Fourth Quarter and Full Year 2011
Highlights
Fourth quarter revenue totaled $32.9 million, a 122% increase
over the same period in 2010
Full year 2011 revenue totaled $84.5 million, a 91% increase
over 2010
Eighteen RIO® systems sold in the fourth quarter, increasing
worldwide commercial installed base to 113 RIO systems and domestic
commercial installed base to 111 RIO systems
A total of 48 RIO systems sold worldwide in 2011, a 45% increase
over 2010
2,258 MAKOplasty® procedures performed in the fourth quarter, a
97% increase over the same period in 2010
6,932 MAKOplasty procedures performed in 2011, a 99% increase
over the same period in 2010
37 MAKOplasty Total Hip Arthroplasty (THA) applications sold in
the fourth quarter
Total of 49 MAKOplasty THA applications sold in 2011, resulting
in 44% of domestic commercial installed base having the MAKOplasty
THA application at year end
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 operating results for
the quarter and year ended December 31, 2011.
Recent Business Developments
RIO Systems – Eighteen RIO systems were sold during the fourth
quarter, of which sixteen were sold to domestic customers and two
were sold to two new international distributors, which will be used
by the distributors to demonstrate MAKOplasty to build interest in
their respective markets. A total of 48 new RIO systems were sold
worldwide in 2011, bringing MAKO's worldwide commercial installed
base of RIO systems to 113 systems and domestic commercial
installed base to 111 RIO systems as of December 31, 2011.
MAKOplasty Procedure Volume – During the fourth quarter, 2,258
MAKOplasty procedures were performed, of which 2,167 were performed
at domestic sites and 117 were Total Hip Arthroplasty (THA)
procedures. The 2,258 MAKOplasty procedures performed represent a
25% increase over the procedures performed in the third quarter of
2011 and a 97% increase over the procedures performed in the fourth
quarter of 2010. The average monthly utilization per system was 7.2
procedures during the fourth quarter of 2011, an increase from 6.5
procedures per system per month in the third quarter of 2011 and
6.7 procedures per system per month in the fourth quarter of 2010.
A total of 6,932 MAKOplasty procedures were performed in 2011,
representing a 99% increase over the total procedures performed in
2010. Through December 31, 2011, a total of 12,801 procedures had
been performed since the first procedure in June 2006.
MAKOplasty Total Hip Arthroplasty Applications – In the fourth
quarter, 37 MAKOplasty THA applications were sold, of which nine
were installed with RIO systems sold during the fourth quarter. A
total of 49 MAKOplasty THA applications were sold in 2011, and as
of December 31, 2011, 44% of MAKO's domestic commercial installed
base of RIO systems has purchased and received the MAKOplasty THA
application.
Clinical Research and Marketing – Efforts to build a strong base
of clinical evidence for MAKOplasty continue, with over 70 clinical
studies currently in process. During the fourth quarter, two
peer-reviewed papers were published demonstrating the accuracy of
implant placement and summarizing robotic systems in orthopedic
surgery.
"We are pleased with our strong operating results for the fourth
quarter and the full year 2011, particularly our 91% growth in
revenue from the prior year. In addition, we believe the increased
level of RIO system sales, initial interest in our hip application,
increased MAKOplasty procedure volume and utilization trends point
to the clinical value of our technology" said Maurice R. Ferre,
M.D., President and Chief Executive Officer of MAKO. "We anticipate
that our positive results in 2011 will carry forward into 2012 as
we continue to drive the adoption of MAKOplasty."
2011 Fourth Quarter Financial Review
Revenue was $32.9 million in the fourth quarter of 2011 compared
to $14.8 million in the fourth quarter of 2010, representing a 122%
increase. Revenue in the fourth quarter of 2011 primarily consisted
of $11.4 million in revenue from the sale of implants and
disposables used in the 2,258 MAKOplasty procedures performed in
the quarter, $19.8 million in revenue from the sale of eighteen RIO
systems and thirty-seven MAKOplasty THA applications and $1.7
million in revenue from service.
Gross profit for the fourth quarter of 2011 was $22.4 million
compared to a gross profit of $8.8 million in the same period in
2010. Gross margin for the fourth quarter of 2011 was 68%,
consisting of a 75% margin on procedure revenue, a 64% margin on
RIO system revenue and a 72% margin on service revenue.
