UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
(Mark One)
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the fiscal year ended December 31, 2014
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number: 001-36687
XENON PHARMACEUTICALS INC.
(Exact Name of Registrant as Specified in its Charter)
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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 |
200 – 3650 Gilmore Way
Burnaby, British Columbia V5G 4W8
(Address of Principal Executive Offices, including zip code)
(Registrant’s Telephone Number, Including Area Code): (604) 484-3300
Securities registered pursuant to Section 12(b) of the Act:
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Name of Exchange on Which Registered |
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Common Shares, no par value per share |
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The NASDAQ Stock Market LLC (The NASDAQ Global Market) |
Securities registered pursuant to Section 12(g) of the Act: None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ¨ No x
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes ¨ No x
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No ¨
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes x No ¨
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of the registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. ¨
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See definitions of “large accelerated filer”, “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.:
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Large accelerated filer |
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Accelerated filer |
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Non-accelerated filer |
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x |
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Smaller reporting company |
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Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Securities Exchange Act of 1934). Yes ¨ No x
The aggregate market value of the voting and non-voting common shares held by non-affiliates of the registrant on November 5, 2014 (including common shares issued in the registrant’s initial public offering), based on the closing price of $10.50 per share for the registrant’s common shares as reported by The NASDAQ Global Market, was approximately $111 million. The registrant has elected to use November 5, 2014 as the calculation date, which was the initial trading date of the registrant’s common shares on The NASDAQ Global Market, because on June 30, 2014 (the last business day of the registrant’s most recently completed second fiscal quarter), the registrant was a privately-held company. Common shares held by each executive officer and director and by each person who owns 5% or more of the outstanding common shares, based on filings with the Securities and Exchange Commission, have been excluded from this computation since such persons may be deemed to be affiliates of the registrant. This determination of affiliate status is not necessarily a conclusive determination for other purposes.
The number of outstanding common shares of the registrant, no par value per share, as of March 9, 2015 was 14,221,600.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the registrant’s definitive Proxy Statement to be filed with the Securities and Exchange Commission in connection with the registrant’s 2015 Annual Meeting of Shareholders, which will be filed subsequent to the date hereof, are incorporated by reference into Part III of this Form 10 K. Such Proxy Statement will be filed with the Securities and Exchange Commission not later than 120 days following the end of the registrant’s fiscal year ended December 31, 2014.
For the Fiscal Year Ended December 31, 2014
Table of Contents
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Item 1. |
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Item 1A. |
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42 |
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Item 1B. |
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78 |
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Item 2. |
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78 |
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Item 3. |
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78 |
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Item 4. |
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78 |
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79 |
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Item 5. |
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79 |
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Item 6. |
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82 |
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Item 7. |
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83 |
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Item 7A. |
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95 |
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Item 8. |
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96 |
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Item 9. |
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122 |
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Item 9A. |
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122 |
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Item 9B. |
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122 |
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123 |
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Item 10. |
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123 |
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Item 11. |
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123 |
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Item 12. |
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123 |
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Item 13. |
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123 |
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Item 14. |
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123 |
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124 |
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Item 15. |
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124 |
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125 |
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Forward-Looking Statements
Certain statements contained in this Annual Report on Form 10-K may constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended and Canadian Securities laws. The words or phrases “would be,” “will allow,” “intends to,” “may,” “believe,” “plan,” “will likely result,” “are expected to,” “will continue,” “is anticipated,” “estimate,” “project,” or similar expressions, or the negative of such words or phrases, are intended to identify “forward-looking statements.” You should read these statements carefully because they discuss future expectations, contain projections of future results of operations or financial condition, or state other “forward-looking” information. These statements relate to our future plans, objectives, expectations, intentions and financial performance and the assumptions that underlie these statements. These forward-looking statements include, but are not limited to:
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our ability to identify additional products or product candidates using our Extreme Genetics discovery platform; |
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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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our ability to advance product candidates into, and successfully complete, clinical trials; |
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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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our ability to achieve profitability; |
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our ability to obtain funding for our operations, including research funding; |
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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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the implementation of our business model and strategic plans; |
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our ability to develop and commercialize product candidates for orphan and niche indications independently; |
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our commercialization, marketing and manufacturing capabilities and strategy; |
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our ability to find families to support our Extreme Genetics discovery platform; |
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our ability to discover genes and drug targets; |
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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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our expectations regarding federal, state and foreign regulatory requirements; |
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the therapeutic benefits, effectiveness and safety of our product candidates; |
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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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the rate and degree of market acceptance and clinical utility of Glybera and future products, if any; |
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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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our ability to maintain and establish collaborations; |
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our use of proceeds from our initial public offering and the concurrent private placement completed in November 2014; |
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our expectations regarding market risk, including interest rate changes and foreign currency fluctuations; |