Company – Scrape Financial
Risk Factors Summary

Risk Factors Update Summary

  • Company entered into a collaboration agreement with Takeda for rusfertide, receiving $300 million upfront and up to $330 million in milestone payments.
  • Failure to comply with regulations could impact potential royalties from worldwide net sales significantly.
  • Global sales for CD therapies increased from $16.2 billion in 2022 to $18.9 billion by 2028.
  • Failure to comply with internal control reporting requirements could lead to loss of investor confidence.
  • Sales of Entyvio ® by Takeda increased from approximately $5.6 billion to $6.4 billion.
  • Volatility in share price could subject us to securities class action litigation, impacting investor confidence.
  • Our current and future development and commercialization collaborations may not be successful. This could negatively impact operations, financial condition, and growth prospects.
  • Phase 3 VERIFY trial for rusfertide in PV initiated, with enrollment completion expected by Q1 2024.
  • Litigation or legal proceedings could severely harm collaborations and our ability to compete.
  • We rely on third parties for clinical trials and good manufacturing processes. Delays or issues could impact regulatory approval.
  • Positive topline results announced for rusfertide in PV, showing significant reduction in phlebotomy need.
  • Tremfya ® sales increased from $2.3 billion in 2021 to $3.1 billion in 2023.
  • Failure to maintain significant rights in collaborations may lead to disputes and impact future development.
  • JNJ-2113 Phase 2b trial results published, demonstrating efficacy in plaque psoriasis treatment.
  • Rusfertide Phase 2 trial results published in New England Journal of Medicine, showing durable hematocrit control.
  • Company earned milestone payments totaling $172.5 million from JNJ for JNJ-2113 development progress.
  • Initiated THRIVE, a Phase 2 long-term extension trial for rusfertide patients, showing positive long-term tolerability.

Full Text Changes in Most Recent 10-K

Intended use: review the highlighted statements. These are additions to the risk factors disclosure in the most recent 10-K filing compared to the previous 10-K filing. Deleted and moved text is less important and is shown for context.

To view the full company filings, click on the following link to be taken to the SEC EDGAR database landing page for the company: https://www.sec.gov/edgar/browse/?CIK=1377121&owner=exclude

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