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Quotes & Info
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| MAKO > SEC Filings for MAKO > Form 10-Q on 8-Aug-2008 | All Recent SEC Filings |
8-Aug-2008
Quarterly Report
Recent key milestones and goals in the development of our business through
June 30, 2008 include the following:
• In January 2008, we obtained 510(k) marketing clearance from the FDA for
version 1.2 of our TGS and commercially launched version 1.2 of our TGS in the
first quarter of 2008.
• In February 2008, we completed the IPO of our common stock, issuing a total of 5.1 million shares at an issue price of $10.00 per share, resulting in net proceeds to the Company of approximately $43.7 million, after underwriting discounts and commissions of $3.6 million and expenses of approximately $3.7 million.
• We are finalizing development of a TGS software application to enable a single MAKO-branded unicompartmental implant system, combining our inlay and onlay system. We expect to commercially introduce this software version 1.3 of our TGS and the MAKO-branded implant by the end of 2008. We have received a 510(k) clearance for the MAKO-branded implant, and we do not anticipate that TGS version 1.3 will require a 510(k) clearance. The functionality to support the use of the MAKO-branded implant with the TGS was included and cleared as part of version 1.2 of our TGS.
• We are currently developing version 2.0 of our TGS and our modular bicompartmental knee implant system, which would enable both unicompartmental and bicompartmental knee resurfacing procedures. We anticipate that we will commercially introduce version 2.0 of the TGS and the bicompartmental implant system in the first half of 2009, subject to regulatory clearances or approvals. If we were to be denied such clearances or approvals, if such clearances or approvals were delayed or if the required development is unsuccessful or delayed, it could have a material adverse impact on our results of operations.
• In the second quarter of 2008, we filed a 510(k) submission with the FDA for version 2.0 of our TGS. We also received a 510(k) clearance for our unicompartmental implant and a 510(k) clearance for our patellofemoral implant, components of the intended bicompartmental implant system.
We believe that the key to growing our business is expanding the application of
MAKOplasty to bicompartmental resurfacing procedures by offering implants that
address mid-stage, bicompartmental degeneration. To successfully commercialize
our products and grow our business, we must gain market acceptance for
MAKOplasty.
Factors Which May Influence Future Results of Operations
The following is a description of factors which may influence our future results
of operations, including significant trends and challenges that we believe are
important to understanding our business and results of operations.
Revenue
Revenue is generated from unit sales of our TGS, including installation
services, training and upgrades and enhancements, from sales of implants and
disposable products, and by providing extended warranty services. To date, we
have generated revenue primarily from the sale of implants and disposable
products utilized in MAKOplasty procedures, the majority of which was from
several significant customers. Recognition of revenue associated with the sale
of TGS units in our statements of operations is dependent upon satisfying all
related revenue recognition criteria, which include the delivery of version 2.0
of the TGS, which is anticipated to be in the first half of 2009, subject to
regulatory clearances or approvals, as more fully described in Item 1, Financial
Statements, Note 2 to the Condensed Financial Statements.
Future revenue from sales of our products is difficult to predict and we expect
that it will only modestly reduce our continuing and increasing losses resulting
from selling, general and administrative expenses, research and development and
other activities for the next several years.
The generation of recurring revenue through sales of our implants, disposable
products and service contracts are an important part of the MAKOplasty business
model. We anticipate that recurring revenue will constitute an increasing
percentage of our total revenue as we leverage each new installation of our TGS
to generate recurring sales of implants and disposable products and as we expand
our implant product offering.
Cost of Revenue
Cost of revenue primarily consists of the direct costs associated with the
manufacture of TGS units, implants and disposable products for which revenue has
been recognized in accordance with our revenue recognition policy. Costs
associated with providing services are expensed as incurred. Cost of revenue
also includes the cost associated with establishing at the time of installation
an accrual for the TGS standard one-year warranty liability and royalties
related to the sale of products covered by licensing arrangements.
The cost of revenue associated with the sale of TGS units is deferred until the
recognition of the related revenue. In addition, we expect that deferred costs
of revenue associated with the sale of TGS will be higher during the deferral
period due to the additional costs associated with providing hardware
enhancements and upgrades through and including the anticipated delivery of
version 2.0 of our TGS.
