Exhibit 99.1

 

 

Orgenesis Provides Fiscal 2020 Year-End Results and Corporate Update;
Expands POCare Therapeutic Pipeline, POCare Technologies, and POCare Network

 

Revenue increases 96% to $7.7 million for 2020

 

Projects to more than double in revenue for 2021 based on current contracts already in hand

 

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

 

GERMANTOWN, MD – March 9, 2021 –

Orgenesis Inc. (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a global biotech company working to unlock the full potential of cell and gene therapies (CGTs), today reported financial results for the year ended December 31, 2020 and provided a business update.

 

Vered Caplan, CEO of Orgenesis, commented, “Just over a year ago, we completed the sale of one of our business divisions, which provided centralized manufacturing subcontracting services to cell and gene biotech companies. This activity was incorporated in the Masthercell subsidiary, a contract development manufacturing organization (CDMO). The CDMO was sold for $315 million, generating approximately $127 million of proceeds to Orgenesis. We determined it was the right time to sell Masthercell in order to maximize value for our shareholders and accelerate the rollout of our other divisions, with a focus on expanding our point-of-care business. Over the past year, we have been hard at work building the foundation for our POCare platform, which we believe has the potential to unlock value across the cell and gene therapy industry. Specifically, the historical centralized production model and resulting high costs of these therapies has inhibited uptake by payors and limited availability for patients. A case in point is CAR-T therapies, which are transforming cancer treatment, but can range in the hundreds of thousands of dollars per patient, per year. In contrast, through our decentralized POCare platform, we are able to provide autologous cell and gene therapies to patients in need at the point-of-care, thereby dramatically lowering costs, streamlining logistics and enhancing distribution.”

 

“Towards this end, we have combined the development of three pillars that are the basis for the POCare platform: Therapies, Technologies and Network. The first pillar, our POCare Therapies, involves licensing and development of breakthrough cell and gene therapies, that are combined with our second pillar of POCare Technologies. Using the advanced array of automation technologies that we have either licensed, developed or partnered with, the therapies are adapted for onsite production and supply. In turn, we support all stages of development and validation of the combination of therapies and processing technologies, from the clinic all the way through to commercialization. To date, we have developed, purchased or in-licensed more than 30 therapies and continue to expand our pipeline through our partnership with the POCare centers. Importantly, we believe our expansive therapeutic pipeline is on par or superior to many of the world’s premier cell and gene therapy companies. We also have our first commercial product on the market, KYSLECEL®, following the acquisition of Koligo. KYSLECEL is commercially available in the United States for chronic and recurrent acute pancreatitis. KYSLECEL is an excellent illustration of our strategy, whereby we are adapting this therapy for onsite automated production and supply through our POCare platform, thus enabling the availability of this therapy.”

 

 
 

 

“This ties into the third pillar of our POCare platform, our POCare Network, where we are partnering with leading hospitals and research centers in 14 countries and setting up GMP processing and supply units as the basis for a harmonized supply network for our therapies. In doing so, we have realized that having a compliant GMP clean room facility is a major bottle neck for many of these institutions, and even for those who do have one, it is usually insufficient in size. Building up high-grade clean rooms is a costly and lengthy process, and running such clean rooms requires highly trained personnel, as well as implementing complex and costly maintenance procedures. In line with our commitment of enabling cell and gene therapies for all, we have invested heavily in new point-of-care technologies that can be integrated into our new Orgenesis Mobile Processing Units and Labs (OMPULs).”

 

“We have made significant progress in the validation, risk analysis, regulatory and other tasks related to the OMPULs, which will be utilized to produce our POCare Therapies. These mobile systems can be deployed onsite at a hospital or medical institution, and can enable parallel processing of therapies at a reduced cost, without the logistical nightmares of a centralized production facility or the difficulty of building cleanrooms in the hospitals. Some of the key advantages of this system are the short set up time, small footprint, lower costs, automated operation, modular format, and highly scalable design. All of these factors enable us to produce autologous cell and gene therapies, along with viral processing capabilities, directly at the point of care in a consistent and standardized manner in all locations. We believe the OMPULs are an important step in the quick expansion of our capacity, and we look forward to expanding both the quantity and locations of our systems.”

 

“We have already established POCare development and service centers in the United States, Belgium, Israel and South Korea, and have established 10 joint venture agreements with regional partners that are financially committed to validate our therapies according to local regulatory requirements. In partnership with them, we have set up a network of hospitals and other partners in a total of 14 countries to date and we expect to sign agreements with many more premier institutions in the coming weeks and months. We have also utilized these partners to develop and adapt our POCare systems to local requirements.”

 

“I am pleased to report that our revenues nearly doubled in 2020 to $7.7 million, which reflects growth in revenues related to technology transfer, setup, and validation of both our therapies and systems for clinical use. We are committed to expanding our capacity and enabling the supply of our therapies globally, which provides us visibility into our future revenue growth. Based on just the existing contracts in hand, we anticipate for revenue to more than double in 2021. I am highly appreciative of our global network partners that helped us to achieve an immense amount of progress over the last year, while facing the tremendous personal and global logistic hardships imposed by COVID-19. We look forward to providing further updates as we advance our therapeutic pipeline, expand our hospital network and deploy our OMPULs worldwide.”

