[FWP] Goldman Sachs Group Inc. Free Writing Prospectus
Ultragenyx Pharmaceutical Inc. (Nasdaq: RARE) disclosed that the U.S. FDA issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) of UX111 (ABO-102), its AAV gene therapy for Sanfilippo syndrome type A. The agency is requesting additional chemistry, manufacturing and controls (CMC) information and remediation of observations from recent facility inspections. The CRL does not cite deficiencies in the clinical data package; the FDA characterized neurodevelopmental and biomarker data as robust and asked only for updated data in the resubmission.
The company believes the cited issues are facility- and process-related and 鈥渞eadily addressable.鈥� Management plans to engage the FDA over the coming months, then resubmit the BLA, which would trigger a new review period of up to six months. No timeline for resubmission was provided, but the disclosure implies at least a several-month delay to potential approval and launch.
Investor takeaway: Receipt of a CRL materially delays potential commercialization and revenue generation from UX111, introduces additional regulatory risk, and may elevate operating costs as manufacturing processes are refined. Mitigating factors include the absence of clinical concerns and the company鈥檚 confidence that CMC issues can be resolved.
Ultragenyx Pharmaceutical Inc. (Nasdaq: RARE) ha comunicato che la FDA statunitense ha emesso una Complete Response Letter (CRL) riguardante la Biologics License Application (BLA) per UX111 (ABO-102), la sua terapia genica AAV per la sindrome di Sanfilippo tipo A. L'agenzia richiede ulteriori informazioni sulla chimica, produzione e controlli (CMC) e la risoluzione delle osservazioni emerse durante recenti ispezioni degli impianti. La CRL non evidenzia carenze nei dati clinici; la FDA ha definito robusti i dati neuroevolutivi e biomarcatori, richiedendo solo dati aggiornati nella nuova presentazione.
L'azienda ritiene che le problematiche siano legate agli impianti e ai processi, e siano 鈥渇acilmente risolvibili.鈥� La direzione intende collaborare con la FDA nei prossimi mesi per poi ripresentare la BLA, il che attiverebbe un nuovo periodo di revisione fino a sei mesi. Non 猫 stata fornita una tempistica per la ripresentazione, ma la comunicazione implica un ritardo di diversi mesi rispetto all'approvazione e al lancio potenziali.
Indicazioni per gli investitori: La ricezione della CRL ritarda significativamente la possibile commercializzazione e generazione di ricavi da UX111, introduce rischi regolatori aggiuntivi e potrebbe aumentare i costi operativi durante la messa a punto dei processi produttivi. Fattori mitiganti sono l'assenza di preoccupazioni cliniche e la fiducia dell'azienda nella risoluzione delle problematiche CMC.
Ultragenyx Pharmaceutical Inc. (Nasdaq: RARE) inform贸 que la FDA de EE. UU. emiti贸 una Carta de Respuesta Completa (CRL) para la Solicitud de Licencia Biol贸gica (BLA) de UX111 (ABO-102), su terapia g茅nica AAV para el s铆ndrome de Sanfilippo tipo A. La agencia solicita informaci贸n adicional sobre qu铆mica, fabricaci贸n y controles (CMC) y la correcci贸n de observaciones derivadas de inspecciones recientes de las instalaciones. La CRL no se帽ala deficiencias en el paquete de datos cl铆nicos; la FDA calific贸 los datos neurodesarrollativos y de biomarcadores como s贸lidos y solo pidi贸 datos actualizados en la nueva presentaci贸n.
La compa帽铆a considera que los problemas se帽alados est谩n relacionados con las instalaciones y los procesos, y son 鈥渇谩cilmente solucionables.鈥� La direcci贸n planea interactuar con la FDA en los pr贸ximos meses para luego volver a presentar la BLA, lo que desencadenar铆a un nuevo periodo de revisi贸n de hasta seis meses. No se proporcion贸 un plazo para la nueva presentaci贸n, pero la divulgaci贸n implica un retraso de varios meses en la posible aprobaci贸n y lanzamiento.
Conclusi贸n para inversores: La recepci贸n de la CRL retrasa significativamente la posible comercializaci贸n y generaci贸n de ingresos de UX111, introduce riesgos regulatorios adicionales y podr铆a aumentar los costos operativos mientras se perfeccionan los procesos de fabricaci贸n. Factores mitigantes incluyen la ausencia de preocupaciones cl铆nicas y la confianza de la compa帽铆a en resolver los problemas CMC.
