Fourth Quarter 2012 and Full Year
Highlights
Fifteen RIO® systems sold in the quarter, of which thirteen were
sold to domestic customers
Total of 45 RIO systems sold worldwide in 2012, increasing
worldwide commercial installed base to 156 RIO systems and domestic
commercial installed base to 151 RIO systems
2,904 MAKOplasty® procedures performed in the quarter, a 29%
increase over the same period in 2011
Total of 10,204 MAKOplasty procedures performed in 2012, a 47%
increase over 2011
Eleven MAKOplasty Total Hip Arthroplasty (THA) applications sold
in the quarter, of which three were sold to existing customers
As of December 31, 2012, 62% of worldwide commercial installed
base is MAKOplasty THA enabled
MAKO Surgical Corp. (Nasdaq:MAKO), a medical device company that
markets its RIO® Robotic Arm Interactive Orthopedic surgical
platform, MAKOplasty® joint specific applications, and proprietary
RESTORIS® implants that together enable orthopedic surgeons to
consistently, reproducibly and precisely treat patient specific
osteoarthritic disease, today announced its selected operating
results for the fourth quarter and the year ended December 31, 2012
in anticipation of its business update presentation at the 31st
Annual J.P. Morgan Healthcare Conference at the Westin St. Francis
Hotel in San Francisco on Wednesday, January 9, 2013 at 7:30 am
PT.
MAKO will provide a live webcast of the business update
presentation. Interested parties may access the live webcast by
visiting the investor relations section of MAKO's web site at
www.makosurgical.com. A replay of the webcast will be available on
the MAKO website after the live presentation.
2012 Fourth Quarter and Full Year Review
RIO Systems – Fifteen RIO systems were sold during the fourth
quarter, of which thirteen were sold to domestic customers and two
were sold through international distributors to hospitals in Italy
and Thailand. The revenue associated with the two RIO systems sold
to and customer accepted by the international distributors will be
deferred until all revenue recognition criteria are satisfied. A
total of 45 new RIO systems were sold worldwide in 2012, bringing
MAKO's worldwide commercial installed base of RIO systems to 156
systems and domestic commercial installed base of RIO systems to
151 systems as of December 31, 2012.
MAKOplasty Procedure Volume – During the fourth quarter, 2,904
MAKOplasty procedures were performed, of which 2,756 were performed
at domestic sites and 395 were Total Hip Arthroplasty (THA)
procedures. The 2,904 MAKOplasty procedures performed represent a
20% increase over the procedures performed in the third quarter of
2012 and a 29% increase over the procedures performed in the fourth
quarter of 2011. The 395 THA procedures performed represent a 31%
increase over the THA procedures performed in the third quarter of
2012. The average monthly utilization per system was 6.6 procedures
during the fourth quarter of 2012, an increase from 6.2 procedures
per system per month in the third quarter of 2012. A total of
10,204 MAKOplasty procedures were performed in 2012, representing a
47% increase over the total procedures performed in 2011. Through
December 31, 2012, approximately 23,000 procedures have been
performed since the first procedure in June 2006.
MAKOplasty Total Hip Arthroplasty – In the fourth quarter,
eleven MAKOplasty THA applications were sold, eight of which were
sold with the RIO systems sales during the quarter and three of
which were sold as upgrades to existing customers with knee-only
commercial systems. As of December 31, 2012, 96 RIO systems, or 62%
of the worldwide commercial installed base, are MAKOplasty THA
enabled.
"We continued to make progress in the fourth quarter towards
reestablishing our growth trajectory in RIO system placements and
putting the building blocks in place to drive MAKOplasty procedure
volume and utilization," said Maurice R. Ferré, M.D., President and
Chief Executive Officer of MAKO. "While 2012 was a challenging year
for MAKO, we believe that the changes we initiated in the second
half of the year will position MAKO well for improved performance
in 2013 and ultimately provide for our long term success."
Conference Call
MAKO will host a conference call on February 26, 2013 at 4:30 pm
ET to discuss its fourth quarter and full year 2012
results. To listen to the conference call, please dial
877-843-0414 for domestic callers and 914-495-8580 for
international callers approximately ten minutes prior to the start
time. The participant code is 86531216. 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 its
RIO® Robotic-Arm Interactive Orthopedic system, joint specific
applications for the knee and hip, and proprietary RESTORIS®
implants for orthopedic procedures called MAKOplasty®. The RIO is a
surgeon-interactive tactile surgical platform that incorporates a
robotic arm and patient-specific visualization technology, which
enables precise, consistently reproducible bone resection for the
accurate insertion and alignment of MAKO's RESTORIS implants. The
MAKOplasty solution incorporates technologies enabled by an
intellectual property portfolio including more than 300 U.S. and
foreign, owned and licensed, patents and patent applications.
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, including access to credit, for the purchase of MAKO's
products or cause MAKO's customers to delay a purchasing decision,
unanticipated changes in the timing of the sales cycle for MAKO's
products or the vetting process undertaken by prospective
customers, changes in competitive conditions and prices in MAKO's
markets, delays in MAKO's product development cycles, unanticipated
issues relating to intended product launches, decreases in sales of
MAKO's principal product lines, decreases in utilization of MAKO's
principal product lines or in procedure volume, the effects of
Hurricane Sandy, increases in expenditures related to increased or
changing governmental regulation or taxation of MAKO's business,
both nationally and internationally, unanticipated issues in
complying with domestic or foreign regulatory requirements related
to MAKO's current products, including Medical Device Reporting
requirements and other required reporting to the United States Food
and Drug Administration, or securing regulatory clearance or
approvals for new products or upgrades or changes to MAKO's current
products, the impact of the United States healthcare reform
legislation enacted in March 2010 on hospital spending,
reimbursement, and the taxing of medical device companies, any
unanticipated impact arising out of the securities class action or
any other litigation, inquiry or investigation brought against
MAKO, 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,
protect and defend MAKO's products. These and other risks are
described in greater detail under Item 1A, "Risk Factors," in
MAKO's periodic filings with the Securities and Exchange
Commission, including MAKO's annual report on Form 10-K for the
year ended December 31, 2011 filed on March 8, 2012. 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®," as well as the "MAKO" logo,
whether standing alone or in connection with the words "MAKO
Surgical Corp." are trademarks of MAKO Surgical Corp.
CONTACT: Investors:
MAKO Surgical Corp.
954-628-1706
investorrelations@makosurgical.com
or
Westwicke Partners
Mark Klausner
443-213-0500
makosurgical@westwicke.com
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