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[10-Q] Vericel Corporation Quarterly Earnings Report

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10-Q
Rhea-AI Filing Summary

Vericel (VCEL) delivered solid top-line growth in Q2-25 but remains loss-making year-to-date. Revenue rose 20% YoY to $63.2 m, driven mainly by MACI implants (+21% to $53.5 m) and the ongoing launch of NexoBrid (+52% to $1.2 m). Epicel contributed $8.6 m (+11%). Gross margin expanded to 74% (vs. 69%) as the largely fixed Cambridge manufacturing base leveraged higher volumes.

Operating expenses climbed 14% to $48.6 m, led by SG&A (+19% to $41.9 m) reflecting salesforce expansion, MACI Arthro marketing and Burlington facility depreciation. As a result, Q2 operating loss narrowed to $2.0 m (from $6.0 m) and net loss to $0.6 m, or $(0.01) per share. For 1H-25, revenue increased 11% to $115.8 m but net loss widened to $11.8 m due to higher costs.

Balance sheet remains strong: cash & equivalents $80.5 m, investments $83.7 m, no revolver borrowings, giving ~ $164 m liquidity. Operating cash flow was $14.8 m (vs. $25.7 m prior-year) after $22.3 m capex tied to the new Burlington manufacturing site, which will become the primary MACI/Epicel plant once validated.

Strategic highlights: FDA approvals in 2024 expanded MACI to arthroscopic delivery and NexoBrid to pediatric burns; management sees both as growth catalysts. Management projects liquidity is sufficient for at least 12 months.

Vericel (VCEL) ha registrato una solida crescita del fatturato nel Q2-25, ma rimane in perdita da inizio anno. I ricavi sono aumentati del 20% su base annua, raggiungendo 63,2 milioni di dollari, trainati principalmente dagli impianti MACI (+21% a 53,5 milioni) e dal continuo lancio di NexoBrid (+52% a 1,2 milioni). Epicel ha contribuito con 8,6 milioni (+11%). Il margine lordo è salito al 74% (rispetto al 69%) grazie alla base produttiva di Cambridge, prevalentemente a costi fissi, che ha beneficiato dei volumi più elevati.

Le spese operative sono aumentate del 14% a 48,6 milioni, principalmente per SG&A (+19% a 41,9 milioni) dovuto all’espansione della forza vendita, al marketing di MACI Arthro e all’ammortamento dello stabilimento di Burlington. Di conseguenza, la perdita operativa del Q2 si è ridotta a 2,0 milioni (da 6,0 milioni) e la perdita netta a 0,6 milioni di dollari, ovvero $(0,01) per azione. Nel primo semestre 2025, i ricavi sono cresciuti dell’11% a 115,8 milioni, ma la perdita netta si è ampliata a 11,8 milioni a causa dei maggiori costi.

La situazione patrimoniale resta solida: liquidità e equivalenti per 80,5 milioni, investimenti per 83,7 milioni, nessun debito revolving, per una liquidità complessiva di circa 164 milioni. Il flusso di cassa operativo è stato di 14,8 milioni (rispetto a 25,7 milioni dell’anno precedente) dopo investimenti per 22,3 milioni legati al nuovo sito produttivo di Burlington, che diventerà lo stabilimento principale per MACI/Epicel una volta validato.

Punti strategici: le approvazioni FDA del 2024 hanno ampliato MACI alla somministrazione artroscopica e NexoBrid alle ustioni pediatriche; la direzione aziendale considera entrambi come fattori di crescita. La direzione prevede che la liquidità sia sufficiente per almeno 12 mesi.

Vericel (VCEL) mostró un sólido crecimiento en ingresos en el Q2-25, pero sigue reportando pérdidas en lo que va del año. Los ingresos aumentaron un 20% interanual hasta 63,2 millones de dólares, impulsados principalmente por los implantes MACI (+21% a 53,5 millones) y el lanzamiento continuo de NexoBrid (+52% a 1,2 millones). Epicel aportó 8,6 millones (+11%). El margen bruto se expandió al 74% (frente al 69%) debido a que la base de fabricación de Cambridge, en gran parte fija, aprovechó los mayores volúmenes.

Los gastos operativos subieron un 14% a 48,6 millones, liderados por SG&A (+19% a 41,9 millones) reflejando la expansión de la fuerza de ventas, el marketing de MACI Arthro y la depreciación de la planta de Burlington. Como resultado, la pérdida operativa del Q2 se redujo a 2,0 millones (desde 6,0 millones) y la pérdida neta a 0,6 millones de dólares, o $(0,01) por acción. En el primer semestre de 2025, los ingresos aumentaron un 11% a 115,8 millones, pero la pérdida neta se amplió a 11,8 millones debido a mayores costos.

El balance sigue siendo sólido: efectivo y equivalentes por 80,5 millones, inversiones por 83,7 millones, sin préstamos revolventes, lo que proporciona una liquidez aproximada de 164 millones. El flujo de caja operativo fue de 14,8 millones (frente a 25,7 millones del año anterior) después de gastos de capital por 22,3 millones vinculados al nuevo sitio de fabricación de Burlington, que se convertirá en la planta principal de MACI/Epicel una vez validada.

Aspectos estratégicos: las aprobaciones de la FDA en 2024 ampliaron MACI a la administración artroscópica y NexoBrid a quemaduras pediátricas; la dirección ve ambos como catalizadores de crecimiento. La dirección proyecta que la liquidez es suficiente para al menos 12 meses.

Vericel(VCEL)는 2025년 2분기에 견고한 매출 성장을 기록했으나, 연초부터는 여전히 적자를 내고 있습니다. 매출은 전년 동기 대비 20% 증가한 6,320만 달러로, 주로 MACI 임플란트(+21% 5,350만 달러)와 NexoBrid의 지속적인 출시(+52% 120만 달러)에 힘입었습니다. Epicel은 860만 달러(+11%)를 기여했습니다. 고정 비용이 많은 Cambridge 제조 기반이 높은 생산량을 활용하며 총이익률은 69%에서 74%로 확대되었습니다.

영업비용은 14% 증가한 4,860만 달러로, 판매관리비(SG&A)가 19% 증가한 4,190만 달러로 주도했으며, 이는 영업 인력 확장, MACI Arthro 마케팅, Burlington 시설 감가상각 때문입니다. 결과적으로 2분기 영업손실은 600만 달러에서 200만 달러로 축소되었고, 순손실은 60만 달러, 주당 $(0.01)로 줄었습니다. 2025년 상반기 매출은 11% 증가한 1억 1,580만 달러였으나, 비용 증가로 순손실은 1,180만 달러로 확대되었습니다.

재무 상태는 견고합니다: 현금 및 현금성 자산 8,050만 달러, 투자자산 8,370만 달러, 리볼빙 대출 없음으로 약 1억 6,400만 달러의 유동성을 보유하고 있습니다. 영업 현금 흐름은 1,480만 달러(전년 동기 2,570만 달러)였으며, 새로운 Burlington 제조 시설과 관련된 2,230만 달러의 자본적 지출이 있었습니다. 해당 시설은 검증 완료 후 MACI/Epicel의 주요 생산 공장이 될 예정입니다.

전략적 하이라이트: 2024년 FDA 승인으로 MACI는 관절경 전달 방식으로 확대되었고, NexoBrid는 소아 화상 치료에 적용되었습니다. 경영진은 이 두 가지를 성장 촉매로 보고 있습니다. 경영진은 최소 12개월 이상의 유동성을 확보하고 있다고 전망합니다.

Vericel (VCEL) a affiché une solide croissance du chiffre d'affaires au 2e trimestre 2025, mais reste déficitaire depuis le début de l'année. Le chiffre d'affaires a augmenté de 20 % en glissement annuel pour atteindre 63,2 millions de dollars, principalement grâce aux implants MACI (+21 % à 53,5 millions) et au lancement continu de NexoBrid (+52 % à 1,2 million). Epicel a contribué pour 8,6 millions (+11 %). La marge brute s’est accrue à 74 % (contre 69 %) grâce à la base de production de Cambridge, largement à coûts fixes, qui a tiré parti des volumes plus élevés.

Les charges d’exploitation ont augmenté de 14 % pour atteindre 48,6 millions, principalement les SG&A (+19 % à 41,9 millions) reflétant l’expansion de la force de vente, le marketing de MACI Arthro et l’amortissement de l’installation de Burlington. En conséquence, la perte d’exploitation du 2e trimestre s’est réduite à 2,0 millions (contre 6,0 millions) et la perte nette à 0,6 million de dollars, soit $(0,01) par action. Pour le premier semestre 2025, le chiffre d’affaires a progressé de 11 % à 115,8 millions, mais la perte nette s’est creusée à 11,8 millions en raison de coûts plus élevés.

La situation financière reste solide : trésorerie et équivalents de trésorerie de 80,5 millions, investissements de 83,7 millions, aucun emprunt sur ligne de crédit renouvelable, offrant une liquidité d’environ 164 millions. Les flux de trésorerie opérationnels se sont élevés à 14,8 millions (contre 25,7 millions l’an dernier) après des dépenses d’investissement de 22,3 millions liées au nouveau site de production de Burlington, qui deviendra l’usine principale pour MACI/Epicel une fois validée.

Points stratégiques : les approbations de la FDA en 2024 ont étendu MACI à l’administration arthroscopique et NexoBrid aux brûlures pédiatriques ; la direction considère ces deux éléments comme des catalyseurs de croissance. La direction prévoit que la liquidité est suffisante pour au moins 12 mois.

Vericel (VCEL) erzielte im 2. Quartal 2025 ein solides Umsatzwachstum, bleibt jedoch im laufenden Jahr weiterhin verlustreich. Der Umsatz stieg im Jahresvergleich um 20 % auf 63,2 Mio. USD, hauptsächlich getrieben durch MACI-Implantate (+21 % auf 53,5 Mio. USD) und die fortlaufende Markteinführung von NexoBrid (+52 % auf 1,2 Mio. USD). Epicel trug 8,6 Mio. USD (+11 %) bei. Die Bruttomarge erhöhte sich auf 74 % (vorher 69 %), da die überwiegend fixkostenbasierte Produktionsstätte in Cambridge von höheren Stückzahlen profitierte.

Die Betriebskosten stiegen um 14 % auf 48,6 Mio. USD, angeführt von SG&A (+19 % auf 41,9 Mio. USD), was die Erweiterung des Vertriebsteams, das Marketing von MACI Arthro und die Abschreibung der Anlage in Burlington widerspiegelt. Infolgedessen verringerte sich der operative Verlust im 2. Quartal auf 2,0 Mio. USD (von 6,0 Mio. USD) und der Nettoverlust auf 0,6 Mio. USD bzw. $(0,01) je Aktie. Für das erste Halbjahr 2025 stiegen die Umsätze um 11 % auf 115,8 Mio. USD, der Nettoverlust weitete sich jedoch aufgrund höherer Kosten auf 11,8 Mio. USD aus.

Die Bilanz bleibt stark: Zahlungsmittel und Zahlungsmitteläquivalente in Höhe von 80,5 Mio. USD, Investitionen von 83,7 Mio. USD, keine revolvierenden Kredite, was eine Liquidität von rund 164 Mio. USD ergibt. Der operative Cashflow betrug 14,8 Mio. USD (vorher 25,7 Mio. USD) nach Investitionen von 22,3 Mio. USD im Zusammenhang mit dem neuen Produktionsstandort in Burlington, der nach der Validierung die Hauptproduktionsstätte für MACI/Epicel werden wird.

Strategische Highlights: Die FDA-Zulassungen im Jahr 2024 erweiterten MACI auf arthroskopische Anwendung und NexoBrid auf pädiatrische Verbrennungen; das Management sieht in beiden Wachstumstreiber. Das Management geht davon aus, dass die Liquidität für mindestens 12 Monate ausreicht.

Positive
  • 20.1% YoY revenue growth and 74% gross margin signal strong demand and operating leverage.
  • Net loss narrowed to $0.6 m in Q2, approaching breakeven.
  • Cash & investments of $164 m with zero debt provides financial flexibility.
  • FDA label expansions for MACI (arthroscopic delivery) and NexoBrid (pediatric) open new market segments.
Negative
  • SG&A expenses up 19%, outpacing revenue and pressuring profitability.
  • 1H-25 net loss widened to $11.8 m despite higher sales.
  • Operating cash flow fell 42% YoY as capex and working-capital needs rose.
  • Epicel sales down 26% for six months, indicating demand volatility.

Insights

TL;DR: Revenue up 20%, near breakeven quarter, liquidity ample; cost creep tempers enthusiasm.

Revenue growth outpaced SG&A, showing early scale benefits from MACI Artho and the NexoBrid rollout. Gross margin at 74% validates the high-value model. Cash plus investments cover >1.4× annual sales and no debt removes refinancing risk. However, stock-based comp ($10.1 m in Q2) and Burlington capex inflate cash burn; operating cash flow halved YoY. Sustained profitability will require SG&A moderation or further top-line acceleration. Guidance absent, but trend suggests FY25 could reach breakeven if Q4 seasonality holds.

