UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 10-Q
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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 the quarterly period ended September 30, 2014
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OR
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Canada
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98-0661854
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification Number)
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200-3650 Gilmore Way
Burnaby, British Columbia V5G 4W8
Canada
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(Address of principal executive offices)
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(604) 484-3300
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(Registrant’s telephone number, including area code)
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Large accelerated filer
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¨
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Accelerated filer
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¨
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Non-accelerated filer
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x
(Do not check if a smaller reporting company)
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Smaller reporting company
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¨
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PAGE
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PART I. FINANCIAL INFORMATION | |||
Item 1: | |||
Item 2: | |||
Item 3: | |||
Item 4: | |||
PART II. OTHER INFORMATION | |||
Item 1: | |||
Item 1A: | |||
Item 2: | |||
Item 6: | |||
SIGNATURES | |||
EXHIBIT INDEX |
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December 31,
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September 30,
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||||||
2013
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2014
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|||||||
Assets
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||||||||
Current assets:
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||||||||
Cash and cash equivalents
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$ | 37,950 | $ | 33,731 | ||||
Marketable securities
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11,326 | 14,205 | ||||||
Accounts receivable
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440 | 162 | ||||||
Prepaid expenses and other current assets
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153 | 171 | ||||||
Total current assets
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49,869 | 48,269 | ||||||
Deferred financing fees
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2,739 | 3,876 | ||||||
Property, plant and equipment, net
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1,879 | 1,999 | ||||||
Total assets
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$ | 54,487 | $ | 54,144 | ||||
Liabilities and Shareholders’ Deficit
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||||||||
Current liabilities:
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||||||||
Accounts payable and accrued expenses (note 7)
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2,283 | 2,821 | ||||||
Deferred revenue
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15,920 | 13,522 | ||||||
Total current liabilities
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18,203 | 16,343 | ||||||
Deferred revenue, less current portion
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11,886 | 2,603 | ||||||
Deferred tenant inducements
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282 | 219 | ||||||
Total
liabilities
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$ | 30,371 | $ | 19,165 | ||||
Collaboration agreements (note 9)
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||||||||
Contingencies (note 10)
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||||||||
Subsequent events (note11)
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||||||||
Redeemable convertible preferred shares:
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||||||||
Series A Convertible Preferred shares, without par value; 1,205,761 authorized and 1,151,468 issued and outstanding at December 31, 2013 and September 30, 2014, respectively
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2,939 | 2,939 | ||||||
Series B Convertible Preferred shares, without par value; 1,028,806 authorized and 994,885 issued and outstanding at December 31, 2013, and September 30, 2014, respectively
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8,683 | 8,683 | ||||||
Series E Convertible Preferred shares, without par value; 4,370,920 authorized and 4,322,126 issued and outstanding at December 31, 2013, and September 30, 2014, respectively
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90,866 | 90,866 | ||||||
Total redeemable convertible preferred shares
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102,488 | 102,488 | ||||||
Shareholders’ deficit:
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||||||||
Common shares, without par value; unlimited shares authorized; 1,344,627 and 1,349,591 issued and outstanding at December 31, 2013 and September 30, 2014, respectively
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6,147 | 6,198 | ||||||
Additional paid-in capital
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29,722 | 30,242 | ||||||
Accumulated deficit
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(116,752 | ) | (104,958 | ) | ||||
Accumulated comprehensive income
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2,511 | 1,009 | ||||||
Total shareholders’ deficit
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$ | (78,372 | ) | $ | (67,509 | ) | ||
Total liabilities, shareholders’ deficit and redeemable convertible preferred shares
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$ | 54,487 | $ | 54,144 |
Three Months Ended
September 30,
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Nine Months Ended
September 30,
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|||||||||||||||
2013
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2014
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2013
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2014
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|||||||||||||
Revenue:
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||||||||||||||||
Collaboration revenue
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$ | 10,786 | $ | 13,192 | $ | 21,771 | $ | 23,489 | ||||||||
Royalties
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2 | 1 | 2 | 3 | ||||||||||||
10,788 | 13,193 | 21,773 | 23,492 | |||||||||||||
Operating expenses:
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||||||||||||||||
Research and development
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2,577 | 3,216 | 9,560 | 8,315 | ||||||||||||
General and administrative
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1,692 | 1,316 | 4,520 | 4,106 | ||||||||||||
Total operating expenses
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4,269 | 4,532 | 14,080 | 12,421 | ||||||||||||
Income from operations
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6,519 | 8,661 | 7,693 | 11,071 | ||||||||||||
Other income (expense):
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||||||||||||||||
Interest income
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117 | 138 | 193 | 416 | ||||||||||||
Interest expense
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(15 | ) | - | (56 | ) | - | ||||||||||
Foreign exchange gain (loss)
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(243 | ) | 392 | 1,677 | 307 | |||||||||||
Gain on write-off and disposal of assets
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- | - | 11 | - | ||||||||||||
Net income
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6,378 | 9,191 | 9,518 | 11,794 | ||||||||||||
Net income attributable to participating securities
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5,059 | 5,596 | 8,199 | 8,199 | ||||||||||||
Net income attributable to common shareholders
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$ | 1,319 | $ | 3,595 | $ | 1,319 | $ | 3,595 | ||||||||
Net income per share attributable to common shareholders:
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||||||||||||||||
Basic
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$ | 0.99 | $ | 2.67 | $ | 0.99 | $ | 2.67 | ||||||||
Diluted
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$ | 0.63 | $ | 1.69 | $ | 0.74 | $ | 1.71 | ||||||||
Weighted-average shares outstanding:
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||||||||||||||||
Basic
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1,337,028 | 1,348,417 | 1,334,905 | 1,346,989 | ||||||||||||
Effects of dilutive securities:
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||||||||||||||||
Stock options
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728,687 | 763,949 | 445,314 | 749,967 | ||||||||||||
Subscription rights
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14,353 | 10,400 | 12,813 | 11,447 | ||||||||||||
Diluted
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2,080,068 | 2,122,766 | 1,793,032 | 2,108,403 |
Three Months Ended
September 30,
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Nine Months Ended
September 30,
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2013
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2014
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2013
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2014
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Net income
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$ | 6,378 | $ | 9,191 | $ | 9,518 | $ | 11,794 | ||||||||
Other comprehensive income (loss):
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||||||||||||||||
Foreign currency translation adjustment
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332 | (1,512 | ) | (458 | ) | (1,502 | ) | |||||||||
Comprehensive income
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$ | 6,710 | $ | 7,679 | $ | 9,060 | $ | 10,292 |
Series A convertible
preferred shares
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Series B convertible
preferred shares
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Series E convertible
preferred shares
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Common shares
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Additional
paid-in
capital
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Accumulated
deficit
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Accumulated
comprehensive
income
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Total
Shareholder's
deficit
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|||||||||||||||||||||||||||||||||||||||||
Shares
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Amount
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Shares
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Amount
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Shares
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Amount
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Shares
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Amount
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|||||||||||||||||||||||||||||||||||||||||
Balance as of December 31, 2012
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1,151,468 | $ | 2,939 | 994,885 | $ | 8,683 | 4,322,126 | $ | 90,866 | 1,330,696 | $ | 6,008 | 29,164 | $ | (128,784 | ) | $ | 3,747 | $ | (89,865 | ) | |||||||||||||||||||||||||||
Net income for the year
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12,032 | 12,032 | ||||||||||||||||||||||||||||||||||||||||||||||
Cumulative translation adjustment
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(1,236 | ) | (1,236 | ) | ||||||||||||||||||||||||||||||||||||||||||||
Stock option compensation expense
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575 | 575 | ||||||||||||||||||||||||||||||||||||||||||||||
Subscription rights
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73 | 73 | ||||||||||||||||||||||||||||||||||||||||||||||
Issuance of common shares on conversion of subscription rights
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5,602 | 45 | (45 | ) | - | |||||||||||||||||||||||||||||||||||||||||||
Issued pursuant to exercise of stock options
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8,329 | 94 | (45 | ) | 49 | |||||||||||||||||||||||||||||||||||||||||||
Balance as of December 31, 2013
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1,151,468 | $ | 2,939 | 994,885 | $ | 8,683 | 4,322,126 | $ | 90,866 | 1,344,627 | $ | 6,147 | $ | 29,722 | $ | (116,752 | ) | $ | 2,511 | $ | (78,372 | ) | ||||||||||||||||||||||||||
Net income for the period
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11,794 | 11,794 | ||||||||||||||||||||||||||||||||||||||||||||||
Cumulative translation adjustment
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(1,502 | ) | (1,502 | ) | ||||||||||||||||||||||||||||||||||||||||||||
Stock option compensation expense
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561 | 561 | ||||||||||||||||||||||||||||||||||||||||||||||
Issuance of common shares on conversion of subscription rights
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3,164 | 32 | (32 | ) | - | |||||||||||||||||||||||||||||||||||||||||||
Issued pursuant to exercise of stock options
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1,800 | 19 | (9 | ) | 10 | |||||||||||||||||||||||||||||||||||||||||||
Balance as of September 30, 2014
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1,151,468 | $ | 2,939 | 994,885 | $ | 8,683 | 4,322,126 | $ | 90,866 | 1,349,591 | $ | 6,198 | $ | 30,242 | $ | (104,958 | ) | $ | 1,009 | $ | (67,509 | ) |
Nine Months Ended September 30,
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2013
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2014
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Operating activities
:
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||||||||
Net income
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$ | 9,518 | $ | 11,794 | ||||
Adjustments to reconcile net income to net cash provided by (used in) operating activities:
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Depreciation and amortization
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531 | 533 | ||||||
Gain on write-off and disposal of assets
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(11 | ) | - | |||||
Stock-based compensation
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413 | 561 | ||||||
Non-cash compensation on issuance of subscription rights
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54 | - | ||||||
