Content analysis
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Legalese | ||
Litigous | ||
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H.S. sophomore Avg
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New words:
AB, al, announced, assert, asserted, behalf, Biovitrum, canceled, captioned, chargeback, consummated, contend, covered, CVR, Del, Hurd, Iceland, injunctive, Katz, law, Liechtenstein, merger, merit, misrepresented, NaN, Norway, Oct, omitted, Orphan, Pharm, promulgated, publ, relief, replacement, resale, rescission, rescissory, Sobi, stockholder, Swedish, tender, thereof, thereunder, UNA, Wang, Wheby
Removed:
accelerated, acceleration, adjudication, affecting, affirmative, arrange, assure, attestation, auditor, begun, body, care, collateral, consent, default, derived, dilute, discontinued, earliest, economic, enable, encumber, enforce, evaluating, expenditure, filer, harm, headcount, incurrence, inquiry, investigation, investor, involved, knowledge, limit, listing, newly, Oversight, payroll, permit, premium, prescribed, principle, projected, refinance, relying, requirement, restrictive, restructure, scaled, securing, senior, suit, written
Financial report summary
?Risks
- We have incurred significant losses since our inception and anticipate that we will continue to incur significant losses for the foreseeable future.
- We have not generated significant revenue and may never be profitable.
- We are heavily dependent on the success of DOPTELET, and if DOPTELET is not successfully commercialized, our business will be harmed.
- If we fail to obtain additional financing, we may be forced to delay, reduce or eliminate our product development programs and/or commercialization activities.
- We are required to make significant payments in connection with our acquisition of DOPTELET from Eisai and our failure to make these payments may adversely affect our ability to progress our development programs.
- We rely on our license agreement with Astellas to provide rights to the core intellectual property relating to DOPTELET. Any termination or loss of rights under that license agreement would have a material adverse effect on our development and commercialization of DOPTELET.
- Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel and consultants.
- Our employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs and vendors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements.
- Product liability lawsuits against us could cause us to incur substantial liabilities and limit commercialization of DOPTELET and any future drugs that we may develop.
- Our business and operations would suffer in the event of computer system failures, cyber-attacks or a deficiency in our cyber-security.
- We, or the third parties upon whom we depend, may be adversely affected by natural disasters and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
- If we are not able to obtain required regulatory approvals, we will not be able to commercialize our drug candidates and our ability to generate revenue will be materially impaired.
- Clinical failure may occur at any stage of clinical development, and the results of our clinical trials may not support our proposed additional indications for DOPTELET, including for ITP and CIT.
- Enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control.
- DOPTELET may fail to achieve market acceptance by physicians, patients, third-party payors or others in the medical community necessary for commercial success.
- The markets for DOPTELET may not be as large as we expect.
- DOPTELET may cause adverse events or have other properties that could limit the scope of market acceptance.
- We may expend our limited resources to pursue a particular indication and fail to capitalize on indications that may be more profitable or for which there is a greater likelihood of success.
- If we are unable to establish effective sales, marketing and distribution capabilities either on our own or in collaboration with third-parties, we may not be successful in commercializing DOPTELET.
- We face substantial competition, which may result in others discovering, developing or commercializing drugs before or more successfully than we do.
- Changes in funding for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal functions on which the operation of our business may rely, which could negatively impact our business.
- We do not have our own manufacturing capabilities and will rely on third parties to produce clinical and commercial supplies of DOPTELET and any future drug candidate.
- We intend to rely on third parties to conduct, supervise and monitor our clinical trials, and if those third parties perform in an unsatisfactory manner, it may harm our business.
- We may seek collaborations with additional third parties for the development or commercialization of DOPTELET. If we are unable to enter into collaborations, or if those collaborations are not successful, we may not be able to capitalize on the market potential of DOPTELET.
- If we are unable to obtain and maintain patent protection for DOPTELET or any future drug candidate, or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize technology and drugs similar or identical to ours, which could have a material adverse effect on our ability to successfully commercialize our technology and drug candidates.
- We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time-consuming and unsuccessful.
- We may not be able to protect our intellectual property rights throughout the world.
- We may be unsuccessful in licensing or acquiring intellectual property from third parties that may be required to develop and commercialize our drug candidates.
- Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business.
- We may be subject to claims by third parties asserting that we or our employees have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property.
- Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities.
- Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.
- The validity, scope and enforceability of any patents listed in the Orange Book that cover DOPTELET can be challenged by competitors.
