Arbutus Biopharma(ABUS)

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Arbutus Biopharma(ABUS) - 2022 Q4 - Annual Report
2023-03-01 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 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 ...
Arbutus Biopharma(ABUS) - 2022 Q3 - Earnings Call Transcript
2022-11-09 15:42
Arbutus Biopharma Corporation (NASDAQ:ABUS) Q3 2022 Earnings Conference Call January 1, 2022 8:45 AM ET Company Participants Lisa Caperelli - Vice President of Investor Relations Bill Collier - President and Chief Executive Officer David Hastings - Chief Financial Officer Gaston Picchio - Chief Development Officer Mike Sofia - Chief Scientific Officer Conference Call Participants Dennis Ding - Jefferies Roy Buchanan - JMP Keay Nakae - Chardan Operator Good day. And thank you for standing by, and welcome to ...
Arbutus Biopharma(ABUS) - 2022 Q2 - Earnings Call Transcript
2022-08-04 19:06
Arbutus Biopharma Corporation (NASDAQ:ABUS) Q2 2022 Earnings Conference Call August 4, 2022 8:45 AM ET Company Participants Lisa Caperelli - Vice President of Investor Relations Bill Collier - President & Chief Executive Officer David Hastings - Chief Financial Officer Gaston Picchio - Chief Development Officer Mike Sofia - Chief Scientific Officer Conference Call Participants Roy Buchanan - JMP Securities Dennis Ding - Jefferies Brian Skorney - Baird Keay Nakae - Chardan Thomas Yip - H.C. Wainwright Operat ...
Arbutus Biopharma(ABUS) - 2022 Q2 - Quarterly Report
2022-08-03 16:00
[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section presents Arbutus Biopharma Corporation's unaudited condensed consolidated financial statements and management's discussion and analysis of its financial condition and results of operations [ITEM 1. FINANCIAL STATEMENTS (UNAUDITED)](index=3&type=section&id=ITEM%201.%20FINANCIAL%20STATEMENTS%20%28UNAUDITED%29) This section presents Arbutus Biopharma Corporation's unaudited condensed consolidated financial statements, including balance sheets, statements of operations, stockholders' equity, and cash flows, along with detailed explanatory notes [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section provides a snapshot of Arbutus Biopharma Corporation's financial position, detailing assets, liabilities, and stockholders' equity at specific reporting dates Table: Condensed Consolidated Balance Sheets | Assets/Liabilities | June 30, 2022 (in thousands) | December 31, 2021 (in thousands) | | :----------------- | :--------------------------- | :------------------------------- | | **Total Assets** | $215,836 | $204,485 | | **Total Liabilities** | $62,694 | $35,046 | | **Total Stockholders' Equity** | $153,142 | $169,439 | - Total assets increased by **$11.35 million (5.5%)** from December 31, 2021, to June 30, 2022, primarily driven by an increase in investments in marketable securities[6](index=6&type=chunk) - Total liabilities significantly increased by **$27.65 million (78.9%)** due to the recognition of deferred license revenue, current and non-current, related to the Qilu agreement[6](index=6&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section details Arbutus Biopharma Corporation's financial performance over specific periods, including revenue, operating expenses, and net loss Table: Condensed Consolidated Statements of Operations and Comprehensive Loss | Metric (in thousands) | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | **Total Revenue** | $14,241 | $2,329 | $26,822 | $4,442 | | **Total Operating Expenses** | $28,350 | $20,971 | $51,905 | $38,760 | | **Loss from Operations** | $(14,109) | $(18,642) | $(25,083) | $(34,318) | | **Net Loss** | $(14,192) | $(19,387) | $(29,957) | $(35,768) | | **Basic and Diluted Loss per Share** | $(0.10) | $(0.23) | $(0.20) | $(0.44) | - Total revenue for the three months ended June 30, 2022, increased significantly by **$11.9 million (511%)** compared to the same period in 2021, primarily due to collaboration and license revenue[9](index=9&type=chunk) - Net loss decreased for both the three-month and six-month periods ended June 30, 2022, compared to 2021, indicating improved financial performance despite increased operating expenses[9](index=9&type=chunk) [Condensed Consolidated Statement of Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statement%20of%20Stockholders'%20Equity) This section outlines changes in Arbutus Biopharma Corporation's stockholders' equity, reflecting net losses, share issuances, and other comprehensive income Table: Condensed Consolidated Statement of Stockholders' Equity | Equity Item (in thousands) | Balance Dec 31, 2021 | Balance June 30, 2022 | | :------------------------- | :------------------- | :-------------------- | | **Total Stockholders' Equity** | $169,439 | $153,142 | | **Common Shares Issued & Outstanding** | 144,987,736 | 148,794,262 | | **Net Loss** | $(15,765) (Q1 2022) | $(14,192) (Q2 2022) | - Total stockholders' equity decreased by **$16.297 million** from December 31, 2021, to June 30, 2022, primarily due to net losses and unrealized losses on available-for-sale securities, partially offset by common share issuances[12](index=12&type=chunk) - The number of common shares outstanding increased by **3,806,526 shares** during the six months ended June 30, 2022, through various issuances including a Share Purchase Agreement and exercise of options[12](index=12&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section details Arbutus Biopharma Corporation's cash inflows and outflows from operating, investing, and financing activities over specific periods Table: Condensed Consolidated Statements of Cash Flows | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :-------------------------------- | :----------------------------- | :----------------------------- | | **Net cash provided by (used in) operating activities** | $326 | $(31,890) | | **Net cash used in investing activities** | $(73,886) | $(20,526) | | **Net cash provided by financing activities** | $11,598 | $31,163 | | **Decrease in cash and cash equivalents** | $(61,962) | $(21,297) | | **Cash and cash equivalents, end of period** | $47,320 | $30,954 | - Operating activities generated **$0.326 million** in cash for the six months ended June 30, 2022, a significant improvement from the **$31.89 million** cash used in the prior year, primarily due to a **$40.0 million** upfront payment from Qilu[16](index=16&type=chunk)[172](index=172&type=chunk) - Net cash used in investing activities increased to **$73.886 million**, mainly due to higher purchases of marketable securities[16](index=16&type=chunk)[173](index=173&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanatory notes supporting the condensed consolidated financial statements, covering accounting policies, fair value measurements, and collaborations [1. Nature of business and future operations](index=8&type=section&id=1.%20Nature%20of%20business%20and%20future%20operations) This section describes Arbutus Biopharma Corporation's core business as a clinical-stage biopharmaceutical company and its strategic focus on developing therapeutics for viral diseases - Arbutus Biopharma Corporation is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for viral diseases, primarily Hepatitis B virus (HBV), SARS-CoV-2, and other coronaviruses[18](index=18&type=chunk) - The company's lead compound, AB-729, an RNAi therapeutic, is in Phase 2 clinical trials for chronic HBV infection and shows evidence of immune re-awakening[18](index=18&type=chunk) Table: Financial Position Highlights | Metric | June 30, 2022 (in millions) | | :----- | :-------------------------- | | **Cash, cash equivalents and marketable securities** | $200.6 | | **Outstanding Debt** | $0 | [2. Significant accounting policies](index=9&type=section&id=2.%20Significant%20accounting%20policies) This section outlines the key accounting principles and methods used in preparing Arbutus Biopharma Corporation's financial statements, including revenue recognition and fair value measurements - The unaudited condensed consolidated financial statements are prepared in accordance with GAAP for interim financial statements and include Arbutus Biopharma Corporation and its wholly-owned subsidiary[22](index=22&type=chunk) - Net loss attributable to common shareholders per share is calculated based on weighted average common shares, with potential common shares excluded if anti-dilutive[24](index=24&type=chunk) - Revenue from collaborations and licenses is recognized using a five-step model (ASC 606), identifying distinct performance obligations and allocating transaction price based on stand-alone selling prices[26](index=26&type=chunk)[27](index=27&type=chunk) [3. Fair value measurements](index=10&type=section&id=3.