Interest accrued on note payable
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35 | - | ||||||
Deferred tenant inducements
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133 | (50 | ) | |||||
Foreign exchange loss (gain)
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23 | 52 | ||||||
Changes in operating assets and liabilities:
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||||||||
Accounts receivable
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(1,022 | ) | 267 | |||||
Prepaid expenses, and other current assets
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(81 | ) | (27 | ) | ||||
Accounts payable and accrued expenses
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2,145 | 614 | ||||||
Deferred revenue
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(12,374 | ) | (10,527 | ) | ||||
Net cash provided by (used in) operating activities
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(636 | ) | 3,217 | |||||
Investing activities
:
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||||||||
Purchases of property, plant and equipment
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(115 | ) | (753 | ) | ||||
Sale of property, plant and equipment
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10 | - | ||||||
Purchase of marketable securities
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(9,513 | ) | (15,334 | ) | ||||
Proceeds from marketable securities
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- | 11,803 | ||||||
Net cash used in investing activities
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(9,618 | ) | (4,284 | ) | ||||
Financing activities
:
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||||||||
Note payable
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(1,701 | ) | - | |||||
Deferred financing costs
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(2,713 | ) | (1,305 | ) | ||||
Proceeds from issuance of common shares
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14 | 10 | ||||||
Net cash used in financing activities
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(4,400 | ) | (1,295 | ) | ||||
Effect of exchange rate changes on cash and
cash equivalents
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(1,897 | ) | (1,857 | ) | ||||
Decrease in cash and cash equivalents
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(16,551 | ) | (4,219 | ) | ||||
Cash and cash equivalents, beginning of period
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60,162 | 37,950 | ||||||
Cash and cash equivalents, end of period
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$ | 43,611 | $ | 33,731 | ||||
Supplemental information:
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Non-cash transactions:
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||||||||
Fair value of stock options transferred from additional paid-in capital to share capital on exercise
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$ | 36 | $ | 9 | ||||
Issuance of common shares on conversion of subscription rights
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19 | 32 | ||||||
Interest paid
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(35 | ) | - |
December 31,
|
September 30,
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|||||||
2013
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2014
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|||||||
Trade payables
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$ | 391 | $ | 511 | ||||
Employee compensation, benefits, and related accruals
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520 | 840 | ||||||
Consulting and contracted research
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412 | 293 | ||||||
Professional fees
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694 | 804 | ||||||
Other
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266 | 373 | ||||||
Total
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$ | 2,283 | $ | 2,821 |
Three Months Ended
September 30,
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Nine Months Ended
September 30,
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2013
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2014
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2013
|
2014
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Outstanding, beginning of period
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1,304,441 | 1,442,741 | 1,128,437 | 1,333,099 | ||||||||||||
Granted
|
42,592 | 6,273 | 292,417 | 163,504 | ||||||||||||
Exercised
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(3,086 | ) | (1,028 | ) | (4,115 | ) | (1,800 | ) | ||||||||
Forfeited and expired
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(876 | ) | (4,411 | ) | (73,668 | ) | (51,228 | ) | ||||||||
Outstanding, end of period
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1,343,071 | 1,443,575 | 1,343,071 | 1,443,575 | ||||||||||||
Exercisable, end of period
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898,894 | 1,078,009 | 898,894 | 1,078,009 |
Three Months Ended
September 30,
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Nine Months Ended
September 30,
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2013
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2014
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2013
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2014
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Average risk-free interest rate
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1.82 | % | 1.95 | % | 1.03 | % | 1.97 | % | ||||||||
Average expected term (in years)
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6.00 | 6.25 | 6.20 | 6.20 | ||||||||||||
Expected volatility
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70 | % | 74 | % | 70 | % | 74 | % | ||||||||
Expected dividend yield
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0.00 | % | 0.00 | % | 0.00 | % | 0.00 | % | ||||||||
Estimated forfeiture rate
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0.00 | % | 0.00 | % | 0.00 | % | 0.00 | % |
Three months ended
September 30,
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Nine months ended
September 30,
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2013 | 2014 | 2013 | 2014 | |||||||||||||
uniQure:
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Milestone payment
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$ | 267 | $ | 14 | $ | 267 | $ | 14 | ||||||||
Teva:
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||||||||||||||||
Recognition of upfront payment
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3,284 | 3,132 | 9,891 | 9,252 | ||||||||||||
Research funding
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169 | 84 | 463 | 251 | ||||||||||||
Genentech:
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||||||||||||||||
Recognition of upfront payment
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824 | 981 | 2,483 | 2,736 | ||||||||||||
Research funding
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1,128 | 994 | 3,385 | 3,249 | ||||||||||||
Milestone payment
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5,093 | 7,987 | 5,093 | 7,987 | ||||||||||||
Genome BC:
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||||||||||||||||
Research funding
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21 | - | 189 | - | ||||||||||||
Total collaboration revenue
|
$ | 10,786 | $ | 13,192 | $ | 21,771 | $ | 23,489 |
Preferred Shares
Outstanding
|
Conversion
into Common
Shares upon
Initial Public
Offering
|
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Series A
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1,151,468 | 1,151,468 | ||||||
Series B
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994,885 | 994,885 | ||||||
Series E
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4,322,126 | 5,579,571 | ||||||
Total
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6,468,479 | 7,725,924 |
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·
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our ability to identify additional products or product candidates using our Extreme Genetics discovery platform;
|
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·
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the initiation, timing, cost, progress and success of our research and development programs, preclinical studies and clinical trials;
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·
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our ability to advance product candidates into, and successfully complete, clinical trials;
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·
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our ability to recruit sufficient numbers of patients for our future clinical trials for orphan or more common indications;
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·
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our ability to achieve profitability;
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·
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our ability to obtain funding for our operations, including research funding;
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·
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our ability to receive milestones, royalties and sublicensing fees under our collaborations, and the timing of such payments;
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·
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the implementation of our business model and strategic plans;
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·
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our ability to develop and commercialize product candidates for orphan and niche indications independently;
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·
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our commercialization, marketing and manufacturing capabilities and strategy;
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·
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our ability to find families to support our Extreme Genetics discovery platform;
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·
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our ability to discover genes and drug targets;
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·
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our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others;
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·
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our expectations regarding federal, state and foreign regulatory requirements;
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·
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the therapeutic benefits, effectiveness and safety of our product candidates;
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·
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the accuracy of our estimates of the size and characteristics of the markets that may be addressed by our products and product candidates;
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·
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the rate and degree of market acceptance and clinical utility of Glybera and future products, if any;
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·
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the timing of and our and our collaborators’ ability to obtain and maintain regulatory approvals for our product candidates;
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·
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our ability to maintain and establish collaborations;
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·
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our use of proceeds from this offering and the concurrent private placement;
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·
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our expectations regarding market risk, including interest rate changes and foreign currency fluctuations;
|
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·
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our belief in the sufficiency of our cash flows to meet our needs for at least the next 12 to 24 months;
|
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·
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our ability to engage and retain the employees required to grow our business;
|
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·
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our future financial performance and projected expenditures;
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·
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developments relating to our competitors and our industry, including the success of competing therapies that are or become available; and
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·
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estimates of our expenses, future revenue, capital requirements and our needs for additional financing.
|
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·
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Glybera, developed by our licensee uniQure Biopharma B.V., or uniQure, the first, and currently the only, gene therapy approved in the EU for the treatment of the orphan disorder lipoprotein lipase deficiency, or LPLD. We believe that uniQure’s commercialization partner, Chiesi Farmaceutici S.p.A., or Chiesi, plans to launch Glybera in the fourth quarter of 2014 or the first quarter of 2015;
|
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·
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TV-45070 (formerly XEN402), a product candidate with four Phase 2 proof-of-concept clinical trials
completed. Our partner Teva is conducting a 300-patient, randomized Phase 2b clinical trial in osteoarthritis, or OA, of the knee and is planning a Phase 2b clinical trial in patients with postherpetic neuralgia, or PHN, that is expected to start in the first half of 2015;
|
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·
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GDC-0276, a product candidate being developed in collaboration with Genentech for the treatment of pain. In September 2014, Genentech initiated a Phase 1 clinical trial for GDC-0276; and
|
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·
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proprietary preclinical programs, including a sodium channel inhibitor for the orphan disorder Dravet Syndrome, or DS, and XEN801, a stearoyl Co-A desaturase, or SCD1, inhibitor for the treatment of acne. We anticipate filing an investigational new drug application, or IND, for XEN801 in the first half of 2015 and an IND for our DS program in 2016.
