Orgenesis Second Quarter 2021 Revenue Increases Over Six-Fold to $10.5 Million Compared to Second Quarter 2020 Reflecting Continued Progress of POCare Platform

Rhea-AI Summary

Orgenesis Inc. (NASDAQ: ORGS) reported a remarkable increase in POCare revenues, surging to $10.5 million for Q2 2021, a more than six-fold rise from $1.75 million in Q2 2020. This growth is attributed to enhanced technology transfer and expansion of partnerships within its POCare network. The company aims to address industry bottlenecks in cell and gene therapy production by offering a decentralized supply model. Orgenesis continues adding advanced clinical trials and expanding its global partnerships, including collaborations with notable healthcare institutions like Johns Hopkins University.

Positive

• Revenue increased to $10.5 million in Q2 2021, up from $1.75 million in Q2 2020.
• Expansion of the POCare Network through new joint ventures and global partnerships.
• Advancements in POCare therapeutic pipeline with multiple development milestones achieved.
• Positive feedback from industry stakeholders regarding the decentralized supply model.

Negative

• None.

Orgenesis to host conference call today at 8:30AM ET

GERMANTOWN, Md., Aug. 05, 2021 (GLOBE NEWSWIRE) -- Orgenesis Inc. (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a global biotech company working to unlock the full potential of cell and gene therapies, today reported financial results for the second quarter ended June 30, 2021.

Vered Caplan, CEO of Orgenesis, stated, “I am pleased to report that our POCare revenues for the second quarter of 2021 increased more than six-fold to $10.5 million compared to $1.75 million for the second quarter of last year, which reflects the sustainability of our POCare strategy. The increase in our revenue is attributable to technology transfer, setup, scale up and validation of our therapeutic pipeline and point-of-care systems for clinical use through long-term contracts with our regional partners. We are rapidly gaining traction with our POCare Platform and continue to add new POCare therapies, technologies, and a growing global network through collaborations with research centers, hospitals and biotech companies.   With the explosive growth of the cell and gene therapy market, the industry faces major bottlenecks and capacity shortages, reflected in the exorbitant costs and manufacturing delays for these therapies. We believe that the current supply models are not optimal for this exciting stage of biotech innovation, both for smaller developers unable to secure capacity and larger developers investing heavily for capacity that may take years before coming online. We believe our strategy of decentralized supply of cell and gene therapies based on standardization of the manufacturing environment could be a solution for this industry, by potentially enabling lower costs, accelerating development and, once validated, could directly address the industry-wide capacity constraints. Current feedback from within the industry has been overwhelmingly positive.”

“We continue to grow our POCare Network via new joint ventures and partnerships with leading hospitals and research institutes in various countries across North America, Europe, Asia, and the Middle East. As an example, we recently entered into an agreement with a local partner to expand our POCare network in Australia. Importantly, each of our partners have committed to support the validation, development, and clinical trials of our advanced therapies and systems in their respective markets. In turn, Orgenesis typically grants its partners geographic rights in exchange for future royalties, and a partnership with Orgenesis to support the supply of the targeted therapies. We believe this is a highly scalable model that de-risks development through outside support from our partners. Moreover, our current reported revenues reflect the validation phase of our roll-out strategy. As we advance the respective point-of-care therapies being developed and validate our decentralized supply model through various regulatory pathways, we expect to increasingly benefit from revenue sharing and royalty agreements with our respective partners, while having the flexibility to rapidly increase capacity in line with demand.”

“We are also expanding our collaboration with a number of leading global healthcare institutions, such as Johns Hopkins University, where we are establishing a point of care development center and are advancing a similar collaboration with UC Davis in California. We are investing to add capacity at a variety of locations in the US and, as an example, we recently began setting up an additional center in the Boston area. Additionally, we have added a number of similar locations across Europe and other territories around the world.”

