BioCardia, Inc. - Quarter Report: 2010 June (Form 10-Q)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
[X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 2010
OR
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from ________to _________
Commission file number: 0-21419
Cardo Medical, Inc.
(Exact name of Registrant as Specified in its Charter)
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9701 Wilshire Blvd., Suite 1100
Beverly Hills, CA 90212
(Address of Principal Executive Offices including Zip Code)
(310) 274-2036
(Registrant's Telephone Number, Including Area Code)
N/A
(Former name, former address and former fiscal year, if changed since last report) Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15 (d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file reports), and (2) has been subject to such filing requirements for the past 90 days.
YES x NO ¨ Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). YES ¨ NO ¨
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See definitions of "large accelerated filer," "accelerated filer" and "smaller reporting company" in Rule 12b-2 of the Exchange Act. (Check one):
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Large accelerated filer ¨ |
Accelerated filer ¨ |
Non-accelerated filer ¨
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Smaller reporting company x |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
As of August 2, 2010, 230,293,141 shares of the issuer's common stock, par value of $0.001 per share, were outstanding.
CARDO MEDICAL, INC.
Table of Contents Page PART I — FINANCIAL INFORMATION 1 Item 1. 1 1 2 3 4 Item 2. 8 Item 4. 18 PART II — OTHER INFORMATION 17 Item 6. 18 19 Exhibit Index
PART I — FINANCIAL INFORMATION ITEM 1 — CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
CARDO MEDICAL, INC.
The accompanying notes are an integral part of these condensed consolidated financial statements.
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The accompanying notes are an integral part of these condensed consolidated financial statements.
2
CARDO MEDICAL, INC.
The accompanying notes are an integral part of these condensed consolidated financial statements.
3
CARDO MEDICAL, INC. NOTE 1 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Cardo Medical, Inc. ("Cardo" or the "Company") is an orthopedic medical
device company specializing in designing, developing and marketing high performance reconstructive joint devices and spinal
surgical devices. Reconstructive joint devices are used to replace knee, hip and other joints that have deteriorated through
disease or injury. Spinal surgical devices involve products to stabilize the spine for fusion and reconstructive procedures.
Within these areas, Cardo intends to focus on the higher-growth sectors of the orthopedic industry, such as advanced
minimally invasive instrumentation and bone-conserving high performance implants. Cardo is focused on developing surgical
devices that will enable surgeons to bridge the gap between soft tissue-driven sports medicine techniques and classical
reconstructive surgical procedures. Basis of Presentation The accompanying condensed consolidated balance sheet as of December 31, 2009, which has been
derived from Cardo's audited financial statements as of that date, and the unaudited condensed consolidated financial
information of Cardo as of June 30, 2010 and for the three and six months ended June 30, 2010 and 2009, has been prepared
in accordance with accounting principles generally accepted in the United States of America ("U.S. GAAP") for
interim financial information and with the instructions to Form 10-Q and Article 8-03 of Regulation S-X. In the opinion of
management, such financial information includes all adjustments (consisting only of normal recurring adjustments) considered
necessary for a fair presentation of the Company's financial position at such date and the operating results and cash flows for
such periods. Operating results for the interim periods ended June 30, 2010 are not necessarily indicative of the results that
may be expected for the entire year. Certain information and footnote disclosure normally included in financial statements in accordance
with generally accepted accounting principles have been omitted pursuant to the rules of the United States Securities and
Exchange Commission ("SEC"). These unaudited financial statements should be read in conjunction with our
audited financial statements and accompanying notes included in the Company's Annual Report on Form 10-K for the year
ended December 31, 2009 filed with the SEC on March 31, 2010. Principles of Consolidation The condensed consolidated financial statements include the accounts of Cardo, Accelerated
Innovation, Inc. ("Accelerated"), Uni-Knee LLC ("Uni") and Cervical Xpand LLC ("Cervical").
All significant intercompany transactions have been eliminated in consolidation. The non-controlling and minority interests in
these companies is represented by a single balance in the condensed consolidated balance sheets. Management's Plan As reflected in the accompanying financial statements, the Company had
losses from operations of $2,937,000 and negative cash flows from operations of $2,593,000 during the six months ended
June 30, 2010, an accumulated deficit of $14,102,000 and limited cash to fund its future operations.
Management anticipates that the Company will sustain losses through the fourth quarter of 2010 and require additional capital to supplement operations.
Thus far, the Company
has been able to finance its operating losses through a series of equity issuances. Nevertheless, there is no assurance that
the Company will be able to finance any future operating losses and as such, there is substantial doubt about the Company's
ability to continue as a going concern. Management is actively seeking various sources of financing; however, there are no
assurances that any such financing can be obtained on favorable terms, if at all. Management is closely monitoring its
operating costs to conserve cash until additional funds become available through financing or operating activities. In view of the matters described in the preceding paragraph, recoverability of a major portion of the
recorded asset amounts shown in the accompanying consolidated balance sheet is dependent upon continued operations of the
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Company, which, in turn, is dependent upon the Company's ability to continue to raise capital and ultimately generate positive cash flows
from operations. The financial statements do not include any adjustments relating to the
recoverability and classification of recorded asset amounts or amounts and
classifications of liabilities that might be necessary should the Company be unable to continue its existence. Net Loss Per Share Basic net (loss) income per
share is computed by using the weighted-average number of common shares outstanding during the period. Diluted net (loss)
income per share is computed giving effect to all dilutive potential common shares that were outstanding during the period.
Dilutive potential common shares consist of incremental common shares issuable upon exercise of stock options or warrants.
