Table of Contents
Results of Operations
Three Months Ended
June 30, 2011 Compared to the Three Months Ended June 30, 2010
Revenue.
Revenue was $18.6 million for the three months ended June 30, 2011, compared to
$10.3 million for the three months ended June 30, 2010. The increase in revenue
of $8.3 million, or 81%, was primarily due to a $3.4 million, or 81%, increase
in procedure revenue, a $3.8 million, or 67%, increase in RIO system revenue
and a $1.1 million, or 322%, increase in service revenue. The $3.4 million
increase in procedure revenue was attributable to an increase in MAKOplasty
procedures performed during the three months ended June 30, 2011 as compared
with the three months ended June 30, 2010. There were 1,557 MAKOplasty procedures
performed during the three months ended June 30, 2011 compared to 793
MAKOplasty procedures performed during the three months ended June 30, 2010.
The increase in MAKOplasty procedures performed was primarily due to the
continued adoption of MAKOplasty, driven by the growth of our commercial
installed base of RIO systems and relatively consistent average utilization per
system and average selling price per procedure. The $3.8 million increase in
RIO system revenue was attributable to $9.5 million of revenue from twelve unit
sales of our RIO system, including ten domestic commercial sales and two
international commercial sales, during the three months ended June 30, 2011, as
compared to the recognition of $5.7 million of revenue from seven unit sales of
our RIO system, including six domestic commercial sales and one international
demonstration system, during the three months ended June 30, 2010. RIO system
revenue for the three months ended June 30, 2011 was reduced by $822,000 for
the deferral of system revenue related to the first year warranty and
maintenance services provided by MAKO. This
deferred revenue will be recognized in service revenue over a twelve-month
period. The $1.1 million increase in service revenue was attributable to
revenue recognized from warranty and maintenance services on the RIO system
hardware. Prior to the fourth quarter of 2010, we did not attribute revenue to
the first year warranty and maintenance obligation for services. We expect our
revenue to continue to increase as unit sales of our RIO system increase in
future periods and the number of MAKOplasty procedures performed increases in
future periods.
Cost
of Revenue.
Cost of revenue was $5.5 million for the
three months ended June 30, 2011, compared to $3.7 million for the three months
ended June 30, 2010. The increase in cost of revenue of $1.8 million, or 49%,
was primarily due to an increase in MAKOplasty procedures performed and to the
recognition of the direct cost of revenue from twelve unit sales of our RIO
system during the three months ended June 30, 2011 as compared to the
recognition of the cost of revenue from seven unit sales of our RIO system
during the three months ended June 30, 2010. This was partially offset by lower
per system material costs and lower per procedure material costs for the three
months ended June 30, 2011, compared to the three months ended June 30, 2010.
We expect our cost of revenue to continue to increase as unit sales of our RIO
system increase in future periods and the number of MAKOplasty procedures
performed increases in future periods.
Selling,
General and Administrative.
Selling, general and
administrative expense was $17.1 million for the three months ended June
30, 2011, compared to $10.7 million for the three months ended June 30,
2010. The increase of $6.4 million, or 60%, was primarily due to an increase in sales, marketing and
operations costs associated with the production and commercialization of our
products and an increase in general and administrative costs to support our
continued growth. Our total number of employees increased from 256 as of June
30, 2010 to 354 as of June 30, 2011. Of the 98 employee increase, 62 were in
sales and marketing. Selling, general and administrative expense for the three
months ended June 30, 2011 included
$2.2 million of stock-based compensation expense compared to $1.4 million for
the three months ended June 30, 2010. The increase in stock-based compensation expense was primarily due to
additional option grants and restricted stock grants made in 2011 combined with
the increase in the price of our common stock. We expect our selling, general
and administrative expenses to continue to increase substantially due to our
planned increase in the number of employees and sales and training programs
necessary to support the sales and marketing efforts associated with the
growing commercialization of our products, and an increased number of
employees, facilities and operating costs necessary to support our continued
growth in operations.
Research
and Development.
