Large accelerated filer o
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Accelerated filer x
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Non-accelerated filer o
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Smaller reporting company x
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Emerging growth company o
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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 curative combination regimen 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 curative combination regimen 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 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 benefits of the reversion of the Ontario Municipal Employees Retirement System (“OMERS”) royalty monetization transaction for our ONPATTRO™ (Patisiran) (“ONPATTRO”) royalty interest;
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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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our expectation for AB-729 for preliminary results from our single-dose Phase 1 trial to be available late in the first quarter of 2020;
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our expectation for AB-729 for preliminary results from multiple-dose Phase 1 trial to be available late in the second half of 2020;
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our expectation that AB-729 could be combined with our lead capsid inhibitor candidate, AB-836, and approved NAs, in our first combination therapy for HBV patients;
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the potential for an oral HBsAg-reducing agent and potential all-oral combination therapy;
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our objective to complete IND/CTA-enabling studies for AB-836 by the end of 2020;
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the potential for AB-836 to be low-dose with a wide therapeutic window and to address known capsid resistant variants T33N and 1105T;
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the potential for AB-836 to have increased potency and an enhanced resistance profile, compared to our previous capsid inhibitor candidate, AB-506;
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the potential for AB-836 to be once-daily dosing;
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our expectation to pursue development of a next generation oral HBV RNA-destabilizer;
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payments from the Gritstone Oncology, Inc. licensing agreement;
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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 mid-2021; and
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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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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 and HBsAg expression;
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developing compounds that target the host immune system; 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 Phase 3 clinical registration program;
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obtain regulatory approval for such a combination regimen; and
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commercialize such combination regimen.
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1.
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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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2.
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Capsid inhibitor (AB-836): this orally available product candidate has the potential to inhibit HBV replication by preventing the assembly of functional viral capsids. HBV core protein assembles into a capsid structure, which is required for viral replication. The current standard-of-care therapy for HBV, primarily NAs that work by inhibiting the viral polymerase, significantly reduce virus replication, but not completely. Capsid inhibitors inhibit replication by destabilizing core particle assembly or disassembly. Capsid inhibitors also have been shown to inhibit the uncoating step of the viral life cycle thus reducing the formation of new covalently closed circular DNA ("cccDNA"), the viral reservoir which resides in the cell nucleus.
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3.
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RNAi (AB-729): this subcutaneously-delivered RNAi therapeutic product candidate targeted to hepatocytes uses our novel covalently conjugated N-acetylgalactosamine (“GalNAc”) delivery technology. AB-729 inhibits viral replication and reduces all HBV antigens, including hepatitis B surface antigen (“HBsAg”) in preclinical models. Reducing HBsAg is thought to be a key prerequisite to enable reawakening of a patient’s immune system to respond to the virus.
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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
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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. Actions under the False Claims Act may be brought by the United States Attorney General or as a qui tam action by a private individual (a whistleblower) in the name of the government and the individual, and the whistleblower may share in any monetary recovery. 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 consulting fees, grants, free travel and other benefits to physicians to induce them to prescribe the company’s products; and inflating prices reported to private price publication services, which are used to set drug payment rates under government healthcare programs. In addition, in recent years the government has pursued civil False Claims Act cases against a number of pharmaceutical companies for causing false claims to be submitted as a result of the marketing of their products for unapproved, and thus non-reimbursable, uses. Because of the threat of treble damages and mandatory penalties per false or fraudulent claim or statement, healthcare and pharmaceutical companies often resolve allegations without admissions of liability for significant and material amounts. Pharmaceutical and other healthcare companies also are subject to other federal false claim laws, including, among others, federal criminal healthcare fraud and false statement statutes that extend to non-government health benefit programs.
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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 the Centers for Medicare and Medicaid Services (“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 (starting in 2021) 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 United States regulators, with more frequent and aggressive investigations and enforcement proceedings by both the Department of Justice and the United States 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.
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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 regulatory 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 Acrotech;
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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 one or more 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 research and development initiatives;
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seek collaborators for one or more of our product candidates or one ore more of our research and development initiatives 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 one or more of our technologies, product candidates or research and development initiatives 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 product candidates 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 research, 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, for which we obtain regulatory approval;
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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 for which we obtain regulatory approval, 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 other regulatory authority outside the United States 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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controlled research and human clinical testing;
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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, among other things, manufacturing, pre-clinical and clinical data; and
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compliance with Good Manufacturing Practice regulations.
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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 candidate’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 approved labeling; and
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distribution and use restrictions imposed by the FDA or other regulatory authorities outside the United States 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 civil penalties, sometimes pursued through whistleblower or qui tam actions, against individuals or entities for, among other things, knowingly presenting, or causing to be presented claims for payment of government funds 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 knowingly obtain, use, or disclose individually identifiable health information maintained by a HIPAA-covered entity in a manner that is not authorized or permitted by HIPAA;
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numerous federal and state laws and regulations that address privacy and data security, including state data breach notifications laws, state health information and/or genetic privacy laws, and federal and state consumer protection laws (e.g., Section 5 of the Federal Trade Commission Act, or FTC Act), govern the collection, use, disclosure and protection of health-related and other personal information, many of which differ from each other in significant ways, thus
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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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•
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analogous state laws and laws and regulations outside the United States, 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 laws and laws outside the United States 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 laws and laws outside the United States 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; and state laws and local ordinances that require identification or licensing of sales representatives.
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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 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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•
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collaborative arrangements in our target markets with leading companies and research institutions.
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•
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safety and effectiveness of our products;
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•
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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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•
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timing and scope of regulatory approvals for these products;
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•
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availability and cost of manufacturing, marketing and sales capabilities;
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•
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price;
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•
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reimbursement coverage; and
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•
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patent position.
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•
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delay, defer or prevent a change in control;
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•
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entrench our management and/or the board of directors; or
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•
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impede a merger, consolidation, takeover or other business combination involving us that other shareholders may desire.
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•
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whether our product candidates can be advanced as expected;
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•
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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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•
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changes in laws or regulations applicable to our product candidates, including but not limited to clinical trial requirements for approvals;
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•
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unanticipated serious safety concerns related to the use of our product candidates;
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•
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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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•
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adverse regulatory decisions;
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•
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the introduction of new products or technologies offered by us or our competitors;
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•
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the inability to effectively manage our growth;
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•
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actual or anticipated variations in quarterly operating results;
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•
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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 United States equity capital markets and general political and economic conditions;
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•
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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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•
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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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•
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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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•
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other events or factors, many of which are beyond our control.
