Bermuda |
2834 |
98-1173944 | ||
(State or Other Jurisdiction of Incorporation or Organization) |
(Primary Standard Industrial Classification Code Number) |
(I.R.S. Employer Identification Number) |
Large accelerated filer | ☐ | Accelerated filer | ☐ | |||
☐ | Smaller reporting company | |||||
Emerging growth company |
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F-1 |
• | our limited operating history and risks involved in biopharmaceutical product development; |
• | our limited experience as a commercial-stage company and ability to successfully commercialize VTAMA ® (tapinarof); |
• | our ability to raise additional capital to fund our business on acceptable terms or at all; |
• | the fact that we will likely incur significant operating losses for the foreseeable future; |
• | the impact of public health outbreaks, epidemics or pandemics (such as the COVID-19 pandemic) on our business (including our clinical trials and preclinical studies), operations and financial condition and results; |
• | our ability to acquire, in-license or discover new product candidates; |
• | our Vant structure and the potential that we may fail to capitalize on certain development opportunities; |
• | clinical trials and preclinical studies, which are very expensive, time-consuming, difficult to design and implement and involve uncertain outcomes; |
• | the unproven nature of our approach to the discovery and development of product candidates from our small molecule discovery engine; |
• | the novelty, complexity and difficulty of manufacturing certain of our products and product candidates, including any manufacturing problems that result in delays in development or commercialization of our products and product candidates; |
• | difficulties we may face in enrolling and retaining patients in clinical trials and/or clinical development activities; |
• | the results of our clinical trials not supporting our proposed claims for a product candidate; |
• | changes in interim, top-line and/or preliminary data from our clinical trials changing as more data becoming available or being delayed due to audit and verification process; |
• | changes in product manufacturing or formulation that could lead to the incurrence of costs or delays; |
• | the failure of any third-party we contract with to conduct, supervise and monitor our clinical trials to perform in a satisfactory manner or to comply with applicable requirements; |
• | the fact that obtaining approvals for new drugs is a lengthy, extensive, expensive and unpredictable process that may end with our inability to obtain regulatory approval by the FDA or other regulatory agencies in other jurisdictions; |
• | the failure of our clinical trials to demonstrate substantial evidence of the safety and efficacy of our products and product candidates, including, but not limited to, scenarios in which our products and product candidates may cause adverse effects that could delay regulatory approval, discontinue clinical trials, limit the scope of approval or generally result in negative media coverage of us; |
• | our inability to obtain regulatory approval for a product or product candidate in certain jurisdictions, even if we are able to obtain approval in certain other jurisdictions; |
• | our ability to effectively manage growth and to attract and retain key personnel; |
• | any business, legal, regulatory, political, operational, financial and economic risks associated with conducting business globally; |
• | our ability to obtain and maintain patent and other intellectual property protection for our technology, products and product candidates; |
• | the inadequacy of patent terms and their scope to protect our competitive position; |
• | the failure to issue (or the threatening of their breadth or strength of protection) or provide meaningful exclusivity for our current and future products and product candidates of our patent applications that we hold or have in-licensed; |
• | the fact that we do not currently and may not in the future own or license any issued composition of matter patents covering certain of our products and product candidates and our inability to be certain that any of our other issued patents will provide adequate protection for such products and product candidates; |
• | the fact that our largest shareholders (and certain members of our management team) own a significant percentage of our stock and will be able to exert significant control over matters subject to shareholder approval; |
• | the outcome of any pending or potential litigation, including but not limited to our expectations regarding the outcome of any such litigation and costs and expenses associated with such litigation; |
• | changes in applicable laws or regulations; |
• | the possibility that we may be adversely affected by other economic, business and/or competitive factors; and |
• | other risks and uncertainties, including those described under the heading “Risk Factors.” |
• | commercially launched VTAMA ® (tapinarof) cream 1% for the treatment of plaque psoriasis in adults; |
• | conducted nine international Phase 3 trials, the last eight of which have been successful; |
• | consummated a $3 billion upfront partnership with Sumitomo Pharma Co., Ltd. (“Sumitomo”); |
• | received five FDA approvals for drugs developed by Vants launched by Roivant, including VTAMA and four drugs that received FDA approval after their transfer to Sumitomo; |
• | built a broad and differentiated pipeline of drugs and drug candidates ranging from early discovery to commercial stage; and |
• | launched Roivant Discovery, our small molecule discovery engine, consisting of a collection of advanced computational physics capabilities, integrated with an in-house wet lab facility. |