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·
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continue our research and preclinical and clinical development of our product candidates;
|
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·
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seek regulatory and marketing approvals for any of our product candidates that successfully complete clinical trials;
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·
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make milestone and other payments under our in-license agreements;
|
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·
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maintain, protect and expand our intellectual property portfolio;
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|
·
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attract, hire and retain skilled personnel; and
|
|
·
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create additional infrastructure to support our operations as a public company and otherwise.
|
Three months ended
September 30,
|
Nine months ended
September 30,
|
|||||||||||||||
2013
|
2014
|
2013
|
2014
|
|||||||||||||
uniQure:
|
||||||||||||||||
Milestone payment
|
$ | 267 | $ | 14 | $ | 267 | $ | 14 | ||||||||
Teva:
|
||||||||||||||||
Recognition of upfront payment
|
3,284 | 3,132 | 9,891 | 9,252 | ||||||||||||
Research funding
|
169 | 84 | 463 | 251 | ||||||||||||
Genentech:
|
||||||||||||||||
Recognition of upfront payment
|
824 | 981 | 2,483 | 2,736 | ||||||||||||
Research funding
|
1,128 | 994 | 3,385 | 3,249 | ||||||||||||
Milestone payment
|
5,093 | 7,987 | 5,093 | 7,987 | ||||||||||||
Genome BC:
|
||||||||||||||||
Research funding
|
21 | - | 189 | - | ||||||||||||
Total collaboration revenue
|
$ | 10,786 | $ | 13,192 | $ | 21,771 | $ | 23,489 |
December 31, 2013
|
September 30, 2014
|
|||||||
Teva
|
$ | 24,691 | $ | 14,332 | ||||
Genentech
|
3,115 | 1,793 | ||||||
Total deferred revenue
|
$ | 27,806 | $ | 16,125 |
Three months ended
September 30,
|
Nine months ended
September 30,
|
|||||||||||||||
2013
|
2014
|
2013
|
2014
|
|||||||||||||
Research and development
|
$ | 2,577 | $ | 3,216 | $ | 9,560 | $ | 8,315 | ||||||||
General and administrative
|
1,692 | 1,316 | 4,520 | 4,106 | ||||||||||||
Total operating expenses
|
$ | 4,269 | $ | 4,532 | $ | 14,080 | $ | 12,421 |
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
|||||||||||||||||||||||
2013
|
2014
|
Change
|
2013
|
2014
|
Change
|
|||||||||||||||||||
Collaboration revenue
|
$ | 10,786 | $ | 13,192 | $ | 2,406 | $ | 21,771 | $ | 23,489 | $ | 1,718 | ||||||||||||
Royalties
|
2 | 1 | (1 | ) | 2 | 3 | 1 | |||||||||||||||||
Research and development expenses
|
2,577 | 3,216 | 639 | 9,560 | 8,315 | (1,245 | ) | |||||||||||||||||
General and administrative expenses
|
1,692 | 1,316 | (376 | ) | 4,520 | 4,106 | (414 | ) | ||||||||||||||||
Other:
|
||||||||||||||||||||||||
Interest income
|
117 | 138 | 21 | 193 | 416 | 223 | ||||||||||||||||||
Interest (expense)
|
(15 | ) | - | 15 | (56 | ) | - | 56 | ||||||||||||||||
Foreign exchange gain (loss)
|
(243 | ) | 392 | 635 | 1,677 | 307 | (1,370 | ) | ||||||||||||||||
Gain on write-off and disposal of assets
|
- | - | 11 | - | (11 | ) | ||||||||||||||||||
Net income
|
$ | 6,378 | $ | 9,191 | $ | 2,813 | $ | 9,518 | $ | 11,794 | $ | 2,276 |
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
|||||||||||||||||||||||
2013
|
2014
|
Change
|
2013
|
2014
|
Change
|
|||||||||||||||||||
Teva collaboration (TV-45070) expenses
|
$ | 203 | $ | 510 | $ | 307 | $ | 685 | $ | 1,044 | $ | 359 | ||||||||||||
Genentech collaboration (GDC-0276 and Genetics) expenses
|
1,237 | 1,250 | 13 | 3,595 | 3,821 | 226 | ||||||||||||||||||
Other collaboration expenses
|
35 | - | (35 | ) | 124 | - | (124 | ) | ||||||||||||||||
Preclinical and discovery program expenses
|
1,102 | 1,456 | 354 | 5,156 | 3,450 | (1,706 | ) | |||||||||||||||||
Total research and development expenses
|
$ | 2,577 | $ | 3,216 | $ | 639 | $ | 9,560 | $ | 8,315 | $ | (1,245 | ) |
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
|||||||||||||||||||||||
2013
|
2014
|
Change
|
2013
|
2014
|
Change
|
|||||||||||||||||||
General and administrative expenses
|
$ | 1,692 | $ | 1,316 | $ | (376 | ) | $ | 4,520 | $ | 4,106 | $ | (414 | ) |
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
|||||||||||||||||||||||
2013
|
2014
|
Change
|
2013
|
2014
|
Change
|
|||||||||||||||||||
Other income (expenses)
|
$ | (141 | ) | $ | 530 | $ | 671 | $ | 1,825 | $ | 723 | $ | (1,102 | ) |
|
·
|
whether our existing collaborations continue to generate research funding, milestone payments and royalties to us;
|
|
·
|
the number and stage of development of future product candidates that we choose to pursue;
|
|
·
|
the scope, progress, results and costs of research and development of our future product candidates independently, and conducting preclinical research and clinical studies;
|
|
·
|
the timing and costs involved in obtaining regulatory approvals for any future product candidates we develop independently;
|
|
·
|
the cost associated with exercising our co-promotion option for TV-45070 in the U.S., should the opportunity arise and we choose to do so;
|
|
·
|
the cost of commercialization activities, if any, of any future product candidates we develop independently that are approved for sale, including marketing, sales and distribution costs;
|
|
·
|
the cost of manufacturing our future product candidates and any products we successfully commercialize independently;
|
|
·
|
our ability to maintain existing collaborations and to establish new collaborations, licensing or other arrangements and the financial terms of such arrangements;
|
|
·
|
the costs of preparing, filing, prosecuting, maintaining, defending and enforcing patents, including litigation costs and the outcome of such litigation; and
|
|
·
|
the timing, receipt and amount of sales, or royalties on Glybera, TV-45070, GDC-0276, and our future product candidates, if any.
|
Nine Months Ended September 30,
|
||||||||
2013
|
2014
|
|||||||
Net cash provided by (used in) operating activities
|
$ | (636 | ) | $ | 3,217 | |||
Net cash used in investing activities
|
(9,618 | ) | (4,284 | ) | ||||
Net cash used in financing activities
|
(4,400 | ) | (1,295 | ) |
● |
continue our research and preclinical and clinical development of our product candidates;
|
● |
expand the scope of our clinical studies for our current and prospective product candidates;
|
● |
initiate additional preclinical, clinical or other studies for our product candidates, including under our collaboration agreements;
|
● |
change or add additional manufacturers or suppliers;
|
● |
seek regulatory and marketing approvals for any of our product candidates that successfully complete clinical studies;
|
● |
seek to identify and validate additional product candidates;
|
● |
acquire or in-license other product candidates and technologies;
|
● |
make milestone or other payments under our in-license agreements including, without limitation, our agreements with the University of British Columbia, or UBC, and the Memorial University of Newfoundland;
|
● |
maintain, protect and expand our intellectual property portfolio;
|
● |
establish a sales, marketing and distribution infrastructure to commercialize any products for which we or one of our collaborators may obtain marketing approval, and for which we have maintained commercial rights;
|
● |
create additional infrastructure to support our operations as a public company and our product development and planned future commercialization efforts; and
|
● |
experience any delays or encounter issues with any of the above.
