Celularity Reports Full Year 2023 Combined Net Sales of $22.8 Million, a 26.7% Increase Over Full Year 2022, and Announces First Half 2024 Expected Combined Net Sales of $26.9 Million Representing 290% Growth Over First Half 2023
Celularity Inc. (Nasdaq: CELU) reported full year 2023 combined net sales of $22.8 million, a 26.7% increase over 2022. The company expects first half 2024 combined net sales of $25.8 to $27.8 million, representing a 290% growth over the first half of 2023. For Q1 2024, Celularity anticipates combined net sales of $14.8 million, surpassing previous guidance. The company is on track to file a 510(k) premarket submission for its Celularity Tendon Wrap in the second half of 2025. Celularity's product portfolio includes four commercial-stage products and three development pipeline candidates, focusing on placental-derived allogeneic allografts and connective tissue matrices for soft tissue repair and reconstructive procedures.
Celularity Inc. (Nasdaq: CELU) ha riportato vendite nette combinate per l'intero anno 2023 di 22,8 milioni di dollari, un aumento del 26,7% rispetto al 2022. L'azienda si aspetta vendite nette combinate per il primo semestre del 2024 di 25,8-27,8 milioni di dollari, il che rappresenta una crescita del 290% rispetto al primo semestre del 2023. Per il primo trimestre del 2024, Celularity prevede vendite nette combinate di 14,8 milioni di dollari, superando le previsioni precedenti. L'azienda è in procinto di presentare una domanda premarket 510(k) per il suo Celularity Tendon Wrap nella seconda metà del 2025. Il portafoglio prodotti di Celularity include quattro prodotti in fase commerciale e tre candidati in fase di sviluppo, concentrandosi su innesti allogenici derivati da placenta e matrici di tessuto connettivo per la riparazione dei tessuti molli e procedure ricostruttive.
Celularity Inc. (Nasdaq: CELU) reportó ventas netas combinadas de $22.8 millones para el año completo 2023, un aumento del 26.7% en comparación con 2022. La compañía espera ventas netas combinadas de $25.8 a $27.8 millones para la primera mitad de 2024, lo que representa un crecimiento del 290% en comparación con la primera mitad de 2023. Para el primer trimestre de 2024, Celularity anticipa ventas netas combinadas de $14.8 millones, superando la guía previa. La empresa está en camino de presentar una solicitud 510(k) para su Celularity Tendon Wrap en la segunda mitad de 2025. El portafolio de productos de Celularity incluye cuatro productos en etapa comercial y tres candidatos en desarrollo, enfocándose en injertos alogénicos derivados de placenta y matrices de tejido conectivo para la reparación de tejidos blandos y procedimientos reconstructivos.
셀룰래리티 Inc. (Nasdaq: CELU)는 2023 회계연도 전체 순매출이 2280만 달러에 이르며, 이는 2022년 대비 26.7% 증가한 수치입니다. 회사는 2024년 상반기 동안의 순매출이 2580만에서 2780만 달러에 이를 것으로 예상, 이는 2023년 상반기 대비 290% 성장하는 것입니다. 2024년 1분기에는 순매출이 1480만 달러를 초과할 것으로 예상하며, 이는 이전 연례 전망을 초과하는 수치입니다. 회사는 2025년 하반기에 Celularity Tendon Wrap에 대한 510(k) 시장 사전 제출을 할 예정입니다. 셀룰래리티의 제품 포트폴리오는 상업 단계에 있는 4개의 제품과 개발 파이프라인 후보 3개를 포함하고 있으며, 연골모세포유래 동종이식편 및 결합조직 매트릭스에 중점을 두어 연부조직 복구 및 재건 수술을 지원합니다.
Celularity Inc. (Nasdaq: CELU) a annoncé un chiffre d'affaires net combiné de 22,8 millions de dollars pour l'année 2023, soit une augmentation de 26,7% par rapport à 2022. La société s'attend à un chiffre d'affaires net combiné de 25,8 à 27,8 millions de dollars pour le premier semestre 2024, ce qui représente une croissance de 290% par rapport au premier semestre de 2023. Pour le premier trimestre de 2024, Celularity anticipe un chiffre d'affaires net combiné de 14,8 millions de dollars, dépassant les prévisions antérieures. L'entreprise est sur la bonne voie pour déposer une demande de précommercialisation 510(k) pour son Celularity Tendon Wrap au second semestre 2025. Le portefeuille de produits de Celularity comprend quatre produits en phase commerciale et trois candidats en développement, axés sur les allogreffes allogéniques dérivées du placenta et les matrices de tissu conjonctif pour la réparation des tissus mous et les procédures reconstructives.