Ultragenyx Pharmaceutical Inc. (雮橃姢雼�: RARE)電� 氙戈淡 FDA臧� 靷绊晞毽彫 歃濏泟甑� A順曥棎 雽�頃� 鞛愳偓鞚� AAV 鞙犾爠鞛� 旃橂鞝� UX111 (ABO-102)鞚� 靸濍頃欖爜 鞝滌牅 項堦皜 鞁犾箔靹�(BLA)鞐� 雽�頃� 鞕勳爠鞚戨嫷靹滍暅(CRL)鞚� 氚滍枆頄堧嫟瓿� 氚濏様鞀惦媹雼�. FDA電� 於旉皜鞝侅澑 頇旐暀, 鞝滌“ 氚� 甏�毽�(CMC) 鞝曤炒鞕� 斓滉芳 鞁滌劋 鞝愱瞼鞐愳劀 氚滉铂霅� 氍胳牅鞝愳潣 靾橃爼 臁办箻毳� 鞖旉惮頃橁碃 鞛堨姷雼堧嫟. CRL鞚� 鞛勳儊 雿办澊韯� 韺偆歆�鞐� 瓴绊暔鞚� 鞐嗢潓鞚� 氇呾嫓頃橁碃; FDA電� 鞁犼步氚滊嫭 氚� 氚旍澊鞓る旎� 雿办澊韯半ゼ 瓴碃頃橂嫟瓿� 韽夑皜頄堨溂氅� 鞛牅於� 鞁� 斓滌嫚 雿办澊韯半 鞖旉惮頄堨姷雼堧嫟.
須岇偓電� 歆�鞝侂悳 氍胳牅霌れ澊 鞁滌劋 氚� 瓿奠爼瓿� 甏�霠悳 瓴冹澊氅� 鈥滌壗瓴� 頃搓舶 臧�電モ�濏晿雼り碃 氤搓碃 鞛堨姷雼堧嫟. 瓴届榿歆勳潃 頄ロ泟 氇� 雼皠 FDA鞕� 順戩潣頃� 頉� BLA毳� 鞛牅於滍暊 瓿勴殟鞚措┌, 鞚措姅 斓滊寑 6臧滌洈鞚� 鞁犼窚 鞁偓 旮瓣皠鞚� 齑夒皽頃� 瓴冹瀰雼堧嫟. 鞛牅於� 鞚检爼鞚� 鞝滉车霅橃 鞎婌晿鞙茧倶, 鞚措矆 瓿奠嫓電� 鞀轨澑 氚� 於滌嫓臧� 氇� 雼� 鞚挫儊 歆�鞐半悹 臧�電レ劚鞚� 鞁滌偓頃╇媹雼�.
韴瀽鞛� 彀戈碃靷暛: CRL 靾橂牴鞚� UX111鞚� 鞛犾灛鞝� 靸侅梾頇� 氚� 靾橃澋 彀届稖鞚� 鞁れ鞝侅溂搿� 歆�鞐办嫓韨り碃, 於旉皜鞝侅澑 攴滌牅 鞙勴棙鞚� 霃勳瀰頃橂┌, 鞝滌“ 瓿奠爼 臧滌劆 瓿检爼鞐愳劀 鞖挫榿 牍勳毄鞚� 歃濌皜頃� 靾� 鞛堨姷雼堧嫟. 鞕勴檾 鞖旍澑鞙茧電� 鞛勳儊鞝� 鞖半牑臧� 鞐嗞碃 須岇偓臧� CMC 氍胳牅毳� 頃搓舶頃� 靾� 鞛堧嫟電� 鞛愳嫚臧愳澊 韽暔霅╇媹雼�.
Ultragenyx Pharmaceutical Inc. (Nasdaq : RARE) a annonc茅 que la FDA am茅ricaine a 茅mis une lettre de r茅ponse compl猫te (CRL) concernant la demande d'autorisation biologique (BLA) pour UX111 (ABO-102), sa th茅rapie g茅nique AAV pour le syndrome de Sanfilippo de type A. L'agence demande des informations suppl茅mentaires sur la chimie, la fabrication et les contr么les (CMC) ainsi que la correction des observations issues des inspections r茅centes des installations. La CRL ne rel猫ve aucune insuffisance dans le dossier clinique ; la FDA a qualifi茅 les donn茅es neurod茅veloppementales et les biomarqueurs de robustes et a seulement demand茅 des donn茅es mises 脿 jour lors de la nouvelle soumission.