 

Conference Call

 

The Company plans to host a conference call at 8:30 AM Eastern Time today, March 9, 2021, to discuss the Company’s financial results for the 2020 fiscal year ended December 31, 2020, 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 +1 973-528-0016 for international callers and using entry code 796258. A webcast of the call may be accessed at https://www.webcaster4.com/Webcast/Page/2585/40294 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/overview#/) through Wednesday, March 9, 2022. A telephone replay of the call will be available approximately one hour following the call, through Tuesday, March 23, 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: 40294.

 

 
 

 

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 press 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 ability to further develop ranpirnase; our reliance on, and our ability to grow, our point-of-care cell therapy platform; our ability to develop cell-based and antiviral technologies; our ability to effectively use the net proceeds from the sale of Masthercell; our ability to achieve and maintain overall profitability; the development of our POCare strategy; the sufficiency of working capital to realize our business plans; our partners’ ability to develop therapies based on our point-of-care cell therapy platform; technology not functioning as expected; our ability to retain key employees; our ability to satisfy the rigorous regulatory requirements for new procedures and therapies; our competitors developing better or cheaper alternatives; the impact of COVID-19 on our operations 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:

Crescendo Communications, LLC

Tel: 212-671-1021

Orgs@crescendo-ir.com

 

Communications contact for Orgenesis

Image Box Communications

Neil Hunter / Michelle Boxall

Tel +44 (0)20 8943 4685

neil@ibcomms.agency / michelle@ibcomms.agency

 

(tables follow)

 

 
 

 

ORGENESIS INC.

CONSOLIDATED BALANCE SHEETS

(U.S. Dollars, in thousands)

 

   December 31, 
   2020   2019 
Assets        
CURRENT ASSETS:          
Cash and cash equivalents  $44,923   $107 
Restricted cash   645    467 
Accounts receivable, net   3,085    1,831 
Prepaid expenses and other receivables   1,070    382 
Grants receivable   169    204 
Inventory   185    136 
Current assets of discontinued operations (See Note 3)   -    75,221 
Total current assets   50,077    78,348 
NON CURRENT ASSETS:          
Deposits  $296   $299 
Loan to related party   -    2,623 
Investments in associates, net   175    - 
Property, plants and equipment, net   3,073    2,305 
Intangible assets, net   13,023    3,348 
Operating lease right-of-use assets   1,474    725 
Goodwill   8,745    4,812 
Other assets   821    35 
Total non-current assets   27,607    14,147 
TOTAL ASSETS  $77,684   $92,495 

 

 
 

 

ORGENESIS INC.

CONSOLIDATED BALANCE SHEETS

(U.S. Dollars, in thousands)

 

    December 31,  
    2020     2019  
Liabilities and equity                
CURRENT LIABILITIES:                
Accounts payable   $ 8,649     $ 5,549  
Accrued expenses and other payables     792       1,615  
Income tax payable     7       -  
Employees and related payables     1,463       1,672  
Advance payments on account of grant     692       523  
Short-term loans and current maturities of long-term loans     145       391  
Contract liabilities     59       325  
Current maturities of finance leases     19       -  
Current maturities of operating leases     485       357  
Current maturities of convertible loans     3,974       416  
Current liabilities of discontinued operations (See Note 3)     -       31,586  
TOTAL CURRENT LIABILITIES     16,285       42,434  
                 
LONG-TERM LIABILITIES:                
Non-current operating leases   $ 1,020     $ 455  
Convertible loans     7,200       12,143  
Retirement benefits obligation     74       41  
Deferred taxes     -       58  
Long-term debt and finance leases     64       -  
Other long-term liabilities     313       331  
TOTAL LONG-TERM LIABILITIES     8,671       13,028  
TOTAL LIABILITIES     24,956       55,462  
COMMITMENTS                
REDEEMABLE NON CONTROLLING INTEREST OF DISCONTINUED OPERATIONS (See Note 3)     -       30,955  
EQUITY:                
Common stock of $0.0001 par value, 145,833,334 shares authorized, 24,223,093 and 16,140,962 shares issued as of December 31, 2020 and December 31, 2019, respectively     3       2  
Additional paid-in capital     140,397       94,691  
Accumulated other comprehensive income     748       213  
Treasury stock at December 31, 2020 55,309 shares     (250 )     -  
Accumulated deficit     (88,319 )     (89,429 )
Equity attributable to Orgenesis Inc.     52,579       5,477  
Non-controlling interests     149       601  
TOTAL EQUITY     52,728       6,078  
TOTAL LIABILITIES AND EQUITY   $ 77,684     $ 92,495  

 

 
 

 

ORGENESIS INC.

