CELU Celularity Inc

Celularity Inc. (Nasdaq: CELU) (the “Company”) a biotechnology company developing allogeneic cell therapies and advanced biomaterial products, today announced expected net sales of its biomaterial products and biobanking businesses for the first quarter 2024 and the full year 2024, respectively, and reiterated its previously disclosed advanced biomaterial product commercial and development pipeline. As used here, “net sales” refers exclusively to revenue from the sale of advanced biomaterial products and biobanking services, respectively, and does not include any revenue from other sources such as license fees and royalties or revenue earned under research collaboration agreements.

For the first quarter 2024, the Company expects combined net sales of its advanced biomaterial product and biobanking businesses to be in the range of $10.25 million to $11.5 million, consisting of expected net sales for its advanced biomaterial product business in the range of $9.0 million to $10.0 million and expected net sales for its biobanking business in the range of $1.37 million to $1.50 million. For the first quarter 2024, the Company expects net sales percentage growth for its advanced biomaterial product business to be in the range of 249% to 287% and net sales percentage growth of its biobanking business to be in the low single to low double-digit range, both compared to the first quarter 2023.

For the full year 2024, the Company expects combined net sales of its advanced biomaterial product and biobanking businesses to be in the range of $50 million to $56 million, consisting of expected net sales of its advanced biomaterial product business in the range of $45.0 million to $50.0 million and expected net sales of its biobanking business in the range of $5.5 million to $6.0 million. For the full year 2024, the Company expects net sales percentage growth of its advanced biomaterial product business to be in the range of 165% to 194% and net sales percentage growth of its biobanking business to be in the in the single digit range, both compared to full year 2023.

“Our sales of advanced biomaterial products grew dramatically in the fourth quarter of 2023 as our newest Biovance 3L product gained traction. We hope to build on the net sales growth we observed in the fourth quarter 2023 and continue to grow net sales of our advanced biomaterial products in 2024, which if achieved would meaningfully increase cash provided by operations and move us toward our goal of becoming a cashflow positive enterprise,” said Robert J. Hariri, M.D., Ph.D., Chairman, Chief Executive Officer, and founder. “We believe Celularity is a novel pairing of commercial-stage, cashflow generating advanced biomaterial product and biobanking businesses and a clinical-stage cell therapy business, all enabled by a unique technology platform that combines cellular and regenerative medicine technologies,” Hariri noted. “We are optimistic about our unique business model and encouraged by the organic growth in revenues, which we intend to complement through expanding into new markets,” said Dr. Hariri, who added, “So far, we see January sales of our advanced biomaterial products trending above our expected net sales for the first quarter 2024. We are continuing to explore ways to leverage our unique technology platform, GMP manufacturing infrastructure, and intellectual property portfolio to attract even more commercial and development relationships that are accretive in the near and long-term.”

The Company in 2024 expects to continue to improve the operational effectiveness of its advanced biomaterial product business and to prepare for a possible second half 2024 commercial launch of a new product for wound care and surgical applications. In addition, the Company expects to pursue additional advanced biomaterial product contract manufacturing opportunities under which it provides product development and manufacturing services for a third party which then sells the product(s) under its own brand name(s). For example, in December 2023, the Company entered into a contract manufacturing arrangement with BioCellgraft Inc. (“BioCellgraft“) under which it agreed to manufacture multiple advanced biomaterial products for BioCellgraft that BioCellgraft will sell in the United States under its own brand names for use in various oral health applications. The Company expects in 2024 to continue to assess opportunities to sell its advanced biomaterial products outside the United States but has, at this time, not included any amount attributable to ex-US sales in expected first quarter 2024 or expected full year 2024 net sales.

The Company expects in future to update expected full year 2024 net sales of its advanced biomaterial product and biobanking businesses. Additionally, the Company expects later this year to initiate 2024 operating earnings guidance ranges.

The Company’s advanced biomaterial product pipeline consists of four commercial-stage products and three development-stage product candidates. The commercial-stage products are off-the-shelf placental-derived allogeneic allografts and connective tissue matrices that it markets primarily under its own brands in the U.S. for use in soft tissue repair and reconstructive procedures including acute and chronic non-healing wounds and burns:

• Biovance®, a human amniotic membrane allograft designed to cover or offer protection from the surrounding environment in soft tissue repair and reconstructive procedure.
• Biovance®3L, a Tri-Layer Biovance® human amniotic membrane allograft designed for use as a covering, barrier, or wrap to surgical sites and to support the treatment of ocular surface disease and ocular surgical applications.
• Interfyl®, a decellularized human placental connective tissue matrix designed for use to replace or supplement damaged or inadequate integumental tissue.
• CentaFlex™, a decellularized human placental matrix allograft derived from human umbilical cord designed for use as a surgical covering, wrap, or barrier to protect and support the repair of damaged tissues.

