Item 1. Financial Statements
Item 1. Financial Statements
XENON PHARMACEUTICALS INC.
Consolidated Balance Sheets
(Unaudited)
(Expressed in thousands of U.S. dollars except share amounts)
September 30,
December 31,
2021
2020
Assets
Current assets:
Cash and cash equivalents
$
87,809
$
45,009
Marketable securities
161,816
131,988
Accounts receivable
3,235
1,822
Prepaid expenses and other current assets
3,454
2,964
256,314
181,783
Operating lease right-of-use asset, net (note 6)
2,967
3,326
Property, plant and equipment, net
4,261
3,554
Deferred tax assets (note 11)
811
523
Total assets
$
264,353
$
189,186
Liabilities and shareholders’ equity
Current liabilities:
Accounts payable and accrued expenses (note 7)
$
9,968
$
10,874
Deferred revenue (note 10)
2,202
3,642
Operating lease liability (note 6)
686
265
12,856
14,781
Operating lease liability, long-term (note 6)
2,558
3,050
$
15,414
$
17,831
Shareholders’ equity:
Preferred shares, without par value; unlimited shares authorized; issued and
outstanding: 1,016,000 (December 31, 2020 - 1,016,000 ) (note 9)
$
7,732
$
7,732
Common shares, without par value; unlimited shares authorized; issued and
outstanding: 41,412,875 (December 31, 2020 - 35,012,125 ) (note 9)
504,386
397,748
Additional paid-in capital
69,621
45,357
Accumulated deficit
( 331,810
)
( 278,492
)
Accumulated other comprehensive loss
( 990
)
( 990
)
$
248,939
$
171,355
Total liabilities and shareholders’ equity
$
264,353
$
189,186
Commitments and contingencies (note 12)
Subsequent event (note 13)
The accompanying notes are an integral part of these financial statements.
-3-
XENON PHARMACEUTICALS INC.
Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
(Expressed in thousands of U.S. dollars except share and per share amounts)
Three Months Ended September 30,
Nine Months Ended September 30,
2021
2020
2021
2020
Revenue (note 10)
$
8,124
$
6,554
$
14,700
$
27,016
Operating expenses:
Research and development
18,891
13,045
53,576
35,556
General and administrative
4,831
3,208
15,279
9,838
23,722
16,253
68,855
45,394
Loss from operations
( 15,598
)
( 9,699
)
( 54,155
)
( 18,378
)
Other income (expense):
Interest income
76
166
203
2,194
Interest expense
—
—
—
( 484
)
Foreign exchange gain (loss)
( 128
)
475
144
899
Loss on repayment of term loan (note 8)
—
—
—
( 988
)
Loss before income taxes
( 15,650
)
( 9,058
)
( 53,808
)
( 16,757
)
Income tax recovery (note 11)
205
203
490
243
Net loss and comprehensive loss
( 15,445
)
( 8,855
)
( 53,318
)
( 16,514
)
Net loss attributable to preferred shareholders
( 362
)
( 250
)
( 1,308
)
( 474
)
Net loss attributable to common shareholders
$
( 15,083
)
$
( 8,605
)
$
( 52,010
)
$
( 16,040
)
Net loss per common share (note 4):
Basic and diluted
$
( 0.36
)
$
( 0.25
)
$
( 1.29
)
$
( 0.47
)
Weighted-average common shares outstanding (note 4):
Basic and diluted
41,193,267
34,994,944
39,599,595
34,387,986
The accompanying notes are an integral part of these financial statements.
-4-
XENON PHARMACEUTICALS INC.
Consolidated Statements of Shareholders’ Equity
(Unaudited)
(Expressed in thousands of U.S. dollars except share amounts)
Convertible
preferred shares
Common shares
Additional
paid-in
capital
Accumulated deficit
Accumulated other
comprehensive
loss (1)
Total shareholders'
equity
Shares
Amount
Shares
Amount
Balance as of
December 31, 2019
1,016,000
$
7,732
28,139,228
$
294,244
$
40,646
$
( 249,655
)
$
( 990
)
$
91,977
Net loss for the period
( 7,484
)
( 7,484
)
Issuance of common shares,
net of issuance costs (note 9a)
6,759,187
102,456
102,456
Stock-based compensation
expense
1,015
1,015
Issued pursuant to exercise
of stock options
57,857
607
( 593
)
14
Balance as of
March 31, 2020
1,016,000
$
7,732
34,956,272
$
397,307
$
41,068
$
( 257,139
)
$
( 990
)
$
187,978
Net loss for the period
( 175
)
( 175
)
Stock-based compensation
expense
1,472
1,472
Issued pursuant to exercise
of stock options
38,518
345
( 322
)
23
Balance as of
June 30, 2020
1,016,000
$
7,732
34,994,790
$
397,652
$
42,218
$
( 257,314
)
$
( 990
)
$
189,298
Net loss for the period
( 8,855
)
( 8,855
)
Stock-based compensation
expense
1,580
1,580
Issued pursuant to exercise
of stock options
156
2
( 2
)
—
Balance as of
September 30, 2020
1,016,000
$
7,732
34,994,946
$
397,654
$
43,796
$
( 266,169
)
$
( 990
)
$
182,023
(1 )
The accumulated other comprehensive loss is entirely related to historical cumulative translation adjustments from the application of U.S. dollar reporting when the functional currency of the Company was the Canadian dollar.
The accompanying notes are an integral part of these financial statements
-5-
XENON PHARMACEUTICALS INC.
Consolidated Statements of Shareholders’ Equity
(Unaudited)
(Expressed in thousands of U.S. dollars except share amounts)
Convertible
preferred shares
Common shares
Additional
paid-in
capital
Accumulated deficit
Accumulated other
comprehensive
loss (1)
Total shareholders'
equity
Shares
Amount
Shares
Amount
Balance as of
December 31, 2020
1,016,000
$
7,732
35,012,125
$
397,748
$
45,357
$
( 278,492
)
$
( 990
)
$
171,355
Net loss for the period
( 15,764
)
( 15,764
)
Issuance of common shares and
pre-funded warrants, net of
issuance costs (note 9a and
note 9c)
5,868,135
99,846
18,769
118,615
Stock-based compensation
expense
1,965
1,965
Issued pursuant to exercise
of stock options
82,455
740
( 634
)
106
Balance as of
March 31, 2021
1,016,000
$
7,732
40,962,715
$
498,334
$
65,457
$
( 294,256
)
$
( 990
)
$
276,277
Net loss for the period
( 22,109
)
( 22,109
)
Stock-based compensation
expense
2,704
2,704
Issued pursuant to exercise
of stock options
154,853
1,017
( 906
)
111
Balance as of
June 30, 2021
1,016,000
$
7,732
41,117,568
$
499,351
$
67,255
$
( 316,365
)
$
( 990
)
$
256,983
Net loss for the period
( 15,445
)
( 15,445
)
Issuance of common shares, net of
issuance costs (note 9a)
275,337
4,730
4,730
Stock-based compensation
expense
2,643
2,643
Issued pursuant to exercise
of stock options
19,970
305
( 277
)
28
Balance as of
September 30, 2021
1,016,000
$
7,732
41,412,875
$
504,386
$
69,621
$
( 331,810
)
$
( 990
)
$
248,939
(1)
The accumulated other comprehensive loss is entirely related to historical cumulative translation adjustments from the application of U.S. dollar reporting when the functional currency of the Company was the Canadian dollar.
The accompanying notes are an integral part of these financial statements.
-6-
XENON PHARMACEUTICALS INC.
Consolidated Statements of Cash Flows
(Unaudited)
(Expressed in thousands of U.S. dollars)
Nine Months Ended September 30,
2021
2020
Operating activities:
Net loss
$
( 53,318
)
$
( 16,514
)
Items not involving cash:
Depreciation
636
442
Amortization of discount on term loan
—
216
Deferred income tax recovery
( 288
)
( 240
)
Stock-based compensation
7,312
4,067
Unrealized foreign exchange loss (gain)
451
( 451
)
Unrealized loss (gain) on marketable securities
72
( 228
)
Loss on repayment of term loan (note 8)
—
988
Changes in operating assets and liabilities:
Accounts receivable
( 940
)
( 827
)
Prepaid expenses and other current assets
( 490
)
421
Accounts payable and accrued expenses
( 787
)
122
Deferred revenue
( 1,440
)
( 23,006
)
Net cash used in operating activities
( 48,792
)
( 35,010
)
Investing activities:
Purchases of property, plant and equipment
( 1,536
)
( 1,809
)
Purchases of marketable securities
( 132,280
)
( 213,560
)
Proceeds from marketable securities
102,479
155,346
Net cash used in investing activities
( 31,337
)
( 60,023
)
Financing activities:
Repayment of term loan and repayment fees (note 8)
—
( 16,743
)
Proceeds from issuance of common shares and pre-funded warrants,
net of issuance costs (note 9a)
123,345
102,456
Issuance of common shares pursuant to exercise of stock options
245
37
Net cash provided by financing activities
123,590
85,750
Effect of exchange rate changes on cash and cash equivalents
( 661
)
( 372
)
Increase in cash and cash equivalents
42,800
( 9,655
)
Cash and cash equivalents, beginning of period
45,009
24,755
Cash and cash equivalents, end of period
$
87,809
$
15,100
Supplemental disclosures:
Interest paid
$
—
$
339
Interest received
2,428
3,058
Cash paid for operating lease
619
469
Supplemental disclosures of non-cash transactions:
Fair value of stock options exercised on a cashless basis
1,583
878
Increase in operating lease liability and accounts receivable related to lease
incentives claimed in the period
493
—
The accompanying notes are an integral part of these financial statements.