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(U.S. Dollars, in thousands, except share and per share amounts)

 

   Year ended December 31, 
   2020   2019 
Revenues  $6,177   $2,629 
Revenues from related party   1,475    1,270 
Total revenues   7,652    3,899 
Cost of research and development and research and development services, net   83,986    14,014 
Amortization of intangible assets   478    430 
Selling, general and administrative expenses   18,973    11,451 
Other income, net   (4)   (21)
Operating loss   95,781    21,975 
Financial expenses, net   1,061    843 
Share in net income of associated companies   (106)   - 
Loss from continuing operation before income taxes   96,736    22,818 
Tax income   (1,609)   (229)
Net loss from continuing operation   95,127    22,589 
Net loss (income) from discontinued operations, net of tax   (95,706)   3,452 
Net loss (income)  $(579)  $26,041 
Net loss attributable to non-controlling interests (including redeemable) from continuing operation   (39)   (99)
Net loss attributable to non-controlling interests (including redeemable) from discontinued operations   (492)   (1,821)
Net loss (income) attributable to Orgenesis Inc.  $(1,110)  $24,121 
Loss (income) per share:          
Basic and diluted from continuing operations  $4.46   $1.41 
Basic and diluted from discontinued operations  $(4.75)  $0.36 
Basic and diluted  $(0.29)  $1.77 
           
Weighted average number of shares used in computation of Basic and Diluted loss per share:          
Basic and diluted   21,320,314    15,907,995 
           
Comprehensive loss (income):          
Net loss from Continuing Operation  $95,127   $22,589 
Net loss (income) from Discontinued Operations, Net of Tax   (95,706)   3,452 
Other Comprehensive (income) loss – Translation adjustment   (341)   456 
Release of translation adjustment due to sale of subsidiary   (194)   - 
Comprehensive loss (income)  $(1,114)  $26,497 
Comprehensive loss attributed to non-controlling interests (including redeemable)   (39)   (99)
Comprehensive loss attributed to non-controlling interests (including redeemable) from discontinued operations   (492)   (1,821)
Comprehensive loss (income) attributed to Orgenesis Inc.  $(1,645)  $24,577 

 

 

 

 


The following information was filed by Orgenesis Inc. (ORGS) on Tuesday, March 9, 2021 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

View differences made from one year to another to evaluate Orgenesis Inc.'s financial trajectory

Compare SEC Filings Year-over-Year (YoY) and Quarter-over-Quarter (QoQ)
Sample 10-K Year-over-Year (YoY) Comparison

Compare this 10-K Annual Report to its predecessor by reading our highlights to see what text and tables were  removed  ,   added    and   changed   by Orgenesis Inc..

Continue

Never Miss A New SEC Filing Again


Real-Time SEC Filing Notifications
Screenshot taken from Gmail for a new 10-K Annual Report
Last10K.com Member Feature

Receive an e-mail as soon as a company files an Annual Report, Quarterly Report or has new 8-K corporate news.

Continue

We Highlighted This SEC Filing For You


SEC Filing Sentiment Analysis - Bullish, Bearish, Neutral
Screenshot taken from Wynn's 2018 10-K Annual Report
Last10K.com Member Feature

Read positive and negative remarks made by management in their entirety without having to find them in a 10-K/Q.

Continue

Widen Your SEC Filing Reading Experience


Increased Reading Area for SEC Filings
Screenshot taken from Adobe Inc.'s 10-Q Quarterly Report
Last10K.com Member Feature

Remove data columns and navigations in order to see much more filing content and tables in one view

Continue

Uncover Actionable Information Inside SEC Filings


SEC Filing Disclosures
Screenshot taken from Lumber Liquidators 10-K Annual Report
Last10K.com Member Feature

Read both hidden opportunities and early signs of potential problems without having to find them in a 10-K/Q

Continue

Adobe PDF, Microsoft Word and Excel Downloads


Download Annual and Quarterly Reports as PDF, Word and Excel Documents
Screenshots of actual 10-K and 10-Q SEC Filings in PDF, Word and Excel formats
Last10K.com Member Feature

Export Annual and Quarterly Reports to Adobe PDF, Microsoft Word and Excel for offline viewing, annotations and analysis

Continue

FREE Financial Statements


Download Annual and Quarterly Reports as PDF, Word and Excel Documents
Screenshot of actual balance sheet from company 10-K Annual Report
Last10K.com Member Feature

Get one-click access to balance sheets, income, operations and cash flow statements without having to find them in Annual and Quarterly Reports

Continue for FREE

Intrinsic Value Calculator


Intrinsic Value Calculator
Screenshot of intrinsic value for AT&T (2019)
Last10K.com Member Feature

Our Intrinsic Value calculator estimates what an entire company is worth using up to 10 years of financial ratios to determine if a stock is overvalued or not

Continue

Financial Stability Report


Financial Stability Report
Screenshot of financial stability report for Coco-Cola (2019)
Last10K.com Member Feature

Our Financial Stability reports uses up to 10 years of financial ratios to determine the health of a company's EPS, Dividends, Book Value, Return on Equity, Current Ratio and Debt-to-Equity

Continue

Get a Better Picture of a Company's Performance


Financial Ratios
Available Financial Ratios
Last10K.com Member Feature

See how over 70 Growth, Profitability and Financial Ratios perform over 10 Years

Continue

Log in with your credentials

or    

Forgot your details?

Create Account