Orgenesis Reports 98% Year-Over-Year Increase in Revenue to $13.6 Million for the Fourth Quarter of 2022
Rapid growth reflects progress of POCare Platform
Orgenesis to host conference call today at 11:00 AM ET
GERMANTOWN, Md., March 21, 2023 (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 the fourth quarter and year ended December 31, 2022.
Vered Caplan, CEO of Orgenesis, said, “I am pleased to report that revenue for the fourth quarter of 2022 increased by 98% to $13.6 million, compared to $6.9 million for the same period last year as we are progressing with the planned rollout of our POCare platform. In addition to our strong revenue growth, we reduced our operating loss by 91% for the fourth quarter of 2022 versus the same period last year, which reflects our cost-effective and highly scalable business model. The goal of our Orgenesis Mobile Processing Units and Labs (OMPUL) strategy is to provide autologous cell and gene therapies to patients in need at the point-of-care, which, in turn, is expected to dramatically lower costs. Our latest investments have allowed us to increase our capacity and advance our go-to-market strategy as we aim to expand the deployment of our Orgenesis Mobile Processing Units and Labs (OMPULs). Most recently, we signed a non-binding memorandum of understanding (MOU) with University of California, Davis (UC Davis) to deploy our OMPULs at UC Davis and other healthcare universities within the State of California. Additionally, we are focused on supporting the POCare Centers located at strategic locations in various countries across North America, Europe, Asia, and the Middle East, which serve as hubs for the respective regions.”
Ms. Caplan continued, “Orgenesis is also advancing our POCare therapeutic pipeline, while leveraging grants and partnerships. In 2022, our subsidiary, Koligo Therapeutics, supplied Kyslecel to five medical institutes supplying total pancreatectomy – islet auto transplant (TP-IAT) cases. Production from this one site enabled Koligo to achieve positive cash flow from operations in the fourth quarter of the year as a separate business unit. Additionally, Koligo passed an FDA inspection of this site as a registered tissue production establishment in February. Following this confirmation of the infrastructure design and production protocols, and building on increasing demand, we are now pursuing plans for site expansion in the US and internationally. In the EU, Koligo is utilizing the expertise of Orgenesis to enable regional production capacity and leverage grants to drive clinical development towards marketing approval.”
The complete financial results for the fourth quarter and year ended December 31, 2022 are available on the Company’s website in the Company’s Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission.
Conference Call
The Company will to host a conference call at 11:00 AM Eastern Time today, March 21, 2023, 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 328506. A webcast of the call may be accessed at https://www.webcaster4.com/Webcast/Page/2585/47900 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 Thursday, March 21, 2024. A telephone replay of the call will be available approximately one hour following the call, through Tuesday, April 04, 2023, 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: 47900.
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, 2022, 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
ORGENESIS INC.
CONSOLIDATED BALANCE SHEETS
(U.S. Dollars, in thousands)
December 31, | |||||
2022 | 2021 | ||||
Assets | |||||
CURRENT ASSETS: | |||||
Cash and cash equivalents | $ | 5,311 | $ | 5,473 | |
Restricted cash | 1,058 | 501 | |||
Accounts receivable, net | 36,183 | 15,245 | |||
Prepaid expenses and other receivables | 958 | 1,188 | |||
Convertible loan to related parties | 2,688 | 3,064 | |||
Grants receivable | – | 169 | |||
Inventory | 120 | 118 | |||
Total current assets | 46,318 | 25,758 | |||
NON CURRENT ASSETS: | |||||
Deposits | $ | 331 | $ | 363 | |
Investments and loans to associates | 135 | 584 | |||
Loans receivable | – | 821 | |||
Property, plants and equipment, net | 22,834 | 10,271 | |||
Intangible assets, net | 9,694 | 11,821 | |||
Operating lease right-of-use assets | 2,304 | 1,015 | |||
Goodwill | 8,187 | 8,403 | |||
Deferred tax | 103 | – | |||
Other assets | 1,022 | 805 | |||
Total non-current assets | 44,610 | 34,083 | |||
TOTAL ASSETS | $ | 90,928 | $ | 59,841 | |
ORGENESIS INC.