Research and development expense was
$5.0 million for the three months ended June 30, 2011, compared to
$3.7 million for the three months ended June 30, 2010. The increase of
$1.3 million, or 36%, was primarily due
to an increase in research and development activities associated with on-going
development of our RIO system, our MAKO implant systems and potential future
products, including our hip MAKOplasty application and associated implant systems. Research and
development expense for the quarter ended June 30, 2011 was also impacted by
$360,000 of expense incurred under the Strategic Alliance Agreement with
Pipeline Biomedical Holding, LLC as discussed in Item 1, Financial
Statements, Note 5 to the Condensed Financial Statements. We expect our research and development expense to increase as we
continue to expand our research and development activities, including the
support of existing products and the research of potential future products, including
our hip MAKOplasty application and associated implant systems.
17
Table of Contents
Depreciation
and Amortization.
Depreciation and amortization
expense was $977,000 for the three months ended June 30, 2011, compared to
$749,000 for the three months ended June 30, 2010. The increase of $228,000, or
30%, was primarily due to an increase
in depreciation of property and equipment as a result of purchases made during
2010 and 2011 due to the growth in our business and the expansion of our
facilities in 2010 to accommodate the increase in employees and operational
activities necessary to support such growth.
Interest
and Other Income.
Interest and other income was
$120,000 for the three months ended June 30, 2011, compared to $64,000 for the
three months ended June 30, 2010. The increase of $56,000, or 88%, was primarily due to higher average
outstanding cash and investment balances during 2011 from the net proceeds of a public offering of our common stock in
November 2010.
Income
Taxes.
No federal income taxes were recognized for the
three months ended June 30, 2011 and 2010, due to net operating losses in each
period. State and local income taxes were $1,000 for the three months ended
June 30, 2011, representing no change from the $1,000 for the three months
ended June 30, 2010. Income taxes recognized to date have not been significant
due to net operating losses we have incurred in each period since our
inception. In addition, no current or
deferred income taxes were recorded for the three months ended June 30,
2011 and 2010, as all income tax
benefits were fully offset by a valuation allowance against our net deferred
income tax assets.
Six Months Ended
June 30, 2011 Compared to the Six Months Ended June 30, 2010
Revenue.
Revenue was $31.6 million for
the six months ended June 30, 2011, compared to $17.5 million for the six months ended June 30, 2010. The increase in revenue
of $14.1 million, or 81%, was primarily due to a $6.3 million, or 80%, increase in procedure revenue, a $5.8 million, or
64%, increase in RIO system revenue and a $2.1 million, or 360%, increase in service revenue. The $6.3 million increase
in procedure revenue was attributable to an increase in MAKOplasty procedures performed during the six months ended June
30, 2011 as compared with the six months ended June 30, 2010. There were 2,861 MAKOplasty procedures performed during the
six months ended June 30, 2011 compared to 1,524 MAKOplasty procedures performed during the six months ended June 30, 2010.
The increase in MAKOplasty procedures performed was primarily due to the continued adoption of MAKOplasty, driven by the
growth of our commercial installed base of RIO systems and relatively consistent average utilization per system and average
selling price per procedure. The $5.8 million increase in RIO system revenue was attributable to $14.8 million of revenue
from nineteen unit sales of our RIO system, including seventeen domestic commercial sales and two international commercial
sales, during the six months ended June 30, 2011, as compared to the recognition of $9.1 million of revenue from eleven unit
sales of our RIO system, including ten domestic commercial sales and one international demonstration system, during the
six months ended June 30, 2010. RIO system revenue for the six months ended June 30, 2011 was reduced by $1.4 million for the
deferral of system revenue related to the first year warranty and maintenance services provided by MAKO. This deferred
revenue will be recognized in service revenue over a twelve-month period. The $2.1 million increase in service revenue was
attributable to revenue recognized from warranty and maintenance services on the RIO system hardware. Prior to the fourth
quarter of 2010, we did not attribute revenue to the first year warranty and maintenance obligation for services.
Cost
of Revenue.
