UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
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þ
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For the quarterly period ended: June 30, 2008
or
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o
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For
the transition period from
to
Commission File Number: 001-33966
MAKO Surgical Corp.
(Exact name of registrant as specified in its charter)
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Delaware
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20-1901148
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(State or Other Jurisdiction of Incorporation
or Organization)
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(I.R.S. Employer Identification No.)
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2555 Davie Road, Fort Lauderdale, Florida 33317
(Address of Principal Executive Offices) (Zip Code)
(954) 927-2044
(Registrants Telephone Number, Including Area Code)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by
Section 13 or 15 (d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days.
Yes
þ
No
o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer,
non-accelerated filer or a smaller reporting company. See definitions of large accelerated
filer, accelerated filer, and smaller reporting company in Rule 12b-2 of the Exchange Act.
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Large Accelerated Filer
o
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Accelerated Filer
o
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Non-accelerated Filer
þ
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Smaller reporting company
o
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Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes
o
No
þ
Number of shares outstanding of each of the issuers classes of common stock as of July 29, 2008:
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Class
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Outstanding at July 29, 2008
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Common Stock
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18,476,919
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MAKO Surgical Corp.
INDEX TO FORM 10-Q
i
PART I
FINANCIAL INFORMATION
Item 1. FINANCIAL STATEMENTS.
MAKO SURGICAL CORP.
Condensed Balance Sheets
(in thousands, except share and per share data)
(Unaudited)
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June 30,
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December 31,
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2008
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2007
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ASSETS
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Current Assets:
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Cash and cash equivalents
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$
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38,075
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$
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9,615
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Short-term investments
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1,034
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3,084
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Accounts receivable
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2,916
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2,213
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Inventory
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3,807
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2,346
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Deferred cost of revenue
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2,155
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Prepaids and other assets
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391
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310
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Total current assets
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48,378
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17,568
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Deferred cost of revenue
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926
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Long-term
investments
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962
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Property and equipment, net
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2,895
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2,321
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Intangible assets, net
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5,147
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5,477
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Other assets
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225
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170
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Deferred initial public offering costs
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2,728
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Total assets
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$
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57,607
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$
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29,190
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LIABILITIES AND STOCKHOLDERS EQUITY (DEFICIT)
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Current Liabilities:
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Accounts payable
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$
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1,489
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$
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1,511
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Accrued compensation and employee benefits
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561
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1,033
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Other accrued liabilities
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2,609
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2,680
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Deferred revenue
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6,445
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50
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Accrued license fee
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3,955
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Total current liabilities
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11,104
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9,229
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Deferred revenue
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96
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3,311
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Total liabilities
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11,200
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12,540
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Commitments and contingencies
Redeemable convertible preferred stock:
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Series A redeemable convertible preferred
stock
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4,806
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Series B redeemable convertible preferred
stock
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23,102
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Series C redeemable convertible preferred
stock
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31,579
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Total redeemable convertible preferred stock
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59,487
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Stockholders equity (deficit):
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Common stock, $0.001 par value;
135,000,000 authorized as of June 30, 2008
and 60,000,000 shares authorized as of
December 31, 2007; 18,129,718 and
1,870,603 shares issued and outstanding as
of June 30, 2008 and December 31, 2007,
respectively
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18
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2
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Additional paid-in capital
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105,537
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Accumulated deficit
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(59,155
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)
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(42,843
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)
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Accumulated other comprehensive income
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7
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4
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Total stockholders equity (deficit)
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46,407
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(42,837
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)
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Total liabilities and stockholders equity
(deficit)
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$
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57,607
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$
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29,190
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See accompanying notes.
1
MAKO SURGICAL CORP.
Condensed Statements of Operations
(in thousands, except per share data)
(Unaudited)
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Three months ended June 30,
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Six months ended June 30,
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2008
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2007
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2008
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2007
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Revenue:
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Products
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$
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579
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$
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97
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$
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993
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$
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192
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Tactile Guidance System
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Other
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125
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9
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208
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14
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Total revenue
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704
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106
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1,201
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206
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Cost of revenue:
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Products
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244
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26
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384
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51
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Tactile Guidance System
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235
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13
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466
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23
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Other
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1
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8
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1
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9
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Total cost of revenue
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480
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47
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851
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83
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Gross profit
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224
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59
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350
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123
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Operating costs and expenses:
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Selling, general and
administrative
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5,119
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2,369
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9,767
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4,302
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Research and development
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2,485
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1,644
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6,094
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3,161
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Depreciation and
amortization
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425
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301
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847
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571
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Total operating costs and
expenses
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8,029
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4,314
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16,708
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8,034
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Loss from operations
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(7,805
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)
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(4,255
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)
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(16,358
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)
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(7,911
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)
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Interest and other income
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241
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316
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401
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552
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Interest and other expenses
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(1
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)
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(76
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)
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(109
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)
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(152
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)
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Net loss
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(7,565
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)
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(4,015
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)
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(16,066
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)
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(7,511
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)
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Accretion of redeemable
convertible preferred stock
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(75
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)
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(44
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)
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(147
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)
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Accrued dividends on
redeemable convertible
preferred stock
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(879
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)
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(521
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)
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(1,561
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)
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Net loss attributable to
common
stockholders
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$
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(7,565
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)
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$
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(4,969
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)
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$
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(16,631
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)
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$
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(9,219
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)
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Net loss per share Basic
and diluted attributable to
common stockholders
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$
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(0.42
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)
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$
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(3.19
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)
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$
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(1.20
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)
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$
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(5.92
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)
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Weighted average common
shares outstanding Basic
and diluted
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18,106
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1,556
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13,809
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1,556
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See accompanying notes.
2
MAKO SURGICAL CORP.
Condensed Statements of Cash Flows
(in thousands)
(Unaudited)
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Six months ended June 30,
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2008
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|
2007
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Operating activities:
|
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|
|
|
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Net loss
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$
|
(16,066
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)
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$
|
(7,511
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)
|
Adjustments to reconcile net loss to net cash used in operating activities:
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Depreciation
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615
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268
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Amortization of intangible assets
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330
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312
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Stock-based compensation
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2,059
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|
149
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Inventory write-down
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77
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|
8
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Accrued interest expense on deferred license fee
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45
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|
147
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Changes in operating assets and liabilities:
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Accounts receivable
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(703
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)
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526
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Inventory
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(1,538
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)
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(533
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)
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Due from related party
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|
29
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|
|
98
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Prepaid and other assets
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(110
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)
|
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|
(382
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)
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Other assets
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|
(53
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)
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Accounts payable
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|
(22
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)
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|
(244
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)
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Accrued compensation and employee benefits
|
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(472
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)
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|
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(203
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)
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Other accrued liabilities
|
|
|
(71
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)
|
|
|
14
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|
Deferred cost of revenue
|
|
|
(1,229
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)
|
|
|
(2
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)
|
Deferred revenue
|
|
|
3,180
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|
|
|
(4
|
)
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
|
(13,929
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)
|
|
|
(7,357
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)
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Investing activities:
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|
|
|
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|
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Purchase of investments
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|
(1,990
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)
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|
|
(14,133
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)
|
Proceeds from sales and maturities of investments
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|
3,081
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|
|
|
5,160
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|
Acquisition of property and equipment
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(1,189
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)
|
|
|
(726
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)
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Payment of deferred license fee on IBM license
|
|
|
(4,000
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)
|
|
|
|
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Acquisition of intangible assets
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|
|
|
|
|
|
(450
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)
|
|
|
|
|
|
|
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Net cash used in investing activities
|
|
|
(4,098
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)
|
|
|
(10,149
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)
|
Financing activities:
|
|
|
|
|
|
|
|
|
Proceeds from initial public offering of common stock, net of underwriting
fees of $3,570
|
|
|
47,430
|
|
|
|
|
|
Deferred initial public offering costs
|
|
|
(972
|
)
|
|
|
|
|
Proceeds from issuance of Series C redeemable convertible preferred stock,
net of stock issuance costs
|
|
|
|
|
|
|
29,916
|
|
Exercise of common stock options for cash
|
|
|
29
|
|
|
|
2
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities
|
|
|
46,487
|
|
|
|
29,918
|
|
|
|
|
|
|
|
|
Net increase in cash and cash equivalents
|
|
|
28,460
|
|
|
|
12,412
|
|
Cash and cash equivalents at beginning of period
|
|
|
9,615
|
|
|
|
2,108
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period
|
|
$
|
38,075
|
|
|
$
|
14,520
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosures of cash flow information
|
|
|
|
|
|
|
|
|
Interest paid
|
|
$
|
|
|
|
$
|
5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash investing and financing activities:
|
|
|
|
|
|
|
|
|
Accretion of redeemable convertible preferred stock
|
|
$
|
44
|
|
|
$
|
147
|
|
Accrued dividends on redeemable convertible preferred stock
|
|
|
521
|
|
|
|
1,561
|
|
Conversion of redeemable convertible preferred stock into 10,945,080
common shares
|
|
|
53,667
|
|
|
|
|
|
Reclassification of accrued dividends on redeemable convertible preferred
stock to additional paid-in capital
|
|
|
6,385
|
|
|
|
|
|
Reclassification of deferred initial public offering costs to additional
paid-in capital
|
|
|
3,700
|
|
|
|
|
|
Interest on note receivable for common stock
|
|
|
|
|
|
|
3
|
|
See accompanying notes.
3
MAKO SURGICAL CORP.
Notes to Condensed Financial Statements
(Unaudited)
1. Description of the Business
MAKO Surgical Corp. (the Company or MAKO) is a medical device company providing innovative
surgical solutions to the orthopedic knee arthroplasty market. The Company was incorporated in the
State of Delaware on November 12, 2004 and is headquartered in Fort Lauderdale, Florida.