No dilutive potential common shares are included in the computation of any diluted per share amount when a loss from
continuing operations is reported by the Company because they are anti-dilutive. Concentrations As of June 30, 2010, the Company had two customers that accounted for 21.8% and 15.0%,
respectively, of its accounts receivable. As of December 31, 2009, the Company had four customers that accounted for
28.2%, 15.6%, 15.4% and 10.0%, respectively, of its accounts
receivable. The Company had four customers that comprised 14.9%, 13.3%, 12.5% and 10.8%, respectively, of
the Company's net sales for the three months ended June 30, 2010. The Company had two customers that comprised 45.3%,
and 28.7%, respectively, of the Company's net sales for the three months ended June 30, 2009. The Company had three customers that comprised 18.9%, 16.1% and 11.3%, respectively, of the
Company's net sales for the six months ended June 30, 2010. The Company had three customers that comprised 31.2%,
26.6%, and 14.9%, respectively, of the Company's net sales for the six months ended June 30, 2009. Reclassifications Certain amounts from prior periods have been reclassified to conform to the current period
presentation. Recent Accounting Pronouncements There are no recently issued accounting pronouncements that the Company has yet to adopt that are
expected to have a material effect on its financial position, results of operations, or cash flows. NOTE 2 — INVENTORY Inventories consisted of the following at: NOTE 3 — SHARE BASED PAYMENT On August 29, 2008, the Company issued options to certain employees and Board members to
purchase membership units in Cardo. The options give the grantees the right to purchase up to 2,398,400 shares of the
Company's common stock at an exercise price of $0.23 per share. The options vest 20% each year over a five-year period
and expire after ten years. The weighted average grant date fair value of options granted was $0.13 per option, for a
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total fair value of $300,000, which will be reflected as an operating expense over the vesting period of the options.
Stock option compensation recognized for the three months ended June 30, 2010 and 2009 in the accompanying condensed consolidated
statements of operations amounted to $17,799 and $31,227, respectively. The fair value of each option award was estimated on the date of grant using
the Black-Scholes option valuation model that uses the assumptions noted in the following table. Because the Black-Scholes
option valuation model incorporates ranges of assumptions for inputs, those ranges are disclosed. To estimate volatility of the
options over their expected terms, the Company measured the historical volatility of the components of the small cap sector of
the Dow Jones medical equipment index for a period equal to the expected life of the Cardo options. It also measured the
volatility of other public companies with similar size and industry characteristics to Cardo for the same period. These
measurements were averaged and the result was used as expected volatility. As there was no history of option lives at Cardo,
the expected term of options granted was the midpoint between the vesting periods and the contractual life of the options. The
risk-free rate for periods within the contractual life of the option was based on the U.S. Treasury yield curve in effect at the time
of grant. The forfeiture rate was based on an analysis of the nature of the recipients' jobs and relationships to the
Company. A summary of stock option activity as of June 30, 2010, and changes during
the period then ended is presented below. The aggregate intrinsic value represents the closing stock price as of June
30, 2010 less the exercise price, multiplied by the number of options that have an exercise price that is less than the closing
stock price. On April 8, 2010, the Board of Directors approved the 2010 Equity Incentive Plan (the "2010
Incentive Plan"), which was voted on and approved by the Company's stockholders at the Annual Meeting held on June
16, 2010. The 2010 Incentive Plan authorizes the Company to grant up to 23,000,000 incentive stock options, stock
appreciation rights, restricted stock grants, restricted stock units, performance shares, performance units or cash awards. As of
the date of this filing, no awards have been granted under the 2010 Incentive Plan. NOTE 4 — STOCKHOLDERS' EQUITY Our authorized capital consists of 750,000,000 shares of common stock and 50,000,000 shares of
preferred stock. Our preferred stock may be designated into series pursuant to authority granted by our Certificate of
Incorporation, and on approval from our Board of Directors. As of June 30, 2010, we did not have any preferred stock issued.
NOTE 5 — SEGMENT INFORMATION The Company's businesses are currently organized into the following two reportable segments;
reconstructive products (the "Reconstructive Division") and spine products (the "Spine Division"). The
Reconstructive Division segment is comprised of activity relating to the Company's unicompartmental knee, patellofemoral
products, and the total knee and hip products. The Spine Division segment is comprised of the spinal lumbar fusion system,
cervical plate and screw systems, and various interbody products. 6
The division into these reportable segments is based on the nature of the products offered.
Management evaluates performance and allocates resources based on several factors, of which the primary financial measure
is segment operating results. Due to the distinct nature of the products in the Company's Reconstructive Division, and the fact
that it has a more developed market for its products, it is considered by management as a separate segment. The Company's
Spine Division is still in the process of developing the market and obtaining instrumentation necessary to sell the products in
greater quantities. As a result of the unique characteristics of this product line, the Spine Division is considered by
management as a separate segment. As of June 30, 2010, the Company's Reconstructive Division includes $1,233,000 of goodwill and
$4,027,000 in other intangible assets, net of amortization, relating to the Company's unicompartmental knee and hip products.