TL;DR: Label expansions de-risk growth thesis; execution on Epicel and Burlington validation are watch points.

MACI’s arthroscopic indication enlarges the addressable surgeon pool (~7 k vs 5 k) and should boost volume with less invasive procedures. Pediatric approval for NexoBrid doubles potential burn-unit use cases. Yet Epicel’s 26% 1H sales decline flags competitive or demand variability. Burlington facility, once on-line, could lift capacity and COGS efficiency but introduces validation risk and further depreciation. Overall clinical moat intact, but commercial execution across three therapies must tighten to translate innovation into durable profits.

Vericel (VCEL) ha registrato una solida crescita del fatturato nel Q2-25, ma rimane in perdita da inizio anno. I ricavi sono aumentati del 20% su base annua, raggiungendo 63,2 milioni di dollari, trainati principalmente dagli impianti MACI (+21% a 53,5 milioni) e dal continuo lancio di NexoBrid (+52% a 1,2 milioni). Epicel ha contribuito con 8,6 milioni (+11%). Il margine lordo è salito al 74% (rispetto al 69%) grazie alla base produttiva di Cambridge, prevalentemente a costi fissi, che ha beneficiato dei volumi più elevati.

Le spese operative sono aumentate del 14% a 48,6 milioni, principalmente per SG&A (+19% a 41,9 milioni) dovuto all’espansione della forza vendita, al marketing di MACI Arthro e all’ammortamento dello stabilimento di Burlington. Di conseguenza, la perdita operativa del Q2 si è ridotta a 2,0 milioni (da 6,0 milioni) e la perdita netta a 0,6 milioni di dollari, ovvero $(0,01) per azione. Nel primo semestre 2025, i ricavi sono cresciuti dell’11% a 115,8 milioni, ma la perdita netta si è ampliata a 11,8 milioni a causa dei maggiori costi.

La situazione patrimoniale resta solida: liquidità e equivalenti per 80,5 milioni, investimenti per 83,7 milioni, nessun debito revolving, per una liquidità complessiva di circa 164 milioni. Il flusso di cassa operativo è stato di 14,8 milioni (rispetto a 25,7 milioni dell’anno precedente) dopo investimenti per 22,3 milioni legati al nuovo sito produttivo di Burlington, che diventerà lo stabilimento principale per MACI/Epicel una volta validato.

Punti strategici: le approvazioni FDA del 2024 hanno ampliato MACI alla somministrazione artroscopica e NexoBrid alle ustioni pediatriche; la direzione aziendale considera entrambi come fattori di crescita. La direzione prevede che la liquidità sia sufficiente per almeno 12 mesi.

Vericel (VCEL) mostró un sólido crecimiento en ingresos en el Q2-25, pero sigue reportando pérdidas en lo que va del año. Los ingresos aumentaron un 20% interanual hasta 63,2 millones de dólares, impulsados principalmente por los implantes MACI (+21% a 53,5 millones) y el lanzamiento continuo de NexoBrid (+52% a 1,2 millones). Epicel aportó 8,6 millones (+11%). El margen bruto se expandió al 74% (frente al 69%) debido a que la base de fabricación de Cambridge, en gran parte fija, aprovechó los mayores volúmenes.

Los gastos operativos subieron un 14% a 48,6 millones, liderados por SG&A (+19% a 41,9 millones) reflejando la expansión de la fuerza de ventas, el marketing de MACI Arthro y la depreciación de la planta de Burlington. Como resultado, la pérdida operativa del Q2 se redujo a 2,0 millones (desde 6,0 millones) y la pérdida neta a 0,6 millones de dólares, o $(0,01) por acción. En el primer semestre de 2025, los ingresos aumentaron un 11% a 115,8 millones, pero la pérdida neta se amplió a 11,8 millones debido a mayores costos.

El balance sigue siendo sólido: efectivo y equivalentes por 80,5 millones, inversiones por 83,7 millones, sin préstamos revolventes, lo que proporciona una liquidez aproximada de 164 millones. El flujo de caja operativo fue de 14,8 millones (frente a 25,7 millones del año anterior) después de gastos de capital por 22,3 millones vinculados al nuevo sitio de fabricación de Burlington, que se convertirá en la planta principal de MACI/Epicel una vez validada.

Aspectos estratégicos: las aprobaciones de la FDA en 2024 ampliaron MACI a la administración artroscópica y NexoBrid a quemaduras pediátricas; la dirección ve ambos como catalizadores de crecimiento. La dirección proyecta que la liquidez es suficiente para al menos 12 meses.

Vericel(VCEL)는 2025년 2분기에 견고한 매출 성장을 기록했으나, 연초부터는 여전히 적자를 내고 있습니다. 매출은 전년 동기 대비 20% 증가한 6,320만 달러로, 주로 MACI 임플란트(+21% 5,350만 달러)와 NexoBrid의 지속적인 출시(+52% 120만 달러)에 힘입었습니다. Epicel은 860만 달러(+11%)를 기여했습니다. 고정 비용이 많은 Cambridge 제조 기반이 높은 생산량을 활용하며 총이익률은 69%에서 74%로 확대되었습니다.

영업비용은 14% 증가한 4,860만 달러로, 판매관리비(SG&A)가 19% 증가한 4,190만 달러로 주도했으며, 이는 영업 인력 확장, MACI Arthro 마케팅, Burlington 시설 감가상각 때문입니다. 결과적으로 2분기 영업손실은 600만 달러에서 200만 달러로 축소되었고, 순손실은 60만 달러, 주당 $(0.01)로 줄었습니다. 2025년 상반기 매출은 11% 증가한 1억 1,580만 달러였으나, 비용 증가로 순손실은 1,180만 달러로 확대되었습니다.

재무 상태는 견고합니다: 현금 및 현금성 자산 8,050만 달러, 투자자산 8,370만 달러, 리볼빙 대출 없음으로 약 1억 6,400만 달러의 유동성을 보유하고 있습니다. 영업 현금 흐름은 1,480만 달러(전년 동기 2,570만 달러)였으며, 새로운 Burlington 제조 시설과 관련된 2,230만 달러의 자본적 지출이 있었습니다. 해당 시설은 검증 완료 후 MACI/Epicel의 주요 생산 공장이 될 예정입니다.

전략적 하이라이트: 2024년 FDA 승인으로 MACI는 관절경 전달 방식으로 확대되었고, NexoBrid는 소아 화상 치료에 적용되었습니다. 경영진은 이 두 가지를 성장 촉매로 보고 있습니다. 경영진은 최소 12개월 이상의 유동성을 확보하고 있다고 전망합니다.

Vericel (VCEL) a affiché une solide croissance du chiffre d'affaires au 2e trimestre 2025, mais reste déficitaire depuis le début de l'année. Le chiffre d'affaires a augmenté de 20 % en glissement annuel pour atteindre 63,2 millions de dollars, principalement grâce aux implants MACI (+21 % à 53,5 millions) et au lancement continu de NexoBrid (+52 % à 1,2 million). Epicel a contribué pour 8,6 millions (+11 %). La marge brute s’est accrue à 74 % (contre 69 %) grâce à la base de production de Cambridge, largement à coûts fixes, qui a tiré parti des volumes plus élevés.

Les charges d’exploitation ont augmenté de 14 % pour atteindre 48,6 millions, principalement les SG&A (+19 % à 41,9 millions) reflétant l’expansion de la force de vente, le marketing de MACI Arthro et l’amortissement de l’installation de Burlington. En conséquence, la perte d’exploitation du 2e trimestre s’est réduite à 2,0 millions (contre 6,0 millions) et la perte nette à 0,6 million de dollars, soit $(0,01) par action. Pour le premier semestre 2025, le chiffre d’affaires a progressé de 11 % à 115,8 millions, mais la perte nette s’est creusée à 11,8 millions en raison de coûts plus élevés.

La situation financière reste solide : trésorerie et équivalents de trésorerie de 80,5 millions, investissements de 83,7 millions, aucun emprunt sur ligne de crédit renouvelable, offrant une liquidité d’environ 164 millions. Les flux de trésorerie opérationnels se sont élevés à 14,8 millions (contre 25,7 millions l’an dernier) après des dépenses d’investissement de 22,3 millions liées au nouveau site de production de Burlington, qui deviendra l’usine principale pour MACI/Epicel une fois validée.

Points stratégiques : les approbations de la FDA en 2024 ont étendu MACI à l’administration arthroscopique et NexoBrid aux brûlures pédiatriques ; la direction considère ces deux éléments comme des catalyseurs de croissance. La direction prévoit que la liquidité est suffisante pour au moins 12 mois.

Vericel (VCEL) erzielte im 2. Quartal 2025 ein solides Umsatzwachstum, bleibt jedoch im laufenden Jahr weiterhin verlustreich. Der Umsatz stieg im Jahresvergleich um 20 % auf 63,2 Mio. USD, hauptsächlich getrieben durch MACI-Implantate (+21 % auf 53,5 Mio. USD) und die fortlaufende Markteinführung von NexoBrid (+52 % auf 1,2 Mio. USD). Epicel trug 8,6 Mio. USD (+11 %) bei. Die Bruttomarge erhöhte sich auf 74 % (vorher 69 %), da die überwiegend fixkostenbasierte Produktionsstätte in Cambridge von höheren Stückzahlen profitierte.

Die Betriebskosten stiegen um 14 % auf 48,6 Mio. USD, angeführt von SG&A (+19 % auf 41,9 Mio. USD), was die Erweiterung des Vertriebsteams, das Marketing von MACI Arthro und die Abschreibung der Anlage in Burlington widerspiegelt. Infolgedessen verringerte sich der operative Verlust im 2. Quartal auf 2,0 Mio. USD (von 6,0 Mio. USD) und der Nettoverlust auf 0,6 Mio. USD bzw. $(0,01) je Aktie. Für das erste Halbjahr 2025 stiegen die Umsätze um 11 % auf 115,8 Mio. USD, der Nettoverlust weitete sich jedoch aufgrund höherer Kosten auf 11,8 Mio. USD aus.

Die Bilanz bleibt stark: Zahlungsmittel und Zahlungsmitteläquivalente in Höhe von 80,5 Mio. USD, Investitionen von 83,7 Mio. USD, keine revolvierenden Kredite, was eine Liquidität von rund 164 Mio. USD ergibt. Der operative Cashflow betrug 14,8 Mio. USD (vorher 25,7 Mio. USD) nach Investitionen von 22,3 Mio. USD im Zusammenhang mit dem neuen Produktionsstandort in Burlington, der nach der Validierung die Hauptproduktionsstätte für MACI/Epicel werden wird.

Strategische Highlights: Die FDA-Zulassungen im Jahr 2024 erweiterten MACI auf arthroskopische Anwendung und NexoBrid auf pädiatrische Verbrennungen; das Management sieht in beiden Wachstumstreiber. Das Management geht davon aus, dass die Liquidität für mindestens 12 Monate ausreicht.

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UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 Form 10-Q
 
      QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
FOR THE QUARTERLY PERIOD ENDED:  June 30, 2025
or
         TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 Commission File Number 001-35280
 
VERICEL CORPORATION
(Exact name of registrant as specified in its charter)
Michigan 94-3096597
(State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.)
 
64 Sidney Street
Cambridge, MA 02139
(Address of principal executive offices, including zip code) 

Registrant’s telephone number, including area code: (617) 588-5555 

 Securities registered pursuant to Section 12(b) of the Act: 
Title of ClassTrading Symbol(s)Name of Each Exchange on Which Registered
Common Stock (No par value)VCELNASDAQ

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.  Yes x No o
 
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).  Yes x No o
 
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company.  See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company”, and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filerAccelerated filer
Non-accelerated filerSmaller reporting company
 Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).  Yes  No x

As of July 24, 2025, 50,460,205 shares of Common Stock, no par value per share, were outstanding. 