-7-
XENON PHARMACEUTICALS INC.
Notes to Consolidated Financial Statements
(Unaudited)
(Expressed in thousands of U.S. dollars except share and per share amounts)
1.
Nature of the business:
Xenon Pharmaceuticals Inc. (the “Company”), incorporated in 1996 under the predecessor to the Business Corporations Act (British Columbia) and continued federally in 2000 under the Canada Business Corporations Act, is a clinical stage biopharmaceutical company focused on developing innovative therapeutics to improve the lives of patients with neurological disorders, with a focus on epilepsy.
The Company has incurred significant operating losses since inception. As of September 30, 2021, the Company had an accumulated deficit of $ 331,810 and a $ 53,318 net loss for the nine months ended September 30, 2021. Management expects to continue to incur significant expenses in excess of revenue and to incur operating losses for the foreseeable future. To date, the Company has financed its operations primarily through funding received from collaboration and license agreements, private placements of common and preferred shares, public offerings of common shares and pre-funded warrants and debt financings.
Until such time as the Company can generate substantial product revenue, if ever, management expects to finance the Company’s cash needs through a combination of collaboration agreements, equity and debt financings. The continuation of research and development activities and the future commercialization of its products are dependent on the Company’s ability to successfully raise additional funds when needed. It is not possible to predict either the outcome of future research and development programs or the Company’s ability to continue to fund these programs in the future.
2.
Basis of presentation:
These consolidated financial statements are presented in U.S. dollars.
The Company has one wholly-owned subsidiary as of September 30, 2021 Xenon Pharmaceuticals USA Inc., which was incorporated in Delaware on December 2, 2016 .
These unaudited interim consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary. All intercompany transactions and balances have been eliminated on consolidation.
The accompanying unaudited interim consolidated financial statements have been prepared in accordance with United States generally accepted accounting principles (“U.S. GAAP”) and pursuant to the rules and regulations of the United States Securities and Exchange Commission (“SEC”) for interim financial information. Accordingly, these consolidated financial statements do not include all of the information and footnotes required for complete consolidated financial statements and should be read in conjunction with the audited consolidated financial statements and notes for the year ended December 31, 2020 and included in the Company’s 2020 Annual Report on Form 10-K filed with the SEC and with the securities commissions in British Columbia, Alberta and Ontario on March 1, 2021.
These unaudited interim consolidated financial statements reflect all adjustments, consisting of normal recurring adjustments, which, in the opinion of management, are necessary for a fair presentation of results for the interim periods presented. The results of operations for the three and nine month periods ended September 30, 2021 and 2020 are not necessarily indicative of results that can be expected for a full year. These unaudited interim consolidated financial statements follow the same significant accounting policies as those described in the notes to the audited consolidated financial statements of the Company included in the Company’s 2020 Annual Report on Form 10-K for the year ended December 31, 2020, with the exception of the policy described in note 3 below.
3 .
Changes in significant accounting policies:
In December 2019, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes. These amendments simplify accounting for income taxes, change the accounting for certain income tax transactions and make certain improvements to the codification. The Company has adopted this standard as of January 1, 2021 on a prospective basis. The adoption of the standard had no impact on the Company’s consolidated balance sheets, consolidated statements of operations and comprehensive loss and consolidated statements of cash flows.
-8-
4 .
Net income (loss) per common share:
Basic net income (loss) per common share is calculated using the two-class method required for participating securities which includes 1,016,000 Series 1 Preferred Shares as a separate class for the three and nine months ended September 30, 2021 (2020 – 1,016,000 ). The convertible preferred shares entitle the holders to participate in dividends and in earnings and losses of the Company on an equivalent basis as common shares. Accordingly, undistributed earnings (losses) are allocated to common shares and participating preferred shares based on the weighted-average shares of each class outstanding during the period.
The weighted average number of common shares used in the basic and diluted net income (loss) per common share calculations for the three and nine months ended September 30, 2021 include the pre-funded warrants issued in connection with the Company’s March 2021 underwritten public offering (note 9c) as the pre-funded warrants are exercisable at any time for nominal cash consideration.
The treasury stock method is used to compute the dilutive effect of the Company’s stock options and warrants. Under this method, the incremental number of common shares used in computing diluted net income (loss) per common share is the difference between the number of common shares assumed issued and purchased using assumed proceeds.
The if-converted method is used to compute the dilutive effect of the Company’s convertible preferred shares. Under the if-converted method, dividends on the preferred shares, if applicable, are added back to earnings attributable to common shareholders, and the preferred shares and paid-in kind dividends are assumed to have been converted at the share price applicable at the end of the period. The if-converted method is applied only if the effect is dilutive.
For the three and nine months ended September 30, 2021 and 2020, all stock options, warrants and convertible preferred shares were anti-dilutive and were excluded from the diluted weighted average common shares outstanding for the period.
5 .
Fair value of financial instruments:
Certain financial instruments and other items are measured at fair value.
To determine the fair value, the Company uses the fair value hierarchy for inputs used to measure fair value of financial assets and liabilities. This hierarchy prioritizes the inputs to valuation techniques used to measure fair value into three levels: Level 1 (highest priority), Level 2, and Level 3 (lowest priority).
•
Level 1 - Unadjusted quoted prices in active markets for identical instruments.
•
Level 2 - Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 inputs include quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, inputs other than quoted prices that are observable for the asset or liability (i.e., interest rates, yield curves, etc.), and inputs that are derived principally from or corroborated by observable market data by correlation or other means (market corroborated inputs).
•
Level 3 - Inputs are unobservable and reflect the Company’s assumptions as to what market participants would use in pricing the asset or liability. The Company develops these inputs based on the best information available.
Assets and liabilities are classified based on the lowest level of input that is significant to the fair value measurements. Changes in the observability of valuation inputs may result in a reclassification of levels for certain securities within the fair value hierarchy.
The Company’s Level 1 assets include cash and cash equivalents and marketable securities with quoted prices in active markets. The carrying amount of accounts receivables, accounts payable and accrued expenses approximates fair value due to the nature and short-term of those instruments.
6 .
Leases:
The Company has one operating lease for research laboratories and office space in Burnaby, British Columbia. In October 2020, the Company entered into a lease amendment for a 21–month committed term from October 1, 2020 to June 30, 2022 and a renewal option for a portion of the facility for a 5 -year term that was reasonably certain of exercise was included in the determination of the right-of-use asset and lease liability.
-9-
The cost components of the operating lease were as follows for the three and nine months ended September 30, 2021 and 2020:
Three Months Ended September 30,
Nine Months Ended September 30,
2021
2020
2021
2020
Lease Cost
Operating lease expense
$
140
$
151
$
419
$
411
Variable lease expense (1)
185
137
559
404
Lease Term and Discount Rate
Remaining lease term (years)
5.75
1.5
5.75
1.5
Discount rate
2.45
%
3.75
%
2.45
%
3.75
%
(1)
Variable lease costs are payments that vary because of changes in facts or circumstances and include common area maintenance and property taxes related to the premises. Variable lease costs are excluded from the calculation of minimum lease payments.
Future minimum lease payments as of September 30, 2021 were as follows:
Year ending December 31:
2021
$
203
2022
697
2023
571
2024
571
2025 and thereafter
1,428
Total future minimum lease payments
$
3,470
Less: imputed interest
( 226
)
Present value of lease liabilities
$
3,244
7 .
Accounts payable and accrued expenses:
Accounts payable and accrued expenses consisted of the following:
September 30,
December 31,
2021
2020
Trade payables
$
3,085
$
3,041
Employee compensation, benefits, and related accruals
3,383
2,859
Consulting and contracted research
3,087
4,738
Professional fees
387
167
Other
26
69
Total
$
9,968
$
10,874
8 .
Term loan:
In August 2018 , the Company entered into an Amended and Restated Loan and Security Agreement (the “Amended and Restated Loan Agreement”) with Silicon Valley Bank (the “Bank”), pursuant to which the Bank agreed to extend a term loan to the Company with a principal amount of $ 15,500 . The Term Loan accrued interest at a floating per annum rate of 0.5 % above the prime rate. The Term Loan was interest-only until March 31, 2020 , followed by 30 equal monthly installments of principal plus interest, originally maturing on September 1, 2022 . In addition, the Company was required to pay a final payment fee of 6.5 % of the Term Loan on the date on which the term loan was prepaid, paid or became due and payable in full.
