic Brachytherapy products to increase as our installed base increases.
Gross Margin:
Three months ended June 30,
2012 2011 Change % Change
Products $ 969 $ 1,140 $ (171 ) (15.0 )%
Service & supply 560 769 (209 ) (27.2 )%
Amortization of acquired intangibles 233 233 - 0 %
Total cost of revenue $ 1,762 $ 2,142 $ (380 ) (17.7 )%
Gross Margin $ 4,169 $ 4,504 $ (335 ) (7.4 )%
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Gross margin for the three month period ended June 30, 2012 was $4.2 million or 70.3% of revenue as compared to $4.5 million or 67.8% of revenue in the three month period ended June 30, 2011. Gross margin percent increased despite the decrease in revenue, due to ongoing expense reductions of our manufacturing costs, primarily labor and overhead. Gross margin percent is impacted by amortization of acquired technology, and costs related to the fixed cost of our manufacturing operation. We expect the gross margin percent to improve slightly as revenues increase and absorb the fixed manufacturing costs and amortization expense.
Operating Expenses:
Three months ended June 30,
2012 2011 Change Change %
Operating expenses:
Engineering and product development $ 1,975 $ 3,304 $ (1,329 ) (40.2 )%
Marketing and sales 2,488 3,945 (1,457 ) (36.9 )%
General and administrative 1,618 3,413 (1,795 ) (52.6 )%
Contingent Consideration - (1,100 ) 1,100 (100.0 )%
Loss on indemnification asset - 250 (250 ) (100.0 )%
Total operating expenses $ 6,081 $ 9,811 $ (3,730 ) (38.0 )%
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Engineering and Product Development. Engineering and product development costs for the three month period ended June 30, 2012 decreased by $1.3 million or 40%, from $3.3 million in 2011 to $2.0 million in 2012. The decrease in engineering and product development costs was primarily due to the decrease in personnel and related expenses and consulting costs, as a result of cost saving measures implemented during the second quarter of 2011.
Marketing and Sales. Marketing and sales expenses decreased by $1.5 million or 37%, from $3.9 million in the three month period ended June 30, 2011 to $2.5 million in three month period ended June 30, 2012. The decrease in marketing and sales expenses primarily resulted from reductions in personnel and related expenses and overhead expenses due to operating expense reductions related to cost saving initiatives implemented at the end of the second quarter of 2011.
General and Administrative. General and administrative expenses decreased by $1.8 million or 53%, from $3.4 million in the three month period ended June 30, 2011 to $1.6 million in for the three month period ended June 30, 2012. The decrease in general and administrative expense is primarily due to reductions in personnel costs related to the cost saving initiatives implemented during the second quarter of 2011, and legal expenses related to on-going patent litigation that was settled in December 2011.
Contingent Consideration. Contingent Consideration represents a gain of $1.1 million in the quarter ended June 30, 2011, as the Company determined that the revenue thresholds as described in Note 4, were unlikely to be met. There were no changes during the six months ended June 30, 2012.
Loss on indemnification asset. The Company recorded an indemnification asset in connection with the acquisition of Xoft in 2010. The loss of $250,000 represented a loss on the asset related to the fair value of the underlying stock.
Other Income and Expense:
Three months ended June 30,
2012 2011 Change Change %
Loss from change in fair value of warrants $ (213 ) $ - (213 ) -
Interest expense (831 ) (111 ) (720 ) 648.6 %
Interest income 13 7 6 85.7 %
$ (1,031 ) $ (104 ) $ (927 ) 891.3 %
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Loss from change in fair value of Warrants. The loss from change in fair value of the warrants resulted from an increase in the fair value of the warrants under the binomial lattice based valuation methodology, due primarily to an increase in volatility, which is one of the key assumptions in determining the value of the warrants.
Interest (Expense)/Income. Interest expense increased by $720,000 or 649% for the three month period ended June 30, 2012 as compared to interest expense of $111,000 in the three month period ended June 30, 2011. Interest expense is due primarily to $727,000 of interest expense related to the financing obligation incurred in January 2012. Interest related to the Hologic and Zeiss settlement obligations was $104,000 as compared to $111,000 in the second quarter of 2011. Interest income reflects income earned from our money market accounts which increased in 2012.
Six months ended June 30, 2012 compared to the six months ended June 30, 2011
Revenue:
Six months ended June 30:
Total revenue for the six month period ended June 30, 2012 was $12.3 million compared with revenue of $14.0 million for the six month period ended June 30, 2011, a decrease of $1.7 million or 12.3%. The decrease in revenue was primarily due to a reduction in digital, MRI and film based revenues offset by increases from the electronic brachytherapy products and an increase in service and supply revenue.
