Orgenesis Reports 425% Increase in Revenue for the Third Quarter of 2021 Compared to Same Period Last Year

Rhea-AI Summary

Orgenesis reported significant financial growth for Q3 2021, with revenue rising to $28.6 million compared to $5.3 million in Q3 2020. The CEO emphasized the advancement of their POCare Platform, designed to address industry challenges like capacity and cost. The company is expanding its global network, collaborating with top institutions to integrate over 30 therapies in areas such as immuno-oncology and auto-immune diseases. A conference call to discuss these developments is scheduled for 8:30 AM ET today.

Positive

• Revenue increased to $28.6 million for the first nine months of 2021, up from $5.3 million year-over-year.
• The POCare Platform is seen as a more advanced, cost-effective solution compared to previous operations.
• Collaboration with leading research centers and biotech companies is expanding.
• Integration of over 30 therapies into the POCare platform enhances development opportunities.

Negative

• None.

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

GERMANTOWN, Md., Nov. 04, 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 third quarter ended September 30, 2021.

Vered Caplan, CEO of Orgenesis, stated, “We are making steady progress rolling out our POCare Platform, as illustrated by our solid revenue growth. Specifically, revenue for the first nine months of 2021 increased to $28.6 million, compared to just $5.3 million for the same period last year. To put the Company’s growth in perspective, our revenue run rate is nearly on par with our former Masthercell CDMO operations at the time of its sale. However, we believe the new POCare platform is far more advanced, cost effective, and scalable.”

“Feedback from within the industry has been encouraging as our POCare platform addresses many of the key challenges facing the industry, including capacity constraints and excessive costs. By producing personalized cell and gene therapies (CGTs) at the point of care, we believe we are able to add new capacity within months instead of years. At the same time, we are advancing the roll out of our Orgenesis Mobile Processing Units & Labs (OMPULs), which are fully integrated, all-in-one bioprocessing units that can be rapidly deployed as a standardized industrial cleanroom alternative at the point of care.”

“While our current revenues reflect the validation phase of our roll-out strategy, we expect to increasingly benefit from revenue sharing and royalty agreements with our respective partners as we potentially advance the respective point-of-care therapies being developed. Importantly, we believe our new model of decentralized supply of cell and gene therapies, based on standardization of the manufacturing environment, represents an attractive and commercially viable path forward for the industry, to unlock the full potential of CGTs.”

“We continue to expand our global network through collaborations with some of the leading research centers, hospitals and biotech companies around the world, such as Johns Hopkins University in the U.S., as well as recent additions in Italy and Spain. We are integrating over 30 therapies, in various development stages, into our POCare platform, spanning immuno-oncology, anti-viral, metabolic/auto-immune diseases, tissue regeneration and more.”

The Company’s complete financial results are available in the Company’s Form 10-Q filed with the Securities and Exchange Commission on November 4, 2021 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, November 4, 2021, to discuss the Company’s financial results for the third quarter ended September 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 877-545-0320 for U.S. callers or for international callers +1 973-528-0002 and by entering access code: 236477. A webcast of the call may be accessed at https://www.webcaster4.com/Webcast/Page/2585/43447 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, November 4, 2022. A telephone replay of the call will be available approximately one hour following the call, through Thursday, November 18, 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: 43447.

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

ORGENESIS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. Dollars in thousands)
(Unaudited)

		As of
		September 30, 2021			December 31, 2020
Assets
CURRENT ASSETS:
Cash and cash equivalents	$	14,917		$	44,923
Restricted cash		487			645
Accounts receivable, net *		15,950			3,085
Prepaid expenses and other receivables		1,667			1,070
Convertible loan to related party		3,018			-
Grants receivable		169			169
Inventory		133			185
Total current assets		36,341			50,077
NON-CURRENT ASSETS:
Deposits	$	358		$	296
Investments in associates, net		397			175
Property, plant and equipment, net		5,706			3,073
Intangible assets, net		12,064			13,023
Operating lease right-of-use assets		1,122			1,474
Goodwill		8,414			8,745
Other assets		802			821
Total non-current assets		28,863			27,607
TOTAL ASSETS	$	65,204		$	77,684

* Including related party in the amount of $1,069 thousand and $744 thousand as of September 30, 2021 and as of December 31, 2020, respectively.