%20Fair%20value%20measurements) This section details Arbutus Biopharma Corporation's methodology for measuring financial instruments at fair value, utilizing a three-level hierarchy based on input observability - The company measures certain financial instruments at fair value using a three-level hierarchy based on observability of inputs[32](index=32&type=chunk) Table: Fair Value Measurements by Level | Item (in thousands) | Level 1 (June 30, 2022) | Level 2 (June 30, 2022) | Level 3 (June 30, 2022) | Total (June 30, 2022) | | :------------------ | :---------------------- | :---------------------- | :---------------------- | :-------------------- | | **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 Assets** | $47,320 | $153,329 | — | $200,649 | | **Liabilities** | | | | | | Liability-classified stock options | — | — | $2 | $2 | | Contingent consideration | — | — | $5,707 | $5,707 | | **Total Liabilities** | — | — | $5,709 | $5,709 | - The fair value of contingent consideration increased by **$0.4 million** from December 31, 2021, to June 30, 2022, reflecting the progression of development programs[34](index=34&type=chunk)[41](index=41&type=chunk) [4. Investments in marketable securities](index=13&type=section&id=4.%20Investments%20in%20marketable%20securities) This section provides details on Arbutus Biopharma Corporation's investments in marketable securities, including their amortized cost and fair value Table: Investments in Marketable Securities | Investment Type (in thousands) | Amortized Cost (June 30, 2022) | Fair Value (June 30, 2022) | | :----------------------------- | :----------------------------- | :------------------------- | | **Cash equivalents** | $23,984 | $23,984 | | **Investments in marketable short-term securities** | $103,925 | $102,879 | | **Investments in marketable long-term securities** | $51,317 | $50,450 | - As of June 30, 2022, the company held **$102.9 million** in short-term marketable securities (maturing in less than one year) and **$50.5 million** in long-term marketable securities (maturing between one and five years)[44](index=44&type=chunk) - There were no realized gains or losses on marketable securities for the three and six months ended June 30, 2022 or 2021[44](index=44&type=chunk) [5. Investment in Genevant](index=14&type=section&id=5.%20Investment%20in%20Genevant) This section describes Arbutus Biopharma Corporation's equity investment in Genevant Sciences Ltd. and the associated licensing agreements for RNA-based applications - Arbutus accounts for its **16% interest** in Genevant Sciences Ltd. as equity securities without readily determinable fair values, with a carrying value of zero as of June 30, 2022[49](index=49&type=chunk) - The company licensed exclusive rights to its LNP and ligand conjugate delivery platforms to Genevant for RNA-based applications outside of HBV, retaining all rights for HBV[46](index=46&type=chunk) - Arbutus is entitled to a specified percentage (**14-20%**) of certain revenue Genevant receives from sublicenses or infringement actions related to the licensed intellectual property[47](index=47&type=chunk)[48](index=48&type=chunk) [6. Accounts payable and accrued liabilities](index=14&type=section&id=6.%20Accounts%20payable%20and%20accrued%20liabilities) This section details the composition and changes in Arbutus Biopharma Corporation's accounts payable and accrued liabilities over specific periods Table: Accounts Payable and Accrued Liabilities | Item (in thousands) | June 30, 2022 | December 31, 2021 | | :------------------ | :------------ | :---------------- | | **Trade accounts payable** | $0 | $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 | - Total accounts payable and accrued liabilities increased by **$1.636 million (15.1%)** from December 31, 2021, to June 30, 2022, primarily due to a significant increase in research and development accruals[51](index=51&type=chunk) [7. Sale of future royalties](index=14&type=section&id=7.