In February 2008, the Company effected a one for 3.03 reverse split of its issued and
outstanding common stock, which has been retroactively reflected in these condensed financial
statements and notes to the condensed financial statements. Also, in February 2008, the Company
completed its initial public offering (IPO) of common stock, issuing a total of 5.1 million
shares at an issue price of $10.00 per share, resulting in net proceeds to the Company, after
expenses, of approximately $43.7 million.
In conjunction with the completion of the Companys IPO in February 2008, all of the Companys
outstanding Series A redeemable convertible preferred stock, Series B redeemable convertible
preferred stock and Series C redeemable convertible preferred stock were converted into
10,945,080 shares of common stock, adjusted for the February 2008 reverse stock split. In
connection therewith, all remaining redeemable convertible preferred stock discounts and accrued
dividends were reclassified to additional paid-in capital and were not paid.
2. Summary of Significant Accounting Policies
Basis of Presentation
In the opinion of management, the accompanying unaudited condensed financial statements
(condensed financial statements) of the Company have been prepared on a basis consistent with the
Companys December 31, 2007 audited financial statements and include all adjustments, consisting of
only normal recurring adjustments, necessary to fairly state the information set forth herein.
These condensed financial statements have been prepared in accordance with the regulations of the
Securities and Exchange Commission and, therefore, omit certain information and footnote disclosure
necessary to present the statements in accordance with accounting principles generally accepted in
the United States of America. These quarterly condensed financial statements should be read in
conjunction with the audited financial statements and notes thereto included in the Companys
Annual Report on Form 10-K for the fiscal year ended December 31, 2007 (the Form 10-K). The
results of operations for the second quarter of 2008 may not be indicative of the results to be
expected for the entire year or any future periods.
Risks and Uncertainties
The Company is subject to risks common to emerging companies in the medical device industry
including, but not limited to: new technological innovations, dependence on key personnel,
dependence on key suppliers, protection of proprietary technology, compliance with government
regulations, uncertainty of widespread market acceptance of products, product liability and the
need to obtain additional financing. The Companys products include components subject to rapid
technological change. Certain components used in manufacturing have relatively few alternative
sources of supply and establishing additional or replacement suppliers for such components cannot
be accomplished quickly. The inability of any of these suppliers to fulfill the Companys supply
requirements may negatively impact future operating results. While the Company has ongoing programs
to minimize the adverse effect of such uncertainty and considers technological change in estimating
its inventory net realizable value, uncertainty continues to exist.
4
The Companys current versions of its Tactile Guidance System (TGS) and its unicompartmental
implants have been cleared by the U.S. Food and Drug Administration (FDA). Certain products
currently under
development by the Company, such as future versions of its TGS and implants, will require
clearance or approval by the FDA or other international regulatory agencies prior to commercial
sale. There can be no assurance that the Companys products will receive the necessary clearances
or approvals. If the Company were to be denied such clearance or approval or such clearance or
approval were delayed, it could have a material adverse impact on the Company.
The Company believes its existing cash, cash equivalents and short-term investment balances,
and interest income earned on these balances will be sufficient to meet its anticipated cash
requirements for approximately the next 12 months. To the extent the Companys available cash, cash
equivalents and short-term investment balances are insufficient to satisfy its operating
requirements after that period, the Company will need to seek additional sources of funds,
including selling additional equity or debt securities or entering into a credit facility. The sale
of additional equity and debt securities may result in dilution to the Companys current
stockholders. If the Company raises additional funds through the issuance of debt securities, these
securities may have rights senior to those of its common stock and could contain covenants that
could restrict its operations. Although the Company currently has no firm agreements or
arrangements with respect to any additional financing, the Company anticipates requiring additional
capital to fund its future operations. Any such required additional capital may not be available on
reasonable terms, or at all. If the Company is unable to obtain additional financing, the Company
may be required to reduce the scope of, delay or eliminate some or all of its planned research,
development and commercialization activities, which could materially harm its business and results
of operations.
Revenue Recognition
Revenue is generated from unit sales of the TGS, including installation services, training,
upgrades and enhancements, from sales of implants and disposable products, and by providing
extended warranty services. The Companys TGS, as well as upgrades and enhancements to its TGS,
include software that is essential to the functionality of the product and, accordingly, the
Company accounts for the sale of the TGS pursuant to Statement of Position No. 97-2,
Software
Revenue Recognition
(SOP 97-2), as amended.
The Company recognizes product revenue for sales of the TGS when there is persuasive evidence
of an arrangement, the fee is fixed or determinable, collection of the fee is probable and delivery
has occurred as prescribed by SOP 97-2. For all sales, the Company uses either a signed agreement
or a binding purchase order as evidence of an arrangement. Such arrangements require the Company to
provide upgrades and enhancements to the TGS unit including delivery of version 2.0 of the TGS,
which is anticipated to occur in the first half of 2009, subject to regulatory clearances or
approvals. All of these customer upgrade rights to receive the upgrades through version 2.0 of the
TGS are on a when and if available basis.
For arrangements with multiple elements, the Company allocates arrangement consideration to
TGS units, upgrades, enhancements and services based upon vendor specific objective evidence
(VSOE) of fair value of the respective elements. As the Company is in the early stages of
commercialization, VSOE of fair value does not yet exist for all the undelivered elements.
Accordingly, all revenue and direct cost of revenue associated with the sale of the TGS are
deferred until the earlier of (1) delivery of all elements or (2) establishment of VSOE of fair
value for all undelivered elements.
Billings on TGS units are currently recorded as deferred revenue. The direct cost of revenue
associated with the sale of TGS units is currently recorded as deferred cost of revenue. Costs
associated with establishing an accrual for the TGS standard one-year warranty liability and
royalties related to the sale of TGS units covered by licensing arrangements are expensed as
incurred and included in Cost of Revenue, Tactile Guidance System, in the condensed statements of
operations. The Company anticipates ultimately recognizing a positive margin on the sales to date
of TGS units, including the satisfaction of the remaining upgrades through the final deliverable of
version 2.0 of the TGS, which is anticipated to be in the first half of 2009. As recognition of the
deferred revenue and deferred cost of revenue balances associated with sales of TGS units are
anticipated to occur within 12 months of June 30, 2008, the Company classified these balances as
current liabilities and current assets, respectively, as of June 30, 2008. If the Company is not
able to deliver version 2.0 of the TGS, customers would retain the original TGS unit sold and the
Company would not be obligated to refund the purchase price of the TGS unit.
5
Product revenue from the sale of implants and disposable products (the Products) is
recognized as revenue in accordance with Staff Accounting Bulletin (SAB) No. 104,
Revenue
Recognition
, when persuasive evidence of an arrangement exists, delivery has occurred or service
has been rendered, the price is fixed or determinable and collectibility is reasonably assured. The
Products are a separate unit of accounting from the TGS as (1) they have value to the customer on a
standalone basis, (2) objective and reliable evidence of the fair value of the item exists and
(3) no right of return exists once the Products are implanted or consumed. Accordingly, as the
Companys implants and disposable products are sold on a procedural basis, the revenue and costs
associated with the sale of Products are recognized at the time of sale (i.e., at the time of the
completion of the related surgical procedure).
Service revenue, which consists of extended warranty services on the TGS hardware, is deferred
and recognized ratably over the service period until no further obligation exists. Costs associated
with providing services are expensed when incurred.
Deferred Revenue and Deferred Cost of Revenue
Deferred revenue consists of deferred product revenue and deferred service revenue. Deferred
product revenue arises from timing differences between the shipment of product and satisfaction of
all revenue recognition criteria consistent with the Companys revenue recognition policy. Deferred
service revenue results from the advance payment for services to be delivered over a period of
time, usually in one-year increments. Service revenue is recognized ratably over the service
period. Deferred cost of revenue consists of the direct costs associated with the manufacture of
TGS units for which the revenue has been deferred in accordance with the Companys revenue
recognition policy. Deferred revenue and associated deferred cost of revenue expected to be
realized within one year are classified as current liabilities and current assets, respectively.
Intangible Assets
The Companys intangible assets are comprised of a purchased patent application and licenses
to intellectual property rights. These intangible assets are carried at cost, net of accumulated
amortization. Amortization is recorded using the straight-line method, over their respective useful
lives (generally the life of underlying patents), which range from approximately 10 to 19 years.
Deferred Initial Public Offering Costs
Specific incremental costs directly associated with the Companys IPO, primarily legal,
accounting and printing costs, were deferred and reflected as an asset until reclassification to
stockholders equity (deficit) upon closing of the IPO in February 2008.
Net Loss Per Share
The Company calculated net loss per share in accordance with Statement of Financial Accounting
Standards (SFAS) No. 128,
Earnings per Share
. Basic earnings per share (EPS) is calculated by
dividing the net income or loss available to common stockholders adjusted for redeemable
convertible preferred stock accretion and dividends by the weighted average number of common shares
outstanding for the period, without consideration for common stock equivalents. Diluted EPS is
computed by dividing the net income or loss available to common stockholders by the weighted
average number of common shares outstanding for the period and the weighted average number of
dilutive common stock equivalents outstanding for the period determined using the treasury-stock
method. The following table sets forth potential shares of common stock that are not included in
the calculation of diluted net loss per share because to do so would be anti-dilutive as of the end
of each period presented:
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
(in thousands)
|
|
2008
|
|
|
2007
|
|
Stock options outstanding
|
|
|
2,191
|
|
|
|
1,263
|
|
Warrants to purchase common stock
|
|
|
463
|
|
|
|
463
|
|
Redeemable convertible preferred stock
|
|
|
|
|
|
|
33,164
|
|
6
Recent Accounting Pronouncements
In September 2006, the FASB issued SFAS No. 157,
Fair Value Measurements
(SFAS 157). SFAS
157 defines fair value, provides a consistent framework for measuring fair value under accounting
principles generally accepted in the United States and expands fair value financial statement
disclosure requirements. SFAS 157 does not require any new fair value measurements. It only applies
to accounting pronouncements that already require or permit fair value measures, except for
standards that relate to stock-based payments.