L'entreprise estime que les probl猫mes cit茅s sont li茅s aux installations et aux proc茅d茅s, et 芦 facilement r茅solvables 禄. La direction pr茅voit d'茅changer avec la FDA dans les prochains mois, puis de soumettre 脿 nouveau la BLA, ce qui d茅clencherait une nouvelle p茅riode d'examen pouvant aller jusqu'脿 six mois. Aucun calendrier de resoumission n'a 茅t茅 communiqu茅, mais la divulgation implique un retard de plusieurs mois avant une 茅ventuelle approbation et commercialisation.
脌 retenir pour les investisseurs : La r茅ception de la CRL retarde consid茅rablement la commercialisation potentielle et la g茅n茅ration de revenus li茅s 脿 UX111, introduit un risque r茅glementaire suppl茅mentaire et pourrait augmenter les co没ts op茅rationnels lors de l'am茅lioration des processus de fabrication. Les facteurs att茅nuants incluent l'absence de pr茅occupations cliniques et la confiance de l'entreprise dans la r茅solution des probl猫mes CMC.
Ultragenyx Pharmaceutical Inc. (Nasdaq: RARE) gab bekannt, dass die US-amerikanische FDA einen Complete Response Letter (CRL) f眉r den Biologics License Application (BLA) von UX111 (ABO-102), ihrer AAV-Gentherapie f眉r das Sanfilippo-Syndrom Typ A, ausgestellt hat. Die Beh枚rde fordert zus盲tzliche Informationen zu Chemie, Herstellung und Kontrollen (CMC) sowie die Behebung von Beanstandungen aus k眉rzlichen Anlageninspektionen. Der CRL f眉hrt keine M盲ngel im klinischen Datenpaket auf; die FDA bewertete die neuroentwicklungsbezogenen und Biomarkerdaten als robust und forderte lediglich aktualisierte Daten bei der erneuten Einreichung.
Das Unternehmen ist der Ansicht, dass die beanstandeten Punkte an den Anlagen und Prozessen liegen und 鈥瀕eicht zu beheben鈥� sind. Das Management plant, in den kommenden Monaten mit der FDA in Kontakt zu treten und dann die BLA erneut einzureichen, was eine neue Pr眉fungsfrist von bis zu sechs Monaten ausl枚sen w眉rde. Ein Zeitplan f眉r die erneute Einreichung wurde nicht genannt, jedoch deutet die Mitteilung auf eine Verz枚gerung von mehreren Monaten bis zur m枚glichen Zulassung und Markteinf眉hrung hin.
Fazit f眉r Investoren: Der Erhalt des CRL verz枚gert die potenzielle Kommerzialisierung und Umsatzerzielung von UX111 erheblich, bringt zus盲tzliche regulatorische Risiken mit sich und k枚nnte die Betriebskosten w盲hrend der Optimierung der Herstellungsprozesse erh枚hen. Mildernde Faktoren sind das Fehlen klinischer Bedenken und das Vertrauen des Unternehmens, die CMC-Probleme l枚sen zu k枚nnen.
- No clinical deficiencies cited; FDA deems neurodevelopmental and biomarker data robust.
- Issues confined to CMC and facilities, which management believes are addressable.
- FDA invites swift resubmission; review clock expected to be six months once filed.
- Complete Response Letter materially delays potential UX111 approval and commercialization.
- Additional CMC work and facility remediation will increase costs and execution risk.
- Timeline for resubmission is uncertain, extending regulatory overhang for investors.
Insights
TL;DR: FDA CRL delays UX111 approval due to CMC and facility issues; clinical data intact.
The FDA鈥檚 Complete Response Letter shifts the regulatory pathway from imminent approval to an undefined remediation phase. CMC and facility observations typically require documentary fixes, supplemental validation runs, or re-inspections鈥攁ll time-consuming and resource-intensive. Although the absence of clinical deficiencies protects the underlying therapeutic rationale, gene therapies face heightened scrutiny on manufacturing consistency, and repeat AAV batches can be costly. Resubmission triggers a new up-to-6-month review clock, so earliest approval now likely slips into 2H 2026. Given UX111 targets an ultra-rare population with limited alternatives, delay erodes potential first-mover advantage and postpones rare-disease priority review vouchers or anticipated cash flows.
