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Share Name | Share Symbol | Market | Type |
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Arbutus Biopharma Corporation | NASDAQ:ABUS | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
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-0.03 | -1.12% | 2.66 | 2.66 | 2.83 | 590 | 13:27:35 |
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our strategy, future operations, pre-clinical research, pre-clinical studies, clinical trials, prospects and the plans of management;
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the discovery, development and commercialization of a cure for chronic hepatitis B infection, a disease of the liver caused by the hepatitis B virus (“HBV”);
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our beliefs and development path and strategy to achieve a cure for HBV;
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obtaining necessary regulatory approvals;
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obtaining adequate financing through a combination of financing activities and operations;
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using the results from our HBV studies to adaptively design additional clinical trials to test the efficacy of the combination therapy and the duration of the result in patients;
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the payment of one-time employee termination benefits, employee relocation costs, and site closure costs, totaling approximately $5,600,000 related to the site consolidation and organizational restructuring to align our HBV business in Warminster, PA;
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the expected timing of and amount for payments related to the Enantigen Therapeutics, Inc.'s transaction and its programs;
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the potential of our drug candidates to improve upon the standard of care and contribute to a curative combination treatment regimen;
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the potential for our royalty entitlement on Onpattro™ (Patisiran) to provide an active royalty stream or to be otherwise monetized in full or part;
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developing a suite of products that intervene at different points in the viral life cycle, with the potential to reactivate the host immune system;
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using pre-clinical results to adaptively design clinical trials for additional cohorts of patients, testing the combination and the duration of therapy;
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selecting combination therapy regimens and treatment durations to conduct Phase 3 clinical trials intended to ultimately support regulatory filings for marketing approval;
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expanding our HBV drug candidate pipeline through internal development, acquisitions and in-licenses;
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the potential of our assets, including our ownership stake in Genevant Sciences Ltd. and our royalty entitlement on Onpattro, to provide significant non-dilutive capital;
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continuing to focus on rapidly advancing AB-506, with top-line results expected in the second quarter of 2019;
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our expectation to initiate a Phase 2 clinical study of AB-506 in the fourth quarter of 2019;
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the potential of AB-506 to be a 'best-in-class' capsid inhibitor with once-daily dosing;
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our expectation to make a decision regarding AB-452 clinical development in the second half of 2019;
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the development of a second-generation RNAi agent, AB-729, and its expected progression into clinical trials in the second quarter of 2019 and the potential to subsequently combine it with AB-506 in the first half of 2020;
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a potential IND/CTA filing for AB-729, with clinical trials in the first half of 2019;
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our expectation to initiate HBV patient dosing on AB-729 in the second half of 2019;
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our expectation to provide an RNA destabilizer program update in the second half of 2019;
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payments from the Gritstone Oncology, Inc. licensing agreement;
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the expectation for organizational changes to result in increased efficiency, a more flexible variable cost structure, and additional preservation of our cash reserves;
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the belief that current legal proceedings will not have a material adverse effect on our consolidated results of operations, cash flows, or financial condition;
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the expected return from strategic alliances, licensing agreements, and research collaborations;
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statements with respect to revenue and expense fluctuation and guidance;
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having sufficient cash resources to fund our operations into 2020;
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obtaining funding to maintain and advance our business from a variety of sources including public or private equity or debt financing, collaborative arrangements with pharmaceutical companies, other non-dilutive commercial arrangements and government grants and contracts;
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on-going arbitration and litigation proceedings; and
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the amount and timing of potential funding
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developing a pipeline of proprietary therapeutic agents that target multiple elements of the HBV viral lifecycle, the most important of which we believe are HBV replication, hepatitis B surface antigen ("HBsAg") expression and immune reactivation; and
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identifying an effective combination of complementary proprietary therapeutic agents administered for a finite treatment duration.
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progress our clinical and pre-clinical product candidates through Phase 1 and Phase 2 clinical trials;
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identify a safe and effective combination regimen to support a robust Phase 3 clinical registration program;
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obtain regulatory approval for such combination regimen; and
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commercialize such combination regimen.
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Nucleos(t)ide analogues (NAs): NAs work by inhibiting HBV DNA polymerase activity and suppressing HBV replication. Oral NAs have become a mainstay of HBV treatment, mainly due to their ability to drive viral load to undetectable levels in the serum of patients, easy single pill once-a-day dosing and lack of significant side effects. However, NAs cure only a small percentage of patients and typically require chronic dosing to maintain their benefits, which can be challenging for patients.
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Capsid inhibitor (AB-506): this orally available product candidate inhibits HBV replication by destabilizing core particle assembly or disassembly through either promoting the assembly of empty capsids or causing core protein to form aberrant polymers. We believe the combination of a capsid inhibitor with an approved NA and a RNA interference
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RNAi (AB-729): this subcutaneously-delivered agent targets a single RNAi trigger sequence that spans all of the HBV transcripts and reduces all of the viral antigens, including hepatitis B surface antigen (HBsAg), which is believed to be involved in immune exhaustion in patients with chronic HBV. We believe the combination of an approved NA, a RNAi agent and a capsid inhibitor, has the potential to lead to important clinical benefits including more effective suppression of viral replication, significantly higher functional cure rates and shortened treatment durations.
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Subject Matter
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Status
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Expiration
Date*
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siRNA and LNP Compositions (HBV)
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Patent applications pending in U.S. and other jurisdictions
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2035
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HBV Capsid Assembly Inhibitor Compositions and Methods of Treatment
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Patent applications pending in U.S. and other jurisdictions
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2032
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Non-Liposomal Systems For Nucleic Acid Delivery
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U.S. Pat. No. 9,518,272
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2031
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(1)
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Patent information current as of
March 5, 2019
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The federal Anti-Kickback Law, which prohibits, among other things, knowingly or willingly offering, paying, soliciting or receiving remuneration, directly or indirectly, in cash or in kind, to induce or reward the purchasing, leasing, ordering or arranging for or recommending the purchase, lease or order of any health care items or service for which payment may be made, in whole or in part, by federal healthcare programs such as Medicare and Medicaid. This statute has been interpreted to apply to arrangements between pharmaceutical companies on one hand and prescribers, purchasers and formulary managers on the other. Liability may be established under the federal Anti-Kickback Law without proving actual knowledge of the statute or specific intent to violate it. In addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Law constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act. Although there are a number of statutory exemptions and regulatory safe harbors to the federal Anti-Kickback Law protecting certain common business arrangements and activities from prosecution or regulatory sanctions, the exemptions and safe harbors are drawn narrowly, and practices that do not fit squarely within an exemption or safe harbor, or for which no exception or safe harbor is available, may be subject to scrutiny.
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The federal civil False Claims Act, which prohibits, among other things, individuals or entities from knowingly presenting, or causing to be presented, a false or fraudulent claim for payment of government funds or knowingly making, using or causing to be made or used, a false record or statement material to an obligation to pay money to the government or knowingly concealing or knowingly and improperly avoiding, decreasing or concealing an obligation to pay money to the federal government. Many pharmaceutical and other healthcare companies have been investigated and have reached substantial financial settlements with the federal government under the civil False Claims Act for a variety of alleged improper marketing activities, including: providing free product to customers with the expectation that the customers would bill federal programs for the product; providing sham
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Analogous state and local laws and regulations, such as state anti-kickback and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers; state and foreign laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers; state laws that restrict the ability of manufacturers to offer co-pay support to patients for certain prescription drugs; and state and foreign laws that require drug manufacturers to report information related to clinical trials, or information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; state laws and local ordinances that require identification or licensing of sales representatives.
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The federal Physician Payment Sunshine Act, being implemented as the Open Payments Program, which requires manufacturers of drugs, devices, biologics, and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to CMS information related to direct or indirect payments and other transfers of value to physicians and teaching hospitals, as well as ownership and investment interests held in the company by physicians and their immediate family members. Beginning in 2022, applicable manufacturers also will be required to report information regarding payments and transfers of value provided to physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, and certified nurse-midwives.
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The federal Foreign Corrupt Practices Act of 1997 and other similar anti-bribery laws in other jurisdictions generally prohibit companies and their intermediaries from providing money or anything of value to officials of foreign governments, foreign political parties or international organizations with the intent to obtain or retain business or seek a business advantage. Recently, there has been a substantial increase in anti-bribery law enforcement activity by U.S. regulators, with more frequent and aggressive investigations and enforcement proceedings by both the Department of Justice and the U.S. Securities and Exchange Commission (the “SEC”). Violations of United States or foreign laws or regulations could result in the imposition of substantial fines, interruptions of business, loss of supplier, vendor or other third-party relationships, termination of necessary licenses and permits and other legal or equitable sanctions. Other internal or government investigations or legal or regulatory proceedings, including lawsuits brought by private litigants, may also follow as a consequence.
