On July 31, 2024 Celularity Inc. (Nasdaq: CELU) ("Celularity") a regenerative and cellular medicine company developing placental-derived allogeneic cell therapies and advanced biomaterial products, reported its 2023 full-year reported combined net sales of its advanced biomaterial product and biobanking businesses and announced first half 2024 expected combined net sales (Press release, Celularity, JUL 31, 2024, View Source [SID1234645200]). As used here, "net sales" refers to direct-customer and distributor product sales of advanced biomaterial products and biobanking services, respectively, and does not include any revenue from other sources such as fees or revenue earned under research collaboration agreements.

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As reported on its Form 10-K for the year ended December 31, 2023, Celularity reported combined net sales of its advanced biomaterial product and biobanking businesses of $22.8 million for the full year 2023, consisting of advanced biomaterial product net sales of $17.3 million and biobanking net sales of $5.4 million. Reported full year 2023 combined net sales of $22.8 million represents an increase of 26.7% over full year 2022 reported combined net sales and is slightly above the high end of the expected full year 2023 combined net sales range of $22.06 million to $22.76 million announced in January.

Full-year 2023 reported combined net sales is inclusive of the fourth quarter 2023, in which Celularity reported combined net sales of its advanced biomaterial product and biobanking businesses of $12.1 million, consisting of advanced biomaterial product net sales of $10.7 million and biobanking net sales of $1.4 million. Reported fourth quarter combined net sales of $12.1 million are also at the high end of the expected net sales range of $11.4 million to $12.1 million announced in January.

Celularity also updated its expected net sales of its biomaterial products and biobanking businesses for the first quarter 2024 and the second quarter 2024, respectively. For the first quarter 2024, Celularity expects combined net sales of its advanced biomaterial product and biobanking businesses of $14.8 million compared to the guidance range of $10.25 million to $11.5 million announced in February, consisting of expected net sales for its advanced biomaterial product business of $13.5 million and expected net sales for its biobanking business of $1.3 million. For the second quarter 2024, Celularity expects combined net sales of its advanced biomaterial product and biobanking businesses of $11.0 to $13.0 million, consisting of expected advanced biomaterial product net sales of $10.0 to $11.5 million and expected biobanking net sales of $1.0 to $1.5 million. For the first half of 2024 combined, Celularity expects combined net sales of its advanced biomaterial product and biobanking businesses between $25.8 and $27.8 million.

"At this midpoint of 2024, we believe Celularity is on a positive revenue trajectory, building on the very strong net sales growth we reported for 2023," said Robert J. Hariri, M.D., Ph.D., Chairman, CEO and founder of Celularity. "The significant increase in our net sales reflects the growing demand for our advanced biomaterial products and biobanking services. While we are encouraged by our progress, we recognize the financial challenges impacting the industry."

Dr. Hariri continued, "As we navigate the second half of 2024, we are committed to expanding our market presence, enhancing our product offerings, and implementing further strategic measures to improve our financial stability. Our team’s relentless dedication to innovation and operational excellence has enabled us to exceed our financial targets, yet we must remain vigilant in managing our resources effectively. We believe that by maintaining a balanced approach, we can continue to drive long-term value for our shareholders while navigating the complexities of our financial landscape."

Celularity’s advanced biomaterial product portfolio consists of four commercial-stage products and three development pipeline product candidates. Celularity’s commercial-stage products are off-the-shelf placental-derived allogeneic allografts and connective tissue matrices marketed 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.
Biovance3L, a tri-layer 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.
Celularity’s advanced biomaterial product developmental pipeline includes human placental tissue derived medical devices that are intended to treat aging-associated and other degenerative diseases and disorders characterized by the progressive loss of function and/or structure of the affected tissues, including:

Celularity Tendon Wrap, a scaffold composed of collagen and other native proteins derived from decellularized human placental tissue that Celularity is developing for use in the management and protection of tendon injuries.
Celularity Bone Void Filler, a moldable bone void filler composed of collagen and other native proteins derived from decellularized human placental tissue that Celularity 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.
Celularity Placental Matrix, a resorbable device composed of extracellular matrix derived from decellularized human placental tissue that Celularity is developing for use as a passive temporary wound covering.