These amounts are expected to be deductible for income tax purposes. The following table sets forth financial information by reportable segment as of June 30, 2010 and for
the three and six months ended June 30, 2010 and 2009: All of the Company's net sales were attributable to activity in the United States. There were no
long-lived assets held in foreign countries. 7
ITEM 2 — MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS The discussion and analysis of our financial condition and results of operations are based on our
consolidated financial statements, which we have prepared in accordance with accounting principles generally accepted in the United States
of America. The preparation of these consolidated financial statements requires us to make estimates and assumptions that affect the
reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial
statements, as well as the reported revenues and expenses during the reporting periods. On an ongoing basis, we evaluate
estimates and judgments, including those described in greater detail below. We base our estimates on historical experience
and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for
making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual
results may differ from these estimates under different assumptions or conditions. As used in this "Management's Discussion and Analysis of Financial Condition and Results of
Operation," except where the context otherwise requires, the term "we," "us," "our" or
"Cardo" refers to the business of Cardo Medical, Inc. The following discussion should be read in conjunction with the information contained in the
unaudited condensed consolidated financial statements and related notes included in Item 1, "Financial
Statements," in this Form 10-Q. Overview Cardo Medical, Inc. is an orthopedic medical device company specializing in designing, developing
and marketing high performance reconstructive joint devices and spinal surgical devices. Reconstructive joint devices are used
to replace knee, hip and other joints that have deteriorated through disease or injury. Spinal surgical devices involve products
to stabilize the spine for fusion and reconstructive procedures. Within these areas, we are focused on developing surgical
devices, instrumentation and techniques that will enable surgeons to move what are typically inpatient surgical procedures to
the outpatient world. We commercialize our reconstructive joint devices through our Reconstructive division and our spine
devices through our Spine division. We launched and commenced sales of our first product in December 2006, which was a
high performance unicompartmental knee replacement. We commenced sales of our other reconstructive products in 2007 and
our spine products in 2008. We are headquartered in Beverly Hills, California. In connection with the consummation of the merger
with clickNsettle.com, Inc. ("CKST"), CKST approved through its stockholders an amendment to its Amended and
Restated Certificate of Incorporation to change its name from "clickNsettle.com, Inc." to "Cardo Medical,
Inc." CKST's trading symbol was "CKST.OB," which has changed to "CDOM.OB" in connection
with the name change. Cardo Medical's common stock is quoted on the National Association of Securities Dealers, Inc.'s,
Over-the-Counter Bulletin Board. Critical Accounting Policies Use of Estimates Financial statements prepared in accordance with United States generally
accepted accounting principles ("U.S. GAAP") require management to make estimates and assumptions that affect
the reported amounts of assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and
expenses during the reporting period. Among other things, management makes estimates relating to allowances for doubtful
accounts, excess and obsolete inventory items, the estimated depreciable lives of property and equipment, the impairment of
goodwill and other intangible assets, share-based payment, deferred income tax assets and the allocation of the purchase
price paid for the minority interests in Accelerated Innovation, Inc. ("Accelerated"), Cervical Xpand LLC
("Cervical ") and Uni-Knee LLC ("Uni"). Given the short operating history of Cardo, actual results could
differ from those estimates. 8
Revenue Recognition We recognize revenue when it is realizable and earned. Management considers revenue to be
realizable and earned when the following criteria are met: persuasive evidence of an arrangement exists, delivery has occurred
or services have been rendered, the seller's price to the buyer is fixed or determinable, and collectability is reasonably
assured. Persuasive evidence of the arrangements occurs when we receive a signed contract from the hospital
in which the surgery will be performed. Within that contract is the price at which the hospital will buy the device. Delivery occurs
on the day of surgery when the device is implanted by the surgeon. Collectability is reasonably assured as we have continuing
relationships with the hospitals and can pursue collections if necessary. As we do not accept returns and do not have any
post-sale obligations, the date of revenue recognition is on the date of surgery. Inventory Inventory is stated at the lower of cost or net realizable value as determined by assessing the gross
profit less selling costs of each inventory item. Cost is determined on a first-in, first-out basis; and the inventory is primarily
comprised of work-in-process and finished goods. Work-in-process consists of fabrication costs paid relating to items not
physically received. Finished goods are completed knee, hip and spine replacement products ready for resale to
customers. At each balance sheet date, management evaluates the ending inventories for excess quantities and
obsolescence. This evaluation includes an analysis of sales levels by product type. Among other factors, we consider current
product configurations, historical and forecasted demand, market conditions and product life cycles when determining the net
realizable value of the inventory. Provisions are made to reduce excess or obsolete inventories to their estimated net realizable
values. Once established, write-downs are considered permanent adjustments to the cost basis of the excess or obsolete
inventory. We did not have any inventory considered by management to be excess or obsolete as of June 30, 2010. Based on
the forecasted sales amounts, we do not expect any changes in net realizable value in the near future. Property and Equipment Property and equipment are recorded at historical cost and depreciated on a straight-line basis over
their estimated useful lives, which range from three to five years. This estimate is based on the useful life of the individual
items. When items are retired or disposed of, income is charged or credited for the difference between the net book value of
the asset and the proceeds realized thereon. Ordinary maintenance and repairs are charged to expense as incurred, and
replacements and betterments are capitalized. This estimate is unlikely to experience any differences from what is reflected in
the financial statements. Goodwill and Other Intangible Assets Goodwill represents the excess of purchase price over fair value of tangible net assets of acquired
businesses after amounts allocated to other intangible assets. Other intangible assets include a royalty agreement, developed
technology and customer relationships which are amortized on a straight-line basis over 2 to 10 years. Goodwill and other
intangible assets were generated when we acquired the non-controlling interests of Accelerated, Cervical and Uni. Goodwill and Long-Lived Assets Impairment Goodwill and long-lived assets are assessed for impairment annually or more frequently if events or
circumstances occur that potentially indicate that the carrying amount of the assets may not be recoverable. We concluded that
there were no such events or changes in circumstances during 2009 or the interim period ended June 30, 2010. We conduct our annual evaluations for impairment at the
end of the fourth quarter of each year. Goodwill impairment testing compares the fair value of a reporting unit with its carrying
value using discounted cash flow projections. Long-lived asset impairment testing compares the projected undiscounted future
cash flows associated with the related assets over their estimated useful lives against their respective carrying amount.