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execute research and development activities using technologies involved in the development of our product candidates;
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build, maintain and protect a strong intellectual property portfolio;
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gain approval and acceptance for the development and commercialization of any product candidates we develop;
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conduct sales and marketing activities;
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develop and maintain successful strategic relationships; and
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manage our spending and cash requirements as our expenses are expected to continue to increase due to research and pre-clinical work, clinical trials, regulatory approvals, commercialization and maintaining our intellectual property portfolio.
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revenues earned from our licensing partners, including Alnylam, Gritstone and Spectrum;
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the extent to which we continue the development of our product candidates or form licensing arrangements to advance our product candidates;
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our decisions to in-license or acquire additional products, product candidates or technology for development;
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our ability to attract and retain corporate partners, and their effectiveness in carrying out the development and ultimate commercialization of our product candidates;
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whether batches of drugs that we manufacture fail to meet specifications resulting in delays and investigational and remanufacturing costs;
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the decisions, and the timing of decisions, made by health regulatory agencies regarding our technology and product candidates;
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competing technological and market developments; and
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prosecuting and enforcing our patent claims and other intellectual property rights.
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significantly delay, scale back or discontinue the development or commercialization of one or more of our product candidates or one or more of our other research and development initiatives;
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seek collaborators for one or more of our current or future product candidates at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available;
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sell or license on unfavorable terms our rights to technologies or product candidates that we otherwise would seek to develop or commercialize ourselves; or
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cease operations.
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continue our research and pre-clinical and clinical development of our product candidates;
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initiate additional pre-clinical, clinical or other studies or trials for our product candidates;
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continue or expand our licensing arrangements with our licensing partners;
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change or add additional manufacturers or suppliers;
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seek regulatory approvals for our product candidates that successfully complete clinical trials;
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establish a sales, marketing and distribution infrastructure to commercialize any products for which we may obtain regulatory approval;
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seek to identify and validate additional product candidates;
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acquire or in-license other product candidates and technologies;
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maintain, protect and expand our intellectual property portfolio;
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attract and retain skilled personnel;
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create additional infrastructure to support our product development and planned future commercialization efforts; and
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experience any delays or encounter issues with any of the above.
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completing research and pre-clinical and clinical development of our product candidates;
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seeking and obtaining regulatory approvals for product candidates for which we complete clinical trials;
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developing a sustainable, scalable, reproducible, and transferable manufacturing process for our product candidates;
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establishing and maintaining supply and manufacturing relationships with third parties that can provide adequate (in amount and quality) products and services to support clinical development and the market demand for our product candidates, if approved;
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launching and commercializing product candidates for which we obtain regulatory approval, either by collaborating with a partner or, if launched independently, by establishing a sales force, marketing, sales operations and distribution infrastructure;
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obtaining market acceptance of our product candidates as viable treatment options;
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addressing any competing technological and market developments;
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implementing additional internal systems and infrastructure, as needed;
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identifying and validating new product candidates;
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negotiating favorable terms in any collaboration, licensing or other arrangements into which we may enter;
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maintaining, protecting and expanding our portfolio of intellectual property rights, including patents, trade secrets and know-how; and
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attracting, hiring and retaining qualified personnel.
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delay or failure in reaching agreement with the FDA or a foreign regulatory authority on the design of a given trial, or in obtaining authorization to commence a trial;
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delay or failure in reaching agreement on acceptable terms with prospective clinical research organizations (“CROs”) and clinical trial sites;
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delay or failure in obtaining approval of an institutional review board (“IRB”) before a clinical trial can be initiated at a given site;
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withdrawal of clinical trial sites from our clinical trials, including as a result of changing standards of care or the ineligibility of a site to participate;
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delay or failure in recruiting and enrolling patients in our clinical trials;
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delay or failure in having patients complete a clinical trial or return for post-treatment follow up;
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clinical sites or investigators deviating from trial protocol, failing to conduct the trial in accordance with applicable regulatory requirements, or dropping out of a trial;
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inability to identify and maintain a sufficient number of trial sites;
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failure of CROs to meet their contractual obligations or deadlines;
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the need to modify a trial protocol;
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unforeseen safety issues;
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emergence of dosing issues;
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lack of effectiveness during clinical trials;
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changes in the standard of care of the indication being studied;
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reliance on third-party suppliers for the clinical trial supply of product candidates;
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inability to monitor patients adequately during or after treatment;
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lack of sufficient funding to finance the clinical trials; and
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changes in governmental regulations or administrative action.
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establishment of the safety and efficacy of the product for each use sought;
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government review and approval of a submission containing manufacturing, pre-clinical and clinical data;
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adherence to Good Manufacturing Practice Regulations during production and storage; and
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control of marketing activities, including advertising and labeling.
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disagreement with the design or implementation of our clinical trials;
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failure to demonstrate that our candidate is safe and effective for the proposed indication;
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failure of clinical trial results to meet the level of statistical significance required for approval;
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failure to demonstrate that the product’s benefits outweigh its risks;
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disagreement with our interpretation of pre-clinical or clinical data; and
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inadequacies in the manufacturing facilities or processes of third-party manufacturers.
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severity of the disease under investigation;
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design of the trial protocol;
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prevalence of the disease/size of the patient population;
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eligibility criteria for the clinical trial in question;
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perceived risks and benefits of the product candidate under study;
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proximity and availability of clinical trial sites for prospective patients;
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availability of competing therapies and clinical trials;
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efforts to facilitate timely enrollment in clinical trials;
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patient referral practices of physicians; and
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ability to monitor patients adequately during and after treatment.
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their efficacy, safety and other potential advantages in relation to alternative treatments;
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their relative convenience and ease of administration;
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the availability of adequate coverage or reimbursement by third parties, such as insurance companies and other healthcare payors, and by government healthcare programs, including Medicare and Medicaid;
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the prevalence and severity of adverse events;
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their cost of treatment in relation to alternative treatments, including generic products;
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the extent and strength of our third party manufacturer and supplier support;
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the extent and strength of marketing and distribution support;
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the limitations or warnings contained in a product’s FDA approved labeling; and
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distribution and use restrictions imposed by the FDA or that are part of a REMS or voluntary risk management plan.
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the federal Anti-Kickback Law prohibits persons from, among other things, knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, the referral of an individual for the furnishing or arranging for the furnishing, or the purchase, lease or order, or arranging for or recommending purchase, lease or order, any good or service for which payment may be made under a federal healthcare program such as Medicare and Medicaid;
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the federal civil False Claims Act imposes penalties, including through civil whistleblower or qui tam actions, against individuals or entities for, among other things, knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement material to an obligation to pay money to the government or knowingly concealing or knowingly and improperly avoiding, decreasing, or concealing an obligation to pay money to the federal government;
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HIPAA imposes criminal liability for knowingly and willfully executing a scheme to defraud any healthcare benefit program, knowingly and willfully embezzling or stealing from a health care benefit program, willfully obstructing a criminal investigation of a health care offense, or knowingly and willfully making false statements relating to healthcare matters;
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HIPAA and its implementing regulations also impose obligations on certain covered entity health care providers, health plans and health care clearinghouses as well as their business associates that perform certain services involving the use or disclosure of individually identifiable health information, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information. We may obtain health information from third parties (including research institutions from which we obtain clinical trial data) that are subject to privacy and security requirements under HIPAA. Although we are not directly subject to HIPAA - other than with respect to providing certain employee benefits - we could potentially be subject to criminal penalties if we, our affiliates, or our agents
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the federal Physician Payment Sunshine Act, being implemented as the Open Payments Program, which requires manufacturers of drugs, devices, biologics, and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to CMS information related to direct or indirect payments and other transfers of value to physicians and teaching hospitals (and certain other practitioners beginning in 2022), as well as ownership and investment interests held in the company by physicians and their immediate family members; and
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analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers; state and foreign laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to certain healthcare providers; state and foreign laws that require drug manufacturers to report information related to clinical trials, or information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; state laws that restrict the ability of manufacturers to offer co-pay support to patients for certain prescription drugs; state laws and local ordinances that require identification or licensing of sales representatives; and state and foreign laws that govern the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
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Alnylam’s and its distributors’ and sublicensees’ ability to effectively market and sell Onpattro in each country where sold;
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the manner of sale, whether directly by Alnylam or by sublicensees or distributors, and the terms of sublicensing and distribution agreements;
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the amount and timing of sales of Alnylam in each country;
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regulatory approvals, appropriate labeling, and desirable pricing, insurance coverage and reimbursement;
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competition; and
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commencement of marketing in additional countries; and
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we may be unable to contract with third-party manufacturers on acceptable terms, or at all, because the number of potential manufacturers is limited. Potential manufacturers of any product candidate that is approved will be subject to FDA compliance inspections and any new manufacturer would have to be qualified to produce our products;
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our third-party manufacturers might be unable to formulate and manufacture our drugs in the volume and of the quality required to meet our clinical and commercial needs, if any;
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our third-party manufacturers may not perform as agreed or may not remain in the contract manufacturing business for the time required to supply our clinical trials through completion or to successfully produce, store and distribute our commercial products, if approved;
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drug manufacturers are subject to ongoing periodic unannounced inspection by the FDA and other government agencies to ensure compliance with cGMP and other government regulations and corresponding foreign standards. We do not have control over third-party manufacturers’ compliance with these regulations and standards, but we may ultimately be responsible for any of their failures;
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if any third-party manufacturer makes improvements in the manufacturing process for our products, we may not own, or may have to share, the intellectual property rights to such improvements; and
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a third-party manufacturer may gain knowledge from working with us that could be used to supply one of our competitors with a product that competes with ours.
