Orgenesis Inc. (ORGS): history, ownership, mission, how it works & makes money

A Brief History of Orgenesis Inc. (ORGS)

Company Overview

Orgenesis Inc. is a biotechnology company focused on developing and commercializing cell and gene therapies. The company was founded in 2010 and is headquartered in Germantown, Maryland.

Development Milestones

• 2013: Orgenesis initiated its first clinical trials for its cell therapy products.
• 2016: The company completed its IPO, raising approximately $5.5 million.
• 2019: Orgenesis announced a partnership with Lonza, a global leader in cell and gene manufacturing.
• 2020: The company reported a significant milestone in its POCare® platform, enhancing the accessibility of its therapies.

Financial Performance

As of Q3 2023, Orgenesis reported the following financial metrics:

Recent Partnerships and Collaborations

Orgenesis has engaged in several strategic partnerships to advance its technology and therapy capabilities:

• 2021: Partnership with Tzamal Medical Center in Israel for the development of advanced cell therapies.
• 2022: Collaboration with the University of Pittsburgh to enhance cell therapy research.
• 2023: Joint venture announced with a European biotech firm to expand its European presence.

Market Position and Growth Prospects

As of 2023, Orgenesis has positioned itself favorably within the cell and gene therapy market, which is projected to reach $138 billion by 2026, growing at a CAGR of 30.7% from 2021 to 2026. The company's innovative POCare® platform is a key driver of its growth strategy.

Stock Performance

Orgenesis Inc. is traded on the NASDAQ under the ticker symbol ORGS. Recent stock performance data includes:

Research and Development Activities

Orgenesis has invested significantly in R&D, with expenditures reported as:

• 2020: $1.8 million
• 2021: $3.5 million
• 2022: $5.2 million
• 2023: Expected to exceed $6 million

Regulatory Approvals

The company has made strides in regulatory approvals:

• 2021: Achieved Orphan Drug Designation for its lead product candidate.
• 2022: Received Fast Track Designation from the FDA.

Future Directions

Looking ahead, Orgenesis aims to expand its pipeline of therapies and enhance its manufacturing capabilities through advancements in its proprietary technologies.

A Who Owns Orgenesis Inc. (ORGS)

Current Ownership Structure

The ownership of Orgenesis Inc. (ORGS) comprises a mix of institutional investors, insiders, and retail shareholders. As of the latest filings, the table below outlines the current ownership percentages among major shareholders:

Major Institutional Investors

Prominent institutional investors holding significant stakes in Orgenesis include:

Insider Holdings

Key insiders involved with Orgenesis and their respective holdings are as follows:

Recent Changes in Ownership

Over the past year, there have been notable changes in the ownership structure:

• The increase in institutional ownership by approximately 5% due to acquisitions.
• A decline in insider ownership percentage, down from 12% last year.
• Retail investors have shown increased interest, evidenced by a 10% growth in shares held.

Conclusion on Ownership Dynamics

The ownership dynamics of Orgenesis Inc. demonstrate a diverse and engaged shareholder base. Institutional investors and insiders play a crucial role in the company's governance and decision-making processes. Current statistics reflect an evolving landscape of ownership, with retail investors gaining a more significant foothold.

Orgenesis Inc. (ORGS) Mission Statement

Overview

Orgenesis Inc. focuses on advancing cell and gene therapies, offering solutions that empower the use of these innovative treatments globally. The company aims to democratize access to regenerative therapies through a robust platform that enhances manufacturing processes and patient access.

Core Values

• Innovation: Continuously develop and improve therapies for a range of diseases.
• Accessibility: Strive to make advanced treatments available to as many patients as possible.
• Collaboration: Partner with various stakeholders to enhance therapeutic reach and efficacy.
• Integrity: Maintain the highest ethical standards in all business practices.

Strategic Goals

The strategic objectives set forth by Orgenesis include:

• Expansion of cell and gene therapy platforms in collaboration with industry leaders.
• Investment in R&D to enhance the manufacturing capabilities of biologics.
• Global expansion to provide therapies across multiple markets.

Financial Highlights

Partnerships and Collaborations

Orgenesis emphasizes strategic partnerships to enhance its mission. Collaborations include:

• Tel Aviv University: Joint research initiatives in regenerative medicine.
• Mahidol University: Development of novel therapies for specific diseases.
• Leading Biopharmaceutical Companies: Leveraging their resources and expertise in manufacturing and distribution.

Patient-Centric Approach

Orgenesis’ mission statement emphasizes a patient-centric approach by:

• Providing tailored therapies based on individual patient needs.
• Engaging with patients and their families to understand treatment impacts.
• Utilizing feedback for continuous improvement of therapeutic offerings.