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•
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the timing, implementation and cost of our research, pre-clinical studies and clinical trials;
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•
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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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•
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the amount and timing of expenditures by practitioners and their patients;
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•
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introduction of new technologies;
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•
|
product liability litigation, class action and derivative action litigation, or other litigation;
|
•
|
the amount and timing of capital expenditures and other costs relating to the expansion of our operations;
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•
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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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•
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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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•
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failure to achieve desired drug discovery outcomes by us or our collaborators;
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•
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failure to obtain industry partner and other third party consents and approvals, when required;
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•
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stock market volatility and market valuations;
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•
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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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•
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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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•
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limited trading volume of our common shares;
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•
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announcements relating to our business or the businesses of our competitors; and
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•
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our ability or inability to raise additional funds.
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|
Year Ended December 31,
|
||||||
|
2019
|
|
2018
|
||||
|
(in thousands)
|
||||||
Total revenue
|
$
|
6,011
|
|
|
$
|
5,945
|
|
Impairment of intangible assets
|
43,836
|
|
|
14,811
|
|
||
Impairment of goodwill
|
22,471
|
|
|
—
|
|
||
Total other operating expenses
|
83,778
|
|
|
80,914
|
|
||
Loss from operations
|
(144,074
|
)
|
|
(89,780
|
)
|
||
Other income (loss)
|
(22,305
|
)
|
|
28,438
|
|
||
Loss before income taxes
|
(166,379
|
)
|
|
(61,342
|
)
|
||
Income tax benefit
|
12,656
|
|
|
4,282
|
|
||
Net loss
|
(153,723
|
)
|
|
(57,060
|
)
|
||
Dividend accretion of convertible preferred shares
|
(11,149
|
)
|
|
(10,091
|
)
|
||
Net loss attributable to common shares
|
$
|
(164,872
|
)
|
|
$
|
(67,151
|
)
|
|
Year ended December 31,
|
||||||||||||
|
2019
|
|
2018
|
||||||||||
|
(in thousands, except percentages)
|
||||||||||||
Revenue from collaborations and licenses
|
|
|
|
|
|
|
|
||||||
Acuitas Therapeutics, Inc.
|
$
|
1,931
|
|
|
32
|
%
|
|
$
|
1,009
|
|
|
17
|
%
|
Alnylam Pharmaceuticals, Inc.
|
—
|
|
|
—
|
%
|
|
197
|
|
|
3
|
%
|
||
Gritstone Oncology, Inc.
|
1,819
|
|
|
30
|
%
|
|
4,318
|
|
|
73
|
%
|
||
Acrotech Biopharma, LLC
|
605
|
|
|
10
|
%
|
|
158
|
|
|
3
|
%
|
||
Other milestone and royalty payments
|
—
|
|
|
—
|
%
|
|
263
|
|
|
4
|
%
|
||
Non-cash royalty revenue
|
|
|
|
|
|
|
|
||||||
Alnylam Pharmaceuticals, Inc.
|
1,656
|
|
|
28
|
%
|
|
—
|
|
|
—
|
%
|
||
Total revenue
|
$
|
6,011
|
|
|
100
|
%
|
|
$
|
5,945
|
|
|
100
|
%
|
|
Year ended December 31,
|
||||||||||||
|
2019
|
|
2018
|
||||||||||
|
(in thousands, except percentages)
|
||||||||||||
Research and development
|
$
|
57,601
|
|
|
38
|
%
|
|
$
|
57,934
|
|
|
61
|
%
|
General and administrative
|
17,727
|
|
|
12
|
%
|
|
16,002
|
|
|
17
|
%
|
||
Depreciation
|
2,028
|
|
|
1
|
%
|
|
2,181
|
|
|
2
|
%
|
||
Site consolidation
|
156
|
|
|
—
|
%
|
|
4,797
|
|
|
5
|
%
|
||
Impairment of intangible assets
|
43,836
|
|
|
29
|
%
|
|
14,811
|
|
|
15
|
%
|
||
Impairment of goodwill
|
22,471
|
|
|
15
|
%
|
|
—
|
|
|
—
|
%
|
||
Arbitration
|
6,266
|
|
|
4
|
%
|
|
—
|
|
|
—
|
%
|
||
Total operating expenses
|
$
|
150,085
|
|
|
100
|
%
|
|
$
|
95,725
|
|
|
100
|
%
|
|
Year ended December 31,
|
||||||||||||
|
2019
|
|
2018
|
||||||||||
|
(in thousands, except percentages)
|
||||||||||||
Interest income
|
$
|
2,111
|
|
|
(9
|
)%
|
|
$
|
3,047
|
|
|
11
|
%
|
Interest expense
|
(2,108
|
)
|
|
9
|
%
|
|
(226
|
)
|
|
(1
|
)%
|
||
Net equity investment (loss) gain
|
(22,522
|
)
|
|
101
|
%
|
|
19,322
|
|
|
68
|
%
|
||
Decrease in fair value of contingent consideration
|
$
|
173
|
|
|
(1
|
)%
|
|
$
|
7,298
|
|
|
26
|
%
|
Foreign exchange gains (losses)
