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Orgenesis First Quarter 2021 Revenue Increases 400% to $9.4 Million Reflecting Initial Success of POCare Platform

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Achieves operating profit for the first quarter of 2021

Cash and cash equivalents of $41.8 million as of March 31, 2021

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

GERMANTOWN, Md., May 07, 2021 (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 (CGTs), today reported financial results for the first quarter ended March 31, 2021.

Vered Caplan, CEO of Orgenesis, stated, “Our first quarter results illustrate the potential of our new POCare strategy, as evidenced by more than a four-fold increase in revenue for the first quarter of 2021. This growth is a direct result of long-term contracts with our regional partners as they work to advance our therapeutic pipeline and scale production capabilities in their respective territories. While we are in the early phases of our rollout, we achieved positive operating income for the quarter and are working aggressively to achieve our goal of building a sustainable long-term profitable business model, which we believe is achievable given the scalability of our POCare strategy. We have also maintained a solid balance sheet with $41.8 million of cash as of March 31, 2021.”

“The goal of our POCare platform is to provide life-changing treatments to large numbers of patients at reduced costs within the point-of-care setting. Initially, we are focusing on autologous, cell-based immunotherapies, therapeutics for metabolic diseases, anti-viral diseases, and tissue regeneration. Towards this end, we have built a robust therapeutic pipeline, which includes more than 30 advanced cell and gene therapies. We continue to expand our pipeline through our growing partnership with researchers, commercial partners and hospitals. As an example, in March, we entered into a second phase of collaboration with Hospital Infantil Universitario Niño Jesús in Madrid with an exclusive license to commercialize the Celyvir solid tumor therapy. At the same time, we have invested in new point-of-care technologies that can be integrated into our new Orgenesis Mobile Processing Units and Labs (OMPULs).”

“We continue to grow our POCare Network, which includes facilities in various countries across North America, Europe, Asia, and the Middle East. As an example, we recently began a collaboration with the Bambino Gesù Children's Hospital in Rome to establish a Point of Care Cell Therapy center at the hospital. We look forward to providing further updates as we advance our therapeutic pipeline, expand our hospital network and deploy our OMPULs worldwide.”

“Given the early stage of our POCare network, our reported revenues reflect just the first phase of our JV partnerships, as we establish point-of-care systems and capabilities for our partners. At the same time, these partners are investing in personnel, regulatory expenses and infrastructure in their respective territories as a basis for our therapeutic pipeline advancement. As our JV partners progress towards commercial production of cell therapies, we expect to continue to generate revenue from supporting them, as well as from future royalties. We believe this is a highly scalable model, substantially de-risked through outside capital from our partners.”

The Company’s complete financial results are available in the Company’s Form 10-Q filed with the Securities and Exchange Commission on May 6, 2021 which is available at www.sec.gov and on the Company’s website.

Conference Call

The Company plans to host a conference call at 8:30 AM Eastern Time today, May 7, 2021, to discuss the Company’s financial results for the first quarter ended March 31, 2021, as well as 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 173027. A webcast of the call may be accessed at https://www.webcaster4.com/Webcast/Page/2585/41278 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 Saturday, May 07, 2022. A telephone replay of the call will be available approximately one hour following the call, through Friday, May 21, 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: 41278.

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 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, 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 coronavirus outbreak, the sufficiency of working capital to realize our business plans, 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 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:
David Waldman
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)
(Unaudited)

As of

March 31,
2021

December 31,
2020

Assets

CURRENT ASSETS:

Cash and cash equivalents

$

41,841

$

44,923

Restricted cash

471

645

Accounts receivable, net

11,354

3,085

Prepaid expenses and other receivables

679

1,070

Grants receivable

168

169

Inventory

200

185

Total current assets

54,713

50,077

NON-CURRENT ASSETS:

Deposits

$

348

$

296

Investments in associates, net

160

175

Property, plant and equipment, net

3,469

3,073

Intangible assets, net

12,675

13,023

Operating lease right-of-use assets

1,341

1,474

Goodwill

8,602

8,745

Other assets

802

821

Total non-current assets

27,397

27,607

TOTAL ASSETS

$

82,110

$

77,684


ORGENESIS INC.

