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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 2022
OR
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the Transition Period from to
Commission File Number: 001-34949
ARBUTUS BIOPHARMA CORPORATION
(Exact Name of Registrant as Specified in Its Charter)
| | | | | | | | |
British Columbia, Canada | | 98-0597776 |
(State or Other Jurisdiction of | | (I.R.S. Employer |
Incorporation or Organization) | | Identification No.) |
701 Veterans Circle, Warminster, PA 18974
(Address of Principal Executive Offices and Zip Code)
267-469-0914
(Registrant’s Telephone Number, Including Area Code)
Securities registered pursuant to Section 12(b) of the Act:
| | | | | | | | |
Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
Common Shares, without par value | ABUS | The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| | | | | | | | | | | | | | |
Large accelerated filer | Accelerated filer | Non-accelerated filer | Smaller reporting company | Emerging growth company |
☐ | ☐ | ☒ | ☒ | ☐ |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes ☐ No ☒
As of August 2, 2022, the registrant had 149,950,606 common shares, without par value, outstanding.
ARBUTUS BIOPHARMA CORPORATION
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS (UNAUDITED)
ARBUTUS BIOPHARMA CORPORATION
Condensed Consolidated Balance Sheets
(Unaudited)
(In thousands of U.S. Dollars, except share and per share amounts)
| | | | | | | | | | | |
| June 30, 2022 | | December 31, 2021 |
Assets | | | |
Current assets: | | | |
Cash and cash equivalents | $ | 47,320 | | | $ | 109,282 | |
Investments in marketable securities, current | 102,879 | | | 46,035 | |
Accounts receivable | 1,970 | | | 899 | |
Prepaid expenses and other current assets | 5,622 | | | 4,445 | |
Total current assets | 157,791 | | | 160,661 | |
Property and equipment, net of accumulated depreciation of $10,132 (December 31, 2021: $9,374) | 5,493 | | | 5,983 | |
Investments in marketable securities, non-current | 50,450 | | | 35,688 | |
Right of use asset | 1,922 | | | 2,092 | |
Other non-current assets | 180 | | | 61 | |
Total assets | $ | 215,836 | | | $ | 204,485 | |
Liabilities and stockholders’ equity | | | |
Current liabilities: | | | |
Accounts payable and accrued liabilities | $ | 12,474 | | | $ | 10,838 | |
Deferred license revenue, current | 16,973 | | | — | |
Lease liability, current | 377 | | | 383 | |
Total current liabilities | 29,824 | | | 11,221 | |
Liability related to sale of future royalties | 14,233 | | | 16,296 | |
Deferred license revenue, non-current | 10,842 | | | — | |
Contingent consideration | 5,707 | | | 5,298 | |
Lease liability, non-current | 2,088 | | | 2,231 | |
Total liabilities | 62,694 | | | 35,046 | |
Stockholders’ equity | | | |
Common shares | | | |
Authorized: unlimited number without par value | | | |
Issued and outstanding: 148,794,262 (December 31, 2021: 144,987,736) | 1,298,409 | | | 1,286,636 | |
Additional paid-in capital | 69,134 | | | 65,485 | |
Deficit | (1,164,304) | | | (1,134,347) | |
Accumulated other comprehensive loss | (50,097) | | | (48,335) | |
Total stockholders’ equity | 153,142 | | | 169,439 | |
Total liabilities and stockholders’ equity | $ | 215,836 | | | $ | 204,485 | |
See accompanying notes to the condensed consolidated financial statements.
ARBUTUS BIOPHARMA CORPORATION
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
(In thousands of U.S. Dollars, except share and per share amounts)
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended June 30, | | Six Months Ended June 30, |
| 2022 | | 2021 | | 2022 | | 2021 |
Revenue | | | | | | | |
Collaborations and licenses | $ | 12,556 | | | $ | 1,185 | | | $ | 23,774 | | | $ | 2,339 | |
Non-cash royalty revenue | 1,685 | | | 1,144 | | | 3,048 | | | 2,103 | |
Total Revenue | 14,241 | | | 2,329 | | | 26,822 | | | 4,442 | |
Operating expenses | | | | | | | |
Research and development | 22,942 | | | 15,799 | | | 41,404 | | | 29,581 | |
General and administrative | 5,200 | | | 4,478 | | | 10,092 | | | 8,356 | |
Change in fair value of contingent consideration | 208 | | | 694 | | | 409 | | | 823 | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
Total operating expenses | 28,350 | | | 20,971 | | | 51,905 | | | 38,760 | |
Loss from operations | (14,109) | | | (18,642) | | | (25,083) | | | (34,318) | |
Other income (loss) | | | | | | | |
Interest income | 396 | | | 31 | | | 555 | | | 70 | |
Interest expense | (482) | | | (763) | | | (988) | | | (1,535) | |
Foreign exchange (loss) gain | 3 | | | (13) | | | 3 | | | 15 | |
| | | | | | | |
Total other loss | (83) | | | (745) | | | (430) | | | (1,450) | |
Loss before income taxes | (14,192) | | | (19,387) | | | (25,513) | | | (35,768) | |
Income tax expense | — | | | — | | | (4,444) | | | — | |
Net loss | $ | (14,192) | | | $ | (19,387) | | | $ | (29,957) | | | $ | (35,768) | |
Items applicable to preferred shares: | | | | | | | |
Dividend accretion of convertible preferred shares. | — | | | (3,266) | | | — | | | (6,478) | |
Net loss attributable to common shares | $ | (14,192) | | | $ | (22,653) | | | $ | (29,957) | | | $ | (42,246) | |
| | | | | | | |
Loss per share | | | | | | | |
Basic and diluted | $ | (0.10) | | | $ | (0.23) | | | $ | (0.20) | | | $ | (0.44) | |
Weighted average number of common shares | | | | | | | |
Basic and diluted | 148,750,048 | | | 96,869,805 | | | 148,589,711 | | | 95,153,545 | |
| | | | | | | |
Comprehensive (loss) income | | | | | | | |
Unrealized (loss) gain on available-for-sale securities | $ | (691) | | | $ | (31) | | | $ | (1,762) | | | $ | (28) | |
Comprehensive loss | $ | (14,883) | | | $ | (19,418) | | | $ | (31,719) | | | $ | (35,796) | |
See accompanying notes to the condensed consolidated financial statements.
