Highlights
Fourth quarter revenue totaled $8.9 million
Commercial installed base increased by seven systems to 36 RIO®
systems
561 MAKOplasty® procedures performed, a 34% sequential increase
from third quarter 2009
MAKO Surgical Corp. (Nasdaq:MAKO), a medical device company that
markets both its RIO® robotic arm interactive orthopedic surgical
platform and proprietary RESTORIS® implants for minimally invasive
orthopedic knee procedures known as MAKOplasty®, today announced
its operating results for the quarter and year ended December 31,
2009.
Recent Business Developments
RIO Systems – Seven RIO systems were installed and customer
accepted at commercial sites during the fourth quarter. These new
systems brought the total number of MAKO's commercial MAKOplasty
systems to 36 as of December 31, 2009.
MAKOplasty Procedure Volume – During the fourth quarter, 561
MAKOplasty procedures were performed, representing a 34% increase
over the third quarter of 2009 and a 181% increase over the fourth
quarter of 2008. The average monthly utilization per commercial
system increased to 6.0 procedures during the fourth quarter up
from 5.4 procedures per system per month in the third quarter of
2009 and 4.0 in the fourth quarter of 2008. A total of 1,602
MAKOplasty procedures were performed in 2009 and 2,384 procedures
had been performed through December 31, 2009 since the first
procedure in June 2006.
Clinical Education – In the fourth quarter, MAKO held two
BioSkills courses, which are designed to bring together current and
prospective MAKOplasty surgeons to share best practices.
Additionally, two manuscripts on MAKOplasty were submitted to
peer-reviewed journals.
"We are pleased that our ongoing focus on execution has
continued to produce strong operating results," said Maurice R.
Ferre, M.D., President and Chief Executive Officer of MAKO.
"The addition of seven new commercial sites, including for the
first time, a sale of a second RIO system to an existing MAKOplasty
site, and the 561 MAKOplasty procedures performed in the fourth
quarter represent an increase of the adoption trends that we
experienced in the first three quarters of 2009."
2009 Fourth Quarter Financial Review
Revenue was $8.9 million in the fourth quarter of 2009 compared
to $1.0 million in the fourth quarter of 2008. Revenue in the
fourth quarter of 2009 primarily consisted of approximately $5.8
million in revenue from the sale of seven RIO systems, and
approximately $2.7 million in revenue from the sale of implants
used in the 561 MAKOplasty procedures performed in the quarter.
Operating expenses were $13.8 million in the fourth quarter of
2009 compared to $10.9 million in the fourth quarter of
2008. The increase in operating expenses is primarily
attributable to an increase in sales and marketing activities for
the continued expansion of the direct sales force and
commercialization of the RIO system and RESTORIS implant products,
and an increase in general and administrative costs as MAKO
continued to build infrastructure to support growth and incurred
costs associated with operating as a public company.
Net loss attributable to common stockholders for the three
months ended December 31, 2009 was $9.3 million, including non-cash
stock-based compensation expense of $1.1 million, or $(0.28) per
basic and diluted share, based on average basic and diluted shares
outstanding of 33.0 million. This compares to a net loss
attributable to common stockholders for the same period in 2008 of
$10.8 million, including non-cash stock-based compensation expense
of $0.7 million, or $(0.48) per basic and diluted share, based on
average basic and diluted shares outstanding of 22.5 million.
Cash, cash equivalents and investments were $71.2 million as of
December 31, 2009, compared to $63.6 million as of December 31,
2008.
2009 Full Year Financial Review
For the year ended December 31, 2009, revenue was $34.2 million,
primarily consisting of $14.7 million of revenue associated with
the sale of nineteen RIO systems, the recognition of $11.3 million
of revenue deferred in prior years and recognized in 2009 upon the
upgrade of seventeen Tactile Guidance System™ (TGS™) units to RIO
systems, and $7.6 million of revenue associated with the sale of
implants used in 1,602 MAKOplasty procedures performed during the
period. This compares to recognized revenue for the year ended
December 31, 2008 of $2.9 million, primarily generated from the
sale of implants used in the 601 MAKOplasty procedures performed in
2008 and deferred revenue of $8.2 million, generated as a result of
the sale and customer acceptance of twelve TGS units during
2008.
The net loss attributable to common stockholders for the year
ended December 31, 2009 was $34.0 million, resulting in a net loss
per common share of $(1.22), based on average basic and diluted
shares outstanding of 27.8 million. This compares to a net loss
attributable to common stockholders for the same period in 2008 of
$37.6 million, or $(2.20) per common share based on average basic
and diluted shares outstanding of 17.1 million. Net loss
attributable to common stockholders in 2008 included non-cash
charges for accretion and dividends on preferred stock of $0.6
million which ceased upon the conversion of the preferred stock
into common stock upon the closing of MAKO's initial public
offering during the first quarter of 2008.
Conference Call
MAKO will host a conference call today at 4:30 pm EST to discuss
its fourth quarter and year-end 2009 results. To listen to the
conference call, please dial 800-967-7187 for domestic callers and
719-457-2734 for international callers approximately ten minutes
prior to the start time. To access the live audio broadcast or the
subsequent archived recording, visit the Investor Relations section
of MAKO's website at www.makosurgical.com.
About MAKO Surgical Corp.
