The $1.0 million increase in service revenue was attributable to an increase in the installed base of RIO systems covered under warranty and maintenance.
We expect our revenue to continue to increase in future periods as unit sales of our RIO system increase, the number of MAKOplasty procedures performed increases, and the installed base of RIO systems covered under warranty and maintenance increases.
Cost of revenue was $5.5 million for the three months ended March 31, 2012, compared to $4.1 million for the three months ended March 31, 2011. The increase in cost of revenue of $1.4 million, or 34%, was primarily due to an increase in MAKOplasty procedures performed and the recognition of the cost of revenue from five unit sales of our RIO system and nine MAKOplasty THA application sales to existing customers during the three months ended March 31, 2012 as compared to the recognition of the cost of revenue from seven unit sales of our RIO system during the three months ended March 31, 2011. This was partially offset by lower per procedure material costs for the three months ended March 31, 2012 compared to the three months ended March 31, 2011. We expect our cost of revenue to continue to increase in future periods as unit sales of our RIO system and applications increase, the number of MAKOplasty procedures performed increases, and the installed base of RIO systems covered under warranty and maintenance increases.
Gross profit for the three months ended March 31, 2012 was $14.2 million compared to a gross profit of $8.9 million for the three months ended March 31, 2011. Total gross margin for the three months ended March 31, 2012 was 72%, including a 77% margin on procedure revenue, a 58% margin on RIO system revenue and a 83% margin on service revenue compared to a gross margin of 69% for the three months ended March 31, 2011, including a 72% margin on procedure revenue, a 62% margin on RIO system revenue and a 78% margin on service revenue. The increase in margin on procedure revenue was primarily attributable to lower material costs per procedure. The decrease in margin on RIO system revenue was primarily attributable to (i) the fact that the MAKOplasty THA application sales for the three months ended March 31, 2012 were primarily retrofit upgrades, which have a higher cost of revenue and (ii) higher indirect costs per system for the three months ended March 31, 2012 compared to the same period in 2011. The increase in margin on service revenue was primarily attributable to a reduction in the frequency of planned preventative maintenance visits as our RIO platform has matured.
Selling, general and administrative expense was $19.8 million for the three months ended March 31, 2012, compared to $14.8 million for the three months ended March 31, 2011. The increase of $5.0 million, or 34%, was primarily due to an increase in sales, marketing and operations costs associated with the commercialization of our products and an increase in general and administrative costs to support our continued growth. Our total number of employees increased from 320 as of March 31, 2011 to 437 as of March 31, 2012. Of the 117 employee increase, 66 were in sales and marketing. Selling, general and administrative expense for the three months ended March 31, 2012 included $2.3 million of stock-based compensation expense compared to $2.0 million for the three months ended March 31, 2011. The increase in stock-based compensation expense was primarily due to additional option grants made in 2012 and 2011 combined with an increase in the price of our common stock. We expect our selling, general and administrative expenses to continue to increase substantially due to our planned increase in the number of employees and sales and training programs necessary to support the sales and marketing efforts associated with the growing commercialization of our products, and an increased number of employees, facilities and operating costs necessary to support our continued growth in operations. In addition, we expect to incur additional costs associated with securing and protecting our intellectual property rights as necessary to support our current and future product offerings.
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Research and Development
Research and development expense was $4.9 million for the three months ended March 31, 2012, compared to $4.2 million for the three months ended March 31, 2011. The increase of $660,000, or 16%, was primarily due to an increase in research and development activities associated with on-going development of our RIO system and applications, our RESTORIS family of implant systems, and potential future products. We expect our research and development expense to increase as we continue to expand our research and development activities, including the support of existing products and the research and development of potential future products.
Depreciation and Amortization
Depreciation and amortization expense was $1.3 million for the three months ended March 31, 2012, compared to $975,000 for the three months ended March 31, 2011. The increase of $299,000, or 31%, was primarily due to an increase in depreciation of property and equipment as a result of purchases made during 2011 and 2012 due to the growth in our business and operational activities necessary to support such growth.
Other Income, net
Other income, net was $58,000 for the three months ended March 31, 2012, compared to other income of $92,000 for the three months ended March 31, 2011. The decrease of $34,000 was primarily due to a lower average cash, cash equivalents and investments balance for the three months ended March 31, 2012 compared to the same period of 2011.
