Form S-3/A Orgenesis Inc.

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As filed with the Securities and Exchange Commission on April 14, 2020

Registration No. 333-237261

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

Amendment No. 1

to

FORM S-3

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

ORGENESIS INC.

(Exact name of registrant as specified in its charter)

Nevada	98-0583166
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification Number)

20271 Goldenrod Lane

Germantown, MD 20876

(480) 659-6404

(Address, including zip code, and telephone number, including area code, of registrant's principal executive offices)

Vered Caplan

Chief Executive Officer

Orgenesis Inc.

20271 Goldenrod Lane

Germantown, MD 20876

(480) 659-6404

(Name, address, including zip code, and telephone number, including area code, of agent for service)

Copies to:

Jeffrey P. Schultz, Esq. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo P.C. 666 Third Avenue New York, NY 10017 Tel: (212) 935-3000

Mark Cohen, Esq. Pearl Cohen Zedek Latzer Baratz LLP 1500 Broadway New York, NY 10036 Tel: (646) 878-0800

Approximate date of commencement of proposed sale to the public: From time to time after the effective date of this Registration Statement.

If the only securities being registered on this form are being offered pursuant to dividend or interest reinvestment plans, please check the following box.  [  ]

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If any of the securities being registered on this form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, other than securities offered only in connection with dividend or interest reinvestment plans, check the following box.  [X]

If this form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  [  ]

If this form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  [  ]

If this form is a registration statement pursuant to General Instruction I.D. or a post-effective amendment thereto that shall become effective upon filing with the Commission pursuant to Rule 462(e) under the Securities Act, check the following box.  [  ]

If this form is a post-effective amendment to a registration statement filed pursuant to General Instruction I.D. filed to register additional securities or additional classes of securities pursuant to Rule 413(b) under the Securities Act, check the following box.  [  ]

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company.  See the definitions of "large accelerated filer," "accelerated filer" "smaller reporting company" and "emerging growth company" in Rule 12b-2 of the Exchange Act.

Large accelerated filer [  ]	Accelerated filer [X]
Non-accelerated filter [  ]	Smaller reporting company [X]
	Emerging growth company [  ]

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. [  ]           

The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until this Registration Statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.

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EXPLANATORY NOTE

 This Pre-Effective Amendment No.  1 (this "Amendment") to the Registration Statement on Form S-3 of Orgenesis Inc. (File No. 333-237261), initially filed on March 18, 2020 (the "Registration Statement"), is being filed as an exhibit-only filing to include updated pro forma financial information for the disposition of Masthercell as of and for the year ended December 31, 2019, filed herewith as Exhibit 99.1.  Accordingly, this Amendment consists only of the facing page, this explanatory note, Item 16 of Part II of the Registration Statement, the signature pages to the Registration Statement and Exhibit 99.1.  The prospectus and the balance of Part II of the Registration Statement are unchanged and have been omitted.

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PART II

INFORMATION NOT REQUIRED IN PROSPECTUS

Item 16.  Exhibits and financial statement schedules.

(a) Exhibits.

See the Exhibit Index attached to this registration statement, which is incorporated by reference herein.

(b) Financial statement schedules.

No financial statement schedules are provided because the information called for is not required or is shown either in the financial statements or the notes thereto.

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SIGNATURES

Pursuant to the requirements of the Securities Act of 1933, the Registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for filing on Form S-3 and has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Germantown, State of Maryland, on April 14, 2020.

	ORGENESIS INC.
	By:	/s/ Vered Caplan Vered Caplan Chief Executive Officer

 

Pursuant to the requirements of the Securities Act of 1933, this registration statement has been signed by the following persons in the capacities and on the dates indicated.

Signature			Title				Date
/s/ Vered Caplan Vered Caplan			Chief Executive Officer and Director (principal executive officer)				April 14, 2020
/s/ Neil Reithinger Neil Reithinger			Chief Financial Officer (principal financial officer and principal accounting officer)				April 14, 2020
*                                 David Sidransky			Director				April 14, 2020
*                                Guy Yachin			Director				April 14, 2020
*                                Ashish Nanda			Director				April 14, 2020
*                              Yaron Adler			Director				April 14, 2020
*                              Mario Philips			Director				April 14, 2020

*By:

/s/ Neil Reithinger Neil Reithinger Attorney-in-fact

April 14, 2020

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EXHIBIT INDEX

Exhibit Number	Description
4.1	Form of Warrant (incorporated by reference to an exhibit to our Current Report on Form 8-K, filed on January 22, 2020)
5.1*	Opinion of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
10.1	Securities Purchase Agreement, dated January 20, 2020, by and among the Company and the Investors (incorporated by reference to an exhibit to our Current Report on Form 8-K, filed on January 22, 2020)
10.2	Registration Rights Agreement, dated January 20, 2020, by and among the Company and the Investors (incorporated by reference to an exhibit to our Current Report on Form 8-K, filed on January 22, 2020)
23.1*	Kesselman & Kesselman, Certified Public Accountants (Isr.), a member firm of PricewaterhouseCoopers International Limited
23.2*	Consent of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. (contained in Exhibit 5.1 hereto)
24.1*	Powers of Attorney (included in the signature page of this registration statement)
99.1	Unaudited pro forma condensed statement of operations for the years ended December 31, 2019 and November 30, 2018 and for the transition month December 2018 and unaudited pro forma condensed balance sheet as of December 31, 2019.
* Previously filed.

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Exhibit 99.1

 As previously disclosed on February 2, 2020, Orgenesis Inc. ("Orgenesis") entered into a Stock Purchase Agreement (the "Purchase Agreement") with GPP-II Masthercell LLC ("GPP" and together with Orgenesis, the "Sellers"), Masthercell Global Inc. ("Masthercell") and Catalent Pharma Solutions, Inc. (the "Buyer").  Pursuant to the terms and conditions of the Purchase Agreement, Sellers agreed to sell 100% of the outstanding equity interests of Masthercell to Buyer (the "Sale") for an aggregate nominal purchase price of $315 million, subject to customary adjustments. The Company determined that the Masthercell business met the criteria to be classified as a discontinued operation.

 On February 10, 2020, the Sale was consummated in accordance with the terms of the Purchase Agreement.  After accounting for GPP's liquidation preference and equity stake in Masthercell as well as SFPI - FPIM's interest in MaSTherCell S.A., distributions to Masthercell option holders and transaction costs, Orgenesis received approximately $126.7 million at the closing of the Sale transaction, of which $7.2 million was used for the repayment of intercompany loans and payables.  Included in this amount is $1.6 million which was deposited into an escrow account in connection with potential adjustments based on working capital and indebtedness at closing.

Financial Statements and Exhibits- Pro forma financial information

 The following unaudited pro forma condensed financial statements giving effect to the Sale are attached hereto:

• Unaudited pro forma condensed balance sheet as of December 31, 2019;

• Unaudited pro forma condensed statement of operations for the year ended December 31, 2019;

• Unaudited pro forma condensed statement of operations for the transition month December 2018;

• Unaudited pro forma condensed statement of operations for the year-ended November 30, 2018.

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Unaudited Pro Forma Condensed Balance Sheet
(Dollars in Thousands, except for share amounts)

		Historical			Pro Forma Adjustments
		As of			As of						As of
		December 31,			December 31,						December 31,
		2019			2019						2019
		Orgenesis			Sale of Masthercell Note 2(c)			Notes 2(a)+(b)			Pro Forma
Assets
CURRENT ASSETS:
Cash and cash  equivalents	$	11,388		$	(11,281	)	$	117,913		$	118,020
Restricted Cash		653			(186	)		1,555			2,022
Accounts receivable, net		8,485			(6,654	)		-			1,831
Intercompany accounts receivables		-			(2,559	)		2,559			-
Prepaid expenses and other receivables		1,227			(845	)		-			382
Grants receivable		2,183			(1,979	)		-			204
Inventory		2,043			(1,907	)		-			136
Total current assets	$	25,979		$	(25,411	)	$	122,027		$	122,595
NON-CURRENT ASSETS:
Deposits		625			(326	)		-			299
Loans to related party		2,623			-			-			2,623
Other intercompany receivables		-			(2,247	)		2,247			-
Property, plant and equipment, net		24,454			(22,149	)		-			2,305
Intangible assets, net		14,206			(10,858	)		-			3,348
Operating lease right-of-use assets		9,585			(8,860	)		-			725
Goodwill		14,941			(10,129	)		-			4,812
Intercompany loan receivable		-			(2,501	)		2,501			-
Other assets		82			(47	)		-			35
Total non-current assets		66,516			(57,117	)		4,748		$	14,147
TOTAL ASSETS	$	92,495		$	(82,528	)	$	126,775		$	136,742