SFAS 157s valuation techniques are based on observable and unobservable inputs. Observable
inputs reflect readily obtainable data from independent sources, while unobservable inputs reflect
our market assumptions. SFAS 157 classifies these inputs into the following hierarchy:
|
|
|
Level 1 Inputs-Quoted prices for identical instruments in active markets.
|
|
|
|
|
Level 2 Inputs-Quoted prices for similar instruments in active markets; quoted prices
for identical or similar instruments in markets that are not active; and model-derived
valuations whose inputs are observable or whose significant value drivers are observable.
|
|
|
|
|
Level 3 Inputs-Instruments with primarily unobservable value drivers.
|
SFAS 157 is effective for fiscal years beginning after November 15, 2007. Effective January 1,
2008, the Company adopted the provisions of SFAS 157. The adoption of SFAS 157 did not have a
material impact on the Companys results of operations and financial condition.
Effective January 1, 2008, the Company adopted SFAS No. 159,
The Fair Value Option for
Financial Assets and Financial LiabilitiesIncluding an amendment of FASB Statement No. 115
(SFAS 159) and has not elected to use fair value measurement on any assets or liabilities under
this statement. The Company has determined that the adoption of SFAS 159 had no effect on its
results of operations and financial position.
Effective January 1, 2008, the Company adopted Emerging Issues Task Force (EITF) Issue
No. 07-03,
Accounting for Nonrefundable Advance Payments for Goods or Services Received for Use in
Future Research and Development Activities
(EITF 07-03). EITF 07-03 requires that nonrefundable
advance payments for goods or services that will be used or rendered for future research and
development activities should be deferred and capitalized. Such amounts should be recognized as an
expense as the related goods are delivered or the related services are performed. Entities should
continue to evaluate whether they expect the goods to be delivered or services to be rendered. If
an entity does not expect the goods to be delivered or services to be rendered, the capitalized
advance payment should be charged to expense. The Company has determined that the adoption of EITF
07-03 had no effect on its results of operations and financial position.
In December 2007, the Financial Accounting Standards Board (FASB) issued SFAS No. 141
(revised 2007),
Business Combinations
(SFAS 141(R)). SFAS 141(R) retains the fundamental
requirements of the original pronouncement requiring that the purchase method be used for all
business combinations. SFAS 141(R) defines the acquirer as the entity that obtains control of one
or more businesses in the business combination, establishes the acquisition date as the date that
the acquirer achieves control and requires the acquirer to recognize the assets acquired,
liabilities assumed and any noncontrolling interest at their fair values as of the acquisition
date. SFAS 141(R) also requires that acquisition-related costs be recognized separately from the
acquisition. SFAS 141(R) will become effective for the Company on January 1, 2009. The Company is
currently evaluating the impact that SFAS 141(R) will have on its financial statements.
7
In December 2007, the FASB issued SFAS No. 160,
Noncontrolling Interests in Consolidated
Financial Statements
(SFAS 160). SFAS 160 establishes accounting and reporting standards for
ownership interests in subsidiaries held by parties other than the parent, the amount of
consolidated net income attributable to the parent and to the noncontrolling interest, changes in a
parents ownership interest and the valuation of retained noncontrolling equity investments when a
subsidiary is deconsolidated. SFAS 160 also establishes reporting requirements that provide
sufficient disclosures that clearly identify and distinguish between the interests of the parent
and the interests of the noncontrolling owners. SFAS 160 will become effective for the Company
beginning in the first quarter of 2009. The Company is currently evaluating the impact that
SFAS 160 will have on its financial statements.
3. Short-Term Investments and Long-Term Investments
The Companys investments are classified as available-for-sale. Available-for-sale securities
are carried at fair value, with the unrealized gains and losses included in other comprehensive
income (loss) within stockholders equity (deficit). Realized gains and losses and declines in
value judged to be other-than-temporary on available-for-sale securities are included in interest
and other expenses. Interest and dividends on securities classified as available-for-sale are
included in interest and other income. The cost of securities sold is based on the specific
identification method.
The amortized cost and fair value of short and long-term investments, with gross unrealized
gains and losses, were as follows:
As of June 30, 2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross
|
|
|
Gross
|
|
|
|
|
|
|
Amortized
|
|
|
Unrealized
|
|
|
Unrealized
|
|
|
Fair
|
|
(in thousands)
|
|
Cost
|
|
|
Gains
|
|
|
Losses
|
|
|
Value
|
|
Short-term investments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. treasury bills
|
|
$
|
992
|
|
|
$
|
7
|
|
|
$
|
|
|
|
$
|
999
|
|
Certificates of deposit
|
|
|
35
|
|
|
|
|
|
|
|
|
|
|
|
35
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total short-term investments
|
|
|
1,027
|
|
|
|
7
|
|
|
|
|
|
|
|
1,034
|
|
Long-term investments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Variable auction rate securities,
net of impairment charge of $63
|
|
|
962
|
|
|
|
|
|
|
|
|
|
|
|
962
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total short and long-term investments
|
|
$
|
1,989
|
|
|
$
|
7
|
|
|
$
|
|
|
|
$
|
1,996
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, 2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross
|
|
|
Gross
|
|
|
|
|
|
|
Amortized
|
|
|
Unrealized
|
|
|
Unrealized
|
|
|
Fair
|
|
(in thousands)
|
|
Cost
|
|
|
Gains
|
|
|
Losses
|
|
|
Value
|
|
Short-term investments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Variable auction rate securities
|
|
$
|
1,550
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
1,550
|
|
U.S. treasury bills
|
|
|
1,505
|
|
|
|
4
|
|
|
|
|
|
|
|
1,509
|
|
Certificates of deposit
|
|
|
25
|
|
|
|
|
|
|
|
|
|
|
|
25
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total short-term investments
|
|
$
|
3,080
|
|
|
$
|
4
|
|
|
$
|
|
|
|
$
|
3,084
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of June 30, 2008 and December 31, 2007, all short-term investments have maturities or
interest reset dates of less than one year.
8
The fair values of the Companys investments based on the level of inputs are summarized
below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements at the Reporting Date Using
|
|
|
|
|
|
|
|
Quoted
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Prices in
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Active
|
|
|
Significant
|
|
|
|
|
|
|
|
|
|
|
Markets for
|
|
|
Other
|
|
|
Significant
|
|
|
|
|
|
|
|
Identical
|
|
|
Observable
|
|
|
Unobservable
|
|
|
|
June 30,
|
|
|
Assets
|
|
|
Inputs
|
|
|
Inputs
|
|
(in thousands)
|
|
2008
|
|
|
(Level 1)
|
|
|
(Level 2)
|
|
|
(Level 3)
|
|
Short-term investments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. treasury bills
|
|
$
|
999
|
|
|
$
|
999
|
|
|
$
|
|
|
|
$
|
|
|
Certificates of deposit
|
|
|
35
|
|
|
|
35
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total short-term investments
|
|
|
1,034
|
|
|
|
1,034
|
|
|
|
|
|
|
|
|
|
Long-term investments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Variable auction rate
securities, net of
impairment charge of $63
|
|
|
962
|
|
|
|
|
|
|
|
|
|
|
|
962
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total short and long-term
investments
|
|
$
|
1,996
|
|
|
$
|
1,034
|
|
|
$
|
|
|
|
$
|
962
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of June 30, 2008, the Company held $1,025,000 par value of variable auction rate securities
issued by two separate funds. In February 2008, the auction rate securities experienced failed
auctions that limited the liquidity of these securities. Based on current market conditions, it is
likely that auction failures will continue. The carrying value of the securities are fully
collateralized by assets held by the funds and were rated AAA prior to the failed auctions of the
securities. Historically, the fair value of auction rate securities approximated par value due to
the frequent resets through the auction rate process. The continued uncertainty in the credit
markets has affected the Companys holdings in auction rate securities, however, and the liquidity
and fair value of these investments has been negatively impacted. As a result, the estimated fair
value of many of these investments no longer approximate par value. As of June 30, 2008, the
carrying value of the Companys auction rate securities was $962,000, which approximates the
estimated fair value as of that date. An other-than-temporary impairment charge of $63,000 was
recorded to reduce the value of its auction rate securities to the new fair value. In addition, as
a result of the unresolved liquidity concerns, the Company reclassified its auction rate securities
from short-term investments to long-term investments.
The Company used a discounted cash flow model to determine the estimated fair value of its
auction rate securities as of June 30, 2008. The assumptions used in preparing the discounted cash
flow model included estimates for interest rates, timing and amount of cash flows and expected
holding periods of the auction rate securities. These assumptions are subject to uncertainties,
are difficult to predict and require significant judgment. The use of different assumptions could
result in significantly different estimates of fair value. The fair value of the Companys auction
rate securities could change significantly based on market conditions and continued uncertainties
in the credit markets. If these uncertainties continue or if these securities experience credit
rating downgrades, the Company may incur additional impairment on its auction rate securities. The
Company will continue to monitor the fair value of its auction rate securities and relevant market
conditions and may record additional impairment charges if future circumstances warrant such
charges.