|
41
|
|
|
—
|
%
|
|
(1,003
|
)
|
|
(4
|
)%
|
||
Total other income (loss)
|
$
|
(22,305
|
)
|
|
100
|
%
|
|
$
|
28,438
|
|
|
100
|
%
|
•
|
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 product candidates;
|
•
|
delays in the development of our product candidates due to pre-clinical and clinical findings;
|
•
|
our decisions to in-license or acquire additional products, product candidates 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,
|
||||||
|
2019
|
|
2018
|
||||
|
(in thousands)
|
||||||
Net loss for the period
|
$
|
(153,723
|
)
|
|
$
|
(57,060
|
)
|
Items not involving cash
|
84,942
|
|
|
(6,531
|
)
|
||
Net change in non-cash operating items
|
(2,225
|
)
|
|
(4,275
|
)
|
||
Net cash used in operating activities
|
$
|
(71,006
|
)
|
|
$
|
(67,866
|
)
|
Net cash provided by (used in) investing activities
|
28,338
|
|
|
(4,127
|
)
|
||
Net cash provided by financing activities
|
37,457
|
|
|
55,646
|
|
||
Effect of foreign exchange rate changes on cash and cash equivalents
|
68
|
|
|
(1,003
|
)
|
||
Decrease in cash and cash equivalents
|
$
|
(5,143
|
)
|
|
$
|
(17,350
|
)
|
Cash and cash equivalents, beginning of period
|
36,942
|
|
|
54,292
|
|
||
Cash and cash equivalents, end of period
|
$
|
31,799
|
|
|
$
|
36,942
|
|
|
Page
|
|
December 31, 2019
|
|
December 31, 2018
|
||||
Assets
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
31,799
|
|
|
$
|
36,942
|
|
Investments in marketable securities
|
59,035
|
|
|
87,675
|
|
||
Accounts receivable
|
1,204
|
|
|
1,431
|
|
||
Prepaid expenses and other assets
|
1,790
|
|
|
3,181
|
|
||
Total current assets
|
93,828
|
|
|
129,229
|
|
||
Investment in Genevant
|
—
|
|
|
22,224
|
|
||
Property and equipment, net of accumulated depreciation
|
8,676
|
|
|
10,145
|
|
||
Right of use asset
|
2,738
|
|
|
—
|
|
||
Intangible assets
|
—
|
|
|
43,836
|
|
||
Goodwill
|
—
|
|
|
22,471
|
|
||
Other non-current assets
|
293
|
|
|
—
|
|
||
Total assets
|
$
|
105,535
|
|
|
$
|
227,905
|
|
Liabilities and stockholders' equity
|
|
|
|
|
|||
Current liabilities:
|
|
|
|
|
|
||
Accounts payable and accrued liabilities
|
$
|
7,098
|
|
|
$
|
9,429
|
|
Site consolidation accrual
|
137
|
|
|
1,331
|
|
||
Liability-classified options
|
253
|
|
|
479
|
|
||
Lease liability, current
|
340
|
|
|
—
|
|
||
Total current liabilities
|
7,828
|
|
|
11,239
|
|
||
Liability related to sale of future royalties
|
18,992
|
|
|
—
|
|
||
Deferred rent and inducements, non-current
|
—
|
|
|
645
|
|
||
Contingent consideration
|
2,953
|
|
|
3,126
|
|
||
Lease liability, non-current
|
3,018
|
|
|
—
|
|
||
Deferred tax liability
|
—
|
|
|
12,661
|
|
||
Total liabilities
|
32,791
|
|
|
27,671
|
|
||
Stockholders’ equity
|
|
|
|
|
|
||
Preferred shares
|
|
|
|
||||
Authorized: unlimited number without par value
|
|
|
|
||||
Issued and outstanding: 1,164,000 (December 31, 2018: 1,164,000)
|
137,285
|
|
|
126,136
|
|
||
Common shares
|
|
|
|
|
|||
Authorized: unlimited number with no par value
|
|
|
|
|
|
||
Issued and outstanding: 64,780,314 (December 31, 2018: 55,518,800)
|
898,535
|
|
|
879,405
|
|
||
Additional paid-in capital
|
55,246
|
|
|
48,084
|
|
||
Deficit
|
(970,093
|
)
|
|
(805,221
|
)
|
||
Accumulated other comprehensive loss
|
(48,229
|
)
|
|
(48,170
|
)
|
||
Total stockholders' equity
|
72,744
|
|
|
200,234
|
|
||
Total liabilities and stockholders' equity
|
$
|
105,535
|
|
|
$
|
227,905
|
|
|
Year ended December 31,
|
||||||
|
2019
|
|
2018
|
||||
Revenue
|
|
|
|
||||
Revenue from collaborations and licenses
|
$
|
4,355
|
|
|
$
|
5,945
|
|
Non-cash royalty revenue
|
1,656
|
|
|
—
|
|
||
Total revenue
|
6,011
|
|
|
5,945
|
|
||
Operating expenses
|
|
|
|
|
|
||
Research and development
|
57,601
|
|
|
57,934
|
|
||
General and administrative
|
17,727
|
|
|
16,002
|
|
||
Depreciation
|
2,028
|
|
|
2,181
|
|
||
Site consolidation
|
156
|
|
|
4,797
|
|
||
Impairment of intangible assets
|
43,836
|
|
|
14,811
|
|
||
Impairment of goodwill
|
22,471
|
|
|
—
|
|
||
Arbitration
|
6,266
|
|
|
—
|
|
||
Total operating expenses
|
150,085
|
|
|
95,725
|
|
||
Loss from operations
|
(144,074
|
)
|
|
(89,780
|
)
|
||
Other income (loss)
|
|
|
|
|
|
||
Interest income
|
2,111
|
|
|
3,047
|
|
||
Interest expense
|
(2,108
|
)
|
|
(226
|
)
|
||
Net equity investment (loss) gain
|
(22,522
|
)
|
|
19,322
|
|
||
Decrease in fair value of contingent consideration
|
173
|
|
|
7,298
|
|
||
Foreign exchange gains (losses)
|
41
|
|
|
(1,003
|
)
|
||
Total other income (loss)
|
(22,305
|
)
|
|
28,438
|
|
||
Loss before income taxes
|
(166,379
|
)
|
|
(61,342
|
)
|
||
Income tax benefit
|
12,656
|
|
|
4,282
|
|
||
Net loss
|
$
|
(153,723
|
)
|
|
$
|
(57,060
|
)
|
Items applicable to preferred shares
|
|
|
|
||||
Dividend accretion of convertible preferred shares
|
(11,149
|
)
|
|
(10,091
|
)
|
||
Net loss attributable to common shares
|
$
|
(164,872
|
)
|
|
$
|
(67,151
|
)
|
Net loss per common share
|
|
|
|
|
|
||
Basic and diluted
|
$
|
(2.89
|
)
|
|
$
|
(1.21
|
)
|
Weighted average number of common shares
|
|
|
|
|
|
||
Basic and diluted
|
57,093,454
|
|
|
55,304,083
|
|
||
Comprehensive income
|
|
|
|
|
|
||
Currency translation adjustment
|
(59
|
)
|
|
15
|
|
||
Comprehensive loss
|
$
|
(153,782
|
)
|
|
$
|
(57,045
|
)
|
|
|
Convertible Preferred Shares
|
|
Common Shares
|
|
|
|
|
|
|
|
|
||||||||||||||||||
|
|
Number of shares
