Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE
COMMISSION
WASHINGTON,
DC 20549
FORM 10-Q
(Mark One)
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x
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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 quarterly period
ended September 30
, 2008
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o
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TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE EXCHANGE ACT
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For the transition period
from to
Commission file
number: 000-28882
WORLD
HEART CORPORATION
(Exact name of registrant as specified in its
charter)
Canada
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52-2247240
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(State
or other jurisdiction of incorporation or organization)
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(IRS
Employer Identification No.)
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7799 Pardee
Lane, Oakland, California, USA, 94621
(Address
of principal executive offices)
(510)
563-5000
(Registrants
telephone number)
(Former name, former address and
former fiscal year, if changed since last report)
N/A
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
x
No
o
Indicate by check mark
whether the Registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer, or a smaller reporting company. See the definitions of large
accelerated filer accelerated filer and smaller reporting company in Rule 12b-2
of the Exchange Act. :
Large accelerated filer
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o
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Accelerated Filer
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o
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Non-accelerated filer
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o
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Smaller reporting company
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x
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(Do not check if
a smaller reporting company)
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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
x
Indicate the number of shares outstanding of
each of the issuers classes of common stock, as of the latest practicable date
:
The number of common shares outstanding as of November 4,
2008 was 13,253,964.
Table of Contents
PART IFINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS.
WORLD HEART
CORPORATION
Condensed Consolidated Balance Sheets
(United States Dollars)
(Unaudited)
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September 30, 2008
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December 31, 2007 (1)
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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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23,876,240
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$
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664,504
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Trade and other receivables, net of
allowance for doubtful accounts of $239,178 at September 30, 2008 and
$265,845 at December 31, 2007
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223,255
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175,170
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Inventory, net of allowance for excess and
obsolete of $2,692,018 at September 30, 2008 and $2,336,733 at December 31,
2007
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51,349
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864,314
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Prepaid expenses
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302,649
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191,464
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24,453,493
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1,895,452
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Long-term assets
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Property and equipment, net of accumulated
depreciation of $2,935,887 at September 30, 2008 and $2,720,087 at December
31, 2007
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638,042
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808,383
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Intangible assets, net of accumulated
amortization of $609,897 at September 30, 2008 and $466,329 at December 31,
2007
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155,772
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299,340
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Other long-term assets
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156,889
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244,420
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950,703
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1,352,143
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Total assets
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$
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25,404,196
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$
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3,247,595
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LIABILITIES AND SHAREHOLDERS' EQUITY
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Current liabilities
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Accounts payable and accrued liabilities
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$
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1,151,508
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$
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1,938,531
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Accrued site restoration
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5,395
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31,000
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Accrued compensation
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520,811
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1,318,091
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Deferred revenue
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1,582
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50,618
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1,679,296
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3,338,240
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Non-current liabilities
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Convertible debenture
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1,000,000
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Total liabilities
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$
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1,679,296
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$
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4,338,240
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Commitments and Contingencies (Note 10)
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Shareholders' equity (deficit)
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Common stock, no par value, 13,253,964
shares issued and outstanding at September 30, 2008 and 383,576 shares issued
and outstanding at December 31, 2007
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325,184,192
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290,750,131
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Additional paid-in-capital
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17,213,097
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5,142,339
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Accumulated other comprehensive income
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(6,285,577
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)
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(6,285,577
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)
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Accumulated deficit
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(312,386,812
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)
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(290,697,538
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)
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Total shareholders' equity (deficit)
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23,724,900
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(1,090,645
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)
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Total liabilities and shareholders' equity
(deficit)
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$
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25,404,196
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$
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3,247,595
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(The accompanying notes are an integral
part of these condensed consolidated financial statements.)
(1)
Derived from the Corporation's audited consolidated financial statements
as of December 31, 2007.
3
Table
of Contents
WORLD HEART CORPORATION
Condensed Consolidated Statements of
Operations
(United States Dollars)
(Unaudited)
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Three Months Ended September 30,
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Nine Months Ended September 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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$
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191,705
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$
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531,575
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$
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1,363,235
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$
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2,227,884
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Cost of goods sold
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(203,289
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)
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(381,875
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)
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(889,720
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)
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(2,273,707
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)
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Gross profit
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(11,584
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)
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149,700
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473,515
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(45,823
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)
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Operating expenses
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Selling, general and administrative
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1,036,002
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1,456,527
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3,441,193
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4,459,171
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Research and development
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2,226,423
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2,164,249
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6,651,608
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7,169,141
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Clinical and marketing support- non-cash
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6,478,619
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Amortization of intangibles
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47,856
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47,856
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143,568
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143,568
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Total operating expenses
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3,310,281
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3,668,632
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16,714,988
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11,771,880
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Operating loss
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(3,321,865
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)
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(3,518,932
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(16,241,473
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(11,817,703
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Other income (expenses)
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Debt inducement expense
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(3,914,357
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)
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(3,914,357
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)
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Unrealized foreign exchange gain (loss)
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15,110
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(160,115
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4,594
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(29,184
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)
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Investment and other income (loss)
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102,834
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665,498
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120,665
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923,696
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Loss on disposal of property and equipment
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(4,632
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)
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(1,659
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)
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Interest expense
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(43,625
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)
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(1,658,703
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)
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Net loss
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$
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(7,161,903
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)
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$
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(3,018,181
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)
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$
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(21,689,274
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)
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$
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(10,924,850
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)
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Weighted average number of common shares
outstanding basic and diluted
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8,962,943
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383,576
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3,295,793
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383,576
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Basic and diluted loss per common share
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$
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(0.80
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)
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$
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(7.87
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$
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(6.58
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$
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(28.48
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(The accompanying notes are an integral part
of these condensed consolidated financial statements.)
4
Table
of Contents
WORLD HEART
CORPORATION
Condensed Consolidated Statements of Cash Flow
(United States Dollars)
(Unaudited)
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Nine Months Ended September 30,
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CASH FLOWS FROM (USED IN)
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2008
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2007
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Operating activities
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Net loss for the period
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$
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(21,689,274
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)
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$
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(10,924,850
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)
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Adjustments to reconcile net loss to net
cash used in operations:
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Amortization and depreciation
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359,369
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522,710
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(Gain) loss on disposal of property and
equipment
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1,659
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Write down of property and equipment
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197,819
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Write down of inventory
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355,285
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425,000
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Non-cash expense on stock options
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211,638
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353,728
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Non-cash interest on debt
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1,466,143
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Non-cash expense for fair value of warrants
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6,478,619
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Non-cash debt inducement expense
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3,914,357
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Unrealized foreign exchange gain (loss)
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(34,471
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)
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(183,440
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Change in operating components of working
capital
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(538,549
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)
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591,063
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Cash used in operating activities
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(9,476,883
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)
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(9,016,311
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)
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Investing activities
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Purchase of property and equipment
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(45,460
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)
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(209,573
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)
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Cash pledged as collateral for site
restoration
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(568,468
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)
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Cash used in investing activities
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(45,460
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)
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(778,041
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)
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Financing activities
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Convertible bridge loan proceeds
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1,400,000
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Convertible debenture proceeds
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4,000,000
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Common shares issued through private
placement
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28,600,000
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Expenses related to private placement and
convertible debenture
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(1,262,291
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)
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Cash provided by financing activities
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32,737,709
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Effect of exchange rates on cash and cash equivalents
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(3,630
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)
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(8,508
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)
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Increase (decrease) in cash and cash
equivalents for the period
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23,211,736
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(9,802,860
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)
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Cash and cash equivalents, beginning of the
period
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664,504
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12,216,671
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Cash and cash equivalents, end of the
period
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$
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23,876,240
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$
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2,413,811
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Supplementary cash flow information
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Bridge loans converted to common stock
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$
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1,400,000
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Note payable and accrued interest converted
to common stock
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$
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5,238,444
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Accrued bonus paid by issuance of stock
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$
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457,908
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(The accompanying notes are an integral part of these
condensed consolidated financial statements.)