The Company is developing a single MAKO-branded unicompartmental implant system
which is expected to launch by the end of 2008. In conjunction with the launch
of the new implant system, the Company anticipates discontinuing portions of its
current implant line. Depending on the timing of the launch, which is dependant
on supply chain and launch strategy, a future write-off of the discontinued
implant inventory is possible. Currently, the Company cannot reasonably estimate
the amount of the charge, if any, relating to the potential write-off of such
inventory; however, depending on the timing of the launch of the new implant
system, a charge of up to $600,000 may be required. No write-off was recorded as
of June 30, 2008.
Selling, General and Administrative Expenses
Our selling, general and administrative expenses consist primarily of
compensation, including stock-based compensation, for sales, marketing,
operations, regulatory, quality, executive, finance, legal and administrative
personnel. Other significant expenses include costs associated with sales and
marketing activities, marketing and advertising materials, professional fees for
legal and accounting services, consulting fees, travel expenses, facility and
related operating costs, and recruiting expenses. Our selling, general and
administrative expenses are expected to continue to increase due to the cost
associated with the expected commercial launch of version 2.0 of our TGS, our
bicompartmental implant system and disposable products, an increased number of
employees necessary to support our continued growth in operations, and the
additional operational and regulatory burdens and costs associated with
operating as a publicly traded company. In addition, we are currently taking
preliminary steps to investigate the feasibility of establishing clinical sites
outside the United States, which may also increase our selling, general and
administrative expenses, and we expect to incur additional costs associated with
protecting our intellectual property rights as necessary to support our future
product offerings.
Research and Development Expenses
Costs related to research, design and development of products are charged to
research and development expense as incurred. These costs include direct salary
costs for research and development employees including stock-based compensation,
cost for materials used in research and development activities and costs for
outside services. Research and development expenses are expected to continue to
increase as we develop version 2.0 of our TGS and our bicompartmental implant
system.
Critical Accounting Policies
A summary of our critical accounting policies is included in our Form 10-K,
Item 7, "Management's Discussion and Analysis of Financial Condition and Results
of Operations." There have been no changes to those policies for the six months
ended June 30, 2008.
Results of Operations
Comparison of the Three Months Ended June 30, 2008 to the Three Months Ended
June 30, 2007
Revenue. Revenue was $704,000 for the three months ended June 30, 2008, compared
to $106,000 for the three months ended June 30, 2007, and was primarily
generated from the sale of implants and disposable products utilized in
MAKOplasty procedures. The increase in revenue of $598,000 was primarily due to
an increase in MAKOplasty procedures performed during the three months ended
June 30, 2008 as compared with the three months ended June 30, 2007. There were
140 procedures performed during the three months ended June 30, 2008 compared to
21 procedures performed during the three months ended June 30, 2007. The
increase was also attributable to a $116,000 increase in other revenue, which
consists primarily of service revenue on extended warranty services and net
royalty revenue. We expect our revenue to increase as the number of MAKOplasty
procedures performed increases in future periods. The deferred revenue balance
was $6.5 million and $696,000 as of June 30, 2008 and 2007, respectively. The
deferred revenue balance primarily consisted of the deferred revenue associated
with the sale of ten and one unit sales of our TGS, as of June 30, 2008 and
2007, respectively. Deferred revenue related to unit sales of our TGS will be
recognized in our statement of operations if and when we have satisfied all
related revenue recognition criteria. The criteria include the delivery of
version 2.0 of the TGS, which is anticipated to be in the first half of 2009,
subject to regulatory clearances or approvals.
Cost of Revenue. Cost of revenue was $480,000 for the three months ended
June 30, 2008, compared to $47,000 for the three months ended June 30, 2007. The
increase in cost of revenue of $433,000 was primarily due to an increase in
MAKOplasty procedures performed, the establishment of warranty accruals on sales
of TGS units and royalties incurred on sales of TGS units during the three
months ended June 30, 2008. We expect our cost of revenue to increase as the
number of MAKOplasty procedures performed increases in future periods. In
addition, anticipated increases in sales of our TGS units will result in an
increase in royalty and warranty expense. The deferred cost of revenue balance
was $2.2 million and $212,000 as of June 30, 2008 and 2007, respectively. The
increase in the deferred cost of revenue balance is primarily related to unit
sales of our TGS during 2008 and 2007. Deferred cost of revenue related to unit
sales of our TGS will be recognized in our statement of operations if and when
we have satisfied all related revenue recognition criteria. The criteria include
the delivery of version 2.0 of the TGS, which is anticipated to be in the first
half of 2009, subject to regulatory clearances or approvals.