CONDENSED CONSOLIDATED BALANCE SHEETS (Cont’d)
(U.S. Dollars in Thousands)
(Unaudited)

As of

March 31,
2021

December 31,
2020

Liabilities and Equity

CURRENT LIABILITIES:

Accounts payable

$

10,294

$

8,649

Accrued expenses and other payables

987

792

Income tax payable

7

7

Employees and related payables

1,638

1,463

Advance payments on account of grant

1,126

692

Short-term loans and current maturities of long- term loans

-

145

Contract liabilities, mainly related party

59

59

Current maturities of finance leases

18

19

Current maturities of operating leases

474

485

Current maturities of convertible loans

4,327

3,974

Total current liabilities

18,930

16,285

LONG-TERM LIABILITIES:

Non-current operating leases

$

895

$

1,020

Convertible loans

7,082

7,200

Retirement benefits obligation

91

74

Non-current finance leases

57

64

Other long-term liabilities

303

313

Total long-term liabilities

8,428

8,671

TOTAL LIABILITIES

27,358

24,956

EQUITY:

Common stock of $0.0001 par value, 145,833,334 shares authorized, 24,469,406 and 24,223,093 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively

3

3

Additional paid-in capital

142,449

140,397

Receipts on account of shares to be allotted

424

-

Accumulated other comprehensive income

471

748

Treasury stock, 57,615 and 55,309 shares as of March 31, 2021 and December 31, 2020, respectively

(260

)

(250

)

Accumulated deficit

(88,538

)

(88,319

)

Equity attributable to Orgenesis Inc.

54,549

52,579

Non-controlling interest

203

149

Total equity

54,752

52,728

TOTAL LIABILITIES AND EQUITY

$

82,110

$

77,684


ORGENESIS INC.

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

Three Months Ended

March 31,
2021

March 31,
2020

Revenues

$

8,232

$

1,385

Revenues from related party

1,157

493

Total revenues

9,389

1,878

Cost of services and other research and development expenses

6,127

4,873

Amortization of intangible assets

238

223

Selling, general and administrative expenses

2,968

3,518

Other income, net

(25

)

(3

)

Operating loss (income)

(81

)

6,733

Financial expenses, net

233

329

Share in net loss of associated companies

15

-

Loss from continuing operation before income taxes

167

7,062

Tax income

(2

)

(47

)

Net loss from continuing operation

165

7,015

Net income from discontinued operations, net of tax

-

(76,465

)

Net loss (income)

165

(69,450

)

Net loss (income) attributable to non-controlling interests from continuing operation

54

(39

)

Net loss attributable to non-controlling interests from discontinued operations

-

(492

)

Net loss (income) attributable to Orgenesis Inc.

219

(69,981

)

Loss (Earning) per share:

Basic and diluted from continuing operations

$

0.01

$

0.39

Basic and diluted from discontinued operations

$

-

$

(4.62

)

Basic and diluted

$

0.01

$

(4.23

)

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

Basic and diluted

24,189,175

17,780,830

Comprehensive loss (income):

Net loss from Continuing Operation

$

165

$

7,015

Net income from Discontinued Operations, Net of Tax

-

(76,465

)

Other Comprehensive loss – Translation adjustment

277

644

Release of translation adjustment due to sale of subsidiary

-

(194

)

Comprehensive loss (income)

442

(69,000

)

Comprehensive loss (income) attributed to non-controlling interests from continuing operation

54

(39

)

Comprehensive income attributed to non-controlling interests from discontinued operation

-

(492

)

Comprehensive loss (income) attributed to Orgenesis Inc.

$

496

$

(69,531

)