Operating expenses were $28.0 million in the fourth quarter of
2011 compared to $18.7 million in the fourth quarter of 2010. The
increase in operating expenses was primarily attributable to the
following: 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 systems; an increase in
research and development activities associated with continuous
improvement of the RIO system and MAKOplasty applications and the
development of potential future products, including the recently
launched MAKOplasty THA application and associated implant systems;
and an increase in general and administrative costs as MAKO
continued to build infrastructure to support growth.
Net loss for the three months ended December 31, 2011 was $5.6
million, or $(0.14) per basic and diluted share, based on average
basic and diluted shares outstanding of 41.3 million. This compares
to a net loss for the same period in 2010 of $9.8 million, or
$(0.26) per basic and diluted share, based on average basic and
diluted shares outstanding of 37.3 million.
Cash, cash equivalents and investments were $58.7 million as of
December 31, 2011 compared to $96.8 million as of December 31,
2010.
2011 Full Year Financial Review
For the year ended December 31, 2011, revenue was $84.5 million,
primarily generated from the sale of 48 RIO systems, 49 MAKOplasty
THA applications, the sale of implants and disposables used in the
6,932 MAKOplasty procedures performed and warranty and maintenance
services provided, compared to $44.3 million for the year ended
December 31, 2010.
The net loss for the year ended December 31, 2011 was $36.1
million, or $(0.89) per basic and diluted share, based on average
basic and diluted shares outstanding of 40.8 million. This compares
to a net loss for the year ended December 31, 2010 of $38.7
million, or $(1.13) per basic and diluted share, based on average
basic and diluted shares outstanding of 34.3 million.
Conference Call
MAKO will host a conference call today at 4:30 pm ET to discuss
its fourth quarter and full year 2011 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
41384079. 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,
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, decreases in
utilization of MAKO's principal product line or in procedure
volume, 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 recently enacted United States healthcare reform
legislation on hospital spending, reimbursement, and the taxing of
medical device companies, the potential impact of the informal
Securities and Exchange Commission inquiry and the findings of that
inquiry, 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 periodic
filings with the Securities and Exchange Commission, including
MAKO's annual report on Form 10-K for the year ended December 31,
2010 filed on March 10, 2011 and quarterly report on Form 10-Q for
the quarter ended September 30, 2011 filed on November 9, 2011.
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.
Condensed Statements of Operations
(unaudited) |
Three Months Ended |
Twelve Months Ended |
(in thousands, except per share data) |
December 31, |
December 31, |
|
2011 |
2010 |
2011 |
2010 |
|
|
|
|
|
Revenue: |
|
|
|
|
Procedures |
$11,387 |
$5,683 |
$34,638 |
$17,620 |
Systems – RIO |
19,774 |
8,287 |
43,927 |
24,928 |
Service |
1,727 |
812 |
5,942 |
1,748 |
Total revenue |
32,888 |
14,782 |
84,507 |
44,296 |
Cost of revenue: |
|
|
|
|
Procedures |
2,795 |
1,860 |
8,793 |
5,960 |
Systems – RIO |
7,196 |
3,731 |
16,695 |
11,171 |
Service |
484 |
356 |
1,395 |
1,042 |
Total cost of revenue |
10,475 |
5,947 |
26,883 |
18,173 |
Gross profit |
22,413 |
8,835 |
57,624 |
26,123 |
Operating costs and expenses: |
|
|
|
|
Selling, general and
administrative |
20,545 |
13,858 |
69,024 |
47,041 |
Research and
development |
6,329 |
3,973 |
20,592 |
14,975 |
Depreciation and
amortization |
1,162 |
877 |
4,291 |
3,043 |
Total operating costs and expenses |
28,036 |
18,708 |
93,907 |
65,059 |
Loss from operations |
(5,623) |
(9,873) |
(36,283) |
(38,936) |
Other income, net |
84 |
61 |
245 |