5
Table
of Contents
WORLD HEART
CORPORATION
Condensed Consolidated Statement of Equity
(United States Dollars)
(Unaudited)
Nine Months Ended September 30, 2008
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Accumulated
Other
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Common Stock
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Additional Paid-in
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Comprehensive
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Accumulated
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Shareholders Equity
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Number
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Amount
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Capital
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Income
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Deficit
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(Deficiency)
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Balance as at
January 1, 2008
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383,576
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$
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290,750,131
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$
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5,142,339
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$
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(6,285,577
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)
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$
|
(290,697,537
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)
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$
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(1,090,644
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)
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Non-cash stock
compensation
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|
|
|
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211,638
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|
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211,638
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Fair value of
beneficial conversion
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|
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1,466,144
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1,466,144
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feature for
convertible debenture
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|
|
|
|
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Warrants issued
in connection with
|
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|
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6,478,619
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6,478,619
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support services
agreement
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Stock issued for
accrued bonus
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3,722
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457,908
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457,908
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Proceeds from
sale of stock, net
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10,000,000
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28,737,709
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(1)
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28,737,709
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Debt inducement
expense
|
|
|
|
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|
3,914,357
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|
|
|
|
|
3,914,357
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|
Conversion of
note payable and accrued interest to common stock
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2,866,667
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5,238,444
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|
|
|
|
|
|
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5,238,444
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|
Net loss for the
nine months ended September 30, 2008
|
|
|
|
|
|
|
|
|
|
(21,689,274
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)
|
(21,689,274
|
)
|
Balance
at September 30, 2008
|
|
13,253,964
|
|
$
|
325,184,192
|
|
$
|
17,213,097
|
|
$
|
(6,285,577
|
)
|
$
|
(312,386,812
|
)
|
$
|
23,724,900
|
|
(1) Includes conversion of $1.4 million
bridge notes payable
(The accompanying notes are an integral part
of these condensed consolidated financial statements.)
6
Table
of Contents
WORLD HEART CORPORATION
Notes to Unaudited Condensed Consolidated Financial Statements
1.
Nature
of Operations of the Corporation
World Heart Corporation (WorldHeart or the Corporation) is
developing and commercializing implantable ventricular assist devices (VADs),
which are mechanical pumps that allow for the restoration of normal blood
circulation to patients suffering from advanced heart failure. WorldHeart has
facilities in Oakland, California, Salt Lake City, Utah and Herkenbosch,
Netherlands. WorldHeart currently derives its revenue from its Novacor LVAS
(left ventricular assist system) and related peripheral equipment which it
sells directly to medical clinics and hospitals in the United States, Europe
and Canada and through distributors in other countries. As previously announced, after more than
twenty years in clinical use, the Corporation is phasing out its first-generation
Novacor LVAS as it approaches the natural end of its life cycle. The
Corporation is focusing on the development of its next-generation Levacor
Rotary VAD (the Levacor) and on activities leading to the start of a U.S.
clinical trial with the Levacor in 2009. The Corporation expects to realize
cost recoveries from the use of the Levacor in a U.S. clinical trial. Such
recoveries are expected to be an important part of the Corporations overall
operating cash flows in the future.
On July 31, 2008, WorldHeart completed a $30.0
million private placement transaction and recapitalization under the terms of
the Recapitalization Agreement dated June 20, 2008 and amended on July 31,
2008 (See Note 9 of the Notes to Unaudited Condensed Consolidated Financial
Statements).
With the completion of the private
placement and recapitalization, the Corporation believes it has sufficient cash
to fund operations for at least twelve months and that it will be able to
realize its assets and discharge its liabilities in the normal course of
business. The Corporation also believes that it can
sustain compliance with NASDAQ Marketplace Rules 4310(c)(3), the Minimum
Equity Rule and 4310(c)(4), the Minimum Bid Price Rule with the issuance of
12.86 million common shares as part of the private placement transaction and
recapitalization and with its recently completed 30-to-1 reverse stock split
(See Note 2 of the Notes to Unaudited Condensed Consolidated Financial
Statements).
2.
Subsequent
Events
Reverse Stock Split
On October 28, 2008, the Corporation effected a
reverse stock split of 30-to-1 of its capital stock. The reverse stock split
was previously approved by the Corporations Board of Directors and by the
Corporations shareholders during the October 9, 2008 Special Meeting of
Shareholders.
Pursuant to the reverse stock split, each holder of
the Corporations common shares, options or warrants on October 28, 2008,
the date of effectiveness of the reverse stock split, became entitled to
receive one new common share, option or warrant in exchange for every thirty
old common shares, options or warrants held by such shareholder.
The effect of the reverse stock split has been
retroactively applied throughout the financial statements contained herein. All
numbers of common shares set forth herein are shown on a post-consolidated
basis, unless otherwise noted.
NASDAQ Notice on Non-Compliance
On October 29, 2008, the Corporation received a NASDAQ Staff
Deficiency Letter indicating that WorldHeart does not comply with Marketplace Rule 4310(c)(7) which
requires the Corporation to maintain a minimum of 500,000 publicly held shares
for continued listing on the NASDAQ Capital Market. For purposes of this
requirement, the number of publicly held shares excludes shares held by
affiliates, including officers, directors, or ten percent shareholders. The
NASDAQ staff is reviewing the Corporations eligibility for continued listing
on the NASDAQ Capital Market and had asked the Corporation to provide, on or
before November 21, 2008, the Corporations specific plan to achieve and
sustain compliance with all the NASDAQ Capital Market listing requirements,
including the time frame for completion of the plan. The Corporation filed a
registration statement to register certain shares held by affiliates and others
that were issued or are issuable in connection with the previously announced
US$30.0 million private placement transaction and recapitalization. The
registration statement has been declared effective and the Corporation expects
that sales in the open market will result in an increase in the number of
publicly held shares. WorldHeart also intends to submit a specific plan to
achieve and sustain compliance with Marketplace Rule 4310(C)(7) by November 21,
2008.
7
Table of Contents
WORLD HEART CORPORATION
Notes to Unaudited Condensed
Consolidated Financial Statements continued
3.
Summary
of Significant Accounting Policies
Basis of presentation
The
accompanying interim condensed unaudited consolidated financial statements have
been prepared by management in accordance with accounting principles generally
accepted in the United States (GAAP) and with the instructions to Form 10-Q
and Article 10 of Regulation S-X. Accordingly, these consolidated
financial statements include all assets, liabilities, revenue and expenses of
the Corporation and its wholly owned subsidiaries: World Heart Inc. and World
Heart B.V. All material inter-company transactions and balances have been
eliminated. These interim unaudited condensed consolidated financial statements
and notes thereto should be read in conjunction with Managements Discussion
and Analysis of Financial Condition and Results of Operations and the audited
financial statements and notes thereto included in the Corporations Annual
Report on Form 10-KSB/A, for the year ended December 31, 2007. In the
opinion of management, the condensed balance sheet at December 31, 2007
which has been derived from audited financial statements and these interim
unaudited consolidated financial statements reflect all normal and recurring
adjustments considered necessary to state fairly the results for the periods
presented. The results for the period ended September 30, 2008 are not
necessarily indicative of the results to be expected for the entire fiscal year
ended December 31, 2008 or for any future period.
Use of estimates
The preparation of these consolidated financial
statements in accordance with accounting principles generally accepted in the
United States of America, requires management to make estimates and assumptions
that affect the reported amounts of assets and liabilities and disclosure of
contingent assets and liabilities at the dates of the financial statements and
the reported amounts of revenue and expenses during the reporting periods. Such
management estimates include allowance for doubtful accounts, sales and other
allowances, inventory reserves, income taxes, realizability of deferred tax
assets, stock-based compensation, deferred revenue, warranty reserves and legal
reserves. Actual results could differ from these estimates.
Revenue recognition
Revenue
from product and service sales is recognized when all of the following criteria
are met: persuasive evidence of an
agreement exists; delivery has occurred or services have been rendered; price
is fixed or determinable; and collection is reasonably assured.
The
significant elements of the Corporations multiple-element offerings are
Implant Kits, Peripherals and Other. For arrangements with multiple elements,
the Corporation recognizes revenue using the residual method as described in
SOP 98-9. Under the residual method, revenue is allocated and deferred for the
undelivered elements based on relative fair value. The determination of fair
value of the undelivered elements in multiple elements arrangements is based on
the price charged when such elements are sold separately, which is commonly
referred to as vendor-specific objective-evidence, or VSOE. Each elements
revenue is recognized when all of the revenue recognition criteria are met for
each of the elements.
Shipping and Handling Costs
In accordance with Emerging Issues Task Force (EITF) 00-10, Accounting
for Shipping and Handling Fees and Costs, the Corporation records freight
billed to its customers as sales of product and services and the related
freight costs as a cost of sales, product and services. The Corporations
shipping and handling costs are not significant.
4.