• | Our limited operating history and the inherent uncertainties and risks involved in biopharmaceutical product development may make it difficult for us to execute on our business model and for you to assess our future viability. |
• | We may never achieve or maintain profitability. |
• | We will require additional capital to fund our operations, and if we fail to obtain necessary financing, we may not be able to successfully market our products, acquire or in-license new products or product candidates, complete the development and commercialization of our products and product candidates and continue to pursue our drug discovery efforts. |
• | We have limited experience as a commercial company and the marketing and sale of VTAMA ® (tapinarof) or any future products may be unsuccessful or less successful than anticipated. |
• | We may not be successful in our efforts to acquire, in-license or discover new product candidates. |
• | We face risks associated with the allocation of capital and personnel across our businesses. |
• | We face risks associated with the Vant structure. |
• | The global pandemic resulting from the outbreak of the novel strain of coronavirus, SARS-CoV-2, COVID-19, could adversely impact our business, including the marketing of our products and our ongoing clinical trials and preclinical studies. |
• | Clinical trials and preclinical studies are very expensive, time-consuming, difficult to design and implement and involve uncertain outcomes. We may encounter substantial delays in clinical trials, or may not be able to conduct or complete clinical trials or preclinical studies on the expected timelines, if at all. |
• | Our approach to the discovery and development of product candidates from our small molecule discovery engine is unproven, which makes it difficult to predict the time, cost of development and likelihood of successfully developing any product candidates from these platforms. |
• | Certain of our product candidates are novel, complex and difficult to manufacture. |
• | Obtaining approval of a new drug is an extensive, lengthy, expensive and inherently uncertain process, and the FDA or another regulator may delay, limit or deny approval. |
• | Our clinical trials may fail to demonstrate substantial evidence of the safety and efficacy of product candidates that we may identify and pursue for their intended uses, which would prevent, delay or limit the scope of regulatory approval and commercialization. |
• | Our products and product candidates may cause adverse effects or have other properties that could delay or prevent their regulatory approval, cause us to suspend or discontinue clinical trials, abandon further development or limit the scope of any approved label or market acceptance. |
• | We depend on the knowledge and skills of our senior leaders and may not be able to manage our business effectively if we are unable to attract and retain key personnel. |
• | We will need to expand our organization and may experience difficulties in managing this growth, which could disrupt operations. |
• | If we are unable to obtain and maintain patent and other intellectual property protection for our technology, products and product candidates or if the scope of the intellectual property protection obtained is not sufficiently broad, we may not be able to compete effectively in our markets. |
• | If the patent applications we hold or have in-licensed with respect to our products or product candidates fail to issue, if their breadth or strength of protection is threatened, or if they fail to provide meaningful exclusivity for our current and future products or product candidates, it could dissuade companies from collaborating with us to develop product candidates, and threaten our ability to commercialize our products. |
• | Patent terms and their scope may be inadequate to protect our competitive position on current and future products and product candidates for an adequate amount of time. |
• | If our performance does not meet market expectations, the price of our securities may decline. |
• | We have incurred and will continue to incur increased costs as a result of operating as a public company and our management has devoted and will continue to devote a substantial amount of time to new compliance initiatives. |
• | Our failure to timely and effectively implement controls and procedures required by Section 404(a) of the Sarbanes-Oxley Act could have a material adverse effect on our business. |
• | Anti-takeover provisions in our memorandum of association, bye-laws and Bermuda law could delay or prevent a change in control, limit the price investors may be willing to pay in the future for our Common Shares and could entrench management. |
• | Our largest shareholders and certain members of our management own a significant percentage of our Common Shares and will be able to exert significant control over matters subject to shareholder approval. |
Issuer |
Roivant Sciences Ltd. |
Common Shares offered by the Company |
Up to 30,750,261 Common Shares, consisting of (i) 20,535,896 Common Shares issuable upon exercise of the Public Warrants and (ii) 10,214,365 Common Shares issuable upon the exercise of the Private Placement Warrants. |
Common Shares outstanding prior to exercise of all Warrants |
684,789,169 Common Shares (as of September 30, 2021) (including Common Shares underlying vested restricted share awards). |
Common Shares outstanding assuming exercise of all Warrants |
715,539,430 Common Shares (based on the number of Common Shares outstanding as of September 30, 2021) (including Common Shares underlying vested restricted share awards). |
Use of Proceeds |
We will receive up to an aggregate of approximately $353.6 million from the exercise of the Warrants, assuming the exercise in full of all of the Warrants for cash. We expect to use any such net proceeds from the exercise of the Warrants for general corporate purposes. See “Use of Proceeds.” |
