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H.S. sophomore Avg
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New words:
abbreviated, absent, AMP, Amsterdam, ANDA, anesthesiologist, Annex, anonyme, antitrust, Apotex, appeal, archived, assumption, attack, authorisation, Barman, BofA, boost, Brexit, Britain, capture, ceiling, cell, certainty, Ciccotelli, CJEU, clearance, Coast, codify, Colorado, Commissioner, concretely, Conference, conspiracy, constitutionality, contemplated, contrast, copy, crystallized, CTA, CTR, CVR, database, Defense, destination, DGCL, disabled, disaggregated, dispute, disseminate, diverge, dual, duty, Eastern, Eiden, elapsed, eleven, engineering, excise, fault, Finuliar, forensic, formula, freestanding, FSS, GB, GMP, Great, Guard, guideline, Hansen, harder, Harmonization, harmonized, height, Helsinki, hereinafter, host, HRSA, HTA, ICH, ID, immune, Importantly, Indian, injured, inpatient, instructed, intentionally, internationally, issuable, JNDA, Kelly, Labour, laid, Langone, Leerink, left, lifted, Longboard, Lupin, magnitude, malware, MDRP, Medison, MHRA, migrated, military, missing, multidisciplinary, narcotic, noninfringement, nonprofit, notably, notified, notifying, obfuscate, occupancy, onsite, organizational, overage, overcharge, pace, PDCO, pendency, Pennsylvania, PIP, portal, precautionary, printing, proactive, psychotropic, purported, ransomware, reassure, recalculation, reframing, reinstitute, reinstituted, rescissory, Rescue, resell, restraining, retail, retailer, rural, safest, Scotland, segregation, seller, solvent, somatic, Southern, statutorily, streamline, supervisory, suspected, SVB, tailored, Takeda, TCA, traceability, transposed, true, UCB, unanimously, unchanged, underage, unnecessary, unsafe, untimely, untrue, VA, validly, vi, Virginia, vitro, vivo, waiting, waived, Wang, watched, Wheeler, Wilhelm, wrongdoing, younger, Zinc
Removed:
Ambien, assignment, Ativan, Belviq, corruption, cyber, deliberate, delivered, destruction, diagnosed, Diastat, Diego, disclosing, discounting, Doose, electronic, eliminating, elimination, entitle, formally, inseverable, insolvent, Judge, mitigating, Onfi, Ovid, owed, protecting, Qsymia, removing, repeal, repealed, ruled, rulemaking, shared, Simplifying, sleep, Sonata, supportable, suspending, sustaining, tenant, theft, transmit, Valium, Versed, viewpoint
Financial report summary
?Competition
PTC Therapeutics • Jazz Pharmaceuticals • GW Pharmaceuticals • Xenon Pharmaceuticals • Zynerba Pharmaceuticals • Stoke Therapeutics • Ovid Therapeutics • Bright Minds BiosciencesRisks
- The conditions under the Merger Agreement to Parent’s consummation of the Offer and our subsequent Merger with Purchaser may not be satisfied at all or in the anticipated timeframe.
- While Parent’s Offer and the proposed Merger are pending, we are subject to business uncertainties and contractual restrictions that could disrupt our business.
- Our executive officers and directors may have interests that are different from, or in addition to, those of our stockholders generally.
- Litigation filed or that may be filed against us and/or the members of our board of directors could prevent or delay the consummation of the Merger.
- Our stockholders may not receive any payment on the CVRs and the CVRs may otherwise expire valueless.
- In the event that the Merger is not consummated, the trading price of our common stock and our future business and results of operations may be negatively affected.
- The Merger Agreement imposes restrictions on the operation of our business prior to closing, which could adversely affect our business.
- If the Merger Agreement is terminated, we may, under certain circumstances, be obligated to pay a termination fee to Parent. These costs could require us to use available cash that would have otherwise been available for other uses.
- Our success depends substantially on Fintepla as commercial product and as a product candidate in other indications as well as our product candidate MT-1621. We cannot be certain that Fintepla will receive additional regulatory approvals we may pursue, or be successfully commercialized, or whether MT-1621 or any future product candidates will receive regulatory approval or be successfully commercialized.
- We may not be successful in executing our sales and marketing strategy for the commercialization of Fintepla.
- We depend on a sole specialty distributor, our customer, for distribution of Fintepla in the United States, and the failure of this specialty distributor to distribute Fintepla effectively would adversely affect sales of Fintepla.