Impairment, if any, is based on the excess of the carrying amount over the fair value, based on market value when available, or
discounted
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expected cash flows, of those assets and is recorded in the period in which the determination is made. These
evaluations require us to make certain assumptions and estimate future revenues and profitability. Based on the assessment performed for the year ended December 31, 2009, we determined that the
fair value of the knee and hip reporting units were in excess of the corresponding assets' carrying value as of
December 31, 2009. Accordingly, no impairment charges were recorded for the year ended December 31, 2009. Share Based Payment In order to determine compensation on options issued to consultants, and employees' options, the fair
value of each option granted is estimated on the date of grant using the Black-Scholes option-pricing model. Management
estimates the requisite service period used in the Black-Scholes calculation based on an analysis of vesting and exercisability
conditions, explicit, implicit, and/or derived service periods, and the probability of the satisfaction of any performance or service
conditions. Management also considers whether the requisite service has been rendered when recognizing compensation
costs. Expected volatilities are based on the historical volatility of the components of the small cap sector of the Dow Jones
medical equipment index for a period equal to the expected life of our options. We also measure the volatility of other public
companies with similar size and industry characteristics to us for the same period. These measurements are averaged and the
result is used as expected volatility. As there is no history of option lives at our company, the expected term of options granted
is the midpoint between the vesting periods and the contractual life of the options. The risk-free rate for periods within the
contractual life of the option is based on the U.S. Treasury yield curve in effect at the time of grant. The forfeiture rate is based
on an analysis of the nature of the recipients' jobs and relationships to us. Income Taxes On August 29, 2008, Cardo LLC consummated a reverse merger with CKST thereby adopting
CKST as the taxpaying entity. Our deferred tax assets and liabilities are recognized to reflect the estimated future tax effects,
calculated at currently effective tax rates, of future deductible or taxable amounts attributable to events that have been
recognized on a cumulative basis in the financial statements. A valuation allowance related to a deferred tax asset is recorded
when it is more likely than not that some portion of the deferred tax asset will not be realized. The estimated value of the
deferred tax assets are subject to significant change based on the company's future profitability. Deferred tax assets and
liabilities are adjusted for the effects of the changes in tax laws and rates of the date of enactment. In June 2008, the Financial Accounting Standards Board ("FASB") sought to reduce the
diversity in practice associated with certain aspects of measurement and recognition in accounting for income taxes. FASB
prescribed a recognition threshold and measurement requirement for the financial statement recognition of a tax position that
has been taken or is expected to be taken on a tax return and also provides guidance on de-recognition, classification, interest
and penalties, accounting in interim periods, disclosure, and transition. As such, we may only recognize or continue to
recognize tax positions that meet a "more likely than not" threshold. Based on this analysis, our tax position is
unlikely to change. Recent Accounting Pronouncements There are no recently issued accounting pronouncements that we have yet to adopt that are expected
to have a material effect on our financial position, results of operations, or cash flows. 10
Results of Operations for the Three Months Ended June 30, 2010 as Compared to the Three Months
Ended June 30, 2009. The following is a comparison of the consolidated results of operations for Cardo for the three
months ended June 30, 2010 and 2009: Revenues During the quarter ended June 30, 2010, we generated revenues of
$1,077,000 compared to $446,000 for the same period in 2009. The $631,000 increase resulted from wider acceptance of our
knee and spine products by orthopedic and back surgeons. We experienced substantial growth in spine sales, an increase of
$431,000, in the current quarter as compared to 2009. We introduced the resale of interbody spinal devices during the 2010
first quarter, which was a major contributor to the increase in spine sales. There were no such comparable interbody sales in
2009. Additionally, our knee products sales increased $232,000 during the current quarter. This was primarily a result of sales
from our total knee system. There were no such comparable total knee sales in 2009. The current quarter increases in knee
and spine sales were offset by a slight decrease in hip sales. Our knee and hip products accounted for 57% of total sales
during the three months ended June 30, 2010 compared to 92% in 2009. Gross Profit During the quarter ended June 30, 2010, we had cost of sales of $221,000
compared to $88,000 during the quarter ended June 30, 2009. Our gross profit percentage was 79.4% during the three
months ended June 30, 2010 compared to 80.3% for the same period in 2009. This slight decrease in 2010 was attributed to
greater sales of spine products that generate margins consistent with hip products, both of which yield profit margins slightly
lower than knee products. As acceptance of our reconstructive and spine products continues to grow, it is expected that our
2010 profit margins will remain mostly consistent with 2009 but significant fluctuations in our sales mix can have an impact on
the overall gross profit. Research and Development Expenses During the quarter ended June 30, 2010, we had research and development
expenses of $313,000 compared to $160,000 for the same period in 2009. The increase in the current year is primarily a result
of direct labor allocations and increase volume of customized instrumentation created for surgeons. Research costs associated
with certain hip products have increased moderately and are likely to increase in the upcoming quarters as we look to enhance
our overall product portfolio. 11
Selling, General and Administrative Expenses During the quarter ended June 30, 2010, we had selling general and
administrative expenses of $2,050,000 compared to $1,545,000 in the same period of 2009, an increase of $505,000. Sales
commissions increased by $153,000 in 2010 which was mostly consistent with our higher sales volume. Depreciation and
amortization expense increased by $50,000 in 2010 because of the acquisition of additional instrumentation required to