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Liabilities and Equity
CURRENT LIABILITIES:
Accounts payable	$	11,305		$	(5,840	)	$	171		$	5,636
Accrued expenses and other payables		1,987			(372	)		18,791			20,406
Employees and related payables		3,719			(2,047	)		-			1,672
Advance payments on account of grant		2,750			(2,227	)		-			523
Short-term loans and current maturities of long term loans		763			(372	)		-			391
Contract liabilities		8,626			(8,301	)		-			325
Current maturities of finance leases		291			(291	)		-			-
Current maturities of operating leases		1,722			(1,365	)		-			357
Current maturities of convertible loans		416			-			-			416
Total current liabilities	$	31,579		$	(20,815	)	$	18,962		$	29,726
LONG-TERM LIABILITIES:
Non-current operating leases		7,524			(7,069	)		-			455
Loans payable		1,230			(1,230	)		-			-
Convertible loans		12,143			-			-			12,143
Retirement benefits obligation		41			-			-			41
Deferred taxes		1,926			(1,868	)		-			58
Long-term debt and finance leases		688			(688	)		-			-
Other long-term liabilities		331			-			-			331
Total long-term liabilities		23,883			(10,855	)		-			13,028
TOTAL LIABILITIES	$	55,462		$	(31,670	)	$	18,962		$	42,754
COMMITMENTS REDEEMABLE NON-CONTROLLING INTEREST		30,955			(30,955	)		-			-
TOTAL EQUITY		6,078			(19,903	)		107,813			93,988
TOTAL LIABILITIES AND EQUITY	$	92,495		$	(82,528	)	$	126,775		$	136,742

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Unaudited Pro Forma Statement of Operations
(Dollars in Thousands, except for share amounts)

		Historical			Pro Forma Adjustments
		Year Ended			Year Ended			Year Ended
		December 31,			December 31,			December 31,
		2019			2019			2019
		Orgenesis			Sale of Masthercell Note 2(d)			Pro Forma
REVENUES	$	33,256		$	(28,929	)	$	4,327
COST OF REVENUES		18,232			(17,527	)		705
COST OF RESEARCH AND DEVELOPMENT AND RESEARCH AND DEVELOPMENT SERVICES, net		12,458			852			13,310
AMORTIZATION OF INTANGIBLE ASSETS		2,061			(1,631	)		430
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES		25,337			(13,959	)		11,378
OTHER INCOME, net		(228	)		207			(21	)
OPERATING LOSS		24,604			(3,129	)		21,475
FINANCIAL EXPENSES, net		874			(31	)		843
LOSS BEFORE INCOME TAXES		25,478			(3,160	)		22,318
TAX EXPENSES (INCOME)		563			(792	)		(229	)
NET LOSS	$	26,041		$	(3,952	)	$	22,089
NET LOSS ATTRIBUTABLE TO NON-CONTROLLING INTERESTS (INCLUDING REDEEMABLE)		(1,920	)		1,821			(99	)
NET LOSS ATTRIBUTABLE TO THE COMPANY	$	24,121		$	(2,131	)	$	21,990
LOSS PER SHARE:
Basic	$	1.77					$	1.54
Diluted	$	1.77					$	1.54
WEIGHTED AVERAGE NUMBER OF SHARES USED IN COMPUTATION OF BASIC AND DILUTED EARNINGS (LOSS) PER SHARE:
Basic		15,907,995						15,907,995
Diluted		15,907,995						15,907,995

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Unaudited Pro Forma Statement of Operations
(Dollars in Thousands, except for share amounts)

		Historical			Pro Forma Adjustments
		One Month Ended			One Month Ended			One Month Ended
		December 31,			December 31,			December 31,
		2018			2018			2018
		Orgenesis			Sale of Masthercell Note 2(e)			Pro Forma
REVENUES	$	1,852		$	(1,709	)	$	143
COST OF REVENUES		1,221			(1,078	)		143
COST OF RESEARCH AND DEVELOPMENT AND RESEARCH AND DEVELOPMENT SERVICES, net		1,431			66			1,497
AMORTIZATION OF INTANGIBLE ASSETS		179			(141	)		38
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES		1,984			(999	)		985
OPERATING LOSS		2,963			(443	)		2,520
FINANCIAL EXPENSES, net		27			(17	)		10
LOSS BEFORE INCOME TAXES		2,990			(460	)		2,530
TAX (INCOME) EXPENSES		(83	)		124			41
NET LOSS	$	2,907		$	(336	)	$	2,571
NET (INCOME) LOSS ATTRIBUTABLE TO NON-CONTROLLING INTERESTS (INCLUDING REDEEMABLE)		(163	)		152			(11	)
NET LOSS ATTRIBUTABLE TO ORGENESIS INC.	$	2,744		$	(184	)	$	2,560
LOSS PER SHARE:
Basic	$	0.19					$	0.17
Diluted	$	0.19					$	0.17
WEIGHTED AVERAGE NUMBER OF SHARES USED IN COMPUTATION OF BASIC AND DILUTED EARNINGS (LOSS) PER SHARE:
Basic		15,423,040						15,423,040
Diluted		15,423,040						15,423,040