ARBUTUS BIOPHARMA CORPORATION
Condensed Consolidated Statement of Stockholders’ Equity
(Unaudited)
(In thousands of U.S. Dollars, except share and per share amounts)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Common Shares | | | | | | | | |
| Number of Shares | | Share Capital | | Additional Paid-In Capital | | Deficit | | Accumulated Other Comprehensive Loss | | Total Stockholders' Equity |
Balance December 31, 2021 | 144,987,736 | | | $ | 1,286,636 | | | $ | 65,485 | | | $ | (1,134,347) | | | $ | (48,335) | | | $ | 169,439 | |
Stock-based compensation | — | | | — | | | 1,736 | | | — | | | — | | | 1,736 | |
Certain fair value adjustments to liability stock option awards | — | | | — | | | 21 | | | — | | | — | | | 21 | |
Issuance of common shares pursuant to the Open Market Sale Agreement | 69,048 | | | 268 | | | — | | | — | | | — | | | 268 | |
Issuance of common shares pursuant to exercise of options | 5,000 | | | 18 | | | (10) | | | — | | | — | | | 8 | |
Issuance of common shares pursuant to ESPP | 86,501 | | | 317 | | | (81) | | | — | | | — | | | 236 | |
Issuance of common shares pursuant to Share Purchase Agreement | 3,579,952 | | | 10,973 | | | — | | | — | | | — | | | 10,973 | |
Unrealized loss on available-for-sale securities | — | | | — | | | — | | | — | | | (1,071) | | | (1,071) | |
Net loss | — | | | — | | | — | | | (15,765) | | | — | | | (15,765) | |
Balance March 31, 2022 | 148,728,237 | | | $ | 1,298,212 | | | $ | 67,151 | | | $ | (1,150,112) | | | $ | (49,406) | | | $ | 165,845 | |
Stock-based compensation | — | | | — | | | 2,064 | | | — | | | — | | | 2,064 | |
Certain fair value adjustments to liability stock option awards | — | | | — | | | 3 | | | — | | | — | | | 3 | |
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Issuance of common shares pursuant to exercise of options | 66,025 | | | 197 | | | (84) | | | — | | | — | | | 113 | |
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Unrealized loss on available-for-sale securities | — | | | — | | | — | | | — | | | (691) | | | (691) | |
Net loss | — | | | — | | | — | | | (14,192) | | | — | | | (14,192) | |
Balance June 30, 2022 | 148,794,262 | | | $ | 1,298,409 | | | $ | 69,134 | | | $ | (1,164,304) | | | $ | (50,097) | | | $ | 153,142 | |
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See accompanying notes to the condensed consolidated financial statements.
ARBUTUS BIOPHARMA CORPORATION
Condensed Consolidated Statement of Stockholders’ Equity
(Unaudited)
(In thousands of U.S. Dollars, except share and per share amounts)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Convertible Preferred Shares | | Common Shares | | | | | | | | |
| Number of Shares | | Share Capital | | Number of Shares | | Share Capital | | Additional Paid-In Capital | | Deficit | | Accumulated Other Comprehensive Loss | | Total Stockholders' Equity |
Balance December 31, 2020 | 1,164,000 | | | $ | 149,408 | | | 89,678,722 | | | $ | 985,939 | | | $ | 60,751 | | | $ | (1,045,961) | | | $ | (48,171) | | | $ | 101,966 | |
Accretion of accumulated dividends on Preferred Shares | — | | | 3,212 | | | — | | | — | | | — | | | (3,212) | | | — | | | — | |
Stock-based compensation | — | | | — | | | — | | | — | | | 1,647 | | | — | | | — | | | 1,647 | |
Certain fair value adjustments to liability stock option awards | — | | | — | | | — | | | — | | | 40 | | | — | | | — | | | 40 | |
Issuance of common shares pursuant to the Open Market Sale Agreement | — | | | — | | | 6,395,780 | | | 26,419 | | | — | | | — | | | — | | | 26,419 | |
Issuance of common shares pursuant to exercise of options | — | | | — | | | 65,952 | | | 335 | | | (127) | | | — | | | — | | | 208 | |
Issuance of common shares pursuant to ESPP | — | | | — | | | 104,917 | | | 425 | | | (178) | | | — | | | — | | | 247 | |
Unrealized gain on available-for-sale securities | — | | | — | | | — | | | — | | | — | | | — | | | 3 | | | 3 | |
Net loss | — | | | — | | | — | | | — | | | — | | | (16,381) | | | — | | | (16,381) | |
Balance March 31, 2021 | 1,164,000 | | | $ | 152,620 | | | 96,245,371 | | | $ | 1,013,118 | | | $ | 62,133 | | | $ | (1,065,554) | | | $ | (48,168) | | | $ | 114,149 | |
Accretion of accumulated dividends on Preferred Shares | — | | | 3,266 | | | — | | | — | | | | | (3,266) | | | — | | | — | |
Stock-based compensation | — | | | — | | | — | | | — | | | 1,758 | | | — | | | — | | | 1,758 | |
Certain fair value adjustments to liability stock option awards | — | | | — | | | — | | | — | | | 51 | | | — | | | — | | | 51 | |
Issuance of common shares pursuant to the Open Market Sale Agreement | — | | | — | | | 1,450,145 | | | 4,274 | | | — | | | — | | | — | | | 4,274 | |
Issuance of common shares pursuant to exercise of options | — | | | — | | | 4,500 | | | 24 | | | (9) | | | — | | | — | | | 15 | |
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Unrealized gain on available-for-sale securities | — | | | — | | | — | | | — | | | — | | | — | | | (31) | | | (31) | |
Net loss | — | | | — | | | — | | | — | | | — | | | (19,387) | | | — | | | (19,387) | |
Balance June 30, 2021 | 1,164,000 | | | $ | 155,886 | | | 97,700,016 | | | $ | 1,017,416 | | | $ | 63,933 | | | $ | (1,088,207) | | | $ | (48,199) | | | $ | 100,829 | |
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See accompanying notes to the condensed consolidated financial statements.