Stock-based
Compensation
On
January 1, 2006, WorldHeart adopted Statement of Financial Accounting
Standards (SFAS) No. 123(R), Accounting for Stock-Based Compensation (FAS
123(R)), using the modified prospective transition method. Under this method,
the provisions of FAS 123(R) apply to all stock-based awards granted after
the effective date. The unrecognized expense of awards not yet vested as of January 1,
2006 is recognized as an expense in the calculation of net income. As FAS 123(R) requires
that stock-based compensation expense be based on awards that are ultimately
expected to vest, stock-based compensation for the third quarter of 2008 has
been reduced for estimated forfeitures. When estimating forfeitures, voluntary
termination behaviors, as well as trends of actual option forfeitures are
considered. To the extent actual forfeitures differ from the Corporations
current estimates, cumulative adjustments to stock-based compensation expense
are recorded.
Except for transactions with employees and directors that are within
the scope of FAS 123(R), all transactions in which goods or services are the
consideration received for the issuance of equity instruments are accounted for
based on the fair value of the consideration received or the fair value of the
equity instruments issued, whichever is more reliably measurable.
Additionally, in accordance with EITF 96-18, Accounting for Equity
Instruments that are Issued to Other Than Employees for Acquiring, or in
Conjunction with Selling Goods or Services or Combined with Cash (EITF 96-18),
the Corporation has determined that the
8
Table of Contents
WORLD HEART CORPORATION
Notes to Unaudited Condensed
Consolidated Financial Statements continued
dates used to value the transaction are either: (1) the date at
which a commitment for performance by the counter party to earn the equity
instruments is established; or (2) the date at which the counter partys
performance is complete.
WorldHeart
uses the Black-Scholes valuation model for estimating the fair value of stock
compensation. The stock-based compensation expense for the three and nine month
periods ended September 30, 2008 and 2007 are as follows:
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
|
(Unaudited)
|
|
2008
|
|
2007
|
|
2008
|
|
2007
|
|
Selling, general and administrative
|
|
$
|
37,518
|
|
$
|
131,293
|
|
$
|
144,645
|
|
$
|
273,149
|
|
Research and development
|
|
20,034
|
|
53,258
|
|
66,993
|
|
80,579
|
|
Total
|
|
$
|
57,552
|
|
$
|
184,551
|
|
$
|
211,638
|
|
$
|
353,728
|
|
As
of September 30, 2008, approximately $501,084 of total unrecognized
compensation cost related to stock options is expected to be recognized over a
period of approximately 10 quarters.
The
aggregate intrinsic value is calculated as the difference between the exercise
price of all outstanding options and the quoted price of our common shares that
were in the money at September 30, 2008. At September 30, 2008, the
aggregate intrinsic value of all outstanding options was zero with a weighted
average remaining contractual term of approximately 5.5 years. Of the 33,533
outstanding options, 26,047 options were exercisable, with a weighted average
remaining contractual life of 4.6 years and 7,486 options were unvested, with a
weighted average remaining contractual life of 7.6 years. No options were
exercised or granted under the Corporations 2006 Equity Incentive Plan during
the third quarter of 2008.
A
summary of the status and changes the Corporations non-vested options, subject
to FAS123(R) calculation as of the quarter ended September 30, 2008
is presented below:
|
|
Shares
|
|
Weighted Average
Grant-Date Fair Value
|
|
Nonvested at December 31, 2007
|
|
12,373
|
|
$
|
90.00
|
|
Granted
|
|
437
|
|
$
|
42.58
|
|
Vested
|
|
(3,728
|
)
|
$
|
45.60
|
|
Forfeited
|
|
(160
|
)
|
$
|
84.90
|
|
Nonvested at March 31, 2008
|
|
8,922
|
|
$
|
106.50
|
|
Granted
|
|
|
|
$
|
0.00
|
|
Vested
|
|
(295
|
)
|
$
|
79.72
|
|
Forfeited
|
|
(211
|
)
|
$
|
82.70
|
|
Nonvested at June 30, 2008
|
|
8,416
|
|
$
|
107.85
|
|
Granted
|
|
|
|
$
|
0.00
|
|
Vested
|
|
(138
|
)
|
$
|
48.26
|
|
Forfeited
|
|
(792
|
)
|
$
|
71.20
|
|
Nonvested at September 30, 2008
|
|
7,486
|
|
$
|
110.50
|
|
Valuation Assumptions
WorldHeart
calculates the fair value of each option award on the date of grant using the
Black-Scholes option pricing model. During
the three months ended September 30, 2008, no stock options were
granted. For the three and nine month
periods ended September 30, 2008, the weighted average fair value of the
options granted was $0 and $59.10, respectively. For the three and nine month
periods ended September 30, 2007, the weighted average fair value of the
options granted was $42.30 and $15.60, respectively. The following weighted
average assumptions were utilized:
9
Table of Contents
WORLD HEART CORPORATION
Notes to Unaudited Condensed
Consolidated Financial Statements continued
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
|
|
|
2008
|
|
2007
|
|
2008
|
|
2007
|
|
Average risk free interest rate
|
|
|
|
4.7
|
%
|
3.4
|
%
|
4.7
|
%
|
Expected life (in years)
|
|
|
|
5.5
|
|
5.5
|
|
5.5
|
|
Expected volatility
|
|
|
|
100
|
%
|
133
|
%
|
99
|
%
|
Dividend yield
|
|
|
|
0
|
%
|
0.0
|
%
|
0
|
%
|
The
dividend yield of zero is based on the fact that WorldHeart has never paid cash
dividends and has no present intention to pay cash dividends. Expected
volatility is based on the historical volatility of the Corporations common
shares over the period commensurate with the expected life of the options. Expected
life in years is based on the simplified method as permitted by the SECs
Staff Accounting Bulletin No. 110 (SAB 110). WorldHeart believes that
all stock options issued under its stock option plans meet the criteria of plain
vanilla stock options. The Corporation uses a term of 5.5 years for all its
stock options. The risk free interest rate is based on average rates for five
and seven-year treasury notes as published by the Federal Reserve. The
following table summarizes stock option and warrant activity for the quarter
ended September 30, 2008:
|
|
Employees
|
|
Non-Employees
|
|
|
|
|
|
|
|
|
|
Options
|
|
Weighted
average
exercise price
|
|
Options
|
|
Weighted
average
exercise price
|
|
Warrants
|
|
Weighted
average
exercise price
|
|
Total
|
|
|
|
#
|
|
$
|
|
#
|
|
$
|
|
#
|
|
$
|
|
#
|
|
December 31, 2007
|
|
31,451
|
|
$
|
351.30
|
|
3,237
|
|
$
|
317.10
|
|
63,663
|
|
$
|
145.20
|
|
98,351
|
|
Granted
|
|
437
|
|
$
|
47.84
|
|
|
|
|
|
90,667
|
|
$
|
52.50
|
|
91,103
|
|
Expired
|
|
(113
|
)
|
$
|
4,962.12
|
|
(11
|
)
|
$
|
4,026.66
|
|
(1,429
|
)
|
$
|
327.00
|
|
(1,553
|
)
|
Forfeited
|
|
(154
|
)
|
$
|
52.20
|
|
|
|
$
|
0.00
|
|
|
|
$
|
0.00
|
|
(154
|
)
|
Outstanding at March 31, 2008
|
|
31,621
|
|
$
|
332.10
|
|
3,226
|
|
$
|
304.50
|
|
152,901
|
|
$
|
87.00
|
|
187,748
|
|
Granted
|
|
|
|
$
|
0.00
|
|
|
|
|
|
|
|
$
|
0.00
|
|
|
|
Expired
|
|
(297
|
)
|
$
|
667.80
|
|
(1
|
)
|
$
|
1,596.00
|
|
(838
|
)
|
$
|
342.25
|
|
(1,136
|
)
|
Forfeited
|
|
(211
|
)
|
$
|
87.84
|
|
|
|
$
|
0.00
|
|
|
|
$
|
0.00
|
|
(211
|
)
|
Outstanding at June 30, 2008
|
|
31,113
|
|
$
|
331.20
|
|
3,225
|
|
$
|
312.30
|
|
152,063
|
|
$
|
85.80
|
|
186,400
|
|
Granted
|
|
0
|
|
$
|
0.00
|
|
|
|
|
|
83,333
|
|
$
|
3.30
|
|
83,333
|
|
Expired
|
|
(6
|
)
|
$
|
3,135.26
|
|
(1
|
)
|
$
|
1,596.00
|
|
(37,667
|
)
|
$
|
2,559.60
|
|
(37,674
|
)
|
Cancelled
|
|
0
|
|
$
|
0.00
|
|
|
|
|
|
(113,333
|
)
|
$
|
0.30
|
|
(113,333
|
)
|
Forfeited
|
|
(798
|
)
|
$
|
70.50
|
|
|
|
|
|
|
|
$
|
0.00
|
|
(798
|
)
|
Outstanding at September 30, 2008
|
|
30,309
|
|
$
|
342.50
|
|
3,224
|
|
$
|
313.00
|
|
84,396
|
|
$
|
7.32
|
|
117,929
|
|
5.
