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New words:
ASCT, ASR, ASU, BP, CEO, CODM, comfort, description, DLBCL, doubtful, enhance, enhanced, FASB, flat, Forteo, half, induction, instruction, leasehold, lenalidomide, men, NDMM, orcelizumab, path, PIDD, PSU, regularly, surrendered, TED, Topic, transition, uncollectible, VYVDURA
Removed:
abroad, abuse, ACA, acceleration, acceptable, acceptance, accommodate, accomplishment, accuracy, accurate, achieve, acquire, acquirer, acquiring, acting, adapt, added, adequately, administer, administering, advertise, advertising, affecting, afford, Affordable, aggressive, Alexion, allegedly, alternate, amortize, Amphadase, Amphastar, ANDA, animal, applicability, approve, articulate, articulated, asserted, assimilating, assume, Assuming, assure, AstraZeneca, attempt, attempted, attempting, attention, attract, attractive, attributable, augment, authority, automatic, Avid, avoid, batch, Bausch, begin, behalf, belonging, bill, bioanalytical, bioequivalence, biopharma, biosimilar, biotechnology, blueprint, borrow, bovine, breach, breakdown, bring, broad, broader, brought, bull, CABENUVA, California, cancellation, capacity, Carlo, carry, Catalent, catastrophic, category, center, cessation, cGMP, challenge, challenged, challenging, charter, chemistry, choice, civil, clarity, clearance, 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hired, hold, holding, Horizon, hospital, hypogonadotropic, IMA, immaterial, impair, impede, implement, implementation, implemented, implementing, import, important, importation, impose, imposed, imposing, imposition, improperly, improving, inability, incentivize, incidence, inconsistent, incorporated, incorporation, incorrect, increasingly, incumbent, incurring, independent, independently, index, Indiana, indirect, induced, inducement, inflation, influence, informal, infrequent, infringe, infringed, infringement, infringing, ingredient, inhibit, injured, innovation, innovative, inspection, instance, institutional, insufficient, insurer, integrated, integrating, integrity, interference, Internet, interpretation, interpreting, interrupted, interruption, introduced, introduction, intrusion, investigate, investigation, invoicing, involving, irrespective, ITP, jeopardized, Jersey, judicial, justify, knowledge, labeled, labeling, lack, landscape, larger, largest, lawsuit, led, legality, Legally, legislation, legislative, leveraged, liable, likelihood, Likewise, limit, limiting, Lipocine, list, lose, lowest, MAA, maintained, maintaining, managed, mandated, manner, marketplace, Medicaid, Medicare, medication, meeting, Mellon, mentioned, merger, merit, methodology, Minnesota, Minnetonka, misappropriation, misleading, Mitigation, mix, mode, Modernization, modify, monetary, monitored, monitoring, Monte, motivate, musculoskeletal, narrow, narrower, natural, negatively, nomination, nonclinical, noncompetitive, noncompliance, observed, Office, official, operation, opposition, oral, overseeing, ovine, owing, owner, packaging, painful, pandemic, participate, passing, patentability, patentable, pathway, payer, PDA, penalize, penalty, pending, perception, periodic, permissible, permit, permitting, person, personal, pertaining, physician, plant, plc, pledged, political, positively, power, practitioner, precedent, preclude, predict, premarket, prepare, preparing, prescribe, prescribing, presence, President, pressure, prevent, prevented, privacy, privately, pro, proceeding, procure, producing, prohibit, prohibitive, projected, promising, promote, promoted, promoting, promotion, promotional, properly, propose, proposed, protect, protecting, proven, proxy, publicly, pursuit, putative, PV, qualified, qualifying, quality, quantity, question, quickly, ram, rapidly, rare, realize, recall, recordkeeping, recover, recurrence, reevaluate, refile, refinance, refusal, refuse, registration, regulate, regulated, reimbursed, reimbursement, reject, released, relief, rely, remain, removed, removing, render, rendering, renew, repay, repayment, represented, reputational, request, requirement, rescinded, resignation, resolution, resolve, resource, responding, restated, restating, restrict, restrictive, restructuring, resulted, retain, retire, reveal, revocation, revoked, revoking, risky, routinely, run, sabotage, safe, safer, sample, San, scale, schedule, scientific, scope, scrutiny, Seasoned, secure, seize, seizure, Senate, sensitive, shareholder, shift, ship, shipping, short, shortening, show, simulation, size, skin, Social, sophisticated, spending, spent, staffing, stopped, storage, store, stored, storing, strategy, stream, streamlined, strength, subsidiary, substance, substantial, substantially, substitutability, substitution, successfully, suffer, sumatriptan, sunshine, supplied, suspend, suspended, suspension, sustain, takeover, targeting, TE, team, technical, technological, TEPEZZA, theft, thrombocytopenia, tie, tier, titled, TLANDO, toxicity, tracing, tracking, trademark, train, trained, transparency, travel, treated, treble, trend, Trump, Trust, trustee, truthful, unapproved, unattractive, unauthorized, unavailable, uncertain, unchanged, undecanoate, unexpected, Union, unique, Unlimited, unmet, unpatented, unpredictable, unproven, unresolvable, unrest, unsuccessful, unwilling, updated, usage, utilize, validity, variation, variety, viable, view, violation, visible, Vitrase, voluntarily, voluntary, voting, vulnerability, warehousing, warning, wide, withdrawal, withdrawn, withheld, workforce, world, write, wrongful, York
Financial report summary
?Risks
- If our partnered or proprietary product candidates do not receive and maintain regulatory approvals, or if approvals are not obtained in a timely manner, such failure or delay would substantially impact our ability to generate revenues.