ARBUTUS BIOPHARMA CORPORATION
Condensed Consolidated Statements of Cash Flow
(Unaudited)
(In thousands of U.S. Dollars)
| | | | | | | | | | | |
| Six Months Ended June 30, |
| 2022 | | 2021 |
OPERATING ACTIVITIES | | | |
Net loss | $ | (29,957) | | | $ | (35,768) | |
Non-cash items: | | | |
Depreciation | 777 | | | 879 | |
Gain on sale of property and equipment | (20) | | | — | |
Stock-based compensation expense | 3,800 | | | 3,378 | |
Unrealized foreign exchange losses (gains) | — | | | 44 | |
Change in fair value of contingent consideration | 409 | | | 823 | |
Non-cash royalty revenue | (3,048) | | | (2,103) | |
Non-cash interest expense | 985 | | | 1,531 | |
Net accretion and amortization of investments in marketable securities | 251 | | | 453 | |
Net change in operating items: | | | |
Accounts receivable | (1,071) | | | 14 | |
Prepaid expenses and other assets | (1,126) | | | (441) | |
Accounts payable and accrued liabilities | 1,660 | | | (582) | |
Deferred license revenue | 27,815 | | | — | |
Other liabilities | (149) | | | (118) | |
Net cash provided by (used in) operating activities | 326 | | | (31,890) | |
INVESTING ACTIVITIES | | | |
Purchase of investments | (84,619) | | | (54,145) | |
Disposition of investments | 11,000 | | | 34,350 | |
Proceeds from sale of property and equipment | 20 | | | — | |
Acquisition of property and equipment | (287) | | | (731) | |
Net cash used in investing activities | (73,886) | | | (20,526) | |
FINANCING ACTIVITIES | | | |
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Issuance of common shares pursuant to Share Purchase Agreement | 10,973 | | | — | |
Issuance of common shares pursuant to the Open Market Sale agreement | 268 | | | 30,693 | |
Issuance of common shares pursuant to exercise of options | 121 | | | 223 | |
Issuance of common shares pursuant to ESPP | 236 | | | 247 | |
Net cash provided by financing activities | 11,598 | | | 31,163 | |
Effect of foreign exchange rate changes on cash and cash equivalents | — | | | (44) | |
Decrease in cash and cash equivalents | (61,962) | | | (21,297) | |
Cash and cash equivalents, beginning of period | 109,282 | | | 52,251 | |
Cash and cash equivalents, end of period | $ | 47,320 | | | $ | 30,954 | |
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Supplemental cash flow information | | | |
Preferred shares dividends accrued | $ | — | | | $ | (6,478) | |
See accompanying notes to the condensed consolidated financial statements.
ARBUTUS BIOPHARMA CORPORATION
Notes to Condensed Consolidated Financial Statements
(Tabular amounts in thousands of U.S. Dollars, except share and per share amounts)
1. Nature of business and future operations
Description of the Business
Arbutus Biopharma Corporation (“Arbutus” or the “Company”) is a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop novel therapeutics that target specific viral diseases. The Company’s current focus areas include Hepatitis B virus (“HBV”), SARS-CoV-2, and coronaviruses. In HBV, the Company is developing an RNA interference (“RNAi”) therapeutic, an oral capsid inhibitor, an oral PD-L1 inhibitor, and an oral RNA destabilizer to potentially identify a combination regimen with the aim of providing a functional cure for patients with chronic HBV infection (“cHBV”) by suppressing viral replication, reducing surface antigen and reawakening the immune system. The Company believes its lead compound, AB-729, is the only RNAi therapeutic with evidence of immune re-awakening, and is currently being evaluated in multiple phase 2 clinical trials. The Company has an ongoing drug discovery and development program directed to identifying novel, orally active agents for treating coronaviruses, including SARS-CoV-2. The Company is also exploring oncology applications for its internal PD-L1 portfolio.
Liquidity
At June 30, 2022, the Company had an aggregate of $200.6 million in cash, cash equivalents and investments in marketable securities. The Company had no outstanding debt as of June 30, 2022. The Company believes it has sufficient cash resources to fund its operations for at least the next 12 months.
The success of the Company is dependent on obtaining the necessary regulatory approvals to bring its products to market and achieve profitable operations. The Company’s research and development activities and the commercialization of its products are dependent on its ability to successfully complete these activities and to obtain adequate financing through a combination of financing activities and operations. It is not possible to predict either the outcome of the Company’s existing or future research and development programs or the Company’s ability to continue to fund these programs in the future.
COVID-19 Impact
The COVID-19 pandemic has resulted in and will likely continue to result in significant disruptions to businesses. Measures implemented around the world in attempts to slow the spread of COVID-19 have had, and will likely continue to have, a major impact on clinical development, at least in the near-term, including shortages and delays in the supply chain and prohibitions in certain countries on enrolling patients in new clinical trials. While the Company has been able to progress with its clinical and pre-clinical activities to date, it is not possible to predict if the COVID-19 pandemic will materially impact the Company’s plans and timelines in the future.
2. Significant accounting policies
Basis of presentation and principles of consolidation
These unaudited condensed consolidated financial statements have been prepared in accordance with United States generally accepted accounting principles (“GAAP”) for interim financial statements and accordingly, do not include all disclosures required for annual financial statements. These statements should be read in conjunction with the Company’s audited consolidated financial statements and notes thereto for the year ended December 31, 2021 included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021. These unaudited condensed consolidated financial statements include the accounts of Arbutus Biopharma Corporation and its one wholly-owned subsidiary, Arbutus Biopharma, Inc., and reflect, in the opinion of management, all adjustments and reclassifications necessary to fairly present the Company’s financial position as of June 30, 2022 and December 31, 2021, the Company’s results of operations for the three and six months ended June 30, 2022 and 2021, and the Company’s cash flows for the six months ended June 30, 2022 and 2021. Such adjustments are of a normal recurring nature. The results of operations for the three and six months ended June 30, 2022 are not necessarily indicative of the results for the full year. These unaudited condensed consolidated financial statements follow the same significant accounting policies as those described in the notes to the audited consolidated financial statements of the Company for the year ended December 31, 2021, except as described below under Recent Accounting Pronouncements.
All intercompany balances and transactions have been eliminated. Certain prior year amounts have been reclassified to conform to the current year presentation.
Net loss attributable to common shareholders per share
Net loss attributable to common shareholders per share is calculated based on the weighted average number of common shares outstanding. Diluted net loss attributable to common shareholders per share does not differ from basic net loss attributable to common shareholders per share for the three and six months ended June 30, 2022 and 2021, since the effect of including potential common shares would be anti-dilutive. For the six months ended June 30, 2022, potential common shares of 15.9 million pertaining to outstanding stock options were excluded from the calculation of net loss attributable to common shareholders per share. A total of approximately 35.4 million outstanding stock options and if-converted Series A participating convertible preferred shares (“Preferred Shares”) were excluded from the calculation for the six months ended June 30, 2021.
On October 18, 2021, the Company’s outstanding Preferred Shares were converted into 22,833,922 common shares. Prior to that date, the Company followed the two-class method when computing net loss attributable to common shareholders per share as the Preferred Shares met the definition of participating securities. The Preferred Shares entitled the holders to participate in dividends but did not require the holders to participate in losses of the Company. Accordingly, net losses attributable to holders of the Company’s common shares were not allocated to holders of the Preferred Shares.
Revenue from collaborations and licenses
The Company generates revenue through certain collaboration agreements and license agreements. Such agreements may require the Company to deliver various rights and/or services, including intellectual property rights or licenses and research and development services. Under such agreements, the Company is generally eligible to receive non-refundable upfront payments, funding for research and development services, milestone payments and royalties.
The Company’s collaboration agreements fall under the scope of Accounting Standards Codification (“ASC”) Topic 808, Collaborative Arrangements (“ASC 808”) when both parties are active participants in the arrangement and are exposed to significant risks and rewards. For certain arrangements under the scope of ASC 808, the Company analogizes to ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”) for some aspects, including for the delivery of a good or service (i.e., a unit of account).