“At the same time, we are incorporating into our clinical activity a number of highly advanced, automated POCare technologies. As an example, we have commenced enrollment for a Phase 2 clinical trial using the Tissue Genesis Icellator^® at the Hospital for Special Surgery (“HSS”) in New York. Orgenesis acquired the Tissue Genesis’ Icellator technology in October 2020. Designed to be used at the point-of-care, the Tissue Genesis Icellator^® is a practical and cost-effective solution for clinical applications of stromal and vascular cells (SVF) from autologous adipose (fat) tissue. Data from this study may support expanded development of the Icellator in other orthopedic applications.   Meanwhile, we are advancing the role out of our Orgenesis Mobile Processing Units & Labs (OMPULs) as a rapid, standardized industrial cleanroom alternative at the point of care.”

“Our progress can also be seen in the advancement of our POCare therapeutic pipeline, spanning immuno-oncology, anti-viral, metabolic/auto-immune diseases, tissue regeneration and more. Our goal is to make these therapies available to large numbers of patients at reduced costs using the point-of-care model. Most recently, in June 2021, we achieved multiple Ranpirnase development milestones following our acquisition of the Tamir Biotechnology assets last year.   We are engaging in additional collaborations to advance our therapeutic pipeline, including collaborations with technology providers for the development of new manufacturing methods for tumor-infiltrating lymphocytes (TIL) and CAR-T/CAR-NK-based therapies. In addition to our technical and manufacturing expertise, we also provide our partners with extensive support for quality assurance, regulatory, and clinical development utilizing our internal expertise with the aim of accelerating the development and commercialization pathway.”

“We have expanded our internal capabilities, including recruitment of leading industry experts to capitalize on this unique opportunity to potentially transform the cell and gene therapy market. We continue to maintain a strong balance sheet with sufficient capital to fund development of our POCare strategy. Our goal is to validate our POCare platform, while building the foundations for our market expansion in the various geographic regions. We look forward to providing further updates as we work in close collaboration with our partners to enable POCare supply worldwide.”

The Company’s complete financial results are available in the Company’s Form 10-Q that will be filed with the Securities and Exchange Commission on August 5, 2021 and which is available at www.sec.gov and on the Company’s website.

Conference Call

The Company plans to host a conference call at 8:30 AM Eastern Time today, August 5, 2021, to discuss the Company’s financial results for the second quarter ended June 30, 2021, as well as the Company’s corporate progress and other developments.

The conference call will be available via telephone by dialing toll free 844-407-9500 for U.S. callers or for international callers +1 862-298-0850. A webcast of the call may be accessed at https://www.webcaster4.com/Webcast/Page/2585/42425 or on the Company’s Investor Events section of the website here.

A webcast replay will be available on the Company’s Investor Events section of the website (https://ir.orgenesis.com/events#/) through Friday, August 5, 2022. A telephone replay of the call will be available approximately one hour following the call, through Thursday, August 19, 2021 and can be accessed by dialing 877-481-4010 for U.S. callers or +1 919-882-2331 for international callers and entering conference ID: 42425.

About Orgenesis

Orgenesis is a global biotech company working to unlock the full potential of cell and gene therapies (CGTs) in an affordable and accessible format. The Orgenesis Point of Care Platform is comprised of three enabling components: a pipeline of licensed POCare Therapeutics that are processed and produced in closed, automated POCare Technology systems across a collaborative POCare Network. Orgenesis identifies promising new therapies and leverages its POCare Platform to provide a rapid, globally harmonized pathway for these therapies to reach and treat large numbers of patients at lowered costs through efficient, scalable, and decentralized production. The POCare Network brings together patients, doctors, industry partners, research institutes and hospitals worldwide to achieve harmonized, regulated clinical development and production of the therapies. Learn more about the work Orgenesis is doing at www.orgenesis.com.