Regulatory Compliance and Quality Assurance

Orgenesis maintains strict adherence to regulatory standards, including:

• Compliance with FDA regulations for clinical trials.
• Continuous monitoring of manufacturing processes to ensure quality.
• Engagement with international regulatory bodies to align global practices.

Conclusion of Mission Alignment

Orgenesis Inc. aligns its mission statement with its operational strategies to ensure a focus on effective treatments and patient accessibility, supported by a robust financial and operational framework.

How Orgenesis Inc. (ORGS) Works

Business Model

Orgenesis Inc. operates primarily within the biopharmaceutical sector, focusing on the development and commercialization of innovative and transformative cell and gene therapies. The company leverages its proprietary technology platform to create and support cell therapies, specifically related to regenerative medicine and advanced therapies.

Technology Platform

The core technology of Orgenesis includes its POCare platform, a disruptive technology aimed at simplifying the manufacturing process of cell and gene therapies. This platform allows Orgenesis to produce therapies closer to the point of care.

Financial Performance

As of Q2 2023, Orgenesis reported revenues of approximately $4.3 million, compared to $6.5 million in the same period of the prior year. The decrease was largely attributed to changes in contract revenue.

Market Position

Orgenesis Inc. is situated within a rapidly growing market, with the global cell therapy market projected to reach $13.6 billion by 2026, growing at a CAGR of approximately 30.4%.

Partnerships and Collaborations

The company has engaged in several strategic partnerships to enhance its capabilities and expand its offerings. Notable collaborations include:

• Partnership with the NIH for developing cell therapy treatments.
• Collaboration with the University of Maryland for research on cell-based therapies.
• Agreement with various contract manufacturing organizations (CMOs) for production scalability.

Clinical Trials

Orgenesis is engaged in multiple clinical trials, including:

• Phase 1/2 Trial for liver-directed gene therapy.
• Phase 2 Trial assessing the efficacy of its cell therapy for autoimmune diseases.

Stock Performance

As of October 2023, Orgenesis Inc. has a market capitalization of approximately $48 million. The stock has shown fluctuations, with a 52-week range of $0.10 to $1.00. The current stock price stands at approximately $0.40.

Research and Development Expenditure

In 2022, Orgenesis allocated around $8 million towards research and development activities. This expenditure is crucial for advancing its therapeutic pipeline and enhancing its technology platform.

Global Reach

Orgenesis has established subsidiaries and partnerships in key global markets, including:

Future Outlook

Analysts forecast that Orgenesis Inc. anticipates significant growth, with projected revenues expected to reach approximately $20 million by 2025, driven by expanding partnerships and advancing clinical trials.

How Orgenesis Inc. (ORGS) Makes Money

Revenue Streams

Orgenesis Inc. generates revenue through several key streams, primarily focused on cell and gene therapies. The company monetizes through:

• Licensing agreements
• Partnerships with pharmaceutical companies
• Research and development services

Licensing Agreements

In 2022, Orgenesis entered into multiple licensing agreements with various biotech firms, receiving upfront payments amounting to approximately $5 million. Additionally, royalty payments from these agreements contributed around $2 million to annual revenue.

Partnerships with Pharmaceutical Companies

Collaborative partnerships are a cornerstone of Orgenesis's business model. For instance, the strategic alliance with a major pharmaceutical firm valued at $20 million has enabled co-development initiatives in advanced therapies, expected to generate substantial profit margins in the upcoming years.

Research and Development Services

Orgenesis also provides contract research and development services to other companies. In fiscal year 2022, revenues from R&D services reached $3.5 million, primarily derived from funded research projects. The company has a pipeline of over 10 projects expected to yield results in the next 3 to 5 years.

Financial Performance

In 2022, Orgenesis reported total revenues of $10 million, with a gross margin of approximately 50%. The company’s operating expenses were about $7 million, resulting in an operating income of $3 million.

Market Size and Potential

Investment and Funding

Orgenesis has successfully secured funding through equity financing. In Q1 2023, the company raised $11 million in a public offering. This capital is earmarked for expanding operational capabilities and advancing clinical trials for several therapies.

Cost Structure

The cost structure of Orgenesis is primarily composed of:

• Research and development costs: $4 million
• General and administrative expenses: $2 million
• Manufacturing costs: $1 million

Future Prospects

With ongoing clinical trials and multiple partnerships, Orgenesis anticipates an annual revenue growth of approximately 30% over the next five years, aiming for a revenue target of $50 million by 2028.