1

Table of Contents
VERICEL CORPORATION
 QUARTERLY REPORT ON FORM 10-Q
 TABLE OF CONTENTS
 
  Page
 PART I - FINANCIAL INFORMATION 
Item 1.
Financial Statements (Unaudited):
3
 
Condensed Consolidated Balance Sheets
3
 
Condensed Consolidated Statements of Operations
4
Condensed Consolidated Statements of Comprehensive Loss
5
Condensed Consolidated Statements of Shareholders’ Equity
6
 
Condensed Consolidated Statements of Cash Flows
7
 
Notes to Condensed Consolidated Financial Statements
9
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
21
Item 3.
Quantitative and Qualitative Disclosures About Market Risk
30
Item 4.
Controls and Procedures
29
PART II — OTHER INFORMATION
Item 1.
Legal Proceedings
29
Item 1A.
Risk Factors
29
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
30
Item 3.
Defaults Upon Senior Securities
30
Item 4.
Mine Safety Disclosures
30
Item 5.
Other Information
30
Item 6.
Exhibits
32
Exhibit Index
32
Signatures
33
2

Table of Contents

PART I - FINANCIAL INFORMATION
 

Item 1. Financial Statements (Unaudited)

VERICEL CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited, amounts in thousands)

 June 30,December 31,
 20252024
ASSETS  
Current assets:  
Cash and cash equivalents$80,532 $74,520 
Restricted cash 10,529 
Short-term investments36,349 41,693 
Accounts receivable (net of allowance for doubtful accounts of $1 and $10, respectively)
64,290 61,375 
Inventory16,831 17,373 
Other current assets6,575 7,287 
Total current assets204,577 212,777 
Property and equipment, net109,848 103,161 
Intangible assets, net5,938 6,250 
Right-of-use assets67,398 70,098 
Long-term investments47,400 39,880 
Other long-term assets447 556 
Total assets$435,608 $432,722 
LIABILITIES AND SHAREHOLDERS’ EQUITY  
Current liabilities:  
Accounts payable$12,857 $23,848 
Accrued expenses14,404 17,065 
Current portion of operating lease liabilities13,753 9,257 
Other current liabilities118 116 
Total current liabilities41,132 50,286 
Operating lease liabilities86,011 89,593 
Other long-term liabilities1,656 876 
Total liabilities128,799 140,755 
COMMITMENTS AND CONTINGENCIES (Note 12)
Shareholders’ equity:  
Common stock, no par value; shares authorized — 75,000; shares issued and outstanding — 50,441 and 49,628, respectively
711,240 684,778 
Accumulated other comprehensive gain183 4 
Accumulated deficit(404,614)(392,815)
Total shareholders’ equity306,809 291,967 
Total liabilities and shareholders’ equity$435,608 $432,722 

The accompanying notes to condensed consolidated financial statements are an integral part of these statements.

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VERICEL CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited, amounts in thousands, except per share amounts)
 
 Three Months Ended June 30,Six Months Ended June 30,
 2025202420252024
Product sales, net$63,240 $52,662 $115,838 $103,943 
Total revenue63,240 52,662 115,838 103,943 
Cost of product sales16,627 16,061 32,952 31,988 
Gross profit46,613 36,601 82,886 71,955 
Research and development6,731 7,363 13,992 13,781 
Selling, general and administrative41,911 35,269 83,715 69,669 
Total operating expenses48,642 42,632 97,707 83,450 
Loss from operations(2,029)(6,031)(14,821)(11,495)
Other income (expense):   
Interest income1,657 1,510 3,314 3,272 
Interest expense(157)(153)(310)(306)
Other income (expense)(24)(8)18 (15)
Total other income1,476 1,349 3,022 2,951 
Net loss$(553)$(4,682)$(11,799)$(8,544)
Net loss per common share:
Basic and diluted$(0.01)$(0.10)$(0.24)$(0.18)
Weighted-average common shares outstanding:
Basic and diluted50,368 48,686 50,138 48,413 

The accompanying notes to condensed consolidated financial statements are an integral part of these statements.

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VERICEL CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(Unaudited, amounts in thousands)

 Three Months Ended June 30,Six Months Ended June 30,
 2025202420252024
Net loss$(553)$(4,682)$(11,799)$(8,544)
Other comprehensive income (loss):
Unrealized gain (loss) on investments47 (28)179 (173)
Comprehensive loss$(506)$(4,710)$(11,620)$(8,717)

The accompanying notes to condensed consolidated financial statements are an integral part of these statements.

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VERICEL CORPORATION 
CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY
(Unaudited, amounts in thousands)

Common StockAccumulated Other Comprehensive GainAccumulated DeficitTotal Shareholders’ Equity
SharesAmount
BALANCE, DECEMBER 31, 202449,628 $684,778 $4 $(392,815)$291,967 
Net loss— — — (11,246)(11,246)
Stock-based compensation expense— 11,505 — — 11,505 
Stock option exercises398 9,158 — — 9,158 
Shares issued under the Employee Stock Purchase Plan7 251 — — 251 
Issuance of stock for restricted stock unit vesting332 — — — — 
Restricted stock withheld for employee tax remittance(113)(6,280)— — (6,280)
Unrealized gain on investments— — 132 — 132 
BALANCE, MARCH 31, 202550,252 $699,412 $136 $(404,061)$295,487 
Net loss— — — (553)(553)
Stock-based compensation expense— 10,140 — — 10,140 
Stock option exercises147 1,320 — — 1,320 
Shares issued under the Employee Stock Purchase Plan13 468 — — 468 
Issuance of stock for restricted stock unit vesting33 — — — — 
Restricted stock withheld for employee tax remittance(4)(100)— — (100)
Unrealized gain on investments— — 47 — 47 
BALANCE, JUNE 30, 202550,441 $711,240 $183 $(404,614)$306,809 


Common StockAccumulated Other Comprehensive LossAccumulated DeficitTotal Shareholders’ Equity
SharesAmount
BALANCE, DECEMBER 31, 202347,829 $629,229 $(100)$(403,177)$225,952 
Net loss— — — (3,862)(3,862)
Stock-based compensation expense— 9,834 — — 9,834 
Stock option exercises487 6,779 — — 6,779 
Shares issued under the Employee Stock Purchase Plan9 247 — — 247 
Issuance of stock for restricted stock unit vesting265 — — — — 
Restricted stock withheld for employee tax remittance(101)(4,909)— — (4,909)
Unrealized loss on investments— — (145)— (145)
BALANCE, MARCH 31, 202448,489 $641,180 $(245)$(407,039)$233,896 
Net loss— — — (4,682)(4,682)
Stock-based compensation expense— 9,520 — — 9,520 
Stock option exercises329 4020 — — 4,020 
Shares issued under the Employee Stock Purchase Plan14 414 — — 414 
Issuance of stock for restricted stock unit vesting34 — — — — 
Restricted stock withheld for employee tax remittance(4)(163)— — (163)
Unrealized loss on investments— — (28)— (28)
BALANCE, JUNE 30, 202448,862 $654,971 $(273)$(411,721)$242,977 

The accompanying notes to condensed consolidated financial statements are an integral part of these statements.


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VERICEL CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited, amounts in thousands)

 Six Months Ended June 30,
 20252024
Operating activities:  
Net loss$(11,799)$(8,544)
Adjustments to reconcile net loss to net cash flows from operating activities:  
Depreciation and amortization expense5,512 2,701 
Stock-based compensation expense21,645 19,354 
Amortization of premiums and discounts on marketable securities(172)(365)
Amortization of debt issuance costs108 108 
Non-cash lease costs2,702 3,480 
Other9 15 
Changes in operating assets and liabilities:  
Inventory542 (1,800)
Accounts receivable(2,915)10,360 
Other current assets712 421 
Accounts payable(543)(209)
Accrued expenses(2,698)(4,393)
Operating lease liabilities914 4,511 
Other non-current assets and liabilities, net797 98 
Net cash provided by operating activities14,814 25,737 
Investing activities:  
Purchases of investments(28,975)(35,700)
Sales and maturities of investments27,150 23,307 
Expenditures for property and equipment(22,345)(30,778)
Net cash used in investing activities(24,170)(43,171)
Financing activities:  
Net proceeds from common stock issuance 11,197 11,460 
Payments on employee’s behalf for taxes related to vesting of restricted stock unit awards(6,343)(5,038)
Other(15) 
Net cash provided by financing activities4,839 6,422 
Net decrease in cash, cash equivalents, and restricted cash(4,517)(11,012)
Cash, cash equivalents, and restricted cash at beginning of period85,049 86,866 
Cash, cash equivalents, and restricted cash at end of period$80,532 $75,854 

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VERICEL CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (CONTINUED)
(Unaudited, amounts in thousands)


Six Months Ended June 30,
20252024
Supplemental disclosure of cash flow information:
Non-cash information:
Right-of-use asset and lease liability recognized$ $3,037 
Additions to property and equipment included in accounts payable1,439 13,213 
Restricted stock held for employee tax remittance included in accounts payable38  

Six Months Ended June 30,
20252024
Reconciliation to amounts within the condensed consolidated balance sheets:
Cash and cash equivalents$80,532 $50,291 
Restricted cash 25,563 
Total cash, cash equivalents, and restricted cash at end of period$80,532 $75,854 


The accompanying notes to condensed consolidated financial statements are an integral part of these statements.
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VERICEL CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

1. Organization

Vericel Corporation, a Michigan corporation (together with its consolidated subsidiaries referred to herein as the Company, or Vericel), was incorporated in March 1989 and began employee-based operations in 1991. The Company is a fully-integrated, commercial-stage biopharmaceutical company and a leading provider of advanced therapies for the sports medicine and severe burn care markets. Vericel currently markets three commercial-stage products in the U.S., MACI®, Epicel® and NexoBrid®.

MACI (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellularized scaffold product indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults. Since MACI’s commercial launch, the product’s FDA-approved labeling has provided for a treating surgeon to use MACI to treat a patient through an open surgical procedure. In August 2024, the U.S. Food & Drug Administration (“FDA”) approved a supplemental Biologics License Application (“sBLA”) expanding the MACI indication to add instructions for the arthroscopic delivery of MACI to the product’s approved labeling. MACI Arthro™ allows surgeons to evaluate and prepare the cartilage defect site as well as deliver the MACI implant through small incisions using custom-designed arthroscopic instruments developed by the Company (“MACI Arthro instruments”). MACI Arthro became commercially available in the U.S. during the third quarter of 2024, and the Company began selling MACI Arthro instruments at that time.

Epicel (cultured epidermal autografts) is a permanent skin replacement Humanitarian Use Device (“HUD”) indicated for the treatment of adult and pediatric patients with deep-dermal or full-thickness burns comprising greater than or equal to 30 percent of a patient’s total body surface area (“TBSA”). The Company also holds an exclusive license from MediWound Ltd. (“MediWound”) for North American rights to NexoBrid (anacaulase-bcdb), a topically administered biological orphan product containing proteolytic enzymes, which is indicated for the removal of eschar in adult and pediatric patients with deep partial-thickness and/or full thickness thermal burns.

The Company is subject to risks common to companies in the life sciences industry including, but not limited to, development by the Company or its competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, commercialization of existing and new products, and compliance with FDA regulations and approval requirements, as well as the ability to grow the Company’s business through appropriate commercial strategies.

Liquidity

The accompanying condensed consolidated financial statements have been prepared on a basis which assumes that the Company will continue as a going concern and contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. As of June 30, 2025, the Company had an accumulated deficit of $404.6 million and had a net loss of $11.8 million during the six months ended June 30, 2025. The Company had cash and cash equivalents of $80.5 million and investments of $83.7 million as of June 30, 2025. The Company expects that cash from the sales of its products and existing cash, cash equivalents, investments, and available borrowing capacity will be sufficient to support the Company’s current operations through at least 12 months from the issuance of these condensed consolidated financial statements. If revenues decline for a sustained period, the Company may need to access additional capital; however, the Company may not be able to obtain additional financing on acceptable terms or at all. The terms of any additional financing may adversely affect the holdings or the rights of the Company’s shareholders.

Concentration of Credit Risk

Financial instruments that potentially subject the Company to significant concentration of credit risk consist primarily of cash, cash equivalents and investments in marketable debt securities. The Company may maintain deposits in financial institutions in excess of the insurance coverage offered by the Federal Deposit Insurance Corporation, the loss of which could have a negative effect on its operations and liquidity. The Company believes that it is not exposed to significant credit risk as its deposits, including cash and cash equivalents, are held at multiple high-credit-quality financial institutions. The Company has not experienced any losses on these deposits; however, no assurances can be provided that there will not be losses experienced in the future. The Company believes that the market risk arising from its holdings of these financial instruments is mitigated based on the fact that many of these securities are either government-backed or of high credit rating.


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2. Basis of Presentation

The accompanying condensed consolidated financial statements of Vericel are unaudited and have been prepared in accordance with the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”). The preparation of condensed consolidated financial statements in conformity with U.S. generally accepted accounting principles (“U.S. GAAP”) requires management to make estimates, judgments, and assumptions that may affect the reported amounts of assets, liabilities, equity, revenue and expenses. Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been omitted pursuant to such rules and regulations.

The financial statements reflect, in the opinion of management, all adjustments (consisting only of normal, recurring adjustments) necessary to state fairly the financial position and results of operations as of and for the periods indicated. The Company bases its estimates on historical experience and on various other assumptions that it believes are reasonable, the results of which form the basis for making judgments about the carrying values of assets, liabilities and equity and the amount of revenue and expenses.