|
|
Share capital
|
|
Number of shares
|
|
Share capital
|
|
Additional paid-in capital
|
|
Deficit
|
|
Accumulated other comprehensive loss
|
|
Total stockholders' equity
|
||||||||||||||
Balance 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
|
|
||||||
Accretion of accumulated dividends on Preferred Shares
|
|
—
|
|
|
10,091
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(10,091
|
)
|
|
—
|
|
|
—
|
|
||||||
Stock-based compensation
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
6,687
|
|
|
—
|
|
|
—
|
|
|
6,687
|
|
||||||
Certain fair value adjustments to liability stock option awards
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
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
|
|
Accretion of accumulated dividends on Preferred Shares
|
|
—
|
|
|
11,149
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(11,149
|
)
|
|
—
|
|
|
—
|
|
||||||
Stock-based compensation
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
7,204
|
|
|
—
|
|
|
—
|
|
|
7,204
|
|
||||||
Certain fair value adjustments to liability stock option awards
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
180
|
|
|
—
|
|
|
—
|
|
|
180
|
|
||||||
Issuance of common shares pursuant to our Open Market Sales Agreement
|
|
—
|
|
|
—
|
|
|
9,138,232
|
|
|
18,601
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
18,601
|
|
||||||
Issuance of common shares pursuant to exercise of options
|
|
—
|
|
|
—
|
|
|
123,282
|
|
|
529
|
|
|
(222
|
)
|
|
—
|
|
|
—
|
|
|
307
|
|
||||||
Currency translation adjustment
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(59
|
)
|
|
(59
|
)
|
||||||
Net loss
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(153,723
|
)
|
|
—
|
|
|
(153,723
|
)
|
||||||
Balance at December 31, 2019
|
|
1,164,000
|
|
|
$
|
137,285
|
|
|
64,780,314
|
|
|
$
|
898,535
|
|
|
$
|
55,246
|
|
|
$
|
(970,093
|
)
|
|
$
|
(48,229
|
)
|
|
$
|
72,744
|
|
|
Year ended December 31,
|
||||||
|
2019
|
|
2018
|
||||
OPERATING ACTIVITIES
|
|
|
|
||||
Net loss for the period
|
$
|
(153,723
|
)
|
|
$
|
(57,060
|
)
|
Items not involving cash:
|
|
|
|
||||
Deferred income tax benefit
|
(12,661
|
)
|
|
(4,282
|
)
|
||
Depreciation
|
2,028
|
|
|
2,181
|
|
||
Loss (gain) on sale of property and equipment
|
20
|
|
|
(26
|
)
|
||
Stock-based compensation expense
|
6,799
|
|
|
6,241
|
|
||
Unrealized foreign exchange (gains) losses
|
(68
|
)
|
|
1,003
|
|
||
Change in fair value of contingent consideration
|
(173
|
)
|
|
(7,298
|
)
|
||
Impairment of intangible assets
|
43,836
|
|
|
14,811
|
|
||
Impairment of goodwill
|
22,471
|
|
|
—
|
|
||
Site consolidation non-cash portion
|
—
|
|
|
396
|
|
||
Net equity investment loss (gain)
|
22,522
|
|
|
(19,557
|
)
|
||
Non-cash royalty revenue
|
(1,656
|
)
|
|
—
|
|
||
Non-cash interest expense
|
2,099
|
|
|
—
|
|
||
Net accretion and amortization of investments in marketable securities
|
(275
|
)
|
|
—
|
|
||
Net change in non-cash operating items:
|
|
|
|
||||
Accounts receivable
|
227
|
|
|
(1,029
|
)
|
||
Accrued revenue
|
—
|
|
|
128
|
|
||
Investment tax credits receivable
|
—
|
|
|
(49
|
)
|
||
Prepaid expenses and other assets
|
1,606
|
|
|
(648
|
)
|
||
Accounts payable and accrued liabilities
|
(2,410
|
)
|
|
(1,266
|
)
|
||
Deferred revenue
|
—
|
|
|
(2,742
|
)
|
||
Site consolidation accrual
|
(983
|
)
|
|
1,331
|
|
||
Other liabilities
|
(665
|
)
|
|
—
|
|
||
Net cash used in operating activities
|
(71,006
|
)
|
|
(67,866
|
)
|
||
INVESTING ACTIVITIES
|
|
|
|
|
|
||
Acquisition of investments
|
(58,759
|
)
|
|
(121,580
|
)
|
||
Disposition of investments
|
87,675
|
|
|
118,566
|
|
||
Proceeds from sale of property and equipment
|
11
|
|
|
25
|
|
||
Acquisition of property and equipment
|
(589
|
)
|
|
(1,138
|
)
|
||
Net cash provided by (used in) investing activities
|
28,338
|
|
|
(4,127
|
)
|
||
FINANCING ACTIVITIES
|
|
|
|
|
|
||
Proceeds from the sale of future royalties
|
18,549
|
|
|
—
|
|
||
Promissory note repayment
|
—
|
|
|
(12,001
|
)
|
||
Proceeds from sale of Preferred Shares, net of issuance costs
|
—
|
|
|
66,265
|
|
||
Issuance of common shares pursuant to exercise of options
|
307
|
|
|
1,382
|
|
||
Issuance of common shares pursuant to Open Market Sales Agreement
|
18,601
|
|
|
—
|
|
||
Net cash provided by financing activities
|
37,457
|
|
|
55,646
|
|
||
Effect of foreign exchange rate changes on cash and cash equivalents
|
68
|
|
|
(1,003
|
)
|
||
Decrease in cash and cash equivalents
|
$
|
(5,143
|
)
|
|
$
|
(17,350
|
)
|
Cash and cash equivalents, beginning of period
|
$
|
36,942
|
|
|
$
|
54,292
|
|
Cash and cash equivalents, end of period
|
$
|
31,799
|
|
|
$
|
36,942
|
|
Supplemental cash flow information
|
|
|
|
|
|
||
Preferred shares dividends accrued
|
$
|
(11,149
|
)
|
|
$
|
(10,091
|
)
|
Initial investment in Genevant
|
$
|
—
|
|
|
$
|
27,377
|
|
Interest paid
|
$
|
—
|
|
|
$
|
104
|
|
•
|
AB-729, a subcutaneously-delivered RNA interference (“RNAi”) therapeutic product candidate currently in a Phase 1a/1b clinical trial with preliminary results anticipated in late March 2020;
|
•
|
AB-836, a next-generation capsid inhibitor product candidate currently advancing through IND-enabling studies; and
|
•
|
other compounds early in the development process, including back-up capsid inhibitors, next-generation oral HBV RNA destabilizers and compounds that inhibit PD-L1.