Six months ended June 30,
2012 2011 Change % Change
Digital & MRI revenue $ 4,511 $ 6,960 $ (2,449 ) (35.2 )%
Film based revenue 792 1,054 (262 ) (24.9 )%
Electronic Brachytherapy 2,351 1,695 656 38.7 %
Service & supply revenue 4,620 4,281 339 7.9 %
Total revenue $ 12,274 $ 13,990 $ (1,716 ) (12.3 )%
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Our digital and MRI CAD revenue for six month period ended June 30, 2012 decreased $2.5 million or 35%, to $4.5 million compared to revenue of $7.0 million in the six month period ended June 30, 2011. This decrease was due primarily to a decrease in market share by our customers which led to decreased demand for our systems.
Revenue from iCAD's film based products decreased 25% or $262,000, to $792,000 in the six month period ended June 30, 2012 from $1.1 million in the six month period ended June 30, 2011. This decrease was primarily attributed to the decline in sales of our TotalLook MammoAdvantage. The TotalLook MammoAdvantage product is used for digitizing film based prior mammography exams for comparative reading and is sold to further optimize workflow in a digital mammography environment. This decrease continues to reflect the expected decrease in demand for film-based products and accessories as the marketplace continues to transition to digital technologies.
Revenue from our Axxent Electronic Brachytherapy System and accessories was $2.4 million in the six month period ended June 30, 2012 an increase of 39% from $1.7 million for the six month period ended June 30, 2011. Demand for the Axxent Electronic Brachytherapy System improved during the quarter, with sales increases for the controllers as well as the related accessories. We believe that there is continued momentum for the Axxent Electronic Brachytherapy System driven primarily for its use in the intra-operative radiation therapy ("IORT") market, particularly breast IORT.
Service and supply revenue increased 7.9% or $339,000 in the six month period ended June 30, 2012, to $4.6 million compared to $4.3 million in six months ended June 30, 2011. Service and supply revenue relating to our digital CAD and TotalLookMammoAdvantage systems was approximately $3.5 million for the six month period ended June 30, 2012 and remained flat as compared to the six months ended June 30, 2011. Service and supply revenue in the second quarter of 2012 included approximately $1.2 million related to the Axxent Electronic Brachytherapy products, which represented an increase of $354,000 or 44% as compared to $798,000 in the six months ended June 30, 2011. Service and supply revenue related to our Electronic Brachytherapy products increased primarily due to increases in service agreements related to sales of the Electronic Brachytherapy system. We expect service and supply revenue for our Electronic Brachytherapy products to increase as our installed base increases.
Gross Margin:
Six months ended June 30,
2012 2011 Change % Change
Products $ 2,076 $ 2,347 $ (271 ) (11.5 )%
Service & supply 1,137 1,541 (404 ) (26.2 )%
Amortization of acquired intangibles 465 466 (1 ) 0.2 %
Total cost of revenue $ 3,678 $ 4,354 $ (676 ) (15.5 )%
Gross Margin $ 8,596 $ 9,636 $ (1,040 ) (10.8 )%
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Gross margin for the six month period ended June 30, 2012 was $8.6 million or 70.0% of revenue as compared to $9.6 million or 68.9% of revenue in the six month period ended June 30, 2011. Gross margin percent remained flat despite the decrease in revenue, due to ongoing expense reductions. Gross margin percent is impacted by amortization of acquired technology, and costs related to the fixed cost of our manufacturing operation. We expect that gross margin percent can improve slightly in the future as revenues increase and absorb the fixed manufacturing costs and amortization expense.
Operating Expenses:
Six months ended June 30,
2012 2011 Change Change %
Operating expenses:
Engineering and product development $ 4,187 $ 6,080 $ (1,893 ) (31.1 )%
Marketing and sales 5,134 7,672 (2,538 ) (33.1 )%
General and administrative 3,236 6,217 (2,981 ) (47.9 )%
Contingent Consideration - (1,100 ) 1,100 (100.0 )%
Loss on indemnification asset - 293 (293 ) (100.0 )%
Total operating expenses $ 12,557 $ 19,161 $ (6,604 ) (34.5 )%
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Engineering and Product Development. Engineering and product development costs for the six month period ended June 30, 2012 decreased by $1.9 million or 31%, from $6.1 million in 2011 to $4.2 million in 2012. The decrease in engineering and product development costs was primarily due to the decrease in personnel and related expenses and consulting costs, as a result of cost saving measures implemented during the second quarter of 2011.
Marketing and Sales. Marketing and sales expenses decreased by $2.5 million or 33%, from $7.7 million in the six month period ended June 30, 2011 to $5.1 million in six month period ended June 30, 2012. The decrease in marketing and sales expenses primarily resulted from reductions in personnel and related expenses and overhead expenses due to operating expense reductions as a result of cost saving initiatives implemented at the end of the second quarter of 2011.
General and Administrative. General and administrative expenses decreased by $3.0 million or 48%, from $6.2 million in the six month period ended June 30, 2011 to $3.2 million in for the six month period ended June 30, 2012. The decrease in general and administrative expense is primarily due to reductions in personnel costs as a result of cost saving initiatives implemented during the second quarter of 2011, legal expenses related to on-going patent litigation that was settled in December 2011, and transaction related costs incurred during the first quarter of 2011 due to the acquisition of Xoft, that did not occur in the first quarter of 2012.
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