Orgenesis Inc. (ORGS)
Chart Events
Performance Outlook
| Previous Close | 4.41 |
| Open | 4.48 |
| Bid | 5.10 x 1200 |
| Ask | 5.15 x 1100 |
| Day's Range | 4.42 - 5.10 |
| 52 Week Range | 4.14 - 8.30 |
| Volume | 286,387 |
| Avg. Volume | 461,396 |
| Market Cap | 123.868M |
| Beta (5Y Monthly) | 1.16 |
| PE Ratio (TTM) | N/A |
| EPS (TTM) | -2.79 |
| Earnings Date | Aug 04, 2021 - Aug 09, 2021 |
| Forward Dividend & Yield | N/A (N/A) |
| Ex-Dividend Date | N/A |
| 1y Target Est | 9.00 |
Fair Value
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- GlobeNewswire
Orgenesis First Quarter 2021 Revenue Increases 400% to $9.4 Million Reflecting Initial Success of POCare Platform
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 StatementsThis 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 WaldmanCrescendo Communications, LLCTel: 212-671-1021ORGS@crescendo-ir.com Communications contact for OrgenesisImage Box CommunicationsNeil Hunter / Michelle BoxallTel +44 (0)20 8943 4685neil@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)
- GlobeNewswire
FDA Approves Orgenesis IDE for Pilot Clinical Trial of its Tissue Genesis Icellator2® to Treat ARDS Resulting from COVID-19 Infection
IDE approval provides important validation of clinical development plans for the Icellator2 GERMANTOWN, Md., May 06, 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, announces it has been granted Investigational Device Exemption (IDE) approval by the United States Food and Drug Administration (FDA) to conduct a first-in-human feasibility study of the Tissue Genesis Icellator2® to treat Acute Respiratory Distress Syndrome (ARDS) resulting from COVID-19 infection. The Tissue Genesis Icellator2 is a point-of-care cell isolation device that rapidly recovers high yields of stromal and vascular cells (“SVF”) from adipose tissue (fat) to be used therapeutically. The SVF derived from the Icellator2 contains a population of mesenchymal stem cells, vascular endothelial cells, and immune cells which migrate to the patient’s lungs and other peripheral sites of inflammation. Published nonclinical and clinical evidence indicate that SVF from the Icellator2 may potentially: (1) stabilize microcirculation to improve oxygenation; (2) maintain T and B lymphocytes to support antibody production; and (3) induce an anti-inflammatory effect. Orgenesis believes the multiple mechanisms of action of the SVF derived from the Icellator2 are important to treat ARDS and other inflammatory disorders. The FDA IDE approval covers 21 patients at one clinical site in the United States. This is the first trial approved by the FDA for intravenous administration of the SVF produced by the Icellator2. The rates of hospitalized patients in the U.S. suffering from ARDS resulting from COVID-19 has declined significantly in recent months. Orgenesis will monitor and evaluate current clinical needs prior to initiating this approved pilot trial. Orgenesis may consider amending its clinical development plan to target treatment of non-COVID-19 related ARDS or treatment of patients who have not recovered from prior COVID-19 infections (so called “long haulers”). Matthew Lehman, U.S. POCare General Manager, stated, “We believe that the FDA’s IDE authorization of the Tissue Genesis Icellator2 clinical trial is a significant milestone for the Company. We are excited to move forward with clinical development of the Icellator to treat ARDS, COVID-19-related complications, and other serious conditions. Our interactions with the FDA through the IDE process will inform our development plans. We look forward to providing further updates on the progress of our Icellator2 clinical trial.” About OrgenesisOrgenesis 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. Learn more about the work Orgenesis is doing at www.orgenesis.com. Notice Regarding Forward-Looking StatementsThis 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. Contact for Orgenesis:Crescendo Communications, LLCTel: 212-671-1021Orgs@crescendo-ir.com
- GlobeNewswire
Orgenesis Schedules First Quarter 2021 Business Update Conference Call
GERMANTOWN, Md., May 05, 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, today announced that it plans to host a conference call at 8:30 AM Eastern Time on Friday, May 7, 2021 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 for international callers +1 973-528-0011 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 OrgenesisOrgenesis 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. Learn more about the work Orgenesis is doing at www.orgenesis.com. Contact for Orgenesis:David WaldmanCrescendo Communications, LLCTel: 212-671-1021