Common Shares offered by the Holders |
Up to 595,134,445 Common Shares, consisting of (i) 22,000,000 Common Shares issued in the PIPE Financing, (ii) up to 10,214,365 Common Shares issuable upon exercise of the Private Placement Warrants and (iii) 562,920,080 issued and outstanding Common Shares held by certain Holders (including Common Shares underlying vested restricted share awards). |
Warrants offered by the Holders |
Up to 10,214,365 Private Placement Warrants. |
Redemption |
The Warrants are redeemable in certain circumstances. See the section entitled “Description of Securities—Warrants” for further discussion. |
Use of Proceeds |
We will not receive any proceeds from any sale of Common Shares by the Holders that has been or will be completed. See “Use of Proceeds.” |
Redemption |
The Warrants are redeemable in certain circumstances. See “Description of Securities—Redeemable Warrants” for further discussion. |
Market for Common Shares and Warrants |
The Common Shares and Public Warrants are currently traded on The Nasdaq Global Market under the symbols “ROIV” and “ROIVW,” respectively. |
Risk Factors |
See “Risk Factors” and other information included in this prospectus for a discussion of factors you should consider before investing in our securities. |
• | successfully commercialize VTAMA; |
• | identify new acquisition or in-licensing opportunities; |
• | successfully complete ongoing preclinical studies and clinical trials and obtain regulatory approvals for our current and future products and product candidates; |
• | successfully identify new product candidates through our small molecule discovery engine and advance those product candidates into preclinical studies and clinical trials; |
• | successfully market our healthcare technology products and services; |
• | raise additional funds when needed and on terms acceptable to us; |
• | attract and retain experienced management and advisory teams; |
• | add operational, financial and management information systems and personnel, including personnel to support clinical, preclinical manufacturing and commercialization efforts and operations; |
• | launch commercial sales of future product candidates, whether alone or in collaboration with others, including establishing sales, marketing and distribution systems; |
• | initiate and continue relationships with third-party suppliers and manufacturers and have commercial quantities of products and product candidates manufactured at acceptable cost and quality levels and in compliance with the U.S. Food and Drug Administration (the “FDA”) and other regulatory requirements; |
• | set acceptable prices for products and product candidates and obtain coverage and adequate reimbursement from third-party payors; |
• | achieve market acceptance of products and product candidates in the medical community and with third-party payors and consumers; and |
• | maintain, expand and protect our intellectual property portfolio. |
• | the time and costs necessary to complete our ongoing, planned and future clinical trials; |
• | the time and costs necessary to pursue regulatory approvals for our current and future product candidates; |
• | the costs associated with future acquisitions or in-licensing transactions; |
• | the progress, timing, scope and costs of our preclinical studies, clinical trials and other related activities, including the ability to enroll patients in a timely manner for our ongoing and planned clinical trials and potential future clinical trials; |
• | the costs associated with our ongoing, planned and future preclinical studies and other drug discovery activities; |
• | our ability to successfully identify and negotiate acceptable terms for third-party supply and contract manufacturing agreements with contract manufacturing organizations (“CMOs”); |
• | the costs of obtaining adequate clinical and commercial supplies of raw materials and drug products for our products and product candidates; |
• | our ability to successfully commercialize VTAMA, including: |
• | the manufacturing, selling and marketing costs associated with VTAMA, including the cost and timing of expanding sales and marketing capabilities or entering into strategic collaborations with third parties; and |
• | the amount and timing of sales and other revenues from VTAMA, including the sales price and the availability of adequate third-party reimbursement. |
• | the cost of filing, prosecuting, defending and enforcing our patent claims and other intellectual property rights, including current and future patent infringement actions brought against third parties; |
• | the cost of defending potential intellectual property disputes, including patent infringement actions brought by third parties against us or any of our current or future products or product candidates; and |
• | our ability to hire, attract and retain qualified personnel. |
• | our ability to recruit and retain effective sales, marketing and customer service personnel; |
• | our ability to obtain access to physicians or persuade adequate numbers of physicians to prescribe VTAMA and any future products; |
• | the inability to manufacture and to price VTAMA and any future products at a price point sufficient to ensure an adequate and attractive level of profitability; |
• | the extent to which coverage and adequate reimbursement for these products will be available from government health administration authorities, private health insurers and other organizations; |
• | the risks associated with potential co-promotion or partnership agreements, including the failure to realize the expected benefits of such arrangements; and |
• | other unforeseen costs, expenses and risks associated with the commercialization of biopharmaceutical products, including compliance costs. |