Cost of revenue was $9.6 million for the six
months ended June 30, 2011, compared to $7.7 million for the six months ended
June 30, 2010. The increase in cost of revenue of $1.9 million, or 25%, was
primarily due to an increase in MAKOplasty procedures performed and to the
recognition of the direct cost of revenue from nineteen unit sales of our RIO
system during the six months ended June 30, 2011 as compared to the recognition
of the cost of revenue from eleven unit sales of our RIO system during the six
months ended June 30, 2010. This was partially offset by lower per system
material costs and lower per procedure material costs for the six months ended
June 30, 2011, compared to the six months ended June 30, 2010. Cost of revenue
for the six months ended June 30, 2010 was also impacted by a write-off of
approximately $1.0 million of excess RESTORIS Classic implants necessitated by
the rapid adoption of the RESTORIS MCK multicompartmental knee implant system,
or RESTORIS MCK, and the corresponding decline in the usage of RESTORIS
Classic. RESTORIS Classic was introduced in the third quarter of 2008 and was
modeled after existing well-known unicompartmental designs. In connection with
the launch of the RIO system, in the second quarter of 2009, we launched our
next generation RESTORIS MCK which was designed as a premium addition to the
RESTORIS product family with the goal of delivering a more natural feeling knee
by preserving bone and providing anatomical features such as high flexion.
18
Table of Contents
Selling,
General and Administrative.
Selling, general and
administrative expense was $31.9 million for the six months ended June 30,
2011, compared to $21.5 million for the six months ended June 30, 2010.
The increase of $10.4 million, or 48%, was primarily due to an increase in sales, marketing and operations
costs associated with the production and commercialization of our products and
an increase in general and administrative costs to support our continued
growth. Our total number of employees increased from 256 as of June 30, 2010 to
354 as of June 30, 2011. Of the 98 employee increase, 62 were in sales and
marketing. Selling, general and administrative expense for the six months ended
June 30, 2010 was also impacted by a write-off of $808,000 of excess RESTORIS
Classic instrumentation necessitated by the rapid adoption of the
RESTORIS MCK, and the corresponding decline in the usage of RESTORIS Classic. Selling, general and administrative
expense for the six months ended June 30, 2011 included $4.2 million of stock-based compensation expense compared to
$2.5 million for the six months ended June 30, 2010. The increase in stock-based compensation
expense was primarily due to additional option grants and restricted stock
grants made in 2010 and 2011 combined with the increase in the price of our
common stock.
Research
and Development.
Research and development expense was
$9.2 million for the six months ended June 30, 2011, compared to
$7.0 million for the six months ended June 30, 2010. The increase of $2.2
million, or 32%, was primarily due to an
increase in research and development activities associated with on-going
development of our RIO system, our MAKO implant systems and potential future
products, including our hip MAKOplasty application and associated implant systems. Research and
development expense for the six months ended June 30, 2011, was also impacted
by $680,000 of expense incurred under the Strategic Alliance Agreement with
Pipeline Biomedical Holding, LLC as discussed in Item 1, Financial
Statements, Note 5 to the Condensed Financial Statements.
Depreciation
and Amortization.
Depreciation and amortization
expense was $2.0 million for the six months ended June 30, 2011, compared to
$1.4 million for the six months ended June 30, 2010. The increase of $581,000,
or 42%, was primarily due to an
increase in depreciation of property and equipment as a result of purchases
made during 2010 and 2011 due to the growth in our business and the expansion
of our facilities in 2010 to accommodate the increase in employees and
operational activities necessary to support such growth.
Interest
and Other Income.
Interest and other income was
$212,000 for the six months ended June 30, 2011, compared to $172,000 for the
six months ended June 30, 2010. The increase of $40,000, or 23%, was primarily due to higher average
outstanding cash and investment balances during 2011 from the net proceeds of a public offering of our common stock in
November 2010.
Income
Taxes.
No federal income taxes were recognized for the
six months ended June 30, 2011 and 2010, due to net operating losses in each
period. State and local income taxes were $41,000 for the six months ended June
30, 2011, compared to $47,000 for the six months ended June 30, 2010. Income
taxes recognized to date have not been significant due to net operating losses
we have incurred in each period since our inception. In addition, no current or deferred income taxes were recorded for the six
months ended June 30, 2011 and 2010,
as all income tax benefits were fully offset by a valuation allowance against
our net deferred income tax assets.