|
● |
completing research, preclinical and clinical development of our product candidates;
|
● |
seeking and obtaining regulatory and marketing approvals for product candidates for which we complete clinical studies;
|
● |
commercializing products for which we obtain regulatory and marketing approval, either with a collaborator or, if launched independently, by establishing sales, marketing and distribution infrastructure;
|
● |
negotiating favorable terms in any collaboration, licensing or other arrangements into which we may enter;
|
● |
obtaining market acceptance of products for which we obtain regulatory and marketing approval as therapies;
|
● |
addressing any competing technological and market developments;
|
● |
establishing and maintaining supply and manufacturing relationships with third parties that can provide adequate (in amount and quality) products and services to support clinical development and the market demand for any approved products in the future;
|
● |
developing a sustainable, scalable, reproducible, and transferable manufacturing processes for any of our products approved in the future;
|
● |
maintaining, protecting, expanding and enforcing our portfolio of intellectual property rights, including patents, trade secrets and know-how;
|
● |
implementing additional internal systems and infrastructure, as needed; and
|
● |
attracting, hiring and retaining qualified personnel.
|
● |
the number and characteristics of the future product candidates we pursue;
|
● |
the scope, progress, results and costs of independently researching and developing any of our future product candidates, and conducting preclinical research and clinical trials;
|
● |
whether our existing collaborations continue to generate substantial milestone payments and, ultimately, royalties on future products for us;
|
● |
the timing of, and the costs involved in, obtaining regulatory approvals for any future product candidates we develop independently;
|
● |
the cost of future commercialization activities, including activities required pursuant to our option to co-promote TV-45070, if exercised by us, and the cost of commercializing any future products we develop independently that are approved for sale;
|
● |
the cost of manufacturing our future products, if any;
|
● |
our ability to maintain existing collaborations and to establish new collaborations, licensing or other arrangements and the financial terms of such agreements;
|
● |
the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patents, including litigation costs and the outcome of such litigation; and
|
● |
the timing, receipt and amount of sales of, or royalties on, Glybera, and our future products, if any.
|
● |
establishment and demonstration of clinical efficacy and safety and acceptance of the same by the medical community;
|
● |
commercialization of competing products;
|
● |
sufficient commercial supply of Glybera;
|
● |
cost-effectiveness of Glybera;
|
● |
the availability of coverage and adequate reimbursement from third parties, including governmental payers, managed care organizations, and private health insurers;
|
● |
the relative cost, safety and efficacy of therapies that exist now or may be developed in the future;
|
● |
whether the product can be manufactured in commercial quantities at acceptable cost;
|
● |
marketing and distribution support for Glybera;
|
● |
the effect of current and future healthcare laws;
|
● |
the acceptance of gene therapies as a class of treatment; and
|
● |
any market or regulatory exclusivities applicable to the product.
|
● |
execute our clinical development plans for later-stage product candidates;
|
● |
obtain required regulatory approvals in each jurisdiction in which we will seek to commercialize products;
|
● |
build and maintain appropriate sales, distribution and marketing capabilities;
|
● |
gain market acceptance for our future products, if any; and
|
● |
manage our spending as costs and expenses increase due to clinical trials, regulatory approvals and commercialization activities.
|
● |
different regulatory requirements for maintaining approval of drugs and biologics in foreign countries;
|
● |
reduced protection for intellectual property rights in certain countries;
|
● |
unexpected changes in tariffs, trade barriers and regulatory requirements;
|
● |
economic weakness, including inflation, political instability or open conflict in particular foreign economies and markets;
|
● |
compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;
|
● |
foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident to doing business in another country;
|
● |
workforce uncertainty in countries where labor unrest is more common than in North America;
|
● |
tighter restrictions on privacy and the collection and use of data, including genetic material, may apply in jurisdictions outside of North America, where we find some of the families with individuals that exhibit the severe phenotypes that we study; and
|
● |
business interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters including earthquakes, typhoons, floods and fires.
|
● |
disruption in our relationships with collaborators or suppliers as a result of such a transaction;
|
● |
unanticipated liabilities related to acquired companies;
|
● |
difficulties integrating acquired personnel, technologies and operations into our existing business;
|
● |
retention of key employees;
|
● |
diversion of management time and focus from operating our business to management of strategic alliances or joint ventures or acquisition integration challenges;
|
● |
increases in our expenses and reductions in our cash available for operations and other uses; and
|
● |
possible write-offs or impairment charges relating to acquired businesses.
|
● |
the FDA, EMA or other regulatory authorities may disagree with the design or implementation of our or our collaborators’ clinical trials;
|
● |
we or our collaborators may be unable to demonstrate to the satisfaction of the FDA, EMA or other regulatory authorities that a product candidate is safe and effective for its proposed indication;
|
● |
the results of clinical trials may not meet the level of statistical significance required by the FDA, EMA or other regulatory authorities for approval;
|
● |
we, or our collaborators, may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks;
|
● |
the FDA, EMA or other regulatory authorities may disagree with our or our collaborators’ interpretation of data from preclinical studies or clinical trials;
|
● |
the data collected from clinical trials of our product candidates may not be sufficient to support the submission of a New Drug Application, or NDA, or other submission or to obtain regulatory approval in the U.S. or elsewhere;
|
● |
the FDA, EMA or other regulatory authorities may fail to approve the manufacturing processes or facilities of third-party manufacturers with which we or our collaborators contract for clinical and commercial supplies; and
|
● |
the approval policies or regulations of the FDA, EMA or other regulatory authorities outside of the U.S. may significantly change in a manner rendering our or our collaborators’ clinical data insufficient for approval.
|
● |
side effects or adverse events in study participants presenting an unacceptable safety risk;
|
● |
inability to reach agreement with prospective contract research organizations, or CROs, and clinical trial sites, or the breach of such agreements;
|
● |
failure of third-party contractors, such as CROs, or investigators to comply with regulatory requirements;
|
● |
delay or failure in obtaining the necessary approvals from regulators or institutional review boards, or IRBs, in order to commence a clinical trial at a prospective trial site, or their suspension or termination of a clinical trial once commenced;
|
● |
a requirement to undertake and complete additional preclinical studies to generate data required to support the submission of an NDA;
|
● |
inability to enroll sufficient patients to complete a protocol, particularly in orphan diseases;
|
● |
difficulty in having patients complete a trial or return for post-treatment follow-up;
|
● |
clinical sites deviating from trial protocol or dropping out of a trial;
|
● |
problems with drug product or drug substance storage and distribution;
|
● |
adding new clinical trial sites;
|
● |
our inability to manufacture, or obtain from third parties, adequate supply of drug substance or drug product sufficient to complete our preclinical studies and clinical trials; and
|
● |
governmental or regulatory delays and changes in regulatory requirements, policy and guidelines.
|
● |
severity of the disease under investigation;
|
● |
design of the study protocol;
|
● |
size of the patient population;
|
● |
eligibility criteria for the study in question;
|
● |
perceived risks and benefits of the product candidate under study;
|
● |
proximity and availability of clinical study sites for prospective patients;
|
● |
availability of competing therapies and clinical studies;
|
● |
efforts to facilitate timely enrollment in clinical studies; and
|
● |
patient referral practices of physicians.
|
● |
identify families as potential candidates for study;
|
● |
obtain their consent to participate in our research;
|
● |
perform medical examinations and gather medical histories;
|
● |
conduct the initial analysis of suitability of the families to participate in our research based on the foregoing; and
|
● |
collect data and biological samples from the family members periodically in accordance with our study protocols.
|
● |
our inability to recruit and retain adequate numbers of effective sales and marketing personnel to or develop alternative sales channels;
|
● |
the inability of sales personnel to obtain access to physicians or persuade adequate numbers of physicians to prescribe any future products;
|
● |
the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; and
|
● |
unforeseen costs and expenses associated with creating and maintaining an independent sales and marketing organization.
|
● |
restrictions on the marketing or manufacturing of the product, withdrawal of the product from the market or voluntary or mandatory product recalls;
|
● |
fines, warning letters or holds on any post-approval clinical trials;
|
● |
refusal by the FDA, EMA or another applicable regulatory authority to approve pending applications or supplements to approved applications filed by us or our collaborators, or suspension or revocation of product license approvals;
|
● |
product seizure or detention, or refusal to permit the import or export of products; and
|
● |
injunctions or the imposition of civil or criminal penalties.