9
The table below provides a reconciliation of auction rate securities assets measured at fair
value on a recurring basis which use Level 3 or significant unobservable inputs for the three and
six months ended June 30, 2008.
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements Using
|
|
|
|
Significant Unobservable Inputs
|
|
|
|
Three Months
|
|
|
Six Months
|
|
|
|
Ended
|
|
|
Ended
|
|
(in thousands)
|
|
June 30, 2008
|
|
|
June 30, 2008
|
|
Balance at March 31, 2008 and
December 31, 2007,
respectively
|
|
$
|
1,487
|
|
|
$
|
|
|
Transfers into Level
3
|
|
|
|
|
|
|
1,550
|
|
Total losses realized included in
earnings
|
|
|
|
|
|
|
(63
|
)
|
Sales/Redemptions
|
|
|
(525
|
)
|
|
|
(525
|
)
|
|
|
|
|
|
|
|
Balance at June 30,
2008
|
|
$
|
962
|
|
|
$
|
962
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The total amount of gains or losses
for the period included in earnings
attributable to the change in
unrealized gains or losses relating
to assets still held at the
reporting date
|
|
$
|
|
|
|
$
|
(63
|
)
|
|
|
|
|
|
|
|
4. Inventory
Inventory consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
|
December 31,
|
|
(in thousands)
|
|
2008
|
|
|
2007
|
|
|
|
|
|
|
|
|
|
|
Raw materials
|
|
$
|
2,241
|
|
|
$
|
974
|
|
Work-in-process
|
|
|
504
|
|
|
|
642
|
|
Finished goods
|
|
|
1,062
|
|
|
|
730
|
|
|
|
|
|
|
|
|
Total inventory
|
|
$
|
3,807
|
|
|
$
|
2,346
|
|
|
|
|
|
|
|
|
5. Commitments and Contingencies
IBM License Agreement
In March 2006, the Company entered into an agreement with International Business Machines
Corporation (IBM) to license, in the Companys field of business, IBMs patent portfolio in
exchange for a payment of $2 million upon execution of the agreement and a deferred payment of
$4 million payable upon a change of control, as defined in the agreement (including, but not
limited to, an initial public offering of the Companys common stock) (the Deferred License Fee).
Upon completion of the Companys IPO in February 2008, the Company paid the $4 million Deferred
License Fee due to IBM.
Contingencies
In November 2007, the Company received a letter from counsel to SensAble Technologies, Inc.
(SensAble), a licensor to the Company, alleging that the Company infringed certain of its patents
and breached a confidentiality provision in the license agreement between SensAble and the Company
dated May 2006 (the SensAble License Agreement). In the letter, SensAble alleged, among other
things, that the Company exceeded the scope of its licensed field of computer-assisted surgery by
using its technology for, among other things, pre-operative planning and post-operative follow-up.
SensAble also alleged that the Companys TGS infringed one or more claims in five U.S. patents that
are not among the patents licensed to the Company pursuant to the SensAble License Agreement.
The Company investigated SensAbles allegations, and, based on the opinion of external
counsel, it believes that if SensAble initiates a lawsuit against the Company, a court should find
that its TGS does not infringe any of the SensAble patents identified in the November 2007 letter.
The Company communicated its belief to SensAble. SensAble has not commenced any legal action
against the Company, but may do so in the future. The letter from counsel to SensAble stated that
unless the Company, among other things, ceases and desists from alleged
infringement of SensAbles patents or pays additional licensing fees, including a proposed
licensing fee of $30 million for additional patents not included in the SensAble License Agreement,
SensAble intends to bring a lawsuit against the Company. The Company intends to vigorously defend
itself against these allegations in the event of a lawsuit. The Company cannot predict the outcome
of this matter at this time.
10
The Company has been a party to other legal contingencies or claims arising in the normal
course of business, none of which the Company believes is material to its financial position,
results of operations or cash flows.
6. Redeemable Convertible Preferred Stock and Stockholders Equity (Deficit)
Redeemable Convertible Preferred Stock
As of June 30, 2008, the Company was authorized to issue 27,000,000 shares of $0.001 par value
preferred stock. As of June 30, 2008, there were no shares of preferred stock issued or
outstanding. All shares of Series A, Series B and Series C redeemable convertible preferred stock
that were issued and outstanding as of December 31, 2007 converted into 10,945,080 shares of common
stock upon closing of the Companys IPO in February 2008.
Common Stock
As of June 30, 2008, the Company was authorized to issue 135,000,000 shares of $0.001 par
value common stock. As of December 31, 2007, the Company was authorized to issue 60,000,000 shares
of $0.001 par value common stock. Common stockholders are entitled to dividends as and if declared
by the Board of Directors, subject to the rights of holders of all classes of stock outstanding
having priority rights as to dividends. There have been no dividends declared to date. The holder
of each share of common stock is entitled to one vote.
In December 2004, the Company issued 189,768 shares of restricted common stock to certain
consultants (the Consultant Restricted Stock). The Consultant Restricted Stock vested in tranches
upon the Companys achievement of certain business milestones and any unvested restricted stock
vested immediately upon completion of an initial public offering of common stock. Upon vesting, the
Company recorded a consulting expense equal to the estimated fair value of the Companys common
stock on the date of vesting. As of January 1, 2008, 94,884 shares of the Consultant Restricted
Stock were unvested. Upon closing of the IPO in February 2008, the vesting of the remaining 94,884
shares of Consultant Restricted Stock was accelerated and the Company recognized $949,000 of
compensation expense associated with the accelerated vesting of the Consultant Restricted Stock
during the six months ended June 30, 2008 based on the IPO price of $10.00 per share.
Comprehensive Loss
Comprehensive loss is defined as the change in equity from transactions and other events and
circumstances other than those resulting from investments by owners and distributions to owners.
For the three months ended June 30, 2008 and 2007, the Company recorded comprehensive losses of
approximately $7,565,000 and $4,009,000, respectively. For the six months ended June 30, 2008 and
2007, the Company recorded comprehensive losses of approximately $16,063,000 and $7,517,000,
respectively.
Stock Option Plans and Stock-Based Compensation
The Company recognizes compensation expense for its stock-based awards in accordance with
SFAS No. 123 Revised,
Share-Based Payment
(SFAS 123(R)). SFAS 123(R) requires the recognition of
compensation expense, using a fair-value based method, for costs related to all stock-based
payments including stock options. SFAS 123(R) requires companies to estimate the fair value of
stock-based payment awards on the date of grant using an option-pricing model.
11
During the three months ended June 30, 2008 and 2007, stock-based compensation expense was
$586,000 and $76,000, respectively. Included within stock-based compensation expense for the three
months ended June
30, 2008 were $359,000 related to stock option grants and $227,000 related to the partial
vesting of 741,075 shares of restricted stock granted to the Companys CEO at various dates from
2005 through 2007. During the six months ended June 30, 2008 and 2007, stock-based compensation
expense was $2,059,000 and $149,000, respectively. Included within stock-based compensation expense
for the six months ended June 30, 2008 were $656,000 related to stock option grants, $454,000
related to the partial vesting of 741,075 shares of restricted stock granted to the Companys CEO
at various dates from 2005 through 2007, and $949,000 related to the vesting of the Consultant
Restricted Stock.
The Companys 2004 Stock Incentive Plan (the 2004 Plan) is described in the Form 10-K. In
January 2008, the Companys Board of Directors and stockholders approved the MAKO Surgical Corp.
2008 Omnibus Incentive Plan (the 2008 Omnibus Incentive Plan, and together with the 2004 Plan,
the Plans). The 2008 Omnibus Incentive Plan became effective upon the closing of the IPO and will
expire January 9, 2018 unless earlier terminated by the Board of Directors. The aggregate number of
shares of the Companys common stock that may be issued initially pursuant to stock awards under
the 2008 Omnibus Incentive Plan is 1,084,703 shares, which includes approximately 85,000 shares
previously reserved but unallocated under the 2004 Plan. Awards under the 2008 Omnibus Incentive
Plan may be made in the form of: stock options, which may be either incentive stock options or
non-qualified stock options; stock appreciation rights; restricted stock; restricted stock units;
dividend equivalent rights; performance shares; performance units; cash-based awards; other
stock-based awards, including unrestricted shares; and any combination of the foregoing.
Generally, the Companys outstanding stock options vest over four years. However, certain
stock options granted in 2004 vested on the date of grant. Stock options granted to certain
non-employee directors generally vest over three years. Continued vesting typically terminates when
the employment or consulting relationship ends. Vesting generally begins on the date of grant;
however, certain stock options granted in 2007 begin vesting upon the achievement of performance
conditions.
Under the terms of the Plans, the maximum term of options intended to be incentive stock
options granted to persons who own at least 10% of the voting power of all outstanding stock on the
date of grant is 5 years. The maximum term of all other options is 10 years.
Activity under the Plans is summarized as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding Options
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
|
Shares/Options
|
|
|
|
|
|
|
Average
|
|
|
|
Available
|
|
|
Number of
|
|
|
Exercise
|
|
(in thousands, except per share data)
|
|
For Grant
|
|
|
Options
|
|
|
Price
|
|
Balance at December 31, 2007
|
|
|
85
|
|
|
|
1,917
|
|
|
$
|
4.81
|
|
Shares reserved
|
|
|
1,000
|
|
|
|
|
|
|
$
|
|
|
Options granted
|
|
|
(323
|
)
|
|
|
323
|
|
|
$
|
8.87
|
|
Options exercised
|
|
|
|
|
|
|
(39
|
)
|
|
$
|
0.76
|
|
Options forfeited
|
|
|
10
|
|
|
|
(10
|
)
|
|
$
|
7.51
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2008
|
|
|
772
|
|
|
|
2,191
|
|
|
$
|
5.55
|
|
|
|
|
|
|
|
|
|
|
|
|
Included in the 2008 stock option grants in the table above are 198,019 incentive stock
options the Company granted to its CEO upon the completion of its IPO in February 2008.