|
|
Useful Life (Years)
|
||
Laboratory equipment
|
|
5
|
|
Computer and office equipment
|
2
|
to
|
5
|
Furniture and fixtures
|
|
5
|
|
|
For the year ended December 31,
|
||||||
|
2019
|
|
2018
|
||||
|
(in thousands, except share and per share amounts)
|
||||||
Numerator:
|
|
|
|
||||
Allocation of distributable earnings
|
$
|
—
|
|
|
$
|
—
|
|
Allocation of undistributable loss
|
(164,872
|
)
|
|
(67,151
|
)
|
||
Allocation of net loss attributed to common shareholders
|
$
|
(164,872
|
)
|
|
$
|
(67,151
|
)
|
Denominator:
|
|
|
|
|
|||
Weighted average number of common shares - basic and diluted
|
57,093,454
|
|
|
55,304,083
|
|
||
Basic and diluted net loss attributable to common shareholders per share
|
$
|
(2.89
|
)
|
|
$
|
(1.21
|
)
|
•
|
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
|
|
Total
|
||||||||
As of December 31, 2019
|
(in thousands)
|
||||||||||||||
Assets
|
|
|
|
|
|
|
|
||||||||
Cash and cash equivalents
|
$
|
31,799
|
|
|
—
|
|
|
—
|
|
|
$
|
31,799
|
|
||
Investments in marketable securities
|
59,035
|
|
|
—
|
|
|
—
|
|
|
59,035
|
|
||||
Total
|
$
|
90,834
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
90,834
|
|
Liabilities
|
|
|
|
|
|
|
|
||||||||
Liability-classified options
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
253
|
|
|
$
|
253
|
|
Contingent consideration
|
—
|
|
|
—
|
|
|
2,953
|
|
|
2,953
|
|
||||
Total
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
3,206
|
|
|
$
|
3,206
|
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
||||||||
As of December 31, 2018
|
(in thousands)
|
||||||||||||||
Assets
|
|
|
|
|
|
|
|
||||||||
Cash and cash equivalents
|
$
|
36,942
|
|
|
—
|
|
|
—
|
|
|
$
|
36,942
|
|
||
Investments in marketable securities
|
87,675
|
|
|
—
|
|
|
—
|
|
|
87,675
|
|
||||
Total
|
$
|
124,617
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
124,617
|
|
Liabilities
|
|
|
|
|
|
|
|
||||||||
Liability-classified options
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
479
|
|
|
$
|
479
|
|
Contingent consideration
|
—
|
|
|
—
|
|
|
3,126
|
|
|
3,126
|
|
||||
Total
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
3,605
|
|
|
$
|
3,605
|
|
|
Liability at beginning of the period
|
|
Fair value of liability-classified options exercised in the period
|
|
Increase (decrease) in fair value of liability
|
|
Liability at end of the period
|
||||||||
|
(in thousands)
|
||||||||||||||
Year ended December 31, 2019
|
$
|
479
|
|
|
$
|
—
|
|
|
$
|
(226
|
)
|
|
$
|
253
|
|
Year ended December 31, 2018
|
$
|
1,239
|
|
|
$
|
(93
|
)
|
|
$
|
(667
|
)
|
|
$
|
479
|
|
|
Liability at beginning of the period
|
|
Increase (decrease) in fair value of liability
|
|
Liability at end of the period
|
||||||
|
(in thousands)
|
||||||||||
Year ended December 31, 2019
|
$
|
3,126
|
|
|
$
|
(173
|
)
|
|
$
|
2,953
|
|
Year ended December 31, 2018
|
$
|
10,424
|
|
|
$
|
(7,298
|
)
|
|
$
|
3,126
|
|
|
Amortized Cost
|
|
Gross Unrealized Gain(1)
|
|
Gross Unrealized Loss(1)
|
|
Fair Value
|
||||||||
As of December 31, 2019
|
(in thousands)
|
||||||||||||||
Cash equivalents
|
|
|
|
|
|
|
|
||||||||
Money market fund
|
$
|
4,106
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
4,106
|
|
US government agency bonds
|
1,511
|
|
|
—
|
|
|
—
|
|
|
1,511
|
|
||||
US treasury bills
|
1,499
|
|
|
—
|
|
|
—
|
|
|
1,499
|
|
||||
Total
|
$
|
7,116
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
7,116
|
|
Investments in marketable securities
|
|
|
|
|
|
|
|
||||||||
US government agency bonds
|
$
|
19,863
|
|
|
$
|
2
|
|
|
$
|
(1
|
)
|
|
$
|
19,864
|
|
US treasury bills
|
15,926
|
|
|
2
|
|
|
$
|
(1
|
)
|
|
15,927
|
|
|||
US government bonds
|
23,246
|
|
|
—
|
|
|
(2
|
)
|
|
23,244
|
|
||||
Total
|
$
|
59,035
|
|
|
$
|
4
|
|
|
$
|
(4
|
)
|
|
$
|
59,035
|
|
|
Amortized Cost
|
|
Gross Unrealized Gain(1)
|
|
Gross Unrealized Loss(1)
|
|
Fair Value
|
||||||||
As of December 31, 2018
|
(in thousands)
|
||||||||||||||
Cash equivalents
|
|
|
|
|
|
|
|
||||||||
Individual savings account
|
$
|
20,420
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
20,420
|
|
Total
|
$
|
20,420
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
20,420
|
|
Investments in marketable securities
|
|
|
|
|
|
|
|
||||||||
Canadian guaranteed investment certificates
|
$
|
71,483
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
71,483
|
|
USD term deposit
|
16,192
|
|
|
—
|
|
|
$
|
—
|
|
|
$
|
16,192
|
|
||
Total
|
$
|
87,675
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
87,675
|
|
6.