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some or all patent applications may not result in the issuance of a patent;
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patents issued may not provide the holder with any competitive advantages;
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patents could be challenged by third parties;
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the patents of others, including Alnylam, could impede our ability to do business;
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competitors may find ways to design around our patents; and
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competitors could independently develop products which duplicate our products.
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much greater financial, technical and human resources than we have at every stage of the discovery, development, manufacture and commercialization process;
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more extensive experience in pre-clinical testing, conducting clinical trials, obtaining regulatory approvals, and in manufacturing, marketing and selling pharmaceutical products;
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product candidates that are based on previously tested or accepted technologies;
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products that have been approved or are in late stages of development; and
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collaborative arrangements in our target markets with leading companies and research institutions.
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safety and effectiveness of our products;
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ease with which our products can be administered and the extent to which patients and physicians accept new routes of administration;
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timing and scope of regulatory approvals for these products;
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availability and cost of manufacturing, marketing and sales capabilities;
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price;
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reimbursement coverage; and
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patent position.
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delay, defer or prevent a change in control;
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entrench our management and/or the board of directors; or
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impede a merger, consolidation, takeover or other business combination involving us that other shareholders may desire.
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whether our clinical trials can be conducted within the timeframe that we expect and whether such trials will yield positive results;
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whether our collaborations can be advanced with positive results within the timeframe and budget that we expect;
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changes in laws or regulations applicable to our products or product candidates, including but not limited to clinical trial requirements for approvals;
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unanticipated serious safety concerns related to the use of our product candidates;
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a decision to initiate a clinical trial, not to initiate a clinical trial or to terminate an existing clinical trial;
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adverse regulatory decisions;
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the introduction of new products or technologies offered by us or our competitors;
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the inability to effectively manage our growth;
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actual or anticipated variations in quarterly operating results;
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the failure to meet or exceed the estimates and projections of the investment community;
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the perception of the biopharmaceutical industry by the public, legislatures, regulators and the investment community;
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the overall performance of the U.S. equity capital markets and general political and economic conditions;
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announcements of significant acquisitions, strategic partnerships, joint ventures, collaborations or capital commitments by us or our competitors;
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disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies;
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additions or departures of key personnel;
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the trading volume of our common shares; and
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other events or factors, many of which are beyond our control.
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the timing, implementation and cost of our research, pre-clinical studies and clinical trials;
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our ability to attract and retain personnel with the necessary strategic, technical and creative skills required for effective operations;
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the amount and timing of expenditures by practitioners and their patients;
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introduction of new technologies;
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product liability litigation, class action and derivative action litigation, or other litigation;
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the amount and timing of capital expenditures and other costs relating to the expansion of our operations;
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the state of the debt and/or equity capital markets at the time of any proposed offering we choose to initiate;
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our ability to successfully integrate new acquisitions into our operations;
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government regulation and legal developments regarding our product candidates in the United States and in the foreign countries in which we may operate in the future; and
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general economic conditions.
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general economic and political conditions in Canada, the United States and globally;
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governmental regulation of the health care and pharmaceutical industries;
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failure to achieve desired drug discovery outcomes by us or our collaborators;
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failure to obtain industry partner and other third party consents and approvals, when required;
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stock market volatility and market valuations;
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competition for, among other things, capital, drug targets and skilled personnel;
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the need to obtain required approvals from regulatory authorities;
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revenue and operating results failing to meet expectations in any particular period;
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investor perception of the health care and pharmaceutical industries;
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limited trading volume of our common shares;
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announcements relating to our business or the businesses of our competitors; and
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•
|
our ability or inability to raise additional funds.
|
|
2018
|
|
|
2017
|
|
||
Total revenue
|
$
|
5.9
|
|
|
$
|
10.7
|
|
Operating expenses
|
95.7
|
|
|
121.6
|
|
||
Loss from operations
|
(89.8
|
)
|
|
(110.9
|
)
|
||
Net loss
|
(57.1
|
)
|
|
(84.4
|
)
|
||
Net loss attributable to common shares
|
(67.2
|
)
|
|
(85.3
|
)
|
|
2018
|
|
|
% of Total
|
|
|
2017
|
|
|
% of Total
|
|
||
Collaborations and contracts
|
|
|
|
|
|
|
|
||||||
Alexion
|
$
|
—
|
|
|
—
|
%
|
|
$
|
8.0
|
|
|
75
|
%
|
Gritstone
|
4.3
|
|
|
73
|
%
|
|
2.5
|
|
|
23
|
%
|
||
Other milestone and royalty payments
|
1.6
|
|
|
27
|
%
|
|
0.2
|
|
|
2
|
%
|
||
Total revenue
|
$
|
5.9
|
|
|
|
|
|
$
|
10.7
|
|
|
|
|
|
2018
|
|
|
% of Total
|
|
|
2017
|
|
|
% of Total
|
|
||
Research and development
|
$
|
57.9
|
|
|
61
|
%
|
|
$
|
62.7
|
|
|
52
|
%
|
General and administrative
|
16.0
|
|
|
17
|
%
|
|
16.1
|
|
|
13
|
%
|
||
Depreciation
|
2.2
|
|
|
2
|
%
|
|
2.0
|
|
|
2
|
%
|
||
Site consolidation
|
4.8
|
|
|
5
|
%
|
|
—
|
|
|
—
|
%
|
||
Impairment of intangible assets
|
14.8
|
|
|
15
|
%
|
|
40.8
|
|
|
34
|
%
|
||
Total operating expenses
|
$
|
95.7
|
|
|
|
|
|
$
|
121.6
|
|
|
|
|
|
2018
|
|
|
2017
|
|
||
Interest income
|
$
|
3.0
|
|
|
$
|
1.5
|
|
Interest expense
|
(0.2
|
)
|
|
(0.3
|
)
|
||
Gain on investment
|
24.9
|
|
|
—
|
|
||
Equity investment loss
|
(5.6
|
)
|
|
—
|
|
||
Decrease (increase) in fair value of contingent consideration
|
7.3
|
|
|
(1.4
|
)
|
||
Foreign exchange gains (losses)
|
(1.0
|
)
|
|
2.3
|
|
||
Total other income (losses)
|
$
|
28.4
|
|
|
$
|
2.1
|
|
•
|
revenue earned from our legacy collaborative partnerships and licensing agreements, including potential royalty payments from Alnylam's Onpattro;
|
•
|
revenue earned from ongoing collaborative partnerships, including milestone and royalty payments;
|
•
|
the extent to which we continue the development of our product candidates, add new product candidates to our pipeline, or form collaborative relationships to advance our products;
|
•
|
delays in the development of our products due to pre-clinical and clinical findings;
|
•
|
our decisions to in-license or acquire additional products or technology for development, in particular for our HBV therapeutics programs;
|
•
|
our ability to attract and retain corporate partners, and their effectiveness in carrying out the development and ultimate commercialization of our product candidates;
|
•
|
whether batches of drugs that we manufacture fail to meet specifications resulting in delays and investigational and remanufacturing costs;
|
•
|
the decisions, and the timing of decisions, made by health regulatory agencies regarding our technology and products;
|
•
|
competing technological and market developments; and
|
•
|
costs associated with prosecuting and enforcing our patent claims and other intellectual property rights, including litigation and arbitration arising in the course of our business activities.
