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.  [  ]


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.


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.


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.


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



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.



Orgenesis Inc.: Exhibit 99.1 - Filed by newsfilecorp.com

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.



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  



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  



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  



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  



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  


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