|
● |
an annual, nondeductible fee on any entity that manufactures or imports certain branded prescription drugs and biologic agents, apportioned among these entities according to their market share in certain government healthcare programs, that began in 2011;
|
● |
an increase in the rebates a manufacturer must pay under the Medicaid Drug Rebate Program to 23.1% and 13% of the average manufacturer price for branded and generic drugs, respectively;
|
● |
a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts to negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D;
|
● |
extension of manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations;
|
● |
expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals and by adding new mandatory eligibility categories for certain individuals with income at or below 133% of the Federal Poverty Level beginning in 2014, thereby potentially increasing manufacturers’ Medicaid rebate liability;
|
● |
expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program;
|
● |
new requirements under the federal Open Payments program, created under Section 6002 of the PPACA and its implementing regulations that manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) report annually to the U.S. Department of Health and Human Services, or HHS, information related to “payments or other transfers of value” made or distributed to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals and that applicable manufacturers and applicable group purchasing organizations report annually to the HHS ownership and investment interests held by physicians (as defined above) and their immediate family members, with data collection required beginning August 1, 2013 and reporting to the Centers for Medicare & Medicaid Services, or CMS, required by March 31, 2014 and by the 90th day of each subsequent calendar year, and disclosure of such information to be made on a publicly available website by September 2014;
|
● |
a requirement to annually report drug samples that manufacturers and distributors provide to physicians, effective April 1, 2012;
|
● |
expansion of healthcare fraud and abuse laws, including the False Claims Act and the Anti-Kickback Statute, new government investigative powers, and enhanced penalties for noncompliance;
|
● |
a licensure framework for follow-on biologic products;
|
● |
a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research;
|
● |
creation of the Independent Payment Advisory Board which, beginning in 2014, will have authority to recommend certain changes to the Medicare program that could result in reduced payments for prescription drugs and those recommendations could have the effect of law even if Congress does not act on the recommendations; and
|
● |
establishment of a Center for Medicare Innovation at CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending that began on January 1, 2011.
|
● |
adverse decisions by Teva or the Joint Development Committee regarding the development and commercialization of TV-45070;
|
● |
possible disagreements as to the timing, nature and extent of our development plans, including clinical trials or regulatory approval strategy;
|
● |
loss of significant rights if we fail to meet our obligations under the agreement;
|
● |
our limited control over clinical trials of TV-45070;
|
● |
changes in key management personnel at Teva, including in members of the Joint Development Committee; and
|
● |
possible disagreements with Teva regarding the agreement, for example, with regard to ownership of intellectual property rights.
|
● |
a collaborator may shift its priorities and resources away from our programs due to a change in business strategies, or a merger, acquisition, sale or downsizing of its company or business unit;
|
● |
a collaborator may cease development in therapeutic areas which are the subject of our strategic alliances;
|
● |
a collaborator may change the success criteria for a particular program or product candidate thereby delaying or ceasing development of such program or candidate;
|
● |
a significant delay in initiation of certain development activities by a collaborator will also delay payment of milestones tied to such activities, thereby impacting our ability to fund our own activities;
|
● |
a collaborator could develop a product that competes, either directly or indirectly, with our current or future products, if any;
|
● |
a collaborator with commercialization obligations may not commit sufficient financial or human resources to the marketing, distribution or sale of a product;
|
● |
a collaborator with manufacturing responsibilities may encounter regulatory, resource or quality issues and be unable to meet demand requirements;
|
● |
a collaborator may exercise its rights under the agreement to terminate our collaboration;
|
● |
a dispute may arise between us and a collaborator concerning the research or development of a product candidate or commercialization of a product resulting in a delay in milestones, royalty payments or termination of a program and possibly resulting in costly litigation or arbitration which may divert management attention and resources;
|
● |
a collaborator may not adequately protect the intellectual property rights associated with a product or product candidate; and
|
● |
a collaborator may use our proprietary information or intellectual property in such a way as to invite litigation from a third party.
|
● |
the development of certain of our current or future product candidates may be terminated or delayed;
|
● |
our cash expenditures related to development of our product candidates would increase significantly and we may need to seek additional financing sooner than expected;
|
● |
we may be required to hire additional employees or otherwise develop expertise, such as clinical, regulatory, sales and marketing expertise, which we do not currently have;
|
● |
we will bear all of the risk related to the development of any such product candidates; and
|
● |
the competitiveness of any product that is commercialized could be reduced.
|
● |
others may be able to make compounds that are similar to our product candidates but that are not covered by the claims of the patents that we or our collaborators own or have exclusively licensed;
|
● |
others may independently develop similar or alternative technologies without infringing our intellectual property rights;
|
● |
issued patents that we own or have exclusively licensed may not provide us with any competitive advantages, or may be held invalid or unenforceable, as a result of legal challenges by our competitors;
|
● |
we may obtain patents for certain compounds many years before we obtain marketing approval for products containing such compounds, and because patents have a limited life, which may begin to run prior to the commercial sale of the related product, the commercial value of our patents may be limited;
|
● |
our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets;
|
● |
we may fail to develop additional proprietary technologies that are patentable;
|
● |
the laws of certain foreign countries may not protect our intellectual property rights to the same extent as the laws of the U.S., or we may fail to apply for or obtain adequate intellectual property protection in all the jurisdictions in which we operate; and
|
● |
the patents of others may have an adverse effect on our business, for example by preventing us from marketing one or more of our product candidates for one or more indications.
|
● |
decreased demand for our product candidates or any resulting products;
|
● |
injury to our reputation;
|
● |
withdrawal of clinical trial participants;
|
● |
costs to defend the related litigation;
|
● |
a diversion of management’s time and our resources;
|
● |
substantial monetary awards to trial participants or patients;
|
● |
product recalls, withdrawals or labeling, marketing or promotional restrictions;
|
● |
loss of revenue;
|
● |
the inability to commercialize our product candidates; and
|
● |
a decline in our share price.
|
● |
the
federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federal and state healthcare programs such as Medicare and Medicaid;
|
● |
federal civil and criminal false claims laws and civil monetary penalty laws, including the federal False Claims Act, which impose criminal and civil penalties, including civil whistleblower or
qui
tam
actions, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, including the Medicare and Medicaid programs, or other third party payers claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;
|
● |
HIPAA, which imposes criminal and civil liability for executing a scheme to defraud any healthcare benefit program and making false statements relating to healthcare matters;
|
● |
HIPAA, as amended by HITECH, and their respective implementing regulations, which impose obligations on covered healthcare providers, health plans, and healthcare clearinghouses, as well as their business associates that create, receive, maintain, or transmit individually identifiable health information for or on behalf of a covered entity, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;
|
● |
the federal Open Payments program, created under Section 6002 of PPACA and its implementing regulations requires manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to HHS information related to “payments or other transfers of value” made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, and applicable manufacturers and applicable group purchasing organizations to report annually to HHS ownership and investment interests held by physicians (as defined above) and their immediate family members, with data collection required beginning August 1, 2013, reporting to the Centers for Medicare & Medicaid Services, or CMS, required by March 31, 2014 (and by the 90th day of each subsequent calendar year), and disclosure of such information to be made on a publicly available website by September 2014; and
|
● |
analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payers, including private insurers; state and foreign laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers; state and foreign laws that require drug manufacturers to report information related to payments to physicians and other healthcare providers or marketing expenditures; and state and foreign laws governing the collection, export, privacy, use and security of biological materials and health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.
|
● |
actions by any of our collaborators regarding our product candidates they are developing, including announcements regarding clinical or regulatory decisions or developments or our collaboration;
|
● |
announcements by us or our competitors of new products, product candidates or new uses for existing products, significant contracts, commercial relationships or capital commitments and the timing of these introductions or announcements;
|
● |
unanticipated serious safety concerns related to Glybera or to the use of any of our products and product candidates;
|
● |
results from or delays of clinical trials of our product candidates;
|
● |
failure to obtain or delays in obtaining product approvals or clearances from regulatory authorities;
|
● |
adverse regulatory or reimbursement announcements;
|
● |
announcements by us or our competitors of significant acquisitions, strategic collaborations, joint ventures or capital commitments;
|
● |
the results of our efforts to discover or develop additional product candidates;
|
● |
our dependence on third parties, including our collaborators, CROs, clinical trial sponsors and clinical investigators;
|
● |
regulatory or legal developments in Canada, the U.S. or other countries;
|
● |
developments or disputes concerning patent applications, issued patents or other proprietary rights;
|
● |
the recruitment or departure of key scientific or management personnel;
|
● |
our ability to successfully commercialize our future product candidates we develop independently, if approved;
|
● |
the level of expenses related to any of our product candidates or clinical development programs;
|
● |
actual or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts;
|
● |
actual or anticipated quarterly variations in our financial results or those of our competitors;
|
● |
any change to the composition of the board of directors or key personnel;
|
● |
expiration of contractual lock-up agreements with our executive officers, directors and security holders;
|
● |
sales of common shares by us or our shareholders in the future, as well as the overall trading volume of our common shares;
|
● |
changes in the structure of healthcare payment systems;
|
● |
commencement of, or our involvement in, litigation;
|
● |
general economic, industry and market conditions in the pharmaceutical and biotechnology sectors and other factors that may be unrelated to our operating performance or the operating performance of our competitors, including changes in market valuations of similar companies; and
|
● |
the other factors described in this “Risk Factors” section.