- Our business is subject to risks arising from epidemic diseases, such as the COVID-19 pandemic.
- Our clinical trials may fail to demonstrate acceptable levels of safety and efficacy for our product candidates, which could prevent or significantly delay their regulatory approval.
- The results of previous clinical trials may not be predictive of future results, and the results of our current and planned clinical trials may not satisfy the requirements of the FDA or non-U.S. regulatory authorities.
- Interim, topline and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
- Delays in the commencement or completion of clinical testing for Fintepla or MT-1621 or pre-clinical or clinical testing for any future product candidates could result in increased costs to us and delay or limit our ability to pursue regulatory approvals for, or generate revenues from, such product candidates.
- We face intense competition, and if our competitors market and/or develop treatments for any of our product candidates’ indications that are marketed more effectively, approved more quickly than our product candidates or demonstrated to be safer or more effective than our products, our commercial opportunities will be reduced or eliminated.
- If Fintepla or MT-1621, if approved, does not achieve broad market acceptance or coverage by third-party payors, the revenues that we generate will be limited.
- Breakthrough therapy designation and access to the PRIME scheme for MT-1621 may not lead to a faster development or regulatory review or approval process, and it does not increase the likelihood that MT1621 or any of our product candidates will receive marketing approval.
- If the FDA does not conclude that certain of our product candidates satisfy the requirements for the Section 505(b)(2) regulatory approval pathway, or if the requirements for such product candidates under Section 505(b)(2) are not as we expect, the approval pathway for those product candidates will likely take significantly longer, cost significantly more and entail significantly greater complications and risks than anticipated, and in either case may not be successful.
- We have a history of significant net losses and negative cash flow from operations. We cannot predict if or when we will become profitable and anticipate that our net losses and negative cash flow from operations will continue for at least the next year.
- We rely on third parties to conduct our pre-clinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our product candidates and our business could be substantially harmed.
- We may engage in strategic transactions that could impact our liquidity, increase our expenses and present significant distractions to our management.
- We are dependent on numerous third parties in our manufacturing supply chain, all of which are currently single source suppliers, for the clinical supply of Fintepla, and if we experience problems with any of these suppliers, the development of Fintepla could be delayed.
- If we are unable to attract and retain key personnel, we may not be able to manage our business effectively or develop our product candidates or commercialize our products.
- Fluctuations in the value of the Euro or UK pound sterling could negatively impact our results of operations and increase our costs.
- If we are unable to achieve and maintain adequate levels of coverage and reimbursement for Fintepla or any of our other product candidates for which we may receive regulatory approval on reasonable pricing terms, their commercial success may be severely hindered.
- We face potential product liability exposure, and if successful claims are brought against us, we may incur substantial liability if our insurance coverage for those claims is inadequate.
- We may be unable to obtain regulatory approvals for or commercialize MT-1621 or any future product candidates outside of the United States.
- Our business involves the use of hazardous materials and we and our third-party manufacturers and suppliers must comply with environmental laws and regulations, which can be expensive and restrict how we do business.
- The UK’s withdrawal from the EU may have a negative effect on global economic conditions, financial markets and our business.
- We may require additional funding in the future to carry out our plan of operations and if we are unable to raise capital when needed, we may be forced to delay, reduce or eliminate our product development programs or future commercialization efforts.
- Our indebtedness and liabilities could limit the cash flow available for our operations, expose us to risks that could adversely affect our business, financial condition and results of operations and impair our ability to satisfy our obligations under the Convertible Senior Notes.
- Our results of operations and liquidity needs could be materially negatively affected by market fluctuations and economic downturn.
- Raising additional funds by issuing securities may cause dilution to existing stockholders and raising funds through lending and licensing arrangements may restrict our operations or require us to relinquish proprietary rights.
- We may be unable to benefit from favorable U.K. tax legislation.
- Our ability to utilize our net operating loss and research and development income tax credit carryforwards may be limited.
- We are exposed to fluctuations in the market values of our investments.
- We may not be able to maintain orphan drug designation or obtain or maintain orphan drug exclusivity for Fintepla or MT-1621.
- Use of our product candidates could be associated with side effects, adverse events or other properties or safety risks, which could delay or preclude approval, cause us to suspend or discontinue clinical trials, abandon a product candidate, limit the commercial profile of the label for an approved product candidate, or result in other significant negative consequences that could severely harm our business, prospects, operating results and financial condition.