Inventory
The
components of net inventory are as follows:
|
|
September 30, 2008
|
|
December 31, 2007
|
|
Raw materials
|
|
$
|
19,624
|
|
$
|
231,850
|
|
Work in progress
|
|
12,699
|
|
280,363
|
|
Finished goods
|
|
19,026
|
|
352,101
|
|
Total inventory
|
|
$
|
51,349
|
|
$
|
864,314
|
|
10
Table of Contents
WORLD HEART CORPORATION
Notes to Unaudited Condensed
Consolidated Financial Statements continued
6.
Current
Liabilities
Accrued
Compensation
Accrued
compensation includes accruals for quarter-end employee wages and Board of
Director fees, vacation, related payroll taxes and clinical and performance
bonus. The components of accrued compensation, inclusive of payroll taxes, are
as follows:
|
|
September 30, 2008
|
|
December 31, 2007
|
|
Wages
|
|
$
|
107,021
|
|
$
|
254,216
|
|
Vacation
|
|
392,565
|
|
432,006
|
|
Bonus
|
|
21,225
|
|
631,869
|
|
Total accrued compensation
|
|
$
|
520,811
|
|
$
|
1,318,091
|
|
During
the third quarter of this year, the Corporation made full payments on deferred
wages owed to six executives and officers of the Corporation.
Performance Bonus
On February 15, 2008, the Compensation Committee of the Board of
Directors approved the 2008 cash performance bonus program. All employees,
including the Corporations executive officers, are eligible for performance
bonuses, which are earned upon the achievement of certain performance
milestones relevant to the Corporations business. As of September 30,
2008, except for a $21,225 balance, the majority of accrued bonuses pursuant to
the terms and conditions of the Corporations 2007 Performance Bonus Plan and
2006 Equity Incentive Plan have been paid, totaling $152,639 in cash and
$457,908 in stock. No accrual for the
2008 cash performance bonus program has been made as the performance milestones
through September 30, 2008 have not been achieved.
Accounts
Payable and Accrued Liabilities
Accounts
payable and accrued liabilities consist of the following:
|
|
September 30, 2008
|
|
December 31, 2007
|
|
Accounts payable
|
|
$
|
208,353
|
|
$
|
847,460
|
|
Accrued liabilities
|
|
843,573
|
|
909,860
|
|
Sales taxes payable
|
|
3,534
|
|
45,719
|
|
Accrued warranty
|
|
96,048
|
|
131,048
|
|
Interest payable
|
|
|
|
4,444
|
|
Total accounts payable and accrued
liabilities
|
|
$
|
1,151,508
|
|
$
|
1,938,531
|
|
7.
Comprehensive
Income
For the three and nine month
periods ended September 30, 2008 and September 30, 2007, there were
no significant differences between the Corporations comprehensive loss and its
net loss.
8.
Convertible
Debentures and Warrants, Beneficial Conversion and Clinical and Marketing Support
Expenses
On July 31, 2008, the Corporation closed a
previously announced $30.0 million private placement transaction and recapitalization
under the
terms of the Recapitalization Agreement (the Recapitalization Agreement)
dated June 20, 2008 and amended on July 31, 2008, among the Corporation, its wholly owned subsidiary World Heart Inc.
(WHI), Abiomed, Inc. (Abiomed), Venrock Partners V, L.P., Venrock Associates
V, L.P. and Venrock Entrepreneurs Fund V, L.P. (collectively Venrock),
Special Situations Fund III QP, L.P., Special Situations Cayman Fund, L.P.,
Special Situations Private Equity Fund, L.P., Special Situations Life Sciences
Fund, L.P. and Austin W. Marxe (collectively SSF) and New Leaf Ventures II,
L.P (New Leaf).
Simultaneously with the closing, Abiomed entered into a Termination and
Release Letter Agreement dated July 31, 2008 with WorldHeart and WHI.
Under the terms of the Termination and Release Letter Agreement, WorldHeart
converted the full amount of principal and interest owed on the $5.0
million 8% Secured Convertible Promissory Note (the Note) previously issued
to Abiomed by the Corporation and WHI into 2,866,666 common shares of the
Corporation (the Conversion). Additionally,
11
Table of
Contents
WORLD
HEART CORPORATION
Notes to Unaudited Condensed Consolidated
Financial Statements - continued
Abiomed released the security interest in all
of the assets of the Corporation and WHI that secured the Note, terminated the
warrants Abiomed held to purchase 113,333 common shares of the Corporation,
forgave other amounts owed by WorldHeart and terminated all the previously
existing agreements, arrangements and understandings with WorldHeart.
The induced conversion of the Note and simultaneous termination of
previously existing agreements, arrangements and understanding between
WorldHeart and Abiomed, and the subsequent issuance of 2,866,666 common shares
of the Corporation, as approved by the Corporations shareholders during its
Special Meeting of Shareholders held on October 9, 2008, were accounted
for under the provisions of SFAS No. 84, Induced Conversion of
Convertible Debt, or SFAS No. 84. The Corporation recorded a
non-recurring expense upon inducement in the amount of approximately $3.9
million against additional paid-in capital.
Prior to the July 31,
2008 termination of the Corporations agreements with Abiomed, on January 3,
2008, the Corporation recorded a non-cash clinical and marketing support
expense of $6.5 million based on the fair value of warrants issued to purchase
90,000 of the Corporations common shares, upon receipt of $4.0 million in
funding from Abiomed pursuant to a now cancelled clinical and marketing support
services agreement. The Corporation applied the provisions of FAS 123R and EITF
96-18 to account for the expense associated with the warrants granted to
Abiomed. The Corporation used the Black-Scholes
method to compute the fair value of the warrants issued as consideration for
the clinical and marketing support services agreement. The measurement dates
used were the dates when the Corporation received funding as defined by EITF
96-18. As a result of the beneficial conversion features of the Note, the
Corporation recorded a non-cash interest expense charge of approximately $1.4
million in the nine-month ended period September 30, 2008.
9. Private
Placement Transaction and Recapitalization
On July 31, 2008, WorldHeart completed a
$30.0 million private placement transaction and recapitalization previously
announced under the terms of the Recapitalization Agreement. Under the terms of
the Recapitalization Agreement, WorldHeart issued 10 million common shares for
an aggregate purchase price of $30.0 million (the Issuance), of which Venrock
invested $11.0 million, SSF invested $9.0 million and New Leaf invested $10.0
million. The purchase price delivered by Venrock and SSF at the closing was
offset by repayment of the principal and interest owed on the bridge loan
facility of $1.4 million (the Bridge Facility) that Venrock and SSF had
previously provided to WorldHeart. Simultaneously with the closing of the
Issuance, Abiomed entered into a Termination and Release Letter Agreement dated
July 31, 2008 with WorldHeart and WHI (See Note 8 of the Notes to
Unaudited Condensed Consolidated Financial Statements). In connection with the
Issuance, the parties to the Recapitalization Agreement entered into a
Registration Rights Agreement dated July 31, 2008, as amended October 31,
2008, to register the common shares issued in connection with the Issuance and
the Conversion.
WorldHeart paid an aggregate cash commission of
$750,000 and issued warrants to purchase an aggregate of 83,333 common shares
to its advisors, Pacific Growth Equities, LLC and Stifel, Nicolaus and Company.
The warrants, with an exercise price of $3.30 per share, were subject to
shareholder approval and were approved by the Corporations shareholders during
the Special Meeting of Shareholders held on October 9, 2008. We calculated
the fair value of the warrants using the Black-Scholes Option Valuation Model.
Accordingly, the amount of $283,000 was attributed to the issuance of warrants
as advisor fees for services related to the financing and recapitalization. The
issuance of the warrants had no impact on total equity and did not impact
operating results for the quarter or nine months ended September 30, 2008.