In May 2020, the Company repaid the total outstanding term loan balance ahead of the maturity date. The repayment consisted of (i) the outstanding principal balance, (ii) a final payment fee of $ 1,008 , which was partially accrued up to the date of repayment, and (iii) a prepayment fee of $ 225 . At the time of repayment, all liabilities and obligations under the Amended and Restated Loan Agreement terminated automatically. The Company recorded a loss on repayment of the term loan of $ 988 , which represents the difference between the carrying value of the term loan on the repayment date and the amount paid to extinguish the term loan. The repayment did not affect the Bank’s rights in connection with the warrant to the Bank to purchase 40,000 of our common shares at a price per common share of $ 9.79 which will remain outstanding until exercised or expired in August 2028.
-10-
9 .
Share capital:
(a)
Financing:
In November 2019, the Company entered into an at-the-market equity offering sales agreement with Jefferies LLC (“Jefferies”) and Stifel, Nicolaus & Company, Incorporated (“Stifel”) to sell common shares of the Company having aggregate gross proceeds of up to $ 50,000 from time to time, through an “at-the-market” equity offering program under which Jefferies and Stifel would act as sales agents. As of December 31, 2019, the Company had sold 805,643 common shares under the sales agreement for proceeds of $ 10,729 , net of commissions and transaction expenses. In January 2020, the Company sold an additional 2,446,687 common shares for proceeds of approximately $ 37,796 , net of commissions and transaction expenses.
In January 2020, the Company entered into an underwriting agreement with Jefferies, Stifel and Guggenheim Securities, LLC, relating to an underwritten public offering of 3,750,000 common shares sold by the Company at a public offering price of $ 16.00 per common share, and granted the underwriters an option for a period of 30 days to purchase up to an additional 562,500 common shares. The public offering was completed in January 2020, and the Company received proceeds of $ 56,265 , net of underwriting discounts, commissions and offering expenses. The underwriters exercised their option in full in February 2020 and the Company received additional proceeds of $ 8,395 , net of underwriting discounts, commissions and offering expenses.
In August 2020, the Company entered into an at-the-market equity offering sales agreement with Jefferies and Stifel to sell common shares of the Company having aggregate gross proceeds of up to $ 100,000 , from time to time, through an “at-the-market” equity offering program under which Jefferies and Stifel would act as sales agents. As of September 30, 2021, 733,000 common shares have been sold under the sales agreement for proceeds of $ 10,693 , net of commissions and transaction expenses.
In March 2021, the Company entered into an underwriting agreement with Jefferies and Stifel, relating to an underwritten public offering of 5,135,135 common shares, including 810,810 common shares sold upon the full exercise of the underwriters’ over-allotment option, at a public offering price of $ 18.50 per common share and pre-funded warrants to purchase 1,081,081 common shares (the “Pre-Funded Warrants”) at $ 18.4999 per Pre-Funded Warrant (note 9c). The public offering was completed in March 2021, and the Company received proceeds of $ 107,922 , net of underwriting discounts, commissions and offering expenses.
In September 2021, in connection with the License and Collaboration Agreement with Neurocrine Biosciences Inc. (“Neurocrine Biosciences”) entered in December 2019 (the "Neurocrine Collaboration Agreement"), the Company executed a Share Purchase Agreement ("SPA") pursuant to which the Company issued 275,337 common shares for an aggregate purchase price of $ 5,500 , or $ 19.9755 per common share, which represents a premium of $ 770 when measured at fair value on the date of issuance. These common shares are subject to lock-up restrictions and standstill agreement for a period of two years after the effective date of the Neurocrine Collaboration Agreement, or December 2, 2021. The SPA contains certain other customary terms and conditions, including mutual representations, warranties and covenants. For additional information regarding the Neurocrine Collaboration Agreement, refer to note 10a.
(b)
Exchange agreement with certain funds affiliated with BVF Partners L.P. (collectively, “BVF”):
In March 2018, the Company and BVF entered into an exchange agreement pursuant to which the Company issued to BVF 2,868,000 Series 1 Preferred Shares in exchange for 2,868,000 common shares which were subsequently cancelled by the Company.
The Company filed articles of amendment creating an unlimited number of Series 1 Preferred Shares. The Series 1 Preferred Shares are convertible into common shares on a one-for-one basis subject to the holder, together with its affiliates, beneficially owning no more than 9.99 % of the total number of common shares issued and outstanding immediately after giving effect to such conversion (the “Beneficial Ownership Limitation”). The holder may reset the Beneficial Ownership Limitation to a higher or lower number, not to exceed 19.99 % of the total number of common shares issued and outstanding immediately after giving effect to such conversion, upon providing written notice to the Company which will be effective 61 days after delivery of such notice. Each Series 1 Preferred Share is also convertible into one common share at any time at the Company’s option without payment of additional consideration, provided that prior to any such conversion, the holder, together with its affiliates, beneficially owns less than 5.00 % of the total number of common shares issued and outstanding and such conversion will not result in the holder, together with its affiliates, beneficially holding more than 5.00 % of the total number of common shares issued and outstanding immediately after giving effect to such conversion. In the event of a change of control, holders of Series 1 Preferred Shares shall be issued one common share for each outstanding Series 1 Preferred Share held immediately prior to the change of control (without regard to the Beneficial Ownership Limitation), and following such conversion, will be entitled to receive the same kind and amount of securities, cash or property that a holder of common shares is entitled to receive in connection with such change of control.
-11-
The Series 1 Preferred Shares rank equally to the common shares in the event of liquidation, dissolution or winding up or other distribution of the assets of the Company among its shareholders and the holders of the Series 1 Preferred Shares are entitled to vote together with the common shares on an as-converted basis and as a single class, subject in the case of each holder of the Series 1 Preferred Shares to the Beneficial Ownership Limitation. Any Series 1 Preferred Shares that are ineligible to be converted into common shares due to the Beneficial Ownership Limitation, measured as of a given record date that applies for a shareholder meeting or ability to act by written consent, shall be deemed to be non-voting securities of the Company. Holders of Series 1 Preferred Shares are entitled to receive dividends (without regard to the Beneficial Ownership Limitation) on the same basis as the holders of common shares. The Company may not redeem the Series 1 Preferred Shares.
The Company recorded the issuance of Series 1 Preferred Shares and corresponding cancellation of common shares at $ 7.61 per share, the estimated weighted average cost at which BVF acquired the common shares. The Series 1 Preferred Shares are recorded wholly as equity under ASC 480, with no bifurcation of conversion feature from the host contract, given that the Series 1 Preferred Shares cannot be cash settled and have no redemption features.
During the year ended December 31, 2018, BVF converted 1,852,000 Series 1 Preferred Shares in exchange for an equal number of common shares of the Company.
BVF was a related party of the Company prior to the closing of the exchange agreement, and continues to be a related party as of September 30, 2021.
(c)
Pre-Funded Warrants:
In connection with an underwritten public offering completed in March 2021, the Company issued 1,081,081 Pre-Funded Warrants at a price of $ 18.4999 per Pre-Funded Warrant which grants the holder the right to purchase up to 1,081,081 common shares at an exercise price of $ 0.0001 per share. The Pre-Funded Warrants are exercisable at the holder’s discretion from the date of issuance until the date the Pre-Funded Warrant is exercised in full. The Company may not affect the exercise of any Pre-Funded Warrant, and a holder will not be entitled to exercise any portion of any Pre-Funded Warrant that, upon giving effect to such exercise, would cause: (i) the aggregate number of common shares beneficially owned by such holder, together with its affiliates, to exceed 4.99% of the total number of common shares outstanding immediately after giving effect to the exercise; or (ii) the combined voting power of the Company’s securities beneficially owned by such holder, together with its affiliates, to exceed 4.99% of the combined voting power of all of the Company’s securities immediately outstanding after giving effect to the exercise, which percentage may be changed at the holder’s election to a higher or lower percentage not in excess of 19.99% upon at least 61 days’ notice to the Company.
Since the Pre-Funded Warrants meet the condition for equity classification, proceeds from issuance of the Pre-Funded Warrants of $ 18,769 , net of underwriting discounts, commissions and offering expenses, are recorded in additional paid-in capital. Upon exercise of the Pre-Funded Warrants, the historical costs recorded in additional paid-in capital along with the exercise price collected from holder will be recorded in common shares. As of September 30, 2021, no Pre-Funded Warrants have been exercised. Pre-funded warrants to purchase 1,081,081 common shares are not included in the number of issued and outstanding common shares as of September 30, 2021.
(d)
Stock-based compensation:
The following table presents stock option activity for the period:
Three Months Ended September 30,
Nine Months Ended September 30,
2021
2020
2021
2020
Outstanding, beginning of period
5,771,051
4,595,432
4,758,997
3,534,236
Granted
236,200
194,400
1,730,650
1,440,050
Exercised (1)
( 41,974
)
( 375
)
( 386,708
)
( 153,417
)
Forfeited, cancelled or expired
( 45,843
)
( 3,363
)
( 183,505
)
( 34,775
)
Outstanding, end of period
5,919,434
4,786,094
5,919,434
4,786,094
Exercisable, end of period
3,068,278
2,324,090
3,068,278
2,324,090
(1)
During the nine months ended September 30, 2021, 61,072 stock options were exercised for the same number of common shares in exchange for cash (nine months ended September 30, 2020 – 10,715 ). In the same period, the Company issued 196,206 common shares (nine months ended September 30, 2020 – 85,816 ) for the cashless exercise of 325,636 stock options (nine months ended September 30, 2020 – 142,702 ).