Income Taxes
No federal income taxes were recognized for the three months ended March 31, 2012 and 2011, due to net operating losses in each period. State and local income taxes for the three months ended March 31, 2012 and 2011 were $25,000 and $40,000, respectively. Income taxes recognized to date have not been significant due to net operating losses we have incurred in each period since our inception. In addition, no deferred income taxes were recorded for the three months ended March 31, 2012 and 2011, as all income tax benefits were fully offset by a valuation allowance against our net deferred income tax assets.
Liquidity and Capital Resources
| | | | | | | | | | | | | |
(in thousands) | | Three Months Ended March 31, | |
| | 2012 | | 2011 | | Change | | % of Change | |
Net cash used in operating activities | | $ | (11,893 | ) | $ | (9,662 | ) | $ | (2,231 | ) | | 23 | % |
Net cash provided by (used in) investing activities | | | 4,843 | | | (713 | ) | | 5,556 | | | (779 | %) |
Net cash provided by financing activities | | | 2,305 | | | 400 | | | 1,905 | | | 476 | % |
Net decrease in cash and cash equivalents | | $ | (4,745 | ) | $ | (9,975 | ) | $ | 5,230 | | | (52 | %) |
We have incurred net losses and negative cash flow from operating activities for each period since our inception in November 2004. As of March 31, 2012, we had an accumulated deficit of $200.8 million and have financed our operations principally through the sale of our equity securities.
As of March 31, 2012, we had $46.8 million in cash, cash equivalents and investments. Our cash and investment balances are held in a variety of interest bearing instruments, including notes and bonds from U.S. government agencies and certificates of deposit.
On May 7, 2012, we entered into a Facility Agreement with affiliates of Deerfield Management Company, L.P., or Deerfield, pursuant to which Deerfield agreed to loan us up to $50 million, subject to the terms and conditions set forth in the Facility Agreement. Under the terms of the agreement, we have the flexibility, but are not required, to draw down on the Facility Agreement in $10 million increments at any time until May 15, 2013. We were not required to pay an upfront transaction fee to Deerfield under the Facility Agreement.
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Any amounts drawn under the Facility Agreement accrue interest at a rate of 6.75% per annum and will be secured by all of our assets excepting only our intellectual property assets. Accrued interest is payable quarterly in cash. We have the right to prepay any amounts owed without penalty. All principal amounts outstanding under the Facility Agreement are payable on the third anniversary of each draw. If no funds have been drawn under the Facility Agreement by May 15, 2013, we are required to pay Deerfield a fee of $1.0 million. As of May 7, 2012, we have not drawn any amounts under the Facility Agreement.
In connection with the execution of the Facility Agreement, on May 7, 2012, we issued to Deerfield warrants to purchase 275,000 shares of our common stock at an exercise price equal to a 20% premium to the mean closing price of our common stock over the 20 trading days beginning on May 8, 2012. As noted above, we have the right to draw down on the Facility Agreement one or more cash disbursements in the minimum amount of $10 million per disbursement. Each $10 million disbursement shall be accompanied by the issuance to Deerfield of warrants to purchase 140,000 shares of common stock, at an exercise price equal to a 20% premium to the mean closing price of our common stock over the 5 trading days following receipt by Deerfield of the draw notice. If we, in our discretion, elect to draw down the entire $50 million available under the Facility Agreement, we will have issued warrants to purchase a total of 975,000 shares of our common stock. The warrants expire seven years from their issuance.
Net Cash Used in Operating Activities
Net cash used in operating activities primarily reflects the net loss for those periods, which was reduced in part by depreciation and amortization and stock-based compensation. Net cash used in operating activities was also reduced by the recognition of research and development expense associated with stock issued under the Strategic Alliance Agreement with Pipeline Biomedical Holding, LLC. Net cash used in operating activities was also affected by changes in operating assets and liabilities. Included in changes in operating assets and liabilities for the three months ended March 31, 2012 are $5.0 million of increases to inventory necessitated by the anticipated increased sales of implants and disposable products and the commercial launch of our MAKOplasty THA application, $2.3 million of increases to prepaid and other current assets, $4.7 million of decreases to accrued compensation and employee benefits due primarily to the payment of 2011 bonuses and 2011 commissions and $3.1 million of decreases to other accrued liabilities. This was partially offset by $8.2 million of decreases to accounts receivable due primarily to collections of sales recognized in the prior year. Included in changes in operating assets and liabilities for the three months ended March 31, 2011 are $2.3 million of increases to inventory necessitated by the anticipated increased sales of implants and disposable products and preparation for the launch of our MAKOplasty THA application in September 2011, and $3.4 million of decreases to accrued compensation and employee benefits due primarily to the payment of year-end bonuses and commissions, which was partially offset by $3.4 million of decreases to accounts receivable.