The Company currently is developing three advanced biomaterial product candidates for indications that include aging-associated and other degenerative diseases and disorders characterized by the progressive loss of function and/or structure of the affected tissues:

• SPARK Celularity Tendon Wrap, a high strength scaffold composed of collagen and other native proteins derived from decellularized human placental tissue that the Company is developing for use in the management and protection of tendon injuries.
• FUSE Celularity Bone Void Filler, an easy to handle, moldable bone void filler composed of collagen and other native proteins derived from decellularized human placental tissue that the Company is developing for use as a passive osteoconductive bone filler in the pelvis, extremities, and posterior-lateral spinal fusion settings as well as other skeletal defects.
• ORCHID Celularity Placental Matrix, a fully resorbable device composed of extracellular matrix derived from decellularized human placental tissue that the Company is developing for use as a passive temporary wound covering and in aesthetics.

The Company’s advanced biomaterial product developmental pipeline includes human placental tissue derived scaffolds that it expects to be regulated in the United States as a device under Section 510(k) of the Food, Drug and Cosmetic Act. Both the Company’s SPARK Celularity Tendon Wrap and FUSE Celularity Bone Void Filler completed preliminary non-binding product classifications and jurisdictional assessments by the U.S. Food and Drug Administration (“FDA”) Office of Combination Products (“OCP”) to be regulated as a device by the FDA Center for Devices and Radiologic Health. Based on the OCP’s preliminary assessment, the Company intends to submit a 510(k) notification for its SPARK Celularity Tendon Wrap in the second half of 2024 and for its FUSE Celularity Bone Void Filler in the second half of 2025. The Company is developing its ORCHID Celularity Placental Matrix as a Class III medical device for which it would be required to submit a premarket approval application (“PMA”) to the FDA. In addition, the Company has a discovery phase program to investigate a human placenta-derived exosome which consists of cytokines, chemokines, and growth factors that have been reported to have regenerative and immuno-regulatory activities for a potential indication, alone or in combination with extracellular matrix derived from decellularized human placental tissue, in mild to moderate knee osteoarthritis, a degenerative joint disease of the knee that is the most prevalent form of osteoarthritis and a leading source of chronic pain and disability in the U.S.

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. These forward-looking statements include statements regarding: (i) our past sales or sales growth; (ii) our future sales or sales growth; (iii) our 2024 financial goals and expectations for future financial results, including levels of net sales; (iv) our expectations regarding our new products; and (v) demand for our products. Forward-looking statements include all statements that are not historical facts and all statements relating to future events, including expectations regarding our operational and efficiency initiatives, our strategy, expected net revenue per unit, forecasted results, and expectations regarding the effect of our actions to improve performance. These forward-looking statements reflect our current expectations and projections with respect to, among other things, the Company’s financial condition, results of operations, plans, objectives, strategy, future performance, and business. In some cases, you can identify forward-looking statements by terminology that may precede, follow or include the words "aim," "anticipate," "believe," “can,” “contemplate,” “continue,” “could,” "estimate," "expect," "forecast," "intend," "likely," “may,” “might,” "outlook," "plan," “possible,” "potential," "project," "projection," "seek," "should," “strive,” “target,” “will,” "would," "will," 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 are subject to risks and uncertainties and we caution against placing undue reliance on such statements. Many factors could cause actual results to differ materially from those described in these forward-looking statements, including but not limited to: our future sales are uncertain and are affected by competition, access to customers, patient access to healthcare providers, the reimbursement environment, and many other factors beyond our ability to control; we may change our plans due to unforeseen circumstances; the regulatory status of our advanced biomaterial products; our ability to develop and maintain sales and marketing capabilities, whether alone or with potential future collaborators; our ability to sell our advanced biomaterial products in other countries depends on a number of factors including the local reimbursement environment, the regulatory status of our advanced biomaterial products, and our ability to establish and manage a third party distribution relationships; the risks associated with our current liquidity as well as developments relating to our competitors and industry, along with those risk factors set forth under the caption “Risk Factors” in The Company’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.

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 we do not presently know, or that we currently believe 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 our 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 our views as of any subsequent date, and we undertake 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 Investor Contact:

Carlos Ramirez SVP, Investor RelationsCelularity Inc.carlos.ramirez@celularity.com