TL;DR: Negative near-term catalyst; manageable if CMC fixes succeed; cash burn may rise.
The CRL removes a near-term approval catalyst investors had embedded in valuation models. Consensus peak-sales timelines must shift, impacting discounted cash-flow calculations. Management鈥檚 assertion that issues are 鈥榬eadily addressable鈥� offers some relief, but execution risk remains, especially given Ultragenyx鈥檚 limited in-house manufacturing track record. Additional spending on remediation and possible re-inspection could expand operating loss in FY25-26. Balance-sheet sufficiency is not discussed in the filing, leaving open questions on runway. Nonetheless, the FDA鈥檚 positive view of efficacy data preserves long-term value of the asset, keeping competitive dynamics unchanged. Overall impact: moderately negative until clarity on resubmission timing emerges.
Ultragenyx Pharmaceutical Inc. (Nasdaq: RARE) ha comunicato che la FDA statunitense ha emesso una Complete Response Letter (CRL) riguardante la Biologics License Application (BLA) per UX111 (ABO-102), la sua terapia genica AAV per la sindrome di Sanfilippo tipo A. L'agenzia richiede ulteriori informazioni sulla chimica, produzione e controlli (CMC) e la risoluzione delle osservazioni emerse durante recenti ispezioni degli impianti. La CRL non evidenzia carenze nei dati clinici; la FDA ha definito robusti i dati neuroevolutivi e biomarcatori, richiedendo solo dati aggiornati nella nuova presentazione.
L'azienda ritiene che le problematiche siano legate agli impianti e ai processi, e siano 鈥渇acilmente risolvibili.鈥� La direzione intende collaborare con la FDA nei prossimi mesi per poi ripresentare la BLA, il che attiverebbe un nuovo periodo di revisione fino a sei mesi. Non 猫 stata fornita una tempistica per la ripresentazione, ma la comunicazione implica un ritardo di diversi mesi rispetto all'approvazione e al lancio potenziali.
Indicazioni per gli investitori: La ricezione della CRL ritarda significativamente la possibile commercializzazione e generazione di ricavi da UX111, introduce rischi regolatori aggiuntivi e potrebbe aumentare i costi operativi durante la messa a punto dei processi produttivi. Fattori mitiganti sono l'assenza di preoccupazioni cliniche e la fiducia dell'azienda nella risoluzione delle problematiche CMC.
Ultragenyx Pharmaceutical Inc. (Nasdaq: RARE) inform贸 que la FDA de EE. UU. emiti贸 una Carta de Respuesta Completa (CRL) para la Solicitud de Licencia Biol贸gica (BLA) de UX111 (ABO-102), su terapia g茅nica AAV para el s铆ndrome de Sanfilippo tipo A. La agencia solicita informaci贸n adicional sobre qu铆mica, fabricaci贸n y controles (CMC) y la correcci贸n de observaciones derivadas de inspecciones recientes de las instalaciones. La CRL no se帽ala deficiencias en el paquete de datos cl铆nicos; la FDA calific贸 los datos neurodesarrollativos y de biomarcadores como s贸lidos y solo pidi贸 datos actualizados en la nueva presentaci贸n.
La compa帽铆a considera que los problemas se帽alados est谩n relacionados con las instalaciones y los procesos, y son 鈥渇谩cilmente solucionables.鈥� La direcci贸n planea interactuar con la FDA en los pr贸ximos meses para luego volver a presentar la BLA, lo que desencadenar铆a un nuevo periodo de revisi贸n de hasta seis meses. No se proporcion贸 un plazo para la nueva presentaci贸n, pero la divulgaci贸n implica un retraso de varios meses en la posible aprobaci贸n y lanzamiento.
Conclusi贸n para inversores: La recepci贸n de la CRL retrasa significativamente la posible comercializaci贸n y generaci贸n de ingresos de UX111, introduce riesgos regulatorios adicionales y podr铆a aumentar los costos operativos mientras se perfeccionan los procesos de fabricaci贸n. Factores mitigantes incluyen la ausencia de preocupaciones cl铆nicas y la confianza de la compa帽铆a en resolver los problemas CMC.