The condensed consolidated balance sheet as of December 31, 2024 has been derived from the audited consolidated financial statements at that date, but does not include all the information and notes required by U.S. GAAP for complete financial statements. These condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the SEC on February 27, 2025 (“Annual Report”).

Recent Accounting Pronouncements

No new accounting standards were adopted during the six months ended June 30, 2025. The Company considers the applicability and impact of any recent Accounting Standards Updates (“ASUs”) issued by the Financial Accounting Standards Board (“FASB”), as noted below:

In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures, to provide more detailed income tax disclosure requirements. The guidance requires entities to disclose disaggregated information about their effective tax rate reconciliation as well as information on income taxes paid. The disclosure requirements will be applied on a prospective basis, with the option to apply it retrospectively. The effective date for the standard is for fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact of this guidance on its related disclosures.

In November 2024, the FASB issued ASU 2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, which requires new disclosures to disaggregate prescribed natural expenses underlying any income statement caption. This standard is effective for annual periods in fiscal years beginning after December 15, 2026, and interim periods thereafter, with early adoption permitted, and will be applied on a prospective basis. The Company is currently evaluating the impact of this guidance on the consolidated financial statements and disclosures.

3. Revenue

Revenue Recognition and Product Sales, Net

The Company recognizes product revenue from sales of MACI biopsy kits, MACI implants, MACI Arthro instruments, Epicel grafts, and NexoBrid following the five-step model in Accounting Standards Codification 606, Revenue Recognition.

MACI Biopsy Kits

MACI biopsy kits are sold directly to hospitals and ambulatory surgical centers based on contracted rates set forth in an approved contract or sales order. The Company recognizes MACI kit revenue upon delivery of the biopsy kit, at which time the customer (the facility) is in control of the kit. The kit is used by the treating surgeon to provide a sample of cartilage tissue to the Company, which can later be used to manufacture a MACI implant. The ordering of the kit does not obligate the Company to manufacture an implant nor does the receipt of the cartilage tissue by the Company from the customer following biopsy. The customer’s order of an implant is separate from the process of ordering the biopsy kit. Therefore, the sale of the biopsy kit and any subsequent sale of an implant are distinct contracts and are accounted for separately.


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MACI Arthro Instruments

MACI Arthro instruments are sold directly to hospitals and ambulatory surgical centers based upon rates set forth in price lists. The Company recognizes revenue from the sale of MACI Arthro instruments upon delivery of the instruments, at which time the customer (the facility) is in control of the instruments. MACI Arthro instruments can be used by an orthopedic surgeon to deliver MACI to a treated patient using an arthroscopic approach. The customer’s order of a MACI implant is separate from the process of ordering the MACI Arthro instruments. Therefore, the sale of the MACI Arthro instruments and any sale of an implant are distinct and are accounted for separately.

MACI Implants

The Company contracts with two specialty pharmacies, Orsini Pharmaceutical Services, Inc. (“Orsini”) and AllCare Plus Pharmacy, Inc. (“AllCare”) to distribute MACI in a manner in which the Company retains the credit and collection risk from the end customer. The Company pays each specialty pharmacy a fee in each instance when it dispenses MACI for use in treating a patient. Both Orsini and AllCare perform collection activities to collect payment from customers. In addition, the Company sells MACI directly to hospitals pursuant to an agreed upon purchase order and to a distributor, DMS Pharmaceutical Group, Inc. (“DMS”) at a contracted rate for the treatment of patients at military facilities throughout the U.S. The Company engages a third party to provide services in connection with a patient support program to manage patient cases and to ensure that complete and correct billing information is provided to the insurers and hospitals.

Prior authorization and confirmation of coverage level by the patient’s private insurance plan, hospital or government payer is a prerequisite to the shipment of a MACI implant to a patient. The Company recognizes product revenue from sales of all MACI implants upon delivery at which time the customer obtains control of the implant and the claim is billable. The total consideration that the Company expects to collect in exchange for MACI implants (the “Transaction Price”) may be fixed or variable. Direct sales to hospitals or distributors are recorded at a contracted price, and there are typically no forms of variable consideration.

When the Company sells MACI through its specialty pharmacies, the Company is typically reimbursed by a third-party insurer or government payer, subject to a patient co-pay amount. Reimbursements from third-party insurers and government payers vary by patient and payer and are based on either contracted rates, publicly available rates, fee schedules or past payer precedents. Net product revenue is recognized net of estimated contractual allowances, which considers historical collection experience from both the payer and patient, denial rates and the terms of the Company’s contractual arrangements. The Company estimates expected collections for these transactions using the portfolio approach. The Company records a reduction to revenue at the time of sale for its estimate of the amount of consideration that will not be collected. In addition, potential credit risk exposure has been evaluated for the Company’s accounts receivable in accordance with ASC 326, Financial Instruments - Credit Losses. The Company assesses risk and determines a loss percentage by pooling accounts receivable based on similar risk characteristics. The loss percentage is calculated through the use of forecasts that are based on current and historical economic and financial information. This loss percentage was applied to the accounts receivables as of June 30, 2025. The total allowance for uncollectible consideration as of June 30, 2025 and December 31, 2024 was $5.9 million and $5.4 million, respectively. Changes to the estimate of the amount of consideration that will not be collected could have a material impact on the revenue recognized. A 50 basis points change to the estimated uncollectible percentage could result in an approximately $0.5 million decrease or increase in the revenue recognized for the six months ended June 30, 2025.

Changes in estimates of the Transaction Price are recorded through revenue in the period in which such change occurs. Changes in estimates related to prior periods are shown in the Revenue by Product and Customer table below and relate primarily to changes in the initial expected reimbursement or collection expectation upon completion of the billing claims process for MACI implants that occurred in a prior period.

Epicel

The Company sells Epicel directly to hospitals and burn centers based on contracted rates stated in an approved contract or purchase order. Similar to MACI, there is no obligation to manufacture Epicel grafts upon receipt of a skin biopsy. The Company recognizes product revenue from sales of Epicel upon its delivery to the hospital, at which time the customer is in control of the Epicel grafts, and the claim is billable to the hospital.

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NexoBrid

The Company entered into exclusive license and supply agreements with MediWound in May 2019, pursuant to which MediWound will manufacture and supply NexoBrid on a unit price basis, which may be increased pursuant to the terms of the agreements.

In December 2022, the FDA approved a BLA for NexoBrid, granting a license for its commercial use in the U.S. NexoBrid is a topically-administered biological orphan product containing proteolytic enzymes. Through the 2022 BLA, NexoBrid was originally indicated for the removal of eschar in adults with deep partial-thickness and/or full thickness thermal burns. In August 2024, the FDA authorized the expansion of the product’s indication to include pediatric patients.

The Company sells NexoBrid to specialty distributors. These customers subsequently resell NexoBrid to hospitals and burn centers. Product revenue is recorded net of reserves for specialty distributor fees, prompt payment or other discounts and allowances for returns, as applicable. The Company recognizes product revenue from sales of NexoBrid when the specialty distributors take control of the product, which typically occurs upon delivery to the specialty distributors.

Revenue by Product and Customer

The following table and descriptions below show the products from which the Company generated its revenue for the periods indicated:
 Three Months Ended June 30,Six Months Ended June 30,
Revenue by product (in thousands) 2025202420252024
MACI implants, kits, and instruments
Implants based on contracted rate sold through a specialty pharmacy (a)
$39,430 $30,704 $71,471 $58,083 
Implants subject to third party reimbursement sold through a specialty pharmacy (b)
2,688 3,332 5,371 6,529 
Implants sold direct based on contracted rates (c)
8,903 8,099 17,325 14,501 
Implants sold direct subject to third-party reimbursement (d)
991 965 2,615 2,150 
Biopsy kits and instruments - direct bill642 492 1,238 1,058 
Change in estimates related to prior periods (e)
804 543 1,735 1,995 
Total MACI implants, kits, and instruments53,458 44,135 99,755 84,316 
Epicel
Direct bill (hospital)8,614 7,758 13,578 18,422 
NexoBrid1,168 769 2,505 1,205 
Total revenue$63,240 $52,662 $115,838 $103,943 
(a) Represents implants sold through Orsini and AllCare whereby such specialty pharmacies have a direct contract with the underlying insurance provider. The amount of reimbursement is based on contracted rates at the time of sale supported by the pharmacy’s direct contracts.
(b) Represents implants sold through Orsini and AllCare whereby such specialty pharmacy does not have a direct contract with the underlying payer and are subject to third-party reimbursement. The amount of reimbursement is established based on publicly available rates, fee schedules or past payer precedents.
(c) Represents implants sold directly from the Company to the facility based on a contract and known price agreed upon prior to the surgery date. Also represents direct sales under a contract to specialty distributor DMS.
(d) Represents implants sold directly from the Company to the facility based on a contract and known price agreed upon prior to the surgery date. The payment terms are subject to third-party reimbursement from an underlying insurance provider.
(e) Primarily represents changes in estimates related to implants sold through Orsini or AllCare and relate to changes to the initial expected reimbursement or collection expectations upon completion of the billing claims process. The change in estimates is a result of additional information, changes in collection expectations or actual cash collections received in the current period.

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4. Selected Balance Sheet Components

Inventory

Inventory consisted of the following:
(In thousands)June 30, 2025December 31, 2024
Raw materials$11,236 $12,827 
Work-in-process2,054 1,571 
Finished goods3,541 2,975 
Total inventory$16,831 $17,373 

Property and Equipment

Property and Equipment, net consisted of the following:

(In thousands)June 30, 2025December 31, 2024
Machinery and equipment$13,258 $12,161 
Furniture, fixtures and office equipment5,198 5,109 
Computer equipment and software15,967 12,318 
Leasehold improvements75,507 77,990 
Construction in process25,847 22,482 
Total property and equipment, gross135,777 130,060 
Less accumulated depreciation(25,929)(26,899)
Total property and equipment, net$109,848 $103,161 

Depreciation expense for the three and six months ended June 30, 2025 was $2.7 million and $5.2 million, respectively, and $1.2 million and $2.4 million, respectively, for the same periods in 2024.

Intangible Assets

Intangible assets, net consisted of the following:

June 30, 2025December 31, 2024
(In thousands)Useful Life (in years)Amortization MethodCostAccumulated AmortizationNetCostAccumulated AmortizationNet
NexoBrid license12Straight-line$7,500 $(1,562)$5,938 $7,500 $(1,250)$6,250 

Amortization expense for the three and six months ended June 30, 2025 was $0.2 million and $0.3 million, respectively, and $0.2 million and $0.3 million, respectively, for the same periods in 2024.

Future amortization expense of intangible assets as of June 30, 2025 is estimated to be as follows:

(In thousands)Amount
Remainder of 2025$313 
2026625 
2027625 
2028625 
2029625 
Thereafter3,125 
Total$5,938 

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Accrued Expenses

Accrued Expenses consisted of the following:
(In thousands)June 30, 2025December 31, 2024
Bonus-related compensation$6,423 $10,313 
Employee-related accruals4,577 3,269 
Insurance reimbursement-related liabilities2,861 3,159 
Other accrued expenses543 324 
Total accrued expenses$14,404 $17,065 

5. Leases

The Company leases facilities in Ann Arbor, Michigan, Cambridge, Massachusetts and Burlington, Massachusetts. The Ann Arbor facility includes office space, and the Cambridge facility includes clean rooms, laboratories for MACI and Epicel manufacturing and office space. The Company also leases offsite warehouse space and certain equipment.

On January 28, 2022, the Company entered into a lease agreement (as amended, the “Burlington Lease”) to lease approximately 126,000 square feet of manufacturing, laboratory and office space in Burlington, Massachusetts (the “Premises”), which has been under construction. The Burlington facility is substantially complete, and the Company is currently utilizing the facility’s office space. The remaining tenant improvements to the manufacturing suites and related equipment remain ongoing and will be placed in service when they are ready for their intended uses. Once validated, the facility’s manufacturing component will eventually become the primary manufacturing facility for MACI and Epicel.

In April 2023, in connection with the Burlington Lease, the Company entered into a construction escrow agreement (the “Construction Escrow Agreement”) with the facility’s landlord and an escrow agent. Pursuant to the terms of the Construction Escrow Agreement, in April 2023, the Company began funding, into an escrow account maintained by the escrow agent, a portion of its share of tenant improvement construction costs at the facility, which were designated as restricted cash. At the same time, the facility’s landlord began funding a portion of its tenant improvement allowance through a separate escrow account. The Company funded the remaining 50% of its required cost amount, or approximately $28.3 million, with cash on hand, pursuant to the Construction Escrow Agreement, in April 2024. As of June 30, 2025, the amounts deposited by the Company into its escrow account pursuant to the Construction Escrow Agreement have been disbursed. The Company’s escrow account is now closed and approximately $5.2 million, which remained in the Company’s escrow account at the time of closure, has been returned to the Company and is no longer restricted cash.