|
Leases
|
|
As of December 31, 2019
|
Weighted-average remaining lease term (years)
|
7.0
|
Weighted average discount rate
|
8.9%
|
|
2019
|
|
2018
|
||||
|
(in thousands)
|
||||||
Cash paid for amounts included in the measurement of lease liabilities
|
$
|
1,116
|
|
|
$
|
—
|
|
|
As of December 31, 2019
|
||
|
(in thousands)
|
||
2020
|
$
|
657
|
|
2021
|
677
|
|
|
2022
|
581
|
|
|
2023
|
598
|
|
|
2024
|
616
|
|
|
Thereafter
|
1,423
|
|
|
Total Lease Payments
|
$
|
4,552
|
|
Less: interest
|
(1,193
|
)
|
|
Present value of lease payments
|
$
|
3,359
|
|
|
Cost
|
|
Accumulated depreciation
|
|
Net book value
|
||||||
December 31, 2019
|
(in thousands)
|
||||||||||
Lab equipment
|
$
|
5,511
|
|
|
$
|
(3,316
|
)
|
|
$
|
2,195
|
|
Leasehold improvements
|
8,521
|
|
|
(2,152
|
)
|
|
6,369
|
|
|||
Computer hardware and software
|
286
|
|
|
(174
|
)
|
|
112
|
|
|||
|
$
|
14,318
|
|
|
$
|
(5,642
|
)
|
|
$
|
8,676
|
|
|
Cost
|
|
Accumulated depreciation
|
|
Net book value
|
||||||
December 31, 2018
|
(in thousands)
|
||||||||||
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
|
|
|||
|
$
|
17,041
|
|
|
$
|
(6,896
|
)
|
|
$
|
10,145
|
|
|
December 31, 2019
|
|
December 31, 2018
|
||||
|
(in thousands)
|
||||||
Trade accounts payable
|
$
|
2,398
|
|
|
$
|
3,192
|
|
Payroll accruals
|
2,314
|
|
|
2,341
|
|
||
Research and development accruals
|
1,433
|
|
|
2,716
|
|
||
Professional fee accruals
|
809
|
|
|
871
|
|
||
Other accrued liabilities
|
144
|
|
|
309
|
|
||
Total
|
$
|
7,098
|
|
|
$
|
9,429
|
|
|
For the Twelve Months Ended December 31, 2019
|
||
|
(in thousands)
|
||
Accrual Balance December 31, 2018
|
$
|
1,331
|
|
|
|
||
Employee severance and relocation expense
|
510
|
|
|
Lease and facility expense
|
(347
|
)
|
|
Total site consolidation expense
|
$
|
163
|
|
|
|
||
Amounts paid and adjustments
|
(1,357
|
)
|
|
Accrual Balance December 31, 2019
|
$
|
137
|
|
12.
|
Sale of future royalties
|
|
Twelve Months Ended December 31, 2019
|
||
|
(in thousands)
|
||
Net liability related to sale of future royalties - beginning balance
|
$
|
—
|
|
Initial recognition of liability
|
30,000
|
|
|
Debt discount and issuance costs
|
(11,451
|
)
|
|
Non-cash interest expense
|
2,099
|
|
|
Net debt discount and issuance costs
|
(9,352
|
)
|
|
Non-cash royalty revenue
|
(1,656
|
)
|
|
Net liability related to sale of future royalties - ending balance
|
$
|
18,992
|
|
|
Stock Options Outstanding
|
|
Vested Stock Options
|
|
Non-Vested Stock Options
|
|||||||||||
|
Number
|
|
Weighted-Average Exercise Price
|
|
Number
|
|
Number
|
|
Weighted-Average Grant-Date Fair Value
|
|||||||
Balance as of December 31, 2018
|
6,331,088
|
|
|
$
|
6.05
|
|
|
2,620,542
|
|
|
3,710,546
|
|
|
$
|
3.39
|
|
Options granted
|
3,018,000
|
|
|
$
|
3.41
|
|
|
—
|
|
|
3,018,000
|
|
|
$
|
2.43
|
|
Options exercised
|
(83,000
|
)
|
|
$
|
3.25
|
|
|
(83,000
|
)
|
|
—
|
|
|
$
|
—
|
|
Options forfeit, canceled or expired
|
(1,016,995
|
)
|
|
$
|
6.98
|
|
|
(477,848
|
)
|
|
(539,147
|
)
|
|
$
|
3.24
|
|
Options vested
|
—
|
|
|
$
|
—
|
|
|
2,234,955
|
|
|
(2,234,955
|
)
|
|
$
|
3.10
|
|
Balance as of December 31, 2019
|
8,249,093
|
|
|
$
|
5.00
|
|
|
4,294,649
|
|
|
3,954,444
|
|
|
$
|
2.86
|
|
|
December 31, 2019
|
|
December 31, 2018
|
||
Expected average option term
|
7.3 years
|
|
|
6.7 years
|
|
Expected volatility
|
75.9
|
%
|
|
75.2
|
%
|
Expected dividends
|
—
|
%
|
|
—
|
%
|
Risk-free interest rate
|
2.27
|
%
|
|
2.81
|
%
|
|
Stock Options Vested and Outstanding
|
|||||
|
Number
|
|
Weighted-Average Exercise Price
|
|||
Balance as of December 31, 2018
|
377,500
|
|
|
$
|
5.81
|
|
Options exercised
|
—
|
|
|
$
|
—
|
|
Options forfeit, canceled or expired
|
(150,000
|
)
|
|
$
|
7.01
|
|
Balance as of December 31, 2019
|
227,500
|
|
|
$
|
5.49
|
|
|
As of December 31, 2019
|
||
Options outstanding and expected to vest
|
|
||
Intrinsic value (in $000s)
|
$
|
96
|
|
Weighted-average term remaining
|
1.6 years
|
|
|
December 31, 2019
|
|
December 31, 2018
|
||||
Stock price
|
$
|
2.78
|
|
|
$
|
3.83
|
|
Expected average option term
|
1.6 years
|
|
|
2.2 years
|
|
||
Expected volatility
|
113.1
|
%
|
|
75.2
|
%
|
||
Expected dividends
|
—
|
%
|
|
—
|
%
|
||
Risk-free interest rate
|
1.59
|
%
|
|
2.48
|
%
|
||
Weighted-average fair value per share
|
$
|
1.11
|
|
|
$
|
1.27
|
|
Total fair value of vested liability-classified options (in $000s)
|
$
|
253
|
|
|
$
|
479
|
|
|
Stock Options Vested and Outstanding
|
||||||||
|
Number of OnCore Options
|
|
