Item 1. Financial Statements
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)
September 30, 2023 December 31, 2022
Assets
Current assets:
Cash and cash equivalents $ 17,531 $ 30,776
Investments in marketable securities, current 116,649 116,137
Accounts receivable 2,171 1,352
Prepaid expenses and other current assets 5,256 2,874
Total current assets 141,607 151,139
Property and equipment, net of accumulated depreciation of $ 11,541
(December 31, 2022: $ 10,801 )
5,033 5,070
Investments in marketable securities, non-current 10,496 37,363
Right of use asset 1,502 1,744
Other non-current assets 3 103
Total assets $ 158,641 $ 195,419
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable and accrued liabilities $ 9,806 $ 16,029
Deferred license revenue, current 12,106 16,456
Lease liability, current 412 372
Total current liabilities 22,324 32,857
Liability related to sale of future royalties 8,110 10,365
Deferred license revenue, non-current — 5,999
Contingent consideration 7,373 7,531
Lease liability, non-current 1,497 1,815
Total liabilities 39,304 58,567
Stockholders’ equity
Common shares
Authorized: unlimited number without par value
Issued and outstanding: 167,695,247
(December 31, 2022: 157,455,363 )
1,346,015 1,318,737
Additional paid-in capital 79,546 72,406
Deficit ( 1,257,340 ) ( 1,203,803 )
Accumulated other comprehensive loss ( 48,884 ) ( 50,488 )
Total stockholders’ equity
119,337 136,852
Total liabilities and stockholders’ equity $ 158,641 $ 195,419
See accompanying notes to the condensed consolidated financial statements.
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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 September 30, Nine Months Ended September 30,
2023 2022 2023 2022
Revenue
Collaborations and licenses $ 3,935 $ 3,607 13,329 27,381
Non-cash royalty revenue 723 2,345 2,667 5,393
Total Revenue 4,658 5,952 15,996 32,774
Operating expenses
Research and development 20,169 20,055 56,136 61,459
General and administrative 5,842 3,493 17,374 13,585
Change in fair value of contingent consideration 205 215 ( 158 ) 624
Total operating expenses 26,216 23,763 73,352 75,668
Loss from operations ( 21,558 ) ( 17,811 ) ( 57,356 ) ( 42,894 )
Other income (loss)
Interest income 1,494 694 4,223 1,249
Interest expense ( 46 ) ( 429 ) ( 415 ) ( 1,417 )
Foreign exchange (gain) loss 6 ( 21 ) 11 ( 18 )
Total other income (loss) 1,454 244 3,819 ( 186 )
Loss before income taxes ( 20,104 ) ( 17,567 ) ( 53,537 ) ( 43,080 )
Income tax expense — — — ( 4,444 )
Net loss $ ( 20,104 ) $ ( 17,567 ) ( 53,537 ) ( 47,524 )
Loss per share
Basic and diluted $ ( 0.12 ) $ ( 0.12 ) ( 0.32 ) ( 0.32 )
Weighted average number of common shares
Basic and diluted 167,512,708 150,995,191 165,085,243 149,385,999
Comprehensive loss
Unrealized gain (loss) on available-for-sale securities $ 584 $ ( 907 ) 1,604 ( 2,669 )
Comprehensive loss $ ( 19,520 ) $ ( 18,474 ) ( 51,933 ) ( 50,193 )
See accompanying notes to the condensed consolidated financial statements.
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ARBUTUS BIOPHARMA CORPORATION
Condensed Consolidated Statements 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, 2022 157,455,363 $ 1,318,737 $ 72,406 $ ( 1,203,803 ) $ ( 50,488 ) $ 136,852
Stock-based compensation expense — — 2,131 — — 2,131
Issuance of common shares pursuant to the Open Market Sale Agreement 7,423,622 19,862 — — — 19,862
Issuance of common shares pursuant to exercise of options 101,356 457 ( 198 ) — — 259
Issuance of common shares pursuant to ESPP 151,852 397 ( 101 ) — — 296
Unrealized gain on available-for-sale securities — — — — 854 854
Net loss — — — ( 16,339 ) — ( 16,339 )
Balance March 31, 2023 165,132,193 $ 1,339,453 $ 74,238 $ ( 1,220,142 ) $ ( 49,634 ) $ 143,915
Stock-based compensation expense — — 2,964 — — 2,964
Issuance of common shares pursuant to the Open Market Sale Agreement 1,790,546 4,742 — — — 4,742
Unrealized gain on available-for-sale securities — — — — 166 166
Net loss — — — ( 17,094 ) — ( 17,094 )
Balance June 30, 2023 166,922,739 $ 1,344,195 $ 77,202 $ ( 1,237,236 ) $ ( 49,468 ) $ 134,693
Stock-based compensation expense — — 2,483 — — 2,483
Issuance of common shares pursuant to the Open Market Sale Agreement 633,922 1,396 — — — 1,396
Issuance of common shares pursuant to ESPP 138,586 424 ( 139 ) — — 285
Unrealized gain on available-for-sale securities — — — — 584 584
Net loss — — — ( 20,104 ) — ( 20,104 )
Balance September 30, 2023 167,695,247 $ 1,346,015 $ 79,546 $ ( 1,257,340 ) $ ( 48,884 ) $ 119,337
See accompanying notes to the condensed consolidated financial statements.
