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Orgenesis Achieves Revenue of $7.2 Million for the First Quarter of 2022

·7 min read
Orgenesis Inc.
Orgenesis Inc.

GERMANTOWN, Md., May 24, 2022 (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 provided a business update for first quarter ended March 31, 2022.

Recent highlights:

Vered Caplan, CEO of Orgenesis, said, “We are completing the first phase of the rollout of our POCare Platform, as we have now built a robust network of POCare centers across Europe, Asia and the Middle East, and are focusing on implementation of our POCare supply strategy in the US. Each of our POCare centers serve as hubs for their respective territories. We have cost effectively executed this model through partnerships with leading hospitals and centers of excellence in the field of cell and gene therapies, which provide us an immediate revenue stream related to process development, technology transfer, setup, and validation of both our POCare systems and Orgenesis Mobile Processing Units and Labs (OMPULs). In turn, we have built out significant capacity to support our anticipated growth.”

“We are now entering the second phase of our rollout. Specifically, we are conducting work related to validation, process development, and supply for clinical trials of advanced therapies utilizing our POCare platform and OMPULs. As these activities ramp up, we expect to benefit from recurring revenue streams, based on long term contracts for the next two to three years. Moreover, if any one of these therapies is granted regulatory approval, we believe that the revenue potential is significant since our POCare strategy positions us as a long term industrial partner. We are currently working to expand our capacity to supply products for over 10 distinct clinical programs. We believe our approach is highly scalable and provides us diversification across multiple revenue generating contracts. As our customers’ needs grow, our goal is to be well prepared to add new capacity utilizing our OMPUL-based approach, within 3-6 months versus the 18-24 months typical for building out additional cleanroom-based manufacturing capacity.”

“Overall, we are witnessing dramatic capacity constraints across the industry. We believe our model is uniquely positioned to address the challenges of current centralized production through a highly innovative decentralized model, which lowers costs, streamlines logistics, and expands capacity. We are overcoming the growing pains and challenges arising from our rapid transformation and believe that our model is essential and sustainable. This is best evidenced by our existing contract pipeline—which has total potential revenue in excess of $75 million for the next two years, as well as our capacity to continually expand our revenue generating relationships with additional biotech companies, therapy developers and other providers such as hospitals and academic centers.”

The complete financial results for the first quarter of 2022 are available on the Company’s website in its Form 10-Q, which has been filed with the Securities and Exchange Commission.

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 at the point of care. The Orgenesis POCare 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. 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 and OMPUL business, 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 COVID-19 pandemic, the sufficiency of working capital to realize our business plans and our ability to raise additional capital, 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, risks relating to legal proceedings against us 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, 2021, 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

ORGENESIS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. Dollars, in thousands, except share and per share amounts)
(Unaudited)

 

 

As of

 

 

March 31,
2022


 

 

December 31,
2021


Assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CURRENT ASSETS:

 

 

 

 

 

 

 

Cash and cash equivalents

$

1,123


 

$

5,473


Restricted cash

 

490


 

 

501


Accounts receivable, net

 

17,075


 

 

15,245


Prepaid expenses and other receivables

 

1,438


 

 

1,188


Convertible Loan receivables-related parties

 

2,969


 

 

3,064


Loans receivable

 

802


 

 

-


Grants receivable

 

-


 

 

169


Inventory

 

113


 

 

118


Total current assets

 

24,010


 

 

25,758


 

 

 

 

 

 

 

 

NON-CURRENT ASSETS:

 

 

 

 

 

 

 

Deposits

$

358


 

$

363


Investments in and loans to associated entities

 

1,574


 

 

584


Loans receivable

 

-


 

 

821


Property, plant and equipment, net

 

11,104


 

 

10,271


Intangible assets, net

 

11,539


 

 

11,821


Operating lease right-of-use assets

 

886


 

 

1,015


Goodwill

 

8,329


 

 

8,403


Other assets

 

738


 

 

805


Total non-current assets

 

34,528


 

 

34,083


TOTAL ASSETS

$

58,538


 

$

59,841



ORGENESIS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (Cont’d)
(U.S. Dollars, in thousands, except share and per share amounts)
(Unaudited)

 

 

As of

 

 

March 31,
2022

 

 

December 31,
2021

Liabilities and Equity

 

 

 

 

 

 

 

 

 

 

 

CURRENT LIABILITIES:

 

 

 

 

 

Accounts payable

$

6,933

 

 

$

5,238

 