ASC 606 requires an entity to recognize the amount of revenue to which it expects to be entitled for the transfer of promised goods or services to customers under a five-step model: (i) identify contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when or as a performance obligation is satisfied.
In contracts where the Company has more than one performance obligation to provide its customer with goods or services, each performance obligation is evaluated to determine whether it is distinct based on whether (i) the customer can benefit from the good or service either on its own or together with other resources that are readily available and (ii) the good or service is
separately identifiable from other promises in the contract. The consideration under the contract is then allocated between the distinct performance obligations based on their respective relative stand-alone selling prices. The estimated stand-alone selling price of each deliverable reflects the Company’s best estimate of what the selling price would be if the deliverable was regularly sold on a stand-alone basis and is determined by reference to market rates for the good or service when sold to others or by using an adjusted market assessment approach if the selling price on a stand-alone basis is not available.
The consideration allocated to each distinct performance obligation is recognized as revenue when control is transferred to the customer for the related goods or services. Consideration associated with at-risk substantive performance milestones, including sales-based milestones, is recognized as revenue when it is probable that a significant reversal of the cumulative revenue recognized will not occur. Sales-based royalties received in connection with licenses of intellectual property are subject to a specific exception in the revenue standards, whereby the consideration is not included in the transaction price and recognized in revenue until the customer’s subsequent sales or usages occur.
Deferred Revenue
When consideration is received or is unconditionally due from a customer, collaborator or licensee prior to the Company completing its performance obligation to the customer, collaborator or licensee under the terms of a contract, deferred revenue is recorded. Deferred revenue expected to be recognized as revenue within the 12 months following the balance sheet date is classified as a current liability. Deferred revenue not expected to be recognized as revenue within the 12 months following the balance sheet date is classified as a long-term liability. In accordance with ASC Topic 210-20, Balance Sheet - Offsetting the Company’s deferred revenue is offset by a contract asset as further discussed in Note 9.
Segment information
The Company operates as a single segment.
Recent accounting pronouncements
The Company has reviewed all recently issued standards and has determined that such standards will not have a material impact on the Company’s financial statements or do not otherwise apply to the Company’s operations.
3. Fair value measurements
The Company measures certain financial instruments and other items at fair value.
To determine the fair value, the Company uses the fair value hierarchy for inputs used in measuring fair value that maximize the use of observable inputs and minimize the use of unobservable inputs by requiring that the most observable inputs be used when available. Observable inputs are inputs market participants would use to value an asset or liability and are developed based on market data obtained from independent sources. Unobservable inputs are inputs based on assumptions about the factors market participants would use to value an asset or liability. The three levels of inputs that may be used to measure fair value are as follows:
•Level 1 inputs are quoted market prices for identical instruments available in active markets.
•Level 2 inputs are inputs other than quoted prices included within Level 1 that are observable for the asset or liability either directly or indirectly. If the asset or liability has a contractual term, the input must be observable for substantially the full term. An example includes quoted market prices for similar assets or liabilities in active markets.
•Level 3 inputs are unobservable inputs for the asset or liability and will reflect management’s assumptions about market assumptions that would be used to price the asset or liability.
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 carrying values of cash and cash equivalents, accounts receivable, accounts payable and accrued liabilities approximate their fair values due to the immediate or short-term maturity of these financial instruments.
To determine the fair value of the contingent consideration (note 8), the Company uses a probability weighted assessment of the likelihood the milestones would be met and the estimated timing of such payments, and then the potential contingent payments were discounted to their present value using a probability adjusted discount rate that reflects the early stage nature of the development program, the time to complete the program development, and overall biotech indices. The Company determined the fair value of the contingent consideration was $5.7 million as of June 30, 2022 and the increase of $0.4 million from December 31, 2021 has been recorded as a component of total operating expenses in the statement of operations and comprehensive loss for the six months ended June 30, 2022. The assumptions used in the discounted cash flow model are level 3 inputs as defined above. The Company assessed the sensitivity of the fair value measurement to changes in these unobservable inputs, and determined that changes within a reasonable range would not result in a materially different assessment of fair value.
The following tables present information about the Company’s assets and liabilities that are measured at fair value on a recurring basis, and indicates the fair value hierarchy of the valuation techniques used to determine such fair value:
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| Level 1 | | Level 2 | | Level 3 | | Total |
As of June 30, 2022 | (in thousands) |
Assets | | | | | | | |
Cash and cash equivalents | $ | 47,320 | | | $ | — | | | $ | — | | | $ | 47,320 | |
Investments in marketable securities, current | — | | | 102,879 | | | — | | | 102,879 | |
Investments in marketable securities, non-current | — | | | 50,450 | | | — | | | 50,450 | |
Total | $ | 47,320 | | | $ | 153,329 | | | $ | — | | | $ | 200,649 | |
Liabilities | | | | | | | |
Liability-classified stock options | $ | — | | | $ | — | | | $ | 2 | | | $ | 2 | |
Contingent consideration | — | | | — | | | 5,707 | | | 5,707 | |
Total | $ | — | | | $ | — | | | $ | 5,709 | | | $ | 5,709 | |
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| Level 1 | | Level 2 | | Level 3 | | Total |
As of December 31, 2021 | (in thousands) |
Assets | | | | | | | |
Cash and cash equivalents | $ | 109,282 | | | $ | — | | | $ | — | | | $ | 109,282 | |
Investments in marketable securities, current | — | | | 46,035 | | | — | | | 46,035 | |
Investments in marketable securities, non-current | — | | | 35,688 | | — | | | 35,688 | |
Total | $ | 109,282 | | | $ | 81,723 | | | $ | — | | | $ | 191,005 | |
Liabilities | | | | | | | |
Liability-classified stock options | $ | — | | | $ | — | | | $ | 26 | | | $ | 26 | |
Contingent consideration | — | | | — | | | 5,298 | | | 5,298 | |
Total | $ | — | | | $ | — | | | $ | 5,324 | | | $ | 5,324 | |
The following table presents the changes in fair value of the Company’s liability-classified stock options:
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| Liability at beginning of the period | | Fair value of liability-classified options exercised in the period | | Decrease in fair value of liability | | Liability at end of the period |
| (in thousands) |
Six Months Ended June 30, 2022 | $ | 26 | | | $ | — | | | $ | (24) | | | $ | 2 | |
Six Months Ended June 30, 2021 | $ | 250 | | | $ | — | | | $ | (118) | | | $ | 132 | |
The following table presents the changes in fair value of the Company’s contingent consideration:
| | | | | | | | | | | | | | | | | |
| Liability at beginning of the period | | Increase in fair value of liability | | Liability at end of the period |
| (in thousands) |
Six Months Ended June 30, 2022 | $ | 5,298 | | | $ | 409 | | | $ | 5,707 | |
Six Months Ended June 30, 2021 | $ | 3,426 | | | $ | 823 | | | $ | 4,249 | |
4. Investments in marketable securities
Investments in marketable securities consisted of the following:
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| Amortized Cost | | Gross Unrealized Gain(1) | | Gross Unrealized Loss(1) | | Fair Value |
As of June 30, 2022 | (in thousands) |
Cash equivalents | | | | | | | |
| | | | | | | |
US government money market fund | $ | 23,984 | | | $ | — | | | $ | — | | | $ | 23,984 | |
| | | | | | | |
Total | $ | 23,984 | | | $ | — | | | $ | — | | | $ | 23,984 | |
Investments in marketable short-term securities | | | | | | | |
US government agency bonds | $ | 19,116 | | | $ | — | | | $ | (192) | | | $ | 18,924 | |
US corporate bonds | 6,499 | | | 5 | | | (19) | | | 6,485 | |
US treasury bills | 8,961 | | | — | | | (56) | | | 8,905 | |
US government bonds | 69,349 | | | — | | | (784) | | | 68,565 | |
Total | $ | 103,925 | | | $ | 5 | | | $ | (1,051) | | | $ | 102,879 | |
Investments in marketable long-term securities | | | | | | | |
US government agency bonds | $ | 12,332 | | | $ | — | | | $ | (304) | | | $ | 12,028 | |
US corporate bonds | 12,135 | | | — | | | (54) | | | 12,081 | |
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US government bonds | 26,850 | | | — | | | (509) | | | 26,341 | |
Total | $ | 51,317 | | | $ | — | | | $ | (867) | | | $ | 50,450 | |
(1) Gross unrealized gain (loss) is pre-tax and is reported in accumulated other comprehensive loss.
