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Orgenesis Provides Fiscal 2020 Year-End Results and Corporate Update; Expands POCare Therapeutic Pipeline, POCare Technologies, and POCare Network Revenue increases 96% to $7.7 million for 2020 Projects to more than doub

Key Takeaway: Provides Fiscal 2020 Year-End Results and Corporate Update; Expands POCare Therapeutic Pipeline, POCare Technologies, and POCare Network increases 96% to $7.7 million for 2020 to more than double in revenue for 2021 based on current contracts already in hand to host conferenc

Full Press Release Details

Provides Fiscal 2020 Year-End Results and Corporate Update;
Expands POCare Therapeutic Pipeline, POCare Technologies, and POCare Network
increases 96% to $7.7 million for 2020
to more than double in revenue for 2021 based on current contracts already in hand
to host conference call today at 8:30AM ET
MD - March 9, 2021 - 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 year ended December 31, 2020 and provided a business update.
Caplan, CEO of Orgenesis, commented, "Just over a year ago, we completed the sale of one of our business divisions, which
provided centralized manufacturing subcontracting services to cell and gene biotech companies. This activity was incorporated
in the Masthercell subsidiary, a contract development manufacturing organization (CDMO). The CDMO was sold for $315 million, generating
approximately $127 million of proceeds to Orgenesis. We determined it was the right time to sell Masthercell in order to maximize
value for our shareholders and accelerate the rollout of our other divisions, with a focus on expanding our point-of-care business.
Over the past year, we have been hard at work building the foundation for our POCare platform, which we believe has the potential
to unlock value across the cell and gene therapy industry. Specifically, the historical centralized production model and resulting
high costs of these therapies has inhibited uptake by payors and limited availability for patients. A case in point is CAR-T therapies,
which are transforming cancer treatment, but can range in the hundreds of thousands of dollars per patient, per year. In contrast,
through our decentralized POCare platform, we are able to provide autologous cell and gene therapies to patients in need at the
point-of-care, thereby dramatically lowering costs, streamlining logistics and enhancing distribution."
this end, we have combined the development of three pillars that are the basis for the POCare platform: Therapies, Technologies
and Network. The first pillar, our POCare Therapies, involves licensing and development of breakthrough cell and gene therapies,
that are combined with our second pillar of POCare Technologies. Using the advanced array of automation technologies that we have
either licensed, developed or partnered with, the therapies are adapted for onsite production and supply. In turn, we support
all stages of development and validation of the combination of therapies and processing technologies, from the clinic all the
way through to commercialization. To date, we have developed, purchased or in-licensed more than 30 therapies and continue to
expand our pipeline through our partnership with the POCare centers. Importantly, we believe our expansive therapeutic pipeline
is on par or superior to many of the world's premier cell and gene therapy companies. We also have our first commercial
product on the market, KYSLECEL , following the acquisition of Koligo. KYSLECEL is commercially available in the United States
for chronic and recurrent acute pancreatitis. KYSLECEL is an excellent illustration of our strategy, whereby we are adapting this
therapy for onsite automated production and supply through our POCare platform, thus enabling the availability of this therapy."
ties into the third pillar of our POCare platform, our POCare Network, where we are partnering with leading hospitals and research
centers in 14 countries and setting up GMP processing and supply units as the basis for a harmonized supply network for our therapies.
In doing so, we have realized that having a compliant GMP clean room facility is a major bottle neck for many of these institutions,
and even for those who do have one, it is usually insufficient in size. Building up high-grade clean rooms is a costly and lengthy
process, and running such clean rooms requires highly trained personnel, as well as implementing complex and costly maintenance
procedures. In line with our commitment of enabling cell and gene therapies for all, we have invested heavily in new point-of-care
technologies that can be integrated into our new Orgenesis Mobile Processing Units and Labs (OMPULs)."
have made significant progress in the validation, risk analysis, regulatory and other tasks related to the OMPULs, which will
be utilized to produce our POCare Therapies. These mobile systems can be deployed onsite at a hospital or medical institution,