Notice Regarding Forward-Looking Statements
This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended. These forward-looking statements involve substantial uncertainties and risks and are based upon our current expectations, estimates and projections and reflect our beliefs and assumptions based upon information available to us at the date of this release. We caution readers that forward-looking statements are predictions based on our current expectations about future events. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions that are difficult to predict. Our actual results, performance or achievements could differ materially from those expressed or implied by the forward-looking statements as a result of a number of factors, including, but not limited to, our reliance on, and our ability to grow, our point-of-care cell therapy platform, our ability to achieve and maintain overall profitability, our ability to manage our research and development programs that are based on novel technologies, our ability to control key elements relating to the development and commercialization of therapeutic product candidates with third parties, the timing of completion of clinical trials and studies, the availability of additional data, outcomes of clinical trials of our product candidates, the potential uses and benefits of our product candidates, our ability to manage potential disruptions as a result of the coronavirus outbreak, the sufficiency of working capital to realize our business plans, the development of our POCare strategy, our trans differentiation technology as therapeutic treatment for diabetes, the technology behind our in-licensed ATMPs not functioning as expected, our ability to further our CGT development projects, either directly or through our JV partner agreements, and to fulfill our obligations under such agreements, our license agreements with other institutions, our ability to retain key employees, our competitors developing better or cheaper alternatives to our products and the risks and uncertainties discussed under the heading "RISK FACTORS" in Item 1A of our Annual Report on Form 10-K for the fiscal year ended December 31, 2020, and in our other filings with the Securities and Exchange Commission. We undertake no obligation to revise or update any forward-looking statement for any reason.

IR contact for Orgenesis:
David Waldman
Crescendo Communications, LLC
Tel: 212-671-1021
ORGS@crescendo-ir.com

Media contact for Orgenesis
Image Box Communications
Neil Hunter / Michelle Boxall
Tel +44 (0)20 8943 4685
neil@ibcomms.agency / michelle@ibcomms.agency

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ORGENESIS INC. CONDENSED CONSOLIDATED BALANCE SHEETS (U.S. Dollars in Thousands) (Unaudited)
		As of
		June 30, 2021				December 31, 2020
Assets
CURRENT ASSETS:
Cash and cash equivalents		$	28,431			$	44,923
Restricted cash			481				645
Accounts receivable, net			17,196				3,085
Prepaid expenses and other receivables			1,399				1,070
Grants receivable			168				169
Inventory			173				185
Total current assets			47,848				50,077
NON-CURRENT ASSETS:
Deposits		$	361			$	296
Investments in associates, net			160				175
Property, plant and equipment, net			4,100				3,073
Intangible assets, net			12,435				13,023
Operating lease right-of-use assets			1,253				1,474
Goodwill			8,599				8,745
Other assets			802				821
Total non-current assets			27,710				27,607
TOTAL ASSETS		$	75,558			$	77,684

ORGENESIS INC. CONDENSED CONSOLIDATED BALANCE SHEETS (Cont’d) (U.S. Dollars in Thousands) (Unaudited)
		As of
		June 30, 2021				December 31, 2020
Liabilities and Equity
CURRENT LIABILITIES:
Accounts payable		$	5,212			$	8,649
Accrued expenses and other payables			2,553				792
Income tax payable			7				7
Employees and related payables			1,971				1,463
Advance payments on account of grant			1,137				692
Short-term loans and current maturities of long- term loans			-				145
Contract liabilities, mainly related party			59				59
Current maturities of finance leases			19				19
Current maturities of operating leases			479				485
Current maturities of convertible loans			6,719				3,974
Total current liabilities			18,156				16,285
LONG-TERM LIABILITIES:
Non-current operating leases		$	792			$	1,020
Convertible loans			4,656				7,200
Retirement benefits obligation			98				74
Non-current finance leases			52				64
Other long-term liabilities			304				313
Total long-term liabilities			5,902				8,671
TOTAL LIABILITIES			24,058				24,956
EQUITY:
Common stock, par value $0.0001 per share, 145,833,334 shares authorized, 24,537,366 and 24,223,093 shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively			3				3
Additional paid-in capital			143,197				140,397
Accumulated other comprehensive income			519				748
Treasury stock 262,090 and 55,309 shares as of June 30, 2021 and December 31, 2020, respectively			(1,159	)			(250	)
Accumulated deficit			(91,197	)			(88,319	)
Equity attributable to Orgenesis Inc.			51,363				52,579
Non-controlling interest			137				149
Total equity			51,500				52,728
TOTAL LIABILITIES AND EQUITY		$	75,558			$	77,684

