Content analysis
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H.S. senior Avg
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New words:
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Removed:
abnormal, Abraxane, accompanied, acuity, acute, adaptive, adjust, agonist, Albireo, Allergan, allocation, amplified, analyzed, aptamer, aramchol, arm, array, arrest, assay, assume, atherosclerotic, attacker, attestation, Australian, autofluorescence, Axcella, bilateral, billing, biopsy, Bird, bleeding, blind, bowel, breakout, British, broaden, broadening, bruising, building, cap, carcinogenicity, cardiac, chemokine, chest, choroidal, cirrhotic, collagen, color, complication, composite, concept, concomitant, confirmation, connective, constellation, constipation, convert, cough, creative, cycle, dedicated, deficiency, delivered, denominated, deposition, desaturase, deter, diarrhea, diet, disciplined, discoloration, disorder, distancing, distension, diversified, Division, dollar, dosed, Dysregulated, earned, efruxifermin, elderly, empirically, enabled, Enanta, encephalopathy, encouraging, ending, Endocrinology, endorsed, epithelium, erythema, esophageal, Euro, evolution, exhibited, eye, farnesoid, fatty, fecal, fielding, Finally, financed, flexible, fluctuation, formation, formula, fourth, FXR, Galectin, gastric, gastrointestinal, gemcitabine, Gemini, genetically, GI, Glympse, greatest, guaranteed, Gyroscope, headache, Hemera, hemorrhage, hepatocellular, Hepatology, histology, histopathologic, honed, Hong, hypertension, hypothetical, imaging, Immuron, impinging, implicated, Index, infection, insult, Intercept, internally, interrogate, interrogation, intervention, irrespective, iveric, kidney, KLB, Kong, language, lanifibranor, largely, leaving, leveraging, lifestyle, Lineage, lipoprotein, lipotoxicity, living, MannKind, maximize, median, MediciNova, membrane, mild, mitigated, mixed, modality, moderate, modest, morbid, motivating, movement, muscle, NAFLD, Nalpropion, native, necroinflammatory, neovascularization, neutralizing, North, Nutrition, obese, obeticholic, observation, ocular, onset, ophthalmologist, OpRegen, optimize, oral, ortholog, ovarian, Overview, paclitaxel, Patch, path, PEGylated, peptide, pharmacologic, pigment, pioglitazone, plaque, pleurisy, pneumonia, PPAR, precursor, predicted, preserving, progressing, progressive, proliferation, proliferative, Promethera, proof, provisional, provoking, quarantine, reaction, reclassified, recouped, rectal, Regenerative, regime, regression, rehabilitation, reinvestment, remeasured, Remeasurement, removing, repealing, resistant, resmetirom, resolution, respiratory, retina, risen, robust, rodent, RPE, ruling, SA, sample, scarring, scheduled, Sea, Seal, selective, semaglutide, sensitizer, sequence, showed, society, specialist, spot, statin, strain, subdivided, Subpart, surgery, swelling, syndrome, Systematically, thing, THR, thyroid, tissue, Tiziana, topline, tract, transient, translational, travel, treatable, unbiased, underinvestment, unilateral, unilaterally, unique, unsuccessfully, upper, urinary, vaccine, variant, variceal, versatile, version, vertigo, Viking, visual, wasting, wet, whichever, widespread, withdrew, worked, worse
Financial report summary
?Competition
Bristol-Myers Squibb • AMGEN • Novo Nordisk • Incyte • Vivus • Mannkind • Astrazeneca • Cymabay Therapeutics • Durect • AgenusRisks
- The Offer and the Merger are subject to a number of conditions beyond our control. Failure to complete the Offer and the Merger within the expected time frame, or at all, could have a material adverse effect on our business, operating results, financial condition and our stock price.
- The Merger Agreement contains provisions that could discourage a potential competing acquirer.
- While the Offer and the Merger are pending, we are subject to business uncertainties and contractual restrictions that limit our ability to pursue financing or BD Arrangements and could disrupt our business, and the Offer and the Merger may impair our ability to attract and retain qualified employees or retain and maintain relationships with our suppliers and other business partners.
- Stockholder litigation could prevent or delay the consummation of the Offer and the Merger or otherwise negatively impact our business, operating results and financial condition.