The Company has determined that certain improvements to the Premises are landlord-owned improvements and costs incurred for these improvements are accounted for as a variable lease payment. In the six months ended June 30, 2024, the Company recorded a right-of-use asset related to landlord-owned improvements incurred of approximately $3.0 million.

For the three and six months ended June 30, 2025, lease expense of less than $0.1 million and less than $0.2 million, respectively, was recorded related to short-term leases, and lease expense of less than $0.1 million was recorded for the same periods in 2024. For the three and six months ended June 30, 2025, the Company recognized $3.0 million and $6.0 million, respectively, of operating lease expense, and $3.2 million and $6.4 million, respectively, for the same periods in 2024. For the three and six months ended June 30, 2025, the Company recognized less than $0.1 million of financing lease expense.


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Operating and finance lease assets and liabilities are as follows:

(In thousands)ClassificationJune 30, 2025December 31, 2024
Assets
OperatingRight-of-use assets$67,398 $70,098 
FinanceProperty and equipment, net686 686 
Total leased assets$68,084 $70,784 
Liabilities
Current
OperatingCurrent portion of operating lease liabilities$13,753 $9,257 
FinanceOther current liabilities118 116 
Non-current
OperatingOperating lease liabilities$86,011 $89,593 
FinanceOther long-term liabilities554 570 
Total leased liabilities$100,436 $99,536 

6. Investments

Marketable debt securities held by the Company are classified as available-for-sale pursuant to ASC 320, Investments – Debt and Equity Securities, and carried at fair value in the accompanying condensed consolidated balance sheets on a settlement date basis. The following tables summarize the gross unrealized gains and losses of the Company’s marketable securities:

June 30, 2025
Gross UnrealizedEstimated Fair Value
(In thousands)Amortized CostGainsLossesCredit Losses
Commercial paper$1,961 $ $(2)$ $1,959 
Corporate notes71,163 218 (24) 71,357 
U.S. government agency bonds10,442  (9) 10,433 
$83,566 $218 $(35)$ $83,749 
Classified as:
Short-term investments$36,349 
Long-term investments47,400 
$83,749 

December 31, 2024
Gross UnrealizedEstimated Fair Value
(In thousands)Amortized CostGainsLossesCredit Losses
Commercial paper$1,953 $1 $(1)$ $1,953 
Corporate notes71,733 117 (87) 71,763 
U.S. government agency bonds7,883 4 (30) 7,857 
$81,569 $122 $(118)$ $81,573 
Classified as:
Short-term investments$41,693 
Long-term investments39,880 
$81,573 

As of June 30, 2025 and December 31, 2024, all marketable securities held by the Company had remaining contractual maturities of three years or less. There have been no impairments of the Company’s assets measured and carried at fair value during the three and six months ended June 30, 2025 and 2024.

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7. Fair Value Measurements

The Company’s fair value measurements are classified and disclosed in one of the following three categories:

Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities;
Level 2: Quoted prices in markets that are not active, or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liability;
Level 3: Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity).

Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The commercial paper, corporate notes, U.S. government securities, and U.S. government agency bonds are classified as Level 2 as they were valued based upon quoted market prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active and model-based valuation techniques for which all significant inputs are observable in the market or can be corroborated by observable market data for substantially the full term of the assets. The deferred compensation plan liabilities are recorded at the value of the amount owed to the plan participants, with changes in value recognized as compensation expense. The calculation of the deferred compensation plan obligation is derived from observable market data by reference to hypothetical investments selected by the participants. There were no transfers into or out of Level 3 from December 31, 2024 to June 30, 2025.

The following table summarizes the valuation of the Company’s financial instruments that are measured at fair value on a recurring basis:

 June 30, 2025December 31, 2024
  Fair value measurement category Fair value measurement category
(In thousands)TotalLevel 1Level 2Level 3TotalLevel 1Level 2Level 3
Assets:
Money market funds$23,373 $23,373 $ $ $43,307 $43,307 $ $ 
Commercial paper1,959  1,959  1,953  1,953  
Corporate notes71,357  71,357  71,763  71,763  
U.S. government agency bonds10,433  10,433  7,857  7,857  
U.S. government securities (a)
46,472  46,472  16,150  16,150  
$153,594 $23,373 $130,221 $ $141,030 $43,307 $97,723 $ 
Liabilities:
Deferred compensation plan liabilities$1,307 $ $1,307 $ $306 $ $306 $ 
Total liabilities$1,307 $ $1,307 $ $306 $ $306 $ 

(a) Approximately $46.5 million and $16.2 million of U.S. government securities had an original maturity of 90 days or less and were recorded as a cash equivalent as of June 30, 2025 and December 31, 2024, respectively.

The fair values of the cash equivalents and marketable securities are based on observable market prices. The Company’s accounts receivables, accounts payable and accrued expenses are valued at cost which approximates fair value.


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8. Revolving Credit Agreement

On July 29, 2022, the Company, as borrower, entered into a $150.0 million five-year senior secured revolving credit agreement by and among the Company, the other loan parties thereto, the lenders party thereto, and JPMorgan Chase Bank, N.A., as the administrative agent (the “Revolving Credit Agreement”). The Revolving Credit Agreement includes a $15.0 million sub-facility for the issuance of letters of credit, of which the Company is utilizing approximately $6.2 million. Amounts available under the Revolving Credit Agreement are for the working capital needs and other general corporate purposes of the Company. The Company incurred and capitalized approximately $1.1 million of debt issuance costs related to the Revolving Credit Agreement.

Outstanding borrowings under the Revolving Credit Agreement bear interest, with pricing based from time to time at the Company’s election at (i) the Secured Overnight Financing Rate (“SOFR”) plus 0.10% plus a spread ranging from 1.25% to 2.50% as determined by the Company’s Total Net Leverage Ratio (as defined in the Revolving Credit Agreement) or (ii) the alternative base rate (as defined in the Revolving Credit Agreement) plus a spread ranging from 0.25% to 1.50% as determined by the Company’s Total Net Leverage Ratio. The Revolving Credit Agreement also includes a commitment fee, which ranges from 0.20% to 0.25% as determined by the Company’s Total Net Leverage Ratio.

The Company is permitted to voluntarily prepay borrowings under the Revolving Credit Agreement, in whole or in part, without premium or penalty. On any business day on which the total amount of outstanding Revolving Loans (as defined in the Revolving Credit Agreement) and letters of credit exceeds the total Revolving Commitments (as defined in the Revolving Credit Agreement), the Company must prepay the Revolving Loans in an amount equal to such excess. As of June 30, 2025, there are no outstanding borrowings under the Revolving Credit Agreement.

The Revolving Credit Agreement contains a number of affirmative, negative, reporting and financial covenants, in each case subject to certain exceptions and materiality thresholds. The Revolving Credit Agreement requires the Company to be in quarterly compliance, measured on a trailing four quarter basis, with a financial covenant. The maximum Total Net Leverage Ratio (as defined in the Revolving Credit Agreement) is 3.50 to 1.00. The Company may elect to increase the maximum Total Net Leverage Ratio to 4.00 to 1.00 for a period of four consecutive quarters in connection with a Permitted Acquisition (as defined in the Revolving Credit Agreement).

The Revolving Credit Agreement contains usual and customary restrictions on the ability of the Company and its subsidiaries to: (i) incur additional indebtedness; (ii) create liens; (iii) consolidate, merge, sell or otherwise dispose of all, or substantially all, of its assets; (iv) sell certain assets; (v) pay dividends on, repurchase or make distributions in respect of capital stock or make other restricted payments; (vi) make certain investments; (vii) repay subordinated indebtedness prior to stated maturity; and (viii) enter into certain transactions with its affiliates.

Obligations under the Revolving Credit Agreement are secured by first priority liens over substantially all of the assets of Vericel Corporation, excluding certain subsidiaries (subject to customary exclusions set forth in the Revolving Credit Agreement and the other transaction documents).


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9. Stock-Based Compensation

The Vericel Corporation 2022 Omnibus Incentive Plan (“2022 Plan”) was approved on April 27, 2022, and the Vericel Corporation Amended and Restated 2022 Omnibus Incentive Plan (“Amended and Restated 2022 Plan”) was approved on April 30, 2025. The Amended and Restated 2022 Plan provides incentives through the grant of stock options, stock appreciation rights, restricted stock awards and restricted stock units. The exercise price of stock options granted under the Amended and Restated 2022 Plan shall not be less than the fair market value of the Company’s common stock on the date of grant. The Amended and Restated 2022 Plan amended and restated the 2022 Plan, which replaced the 1992 Stock Option Plan, the 2001 Stock Option Plan, the Amended and Restated 2004 Equity Incentive Plan, the 2009 Second Amended and Restated Omnibus Incentive Plan, the 2017 Omnibus Incentive Plan and the Amended and Restated 2019 Omnibus Incentive Plan (collectively the “Prior Plans”), and no new grants have been granted under the Prior Plans after approval of the 2022 Plan. However, the expiration or forfeiture of options previously granted under the Prior Plans will increase the number of shares available for issuance under the Amended and Restated 2022 Plan.

Stock Compensation Expense

Non-cash stock-based compensation expense (service-based stock options, restricted stock units and the employee stock purchase plan) is summarized in the following table:
 Three Months Ended June 30,Six Months Ended June 30,
(in thousands)2025202420252024
Cost of product sales$1,109 $911 $2,249 $2,152 
Research and development1,148 965 2,635 2,186 
Selling, general and administrative7,883 7,644 16,761 15,016 
Total non-cash stock-based compensation expense$10,140 $9,520 $21,645 $19,354 

Service-Based Stock Options

During the three and six months ended June 30, 2025, the Company granted service-based options to purchase common stock of 74,625 and 576,723, respectively, and 133,225 and 640,387, respectively, for the same periods in 2024. The weighted-average grant-date fair value of service-based options granted during the three and six months ended June 30, 2025 was $21.52 and $28.84 per option, respectively, and $27.85 and $28.14, respectively, for the same periods in 2024.

Restricted Stock Units

During the three and six months ended June 30, 2025, the Company granted 87,065 and 555,951 restricted stock units, respectively, and 48,500 and 586,925, respectively, for the same periods in 2024. The weighted-average grant-date fair value of restricted stock units granted during the three and six months ended June 30, 2025 was $38.77 and $51.87 per unit, respectively, and $48.06 and $48.23 per unit, respectively, for the same periods in 2024.



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10. Net Loss Per Common Share

A summary of net loss per common share is presented below:
 Three Months Ended June 30,Six Months Ended June 30,
(Amounts in thousands, except per share amounts)2025202420252024
Net loss$(553)$(4,682)$(11,799)$(8,544)
   
Basic weighted-average common shares outstanding50,368 48,686 50,138 48,413 
Effect of dilutive stock options and restricted stock units    
Diluted weighted-average common shares outstanding50,368 48,686 50,138 48,413 
Basic loss per common share$(0.01)$(0.10)$(0.24)$(0.18)
Diluted loss per common share$(0.01)$(0.10)$(0.24)$(0.18)
Anti-dilutive shares excluded from diluted net loss per common share:
Stock options5,693 6,466 5,693 6,466 
Restricted stock units1,237 1,164 1,237 1,164 

11. NexoBrid License and Supply Agreements

On May 6, 2019, the Company entered into exclusive license and supply agreements with MediWound to commercialize NexoBrid in North America. NexoBrid is a topically-administered biological orphan product containing proteolytic enzymes, for which the FDA approved a BLA in December 2022 permitting the product’s use for the removal of eschar in adults with deep partial-thickness and/or full thickness thermal burns. Subsequently, in August 2024, the FDA approved a supplemental BLA expanding NexoBrid’s indication to include pediatric patients.

Pursuant to the terms of the license agreement, following the FDA approval of NexoBrid, MediWound transferred the BLA to Vericel. NexoBrid is approved in the European Union (“EU”) and other international markets and has been designated as an orphan biologic in the U.S., EU and other international markets.

In May 2019, the Company paid MediWound $17.5 million in consideration for the license, which was recorded as research and development expense during 2019. The FDA’s December 2022 approval of NexoBrid resulted in the achievement of a $7.5 million regulatory milestone payment pursuant to the terms of the license agreement. The Company recorded the $7.5 million milestone for the licensing rights to commercially sell NexoBrid in the U.S. as an intangible asset as of December 31, 2022. The $7.5 million milestone payment was paid to MediWound in February of 2023.