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| Amortized Cost | | Gross Unrealized Gain(1) | | Gross Unrealized Loss(1) | | Fair Value |
As of December 31, 2021 | (in thousands) |
Cash equivalents | | | | | | | |
US government money market fund | $ | 62,836 | | | $ | — | | | $ | — | | | $ | 62,836 | |
| | | | | | | |
| | | | | | | |
Total | $ | 62,836 | | | $ | — | | | $ | — | | | $ | 62,836 | |
Investments in marketable short-term securities | | | | | | | |
US government agency bonds | $ | 8,131 | | | $ | — | | | $ | (11) | | | $ | 8,120 | |
US treasury bills | 37,968 | | | — | | | (53) | | | 37,915 | |
Total | $ | 46,099 | | | $ | — | | | $ | (64) | | | $ | 46,035 | |
Investments in marketable long-term securities | | | | | | | |
US government agency bonds | $ | 13,068 | | | $ | — | | | $ | (29) | | | $ | 13,039 | |
US treasury bills | 22,707 | | | — | | | (58) | | | 22,649 | |
Total | $ | 35,775 | | | $ | — | | | $ | (87) | | | $ | 35,688 | |
(1) Gross unrealized gain (loss) is pre-tax and is reported in accumulated other comprehensive loss.
The contractual term to maturity of the $102.9 million of short-term marketable securities held by the Company as of June 30, 2022 is less than one year. As of June 30, 2022, the Company held $50.5 million of long-term marketable securities with contractual maturities of more than one year, but less than five years. As of December 31, 2021, the Company’s $46.0 million of short-term marketable securities had contractual maturities of less than one year, while the Company’s $35.7 million of long-term marketable securities had maturities of more than one year, but less than five years.
There were no realized gains or losses for the three and six months ended June 30, 2022 or 2021.
5. Investment in Genevant
In April 2018, the Company entered into an agreement with Roivant Sciences Ltd. (“Roivant”), its largest shareholder, to launch Genevant Sciences Ltd. (“Genevant”), a company focused on the discovery, development, and commercialization of a broad range of RNA-based therapeutics enabled by the Company’s lipid nanoparticle (“LNP”) and ligand conjugate delivery technologies. The Company licensed exclusive rights to its LNP and ligand conjugate delivery platforms to Genevant for RNA-based applications outside of HBV, except to the extent certain rights had already been licensed to other third parties (the “Genevant License”). The Company retained all rights to its LNP and conjugate delivery platforms for HBV.
Under the Genevant License, as amended, if a third party sublicensee of intellectual property licensed by Genevant from the Company commercializes a sublicensed product, the Company becomes entitled to receive a specified percentage of certain revenue that may be received by Genevant for such sublicense, including royalties, commercial milestones and other sales-related revenue, or, if less, tiered low single-digit royalties on net sales of the sublicensed product. The specified percentage is 20% in the case of a mere sublicense (i.e., naked sublicense) by Genevant without additional contribution and 14% in the case of a bona fide collaboration with Genevant.
Additionally, if Genevant receives proceeds from an action for infringement by any third parties of the Company’s intellectual property licensed to Genevant, the Company would be entitled to receive, after deduction of litigation costs, 20% of the proceeds received by Genevant or, if less, tiered low single-digit royalties on net sales of the infringing product (inclusive of the proceeds from litigation or settlement, which would be treated as net sales).
The Company accounts for its interest in Genevant as equity securities without readily determinable fair values. Accordingly, an estimate of the fair value of the securities is based on the original cost less previously recognized equity method losses, less impairments, plus or minus changes resulting from observable price changes in orderly transactions for identical or a similar Genevant securities. As of June 30, 2022, the carrying value of the Company’s investment in Genevant was zero and the Company owned approximately 16% of the common equity of Genevant.
6. Accounts payable and accrued liabilities
Accounts payable and accrued liabilities are comprised of the following:
| | | | | | | | | | | |
| June 30, 2022 | | December 31, 2021 |
| (in thousands) |
Trade accounts payable | $ | — | | | $ | 3,174 | |
Research and development accruals | 9,455 | | | 2,371 | |
Professional fee accruals | 415 | | | 983 | |
Payroll accruals | 2,632 | | | 4,279 | |
Other accrued liabilities | (28) | | | 31 | |
Total accounts payable and accrued liabilities | $ | 12,474 | | | $ | 10,838 | |
7. Sale of future royalties
On July 2, 2019, the Company entered into a Purchase and Sale Agreement (the “Agreement”) with the Ontario Municipal Employees Retirement System (“OMERS”), pursuant to which the Company sold to OMERS part of its royalty interest on future global net sales of ONPATTRO® (Patisiran) (“ONPATTRO”), an RNA interference therapeutic currently being sold by Alnylam Pharmaceuticals, Inc. (“Alnylam”).