support base inventory levels and continued sales increases. Travel to new and prospective hospitals and industry
conferences increased in 2010 along with rent and office expenses as we added office space and our overall business activity
was greater than it was in 2009. In addition, professional fees increased $226,000 during the quarter ended June 30, 2010
compared to 2009 as a result of exploring strategic opportunities, expanding corporate activities and additional regulatory
filings. Interest and Other Income During the quarter ended June 30, 2010, we had interest income of $25,000
compared to $8,000 during the same period in 2009. Interest income is earned on our excess cash balances, which were lower
in 2010. We sold some instruments which resulted in $22,000 of other income during the quarter ended June 30, 2010. Results of Operations for the Six Months Ended June 30, 2010 as Compared to the Six Months Ended
June 30, 2009. The following is a comparison of the consolidated results of operations for Cardo for the six
months ended June 30, 2010 and 2009: Revenues During the six months ended June 30, 2010, we generated revenues of
$1,979,000 compared to $878,000 for the same period in 2009. The $1,101,000 increase primarily resulted from wider
acceptance of our knee and spine products by orthopedic and back surgeons. We experienced substantial growth in spine
sales, an increase of $836,000 in 2010 compared to 2009. We introduced the resale of interbody spinal devices during the
2010 first quarter, which was a major contributor to the increase in spine sales. There were no such comparable interbody
sales in 2009. Additionally, our knee products sales increased $216,000 during 2010 compared to 2009. This was primarily a
result of sales from our total knee system. There were no such comparable total knee sales in 2009. Our knee and hip
products accounted for 55% of total sales during the six months ended June 30, 2010 compared to 94% in 2009. 12
Gross Profit During the six months ended June 30, 2010, we had cost of sales of
$393,000 compared to $170,000 during the six months ended June 30, 2009. Our gross profit percentage was 80.1% during
the six months ended June 30, 2010 compared to 80.6% for the same period in 2009. This slight decrease in 2010 was
attributed to greater sales of spine products that generate margins consistent with hip products, both of which yield profit
margins lower than knee products. As acceptance of our reconstructive and spine products continues to grow, it is expected
that our 2010 profit margins will remain mostly consistent with 2009 but significant fluctuations in our sales mix can have an
impact on the overall gross profit. Research and Development Expenses During the six months ended June 30, 2010, we had research and
development expenses of $599,000 compared to $206,000 for the same period in 2009. The increase in the current year is
primarily a result of direct labor allocations and increase volume of custom instruments created for surgeons. Research costs
associated with certain hip products have increased moderately and are likely to increase in the upcoming quarters as we look
to enhance our overall product portfolio. Selling, General and Administrative Expenses During the six months ended June 30, 2010, we had selling general and
administrative expenses of $3,956,000 compared to $3,081,000 in the same period of 2009, an increase of $875,000. Sales
commissions increased by $350,000 in 2010 which was driven by higher sales volume and commission rates on certain
products. Depreciation and amortization expense increased by $121,000 in 2010 because of the acquisition of additional
instrumentation required to support base inventory levels and continued sales increases. Travel to new and prospective
hospitals and industry conferences increased in 2010 along with rent and office expenses as we added office space and our
overall business activity was greater than it was in 2009. In addition, professional fees increased $327,000 during the six
months ended June 30, 2010 compared to 2009 as a result of exploring strategic opportunities, expanding corporate activities
and more regulatory filings. Interest and Other Income During the six months ended June 30, 2010, we had interest income of
$32,000 compared to $16,000 during the same period in 2009. Interest income is earned on our excess cash balances, which
were lower in 2010. We sold some instruments which resulted in $22,000 of other income during the six months ended June
30, 2010. Segment Information Our businesses are currently organized into the following two reportable
segments; reconstructive products (the "Reconstructive Division") and spine products (the "Spine
Division"). The Reconstructive Division segment is comprised of activity relating to the Company's unicompartmental
knee, patellofemoral products, and the total knee and hip products. The Spine Division segment is comprised of the spinal
lumbar fusion system, cervical plate and screw systems, and various interbody products. The division into these reportable segments is based on the nature of the products offered.
Management evaluates performance and allocates resources based on several factors, of which the primary financial measure
is segment operating results. Due to the distinct nature of the products in our Reconstructive Division, and the fact that it has a
more developed market for its products, it is considered by management as a separate segment. Our Spine Division is still in
the process of developing the market and obtaining instrumentation necessary to sell the products in greater quantities. As a
result of the unique characteristics of this product line, the Spine Division is considered by management as a separate
segment. As of June 30, 2010, our Reconstructive Division included $1,233,000 of
goodwill and $4,027,000 in other intangible assets, net of amortization, relating to our unicompartmental knee and hip
products. These amounts are expected to be deductible for income tax purposes. 13
The following table sets forth summarized financial results by reportable segment for the three and six
months ended June 30, 2010 and 2009: All of the Company's net sales were attributable to activity in the United States. There were no long-lived
assets held in foreign countries. Liquidity and Capital Resources Net cash used in operating activities was $2,593,000 for the six months ended June 30, 2010
compared to $2,207,000 for the same period in 2009. The primary use of cash in 2010 beyond wages and other operating
costs was the continued build-up of inventory, which has increased $1,134,000 during the current year. Net cash used in investing activities was $715,000 for the six months ended June 30, 2010 compared