Net Cash Provided by (Used in) Investing Activities
Net cash provided by investing activities for the three months ended March 31, 2012 was primarily attributable to proceeds of $10.2 million from sales and maturities of investments, which was partially offset by the purchase of investments of $3.2 million and purchases of property and equipment of $2.2 million due to the growth in our business. Net cash used in investing activities for the three months ended March 31, 2011 was primarily attributable to the purchase of investments of $15.1 million and purchases of property and equipment of $1.3 million, which was partially offset by proceeds of $15.6 million from sales and maturities of investments.
Net Cash Provided by Financing Activities
Net cash provided by our financing activities for the three months ended March 31, 2012 and 2011 was primarily attributable to proceeds received under our employee stock purchase plan of $360,000 and $241,000, respectively, and to proceeds received on the exercise of stock options and warrants of $2.0 million and $516,000, respectively.
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Operating Capital and Capital Expenditure Requirements
To date, we have not achieved profitability. We anticipate that we will continue to incur substantial net losses for at least the next two years as we expand our sales and marketing capabilities in the orthopedic products market, continue to commercialize our RIO system and MAKOplasty applications, including our MAKOplasty THA application that we commercially launched in September 2011, and our implant systems, continue research and development of existing and future products, and continue development of the corporate infrastructure required to sell and market our products and support operations. We also expect to experience increased cash requirements for inventory and property and equipment in conjunction with the continued commercialization of our RIO system and implant systems, and introducing other potential future applications.
In executing our current business plan, we believe our cash, cash equivalents and investment balances as of March 31, 2012, and interest income we earn on these balances will be sufficient to meet our anticipated cash requirements for at least the next twelve months. To the extent our available cash, cash equivalents and investment balances are insufficient to satisfy our operating requirements, we will need to seek additional sources of funds, including selling additional equity, debt or other securities or drawing on our available credit facility, or modify our current business plan. The sale of additional equity or convertible debt securities may result in dilution to our current stockholders. If we raise additional funds through the issuance of debt securities, these securities may have rights senior to those of our common stock and could contain covenants that could restrict our operations and ability to issue dividends. We may also require additional capital beyond our currently forecasted amounts. Any required additional capital, whether forecasted or not, may not be available on reasonable terms, or at all. If we are unable to obtain additional financing, we may be required to reduce the scope of, delay or eliminate some or all of our planned research, development and commercialization activities, which could materially harm our business and results of operations.
Because of the numerous risks and uncertainties associated with the development of medical devices and the current economic situation, we are unable to estimate the exact amounts of capital outlays and operating expenditures necessary to complete the development of our products and successfully deliver commercial products to the market. Our future capital requirements will depend on many factors, including but not limited to the following:
| | |
| • | the revenue generated by sales of our current and future products; |
| | |
| • | the expenses we incur in selling and marketing our products and supporting our growth; |
| | |
| • | the costs and timing of domestic and foreign regulatory clearance or approvals for new products or upgrades or changes to our products; |
| | |
| • | the expenses we incur in complying with domestic or foreign regulatory requirements imposed on medical device companies; |
| | |
| • | the rate of progress, cost and success or failure of on-going development activities; |
| | |
| • | the emergence of competing or complementary technological developments; |
| | |
| • | the costs of filing, prosecuting, defending and enforcing any patent or license claims and other intellectual property rights, or participating in litigation related activities; |
| | |
| • | the terms and timing of any collaborative, licensing, or other arrangements that we may establish; |
| | |
| • | the impact of the United States healthcare reform legislation enacted in March 2010 on hospital spending, reimbursement, and the taxing of medical device companies; |
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| | |
| • | the acquisition of businesses, products and technologies; and |
| | |
| • | general economic conditions and interest rates. |
Contractual Obligations
At March 31, 2012, we were committed to make future purchases for inventory and other items that occur in the ordinary course of business under various purchase arrangements with fixed purchase provisions aggregating $16.5 million.
Other than as described above and scheduled payments through March 31, 2012, there have been no significant changes in our contractual obligations during the three months ended March 31, 2012 as compared to the contractual obligations described in our Form 10-K for the year ended December 31, 2011.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
Our exposure to market risk is confined to our cash, cash equivalents, investments and exchange rate risk on international sales. The goals of our cash investment policy are the security of the principal invested and fulfillment of liquidity needs, with the need to maximize value being an important consideration. To achieve our goals, we maintain a portfolio of cash equivalents and investments in a variety of securities including notes and bonds from U.S. government agencies and certificates of deposit. The securities in our investment portfolio are not leveraged and are classified as available-for-sale. We currently do not hedge interest rate exposure or exchange rate risk. We do not believe that a variation in market rates of interest would significantly impact the value of our investment portfolio. We do not believe that a variation in the value of the U.S. dollar relative to foreign currencies would significantly impact our results of operations.