ONPATTRO utilizes the Company’s LNP technology, which was licensed to Alnylam pursuant to the Cross-License Agreement, dated November 12, 2012, by and between the Company and Alnylam (the “LNP License Agreement”). Under the terms of the LNP License Agreement, the Company is entitled to tiered royalty payments on global net sales of ONPATTRO ranging from 1.00% to 2.33% after offsets, with the highest tier applicable to annual net sales above $500 million. This royalty interest was sold to OMERS, effective as of January 1, 2019, for $20 million in gross proceeds before advisory fees. OMERS will retain this entitlement until it has received $30 million in royalties, at which point 100% of such royalty interest on future global net sales of ONPATTRO will revert to the Company. OMERS has assumed the risk of collecting up to $30 million of future royalty payments from Alnylam and the Company is not obligated to reimburse OMERS if they fail to collect any such future royalties.
The $30 million in royalties to be paid to OMERS is accounted for as a liability, with the difference between the liability and the gross proceeds received accounted for as a discount. The discount, as well as $1.5 million of transaction costs, will be amortized as interest expense based on the projected balance of the liability as of the beginning of each period. As of June 30, 2022, the Company estimated an effective annual interest rate of approximately 12%. Over the course of the Agreement, the actual interest rate will be affected by the amount and timing of royalty revenue recognized and changes in the timing of forecasted royalty revenue. On a quarterly basis, the Company will reassess the expected timing of the royalty revenue, recalculate the amortization and effective interest rate and adjust the accounting prospectively as needed.
The Company recognizes non-cash royalty revenue related to the sales of ONPATTRO during the term of the Agreement. As royalties are remitted to OMERS from Alnylam, the balance of the recognized liability is effectively repaid over the life of the Agreement. From the inception of the royalty sale through June 30, 2022, the Company has recorded an aggregate of $14.2 million of non-cash royalty revenue for royalties earned by OMERS. There are a number of factors that could materially affect the amount and timing of royalty payments from Alnylam, none of which are within the Company’s control.
During the six months ended June 30, 2022, the Company recognized non-cash royalty revenue of $3.0 million and non-cash interest expense of $1.0 million. During the six months ended June 30, 2021, the Company recognized non-cash royalty revenue of $2.1 million and related non-cash interest expense of $1.5 million.
The table below shows the activity related to the net liability for the six months ended June 30, 2022 and 2021:
| | | | | | | | | | | |
| Six Months Ended June 30, |
| 2022 | | 2021 |
| (in thousands) |
Net liability related to sale of future royalties - beginning balance | $ | 16,296 | | | $ | 19,554 | |
Non-cash royalty revenue | (3,048) | | | (2,103) | |
Non-cash interest expense | 985 | | | 1,531 | |
Net liability related to sale of future royalties - ending balance | $ | 14,233 | | | $ | 18,982 | |
In addition to the royalty from the LNP License Agreement, the Company is also receiving a second royalty interest ranging from 0.75% to 1.125% on global net sales of ONPATTRO, with 0.75% applying to sales greater than $500 million, originating from a settlement agreement and subsequent license agreement with Acuitas Therapeutics, Inc. (“Acuitas”). The royalty from Acuitas has been retained by the Company and was not part of the royalty sale to OMERS.
8. Contingencies and commitments
Arbitration with the University of British Columbia
Certain early work on lipid nanoparticle delivery systems and related inventions was undertaken at the University of British Columbia (“UBC”), as well as by the Company that was subsequently assigned to UBC. These inventions are licensed to the Company by UBC under a license agreement, initially entered into in 1998 and as amended in 2001, 2006 and 2007. The Company has granted sublicenses under the UBC license to certain third parties, including Alnylam.
On December 18, 2020, UBC delivered to the Company a notice of arbitration alleging that under the cross license between UBC and Arbutus, it is due royalties of $2.0 million plus interest arising from the Company’s sale to OMERS of part of its royalty interest on future global net sales of ONPATTRO, currently being sold by Alnylam. Oral hearings for this matter were held in April 2022 and, on July 11, 2022, the arbitrator issued his decision fully dismissing UBC’s claim for royalties. As a result, no payments are owed to UBC and the Company intends to pursue an award for reimbursement of costs and attorneys’ fees.
Stock Purchase Agreement with Enantigen
In October 2014, Arbutus Inc., the Company’s wholly-owned subsidiary, acquired all of the outstanding shares of Enantigen Therapeutics, Inc. (“Enantigen”) pursuant to a stock purchase agreement. The amount paid to Enantigen’s selling shareholders could be up to an additional $102.5 million in sales performance milestones in connection with the sale of the first commercialized product by the Company for the treatment of HBV, regardless of whether such product is based upon assets acquired under this agreement, and a low single-digit royalty on net sales of such first commercialized HBV product, up to a maximum royalty payment of $1.0 million that, if paid, would be offset against the Company’s milestone payment obligations. Certain other development milestones related to the acquisition were tied to programs which are no longer under development by the Company, and therefore the contingency related to those development milestones is zero.
The contingent consideration is a financial liability and is measured at its fair value at each reporting period, with any changes in fair value from the previous reporting period recorded in the statements of operations and comprehensive loss (see note 3).
The fair value of the contingent consideration was $5.7 million as of June 30, 2022.
9. Collaborations, contracts and licensing agreements
Collaborations
Qilu Pharmaceutical Co., Ltd.
In December 2021, the Company entered into a technology transfer and licensing agreement (the “License Agreement”) with Qilu Pharmaceutical Co., Ltd. (“Qilu”), pursuant to which the Company granted Qilu a sublicensable, royalty-bearing license, under certain intellectual property owned by the Company, which is non-exclusive as to development and manufacturing and exclusive with respect to commercialization of AB-729, including pharmaceutical products that include AB-729, for the treatment or prevention of hepatitis B in China, Hong Kong, Macau and Taiwan (the “Territory”).
In partial consideration for the rights granted by the Company, Qilu paid the Company a one-time upfront cash payment of $40.0 million, net of withholding taxes, on January 5, 2022, and agreed to pay the Company milestone payments totaling up to $245.0 million, net of withholding taxes, upon the achievement of certain technology transfer, development, regulatory and commercialization milestones. Qilu paid $4.4 million of withholding taxes to the Chinese taxing authority on the Company’s behalf, related to the upfront cash payment. In addition, Qilu agreed to pay the Company double digit royalties into the low twenties percent based upon annual net sales of AB-729 in the Territory. The royalties are payable on a product-by-product and region-by-region basis, subject to certain limitations.
Qilu is responsible for all costs related to developing, obtaining regulatory approval for, and commercializing AB-729 for the treatment or prevention of hepatitis B in the Territory. Qilu is required to use commercially reasonable efforts to develop, seek regulatory approval for, and commercialize at least one AB-729 product candidate in the Territory. A joint development committee has been established between the Company and Qilu to coordinate and review the development, manufacturing and commercialization plans. Both parties also have entered into a supply agreement and related quality agreement pursuant to which the Company will manufacture or have manufactured and supply Qilu with all quantities of AB-729 necessary for Qilu to develop and commercialize in the Territory until the Company has completed manufacturing technology transfer to Qilu and approval of a product manufactured by Qilu, or its designated contract manufacturing organization, by the National Medical Products Administration in China for AB-729.