to $661,000 for the same period in 2009. The cash used for investment activities during 2010 was attributed to the purchase of
equipment to accommodate our operational and corporate growth as well as additional instrumentation required in order to
support current and anticipated future sales levels. There was no cash raised by financing activities during the six months ended June 30, 2010 compared
to $3,023,000 in 2009. The prior year amount reflects the net proceeds from a private placement. Although we may not have
sufficient cash to fund our operations for the remainder of 2010, our current working capital should allow us to meet our needs
through the third fiscal quarter of 2010. We raised nearly $6 million net proceeds during the fourth quarter of 2009 through private placements;
however, the available funds are not projected to meet all of our working capital needs for the next twelve months. We
anticipate that we will sustain losses through the fourth quarter of 2010, and require additional capital to supplement
14
operations which creates substantial doubt about our ability to continue as a going concern. Management is
actively seeking various sources of financing; however, there are no assurances that any such financing can be obtained on
favorable terms, if at all. Management is closely monitoring its operating costs to conserve cash until additional funds become
available through financing or operating activities. Management intends to use borrowings and/or securities sales to provide additional cash to fund our
operations. However, we cannot assure you that debt or equity financing, if and when required, will be available. Our ability to
continue as a going concern is dependent upon receiving additional funds either through the issuance of debt or through
common and/or preferred stock and the success of management's plan to expand sales. Although we may obtain external
financing through the sales of our securities, there can be no assurance that such financing will be available, or if available,
that any such financing would be on terms acceptable to us. If we are unable to fund our cash flow needs, we may have to
reduce or stop planned growth or scale back operations and reduce staff. Forward-Looking Statements Some of the statements in this Quarterly Report on Form 10-Q are "forward-looking
statements," as that term is defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements
may be identified by the use of words such as "may," "will," "should," "anticipate,"
"estimate," "expect," "plan," "believe," "predict,"
"potential," "project," "target," "forecast," "intend,"
"assume," "guide," "seek" and similar expressions. Forward-looking statements do not relate
strictly to historical or current matters. Rather, forward-looking statements are predictive in nature and may depend upon or
refer to future events, activities or conditions. Although we believe that these statements are based upon reasonable
assumptions, we cannot provide any assurances regarding future results. We undertake no obligation to revise or update any
forward-looking statements, or to make any other forward-looking statements, whether as a result of new information, future
events or otherwise. Because forward-looking statements relate to matters that have not yet occurred, these statements are
inherently subject to risks and uncertainties. Many factors could cause our actual activities or results to differ materially from
the activities and results anticipated in forward-looking statements. Information regarding our risk factors appears in
Part I, Item 1A, "Risk Factors," in our Annual Report on Form 10-K for the year ended
December 31, 2009 and includes the following:
YES ¨
NO x
Financial Statements
Condensed Consolidated Balance Sheets at June 30, 2010 (Unaudited) and
December 31, 2009
Condensed Consolidated Statements of
Operations (Unaudited) — Three and Six Months Ended June 30, 2010 and 2009
Condensed Consolidated Statements of Cash
Flows (Unaudited) — Six Months Ended June 30, 2010 and 2009
Notes to Condensed Consolidated Financial
Statements (Unaudited)
Management's Discussion and Analysis of Financial
Condition and Results of Operations
Controls and Procedures
Exhibits
Signatures
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share amounts)
June 30
December 31,
2010
2009
(Unaudited)
Assets
Current assets
Cash
$
1,665
$
4,973
Accounts receivable
567
307
Inventories
4,390
3,256
Prepaid expenses and other current assets
84
65
Total current assets
6,706
8,601
Property and equipment, net
1,607
1,228
Goodwill
1,233
1,233
Other intangible assets, net
4,027
4,353
Deposits and other assets, net
147
173
Total assets
$
13,720
$
15,588
Liabilities and Stockholders' Equity
Current liabilities
Accounts payable and accrued expenses
$
1,884
$
851
Stockholders' equity
Common stock, $0.001 par value, 750,000,000 million shares authorized,
230,293,141 issued and outstanding as of June 30, 2010 (unaudited)
and December 31, 2009
230
230
Additional paid-in capital
25,758
25,722
Note receivable from stockholder
(50)
(50)
Accumulated deficit
(14,102)
(11,165)
Total stockholders' equity
11,836
14,737
Total liabilities and stockholders' equity
$
13,720
$
15,588
Three Months Ended
Six Months Ended
June 30,
June 30,
2010
2009
2010
2009
Net sales
$
1,077
$
446
$
1,979
$
878
Cost of sales
221
88
393
170
Gross profit
856
358
1,586
708
Research and development expenses
313
160
599
206
Selling, general and administrative expenses
2,050
1,545
3,956
3,081
Loss from operations
(1,507)
(1,347)
(2,969)
(2,579)
Interest and other income, net
25
8
32
16
Loss before income tax provision
(1,482)
(1,339)
(2,937)
(2,563)
Provision for income taxes
-
-
-
-
Net loss
$
(1,482)
$
(1,339)
$
(2,937)
$
(2,563)
Net loss available to common stockholders per share:
Basic and diluted
$
(0.01)
$
(0.01)
$
(0.01)
$
(0.01)
Weighted average shares outstanding:
Basic and diluted
230,293,141
203,360,271
230,293,141
203,360,271
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
Six Months Ended
June 30,
2010
2009
Cash flows from operating activities
Net loss
$
(2,937)
$
(2,563)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
687
565
Stock option compensation
35
62
Changes in operating assets and liabilities:
Accounts receivable
(259)
(54)
Inventories
(1,134)
(634)
Prepaid expenses and other current assets
(18)
(7)
Accounts payable and accrued expenses
1,033
424
Net cash used in operating activities
(2,593)
(2,207)
Cash flows from investing activities
Purchases of property and equipment
(715)
(651)
Increase in other assets
-
(10)
Net cash used in investing activities
(715)
(661)
Cash flows from financing activities
Proceeds from private placements, net of issuance costs
-
3,023
Net cash provided by financing activities
-
3,023
Net change in cash
(3,308)
155
Cash, beginning of period
4,973
3,095
Cash, end of period
$
1,665