ITEM 4. CONTROLS AND PROCEDURES.
Disclosure Controls and Procedures.
In accordance with Rule 13a-15(b) of the Securities Exchange Act of 1934, or the Exchange Act, our management evaluated, with the participation of our chief executive officer and chief financial officer, or the Certifying Officers, the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Exchange Act) as of March 31, 2012. Based upon their evaluation of these disclosure controls and procedures, our Certifying Officers concluded that the disclosure controls and procedures were effective as of March 31, 2012 to provide reasonable assurance that information required to be disclosed by us in the reports we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time period specified in the rules and forms of the Securities and Exchange Commission, and to provide reasonable assurance that information required to be disclosed by us in the reports we file or submit under the Exchange Act is accumulated and communicated to our management, including our principal executive and principal financial officers, as appropriate, to allow timely decisions regarding required disclosure.
We believe that a controls system, no matter how well designed and operated, is based in part upon certain assumptions about the likelihood of future events, and therefore can only provide reasonable, not absolute, assurance that the objectives of the controls system are met, and no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within a company have been detected.
Changes in Internal Control over Financial Reporting.
There have been no changes in our internal control over financial reporting during the quarter ended March 31, 2012 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II
OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
None
ITEM 1A. RISK FACTORS.
There have been no material changes in our risk factors from those disclosed in our Form 10-K for the year ended December 31, 2011.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.
| |
(c) | Issuer Purchases of Equity Securities |
The following table summarizes the surrenders of the Company’s common stock during the three month period ended March 31, 2012:
| | | | | | | | | | | | | |
| | Total Number of Shares Purchased(1) | | Average Price Paid per Share(1) | | Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs | | Maximum Dollar Value of Shares that May Yet be Purchased Under the Plans or Programs | |
Period | | | | | | | | | | | | | |
January 1 to 31, 2012 | | | — | | $ | — | | | — | | $ | — | |
February 1 to 29, 2012 | | | 2,278 | | | 35.62 | | | — | | | — | |
March 1 to 31, 2012 | | | — | | | — | | | — | | | — | |
| | | 2,278 | | $ | 35.62 | | | — | | $ | — | |
| |
(1) | Represents the surrender of shares of common stock of the Company to satisfy the tax withholding obligations associated with the vesting of restricted stock under the Company’s equity incentive plans. |
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable
ITEM 5. OTHER INFORMATION.
We take matters relating to regulatory compliance very seriously. In 2012, as part of our ongoing internal quality management initiatives and systems enhancements, we undertook a retrospective review of all product complaints to determine if we may have inadvertently failed to file certain Medical Device Reporting (“MDR”) reports with the U.S. Food and Drug Administration (the “FDA”) during the period 2010 to present. Based upon criteria set by the FDA as well as our own internal MDR reporting criteria, our internal review preliminarily identified potential MDR reportability for 105 of such complaints. Significantly, no new or unknown product safety issues were discovered in this retrospective review.
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On May 4, 2012, we met with and solicited the advice of the FDA as to the reasonableness of our enhanced MDR reporting systems and retrospective review, which resulted in the submission of 120 MDR filings on May 7, 2012. The filing of these MDR reports could result in scrutiny of the MDR reports, or an inspection of our records and reporting procedures, by the FDA, which could result in issuance of a warning letter with respect to such procedures. We do not believe, however, based upon the nature of the MDR reports, our interactions with the FDA and all other information currently available to us, that the filing of these MDR reports and the potential regulatory and other consequences related to such filing, if any, will have a material adverse impact on our results of operations.
We have implemented corrective and preventive actions, including revised internal reporting procedures, revised standard operating procedures and additional employee training, to address and prevent regulatory issues from occurring in the future. We believe that we have made significant progress in transitioning our organization to increase focus on regulatory compliance and in implementing solutions to enhance our quality systems. Notwithstanding our continuing efforts in these areas, scrutiny or inspection by the FDA could result in regulatory consequences to us as described in greater detail under Item 1A, “Risk Factors,” in our periodic filings with the Securities and exchange Commission, including our annual report on Form 10-K for the year ended December 31, 2011.