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The fair value of each stock option granted is estimated using the Black-Scholes option-pricing model with the following weighted-average assumptions:
Three Months Ended
September 30,
Nine Months Ended
September 30,
2021
2020
2021
2020
Average risk-free interest rate
1.00
%
0.40
%
1.16
%
0.72
%
Expected volatility
68
%
68
%
68
%
68
%
Average expected term (in years)
6.77
6.64
6.69
6.79
Expected dividend yield
0
%
0
%
0
%
0
%
Weighted average fair value of stock options granted
$
10.74
$
7.03
$
12.41
$
7.46
10 .
Revenue:
Revenue was as follows for the three and nine months ended September 30, 2021 and 2020 :
Three Months Ended September 30,
Nine Months Ended September 30,
2021
2020
2021
2020
Neurocrine Biosciences:
Recognition of the transaction price
$
823
$
5,246
$
1,440
$
23,006
Research and development services
2,031
1,308
4,990
4,010
Milestone payments
5,270
—
5,270
—
Flexion:
Milestone payments
—
—
3,000
—
Total collaboration revenue
$
8,124
$
6,554
$
14,700
$
27,016
(a)
Neurocrine Biosciences license and collaboration agreement :
In December 2019, the Company entered into the Neurocrine Collaboration Agreement with Neurocrine Biosciences . Pursuant to this agreement, the Company granted an exclusive license to XEN901, now known as NBI-921352, and an exclusive license to pre-clinical compounds for development, XEN393, XPC’535 and XPC’391 (collectively, the “DTCs”). The agreement also includes a two-year research collaboration to discover, identify and develop additional novel Nav1.6 and Nav1.2/1.6 inhibitors (“Research Compounds”) which has been extended to June 2022. The Company and Neurocrine Biosciences are collaborating on the conduct of two collaboration programs: (a) a joint research collaboration to discover, identify and preclinically develop Research Compounds (the “Research Program”) and (b) a collaborative development program for NBI-921352 and two DTCs selected by the joint steering committee (the “Initial Development Program”).
At execution of the agreement, Neurocrine Biosciences paid the Company an upfront cash payment of $ 30,000 and a $ 20,000 equity investment in the Company. The equity investment was measured at fair value of $ 16,667 on the date of issuance and the resulting premium of $ 3,333 , together with the upfront cash payment totaling $ 33,333 , was the transaction price of the arrangement for allocation to the performance obligations. The agreement includes the following performance obligations: (i) an exclusive license to NBI-921352 with associated technology and know-how transfer, (ii) an exclusive license to the DTCs with associated know-how transfer, (iii) a license to Research Compounds and research services under the Research Program, (iv) development services under the Initial Development Program for NBI-921352, and (v) development services under the Initial Development Program for the DTCs. The total transaction price of $ 33,333 was allocated to performance obligation (v) based on its estimated standalone selling price determined based on internal development plans and budget, with the balance allocated to performance obligations (i) and (ii) by the residual approach. The Company allocated the transaction price as follows: $ 28,807 to performance obligations (i) and (ii), completed as of December 2020 , and $ 5,118 , which includes $ 592 of variable consideration, to performance obligation (v), which is expected to be completed by Q1 2022.
The arrangement consideration related to the services under performance obligations (iii) and (iv) to be performed on behalf of Neurocrine Biosciences were excluded from the initial transaction price allocation because the consideration and performance are contingent upon Neurocrine Biosciences requesting performance of the services and these services are priced at an estimated fair value. None of the at-risk substantive performance milestones, including development, regulatory and sales-based milestones, were included in the transaction price at the inception of the agreement, as all milestone amounts are outside the control of the Company and contingent upon Neurocrine Biosciences’s efforts and success in future clinical trials.
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In September 2021, based on the regulatory approval of a clinical trial application in Europe for NBI-921352 for focal-onset seizures in adults, the Company received an aggregate milestone payment of $ 10,000 in the form of $ 4,500 in cash and a $ 5,500 equity investment in the Company . The equity investment was measured at fair value of $ 4,730 on the date of issuance and the resulting premium of $ 770 , with the cash payment of $ 4,500 , was recognized as revenue in the period as the Company did no t have any remaining performance obligations in relation to this milestone on the date it was achieved .
The Company will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur.
During the three and nine month periods ended September 30, 2021, the Company recognized $ 2,854 and $ 6,430 of revenue, respectively (three and nine months ended September 30, 2020 – $ 6,554 and $ 27,016 respectively), which comprised of $ 2,031 and $ 4,990 , respectively (three and nine months ended September 30, 2020 – $ 1,308 and $ 4,010 respectively), for the research and development services under (iii) the Research Program and (iv) the Initial Development Program for NBI-921352; and $ 823 and $ 1,440 , respectively (three and nine months ended September 30, 2020 – $ 348 and $ 824 respectively), for (v) development services under the Initial Development Program for the DTCs. During the three and nine months ended September 30, 2020, the Company also recognized revenue of $ 4,898 and $ 22,182 , respectively, associated with (i) the exclusive license to NBI-921352 and (ii) the exclusive license to the DTCs. As of September 30, 2021, there is $ 2,052 of accounts receivable and $ 2,202 of deferred revenue related to the Neurocrine Collaboration Agreement, which is classified as current on the balance sheet based on the period the services are expected to be delivered.
The Company has an option to co-fund 50 % of the development costs of NBI-921352 or another product candidate in the U.S., exercisable upon achievement of certain milestones, in exchange for increased U.S. royalties. The Company has not exercised this option as of September 30, 2021.
(b)
Flexion definitive agreement:
In September 2019, the Company entered into an agreement with Flexion Therapeutics Inc. (“Flexion”) pursuant to which Flexion acquired all rights with respect to XEN402, and a related compound (collectively “XEN402”), including certain regulatory documentation, intellectual property rights, reports, data and all quantities of XEN402, now known as FX301, owned or controlled by the Company.
During the nine months ended September 30, 2021, the U.S. Food and Drug Administration cleared the first investigational new drug application for FX301 and Flexion initiated a Phase 1b clinical trial, resulting in milestone payments of $ 1,000 and $ 2,000 paid to the Company, respectively. Pursuant to terms of the agreement, the Company will also be eligible for a development milestone payment of $ 5,000 upon initiation of a Phase 2 proof-of-concept clinical trial. Following successful proof-of-concept, the Company may be entitled to future clinical development and global regulatory approval milestone payments of up to $ 40,750 , commercial milestone payments of up to $ 75,000 , as well as future royalties ranging from mid-single to low-double digit percentages. These additional amounts will be recognized as determinable.
11 .
Income taxes:
Income tax recovery for the three and nine months ended September 30, 2021 and 2020 arose from the operations of Xenon Pharmaceuticals USA Inc., the Company’s wholly-owned subsidiary in the United States. Deferred income tax assets recorded on the consolidated balance sheets as of September 30, 2021 and December 31, 2020 resulted from the temporary differences between the amounts of assets and liabilities recognized for financial statement and income tax purposes related to the operations of Xenon Pharmaceuticals USA Inc. The realization of deferred income tax assets is dependent upon the generation of sufficient taxable income during future periods in which the temporary differences are expected to reverse.
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12 .
Commitments and contingencies:
(a)
Priority access agreement with Medpace Inc. (“Medpace”):
In August 2015, the Company entered into a priority access agreement with Medpace for the provision of certain clinical development services, under which the Company has committed to using Medpace non-exclusively for clinical development services over the five-year term of the agreement which ended in August 2020. The Company has committed to $ 7,000 of services over the term of the agreement of which $ 3,677 of services have been received and $ 3,323 remains committed as of September 30, 2021. As the Company did not meet the commitment to retain Medpace for $7,000 of services prior to August 2020, the Company is required to provide Medpace the exclusive right to perform all subsequent outsourced clinical development work until such $7,000 commitment has been satisfied, subject to the availability of appropriate Medpace resources and reasonable service rates. If the Company decides not to retain Medpace for the provision of clinical development services, the Company may satisfy its obligations under the priority access agreement by paying Medpace an amount equal to half of the unsatisfied portion. The Company intends to continue to utilize Medpace for clinical development work where suitable in order to fulfill the remaining commitment; therefore, no liability has been recognized as of September 30, 2021 with respect to the unsatisfied portion under the priority access agreement.
(b)
License, manufacture and supply agreement:
In March 2017, the Company entered into a license, manufacture and supply agreement with a pharmaceutical contract manufacturing organization for the access and use of certain regulatory documents as well as for the manufacture and supply of clinical and commercial drug product to support the development of XEN007. Under the terms of the agreement, the Company will be required to pay a low single-digit percentage royalty on net sales of any products developed and commercialized under the agreement.
(c)
Asset purchase agreement with 1st Order Pharmaceuticals, Inc. (“1st Order”):
In April 2017, the Company acquired XEN1101 (previously known as 1OP2198) from 1st Order pursuant to an asset purchase agreement. In August 2020, the Company and 1st Order amended the asset purchase agreement to amend certain definitions in the agreement and to modify the payment schedule for certain milestones. Future potential payments to 1st Order related to the XEN1101 program include up to $ 1,200 in clinical development milestones, up to $ 6,000 in regulatory milestones, and $ 500 in other milestones. To date, the Company has paid $ 300 based on progress against these milestones. There are no royalty obligations to 1st Order.