|
|
Year ended December 31
|
|
||||||
|
2018
|
|
2017
|
|
||||
Net loss for the year
|
$
|
(57.1
|
)
|
|
$
|
(84.4
|
)
|
|
Adjustments to reconcile net loss to net cash used in operating activities
|
(6.5
|
)
|
|
32.7
|
|
|
||
Changes in operating assets and liabilities
|
(4.3
|
)
|
|
3.1
|
|
|
||
Net cash used in operating activities
|
(67.9
|
)
|
|
(48.6
|
)
|
|
||
Net cash provided by (used in) investing activities
|
(4.1
|
)
|
|
27.8
|
|
|
||
Net cash provided by financing activities
|
55.6
|
|
|
49.3
|
|
|
||
Effect of foreign exchange rate changes on cash & cash equivalents
|
(1.0
|
)
|
|
2.4
|
|
|
||
Net increase (decrease) in cash, cash equivalents and restricted cash
|
(17.4
|
)
|
|
30.9
|
|
|
||
Cash, cash equivalents and restricted cash, beginning of year
|
54.3
|
|
|
23.4
|
|
|
||
Cash, cash equivalents and restricted cash, end of year
|
$
|
36.9
|
|
|
$
|
54.3
|
|
|
|
Page
|
|
December 31, 2018
|
|
December 31, 2017
|
||||
Assets
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
36,942
|
|
|
$
|
54,292
|
|
Short-term investments
|
87,675
|
|
|
72,060
|
|
||
Accounts receivable
|
1,431
|
|
|
402
|
|
||
Accrued revenue
|
—
|
|
|
128
|
|
||
Investment tax credits receivable
|
389
|
|
|
340
|
|
||
Prepaid expenses and other assets
|
2,792
|
|
|
2,144
|
|
||
Total current assets
|
129,229
|
|
|
129,366
|
|
||
Restricted investment (note 9)
|
—
|
|
|
12,601
|
|
||
Investment in Genevant (note 4)
|
22,224
|
|
|
—
|
|
||
Property and equipment, (at cost, net of accumulated depreciation ($6,896)
(2017 - ($12,671)) (note 5)
|
10,145
|
|
|
12,183
|
|
||
Intangible assets (note 6)
|
43,836
|
|
|
58,647
|
|
||
Goodwill (note 6)
|
22,471
|
|
|
24,364
|
|
||
Total assets
|
$
|
227,905
|
|
|
$
|
237,161
|
|
Liabilities and stockholders' equity
|
|
|
|
|
|
||
Current liabilities:
|
|
|
|
|
|
||
Accounts payable and accrued liabilities (note 7)
|
$
|
9,429
|
|
|
$
|
10,646
|
|
Deferred revenue (note 11)
|
—
|
|
|
2,742
|
|
||
Site consolidation accrual (note 8)
|
1,331
|
|
|
—
|
|
||
Liability-classified options (notes 2 and 12)
|
479
|
|
|
1,239
|
|
||
Total current liabilities
|
11,239
|
|
|
14,627
|
|
||
Deferred rent and inducements, long term
|
645
|
|
|
693
|
|
||
Loan payable (notes 2 and 9)
|
—
|
|
|
12,001
|
|
||
Contingent consideration (note 15)
|
3,126
|
|
|
10,424
|
|
||
Deferred tax liability (note 13)
|
12,661
|
|
|
16,943
|
|
||
Total liabilities
|
27,671
|
|
|
54,688
|
|
||
Stockholders’ equity:
|
|
|
|
|
|
||
Preferred shares (note 10)
|
|
|
|
||||
Authorized - 1,164,000 with no par value
|
|
|
|
||||
Issued and outstanding: 1,164,000 (December 31, 2017 - 500,000)
|
126,136
|
|
|
49,780
|
|
||
Common shares (note 10)
|
|
|
|
|
|
||
Authorized - unlimited number with no par value
|
|
|
|
|
|
||
Issued and outstanding: 55,518,800 (December 31, 2017 - 55,060,650)
|
879,405
|
|
|
876,108
|
|
||
Additional paid-in capital
|
48,084
|
|
|
42,840
|
|
||
Deficit
|
(805,221
|
)
|
|
(738,070
|
)
|
||
Accumulated other comprehensive loss
|
(48,170
|
)
|
|
(48,185
|
)
|
||
Total stockholders' equity
|
200,234
|
|
|
182,473
|
|
||
Total liabilities and stockholders' equity
|
$
|
227,905
|
|
|
$
|
237,161
|
|
|
Year ended December 31,
|
|||||||
|
2018
|
|
2017
|
|
||||
|
|
|
|
|
||||
Revenue (note 11)
|
5,945
|
|
|
10,700
|
|
|
||
|
|
|
|
|
||||
Expenses
|
|
|
|
|
|
|
||
Research and development
|
57,934
|
|
|
62,676
|
|
|
||
General and administrative
|
16,002
|
|
|
16,129
|
|
|
||
Depreciation of property and equipment
|
2,181
|
|
|
2,027
|
|
|
||
Site consolidation (note 8)
|
4,797
|
|
|
—
|
|
|
||
Impairment of intangible assets (note 6)
|
14,811
|
|
|
40,798
|
|
|
||
Total expenses
|
95,725
|
|
|
121,630
|
|
|
||
|
|
|
|
|
||||
Loss from operations
|
(89,780
|
)
|
|
(110,930
|
)
|
|
||
|
|
|
|
|
||||
Other income (loss)
|
|
|
|
|
|
|
||
Interest income
|
3,047
|
|
|
1,538
|
|
|
||
Interest expense
|
(226
|
)
|
|
(261
|
)
|
|
||
Gain on investment (note 4)
|
24,884
|
|
|
—
|
|
|
||
Equity investment (loss) (note 4)
|
(5,562
|
)
|
|
—
|
|
|
||
Foreign exchange gains/(loss)
|
(1,003
|
)
|
|
2,301
|
|
|
||
Decrease (increase) in fair value of warrant liability (note 3)
|
—
|
|
|
(22
|
)
|
|
||
Decrease (increase) in fair value of contingent consideration (note 3)
|
7,298
|
|
|
(1,359
|
)
|
|
||
Total other income
|
$
|
28,438
|
|
|
$
|
2,197
|
|
|
Loss before income taxes
|
(61,342
|
)
|
|
(108,733
|
)
|
|
||
Deferred income tax recovery (notes 13)
|
4,282
|
|
|
24,320
|
|
|
||
Net loss
|
$
|
(57,060
|
)
|
|
$
|
(84,413
|
)
|
|
|
|
|
|
|
||||
Items applicable to preferred shares
|
|
|
|
|
||||
Accrual of coupon on convertible preferred shares (note 10)
|
(10,091
|
)
|
|
(911
|
)
|
|
||
|
|
|
|
|
||||
Net loss attributable to common shares
|
$
|
(67,151
|
)
|
|
$
|
(85,324
|
)
|
|
Net loss attributable to common shareholders, per share
|
|
|
|
|
|
|
||
Basic
|
$
|
(1.21
|
)
|
|
$
|
(1.56
|
)
|
|
Diluted
|
$
|
(1.21
|
)
|
|
$
|
(1.56
|
)
|
|
Weighted average number of common shares
|
|
|
|
|
|
|
||
Basic
|
55,304,083
|
|
|
54,723,272
|
|
|
||
Diluted
|
55,304,083
|
|
|
54,723,272
|
|
|
||
Other Comprehensive loss
|
|
|
|
|
|
|
||
Cumulative translation adjustment
|
15
|
|
|
—
|
|
|
||
Comprehensive loss
|
$
|
(57,045
|
)
|
|
$
|
(84,413
|
)
|
|
|
Convertible Preferred Shares
|
Common Shares
|
|
|
|
|
|
|
|
|
|||||||||||||||||
|
Number of Shares
|
Amount
|
Number
of shares |
|
Amount
|
|
Additional paid-in
capital |
|
Deficit
|
|
Accum-
ulated other compre- hensive loss |
|
Total
stockholders' equity |
||||||||||||||
Balance at December 31, 2016
|
—
|
|
—
|
|
54,841,494
|
|
|
867,393
|
|
|
36,543
|
|
|
(652,746
|
)
|
|
(48,185
|
)
|
|
203,005
|
|
||||||
Issuance of Series A Preferred Shares, net of issuance cost
|
500,000
|
|
48,869
|
|
—
|
|
|
—
|
|
|
|
|
|
|
|
|
48,869
|
|
|||||||||
Accrual of coupon on Preferred Shares (note 10)
|
—
|
|
911
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(911