As of June 30, 2008, there was total unrecognized compensation cost of approximately
$4,907,000, adjusted for estimated forfeitures, related to non-vested stock-based payments granted
to the Companys employees and non-employee directors. Total unrecognized compensation cost will be
adjusted for future changes in estimated forfeitures, and is expected to be recognized over a
remaining weighted average period of 2.47 years as of June 30, 2008.
12
The estimated grant date fair values of the stock option grants were calculated using the
Black-Scholes-Merton valuation model, based on the following assumptions:
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|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30,
|
|
|
|
2008
|
|
|
2007
|
|
Risk-free interest rate
|
|
|
3.44% 3.54
|
%
|
|
|
4.51% 4.96
|
%
|
Expected life
|
|
6.25 years
|
|
|
6.25 years
|
|
Expected dividends
|
|
|
|
|
|
|
|
|
Expected volatility
|
|
|
56.49% 56.78
|
%
|
|
|
57.10% 60.00
|
%
|
Employee Stock Purchase Plan
In January 2008, the Companys Board of Directors and stockholders approved the MAKO Surgical
Corp. 2008 Employee Stock Purchase Plan (the 2008 Employee Stock Purchase Plan). The 2008
Employee Stock Purchase Plan became effective upon closing of the IPO. The 2008 Employee Stock
Purchase Plan authorizes the issuance of 625,000 shares of the Companys common stock for purchase
by eligible employees of the Company or any of its participating affiliates. The shares of common
stock issuable under the 2008 Employee Stock Purchase Plan may be authorized but unissued shares,
treasury shares or shares purchased on the open market. The purchase price for an offering period
may not be less than 85% of the fair market value of the Companys common stock on the first
trading day of the offering period or the day on which the shares are purchased, whichever is
lower. No shares were issued under the 2008 Employee Stock Purchase Plan during the six months
ended June 30, 2008; however, the Company anticipates offering shares under the 2008 Employee Stock
Purchase Plan by the end of 2008.
Warrants
In December 2004, the Company issued warrants to purchase 462,716 shares of common stock at a
purchase price of $0.03 per share. The warrants are immediately exercisable at an exercise price of
$3.00 per share (after giving effect to the one for 3.03 reverse split of the Companys common
stock), and expire in December 2014. As of June 30, 2008, all the warrants were outstanding and
exercisable and none had been exercised.
7. Income Taxes
The Company accounts for income taxes under SFAS No. 109,
Accounting for Income
Taxes
. Deferred income taxes and liabilities are determined based upon differences between
financial reporting and tax bases of assets and liabilities and are measured using the enacted tax
rates and laws that will be in effect when the differences are expected to reverse.
Due to uncertainty surrounding realization of the deferred income tax assets in future
periods, the Company has recorded a 100% valuation allowance against its net deferred income tax
assets. If it is determined in the future that it is more likely than not that the deferred income
tax assets are realizable, the valuation allowance will be reduced.
In July 2006, the FASB issued Interpretation No. 48 (FIN 48),
Accounting for Uncertainty in
Income Taxes
. FIN 48 clarifies the accounting for uncertainty in income taxes by prescribing the
recognition threshold a tax position is required to meet before being recognized in the financial
statements. It also provides guidance on derecognition, classification, interest and penalties,
accounting in interim periods, disclosure and transition. The Company adopted the provisions of
FIN 48 effective January 1, 2007. The adoption of this statement did not result in a cumulative
accounting adjustment and did not impact the Companys financial position, results of operations or
cash flows. In accordance with FIN 48, paragraph 19, the Company has decided to classify any
interest and penalties as a component of tax expense. As of June 30, 2008, the Company had no
unrecognized tax benefits. To date, there have been no interest or penalties charged to the Company
in relation to the underpayment of income taxes. The Company files federal and state income tax
returns in several jurisdictions in the United
States. The tax years from 2004 through 2007 remain open and are subject to examination by the
appropriate governmental agencies.
13
Item 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
In this report, MAKO Surgical, MAKO, the Company, we, us and our refer to MAKO
Surgical Corp.
The following discussion and analysis of our financial condition and results of operations
should be read together with our condensed financial statements and related notes appearing
elsewhere in this report. This report contains forward-looking statements regarding, among other
things, statements related to expectations, goals, plans, objectives and future events. We intend
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, you can identify forward-looking statements 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. Examples of such statements include, but are not limited to,
statements about the timing and number of planned new product introductions, market acceptance of
the MAKOplasty solution, the future availability of implants and components of our Tactile Guidance
System, or TGS, from third-party suppliers, including single-source suppliers, the anticipated
adequacy of our capital resources to meet the needs of our business, our ability to sustain, and
our goals for, sales and earnings growth and our success in achieving timely approval or clearance
of products with domestic and foreign regulatory entities. These statements are based on the
current estimates and assumptions of our management as of the date of this report 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 our ability to control or predict. Such factors, among others, may have a material
adverse effect on our business, financial condition and results of operations and may include
changes in competitive conditions and prices in our markets, decreases in sales of our principal
product lines, increases in expenditures related to increased governmental regulation of our
business, loss of key management and other personnel or inability to attract such management and
other personnel, unanticipated intellectual property expenditures required to develop and market
our products and unanticipated issues in securing regulatory clearance or approvals for upgrades or
changes to our products. These and other risks are described in greater detail under Item 1A, Risk
Factors, contained in our annual report on Form 10-K, or Form 10-K, filed with the Securities and
Exchange Commission, or SEC, on March 31, 2008. Given these uncertainties, you should not place
undue reliance on these forward-looking statements. We do not undertake any obligation to release
any revisions to these forward-looking statements publicly to reflect events or circumstances in
the future, even if new information becomes available.
MAKOplasty
®
, Tactile Guidance System and TGS, as well as the MAKO logo, whether
standing alone or in connection with the words MAKO Surgical Corp. are trademarks of MAKO
Surgical Corp.
Overview
We are a medical device company that markets our advanced robotic-arm solution and orthopedic
implants for minimally invasive orthopedic knee procedures. We offer MAKOplasty, an innovative,
restorative surgical solution that enables orthopedic surgeons to consistently, reproducibly and
precisely treat patient-specific, early to mid-stage osteoarthritic knee disease. In February 2008,
our common stock began trading on The NASDAQ Global Market under the ticker symbol MAKO and we
closed our initial public offering, or IPO.
Through June 30, 2008, our revenue was primarily generated from the sale of our implants and
disposable products utilized in MAKOplasty procedures. In accordance with our revenue recognition
policy, upon customer acceptance of the sale of our TGS, we defer recognition of the related
revenue and cost of revenue until delivery of version 2.0 of the TGS, which is anticipated in the
first half of 2009, subject to regulatory clearances or approvals. We have incurred net losses in
each year since our inception and, as of June 30, 2008, we had an accumulated deficit of
$59.2 million. We expect to continue to incur significant operating losses as we increase our sales
and marketing activities and otherwise continue to invest capital in the development and expansion
of our products and our business generally. We also expect that our general and administrative
expenses will
increase due to additional operational and regulatory costs and burdens associated with
operating as a public company and due to the rapid expansion of our operations.
14
Recent key milestones and goals in the development of our business through June 30, 2008
include the following:
|
In January 2008, we obtained 510(k) marketing clearance from the FDA for version 1.2 of
our TGS and commercially launched version 1.2 of our TGS in the first quarter of 2008.
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|
|
In February 2008, we completed the IPO of our common stock, issuing a total of 5.1
million shares at an issue price of $10.00 per share, resulting in net proceeds to the Company
of approximately $43.7 million, after underwriting discounts and commissions of $3.6 million
and expenses of approximately $3.7 million.
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|
|
We are finalizing development of a TGS software application to enable a single
MAKO-branded unicompartmental implant system, combining our inlay and onlay system. We expect
to commercially introduce this software version 1.3 of our TGS and the MAKO-branded implant by
the end of 2008. We have received a 510(k) clearance for the MAKO-branded implant, and we do
not anticipate that TGS version 1.3 will require a 510(k) clearance. The functionality to
support the use of the MAKO-branded implant with the TGS was included and cleared as part of
version 1.2 of our TGS.
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|
|
We are currently developing version 2.0 of our TGS and our modular bicompartmental knee
implant system, which would enable both unicompartmental and bicompartmental knee resurfacing
procedures. We anticipate that we will commercially introduce version 2.0 of the TGS and the
bicompartmental implant system in the first half of 2009, subject to regulatory clearances or
approvals. If we were to be denied such clearances or approvals, if such clearances or
approvals were delayed or if the required development is unsuccessful or delayed, it could have
a material adverse impact on our results of operations.
|
|
|
In the second quarter of 2008, we filed a 510(k) submission with the FDA for version 2.0
of our TGS. We also received a 510(k) clearance for our unicompartmental implant and a 510(k)
clearance for our patellofemoral implant, components of the intended bicompartmental implant
system.
|
We believe that the key to growing our business is expanding the application of MAKOplasty to
bicompartmental resurfacing procedures by offering implants that address mid-stage, bicompartmental
degeneration. To successfully commercialize our products and grow our business, we must gain market
acceptance for MAKOplasty.
