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

·8 min read
Orgenesis Inc.
Orgenesis Inc.

Secures Funding from Metalmark Capital Partners to Drive Growth

Orgenesis to Host Conference Call Today, August 16, 2022 at 11 AM Eastern Time

GERMANTOWN, Md., Aug. 16, 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 (CGT), today provided a business update for second quarter ending June 30, 2022.

Vered Caplan, CEO of Orgenesis, said, “We are progressing with our transition to the second phase of the planned rollout of our POCare platform. This includes revenue generation from the validation, process development, and supply of advanced therapies that utilize our POCare platform and Orgenesis Mobile Processing Units and Labs (OMPULs). As a result of the successful execution of the first phase, our global supply network now spans North America, Europe, Asia, and the Middle East. Within the U.S. specifically, we are expanding our capacity and collaborations with a number of leading global healthcare institutions such as Johns Hopkins to establish a new POCare Center, also known as the Maryland Center for Cell Therapy Manufacturing.”

“Feedback from within the industry based on Orgenesis’ progress has been overwhelmingly positive. This is a result of our ability to reduce costs and add capacity in significantly less time than required for traditional clean rooms. We have multiple contracts with biotech companies from the U.S., E.U., Asia and the Middle East. Importantly, we believe we have built a highly scalable business model, and expect to benefit from growth in high margin, recurring revenue streams, based on future royalties and long-term contracts for industrializing and supplying these cell and gene therapies.”

Ms. Caplan continued, “I am pleased to report that we secured a $10 million loan within our newly formed subsidiary for Orgenesis’ point of care services business for treating patients (POCare Services) with Metalmark Capital Partners, a premier investment firm with deep expertise in the healthcare sector. Metalmark will provide ongoing advice to help us accelerate the rollout of our POCare platform and these critical CGT services.”

“In addition to our POCare Services platform, we are advancing our POCare therapeutic pipeline, which now spans over 16 distinct clinical programs in the field of immuno-oncology, anti-viral, metabolic/auto-immune diseases, and tissue regeneration. Our cost-efficient strategy involves leveraging government grants and funding from regional partners for our innovations and in-licensed therapies from leading research centers, hospitals and biotech companies. Most recently, in May 2022, we were awarded a €4M European Innovation Council Pathfinder Grant to advance technologies for the production of personalized autologous induced pluripotent stem cells (iPSCs) that can be utilized for regenerative medicine. Overall, we believe our therapeutic pipeline holds unlocked potential as we advance each of these assets through key clinical and pre-clinical milestones.”

The complete financial results for the second quarter of 2022 and details on the $10 million loan to our subsidiary are available on the Company’s website in the Company’s Form 10-Q and 8-K, respectively, which have been filed with the Securities and Exchange Commission.

Conference Call
The Company will host a conference call today, August 16, 2022, at 11:00 AM Eastern Time to discuss the company’s corporate progress and other developments.

The conference call will be available via telephone by dialing toll free 888-506-0062 for U.S. callers or +1 973-528-0011 for international callers and using entry code 223911. A webcast of the call may be accessed at https://www.webcaster4.com/Webcast/Page/2585/46399 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 Wednesday, August 16, 2023. A telephone replay of the call will be available approximately one hour following the call, through Tuesday, August 30, 2022 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: 46399.

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
IB Communications
Neil Hunter / Michelle Boxall
Tel +44 (0)20 8943 4685
neil@ibcomms.agency / michelle@ibcomms.agency

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

 

 

 

 

 

 

 

 

 

 

 

As of

 

 

 

June 30,
2022

 

 

December 31,
2021

 

Assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CURRENT ASSETS:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

2,303

 

 

$

5,473

 

Restricted cash

 

 

457

 

 

 

501

 

Accounts receivable, net *

 

 

18,786

 

 

 

15,245

 

Prepaid expenses and other receivables

 

 

793

 

 

 

1,188

 

Convertible loan receivable-related party

 

 

3,012

 

 

 

3,064

 

Grants receivable

 

 

-

 

 

 

169

 

Inventory

 

 

107

 

 

 

118

 

Total current assets

 

 

25,458

 

 

 

25,758

 

 

 

 

 

 

 

 

 

 

NON-CURRENT ASSETS:

 

 

 

 

 

 

 

 

Deposits

 

$

329

 

 

$

363

 

Investments and loans to associates

 

 

1,750

 

 

 

584

 

Loans receivable

 

 

-

 

 

 

821

 

Property, plant and equipment, net

 

 

14,388

 

 

 

10,271

 

Intangible assets, net

 

 

11,207

 

 

 

11,821

 

Operating lease right-of-use assets

 

 

757

 

 

 

1,015

 

Goodwill

 

 

8,174

 

 

 

8,403

 

Other assets

 

 

736

 

 

 

805

 

Total non-current assets

 

 

37,341

 

 

 

34,083

 

TOTAL ASSETS

 

$

62,799

 

 

$

59,841

 

 

*

Including related party in the amount of $2,039 thousand and $1,972 thousand as of June 30, 2022 and as of December 31, 2021, respectively.