In accordance with terms pursuant to the Recapitalization Agreement,
the following terms were satisfied and, where required, carried by majority
votes by the Corporations shareholders during the Special Meeting of
Shareholders held on October 9, 2008:
(i)
The approval of a reverse split of
its common shares;
(ii)
The election as Directors of the Corporation of the nominees of each of Abiomed, Venrock, SSF and
New Leaf , to hold office until the next annual meeting
or until their successors are elected or appointed; and
(iii)
The termination of Abiomeds current distribution rights with WorldHeart and replacement
with reduced distribution rights, under which WorldHeart is required to
negotiate in good faith with Abiomed regarding distribution arrangements for
certain of the Corporations products before engaging a third-party distributor;
and
(iv)
The establishment of an equity incentive program for the benefit of
the Corporations independent directors, officers, employees and consultants
covering, together with the Corporations existing plans, a maximum of
1,466,666 common shares of WorldHeart.
12
Table of
Contents
WORLD
HEART CORPORATION
Notes to Unaudited Condensed Consolidated
Financial Statements - continued
10. Commitment
and Contingencies
On September 15, 2008, WorldHeart and
LaunchPoint Technologies LLC (LaunchPoint) entered into an Assignment
Agreement (the Agreement) wherein all of LaunchPoints right, title and
interest in and to the assigned technology and intellectual property relating
to physiological control of rotary blood pumps were assigned, sold,
transferred granted and delivered to WorldHeart for $230,000. In addition, the
Agreement confirmed a 0.5% royalty on net future sales through 2020 of products
using such technology. The purchase price of $230,000 will be paid in equal
installments of $10,000 over 23 months beginning in October 2008.
Under the Agreement, LaunchPoint
agreed to provide exclusive research and development (R&D) services to
WorldHeart, for approximately two years, for the design, production,
distribution or sale of rotary blood pumps that provide assisted circulation.
In return, WorldHeart will engage LaunchPoint in Active Projects with one of
them being the Pediatric Ventricular Assist Device (PediaFLow) project. The
PediaFlow is a small, magnetically levitated rotary VAD intended for use in
newborns and infants. WorldHeart will provide LaunchPoint with an annual
funding of $120,000 until termination on either (i) the second anniversary
of the Agreement, (ii) expiration of the period of exclusivity according
to the terms of any Active Project or (iii) termination of R&D
services pursuant to any Active Project.
The Corporation accounted for the purchase of
R&D technology under the Agreement in accordance with Financial Accounting
Standards Board (FASB) Statement No. 2, Accounting for Research and
Development Costs, as interpreted by FASB Interpretation (FIN) No. 4, Applicability
of FASB Statement No. 2 to Business Combinations Accounted for by the
Purchase Method. The Corporation recorded a one time R&D expense of
$230,000 during the quarter ended September 30, 2008 based on the fact
that alternative future value or realizability of this technology is not
determinable as of the date of the Agreement.
11.
Recent Accounting Pronouncements
Since
the beginning of 2008 the following new standards have been issued that may
impact the Corporation:
In
June 2008, the FASB issued FASB Staff Position (FSP) EITF 03-6-1, Determining
Whether Instruments Granted in Share-Based Payment Transactions Are
Participating Securities. This FSP provides that unvested share-based payment
awards that contain non-forfeitable rights to dividends or dividend equivalents
(whether paid or unpaid) are participating securities and shall be included in
the computation of earnings per share pursuant to the two-class method. The FSP
is effective for financial statements issued for fiscal years beginning after December 15,
2008, and interim periods within those years. This FSP is not applicable to
WorldHeart since the Corporation does not issue dividends and has no intention
to do so.
In
April 2008, the FASB issued FSP FAS 142-3, Determination of the
Useful Life of Intangible Assets (FSP FAS 142-3). FSP FAS 142-3
amends the factors that should be considered in developing renewal or extension
assumptions used to determine the useful life of a recognized intangible asset
under FASB Statement No.142, Goodwill and Other Intangible Assets. FSP
FAS 142-3 also requires expanded disclosure related to the determination
of intangible asset useful lives. FSP FAS 142-3 is effective for financial
statements issued for fiscal years beginning after December 15, 2008, and
interim periods within those fiscal years. The Corporation is currently
evaluating the impact this adoption may have on its results of operations and
financial condition, but does not expect it will have a material impact, if
any.
In
September 2006, the FASB issued SFAS No. 157, Fair Value
Measurements (SFAS 157). SFAS 157 defines fair value, establishes
a framework and gives guidance regarding the methods used for measuring fair
value, and expands disclosures about fair value measurements. In February 2008,
the FASB issued FASB Staff Position 157-1, Application of FASB Statement No. 157
to FASB Statement No. 13 and Other Accounting Pronouncements That Address
Fair Value Measurements for Purposes of Lease Classification or Measurement
under Statement 13 (FSP 157-1) and FASB Staff Position 157-2, Effective
Date of FASB Statement No. 157 (FSP 157-2). FSP 157-1 amends
SFAS 157 to remove certain leasing transactions from its scope. FSP 157-2
delays the effective date of SFAS 157 for all non-financial assets and
non-financial liabilities, except for items that are recognized or disclosed at
fair value in the financial statements on a recurring basis (at least
annually), until fiscal years beginning after November 15, 2008.
SFAS 157 is effective for financial statements issued for fiscal years
beginning after November 15, 2007, and interim periods within those fiscal
years. The measurement and disclosure requirements related to financial assets
and financial liabilities are effective beginning the first quarter of fiscal
2009. The Corporation does not believe that the adoption of SFAS 157 for
financial assets and financial liabilities will have a material impact on its
financial position or results of operations. The Corporation is currently
assessing the impact that SFAS 157 will have on its results of operations
and financial position when it is applied to non-financial assets and
non-financial liabilities beginning in the first quarter of fiscal 2010.
13
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Contents
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
INTRODUCTION
World Heart Corporation and its subsidiaries are
collectively referred to as WorldHeart or the Corporation. The following
Management Discussion and Analysis of Financial Condition and Results of
Operations (MD&A) discusses material changes in WorldHearts financial
condition and results of operations and cash flows for the three and nine
months ended September 30, 2008 and September 30, 2007. Such
discussion and comments on the liquidity and capital resources should be read
in conjunction with the information contained in WorldHearts audited
consolidated financial statements for the year ended December 31, 2007,
prepared in accordance with U.S. GAAP included in our Annual Report on Form 10KSB/A
for the fiscal year ended December 31, 2007.
The
discussion and comments contained hereunder include both historical information
and forward-looking information. The forward-looking information, which
generally is information stated to be anticipated, expected, or projected by
management, involves known and unknown risks, uncertainties and other factors
that may cause the actual results and performance to be materially different
from any future results and performance expressed or implied by such
forward-looking information. Potential risks and uncertainties include, without
limitation: our need for additional significant financing in the future; costs
and delays associated with research and development, pre-clinical testing and
clinical trials for our products and next-generation product candidates, such
as the Levacor Rotary VAD; our ability to manufacture, sell and market our
products; decisions, and the timing of decisions, made by health regulatory
agencies regarding approval of our products; competition from other products
and therapies for heart failure; continued slower than anticipated destination
therapy adoption rate for VADs; limitations on third-party reimbursements; our
ability to obtain and enforce in a timely manner patent and other intellectual
property protection for our technology and products; our ability to avoid,
either by product design, licensing arrangement or otherwise, infringement of
third parties intellectual property; our ability to enter into corporate
alliances or other strategic relationships relating to the development and
commercialization of our technology and products; loss of commercial market
share to competitors due to our financial condition; our ability to remain
listed on the NASDAQ Capital Market; as well as other risks and uncertainties
set forth under the heading Risk Factors in our Annual Report on Form 10-KSB/A,
for the fiscal year ended December 31, 2007.
OVERVIEW
We
are engaged in development of mechanical circulatory support systems focused on
developing and commercializing implantable ventricular assist devices (VADs),
which are mechanical pumps that allow for the restoration of normal blood
circulation to patients suffering from advanced heart failure.
To
date we derive most of our revenue from our Novacor LVAS (Novacor LVAS or Novacor)
and related peripheral equipment, which we sell directly to medical clinics and
hospitals in the United States, Europe and Canada and through distributors in
certain other countries. The Novacor LVAS is commercially approved for use as a
bridge-to-transplant in the United States and Canada. In Europe, the Novacor
LVAS has unrestricted approval for use as an alternative to transplantation,
Bridge-to-Transplantation and to support patients who may be able to recover
the use of their natural heart. In Japan, the device is commercially approved
for use in cardiac patients at risk of imminent death from non-reversible left
ventricular failure for which there is no alternative except heart
transplantation.