317 |
Loss before income taxes |
(5,539) |
(9,812) |
(36,038) |
(38,619) |
Income tax expense |
45 |
5 |
105 |
68 |
Net loss |
($5,584) |
($9,817) |
($36,143) |
($38,687) |
Net loss per share - Basic and
diluted |
($0.14) |
($0.26) |
($0.89) |
($1.13) |
Weighted average common shares outstanding -
Basic and diluted |
41,297 |
37,281 |
40,752 |
34,349 |
|
|
|
|
|
|
|
|
|
Condensed Balance Sheets
(unaudited) |
December 31, |
December 31, |
(in thousands) |
2011 |
2010 |
|
|
|
Current Assets: |
|
|
Cash and cash
equivalents |
$13,438 |
$27,108 |
Short-term
investments |
36,354 |
46,401 |
Accounts receivable |
20,783 |
11,560 |
Inventory |
19,529 |
10,504 |
Deferred cost of
revenue |
160 |
― |
Prepaid and other current
assets |
1,800 |
1,283 |
Total current assets |
92,064 |
96,856 |
Long-term investments |
8,902 |
23,283 |
Property and equipment, net |
19,389 |
9,212 |
Intangible assets, net |
7,284 |
7,530 |
Other assets |
132 |
198 |
Total assets |
$127,771 |
$137,079 |
|
|
|
Current Liabilities: |
|
|
Accounts payable |
$4,231 |
$1,518 |
Accrued compensation and
employee benefits |
7,579 |
5,546 |
Other accrued
liabilities |
10,622 |
5,064 |
Deferred revenue |
4,826 |
3,071 |
Total current liabilities |
27,258 |
15,199 |
Deferred revenue, non-current |
75 |
109 |
Total liabilities |
27,333 |
15,308 |
Stockholders' equity: |
|
|
Common stock |
41 |
40 |
Additional paid-in
capital |
289,352 |
274,712 |
Accumulated deficit |
(189,025) |
(152,882) |
Accumulated other
comprehensive gain (loss) |
70 |
(99) |
Total stockholders' equity |
100,438 |
121,771 |
Total liabilities and stockholders'
equity |
$127,771 |
$137,079 |
|
|
|
|
|
|
Condensed Statements of Cash Flows
(unaudited) |
Twelve Months
Ended |
(in thousands) |
December
31, |
|
2011 |
2010 |
Operating activities: |
|
|
Net loss |
($36,143) |
($38,687) |
Adjustments to reconcile net loss to net cash
used in operating activities: |
|
|
Depreciation |
4,352 |
2,445 |
Amortization of intangible assets |
1,446 |
1,070 |
Stock-based compensation |
9,901 |
6,371 |
Inventory write-down |
256 |
1,701 |
Amortization of premium on investment
securities |
476 |
480 |
Loss on asset impairment |
146 |
1,248 |
Provision for doubtful accounts |
158 |
― |
Issuance of restricted stock under
development agreement |
1,691 |
― |
Changes in operating assets and
liabilities: |
|
|
Accounts receivable |
(9,381) |
(5,024) |
Inventory |
(11,619) |
(6,087) |
Deferred cost of
revenue |
(160) |
― |
Prepaid and other current
assets |
(517) |
(751) |
Other assets |
66 |
(57) |
Accounts payable |
2,713 |
359 |
Accrued compensation and
employee benefits |
2,033 |
1,837 |
Other accrued
liabilities |
5,558 |
2,192 |
Deferred revenue |
1,721 |
2,611 |
Net cash used in operating activities |
(27,303) |
(30,292) |
Investing activities: |
|
|
Purchase of investments |
(33,131) |
(65,828) |
Proceeds from sales and maturities of
investments |
57,252 |
49,692 |
Acquisition of property and equipment |
(12,337) |
(2,628) |
Acquisition of intangible assets |
(1,200) |
(1,312) |
Net cash provided by (used in) investing
activities |
10,584 |
(20,076) |
Financing activities: |
|
|
Proceeds from issuance of common stock in
equity financing |
― |
59,708 |
Equity financing costs |
― |
(425) |
Proceeds from employee stock purchase
plan |
1,168 |
765 |
Exercise of common stock options and warrants
for cash |
2,932 |
611 |
Payment of payroll taxes relating to vesting
of restricted stock |
(10,514) |
(342) |
Net cash provided by financing
activities |
3,049 |
60,317 |
Net increase (decrease) in cash and cash
equivalents |
(13,670) |
9,949 |
Cash and cash equivalents at beginning of
year |
27,108 |
17,159 |
Cash and cash equivalents at end of year |
$13,438 |
$27,108 |
CONTACT: Investors:
MAKO Surgical Corp.
954-628-1706
investorrelations@makosurgical.com
or
Westwicke Partners
Mark Klausner
443-213-0500
makosurgical@westwicke.com
Mako Surgical Corp. (MM) (NASDAQ:MAKO)
Historical Stock Chart
From May 2024 to Jun 2024
Mako Surgical Corp. (MM) (NASDAQ:MAKO)
Historical Stock Chart
From Jun 2023 to Jun 2024