Number of Equivalent Company Common Shares
|
|
Weighted-Average Exercise Price
|
||||
Balance as of December 31, 2018
|
139,290
|
|
|
140,273
|
|
|
$
|
0.56
|
|
Options exercised
|
(40,000
|
)
|
|
(40,282
|
)
|
|
$
|
0.58
|
|
Options forfeit, canceled or expired
|
—
|
|
|
—
|
|
|
$
|
—
|
|
Balance as of December 31, 2019
|
99,290
|
|
|
99,991
|
|
|
$
|
0.56
|
|
|
As of December 31, 2019
|
||
Vested stock options
|
|
||
Intrinsic value (in $000s)
|
$
|
222,248
|
|
Weighted-average term remaining
|
4.9 years
|
|
|
Year Ended December 31
|
||||||
|
2019
|
|
2018
|
||||
|
(in thousands)
|
||||||
Research and development
|
$
|
2,971
|
|
|
$
|
2,670
|
|
General and administrative
|
3,828
|
|
|
3,337
|
|
||
Total
|
$
|
6,799
|
|
|
$
|
6,007
|
|
|
Year ended December 31,
|
||||||
|
2019
|
|
2018
|
||||
|
(in thousands)
|
||||||
Computed taxes (benefits) at Canadian federal and provincial tax rates
|
$
|
(44,922
|
)
|
|
$
|
(16,563
|
)
|
Difference between statutory rate and foreign rate
|
8,356
|
|
|
—
|
|
||
Adjustments to prior year
|
(525
|
)
|
|
—
|
|
||
Permanent and other differences
|
3,458
|
|
|
(2,328
|
)
|
||
Change in valuation allowance - other
|
19,078
|
|
|
13,062
|
|
||
Difference due to income taxed at foreign rates
|
(3,343
|
)
|
|
(138
|
)
|
||
Stock-based compensation
|
523
|
|
|
1,685
|
|
||
Impairment of goodwill
|
4,719
|
|
|
—
|
|
||
Deferred income tax benefit
|
$
|
(12,656
|
)
|
|
$
|
(4,282
|
)
|
|
As of December 31,
|
||||||
|
2019
|
|
2018
|
||||
|
(in thousands)
|
||||||
Deferred tax assets (liabilities):
|
|
|
|
||||
Non-capital loss carryforwards
|
$
|
59,956
|
|
|
$
|
51,575
|
|
Research and development deductions
|
16,349
|
|
|
15,803
|
|
||
Book amortization in excess of tax
|
(914
|
)
|
|
(608
|
)
|
||
Share issue costs
|
202
|
|
|
307
|
|
||
Revenue recognized for tax purposes in excess of revenue recognized for accounting purposes
|
5,128
|
|
|
—
|
|
||
Tax value in excess of accounting value in lease inducements
|
705
|
|
|
147
|
|
||
Federal investment tax credits
|
7,325
|
|
|
9,686
|
|
||
Provincial investment tax credits
|
4,535
|
|
|
3,955
|
|
||
In-process research and development
|
—
|
|
|
(12,664
|
)
|
||
Upfront license fees
|
236
|
|
|
283
|
|
||
Equity accounted for investment
|
3,038
|
|
|
37
|
|
||
Other
|
6,202
|
|
|
2,503
|
|
||
Total deferred tax assets (liabilities)
|
102,762
|
|
|
71,024
|
|
||
Valuation allowance
|
(102,762
|
)
|
|
(83,685
|
)
|
||
Net deferred tax assets (liabilities)
|
$
|
—
|
|
|
$
|
(12,661
|
)
|
|
Quarters Ended
|
||||||||||||||||||
|
March 31
|
|
June 30
|
|
September 301
|
|
December 31
|
|
Full Year
|
||||||||||
2019
|
(in thousands, except per share data)
|
||||||||||||||||||
Total revenue
|
$
|
679
|
|
|
$
|
653
|
|
|
$
|
3,061
|
|
|
$
|
1,618
|
|
|
$
|
6,011
|
|
Loss from operations
|
$
|
(19,071
|
)
|
|
$
|
(20,515
|
)
|
|
$
|
(91,401
|
)
|
|
$
|
(13,087
|
)
|
|
$
|
(144,074
|
)
|
Net loss
|
$
|
(23,251
|
)
|
|
$
|
(23,315
|
)
|
|
$
|
(82,503
|
)
|
|
$
|
(24,654
|
)
|
|
$
|
(153,723
|
)
|
Net loss attributable to common shares
|
$
|
(25,966
|
)
|
|
$
|
(26,077
|
)
|
|
$
|
(85,295
|
)
|
|
$
|
(27,534
|
)
|
|
$
|
(164,872
|
)
|
Basic and diluted net income/(loss) per common share
|
$
|
(0.47
|
)
|
|
$
|
(0.46
|
)
|
|
$
|
(1.50
|
)
|
|
$
|
(0.46
|
)
|
|
$
|
(2.89
|
)
|
1
|
In the third quarter of 2019, the Company recorded non-cash impairment charges of $43.8 million and $22.5 million, respectively, to reduce the carrying value of its IPR&D intangible assets and goodwill to zero. The Company also recognized a corresponding income tax benefit of $12.7 million related to the decrease in its deferred tax liability related to the IPR&D intangible assets. See note 8 for more information.
|
|
Quarters Ended
|
||||||||||||||||||
|
March 31
|
|
June 30
|
|
September 301
|
|
December 31
|
|
Full Year
|
||||||||||
2018
|
(in thousands, except per share data)
|
||||||||||||||||||
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 income/(loss) attributable to common shares
|
$
|
(19,765
|
)
|
|
$
|
550
|
|
|
$
|
(27,040
|
)
|
|
$
|
(20,896
|
)
|
|
$
|
(67,151
|
)
|
Basic and diluted net income/(loss) per common share
|
$
|
(0.36
|
)
|
|
$
|
0.01
|
|
|
$
|
(0.49
|
)
|
|
$
|
(0.38
|
)
|
|
$
|
(1.21
|
)
|
1
|
In the third quarter of 2018, the Company recorded a $14.8 million non-cash impairment charge to reduce the carrying value of its IPR&D intangible assets, as well as a corresponding income tax benefit of $4.3 million related to the decrease in the related deferred tax liability.