Selling, General and Administrative. Selling, general and administrative expense
was $5.1 million for the three months ended June 30, 2008, compared to
$2.4 million for the three months ended June 30, 2007. The increase of
$2.7 million, or 116%, was primarily due to an increase in sales, marketing and
operations costs associated with the commercialization of our products and an
increase in general and administrative costs to support growth and costs
associated with operating as a public company. Selling, general and
administrative expense for the second quarter of 2008 also included $484,000 of
stock-based compensation expense compared with $53,000 for the comparable
quarter of 2007. The increase in stock-based compensation expense was primarily
due to additional option and restricted stock grants made in 2008 and 2007. We
expect our selling, general and administrative expense to continue to increase
substantially due to our planned increase in the number of employees necessary
to support the sales and marketing efforts associated with the growing
commercialization of MAKOplasty, the anticipated commercial launch of version
2.0 of our TGS in the first half of 2009, continued growth in operations and the
costs associated with operating as a public company.
Research and Development. Research and development expense was $2.5 million for
the three months ended June 30, 2008, compared to $1.6 million for the three
months ended June 30, 2007. The increase of $841,000, or 51%, was primarily due
to an increase in research and development activities associated with on-going
development of versions 1.2 and 2.0 of our TGS and the MAKO implant systems. We
expect our research and development expense to continue to increase as we
continue to expand our research and development activities, including the
development of version 2.0 of our TGS and our implant systems.
Depreciation and Amortization. Depreciation and amortization expense was
$425,000 for the three months ended June 30, 2008, compared to $301,000 for the
three months ended June 30, 2007. The increase of $124,000, or 41%, was
primarily due to an increase in depreciation of property and equipment as a
result of purchases made during 2008 and 2007.
Interest and Other Income. Interest income was $241,000 for the three months
ended June 30, 2008, compared to $316,000 for the three months ended June 30,
2007. The decrease of $75,000, or 24%, was primarily due to lower yields
realized on our cash, cash equivalents and investments for the three months
ended June 30, 2008 compared with the same period of 2007.
Interest and Other Expenses. Interest and other expenses were $1,000 for the
three months ended June 30, 2008, compared to $76,000 for the three months ended
June 30, 2007. Through February 2008, interest and other expense consisted
primarily of the amortization of the $590,000 discount associated with a
deferred payment to IBM of $4.0 million which had been fully amortized and paid
upon the completion of our IPO in February 2008.
Income Taxes. No income taxes were recognized for the three months ended
June 30, 2008 and 2007, due to net operating losses in each period. In addition,
no current or deferred income taxes were recorded for the three months ended
June 30, 2008 and 2007, as all income tax benefits were fully offset by a
valuation allowance against our net deferred income tax assets.
Comparison of the Six Months Ended June 30, 2008 to the Six Months Ended
June 30, 2007
Revenue. Revenue was $1.2 million for the six months ended June 30, 2008,
compared to $206,000 for the six months ended June 30, 2007, and was primarily
generated from the sale of implants and disposable products utilized in
MAKOplasty procedures. The increase in revenue of $995,000 was primarily due to
an increase in MAKOplasty procedures performed during the six months ended
June 30, 2008. There were 242 procedures performed during the six months ended
June 30, 2008 compared to 42 procedures performed during the six months ended
June 30, 2007. The increase was also attributable to a $194,000 increase in
other revenue, which consists primarily of service revenue on extended warranty
services and net royalty revenues.
Cost of Revenue. Cost of revenue was $851,000 for the six months ended June 30,
2008, compared to $83,000 for the six months ended June 30, 2007. The increase
in cost of revenue of $768,000 was primarily due to an increase in MAKOplasty
procedures performed, the establishment of warranty accruals on sales of TGS
units and royalties incurred on sales of TGS units during the six months ended
June 30, 2008.
Selling, General and Administrative. Selling, general and administrative expense
was $9.8 million for the six months ended June 30, 2008, compared to
$4.3 million for the six months ended June 30, 2007. The increase of
$5.5 million, or 127%, was primarily due to an increase in sales, marketing and
operations costs associated with the commercialization of our products and an
increase in general and administrative costs to support growth and costs
associated with operating as a public company. Selling, general and
administrative expense for the six months ended June 30, 2008 also included
$908,000 of stock-based compensation expense compared with $110,000 for the same
period of 2007. The increase in stock-based compensation expense was primarily
due to additional option and restricted stock grants made in 2008 and 2007.