ITEM 6. EXHIBITS.
| | |
Exhibit No. | | Description |
| | |
4.1 | | Form of Warrant to purchase shares of common stock of MAKO Surgical Corp. (incorporated by reference to the Company’s Form 8-K as filed on May 7, 2012) |
| | |
10.1 | | Facility Agerement dated May7, 2012 by and among MAKO Surgical Corp., Deerfield Private Design Fund II, L.P. and Deerfield Private Design International II, L.P. (incorporated by reference to the Company’s Form 8-K as filed on May 7, 2012) |
| | |
10.2 | | Registration Rights Agreement dated May7, 2012 by and among MAKO Surgical Corp., Deerfield Private Design Fund II, L.P. and Deerfield Private Design International II, L.P. (incorporated by reference to the Company’s Form 8-K as filed on May 7, 2012) |
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10.3 | | Form of Security Agreement (incorporated by reference to the Company’s Form 8-K as filed on May 7, 2012) |
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10.4 | | Employment Agreement between Registrant and Lawrence T. Gibbons, effective as of February 3, 2012 (incorporated by reference to the Company’s Form 8-K as filed on January 31, 2012) |
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10.5 | | 2012 Leadership Cash Bonus Plan (incorporated by reference to the Company’s Form 8-K as filed on February 27, 2012) |
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31.1 | | Certification of Chief Executive Officer pursuant to Rule 13a-14(a) of the Exchange Act |
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31.2 | | Certification of Chief Financial Officer pursuant to Rule 13a-14(a) of the Exchange Act |
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32.1 | | Certification of Chief Executive Officer pursuant to 18 U.S.C. §1350 |
| | |
32.2 | | Certification of Chief Financial Officer pursuant to 18 U.S.C. §1350 |
| | |
101 | | The following materials from MAKO Surgical Corp.’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2012, formatted in XBRL (Extensible Business Reporting Language): (i) Condensed Balance Sheets, (ii) Condensed Statements of Operations, (iii) Condensed Statements of Cash Flows, and (iv) Notes to Condensed Financial Statements, tagged as blocks of text. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| | |
| MAKO Surgical Corp. |
| |
Date: May 7, 2012 | By: | /s/ Fritz L. LaPorte |
| | Fritz L. LaPorte |
| | Senior Vice President of Finance and |
| | Administration, Chief Financial Officer and Treasurer |
| | (Principal Financial Officer and Authorized Signatory) |
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EXHIBIT INDEX
| | |
Exhibit No. | | Description |
| | |
4.1 | | Form of Warrant to purchase shares of common stock of MAKO Surgical Corp. (incorporated by reference to the Company’s Form 8-K as filed on May 7, 2012) |
| | |
10.1 | | Facility Agerement dated May7, 2012 by and among MAKO Surgical Corp., Deerfield Private Design Fund II, L.P. and Deerfield Private Design International II, L.P. (incorporated by reference to the Company’s Form 8-K as filed on May 7, 2012) |
| | |
10.2 | | Registration Rights Agreement dated May 7, 2012 by and among MAKO Surgical Corp., Deerfield Private Design Fund II, L.P. and Deerfield Private Design International II, L.P. (incorporated by reference to the Company’s Form 8-K as filed on May 7, 2012) |
| | |
10.3 | | Form of Security Agreement (incorporated by reference to the Company’s Form 8-K as filed on May 7, 2012) |
| | |
10.4 | | Employment Agreement between Registrant and Lawrence T. Gibbons, effective as of February 3, 2012 (incorporated by reference to the Company’s Form 8-K as filed on January 31, 2012) |
| | |
10.5 | | 2012 Leadership Cash Bonus Plan (incorporated by reference to the Company’s Form 8-K as filed on February 27, 2012) |
| | |
31.1 | | Certification of Chief Executive Officer pursuant to Rule 13a-14(a) of the Exchange Act |
| | |
31.2 | | Certification of Chief Financial Officer pursuant to Rule 13a-14(a) of the Exchange Act |
| | |
32.1 | | Certification of Chief Executive Officer pursuant to 18 U.S.C. §1350 |
| | |
32.2 | | Certification of Chief Financial Officer pursuant to 18 U.S.C. §1350 |
| | |
101 | | The following materials from MAKO Surgical Corp.’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2012, formatted in XBRL (Extensible Business Reporting Language): (i) Condensed Balance Sheets, (ii) Condensed Statements of Operations, (iii) Condensed Statements of Cash Flows, and (iv) Notes to Condensed Financial Statements, tagged as blocks of text. |
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