Factors Which May Influence Future Results of Operations
The following is a description of factors which may influence our future results of
operations, including significant trends and challenges that we believe are important to
understanding our business and results of operations.
Revenue
Revenue is generated from unit sales of our TGS, including installation services, training and
upgrades and enhancements, from sales of implants and disposable products, and by providing
extended warranty services. To date, we have generated revenue primarily from the sale of implants
and disposable products utilized in MAKOplasty procedures, the majority of which was from several
significant customers. Recognition of revenue associated with the sale of TGS units in our
statements of operations is dependent upon satisfying all related revenue recognition criteria,
which include the delivery of version 2.0 of the TGS, which is anticipated to be in the first half
of 2009, subject to regulatory clearances or approvals, as more fully described in Item 1,
Financial Statements, Note 2 to the Condensed Financial Statements.
15
Future revenue from sales of our products is difficult to predict and we expect that it will
only modestly reduce our continuing and increasing losses resulting from selling, general and
administrative expenses, research and development and other activities for the next several years.
The generation of recurring revenue through sales of our implants, disposable products and
service contracts are an important part of the MAKOplasty business model. We anticipate that
recurring revenue will constitute an increasing percentage of our total revenue as we leverage each
new installation of our TGS to generate recurring sales of implants and disposable products and as
we expand our implant product offering.
Cost of Revenue
Cost of revenue primarily consists of the direct costs associated with the manufacture of TGS
units, implants and disposable products for which revenue has been recognized in accordance with
our revenue recognition policy. Costs associated with providing services are expensed as incurred.
Cost of revenue also includes the cost associated with establishing at the time of installation an
accrual for the TGS standard one-year warranty liability and royalties related to the sale of
products covered by licensing arrangements.
The cost of revenue associated with the sale of TGS units is deferred until the recognition of
the related revenue. In addition, we expect that deferred costs of revenue associated with the sale
of TGS will be higher during the deferral period due to the additional costs associated with
providing hardware enhancements and upgrades through and including the anticipated delivery of
version 2.0 of our TGS.
The Company is developing a single MAKO-branded unicompartmental implant system which is
expected to launch by the end of 2008. In conjunction with the launch of the new implant system,
the Company anticipates discontinuing portions of its current implant line. Depending on the
timing of the launch, which is dependant on supply chain and launch strategy, a future write-off of
the discontinued implant inventory is possible. Currently, the Company cannot reasonably estimate
the amount of the charge, if any, relating to the potential write-off of such inventory; however,
depending on the timing of the launch of the new implant system, a charge of up to $600,000 may be
required. No write-off was recorded as of June 30, 2008.
Selling, General and Administrative Expenses
Our selling, general and administrative expenses consist primarily of compensation, including
stock-based compensation, for sales, marketing, operations, regulatory, quality, executive,
finance, legal and administrative personnel. Other significant expenses include costs associated
with sales and marketing activities, marketing and advertising materials, professional fees for
legal and accounting services, consulting fees, travel expenses, facility and related operating
costs, and recruiting expenses. Our selling, general and administrative expenses are expected to
continue to increase due to the cost associated with the expected commercial launch of version 2.0
of our TGS, our bicompartmental implant system and disposable products, an increased number of
employees necessary to support our continued growth in operations, and the additional operational
and regulatory burdens and costs associated with operating as a publicly traded company. In
addition, we are currently taking preliminary steps to investigate the feasibility of establishing
clinical sites outside the United States, which may also increase our selling, general and
administrative expenses, and we expect to incur additional costs associated with protecting our
intellectual property rights as necessary to support our future product offerings.
Research and Development Expenses
Costs related to research, design and development of products are charged to research and
development expense as incurred. These costs include direct salary costs for research and
development employees including stock-based compensation, cost for materials used in research and
development activities and costs for outside services. Research and development expenses are
expected to continue to increase as we develop version 2.0 of our TGS and our bicompartmental
implant system.
16
Critical Accounting Policies
A summary of our critical accounting policies is included in our Form 10-K, Item 7,
Managements Discussion and Analysis of Financial Condition and Results of Operations. There have
been no changes to those policies for the six months ended June 30, 2008.
Results of Operations
Comparison of the Three Months Ended June 30, 2008 to the Three Months Ended June 30, 2007
Revenue.
Revenue was $704,000 for the three months ended June 30, 2008, compared to $106,000
for the three months ended June 30, 2007, and was primarily generated from the sale of implants and
disposable products utilized in MAKOplasty procedures. The increase in revenue of $598,000 was
primarily due to an increase in MAKOplasty procedures performed during the three months ended June
30, 2008 as compared with the three months ended June 30, 2007. There were 140 procedures performed
during the three months ended June 30, 2008 compared to 21 procedures performed during the three
months ended June 30, 2007. The increase was also attributable to a $116,000 increase in other
revenue, which consists primarily of service revenue on extended warranty services and net royalty
revenue. We expect our revenue to increase as the number of MAKOplasty procedures performed
increases in future periods. The deferred revenue balance was $6.5 million and $696,000 as of June
30, 2008 and 2007, respectively. The deferred revenue balance primarily consisted of the deferred
revenue associated with the sale of ten and one unit sales of our TGS, as of June 30, 2008 and
2007, respectively. Deferred revenue related to unit sales of our TGS will be recognized in our
statement of operations if and when we have satisfied all related revenue recognition criteria. The
criteria include the delivery of version 2.0 of the TGS, which is anticipated to be in the first
half of 2009, subject to regulatory clearances or approvals.
Cost of Revenue.
Cost of revenue was $480,000 for the three months ended June 30, 2008,
compared to $47,000 for the three months ended June 30, 2007. The increase in cost of revenue of
$433,000 was primarily due to an increase in MAKOplasty procedures performed, the establishment of
warranty accruals on sales of TGS units and royalties incurred on sales of TGS units during the
three months ended June 30, 2008. We expect our cost of revenue to increase as the number of
MAKOplasty procedures performed increases in future periods. In addition, anticipated increases in
sales of our TGS units will result in an increase in royalty and warranty expense. The deferred
cost of revenue balance was $2.2 million and $212,000 as of June 30, 2008 and 2007, respectively.
The increase in the deferred cost of revenue balance is primarily related to unit sales of our TGS
during 2008 and 2007. Deferred cost of revenue related to unit sales of our TGS will be recognized
in our statement of operations if and when we have satisfied all related revenue recognition
criteria. The criteria include the delivery of version 2.0 of the TGS, which is anticipated to be
in the first half of 2009, subject to regulatory clearances or approvals.
Selling, General and Administrative.
Selling, general and administrative expense was
$5.1 million for the three months ended June 30, 2008, compared to $2.4 million for the three
months ended June 30, 2007. The increase of $2.7 million, or 116%, 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 growth and costs associated with
operating as a public company. Selling, general and administrative expense for the second quarter
of 2008 also included $484,000 of stock-based compensation expense compared with $53,000 for the
comparable quarter of 2007. The increase in stock-based compensation expense was primarily due to
additional option and restricted stock grants made in 2008 and 2007. We expect our selling, general
and administrative expense to continue to increase substantially due to our planned increase in the
number of employees necessary to support the sales and marketing efforts associated with the
growing commercialization of MAKOplasty, the anticipated commercial launch of version 2.0 of our
TGS in the first half of 2009, continued growth in operations and the costs associated with
operating as a public company.
Research and Development.
Research and development expense was $2.5 million for the three
months ended June 30, 2008, compared to $1.6 million for the three months ended June 30, 2007. The
increase of $841,000, or 51%, was primarily due to an increase in research and development
activities associated with on-going development of versions 1.2 and 2.0 of our TGS and the MAKO
implant systems. We expect our research
and development expense to continue to increase as we continue to expand our research and
development activities, including the development of version 2.0 of our TGS and our implant
systems.
17
Depreciation and Amortization.
Depreciation and amortization expense was $425,000 for the
three months ended June 30, 2008, compared to $301,000 for the three months ended June 30, 2007.
The increase of $124,000, or 41%, was primarily due to an increase in depreciation of property and
equipment as a result of purchases made during 2008 and 2007.
Interest and Other Income.
Interest income was $241,000 for the three months ended June 30,
2008, compared to $316,000 for the three months ended June 30, 2007. The decrease of $75,000, or
24%, was primarily due to lower yields realized on our cash, cash equivalents and investments for
the three months ended June 30, 2008 compared with the same period of 2007.
Interest and Other Expenses.
Interest and other expenses were $1,000 for the three months
ended June 30, 2008, compared to $76,000 for the three months ended June 30, 2007. Through February
2008, interest and other expense consisted primarily of the amortization of the $590,000 discount
associated with a deferred payment to IBM of $4.0 million which had been fully amortized and paid
upon the completion of our IPO in February 2008.
Income Taxes.
No income taxes were recognized for the three months ended June 30, 2008 and
2007, due to net operating losses in each period. In addition, no current or deferred income taxes
were recorded for the three months ended June 30, 2008 and 2007, as all income tax benefits were
fully offset by a valuation allowance against our net deferred income tax assets.
Comparison of the Six Months Ended June 30, 2008 to the Six Months Ended June 30, 2007
Revenue.
Revenue was $1.2 million for the six months ended June 30, 2008, compared to
$206,000 for the six months ended June 30, 2007, and was primarily generated from the sale of
implants and disposable products utilized in MAKOplasty procedures. The increase in revenue of
$995,000 was primarily due to an increase in MAKOplasty procedures performed during the six months
ended June 30, 2008. There were 242 procedures performed during the six months ended June 30, 2008
compared to 42 procedures performed during the six months ended June 30, 2007. The increase was
also attributable to a $194,000 increase in other revenue, which consists primarily of service
revenue on extended warranty services and net royalty revenues.
