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8-K - FORM 8-K - ICAD INC | c16694e8vk.htm |
Exhibit
99.1
Press Release
FOR IMMEDIATE RELEASE
ICAD REPORTS FIRST QUARTER FINANCIAL RESULTS
Conference Call to be Held Wednesday, May 4th at 10:00 a.m. Eastern Time
NASHUA, N.H. (May 3, 2011) iCAD, Inc. (NASDAQ: ICAD), an industry-leading provider of advanced
image analysis, workflow solutions and radiation therapies for the early identification and
treatment of cancer, today reported financial results for the first quarter of fiscal year 2011.
Total revenue for the three months ended March 31, 2011, was $7.3 million, compared to $6.5 million
in the same period last year, an increase of $0.8 million or 13%.
Ken Ferry, President and CEO of iCAD, commented, First quarter sales growth was led by the
addition of the Axxent® eBx Electronic Brachytherapy System and higher service and
supply revenue offset by softness in the digital mammography and film-based segments. We continued
to advance our product development efforts with the introduction of SecondLook®
Premier*, our next generation digital mammography computer-aided detection (CAD) system in Europe,
and the presentation of positive data in support of the clinical utility of VeraLook® in
virtual colonoscopy at a major European medical congress. In addition, we made significant
progress with the integration of the Xoft business, which broadens our footprint in oncology and
allows us to bring targeted technologies to cancer patients throughout the continuum of care,
including detection, diagnosis, treatment and therapy monitoring.
Our new products are beginning to gain market acceptance and traction as evidenced by the strong
growth of our image analysis solutions for breast and prostate MRI. In the quarter, this growth
underscored the success of our clinical marketing and medical education programs and also
highlighted the positive response from clinicians to recently launched image analysis and workflow
enhancements. We look forward to further penetrating these and new markets with our advanced MRI
products, which offer a comprehensive quantitative image analysis for cancer detection,
localization, staging, treatment planning and serial monitoring.
The Axxent eBx System added over $1.3 million to our revenue during the quarter and we continue to
believe that this innovative technology will be a significant growth engine for iCAD. In addition,
we have made significant progress with the development of a new shielding product for the Axxent
system for use in intraoperative radiation therapy. We plan to file a 510(k) application for the
new product this month.
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Finally, we are particularly optimistic that the positive data from a recently published landmark
clinical study comparing intraoperative radiation therapy (IORT) with traditional external beam
radiation will be instrumental in obtaining a favorable reimbursement decision from the Centers for
Medicare and Medicaid Services this summer. We believe such reimbursement, coupled with the
positive clinical data, should be a catalyst for accelerating adoption of the Axxent system,
resulting in a significant revenue growth opportunity for iCAD, concluded Mr. Ferry.
First Quarter Financial Results
Revenue: Total revenue for the first quarter of 2011 was $7.3 million, a 13% increase
compared with total revenue of $6.5 million for the first quarter of 2010, primarily the result of
increased revenue from the Axxent eBx System offset by declines in the digital and film-based
segments.
Three Months Ended | Three Months Ended | |||||||||||
March 31, 2011 | March 31, 2010 | Growth | ||||||||||
Digital & MRI revenue |
$ | 3,763 | $ | 4,165 | (10 | )% | ||||||
Film based revenue |
517 | 1,046 | (51 | )% | ||||||||
Electronic
brachytherapy |
960 | | | |||||||||
Service & supply
revenue |
2,104 | 1,309 | 61 | % | ||||||||
Total revenue |
$ | 7,344 | $ | 6,520 | 13 | % |
Gross Margin: Gross margin for the first quarter of 2011 was $5.6 million, or 76.2%,
compared with $5.7 million, or 87.0% for the first quarter of 2010. The first quarter gross margin
was impacted by the acquisition of Xoft, Inc., including a $228,000 amortization expense combined
with additional manufacturing investments for the Axxent system.
Net Loss: For the first quarter of 2011, the Company posted a net loss of $4.2 million, or
$0.08 per share, compared with a net loss of $1.2 million, or $0.03 per share in the first quarter
of 2010. The $3.0 million increase in net loss was driven primarily by higher operating expenses
related to the Xoft acquisition.