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ARBUTUS BIOPHARMA CORPORATION
Condensed Consolidated Statements 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 expense — — 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 expense — — 2,064 — — 2,064
Certain fair value adjustments to liability stock option awards — — 3 — — 3
Issuance of common shares pursuant to exercise of options 66,025 197 ( 84 ) — — 113
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
Stock-based compensation expense — — 1,715 — — 1,715
Certain fair value adjustments to liability stock option awards — — 2 — — 2
Issuance of common shares pursuant to the Open Market Sale Agreement 3,832,717 8,973 — — — 8,973
Issuance of common shares pursuant to ESPP 84,723 272 ( 113 ) — — 159
Unrealized loss on available-for-sale securities — — — — ( 907 ) ( 907 )
Net loss — — — ( 17,567 ) — ( 17,567 )
Balance September 30, 2022 152,711,702 $ 1,307,654 $ 70,738 $ ( 1,181,871 ) $ ( 51,004 ) $ 145,517
See accompanying notes to the condensed consolidated financial statements.
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ARBUTUS BIOPHARMA CORPORATION
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(In thousands of U.S. Dollars)
Nine Months Ended September 30,
2023 2022
OPERATING ACTIVITIES
Net loss $ ( 53,537 ) $ ( 47,524 )
Non-cash items:
Depreciation 1,045 1,120
Gain on sale of property and equipment ( 20 ) ( 20 )
Stock-based compensation expense 7,578 5,515
Change in fair value of contingent consideration ( 158 ) 624
Non-cash royalty revenue ( 2,667 ) ( 5,393 )
Non-cash interest expense 412 1,413
Net accretion and amortization of investments in marketable securities ( 1,577 ) 170
Net change in operating items:
Accounts receivable ( 819 ) ( 936 )
Prepaid expenses and other assets ( 2,040 ) 27
Accounts payable and accrued liabilities ( 6,223 ) 1,456
Change in deferred license revenue ( 10,349 ) 25,463
Other liabilities ( 289 ) ( 281 )
Net cash used in operating activities ( 68,644 ) ( 18,366 )
INVESTING ACTIVITIES
Purchase of investments in marketable securities ( 56,490 ) ( 117,266 )
Disposition of investments in marketable securities 86,026 30,000
Proceeds from sale of property and equipment 20 20
Acquisition of property and equipment ( 1,008 ) ( 378 )
Net cash provided by (used in) investing activities 28,548 ( 87,624 )
FINANCING ACTIVITIES
Issuance of common shares pursuant to Share Purchase Agreement — 10,973
Issuance of common shares pursuant to the Open Market Sale Agreement 26,000 9,241
Issuance of common shares pursuant to exercise of stock options 259 121
Issuance of common shares pursuant to exercise of ESPP 581 395
Net cash provided by financing activities 26,840 20,730
Effect of foreign exchange rate changes on cash and cash equivalents 11 ( 18 )
Decrease in cash and cash equivalents ( 13,245 ) ( 85,278 )
Cash and cash equivalents, beginning of period 30,776 109,282
Cash and cash equivalents, end of period $ 17,531 $ 24,004
See accompanying notes to the condensed consolidated financial statements.