(d)
License agreement:
In July 2017, the Company entered into a license agreement with a pharmaceutical company for the access and use of certain regulatory documents to support the development of XEN007. Future potential payments include $ 2,000 in clinical development milestones, up to $ 7,000 in regulatory milestones, plus a low-to-mid single-digit percentage royalty on net sales of any products developed and commercialized under the agreement. No amounts have been accrued to date based on the progress against these milestones.
(e)
Guarantees and indemnifications:
The Company has entered into license and research agreements with third parties that include indemnification provisions that are customary in the industry. These indemnification provisions generally require the Company to compensate the other party for certain damages and costs incurred as a result of third-party claims or damages arising from these transactions.
The maximum amount of potential future indemnification is unlimited; however, the Company currently holds commercial and product liability insurance. This insurance limits the Company’s exposure and may enable it to recover a portion of any future amounts paid. Historically, the Company has not made any indemnification payments under such agreements and the Company believes that the fair value of these indemnification obligations is minimal. Accordingly, the Company has not recognized any liabilities relating to these obligations for any period presented.
13.
Subsequent event:
On October 5, 2021, the Company entered into an underwriting agreement with Jefferies, SVB Leerink LLC and Stifel, relating to an underwritten public offering of 10,000,000 common shares, including 1,525,423 common shares sold upon the full exercise of the underwriters’ over-allotment option, at a public offering price of $ 29.50 per common share and pre-funded warrants to purchase 1,694,915 common shares at $ 29.4999 per pre-funded warrant, with each pre-funded warrant having an exercise price per share of $ 0.0001 . The public offering was completed on October 8, 2021, and the Company received proceeds of $ 324,300 , net of underwriting discounts and commissions, but before offering expenses .
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ITEM 2. MANAGE MENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
This section should be read in conjunction with our unaudited interim consolidated financial statements and related notes included in Part I, Item 1 of this report and our audited consolidated financial statements and related notes thereto and management’s discussion and analysis of financial condition and results of operations for the year ended December 31, 2020 included in our Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission on March 1, 2021 and with the securities commissions in British Columbia, Alberta and Ontario on March 1, 2021.
Forward-Looking Statements
Certain statements contained in this Quarterly Report on Form 10-Q 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 :
•
our ability to identify additional products or product candidates either from our internal research efforts or though acquiring or in-licensing other product candidates or technologies;
•
the initiation, timing, cost, progress and success of our research and development programs, pre-clinical studies, and clinical trials;
•
our ability to advance product candidates into, and successfully complete, clinical trials;
•
our ability to recruit sufficient numbers of patients for our current and future clinical trials for orphan or more common indications;
•
the direct and indirect impact of COVID-19 on our business and operations, including supply chain, manufacturing, research and development costs, clinical trial conduct, clinical trial data and employees;
•
our ability to achieve profitability;
•
our ability to obtain funding for our operations;
•
our ability to receive milestones, royalties and sublicensing fees under our collaborations, and the timing of such payments;
•
the timing and magnitude of potential milestone payments under our product acquisition and in-licensing agreements;
•
the implementation of our business model and strategic plans;
•
our ability to develop and commercialize product candidates for orphan and niche indications or more common indications independently;
•
our pre-commercial, commercialization, marketing, and manufacturing capabilities and strategy;
•
our ability to identify drug targets;
•
our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others;
•
our expectations regarding federal, state and foreign regulatory requirements;
•
the therapeutic benefits, effectiveness and safety of our product candidates;
•
the accuracy of our estimates of the size and characteristics of the markets that may be addressed by our products and product candidates and our ability to obtain suitable pricing and receive reimbursements from health agencies;
•
the rate and degree of market acceptance and clinical utility of any future products;
•
the timing of, and our and our collaborators’ ability to obtain and maintain, regulatory approvals for our product candidates;
•
our ability to maintain and establish collaborations;
•
our expectations regarding market risk, including interest rate changes and foreign currency fluctuations;
-16-
•
our belief in the sufficiency of our cash, cash equivalents and marketable securities to meet our needs for at least the next 12 months;
•
our ability to engage and retain the employees required to grow our business;
•
our future financial performance and projected expenditures;
•
developments relating to our competitors and our industry, including the success of competing therapies that are or become available; and
•
estimates of our expenses, future revenue, capital requirements and our needs for additional financing.
These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements. Factors that might cause such a difference include, but are not limited to, those discussed in this report in Part II, Item 1A — “Risk Factors,” and elsewhere in this report. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. These statements, like all statements in this report, speak only as of their date, and we undertake no obligation to update or revise these statements in light of future developments, except as required by law. In this report, “we,” “our,” “us,” “Xenon,” and “the Company” refer to Xenon Pharmaceuticals Inc. and its subsidiary. Unless otherwise noted, all dollar amounts in this report are expressed in United States dollars.
In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report on Form 10-Q, and although we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted a thorough inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and you are cautioned not to unduly rely upon these statements.
Overview
We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders. We are advancing a novel product pipeline of neurology-focused therapies to address areas of high unmet medical need, with a focus on epilepsy .
Proprietary Programs
XEN1101
XEN1101 is a differentiated Kv7 potassium channel opener being developed for the treatment of epilepsy and major depressive disorder, or MDD. On October 4, 2021, we announced positive topline data from the Phase 2b ‘X-TOLE’ clinical trial, which was designed as a randomized, double-blind, placebo-controlled, multicenter study to evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as an adjunctive treatment for adult patients with focal epilepsy. The trial met its primary efficacy endpoint with XEN1101 demonstrating a statistically significant and dose-dependent reduction from baseline in monthly (defined as 28 days) focal seizure frequency when compared to placebo (monotonic dose response; p<0.001). Additional primary and secondary measures included a pairwise comparison of each active dose to placebo and a responder analysis with the proportion of patients who achieved a 50% or greater reduction in monthly focal seizure frequency from baseline. These results are shown in the following table; all p-values are 2-sided comparing the active dose to placebo:
XEN1101 25 mg
(N=112)
XEN1101 20 mg
(N=51)
XEN1101 10 mg
(N=46)
Placebo
(N=114)
Median Reduction from Baseline in Monthly Focal Seizure Frequency
52.8%
(p<0.001)
46.4%
(p<0.001)
33.2%
(p=0.035)
18.2%
Patients with at least a 50% Reduction in Monthly Focal Seizure Frequency from Baseline
54.5%
(p<0.001)
43.1%
(p<0.001)
28.3%
(p=0.037)
14.9%
-17-
We anticipate participating in an “end-of-Phase 2” meeting with the U.S. Food and Drug Administration, or FDA, in the second quarter of 2022 to support the initiation of its Phase 3 XEN1101 clinical program in adult patients with focal epilepsy, estimated in the second half of the year. In addition, the X-TOLE open-label extension, which has been extended to three years, is expected to continue to generate important long-term data for XEN1101. In parallel, based on the strength of the X-TOLE topline efficacy data, we are evaluating other potential epilepsy indications for the future development of XEN1101. We continue to execute on our strategy to expand the intellectual property portfolio that protects XEN1101. During the third quarter and subsequent to quarter-end, two U.S. patents were issued to us with claims related to: (1) four distinct crystalline forms of XEN1101 drug substance (including the forms used in current and future clinical development) along with methods for their preparation; and (2) methods of enhancing the bioavailability of XEN1101 by administration with or close to a meal (consistent with the dosing of XEN1101 in our clinical studies). These U.S. patents are expected to expire in 2039 and 2040, respectively, absent any extensions of patent term.
Based on its differentiated Kv7 mechanism of action, we are expanding the development of XEN1101 to support proof-of-concept studies in MDD, which are supported by XEN1101 pre-clinical and clinical data, and previous ezogabine clinical data that explored the targeting of KCNQ channels as a treatment for MDD. We are collaborating with the Icahn School of Medicine at Mount Sinai to conduct an investigator-sponsored Phase 2 proof-of-concept, multi-site, randomized, parallel-arm, placebo-controlled clinical trial of XEN1101 for the treatment of MDD, with patient enrollment underway. Approximately 60 patients with MDD will be randomized in a 1:1 fashion to XEN1101 (N=30) or matching placebo (N=30), with subjects taking 20 mg once a day of either XEN1101 or placebo for 8 weeks. The primary objective is to investigate the effect of XEN1101 on brain measures of reward using functional Magnetic Resonance Imaging, or fMRI. Secondary endpoints include clinical measures of depression and anhedonia. In addition, we are planning a larger company-sponsored clinical study in MDD with XEN1101, which is expected to be initiated in the first half of 2022.
XEN496
XEN496, a Kv7 potassium channel opener, is a proprietary pediatric formulation of the active ingredient ezogabine being developed for the treatment of KCNQ2 developmental and epileptic encephalopathy, or KCNQ2-DEE. We received Fast Track designation and Orphan Drug Designation for XEN496 for the treatment of seizures associated with KCNQ2-DEE from the FDA, as well as orphan medicinal product designation from the European Commission. A Phase 3 randomized, double-blind, placebo-controlled, parallel group, multicenter clinical trial, called the ‘EPIK’ study, is underway to evaluate the efficacy, safety, and tolerability of XEN496 administered as adjunctive treatment in approximately 40 pediatric patients aged one month to less than six years with KCNQ2-DEE. We anticipate that the EPIK study will be completed in the first half of 2023.