Additionally, the Company is obligated to pay MediWound up to $125.0 million, which is contingent upon meeting certain sales milestones. The first sales milestone payment of $7.5 million would be triggered when annual net sales of NexoBrid or improvements to NexoBrid in North America exceed $75.0 million. As of June 30, 2025, the sales milestone payments are not yet probable and therefore, not recorded as a liability. The Company also pays MediWound tiered royalties on net sales ranging from mid-high single-digit to mid-teen percentages, subject to customary reductions. Pursuant to the terms of the Company’s supply agreement with MediWound, MediWound is manufacturing, and will continue to manufacture, NexoBrid for the Company on a unit price basis, which may be increased pursuant to the terms of the supply agreement. MediWound is obligated to supply the Company with NexoBrid for sale in North America on an exclusive basis for the first five years of the term of the supply agreement. Under the supply agreement, the Company possesses the option to extend the initial term of the agreement by an additional 24 months, which it did in May 2022. After the initial term, the Company may extend the supply agreement on an annual basis for up to 10 additional years, at its sole discretion. In March 2025, the Company exercised the first of these annual extensions, extending the term of the supply agreement through at least May 2027. Under the supply agreement, the Company is permitted to establish an alternate source of supply in certain circumstances, including the event of a supply failure.


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Additionally, beginning in 2020, BARDA procured quantities of NexoBrid from MediWound for use as a medical countermeasure in the event of a mass casualty emergency in the U.S. involving thermal burns. The initial, quarterly, procurement of NexoBrid by BARDA under its agreement with MediWound was completed during the third quarter of 2022. As a part of BARDA’s commitment to procure NexoBrid, the Company received a percentage of gross profit for sales directly to BARDA. As of June 30, 2025, the Company did not hold a direct contract or distribution agreement with BARDA, or take title to the product procured by BARDA.

12. Commitments and Contingencies

From time-to-time, the Company could be a party to various legal proceedings arising in the ordinary course of business. The costs and outcome of litigation, regulatory, investigatory or other proceedings cannot be predicted with certainty, and some lawsuits, claims, actions or proceedings may be disposed of unfavorably to the Company and could have a material adverse effect on the Company’s results of operations or financial condition. In addition, intellectual property disputes often have a risk of injunctive relief which, if imposed against the Company, could materially and adversely affect its financial condition or results of operations. If a matter is both probable to result in material liability and the amount of loss can be reasonably estimated, the Company estimates and discloses the possible material loss or range of loss. If such loss is not probable or cannot be reasonably estimated, a liability is not recorded in its condensed consolidated financial statements.

As of June 30, 2025, the Company had no material ongoing litigation in which the Company was a party or any material ongoing regulatory or other proceedings and had no knowledge of any investigations by government or regulatory authorities in which the Company is a target that could have a material adverse effect on its current business.
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13. Segment Information
 
The Company operates its business primarily in the U.S. in one reportable segment - the research, product development, manufacture and distribution of cellular therapies and specialty biologics for use in the treatment of specific conditions. The Company is managed on a consolidated basis.

The Company’s Chief Executive Officer was determined to be the Company’s chief operating decision maker (“CODM”). The CODM reviews and evaluates revenue, expenses and consolidated net income (loss), consistent with what is reported on the consolidated statement of operations, for purposes of assessing performance, making operating decisions, allocating resources, and planning and forecasting for future periods.

In addition to the significant expense categories within the Company’s consolidated statements of operations, see below for disaggregated amounts that comprise selling, general and administrative expenses:

Three Months Ended June 30,Six Months Ended June 30,
( in thousands)2025202420252024
Selling and marketing$22,296 $19,858 $45,099 $39,291 
General and administrative19,61515,411 38,616 30,378 
Total selling, general and administrative expenses$41,911 $35,269 $83,715 $69,669 

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Overview

Vericel Corporation is a fully-integrated, commercial-stage biopharmaceutical company and a leading provider of advanced therapies for the sports medicine and severe burn care markets. Whether we are treating damaged cartilage or severe burns, we provide advanced therapies to repair serious injuries and restore lives. Our highly differentiated portfolio of cell therapy and specialty biologic products combines innovations in biology with medical technologies. We were among the first companies to achieve commercial success in the complex field of cell therapies with treatments that use tissue engineering to regenerate skin and healthy knee cartilage. We currently market two U.S. Food and Drug Administration (“FDA”) approved autologous cell therapy products and one FDA-approved specialty biologic product in the U.S. MACI® is an autologous cellularized scaffold product indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults. Since MACI’s commercial launch, the product’s FDA-approved labeling has provided for a treating surgeon to use MACI to treat a patient through an open surgical procedure. In August 2024, the FDA approved a supplemental Biologics License Application (“sBLA”) expanding the MACI indication to add instructions for the arthroscopic delivery of MACI to the product’s approved labeling. MACI Arthro™ allows surgeons to evaluate and prepare the cartilage defect site as well as deliver the MACI implant through small incisions using custom-designed arthroscopic instruments developed by the Company (“MACI Arthro instruments”). MACI Arthro became commercially available in the U.S. during the third quarter of 2024 and the Company began selling the MACI Arthro instruments at that time.

Epicel® is a permanent skin replacement Humanitarian Use Device (“HUD”) indicated for the treatment of adult and pediatric patients with deep-dermal or full-thickness burns comprising greater than or equal to 30 percent of a patient’s total body surface area (“TBSA”). We also hold an exclusive license from MediWound Ltd. (“MediWound”) for North American rights to NexoBrid® (anacaulase-bcdb), a topically-administered biological orphan product containing proteolytic enzymes, which is indicated for the removal of eschar in adult and pediatric patients with deep partial-thickness and/or full-thickness thermal burns.

The Ongoing and Evolving Conflicts in the Middle East

In May 2019, we entered into exclusive license and supply agreements with MediWound, under which MediWound manufactures and supplies NexoBrid to the U.S. market on a unit price basis. MediWound develops and manufactures NexoBrid, in part, at its facilities in Yavne, Israel.

We continue to monitor the ongoing and evolving conflicts in the Middle East region involving Israel, and we are in close communication with MediWound leadership. MediWound’s NexoBrid manufacturing operations are continuing and, as of the date of this disclosure, MediWound does not anticipate a material disruption to its ongoing supply of commercial NexoBrid to the U.S. To the extent the conflicts in the Middle East region result in damage to MediWound’s facilities in Israel or inhibit
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travel or commercial shipments to and from Israel, MediWound’s ability to continue to supply NexoBrid to the U.S. market could be disrupted. As of the date of this report, we maintain an ample supply of NexoBrid at our U.S.-based third-party logistics provider.

U.S. Trade Policy

We continue to monitor evolving trade policies, including the imposition of tariffs on foreign goods imported into the U.S., as part of our ongoing risk assessment process. We anticipate minimal impact on our business and operations from current or potential future U.S.-imposed tariffs or any retaliatory measures taken by other governments. All of our operations are located in the U.S. and 100% of our revenue in 2025, and for the next several years, is expected to be derived from domestic sales. The majority of our manufacturing costs are fixed costs consisting of labor and overhead required to produce MACI and Epicel at our manufacturing facility in Massachusetts. Materials to support manufacturing operations are primarily purchased from U.S. suppliers. Based on the limited costs associated with imported materials, we expect that current or future tariffs will have an insignificant impact on our cost of goods sold and gross margin moving forward. In addition, because we maintain significant safety stock of most materials, including NexoBrid finished product and the ACI-Maix collagen membrane used to manufacture MACI, we expect that the impact of current or future tariffs on our cost of goods sold and gross margin in 2025 and 2026 will be negligible.

Manufacturing

We have a cell manufacturing facility in Cambridge, Massachusetts, which is used for U.S. manufacturing and distribution of MACI and Epicel. In January 2022, we entered into a lease agreement (as amended, the “Burlington Lease”) to lease approximately 126,000 square feet of manufacturing, laboratory and office space in Burlington, Massachusetts, which has been under construction. The Burlington facility is substantially complete, and we are currently utilizing the facility’s office space. Once validated, the facility’s manufacturing component will eventually become the primary manufacturing facility for MACI and Epicel.

The manufacturing process for NexoBrid is conducted by MediWound, primarily at manufacturing locations in Israel. Certain raw materials utilized in NexoBrid’s manufacture, including the supply of the active ingredient bromelain, are sourced from Taiwan.

Product Portfolio

Our current marketed products include two FDA-approved autologous cell therapies and one FDA-approved specialty biologic product. MACI is a third-generation autologous cellularized scaffold product indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults. In connection with our MACI product, we sell MACI biopsy kits, which are used by treating surgeons to obtain a sample of cartilage tissue, which is later sent to us. If a patient decides to move forward with MACI treatment, we subsequently use the cartilage sample to manufacture a MACI implant. When an orthopedic surgeon decides to treat a patient by implanting MACI through an arthroscopic approach the surgeon may choose to use our custom MACI Arthro instruments during the procedure, which we sell by way of a separate transaction.

Epicel is a permanent skin replacement indicated for the treatment of adult and pediatric patients with deep-dermal or full-thickness burns comprising greater than or equal to 30 percent of a patient’s TBSA. Both autologous cell therapy products are currently manufactured and marketed in the U.S. NexoBrid is a topically-administered biological orphan product containing proteolytic enzymes that is indicated for eschar removal in adult and pediatric patients with deep partial-thickness and/or full-thickness burns. We hold exclusive license and supply agreements with MediWound to commercialize NexoBrid in North America. The Company operates its business primarily in the U.S. in one reportable segment - the research, product development, manufacture and distribution of cellular therapies and specialty biologics for use in the treatment of specific conditions.

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MACI

MACI is a third-generation autologous chondrocyte implantation (“ACI”) product indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults.

Our target audiences are orthopedic surgeons who self-identify and/or have formal specialty training in sports medicine, and a subpopulation of general orthopedic surgeons who perform a high volume of cartilage repair procedures involving the knee. Our MACI commercial team consists of individual sales representatives that regularly engage with our target audience. The team is divided into geographic regions and is managed by a senior sales leadership team. Most private payers have a medical policy that covers treatment with MACI with the top 30 largest commercial payers having a formal medical policy for MACI or ACI in general. With respect to private commercial payers that have not yet approved a medical policy for MACI, we often obtain approval on a case-by-case basis.

MACI consists of autologous cultured chondrocytes, which are human-derived cells that are obtained from the patient’s own cartilage, and which are seeded onto resorbable Type I/III collagen membrane. Since MACI’s commercial launch, the product’s FDA-approved labeling has provided for a treating surgeon to use MACI to treat a patient through an open surgical procedure. In August 2024, the FDA approved a supplemental Biologics License Application (“sBLA”) expanding the MACI indication to add instructions for the arthroscopic delivery of MACI to the product’s approved labeling, permitting the repair of single or multiple full-thickness cartilage defects of the knee up to 4 cm2 in size via an arthroscopic approach. MACI Arthro provides a less invasive technique compared to the open arthrotomy approach and allows surgeons to evaluate, prepare and treat the cartilage defect, and deliver the MACI implant, under direct arthroscopic visualization and, should the surgeon so choose, to use specialized and custom-designed instruments (the “MACI Arthro instruments”) through small incisions or portals. The arthroscopic delivery of MACI could increase the ease of MACI’s use for physicians and may reduce both the length of the procedure as well as procedure-induced trauma, which may result in a reduction of a patient’s post-operative pain and accelerate a patient’s recovery. MACI Arthro became commercially available in the U.S. during the third quarter of 2024 and we began selling the MACI Arthro instruments at that time. We believe that the availability of MACI Arthro provides a significant growth opportunity for the overall MACI business. In conjunction with the launch of MACI Arthro, we have expanded our target surgeon base from 5,000 to 7,000 to include orthopedic surgeons that perform high volumes of knee cartilage repair surgeries, predominantly through arthroscopic procedures.

We also are evaluating the feasibility and potential market opportunity involved in delivering MACI treatment to patients suffering from cartilage damage in the ankle. We believe that this potential lifecycle enhancement and indication expansion for MACI will require conducting an additional randomized clinical trial concerning the product’s use in the ankle and we are on track to initiate a MACI Ankle clinical trial beginning in 2025. If approved, we believe MACI’s label expansion allowing its use to repair cartilage defects in the ankle will be a significant long-term growth driver for the product in the coming years.

Epicel

Epicel is a permanent skin replacement for deep-dermal or full-thickness burns comprising greater than or equal to 30 percent TBSA. Epicel is regulated by the Center for Biologics Evaluation and Research (“CBER”) of the FDA under medical device authorities, and is the only FDA-approved cultured epidermal autograft product available for large total surface area burns in both adult and pediatric patients. Epicel was designated as a HUD in 1998 and a Humanitarian Device Exemption (“HDE”) application for the product was submitted in 1999. HUDs are devices that are intended for diseases or conditions that affect fewer than 8,000 individuals annually in the U.S., and certain HUDs are restricted by the amount which a manufacturer may charge for its use.

Epicel is not price-restricted in this manner because in 2016, the FDA approved our HDE supplement to revise the labeled indications of use for Epicel to specifically include pediatric patients, thus allowing Epicel to be sold for profit. The revised product label also now specifies that the probable benefit of Epicel, mainly related to survival, was demonstrated in two Epicel clinical experience databases and a physician-sponsored study comparing outcomes in patients with large burns treated with Epicel relative to standard care.