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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 a functional cure for patients with chronic hepatitis B virus (“cHBV”). The Company believes the key to success in developing a functional cure involves suppressing HBV DNA, reducing surface antigen and boosting HBV-specific immune response. The Company’s pipeline of internally developed, proprietary compounds includes an RNAi therapeutic, imdusiran (AB-729), and an oral PD-L1 inhibitor, AB-101. Imdusiran has generated meaningful clinical data demonstrating an impact on both surface antigen reduction and reawakening of the HBV-specific immune response. Imdusiran is currently in two Phase 2a combination clinical trials. AB-101 is currently being evaluated in a Phase 1a/1b clinical trial. Additionally, the Company has identified compounds in its internal PD-L1 portfolio that could be used in oncology indications.
Liquidity
At September 30, 2023, the Company had an aggregate of $ 144.7 million in cash, cash equivalents and investments in marketable securities. The Company had no outstanding debt as of September 30, 2023. 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.
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 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, 2022 included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022. 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 September 30, 2023 and December 31, 2022, the Company’s results of operations for the three and nine months ended September 30, 2023 and 2022, and the Company’s cash flows for the nine months ended September 30, 2023 and 2022. Such adjustments are of a normal recurring nature. The results of operations for the three and nine months ended September 30, 2023 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, 2022, 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.
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Net loss per share
Net loss per share is calculated based on the weighted average number of common shares outstanding. Diluted net loss per share does not differ from basic net loss per share for the three and nine months ended September 30, 2023 and 2022, since the effect of including potential common shares would be anti-dilutive. For the nine months ended September 30, 2023, potential common shares of 21.0 million pertaining to outstanding stock options and unvested restricted stock units were excluded from the calculation of net loss per share. A total of approximately 15.9 million outstanding stock options were excluded from the calculation for the nine months ended September 30, 2022.
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 (“ASC 210-20”) 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.
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Recent accounting pronouncements
In June 2016, the Financial Accounting Standards Board issued Accounting Standards Update 2016-13, Financial Instruments - Credit Losses: Measurement of Credit Losses in Financial Instruments (“ASC 326”). The guidance is effective for the Company beginning January 1, 2023 and it changes how entities account for credit losses on the financial assets and other instruments that are not measured at fair value through net income, including available-for-sale debt securities. The adoption of ASC 326 did not have a material impact on the consolidated financial statements.
The Company has reviewed all other 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 are 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 $ 7.4 million as of September 30, 2023 and the decrease of $ 0.2 million from December 31, 2022 has been recorded as a component of total operating expenses in the statements of operations and comprehensive loss for the nine months ended September 30, 2023. 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.
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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:
Level 1 Level 2 Level 3 Total
As of September 30, 2023 (in thousands)
Assets
Cash and cash equivalents $ 17,531 $ — $ — $ 17,531
Investments in marketable securities, current — 116,649 — 116,649
Investments in marketable securities, non-current — 10,496 — 10,496
Total $ 17,531 $ 127,145 $ — $ 144,676
Liabilities
Contingent consideration — — 7,373 7,373
Total $ — $ — $ 7,373 $ 7,373
Level 1 Level 2 Level 3 Total
As of December 31, 2022 (in thousands)
Assets
Cash and cash equivalents $ 30,776 $ — $ — $ 30,776
Investments in marketable securities, current — 116,137 — 116,137
Investments in marketable securities, non-current — 37,363 — 37,363
Total $ 30,776 $ 153,500 $ — $ 184,276
Liabilities
Contingent consideration — — 7,531 7,531
Total $ — $ — $ 7,531 $ 7,531
The following table presents the changes in fair value of the Company’s contingent consideration:
Liability at beginning of the period Change in fair value of liability Liability at end of the period
(in thousands)
Nine Months Ended September 30, 2023 $ 7,531 $ ( 158 ) $ 7,373
Nine Months Ended September 30, 2022 $ 5,298 $ 624 $ 5,922
See Note 4 for additional information regarding the fair value of the Company’s investments in marketable securities.
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4. Investments in marketable securities
Investments in marketable securities consisted of the following:
Amortized Cost Gross Unrealized Gain (1)
Gross Unrealized Loss (1)
Fair Value
As of September 30, 2023 (in thousands)
Cash equivalents
Money market $ 10,805 $ — $ — $ 10,805
Total $ 10,805 $ — $ — $ 10,805
Investments in marketable short-term securities
US government agency bonds $ 31,706 $ — $ ( 158 ) $ 31,548
US corporate bonds 57,692 — ( 341 ) 57,351
US treasury bills 10,940 — ( 2 ) 10,938
Yankee bonds 2,000 — ( 32 ) 1,968
US government bonds 14,985 — ( 141 ) 14,844
Total $ 117,323 $ — $ ( 674 ) $ 116,649
Investments in marketable long-term securities
US corporate bonds 10,522 — ( 29 ) 10,496
Total $ 10,522 $ 3 $ ( 29 ) $ 10,496
(1) Gross unrealized gain (loss) is pre-tax and is reported in accumulated other comprehensive loss.