|
● |
shareholders cannot amend our articles unless such amendment is approved by shareholders holding at least two-thirds of the shares entitled to vote on such approval;
|
● |
our board of directors may, without shareholder approval, issue preferred shares having any terms, conditions, rights, preferences and privileges as the board of directors may determine; and
|
● |
shareholders must give advance notice to nominate directors or to submit proposals for consideration at shareholders’ meetings.
|
● |
significant impairment of the liquidity for our common shares, which may substantially decrease the trading price of our common shares;
|
● |
a limited availability of market quotations for our securities;
|
● |
a determination that our common shares is a “penny stock” which will require brokers trading in our common shares to adhere to more stringent rules and possibly resulting in a reduced level of trading activity in the secondary trading market for our common shares;
|
● |
a limited amount of news and analyst coverage for our company; and
|
● |
a decreased ability to issue additional securities or obtain additional financing in the future.
|
Item
6.
|
Exhibits
|
Exhibit
Number
|
Description
|
|
3.1
|
Articles of the Company.
|
|
3.2
|
Amended and Restated By-laws of the Company.
|
|
10.1
|
Lease, dated as of 2001, by and between the Company and Discovery Parks Incorporated, as amended through July 1, 2014.(1)
|
|
31.1
|
Certification of Chief Executive Officer pursuant to Rule 13a-14(a).
|
|
31.2
|
Certification of Chief Financial Officer pursuant to Rule 13a-14(a).
|
|
32.1*
|
Certification of Chief Executive Officer pursuant to 18 U.S.C Section 1350.
|
|
32.2*
|
Certification of Chief Financial Officer pursuant to 18 U.S.C Section 1350.
|
|
101**
|
The following financial statements from the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2014, formatted in XBRL: (i) Statements of Cash Flows, (ii) Statements of Operations, (iii) Statements of Comprehensive Income (Loss), (iv) Balance Sheets, and (v) Notes to Financial Statements, tagged as blocks of text and including detailed tags.
|
(1)
|
Incorporated by reference to Exhibit 10.14 of our Registration Statement on Form S-1 filed with the Securities and Exchange Commission on September 10, 2014.
|
* |
The Certifications attached as Exhibits 32.1 and 32.2 that accompany this Quarterly Report on Form 10-Q are not deemed filed with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of Xenon Pharmaceuticals Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Form 10-Q, irrespective of any general incorporation language contained in such filing.
|
**
|
Pursuant to Rule 406T of Regulation S-T, the Interactive Data Files in Exhibit 101 hereto are deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, are deemed not filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and otherwise are not subject to liability under those sections.
|
XENON PHARMACEUTICALS INC.
|
|||
Date: December 15, 2014
|
By:
|
/s/ Simon Pimstone
|
|
Simon Pimstone
|
|||
President and Chief Executive Officer
(Principal Executive Officer)
|
Exhibit
Number
|
Description
|
|
3.1
|
Articles of the Company.
|
|
3.2
|
Amended and Restated By-laws of the Company.
|
|
10.1
|
Lease, dated as of 2001, by and between the Company and Discovery Parks Incorporated, as amended through July 1, 2014.(1)
|
|
31.1
|
Certification of Chief Executive Officer pursuant to Rule 13a-14(a).
|
|
31.2
|
Certification of Chief Financial Officer pursuant to Rule 13a-14(a).
|
|
32.1*
|
Certification of Chief Executive Officer pursuant to 18 U.S.C Section 1350.
|
|
32.2*
|
Certification of Chief Financial Officer pursuant to 18 U.S.C Section 1350.
|
|
101**
|
The following financial statements from the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2014, formatted in XBRL: (i) Statements of Cash Flows, (ii) Statements of Operations, (iii) Statements of Comprehensive Income (Loss), (iv) Balance Sheets, and (v) Notes to Financial Statements, tagged as blocks of text and including detailed tags.
|
(1)
|
Incorporated by reference to Exhibit 10.14 of our Registration Statement on Form S-1 filed with the Securities and Exchange Commission on September 10, 2014.
|
* |
The Certifications attached as Exhibits 32.1 and 32.2 that accompany this Quarterly Report on Form 10-Q are not deemed filed with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of Xenon Pharmaceuticals Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Form 10-Q, irrespective of any general incorporation language contained in such filing.
|
**
|
Pursuant to Rule 406T of Regulation S-T, the Interactive Data Files in Exhibit 101 hereto are deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, are deemed not filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and otherwise are not subject to liability under those sections.
|
1.1
|
Definitions.
|
(a)
|
“
Act
” means the
Canada Business Corporations Act
, including the regulations thereunder, as amended from time to time;
|
(b)
|
“
Applicable Securities Laws
” means the applicable securities legislation of each relevant province and territory of Canada and the United States of America and relevant state thereof, as amended from time to time, the rules, regulations and forms made or promulgated under any such statute and the published national instruments, multilateral instruments, policies, bulletins and notices of the securities commission and similar regulatory authority, as amended
|
(c)
|
“
Articles
” shall mean the articles of the Corporation, as may be amended from time to time;
|
(d)
|
“
Board
” means the board of directors of the Corporation;
|
(e)
|
“
Business Day
” means a day other than a Saturday, Sunday or statutory holiday in the Province of British Columbia.
|
(f)
|
“
By-law No. 1
” means this amended and restated By-law No. 1, as may be amended from time to time;
|
(g)
|
“
By-laws
” means this By-law No. 1 and all other by-laws of the Corporation from time to time in force and effect;
|
(h)
|
“
Corporation
” means Xenon Pharmaceuticals Inc.;
|
(i)
|
“
Public Announcement
” means disclosure by a press release disseminated through a national news service in Canada or the United States of America, or in a document publicly filed by the Corporation under its profile on the System of Electronic Document Analysis and Retrieval at www.sedar.com or on the Electronic Data Gathering, Analysis and Retrieval system (EDGAR System) at www.sec.gov or such other means as may be prescribed under Applicable Securities Laws; and
|
(j)
|
“
Shareholders’ Meetings
” means the annual meetings of shareholders and the special meetings of shareholders.
|
2.1
|
Registered Office.
|
2.2
|
Additional Offices.
|
3.1
|
Annual Meetings.
|
3.2
|
Special Meetings.
|
3.3
|
Electronic Meetings.
|
(a)
|
participate in a Shareholders’ Meeting; and
|
(b)
|
be deemed present in person and vote at a Shareholders’ Meeting, whether such meeting is to be held at a designated place or solely by means of a telephonic, electronic or other communication facility, provided that such meeting is held in accordance with the Act and related regulations and any policy and guidelines approved by the Board.
|
3.4
|
Notice.
|
3.5
|
Quorum.
|
3.6
|
Adjournments.
|
(a)
|
Adjournments for less than 30 days.
Any Shareholders’ Meeting may be adjourned by the Chair of the meeting, from time to time, whether or not there is a quorum, to reconvene at the same or some other place. If the meeting is adjourned for less than 30 days, notice need not be given of any such adjourned meeting other than by announcement at the earliest meeting that it is adjourned.
|
(b)
|
Adjournments for 30 days or more.
If the adjournment is for 30 days or more, or if after the adjournment a new record date is fixed for the adjourned meeting, notice of the adjourned meeting shall be given as for an original meeting and unless required under the Act, solicitation of proxies will not be mandatory.
|
(c)
|
Adjourned Meetings
. At the adjourned meeting, the shareholders, or the holders of any class or series of shares entitled to vote separately as a class, as the case may be, may transact any business that might have been transacted at the original meeting. If the original meeting was adjourned for lack of a quorum, at the adjourned meeting, the shareholders present in person or their duly appointed proxyholders so present shall form the quorum whatever the number of shares represented. If the original meeting was adjourned for any other reason, the quorum requirement for the adjourned meeting shall be the same as that for the original meeting.
|
3.7
|
Conduct of Meetings.
|
(a)
|
Appointment of Chair.
The Chair of each Shareholders’ Meeting shall be such person as may be appointed by the Board or, if no such person is appointed or such appointed person is unable or unwilling to so act, the Chair of the Board or, if the Chair of the Board is unable or unwilling to so act, the Chief Executive Officer or, if the Chief Executive Officer is unable or unwilling to so act, one of the directors present as may be chosen by the persons present and entitled to vote at such Shareholders’ Meeting or, if no such director is present or willing to act, provided that such Shareholders’ Meeting has been duly called and convened, any person present as may be chosen by the persons present and entitled to vote at such Shareholders’ Meeting.
|
(b)
|
Procedures.