ORGENESIS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (Cont’d)
(U.S. Dollars in thousands)
(Unaudited)

		As of
		September 30, 2021				December 31, 2020
Liabilities and Equity
CURRENT LIABILITIES:
Accounts payable	$	3,056			$	8,649
Accrued expenses and other payables		2,474				792
Income tax payable		74				7
Employees and related payables		1,919				1,463
Advance payments on account of grant		1,108				692
Short-term loans and current maturities of long-term loans		-				145
Contract liabilities		59				59
Current maturities of finance leases		18				19
Current maturities of operating leases		476				485
Current maturities of convertible loans		4,382				3,974
Total current liabilities		13,566				16,285
LONG-TERM LIABILITIES:
Non-current operating leases	$	665			$	1,020
Convertible loans		7,277				7,200
Retirement benefits obligation		98				74
Non-current finance leases		47				64
Other long-term liabilities		290				313
Total long-term liabilities		8,377				8,671
TOTAL LIABILITIES		21,943				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 September 30, 2021 and December 31, 2020, respectively		3				3
Additional paid-in capital		145,338				140,397
Accumulated other comprehensive income		290				748
Treasury stock 262,090 and 55,309 shares as of September 30, 2021 and December 31, 2020, respectively		(1,159	)			(250	)
Accumulated deficit		(101,356	)			(88,319	)
Equity attributable to Orgenesis Inc.		43,116				52,579
Non-controlling interest		145				149
Total equity		43,261				52,728
TOTAL LIABILITIES AND EQUITY	$	65,204			$	77,684

The accompanying notes are an integral part of these condensed consolidated financial statements.

ORGENESIS INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (INCOME)
(U.S. Dollars in thousands, except share and loss per share amounts)
(Unaudited)

			Three Months Ended								Nine Months Ended
			September 30, 2021				September 30, 2020				September 30, 2021				September 30, 2020
Revenues		$	7,606			$	1,450			$	25,656			$	4,305
Revenues from related party			1,070				279				2,954				1,051
Total revenues			8,676				1,729				28,610				5,356
Cost of services and other research and development expenses			10,007				6,951				25,861				36,787
Amortization of intangible assets			236				87				713				258
Selling, general and administrative expenses			6,092				4,042				11,961				11,171
Other income, net			(3	)			(5	)			(31	)			(9	)
Operating loss			7,656				9,346				9,894				42,851
Financial expenses, net *			2,410				238				3,049				904
Share in net loss of associated companies			18				-				33				-
Loss from continuing operations before income taxes			10,084				9,584				12,976				43,755
Tax expenses (income)			67				(18	)			65				(53	)
Net loss from continuing operations			10,151				9,566				13,041				43,702
Net income from discontinued operations, net of tax			-				(7,132	)			-				(90,318	)
Net loss (income)			10,151				2,434				13,041				(46,616	)
Net loss (income) attributable to non-controlling interests from continuing operations			8				(7	)			(4	)			(40	)
Net income attributable to non-controlling interests from discontinued operations			-				-				-				(492	)
Net loss (income) attributable to Orgenesis Inc.		$	10,159			$	2,427			$	13,037			$	(47,148	)
Loss (Earnings) per share:
Basic and diluted from continuing operations		$	0.42			$	0.43			$	0.54			$	2.13
Basic and diluted from discontinued operations		$	-			$	(0.32	)		$	-			$	(4.69	)
Basic and diluted		$	0.42			$	0.11			$	0.54			$	(2.56	)
Weighted average number of shares used in computation of Basic and Diluted loss (earnings) per share:
Basic and diluted			24,275,276				22,094,470				24,278,292				20,469,470
Comprehensive loss (income):
Net loss from continuing operations		$	10,151			$	9,566			$	13,041			$	43,702
Net income from discontinued operations, net of tax			-				(7,132	)			-				(90,318	)
Other comprehensive loss (income)- translation adjustments			229				(282	)			458				115
Release of translation adjustment due to sale of subsidiary			-				-				-				(194	)
Comprehensive loss (income)			10,380				2,152				13,499				(46,695	)
Comprehensive (loss) income attributed to non-controlling interests from continuing operations			8				(7	)			(4	)			(40	)
Comprehensive income attributed to non-controlling interests from discontinued operations			-				-				-				(492	)
Comprehensive loss (income) attributed to Orgenesis Inc.		$	10,388			$	2,145			$	13,495			$	(47,227	)

* Including loss from extinguishment in connection with convertible loan restructuring in the amount of $ 1,865 thousand for the three and nine months ended September 30, 2021.

FAQ

What were Orgenesis's Q3 2021 financial results?

Orgenesis reported Q3 2021 revenue of $28.6 million, a significant increase from $5.3 million in Q3 2020.

When is Orgenesis's conference call scheduled?

The conference call is scheduled for 8:30 AM ET on November 4, 2021.

What is the POCare Platform mentioned by Orgenesis?

The POCare Platform is a system designed to produce personalized cell and gene therapies at the point of care, aimed at addressing capacity and cost issues.

Which therapies is Orgenesis integrating into its POCare platform?

Orgenesis is integrating over 30 therapies across various development stages, including immuno-oncology and metabolic diseases.

What are the future expectations for Orgenesis's revenue?

Orgenesis expects to benefit from revenue sharing and royalty agreements as they advance point-of-care therapies.