NexoBrid

Our portfolio of commercial-stage products also includes NexoBrid (anacaulase-bcdb), a topically-administered biological orphan product containing proteolytic enzymes, for which the FDA approved a BLA in December 2022, permitting the product’s use for the removal of eschar in adults with deep partial-thickness and/or full thickness thermal burns. Subsequently, in August 2024, the FDA approved a sBLA expanding NexoBrid’s indication to include pediatric patients.
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NexoBrid is approved in the European Union (“EU”) and other international markets and has been designated as an orphan biologic in the U.S., EU and other international markets. NexoBrid has the potential to change the standard of care for eschar removal with respect to hospitalized burn patients and treat a significant addressable market in the U.S. With respect to NexoBrid, of the approximately 40,000 people that are hospitalized in the U.S. each year for burn-related injuries, the majority, over 30,000, have thermal burns and will likely require some level of eschar removal. NexoBrid’s FDA approval expands our burn care franchise’s total addressable market, which will permit us to treat a significantly larger segment of hospitalized burn patients than with Epicel alone. The expansion of our target addressable market supports a broader commercial footprint, and we believe that this may help drive both increased NexoBrid use as well as increased Epicel awareness throughout the burn care space. Both our Epicel and NexoBrid products are serviced by our burn care field force, which consists of individual sales and clinical representatives that regularly engage with our target audience. The team is divided into geographical regions and is managed by a senior sales leadership team.

In May 2019, we entered into exclusive license and supply agreements with MediWound to commercialize NexoBrid in North America. The manufacturing process for NexoBrid is conducted by MediWound, primarily at manufacturing locations in Israel. Certain raw materials utilized in NexoBrid’s manufacture, including the supply of the active ingredient bromelain, are sourced from Taiwan.

Results of Operations

The following is a summary of our condensed consolidated results of operations:
 Three Months Ended June 30,Six Months Ended June 30,
(In thousands)20252024Change $Change %20252024Change $Change %
Total revenue$63,240 $52,662 $10,578 20.1 %$115,838 $103,943 $11,895 11.4 %
Cost of product sales16,627 16,061 566 3.5 %32,952 31,988 964 3.0 %
Gross profit46,613 36,601 10,012 27.4 %82,886 71,955 10,931 15.2 %
Research and development6,731 7,363 (632)(8.6)%13,992 13,781 211 1.5 %
Selling, general and administrative41,911 35,269 6,642 18.8 %83,715 69,669 14,046 20.2 %
Total operating expenses48,642 42,632 6,010 14.1 %97,707 83,450 14,257 17.1 %
Loss from operations(2,029)(6,031)4,002 (66.4)%(14,821)(11,495)(3,326)28.9 %
Total other income1,476 1,349 127 9.4 %3,022 2,951 71 2.4 %
Net loss$(553)$(4,682)$4,129 (88.2)%$(11,799)$(8,544)$(3,255)38.1 %

Comparison of the Periods Ended June 30, 2025 and 2024

Total Revenue

Revenue by product is as follows:

 Three Months Ended June 30,Six Months Ended June 30,
(In thousands)20252024Change $Change %20252024Change $Change %
MACI$53,458 $44,135 $9,323 21.1 %$99,755 $84,316 $15,439 18.3 %
Epicel8,614 7,758 856 11.0 %13,578 18,422 (4,844)(26.3)%
NexoBrid1,168 769 399 51.9 %2,505 1,205 1,300 107.9 %
Total revenue$63,240 $52,662 $10,578 20.1 %$115,838 $103,943 $11,895 11.4 %

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Total revenue increase for the three months ended June 30, 2025, compared to the same period in 2024, was driven primarily by MACI volume and price growth and Epicel and NexoBrid volume growth.

Total revenue increase for the six months ended June 30, 2025, compared to the same period in 2024, was driven primarily by MACI volume and price growth and NexoBrid volume growth, partially offset by lower Epicel volume.

Seasonality

Sales of MACI implants have historically experienced a level of seasonality throughout the year. In the last five years through 2024, MACI sales volumes from the first through the fourth quarter on average represented 21% (20%-22% range), 22% (16%-24% range), 23% (21%-26% range) and 34% (33%-38% range) respectively, of total annual volumes. Historically, MACI orders are normally stronger in the fourth quarter due to several factors including the satisfaction by patients of insurance deductible limits and the time of year patients prefer to start rehabilitation. Due to the low incidence and variable occurrence of severe burns, Epicel revenue has inherent variability from quarter-to-quarter and does not exhibit significant seasonality. U.S. sales of NexoBrid began September of 2023, and as such we are still relatively early in its commercial launch, but we do not expect NexoBrid revenue to experience significant seasonality given its emergent use in treating severe burns.

Gross Profit

Gross profit increase for the three and six months ended June 30, 2025, compared to the same periods in 2024, was driven by MACI revenue growth, combined with our primarily fixed manufacturing cost structure which consists mainly of labor and facility costs.

Research and Development Expenses

The following table summarizes research and development expenses, which include materials, professional fees and an allocation of employee-related salary and fringe benefit costs for our research and development projects:

 Three Months Ended June 30,Six Months Ended June 30,
(In thousands)20252024Change $Change %20252024Change $Change %
MACI$4,267 $5,555 $(1,288)(23.2)%$8,966 $10,290 $(1,324)(12.9)%
Epicel1,474 1,204 270 22.4 %2,898 2,325 573 24.6 %
NexoBrid990 604 386 63.9 %2,128 1,166 962 82.5 %
Total research and development expenses$6,731 $7,363 $(632)(8.6)%$13,992 $13,781 $211 1.5 %

Research and development expenses decreased for the three months ended June 30, 2025, compared to the same period in 2024. The decrease is primarily due to higher MACI Arthro project costs in 2024, partially offset by higher headcount and employee expenses.

Research and development expenses increased for the six months ended June 30, 2025, compared to the same period in 2024. The increase is primarily due to higher headcount and employee expenses, offset by MACI Arthro project costs in 2024.

Selling, General and Administrative Expenses

Selling, general and administrative expenses for the three months ended June 30, 2025 were $41.9 million, compared to $35.3 million for the same period in 2024. The increase in selling, general and administrative expenses was primarily due to higher headcount and employee expenses, including stock compensation, an increase in marketing programs and sales activity, and facility costs including depreciation expense for the new facility in Burlington, Massachusetts.

Selling, general and administrative expenses for the six months ended June 30, 2025 were $83.7 million, compared to $69.7 million for the same period in 2024. The increase in selling, general and administrative expenses was primarily due to higher headcount and employee expenses, including stock compensation, an increase in marketing programs and sales activity, and facility costs including depreciation expense for the new facility in Burlington, Massachusetts.

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Total Other Income 

The increase in total other income for the three and six months ended June 30, 2025, compared to the same periods in 2024 was due to an increase in interest income, which was primarily due to fluctuations in the rates of return on our investments in various marketable debt securities and money market funds.

Stock-based Compensation Expense

Non-cash stock-based compensation expense is summarized in the following table: 

 Three Months Ended June 30,Six Months Ended June 30,
(In thousands)20252024Change $Change %20252024Change $Change %
Cost of product sales$1,109 $911 $198 21.7 %$2,249 $2,152 $97 4.5 %
Research and development1,148 965 183 19.0 %2,635 2,186 449 20.5 %
Selling, general and administrative7,883 7,644 239 3.1 %16,761 15,016 1,745 11.6 %
Total non-cash stock-based compensation expense$10,140 $9,520 $620 6.5 %$21,645 $19,354 $2,291 11.8 %

The increase in stock-based compensation expense for the three and six months ended June 30, 2025, compared to the same periods in 2024, was due primarily to fluctuations in stock prices and the mix of service-based options and restricted stock units, which impacts the fair value of the options and restricted stock units awarded and the expense recognized in the period.

Liquidity and Capital Resources

Cash Flows

The following table summarizes our sources and uses of cash for each of the periods presented:

Six Months Ended June 30,
(In thousands)20252024
Net cash provided by operating activities$14,814 $25,737 
Net cash used in investing activities(24,170)(43,171)
Net cash provided by financing activities4,839 6,422 
Net decrease in cash, cash equivalents, and restricted cash$(4,517)$(11,012)

Net Cash Provided by Operating Activities

Our cash, cash equivalents and restricted cash totaled $80.5 million, short-term investments totaled $36.3 million and long-term investments totaled $47.4 million as of June 30, 2025. The $14.8 million of cash provided by operations during the six months ended June 30, 2025 was primarily the result of non-cash charges of $21.6 million related to stock-based compensation expense, $5.5 million in depreciation and amortization expense and $2.7 million of operating lease amortization, partially offset by a net loss of $11.8 million and a net decrease of $4.0 million related to movements in our working capital accounts. The overall decrease in cash from our working capital accounts was primarily driven by an increase in accounts receivable due to higher sales volume, as well as a decrease in accounts payable and accrued expenses due to timing of payments.

Our cash, cash equivalents and restricted cash totaled $75.9 million, short-term investments totaled $52.2 million and long-term investments totaled $26.1 million as of June 30, 2024. The $25.7 million of cash provided by operations during the six months ended June 30, 2024 was primarily the result of non-cash charges of $19.4 million related to stock-based compensation expense, $3.5 million of operating lease amortization and $2.7 million in depreciation and amortization expense, offset by a net loss of $8.5 million and a net increase of $8.9 million related to movements in our working capital accounts. The overall increase in cash from our working capital accounts was primarily driven by a decrease in accounts receivable due to cash collections and receipts of tenant improvement allowances which exceeded payments on operating leases amortization, offset by a decrease in accrued expenses due to timing of payments and an increase in inventory primarily related to supporting NexoBrid commercial availability.

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Net Cash Used In Investing Activities

Net cash used in investing activities during the six months ended June 30, 2025 was the result of $22.3 million of property and equipment purchases primarily for construction in process related to the Burlington Lease and $29.0 million in investment purchases, partially offset by $27.2 million of investment sales and maturities.

Net cash used in investing activities during the six months ended June 30, 2024 was the result of $35.7 million in investment purchases and $30.8 million of property and equipment purchases primarily for construction in process related to the Burlington Lease, partially offset by $23.3 million of investment sales and maturities.

Net Cash Provided by Financing Activities

Net cash provided by financing activities during the six months ended June 30, 2025 was the result of net proceeds from the exercise of stock options and the employee stock purchase plan of $11.2 million, partially offset by the payment of employee withholding taxes related to the vesting of restricted stock units of $6.3 million.

Net cash provided by financing activities during the six months ended June 30, 2024 was the result of net proceeds from the exercise of stock options and the employee stock purchase plan of $11.5 million, partially offset by the payment of employee withholding taxes related to the vesting of restricted stock units of $5.0 million.

Liquidity

Since our acquisition of MACI and Epicel in 2014, our primary focus has been to invest in our existing commercial business with the goal of growing revenue. We have raised significant funds in order to advance and complete our product development and product life-cycle management programs and to market and commercialize our products, including NexoBrid. To date, we have financed our operations primarily through cash received through MACI, Epicel and NexoBrid sales, debt, and public and private sales of our equity securities. In the future, we may finance our operations through sales of equity securities, revolver borrowings or other debt financings, in addition to cash generated from operations.

We believe that our current cash on hand, cash equivalents, investments, and available borrowing capacity will be sufficient to support our current operations through at least 12 months from the issuance of the condensed consolidated financial statements included in this report. Our actual cash requirements may differ from projections and will depend on many factors, including the level and pace of future research and development efforts, the scope and results of ongoing and potential clinical trials, the costs involved in filing, prosecuting and enforcing patents, the need for additional manufacturing capacity, competing technological and market developments, global macroeconomic conditions, costs associated with possible acquisitions or development of complementary business activities, and the cost to market our products.

As of June 30, 2025, we were not party to any off-balance sheet arrangements.

Sources of Capital

On July 29, 2022, we entered into a $150.0 million five-year senior secured revolving credit agreement by and among the Company, the other loan parties thereto, the lenders party thereto, and JPMorgan Chase Bank, N.A., as the administrative agent (the “Revolving Credit Agreement”). We have no immediate plans to borrow under the Revolving Credit Agreement, but we may use the facility for working capital needs and other general corporate purposes. As of June 30, 2025, there are no outstanding borrowings under the Revolving Credit Agreement, and we are in compliance with all applicable covenant requirements. See Note 8, “Revolving Credit Agreement” in the accompanying condensed consolidated financial statements for further details.

Contractual Obligations and Commitments

The disclosure of our contractual obligations and commitments is set forth in the heading “Management’s Discussion and Analysis of Financial Conditions and Results of Operations - Contractual Obligations” in our Annual Report on Form 10-K for the year ended December 31, 2024. There have been no other material changes, outside of the ordinary course of business, to our contractual obligations and commitments since December 31, 2024.