- Use of our partnered or proprietary products and product candidates could be associated with adverse events or product recalls.
- If our contract manufacturers or vendors are unable or unwilling for any reason to manufacture and supply to us bulk rHuPH20 or other raw materials, reagents, components or devices in the quantity and quality required by us or our partners for use in the production of our proprietary or partnered products and product candidates, our and our partners’ product development and commercialization efforts could be delayed or stopped and our business results associated with operations and our collaborations could be harmed.
- We rely on third parties to perform necessary services for our products including services related to the distribution, invoicing, rebates and contract administration, co-pay program administration, sample distribution and administration, storage and transportation of our products. If anything should impede their ability to meet their commitments this could impact our business performance.
- If we or any party to a key collaboration agreement fail to perform material obligations under such agreement, or if a key collaboration agreement is terminated for any reason, our business could suffer.
- Hylenex and our partners’ ENHANZE products and product candidates rely on the rHuPH20 enzyme, and any adverse development regarding rHuPH20 could substantially impact multiple areas of our business, including current and potential ENHANZE collaborations, as well as any proprietary programs.
- Our business strategy is focused on growth of our ENHANZE and auto-injector technologies, our commercial products and potential growth through acquisition. Currently, ENHANZE is the largest revenue driver and as a result there is a risk for potential negative impact from adverse developments. Future expansion of our strategic focus to additional applications of our ENHANZE technology or by acquiring new technologies may require the use of additional resources, result in increased expense and ultimately may not be successful.
- Our partnered or proprietary product candidates may not receive regulatory approvals or their development may be delayed for a variety of reasons, including delayed or unsuccessful clinical trials, regulatory requirements or safety concerns. If we or our partners fail to obtain, or have delays in obtaining, regulatory approvals for any product candidates, our business, financial condition and results of operations may be materially adversely affected.
- Our third-party partners are responsible for providing certain proprietary materials that are essential components of our partnered products and product candidates, and any failure to supply these materials could delay the development and commercialization efforts for these partnered products and product candidates and/or harm our collaborations. Our partners are also responsible for distributing and commercializing their products, and any failure to successfully commercialize their products could materially adversely affect our revenues.
- If we or our partners fail to comply with regulatory requirements applicable to promotion, sale and manufacturing of approved products, regulatory agencies may take action against us or them, which could harm our business.
- Failure of our auto-injector and specialty products business to perform could adversely impact future business and operations.
- Business interruptions resulting from pandemics or similar public health crises could cause a disruption of the development of our and our partnered product candidates and commercialization of our approved and our partnered products, impede our ability to supply bulk rHuPH20 to our ENHANZE partners or procure and sell our proprietary products and otherwise adversely impact our business and results of operations.
- We may need to raise additional capital in the future and there can be no assurance that we will be able to obtain such funds.
- We currently have significant debt and may incur additional debt. Failure by us to fulfill our obligations under the applicable debt agreements may cause repayment obligations to accelerate.
- The conditional conversion feature of the Convertible Notes, if triggered, may adversely affect our financial condition and operating results.
- Conversion of our Convertible Notes may dilute the ownership interest of existing stockholders or may otherwise depress the price of our common stock.
- If proprietary or partnered product candidates are approved for commercialization but do not gain market acceptance resulting in commercial performance below that which was expected or projected, our business may suffer.
- Our ability to license our ENHANZE and device technologies to our partners depends on the validity of our patents and other proprietary rights.