Non-GAAP Adjusted EBITDA: Non-GAAP Adjusted EBITDA was a loss of $2.3 million in the first
quarter of 2011, compared to a loss of $300,000 in the first quarter of 2010.
Cash and Cash Flow: The Company ended the first quarter of 2011 with a cash and cash
equivalents balance of $11.3 million and no long-term debt. For the first quarter ended March 31,
2011, net cash used by operations was $4.9 million.
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Kevin C. Burns, Executive Vice President and CFO, said iCAD is pursuing a significant growth
opportunity that requires investment in the short term. While we continue to focus on increasing
growth for our CAD product portfolio, we will also continue to make significant investments in the
Axxent eBx System. The Company continues to make progress with the integration of Xoft and we are
confident that our ongoing investments in expanding the sales and marketing efforts for this
disruptive platform technology will provide significant growth opportunities for iCAD in the
future.
Financial Guidance
iCAD today adjusted financial guidance provided on December 17, 2010. The Company expects 2011
total revenue to be in the range of $32 million to $35 million, with a gross margin in the mid 70%
range for fiscal year 2011. The Company intends to update guidance, as appropriate, on a quarterly
basis going forward.
Use of Non-GAAP Financial Measures
In the Companys earnings releases, conference calls, slide presentations or webcasts, the Company
may use or discuss non-GAAP financial measures as defined by SEC Regulation G. The GAAP financial
measure most directly comparable to each non-GAAP financial measure used or discussed, and a
reconciliation of the differences between each non-GAAP financial measure and the comparable GAAP
financial measure, is included in this press release after the condensed consolidated financial
statements. The Companys earnings press releases containing such non-GAAP reconciliations can be
found on the Investors section of the Companys web site at
http://www.icadmed.com.
Conference Call
iCAD management will host an investment community conference call beginning at 10:00 a.m. Eastern
time on Wednesday, May 4, 2011 to discuss these results and answer questions. Shareholders and
other interested parties may participate in the conference call by dialing 866-362-4820 (domestic)
or 617-597-5345 (international) and entering passcode 70731575. The call will also be broadcast
live on the Internet at www.streetevents.com,
www.fulldisclosure.com and
www.icadmed.com.
A replay of the conference call will be accessible two hours after its completion through May 11,
2011 by dialing 888-286-8010 (domestic) or 617-801-6888 (international) and entering passcode
94609121. The call will also be archived for 90 days at
www.streetevents.com,
www.fulldisclosure.com and www.icadmed.com.
* Investigational Device. Limited by Federal Law to Investigational Use Only. Available Outside US.
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About iCAD
iCAD, Inc. is an industry-leading provider of advanced image analysis and workflow solutions that
enable healthcare professionals to better serve patients by identifying pathologies and pinpointing
the most prevalent cancers earlier. iCAD offers a comprehensive range of high-performance,
upgradeable Computer-Aided Detection (CAD) systems and workflow solutions for mammography, Magnetic
Resonance Imaging (MRI) and Computed Tomography (CT). iCAD recently acquired Xoft, Inc., developer
of the Axxent® eBx electronic brachytherapy system. Axxent uses non-radioactive
miniaturized X-ray tube technology and is FDA-cleared for the treatment of early stage breast
cancer, skin cancer and endometrial cancer. The Axxent System is also cleared for use in the
treatment of other cancers or conditions where radiation therapy is indicated including
Intraoperative Radiation Therapy (IORT). For more information, call (877) iCADnow or visit
www.icadmed.com.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995:
Certain statements contained in this News Release constitute forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking
statements involve a number of known and unknown risks, uncertainties and other factors which may
cause the actual results, performance or achievements of the Company to be materially different
from any future results, performance or achievements expressed or implied by such forward-looking
statements. Such factors include, but are not limited to, the Companys ability to defend itself in
litigation matters, the Companys ability to identify a replacement for the Axxent FlexiShield
Mini, the risks relating to the Companys acquisition of Xoft including, the expected benefits of
the acquisition may not be achieved in a timely manner, or at all; the Xoft business operations may
not be successfully integrated with iCADs and iCAD may be unable to achieve the expected
synergies, business and strategic objectives following the transaction, the risks of uncertainty of
patent protection; the impact of supply and manufacturing constraints or difficulties; product
market acceptance; possible technological obsolescence; increased competition; customer
concentration; and other risks detailed in the Companys filings with the Securities and Exchange
Commission. The words believe, demonstrate, intend, expect, estimate, anticipate,
likely, 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. The Company is under no obligation to provide any updates to any information
contained in this release. For additional disclosure regarding these and other risks faced by
iCAD, please see the disclosure contained in our public filings with the Securities and Exchange
Commission, available on the Investors section of our website at http://www.icadmed.com and on the
SECs website at http://www.sec.gov.