ORGENESIS INC. CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (U.S. Dollars in Thousands, Except Share and Loss Per Share Amounts) (Unaudited)
		Three Months Ended								Six Months Ended
		June 30, 2021				June 30, 2020				June 30, 2021					June 30, 2020
Revenues		$	9,818			$	1,470			$	18,050			$	2,855
Revenues from related party			727				279				1,884				772
Total revenues			10,545				1,749				19,934				3,627
Cost of services and other research and development expenses			9,727				24,963				15,854				29,836
Amortization of intangible assets			239				(52	)			477				171
Selling, general and administrative expenses			2,901				3,611				5,869				7,129
Other income, net			(3	)			(1	)			(28	)			(4	)
Operating loss (income)			2,319				26,772				2,238				33,505
Financial expenses, net			406				337				639				666
Share in net loss of associated companies			-				-				15				-
Loss from continuing operation before income taxes			2,725				27,109				2,892				34,171
Tax income			-				12				(2	)			(35	)
Net loss from continuing operation			2,725				27,121				2,890				34,136
Net income from discontinued operations, net of tax			-				(6,721	)			-				(83,186	)
Net loss (income)			2,725				20,400				2,890				(49,050	)
Net loss (income) attributable to non-controlling interests from continuing operation			(66	)			6				(12	)			(33	)
Net loss attributable to non-controlling interests from discontinued operations			-				-				-				(492	)
Net loss (income) attributable to Orgenesis Inc.			2,659				20,406				2,878				(49,575	)
Loss (Earning) per share:
Basic and diluted from continuing operations		$	0.11			$	1.26			$	0.12			$	1.73
Basic and diluted from discontinued operations		$	-			$	(0.31	)		$	-			$	(4.52	)
Basic and diluted		$	0.11			$	0.95			$	0.12			$	(2.79	)
Weighted average number of shares used in computation of Basic and Diluted loss per share:
Basic and diluted			24,365,746				21,515,254				24,279,826				19,648,042
Comprehensive loss (income):
Net loss from Continuing Operation		$	2,725			$	27,121			$	2,890			$	34,136
Net income from Discontinued Operations, Net of Tax			-				(6,721	)			-				(83,186	)
Other Comprehensive loss – Translation adjustment			(48	)			(247	)			229				397
Release of translation adjustment due to sale of subsidiary			-				-				-				(194	)
Comprehensive loss (income)			2,677				20,153				3,119				(48,847	)
Comprehensive loss (income) attributed to non-controlling interests from continuing operation			(66	)			6				(12	)			(33	)
Comprehensive income attributed to non-controlling interests from discontinued operation			-				-				-				(492	)
Comprehensive loss (income) attributed to Orgenesis Inc.		$	2,611			$	20,159			$	3,107			$	(49,372	)

FAQ

What were Orgenesis's financial results for Q2 2021?

Orgenesis reported a revenue of $10.5 million for Q2 2021, a significant increase compared to $1.75 million in Q2 2020.

What is the POCare strategy of Orgenesis?

The POCare strategy involves providing decentralized supply of cell and gene therapies to address industry bottlenecks and accelerate development.

Who are Orgenesis's partners in the POCare network?

Orgenesis has partnered with leading hospitals and research institutions globally, including agreements in Australia and collaborations with Johns Hopkins University.

What new clinical trials is Orgenesis conducting?

Orgenesis is currently enrolling for a Phase 2 clinical trial using the Tissue Genesis Icellator® at the Hospital for Special Surgery in New York.

How is Orgenesis expanding its operational capabilities?

Orgenesis is adding capacity in various locations, including setting up an additional center in Boston and expanding efforts across Europe.