Liquidity and Capital Resources
|
|
|
|
|
|
|
|
(in thousands)
|
|
Six
Months Ended June 30,
|
|
|
|
2011
|
|
2010
|
|
Cash used in operating
activities
|
|
$
|
(18,833
|
)
|
$
|
(19,475
|
)
|
Cash (used in) provided by
investing activities
|
|
|
(2,637
|
)
|
|
12,198
|
|
Net cash provided by
financing activities
|
|
|
1,733
|
|
|
403
|
|
Net decrease in cash and
cash equivalents
|
|
$
|
(19,737
|
)
|
$
|
(6,874
|
)
|
19
Table of Contents
We
have incurred net losses and negative cash flow from operating activities for
each period since our inception in November 2004. As of June 30, 2011, we had
an accumulated deficit of $173.8 million, and we have historically
financed our operations principally through the sale of our equity securities.
As
of June 30, 2011, we had $76.8 million in cash, cash equivalents and
investments. Our cash and investment balances are held in a variety of interest
bearing instruments, including notes and bonds from U.S. government agencies,
certificates of deposit and investment grade rated U.S. corporate debt.
Net Cash Used in
Operating Activities
Net
cash used in operating activities primarily reflects the net loss for those
periods, which was reduced in part by depreciation and amortization and stock-based
compensation. Net cash used in operating activities was also affected by
changes in operating assets and liabilities. Included in changes in operating
assets and liabilities for the six months ended June 30, 2011 are $5.6 million
of increases to inventory necessitated by increased sales of implants and
disposable products and preparation for the anticipated launch of our hip
MAKOplasty application in the second half of 2011 and $2.1 million of decreases
to accrued compensation and employee benefits due primarily to the payment of
2010 year-end bonuses and commissions. For the six months ended June 30, 2010,
inventory write-downs of $1.1 million and property and equipment write-downs of
$986,000 were incurred primarily due to the write-off of excess RESTORIS
Classic implants and instrumentation necessitated by the rapid adoption of
RESTORIS MCK. Included in changes in operating assets and liabilities for the
six months ended June 30, 2010 are approximately $4.4 million of increases to
inventory necessitated by increased sales of implants and disposable products,
$2.6 million of increases to accounts receivable due to increased sales in
2010, $1.1 million of decreases to accrued compensation and employee benefits
due primarily to the payment of year-end bonuses, which was partially offset by
$1.9 million of increases to other accrued liabilities.
Net Cash (Used in)
Provided by Investing Activities
Net
cash used in investing activities for the six months ended June 30, 2011 was
primarily attributable to the purchase of investments of $22.7 million and
purchases of property and equipment of $2.8 million, which was partially offset
by proceeds of $22.8 million from sales and maturities of investments. Net cash
provided by investing activities for the six months ended June 30, 2010 was
primarily attributable to proceeds of $22.8 million from sales and maturities
of investments, which was partially offset by the purchase of investments of
$8.5 million.
Net Cash Provided by
Financing Activities
Net
cash provided by financing activities for the six months ended June 30, 2011
and 2010 was primarily attributable to proceeds received under our employee
stock purchase plan and to proceeds received on the exercise of stock options
and warrants.
Operating Capital
and Capital Expenditure Requirements
To
date, we have not achieved profitability. We anticipate that we will continue
to incur substantial net losses for at least the next two or three years as we
expand our sales and marketing capabilities in the orthopedic products market,
continue to commercialize our RIO system and RESTORIS family of implants,
continue research and development of existing and future products, including
our hip MAKOplasty application and associated implant systems, and continue
development of the corporate infrastructure required to sell and market our
products and support operations. We also expect to experience increased cash
requirements for inventory and property and equipment in conjunction with the
continued commercialization of our RIO system and RESTORIS family of implants
and introducing other potential future applications, including our hip
MAKOplasty application and associated implant systems.
20
Table of Contents
In
executing our current business plan, we believe our existing cash, cash
equivalents and investment balances, and interest income we earn on these
balances will be sufficient to meet our anticipated cash requirements for at
least the next twelve months. To the extent our available cash, cash equivalents
and investment balances are insufficient to satisfy our operating requirements,
we will need to seek additional sources of funds, including selling additional
equity, debt or other securities or entering into a credit facility, or modify
our current business plan. The sale of additional equity and convertible debt
securities may result in dilution to our current stockholders. If we raise
additional funds through the issuance of debt securities, these securities may
have rights senior to those of our common stock and could contain covenants
that could restrict our operations and issuance of dividends. We may also
require additional capital beyond our currently forecasted amounts. Any
required additional capital, whether forecasted or not, may not be available on
reasonable terms, or at all. If we are unable to obtain additional financing,
we may be required to reduce the scope of, delay or eliminate some or all of
our planned research, development and commercialization activities, which could
materially harm our business and results of operations.