Amortized Cost Gross Unrealized Gain (1)
Gross Unrealized Loss (1)
Fair Value
As of December 31, 2022 (in thousands)
Cash equivalents
Money market $ 23,218 $ — $ — $ 23,218
Total $ 23,218 $ — $ — $ 23,218
Investments in marketable short-term securities
US government agency bonds $ 26,686 $ — $ ( 424 ) $ 26,262
US corporate bonds 27,144 — ( 303 ) 26,841
US treasury bills 8,483 — ( 16 ) 8,467
US government bonds $ 55,361 $ — $ ( 794 ) $ 54,567
Total $ 117,674 $ — $ ( 1,537 ) $ 116,137
Investments in marketable long-term securities
US government agency bonds $ 3,724 $ — $ ( 130 ) $ 3,594
US treasury bills 25,433 — ( 336 ) 25,097
US government bonds 8,972 — ( 300 ) 8,672
Total $ 38,129 $ — $ ( 766 ) $ 37,363
(1) Gross unrealized gain (loss) is pre-tax and is reported in accumulated other comprehensive loss.
The contractual term to maturity of the $ 116.6 million of short-term marketable securities held by the Company as of September 30, 2023 is less than one year. As of September 30, 2023, the Company held $ 10.5 million of long-term marketable securities with contractual maturities of more than one year, but less than five years. As of December 31, 2022, the Company’s $ 116.1 million of short-term marketable securities had contractual maturities of less than one year, while the Company’s $ 37.4 million of long-term marketable securities had maturities of more than one year, but less than five years.
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At September 30, 2023 and December 31, 2022, the Company had 40 and 53 , respectively, available-for-sale investment debt securities in an unrealized loss position without an allowance for credit losses. Unrealized losses on the Company’s investments in debt securities have not been recognized into income as the issuers’ bonds are of high credit quality and the decline in fair value is largely due to market conditions and/or changes in interest rates. The Company does not intend to sell and it is more likely than not that the Company will not be required to sell the securities prior to the anticipated recovery of their amortized cost basis. The issuers continue to make timely interest payments on the bonds. The fair value is expected to recover as the bonds approach maturity.
Accrued interest receivable on investments in marketable securities of $ 0.6 million at both September 30, 2023 and December 31, 2022 is included in prepaid expenses and other current assets.
The Company had realized gains of less than $ 0.1 million for both the three and nine months ended September 30, 2023 and 2022.
See Note 3 for additional information regarding the fair value of the Company’s investments in marketable securities.
5. Investment in Genevant
In April 2018, the Company entered into an agreement with Roivant Sciences Ltd., 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 September 30, 2023, 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:
September 30, 2023 December 31, 2022
(in thousands)
Trade accounts payable $ 2,260 $ 3,520
Research and development accruals 4,210 8,261
Professional fee accruals 691 512
Payroll accruals 2,645 3,730
Other accrued liabilities — 6
Total accounts payable and accrued liabilities $ 9,806 $ 16,029
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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 September 30, 2023, the Company estimated an effective annual interest rate of approximately 2.3 %. 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 September 30, 2023, the Company has recorded an aggregate of $ 21.5 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 nine months ended September 30, 2023, the Company recognized non-cash royalty revenue of $ 2.7 million and related non-cash interest expense of $ 0.4 million. During the nine months ended September 30, 2022, the Company recognized non-cash royalty revenue of $ 5.4 million and related non-cash interest expense of $ 1.4 million.
The table below shows the activity related to the net liability for the nine months ended September 30, 2023 and 2022:
Nine Months Ended September 30,
2023 2022
(in thousands)
Net liability related to sale of future royalties - beginning balance $ 10,365 $ 16,296
Non-cash royalty revenue ( 2,667 ) ( 5,393 )
Non-cash interest expense 412 1,413
Net liability related to sale of future royalties - ending balance $ 8,110 $ 12,316
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.