For Investor Relations, contact Kevin Burns of iCAD, Inc. at 937-431-7967 or via email at
kburns@icadmed.com or Anne Marie Fields of Lippert/Heilshorn & Associates, Inc.
at 212-838-3777 or via email at afields@lhai.com
kburns@icadmed.com or Anne Marie Fields of Lippert/Heilshorn & Associates, Inc.
at 212-838-3777 or via email at afields@lhai.com
For media inquiries, contact Liza Heapes of MSL Boston
at 617-369-8787 or via e-mail at liza.heapes@mslgroup.com
at 617-369-8787 or via e-mail at liza.heapes@mslgroup.com
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CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited, in thousands, except per share amounts)
March 31, | December 31, | |||||||
2011 | 2010 | |||||||
Assets |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 11,312 | $ | 16,269 | ||||
Trade accounts receivable, net of allowance for doubtful
accounts of $50 in 2011 and 2010 |
4,075 | 3,389 | ||||||
Inventory, net |
3,074 | 3,489 | ||||||
Prepaid expenses and other current assets |
680 | 581 | ||||||
Total current assets |
19,141 | 23,728 | ||||||
Property and equipment, net of accumulated depreciation |
2,555 | 2,774 | ||||||
Other assets: |
||||||||
Deposits |
620 | 675 | ||||||
Intangible assets, net of accumulated amortization |
18,631 | 21,165 | ||||||
Goodwill |
47,365 | 45,689 | ||||||
Total other assets |
66,616 | 67,529 | ||||||
Total assets |
$ | 88,312 | $ | 94,031 | ||||
Liabilities and Stockholders Equity |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 2,556 | $ | 2,500 | ||||
Accrued expenses |
3,748 | 5,521 | ||||||
Deferred rent |
390 | 381 | ||||||
Deferred revenue |
4,781 | 4,906 | ||||||
Total current liabilities |
11,475 | 13,308 | ||||||
Contingent consideration liability |
4,900 | 5,000 | ||||||
Long-term deferred rent |
316 | 402 | ||||||
Long-term deferred revenue |
1,601 | 961 | ||||||
Long-term settlement costs |
686 | 1,135 | ||||||
Other long-term liabilities |
83 | 15 | ||||||
Total liabilities |
19,061 | 20,821 | ||||||
Stockholders equity: |
||||||||
Preferred stock, $.01 par value: authorized 1,000,000 shares;
none issued. |
| | ||||||
Common stock, $.01 par value: authorized 85,000,000
shares; issued 54,551,140 in 2011 and 54,383,747 in 2010;
outstanding 54,483,264 in 2011 and 54,315,871 in 2010 |
545 | 544 | ||||||
Additional paid-in capital |
163,342 | 163,101 | ||||||
Accumulated deficit |
(93,686 | ) | (89,485 | ) | ||||
Treasury stock at cost (67,876 shares) |
(950 | ) | (950 | ) | ||||
Total stockholders equity |
69,251 | 73,210 | ||||||
Total liabilities and stockholders equity |
$ | 88,312 | $ | 94,031 | ||||
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited, in thousands, except per share amounts)
Three Months Ended | Three Months Ended | |||||||
March 31, 2011 | March 31, 2010 | |||||||
Revenue |
||||||||
Products |
$ | 5,217 | $ | 5,212 | ||||
Service and supplies |
2,127 | 1,309 | ||||||
Total revenue |
7,344 | 6,521 | ||||||
Cost of revenue |
||||||||
Products |
1,440 | 667 | ||||||
Service and supplies |
309 | 180 | ||||||
Total cost of revenue |
1,749 | 847 | ||||||
Gross margin |
5,595 | 5,674 | ||||||
Operating expenses: |
||||||||
Engineering and product development |
2,776 | 1,556 | ||||||
Marketing and sales |
4,190 | 2,833 | ||||||
General and administrative |
2,804 | 2,486 | ||||||
Total operating expenses |
9,770 | 6,875 | ||||||
Loss from operations |
(4,175 | ) | (1,201 | ) | ||||
Interest (expense) income net |
(26 | ) | 18 | |||||
Net loss |
$ | (4,201 | ) | $ | (1,183 | ) | ||
Net loss per share: |
||||||||
Basic and Diluted |
$ | (0.08 | ) | $ | (0.03 | ) | ||
Weighted average number of shares used in
computing loss per share: |
||||||||
Basic and diluted |
54,365,955 | 45,686,285 | ||||||
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RECONCILIATION OF NON-GAAP FINANCIAL MEASURES TO COMPARABLE GAAP MEASURES
(Unaudited, in thousands, except per share amounts)
(Unaudited, in thousands, except per share amounts)
The following is a reconciliation of the non-GAAP financial measures used by the Company to
describe the Companys financial results determined in accordance with United States generally
accepted accounting principles (GAAP). An explanation of these measures is also included below
under the heading Explanation of Non-GAAP Financial Measures.