|
)
|
|
—
|
|
|
—
|
|
||||||
Stock-based compensation
|
—
|
|
—
|
|
—
|
|
|
7,972
|
|
|
6,886
|
|
|
—
|
|
|
—
|
|
|
14,858
|
|
||||||
Certain fair value adjustments to liability stock option awards (notes 3 and 12)
|
—
|
|
—
|
|
—
|
|
|
—
|
|
|
(540
|
)
|
|
—
|
|
|
—
|
|
|
(540
|
)
|
||||||
Issuance of common shares pursuant to exercise of options
|
—
|
|
—
|
|
40,156
|
|
|
262
|
|
|
(49
|
)
|
|
—
|
|
|
—
|
|
|
213
|
|
||||||
Issuance of common shares pursuant to exercise of warrants
|
—
|
|
—
|
|
179,000
|
|
|
481
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
481
|
|
||||||
Net loss
|
—
|
|
—
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(84,413
|
)
|
|
—
|
|
|
(84,413
|
)
|
||||||
Balance at December 31, 2017
|
500,000
|
|
$
|
49,780
|
|
55,060,650
|
|
|
876,108
|
|
|
42,840
|
|
|
(738,070
|
)
|
|
(48,185
|
)
|
|
182,473
|
|
|||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Issuance of Preferred Shares, net of issuance cost
|
664,000
|
|
66,265
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
66,265
|
|
||||||
Accrual of coupon on Preferred Shares (note 10)
|
—
|
|
10,091
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(10,091
|
)
|
|
—
|
|
|
—
|
|
||||||
Stock-based compensation
|
—
|
|
—
|
|
—
|
|
|
—
|
|
|
6,687
|
|
|
—
|
|
|
—
|
|
|
6,687
|
|
||||||
Certain fair value adjustments to liability stock option awards (notes 3 and 12)
|
—
|
|
—
|
|
—
|
|
|
—
|
|
|
472
|
|
|
—
|
|
|
—
|
|
|
472
|
|
||||||
Issuance of common shares pursuant to exercise of options
|
—
|
|
—
|
|
458,150
|
|
|
3,297
|
|
|
(1,915
|
)
|
|
—
|
|
|
—
|
|
|
1,382
|
|
||||||
Currency translation adjustment
|
—
|
|
—
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
15
|
|
|
15
|
|
||||||
Net loss
|
—
|
|
—
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(57,060
|
)
|
|
—
|
|
|
(57,060
|
)
|
||||||
Balance at December 31, 2018
|
1,164,000
|
|
$
|
126,136
|
|
55,518,800
|
|
|
$
|
879,405
|
|
|
$
|
48,084
|
|
|
$
|
(805,221
|
)
|
|
$
|
(48,170
|
)
|
|
$
|
200,234
|
|
|
Year ended December 31,
|
|||||||
|
2018
|
|
2017
|
|
||||
OPERATING ACTIVITIES
|
|
|
|
|
||||
Net loss for the period
|
$
|
(57,060
|
)
|
|
$
|
(84,413
|
)
|
|
Items not involving cash:
|
|
|
|
|
|
|
||
Deferred income tax benefit (notes 2 and 13)
|
(4,282
|
)
|
|
(24,320
|
)
|
|
||
Depreciation of property and equipment
|
2,181
|
|
|
2,027
|
|
|
||
Gain on sale of property and equipment
|
(26
|
)
|
|
(3
|
)
|
|
||
Stock-based compensation
|
6,241
|
|
|
15,117
|
|
|
||
Unrealized foreign exchange gains (losses)
|
1,003
|
|
|
(2,374
|
)
|
|
||
Change in fair value of warrant liability
|
—
|
|
|
22
|
|
|
||
Change in fair value of contingent consideration
|
(7,298
|
)
|
|
1,359
|
|
|
||
Impairment of intangible assets (note 6)
|
14,811
|
|
|
40,798
|
|
|
||
Site consolidation non-cash portion
|
396
|
|
|
—
|
|
|
||
Gain on equity investment
|
(24,884
|
)
|
|
—
|
|
|
||
Equity investment loss
|
5,327
|
|
|
—
|
|
|
||
Net change in non-cash operating items:
|
|
|
|
|
|
|
||
Accounts receivable
|
(1,029
|
)
|
|
(129
|
)
|
|
||
Accrued revenue
|
128
|
|
|
—
|
|
|
||
Investment tax credits receivable
|
(49
|
)
|
|
(47
|
)
|
|
||
Prepaid expenses and other assets
|
(648
|
)
|
|
(833
|
)
|
|
||
Accounts payable and accrued liabilities
|
(1,266
|
)
|
|
736
|
|
|
||
Deferred revenue
|
(2,742
|
)
|
|
2,727
|
|
|
||
Deferred rent and inducements
|
—
|
|
|
693
|
|
|
||
Site consolidation accrual
|
1,331
|
|
|
—
|
|
|
||
Net cash used in operating activities
|
(67,866
|
)
|
|
(48,640
|
)
|
|
||
|
|
|
|
|
||||
INVESTING ACTIVITIES
|
|
|
|
|
|
|
||
Disposition (acquisition) of investments
|
(3,014
|
)
|
|
35,086
|
|
|
||
Proceeds from sale of property and equipment
|
25
|
|
|
3
|
|
|
||
Acquisition of property and equipment
|
(1,138
|
)
|
|
(7,264
|
)
|
|
||
Net cash provided by (used in) investing activities
|
(4,127
|
)
|
|
27,825
|
|
|
||
|
|
|
|
|
||||
FINANCING ACTIVITIES
|
|
|
|
|
|
|
||
Promissory note repayment
|
(12,001
|
)
|
|
—
|
|
|
||
Proceeds from sale of Preferred Shares, net of issuance costs
|
66,265
|
|
|
48,869
|
|
|
||
Issuance of common shares pursuant to exercise of options
|
1,382
|
|
|
100
|
|
|
||
Issuance of common shares pursuant to exercise of warrants
|
—
|
|
|
353
|
|
|
||
Net cash provided by financing activities
|
55,646
|
|
|
49,322
|
|
|
||
|
|
|
|
|
||||
Effect of foreign currency rate changes on cash and cash equivalents
|
(1,003
|
)
|
|
2,372
|
|
|
||
|
|
|
|
|
||||
Increase in cash and cash equivalents
|
(17,350
|
)
|
|
30,879
|
|
|
||
Cash and cash equivalents, beginning of period
|
54,292
|
|
|
23,413
|
|
|
||
Cash and cash equivalents, end of period
|
$
|
36,942
|
|
|
$
|
54,292
|
|
|
Supplemental cash flow information
|
|
|
|
|
|
|
||
Preferred shares dividends accrued
|
$
|
10,091
|
|
|
$
|
—
|
|
|
Investment in Genevant (note 4)
|
$
|
27,377
|
|
|
$
|
—
|
|
|
Investment tax credits received
|
$
|
—
|
|
|
$
|
108
|
|
|
|
Useful life (years)
|
||||
Laboratory equipment
|
|
|
5
|
|
|
Computer and office equipment
|
2
|
|
to
|
|
5
|
Furniture and fixtures
|
|
|
5
|
|
|
|
For the year ended December 31
|
||||||||||||
|
2018
|
|
2017
|
||||||||||
Numerator:
|
Common Shares
|
Preferred Shares
|
|
Common Shares
|
Preferred Shares
|
||||||||
Allocation of distributable earnings
|
$
|
—
|
|
$
|
10,091
|
|
|
$
|
—
|
|
$
|
911
|
|
Allocation of undistributed earnings (loss)
|
(67,151
|
)
|
—
|
|
|
(85,324
|
)
|
—
|
|
||||
Allocation of earnings (loss) attributed to shareholders
|
$
|
(67,151
|
)
|
$
|
10,091
|
|
|
$
|
(85,324
|
)
|
$
|
911
|
|
Denominator:
|
|
|
|
|
|
|
|
|
|||||
Weighted average number of shares - basic and diluted
|
55,304,083
|
|
1,142,170
|
|
|
54,723,272
|
|
104,110
|
|
||||
Basic and diluted net loss attributable to shareholders per share
|
$
|
(1.21
|
)
|
$
|
8.83
|
|
|
$
|
(1.56
|
)
|
$
|
8.75
|
|
•
|
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.