Because
of the numerous risks and uncertainties associated with the development of
medical devices and the current economic situation, we are unable to estimate
the exact amounts of capital outlays and operating expenditures necessary to
complete the development of our products and successfully deliver commercial
products to the market. Our future capital requirements will depend on many
factors, including but not limited to the following:
|
|
|
the revenue generated by sales of our current and future products;
|
|
|
|
the expenses we incur in selling and marketing our products and supporting our growth;
|
|
|
|
the costs and timing of regulatory clearance or approvals for new products or upgrades or changes
to our products;
|
|
|
|
the rate of progress, cost and success or failure of on-going development activities;
|
|
|
|
the expenses we incur in complying with regulatory requirements imposed on medical device companies;
|
|
|
|
the emergence of competing or complementary technological developments;
|
|
|
|
the costs of filing, prosecuting, defending and enforcing any patent or license claims and other
intellectual property rights, or participating in litigatio
n related activities;
|
|
|
|
the terms
and timing of any collaborative, licensing, or other arrangements that we may
establish;
|
|
|
|
the future
unknown impact of recently enacted healthcare legislation;
|
|
|
|
the
acquisition of businesses, products and technologies; and
|
|
|
|
general
economic conditions and interest rates.
|
Contractual
Obligations
At
June 30, 2011, we were committed to make future purchases for inventory related
items and instrumentation under various purchase arrangements with fixed
purchase provisions aggregating $13.0 million.
Other
than as described above and scheduled payments through June 30, 2011, there
have been no significant changes in our contractual obligations during the six
months ended June 30, 2011 as compared to the contractual obligations described
in our Form 10-K for the year ended December 31, 2010.
Off-Balance Sheet Arrangements
We
do not have any off-balance sheet arrangements.
21
Table of Contents
I
TEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT
MARKET RISK.
Our
exposure to market risk is confined to our cash, cash equivalents, investments
and exchange rate risk on international sales. The goals of our cash investment
policy are the security of the principal invested and fulfillment of liquidity
needs, with the need to maximize value being an important consideration. To
achieve our goals, we maintain a portfolio of cash equivalents and investments in
a variety of securities including notes and bonds from U.S. government
agencies, certificates of deposit and investment grade rated U.S. corporate
debt. The securities in our investment portfolio are not leveraged and are
classified as available-for-sale. We currently do not hedge interest rate
exposure or exchange rate risk. We do not believe that a variation in market
rates of interest would significantly impact the value of our investment
portfolio. We do not believe that a variation in the value of the U.S. dollar
relative to foreign currencies would significantly impact our results of
operations.
I
TEM 4. CONTROLS AND PROCEDURES.
Disclosure
Controls and Procedures.
In
accordance with Rule 13a-15(b) of the Securities Exchange Act of 1934, or the
Exchange Act, our management evaluated, with the participation of our chief
executive officer and chief financial officer, or the Certifying Officers, the
effectiveness of the design and operation of our disclosure controls and
procedures (as defined in Rule 13a-15(e) under the Exchange Act) as of June 30,
2011. Based upon their evaluation of these disclosure controls and procedures,
our Certifying Officers concluded that the disclosure controls and procedures
were effective as of June 30, 2011 to provide reasonable assurance that
information required to be disclosed by us in the reports we file or submit
under the Exchange Act is recorded, processed, summarized and reported within
the time period specified in the rules and forms of the Securities and Exchange
Commission, and to provide reasonable assurance that information required to be
disclosed by us in the reports we file or submit under the Exchange Act is
accumulated and communicated to our management, including our principal
executive and principal financial officers, as appropriate, to allow timely
decisions regarding required disclosure.