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8. Contingencies and commitments
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 $ 7.4 million as of September 30, 2023.
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 imdusiran, including pharmaceutical products that include imdusiran, 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 imdusiran 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 imdusiran 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 imdusiran 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 imdusiran necessary for Qilu to develop and commercialize in the Territory until the Company has completed manufacturing technology transfer to Qilu and Qilu has received all approvals required for it or its designated contract manufacturing organization to manufacture imdusiran in the Territory.
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 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.
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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 (as defined in the License Agreement) (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 nine months ended September 30, 2023:
Nine Months Ended September 30, 2023
Transaction Price Cumulative Collaboration Revenue Recognized Deferred License Revenue
(in thousands)
Combined performance obligation $ 49,270 $ 36,364 $ 12,906
Less contract asset ( 800 )
Total deferred license revenue 12,106
Less current portion of deferred license revenue 12,106
Non-current deferred license revenue $ —
The Company recognized $ 3.2 million and $ 10.3 million of revenue based on labor hours expended by the Company on its Manufacturing Obligations during the three and nine months ended September 30, 2023, respectively, and $ 2.4 million and $ 23.0 million during the three and nine months ended September 30, 2022, respectively.
As of September 30, 2023, the balance of the deferred license revenue was $ 12.9 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 $ 12.1 million. The $ 4.4 million of withholding taxes paid by Qilu on behalf of the Company was recorded as income tax expense during the twelve months ended December 31, 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 recognized amortization expense of less than $ 0.1 million and $ 0.1 million for the three and nine months ended September 30, 2023, respectively, and less than $ 0.1 million and $ 0.3 million for the three and nine months ended September 30, 2022, respectively.
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.
Barinthus Biotherapeutics plc
In July 2021, the Company entered into a clinical collaboration agreement with Barinthus Biotherapeutics plc (“Barinthus”),
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formerly Vaccitech plc, to evaluate imdusiran followed by Barinthus’ VTP-300, an HBV antigen specific immunotherapy, and ongoing nucleos(t)ide analogue therapy in patients with cHBV. Recently, the clinical trial was amended and is now dosing patients in an additional treatment arm that includes an approved PD-1 monoclonal antibody inhibitor, nivolumab (Opdivo ® ).
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 Barinthus. The Company and Barinthus retain full rights to their respective product candidates and will split all costs associated with the clinical trial. The Company incurred $ 0.7 million and $ 1.6 million of expenses, net of reimbursements from Barinthus, related to the collaboration during the three and nine months ended September 30, 2023, respectively, and reflected those costs in research and development in the statements of operations and comprehensive loss. The Company incurred $ 0.3 million and $ 0.7 million of such costs for the same respective periods in 2022.
Assembly Biosciences, Inc.
In August 2020, the Company entered into a clinical collaboration agreement with Assembly Biosciences, Inc. (“Assembly”) to evaluate imdusiran in combination with Assembly’s first-generation HBV core inhibitor (capsid inhibitor) candidate vebicorvir (“VBR”) and standard-of-care NA therapy for the treatment of patients with HBV infection. After completing enrollment in the Phase 2a proof-of-concept clinical trial, in July 2022, Assembly announced its plan to discontinue development of VBR. In consultation with Assembly, the Company continued dosing patients in this clinical trial until completion of the final, on-treatment visit at week 48, at which point both parties mutually agreed to discontinue the clinical trial. The Company and Assembly shared in the costs of the collaboration. The Company incurred $ 0.1 million and $ 1.4 million of expenses related to the collaboration during the three and nine months ended September 30, 2023, respectively, and $ 0.6 million and $ 2.1 million during the three and nine months ended September 30, 2022, respectively. Those costs are reflected in research and development in the statements 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 imdusiran compound.
X-Chem, Inc. and Proteros biostructures GmbH
In March 2021, the Company entered into a discovery research and license agreement, as amended, 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”). The agreement was designed to accelerate the development of pan-coronavirus agents to treat COVID-19 and potential future coronavirus outbreaks. This collaboration brought 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 allowed 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 to progress to clinical candidates. Through this collaboration, the Company 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. In the fourth quarter of 2022, the Company nominated AB-343 as its lead candidate that inhibits Mpro.