Ultragenyx Pharmaceutical Inc. (雮橃姢雼�: RARE)電� 氙戈淡 FDA臧� 靷绊晞毽彫 歃濏泟甑� A順曥棎 雽�頃� 鞛愳偓鞚� AAV 鞙犾爠鞛� 旃橂鞝� UX111 (ABO-102)鞚� 靸濍頃欖爜 鞝滌牅 項堦皜 鞁犾箔靹�(BLA)鞐� 雽�頃� 鞕勳爠鞚戨嫷靹滍暅(CRL)鞚� 氚滍枆頄堧嫟瓿� 氚濏様鞀惦媹雼�. FDA電� 於旉皜鞝侅澑 頇旐暀, 鞝滌“ 氚� 甏�毽�(CMC) 鞝曤炒鞕� 斓滉芳 鞁滌劋 鞝愱瞼鞐愳劀 氚滉铂霅� 氍胳牅鞝愳潣 靾橃爼 臁办箻毳� 鞖旉惮頃橁碃 鞛堨姷雼堧嫟. CRL鞚� 鞛勳儊 雿办澊韯� 韺偆歆�鞐� 瓴绊暔鞚� 鞐嗢潓鞚� 氇呾嫓頃橁碃; FDA電� 鞁犼步氚滊嫭 氚� 氚旍澊鞓る旎� 雿办澊韯半ゼ 瓴碃頃橂嫟瓿� 韽夑皜頄堨溂氅� 鞛牅於� 鞁� 斓滌嫚 雿办澊韯半 鞖旉惮頄堨姷雼堧嫟.
須岇偓電� 歆�鞝侂悳 氍胳牅霌れ澊 鞁滌劋 氚� 瓿奠爼瓿� 甏�霠悳 瓴冹澊氅� 鈥滌壗瓴� 頃搓舶 臧�電モ�濏晿雼り碃 氤搓碃 鞛堨姷雼堧嫟. 瓴届榿歆勳潃 頄ロ泟 氇� 雼皠 FDA鞕� 順戩潣頃� 頉� BLA毳� 鞛牅於滍暊 瓿勴殟鞚措┌, 鞚措姅 斓滊寑 6臧滌洈鞚� 鞁犼窚 鞁偓 旮瓣皠鞚� 齑夒皽頃� 瓴冹瀰雼堧嫟. 鞛牅於� 鞚检爼鞚� 鞝滉车霅橃 鞎婌晿鞙茧倶, 鞚措矆 瓿奠嫓電� 鞀轨澑 氚� 於滌嫓臧� 氇� 雼� 鞚挫儊 歆�鞐半悹 臧�電レ劚鞚� 鞁滌偓頃╇媹雼�.
韴瀽鞛� 彀戈碃靷暛: CRL 靾橂牴鞚� UX111鞚� 鞛犾灛鞝� 靸侅梾頇� 氚� 靾橃澋 彀届稖鞚� 鞁れ鞝侅溂搿� 歆�鞐办嫓韨り碃, 於旉皜鞝侅澑 攴滌牅 鞙勴棙鞚� 霃勳瀰頃橂┌, 鞝滌“ 瓿奠爼 臧滌劆 瓿检爼鞐愳劀 鞖挫榿 牍勳毄鞚� 歃濌皜頃� 靾� 鞛堨姷雼堧嫟. 鞕勴檾 鞖旍澑鞙茧電� 鞛勳儊鞝� 鞖半牑臧� 鞐嗞碃 須岇偓臧� CMC 氍胳牅毳� 頃搓舶頃� 靾� 鞛堧嫟電� 鞛愳嫚臧愳澊 韽暔霅╇媹雼�.
Ultragenyx Pharmaceutical Inc. (Nasdaq : RARE) a annonc茅 que la FDA am茅ricaine a 茅mis une lettre de r茅ponse compl猫te (CRL) concernant la demande d'autorisation biologique (BLA) pour UX111 (ABO-102), sa th茅rapie g茅nique AAV pour le syndrome de Sanfilippo de type A. L'agence demande des informations suppl茅mentaires sur la chimie, la fabrication et les contr么les (CMC) ainsi que la correction des observations issues des inspections r茅centes des installations. La CRL ne rel猫ve aucune insuffisance dans le dossier clinique ; la FDA a qualifi茅 les donn茅es neurod茅veloppementales et les biomarqueurs de robustes et a seulement demand茅 des donn茅es mises 脿 jour lors de la nouvelle soumission.
