Second Quarter 2012 Highlights
Second quarter revenue totaled
Nine RIO® systems sold in the second quarter, increasing worldwide commercial installed base to 126 RIO systems and domestic commercial installed base to 123 RIO systems
A total of fifteen RIO systems sold worldwide in the first six months of 2012
2,590 MAKOplasty® procedures performed in the second quarter, a 66% increase over the same period in 2011
4,887 MAKOplasty procedures performed in the first six months of 2012, a 71% increase over the same period in 2011
Nine MAKOplasty Total Hip Arthroplasty (THA) applications sold in the second quarter, of which two were sold to existing customers
As of
Recent Business Developments
RIO Systems — Nine RIO systems were sold during the second quarter, of which eight were sold to domestic customers and one was sold to its Chinese distributor, which in turn sold it for commercial use to a prominent hospital in Hong Kong. These nine RIO systems bring MAKO's worldwide commercial installed base of RIO systems to 126 systems and domestic commercial installed base to 123 systems as of
MAKOplasty Procedure Volume — During the second quarter, 2,590 MAKOplasty procedures were performed, of which 2,494 were performed at domestic sites. Of the 2,494 domestic procedures, 280 were Total Hip Arthroplasty (THA) procedures. The 2,590 MAKOplasty procedures performed represent a 13% increase over the procedures performed in the first quarter of 2012 and a 66% increase over the procedures performed in the second quarter of 2011. The average monthly utilization per system was 7.2 procedures during the second quarter of 2012, an increase from 6.6 procedures per system per month in the first quarter of 2012 and 6.4 procedures per system per month in the second quarter of 2011. Through
MAKOplasty Total Hip Arthroplasty Applications — In the second quarter, nine MAKOplasty THA applications were sold, seven of which were sold with the domestic RIO systems sales during the quarter and two of which were sold as upgrades to existing commercial systems. As of
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 second quarter, Dr.
"As noted in our release of selected operating results on
2012 Second Quarter Financial Review
Revenue was
Gross profit for the second quarter of 2012 was
Operating expenses were
Net loss for the three months ended
Cash, cash equivalents and investments were
2012 Six-Month Financial Review
Revenue was
The net loss for the six months ended
Outlook
Guidance of 42 to 48 expected annual RIO system sales and 11,000 to 12,000 expected annual MAKOplasty procedures remains unchanged from the guidance provided in the press release attached as Exhibit 99.1 to MAKO's Current Report on Form 8-K filed with the
Conference Call
MAKO will host a conference call today at
About
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,
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, 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
"MAKOplasty®," "RESTORIS®," "RIO®," as well as the "MAKO" logo, whether standing alone or in connection with the words "
|
Condensed Statements of Operations (unaudited) (in thousands, except per share data) |
Three Months Ended |
Six Months Ended |
||
| 2012 | 2011 | 2012 | 2011 | |
| Revenue: | ||||
| Procedures |
|
|
|
|
| Systems | 8,183 | 9,474 | 14,054 | 14,838 |
| Service | 2,474 | 1,429 | 4,680 | 2,624 |
| Total revenue | 23,675 | 18,579 | 43,314 | 31,605 |
| Cost of revenue: | ||||
| Procedures | 3,118 | 1,716 | 5,775 | 3,514 |
| Systems | 2,796 | 3,488 | 5,244 | 5,526 |
| Service | 451 | 274 | 832 | 533 |
| Total cost of revenue | 6,365 | 5,478 | 11,851 | 9,573 |
| Gross profit | 17,310 | 13,101 | 31,463 | 22,032 |
| Operating costs and expenses: | ||||
| Selling, general and administrative | 19,284 | 17,137 | 39,072 | 31,946 |
| Research and development | 5,244 | 5,015 | 10,098 | 9,209 |
| Depreciation and amortization | 1,270 | 977 | 2,544 | 1,952 |