Accrued expenses and other payables

 

1,076

 

 

 

485

 

Income tax payable

 

91

 

 

 

54

 

Employees and related payables

 

2,041

 

 

 

1,907

 

Advance payments on account of grant

 

1,216

 

 

 

1,238

 

Contract liabilities

 

70

 

 

 

59

 

Current maturities of finance leases

 

18

 

 

 

18

 

Current maturities of operating leases

 

451

 

 

 

481

 

Current maturities of convertible loans

 

3,357

 

 

 

5,885

 

Total current liabilities

 

15,253

 

 

 

15,365

 

 

 

 

 

 

 

LONG-TERM LIABILITIES:

 

 

 

 

 

Non-current operating leases

$

461

 

 

$

561

 

Convertible loans

 

7,544

 

 

 

4,854

 

Retirement benefits obligation

 

105

 

 

 

101

 

Non-current finance leases

 

36

 

 

 

41

 

Other long-term liabilities

 

282

 

 

 

288

 

Total long-term liabilities

 

8,428

 

 

 

5,845

 

TOTAL LIABILITIES

 

23,681

 

 

 

21,210

 

 

 

 

 

 

 

 

 

 

 

 

 

EQUITY:
Common stock of $0.0001 par value:
Authorized at March 31, 2022 and December 31, 2021: 145,833,334 shares; Issued at March 31, 2022 and December 31, 2021: 25,107,323 and 24,567,366 shares, respectively; Outstanding at March 31, 2022 and December 31, 2021: 24,820,756 and 24,280,799 shares, respectively.

 

3

 

 

 

3

 

Additional paid-in capital

 

146,290

 

 

 

145,916

 

Accumulated other comprehensive income

 

56

 

 

 

207

 

Treasury stock, 286,567 shares as of March 31, 2022 and December 31, 2021

 

(1,266

)

 

 

(1,266

)

Accumulated deficit

 

(110,381

)

 

 

(106,372

)

Equity attributable to Orgenesis Inc.

 

34,702

 

 

 

38,488

 

Non-controlling interest

 

155

 

 

 

143

 

Total equity

 

34,857

 

 

 

38,631

 

TOTAL LIABILITIES AND EQUITY

$

58,538

 

 

$

59,841

 


ORGENESIS INC.
CONDENSED CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(U.S. Dollars in Thousands, Except Share and Loss Per Share Amounts)
(Unaudited)

 

Three Months Ended

 

 

March 31,

 

 

 

March 31,

2022

 

2021

 

POC development services

$

5,689

 

 

$

7,987

 

POC development services from related party

 

635

 

 

 

1,157

 

Cell process development services and hospital services

 

888

 

 

 

245

 

Total revenues

 

7,212

 

 

 

9,389

 

Cost of revenues cell process development services and hospital services

 

714

 

 

 

770

 

Cost of development services and research and development expenses

 

6,651

 

 

 

5,357

 

Amortization of intangible assets

 

232

 

 

 

238

 

Selling, general and administrative expenses

 

2,851

 

 

 

2,968

 

Operating loss (income)

 

3,236

 

 

 

(56

)

Other income, net

 

-

 

 

 

(25

)

Financial expenses, net

 

213

 

 

 

233

 

Share in net loss of associated companies

 

547

 

 

 

15

 

Loss before income taxes

 

3,996

 

 

 

167

 

Tax (income) expense

 

1

 

 

 

(2

)

Net loss

 

3,997

 

 

 

165

 

Net loss attributable to non-controlling interests

 

12

 

 

 

54

 

Net loss attributable to Orgenesis Inc.

 

4,009

 

 

 

219

 

 

 

 

 

 

 

 

Loss per share:

 

 

 

 

 

 

Basic and diluted

$

0.16

 

 

$

0.01

 

 

 

 

 

 

 

 

Weighted average number of shares used in computation of Basic and Diluted loss per share:

 

 

 

 

 

 

Basic and diluted

 

24,600,954

 

 

 

24,192,951

 

 

 

 

 

 

 

 

Comprehensive loss:

 

 

 

 

 

 

Net loss

$

3,997

 

 

$

165

 

Other Comprehensive loss – Translation adjustment

 

151

 

 

 

277

 

Comprehensive loss

 

4,148

 

 

 

442

 

Comprehensive loss attributed to non-controlling interests

 

12

 

 

 

54

 

Comprehensive loss attributed to Orgenesis Inc.

$

4,160

 

 

$

496