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Unaudited Pro Forma Statement of Operations
(Dollars in Thousands, except for share amounts)

		Historical			Pro Forma Adjustments
		Year Ended			Year Ended			Year Ended
		November 30,			November 30,			November 30,
		2018			2018			2018
		Orgenesis			Sale of Masthercell Note 2(f)			Pro Forma
REVENUES	$	18,655		$	(17,273	)	$	1,382
COST OF REVENUES		10,824			(9,403	)		1,421
COST OF RESEARCH AND DEVELOPMENT AND RESEARCH AND DEVELOPMENT SERVICES, net		6,464			1,259			7,723
AMORTIZATION OF INTANGIBLE ASSETS		1,913			(1,725	)		188
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES		16,303			(6,196	)		10,107
OTHER INCOME, net		(2,930	)		(1,600	)		(4,530	)
OPERATING LOSS		13,919			(392	)		13,527
FINANCIAL EXPENSES, net		3,117			(185	)		2,932
SHARE IN NET LOSS OF ASSOCIATED COMPANIES		731			-			731
LOSS BEFORE INCOME TAXES		17,767			(577	)		17,190
TAX EXPENSES		1,337			(1,185	)		152
NET LOSS	$	19,104		$	(1,762	)	$	17,342
NET (INCOME) LOSS ATTRIBUTABLE TO NON-CONTROLLING INTERESTS (INCLUDING REDEEMABLE)		(813	)		771			(42	)
NET LOSS ATTRIBUTABLE TO ORGENESIS INC.	$	18,291		$	(991	)	$	17,300
LOSS PER SHARE:
Basic	$	1.43					$	1.30
Diluted	$	1.43					$	1.30
WEIGHTED AVERAGE NUMBER OF SHARES USED IN COMPUTATION OF BASIC AND DILUTED EARNINGS (LOSS) PER SHARE:
Basic		13,374,103						13,374,103
Diluted		13,374,103						13,374,103

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1. Basis of Presentation

The historical financial information has been adjusted to give pro forma effect to events that are (i) directly attributable to the divestiture, (ii) factually supportable and (iii) expected to have a continuing impact on the combined results. The pro forma adjustments are preliminary and based on estimates and have been prepared to illustrate the estimated effect of the divestiture. The pro forma financial information presented is not intended to reflect or be indicative of the Company's consolidated results of operations or financial position had the divestiture occurred as of the dates presented and should not be taken as a representation or projection of the Company's future consolidated results of operations or financial condition. The pro forma adjustments described below were based on management's assumptions and estimates, including assumptions relating to consideration received.

The Company's historical results are derived from its audited balance sheet as of December 31, 2019, audited statements of operations for the year ended December 31, 2019.

2. Notes to Unaudited Pro Forma Adjustments

(a)	Represents the cash proceeds from closing the Transaction, net of repayment of Orgenesis loans and intercompany balances to Masthercell The net adjustment for cash is as follows (dollars in millions):

		Total
Aggregate nominal purchase price from the sale	$	315.0
Less: GPP liquidation preference and equity stake in Masthercell, SFPI - FPIM's interest in MaSTherCell S.A., distributions to Masthercell option holders, and transaction costs		(188.3	)
Estimated cash proceeds from the Transaction to the Company		126.7
Less: Payment of intercompany loans and payables		(7.2	)
Net cash adjustment (including $1.6M to be released from Escrow)	$	119.5

(b)	Represents the estimated tax effect of the Transaction assuming a combined statutory tax rate of 29% after utilizing accumulated net operating losses of approximately $29 million
(c)	Represents the historical balances of Masthercell at December 31, 2019
(d)	Represents the historical results of operations of Masthercell for the year ended December 31, 2019
(e)	Represents the historical results of operations of Masthercell for the transition month ended December 31, 2018
(f)	Represents the historical results of operations of Masthercell for the year ended November 30, 2018

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