|
|
Level 1
|
|
|
Level 2
|
|
|
Level 3
|
|
|
December 31, 2018
|
|
||
Assets
|
|
|
|
|
|
|
|
||||||
Cash and cash equivalents
|
$
|
36,942
|
|
|
—
|
|
|
—
|
|
|
$
|
36,942
|
|
Short-term investments
|
87,675
|
|
|
—
|
|
|
—
|
|
|
87,675
|
|
||
Restricted investment
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||
Total
|
$
|
124,617
|
|
|
—
|
|
|
—
|
|
|
$
|
124,617
|
|
Liabilities
|
|
|
|
|
|
|
|
|
|
|
|
||
Liability-classified stock option awards
|
—
|
|
|
—
|
|
|
479
|
|
|
479
|
|
||
Contingent consideration
|
—
|
|
|
—
|
|
|
3,126
|
|
|
3,126
|
|
||
Total
|
—
|
|
|
—
|
|
|
3,605
|
|
|
$
|
3,605
|
|
|
Level 1
|
|
|
Level 2
|
|
|
Level 3
|
|
|
December 31, 2017
|
|
|||
Assets
|
|
|
|
|
|
|
|
|
|
|
|
|||
Cash and cash equivalents
|
$
|
54,292
|
|
|
—
|
|
|
—
|
|
|
$
|
54,292
|
|
|
Guaranteed investment certificates
|
72,060
|
|
|
—
|
|
|
—
|
|
|
72,060
|
|
|||
Restricted investment
|
12,601
|
|
|
—
|
|
|
—
|
|
|
12,601
|
|
|||
Total
|
$
|
138,953
|
|
|
—
|
|
|
—
|
|
|
$
|
138,953
|
|
|
Liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
|
|
|
|||||
Liability-classified stock option awards
|
—
|
|
|
—
|
|
|
1,239
|
|
|
1,239
|
|
|||
Contingent consideration
|
—
|
|
|
—
|
|
|
10,424
|
|
|
10,424
|
|
|||
Total
|
—
|
|
|
—
|
|
|
$
|
11,663
|
|
|
$
|
11,663
|
|
|
Liability at beginning
of the period
|
|
Fair value of
warrants exercised
in the period
|
|
Increase (decrease) in fair
value of warrants
|
|
Foreign exchange
loss
|
|
Liability at end
of the period
|
||||||||||
Year ended December 31, 2017
|
$
|
107
|
|
|
$
|
(129
|
)
|
|
$
|
22
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Year ended December 31, 2018
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Liability at beginning of the period
|
|
Fair value of
liability-classified stock option awards exercised
in the period
|
|
Increase (decrease) in fair
value of liability
|
|
Liability at end
of the period
|
||||||||
Year ended December 31, 2017
|
$
|
553
|
|
|
$
|
(103
|
)
|
|
$
|
789
|
|
|
$
|
1,239
|
|
Year ended December 31, 2018
|
$
|
1,239
|
|
|
$
|
(93
|
)
|
|
$
|
(667
|
)
|
|
$
|
479
|
|
|
Contingent consideration at beginning
of the period
|
|
Increase in fair
value of contingent consideration
|
|
Contingent consideration at end
of the period
|
||||||
Year ended December 31, 2017
|
$
|
9,065
|
|
|
$
|
1,359
|
|
|
$
|
10,424
|
|
Year ended December 31, 2018
|
$
|
10,424
|
|
|
$
|
(7,298
|
)
|
|
$
|
3,126
|
|
|
Year ended December 31, 2018
|
||
Beginning balance
|
$
|
—
|
|
Initial investment in Genevant
|
27,377
|
|
|
Share of stock based compensation for Genevant employees who continue to vest in Arbutus stock options
|
159
|
|
|
Share of net loss (on a one-quarter lag basis)
|
(5,206
|
)
|
|
Dilution loss
|
(122
|
)
|
|
Share of comprehensive loss - currency translation adjustment
|
16
|
|
|
Ending balance
|
$
|
22,224
|
|
|
2018
|
||
Balance Sheet:
|
|
||
Current assets
|
$
|
32,027
|
|
Non-current assets
|
1,644
|
|
|
Total assets
|
33,671
|
|
|
|
|
||
Current liabilities
|
4,911
|
|
|
Non-current liabilities
|
253
|
|
|
Shareholders' equity
|
28,507
|
|
|
Total liabilities and shareholders' equity
|
$
|
33,671
|
|
|
2018
|
||
Results of Operations:
|
|
||
Revenue
|
$
|
—
|
|
Gross profit
|
—
|
|
|
Operating Loss
|
(12,421
|
)
|
|
Net Loss
|
$
|
(12,770
|
)
|
December 31, 2018
|
Cost
|
|
|
Accumulated
depreciation
|
|
|
Net
book value
|
|
|||
Lab equipment
|
$
|
5,420
|
|
|
$
|
(2,455
|
)
|
|
$
|
2,965
|
|
Leasehold improvements
|
9,308
|
|
|
(2,401
|
)
|
|
6,907
|
|
|||
Computer hardware and software
|
2,313
|
|
|
(2,040
|
)
|
|
273
|
|
|||
Furniture and fixtures
|
—
|
|
|
—
|
|
|
—
|
|
|||
|
$
|
17,041
|
|
|
$
|
(6,896
|
)
|
|
$
|
10,145
|
|
December 31, 2017
|
Cost
|
|
|
Accumulated
depreciation
|
|
|
Net
book value
|
|
|||
Lab equipment
|
$
|
9,567
|
|
|
$
|
(5,325
|
)
|
|
$
|
4,242
|
|
Leasehold improvements
|
12,578
|
|
|
(5,139
|
)
|
|
7,439
|
|
|||
Computer hardware and software
|
2,318
|
|
|
(1,878
|
)
|
|
440
|
|
|||
Furniture and fixtures
|
391
|
|
|
(329
|
)
|
|
62
|
|
|||
|
$
|
24,854
|
|
|
$
|
(12,671
|
)
|
|
$
|
12,183
|
|
Year ended December 31,
|
2018
|
|
2017
|
|
||
IPR&D – Immune Modulators
|
$
|
—
|
|
$
|
—
|
|
IPR&D – Antigen Inhibitors
|
—
|
|
14,811
|
|
||
IPR&D – cccDNA Sterilizers
|
43,836
|
|
43,836
|
|
||
Total IPR&D
|
$
|
43,836
|
|
$
|
58,647
|
|
|
December 31, 2018
|
|
December 31, 2017
|
||||
Trade accounts payable
|
$
|
3,192
|
|
|
$
|
1,987
|
|
Payroll accruals
|
2,341
|
|
|
2,893
|
|
||
Research and development accruals
|
2,716
|
|
|
4,937
|
|
||
Professional fee accruals
|
871
|
|
|
429
|
|
||
Deferred lease inducements
|
—
|
|
|
42
|
|
||
Other accrued liabilities
|
309
|
|
|
358
|
|
||
|
$
|
9,429
|
|
|
$
|
10,646
|
|
Description of expense
|
Twelve months ended December 31, 2018
|
||
Employee severance
|
$
|
2,851
|
|
Employee relocation
|
823
|
|
|
Lease and facility
|
1,123
|
|
|
Total site consolidation expense
|
4,797
|
|
|
Amounts paid and adjustments
|
(3,466
|
)
|
|
Accrued balance
|
$
|
1,331
|
|
|
Year ended December 31
|
|||||||
|
2018
|
|
2017
|
|
||||
Alexion (a)
|
$
|
—
|
|
|
$
|
7,956
|
|
|
Gritstone (b)
|
4,318
|
|
|
2,499
|
|
|
||
Other milestone and royalty payments (c)
|
1,627
|
|
|
245
|
|
|
||
Total revenue
|
$
|
5,945
|
|
|
$
|
10,700
|
|
|
|
Year ended December 31
|
||||||
|
2018
|
|
2017
|
||||
Gritstone (b)
|
$
|
—
|
|
|
$
|
2,727
|
|
Other
|
—
|
|
|
15
|
|
||
Total deferred revenue
|
$
|
—
|
|
|
$
|
2,742
|
|
|
Number of optioned
common shares
|
|
Weighted average exercise price
|
|
Aggregate intrinsic value
|
|||||
Balance, December 31, 2016
|
2,911,204
|
|
|
8.53
|
|
|
56
|
|
||
Options granted
|
2,026,500
|
|
|
3.20
|
|
|
|
|||
Options exercised
|
(11,105
|
)
|
|
3.45
|
|
|
13
|
|
||
Options forfeited, canceled or expired
|
(208,272
|
)
|
|
11.41
|
|
|
|
|
||
Balance, December 31, 2017
|
4,718,327
|
|
|
$
|
6.06
|
|
|
$
|