$
3,250
Supplemental disclosure of cash flow information:
Interest paid
$
-
$
-
Income taxes paid
$
-
$
-
Notes to Condensed Consolidated Financial Statements
June 30, 2010
(Unaudited)
(In thousands)
June 30
December 31,
2010
2009
(Unaudited)
Packaging materials
$
82
$
24
Work in process
1,134
360
Finished goods
3,174
2,872
$
4,390
$
3,256
Weighted-
Weighted-
Average
Average
Remaining
Aggregate
Exercise
Contractual
Intrinsic
Options
Price
Life (Years)
Value
Outstanding at December 31, 2009
2,036,000
$
0.23
Granted
-
-
Exercised
-
-
Forfeited
(45,600)
$
0.23
Outstanding at June 30, 2010 (unaudited)
1,990,400
$
0.23
8.17
$
537,408
Exercisable at June 30, 2010 (unaudited)
398,080
$
0.23
8.17
$
107,482
(In thousands)
Reconstructive
Spine
Division
Division
Corporate
Total
Six Months Ended June 30, 2010 (unaudited)
Net sales
$
1,089
$
890
$
-
$
1,979
Total cost of sales and operating expenses
204
189
3,868
4,261
Depreciation and amortization
658
6
23
687
Interest and other income, net
-
-
32
32
Net income (loss)
$
227
$
695
$
(3,859)
$
(2,937)
Property and equipment acquisitions
$
526
$
72
$
117
$
715
Total assets
$
9,817
$
1,904
$
1,999
$
13,720
Six Months Ended June 30, 2009 (unaudited)
Net sales
$
824
$
54
$
-
$
878
Total cost of sales and operating expenses
156
13
2,723
2,892
Depreciation and amortization
545
2
18
565
Interest and other income, net
-
-
16
16
Net income (loss)
$
123
$
39
$
(2,725)
$
(2,563)
Three Months Ended June 30, 2010 (unaudited)
Net sales
$
612
$
465
$
-
$
1,077
Total cost of sales and operating expenses
118
103
2,013
2,234
Depreciation and amortization
332
3
15
350
Interest and other income, net
-
-
25
25
Net income (loss)
$
162
$
359
$
(2,003)
$
(1,482)
Three Months Ended June 30, 2009 (unaudited)
Net sales
$
412
$
34
$
-
$
446
Total cost of sales and operating expenses
80
8
1,406
1,494
Depreciation and amortization
288
1
10
299
Interest and other income, net
-
-
8
8
Net income (loss)
$
44
$
25
$
(1,408)
$
(1,339)
(In thousands)
Three Months Ended
June 30,
2010
2009
Variance
Net sales
$
1,077
$
446
$
631
Cost of sales
221
88
133
Gross profit
856
358
498
Research and development expenses
313
160
153
Selling, general and administrative expenses
2,050
1,545
505
Loss from operations
(1,507)
(1,347)
(160)
Interest and other income, net
25
8
17
Loss before income tax provision
(1,482)
(1,339)
(143)
Provision for income taxes
-
-
-
Net loss
$
(1,482)
$
(1,339)
$
(143)
(In thousands)
Six Months Ended
June 30,
2010
2009
Variance
Net sales
$
1,979
$
878
$
1,101
Cost of sales
393
170
223
Gross profit
1,586
708
878
Research and development expenses
599
206
393
Selling, general and administrative expenses
3,956
3,081
875
Loss from operations
(2,969)
(2,579)
(390)
Interest and other income, net
32
16
16
Loss before income tax provision
(2,937)
(2,563)
(374)
Provision for income taxes
-
-
-
Net loss
$
(2,937)
$
(2,563)
$
(374)
(In thousands)
Reconstructive
Spine
Division
Division
Corporate
Total
Six Months Ended June 30, 2010 (unaudited)
Net sales
$
1,089
$
890
$
-
$
1,979
Total cost of sales and operating expenses
204
189
3,868
4,261
Depreciation and amortization
658
6
23
687
Interest and other income, net
-
-
32
32
Net income (loss)
$
227
$
695
$
(3,859)
$
(2,937)
Six Months Ended June 30, 2009 (unaudited)
Net sales
$
824
$
54
$
-
$
878
Total cost of sales and operating expenses
156
13
2,723
2,892
Depreciation and amortization
545
2
18
565
Interest and other income, net
-
-
16
16
Net income (loss)
$
123
$
39
$
(2,725)
$
(2,563)
Three Months Ended June 30, 2010 (unaudited)
Net sales
$
612
$
465
$
-
$
1,077
Total cost of sales and operating expenses
118
103
2,013
2,234
Depreciation and amortization
332
3
15
350
Interest and other income, net
-
-
25
25
Net income (loss)
$
162
$
359
$
(2,003)
$
(1,482)
Three Months Ended June 30, 2009 (unaudited)
Net sales
$
412
$
34
$
-
$
446
Total cost of sales and operating expenses
80
8
1,406
1,494
Depreciation and amortization
288
1
10
299
Interest and other income, net
-
-
8
8
Net income (loss)
$
44
$
25
$
(1,408)
$
(1,339)
15
- Our business plan relies on certain assumptions about the market for our products, which, if incorrect, may adversely affect our business and profitability.
- We expect to face significant competition as a result of the rapid technological changes in the medical devices industry, which could have an adverse effect on our business, financial condition or results of operations.
- We rely on single source manufacturers, which could impair our ability to meet demand for delivering our products in a timely manner or within our budget.
- Loss of any major customer could have a material adverse effect on our business, financial condition and results of operations.
- Our growth will depend on developing new products or product enhancements, requiring significant research and development, clinical trials and regulatory approvals, all of which are expensive and time-consuming and may not result in a commercially viable product.
- If we choose to grow our business by acquiring new and complementary businesses, products or technologies, we may be unable to complete these acquisitions or successfully integrate them in a cost-effective and non-disruptive manner.
- We rely on our independent sales distributors and sales representatives to market and sell our products.
- We are dependent on the services of Andrew A. Brooks, M.D. and Michael Kvitnitsky, and the loss of either of them could harm our business.
- Failure to attract and retain skilled personnel and cultivate key academic collaborations will delay product development programs and business development efforts.
- If conflicts arise between collaborators or advisors and us, any of these parties may act in its self-interest, which may be adverse to our interests and the interests of our stockholders.
- If we fail to properly manage our anticipated growth, our business could suffer.
- If we fail to upgrade our management information systems, or if those systems do not operate as expected, we could experience significant disruption of our business and product developments and our results could suffer.
- If a natural or man-made disaster strikes a facility in which our products are manufactured, we could be unable to deliver our products for a substantial amount of time and our sales could decline.
- If we decide to market and sell our devices and products internationally, we would be subject to various risks relating to our international activities, which could negatively impact our business and financial results.
- We are subject to substantial governmental regulation that could change and thus force us to make modifications to how we develop, manufacture and price our products. Compliance with the various complex laws and regulations is costly and time consuming, and failure to comply can have adverse consequences on our business.
