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New words:
accurately, advertisement, alter, ASU, building, burden, card, care, civil, compete, compliant, concomitant, confirmatory, criminal, death, decline, dedicated, defense, demand, detain, Dier, diligence, disposition, disqualifying, dissemination, earn, earned, England, ensure, entry, Evercore, excluding, expiry, export, FASB, feasible, FIFO, finite, focusing, force, Fred, guarantee, health, hepatology, hire, hiring, hypertension, inadvertently, insider, Intangible, introduced, inventory, legislation, Mardi, MASH, maximum, medical, medication, Medicine, misuse, Modification, monetary, morbidity, navigate, negotiate, nomenclature, order, Overview, pathway, permit, permitted, Piper, pivotal, post, preapproval, premature, profitability, promotional, published, Raw, recall, receipt, recoverability, recoverable, refine, refuse, relationship, Rezdiffra, RSU, Sandler, satisfy, scheduled, seek, Segment, seize, side, specialist, statutory, strategy, submit, submitted, Title, Topic, traditional, transforming, ultimately, uncontrolled, untitled, verification, warning, withdraw, withdrawal, women, write
Removed:
accelerating, accredited, addressing, anticipate, arm, assigned, assuming, beta, breakthrough, carried, cholesterol, clinically, commitment, commonly, compound, conclusion, confidence, consent, continuing, daily, decompensation, dosed, dual, efficient, endpoint, enrolled, exceeded, existing, expedite, filing, guidance, hepatic, hormone, increasing, individual, inflammatory, initiated, institutional, intensive, involved, involving, July, labor, LDL, lowering, main, measure, mg, multicenter, NAS, NDA, noninvasive, obesity, opened, Opportunity, organizational, participating, participation, people, pill, placebo, potentially, precautionary, preliminary, protocol, pursuing, randomized, receptor, recruited, registered, relation, requiring, rest, Score, selective, serial, successive, suffer, sufficiency, surrogate, thyroid, timeline, world, worsening
Financial report summary
?Competition
Bristol-Myers Squibb • Pfizer • AMGEN • Gilead Sciences • Durect • Novartis • Sanofi • Gyre Therapeutics • Galectin Therapeutics • Enanta PharmaceuticalsRisks
- Our business depends on the success of resmetirom. If we are unable to obtain regulatory approval for and successfully commercialize resmetirom, or we experience significant delays in doing so, our business will be materially harmed.
- If approved, we will be highly dependent on the commercial success of resmetirom. We may not be able to meet expectations with respect to sales of our products if approved by the FDA, or attain profitability and positive cash-flow from operations.
- Clinical trials are very expensive, time-consuming and difficult to design and implement and involve uncertain outcomes. Furthermore, the results of preclinical studies and early clinical trials are not always predictive of future results. Any product candidate that we advance into clinical trials, including resmetirom, may not have favorable results in later clinical trials or receive regulatory approval.
- Because resmetirom has not yet received regulatory approval for any indication, it is difficult to predict the time and cost of development and our ability to successfully complete clinical development and obtain the necessary regulatory approvals for commercialization.
- If clinical trials or regulatory approval processes for our product candidates are prolonged, delayed or suspended, we may be unable to commercialize our product candidates on a timely basis, which would require us to incur additional costs and delay our receipt of any revenue from potential product sales.
- If we inadvertently fail to comply with foreign regulatory requirements governing human clinical trials and marketing approval for drugs, we could be prevented from selling our drug candidates in foreign markets, which may adversely affect our operating results and financial condition.
- We depend on enrollment of patients in our clinical trials for our product candidates. If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
- Any product candidate in our current or future clinical trials may cause unacceptable adverse events or side effects or have other properties that may delay or prevent its regulatory approval or commercialization or limit its commercial potential.
- We have received Fast Track Designation from the FDA for resmetirom for NASH; however, such designation may not actually lead to a faster development or regulatory review or approval process, and the designation may be rescinded if the product candidate no longer meets the qualifying criteria for Fast Track.
- Breakthrough therapy or priority review by the FDA for any product candidate may not lead to faster development, regulatory review or approval processes, and it does not increase the likelihood that our product candidates will receive marketing approval.
- Our product candidates will remain subject to ongoing regulatory review even if they receive marketing approval, and if we fail to comply with continuing regulations, we could lose these approvals and the sale of any approved commercial products could be suspended.
- We operate in a highly competitive and rapidly changing industry, and our product candidates may become obsolete.
- If the FDA or other applicable regulatory authorities approve generic products that compete with any of our or any of our partners’ product candidates, the sales of our product candidates would be adversely affected.
- If payers excessively restrict our future products or physicians and patients do not accept our future products or if the market for indications for which any product candidate is approved is smaller than expected, our ability to generate revenues will be impacted.
- As we evolve from a company that is primarily involved in clinical development to a company that is also involved in commercialization, we may encounter difficulties in expanding our operations successfully, including successfully optimizing manufacturing for our product/product candidate in sufficient quality and quantity or within targeted timelines.
- If we are unable to successfully further develop and maintain internal commercialization capabilities, future sales of our products, if approved, may be negatively impacted.
- The insurance coverage and reimbursement status of newly-approved products is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for new or current products could limit our ability to market those products and decrease our ability to generate revenue.