Research and Development. Research and development expense was $6.1 million for
the six months ended June 30, 2008, compared to $3.2 million for the six months
ended June 30, 2007. The increase of $2.9 million, or 93%, was primarily due to
an increase in research and development activities associated with on-going
development of versions 1.2 and 2.0 of our TGS and the MAKO implant systems; and
a nonrecurring charge of $949,000 associated with the vesting in full, upon
completion of our IPO in February 2008, of restricted common stock issued
pursuant to business consultation agreements entered into in December 2004.
Depreciation and Amortization. Depreciation and amortization expense was
$847,000 for the six months ended June 30, 2008, compared to $571,000 for the
six months ended June 30, 2007. The increase of $276,000, or 48%, was primarily
due to an increase in depreciation of property and equipment as a result of
purchases made during 2008 and 2007.
Interest and Other Income. Interest income was $401,000 for the six months ended
June 30, 2008, compared to $552,000 for the six months ended June 30, 2007. The
decrease of $151,000, or 27%, was primarily due to lower yields realized on our
cash, cash equivalents and investments for the six months ended June 30, 2008
compared with the same period of 2007.
Interest and Other Expenses. Interest and other expenses were $109,000 for the
six months ended June 30, 2008, compared to $152,000 for the six months ended
June 30, 2007. Through February 2008, interest and other expense consisted
primarily of the amortization of the $590,000 discount associated with a
deferred payment to IBM of $4.0 million which had been fully amortized and paid
upon the completion of our IPO in February 2008. Interest and other expense also
included the write down of our variable auction rate securities in the first
quarter of 2008 as discussed below under the caption, "Liquidity and Capital
Resources," and in Item 1, Financial Statements, Note 3, Short-Term and
Long-Term Investments.
Income Taxes. No income taxes were recognized for the six months ended June 30,
2008 and 2007, due to net operating losses in each period. In addition, no
current or deferred income taxes were recorded for the six months ended June 30,
2008 and 2007, as all income tax benefits were fully offset by a valuation
allowance against our net deferred income tax assets.
Liquidity and Capital Resources
Six Months Ended June 30,
(in thousands) 2008 2007
Cash used in operating activities $ (13,929 ) $ (7,357 )
Cash used in investing activities (4,098 ) (10,149 )
Cash provided by financing activities 46,487 29,918
Net increase in cash and cash equivalents $ 28,460 $ 12,412
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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, 2008, we had an
accumulated deficit of $59.2 million and financed our operations principally
through the sale of Series A, Series B and Series C redeemable convertible
preferred stock and the completion of the IPO of our common stock. Through
June 30, 2008, we received net proceeds of $52.2 million from the issuance of
Series A, Series B and Series C redeemable convertible preferred stock. In
February 2008, we completed our IPO of common stock, issuing a total of
5.1 million shares at an issue price of $10.00 per share, resulting in net
proceeds to us, after expenses, of approximately $43.7 million. In conjunction
with the closing of the IPO, in February 2008, all of our outstanding Series A,
Series B and Series C redeemable convertible preferred stock was converted into
10,945,080 shares of common stock, as adjusted for a one-for-3.03 reverse stock
split, which has been retroactively reflected in the accompanying condensed
financial statements.
As of June 30, 2008, we had approximately $39.1 million in cash, cash
equivalents and short-term investments. Our cash and short-term investment
balances are held in a variety of interest bearing instruments, including U.S.
treasury bills and certificates of deposit.
As of June 30, 2008, we held $1,025,000 par value of variable auction rate
securities issued by two separate funds. In February 2008, the auction rate
securities experienced failed auctions that limited the liquidity of these
securities. Based on current market conditions, it is likely that auction
failures will continue. The carrying value of the securities are fully
collateralized by assets held by the funds and were rated AAA prior to the
failed auctions of the securities. Historically the fair value of auction rate
securities approximated par value due to the frequent resets through the auction
rate process. The continued uncertainty in the credit markets has affected our
holdings in auction rate securities, however, and the liquidity and fair value
of these investments has been negatively impacted. As a result, the estimated
fair value of many of these investments no longer approximate par value. As of
June 30, 2008, the carrying value of the Company's auction rate securities was
$962,000, which approximates the estimated fair value as of that date. An
other-than-temporary impairment charge of $63,000 was recorded to reduce the
value of our auction rate securities to the new fair value. In addition, as a
result of the unresolved liquidity concerns, we reclassified our auction rate
securities from short-term investments to long-term investments.
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, stock-based
compensation and accrued interest; and was also affected by changes in operating
assets and liabilities. Included in the changes in operating assets for the six
months ended June 30, 2008 are approximately $3.2 million of increases to the
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