Other Updates
XEN007 (active ingredient flunarizine) is a CNS-acting Cav2.1 and T-type calcium channel modulator that is being studied in treatment-resistant absence seizures. To date, a total of eight subjects have been enrolled in an investigator-led Phase 2 proof-of-concept study examining the potential clinical efficacy, safety, and tolerability of XEN007 as an adjunctive treatment in pediatric patients diagnosed with treatment-resistant absence seizures, including childhood absence epilepsy and juvenile absence epilepsy. Given the prioritized focus on the development plans for XEN1101 and XEN496, we are not planning any company-sponsored XEN007 development activities in 2022.
Partnered Programs
NBI-921352
We have an ongoing collaboration with Neurocrine Biosciences Inc., or Neurocrine Biosciences, to develop treatments for epilepsy. Neurocrine Biosciences has an exclusive license to XEN901, now known as NBI-921352, a selective Nav1.6 sodium channel inhibitor. Neurocrine Biosciences is conducting a Phase 2 clinical trial evaluating NBI-921352 in adolescent patients (aged 12 years and older) with SCN8A developmental and epileptic encephalopathy, or SCN8A-DEE. In addition, a second Phase 2 clinical trial has recently been initiated evaluating NBI-921352 in adult patients with focal-onset seizures. We received an aggregate milestone payment of $10.0 million in the form of cash and an equity investment in September 2021 based on the regulatory approval of a clinical trial application in Europe for NBI-921352 for focal-onset seizures in adults. Upon FDA acceptance of a protocol amendment for NBI-921352 in pediatric patients (aged 2-11 years) with SCN8A-DEE, we are eligible to receive an aggregate payment of $15.0 million in the form of 45% cash and a 55% equity investment in our common shares at a 15% premium to our 30-day trailing volume weighted average price at that time.
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FX301
Flexion Therapeutics, Inc., or Flexion, acquired the global rights to develop and commercialize XEN402, a Nav1.7 inhibitor also known as funapide. Flexion’s FX301 consists of XEN402 formulated for extended release from a thermosensitive hydrogel. The initial development of FX301 is intended to support administration as a peripheral nerve block for control of post-operative pain. Flexion is conducting a Phase 1b proof-of-concept trial evaluating the safety and tolerability of FX301 administered as a single-dose, popliteal fossa block (a commonly used nerve block in foot and ankle-related surgeries) in patients undergoing bunionectomy. Following the decision to expand the study with an additional cohort, Flexion now anticipates having data available in the first quarter of 2022. Pursuant to the terms of the agreement, we are eligible to receive certain clinical, regulatory, and commercial milestone payments, as well as future sales royalties.
We have funded our operations primarily through the sale of equity securities, funding received from our licensees and collaborators, and debt financing. For the nine months ended September 30, 2021 and 2020, we recognized revenue of $14.7 million and $27.0 million, respectively, in connection with our agreements with Neurocrine Biosciences and Flexion. We had a net loss of $53.3 million for the nine months ended September 30, 2021 and an accumulated deficit of $331.8 million as of September 30, 2021, from expenses incurred in connection with our research and development programs and from general and administrative costs associated with our operations.
We do not generate any royalty revenue from product sales, and do not otherwise anticipate generating revenue from product sales for the foreseeable future, if ever . We expect that our revenue in the near term will be substantially dependent on our collaboration agreements. Given the uncertain nature of clinical development of our current and future product candidates and the commercialization of current and future products, we cannot predict when or whether we will receive further milestone payments under our current or future collaboration agreements or whether we will be able to report either revenue or net income in future years.
We expect to continue to incur significant expenses and operating losses for the foreseeable future. We anticipate that our expenses will increase as we:
•
continue our research and pre-clinical and clinical development of our product candidates either from our internal research efforts or through acquiring or in-licensing other product candidates or technologies;
•
seek regulatory and marketing approvals for any of our product candidates that successfully complete clinical trials;
•
make milestone and other payments under our in-license or other agreements;
•
maintain, protect and expand our intellectual property portfolio;
•
attract, hire and retain skilled personnel; and
•
create additional infrastructure to support our operations.
Financial Operations Overview
Revenue
To date, our revenue has been primarily derived from collaboration and licensing agreements. We do not generate any royalty revenue from product sales , and do not otherwise anticipate generating revenue from product sales for the foreseeable future, if ever.
The following table is a summary of revenue recognized from our current collaboration and licensing agreements for the three and nine months ended September 30, 2021 and 2020 (in thousands):
Three Months Ended September 30,
Nine Months Ended September 30,
2021
2020
2021
2020
Neurocrine Biosciences:
Recognition of the transaction price
$
823
$
5,246
$
1,440
$
23,006
Research and development services
2,031
1,308
4,990
4,010
Milestone payments
5,270
—
5,270
—
Flexion:
Milestone payments
—
—
3,000
—
Total collaboration revenue
$
8,124
$
6,554
$
14,700
$
27,016
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Pursuant to the terms of our license and collaboration agreement with Neurocrine Biosciences, we received an upfront cash payment of $30.0 million and a $20.0 million equity investment in our common shares at the inception of the agreement in December 2019. The equity investment was measured at fair value on the date of issuance and the resulting premium, together with the upfront cash payment and variable consideration which is probable that a significant reversal of the cumulative revenue recognized will not occur, is the transaction price of the arrangement at the inception of the agreement for allocation to the performance obligations. The allocation was based on the relative estimated standalone selling prices of each obligation under the agreement including: (i) an exclusive license to NBI-921352 with associated technology and know-how transfer, (ii) an exclusive license to pre-clinical compounds for development, XEN393, XPC’535 and XPC’391, collectively referred to as the development track candidates, or the DTCs, with associated know-how transfer, and (iii) development services under the initial development program for the DTCs. In September 2021, based on the regulatory approval of a clinical trial application in Europe for NBI-921352 for focal-onset seizures in adults, we received an aggregate milestone payment of $10.0 million in the form of $4.5 million cash and a $5.5 million equity investment in our common shares. The equity investment was measured at fair value of $4.7 million on the date of issuance and the resulting premium of $0.8 million, with the cash payment of $4.5 million, was recognized as revenue in the period. In the three and nine months ended September 30, 2021, we also recognized $0.8 million and $1.4 million, respectively, of the transaction price allocated to performance obligations (i), (ii) and (iii), compared to $5.2 million and $23.0 million, respectively, for the three and nine months ended September 30, 2020. Performance obligations (i) and (ii) were completed as of December 31, 2020 . Performance obligation (iii) is expected to be completed by Q1 2022. Research and development services are recognized into revenue at fair market value as the services are rendered.
In the nine months ended September 30, 2021, we recognized revenue of $3.0 million in connection with our agreement with Flexion for the global rights to develop and commercialize FX301 which included a $1.0 million milestone for the clearance of an investigational new drug application by the FDA and a $2.0 million milestone for the initiation of a Phase 1b clinical trial. No revenue was recognized for the three and nine months ended September 30, 2020 in connection with our agreement with Flexion.
As our other internal and partnered products are in various stages of clinical and pre-clinical development, we do not expect to generate any revenue from product sales for at least the next several years. We expect that any revenue for the next several years will be derived from milestone payments and research and development funding under our current collaboration agreements and any additional collaboration agreements that we may enter into in the future. We cannot provide any assurance as to the extent or timing of future milestone payments or royalty payments or that we will receive any future payments at all .
We expect that any revenue we generate will fluctuate quarter to quarter as a function of the timing and amount of milestones and other payments from our existing collaborations and any future collaborations.
As of September 30, 2021, there is $2.2 million remaining in deferred revenue from the upfront payment received under our license and collaboration agreement with Neurocrine Biosciences.
Operating Expenses
The following table summarizes our operating expenses for the three and nine months ended September 30, 2021 and 2020 (in thousands):
Three Months Ended September 30,
Nine Months Ended September 30,
2021
2020
2021
2020
Research and development
$
18,891
$
13,045
$
53,576
$
35,556
General and administrative
4,831
3,208
15,279
9,838
Total operating expenses
$
23,722
$
16,253
$
68,855
$
45,394
Research and Development Expenses
Research and development expenses represent costs incurred to conduct research and development of our proprietary product candidates, including any acquired or in-licensed product candidates or technology, and costs to support our partnered product candidates .
Research and development expenses consist of costs incurred in performing research and development activities, including salary, related benefits and stock-based compensation for employees engaged in scientific research and development, third-party contract costs relating to research, formulation, process development and manufacturing, pre-clinical studies and clinical trial activities, third-party acquisition, license and collaboration fees, laboratory consumables and allocated facility-related and information technology costs.
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Project-specific expenses reflect costs directly attributable to our clinical development candidates for which we have incurred significant expenses. All remaining research and development expenses are reflected in pre-clinical, discovery and other internal program expenses. At any given time, we have several active early-stage research and drug discovery programs. Our personnel and infrastructure are typically deployed over multiple projects and are not directly linked to any individual internal early-stage research or drug discovery program. Therefore, we do not maintain financial information for our internal early-stage research and internal drug discovery programs on a project-specific basis.