MAKO Surgical Corp. is a medical device company that markets
both its RIO® Robotic-Arm Interactive Orthopedic system and its
proprietary RESTORIS® implants for minimally invasive orthopedic
knee procedures. The MAKO RIO is a surgeon-interactive tactile
surgical platform that incorporates a robotic arm and
patient-specific visualization technology and prepares the knee
joint for the insertion and alignment of MAKO's resurfacing
RESTORIS implants through a minimal incision. The FDA-cleared RIO
system allows surgeons to provide a precise, consistently
reproducible tissue-sparing, bone resurfacing procedure called
MAKOplasty® to a large, yet underserved patient population
suffering from early to mid-stage osteoarthritic knee disease. MAKO
has an intellectual property portfolio of more than 250 licensed or
owned patents and patent applications relating to the areas of
robotics, haptics, computer assisted surgery and implants.
Additional information can be found at www.makosurgical.com.
Forward-Looking Statements
This press release contains forward-looking statements
regarding, among other things, statements related to expectations,
goals, plans, objectives and future events. MAKO intends such
forward-looking statements to be covered by the safe harbor
provisions for forward-looking statements contained in Section 21E
of the Securities Exchange Act of 1934 and the Private Securities
Reform Act of 1995. In some cases, forward-looking statements can
be identified by the following words: "may," "will," "could,"
"would," "should," "expect," "intend," "plan," "anticipate,"
"believe," "estimate," "predict," "project," "potential,"
"continue," "ongoing" or the negative of these terms or other
comparable terminology, although not all forward-looking statements
contain these words. These statements are based on the current
estimates and assumptions of our management as of the date of this
press release and are subject to risks, uncertainties, changes in
circumstances, assumptions and other factors that may cause actual
results to differ materially from those indicated by
forward-looking statements, many of which are beyond MAKO's ability
to control or predict. Such factors, among others, may have a
material adverse effect on MAKO's business, financial condition and
results of operations and may include the potentially significant
impact of a continued economic downturn or delayed economic
recovery on the ability of MAKO's customers to secure adequate
funding to buy MAKO's products or cause MAKO's customers to delay a
purchasing decision, changes in competitive conditions and prices
in MAKO's markets, unanticipated issues relating to intended
product launches, decreases in sales of MAKO's principal product
lines, increases in expenditures related to increased or changing
governmental regulation or taxation of MAKO's business,
unanticipated issues in securing regulatory clearance or approvals
for upgrades or changes to MAKO's products, unanticipated issues
associated with any healthcare reform legislation that may be
enacted, loss of key management and other personnel or inability to
attract such management and other personnel and unanticipated
intellectual property expenditures required to develop, market, and
defend MAKO's products. These and other risks are described in
greater detail under Item 1A, "Risk Factors," in MAKO's quarterly
report on Form 10-Q for the quarter ended June 30, 2009 filed with
the Securities and Exchange Commission on August 5, 2009. Given
these uncertainties, undue reliance should not be placed on these
forward-looking statements. MAKO does not undertake any obligation
to release any revisions to these forward-looking statements
publicly to reflect events or circumstances after the date of this
press release or to reflect the occurrence of unanticipated
events.
"MAKOplasty®," "RESTORIS®," "RIO®," "Tactile Guidance System™"
and "TGS™," as well as the "MAKO" logo, whether standing alone or
in connection with the words "MAKO Surgical Corp." are trademarks
of MAKO Surgical Corp.
Condensed Statements of Operations (unaudited)
Three Months Ended
Year Ended
(in thousands, except per share data)
December 31,
December 31,
2009
2008
2009
2008
Revenue:
Procedures
$2,740
$827
$7,550
$2,457
Systems – RIO
5,787
--
14,715
--
Systems – TGS, previously deferred
--
--
11,297
--
Service and other
324
138
646
487
Total Revenue
8,851
965
34,208
2,944
Cost of revenue:
Procedures
870
540
3,337
1,521
Systems – RIO
3,439
616
9,032
1,692
Systems – RIO upgrades
--
--
5,183
--
Systems – TGS, previously deferred
--
--
3,606
--
Service and other
80
79
546
233
Total cost of revenue
4,389
1,235
21,704
3,446
Gross profit (loss)
4,462
(270)
12,504
(502)
Operating costs and expenses:
Selling, general and administrative
9,763
7,126
31,878
23,158
Research and development
3,766
3,266
13,127
12,472
Depreciation and amortization
289
498
1,951
1,828
Total operating costs and expenses
13,818
10,890
46,956
37,458
Loss from operations
(9,356)
(11,160)
(34,452)
(37,960)
Interest and other income
84
346
432
988
Interest and other expenses
(3)
--
(3)
(110)
Net loss
($9,275)
($10,814)
($34,023)
($37,082)
Net loss attributable to common stockholders
($9,275)
($10,814)
($34,023)
($37,647)
Net loss per share - Basic and diluted attributable to common
stockholders
($0.28)
($0.48)
($1.22)
($2.20)
Weighted average common shares outstanding - Basic and
diluted
32,964
22,546
27,806
17,096
Selected Balance Sheet Data (unaudited)
(in thousands)
December 31,
December 31,
2009
2008
Cash, cash equivalents and investments
$71,213
$63,624
Deferred cost of revenue
--
3,608
Total assets
99,103
86,533
Deferred revenue
569
11,589
Long-term debt
--
--
Additional paid-in capital
204,977
146,607
Accumulated deficit
(114,195)
(80,172)
Total stockholders' equity
90,794
66,514
CONTACT: MAKO Surgical Corp.
Investors:
Susan M. Verde
954-927-2044 x349
sverde@makosurgical.com
Westwicke Partners
Mark Klausner
443-213-0500
mark.klausner@westwicke.com
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