and can enable parallel processing of therapies at a reduced cost, without the logistical nightmares of a centralized production
facility or the difficulty of building cleanrooms in the hospitals. Some of the key advantages of this system are the short set
up time, small footprint, lower costs, automated operation, modular format, and highly scalable design. All of these factors enable
us to produce autologous cell and gene therapies, along with viral processing capabilities, directly at the point of care in a
consistent and standardized manner in all locations. We believe the OMPULs are an important step in the quick expansion of our
capacity, and we look forward to expanding both the quantity and locations of our systems."
have already established POCare development and service centers in the United States, Belgium, Israel and South Korea, and have
established 10 joint venture agreements with regional partners that are financially committed to validate our therapies according
to local regulatory requirements. In partnership with them, we have set up a network of hospitals and other partners in a total
of 14 countries to date and we expect to sign agreements with many more premier institutions in the coming weeks and months. We
have also utilized these partners to develop and adapt our POCare systems to local requirements."
am pleased to report that our revenues nearly doubled in 2020 to $7.7 million, which reflects growth in revenues related to technology
transfer, setup, and validation of both our therapies and systems for clinical use. We are committed to expanding our capacity
and enabling the supply of our therapies globally, which provides us visibility into our future revenue growth. Based on just
the existing contracts in hand, we anticipate for revenue to more than double in 2021. I am highly appreciative of our global
network partners that helped us to achieve an immense amount of progress over the last year, while facing the tremendous personal
and global logistic hardships imposed by COVID-19. We look forward to providing further updates as we advance our therapeutic
pipeline, expand our hospital network and deploy our OMPULs worldwide."
Company plans to host a conference call at 8:30 AM Eastern Time today, March 9, 2021, to discuss the Company's financial
results for the 2020 fiscal year ended December 31, 2020, as well as the Company's corporate progress and other developments.
conference call will be available via telephone by dialing toll free 877-545-0320 for U.S. callers or +1 973-528-0016 for international
callers and using entry code 796258. A webcast of the call may be accessed at https://www.webcaster4.com/Webcast/Page/2585/40294
or on the Company's Investor Events section of the website here.
webcast replay will be available on the Company's Investor Events section of the website (https://ir.orgenesis.com/overview#/)
through Wednesday, March 9, 2022. A telephone replay of the call will be available approximately one hour following the call,
through Tuesday, March 23, 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: 40294.
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
Regarding Forward-Looking Statements
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 press 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 ability to further develop ranpirnase; our reliance
on, and our ability to grow, our point-of-care cell therapy platform; our ability to develop cell-based and antiviral technologies;
our ability to effectively use the net proceeds from the sale of Masthercell; our ability to achieve and maintain overall profitability;
the development of our POCare strategy; the sufficiency of working capital to realize our business plans; our partners'
ability to develop therapies based on our point-of-care cell therapy platform; technology not functioning as expected; our ability
to retain key employees; our ability to satisfy the rigorous regulatory requirements for new procedures and therapies; our competitors
developing better or cheaper alternatives; the impact of COVID-19 on our operations 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:
contact for Orgenesis
Hunter / Michelle Boxall
Dollars, in thousands)
December 31,
2020 2019
Assets
CURRENT ASSETS:
Cash and cash equivalents $ 44,923 $ 107
Restricted cash 645 467
Accounts receivable, net 3,085 1,831
Prepaid expenses and other receivables 1,070 382
Grants receivable 169 204
Inventory 185 136
Current assets of discontinued operations (See Note 3) - 75,221
Total current assets 50,077 78,348
NON CURRENT ASSETS:
Deposits $ 296 $ 299
Loan to related party - 2,623
Investments in associates, net 175 -
Property, plants and equipment, net 3,073 2,305
Intangible assets, net 13,023 3,348
Operating lease right-of-use assets 1,474 725
Goodwill 8,745 4,812
Other assets 821 35
Total non-current assets 27,607 14,147
TOTAL ASSETS $ 77,684 $ 92,495
Dollars, in thousands)
Last updated: Mar 9, 2021