• | our ability to sell and market our current and future products and, if approved, product candidates, including as a result of government- or employer-imposed remote work orders and travel and workplace visitor restrictions; |
• | a decrease in patient health care utilization due to quarantines, travel restrictions, work from home orders or other public health measures; |
• | delays or disruptions in our commercial supply chain including as a result of quarantines, travel restrictions, work from home orders or other public health measures; |
• | delays or difficulties in enrolling patients in our clinical trials, and the consequences of such delays or difficulties, including terminating clinical trials prematurely; |
• | delays or difficulties in clinical site initiation, including difficulties in recruiting clinical site investigators and clinical site staff; |
• | delays or disruptions in nonclinical experiments due to unforeseen circumstances at contract research organizations (“CROs”), and vendors along their supply chain; |
• | increased rates of patients withdrawing from our clinical trials following enrollment as a result of contracting COVID-19, being forced to quarantine or not accepting home health visits; |
• | diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical trials; |
• | interruption of key clinical trial activities, such as clinical trial site data monitoring, due to limitations on travel imposed or recommended by federal or state governments, employers and others or interruption of clinical trial subject visits and study procedures (particularly any procedures that may be deemed non-essential), which may impact the integrity of subject data and clinical study endpoints; |
• | interruption or delays in the operations of the FDA and comparable non-U.S. regulatory agencies, which may impact review and approval timelines; |
• | interruption of, or delays in receiving, supplies of our product candidates from our contract manufacturing organizations due to staffing shortages, production slowdowns or stoppages and disruptions in delivery systems; |
• | limitations on employee resources that would otherwise be focused on the conduct of our clinical trials and preclinical studies, including because of sickness of employees or their families, the desire of employees to avoid contact with large groups of people and increased reliance on working from home or mass transit disruptions; |
• | other disruptions to our business generally, including remote working activities and the implementation of new health and safety requirements for our employees; and |
• | waiver or suspension of patent or other intellectual property rights. |
• | increased operating expenses and cash requirements; |
• | the assumption of indebtedness or contingent liabilities; |
• | the issuance of our or our subsidiaries’ equity securities which would result in dilution to existing shareholders; |
• | assimilation of operations, intellectual property and products, including difficulties associated with integrating new personnel; |
• | diversion of management time and focus away from operating our business; |
• | the loss of key personnel and uncertainties in our ability to maintain key business relationships; |
• | risks and uncertainties associated with the counterparty to any such transaction; |
• | our inability to eventually generate revenue from acquired technology or products or product candidates sufficient to meet our objectives in undertaking the acquisition or even to offset the associated acquisition and maintenance costs; |
• | litigation or other claims, including claims from terminated employees, customers, former shareholders or other third parties. |
• | conducting research and development activities in new therapeutic areas or treatment approaches in which we have little to no experience; |
• | diversion of financial and managerial resources from existing operations; |
• | actual or potential conflicts among new and existing Vants to the extent they have overlapping or competing areas of focus or pipeline products; |
• | successfully negotiating a proposed acquisition, in-license or investment in a timely manner and at a price or on terms and conditions favorable to us; |
• | successfully combining and integrating a potential acquisition into our existing business to fully realize the benefits of such acquisition; |
• | the impact of regulatory reviews on a proposed acquisition, in-license or investment; and |
• | the outcome of any legal proceedings that may be instituted with respect to the proposed acquisition, in-license or investment. |
• | failure to obtain regulatory authorization to commence a clinical trial or reaching consensus with regulatory authorities regarding the design or implementation of our studies; |
• | other regulatory issues, including the receipt of any inspectional observations on FDA’s Form-483, Warning or Untitled Letters, clinical holds, or complete response letters or similar communications/objections by other regulatory authorities; |
• | unforeseen safety issues, or subjects experiencing severe or unexpected adverse events; |
• | occurrence of serious adverse events in trials of the same class of agents conducted by other sponsors; |
• | lack of effectiveness during clinical trials; |
• | resolving any dosing issues, including those raised by the FDA or other regulatory authorities; |
• | inability to reach agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; |
• | slower than expected rates of patient recruitment or failure to recruit suitable patients to participate in a trial; |
• | failure to add a sufficient number of clinical trial sites; |
• | unanticipated impact from changes in or modifications to protocols or clinical trial design, including those that may be required by the FDA or other regulatory authorities; |