In
July 2005, we acquired the assets of MedQuest Products, Inc. (MedQuest),
including a rotary VAD, now called the Levacor Rotary VAD. In conjunction with
the acquisition, we
raised
approximately $22.7 million in gross financing proceeds from a private
placement with Maverick Venture Management, LLC and the exercise of certain
warrants and also converted all of its remaining convertible debentures from an
earlier financing.
Pre-clinical testing of the Levacor
Rotary VAD was accelerated after the acquisition, with successful initial human
feasibility use in Europe in 2006.
In
November 2006, we announced a restructuring plan, which included a
reduction of commercial operations associated with the Novacor LVAS, and a
refocusing of our resources on the development of the next generation product,
particularly the Levacor Rotary VAD. After more than twenty years in clinical
use, the Novacor LVAS has reached the natural end of its life cycle and we have
been focusing on the development of the Levacor Rotary VAD and on activities
leading to the start of a US clinical trial with the Levacor Rotary VAD in
2009.
In
July 2008, we completed a $30.0 million private placement transaction and
recapitalization under the terms of the Recapitalization Agreement (the Recapitalization
Agreement) dated June 20, 2008 and amended on July 31, 2008, among
the Corporation, our wholly owned subsidiary World Heart Inc. (WHI), Abiomed, Inc.
(Abiomed), Venrock Partners V, L.P., Venrock Associates V, L.P. and Venrock
Entrepreneurs Fund V, L.P. (collectively, Venrock), Special Situations Fund
III QP, L.P., Special Situations Cayman Fund, L.P., Special Situations Private
Equity Fund, L.P., Special Situations Life Sciences Fund, L.P. and Austin W.
Marxe (collectively, SSF) and New Leaf Ventures II, L.P. (New Leaf).Simultaneously
with the closing of the recapitalization,
Abiomed
entered into a Termination and Release Letter Agreement with us and converted
the full amount of
14
Table
of Contents
principal
and interest owed on the $5,000,000 8% Secured Convertible Promissory Note (the
Note) previously issued to Abiomed by the Corporation and WHI into 2,866,667
of our common shares (the Conversion), released the security interest in all
of our assets and those of WHI that secured the Note, terminated the warrant
Abiomed held to purchase 113,333 of our common shares, forgave other amounts we
owed to Abiomed and terminated previously existing agreements, arrangements and
understandings with us. The purchase price delivered by Venrock and SSF at the
closing was offset by repayment of the principal and interest owed on the
bridge loan facility (the Bridge Loan) of $1,400,000 that Venrock and SSF had
previously provided to us.
As part of the recapitalization
transaction, we issued warrants to purchase an aggregate of 83,333 common
shares to our advisors, Pacific Growth Equities, LLC and Stifel, Nicolaus and
Company (See Notes 8 and 9 of the Notes to Unaudited Condensed Consolidated
Financial Statements).
In
August 2008, we announced that we were embarking on a phased consolidation
into our current facility in Salt Lake City, Utah. This included a search for a
new CEO to reside in Salt Lake City and the termination or relocation of
several employees from our Oakland facility by approximately mid 2009. We are
still in the process of evaluating all our alternatives and expect to complete
the evaluation process by early 2009, at which time we will determine the impact, if any, on our financial position.
Research
and development by our competitors is proceeding on several rotary flow
devices. Certain of these devices have received the CE mark in Europe and are
advancing through clinical trials in the United States and Europe, and one
device has just received U.S. marketing approval. We believe that our Levacor
VAD is the most advanced fourth-generation rotary device under development.
Although
the patient population for Destination Therapy, the implanting of a VAD to
provide support for a patient not currently eligible for a heart transplant,
continues to be largely untreated by cardiac assist devices, and the adoption
rates have been slower than anticipated, we believe that the Destination
Therapy market will evolve more rapidly when newer devices are evaluated
clinically and as experience with next-generation VADs increases.
Summary
of Quarterly Results
In thousands
(000s) except for per share amounts
(Unaudited)
|
|
Three Months Ended
|
|
|
|
September 30,
|
|
June 30
|
|
March 31,
|
|
December 31,
|
|
|
|
2008
|
|
2008
|
|
2008
|
|
2007
|
|
|
|
|
|
|
|
|
|
|
|
Net revenue
|
|
$
|
192
|
|
$
|
536
|
|
$
|
635
|
|
$
|
348
|
|
Net loss for the period
|
|
(7,162
|
)
|
(3,049
|
)
|
(11,478
|
)
|
(7,639
|
)
|
Net loss applicable to common shareholders
|
|
(7,162
|
)
|
(3,049
|
)
|
(11,478
|
)
|
(7,639
|
)
|
Basic and diluted loss per share
|
|
$
|
(0.80
|
)
|
$
|
(7.94
|
)
|
$
|
(29.92
|
)
|
$
|
(19.92
|
)
|
|
|
Three Months Ended
|
|
|
|
September 30,
|
|
June 30,
|
|
March 31,
|
|
December 31,
|
|
|
|
2007
|
|
2007
|
|
2007
|
|
2006
|
|
|
|
|
|
|
|
|
|
|
|
Net revenue
|
|
$
|
532
|
|
$
|
849
|
|
$
|
848
|
|
$
|
956
|
|
Net loss for the period
|
|
(3,018
|
)
|
(4,477
|
)
|
(3,430
|
)
|
(5,136
|
)
|
Net loss applicable to common shareholders
|
|
(3,018
|
)
|
(4,477
|
)
|
(3,430
|
)
|
(5,136
|
)
|
Basic and diluted loss per share
|
|
$
|
(7.87
|
)
|
$
|
(11.67
|
)
|
$
|
(8.94
|
)
|
$
|
(23.21
|
)
|
15
Table
of Contents
RESULTS OF OPERATIONS FOR THE THREE AND NINE MONTH
PERIODS ENDED SEPTEMBER 30, 2008 COMPARED WITH THE THREE AND NINE MONTH
PERIODS ENDED SEPTEMBER 30, 2007
In thousands (000s) except for per share
amounts
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
|
(Unaudited)
|
|
2008
|
|
2007
|
|
2008
|
|
2007
|
|
Revenue
|
|
$
|
192
|
|
$
|
532
|
|
1,363
|
|
$
|
2,228
|
|
Cost of goods sold
|
|
(204
|
)
|
(382
|
)
|
(889
|
)
|
(2,274
|
)
|
|
|
|
|
|
|
|
|
|
|
Gross profit
|
|
(12
|
)
|
150
|
|
474
|
|
(46
|
)
|
|
|
|
|
|
|
|
|
|
|
Operating expenses
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative
|
|
1,036
|
|
1,457
|
|
3,441
|
|
4,459
|
|
Research and development
|
|
2,226
|
|
2,164
|
|
6,651
|
|
7,169
|
|
Clinical and marketing support- non-cash
|
|
|
|
|
|
6,479
|
|
|
|
Amortization of intangibles
|
|
48
|
|
48
|
|
144
|
|
144
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
3,310
|
|
3,669
|
|
16,715
|
|
11,772
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss
|
|
(3,322
|
)
|
(3,519
|
)
|
(16,241
|
)
|
(11,818
|
)
|
|
|
|
|
|
|
|
|
|
|
Other income (expense)
|
|
(3,840
|
)
|
501
|
|
(5,448
|
)
|
893
|
|
|
|
|
|
|
|
|
|
|
|
Net loss applicable to common shareholders
|
|
$
|
(7,162
|
)
|
$
|
(3,018
|
)
|
$
|
(21,689
|
)
|
$
|
(10,925
|
)
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares
outstanding basic and diluted
|
|
8,963
|
|
384
|
|
3,296
|
|
384
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per common share
|
|
$
|
(0.80
|
)
|
$
|
(7.87
|
)
|
$
|
(6.58
|
)
|
$
|
(28.48
|
)
|
Revenue:
In the past,
sales of
Novacor LVAS implant kits and related peripheral equipment and services
accounted for the majority of our revenue. In addition, we generate revenue
from sales of SPUS (Segmented Poly Urethane Solution) used by one other medical
device manufacturer, which have contributed a greater percentage of overall
revenue in recent quarters. We primarily sell our products directly, except for
a few countries where we sell through distributors.