L'entreprise estime que les probl猫mes cit茅s sont li茅s aux installations et aux proc茅d茅s, et 芦 facilement r茅solvables 禄. La direction pr茅voit d'茅changer avec la FDA dans les prochains mois, puis de soumettre 脿 nouveau la BLA, ce qui d茅clencherait une nouvelle p茅riode d'examen pouvant aller jusqu'脿 six mois. Aucun calendrier de resoumission n'a 茅t茅 communiqu茅, mais la divulgation implique un retard de plusieurs mois avant une 茅ventuelle approbation et commercialisation.
脌 retenir pour les investisseurs : La r茅ception de la CRL retarde consid茅rablement la commercialisation potentielle et la g茅n茅ration de revenus li茅s 脿 UX111, introduit un risque r茅glementaire suppl茅mentaire et pourrait augmenter les co没ts op茅rationnels lors de l'am茅lioration des processus de fabrication. Les facteurs att茅nuants incluent l'absence de pr茅occupations cliniques et la confiance de l'entreprise dans la r茅solution des probl猫mes CMC.
Ultragenyx Pharmaceutical Inc. (Nasdaq: RARE) gab bekannt, dass die US-amerikanische FDA einen Complete Response Letter (CRL) f眉r den Biologics License Application (BLA) von UX111 (ABO-102), ihrer AAV-Gentherapie f眉r das Sanfilippo-Syndrom Typ A, ausgestellt hat. Die Beh枚rde fordert zus盲tzliche Informationen zu Chemie, Herstellung und Kontrollen (CMC) sowie die Behebung von Beanstandungen aus k眉rzlichen Anlageninspektionen. Der CRL f眉hrt keine M盲ngel im klinischen Datenpaket auf; die FDA bewertete die neuroentwicklungsbezogenen und Biomarkerdaten als robust und forderte lediglich aktualisierte Daten bei der erneuten Einreichung.
Das Unternehmen ist der Ansicht, dass die beanstandeten Punkte an den Anlagen und Prozessen liegen und 鈥瀕eicht zu beheben鈥� sind. Das Management plant, in den kommenden Monaten mit der FDA in Kontakt zu treten und dann die BLA erneut einzureichen, was eine neue Pr眉fungsfrist von bis zu sechs Monaten ausl枚sen w眉rde. Ein Zeitplan f眉r die erneute Einreichung wurde nicht genannt, jedoch deutet die Mitteilung auf eine Verz枚gerung von mehreren Monaten bis zur m枚glichen Zulassung und Markteinf眉hrung hin.
Fazit f眉r Investoren: Der Erhalt des CRL verz枚gert die potenzielle Kommerzialisierung und Umsatzerzielung von UX111 erheblich, bringt zus盲tzliche regulatorische Risiken mit sich und k枚nnte die Betriebskosten w盲hrend der Optimierung der Herstellungsprozesse erh枚hen. Mildernde Faktoren sind das Fehlen klinischer Bedenken und das Vertrauen des Unternehmens, die CMC-Probleme l枚sen zu k枚nnen.