%20Sale%20of%20future%20royalties) This section describes Arbutus Biopharma Corporation's agreement for the sale of future ONPATTRO royalties and the associated financial impact - Arbutus sold a portion of its ONPATTRO royalty interest to OMERS for **$20 million** in 2019, with OMERS retaining entitlement until **$30 million** in royalties are received, after which rights revert to Arbutus[52](index=52&type=chunk) Table: Sale of Future Royalties Impact | Item (in thousands) | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :------------------ | :----------------------------- | :----------------------------- | | **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 | - The net liability related to the sale of future royalties decreased to **$14.233 million** as of June 30, 2022, from **$16.296 million** at the beginning of the period, reflecting the ongoing repayment through royalties[56](index=56&type=chunk) [8. Contingencies and commitments](index=15&type=section&id=8.%20Contingencies%20and%20commitments) This section addresses Arbutus Biopharma Corporation's potential financial obligations and legal claims, including arbitration and contingent consideration - An arbitration claim by the University of British Columbia (UBC) for **$2.0 million** in royalties from the ONPATTRO royalty sale was fully dismissed on July 11, 2022, with Arbutus intending to seek reimbursement for costs[58](index=58&type=chunk) - Contingent consideration related to the 2014 acquisition of Enantigen Therapeutics, Inc. was valued at **$5.7 million** as of June 30, 2022, tied to sales performance milestones for the first commercialized HBV product[60](index=60&type=chunk)[61](index=61&type=chunk) [9. Collaborations, contracts and licensing agreements](index=16&type=section&id=9.%20Collaborations,%20contracts%20and%20licensing%20agreements) This section details Arbutus Biopharma Corporation's strategic collaborations, licensing agreements, and their financial implications, including upfront payments and milestone opportunities - In December 2021, Arbutus entered a licensing agreement with Qilu Pharmaceutical Co., Ltd. for AB-729 in China, Hong Kong, Macau, and Taiwan, receiving a **$40.0 million** upfront payment and potential milestone payments up to **$245.0 million**, plus double-digit royalties[62](index=62&type=chunk)[63](index=63&type=chunk) Table: Qilu Licensing Agreement Financials | Item (in thousands) | Transaction Price | Collaboration Revenue Recognized (Six Months Ended June 30, 2022) | Deferred License Revenue (June 30, 2022) | | :------------------ | :---------------- | :-------------------------------------------------------------- | :--------------------------------------- | | **Combined performance obligation** | $49,270 | $20,655 | $28,615 | | **Net deferred license revenue liability** | | | $27,815 | - Arbutus has ongoing clinical collaborations for AB-729 with Vaccitech plc (Phase 2a, VTP-300 vaccine) and Assembly Biosciences, Inc. (Phase 2a, VBR capsid inhibitor), sharing costs for these trials[71](index=71&type=chunk)[72](index=72&type=chunk) - The collaboration with Antios for AB-729 was terminated due to patient loss to follow-up in Ukraine, and Assembly Biosciences announced plans to discontinue development of VBR, though Arbutus plans to continue dosing in their joint trial[72](index=72&type=chunk)[118](index=118&type=chunk) - A discovery research and license agreement with X-Chem and Proteros focuses on novel inhibitors for SARS-CoV-2 nsp5 main protease, with a candidate expected to be nominated in H2 2022[73](index=73&type=chunk) [10. Shareholders' equity](index=19&type=section&id=10.%20Shareholders%27%20equity) This section provides information on Arbutus Biopharma Corporation's share capital, stock-based compensation, and changes in common shares outstanding - The company's authorized share capital includes an unlimited number of common and preferred shares, and **1,164,000 Series A** participating convertible preferred shares[79](index=79&type=chunk) Table: Stock-based Compensation Expense | Stock-based Compensation (in thousands) | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :-------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | **Research and development** | $696 | $578 | $1,454 | $1,418 | | **General and administrative** | $1,369 | $1,165 | $2,346 | $1,960 | | **Total stock compensation expense** | $2,065 | $1,743 | $3,800 | $3,378 | - During the six months ended June 30, 2022, Arbutus issued **69,048 common shares** through its Open Market Sale Agreement, generating approximately **$0.3 million** in net proceeds[83](index=83&type=chunk) - Roivant Sciences Ltd. converted its Series A Preferred Shares into **22,833,922 common shares** on October 18, 2021, and now owns approximately **26%** of Arbutus's outstanding common shares[85](index=85&type=chunk) [11. Related party transactions](index=20&type=section&id=11.