• | inability or unwillingness of clinical investigators or study participants to follow our clinical and other applicable protocols or applicable regulatory requirements; |
• | an IRB or EC refusing to approve, suspending, or terminating the trial at an investigational site, precluding enrollment of additional subjects, or withdrawing their approval of the trial; |
• | premature discontinuation of study participants from clinical trials or missing data; |
• | failure to manufacture or release sufficient quantities of our product candidates or failure to obtain sufficient quantities of active comparator medications for our clinical trials, if applicable, that in each case meet our quality standards, for use in clinical trials; |
• | inability to monitor patients adequately during or after treatment; or |
• | inappropriate unblinding of trial results. |
• | inability to meet our product specifications and quality requirements consistently; |
• | delay or inability to procure or expand sufficient manufacturing capacity; |
• | manufacturing and product quality issues related to scale-up of manufacturing; |
• | costs and validation of new equipment and facilities required for scale-up; |
• | failure to comply with applicable laws, regulations and standards, including cGMP and similar standards; |
• | deficient or improper record-keeping; |
• | inability to negotiate manufacturing agreements with third parties under commercially reasonable terms; |
• | termination or nonrenewal of manufacturing agreements with third parties in a manner or at a time that is costly or damaging to us; |
• | reliance on a limited number of sources, and in some cases, single sources for product components, such that if we are unable to secure a sufficient supply of these product components, we will be unable to manufacture and sell our products or product candidates in a timely fashion, in sufficient quantities or under acceptable terms; |
• | lack of qualified backup suppliers for those components that are currently purchased from a sole or single source supplier; |
• | operations of our third-party manufacturers or suppliers could be disrupted by conditions unrelated to our business or operations, including the bankruptcy of the manufacturer or supplier or other regulatory sanctions related to the manufacturer of another company’s product candidates; |
• | carrier disruptions or increased costs that are beyond our control; and |
• | failure to deliver our products or product candidates under specified storage conditions and in a timely manner. |
• | we may not be able to demonstrate that a product candidate is safe and effective as a treatment for the targeted indications, and in the case of our product candidates regulated as biological products, that the product candidate is safe, pure and potent for use in its targeted indication, to the satisfaction of the FDA or other relevant regulatory authorities; |
• | the FDA or other relevant regulatory authorities may require additional pre-approval studies or clinical trials, which would increase costs and prolong development timelines; |
• | the results of clinical trials may not meet the level of statistical or clinical significance required by the FDA or other relevant regulatory authorities for marketing approval; |
• | the FDA or other relevant regulatory authorities may disagree with the number, design, size, conduct or implementation of clinical trials, including the design of proposed preclinical and early clinical trials of any future product candidates; |
• | the CROs that we retain to conduct clinical trials may take actions outside of our control, or otherwise commit errors or breaches of protocols, that adversely impact the clinical trials and ability to obtain marketing approvals; |
• | the FDA or other relevant regulatory authorities may not find the data from nonclinical, preclinical studies or clinical trials sufficient to demonstrate that the clinical and other benefits of a product candidate outweigh its safety risks; |
• | the FDA or other relevant regulatory authorities may disagree with an interpretation of data or significance of results from nonclinical, preclinical studies or clinical trials or may require additional studies; |
• | the FDA or other relevant regulatory authorities may not accept data generated at clinical trial sites; |
• | if an NDA, BLA or a similar application is reviewed by an advisory committee, the FDA or other relevant regulatory authority, as the case may be, may have difficulties scheduling an advisory committee meeting in a timely manner or the advisory committee may recommend against approval of our application or may recommend that the FDA or other relevant regulatory authorities, as the case may be, require, as a condition of approval, additional nonclinical, preclinical studies or clinical trials, limitations on approved labeling or distribution and use restrictions; |
• | the FDA or other relevant regulatory authorities may require development of a risk evaluation and mitigation strategy (“REMS”) or its equivalent, as a condition of approval; |
• | the FDA or other relevant regulatory authorities may require additional post-marketing studies and/or patient registries for product candidates; |
• | the FDA or other relevant regulatory authorities may find the chemistry, manufacturing and controls data insufficient to support the quality of our product candidates; |
• | the FDA or other relevant regulatory authorities may identify deficiencies in the manufacturing processes or facilities of third-party manufacturers; or |
• | the FDA or other relevant regulatory authorities may change their approval policies or adopt new regulations. |