- The pricing of pharmaceutical products has come under increasing scrutiny as part of a global trend toward healthcare cost containment. Resulting changes in healthcare law and policy, including recently enacted changes to Medicare, may impact our business in ways that we cannot currently predict, which could have a material adverse effect on our business and financial condition.
- If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate program or other governmental pricing programs after we begin participating in these programs, we could be subject to additional rebate requirements, penalties, or other sanctions, which could have a material adverse effect on our business, financial condition, results of operations, and growth prospects.
- If any product liability lawsuits are successfully brought against us or any of our collaborative partners, we may incur substantial liabilities and may be required to limit commercialization of our product candidates.
- Our employees, contractors, vendors and partners may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading.
- We enter into various contracts in the normal course of our business in which we indemnify the other party to the contract. In the event we have to perform under these indemnification provisions, it could have a material adverse effect on our business, financial condition and results of operations.
- If we fail to develop and commercialize other product candidates, we may be unable to grow our business.
- If we lose key senior management personnel, it could have a material adverse effect on our business and stock price.
- Even if we obtain FDA approval of resmetirom or any other future product candidate, we may never obtain approval or commercialize our products outside of the United States, which would limit our ability to realize their full market potential.
- If we do not obtain protection under the Hatch-Waxman Act and similar foreign legislation by extending the term of patents covering each of our product candidates, our business may be materially harmed.
- If we or our partners market products in a manner that violates fraud and abuse and other healthcare laws, or if we or our partners violate government price reporting laws, we or our partners may be subject to administrative civil and/or criminal penalties.
- If the third parties on which we rely for the conduct of our clinical trials and results do not perform our clinical trial activities in accordance with good clinical practices and related regulatory requirements, we may be unable to obtain regulatory approval for or commercialize our product candidates.
- We have relied on, and expect to continue to rely on, third-party manufacturers to produce our product candidates.
- A failure of our information technology infrastructure and cybersecurity threats may adversely affect our business and operations.
- Failure to comply with health and data protection laws and regulations could lead to government enforcement actions (which could include civil or criminal penalties), private litigation and/or adverse publicity, and could negatively affect our operating results and business.
- Our rights to develop and commercialize our product candidates are subject in part to the terms and conditions of a license to resmetirom granted to us by Roche.
- We may fail to comply with any of our obligations under agreements pursuant to which we license rights or technology, which could result in the loss of rights or technology that are material to our business.
- Recent patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents.
- Claims by third parties that we infringe their proprietary rights may result in liability for damages or prevent or delay our developmental and commercialization efforts.
- We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time consuming, and unsuccessful. Further, our issued patents could be found invalid or unenforceable if challenged in court.
- We may not be successful in obtaining or maintaining necessary rights to our product candidates through acquisitions and in-licenses.
- 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.
- If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
- We may not be able to protect our intellectual property rights throughout the world.
- If we fail to obtain the capital necessary to fund all of our planned operations, we may be unable to successfully develop and commercialize resmetirom and other future product candidates.
- Our ability to use net operating loss and tax credit carryforwards and certain built-in losses to reduce future tax payments may be limited by provisions of the Internal Revenue Code.
- Our Loan and Security Agreement contains restrictive and financial covenants that may limit our operating flexibility.
- Our failure to comply with the covenants or other terms of the Loan Agreement, including as a result of events beyond our control, could result in a default under the Loan Agreement that could materially and adversely affect our business.
- The price of our common stock has been, and may continue to be, volatile.
- A small number of our stockholders beneficially own a substantial amount of our outstanding common stock and may be deemed to have substantial control over us; therefore, your ability to influence corporate matters may be limited.
- Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition of our company, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.
- Future sales and issuances of our common stock or rights to purchase common stock could result in additional dilution of the percentage ownership of our stockholders and could cause our share price to fall.
- Funds affiliated with Baker Bros. Advisors LP hold a significant portion of our total outstanding shares of common stock (including shares of our common stock issuable upon conversion of shares of our Series A Convertible Preferred Stock and Series B Convertible Preferred Stock and pre-funded warrants), and any sale of such shares into the market,
- or perception that sales could occur, in the future could cause the market price of our common stock to drop significantly.
- Sales of a significant number of shares of our common stock in the public markets or significant short sales of our common stock, or the perception that such sales could occur, could depress the market price of our common stock and impair our ability to raise capital.
- We do not anticipate paying cash dividends on our common stock, and accordingly, stockholders must rely on stock appreciation for any return on their investment.
Management Discussion
- We had no revenue for the three months ended March 31, 2024 and 2023. Rezdiffra became available in the United States in April 2024.
- Our research and development expenses were $71.2 million for the three months ended March 31, 2024, compared to $62.2 million in the corresponding period in 2023. Research and development expenses increased by $9.1 million in the 2024 period due primarily to an increase related to timing of manufacturing, an increase in headcount, and a corresponding increase in stock compensation expense.
- Our selling, general and administrative expenses were $80.8 million for the three months ended March 31, 2024, compared to $16.2 million in the corresponding period in 2023. Selling, general and administrative expenses increased by $64.6 million in the 2024 period due primarily to increases in commercial preparation activities, including a corresponding increase in headcount, and an increase in stock compensation expense. We believe our selling, general and administrative expenses may increase over time as we continue with commercialization activities and expand our operating activities.