- If we do not obtain protection under the Hatch-Waxman Amendments to extend the patent term and obtain data exclusivity for DOPTELET, our business may be materially harmed.
- Changes in U.S. patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our current or any future drug candidates.
- If we fail to comply with our obligations under any license, collaboration or other agreement, we may be required to pay damages and could lose intellectual property rights that are necessary for developing and protecting our drug candidates, or we could lose certain rights to grant sublicenses.
- Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
- Any trademarks we have obtained or may obtain may be infringed or otherwise violated, or successfully challenged, resulting in harm to our business.
- Intellectual property rights do not necessarily address all potential threats to our competitive position.
- Clinical development involves a lengthy and expensive process, with an uncertain outcome. We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of any future drug candidates we may develop.
- We may never obtain approval for or commercialize DOPTELET outside the United States, which would limit our ability to realize its full market potential.
- A variety of risks associated with marketing DOPTELET internationally could harm our business.
- We still face extensive regulatory requirements for DOPTELET and our drug candidates may face future development and regulatory difficulties.
- Our current and future relationships with third-party payors, health care professionals and customers in the United States and elsewhere may be subject, directly or indirectly, to applicable anti-kickback, fraud and abuse, false claims, physician payment transparency, health information privacy and security and other healthcare laws and regulations, which could expose us to significant penalties.
- Recently enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize DOPTELET and affect the prices we may obtain.
- Coverage and adequate reimbursement may not be available for DOPTELET, which could make it difficult for us to sell our drugs profitably.
- Governments outside the United States tend to impose strict price controls, which may adversely affect our revenue, if any.
- We are subject to governmental economic sanctions and export and import controls that could impair our ability to compete in international markets or subject us to liability if we are not in compliance with applicable laws.
- We are subject to anti-corruption and anti-money laundering laws with respect to our operations and non-compliance with such laws can subject us to criminal and/or civil liability and harm our business.
- An active trading market for our common stock may not continue to be developed or be sustained.
- The trading price of the shares of our common stock may be volatile, and purchasers of our common stock could incur substantial losses.
- If equity research analysts do not publish research or reports, or publish unfavorable research or reports, about us, our business or our market, our stock price and trading volume could decline.
- The issuance of additional stock in connection with financings, acquisitions, investments, our stock incentive plans or otherwise will dilute all other stockholders.
- Sales of a substantial number of our shares into the market could cause the market price of our common stock to drop significantly, even if our business is doing well.
- Provisions in our corporate charter documents and under Delaware law may prevent or frustrate attempts by our stockholders to change our management and hinder efforts to acquire a controlling interest in us, and the market price of our common stock may be lower as a result.
- Concentration of ownership of our common stock among our existing executive officers, directors and their affiliates may prevent our other stockholders from influencing significant corporate decisions.
- We are an “emerging growth company” and, as a result of the reduced disclosure and governance requirements applicable to emerging growth companies, our common stock may be less attractive to investors.
- If we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired.
- The 2017 comprehensive tax reform bill could adversely affect our business and financial condition.
- We might not be able to utilize a significant portion of our net operating loss carryforwards.
- Because we do not anticipate paying any cash dividends on our common stock in the foreseeable future, capital appreciation, if any, will be your sole source of gains.
- We incur increased costs and demands upon management as a result of being a public company.
- Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware is the exclusive forum for certain litigation that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
Management Discussion
- During the year ended December 31, 2018, product sales, net consisted of sales of DOPTELET, which we launched on June 4, 2018. In addition, we recognized the $2.6 million of the upfront payment received from our development and distribution agreement with Fosun. We did not recognize any revenue during the year ended December 31, 2017.
- Cost of product sales of $1.2 million for the year ended December 31, 2018 consisted of the cost of inventory that was purchased from Eisai that was sold after FDA approval, royalty payments to Astellas and certain distribution and overhead costs. In addition, for the year ended December 31, 2018, cost of product sales included $0.3 million related to stock-based compensation charges.
- Research and development expenses increased by $2.6 million, to $18.3 million for the year ended December 31, 2018 from $15.7 million for the year ended December 31, 2017, primarily driven by the initiation of clinical trials to evaluate DOPTELET for the treatment of PST and CIT and increased employee headcount, partially offset by the $1.0 million milestone payment that we became obligated to pay Astellas in 2017 upon the submission of the NDA and the completion of the clinical trials in 2017 of DOPTELET for the treatment of thrombocytopenia in patients with CLD, scheduled to undergo a procedure.