• | regulatory authorities may withdraw, suspend, vary, or limit their approval of the product or require a REMS (or equivalent outside the United States) to impose restrictions on its distribution or other risk management measures; |
• | regulatory authorities may require that we recall a product; |
• | additional restrictions being imposed on the distribution, marketing or manufacturing processes of the products or any components thereof, including a “black box” warning or contraindication on product labels or communications containing warnings or other safety information about the product; |
• | regulatory authorities may require the addition of labeling statements, such as warnings or contraindications, require other labeling changes of a product or require field alerts or other communications to physicians, pharmacies or the public; |
• | we may be required to change the way a product is administered or distributed, conduct additional clinical trials, change the labeling of a product or conduct additional post-marketing studies or surveillance; |
• | we may be required to repeat preclinical studies or clinical trials or terminate programs for a product candidate, even if other studies or trials related to the program are ongoing or have been successfully completed; |
• | we may be sued and held liable for harm caused to patients, or may be subject to fines, restitution or disgorgement of profits or revenues; |
• | physicians may stop prescribing a product; |
• | reimbursement may not be available for a product; |
• | we may elect to discontinue the sale of our products; |
• | our products may become less competitive; and |
• | our reputation may suffer. |
• | restrictions on the manufacture of such products or product candidates; |
• | restrictions on the labeling or marketing of such products or product candidates, including a “black box” warning or contraindication on the product label or communications containing warnings or other safety information about the product; |
• | restrictions on product distribution or use; |
• | requirements to conduct post-marketing studies or clinical trials, or any regulatory holds on our clinical trials; |
• | requirement of a REMS (or equivalent outside the United States); |
• | Warning or Untitled Letters or similar communications from other relevant regulatory authorities; |
• | withdrawal of the product or product candidates from the market; |
• | refusal to approve pending applications or supplements to approved applications that we submit; |
• | recall of products or product candidates; |
• | fines, restitution or disgorgement of profits or revenues; |
• | suspension, variation or withdrawal of marketing approvals; |
• | refusal to permit the import or export of our products or product candidates; |
• | seizure of our products or product candidates; or |
• | lawsuits, injunctions or the imposition of civil or criminal penalties. |
• | monitoring and assuring regulatory compliance for clinical trials, manufacturing and testing of good applicable practice (“GxP”) (e.g., GCP, GLP and GMP regulated) products; |
• | monitoring and providing oversight of all GxP suppliers (e.g., contract development manufacturing organizations and CROs); |
• | establishing and maintaining an integrated, robust quality management system for clinical, manufacturing, supply chain and distribution operations; and |
• | cultivating a proactive, preventative quality culture and employee and supplier training to ensure quality. |
• | the efficacy and safety of such products and product candidates as demonstrated in pivotal clinical trials and published in peer-reviewed journals; |
• | the potential and perceived advantages compared to alternative treatments, including any similar generic treatments; |
• | the ability to offer these products for sale at competitive prices; |
• | the ability to offer appropriate patient financial assistance programs, such as commercial insurance co-pay assistance; |
• | convenience and ease of dosing and administration compared to alternative treatments; |
• | the clinical indications for which the product or product candidate is approved by FDA or comparable non-U.S. regulatory agencies; |
• | product labeling or product insert requirements of the FDA or other comparable non-U.S. regulatory authorities, including any limitations, contraindications or warnings contained in a product’s approved labeling; |
• | restrictions on how the product is dispensed or distributed; |
• | the timing of market introduction of competitive products; |
• | publicity concerning these products or competing products and treatments; |
• | the strength of marketing and distribution support; |
• | favorable third-party coverage and sufficient reimbursement; and |
• | the prevalence and severity of any side effects or adverse events. |
• | the inability to recruit and retain adequate numbers of effective sales, marketing, reimbursement, customer service, medical affairs, and other support personnel; |
• | the inability of sales personnel to obtain access to physicians or persuade adequate numbers of physicians to prescribe any future approved products; |
• | the inability of reimbursement professionals to negotiate arrangements for formulary access, reimbursement, and other acceptance by payors; |
• | the inability to price products at a sufficient price point to ensure an adequate and attractive level of profitability; |
• | restricted or closed distribution channels that make it difficult to distribute our products to segments of the patient population; |
• | the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; and |
• | unforeseen costs and expenses associated with creating an independent commercialization organization. |
