Celularity Announces Advisory Guidance From Tamer Group Regarding Anticipated 2023 Purchase Orders for Celularity Branded Halal-Certified Biomaterial Products

Rhea-AI Summary

Celularity expects $60-80 million in 2023 purchase orders for Halal-Certified biomaterial products in Saudi Arabia.

Positive

• Celularity has been advised by Tamer Group to expect $60-80 million in purchase orders for their Halal-Certified biomaterial products in Saudi Arabia through the end of 2023. This will guide operations planning and position Celularity for product distribution launches in the Middle East.

Negative

• There can be no assurance that Celularity will realize any purchase orders. The actual amount may be less or greater than the estimated range and may not result in any revenue.

• Celularity has been advised by the Tamer Group to expect at least $60 million to $80 million in 2023 purchase orders for Celularity's branded Halal-Certified biomaterial products

• Tamer Group is the exclusive distributor of Celularity's branded Halal-Certified biomaterial products in the Kingdom of Saudi Arabia

• Issuance of purchase orders conditioned upon receipt of regulatory approvals and other customary conditions precedent
  

FLORHAM PARK, N.J., May 10, 2023 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (Celularity), a biotechnology company developing placental-derived allogeneic cell therapies and biomaterial products, today announced that it has been advised by Farouk, Maamoun Tamer & Co. (Tamer Group), the exclusive distributor for Celularity's branded Halal-Certified biomaterial products in the Kingdom of Saudi Arabia, that it expects to submit purchase orders through the end of 2023 in the range of $60 million to $80 million.

“We deeply appreciate Tamer advising us about its anticipated 2023 purchase orders, which will further guide operations planning at our Florham Park, N.J., facility where we manufacture Celularity's branded biomaterial products,” said Robert J. Hariri, M.D., Ph.D., Celularity’s CEO, Chairman and Founder. “Celularity’s biomaterial inventory and rapidly scalable production capacity ideally positions us for product distribution launches in the Middle East and to move quickly on opportunities to expand sales in this and other markets.”

In January 2023, Celularity and CH Trading Group LLC (CH Trading Group) announced the execution of an agreement with Tamer to be the exclusive distributor for Celularity's Halal-Certified branded biomaterial products in the Kingdom Saudi Arabia.

Speaking on behalf of Tamer Group, Yasser Khattab, Tamer Healthcare CEO, said, “In preparation for an anticipated second quarter 2023 launch under our exclusive distribution agreement, we advised Celularity and CH Trading Group that we expect to submit purchase orders for Celularity's branded biomaterial products totaling at least $60 million to $80 million through the end of 2023. We look forward to a long and productive partnership with Celularity and CH Trading Group to bring Celularity’s Halal-Certified biomaterial products to patients in need in the Kingdom of Saudi Arabia.”

Ahmed Mousa, M.D., Business Development Head and leading Tamer Life Sciences project, added, “Such collaboration aligns with the Kingdom of Saudi Arabia Vision 2030 goals for developing science, research & innovation, and importantly advances the current focus on economic diversification, job creation, and localization of production, technology transfer, clinical trials, training & education.”

The advisory guidance provided by Tamer Group is a non-binding estimate provided for planning purposes and is subject to a number of conditions precedent, including receipt of regulatory authorization to distribute Celularity biomaterial products in the Kingdom of Saudi Arabia and other customary conditions precedent for international distribution of regulated products. Some of these factors are outside the control of Tamer Group and Celularity. There can be no assurance that Celularity will realize any purchase orders. If it does, the actual amount of any purchase orders may be materially less or greater than the estimated range disclosed above and may not result in any revenue to Celularity. Celularity recognizes revenue only when product is shipped to a customer, net of the allowance, if any, for return of damaged or defective goods.

About Celularity

Celularity Inc. (Nasdaq: CELU) headquartered in Florham Park, N.J., is a biotechnology company leading the next evolution in cellular and regenerative medicine by developing allogeneic cryopreserved off-the-shelf placental-derived cell therapies, including therapeutic programs using mesenchymal-like adherent stromal cells (MLASCs), T-cells engineered with CAR (CAR T-cells), and genetically modified and unmodified natural killer (NK) cells targeting indications in autoimmune, infectious and degenerative diseases, and cancer. Celularity also develops, manufactures and commercializes innovative biomaterial products also derived from the postpartum placenta. Celularity believes that by harnessing the placenta’s unique biology and ready availability, it can develop therapeutic solutions that address significant unmet global needs for effective, accessible, and affordable therapies.