- We may become involved in securities class action litigation due to the Offer and the Merger that could divert management’s attention and harm our business, and adversely affect our ability to consummate the Offer and the Merger within the expected time frame or at all.
- Our executive officers and directors may have interests in the Offer and the Merger that are different from, or in addition to, those of our stockholders generally.
- We have incurred, and will continue to incur, direct and indirect costs as a result of the Offer and the Merger.
- We have incurred net losses every year since our inception and have no meaningful source of revenue. We expect to continue to incur significant operating losses and may never become profitable.
- We have minimal committed external funding for our development efforts and will need to rely on our own financial resources and our ability to raise additional capital in order to further our development efforts.
- We need significant additional capital to proceed with development and commercialization of our current and potential future product candidates and our other operations. We may not be able to access sufficient capital on acceptable terms, if at all, and, as a result, we may need to significantly delay, scale back or discontinue development of or abandon some or all of our product candidates, or scale back or discontinue our discovery research efforts, any of which could have a material adverse effect on our business, operating results and prospects, or we may be required to cease operations altogether.
- Raising additional capital may cause dilution to our existing stockholders, lead to restrictions on our operations or require us to relinquish rights to our product candidates or intellectual property.
- We expect to depend in the future on BD Arrangements with third-party partners for the development and commercialization of our product candidates and for revenue. If we are unable to secure those BD Arrangements on beneficial terms, if at all, or if any such future arrangements are not successful, we may not be able to capitalize on the market potential of our product candidates or continue their development.
- We may not be able to obtain and maintain the relationships with third parties that are necessary to develop, commercialize and manufacture some or all of our product candidates.
- We rely completely on CMOs for the manufacture of our product candidates, and we are subject to many manufacturing risks, any of which could substantially increase our costs and limit supply of our product candidates and any future products.
- We have no experience in sales, marketing and distribution and may have to enter into agreements with third parties to perform these functions, which could prevent us from successfully commercializing our product candidates.
- Our product candidates must undergo rigorous clinical trials before seeking regulatory approvals, and clinical trials may be delayed, suspended or terminated at any time for many reasons, any of which could delay or prevent regulatory approval and, if approval is granted, commercialization of our product candidates.
- If clinical trials of our product candidates fail to produce positive results or to demonstrate safety and efficacy to the satisfaction of the FDA or comparable health authorities or sufficient to demonstrate differentiation from other approved therapies or therapies in development, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
- Success in preclinical studies or earlier-stage clinical trials may not be indicative of results in future clinical trials.
- Our product candidates may cause undesirable side effects or adverse events or have other properties or safety risks, which could delay or prevent continued clinical development or their regulatory approval or limit the commercial profile of any approved label.
- We may not successfully identify new product candidates to expand our development pipeline.
- We may fail to select or capitalize on the most scientifically, clinically and commercially promising or profitable product candidates.
- We must attract and retain highly skilled employees in order to succeed. If we are not able to retain our current senior management team, or to continue to attract and retain qualified scientific, technical and business personnel, our business will suffer.
- We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than us.
- Our product candidates may not achieve adequate market acceptance among physicians, patients, healthcare payors and others in the medical community necessary for commercial success.
- Even if we obtain approval to market our products, these products may become subject to unfavorable pricing regulations, reimbursement practices from third-party payors or healthcare reform initiatives in the United States and abroad, which could harm our business.
- Our international operations may expose us to business, regulatory, political, operational, financial, pricing and reimbursement risks associated with doing business outside of the United States.
- Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop.
- Our relationships with healthcare providers, customers and third-party payors will be subject to applicable anti-kickback, fraud and abuse, transparency and other healthcare laws and regulations, which, if violated, could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens and diminished profits and future earnings.
- Our business could be materially and adversely affected in the future by the effects of disease outbreaks, epidemics and pandemics.
- The regulatory approval processes of the FDA and comparable foreign health authorities are lengthy and inherently unpredictable. Our inability to obtain regulatory approval for our product candidates would substantially harm our business.
- Our failure to obtain health authority approval in foreign jurisdictions would prevent us from marketing our product candidates outside the United States.
- Even if our product candidates receive regulatory approval, they may still face future development and regulatory difficulties.