Free Writing Prospectus pursuant to Rule 433 dated July 11, 2025
Registration Statement No. 333-284538
|
Market Linked Securities — Autocallable with Contingent Coupon and Contingent Downside Principal at Risk Securities Linked to the Class A Common Stock of Robinhood Markets, Inc. due July 22, 2026 |
Summary of Terms |
|
|
|
Company (Issuer) and Guarantor: |
GS Finance Corp. (issuer) and The Goldman Sachs Group, Inc. (guarantor) |
|
Hypothetical Payout Profile (Maturity Payment Amount)
If the securities are not automatically called prior to stated maturity and the ending price is less than the downside threshold price, you will lose more than 40%, and possibly all, of the face amount of your securities at stated maturity. Any return on the securities will be limited to the sum of your contingent coupon payments, if any. You will not participate in any appreciation of the underlying stock, but you will have full downside exposure to the underlying stock if the ending price is less than the downside threshold price. You should read the accompanying preliminary pricing supplement dated July 11, 2025, which we refer to herein as the accompanying preliminary pricing supplement, to better understand the terms and risks of your investment, including the credit risk of GS Finance Corp. and The Goldman Sachs Group, Inc. The securities are part of the Medium-Term Notes, Series F program of GS Finance Corp. and are fully and unconditionally guaranteed by The Goldman Sachs Group, Inc. This document should be read in conjunction with the following: ● Preliminary pricing supplement dated July 11, 2025 ● WFS product supplement no. 5 dated February 14, 2025 ● Prospectus supplement dated February 14, 2025 ● Prospectus dated February 14, 2025
|
Market Measure (the “underlying stock”): |
the Class A common stock of Robinhood Markets, Inc. (current Bloomberg ticker: “HOOD UW”) |
|
|
Pricing date: |
expected to be July 17, 2025 |
|
|
Issue date: |
expected to be July 22, 2025 |
|
|
Final calculation day: |
expected to be July 17, 2026 |
|
|
Stated maturity date: |
expected to be July 22, 2026 |
|
|
Starting price: |
the stock closing price of the underlying stock on the pricing date |
|
|
Ending price: |
the stock closing price of the underlying stock on the final calculation day |
|
|
Performance factor: |
the ending price divided by the starting price (expressed as a percentage) |
|
|
Automatic call: |
If the stock closing price of the underlying stock on any call date is greater than or equal to the starting price, the securities will be automatically called, and on the related call settlement date you will be entitled to receive a cash payment per security in U.S. dollars equal to the face amount plus a final contingent coupon payment. The securities will not be subject to automatic call until the January 2026 calculation day. |
|
|
Downside threshold price: |
60% of the starting price |
|
|
Contingent coupon payment: |
Subject to the automatic call, on each contingent coupon payment date, for each $1,000 of the outstanding face amount, you will receive a contingent coupon payment equal to at least $21.667 (equivalent to a contingent coupon rate of at least approximately 26.00% per annum) (set on the pricing date) if, and only if, the stock closing price of the underlying stock on the related calculation day is greater than or equal to the coupon threshold price. |
|
|
Coupon threshold price: |
60% of the starting price |
|
|
Call dates: |
each calculation day commencing in January 2026 and ending in June 2026 |
|
|
Call settlement date: |
the contingent coupon payment date immediately following the applicable call date |
|
|
Calculation days: |
monthly, on the 17th day of each month, commencing in August 2025 and ending in June 2026, and the final calculation day |
|
|
Contingent coupon payment dates: |
monthly, on the third business day following each calculation day; provided that the contingent coupon payment date with respect to the final calculation day will be the stated maturity date |
|
|
Maturity payment amount (for each $1,000 face amount of your securities): |
• if the ending price is greater than or equal to the downside threshold price: $1,000; or • if the ending price is less than the downside threshold price: $1,000 × performance factor |
|
The estimated value of your securities at the time the terms of your securities are set on the pricing date is expected to be between $925 and $955 per $1,000 face amount. See the accompanying preliminary pricing supplement for a further discussion of the estimated value of your securities. |
Underwriting discount: |
up to 1.075% of the face amount*; Wells Fargo Securities, LLC (“WFS”) is the agent for the distribution of the securities. WFS will receive the underwriting discount of up to 1.075% of the aggregate face amount of the securities sold. The agent may resell the securities to Wells Fargo Advisors (“WFA”) at the original issue price of the securities less a concession of 0.50% of the aggregate face amount of the securities. In addition to the selling concession received by WFA, WFS advises that WFA may also receive out of the underwriting discount a distribution expense fee of 0.075% for each $1,000 face amount of a security WFA sells. |
|
|
CUSIP: |
40058JNT8 |
|
|
Tax consequences: |
See “Supplemental Discussion of U.S. Federal Income Tax Considerations” in the accompanying preliminary pricing supplement |
|
|
* In addition, in respect of certain securities sold in this offering, GS&Co. may pay a fee of up to 0.20% of the aggregate face amount of the securities sold to selected securities dealers in consideration for marketing and other services in connection with the distribution of the securities to other securities dealers. |
|
|
|
The securities have more complex features than conventional debt securities and involve risks not associated with conventional debt securities. See “Risk Factors” in this term sheet and in the accompanying preliminary pricing supplement. This document does not provide all of the information that an investor should consider prior to making an investment decision. You should not invest in the securities without reading the accompanying preliminary pricing supplement and related documents for a more detailed description of the underlying stock, the terms of the securities and certain risks.