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

 

 

As of

 

 

 

June 30,
2022

 

 

December 31,
2021

 

Liabilities and Equity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CURRENT LIABILITIES:

 

 

 

 

 

 

 

 

Accounts payable

 

$

5,203

 

 

$

5,238

 

Accrued expenses and other payables

 

 

1,763

 

 

 

485

 

Income tax payable

 

 

83

 

 

 

54

 

Employees and related payables

 

 

1,998

 

 

 

1,907

 

Advance payments on account of grant

 

 

1,144

 

 

 

1,238

 

Contract liabilities

 

 

70

 

 

 

59

 

Current maturities of finance leases

 

 

17

 

 

 

18

 

Current maturities of operating leases

 

 

399

 

 

 

481

 

Current maturities of convertible loans

 

 

5,568

 

 

 

5,885

 

Total current liabilities

 

 

16,245

 

 

 

15,365

 

 

 

 

 

 

 

 

 

 

LONG-TERM LIABILITIES:

 

 

 

 

 

 

 

 

Non-current operating leases

 

$

352

 

 

$

561

 

Convertible loans

 

 

13,943

 

 

 

4,854

 

Retirement benefits obligation

 

 

123

 

 

 

101

 

Non-current finance leases

 

 

29

 

 

 

41

 

Other long-term liabilities

 

 

264

 

 

 

288

 

Total long-term liabilities

 

 

14,711

 

 

 

5,845

 

TOTAL LIABILITIES

 

 

30,956

 

 

 

21,210

 

 

 

 

 

 

 

 

 

 

EQUITY:

 

 

 

 

 

 

 

 

Common stock of $0.0001 par value: Authorized at June 30, 2022 and December 31, 2021: 145,833,334 shares; Issued at June 30, 2022 and December 31, 2021: 25,107,323 and 24,567,366 shares, respectively; Outstanding at June 30, 2022 and December 31, 2021: 24,820,756 and 24,280,799 shares, respectively

 

 

3

 

 

 

3

 

Additional paid-in capital

 

 

146,919

 

 

 

145,916

 

Receipts on account of shares and warrants to be allotted

 

 

2,175

 

 

 

-

 

Accumulated other comprehensive income (loss)

 

 

(270

)

 

 

207

 

Treasury stock 286,567 shares as of June 30, 2022 and December 31, 2021

 

 

(1,266

)

 

 

(1,266

)

Accumulated deficit

 

 

(115,808

)

 

 

(106,372

)

Equity attributable to Orgenesis Inc.

 

 

31,753

 

 

 

38,488

 

Non-controlling interest

 

 

90

 

 

 

143

 

Total equity

 

 

31,843

 

 

 

38,631

 

TOTAL LIABILITIES AND EQUITY

 

$

62,799

 

 

$

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

 

 

Six Months Ended

 

 

 

June 30, 2022

 

 

June 30, 2021

 

 

June 30, 2022

 

 

June 30, 2021

 

Revenues

 

$

6,699

 

 

$

9,818

 

 

$

13,276

 

 

$

18,050

 

Revenues from related party

 

 

502

 

 

 

727

 

 

 

1,137

 

 

 

1,884

 

Total revenues

 

 

7,201

 

 

 

10,545

 

 

 

14,413

 

 

 

19,934

 

Cost of revenues, development services and research and development expenses

 

 

8,901

 

 

 

9,727

 

 

 

16,266

 

 

 

15,854

 

Amortization of intangible assets

 

 

229

 

 

 

239

 

 

 

461

 

 

 

477

 

Selling, general and administrative expenses

 

 

2,803

 

 

 

2,901

 

 

 

5,654

 

 

 

5,869

 

Operating loss

 

 

4,732

 

 

 

2,322

 

 

 

7,968

 

 

 

2,266

 

Other income, net

 

 

(8

)

 

 

(3

)

 

 

(8

)

 

 

(28

)

Financial expenses, net

 

 

389

 

 

 

406

 

 

 

602

 

 

 

639

 

Share in net loss of associated companies

 

 

368

 

 

 

-

 

 

 

915

 

 

 

15

 

Loss before income taxes

 

 

5,481

 

 

 

2,725

 

 

 

9,477

 

 

 

2,892

 

Tax expenses (income)

 

 

11

 

 

 

-

 

 

 

12

 

 

 

(2

)

Net loss

 

 

5,492

 

 

 

2,725

 

 

 

9,489

 

 

 

2,890

 

Net loss attributable to non-controlling interests

 

 

(65

)

 

 

(66

)

 

 

(53

)

 

 

(12

)

Net loss attributable to Orgenesis Inc.

 

$

5,427

 

 

$

2,659

 

 

$

9,436

 

 

$

2,878

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss per share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted

 

$

0.22

 

 

$

0.11

 

 

$

0.38

 

 

$

0.12

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted

 

 

24,820,756

 

 

 

24,365,746

 

 

 

24,711,462

 

 

 

24,279,826

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

5,492

 

 

$

2,725

 

 

$

9,489

 

 

$

2,890

 

Other comprehensive loss (income) - translation adjustments

 

 

326

 

 

 

(48

)

 

 

477

 

 

 

229

 

Comprehensive loss

 

 

5,818

 

 

 

2,677

 

 

 

9,966

 

 

 

3,119

 

Comprehensive loss attributed to non-controlling interests

 

 

(65

)

 

 

(66

)

 

 

(53

)

 

 

(12

)

Comprehensive loss attributed to Orgenesis Inc.

 

$

5,753

 

 

$

2,611

 

 

$

9,913

 

 

$

3,107