Celularity Inc. (Nasdaq: CELU) berichtete von kombinierten Nettoumsätzen von 22,8 Millionen US-Dollar im Gesamtjahr 2023, was einem Anstieg von 26,7% im Vergleich zu 2022 entspricht. Das Unternehmen erwartet kombinierte Nettoumsätze von 25,8 bis 27,8 Millionen US-Dollar für die erste Hälfte des Jahres 2024, was ein Wachstum von 290% im Vergleich zur ersten Hälfte des Jahres 2023 darstellt. Für das erste Quartal 2024 erwartet Celularity kombinierte Nettoumsätze von 14,8 Millionen US-Dollar, die die bisherigen Prognosen übertreffen. Das Unternehmen ist auf dem besten Weg, einen 510(k) Antrag für sein Celularity Tendon Wrap in der zweiten Hälfte des Jahres 2025 einzureichen. Das Produktportfolio von Celularity umfasst vier Produkte in der kommerziellen Phase und drei Entwicklungsanwärter, mit einem Fokus auf plazentaarisierte allogene Allografts und Bindegewebsmatrizen zur Reparatur von Weichgeweben und rekonstruktiven Eingriffen.
- Full year 2023 combined net sales increased by 26.7% to $22.8 million
- Expected first half 2024 combined net sales of $25.8 to $27.8 million, representing 290% growth over first half 2023
- Q1 2024 expected combined net sales of $14.8 million, exceeding previous guidance
- Growing demand for advanced biomaterial products and biobanking services
- Acknowledgment of financial challenges impacting the industry
- Need for further strategic measures to improve financial stability
Insights
Celularity's financial performance shows promising growth, with full-year 2023 combined net sales reaching
The breakdown of Q1 2024 expected net sales is particularly noteworthy, with
However, investors should consider the company's acknowledgment of "financial challenges impacting the industry." This cautionary note, combined with the need for "further strategic measures to improve financial stability," indicates that while revenue growth is strong, profitability and cash flow management may still be areas of concern.
The company's diverse product portfolio, including four commercial-stage products and three in development, provides multiple revenue streams and potential growth avenues. The planned 510(k) submission for the Celularity Tendon Wrap in 2025 could open up new market opportunities if successful.
Overall, while the revenue trajectory is highly positive, investors should closely monitor the company's ability to translate this top-line growth into improved bottom-line results and sustainable financial health.
Celularity's product portfolio demonstrates a strong focus on regenerative medicine using placental-derived tissues. Their commercial products, including Biovance®, Biovance®3L, Interfyl® and CentaFlex®, target the growing market for soft tissue repair and reconstructive procedures. These products leverage the unique properties of placental tissues, which are rich in growth factors and extracellular matrix components.
The development pipeline is particularly intriguing, with products like the Celularity Tendon Wrap and Bone Void Filler addressing significant unmet needs in orthopedics and wound care. The planned 510(k) submission for the Tendon Wrap in 2025 could be a major milestone, potentially opening up a new revenue stream in the orthopedic market.
From a scientific perspective, the use of decellularized human placental tissue in these applications is innovative. It offers potential advantages over synthetic materials or animal-derived products in terms of biocompatibility and regenerative potential. However, long-term clinical data will be important to establish the efficacy and safety of these products, especially for the pipeline candidates.
The company's focus on "aging-associated and other degenerative diseases" aligns well with demographic trends and increasing demand for regenerative therapies. If Celularity can demonstrate superior clinical outcomes with its placental-derived products, it could capture a significant share of this growing market.
Investors should keep an eye on upcoming clinical trials and regulatory milestones, particularly for the pipeline products, as these will be critical in determining the long-term success and market potential of Celularity's technology platform.
- For the first quarter 2024, Celularity expects combined net sales of
$14.8 million for its advanced biomaterial product and biobanking businesses, compared to the$10.25 million to$11.5 million guidance range previously announced in February.
- Celularity’s expected combined net sales for the first half 2024 are
$25.8 t o$27.8 million compared to$6.9 million of net sales in the first of 2023 at the midpoint of the 2024 range.
- Celularity reiterated it is on track to file a 510(k) premarket submission for its Celularity Tendon Wrap in the second half 2025, the first of three planned advanced biomaterial medical devices.
FLORHAM PARK, N.J., July 31, 2024 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (“Celularity”) a regenerative and cellular medicine company developing placental-derived allogeneic cell therapies and advanced biomaterial products, today announced 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. 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.
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
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
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
“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.
- Biovance®3L, 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.
About Celularity
Celularity Inc. (NASDAQ: CELU) is an innovative regenerative and cellular medicine company. It is developing and commercializing advanced biomaterial products and allogeneic, cryopreserved, placental-derived cell therapies, all derived from the postpartum placenta. What sets Celularity apart is its therapeutic programs that target aging-related diseases, including degenerative diseases, cancer, and immune disorders, using mesenchymal-like adherent stromal cells (MLASCs), T-cells engineered with CAR (CAR T-cells), and genetically modified and unmodified natural killer (NK) cells. Celularity’s unique approach, harnessing the placenta’s biology and ready availability, is paving the way for therapeutic solutions that address significant unmet global needs for effective, accessible, and affordable therapies.
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 2023 sales and sales growth relative to prior periods; (ii) our expected 2024 sales and sales growth relative to prior periods; (iii) our future sales or sales growth; (iv) our 2024 financial goals and expectations for future financial results, including levels of net sales; (v) our expectations regarding our new products; and (vi) 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 July 30, 2024, 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.
Investor Contact:
Carlos Ramirez
Senior Vice President, Celularity Inc.
Carlos.ramirez@celularity.com
Media Contact:
Raquel Cona / Michaela Fawcett
KCSA Strategic Communications
rcona@kcsa.com / mfawcett@kcsa.com
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