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Endo, Inc. (OTCQX: NDOI) is a diversified specialty pharmaceutical company focused on developing and delivering life-enhancing therapies. With a commitment to creating value for shareholders, Endo is dedicated to transforming insights into essential medicines to help individuals live their best life. The company recently commenced trading on the OTCQX Best Market under the ticker symbol NDOI, signaling its dedication to providing a valuable trading experience for U.S. investors and institutions.
Endo (OTCQX: NDOI) presented data from a Phase 2 clinical study of collagenase clostridium histolyticum (CCH) in patients with plantar fibromatosis at the American Orthopaedic Foot & Ankle Society's annual meeting. The study showed a trend in CCH treatment effect over placebo for reducing pain, as measured by the Foot Function Index Total Pain subscale score. There were also nominally significant improvements in investigator assessment, nodular hardness, and nodule consistency. The safety profile of CCH was consistent with previous studies, with most adverse events being local and mild to moderate. No treatment-related serious adverse events were reported. Endo is currently enrolling patients for a pivotal Phase 3 program for CCH in plantar fibromatosis.
Endo, Inc. (OTCQX: NDOI) has announced a CEO transition. The Board of Directors has initiated a search for a new CEO, with Spencer Stuart assisting in the process. Blaise Coleman will depart as President & CEO and from the Board on August 29, 2024. Scott Hirsch, who joined the Board in April 2024, has been appointed as Interim CEO.
Hirsch brings over 20 years of experience in healthcare and was formerly the CEO of Solta Medical. The Board aims to find a new chief executive to guide Endo through its next phase of development, including the goal of re-listing on a national stock exchange. The company is focusing on execution across its branded, sterile injectables, and generics portfolios to position for long-term growth.
Endo Inc. (OTCQX: NDOI) reported its Q2 2024 financial results, showing mixed performance across segments. Total revenues decreased 18% to $447 million compared to Q2 2023, primarily due to declines in Generic Pharmaceuticals and Sterile Injectables segments. However, the Branded Pharmaceuticals segment grew 6% to $225 million, driven by an 8% increase in XIAFLEX® revenues to $127 million. The company reported a net income of $6.38 billion, largely due to gains from restructuring.
Endo raised its 2024 financial outlook, now expecting total revenues of $1.72-$1.78 billion and adjusted EBITDA of $635-$655 million. For 2025, the company projects low-single digit revenue growth and mid to high-single digit adjusted EBITDA growth. The company ended Q2 2024 with $294 million in cash and cash equivalents.
Endo (OTCQX: NDOI) presented new data on collagenase clostridium histolyticum (CCH) and plantar fibromatosis at the American Podiatric Medical Association's annual meeting. The presentations included results from a Phase 2 study of CCH in plantar fibromatosis patients and a retrospective analysis of patient medical records.
Key findings from the Phase 2 study showed:
- A trend in CCH treatment effect over placebo for reducing pain
- Nominally significant improvements in investigator assessment, nodular hardness, and nodule consistency
- A safety profile consistent with previous CCH studies
The retrospective analysis of 2,273 patient charts revealed that nearly two-thirds of patients reported foot pain, with 90% describing it as moderate or severe. Endo is currently enrolling patients in a Phase 3 study to further explore CCH as a potential nonsurgical treatment option for plantar fibromatosis.
Endo, Inc. (OTCQX: NDOI) has announced that it will release its second quarter 2024 financial results on August 27, 2024, before the market opens. The company's senior management team will host a conference call and live webcast for investors at 8:00 a.m. ET on the same day. Investors can participate by dialing 800-836-8184 (U.S. and Canada toll-free) or 646-357-8785 (outside the U.S.), or by joining the live webcast through a provided link. Participants are advised to join 10 minutes before the scheduled start time. A replay of the webcast will be available within 24 hours on the company's investor relations website.
Endo, Inc. (OTCQX: NDOI) announced that the SEC has declared effective its Form S-1 registration statement for the resale of existing shares held by current shareholders. This move aims to enhance shareholder liquidity and create an orderly trading market for its common stock. Importantly, no new shares are being issued or sold, and the number of outstanding shares remains unchanged.
The company is now subject to the Securities Exchange Act of 1934, requiring regular SEC filings. Endo is targeting to list on the NYSE later in 2024, subject to approvals and conditions. Currently, Endo's shares trade on the OTCQX® Best Market, with financial disclosures and trading statistics available on www.otcmarkets.com.
Endo (OTCQX: NDOI) has released its annual Corporate Responsibility Report for 2023, highlighting progress across four key pillars: Business Practices, Team, Customers, and World. Notable achievements include:
Business Practices: 99.8% on-time completion rate for information security training, 99% awareness of ethical reporting procedures, and a 200% increase in LGBTQ-owned suppliers.
Team: Improved safety with a 0.1 Recordable Incident Rate, 16% internal promotion rate, and 2,000 volunteer hours in India.
Customers: 1,200 improvement ideas submitted, establishment of a Clinical Advisory Board, and donation of 402,000 medicine units to 23 countries.
World: 10% increase in recycling, 15% reduction in emissions, and improved water stewardship.
Endo USA, Inc., a subsidiary of Endo, Inc (OTCQX: NDOI), has issued a voluntary nationwide recall of one lot of Clonazepam Orally Disintegrating Tablets, USP (C-IV) due to mislabeling. The recall affects lot number 550147301, where some cartons incorrectly show the strength as 0.125 mg instead of 0.25 mg. This error poses potential risks, including significant sedation, dizziness, and respiratory depression.
The affected product was distributed to retail pharmacies nationwide. Endo is notifying wholesalers and retailers, arranging for the return of existing inventory. Consumers are advised to discontinue use of the product and consult a physician if they inadvertently took a higher dose. No adverse events have been reported to date.
Endo (OTCQX: NDOI) has launched tiopronin delayed-release tablets, a generic version of Travere Therapeutics' THIOLA EC®. This medication is used to prevent cystine kidney stones in certain adult and pediatric patients. Endo is offering copay assistance for eligible patients. The launch strengthens Endo's generic product portfolio and reinforces its position as a reliable supplier.
The drug is indicated for use in combination with high fluid intake, alkali, and dietary changes. It is approved for adults and children 9 years and older with severe homozygous cystinuria who don't respond to other measures alone. Key safety information includes contraindications for hypersensitivity, warnings about proteinuria, and common adverse reactions such as nausea and rash.
Endo, a specialty pharmaceutical company, has filed a registration statement on Form S-1 with the SEC to register certain shares of common stock held by current shareholders. The company emphasizes there will be no new shares issued or sold, and the total number of outstanding shares remains unchanged. The registration statement is part of Endo's strategy to list its common stock on the NYSE, expected later in 2024, pending SEC approval and other customary conditions. Currently, Endo's stock trades on the OTCQX® Best Market, where U.S. investors can access financial disclosures and trading statistics. This release does not constitute an offer to sell or buy securities.
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