We expense all research and development costs as incurred. We expect that our research and development expenses will increase in the future as we advance our proprietary product candidates through clinical development, advance our internal drug discovery programs into pre-clinical development and continue our early-stage research. The increase in expense will likely include added personnel and third-party contracts related to research, formulation, process development and manufacturing, pre-clinical studies and clinical trial activities as well as third-party acquisition, license and collaboration fees and laboratory consumables.
Clinical development timelines, likelihood of regulatory approval, and commercialization and associated costs are uncertain, difficult to estimate, and can vary significantly. We anticipate determining which research and development projects to pursue as well as the level of funding available for each project based on the scientific research and pre-clinical and clinical results of each product candidate and related regulatory action. We expect our research and development expenses to continue to represent our largest category of operating expenses for at least the next 12 to 24 months.
General and Administrative Expenses
General and administrative expenses consist primarily of salary, related benefits and stock-based compensation of our executive, finance, legal, business development, commercial and administrative functions, travel expenses, allocated facility-related and information technology costs not otherwise included in research and development expenses, director compensation, director’s and officer’s insurance premiums, investor relations costs and professional fees for auditing, tax and legal services, including legal expenses for intellectual property protection.
We expect that general and administrative expenses will increase in the future as we expand our operating activities to support increased research and development activities and the potential commercialization of our product candidates.
Other Income (Expense)
Interest Income. Interest income consists of income earned on our cash and investment balances. We anticipate that our interest income will continue to fluctuate depending on our cash and investment balances and interest rates.
Interest Expense. Interest expense consists of accrual of the final payment fee, amortization of debt discounts, and interest charged on our borrowings with Silicon Valley Bank. In May 2020, we repaid the total outstanding term loan balance ahead of the maturity date.
Foreign Exchange Gain (Loss). Net foreign exchange gains and losses consisted of gains and losses from the impact of foreign exchange fluctuations on our monetary assets and liabilities that are denominated in currencies other than the U.S. dollar (principally the Canadian dollar). We will continue to incur substantial expenses in Canadian dollars and will remain subject to risks associated with foreign currency fluctuations.
Loss on repayment of term loan. In May 2020, we repaid the total outstanding balance of our term loan with Silicon Valley Bank ahead of the maturity date. We recorded a one-time loss of $1.0 million on the repayment of the term loan, inclusive of repayment fees.
Critical Accounting Policies and Significant Judgments and Estimates
Our management’s discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in conformity with generally accepted accounting principles in the U.S., or U.S. GAAP. The preparation of our consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the revenue and expenses incurred during the reported periods. We base estimates on our historical experience, known trends and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
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Critical accounting policies and significant judgments and estimates are those that we consider the most important to the portrayal of our financial condition and results of operations because they require our most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. Our critical accounting policies and significant estimates include those related to:
•
revenue recognition;
•
research and development costs; and
•
stock-based compensation
There have been no material changes in our critical accounting policies and significant judgments and estimates during the nine months ended September 30, 2021, as compared to those disclosed in “Management’s Discussion and Analysis of Financial Conditions and Results of Operations - Critical Accounting Policies and Significant Judgments and Estimates” included in our 2020 Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission, or SEC, and with the securities commissions in British Columbia, Alberta and Ontario, or the Canadian Securities Commissions, on March 1, 2021. We believe that the accounting policies discussed in the Annual Report are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s judgments and estimates.
Results of Operations
Comparison of Three and Nine Months Ended September 30, 2021 and 2020
The following table summarizes the results of our operations for the three and nine months ended September 30, 2021 and 2020 together with changes in those items (in thousands):
Three Months Ended September 30,
Change
2021 vs. 2020
Nine Months Ended September 30,
Change
2021 vs. 2020
2021
2020
Increase/(Decrease)
2021
2020
Increase/(Decrease)
Revenue
$
8,124
$
6,554
$
1,570
$
14,700
$
27,016
$
(12,316
)
Research and development expenses
18,891
13,045
5,846
53,576
35,556
18,020
General and administrative expenses
4,831
3,208
1,623
15,279
9,838
5,441
Other:
Interest income
76
166
(90
)
203
2,194
(1,991
)
Interest expense
—
—
—
—
(484
)
484
Foreign exchange gain (loss)
(128
)
475
(603
)
144
899
(755
)
Loss on repayment of term loan
—
—
—
—
(988
)
988
Loss before income taxes
$
(15,650
)
$
(9,058
)
$
(6,592
)
$
(53,808
)
$
(16,757
)
$
(37,051
)
Revenue
Revenue increased by $1.6 million and decreased by $12.3 million in the three and nine months ended September 30, 2021 as compared to the three and nine months ended September 30, 2020, respectively. Revenue for the three and nine months ended September 30, 2021 related to recognition of $5.3 million of milestone revenue, $0.8 million and $1.4 million, respectively, of deferred revenue as well as $2.0 million and $5.0 million, respectively, for research and development services under our license and collaboration agreement with Neurocrine Biosciences, as compared to recognition of $5.2 million and $23.0 million, respectively, of deferred revenue and $1.3 million and $4.0 million, respectively, for research and development services in the comparative periods. Revenue for the nine months ended September 30, 2021 also included $3.0 million in milestone revenue recognized in connection with our agreement with Flexion, whereas no revenue was recognized in connection with this agreement for the nine months ended September 30, 2020.
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Research and Development Expenses
The following table summarizes research and development expenses for the three and nine months ended September 30, 2021 and 2020 together with changes in those items (in thousands):
Three Months Ended September 30,
Change
2021 vs. 2020
Nine Months Ended September 30,
Change
2021 vs. 2020
2021
2020
Increase/(Decrease)
2021
2020
Increase/(Decrease)
XEN1101
$
8,250
$
6,240
$
2,010
$
23,252
$
16,785
$
6,467
XEN496
4,213
3,116
1,097
14,127
7,672
6,455
NBI-921352
302
117
185
1,035
1,380
(345
)
Pre-clinical, discovery and other programs
6,126
3,572
2,554
15,162
9,719
5,443
Total research and development
$
18,891
$
13,045
$
5,846
$
53,576
$
35,556
$
18,020
Research and development expenses increased by $5.8 million and $18.0 million in the three and nine months ended September 30, 2021 as compared to the three and nine months ended September 30, 2020. The increases were primarily attributable to increased spending on our clinical development product candidates XEN1101 and XEN496 as well as increased spending on our pre-clinical, discovery and other internal programs.
General and Administrative Expenses
The following table summarizes general and administrative expenses for the three and nine months ended September 30, 2021 and 2020 together with changes in those items (in thousands):
Three Months Ended September 30,
Change
2021 vs. 2020
Nine Months Ended September 30,
Change
2021 vs. 2020
2021
2020
Increase/(Decrease)
2021
2020
Increase/(Decrease)
General and administrative
$
4,831
$
3,208
$
1,623
$
15,279
$
9,838
$
5,441
General and administrative expenses increased by $1.6 million and $5.4 million in the three and nine months ended September 30, 2021 as compared to the three and nine months ended September 30, 2020. The increases were primarily attributable to increased stock-based compensation expense due to an increase in the number of options granted at a higher fair value, higher salaries and benefits due to increased headcount to support our expanding research and development activities, increased legal fees for intellectual property protection , and increased market research costs .
Other Income (Expense)
The following table summarizes our other income (expense) for the three and nine months ended September 30, 2021 and 2020 together with changes in those items (in thousands):
Three Months Ended September 30,
Change
2021 vs. 2020
Nine Months Ended September 30,
Change
2021 vs. 2020
2021
2020
Increase/(Decrease)
2021
2020
Increase/(Decrease)
Other income (expense)
$
(52
)
$
641
$
(693
)
$
347
$
1,621
$
(1,274
)
Other income (expense) decreased by $0.7 million and $1.3 million in the three and nine months ended September 30, 2021 as compared to the three and nine months ended September 30, 2020. We recorded a foreign exchange loss of $0.1 million for the three months ended September 30, 2021 as compared to a $0.5 million foreign exchange gain for the same period in 2020, largely due to a decrease in cash and cash equivalent and marketable securities denominated in Canadian dollars and 2% decrease as compared to a 2% increase in the value of the Canadian dollar, respectively.
For the nine months ended September 30, 2021, the decrease was primarily attributable to lower interest income due to a decrease in market yields on investments as well as a lower foreign exchange gain due to a decrease in cash and cash equivalents and marketable securities denominated in Canadian dollars. This decrease was partially offset by a one-time loss on the repayment of our term loan with Silicon Valley Bank of $1.0 million in the same period in 2020.
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Liquidity and Capital Resources
To date, we have financed our operations primarily through funding received from collaboration and license agreements, private placements of our common and preferred shares, public offerings of our common shares and pre-funded warrants, and debt financing. As of September 30, 2021, we had cash and cash equivalents and marketable securities of $249.6 million.