Concurrent with the execution of the License Agreement, the Company entered into a Share Purchase Agreement (the “Share Purchase Agreement”) with Anchor Life Limited, a company established pursuant to the applicable laws and regulations of Hong Kong and an affiliate of Qilu (the “Investor”), pursuant to which the Investor purchased 3,579,952 of the Company’s common shares, without par value (the “Common Shares”), at a purchase price of USD $4.19 per share, which was a 15% premium on the thirty-day average closing price of the Common Shares as of the close of trading on December 10, 2021 (the “Share Transaction”). The Company received $15.0 million of gross proceeds from the Share Transaction on January 6, 2022. The Common Shares sold to the Investor in the Share Transaction represented approximately 2.5% of the Common Shares outstanding immediately prior to the execution of the Share Purchase Agreement.
The License Agreement falls under the scope of ASC 808 as both parties are active participants in the arrangement and are exposed to significant risks and rewards. While this arrangement is in the scope of ASC 808, the Company analogizes to ASC 606 for some aspects of this arrangement, including for the delivery of a good or service (i.e., a unit of account). In accordance
with the guidance, the Company identified the following commitments under the arrangement: (i) rights to develop, use, sell, have sold, offer for sale and import any product comprised of Licensed Product (the “Qilu License”) and (ii) drug supply obligations and manufacturing technology transfer (the “Manufacturing Obligations”). The Company determined that these two commitments are not distinct performance obligations for purposes of recognizing revenue as the manufacturing process is highly specialized and Qilu would not be able to benefit from the Qilu License without the Company’s involvement in the manufacturing activities until the transfer of the manufacturing know-how is complete. As such, the Company will combine these commitments into one performance obligation to which the transaction price will be allocated to and will recognize this transaction price associated with the bundled performance obligation over time using an inputs method based on labor hours expended by the Company on its Manufacturing Obligations.
The Company determined the initial transaction price of the combined performance obligation to be $49.3 million, which includes the $40.0 million upfront fee, $4.4 million of withholding taxes paid by Qilu on behalf of the Company, the premium paid for the Share Transaction of $4.1 million, and $0.8 million associated with certain manufacturing costs expected to be reimbursed by Qilu. The Company determined the Milestone Payments to be variable consideration subject to constraint at inception. At the end of each subsequent reporting period, the Company will reevaluate the probability of achievement of the future development, regulatory, and sales milestones subject to constraint and, if necessary, will adjust its estimate of the overall transaction price. Any such adjustments will be recorded on a cumulative catch-up basis, which would affect revenues and earnings in the period of adjustment. The following table outlines the transaction price and the changes to the related asset and liability balances during the six months ended June 30, 2022:
| | | | | | | | | | | | | | | | | |
| Six Months Ended June 30, 2022 |
| Transaction Price | | Cumulative Collaboration Revenue Recognized | | Deferred License Revenue |
| (in thousands) |
Combined performance obligation | $ | 49,270 | | | $ | 20,655 | | | $ | 28,615 | |
Less contract asset | | | | | (800) | |
Total deferred license revenue | | | | | 27,815 | |
Less current portion of deferred license revenue | | | | | 16,973 | |
Non-current deferred license revenue | | | | | $ | 10,842 | |
As of June 30, 2022, the balance of the deferred license revenue was $28.6 million, which, in accordance with ASC 210-20, was partially offset by the contract asset associated with the manufacturing cost reimbursement of $0.8 million, resulting in a net deferred license revenue liability of $27.8 million. The $4.4 million of withholding taxes paid by Qilu on behalf of the Company was recorded as income tax expense during the six months ended June 30, 2022.
The Company incurred $0.6 million of incremental costs in obtaining the Qilu License, which the Company capitalized in other current assets and other assets and amortizes as a component of general and administrative expense commensurate with the recognition of the combined performance obligation.
The Company reevaluates the transaction price and the total estimated labor hours expected to be incurred to satisfy the performance obligations and adjusts the deferred revenue at the end of each reporting period. Such changes will result in a change to the amount of collaboration revenue recognized and deferred revenue.
Vaccitech plc
In July 2021, the Company entered into a clinical collaboration agreement with Vaccitech plc (“Vaccitech”) to evaluate AB-729 followed by Vaccitech’s VTP-300, a proprietary T cell stimulating therapeutic vaccine, in nucleos(t)ide reverse transcriptase inhibitor (“NrtI”)-suppressed patients with cHBV.
The Company is responsible for managing this Phase 2a proof-of-concept clinical trial, subject to oversight by a joint development committee comprised of representatives from the Company and Vaccitech. The Company and Vaccitech retain full rights to their respective product candidates and will split all costs associated with the clinical trial. The Company incurred $0.8 million of costs, net of reimbursements from Vaccitech, related to the collaboration during the six months ended June 30, 2022 and reflected those costs in research and development in the statement of operations and comprehensive loss.
Assembly Biosciences, Inc.
In August 2020, the Company entered into a clinical collaboration agreement with Assembly Biosciences, Inc. (“Assembly”) to evaluate AB-729 in combination with Assembly’s HBV core inhibitor (capsid inhibitor) candidate vebicorvir (“VBR”) and standard-of-care NA therapy for the treatment of patients with HBV infection. Assembly has completed enrollment in the clinical trial. In July 2022, Assembly announced its plan to discontinue development of VBR. Despite this, in consultation with Assembly, the Company plans to continue dosing patients in the Phase 2a proof-of-concept clinical trial in order to fully and accurately assess the results. The Company and Assembly are sharing in the costs of the collaboration. The Company incurred $1.4 million and $1.2 million of costs related to the collaboration during the six months ended June 30, 2022 and 2021, respectively, and reflected those costs in research and development in the statement of operations and comprehensive loss. Except to the extent necessary to carry out Assembly’s responsibilities with respect to the collaboration trial, the Company has not provided any license grant to Assembly for use of its AB-729 compound.
X-Chem, Inc. and Proteros biostructures GmbH
In March 2021, the Company entered into a discovery research and license agreement with X-Chem, Inc. (“X-Chem”) and Proteros biostructures GmbH (“Proteros”) to focus on the discovery of novel inhibitors targeting the SARS-CoV-2 nsp5 main protease (Mpro). This collaboration brings together the Company’s expertise in the discovery and development of antiviral agents with X-Chem’s industry leading DNA-encoded library (DEL) technology and Proteros’ protein sciences, biophysics and structural biology capabilities and provides important synergies to potentially identify safe and effective therapies against coronaviruses including SARS-CoV-2. The collaboration allows for the rapid screening of one of the largest small molecule libraries against Mpro (an essential protein required for the virus to replicate itself) and the use of state-of-the-art structure guided methods to rapidly optimize Mpro inhibitors, which the Company could potentially progress to clinical candidates. The agreement provides for payments by the Company to X-Chem and Proteros upon satisfaction of certain development, regulatory and commercial milestones, as well as royalties on sales. The agreement with X-Chem and Proteros was amended effective March 31, 2022 primarily to extend the term of the collaboration and update the funding and fee structure. Through this collaboration, the Company has identified and obtained a worldwide exclusive license to several molecules that inhibit Mpro, a validated target for the treatment of COVID-19 and potential future coronavirus outbreaks. The Company incurred $0.3 million and $1.2 million of costs related to the collaboration during the six months ended June 30, 2022 and 2021, respectively, and reflected those costs in research and development in the statements of operations and comprehensive loss.
