Highlights
Third quarter revenue totaled $6.7 million
Commercial installed base increased by six systems to 29 RIO(R)
systems
418 MAKOplasty(R) procedures performed, a 17% increase from second
quarter 2009
Capital sales force size doubled to 16 sales people
$58.4 million equity financing completed
FORT LAUDERDALE, Fla., Nov. 3, 2009 (GLOBE NEWSWIRE) -- MAKO Surgical Corp.
(Nasdaq:MAKO), a medical device company that markets both its RIO(R) robotic arm
interactive orthopedic surgical platform and proprietary RESTORIS(R) implants
for minimally invasive orthopedic knee procedures known as MAKOplasty(R), today
announced its operating results for the quarter ended September 30, 2009.
Recent Business Developments
RIO Systems - Six RIO systems were installed and customer accepted at commercial
sites during the third quarter. These new sites brought the total number of
MAKO's commercial MAKOplasty sites to 29 as of September 30, 2009.
MAKOplasty Procedure Volume - During the third quarter, 418 MAKOplasty
procedures were performed, representing a 17% increase over the second quarter
of 2009 and a 163% increase over the third quarter of 2008. As of September 30,
2009, a total of 1,041 MAKOplasty procedures have been performed in 2009 and
1,823 procedures have been performed since the first procedure in June 2006.
Clinical Education - In the third quarter, MAKO held three BioSkills courses,
which are designed to bring together current and prospective MAKOplasty surgeons
to share best practices. Additionally, an article was published in a
peer-reviewed journal bringing the total number of peer reviewed articles on
MAKOplasty to fourteen.
Commercialization Growth - MAKO recently doubled the size of its capital sales
force to 16 sales people in the field selling RIO systems.
Equity Financing - In August 2009, MAKO closed a $58.4 million public offering
of our common stock with net proceeds of $54.3 million after underwriting
discounts and commissions and expenses of the offering. The net proceeds are
anticipated to be used to support commercialization, sales, marketing and
general administrative activities, for research and product development
activities and to fund working capital and other general corporate purposes.
"We are pleased that our continued focus on execution produced strong operating
results in the third quarter," said Maurice R. Ferre, M.D., President and Chief
Executive Officer of MAKO. "The 418 MAKOplasty procedures performed by our
customers and the addition of six new commercial sites represent an increase in
the adoption trends we experienced in the first half of 2009. In addition, we
are gratified that we have received additional capital that we believe is
adequate to allow for the continued execution of our business plan."
2009 Third Quarter Financial Review
Revenue was $6.7 million in the third quarter of 2009 compared to $0.8 million
in the third quarter of 2008. The revenue in the third quarter of 2009 primarily
consisted of approximately $4.6 million in revenue from the sale of six RIO
systems, and approximately $2.0 million in revenue from the sale of implants
used in the 418 MAKOplasty procedures performed in the quarter.
Operating expenses were $12.3 million in the third quarter of 2009 compared to
$9.9 million in the third 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
September 30, 2009 was $9.4 million, including non-cash stock-based compensation
expense of $1.1 million, or $(0.33) per basic and diluted share, based on
average basic and diluted shares outstanding of 28.6 million. This compares to a
net loss attributable to common stockholders for the same period in 2008 of
$10.2 million, including non-cash stock-based compensation expense of $0.6
million, or $(0.56) per basic and diluted share, based on average basic and
diluted shares outstanding of 18.1 million.
Cash, cash equivalents and investments were $80.1 million as of September 30,
2009, which included the net proceeds of the equity financing, compared to $63.6
million as of December 31, 2008.
2009 Nine-Month Financial Review
For the nine months ended September 30, 2009, revenue was $25.4 million,
primarily generated from the recognition of deferred revenue associated with the
upgrade of seventeen TGS units to RIO systems, the sale of twelve RIO systems,
and the sale of implants used in 1,041 MAKOplasty procedures performed during
the period. The net loss attributable to common stockholders for the nine month
period was $24.7 million, resulting in a net loss per common share of $(0.95) in
the nine-month period ended September 30, 2009, compared to a net loss
attributable to common stockholders of $26.8 million or $(1.76) per common share
in the same period in 2008. 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 EDT to discuss its third
quarter of 2009 results. To listen to the conference call, please dial
800-926-7061 for domestic callers and 913-312-0841 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(R)
Robotic-Arm Interactive Orthopedic system and its proprietary RESTORIS(R)
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(R) 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 further or continued economic downturn
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 product releases, 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 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 and market 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(R)," "RESTORIS(R)," "RIO(R)," "Tactile Guidance System(TM)" and
"TGS(TM)," 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)
(in thousands, except per share data)
Three Months Ended Nine Months Ended
September 30, September 30,
------------------ ------------------
2009 2008 2009 2008
-------- -------- -------- --------
Revenue:
Procedures $ 1,986 636 $ 4,810 1,630
Systems - RIO 4,634 -- 8,928 --
Systems - TGS,
previously deferred -- -- 11,297 --
Service and other 106 141 322 349
-------- -------- -------- --------
Total Revenue 6,726 777 25,357 1,979
Cost of revenue:
Procedures 912 597 2,467 981
Systems - RIO 2,893 611 5,593 1,076
Systems - RIO upgrades -- -- 5,183 --
Systems - TGS, previously
deferred -- -- 3,606 --
Service and other 156 153 466 154
-------- -------- -------- --------
Total cost of revenue 3,961 1,361 17,315 2,211
-------- -------- -------- --------
Gross profit (loss) 2,765 (584) 8,042 (232)
-------- -------- -------- --------
Operating costs and expenses:
Selling, general and
administrative 7,910 6,265 22,115 16,032
Research and development 3,758 3,111 9,361 9,206
Depreciation and
amortization 595 483 1,662 1,330
-------- -------- -------- --------
Total operating costs
and expenses 12,263 9,859 33,138 26,568
-------- -------- -------- --------
Loss from operations (9,498) (10,443) (25,096) (26,800)
Interest and other income 59 241 348 642
Interest and other expenses -- -- -- (110)
-------- -------- -------- --------
Net loss $ (9,439) $(10,202) $(24,748) $(26,268)
======== ======== ======== ========
Net loss attributable to
common stockholders $ (9,439) $(10,202) $(24,748) $(26,833)
======== ======== ======== ========
Net loss per share - Basic
and diluted attributable to
common stockholders $ (0.33) $ (0.56) $ (0.95) $ (1.76)
======== ======== ======== ========
Weighted average common
shares outstanding -
Basic and diluted 28,615 18,149 26,068 15,266
======== ======== ======== ========
Selected Balance Sheet Data (unaudited)
(in thousands)
September 30, December 31,
2009 2008
------------- -------------
Cash, cash equivalents and
investments $ 80,120 $ 63,624
Deferred cost of revenue -- 3,608
Total assets 106,856 86,533
Deferred revenue 250 11,589
Long-term debt -- --
Additional paid-in capital 203,855 146,607
Accumulated deficit (104,920) (80,172)
Total stockholders' equity 99,035 66,514
-0-
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