About Your Securities |
GS Finance Corp. and The Goldman Sachs Group, Inc. have filed a registration statement (including a prospectus, as supplemented by the prospectus supplement, WFS product supplement no. 5 and preliminary pricing supplement listed below) with the Securities and Exchange Commission (SEC) for the offering to which this communication relates. Before you invest, you should read the prospectus, prospectus supplement, WFS product supplement no. 5 and preliminary pricing supplement, and any other documents relating to this offering that GS Finance Corp. and The Goldman Sachs Group, Inc. have filed with the SEC for more complete information about us and this offering. You may get these documents without cost by visiting EDGAR on the SEC web site at sec.gov. Alternatively, we will arrange to send you the prospectus, prospectus supplement, WFS product supplement no. 5 and preliminary pricing supplement if you so request by calling (212) 357-4612.
Risk Factors |
An investment in the securities is subject to risks. Many of the risks are described in the accompanying preliminary pricing supplement, accompanying WFS product supplement no. 5, accompanying prospectus supplement and accompanying prospectus. Below we have provided a list of risk factors discussed in the accompanying preliminary pricing supplement (but not those discussed in the accompanying WFS product supplement no. 5, accompanying prospectus supplement and accompanying prospectus). In addition to the below, you should read in full “Selected Risk Considerations” in the accompanying preliminary pricing supplement, “Risk Factors” in the accompanying WFS product supplement no. 5, as well as the risks and considerations described in the accompanying prospectus supplement and accompanying prospectus.
The following risk factors are discussed in greater detail in the accompanying preliminary pricing supplement:
Risks Related to Structure, Valuation and Secondary Market Sales ▪ The Estimated Value of Your Securities At the Time the Terms of Your Securities Are Set On the Pricing Date (as Determined By Reference to Pricing Models Used By GS&Co.) Is Less Than the Original Offering Price Of Your Securities ▪ The Securities Are Subject to the Credit Risk of the Issuer and the Guarantor ▪ You May Lose Your Entire Investment in the Securities ▪ The Return on Your Securities May Change Significantly Despite Only a Small Change in the Price of the Underlying Stock ▪ You May Not Receive a Contingent Coupon on Any Contingent Coupon Payment Date ▪ A Higher Contingent Coupon, a Lower Coupon Threshold Price and/or a Lower Downside Threshold Price May Reflect Greater Expected Volatility of the Underlying Stock, and Greater Expected Volatility Generally Indicates An Increased Risk of Declines in the Price of the Underlying Stock and, Potentially, a Significant Loss at Maturity |
|
▪ Your Securities Are Subject to Automatic Redemption ▪ The Contingent Coupon Does Not Reflect the Actual Performance of the Underlying Stock from the Pricing Date to Any Calculation Day or from Calculation Day to Calculation Day ▪ The Market Value of Your Securities May Be Influenced by Many Unpredictable Factors ▪ We Will Not Hold Shares of the Underlying Stock for Your Benefit ▪ You Have No Shareholder Rights or Rights to Receive the Underlying Stock Additional Risks Related to the Underlying Stock ▪ The Underlying Stock Has a Very Limited Trading History Risks Related to Tax ▪ Certain Considerations for Insurance Companies and Employee Benefit Plans ▪ The Tax Consequences of an Investment in Your Securities Are Uncertain ▪ Foreign Account Tax Compliance Act (FATCA) Withholding May Apply to Payments on Your Securities, Including as a Result of the Failure of the Bank or Broker Through Which You Hold the Securities to Provide Information to Tax Authorities |
Wells Fargo Advisors is a trade name used by Wells Fargo Clearing Services, LLC and Wells Fargo Advisors Financial Network, LLC, members SIPC, separate registered broker-dealers and non-bank affiliates of Wells Fargo & Company.
This document does not provide all of the information that an investor should consider prior to making an investment decision. You should not invest in the securities without reading the accompanying preliminary pricing supplement and related documents for a more detailed description of the underlying stock, the terms of the securities and certain risks.
Source:
FAQ
Why did the FDA issue a CRL to Ultragenyx (RARE) for UX111?
Does the CRL affect the clinical efficacy of UX111?
How long could UX111 approval be delayed?
What is the financial impact of the FDA CRL on Ultragenyx?
What are the next steps for Ultragenyx following the CRL?