%20Related%20party%20transactions) This section discloses transactions between Arbutus Biopharma Corporation and related parties, specifically administrative services provided to Genevant - Genevant purchased administrative services from Arbutus, with income from these services being less than **$0.1 million** for both the three and six months ended June 30, 2022 and 2021, and netted against R&D expenses[87](index=87&type=chunk) [ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS](index=21&type=section&id=ITEM%202.%20MANAGEMENT'S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) This section provides management's analysis of Arbutus Biopharma Corporation's financial condition and operational results, covering strategic initiatives, product candidate progress, and liquidity [OVERVIEW](index=23&type=section&id=OVERVIEW) This section provides a high-level summary of Arbutus Biopharma Corporation's focus as a clinical-stage biopharmaceutical company and its pipeline for viral diseases - Arbutus is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for Hepatitis B virus (HBV), SARS-CoV-2, and other coronaviruses[97](index=97&type=chunk) - The company's HBV pipeline includes an RNAi therapeutic (AB-729), an oral capsid inhibitor, an oral PD-L1 inhibitor, and an oral RNA destabilizer, aiming for a functional cure for chronic HBV[97](index=97&type=chunk) - AB-729 is the lead RNAi therapeutic, currently in multiple Phase 2 clinical trials, with evidence of immune re-awakening[97](index=97&type=chunk) [Strategy](index=23&type=section&id=Strategy) This section outlines Arbutus Biopharma Corporation's strategic approach to developing a comprehensive portfolio of compounds for chronic HBV and advancing antiviral candidates for coronaviruses - Arbutus's strategy involves developing a broad portfolio of compounds targeting cHBV, including AB-729 (RNAi therapeutic), AB-836 (oral capsid inhibitor), AB-101 (oral PD-L1 inhibitor), and AB-161 (oral HBV RNA destabilizer), to achieve a functional cure[98](index=98&type=chunk)[99](index=99&type=chunk) - AB-729 is being evaluated in three Phase 2a proof-of-concept clinical trials in combination with other agents, positioning it as a cornerstone therapeutic[98](index=98&type=chunk)[100](index=100&type=chunk) - The company is also advancing small molecule antiviral candidates for COVID-19 and future coronavirus outbreaks, with a focus on Mpro and nsp12 viral polymerase inhibitors[104](index=104&type=chunk) [Our Product Candidates](index=24&type=section&id=Our%20Product%20Candidates) This section provides updates on the clinical and preclinical progress of Arbutus Biopharma Corporation's key product candidates for HBV and COVID-19 - AB-729 (GalNAc RNAi) continues to show robust HBsAg declines and immune restoration in Phase 1a/1b trials, with **76%** of patients achieving HBsAg <100 IU/mL and **50%** maintaining it 24 weeks post-last dose[109](index=109&type=chunk)[111](index=111&type=chunk) - AB-836 (Oral Capsid Inhibitor) demonstrated potent HBV replication inhibition in Phase 1a/1b, but transient Grade 3/4 ALT elevations were observed in some patients, prompting an additional Phase 1 trial in healthy volunteers[122](index=122&type=chunk) - AB-101 (Oral PD-L1 Inhibitor) showed preclinical activity in activating HBV-specific T-cells and profound tumor reduction in mouse models, with IND-enabling studies anticipated to complete in H2 2022[125](index=125&type=chunk) - AB-161 (Oral HBV RNA Destabilizer), a next-generation compound, is advancing through IND-enabling studies expected to complete in H2 2022, designed to avoid peripheral neuropathy seen in a prior