| Total operating costs and expenses | 25,798 | 23,129 | 51,714 | 43,107 |
| Loss from operations | (8,488) | (10,028) | (20,251) | (21,075) |
| Other income (expense), net | (33) | 120 | 25 | 212 |
| Loss before income taxes | (8,521) | (9,908) | (20,226) | (20,863) |
| Income tax expense | 14 | 1 | 39 | 41 |
| Net loss |
|
|
|
|
| Net loss per share - Basic and diluted |
|
|
|
|
| Weighted average common shares outstanding - Basic and diluted | 42,161 | 40,605 | 41,927 | 40,358 |
| Condensed Balance Sheets (unaudited) |
|
|
| (in thousands) | 2012 | 2011 |
| Current Assets: | ||
| Cash and cash equivalents |
|
|
| Short-term investments | 25,335 | 36,354 |
| Accounts receivable | 19,014 | 20,783 |
| Inventory | 28,905 | 19,529 |
| Deferred cost of revenue | 618 | 160 |
| Financing commitment asset | 3,672 | ― |
| Prepaid and other current assets | 4,514 | 1,800 |
| Total current assets | 91,495 | 92,064 |
| Long-term investments | 531 | 8,902 |
| Property and equipment, net | 21,846 | 19,389 |
| Intangible assets, net | 6,510 | 7,284 |
| Other assets | 169 | 132 |
| Total assets |
|
|
| Current Liabilities: | ||
| Accounts payable |
|
|
| Accrued compensation and employee benefits | 2,832 | 7,579 |
| Other accrued liabilities | 9,257 | 10,622 |
| Deferred revenue | 7,092 | 4,826 |
| Total current liabilities | 27,188 | 27,258 |
| Deferred revenue, non-current | 187 | 75 |
| Total liabilities | 27,375 | 27,333 |
| Stockholders' equity: | ||
| Common stock | 42 | 41 |
| Additional paid-in capital | 302,385 | 289,352 |
| Accumulated deficit | (209,290) | (189,025) |
| Accumulated other comprehensive gain | 39 | 70 |
| Total stockholders' equity | 93,176 | 100,438 |
| Total liabilities and stockholders' equity |
|
|
| Condensed Statements of Cash Flows (unaudited) | Six Months Ended | |
| (in thousands) |
|
|
| 2012 | 2011 | |
| Operating activities: | ||
| Net loss |
|
|
| Adjustments to reconcile net loss to net cash used in operating activities: | ||
| Depreciation | 2,832 | 2,081 |
| Amortization of intangible assets | 839 | 640 |
| Stock-based compensation | 6,122 | 4,946 |
| Inventory write-down | 95 | 28 |
| Amortization of premium on investment securities | 221 | 195 |
| Loss on asset impairment | 511 | 148 |
| Provision for doubtful accounts | 77 | 154 |
| Issuance of restricted stock under development agreement | 454 | 1,080 |
| Non-cash changes under credit facility | (62) | ― |
| Changes in operating assets and liabilities: | ||
| Accounts receivable | 1,692 | (612) |
| Inventory | (11,432) | (5,583) |
| Deferred cost of revenue | (458) | (97) |
| Prepaid and other current assets | (2,714) | (955) |
| Other assets | (37) | 33 |
| Accounts payable | 3,776 | 663 |
| Accrued compensation and employee benefits | (4,747) | (2,090) |
| Other accrued liabilities | (1,365) | 949 |
| Deferred revenue | 2,378 | 491 |
| Net cash used in operating activities | (22,083) | (18,833) |
| Investing activities: | ||
| Purchase of investments | (3,160) | (22,703) |
| Proceeds from sales and maturities of investments | 22,298 | 22,820 |
| Acquisition of property and equipment | (3,839) | (2,754) |
| Acquisition of intangible assets | (65) | ― |
| Net cash provided by (used in) investing activities | 15,234 | (2,637) |
| Financing activities: | ||
| Proceeds from employee stock purchase plan | 844 | 469 |
| Exercise of common stock options and warrants for cash | 2,176 | 1,930 |
| Payment of payroll taxes relating to vesting of restricted stock | (172) | (666) |
| Net cash provided by financing activities | 2,848 | 1,733 |
| Net decrease in cash and cash equivalents | (4,001) | (19,737) |
| Cash and cash equivalents at beginning of period | 13,438 | 27,108 |
| Cash and cash equivalents at end of period |
|
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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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