The Board may adopt such rules and regulations for the conduct of the Shareholders’ Meeting as it shall deem appropriate. Except to the extent inconsistent with the By-laws or such rules and regulations as adopted by the Board, the Chair of any Shareholders’ Meeting shall have the right and authority to convene and to adjourn the meeting, to prescribe such rules, regulations and procedures and to do all such acts as, in the judgment of such Chair, are appropriate for the proper conduct of the meeting. Such rules, regulations or procedures, whether adopted by the Board or prescribed by the Chair of the meeting, may include, without limitation, the following:
|
(i)
|
the establishment of an agenda or order of business for the meeting;
|
(ii)
|
rules and procedures for maintaining order at the meeting and the safety of those present;
|
(iii)
|
limitations on attendance at or participation in the meeting to those persons entitled to be present; and
|
(iv)
|
restrictions on entry to the meeting after the time fixed for the commencement thereof.
|
3.8
|
Persons Entitled to be Present.
|
4.1
|
Voting Lists.
|
4.2
|
Manner of Voting.
|
4.
3
|
Ballot.
|
4.4
|
Electronic Voting
.
|
(a)
|
Electronic Voting Permitted.
Notwithstanding Section 4.2, any person participating in a Shareholders’ Meeting by a telephonic, electronic or other communication facility and entitled to vote at the meeting may vote by means of any telephonic, electronic or other communication facility that the Corporation has made available for that purpose.
|
(b)
|
Communication Facility
.
Any vote referred to in Section 4.2 or Section 4.3 may be held entirely by means of a telephonic, electronic or other communication facility if the Corporation makes available such a communication facility, provided, in each case, that the facility:
|
A.
|
enables the votes to be gathered in a manner that permits their subsequent verification; and
|
B.
|
permits the tallied votes to be presented to the Corporation without it being possible for the Corporation to identify how each shareholder or group of shareholders voted.
|
4.5
|
Proxies.
|
(a)
|
Appointment of Proxyholders.
A shareholder entitled to vote at a Shareholders’ Meeting may by means of a proxy appoint a proxyholder or one or more alternate proxyholders, who are not required to be shareholders, to attend and act at the meeting in the manner and to the extent authorized by the proxy and with the authority conferred by the proxy. A proxy shall be executed by the shareholder or by the shareholder’s attorney authorized in writing. A proxy is valid only at the meeting in respect of which it is given or any adjournment thereof.
|
(b)
|
Deposit of Proxies.
The Board may specify in a notice calling a Shareholders’ Meeting a time, preceding the time of such meeting by not more than 48 hours, exclusive of non-Business Days, before which time proxies to be used at such meeting must be deposited with the Corporation or its agent specified in such proxy, in accordance with the instructions set forth in such proxy. Unless otherwise determined by the Board, a proxy shall be acted upon only if, prior to the time so specified, it shall have been deposited in accordance with the instructions set forth in the proxy or, if no such time is specified in the proxy, it shall have been received by the Corporate Secretary of the Corporation or by the Chair of the meeting or any adjournment thereof prior to the commencement of such meeting.
|
(c)
|
Revocation of Proxies.
A shareholder may revoke a proxy by depositing, in the manner for the deposit of proxies set forth in the proxy or related proxy materials, an instrument in writing executed by the shareholder or the shareholder’s attorney authorized in writing at the registered office of the Corporation at any time up to and including the last Business Day preceding the day of the meeting, or an adjournment thereof, at which the proxy is to be used or with the Chair of the meeting on the day of the meeting or an adjournment thereof.
|
4.6
|
Adjournments.
|
5.1
|
Powers.
|
5.2
|
Election and Term.
|
5.3
|
Number and Vacancies.
|
5.4
|
Remuneration.
|
5.5
|
Advance Notice for Nomination of Directors.
|
(a)
|
Meetings of Shareholders
. Subject to the Act, only persons who are nominated in accordance with the following procedures shall be eligible for election as directors of the Corporation. Nominations of persons for election to the Board of the Corporation may be made at any annual meeting of shareholders, or at any special meeting of shareholders if one of the purposes for which the special meeting was called was the election of directors:
|
(i)
|
by or at the direction of the Board, including pursuant to a notice of meeting;
|
(ii)
|
by or at the direction or request of one or more shareholders pursuant to a proposal made in accordance with the provisions of the Act, or a requisition of the shareholders made in accordance with the provisions of the Act; or
|
(iii)
|
by any person (a “
Nominating Shareholder
”): (a) who, at the close of business on the date of the giving of the notice provided for below in this Section 5.5 and at the close of business on the record date for notice of such meeting, is entered in the securities register of the Corporation as a holder of one or more shares carrying the right to vote at such meeting or who beneficially owns shares that are entitled to be voted at such meeting and provides evidence satisfactory to the Corporation of such beneficial ownership; and (b) who complies with the notice procedures set forth in this Section 5.5.
|
(b)
|
Timely Notice
. In addition to the other requirements for nominations set forth in this Section 5.5 and under applicable laws, for a nomination to be made by a Nominating Shareholder, the Nominating Shareholder must have given timely notice thereof in proper written form to the Corporate Secretary of the Corporation at the principal executive office of the Corporation.
To be timely, a Nominating Shareholder’s notice to the Corporate Secretary of the Corporation must be made:
|
(i)
|
in the case of an annual meeting of shareholders, not less than 30 nor more than 65 days prior to the date of the annual meeting of shareholders; provided, however, that in the event that the annual meeting of shareholders is to be held on a date that is less than 50 days after the date (the “
Notice Date
”) on which the first Public Announcement of the date of the annual meeting was made, notice by the Nominating Shareholder must be made not later than the close of business on the tenth (10th) day following the Notice Date; and
|
(ii)
|
in the case of a special meeting (which is not also an annual meeting) of shareholders called for the purpose of electing directors (whether or not called for other purposes), not later than the close of business on the fifteenth (15th) day following the day on which the first Public Announcement of the date of the special meeting of shareholders was made.
|
(c)
|
Proper Written Form
. To be in proper written form, a Nominating Shareholder’s notice to the Corporate Secretary must set forth the following information and include a certification by the Nominating Shareholder that all information contained in the Nominating Shareholder’s notice contains no untrue statement of material fact and does not omit to state a material fact that is required to be stated or that is necessary to make a statement not misleading in light of the circumstances in which it was made and a certification by the person that the Nominating Shareholder is proposing to nominate for election as a director (the “Proposed Nominee”) that the information in relation to him/her as contained in the Nominating Shareholder’s notice is true and accurate:
|
(i)
|
as to each person whom the Nominating Shareholder proposes to nominate for election as a director:
|
A.
|
the name, age, business address and residential address of the person;
|
B.
|
the principal occupation or employment of the person for the most recent five years, and the name and principal business of any Company in which any such employment is carried on;
|
C.
|
the citizenship and place of residence of such person;
|
D.
|
the class or series and number of shares in the capital of the Corporation which are controlled or which are owned beneficially or of record by the person as of the record date for the Shareholders’ Meeting (if such date shall then have been made publicly available and shall have occurred) and as of the date of such notice;
|
E.
|
any other information relating to the person that would be required to be disclosed in a dissident’s proxy circular in connection with solicitations of proxies for election of directors pursuant to the Act and Applicable Securities Laws; and
|
F.
|
such person’s written consent to being named in the notice as a nominee and to serving as a director of the Corporation if elected.
|
(ii)
|
as to the Nominating Shareholder giving the notice: (A) the name and address of such Nominating Shareholder, as they appear on the securities register of the Corporation; (B) the number of securities of each class or series of securities of the Corporation owned of record and beneficially by, or under the control or direction of, directly or indirectly, such Nominating Shareholder; (C) full particulars regarding any agreement, arrangement or understanding with respect to the nomination between or among such Nominating Shareholder, any of their respective affiliates or associates, and any others acting jointly or in concert with any of the foregoing, including the nominee; (D) full particulars regarding any agreement, arrangement or understanding (including any derivative or short positions, profit interests, options, warrants, convertible securities, stock appreciation or similar rights, hedging transactions, and borrowed or loaned shares) that has been entered into as of the date of the notice by, or on behalf of, such Nominating Shareholder, whether or not such instrument or right shall be subject to settlement in underlying securities of the Corporation, the effect or intent of which is to mitigate loss to, manage risk or benefit of share price changes for, or increase or decrease the voting power of, such Nominating Shareholder with respect to securities of the Corporation; (E) full particulars regarding any proxy, contract, agreement, arrangement or understanding pursuant to which such Nominating Shareholder has a right to vote or direct or control the voting of any securities of the Corporation; and (F) any other information relating to such Nominating Shareholder that would be required to be made in a dissident's proxy circular in connection with solicitations of proxies for election of directors pursuant to the Act and Applicable Securities Laws (as defined below).
|
A.
|
The Corporation may require any proposed nominee to furnish such other information and documents as may reasonably be required by the Corporation to (A) determine the eligibility of such proposed nominee to serve as an independent director of the Corporation or that could be material to a reasonable shareholder's understanding of the independence and/or qualifications in respect of financial literacy, or lack thereof, of such proposed nominee, or (B) satisfy the requirements of the Act, the Applicable Securities Laws and applicable stock exchange rules.
|
B.
|
In addition, a Nominating Shareholder's notice (including but not limited to related certification) shall be promptly updated and supplemented, if necessary, so that the information provided or required to be provided in such notice shall be true and correct as of the record date for the meeting.
|
(d)
|
Eligibility for nomination.