The composition of revenue in thousands ($000s)
is as follows except for units:
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
|
|
|
2008
|
|
2007
|
|
2008
|
|
2007
|
|
(Unaudited)
|
|
$
|
|
Units
|
|
$
|
|
Units
|
|
$
|
|
Units
|
|
$
|
|
Units
|
|
Novacor Product Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Implant kits
|
|
$
|
|
|
|
|
$
|
306
|
|
4
|
|
$
|
318
|
|
5
|
|
$
|
990
|
|
14
|
|
Peripherals and other
|
|
102
|
|
|
|
136
|
|
|
|
440
|
|
|
|
938
|
|
|
|
|
|
102
|
|
|
|
442
|
|
|
|
758
|
|
|
|
1,928
|
|
|
|
SPUS Revenues
|
|
90
|
|
|
|
90
|
|
|
|
605
|
|
|
|
300
|
|
|
|
Total Revenue
|
|
$
|
192
|
|
|
|
$
|
532
|
|
|
|
$
|
1,363
|
|
|
|
$
|
2,228
|
|
|
|
Revenue for the quarter ended September 30, 2008 was $192,000
reflecting a decrease of $340,000, or 64%, compared with the quarter ended September 30,
2007. There were no Novacor LVAS implant kits sold in the quarter ended September 30,
2008 compared to 4 implant kits sold in the quarter ended September 30,
2007. Novacor peripherals and other revenue, including Novacor LVAS hardware,
peripherals, and services, were $102,000 for the quarter ended September 30,
2008, a decrease of $34,000, or 25%, compared with Novacor peripherals and
services of $136,000 recorded in the quarter ended September 30, 2007.
16
Table of Contents
We do not expect to sell any additional
Novacor implant kits in the future as the Novacor LVAS has reached the natural
end of its life cycle and we are phasing out the product.
SPUS revenue was $90,000 for the quarter
ended September 30, 2008, or 47% of total revenue and $90,000 for the
quarter ended September 30, 2007, or 17% of total revenue. SPUS revenue in
recent quarters has become a greater percentage of our total revenue as Novacor
product revenues have declined, and we expect this trend to continue throughout
the remainder of 2008.
Revenue for the first nine months of 2008 was $1,363,000, a decrease of
$865,000, or 39%, compared with $2,228,000 recorded in the same period of 2007.
Novacor implant kits recognized as revenue for the nine months ended September 30,
2008 totaled five compared with 14 during the same period of 2007. Revenue
generated from Novacor products was $758,000 for the first nine months of 2008
compared to $1,928,000 for the same nine-month period in 2007, a decrease of
$1,170,000, or 61%. We anticipate no implant kit sales and continued declining
Novacor peripheral and other revenue throughout the remainder of 2008.
SPUS revenue, on the other hand, increased
from $300,000 in the first nine months of 2007 to $605,000 in the first nine
months of 2008, an increase of $305,000, or 102%. SPUS revenue was 44% of total
revenue in the first nine months of 2008, compared with 13% of total revenue in
the first nine months of 2007.
Cost of goods
sold:
For the three
months ended September 30, 2008, cost of goods sold was greater than
revenue at 106% of revenue, as an additional $99,000 of Novacor inventory
write-downs were taken in the quarter. Cost of goods sold for the three months
ended September 30, 2007 was 72% of revenue. Cost of goods sold as a
percent of revenue was 65% and 102% for the nine-month periods ended September 30,
2008 and September 30, 2007, respectively. The higher cost of goods sold
in the prior years nine-month period ended September 30, 2007 was due,
principally, to the write-off of excess Novacor LVAS inventories and expensing
of manufacturing variances. Gross profit for the nine-month period of 2008 has
improved when compared to the same periods in 2007 as a result of the shift in
revenue from lower margin Novacor products to higher margin SPUS product.
Selling
, general and administrative:
Selling, general and administrative
expenses consist primarily of payroll and related expenses for executives,
sales, marketing, accounting and administrative personnel. Selling expenses
primarily relate to enrollment of new centers in the anticipated Levacor
clinical trials, field support of existing Novacor patients and marketing/trade
show costs. Our other administrative expenses include professional fees,
communication expenses, insurance premiums, public reporting costs and general
corporate expenses.
The composition of selling,
general and administrative
expenses
in thousands ($000s) is as follows:
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
|
(Unaudited)
|
|
2008
|
|
2007
|
|
2008
|
|
2007
|
|
|
|
|
|
|
|
|
|
|
|
Selling
|
|
$
|
214
|
|
$
|
199
|
|
$
|
693
|
|
$
|
1,051
|
|
General and administrative
|
|
822
|
|
1,258
|
|
2,748
|
|
3,408
|
|
Total
|
|
$
|
1,036
|
|
$
|
1,457
|
|
$
|
3,441
|
|
$
|
4,459
|
|
Selling expenses for the three
months ended September 30, 2008 increased by $15,000, or 8%, compared with
the same period in 2007. For the nine-month period ended September 30,
2008 selling expenses decreased $358,000, or 34%, compared with the nine-month
period ended September 30, 2007. The decrease is attributable to our November 2006
restructuring, which eliminated most of our sales force by the second quarter
of 2007, as well as reduced personnel costs in Europe. For the three and nine
month periods ended September 30, 2008, we recorded $5,000 and $16,000,
respectively, in stock-based compensation expense compared with $0 in the
comparable 2007 periods. Selling expenses are expected to remain at current
levels for the next several quarters.
General and administrative
expenses for the three months ended September 30, 2008 decreased by
$436,000, or 35% compared with the same period in 2007. For the nine-month
period ended September 30, 2008, general and administrative expenses
decreased $660,000, or 19% compared with the nine-month period ended September 30,
2007. The decreases in both, the current quarter and nine months to date are
attributable to non-recurring charges incurred in 2007 for site restoration of
one of the two Oakland headquarters buildings previously occupied under a lease
which expired in April, 2007, cost savings realized from consolidation of our
Oakland facilities in late 2007, reduced legal expenses and $0 provision for
the 2008 annual employee bonus plan as performance milestones through September 30,
2008 have not been met. For the three and nine month periods ended September 30,
2008, we recorded $32,000, and $128,000, respectively, in stock-based
compensation expense compared with $131,000 and $273,000 recorded in the
comparable 2007 periods. General and administrative expenses are expected to
remain at about current levels for the next several quarters.
17
Table
of Contents
Research and
development:
Research and development expenses consist principally of salaries and
related expenses for research personnel, consulting, prototype manufacturing,
testing, clinical trials, material purchases and regulatory affairs incurred at
our Oakland and Salt Lake City facilities.
Research and development expenses for the three months ended September 30,
2008 increased $62,000, or 3%, compared with the three months ended September 30,
2007. The increase is attributable to non-recurring charges incurred related to
the R&D purchased technology from LaunchPoint in the third quarter of 2008
(See Note 10 of the Notes to Unaudited Condensed Consolidated Financial
Statements), offset in part by third quarter 2007 expenses
related to site restoration of one
of the two Oakland headquarters buildings previously occupied under a lease,
which expired in April 2007, and cost savings from consolidation of the
Oakland facilities during the fourth quarter of 2007. Additionally, due to cash
constraints during the second quarter of 2008 and into the third quarter of
2008, expenditures for Levacor development were curtailed. Research and development expenses for the
nine-month period ended September 30, 2008 decreased by $517,500, or 7%,
from the nine-month period ended September 30, 2007, primarily related to the non-recurring site
restoration charges incurred in 2007, the Oakland facilities consolidation and
$0 provision for the 2008 annual employee bonus plan as performance milestones
through September 30, 2008 have not been met. Research and
development expenses for our Levacor Rotary VAD are expected to increase during
the remainder of 2008 with additional development and pre-clinical testing.
Clinical and
marketing support-non-cash:
In the first quarter of
2008,
we recorded non-cash expense of $6.5 million
related to the fair value of the warrants to purchase 90,000 shares issued to
Abiomed. There was no such charge recorded for the quarter and nine-month period
ended September 30, 2007. (See Note 8 of the Notes to Unaudited Condensed
Consolidated Financial Statements).
Debt
inducement expense:
In the third quarter of
2008, we recorded an expense of $3.9 million associated with the induced
conversion of the Abiomed Note and termination of previously existing
agreements and warrants (See Note 8 and Note 9
of the Notes
to Unaudited Condensed Consolidated Financial Statements
). There was no such charge
recorded for the quarter and nine- month period ended September 30, 2007.
Amortization
of intangibles:
Amortization of the acquired MedQuest workforce for the quarter
ended September 30, 2008 and September 30, 2007 was $48,000 for both
periods. Amortization expense for the nine-month period September 30, 2008
and September 30, 2007 was $144,000, for both periods. This intangible
asset is being amortized on a straight-line basis over four years.