|
Exhibit
|
|
Description
|
|
|
|
2.1*
|
|
|
|
|
|
3.1*
|
|
|
|
|
|
3.2*
|
|
|
|
|
|
4.1*
|
|
|
|
|
|
4.2**
|
|
|
|
|
|
10.1†*
|
|
|
|
|
|
10.2†*
|
|
|
|
|
|
10.3†*
|
|
|
|
|
|
10.4**#
|
|
|
|
|
|
10.5†*
|
|
|
|
|
|
10.6†*
|
|
|
|
|
|
10.7†*
|
|
|
|
|
|
10.8†*
|
|
|
|
|
|
10.9*
|
|
|
|
|
|
10.10†*
|
|
|
|
|
|
10.11†*
|
|
|
|
|
|
10.12*
|
|
|
|
|
|
10.13*
|
|
|
|
|
|
10.14*
|
|
|
|
|
|
10.15*
|
|
|
|
|
|
10.16*
|
|
|
|
|
|
10.17*#
|
|
|
|
|
|
10.18†*
|
|
|
|
|
|
10.19*#
|
|
|
|
|
|
10.20*
|
|
|
|
|
|
10.21*
|
|
|
|
|
|
10.22*†
|
|
|
|
|
|
10.23*†
|
|
|
|
|
|
10.24*
|
|
|
|
|
|
10.25*
|
|
|
|
|
|
10.26*
|
|
|
|
|
|
10.27*
|
|
|
|
|
|
10.28*
|
|
|
|
|
|
10.29*
|
|
|
|
|
|
10.30*#
|
|
|
|
|
|
10.31*
|
|
|
|
|
|
10.32*
|
|
|
|
|
|
10.33*
|
|
|
|
|
|
10.34**
|
|
|
|
|
|
10.35*#
|
|
|
|
|
|
10.36*#
|
|
|
|
|
|
10.37*#
|
|
|
|
|
|
10.38*
|
|
|
|
|
|
10.39*#
|
|
|
|
|
|
10.40*
|
|
|
|
|
|
10.41*
|
|
|
|
|
|
10.42*
|
|
|
|
|
|
10.43*
|
|
|
|
|
|
10.44*
|
|
|
|
|
|
10.45*
|
|
|
|
|
|
10.46*
|
|
|
|
|
|
10.47*
|
|
|
|
|
|
16.1*
|
|
|
|
|
|
21.1**
|
|
|
|
|
|
23.1**
|
|
|
|
|
|
23.2**
|
|
|
|
|
|
31.1**
|
|
|
|
|
|
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
|
†
|
Portions of this exhibit have been omitted in compliance with Item 601 of Regulation S-K.
|
#
|
Management Contract
|
Item 16.
|
Form 10-K Summary
|
|
ARBUTUS BIOPHARMA CORPORATION
|
|
|
|
|
|
By:
|
/s/ William Collier
|
|
|
William Collier
|
|
|
President and Chief Executive Officer
|
Signatures
|
|
Capacity in Which Signed
|
|
|
|
/s/ Frank Torti, M.D.
|
|
Director (Chairman)
|
Dr. Frank Torti, M.D.
|
|
|
|
|
|
/s/ William Collier
|
|
President and Chief Executive Officer and Director
|
William Collier
|
|
(Principal Executive Officer)
|
|
|
|
/s/ David C. Hastings
|
|
Chief Financial Officer
|
David C. Hastings
|
|
(Principal Financial Officer)
|
|
|
|
/s/ Daniel Burgess
|
|
Director
|
Daniel Burgess
|
|
|
|
|
|
/s/ Richard C. Henriques
|
|
Director
|
Richard C. Henriques
|
|
|
|
|
|
/s/ Keith Manchester
|
|
Director
|
Keith Manchester
|
|
|
|
|
|
/s/ Eric Venker, M.D., PharmD
|
|
Director
|
Eric Venker, M.D., PharmD
|
|
|
|
|
|
/s/ James Meyers
|
|
Director
|
James Meyers
|
|
|
|
|
|
/s/ Andrew Cheng, M.D., Ph. D
|
|
Director
|
Andrew Cheng, M.D., Ph. D
|
|
|
•
|
thirty percent (30%) of our issued and outstanding common shares calculated on a partially diluted basis as of a particular date, Roivant has the right to nominate three (3) individuals for election to our Board of Directors at each shareholder meeting, one (1) of whom must satisfy the applicable independence standards;
|
•
|
twenty percent (20%) of our issued and outstanding common shares calculated on a partially diluted basis as of a particular date, Roivant has the right to nominate two (2) individuals for election to our Board of Directors at each shareholder meeting; and
|
•
|
ten percent (10%) of our issued and outstanding common shares calculated on a partially diluted basis as of a particular date, Roivant has the right to nominate one (1) individual for election to our Board of Directors at each shareholder meeting.
|
1)
|
Registration Statement (Form S-3 No. No. 333-235674) pertaining to the offering, issuance and sale of up to $150,000,000 of common shares, preferred shares, warrants, debt securities and units of Arbutus Biopharma Corporation,
|
2)
|
Registration Statement (Form S-8 No. 333-233192) pertaining to the Inducement Plan of Arbutus Biopharma Corporation,
|
3)
|
Registration Statement (Form S-8 No. 333-228919) pertaining to the 2011 Omnibus Share Compensation Plan,
|
4)
|
Registration Statement (Form S-8 No. 333-212115) pertaining to the 2016 Omnibus Share and Incentive Plan,
|
5)
|
Registration Statement (Form S-8 No. 333‑202762) pertaining to the OnCore Biopharma, Inc. 2014 Equity Incentive Plan, and
|
6)
|
Registration Statement (Form S-8 No. 333-186185) pertaining to the Tekmira 2011 Omnibus Share
|
1.
|
I have reviewed this Form 10-K;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
(a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
(b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
(c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
(d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an the annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
(a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
(b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
|
|
|
/s/ William Collier
|
|
Name:
|
|
William Collier
|
|
Title:
|
|
President and Chief Executive Officer
|
|
|
|
(Principal Executive Officer)
|
1.
|
I have reviewed this Form 10-K;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a.
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b.
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
c.
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d.
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
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5.
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The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
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a.
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All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
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b.
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Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting
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/s/ David Hastings
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Name:
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David Hastings
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Title:
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Chief Financial Officer
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1.
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The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
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2.
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of the operations of the Company.
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/s/ William Collier
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Name:
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|
William Collier
|
|
Title:
|
|
President and Chief Executive Officer
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|
|
|
(Principal Executive Officer)
|
1.
|
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
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2.
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of the operations of the Company.
|
|
|
|
/s/ David Hastings
|
|
Name:
|
|
David Hastings
|
|
Title:
|
|
Chief Financial Officer
|