Content analysis
?Positive | ||
Negative | ||
Uncertain | ||
Constraining | ||
Legalese | ||
Litigous | ||
Readability |
H.S. sophomore Avg
|
New words:
abbreviated, abeyance, academic, accuracy, Allen, Andrea, Arab, array, Aruvant, ASU, attrition, automate, Automatic, automatically, ban, biannual, bioresearch, biosimilar, Braun, burn, CDC, CE, CENTRISOL, clarification, Clawback, composed, Concerto, consummated, contemplated, content, convening, crime, curb, cyber, cybercrime, cybersecurity, de, detract, deviation, disagree, draft, Drexel, Drogan, East, eisneramper, email, enterprise, Evoqua, FASB, FDASIA, field, froze, GCP, graduate, Hemavant, Heslin, Houston, impassible, implantable, implicit, indirect, inherited, IRB, IRC, Jesse, Joan, judgement, lapse, Lau, lowest, main, manual, maximum, MBA, MDR, Methodist, Microcap, Middle, misbranded, misuse, Modernization, MPEEM, Neri, Nissenson, Nonrecurring, Northeast, novo, Ohio, onboarding, Outset, permission, petition, Pharam, phishing, pioneering, pose, posed, postmarket, predicate, preset, QSR, qualification, rebate, recency, reclassification, regular, reject, reload, RENASOL, rent, repaid, repair, repose, residing, resubmitted, route, rural, Sanderling, Smiley, sound, steadfast, streamlined, stricter, subset, succeeding, sum, switching, Tablo, telemedicine, tie, titled, Topic, tracking, transmit, trust, truthful, unannounced, unaware, uncleared, undergraduate, underserved, undisclosed, unpaid, unreliable, unscheduled, unskilled, untitled, Utah, Villanova, warning, west, winter, Zyla
Removed:
abandon, abandonment, accompanied, accurate, ad, adequately, administered, advanced, afforded, agreeing, Aid, alliance, anticoagulant, API, apparent, arranging, assigned, assignment, assume, authorization, balanced, biochemical, biological, bleach, BPCA, breadth, bringing, Canada, carryback, categorized, CFR, challenge, Children, Chile, Chioini, choose, claimed, clinically, commencement, condensed, contrast, credited, DEA, decide, declared, demonstration, derive, derived, descale, detailed, disagreement, discover, disinfection, distracting, dosage, dose, dosing, economically, educational, Ellison, employ, enabled, enlist, enroll, enrollment, entering, epidemic, Europe, European, exploring, fashion, feedback, fewer, force, foresee, forfeited, formulation, Fosun, foundational, frequent, gain, gallon, guide, halt, heparin, hinder, hospitalized, impossible, improving, IND, ineffective, inflammation, infringed, ingredient, initiated, inoperable, inter, interact, interference, invalidate, invest, investigating, Japan, joint, Klema, legislation, leveraging, maintained, majeure, McGarry, mentioned, metabolism, methodology, nonclinical, novelty, obsolete, open, Orange, orphan, overlap, partnering, path, Paul, payer, pertinent, Peru, pharmacologic, pharmacological, phase, pipeline, population, portrayal, PREA, preceding, predictive, preliminary, preserve, prioritizing, priority, proceeding, promising, prospectively, protective, proving, put, rare, recommend, redacted, reinstated, relief, removed, rendered, reproduce, requested, reserving, resume, robust, satisfied, scenario, seeking, sequential, Shanghai, shift, shipped, Skibsted, slowdown, solid, sparing, stage, stiff, strict, subpoena, subpopulation, suffered, TCJA, temporarily, therapeutic, therapy, thereunder, timeframe, timeline, travel, unforeseen, validity, varying, vitro, widely, withdraw
Financial report summary
?Risks
- Our A&R Loan Agreement with Innovatus contains certain covenants that could adversely affect our operations and, if an event of default were to occur, we could be forced to repay the outstanding indebtedness sooner than planned and possibly at a time when we do not have sufficient capital to meet this obligation. The occurrence of any of these events could cause a significant adverse impact on our business, prospects and share price.
- Our existing capital resources may not be adequate to finance our operating cash requirements for the length of time that we have estimated and additional capital that we may need to operate or expand our business may not be available.
- Our revenue growth and profitability projections are based on various assumptions that may not come to fruition.
- Our agreement with our largest customer in our concentrates business is set to expire on December 31, 2024 and our inability to negotiate a new agreement would have a material and adverse effect on our financial condition and results of operations.
- Market dynamics in our concentrates business have resulted in fluctuating volumes that could lead to the implementation of cost-saving measures that would have a material and adverse effect on our business.
- We may fail to realize the anticipated benefits of the Evoqua Acquisition, including an improved financial position, and those benefits may take longer to realize than expected.
- We depend on a third party to manufacture products for the business that was the subject of the Evoqua Acquisition. If this organization is unable or unwilling to manufacture our newly acquired concentrates products, or if the organization fails to comply with applicable regulations or otherwise fails to meet our requirements, our business will be harmed.