We have incurred significant operating losses since inception. We had a $53.3 million net loss for the nine months ended September 30, 2021 and an accumulated deficit of $331.8 million from inception through September 30, 2021. We expect to continue to incur significant expenses in excess of our revenue and expect to incur operating losses over the next several years. Our net losses may fluctuate significantly from quarter to quarter and year to year. We expect to incur significant expenses and increasing operating losses for the foreseeable future as we continue our research and pre-clinical and clinical development of our product candidates; expand the scope of our studies for our current and prospective product candidates; initiate additional pre-clinical, clinical or other studies for our product candidates; change or add additional manufacturers or suppliers and manufacture drug supply and drug product for clinical trials and commercialization; 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 or other agreements, including, without limitation, payments to Memorial University of Newfoundland, 1st Order Pharmaceuticals, Inc. and other third parties; maintain, protect and expand our intellectual property portfolio; establish a sales, marketing and distribution infrastructure to commercialize any products for which we may obtain marketing approval; create additional infrastructure and incur additional costs to support our operations and our product development and planned future commercialization efforts; and experience any delays or encounter issues with any of the above.
Until such time as we can generate substantial product revenue, if ever, we expect to finance our cash needs through a combination of collaboration agreements and equity or debt financings. For example, in October 2021, we entered into an underwriting agreement with Jefferies LLC, or Jefferies, SVB Leerink LLC, or SVB Leerink, and Stifel, Nicolaus & Company, Incorporated, or Stifel, relating to an underwritten public offering of 10,000,000 common shares, including 1,525,423 common shares sold upon the full exercise of the underwriters’ over-allotment option, at a public offering price of $29.50 per common share, and pre-funded warrants to purchase 1,694,915 common shares at $29.4999 per pre-funded warrant, with each pre-funded warrant having an exercise price of $0.0001. The public offering was completed on October 8, 2021, and we received proceeds of $324.3 million, net of underwriting discount and commissions, but before offering expenses . In September 2021, pursuant to the terms of our license and collaboration agreement with Neurocrine Biosciences, we received a cash payment of $4.5 million and we issued 275,337 common shares to Neurocrine Biosciences for an aggregate purchase price of $5.5 million. In March 2021, we entered into an underwriting agreement with Jefferies and Stifel relating to an underwritten public offering of 5,153,135 common shares, including 810,810 shares sold upon the full exercise of the underwriters’ option to purchase additional shares, and pre-funded warrants to purchase 1,081,081 common shares. The common shares were offered at a public offering price of $18.50 per common share and the pre-funded warrants were offered at a price of $18.4999 per pre-funded warrant, for proceeds of $107.9 million, net of underwriting discounts, commissions and offering expenses. In August 2020, we entered into an at-the-market equity offering sales agreement with Jefferies and Stifel, to sell our common shares having aggregate sales proceeds of up to $100.0 million, from time to time, through an “at-the-market” equity offering program under which Jefferies and Stifel are acting as sales agents. As of September 30, 2021, we had sold an aggregate of 733,000 common shares for proceeds of $10.7 million, net of commissions and transaction expenses. In addition, in January 2020, we entered into an underwriting agreement with Jefferies, Stifel, and Guggenheim Securities, LLC, relating to an underwritten public offering of 3,750,000 common shares at a public offering price of $16.00 per common share, and granted the underwriters an option for a period of 30 days to purchase up to an additional 562,500 common shares. The public offering was completed in January 2020 and the underwriters’ option was exercised in full in February 2020. We issued an aggregate of 4,312,500 common shares and raised total proceeds of $64.7 million, net of underwriting discounts, commissions and offering expenses. Further, in November 2019, we entered into an at-the-market equity offering sales agreement with Jefferies and Stifel, to sell our common shares having aggregate sales proceeds of up to $50.0 million, from time to time, through an “at-the-market” equity offering program under which Jefferies and Stifel acted as sales agent. As of January 2020, we had sold an aggregate of 3,252,330 common shares for proceeds of $48.5 million, net of commissions and transaction expenses.
Except for any obligations of our collaborators to make milestone payments a nd research and development funding under our agreements with them , we do not have any committed external sources of capital. To the extent that we raise additional capital through the future sale of equity or debt, the ownership interest of our shareholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our existing shareholders. If we raise additional funds through collaboration agreements in the future, we may have to relinquish valuable rights to our technologies, future revenue streams or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
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Our future capital requirements are difficult to forecast and will depend on many factors, including:
•
the number and characteristics of the future product candidates we pursue either from our internal research efforts or through acquiring or in-licensing other product candidates or technologies;
•
the scope, progress, results and costs of independently researching and developing any of our future product candidates, including conducting pre-clinical research and clinical trials;
•
whether our existing collaborations continue to generate substantial milestone payments and, ultimately, royalties on future approved products for us;
•
the timing of, and the costs involved in, obtaining regulatory approvals for any future product candidates we develop independently;
•
the timing and magnitude of potential milestone payments and royalties under our product acquisition and in-license agreements;
•
the cost of pre-commercial activities in advance of product commercialization as well as commercializing any future products we develop independently that are approved for sale;
•
the cost of manufacturing our future product candidates and 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 our future products, if any.
Based on our research and development plans and our timing expectations related to the progress of our programs, we expect that our existing cash and cash equivalents and marketable securities as of the date of this report will enable us to fund our operating expenses and capital expenditure requirements for at least the next 12 months. We have based this estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we expect. Additionally, the process of testing drug candidates in clinical trials is costly, and the timing of progress in these trials remains uncertain.
Cash Flows
The following table shows a summary of our cash flows for the nine months ended September 30, 2021 and 2020 (in thousands):
Nine Months Ended September 30,
2021
2020
Net cash used in operating activities
$
(48,792
)
$
(35,010
)
Net cash used in investing activities
(31,337
)
(60,023
)
Net cash provided by financing activities
123,590
85,750
Operating Activities
For the nine months ended September 30, 2021, net cash used in operating activities totaled $48.8 million, compared to $35.0 million for the same period in 2020. The increase in cash used in operating activities was primarily related to higher expenditures for the clinical development of our proprietary product candidates and pre-clinical, discovery and other internal programs , higher general and administrative expenses and lower interest income for the nine months ended September 30, 2021 as compared to the same period in 2020, partially offset by $8.3 million in milestone revenue recognized in connection with our agreements with Neurocrine Biosciences and Flexion in the nine months ended September 30, 2021 and changes in operating assets and liabilities.
Investing Activities
For the nine months ended September 30, 2021, net cash used in investing activities totaled $31.3 million, compared to $60.0 million for the same period in 2020. The change in cash used in investing activities was driven primarily by a decrease in purchases of marketable securities, net of redemptions.
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Financing Activities
For the nine months ended September 30, 2021, net cash provided by financing activities totaled $123.6 million, compared to $85.8 million for the same period in 2020. The increase in cash provided by financing activities was primarily related to net proceeds of $123.3 million from the issuance of common shares and pre-funded warrants during the nine months ended September 30, 2021 as compared to $102.5 million from the issuance of common shares, partially offset by repayment of the term loan, for the same period in 2020.
Contractual Obligations and Commitments
Our future significant contractual obligations as of December 31, 2020 were reported in our Annual Report on Form 10-K, filed with the SEC and the Canadian Securities Commissions on March 1, 2021.
As of September 30, 2021, there have been no material changes from the contractual commitments previously disclosed in the Annual Report on Form 10-K.
Inflation
We do not believe that inflation has had a material effect on our business, financial condition or results of operations in the last two fiscal years.
Off-Balance Sheet Arrangements
We do not engage in any off-balance sheet financing activities. We do not have any interest in entities referred to as variable interest entities, which include special purposes entities and other structured finance entities.
Outstanding Share Data
As of November 8, 2021, we had 51,589,279 common shares issued and outstanding, outstanding pre-funded warrants to purchase an additional 2,775,996 common shares, outstanding stock options to purchase an additional 5,677,702 common shares and an outstanding warrant to purchase an additional 40,000 common shares. In addition, we had 1,016,000 Series 1 Preferred Shares issued and outstanding. The Series 1 Preferred Shares are convertible into common shares on a one-for-one basis subject to the holder, together with its affiliates, beneficially owning no more than 9.99% of the total number of common shares issued and outstanding immediately after giving effect to such conversion, or the Beneficial Ownership Limitation. The holder may reset the Beneficial Ownership Limitation to a higher or lower number, not to exceed 19.99% of the total number of common shares issued and outstanding immediately after giving effect to such conversion, upon providing written notice to us which will be effective 61 days after delivery of such notice. The holders of the Series 1 Preferred Shares are entitled to vote together with the common shares on an as-converted basis and as a single class, subject in the case of each holder of the Series 1 Preferred Shares to the Beneficial Ownership Limitation. The Series 1 Preferred Shares may be “restricted securities” as such term is defined under applicable Canadian securities laws, as any Series 1 Preferred Shares that are ineligible to be converted into common shares due to the Beneficial Ownership Limitation, measured as of a given record date that applies for a shareholder meeting or ability to act by written consent, shall be deemed to be non-voting securities. For additional information regarding our Series 1 Preferred Shares, see note 10b to our consolidated financial statements included in Part I, Item 1 of this report.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
As a smaller reporting company, we are not required to provide the information requested by this item pursuant to Item 305(e) of Regulation S-K.
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.