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Orgenesis Inc.

ORGS / NasdaqGS / $7.07

March 3, 2021

 

Business Overview

 

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Orgenesis Inc. (the Company) is developing point-of-care (POCare) solutions for development and commercialization of cell and gene therapies (CGTs), which are large and very rapidly growing markets. CGTs strive to prevent or treat human disease by administering to a patient his own cells that have been processed and treated ex vivo.

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CGTs are focused on a great variety of treatments, including cell-based immunotherapies, therapeutics for metabolic diseases, neurodegenerative diseases, and tissue regeneration.

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An industry source estimates that the annual global market for cell and gene medicines will expand sharply to approximately $150 billion by 2025.

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The POCare business model, initiated in second-quarter 2019, represents a paradigm shift in the industry, reflecting cell processing and treatment within the POCare setting; delivery of unique cell and gene therapy capabilities in a cost effective, high quality, and scalable manner; a global network of leading healthcare facilities; and an expanding therapeutic pipeline based on academic and hospital collaborations.

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The POCare platform is designed to help hospitals and academic institutions take innovative therapies from the research lab to the market and into patients at scale. The Company provides therapeutic product development assistance; POCare processing, manufacturing, and production expertise; therapeutic regulatory and clinical assistance; and therapeutic product commercialization and distribution.

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Management believes that an efficient POCcare system will lower the high costs of CGTs, including Immuno-oncology therapies by up to 90%.

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The Company has considerable validation of its IP strategy, as it has many licensed therapeutics and achieved technology milestones.

 

 

2021 Focus

 

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The worldwide CGT-related clinical trial pipeline bodes well for continuing expansion of the market.

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Management is striving to establish additional joint ventures with leading universities and healthcare institutions worldwide, thereby providing the Company with development funding for therapies, reducing risk, and creating a faster pathway to market versus the traditional biotech model.

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In October 2020, the Company announced completion of the acquisition of Koligo Therapeutics, Inc., a regenerative medicine company, and that it had acquired substantially all of the assets of Tissue Genesis, LLC, adding to a growing list of PICare technology resources.

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A February 2020 collaboration agreement with the John Hopkins University to develop and supply a variety of cell and gene therapies and technologies was the third major such agreement signed by an international institution in recent months.

 

 

Orgenesis Sold a Business to Focus on POCare Solutions for CGTs

 

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The Company generated significant value by building and selling its contract development manufacturing organization (Masthercell Global, Inc.) in February 2020. The revenues of that business had grown from $3 million in 2015 to a run rate of approximately $30 million.

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The sale price of $315 million generated net proceeds of $127 million.

 

 

Management

 

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The backgrounds of the management and directors are outlined on the ORGS website. The individuals have significant experience in CGTs and other biotechnologies, early stage companies, international marketing, as well as corporate finance and capital markets. Vered Caplan is the President and CEO.

 

 

Financials

 

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Income Statement (9 months through 09/30/20 vs. 09/30/19)

 

Revenue: 5,356,000 vs. 2,782,000

Operating income (loss): (42,851,000) vs. (17,156,000)

Other income (expense): (904,000) vs. (494,000)

Pretax income (loss): (43,755,000) vs. (17,750,000)

Net income (loss): (43,702,000) vs. (17,638,000)

Net income (loss) attributable to discontinued operations, net: 95,892,000 vs. (1,551,000)

Net income (loss) attributable to Orgenesis: 52,722,000 vs. (18,061,000)

Net income (loss) per diluted common share: 2.56 vs. (1.35)

 

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Balance Sheet (09/30/20)

 

Cash & equivalents: 88,758,000

Total current assets: 94,983,000

Total assets: 110,752,000

Current liabilities: 12,355,000

Long-term liabilities: 11,589,000

Equity attributable to Orgenesis Inc.: 86,660,000

Number of common shares outstanding (11/05/20): 24,156,183

 

 

Valuation Considerations

 

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The market for CGTs is large and growing rapidly. The Orgenesis POCare operations presently have only a small revenue base, but Orgenesis has plans to transform development and commercialization of various therapies through POCare solutions.

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The cash position is robust following sale of Masthercell Global, Inc. and a $9.2 million private placement in January 2020. New joint ventures might provide additional funding for therapies.

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On January 20, 2020, the Company sold 2,200,000 shares of its common stock at $4.20 per share; the buyers also received three-year warrants to purchase up to 1,000,000 common shares at $5.50 apiece. On March 18, 2020, ORGS filed an S-3 Registration Statement for those common and warrant shares.

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The impact from COVID-19 remains an uncertainly. In addition, the Company website and SEC filings list a number of risks and are hereby incorporated by reference.

 

 

Contact

 

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Website: http://www.orgenesis.com

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Executive offices: 20271 Goldenrod Lane, Germantown, MD 20876; Phone 480 659 6404

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Investor contact: David Waldman, Crescendo Communications, LLC; Phone 917.355.2239

 

 

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