generation[128](index=128&type=chunk) - The COVID-19 research program, in collaboration with X-Chem and Proteros, has identified several Mpro inhibitors, with a candidate expected to be nominated for IND-enabling studies in H2 2022[130](index=130&type=chunk) [COVID-19 Impact](index=29&type=section&id=COVID-19%20Impact) This section discusses the ongoing and potential disruptions caused by the COVID-19 pandemic on Arbutus Biopharma Corporation's clinical development and operational timelines - The COVID-19 pandemic has caused and may continue to cause significant disruptions to clinical development, including supply chain delays and patient enrollment challenges[131](index=131&type=chunk) - While clinical and pre-clinical activities have progressed, the future impact of the pandemic on plans and timelines remains unpredictable[131](index=131&type=chunk) [Other Collaborations and Royalty Entitlements](index=29&type=section&id=Other%20Collaborations%20and%20Royalty%20Entitlements) This section details Arbutus Biopharma Corporation's additional collaborations, royalty interests, and ongoing intellectual property litigation related to its LNP technology - Arbutus has a technology transfer and license agreement with Qilu Pharmaceutical Co., Ltd. for AB-729 in specific Asian territories, including an upfront payment and potential milestones and royalties[132](index=132&type=chunk) - The company holds two royalty entitlements on Alnylam's ONPATTRO sales: one partially sold to OMERS (with **$14.2 million** collected by OMERS as of June 30, 2022) and another retained from Acuitas Therapeutics[134](index=134&type=chunk)[135](index=135&type=chunk) - Arbutus and Genevant filed a patent infringement lawsuit against Moderna for the use of patented LNP technology in MRNA-1273, seeking damages but not an injunction[147](index=147&type=chunk) - Acuitas Therapeutics filed a declaratory judgment lawsuit against Arbutus and Genevant regarding patent infringement and validity concerning Pfizer and BioNTech's COMIRNATY vaccine[148](index=148&type=chunk) - The Federal Circuit upheld the validity of all claims in Arbutus's '069 patent and certain claims in the '435 patent against Moderna's Inter Partes Review petitions[143](index=143&type=chunk)[144](index=144&type=chunk) [CRITICAL ACCOUNTING POLICIES AND SIGNIFICANT JUDGEMENTS AND ESTIMATES](index=32&type=section&id=CRITICAL%20ACCOUNTING%20POLICIES%20AND%20SIGNIFICANT%20JUDGEMENTS%20AND%20ESTIMATES) This section discusses the critical accounting policies and significant management judgments and estimates used in preparing Arbutus Biopharma Corporation's financial statements - The preparation of financial statements requires management to make estimates and assumptions that affect reported asset, liability, revenue, and expense amounts[149](index=149&type=chunk) - No significant changes in critical accounting policies and estimates were reported compared to the Annual Report on Form 10-K for the year ended December 31, 2021[149](index=149&type=chunk) [RECENT ACCOUNTING PRONOUNCEMENTS](index=32&type=section&id=RECENT%20ACCOUNTING%20PRONOUNCEMENTS) This section addresses the impact of recently issued accounting standards on Arbutus Biopharma Corporation's financial statements - The company has reviewed recently issued accounting standards and determined that they will not have a material impact on its financial statements upon adoption[150](index=150&type=chunk) [RESULTS OF OPERATIONS](index=32&type=section&id=RESULTS%20OF%20OPERATIONS) This section analyzes Arbutus Biopharma Corporation's financial performance, detailing fluctuations in revenue, operating expenses, and net loss over specific periods Table: Results of Operations Summary | Metric (in thousands) | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | **Total Revenue** | $14,241 | $2,329 | $26,822 | $4,442 | | **Total Operating Expenses** | $28,350 | $20,971 | $51,905 | $38,760 | | **Loss from Operations** | $(14,109) | $(18,642) | $(25,083) | $(34,318) | | **Net Loss attributable to common shares** | $(14,192) | $(22,653) | $(29,957) | $(42,246) | - Total revenue increased by **$11.9 million (511%)** for the three months and **$22.4 million (504%)** for the six months ended June 30, 2022, primarily due to the