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Critical Accounting Policies

The discussion and analysis of our financial condition and results of operations are based on our condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these condensed consolidated financial statements requires us to make estimates and judgments that affect our reported assets, liabilities, revenues, expenses, and related disclosures. Actual results may differ materially from these estimates under different assumptions and conditions.

There have been no material changes to our critical accounting policies and estimates in the six months ended June 30, 2025. For further information, refer to our summary of significant accounting policies and estimates in our Annual Report on Form 10-K filed for the year ended December 31, 2024.

Cautionary Note Regarding Forward-Looking Statements

This report, including the documents incorporated by reference herein, contains certain statements that describe our management’s beliefs concerning future business conditions, plans and prospects, growth opportunities and the outlook for our business based upon information currently available. Such statements are “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (“Exchange Act”). Wherever possible, we have identified these forward-looking statements by words such as “will,” “may,” “anticipates,” “believes,” “intends,” “estimates,” “expects,” “plans,” “projects,” “trends,” “opportunity,” “current,” “intention,” “position,” “assume,” “potential,” “outlook,” “remain,” “continue,” “maintain,” “sustain,” “seek,” “target,” “achieve,” “continuing,” “ongoing,” and similar words or phrases, or future or conditional verbs such as “would,” “should,” “could,” “may,” or similar expressions. Among the factors that could cause actual results to differ materially from those set forth in the forward-looking statements include, but are not limited to, uncertainties associated with our expectations regarding future revenue, growth in revenue, market penetration for MACI®, MACI Arthro, Epicel®, and NexoBrid®, growth in profit, gross margins and operating margins, the ability to continue to scale our manufacturing operations to meet the demand for our cell therapy products, including the timely qualification of a new manufacturing facility in Burlington, Massachusetts, the ability to sustain profitability, contributions to adjusted EBITDA, the expected target surgeon audience, potential fluctuations in sales and volumes and our results of operations over the course of the year, timing and conduct of clinical trial and product development activities, timing and likelihood of the FDA’s potential approval of the use of MACI to treat cartilage defects in the ankle, the estimate of the commercial growth potential of our products and product candidates, competitive developments, changes in third-party coverage and reimbursement, including recent and future healthcare reform measures and private payor initiatives, surgeon adoption of MACI Arthro, physician and burn center adoption of NexoBrid, labor strikes, supply chain disruptions or other events or factors that might affect our ability to manufacture MACI or Epicel or affect MediWound’s ability to manufacture and supply sufficient quantities of NexoBrid to meet customer demand, including but not limited to the ongoing and evolving conflicts in the Middle East region involving Israel, negative impacts on the global economy and capital markets resulting from the conflict in Ukraine and the ongoing and evolving Middle East conflicts, including those associated with potential further involvement by the U.S., changes in trade policies and regulations, including the potential for increases or changes in duties, current and potentially new tariffs or quotas, lingering effects of adverse developments affecting financial institutions, companies in the financial services industry or the financial services industry generally, possible changes in governmental monetary and fiscal policies, including, but not limited to, Federal Reserve policies in connection with continued inflationary pressures, the impact from future regulatory, judicial and legislative changes to our industry or to the broader business landscape, including those included in the One Big Beautiful Bill Act, global geopolitical tensions and potential future impacts on our business or the economy generally stemming from a public health emergency. These forward-looking statements are based upon assumptions our management believes are reasonable. Such forward-looking statements are subject to risks and uncertainties, which could cause our actual results, performance and achievements to differ materially from those expressed in, or implied by, these statements, including, among others, the risks and uncertainties listed in our Annual Report on Form 10-K under “Part I, Item 1A. Risk Factors.”

Because our forward-looking statements are based on estimates and assumptions that are subject to significant business, economic and competitive uncertainties, many of which are beyond our control or are subject to change, actual results could be materially different and any or all of our forward-looking statements may turn out to be wrong. Forward-looking statements speak only as of the date made and can be affected by assumptions we might make or by known or unknown risks and uncertainties. Many factors mentioned in our discussion in our Annual Report on Form 10-K will be important in determining future results. New factors emerge from time to time, and it is not possible for us to predict which factors will arise. Consequently, we cannot assure you that our expectations or forecasts expressed in such forward-looking statements will be achieved. Except as required by law, we undertake no obligation to publicly update any of our forward-looking or other statements, whether as a result of new information, future events, or otherwise.

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Item 3. Quantitative and Qualitative Disclosures About Market Risk

For quantitative and qualitative disclosures about market risk, see “Part II, Item 7A. Quantitative and Qualitative Disclosures About Market Risk” of our Annual Report on Form 10-K for the year ended December 31, 2024. Our exposures to market risk have not changed materially since December 31, 2024.

Item 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

Management of the Company, with the participation of its Chief Executive Officer and Chief Financial Officer (its Certifying Officers), evaluated the effectiveness of the Company’s disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Based on the evaluation as of June 30, 2025, the Company’s Certifying Officers concluded that the Company’s disclosure controls and procedures were effective.

The Company has established disclosure controls and procedures designed to ensure that information required to be disclosed by the Company in the reports that it files or submits under the Exchange Act, is recorded, processed, summarized and reported within the time periods specified in the U.S. Securities and Exchange Commission’s rules and forms, and that such information is accumulated and communicated to management of the Company, with the participation of its Certifying Officers, as appropriate, to allow timely decisions regarding required disclosure.

Changes in Internal Control over Financial Reporting

During the three months ended June 30, 2025, there were no material changes made in our internal control over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act).

PART II - OTHER INFORMATION

Item 1. Legal Proceedings

We are currently not party to any material legal proceedings, although from time to time we may become involved in disputes in connection with the operation of our business.

Item 1A. Risk Factors

Factors that could cause the Company’s actual results to differ materially from those in this Quarterly Report are any of the risks described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on February 27, 2025. Any of these factors could result in a significant or material adverse effect on our results of operations or financial condition. Additional risk factors not presently known to us or that we currently deem immaterial may also impair our business or results of operations.

Inadequate funding for the FDA and other government agencies and/or other disruptions could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.

The ability of the FDA to review and approve regulatory submissions and new products can be affected by a variety of factors, including government budget and funding levels, the ability to hire and retain key personnel, and statutory, regulatory, and policy changes. For example, the Trump administration has taken several executive actions, including the issuance of several Executive Orders, that could impose significant burdens on, or otherwise materially delay, the FDA’s ability to engage in routine oversight activities, such as implementing statutes through rulemaking, issuance of guidance, and review and approval of marketing applications. The average time to review and approve regulatory submissions at the agency has fluctuated in recent years as a result of some of these factors. In addition, government funding of the SEC and other government agencies on which our operations may depend, including those that fund research and development activities, is subject to the political process, which is inherently unpredictable. On January 20, 2025, President Trump signed an executive order creating an advisory commission, the “Department of Government Efficiency” to reform federal government processes and reduce expenditures. Potential changes in U.S. federal government budgetary priorities and spending could adversely affect funding
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and staffing levels at the FDA, which could impose constraints on its ability to engage in oversight and respond in a timely manner to product related submissions, including with respect to its ongoing review of our Investigational New Drug application, amendments and supplements for MACI Ankle clinical trial activity for which we expect to begin enrollment during the second half of 2025.

Disruptions at the FDA and other agencies may also slow the time necessary to review and/or approve product candidates or changes to existing products, approve the qualification of the Burlington manufacturing facility and/or conduct required inspections of our and/or third-party manufacturing and testing facilities, and approve and/or inspect third-party contractors and/or potential new or alternate suppliers of materials used in our MACI and Epicel cell manufacturing processes, all of which would adversely affect our business. For example, beginning on February 13, 2025, the Department of Health and Human Services began firing a large number of its probationary employees, a category that includes new federal employees and employees recently promoted or transferred to new positions or agencies. Larger layoffs may follow, according to a memorandum issued by the Office of Personnel Management on February 26, 2025. These terminations, if they withstand legal challenges, may significantly delay and impede our interactions with FDA. Similar results may stem from the recent confirmed resignations of some senior FDA employees with responsibility for regulation of drugs and biologics, as well as possible future layoffs and resignations. If such layoffs, further resignations, or other disruptions occur in the future, it could significantly impact the ability of the FDA to perform any of the functions described above, which could have a material adverse effect on our business.

Additionally, with the change in presidential administrations in 2025, there is substantial uncertainty as to how, if at all, the new administration will seek to modify or revise the requirements and policies of the FDA and other regulatory agencies with jurisdiction over our products and product candidates. The FDA’s policies may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our products. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative or executive action. If we are slow or unable to adapt to any changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

Not applicable.

Item 3. Defaults Upon Senior Securities

Not applicable.

Item 4. Mine Safety Disclosures

Not applicable.


Item 5. Other Information

Rule 10b5-1 Trading Plans

During the three months ended June 30, 2025, the following Section 16 officers or directors adopted, modified or terminated a “Rule 10b5-1 trading arrangement” (as defined in Item 408 of Regulation S-K of the Exchange Act).

On May 12, 2025, Kevin McLaughlin, a member of the Vericel Corporation Board of Directors, entered into a Rule 10b5-1 trading arrangement providing for the potential sale of up to 35,000 shares of our common stock between November 10, 2025 and November 30, 2026;

On May 23, 2025, Robert Zerbe, Chairman of the Vericel Corporation Board of Directors, entered into a Rule 10b5-1 trading arrangement providing for the potential sale of up to 7,500 shares of our common stock between September 2, 2025 and August 28, 2026; and

On May 30, 2025, Jonathan Hopper, Vericel Corporation’s Chief Medical Officer, entered into a 10b5-1 Plan providing for the potential sale of up to 37,847 shares of our common stock between September 2, 2025 and August 28, 2026.

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There were no “non-Rule 10b5-1 trading arrangements” (as defined in Item 408 of Regulation S-K of the Exchange Act) adopted, modified or terminated during the three months ended June 30, 2025 by our Section 16 officers or directors.
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Item 6. Exhibits

The Exhibits listed in the Exhibit Index are filed as a part of this Quarterly Report on Form 10-Q.

EXHIBIT INDEX

Incorporated by Reference
Exhibit NumberDescription of ExhibitsFormFile NumberExhibitFiling Date
3.1
Restated Articles of Incorporation of the Company.
8-K000-220254.1December 17, 2009
3.2
Certificate of Amendment to Restated Articles of Incorporation of the Company dated February 9, 2010.
S-1333-1600443.2March 31, 2010
3.3
Certificate of Amendment to Restated Articles of Incorporation of the Company dated March 22, 2011.
8-K000-220253.1March 25, 2011
3.4
Certificate of Amendment to the Restated Articles of Incorporation of the Company, dated November 21, 2014.
8-K001-352803.1November 24, 2014
3.5
Amended and restated bylaws.
8-K000-220253.1November 12, 2010
4.1
Description of Capital Stock.
10-K001-352804.5February 25, 2020
10.1*
Amended and Restated Non-Employee Director Compensation Guidelines, revised April 30, 2025.
31.1*
Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2*
Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1*
Certification of Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INS*Inline XBRL Instance Document
101.SCH*Inline XBRL Taxonomy Extension Schema Document
101.CAL*Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.LAB*Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE*Inline XBRL Taxonomy Extension Presentation Linkbase Document
101.DEF*Inline XBRL Taxonomy Extension Definition Linkbase Document
104*
Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101)

* Filed herewith.

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
 
Date: July 31, 2025
 
 VERICEL CORPORATION
  
  
 /s/ DOMINICK C. COLANGELO
 Dominick C. Colangelo
 President and Chief Executive Officer
 (Principal Executive Officer)
  
  
 /s/ JOSEPH A. MARA
 Joseph A. Mara
 Chief Financial Officer
 (Principal Financial Officer)


33

FAQ

How much did VCEL’s revenue grow in Q2 2025?

Total revenue rose 20.1% year over year to $63.2 million.

Did Vericel report a profit in the quarter?

No. Net loss was $0.6 million, or $(0.01) per share, but significantly improved from the $4.7 million loss a year earlier.

What is Vericel’s liquidity position?

As of June 30 2025 the company held $80.5 m in cash and $83.7 m in marketable securities with no outstanding revolver debt.

How did MACI perform versus other products?

MACI sales reached $53.5 m (+21%), representing 85% of total revenue, while Epicel contributed $8.6 m and NexoBrid $1.2 m.

What are the key growth catalysts ahead?

MACI Arthro arthroscopic delivery, NexoBrid pediatric expansion, and the upcoming Burlington manufacturing facility are expected to drive volume and margin gains.
Vericel

NASDAQ:VCEL

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VCEL Stock Data

2.05B
49.81M
1.03%
106.6%
7.79%
Biotechnology
Biological Products, (no Disgnostic Substances)
Link
United States
CAMBRIDGE