- We have been and may continue to be materially and adversely affected by increases in raw material, labor and transportation costs and may be unable to recover certain costs due to provisions in our largest customer contract and other fixed price contracts and we may lose other customers due to price sensitivity.
- A few customers account for a substantial portion of the end user sales of our concentrate products. The loss of any of these customers could materially and adversely affect our business, results of operations, financial position and cash flows.
- Unfavorable weather, economic conditions or supply shortages could materially and adversely affect our business, financial condition or results of operations.
- We face competition in the concentrates market and have a large competitor with substantial resources.
- Our production and other processes are largely manual, which introduces risk of error and may result in rising production costs.
- Our business depends on government funding of health care, and changes could impact our ability to be paid in full for our products, increase prices or cause consolidation in the dialysis provider market.
- Our medical device products are life sustaining and any failure to supply them to our customers and resulting scrutiny related to such circumstances could negatively impact our reputation and stock price.
- We may not be successful in expanding our business or in our business development efforts related to in-licensing, acquisitions or other business collaborations. Even if we are able to enter into business development arrangements, they could have a negative impact on our business and our profitability.
- Our international partnerships for Triferic involve risks that may materially impact those international relationships or our business generally.
- We have in-licensed rights to certain patents that cover Triferic. If we fail to remain in compliance with these license agreements, we could forfeit the rights to these patents, which could negatively impact our partners' ability to commercialize our products and result in our noncompliance with those partnership agreements.
- Our business and operations would suffer in the event of a security breach, system failure, invasion, corruption, destruction or interruption of our or our business partners’ critical information technology systems or infrastructure.
- Our future success depends on our ability to retain executives and key employees and to attract, retain and motivate qualified personnel in the future.
- We use hazardous materials, and any claims relating to improper handling, storage or disposal of these materials could be time consuming or costly.
- Our business operations may subject us to numerous commercial disputes, claims, lawsuits and/or investigations.
- We may become the target of litigation, which is costly and time-consuming to defend.
- Our products may have or have had undesirable side effects, and our product liability insurance may not be sufficient to protect us from material liability or harm to our business.
- We could be found to be infringing intellectual property rights of third parties, which could prevent us from selling products and could require us to pay significant damages and compel us to defend against litigation. We may be subject to claims that our employees or directors have wrongfully used or disclosed alleged trade secrets of their former employers.
- Our business could be impacted as a result of actions by activist stockholders, including as a result of a potential proxy contest for the election of directors at our annual meeting.
- The market price of our common stock has fluctuated in the past, and is likely to continue to be volatile, which could subject us to litigation.
- Shares eligible for future sale may affect the market price of our common stock.
- We may fail to qualify for continued listing on Nasdaq, which could make it more difficult for our stockholders to sell their shares.
- Our ability to use our net operating loss carryforwards to offset potential taxable income and related income taxes that would otherwise be due may be limited.
- We do not anticipate paying dividends in the foreseeable future.
- If securities analysts do not publish research or reports about our business, or if they publish negative evaluations, the price of our common stock could decline.
- Our business could be adversely affected by economic downturns, inflation, increases in interest rates, natural disasters, public health crises, political crises, geopolitical events, such as the crisis in Ukraine and the Middle East, or other macroeconomic conditions, which could have a material and adverse effect on our results of operations and financial condition.
- We are not subject to the provisions of Section 203 of the Delaware General Corporation Law, which could negatively affect your investment.
- Our certificate of incorporation provides that the Court of Chancery of the State of Delaware 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.
Management Discussion
- During the year ended December 31, 2023, our net sales were $83.6 million compared to net sales of $72.8 million during the year ended December 31, 2022. Net sales of hemodialysis concentrates to dialysis providers and distributors in the
- United States and abroad were $81.3 million for the year ended December 31, 2023 compared to $71.7 million for the year ended December 31, 2022. Net sales of Triferic (dialysate) were $2.3 million and $1.2 million for the years ended December 31, 2023 and 2022, respectively. The increase in net sales of Triferic (dialysate) was due to Wanbang's decision to not bring the product forward to registration. The increase of $10.8 million in net sales is primarily due to the restructuring of our products purchase agreement with DaVita, the reacquired rights to commercialize and distribute our products, the asset acquisition of Evoqua, onboarding of new customers and increased pricing to other customers. During 2022, the Company made a strategic decision to discontinue its NDAs for Triferic and Triferic AVNU in the United States.
- Cost of sales during the year ended December 31, 2023 was $74.9 million, resulting in gross profit of $8.7 million, compared to cost of sales of $68.7 million and a gross profit of $4.1 million during the year ended December 31, 2022. Gross profit increased by $4.6 million during the year ended December 31, 2023 compared to the year ended December 31, 2022 primarily due to the restructuring of our supply contract with DaVita in 2022, lower distribution costs, onboarding of new customers, increased pricing to other customers and net impact of recording the remaining deferred license revenue associated with Wanbang and the associated inventory reserve as described above.