- Even if we are able to obtain regulatory approvals for any of our product candidates, if they exhibit harmful side effects after approval, our regulatory approvals could be revoked or otherwise negatively impacted.
- Our success depends in significant part upon our ability to obtain and maintain intellectual property protection for our products and technologies.
- We may be unable to obtain intellectual property rights or technologies necessary to develop and commercialize our product candidates.
- We could lose the ability to continue the development and commercialization of our products or product candidates if we breach any license agreement related to those products or product candidates.
- We may become involved in lawsuits or other proceedings to protect or enforce our intellectual property, which could be expensive, time-consuming and unsuccessful and have a material adverse effect on the success of our business.
- Third parties may initiate legal proceedings against us alleging that we infringe their intellectual property rights or we may initiate legal proceedings against third parties to challenge the validity or scope of the third-party 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 not be able to protect our intellectual property rights throughout the world.
- We have in the past and may in the future fail to continue to meet the listing standards of Nasdaq, and as a result our common stock may be delisted, which could have a material adverse effect on the liquidity of our common stock.
- The market price of our common stock has been and may continue to be volatile, and you could lose all or part of your investment.
- Because of volatility in our trading price and trading volume, we may incur significant costs from class action securities litigation.
- Our principal stockholders, including entities affiliated with The Column Group, Merck and management, own a substantial percentage of our stock and collectively will be able to exert significant control over matters subject to stockholder approval.
- We are a “smaller reporting company” and the reduced disclosure requirements applicable to such companies that we have availed ourselves of may make our common stock less attractive to investors.
- An active trading market for our common stock may not be sustained and sales of a substantial number of shares of our common stock in the public market could cause our stock price to fall.
- We do not intend to pay dividends on our common stock so any returns will be limited to the value of our stock.
- Some provisions of our charter documents and Delaware law may have anti-takeover effects or could otherwise discourage an acquisition of us by others, even if an acquisition would benefit our stockholders, and may prevent attempts by our stockholders to replace or remove our current management.
- Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware and the federal district courts of the United States will be the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
- We, our CROs, our CMOs, our current and potential future partners and other third parties we rely on or partner with could experience a cybersecurity incident that could harm our business.
- We are subject to rapidly changing and increasingly stringent foreign and domestic laws and regulations relating to privacy, data protection and information security. The restrictions imposed by these requirements or our actual or perceived failure to comply with them could harm our business.
- Our operations are vulnerable to interruption by fire, earthquake, power loss, telecommunications failure, terrorist activity and other events beyond our control, which could harm our business.
- We use and generate materials that may expose us to material liability.
- Our ability to use net operating loss carryforwards and certain other tax attributes to offset taxable income could be limited.
- New tax laws or regulations, changes to existing tax laws or regulations or changes in their application to us or our customers may have a material adverse effect on our business, cash flows, financial condition or results of operations.
- Future changes in financial accounting standards or practices may cause adverse and unexpected revenue fluctuations and adversely affect our reported results of operations.
- We continue to incur increased costs as a result of operating as a public company, and our management devotes substantial time to new compliance initiatives. In addition, we are obligated to develop and maintain proper and effective internal control over financial reporting. In the future, we may not complete our analysis of our internal control over financial reporting in a timely manner, or our internal control over financial reporting may not be determined to be effective, which may adversely affect investor confidence in our company and, as a result, the value of our common stock.
- Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
- 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.
Management Discussion
- Revenue decreased $50.9 million and $22.5 million in the years ended December 31, 2023 and 2022, respectively, compared to the prior year periods primarily due to a decrease in R&D revenue under our collaboration with Merck.
- Due to the nature of our collaboration with Merck, the timing of related revenue recognition and the substantial decrease in the level of funding we received from Merck in 2023, our revenue has fluctuated from period to period in the past. In the first half of 2024, we expect funding, and related party revenue, from Merck to be minimal. We do not expect the research program term of the collaboration to be extended and accordingly we do not expect any funding from Merck thereafter.
- (1) Internal and unallocated R&D expenses consist primarily of research supplies and consulting fees, which we deploy across multiple R&D programs and include restructuring charges of $3.8 million in the year ended December 31, 2023.