Royalty Entitlements
Alnylam Pharmaceuticals, Inc. and Acuitas Therapeutics, Inc.
The Company has two royalty entitlements to Alnylam Pharmaceuticals, Inc.’s (“Alnylam”) global net sales of ONPATTRO.
In 2012, the Company entered into a license agreement with Alnylam that entitles Alnylam to develop and commercialize products with the Company’s LNP technology. Alnylam launched ONPATTRO, the first approved application of the Company’s LNP technology, in 2018. Under the terms of this license agreement, the Company is entitled to tiered royalty payments on global net sales of ONPATTRO ranging from 1.00% - 2.33% after offsets, with the highest tier applicable to annual net sales above $500 million. This royalty interest was sold to OMERS, effective as of January 1, 2019, for $20 million in gross proceeds before advisory fees. OMERS will retain this entitlement until it has received $30 million in royalties, at which point 100% of this royalty entitlement on future global net sales of ONPATTRO will revert back to the Company. OMERS has assumed the risk of collecting up to $30 million of future royalty payments from Alnylam and the Company is not obligated to reimburse OMERS if they fail to collect any such future royalties. If this royalty entitlement reverts to the Company, it has the potential to provide an active royalty stream or to be otherwise monetized again in full or in part. From the inception of the royalty sale through June 30, 2022, an aggregate of $14.2 million of royalties have been earned by OMERS.
The Company also is receiving a second royalty interest of 0.75% to 1.125% on global net sales of ONPATTRO, with 0.75% applying to sales greater than $500 million, originating from a settlement agreement and subsequent license agreement with Acuitas Therapeutics, Inc. (“Acuitas”). This royalty entitlement from Acuitas has been retained by the Company and was not part of the royalty entitlement sale to OMERS.
Revenues are summarized in the following table:
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended June 30, | | Six Months Ended June 30, |
| 2022 | | 2021 | | 2022 | | 2021 |
| (in thousands) | | (in thousands) |
Revenue from collaborations and licenses |
Acuitas Therapeutics, Inc. | $ | 1,550 | | | $ | 1,163 | | | $ | 3,084 | | | $ | 2,258 | |
Qilu Pharmaceutical Co., Ltd. | 11,024 | | | — | | | 20,655 | | | — | |
Other milestone and royalty payments | (18) | | | 22 | | | 35 | | | 81 | |
Non-cash royalty revenue | | | | | | | |
Alnylam Pharmaceuticals, Inc. | 1,685 | | | 1,144 | | | 3,048 | | | 2,103 | |
Total revenue | $ | 14,241 | | | $ | 2,329 | | | $ | 26,822 | | | 4,442 | |
10. Shareholders’ equity
Authorized share capital
The Company’s authorized share capital consists of an unlimited number of common shares and preferred shares, without par value, and 1,164,000 Series A participating convertible preferred shares, without par value.
Open Market Sale Agreement
The Company has an Open Market Sale Agreement with Jefferies LLC (“Jefferies”) dated December 20, 2018, as amended by Amendment No. 1, dated December 20, 2019, Amendment No. 2, dated August 7, 2020 and Amendment No. 3, dated March 4, 2021 (as amended, the “Sale Agreement”), under which it may issue and sell common shares, from time to time.
On December 23, 2019, the Company filed a shelf registration statement on Form S-3 with the Securities and Exchange Commission (the “SEC”) (File No. 333-235674) and accompanying base prospectus, which was declared effective by the SEC on January 10, 2020 (the “January 2020 Registration Statement”), for the offer and sale of up to $150.0 million of the Company’s securities. The January 2020 Registration Statement also contained a prospectus supplement in connection with the offering of up to $75.0 million of the Company’s common shares pursuant to the Sale Agreement. This prospectus supplement was fully utilized during 2020. On August 7, 2020, the Company filed a prospectus supplement with the SEC (the “August 2020 Prospectus Supplement”) in connection with the offering of up to an additional $75.0 million of its common shares pursuant to the Sale Agreement under the January 2020 Registration Statement. The August 2020 Prospectus Supplement was fully utilized during 2020.
On August 28, 2020, the Company filed a shelf registration statement on Form S-3 with the SEC (File No. 333-248467) and accompanying base prospectus, which was declared effective by the SEC on October 22, 2020 (the “October 2020 Registration Statement”), for the offer and sale of up to $200.0 million of the Company’s securities. On March 4, 2021, the Company filed a prospectus supplement with the SEC (the “March 2021 Prospectus Supplement”) in connection with the offering of up to an additional $75.0 million of its common shares pursuant to the Sale Agreement under the October 2020 Registration Statement. The March 2021 Prospectus Supplement was fully utilized during 2021. On October 8, 2021, the Company filed a prospectus supplement with the SEC (the “October 2021 Prospectus Supplement”) in connection with the offering of up to an additional $75.0 million of its common shares pursuant to the Sale Agreement under the October 2020 Registration Statement.
On March 3, 2022, the Company filed a prospectus supplement with the SEC (the “March 2022 Prospectus Supplement”) in connection with the offering of up to an additional $100.0 million of its common shares pursuant to the Sale Agreement under: (i) the January 2020 Registration Statement; (ii) the October 2020 Registration Statement; and (iii) a shelf registration statement on Form S-3 (File No. 333-260782) that was declared effective by the SEC on November 18, 2021.
During the six months ended June 30, 2022, the Company issued 69,048 common shares pursuant to the Sale Agreement, resulting in net proceeds of approximately $0.3 million. For the six months ended June 30, 2021, the Company issued 6,395,780 common shares pursuant to the Sale Agreement, resulting in net proceeds of approximately $26.4 million. As of June 30, 2022, there was approximately $152.0 million remaining available in aggregate under the October 2021 Prospectus Supplement and the March 2022 Prospectus Supplement.
Stock-based compensation
The table below summarizes information about the Company’s stock based compensation for the three and six months ended June 30, 2022 and 2021 and the expense recognized in the condensed consolidated statements of operations:
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended June 30, | | Six Months Ended June 30, |
| 2022 | | 2021 | | 2022 | | 2021 |
| (in thousands, except share and per share data) |
Options g |