- Even though we have obtained regulatory approval for Fintepla, and even if we obtain approval for MT-1621 or any other product candidate, we will remain subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense. Additionally, our product candidates, if approved, could be subject to labeling and other restrictions on marketing or withdrawal from the market, and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our product candidates, when and if any of them are approved.
- Disruptions at the FDA and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, which could negatively impact our business.
- The successful commercialization of Fintepla and our product candidates will depend in part on the extent to which third-party payors, including governmental authorities and private health insurers, provide funding, establish favorable coverage and pricing policies, and set adequate reimbursement levels. Failure to obtain or maintain coverage and adequate reimbursement for Fintepla or any of our product candidates, if approved, could limit our ability to market those products and decrease our ability to generate revenue.
- Evolving health policy and associated legislative changes aimed at lowering healthcare expenditure could impact the commercialization of Fintepla and our product candidates. Pharmaceutical pricing has been, and likely will continue to be, a central component of these efforts.
- If we fail to comply with reporting and payment obligations under the Medicaid Drug Rebate Program or other governmental pricing programs, we could be subject to additional reimbursement requirements, penalties, sanctions and fines, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
- Healthcare reform measures and changes in policies, funding, staffing and leadership at the FDA and other agencies could hinder or prevent the commercial success of Fintepla or any of our product candidates that may be approved by the FDA or foreign regulatory authorities.
- We may incur liability if our continuing medical or health education programs and/or product promotions are determined, or are perceived, to be inconsistent with regulatory guidelines.
- If we do not comply with federal, state and foreign healthcare laws, including fraud and abuse laws, we could face substantial penalties and our business, results of operations, financial condition and prospects could be adversely affected.
- Actual or perceived failures to comply with applicable data protection, privacy and security laws, regulations, standards and other requirements could adversely affect our business, results of operations, and financial condition.
- Our success depends in part on our ability to protect our intellectual property. It is difficult and costly to protect our proprietary rights and technology, and we may not be able to ensure their protection.
- If we fail to comply with our obligations in our intellectual property licenses with third parties, we could lose license rights that are important to our business.
- We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights, and we may be unable to protect our rights to our products and technology.
- If we are sued for infringing intellectual property rights of third parties, it will be costly and time consuming, and an unfavorable outcome in that litigation would have a material adverse effect on our business.
- Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
- We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
- The market price of our common stock has fluctuated and is likely to continue to fluctuate substantially.
- Our quarterly operating results may fluctuate significantly.
- Our operating results may fluctuate significantly, which makes our future operating results difficult to predict.
- We have been involved in securities class action litigation and may become involved in future securities class action litigation that could divert management’s attention and adversely affect our business and could subject us to significant liabilities.
- If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.
- Future sales of our common stock or securities convertible or exchangeable for our common stock may depress our stock price.
- Anti-takeover provisions under our charter documents and Delaware law could delay or prevent a change of control which could limit the market price of our common stock and may prevent or frustrate attempts by our stockholders to replace or remove our current management.
- We have never paid dividends on our capital stock, and we do not anticipate paying any cash dividends in the foreseeable future.
- As a result of operating as a public company, we incur significant legal and accounting compliance costs and we are subject to the Sarbanes-Oxley Act, and we can provide no assurance that we will, at all times, in the future be able to report that our internal controls over financial reporting are effective.
- In connection with the reporting of our financial condition and results of operations, we are required to make estimates and judgments which involve uncertainties, and any significant differences between our estimates and actual results could have an adverse impact on our financial position, results of operations and cash flows.
- Changes in accounting standards and their interpretations could adversely affect our operating results.
- Our business and operations may suffer in the event of system failures, which could materially affect our results.
Management Discussion
- We began to generate product revenue following the approval of Fintepla for Dravet syndrome by the FDA and the EMA in 2020. Prior to the commercial launch of Fintepla in July 2020, our revenues were generated solely from a collaboration agreement with Shinyaku entered into in March 2019.
- Net product sales increased by $65.2 million during the year ended December 31, 2021, compared to the year ended December 31, 2020, as a result of an entire year of Fintepla sales following commercial launch in the U.S. in the third quarter of 2020, and Germany and France in 2021.
- We expect net product sales to increase during 2022 as compared to 2021 as we continue to retain and expand our patient base in existing markets, as well as launch our approved product into additional markets following the country-by-country reimbursement approval process in Europe, including the United Kingdom, Italy and Spain.