We
believe that a controls system, no matter how well designed and operated, is
based in part upon certain assumptions about the likelihood of future events,
and therefore can only provide reasonable, not absolute, assurance that the
objectives of the controls system are met, and no evaluation of controls can
provide absolute assurance that all control issues and instances of fraud, if
any, within a company have been detected.
Changes in Internal Control over Financial
Reporting.
There
have been no changes in our internal control over financial reporting during
the quarter ended June 30, 2011 that have materially affected, or are reasonably
likely to materially affect, our internal control over financial reporting.
22
Table of Contents
P
ART II
OTHER INFORMATION
I
TEM 1A. RISK FACTORS.
There have
been no material changes in our risk factors from those disclosed in our Form
10-K for the year ended December 31, 2010.
I
TEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND
USE OF PROCEEDS.
(c) Issuer Purchases of Equity Securities
The
following table summarizes the surrenders of the Companys common stock during
the three month period ended June 30, 2011:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
Number of
Shares
Purchased(1)
|
|
Average
Price Paid
per Share(1)
|
|
Total Number
of Shares
Purchased as
Part of Publicly
Announced
Plans or
Programs
|
|
Maximum
Dollar Value of
Shares that May
Yet be
Purchased
Under the Plans
or Programs
|
|
Period
|
|
|
|
|
|
|
|
|
|
|
|
|
|
April 1 to 30, 2011
|
|
|
|
|
$
|
|
|
|
|
|
$
|
|
|
May 1 to 31, 2011
|
|
|
10,195
|
|
|
30.27
|
|
|
|
|
|
|
|
June 1 to 30, 2011
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,195
|
|
$
|
30.27
|
|
|
|
|
$
|
|
|
|
|
(1)
|
Represents the surrender of
shares of common stock of the Company to satisfy the tax withholding
obligations associated with the vesting of restricted stock.
|
I
TEM 6. EXHIBITS.
|
|
|
|
Exhibit
No.
|
|
Description
|
|
31.1
|
|
Certification
of Chief Executive Officer pursuant to Rule 13a-14(a) of the Exchange Act
|
31.2
|
|
Certification
of Chief Financial Officer pursuant to Rule 13a-14(a) of the Exchange Act
|
32.1
|
|
Certification
of Chief Executive Officer pursuant to 18 U.S.C. §1350
|
32.2
|
|
Certification
of Chief Financial Officer pursuant to 18 U.S.C. §1350
|
101
|
|
The
following materials from MAKO Surgical Corp.s Quarterly Report on Form 10-Q
for the quarter ended June 30, 2011, formatted in XBRL (Extensible Business
Reporting Language): (i) Condensed Balance Sheets, (ii) Condensed Statements
of Operations, (iii) Condensed Statements of Cash Flows, and (iv) Notes to
Condensed Financial Statements, tagged as blocks of text.
|
23
Table of Contents
S
IGNATURES
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.
|
|
|
|
|
MAKO
Surgical Corp.
|
|
|
|
|
Date: August
9, 2011
|
By:
|
/s/ Fritz L.
LaPorte
|
|
|
|
Fritz L.
LaPorte
|
|
|
|
Senior Vice
President of Finance and
Administration, Chief Financial Officer and Treasurer
(Principal Financial Officer and Authorized Signatory)
|
24
Table of Contents
E
XHIBIT INDEX
|
|
|
|
Exhibit No.
|
|
Description
|
|
31.1
|
|
Certification
of Chief Executive Officer pursuant to Rule 13a-14(a) of the Exchange Act
|
31.2
|
|
Certification
of Chief Financial Officer pursuant to Rule 13a-14(a) of the Exchange Act
|
32.1
|
|
Certification
of Chief Executive Officer pursuant to 18 U.S.C. §1350
|
32.2
|
|
Certification
of Chief Financial Officer pursuant to 18 U.S.C. §1350
|
101
|
|
The
following materials from MAKO Surgical Corp.s Quarterly Report on Form 10-Q
for the quarter ended June 30, 2011, formatted in XBRL (Extensible Business
Reporting Language): (i) Condensed Balance Sheets, (ii) Condensed Statements
of Operations, (iii) Condensed Statements of Cash Flows, and (iv) Notes to
Condensed Financial Statements, tagged as blocks of text.
|
25
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