The agreement, as amended, provided 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 Company incurred less than $ 0.1 million and $ 1.0 million of expenses related to the collaboration during the three and nine months ended September 30, 2023, respectively, and $ 0.6 million and $ 0.9 million during the three and nine months ended September 30, 2022, respectively. Those costs are reflected in research and development in the statements of operations and comprehensive loss.
During the third quarter of 2023, the Company discontinued its efforts to identify and develop a coronavirus combination therapy due to an unfavorable pharmacokinetic (PK) profile noted in the IND-enabling studies for AB-343. The Company also terminated this discovery research and license agreement with X-Chem and Proteros.
Royalty Entitlements
Alnylam Pharmaceuticals, Inc. and Acuitas Therapeutics, Inc.
The Company has two royalty entitlements to Alnylam’s global net sales of ONPATTRO.
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In 2012, the Company entered into the LNP 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 September 30, 2023, an aggregate of $ 21.5 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. 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 September 30, Nine Months Ended September 30,
2023 2022 2023 2022
(in thousands) (in thousands)
Revenue from collaborations and licenses
Acuitas Therapeutics, Inc. $ 714 $ 1,256 $ 2,980 $ 4,339
Qilu Pharmaceutical Co., Ltd. 3,221 2,352 10,349 23,007
Other milestone and royalty payments — — — 35
Non-cash royalty revenue
Alnylam Pharmaceuticals, Inc. 723 2,344 2,667 5,393
Total revenue $ 4,658 $ 5,952 $ 15,996 $ 32,774
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 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 the Company 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 for an offering of up to $ 50.0 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”) for an 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. The January 2020 Registration Statement expired in January 2023.
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
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prospectus supplement with the SEC (the “March 2021 Prospectus Supplement”) for an 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”) for an 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 October 2020 Registration Statement expired in October 2023 with $ 29.3 million that was not utilized under the October 2021 Prospectus Supplement.
On November 4, 2021, the Company filed a shelf registration statement on Form S-3 with the SEC (File No. 333-260782) and accompanying base prospectus, which was declared effective by the SEC on November 18, 2021 (the “November 2021 Registration Statement”), for the offer and sale of up to $ 250.0 million of the Company’s securities.
On March 3, 2022, the Company filed a prospectus supplement with the SEC (the “March 2022 Prospectus Supplement”) for an 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) the November 2021 Registration Statement, of which only the November 2021 Registration Statement remains active.
During the three and nine months ended September 30, 2023, the Company issued 633,922 and 9,848,090 common shares pursuant to the Sale Agreement, respectively, resulting in net proceeds of approximately $ 1.4 million and $ 26.0 million, respectively. During the three and nine months ended September 30, 2022, the Company issued 3,832,717 common shares pursuant to the Sale Agreement, resulting in net proceeds of $ 9.0 million. As of September 30, 2023, there was approximately $ 104.3 million of common shares remaining available in aggregate under the October 2021 Prospectus Supplement and March 2022 Prospectus Supplement. In October 2023, the October 2020 Registration Statement expired with $ 29.3 million that was not utilized under the October 2021 Prospectus Supplement, leaving $ 75.0 million remaining available under the March 2022 Prospectus Supplement pursuant to the November 2021 Registration Statement.
Stock-based compensation
The table below summarizes information about the Company’s stock-based compensation for the three and nine months ended September 30, 2023 and 2022 and the expense recognized in the condensed consolidated statements of operations:
Three Months Ended September 30, Nine Months Ended September 30,
2023 2022 2023 2022
(in thousands, except share and per share data)
Stock options
Options granted during period 784,240 62,700 5,082,640 4,797,000
Weighted average exercise price $ 2.25 $ 2.37 $ 2.78 $ 2.77
Restricted stock units (“RSUs”)
Restricted stock units granted during period — — 1,344,550 —
Grant date fair value $ — $ — $ 2.90 $ —
Stock compensation expense
Research and development $ 1,002 $ 736 $ 2,854 $ 2,191
General and administrative 1,481 978 4,724 3,324
Total stock compensation expense $ 2,483 $ 1,714 $ 7,578 $ 5,515
The RSUs vest over three years in equal annual installments beginning one year from the grant date.
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11. Subsequent events
On November 6, 2023, the Company reduced its workforce by 24 % primarily affecting its research function. As a result, the Company will incur a one-time restructuring charge of approximately $ 1.1 million that will be recorded in the fourth quarter of 2023. The Company has maintained a group of research scientists as it remains committed to continuing discovery research in HBV.
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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.