Qilu licensing agreement and increased royalty revenue from Alnylam and Acuitas[155](index=155&type=chunk) - Research and development expenses increased by **$7.1 million (45%)** for the three months and **$11.8 million (40%)** for the six months ended June 30, 2022, driven by AB-729 Phase 2a trials and early-stage programs (AB-101, AB-161)[159](index=159&type=chunk) - Income tax expense of **$4.4 million** was recognized for the six months ended June 30, 2022, related to withholding taxes paid by Qilu on the upfront license fee[168](index=168&type=chunk) [LIQUIDITY AND CAPITAL RESOURCES](index=36&type=section&id=LIQUIDITY%20AND%20CAPITAL%20RESOURCES) This section assesses Arbutus Biopharma Corporation's ability to meet its financial obligations, detailing cash flows, available capital, and future funding expectations Table: Cash Flow Summary | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :-------------------------------- | :----------------------------- | :----------------------------- | | **Net cash provided by (used in) operating activities** | $326 | $(31,890) | | **Net cash used in investing activities** | $(73,886) | $(20,526) | | **Net cash provided by financing activities** | $11,598 | $31,163 | | **Decrease in cash and cash equivalents** | $(61,962) | $(21,297) | | **Cash and cash equivalents, end of period** | $47,320 | $30,954 | - As of June 30, 2022, Arbutus had **$200.6 million** in cash, cash equivalents, and marketable securities, with no outstanding debt[175](index=175&type=chunk) - The company expects its current cash resources to fund operations into the second quarter of 2024, with an anticipated net cash burn between **$90 million** and **$95 million** in 2022[184](index=184&type=chunk) - Future funding needs will depend on factors like the COVID-19 pandemic's impact, revenue from collaborations, milestone payments, development progress, and intellectual property litigation costs[184](index=184&type=chunk) [OFF-BALANCE SHEET ARRANGEMENTS](index=38&type=section&id=OFF-BALANCE%20SHEET%20ARRANGEMENTS) This section confirms that Arbutus Biopharma Corporation has no material off-balance sheet arrangements impacting its financial condition or results of operations - Arbutus has no off-balance sheet arrangements that are material to its financial condition, revenues, expenses, results of operations, liquidity, capital expenditures, or capital resources[185](index=185&type=chunk) [ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK](index=38&type=section&id=ITEM%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) As a smaller reporting company, Arbutus Biopharma Corporation is not required to provide quantitative and qualitative disclosures about market risk - As a smaller reporting company, Arbutus Biopharma Corporation is not required to provide quantitative and qualitative disclosures about market risk[186](index=186&type=chunk) [ITEM 4. CONTROLS AND PROCEDURES](index=39&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES) This section confirms the effectiveness of Arbutus Biopharma Corporation's disclosure controls and procedures and reports no material changes in internal control over financial reporting - Management, including the principal executive and financial officers, concluded that disclosure controls and procedures were effective at a reasonable assurance level as of June 30, 2022[187](index=187&type=chunk) - There were no material changes in internal control over financial reporting during the three months ended June 30, 2022[188](index=188&type=chunk) [PART II. OTHER INFORMATION](index=40&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section provides additional information beyond the financial statements, including legal proceedings, risk factors, and other required disclosures [ITEM 1. LEGAL PROCEEDINGS](index=40&type=section&id=ITEM%201.