To learn more, visit celularity.com

About Celularity Biomaterials

Celularity’s suite of biomaterial products that are Halal-Certified under globally recognized Circle H International Inc. standards include:

• Biovance®, a decellularized, dehydrated human amniotic membrane derived from the placenta of a healthy, full-term pregnancy. Biovance® is an intact, extracellular matrix structure that is indicated for use in the United States as a natural scaffold to support the body’s wound healing process.
• Biovance® 3L and Biovance® 3L Ocular, tri-layer human amniotic membrane products focused on the surgical and ocular markets and available in both sheet and disk form.
• Interfyl®, a human connective tissue matrix derived from the placenta of a healthy, full-term pregnancy. It is indicated for use in the United States to replace or supplement damaged or inadequate integumental tissue resulting from wounds, trauma, or surgery.
• CentaFlex®, a decellularized human placental matrix derived from the umbilical cord that is indicated for use in the United States as a surgical covering, wrap or barrier to protect and support the repair of damaged tissue.

About Tamer Group

Tamer Group is a pharmaceutical and medical products distributor and manufacturer based in KSA (Kingdom of Saudi Arabia). It is the biggest pharma company, representing and partnering with top pharma and medical products companies, also serving the GCC and MEA regions. Tamer Group’s focus is on breakthrough therapeutic and diagnostic innovations to better serve the region’s unique patients’ needs, in collaboration with support from the various governmental, national and regional agencies and research centers, from early clinical development through commercialization.  

To learn more, visit tamergroup.com

Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995, as well as within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “can,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “forecast,” “intends,” “may,” “might,” “outlook,” “plan,” “possible,” “potential,” “predict,” “project,” “seek,” “should,” “strive,” “target,” “will,” “would” and the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. The forward-looking statements in this press release include express or implied statements regarding the Tamer Group’s projected purchase orders and the impact on Celularity’s 2023 revenues. Many factors could cause actual results to differ materially from those described in these forward-looking statements, including but not limited to: the non-binding nature of the purchase order guidance; the risk that the purchase orders may never materialize; as well as other commercial risks associated with the Tamer Group distribution agreement; as well as the inherent risks in biotechnological development, including with respect to the development of novel cellular therapies, and the clinical trial and regulatory approval process; and risks associated with Celularity’s current liquidity, as well as developments relating to Celularity’s competitors and industry, along with those risk factors set forth under the caption “Risk Factors” in Celularity’s annual report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 31, 2023, and other filings with the SEC. These risks and uncertainties may be amplified by current economic situations, including inflation, supply chain issues and overall economic uncertainty, as well as the risks of expanding the biomaterials business internationally. If any of these risks materialize or underlying assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Celularity does not presently know, or that Celularity currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, these forward-looking statements reflect Celularity’s current expectations, plans, or forecasts of future events and views as of the date of this communication. Subsequent events and developments could cause assessments to change. Accordingly, forward-looking statements should not be relied upon as representing Celularity’s views as of any subsequent date, and Celularity undertakes no obligation to update forward-looking statements to reflect events or circumstances after the date hereof, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Celularity Media Contact:
Paul Graves SVP, Chief Communications Officer
Celularity Inc.
paul.graves@celularity.com

FAQ

What is the estimated range for Celularity's purchase orders in Saudi Arabia?

The estimated range for Celularity's purchase orders in Saudi Arabia is $60-80 million through the end of 2023.

Who is the exclusive distributor of Celularity's biomaterial products in Saudi Arabia?

Tamer Group is the exclusive distributor of Celularity's biomaterial products in Saudi Arabia.

What factors could affect the realization of purchase orders?

Factors such as regulatory authorization and other customary conditions precedent for international distribution could affect the realization of purchase orders.

When will the second quarter 2023 launch of Celularity's biomaterial products in Saudi Arabia take place?

The second quarter 2023 launch of Celularity's biomaterial products in Saudi Arabia is anticipated.

What are the benefits of the collaboration between Celularity and Tamer Group?

The collaboration aligns with the goals of developing science, research, and innovation in Saudi Arabia, as well as economic diversification, job creation, and localization of production.