• | the federal Anti-Kickback Statute, which is a criminal law that prohibits, among other things, persons and entities from 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, either the referral of an individual for, or the purchase, lease, order or recommendation of, any good, facility, item or service, for which payment may be made, in whole or in part, under a federal healthcare program (such as Medicare and Medicaid). The term “remuneration” has been broadly interpreted by the federal government to include anything of value. Although there are a number of statutory exceptions and regulatory safe harbors protecting certain activities from prosecution, the exceptions and safe harbors are drawn narrowly, and arrangements may be subject to scrutiny or penalty if they do not fully satisfy all elements of an available exception or safe harbor. Practices that involve remuneration that may be alleged to be intended to induce prescribing, purchases or recommendations may be subject to scrutiny if they do not qualify for an exception or safe harbor. A person or entity does not need to have actual knowledge of the federal Anti-Kickback Statute or specific intent to violate it to have committed a violation; in addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act. Violations of the federal Anti-Kickback Statute may result in civil monetary penalties up to $100,000 for each violation. Civil penalties for such conduct can further be assessed |
under the federal False Claims Act. Violations can also result in criminal penalties, including criminal fines and imprisonment of up to 10 years. Similarly, violations can result in exclusion from participation in government healthcare programs, including Medicare and Medicaid; |
• | the federal false claims laws, including the False Claims Act, which imposes civil penalties, including through civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent; knowingly making, using or causing to be made or used, a false record or statement material to a false or fraudulent claim; or knowingly making or causing to be made, a false statement to avoid, decrease or conceal an obligation to pay money to the federal government. When an entity is determined to have violated the federal civil False Claims Act, the government may impose civil fines and penalties currently ranging from $11,803 to $23,607 for each false claim or statement for penalties assessed after December 13, 2021, plus treble damages, and exclude the entity from participation in Medicare, Medicaid and other federal healthcare programs; |
• | the federal health care fraud statute (established by Health Insurance Portability and Accountability Act of 1996 (“HIPAA”)), which imposes criminal and civil liability for, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or making false or fraudulent statements relating to healthcare matters; similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation; |
• | the Administrative Simplification provisions of HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”), and their implementing regulations, which impose obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security, and transmission of individually identifiable health information on health plans, health care clearing houses and most healthcare providers (collectively, “covered entities”), and such covered entities’ “business associates,” defined as independent contractors or agents of covered entities that create, receive or obtain protected health information in connection with providing a service for or on behalf of the covered entity; |
• | various privacy, cybersecurity and data protection laws, rules and regulations at the international, federal, state and local level impose obligations with respect to safeguarding the privacy, security, and cross-border transmission of personal data and health information; |
• | the federal Civil Monetary Penalties Law, which authorizes the imposition of substantial civil monetary penalties against an entity that engages in activities including, among others (1) knowingly presenting, or causing to be presented, a claim for services not provided as claimed or that is otherwise false or fraudulent in any way; (2) arranging for or contracting with an individual or entity that is excluded from participation in federal health care programs to provide items or services reimbursable by a federal health care program; (3) violations of the federal Anti-Kickback Statute; or (4) failing to report and return a known overpayment; |
• | the federal Physician Payments Sunshine Act, which requires certain 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 government information related to payments or other “transfers of value” made to physicians, certain other healthcare providers, and teaching hospitals, and requires applicable manufacturers and group purchasing organizations to report annually to the government ownership and investment interests held by the physicians described above and their immediate family members and payments or other “transfers of value” to such physician owners (covered manufacturers are required to submit reports to the government by the 90th day of each calendar year); and |
• | analogous state and EU and foreign national laws and regulations, such as state anti-kickback and false claims laws, which may apply to our business practices, including but not limited to, research, |
distribution, sales, and marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers, or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state 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, and state laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and several recently passed state laws that require disclosures related to state agencies and/or commercial purchasers with respect to certain price increases that exceed a certain level as identified in the relevant statutes, some of which contain ambiguous requirements that government officials have not yet clarified; and EU and foreign national laws prohibiting promotion of prescription-only medicinal products to individuals other than healthcare professionals, governing strictly all aspects of interactions with healthcare professionals and healthcare organizations, including prior notification, review and/or approval of agreements with healthcare professionals, and requiring public disclosure of transfers of value made to a broad range of stakeholders, including healthcare professionals, healthcare organizations, medical students, physicians associations, patient organizations and editors of specialized press. |