%20LEGAL%20PROCEEDINGS) This section details Arbutus Biopharma Corporation's ongoing legal proceedings, including patent infringement lawsuits against Moderna and Acuitas, and the dismissal of an arbitration claim by UBC - Arbutus and Genevant filed a lawsuit against Moderna for infringement of multiple U.S. patents related to nucleic acid-lipid particles in Moderna's COVID-19 vaccine (MRNA-1273), seeking damages[190](index=190&type=chunk) - Acuitas Therapeutics filed a declaratory judgment lawsuit against Arbutus and Genevant, seeking a declaration that Arbutus's patents are not infringed by Pfizer and BioNTech's COMIRNATY vaccine and that the patents are invalid[191](index=191&type=chunk) - An arbitration claim by the University of British Columbia (UBC) for **$2.0 million** in royalties was fully dismissed on July 11, 2022, with Arbutus planning to seek reimbursement for costs and attorneys' fees[192](index=192&type=chunk) [ITEM 1A. RISK FACTORS](index=40&type=section&id=ITEM%201A.%20RISK%20FACTORS) This section highlights the significant risk factor concerning the impact of military action in Ukraine on Arbutus Biopharma Corporation's clinical trials, causing potential delays and increased costs - Several clinical trials, including those for AB-836 and AB-729, have been impacted or could be further delayed/suspended due to military action in Ukraine, leading to patient loss to follow-up and increased costs[193](index=193&type=chunk)[195](index=195&type=chunk) - The company intends to utilize alternative clinical trial sites for affected trials, but the availability and timeliness of such sites are uncertain, potentially causing significant delays in product candidate development[193](index=193&type=chunk)[196](index=196&type=chunk) - No other material changes in risk factors were disclosed compared to the Annual Report on Form 10-K for the fiscal year ended December 31, 2021[197](index=197&type=chunk) [ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS](index=41&type=section&id=ITEM%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECURITIES%20AND%20USE%20OF%20PROCEEDS) This section confirms no unregistered sales of equity securities or use of proceeds were reported for the period - No unregistered sales of equity securities or use of proceeds were reported for the period[197](index=197&type=chunk) [ITEM 3. DEFAULTS UPON SENIOR SECURITIES](index=41&type=section&id=ITEM%203.%20DEFAULTS%20UPON%20SENIOR%20SECURITIES) This section confirms no defaults upon senior securities were reported for the period - No defaults upon senior securities were reported for the period[197](index=197&type=chunk) [ITEM 4. MINE SAFETY DISCLOSURES](index=41&type=section&id=ITEM%204.%20MINE%20SAFETY%20DISCLOSURES) This section states that mine safety disclosures are not applicable to Arbutus Biopharma Corporation - Mine safety disclosures are not applicable to Arbutus Biopharma Corporation[197](index=197&type=chunk) [ITEM 5. OTHER INFORMATION](index=41&type=section&id=ITEM%205.%20OTHER%20INFORMATION) This section confirms no other information was reported for the period - No other information was reported for the period[197](index=197&type=chunk) [EXHIBIT INDEX](index=42&type=section&id=EXHIBIT%20INDEX) This section provides a comprehensive list of all exhibits filed with the report [SIGNATURES](index=43&type=section&id=SIGNATURES) This section contains the required signatures of the company's authorized officers, certifying the accuracy of the report
Arbutus Biopharma(ABUS) - 2022 Q1 - Earnings Call Transcript
2022-05-05 18:05
Arbutus Biopharma Corp, Inc. (NASDAQ:ABUS) Q1 2022 Earnings Conference Call May 5, 2022 8:45 AM ET Company Participants Lisa Caperelli - VP, IR William Collier - President, CEO & Director Michael Sofia - Chief Scientific Officer David Hastings - CFO & CAO Gaston Picchio - Chief Development Officer Conference Call Participants Douglas Buchanan - JMP Securities Yuchen Ding - Jefferies Thomas Yip - H.C. Wainwright & Co. Luke Herrmann - Robert W. Baird & Co. Keay Nakae - Chardan Capital Markets Operator Good da ...
Arbutus Biopharma(ABUS) - 2021 Q4 - Earnings Call Transcript
2022-03-03 19:31
Arbutus Biopharma Corporation (NASDAQ:ABUS) Q4 2021 Earnings Conference Call March 3, 2022 8:45 AM ET Company Participants Lisa Caperelli - Vice President, Investor Relations William Collier - President and Chief Executive Officer David Hastings - Chief Financial Officer Gaston Picchio - Chief Development Officer Michael Sofia - Chief Scientific Officer Conference Call Participants Roy Buchanan - JMP Securities Dennis Ding - Jefferies Ed Arce - H.C. Wainwright Brian Skorney - Baird Operator Good day and th ...