Foreign
Exchange:
Foreign exchange transactions resulted
in gains of $15,000 and $5,000 for the three and nine-month periods ended September 30,
2008 respectively. This compares with losses of $160,000 and $29,000 for the
three and nine-month periods ended September 30, 2007 respectively.
Investment
and other income:
Investment and other income for
the quarter ended September 30, 2008 was $103,000 compared to $665,000
during the quarter ended September 30, 2007. The 2007 period included
$620,000 of other income from the recognition of deferred revenue for certain
previously shipped Novacor product and the recognition of deferred clinical
fees associated with previously shipped Levacor VAD clinical product.
Investment and other income for the nine-month period ended September 30,
2008 was $121,000, compared to $924,000 for the nine-month period ended September 30,
2007. The decrease is primarily attributable to lower average invested cash
balances along with lower interest rates, immediate payment discounts granted
to customers in the second quarter of 2008 and the recognition in the
nine-month period ended September 30, 2007 of deferred revenue and
clinical fees.
Interest
expense:
Interest expense was $44,000 for the
third quarter of 2008 compared to $0 for the third quarter of 2007. In the
third quarter of 2008, interest expense on the Abiomed Note was $35,000 and
interest expense on the Bridge Loan was $8,000. For the nine-month period ended
September 30, 2008, interest expense was $1,659,000. Interest expense of
$1,414,000 for the nine-month period ended September 30, 2008 was related
to the beneficial conversion feature of the Abiomed Note recorded in the first
quarter, $234,000 was interest expense on the Note and $10,000 was interest
expense on the Bridge Loan. The Note and accumulated interest was converted
into common shares as part of the Recapitalization Agreement and the Bridge
Loan, along with accumulated interest, was deducted from the final
recapitalization proceeds. There were no such charges recorded for the quarter
and nine month periods ended September 30, 2007 (See Note 8 and Note 9 of
the Notes to Unaudited Condensed Consolidated Financial Statements). We do not
anticipate incurring interest expense in the foreseeable future.
18
Table of Contents
LIQUIDITY AND CAPITAL RESOURCES
Historically, we have funded
losses from operations through the sale of equity and issuance of debt
instruments. Combined with revenue and investment income, these funds have
provided us with the resources to operate our business, sell and support our
products, fund our research and development program and clinical trials, apply
for and obtain the necessary regulatory approvals and develop new technologies
and products.
At September 30, 2008,
we had cash and cash equivalents of $23.9 million, an increase of $23.2 million
from December 31, 2007. We received $4.0 million in proceeds in January 2008
from the second tranche of the Abiomed Note, Bridge Loan proceeds of $1.0
million in June 2008 and another $0.4 million in July 2008, and
recapitalization proceeds of $28.6 million, net of deductions of Bridge Loans
and interest, on July 31, 2008. For the first nine months of 2008, cash
used to fund operating activities was $9.5 million, consisting primarily of the
net loss for the period of $21.7 million, offset by non-cash charges of $1.5
million related to the beneficial conversion feature of the Abiomed note, $6.5
million related to the fair value of warrants issued to Abiomed and $3.9
million related to the Abiomed induced warrant conversion charge. Additional
non-cash charges of $0.9 million consist of amortization and depreciation,
write-down of inventory and stock option expense. Working capital changes
consisted of a $0.5 million decrease in inventories and a $1.0million decrease
in accounts payable and accrued compensation offset by an increase of $0.1
million in accounts receivable and prepaid expenses.
Investing activities in 2008
requiring cash resources consisted of $45,000 in property and equipment
additions.
On July 31, 2008, WorldHeart completed a $30.0 million private
placement transaction and recapitalization under the terms of the
Recapitalization Agreement dated June 20, 2008 and amended on July 31,
2008 (See Note 9
of the Notes to Unaudited Condensed Consolidated
Financial Statements
). With the completion of the private placement and recapitalization,
the Corporation believes it has sufficient cash to fund operations for at least
twelve months and believes that it will be able to realize its assets and discharge
its liabilities in the normal course of business.
CRITICAL ACCOUNTING ESTIMATES
As a result of the
Corporations decision to reduce commercial operations associated with the
Novacor LVAS, and refocus its resources on the development of its next generation
products, WorldHeart wrote-off $4.6 million of Novacor related inventories in
2006 that management estimated were surplus. In 2007 the Corporation wrote off
an additional $1.4 million of inventory. Through the first nine months of 2008
an additional $0.4 million of Novacor inventory was written-off. Management
estimated future usage of inventory on hand by projecting future sales of its
Novacor product, and used these to predict raw material parts and components
that would be consumed in manufacturing product to meet these sales. Future
write-downs may be required based on actual sales achieved and will be recorded
when they can be reasonably determined.
OFF- BALANCE SHEET ARRANGEMENTS
None.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET
RISK
Not
Required
ITEM 4. CONTROLS AND PROCEDURES
Evaluation
of disclosure controls and procedures
: Based on their
evaluation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and
15d-15(e) under the Exchange Act) as of September 30
, 2008
, our
president and chief executive officer (principal executive officer) and our
chief financial officer (principal accounting and financial officer) have
concluded that our disclosure controls and procedures are effective at the
reasonable assurance level.
Changes in
internal control over financial reporting:
There was no
change in our internal control over financial reporting that occurred during
the quarter ended
September 30, 2008
that has materially
affected, or is reasonably likely to materially affect, our internal control
over financial reporting.
19
Table
of Contents
PART IIOTHER
INFORMATION
ITEM 1. LEGAL PROCEEDINGS
In the normal course of
business, we may be a party to legal proceedings. We are not currently a party
to any material legal proceedings, except as described in our Annual report on Form 10-KSB/A
for the year ended December 31, 2007.
ITEM 2.
UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
(None)
ITEM 3.
DEFAULTS UPON SENIOR SECURITIES
(None)
ITEM 4.
SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
(None)
ITEM 5.
OTHER INFORMATION
(None)
ITEM
6. EXHIBITS
(a)
Exhibits
|
|
|
Exhibit 3.1
|
|
Amendment to Articles,
dated October 27, 2008 (4)
|
|
|
|
Exhibit 4.1
|
|
Share certificate
|
|
|
|
Exhibit 4.2
|
|
Registration Rights
Agreement between World Heart Corporation, its wholly-owned subsidiary World
Heart Inc. and certain investors named therein dated as of July 31, 2008
(1)
|
|
|
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Exhibit 4.3
|
|
Recapitalization
Agreement between World Heart Corporation, its wholly-owned subsidiary World
Heart Inc. and certain investors named therein dated as of June 20, 2008
(2)
|
|
|
|
Exhibit 4.4
|
|
Amendment No. 1 to
the Recapitalization Agreement among World Heart Corporation, its
wholly-owned subsidiary World Heart Inc. and certain investors named therein
dated as of July 31, 2008 (1)
|
|
|
|
Exhibit 4.5
|
|
Amendment and Waiver to
Registration Rights Agreement between World Heart Corporation, its
wholly-owned subsidiary World Heart Inc. and certain investors named therein
dated as of November 3, 2008 (3)
|
|
|
|
Exhibit 10.1
|
|
Release Agreement (1)
|
|
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Exhibit 10.2
|
|
Consulting Agreement
Amendment, dated October 30, 2008, between World Heart Inc. and Pellone
Enterprises Incorporated (4)
|
|
|
|
Exhibit 31.1
|
|
Certification of
Principal Executive Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
|
|
Exhibit 31.2
|
|
Certification of
Principal Financial Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
|
|
Exhibit 32.1
|
|
Certification of
Principal Executive Officer pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002, 18 U.S.C. 1350.
|
|
|
|
Exhibit 32.2
|
|
Certification of
Principal Financial Officer pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002, 18 U.S.C. 1350.
|
(1) Incorporated
by reference to exhibits to our Current Report on Form 8-K filed August 6,
2008.
(2) Incorporated
by reference to exhibits to our Current Report on Form 8-K filed June 30,
2008.
(3) Incorporated
by reference to exhibits to our Registration Statement on Form S-3 filed November 6,
2008.
(4) Incorporated
by reference to exhibits to our Current Report on Form 8-K filed October 31,
2008.
20
Table of Contents
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.
|
World Heart Corporation
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(Registrant)
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Dated:
November 14, 2008
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/s/ Jal S. Jassawalla
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|
Jal S.
Jassawalla, President and Chief
Executive Officer
|
|
|
Dated: November 14, 2008
|
/s/ David Pellone
|
|
David
Pellone, Vice President, Finance
and Chief Financial Officer
|
21
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