No person shall be eligible for election as a director of the Corporation unless nominated in accordance with the provisions of this Section 5.5; provided, however, that nothing in this Section 5.5 shall be deemed to preclude discussion by a shareholder (as distinct from the nomination of directors) at a Shareholders’ Meeting of any matter in respect of which it would have been entitled to submit a proposal pursuant to the provisions of the Act or at the discretion of the Chair. The Chair of the meeting shall have the power and duty to determine whether a nomination was made in accordance with the procedures set forth in the By-laws and, if any proposed nomination is not in compliance with the By-laws, to declare that such defective nomination shall be disregarded.
|
(e)
|
Notice.
Notwithstanding any other provision of this By-law, a Nominating Shareholder’s notice given to the Corporate Secretary of the Corporation pursuant to this By-law may only be given by personal delivery, facsimile transmission or by email (at such email address as may be stipulated from time to time by the Corporate Secretary of the Corporation for purposes of such notice), and shall be deemed to have been given and made only at the time it is served by personal delivery, email or sent by facsimile transmission (provided that receipt of confirmation of such transmission has been received) to the Corporate Secretary at the address of the principal executive office of the Corporation; provided that if such delivery or electronic communication is made on a day which is a not a Business Day or later than 5:00 p.m. (Eastern Standard Time) on a day which is a Business Day, then such delivery or electronic communication shall be deemed to have been made on the subsequent day that is a Business Day.
|
(f)
|
Waiver of requirement.
Notwithstanding any other provision in this Section 5.5, the Board may, in its sole discretion, waive any requirement in this Section 5.5.
|
(g)
|
No right for inclusion of details in Management Proxy Circular of the Corporation
. Compliance with the notice and nomination procedure set out in this section 5.5 shall not result in any obligation or requirement on the Corporation to include the name the person nominated by the Nominating Shareholder or any other information provided by such Nominating Shareholder in the management proxy circular for any Shareholders’ Meeting or any other disclosure documents of the Corporation.
|
6.1
|
Meetings.
|
(a)
|
Calling of Board Meeting
. The Board shall meet at least annually and may meet more frequently as needed. Meetings of the Board may be called by the Chair of the Board, the Chief Executive Officer, or any two directors,
as the case may be, and shall be held at such time, date and place as may be determined by the person calling the meeting, subject to the quorum requirements being satisfied.
|
(b)
|
Notice of Board Meeting
. Notice of each meeting of the Board shall be given to each director (i) not later than the day before the meeting if such notice is given by hand delivery or by means of a form of electronic document; (ii) at least two days before the meeting if such notice is sent by a nationally recognized overnight delivery service; and (iii) at least five days before the meeting if such notice is sent through ordinary mail. If the Corporate Secretary shall fail or refuse to give such notice, then the notice may be given by the individual(s) who called the meeting. Any director may at any time waive the provision of the notice in accordance with Article 11.
|
(c)
|
Except as required by the Act, a notice of meeting need not specify the purpose of or the business to be transacted at the meeting.
|
(d)
|
Notwithstanding Section 6.1(a), a special meeting may be held at any time without notice if all of the directors are present or if those not present waive notice of the meeting in accordance with Article 11.
|
6.2
|
Quorum
|
6.3
|
Adjournment
|
6.4
|
Voting.
|
(a)
|
No Tie-breaking vote.
Each director is entitled to one vote on each matter. At all meetings of the Board every question will be decided by a majority of the votes cast on the question; if the Board considers any action that results in an equal number of the directors at the meeting voting for and against the action, then in such case, the Chair of the Board shall not be entitled to cast a tie-breaking vote with respect to such action.
|
(b)
|
Electronic Voting.
Subject to the Act, a director participating in a meeting by a telephonic, electronic or other communication facility may vote by any reasonable means (including verbal assent) given the nature of such communication facility.
|
6.5
|
Organization.
|
6.6
|
Action by the Board.
|
6.7
|
Delegation.
|
7.1
|
Establishment.
|
7.2
|
Available Powers.
|
7.3
|
Alternate Members.
|
7.4
|
Procedures.
|
9.1
|
Registered Shareholders.
|
9.2
|
Regulations.
|
9.3
|
Transfer Agent and Registrar.
|
10.1
|
Indemnification.
|
10.2
|
Limitation of Liability.
|
(a)
|
the acts, receipts, neglects or defaults of any other director, officer, employee or agent of the Corporation or any other person;
|
(b)
|
any loss, damage or expense happening to the Corporation through the insufficiency or deficiency of title to any property acquired by, for, or on behalf of the Corporation, or for the insufficiency or deficiency of any security in or upon which any of the moneys of the Corporation shall be loaned out or invested;
|
(c)
|
any loss or damage arising from the bankruptcy, insolvency or tortious act of any person, firm or corporation, including any person, firm or corporation with whom any moneys, securities or other assets belonging to the Corporation shall be lodged or deposited;
|
(d)
|
any loss, conversion, misapplication or misappropriation of or any damage resulting from any dealings with any moneys, securities or other assets belonging to the Corporation; or
|
(e)
|
any other loss, damage or misfortune whatever which may happen in the execution of the duties of the director’s or officer’s respective office or in relation thereto,
|
10.3
|
Indemnification of Others.
|
10.4
|
Insurance.
|
10.5
|
Indemnities Not Exclusive.
|
(a)
|
sent by prepaid mail or delivered personally to such person; or
|
(b)
|
sent, delivered or provided by electronic means to such person to the extent permitted by the Act.
|
12.1
|
Banking Arrangements.
|
12.2
|
Borrowing.
|
(a)
|
Borrowing
. Without limiting the general powers of the Board as provided in the Act and in the By-laws, the Board may from time to time, without authorization of the shareholders, on behalf of the Corporation:
|
(i)
|
borrow money on the credit of the Corporation;
|
(ii)
|
issue, reissue, sell, pledge or hypothecate debt obligations of the Corporation;
|
(iii)
|
give a guarantee on behalf of the Corporation to secure performance of an obligation of any person; and
|
(iv)
|
mortgage, hypothecate, pledge or otherwise create a security interest in all or any property of the Corporation, owned or subsequently acquired, to secure any obligation of the Corporation.
|
13.1
|
Dividends.
|
(a)
|
Subject to the Act, the Board may from time to time declare, and the Corporation may pay, dividends (payable in cash, property, fully paid shares of the Corporation or such other form as the Board may determine) to the shareholders.
|
(b)
|
Any dividend unclaimed after a period of two years from the date on which the dividend has been declared to be payable shall be forfeited and shall revert to the Corporation.
|
13.
2
|
Financial Year.
|
13.
3
|
Seal.
|
13.4
|
Books and Records.
|
13.
5
|
Securities of Other Corporations.
|
13.6
|
Execution of Instruments.
|
13.7
|
Omissions and Errors.
|
13.
8
|
Persons Entitled by Death or Operation of Law.
|
13.9
|
Invalidity.
|
13.10
|
Effective Date.
|
13.11
|
Repeal.
|
/s/ Simon Pimstone | |||
Chief Executive Officer
|
|||
1.
|
I have reviewed this Quarterly Report on Form 10-Q of Xenon Pharmaceuticals Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a)
|
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b)
|
evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
c)
|
disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
a)
|
all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
b)
|
any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
/s/ Simon Pimstone
|
||
Simon Pimstone
|
||
President and Chief Executive Officer
(Principal Executive Officer)
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q of Xenon Pharmaceuticals Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a)
|
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
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b)
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evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
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c)
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disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
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5.
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The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
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a)
|
all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
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b)
|
any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
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/s/ Ian Mortimer
|
||
Ian Mortimer
|
||
Chief Financial Officer
(Principal Financial and Accounting Officer)
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(1)
|
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
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/s/ Simon Pimstone
|
||
Simon Pimstone
|
||
President and Chief Executive Officer
(Principal Executive Officer)
|
(1)
|
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
/s/ Ian Mortimer
|
||
Ian Mortimer | ||
Chief Financial Officer
(Principal Financial and Accounting Officer)
|