- Federal regulatory reforms may adversely affect our ability to sell our products profitably.
- We have not yet collected long-term clinical data to support the safety of our products, and our products may, therefore, prove to be less safe and effective than initially thought.
- The FDA requires us to obtain new Section 510(k) clearances or premarket approvals for modifications to our approved products. Otherwise, we may have to cease marketing, or to recall, the modified products until clearances are obtained.
- If we or our third-party manufacturers fail to comply with the FDA's Quality System Regulations, the manufacture of our products could be interrupted and our product sales and operating results could suffer.
- Some proponents have advocated the creation of a national database or registry that tracks how patients with artificial joints fare. Any requirement for surgeons to participate in such a registry may adversely affect our ability to sell our products profitably.
- We are an orthopedic medical device company with a limited operating history and our business may not become profitable.
- Our quarterly financial results are likely to fluctuate significantly because our sales prospects are uncertain and our sales are difficult to forecast.
16
- If we cannot adequately protect our patents and other intellectual property rights, we may lose market share to our competitors and be unable to operate our business profitably.
- Changes to intellectual property laws may negatively impact our ability to protect our intellectual property.
- The medical device industry is characterized by patent and other intellectual property litigation, and we could become subject to litigation that could be costly, result in diverting management's time and efforts, require us to pay damages, and/or prevent us from marketing our existing or future products.
- Patent infringement lawsuits brought against us could have a material adverse affect on our ability to develop and sell our products and to operate profitably.
- We may be subject to damages resulting from claims that we or our employees or consultants have wrongfully used or disclosed alleged trade secrets of their former employers.
- Some countries may require us to grant compulsory licenses to third parties. These licenses could be extended to include some of our products or potential product, which may limit our potential revenue opportunities.
- Fluctuations in the cost and availability of insurance could adversely affect our profitability or our risk management profile.
- Potential future product liability claims and other litigation, including contract litigation, may adversely affect our business, reputation and ability to attract and retain customers.
- Any claims relating to our making improper payments to physicians for consulting services, or other potential violations of regulations governing interactions between us and healthcare providers, could be time-consuming and costly.
- Our common stock may be thinly traded.
- We expect that the price of our common stock will fluctuate substantially, potentially adversely affecting the ability of investors to sell their shares.
- We may become involved in securities class action litigation that could divert management's attention and harm its business.
- Securities analysts may elect not to report on our common stock or may issue negative reports that adversely affect the price of our common stock.
- Anti-takeover provisions in our charter documents and Delaware law may discourage or prevent a change in control, even if an acquisition would be beneficial to our stockholders, which could affect our stock price adversely and prevent attempts by our stockholders to replace or remove our current management.
- Because our common stock may be a "penny stock," it may be more difficult for investors to sell shares of our common stock, and the market price of our common stock may be adversely affected.
- A significant number of shares will become eligible for future sale by our stockholders and the sale of those shares could adversely affect the stock price.
- Directors, executive officers, principal stockholders and affiliated entities own a significant percentage of our capital stock, and they may make decisions that you do not consider to be in the best interests of our stockholders.
- Our stock price could decline as a result of our failure to meet reporting and other regulatory requirements.
- Failure to maintain effective internal controls in accordance with Section 404 of the Sarbanes-Oxley Act could have a material adverse effect on our business and stock price.
- Our status as a public company may make it more difficult to attract and retain officers and directors.
- Compliance with changing regulations concerning corporate governance and public disclosure may result in additional expenses.
- Stockholders may experience significant dilution if future equity offerings are used to fund operations or acquire complementary businesses.
17
- We do not intend to pay cash dividends. Any return on investment may be limited to the value of our common stock, if any.
- Our Certificate of Incorporation grants our Board of Directors the power to designate and issue additional shares of common and/or preferred stock.
Additional information concerning these risk factors can be found in our other filings made with the SEC. Forward-looking statements in this Quarterly Report on Form 10-Q should be evaluated in light of these important factors.
ITEM 4 — CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, that are designed to ensure that information required to be disclosed in our reports under the Exchange Act, is recorded, processed, summarized and reported within the time periods specified in the Commission's rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and our principal financial officer, as appropriate, to allow timely decisions regarding required disclosure.
We carried out an evaluation under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, of the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) and 15d-15(e) under the Exchange Act) as of the end of the period covered by this quarterly report. Based on this evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of June 30, 2010.
Changes in Internal Control Over Financial Reporting
There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended June 30, 2010 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II — OTHER INFORMATION
The following exhibits are filed as part of, or incorporated by reference into this Report:
|
Exhibit Number |
Exhibit Title |
|
|
10.1 |
Cardo Medical, Inc. 2010 Equity Incentive Plan *+ |
|
|
31.1 |
|
Certification of Chief Executive Officer of Cardo Medical, Inc., as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 * |
|
31.2 |
Certification of Chief Financial Officer of Cardo Medical, Inc., as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 * |
|
|
32.1 |
Certification of Chief Executive Officer of Cardo Medical, Inc. pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 ** |
|
|
32.2 |
Certification of Chief Financial Officer of Cardo Medical, Inc. pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 ** |
|
|
* |
Filed herewith |
|
|
** |
Furnished herewith |
|
|
+ |
Management compensation plan or agreement |
18
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
CARDO MEDICAL, INC. |
|
|
|
|
|
|
|
|
|
|
August 12, 2010 |
By: |
/s/ Andrew A. Brooks |
|
|
|
Andrew A. Brooks |
|
|
|
Chief Executive Officer |
|
|
|
|
|
|
|
|
|
August 12, 2010 |
By: |
/s/ Derrick Romine |
|
|
|
Derrick Romine |
|
|
|
Chief Financial Officer |
19
INDEX TO EXHIBITS
20