5,842
|
|
Options granted
|
2,557,669
|
|
|
$
|
5.87
|
|
|
|
||
Options exercised
|
(357,072
|
)
|
|
$
|
3.60
|
|
|
$
|
1,142
|
|
Options forfeited, canceled or expired
|
(587,836
|
)
|
|
$
|
6.71
|
|
|
|
||
Balance, December 31, 2018
|
6,331,088
|
|
|
$
|
6.05
|
|
|
$
|
1,170
|
|
|
|
Options outstanding December 31, 2018
|
|
Options exercisable December 31, 2018
|
||||||||||||||||||
Range of
Exercise prices (US$)
|
|
Number
of options
outstanding
|
|
|
Weighted
average
remaining
contractual
life (years)
|
|
|
Weighted
average
exercise
price (US$)
|
|
|
Number
of options
exercisable
|
|
|
|
Weighted
average
exercise
price (US$)
|
|
||||||
$1.54
|
|
to
|
|
$3.22
|
|
1,541,466
|
|
|
8.1
|
|
|
3.13
|
|
|
545,966
|
|
|
|
3.09
|
|
||
$3.23
|
|
to
|
|
$3.92
|
|
340,252
|
|
|
6.4
|
|
|
3.57
|
|
|
248,750
|
|
|
|
3.57
|
|
||
$3.93
|
|
to
|
|
$3.96
|
|
1,084,991
|
|
|
7.2
|
|
|
3.94
|
|
|
729,085
|
|
|
|
3.94
|
|
||
$3.97
|
|
to
|
|
$4.96
|
|
369,850
|
|
|
9.1
|
|
|
4.41
|
|
|
51,833
|
|
|
|
3.99
|
|
||
$4.97
|
|
to
|
|
$5.34
|
|
1,464,204
|
|
|
9.3
|
|
|
5.20
|
|
|
61,450
|
|
|
|
5.20
|
|
||
$5.35
|
|
to
|
|
$12.55
|
|
769,075
|
|
|
8.4
|
|
|
8.09
|
|
|
222,208
|
|
|
|
7.95
|
|
||
$12.56
|
|
to
|
|
$17.57
|
|
761,250
|
|
|
6.1
|
|
|
16.44
|
|
|
761,250
|
|
|
|
16.44
|
|
||
$1.54
|
|
to
|
|
$17.57
|
|
6,331,088
|
|
|
8.0
|
|
|
$
|
6.05
|
|
|
2,620,542
|
|
|
|
$
|
7.73
|
|
|
Number of optioned
common shares
|
|
Weighted average
fair value
|
|||
Non-vested at December 31, 2017
|
3,198,196
|
|
|
$
|
3.23
|
|
Options granted
|
2,557,669
|
|
|
4.08
|
|
|
Options vested
|
(1,584,733
|
)
|
|
4.36
|
|
|
Non-vested options forfeited
|
(460,586
|
)
|
|
2.82
|
|
|
Non-vested at December 31, 2018
|
3,710,546
|
|
|
$
|
3.39
|
|
|
December 31,
|
|
December 31,
|
||||
|
2018
|
|
2017
|
||||
Stock price
|
$
|
3.83
|
|
|
$
|
5.05
|
|
Dividend yield
|
—
|
%
|
|
—
|
%
|
||
Expected volatility
|
75.20
|
%
|
|
70.31
|
%
|
||
Risk-free interest rate
|
2.48
|
%
|
|
2.10
|
%
|
||
Expected average term (years)
|
2.2
|
|
|
4.3
|
|
||
Weighted average fair value per share of options outstanding
|
$
|
1.27
|
|
|
$
|
2.75
|
|
Fair value of vested liability-classified options (in thousands)
|
$
|
479
|
|
|
$
|
1,239
|
|
|
Number of optioned
common shares
|
|
Weighted average exercise price
|
|
Aggregate intrinsic value
(in thousands)
|
|||||
Balance, December 31, 2017
|
451,500
|
|
|
$
|
5.78
|
|
|
$
|
525
|
|
Options exercised
|
(30,000
|
)
|
|
1.73
|
|
|
71
|
|
||
Options forfeited, canceled, or expired
|
(44,000
|
)
|
|
3.63
|
|
|
—
|
|
||
Balance, December 31, 2018
|
377,500
|
|
|
$
|
5.81
|
|
|
$
|
224
|
|
|
|
Options outstanding December 31, 2018
|
|
Options exercisable December 31, 2018
|
||||||||||||||||
Range of
Exercise prices (US$)
|
|
Number
of options
outstanding
|
|
|
Weighted
average
remaining
contractual
life (years)
|
|
Weighted
average
exercise
price
|
|
|
Number
of options
exercisable
|
|
|
Weighted
average
exercise
price
|
|
||||||
$1.25
|
|
to
|
|
$2.29
|
|
80,000
|
|
|
2.8
|
|
$
|
1.50
|
|
|
80,000
|
|
|
$
|
1.50
|
|
$2.60
|
|
to
|
|
$3.30
|
|
35,000
|
|
|
1.9
|
|
2.82
|
|
|
35,000
|
|
|
2.82
|
|
||
$3.31
|
|
to
|
|
$5.23
|
|
40,000
|
|
|
3.8
|
|
3.78
|
|
|
40,000
|
|
|
3.78
|
|
||
$5.24
|
|
to
|
|
$7.93
|
|
150,000
|
|
|
4.8
|
|
6.69
|
|
|
150,000
|
|
|
6.69
|
|
||
$7.94
|
|
to
|
|
$10.60
|
|
17,500
|
|
|
2.6
|
|
9.18
|
|
|
17,500
|
|
|
9.18
|
|
||
$10.61
|
|
to
|
|
$12.03
|
|
55,000
|
|
|
5.1
|
|
12.03
|
|
|
55,000
|
|
|
12.03
|
|
||
$1.25
|
|
to
|
|
$12.03
|
|
377,500
|
|
|
3.9
|
|
$
|
5.82
|
|
|
377,500
|
|
|
$
|
5.82
|
|
|
Number of Protiva
Options
|
|
|
Equivalent number
of Company
common shares
|
|
|
Weighted
average exercise
price (C$)
|
|
|
Weighted
average exercise
price (US$)
|
|
||
Balance, December 31, 2016
|
46,000
|
|
|
31,058
|
|
|
0.30
|
|
|
0.22
|
|
||
Options exercised
|
(6,000
|
)
|
|
(4,051
|
)
|
|
0.30
|
|
|
0.23
|
|
||
Options forfeited, canceled or expired
|
—
|
|
|
—
|
|
|
—
|
|
|
N/A
|
|
||
Balance, December 31, 2017
|
40,000
|
|
|
27,007
|
|
|
0.30
|
|
|
0.24
|
|
||
Options exercised
|
(40,000
|
)
|
|
(27,007
|
)
|
|
0.30
|
|
|
0.24
|
|
||
Options forfeited, canceled or expired
|
—
|
|
|
—
|
|
|
—
|
|
|
N/A
|
|
||
Balance, December 31, 2018
|
—
|
|
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Number of OnCore
Options
|
|
|
Equivalent number
of Company
common shares
|
|
|
Weighted
average exercise
price (US$)
|
|
|
Balance, December 31, 2017
|
183,040
|
|
|
184,332
|
|
|
$
|
0.57
|
|
Options exercised
|
(43,750
|
)
|
|
(44,059
|
)
|
|
0.58
|
|
|
Options forfeited, canceled or expired
|
—
|
|
|
—
|
|
|
N/A
|
|
|
Balance, December 31, 2018
|
139,290
|
|
|
140,273
|
|
|
$
|
0.56
|
|
|
Number of
OnCore Options
|
|
|
Equivalent number
of Company
common shares
|
|
|
Weighted
average
fair value (US$)
|
|
|
Non-vested at December 31, 2017
|
32,128
|
|
|
32,354
|
|
|
$
|
17.83
|
|
Options vested
|
(32,128
|
)
|
|
(32,354
|
)
|
|
17.83
|
|
|
Non-vested options forfeited
|
—
|
|
|
—
|
|
|
N/A
|
|
|
Non-vested at December 31, 2018
|
—
|
|
|
—
|
|
|
$
|
17.83
|
|
|
Year ended December 31
|
||||||
|
2018
|
|
|
2017
|
|
||
Research, development, collaborations and contracts expenses
|
$
|
2,670
|
|
|
$
|
9,236
|
|
General and administrative expenses
|
3,337
|
|
|
5,881
|
|
||
Total
|
$
|
6,007
|
|
|
$
|
15,117
|
|
|
Year ended December 31,
|
||||||
|
2018
|
|
|
2017
|
|
||
Computed taxes (recoveries) at Canadian federal and provincial tax rates
|
$
|
(19,287
|
)
|
|
$
|
(28,270
|
)
|
Difference due to change in tax rate on opening deferred taxes
|
—
|
|
|
(6,633
|
)
|
||
Permanent and other differences
|
396
|
|
|
1,476
|
|
||
Change in valuation allowance - other
|
13,062
|
|
|
6,945
|
|
||
Difference due to income taxed at foreign rates
|
(138
|
)
|
|
(966
|
)
|
||
Stock-based compensation
|
1,685
|
|
|
3,128
|
|
||
Impairment of goodwill
|
—
|
|
|
—
|
|
||
Deferred income tax recovery