While management believes that these non-GAAP financial measures provide useful supplemental
information to investors regarding the underlying performance of the Companys business operations,
investors are reminded to consider these non-GAAP measures in addition to, and not as a substitute
for, financial performance measures prepared in accordance with GAAP. In addition, it should be
noted that these non-GAAP financial measures may be different from non-GAAP measures used by other
companies, and management may utilize other measures to illustrate performance in the future.
Non-GAAP measures have limitations in that they do not reflect all of the amounts associated with
the Companys results of operations as determined in accordance with GAAP.
Non-GAAP Adjusted EBITDA
Set forth below is a reconciliation of the Companys Non-GAAP Adjusted EBITDA
(Unaudited, in thousands)
(Unaudited, in thousands)
Three Months Ended | Three Months Ended | |||||||
March 31, 2011 | March 31, 2010 | |||||||
GAAP net loss |
$ | (4,201 | ) | $ | (1,183 | ) | ||
Add: Interest (expense) income net |
26 | (18 | ) | |||||
Add: Stock-based compensation expense |
268 | 483 | ||||||
Add: Depreciation |
295 | 126 | ||||||
Add: Amortization of purchased intangibles |
524 | 292 | ||||||
Add: Xoft acquisition and other related
expenses |
784 | | ||||||
Non-GAAP Adjusted EBITDA |
$ | (2,304 | ) | $ | (300 | ) | ||
Explanation of Non-GAAP Financial Measures
The Company reports its financial results in accordance with United States generally accepted
accounting principles, or GAAP. However, management believes that in order to properly understand
the Companys short-term and long-term financial and operational trends, investors may wish to
consider the impact of certain non-cash or non-recurring items, when used as a supplement to
financial performance measures in accordance with GAAP. These items result from facts and
circumstances that vary in frequency and/or impact on continuing operations. Management also uses
results of operations before such items to evaluate the operating performance of the Company and
compare it against past periods, make operating decisions, and serve as a basis for strategic
planning. These non-GAAP financial measures provide management with additional means to understand
and evaluate the operating results and trends in the Companys ongoing
business by eliminating certain non-cash expenses and other items that management believes might
otherwise make comparisons of the Companys ongoing business with prior periods more difficult,
obscure trends in ongoing operations, or reduce managements ability to make useful forecasts.
Management believes that these non-GAAP financial measures provide additional means of evaluating
period-over-period operating performance. In addition, management understands that some investors
and financial analysts find this information helpful in analyzing the Companys financial and
operational performance and comparing this performance to its peers and competitors.
Management defines Non-GAAP Adjusted EBITDA as the sum of GAAP net loss before provision for
income taxes, Xoft acquisition and other related expenses, total other (income) expense,
stock-based
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compensation expense, acquisition and other related expense, depreciation and
amortization, and amortization of purchased intangibles. Management considers this non-GAAP
financial measure to be important indicators of the Companys operational strength and performance
of its business and a good measure of its historical operating trends, in particular the extent to
which ongoing operations impact the Companys overall financial performance.
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