• | the demand for our products and, if approved, product candidates; |
• | our ability to receive or set a price that we believe is fair for our products; |
• | our ability to generate revenue and achieve or maintain profitability; |
• | the amount of taxes that we are required to pay; and |
• | the availability of capital. |
• | multiple conflicting and changing laws and regulations such as tax laws, export and import restrictions, employment laws, anti-bribery and anti-corruption laws, regulatory requirements and other governmental approvals, permits and licenses; |
• | failure by us or our collaborators to obtain appropriate licenses or regulatory approvals for the sale or use of our products or, if approved, product candidates, in various countries; |
• | difficulties in managing operations in different jurisdictions; |
• | complexities associated with managing multiple payor-reimbursement regimes or self-pay systems; |
• | financial risks, such as longer payment cycles, difficulty enforcing contracts and collecting accounts receivable and exposure to currency exchange rate fluctuations; |
• | varying protection for intellectual property rights; |
• | natural disasters, political and economic instability, including wars, terrorism and political unrest, outbreak of disease, boycotts, curtailment of trade and other business restrictions; and |
• | failure to comply with the United States Foreign Corrupt Practices Act (the “FCPA”), including its books and records provisions and its anti-bribery provisions, the United Kingdom Bribery Act 2010 (the “U.K. Bribery Act”), and similar anti-bribery and anti-corruption laws in other jurisdictions, for example by failing to maintain accurate information and control over sales or distributors’ activities. |
• | Roflumilast, a PDE4 inhibitor, a potential competitor to VTAMA, which in May 2022 was approved by the FDA for the treatment of plaque psoriasis in adults in the U.S. under the brand name VTAMA cream and which is also in development by Dermavant for the topical treatment of atopic dermatitis; |
• | Ruxolitinib, a topical Janus kinase inhibitor, a potential competitor to VTAMA, in development by Dermavant for the topical treatment of atopic dermatitis; |
• | Teprotumumab, an insulin-like growth factor-1 receptor inhibitor, which in January 2020 was approved by the FDA for the treatment of TED, a potential competitor to batoclimab, in development by Immunovant for the treatment of TED and other autoimmune diseases; |
• | VYVGART ™ (efgartigimod alfa-fcab), a neonatal Fc receptor blocker, which in December 2021 was approved by the FDA for the treatment of MG in adults who test positive for the anti-acetylcholine receptor antibody, a potential competitor to batoclimab, in development by Immunovant for the treatment of MG and other autoimmune diseases; |
• | Efgartigimod, an anti-FcRn antibody fragment, nipocalimab, an anti-FcRn antibody, Zilucoplan, a peptide inhibitor of C5, and inebilizumab, a CD19-targeted humanized monoclonal antibody, all potential competitors to batoclimab, in development by Immunovant for the treatment of MG and other autoimmune diseases; |
• | Ultomiris (Ravulizumab-cwvz), a complement inhibitor, which in April 2022 was approved by the FDA for the treatment of generalized MG in adults who are anti-acetylcholine receptor antibody-positive, a potential competitor to batoclimab, in development by Immunovant for the treatment of MG and other autoimmune diseases; |
• | Rituximab, a monoclonal antibody, a potential competitor to batoclimab, in development by Immunovant for the treatment of TED, WAIHA and other autoimmune diseases; |
• | Fostamatinib, a syk inhibitor, ibrutinib, a BTK inhibitor, and ANX005, an antibody inhibitor, all potential competitors to batoclimab, in development by Immunovant for the treatment of WAIHA and other autoimmune diseases; and |
• | delays in or an inability to commercialize VTAMA, and any future products for which we obtain marketing approval; |
• | impairment of our business reputation and significant negative media attention; |
• | delay or termination of clinical trials, or withdrawal of participants from our clinical trials; |
• | significant costs to defend the related litigation; |
• | distraction of management’s attention from our primary business; |
• | substantial monetary awards to patients or other claimants; |
• | product recalls, withdrawals or labeling, marketing or promotional restrictions; |
• | decreased demand for our products, existing product candidates or any future product candidate, if approved; and |
• | loss of revenue. |
• | the scope of rights granted under the license agreement and other interpretation-related issues; |
• | our financial or other obligations under the license agreement; |
• | the extent to which our technology, products or product candidates infringe on intellectual property of the licensor that is not subject to the licensing agreement; |
• | the sublicensing of patent and other rights; |
• | our diligence obligations under the license agreements and what activities satisfy those diligence obligations; |
• | the inventorship or ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners; and |
• | the priority of invention of patented technology. |