CONSOLIDATED BALANCE SHEETS
(U.S. Dollars, in thousands)
December 31, | |||||
2022 | 2021 | ||||
Liabilities and equity | |||||
CURRENT LIABILITIES: | |||||
Accounts payable | $ | 4,429 | $ | 5,238 | |
Accrued expenses and other payables | 2,578 | 485 | |||
Income tax payable | 289 | 54 | |||
Employees and related payables | 1,860 | 1,907 | |||
Advance payments on account of grant | 1,578 | 1,238 | |||
Contract liabilities | 70 | 59 | |||
Current maturities of finance leases | 60 | 18 | |||
Current maturities of operating leases | 542 | 481 | |||
Short-term and current maturities of convertible loans | 4,504 | 5,885 | |||
TOTAL CURRENT LIABILITIES | 15,910 | 15,365 | |||
LONG-TERM LIABILITIES: | |||||
Non-current operating leases | $ | 1,728 | $ | 561 | |
Convertible loans | 13,343 | 4,854 | |||
Retirement benefits obligation | 163 | 101 | |||
Long-term debt and finance leases | 95 | 41 | |||
Advance payments on account of grant | 144 | – | |||
Other long-term liabilities | 271 | 288 | |||
TOTAL LONG-TERM LIABILITIES | 15,744 | 5,845 | |||
TOTAL LIABILITIES | 31,654 | 21,210 | |||
REDEEMABLE NON-CONTROLLING INTEREST | 30,203 | – | |||
EQUITY: | |||||
| Common stock of $0.0001 par value: | |||||
Authorized at December 31, 2022 and December 31, 2021: 145,833,334 | |||||
shares; Issued at December 31, 2022 and December 31, 2021: 25,832,322 | 3 | 3 | |||
Additional paid-in capital | 150,355 | 145,916 | |||
Accumulated other comprehensive income (loss) | (270) | 207 | |||
| Treasury stock 286,567 shares as of December 31, 2022 and December | |||||
31, 2021 | (1,266) | (1,266) | |||
Accumulated deficit | (121,261) | (106,372) | |||
Equity attributable to Orgenesis Inc. | 27,561 | 38,488 | |||
Non-controlling interests | 1,510 | 143 | |||
TOTAL EQUITY | 29,071 | 38,631 | |||
TOTAL LIABILITIES AND EQUITY | $ | 90,928 | $ | 59,841 | |
ORGENESIS INC.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(U.S. Dollars, in thousands, except share and per share amounts)
Years Ended December 31, | |||||
2022 | 2021 | ||||
Revenues | $ | 34,741 | $ | 31,646 | |
Revenues from related party | 1,284 | 3,856 | |||
Total revenues | 36,025 | 35,502 | |||
| Cost of revenues, development services and research and development | |||||
expenses | 27,066 | 36,644 | |||
Amortization of intangible assets | 911 | 948 | |||
Selling, general and administrative expenses | 15,589 | 14,710 | |||
Impairment expenses of intangible assets | 1,061 | – | |||
Operating loss | 8,602 | 16,800 | |||
Other income, net | (173) | (2,278) | |||
Loss from extinguishment in connection with convertible loan | 52 | 1,865 | |||
Financial expenses, net | 1,971 | 1,292 | |||
Share in net loss of associated companies | 1,508 | 272 | |||
Loss before income taxes | 11,960 | 17,951 | |||
Tax (income) expense | 209 | 108 | |||
Net loss | $ | 12,169 | $ | 18,059 | |
Net income (loss) attributable to non-controlling interests | 2,720 | (6) | |||
Net loss attributable to Orgenesis Inc. | $ | 14,889 | $ 18,053 | ||
Loss per share: | |||||
Basic and diluted | $ | 0.59 | $ | 0.74 | |
| Weighted average number of shares used in computation of Basic and | |||||
Diluted loss per share: | |||||
Basic and diluted | 25,096,284 | 24,273,658 | |||
Comprehensive loss: | |||||
Net loss | $ | 12,169 | $ | 18,059 | |
Other Comprehensive loss – Translation adjustment | 477 | 541 | |||
Comprehensive loss | $ | 12,646 | $ | 18,600 | |
Comprehensive income (loss) attributed to non-controlling interests | 2,720 | (6) | |||
Comprehensive loss attributed to Orgenesis Inc. | $ | 15,366 | $ | 18,594 | |