|
$
|
(4,282
|
)
|
|
$
|
(24,320
|
)
|
|
As at December 31,
|
||||||
|
2018
|
|
|
2017
|
|
||
Deferred tax assets (liabilities):
|
|
|
|
||||
Non-capital loss carryforwards
|
$
|
51,575
|
|
|
$
|
36,652
|
|
Research and development deductions
|
15,803
|
|
|
16,603
|
|
||
Book amortization in excess of tax
|
(608
|
)
|
|
(650
|
)
|
||
Share issue costs
|
307
|
|
|
456
|
|
||
Revenue recognized for tax purposes in excess of revenue recognized for accounting purposes
|
—
|
|
|
1,162
|
|
||
Tax value in excess of accounting value in lease inducements
|
147
|
|
|
173
|
|
||
Federal investment tax credits
|
9,686
|
|
|
9,079
|
|
||
Provincial investment tax credits
|
3,955
|
|
|
4,819
|
|
||
In-process research and development
|
(12,664
|
)
|
|
(16,943
|
)
|
||
Upfront license fees
|
283
|
|
|
311
|
|
||
Equity accounted for investment
|
37
|
|
|
—
|
|
||
Other
|
2,503
|
|
|
2,017
|
|
||
Total deferred tax assets (liabilities)
|
71,024
|
|
|
53,679
|
|
||
Valuation allowance
|
(83,685
|
)
|
|
(70,622
|
)
|
||
Net deferred tax assets (liabilities)
|
$
|
(12,661
|
)
|
|
$
|
(16,943
|
)
|
Year ended December 31, 2019
|
$
|
746
|
|
Year ended December 31, 2020
|
766
|
|
|
Year ended December 31, 2021
|
787
|
|
|
Year ended December 31, 2022 and after
|
3,813
|
|
|
|
$
|
6,112
|
|
|
December 31, 2018
|
|
December 31, 2017
|
||||
Cash, cash equivalents and short-term investments
|
$
|
124,617
|
|
|
$
|
126,352
|
|
Less: Accounts payable and accrued liabilities
|
(9,429
|
)
|
|
(10,646
|
)
|
||
|
$
|
115,188
|
|
|
$
|
115,706
|
|
|
December 31, 2018
|
December 31, 2017
|
||||
Cash and cash equivalents and short-term investments
|
$
|
1,427
|
|
$
|
25,921
|
|
Accounts receivable
|
293
|
|
375
|
|
||
Accrued revenue
|
—
|
|
—
|
|
||
Accounts payable and accrued liabilities
|
—
|
|
(1,273
|
)
|
||
|
$
|
1,720
|
|
$
|
25,023
|
|
|
2018
|
||||||||||||||||||
|
Q1
|
|
|
Q2
|
|
|
Q3
|
|
|
Q4
|
|
|
Total
|
|
|||||
Revenue
|
$
|
1,436
|
|
|
$
|
1,244
|
|
|
$
|
1,587
|
|
|
$
|
1,678
|
|
|
$
|
5,945
|
|
Loss from operations
|
(18,405
|
)
|
|
(22,046
|
)
|
|
(32,426
|
)
|
|
(16,903
|
)
|
|
(89,780
|
)
|
|||||
Net loss
|
$
|
(17,429
|
)
|
|
$
|
3,091
|
|
|
$
|
(24,473
|
)
|
|
$
|
(18,249
|
)
|
|
$
|
(57,060
|
)
|
Net loss attributable to common shares
|
(19,765
|
)
|
|
550
|
|
|
(27,040
|
)
|
|
(20,896
|
)
|
|
(67,151
|
)
|
|||||
Basic net income/(loss) per common share
|
$
|
(0.36
|
)
|
|
$
|
0.01
|
|
|
$
|
(0.49
|
)
|
|
$
|
(0.38
|
)
|
|
$
|
(1.21
|
)
|
Diluted net income/(loss) per common share
|
$
|
(0.36
|
)
|
|
$
|
0.01
|
|
|
$
|
(0.49
|
)
|
|
$
|
(0.38
|
)
|
|
$
|
(1.21
|
)
|
|
2017
|
||||||||||||||||||
|
Q1
|
|
|
Q2
|
|
|
Q3
|
|
|
Q4
|
|
|
Total
|
|
|||||
Revenue
|
$
|
235
|
|
|
$
|
1,039
|
|
|
$
|
6,892
|
|
|
$
|
2,534
|
|
|
$
|
10,700
|
|
Loss from operations
|
(18,299
|
)
|
|
(19,485
|
)
|
|
(12,897
|
)
|
|
(60,249
|
)
|
|
(110,930
|
)
|
|||||
Net loss
|
$
|
(18,627
|
)
|
|
$
|
(18,255
|
)
|
|
$
|
(11,600
|
)
|
|
$
|
(35,931
|
)
|
|
$
|
(84,413
|
)
|
Net loss attributable to common shares
|
$
|
(18,627
|
)
|
|
$
|
(18,255
|
)
|
|
$
|
(11,600
|
)
|
|
$
|
(36,842
|
)
|
|
$
|
(85,324
|
)
|
Basic and diluted net loss per common share
|
$
|
(0.34
|
)
|
|
$
|
(0.33
|
)
|
|
$
|
(0.21
|
)
|
|
$
|
(0.67
|
)
|
|
$
|
(1.56
|
)
|
Exhibit
Number |
|
Description
|
|
|
|
|
||
|
|
|
3.1*
|
|
|
|
|
|
3.2*
|
|
|
|
|
|
|
||
|
|
|
10.1†*
|
|
|
|
|
|
10.2†*
|
|
|
|
|
|
|
||
|
|
|
10.4†*
|
|
|
|
|
|
10.5†*
|
|
|
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
10.9**#
|
|
|
|
|
|
10.10†*
|
|
|
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
10.14*
|
|
|
|
|
|
10.15†*
|
|
|
|
|
|
|
||
|
|
|
10.17*
|
|
|
|
|
|
10.18*
|
|
|
|
|
|
10.19*
|
|
|
|
|
|
10.20*
|
|
|
|
|
|
10.21*
|
|
|
|
|
|
|
||
|
|
|
10.23*
|
|
|
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
10.27*#
|
|
|
|
|
|
10.28†*
|
|
|
|
|
|
10.29†*
|
|
|
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
10.35*
†
|
|
|
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
|
|
|
|
|
10.40*
|
|
|
|
|
|
10.41*
|
|
|
|
|
|
10.42*
|
|
|
|
|
|
10.43*#
|
|
|
|
|
|
10.44*#
|
|
|
|
|
|
10.45*#
|
|
|
|
|
|
10.46**
|
|
|
|
|
|
10.47*
|
|
|
|
|
|
10.50*
|
|
|
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
23.1**
|
|
|
|
|
|
|
||
|
|
|
31.2**
|
|
|
|
|
|
32.1**
|
|
|
|
|
|
32.2**
|
|
|
|
|
|
101.INS**
|
|
XBRL Instance Document
|
101.SCH**
|
|
XBRL Taxonomy Extension Schema Document
|
101.CAL**
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
101.DEF**
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
101.LAB**
|
|
XBRL Taxonomy Extension Label Linkbase Document
|
101.PRE**
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
|
*
|
Previously filed
|
**
|
Filed herewith
|
†
|
Confidential treatment granted as to portions of this exhibit.
|
#
|
Management Contract
|
Item 16.
|
Form 10-K Summary
|
|
ARBUTUS BIOPHARMA CORPORATION
|
|
|
|
|
|
By:
|
/s/ Mark Murray
|
|
|
Mark Murray
|
|
|
President and Chief Executive Officer
|
Signatures
|
|
Capacity in Which Signed
|
|
|
|
|
|
|
/s/ Frank Torti, M.D.
|
|
Director (Chairman)
|
Dr. Frank Torti, M.D.
|
|
|
|
|
|
/s/ Mark Murray
|
|
President and Chief Executive Officer and Director
|
Mark Murray
|
|
(Principal Executive Officer)
|
|
|
|
/s/ David C. Hastings
|
|
Chief Financial Officer
|
David C. Hastings
|
|
(Principal Financial Officer)
|
|
|
|
/s/ Koert VandenEnden
|
|
Chief Accounting Officer
|
Koert VandenEnden
|
|
(Principal Accounting Officer)
|
|
|
|
/s/ Daniel Burgess
|
|
Director
|
Daniel Burgess
|
|
|
|
|
|
/s/ Richard C. Henriques
|
|
Director
|
Richard C. Henriques
|
|
|
|
|
|
/s/ Keith Manchester
|
|
Director
|
Keith Manchester
|
|
|
|
|
|
/s/ Myrtle Potter
|
|
Director
|
Myrtle Potter
|
|
|
|
|
|
/s/ James Meyers
|
|
Director
|
James Meyers
|
|
|
1 Year Arbutus Biopharma Chart |
1 Month Arbutus Biopharma Chart |
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