Cost of Revenue.
Cost of revenue was $851,000 for the six months ended June 30, 2008,
compared to $83,000 for the six months ended June 30, 2007. The increase in cost of revenue of
$768,000 was primarily due to an increase in MAKOplasty procedures performed, the establishment of
warranty accruals on sales of TGS units and royalties incurred on sales of TGS units during the six
months ended June 30, 2008.
Selling, General and Administrative.
Selling, general and administrative expense was
$9.8 million for the six months ended June 30, 2008, compared to $4.3 million for the six months
ended June 30, 2007. The increase of $5.5 million, or 127%, 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 growth and costs associated with operating
as a public company. Selling, general and administrative expense for the six months ended June 30,
2008 also included $908,000 of stock-based compensation expense compared with $110,000 for the same
period of 2007. The increase in stock-based compensation expense was primarily due to additional
option and restricted stock grants made in 2008 and 2007.
Research and Development.
Research and development expense was $6.1 million for the six
months ended June 30, 2008, compared to $3.2 million for the six months ended June 30, 2007. The
increase of $2.9 million, or 93%, was primarily due to an increase in research and development
activities associated with on-going development of versions 1.2 and 2.0 of our TGS and the MAKO
implant systems; and a nonrecurring charge of $949,000 associated with the vesting in full, upon
completion of our IPO in February 2008, of restricted common stock issued pursuant to business
consultation agreements entered into in December 2004.
18
Depreciation and Amortization.
Depreciation and amortization expense was $847,000 for the six
months ended June 30, 2008, compared to $571,000 for the six months ended June 30, 2007. The
increase of $276,000, or 48%, was primarily due to an increase in depreciation of property and
equipment as a result of purchases made during 2008 and 2007.
Interest and Other Income.
Interest income was $401,000 for the six months ended June 30,
2008, compared to $552,000 for the six months ended June 30, 2007. The decrease of $151,000, or
27%, was primarily due to lower yields realized on our cash, cash equivalents and investments for
the six months ended June 30, 2008 compared with the same period of 2007.
Interest and Other Expenses.
Interest and other expenses were $109,000 for the six months
ended June 30, 2008, compared to $152,000 for the six months ended June 30, 2007. Through February
2008, interest and other expense consisted primarily of the amortization of the $590,000 discount
associated with a deferred payment to IBM of $4.0 million which had been fully amortized and paid
upon the completion of our IPO in February 2008. Interest and other expense also included the write
down of our variable auction rate securities in the first quarter of 2008 as discussed below under
the caption, Liquidity and Capital Resources, and in Item 1, Financial Statements, Note 3,
Short-Term and Long-Term Investments
.
Income Taxes.
No income taxes were recognized for the six months ended June 30, 2008 and
2007, due to net operating losses in each period. In addition, no current or deferred income taxes
were recorded for the six months ended June 30, 2008 and 2007, as all income tax benefits were
fully offset by a valuation allowance against our net deferred income tax assets.
Liquidity and Capital Resources
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30,
|
|
(in thousands)
|
|
2008
|
|
|
2007
|
|
Cash used in operating activities
|
|
$
|
(13,929
|
)
|
|
$
|
(7,357
|
)
|
Cash used in investing activities
|
|
|
(4,098
|
)
|
|
|
(10,149
|
)
|
Cash provided by financing activities
|
|
|
46,487
|
|
|
|
29,918
|
|
|
|
|
|
|
|
|
Net increase in cash and cash equivalents
|
|
$
|
28,460
|
|
|
$
|
12,412
|
|
|
|
|
|
|
|
|
We have incurred net losses and negative cash flow from operating activities for each period
since our inception in November 2004. As of June 30, 2008, we had an accumulated deficit of
$59.2 million and financed our operations principally through the sale of Series A, Series B and
Series C redeemable convertible preferred stock and the completion of the IPO of our common stock.
Through June 30, 2008, we received net proceeds of $52.2 million from the issuance of Series A,
Series B and Series C redeemable convertible preferred stock. In February 2008, we completed our
IPO of common stock, issuing a total of 5.1 million shares at an issue price of $10.00 per share,
resulting in net proceeds to us, after expenses, of approximately $43.7 million. In conjunction
with the closing of the IPO, in February 2008, all of our outstanding Series A, Series B and
Series C redeemable convertible preferred stock was converted into 10,945,080 shares of common
stock, as adjusted for a one-for-3.03 reverse stock split, which has been retroactively reflected
in the accompanying condensed financial statements.
As of June 30, 2008, we had approximately $39.1 million in cash, cash equivalents and
short-term investments. Our cash and short-term investment balances are held in a variety of
interest bearing instruments, including U.S. treasury bills and certificates of deposit.
As of June 30, 2008, we held $1,025,000 par value of variable auction rate securities issued
by two separate funds. In February 2008, the auction rate securities experienced failed auctions
that limited the liquidity of these securities. Based on current market conditions, it is likely
that auction failures will continue. The carrying value of the securities are fully collateralized
by assets held by the funds and were rated AAA prior to the failed auctions of the securities.
Historically the fair value of auction rate securities approximated par value due to the frequent
resets through the auction rate process. The continued uncertainty in the credit markets has
affected our holdings in auction rate securities, however, and the liquidity and fair value of
these investments has been negatively impacted. As a result, the estimated fair value of many of
these investments no longer approximate par value. As of June 30, 2008, the carrying value of the
Companys auction rate securities was $962,000, which
approximates the estimated fair value as of that date. An other-than-temporary impairment
charge of $63,000 was recorded to reduce the value of our auction rate securities to the new fair
value. In addition, as a result of the unresolved liquidity concerns, we reclassified our auction
rate securities from short-term investments to long-term investments.
19
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, stock-based compensation and accrued
interest; and was also affected by changes in operating assets and liabilities. Included in the
changes in operating assets for the six months ended June 30, 2008 are approximately $3.2 million
of increases to the deferred revenue balance, partially offset by approximately $1.2 million of
increases to the deferred cost of revenue balance. No significant change to the deferred revenue
and deferred cost of revenue balances occurred during the same period of 2007. The increases to the
deferred revenue and deferred cost of revenue balances are primarily related to unit sales of our
TGS. Deferred revenue and deferred cost of revenue related to unit sales of our TGS will be
recognized in the statements of operations upon satisfaction of all related revenue recognition
criteria.
Net Cash Used in Investing Activities
Net cash used in investing activities for the six months ended June 30, 2008 is primarily
attributable to the payment of the $4.0 million deferred license fee due to IBM upon completion of
our IPO, as discussed under the caption Contractual Obligations, to purchases of $1.2 million of
property and equipment as we invest in the infrastructure of our growing company and to $2.0
million of purchases of investments, which was partially offset by proceeds of $3.1 million from
sales and maturities of investments. Net cash used in investing activities for the six months ended
June 30, 2007 is primarily attributable to the purchases and proceeds of investments as we manage
our investment portfolio to provide interest income and liquidity. Investing activities for the six
months ended June 30, 2007 were also reduced by the purchase of property and equipment and
acquisition of intangible assets.
Net Cash Provided by Financing Activities
Net cash provided by our financing activities for the six months ended June 30, 2008 and 2007
was primarily attributable to net proceeds received in connection with our IPO in February 2008 and
the issuance of Series C redeemable convertible preferred stock in February 2007, respectively.
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 several years as we expand our sales and marketing
capabilities in the orthopedic products market, develop version 2.0 of our TGS and our
bicompartmental implant system and continue to develop the corporate infrastructure required to
sell and market our products and operate as a public company. We also expect to experience
increased cash requirements for inventory and property and equipment in conjunction with the
anticipated commercial launch of version 2.0 of our TGS and bicompartmental implant system in the
first half of 2009, subject to regulatory clearances or approvals.
We believe our existing cash, cash equivalents and short-term investment balances, and
interest income we earn on these balances will be sufficient to meet our anticipated cash
requirements for approximately the next 12 months. To the extent our available cash, cash
equivalents and short-term investment balances are insufficient to satisfy our operating
requirements after that period, we will need to seek additional sources of funds, including selling
additional equity or debt securities or entering into a credit facility. The sale of additional
equity and 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.
Although we currently have no firm agreements or arrangements with respect to any additional
financing, we anticipate requiring additional capital to fund our future operations. Any such
required additional capital 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.
20
We are in the process of developing version 2.0 of our TGS. If completion of version 2.0 of
our TGS unit is unsuccessful or delayed, or regulatory clearances or approvals are denied or
delayed, it could have a material adverse impact on our results of operations and financial
position and we may be unable to recognize any revenue associated with sales of our TGS. No right
of return exists on sales of prior versions of our TGS if we are unable to complete and deliver
version 2.0 of our TGS as anticipated.
Because of the numerous risks and uncertainties associated with the development of medical
devices, such as version 2.0 of our TGS and bicompartmental implant system, we are unable to
estimate the exact amounts of capital outlays and operating expenditures necessary to complete the
development of the 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;
|
|
|
|
|
the costs and timing of regulatory clearance or approvals for upgrades or changes to our
products;
|
|
|
|
|
the rate of progress and cost of on-going development activities;
|
|
|
|
|
the success of our on-going research and development efforts;
|
|
|
|
|
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; and
|
|
|
|
|
the acquisition of businesses, products and technologies, although we currently have no
understandings, commitments or agreements relating to any material transaction of this type.
|
Contractual Obligations
In March 2006, we entered into a license agreement with IBM in exchange for a payment of
$2.0 million upon execution of the agreement and a payment of $4.0 million in the form of a
deferred license fee to IBM upon, among other things, the closing of the IPO of our common stock.