- Developing, manufacturing and marketing pharmaceutical products for human use involves significant product liability risks for which we may have insufficient insurance coverage.
- If our partners do not achieve projected development, clinical, or regulatory goals in the timeframes publicly announced or otherwise expected, the commercialization of our partners products may be delayed and, as a result, our business, financial condition, and results of operations may be adversely affected.
- Future acquisitions could disrupt our business and impact our financial condition.
- Our effective tax rate may fluctuate, and we may incur obligations in tax jurisdictions in excess of accrued amounts.
- Our stock price is subject to significant volatility.
- Future transactions where we raise capital may negatively affect our stock price.
- Anti-takeover provisions in our charter documents, the Indentures and Delaware law may make an acquisition of us more difficult.
- Our and our partnered products must receive regulatory approval before they can be sold, and compliance with the extensive government regulations is expensive and time consuming and may result in the delay or cancellation of our or our partnered product sales, introductions or modifications.
- Because some of our and our partners’ products and product candidates are considered to be drug/device combination products, the approval and post-approval requirements that we and they are required to comply with can be more complex.
- We may be subject, directly or indirectly, to various broad federal and state healthcare laws. If we are unable to comply, or have not fully complied, with such laws, we could face civil, criminal and administrative penalties, damages, monetary fines, disgorgement, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings and curtailment or restructuring of our operations, any of which could adversely affect our ability to operate.
- We may be required to initiate or defend against legal proceedings related to intellectual property rights, which may result in substantial expense, delay and/or cessation of certain development and commercialization of our products.
- We may incur significant liability if it is determined that we are promoting or have in the past promoted the “off-label” use of drugs or medical devices, or otherwise promoted or marketed approved products in a manner inconsistent with the FDA’s requirements.
- For certain of our products, we and our independent contractors, distributors, prescribers, and dispensers are required to comply with regulatory requirements related to controlled substances, which will require the expenditure of additional time and will incur additional expenses to maintain compliance and may subject us to additional penalties for noncompliance, which could inhibit successful commercialization.
- Patent protection for biotechnology inventions and for inventions generally is subject to significant scrutiny; if patent laws or the interpretation of patent laws change, our business may be adversely impacted because we may lose the ability to obtain patent protection or enforce our intellectual property rights against competitors who develop and commercialize products based on our discoveries.
- If third-party reimbursement and customer contracts are not available, our proprietary and partnered products may not be accepted in the market resulting in commercial performance below that which was expected or projected.
- The rising cost of healthcare and related pharmaceutical product pricing has led to cost containment pressures from third-party payers as well as changes in federal coverage and reimbursement policies and practices that could cause us and our partners to sell our products at lower prices, and impact access to our and our partners’ products, resulting in less revenue to us.
- We face competition and rapid technological change that could result in the development of products by others that are competitive with our proprietary and partnered products, including those under development.
- If we are unable to attract, hire and retain key personnel our business could be negatively affected.
- Our operations might be interrupted by the occurrence of a natural disaster or other catastrophic event.
- Cyberattacks, security breaches or system breakdowns may disrupt our operations and harm our operating results and reputation.
Management Discussion
- The increase in royalties was primarily driven by continued sales uptake of DARZALEX SC by Janssen and Phesgo by Roche in all geographies and the launch of Vyvgart by argenx, partially offset by slightly lower sales of Herceptin SC and MabThera SC by Roche. We expect royalty revenue to continue to grow as a result of our 2020 and 2023 ENHANZE partner product launches, offsetting the ongoing impact from IV biosimilars on pricing of mature partner products delivered SC with ENHANZE and the impact of a royalty rate reduction in March of 2024 for certain sales of DARZALEX SC outside of the U.S.
- The decrease in product sales, net was primarily due to lower sales of bulk rHuPH20 due to the timing of shipment to our partners, partially offset by contributions from our proprietary and device partnered products. We expect sales of our proprietary products will grow in future years as we continue to gain market share in the TRT market. We expect product sales of bulk rHuPH20 and device partnered products to fluctuate in future periods based on the needs of our partners.
- The increase in revenues under collaborative agreements was primarily due to the timing of milestones driven by partner activities. Revenue from upfront licenses fees, license fees for the election of additional targets, license maintenance fees and other license fees and event-based payments vary from period to period based on our ENHANZE collaboration activity. We expect these revenues to continue to fluctuate in future periods based on our partners’ ability to meet various clinical and regulatory milestones set forth in such agreements and our ability to obtain new collaborative agreements.