In February 2008, upon closing of our IPO, the Company paid the $4.0 million deferred license fee
due to IBM.
Other than as described above and scheduled payments through June 30, 2008, there have been no
significant changes in our contractual obligations during the six months ended June 30, 2008 as
compared to the contractual obligations described in our Form 10-K.
Recent Accounting Pronouncements
Effective January 1, 2008, we adopted SFAS No. 157,
Fair Value Measurements
, or SFAS 157. SFAS
157 defines fair value, provides a consistent framework for measuring fair value under accounting
principles generally accepted in the United States and expands fair value financial statement
disclosure requirements. SFAS 157 does not require any new fair value measurements. It only applies
to accounting pronouncements that already require or permit fair value measures, except for
standards that relate to share-based payments.
21
SFAS 157s valuation techniques are based on observable and unobservable inputs. Observable
inputs reflect readily obtainable data from independent sources, while unobservable inputs reflect
our market assumptions. SFAS 157 classifies these inputs into the following hierarchy:
|
|
|
Level 1 Inputs- Quoted prices for identical instruments in active markets.
|
|
|
|
|
Level 2 Inputs- Quoted prices for similar instruments in active markets; quoted prices
for identical or similar instruments in markets that are not active; and model-derived
valuations whose inputs are observable or whose significant value drivers are observable.
|
|
|
|
|
Level 3 Inputs- Instruments with primarily unobservable value drivers.
|
The adoption of SFAS 157 did not have a material impact on our results of operations and
financial condition.
Effective January 1, 2008, we adopted SFAS No. 159,
The Fair Value Option for Financial Assets
and Financial LiabilitiesIncluding an amendment of FASB Statement No. 115,
or SFAS 159, and have
not elected to use fair value measurement on any assets or liabilities under this statement. We
have determined that the adoption of SFAS 159 had no effect on our results of operations and
financial position.
Effective January 1, 2008, we adopted EITF Issue No. 07-03,
Accounting for Nonrefundable
Advance Payments for Goods or Services Received for Use in Future Research and Development
Activities
, or EITF 07-03. EITF 07-03 requires that nonrefundable advance payments for goods or
services that will be used or rendered for future research and development activities should be
deferred and capitalized. Such amounts should be recognized as an expense as the related goods are
delivered or the related services are performed. Entities should continue to evaluate whether they
expect the goods to be delivered or services to be rendered. If an entity does not expect the goods
to be delivered or services to be rendered, the capitalized advance payment should be charged to
expense. We have determined that the adoption of EITF 07-03 had no effect on our results of
operations and financial position.
Other than as described above, there have been no significant changes in Recent Accounting
Pronouncements during the six months ended June 30, 2008 as compared to the Recent Accounting
Pronouncements described in our Form 10-K.
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 and short-term
investments that have maturities or interest reset dates of less than one year. 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. The securities
in our investment portfolio are not leveraged, are classified as available for sale and are
generally short-term in nature. We currently do not hedge interest rate exposure. Because of the
short-term maturities of our investments, we do not believe that a variation in market rates would
have any material impact on the value of our investment portfolio.
22
As of June 30, 2008, we held $1,025,000 par value of variable auction rate securities issued
by two separate funds. In February 2008, the auction rate securities experienced failed auctions
that limited the liquidity of these securities. Based on current market conditions, it is likely
that auction failures will continue. The carrying value of the securities are fully collateralized
by assets held by the funds and were rated AAA prior to the failed auctions of the securities.
Historically the fair value of auction rate securities approximated par value due to the frequent
resets through the auction rate process. The continued uncertainty in the credit markets has
affected our holdings in auction rate securities, however, and the liquidity and fair value of
these investments has been negatively impacted. As a result, the estimated fair value of many of
these investments no longer approximate par
value. As of June 30, 2008, the carrying value of the Companys auction rate securities was
$962,000, which approximates the estimated fair value as of that date. An other-than-temporary
impairment charge of $63,000 was recorded to reduce the value of our auction rate securities to the
new fair value. In addition, as a result of the unresolved liquidity concerns, we reclassified our
auction rate securities from short-term investments to long-term investments.
Item 4T. 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 June
30, 2008. Based upon their evaluation of these disclosure controls and procedures, our Certifying
Officers concluded that the disclosure controls and procedures were effective as of June 30, 2008
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 SEC rules and forms, 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.
23
PART II
OTHER INFORMATION
Item 1. LEGAL PROCEEDINGS.
The information with respect to SensAble Technologies, Inc. set forth in Part I, Item 1,
Financial Statements, Note 5,
Commitments and Contingencies
, of this report is incorporated into
this item by this reference.
Item 1A. RISK FACTORS.
There have been no material changes in our risk factors from those disclosed in our Form 10-K.
Item 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.
Our IPO was effected through a registration statement on Form S-1 (File No. 333-146162) that
was declared effective by the SEC on February 14, 2008. We registered 5,100,000 shares of our
common stock with an aggregate offering price of $51 million, all of which shares we sold. The
offering was completed after the sale of all 5,100,000 shares. J.P. Morgan Securities Inc. and
Morgan Stanley & Co. Incorporated were the joint book-running managing underwriters of the IPO and
Cowen and Company and Wachovia Securities acted as co-managers. The underwriters elected not to
exercise their over-allotment option. We paid $3.6 million of the proceeds in underwriting
discounts and commissions and incurred an additional $3.7 million of expenses. None of the expenses
were paid, directly or indirectly, to directors, officers or persons owning 10% or more of our
common stock, or to our affiliates.
We currently intend to use the proceeds from the IPO, net of the payment of the $4.0 million
IBM deferred license fee and the underwriting discounts and commissions, as set forth below. See
Part I, Item 1, Financial Statements, Note 5,
Commitments and Contingencies
, and Item 2,
Managements Discussion and Analysis of Financial Condition and Results of Operations, of this
report for more information regarding payment of the IBM license fee.
|
|
|
Approximately $14.0 $20.0 million for the expansion of sales and marketing activities;
|
|
|
|
|
Approximately $12.0 $18.0 million for continuation of research and development
activities; and
|
|
|
|
|
The remainder to fund working capital and other general corporate purposes, including
the expenses associated with the IPO.
|
Management has broad discretion over the uses of the proceeds of the IPO. Except for payment
of the IBM deferred license fee, we did not use any material amount of the IPO proceeds during the
three months ended March 31, 2008. Since April 1, 2008, we have used approximately $3.5 million of
the proceeds for sales and marketing activities, $2.6 million for research and development
activities and $2.0 million for working capital and general corporate purposes. The remainder of
the IPO proceeds is invested in highly liquid, short-term, interest-bearing funds.
24
Item 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS.
We held our 2008 Annual Meeting of Stockholders on June 3, 2008 at our facility in Fort
Lauderdale, Florida. We submitted the following matters to a vote of our stockholders, with the
results of voting as follows:
Proposal 1 Election of two Class I directors, each to serve until the 2011 Annual Meeting of
Stockholders and until his successor is duly elected and qualified:
|
|
|
|
|
|
|
|
|
NOMINEE
|
|
FOR
|
|
|
WITHHELD
|
|
|
|
|
|
|
|
|
|
|
S. Morry Blumenfeld, Ph.D.
|
|
|
11,614,927
|
|
|
|
544,848
|
|
William D. Pruitt
|
|
|
11,615,027
|
|
|
|
544,748
|
|
Our other directors who were in office prior to the 2008 Annual Meeting of Stockholders and
with terms of office that continue after the meeting are Gerald A. Brunk, Marcelo G. Chao,
Christopher C. Dewey, Charles W. Federico, Maurice R. Ferré, M.D., and Frederic H. Moll, M.D.
Proposal 2 Ratification of the appointment of Ernst & Young LLP as our independent
registered public accounting firm for 2008:
|
|
|
|
|
|
|
|
|
FOR
|
|
AGAINST
|
|
|
ABSTAIN
|
|
12,156,114
|
|
|
2,861
|
|
|
|
800
|
|
Item 6. EXHIBITS.
|
|
|
Exhibit
|
|
|
No.
|
|
Description
|
|
|
|
3.1
|
|
Third Amended and Restated Certificate of Incorporation of the
Registrant, dated February 20, 2008 (1)
|
|
|
|
3.2
|
|
Third Amended and Restated Bylaws of the Registrant effective as of
February 20, 2008 (1)
|
|
|
|
4.1
|
|
Second Amended and Restated Registration Rights Agreement, dated
February 6, 2007, between the Registrant and certain of its
stockholders (2)
|
|
|
|
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 to18 U.S.C. §1350
|
|
|
|
32.2
|
|
Certification of Chief Financial Officer pursuant to18 U.S.C. §1350
|
|
|
|
(1)
|
|
Incorporated by reference to Registrants Annual Report on Form 10-K filed with the SEC
on March 31, 2008
|
|
(2)
|
|
Incorporated by reference to Registrants Registration Statement on Form S-1, as
amended, filed with the SEC on September 19, 2007
|
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: August 8, 2008
|
By:
|
/s/ Fritz L. LaPorte
|
|
|
|
Fritz L. LaPorte
|
|
|
|
Senior Vice President of Finance and
Administration,
Chief Financial Officer and
Treasurer
|
|
25
EXHIBIT INDEX
|
|
|
Exhibit
|
|
|
No.
|
|
Description
|
|
|
|
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 to18 U.S.C. §1350
|
|
|
|
32.2
|
|
Certification of Chief Financial Officer pursuant to18 U.S.C. §1350
|
26
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