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Alvotech鈥檚 July 2025 Form 6-K details governance, commercial, regulatory and financing actions since its Q1 report.
- Governance: Six directors re-elected; veteran executive Linda J贸nsd贸ttir appointed CFO; COO Faysal Kalmoua exits board and management.
- Commercial: Advanz Pharma partnership broadened to three new biosimilars (milestones up to 鈧�160 m) and separate AVT10 (Cimzia) deal; global Keytruda biosimilar co-development with Dr. Reddy鈥檚.
- M&A: Acquired Swiss packager Ivers-Lee and Xbrane鈥檚 Swedish R&D team plus Cimzia candidate for c.SEK 275 m.
- Pipeline: CHMP positive opinion for AVT06 (Eylea); AVT23 (Xolair) study shows therapeutic equivalence.
- Manufacturing risk: FDA pre-approval inspection (26 Jun鈥�4 Jul) issued Form 483 citing operational, documentation and quality control deficiencies; detailed response submitted 25 Jul.
- Financing: Oversubscribed SDR IPO (SEK 39 m) and institutional placement (SEK 750 m) add >3,000 new holders; term-loan amendment folds second tranche, trims margin to SOFR+6.0%, facility now $1.081 bn, cash $152 m.
New capital and partnerships enhance growth prospects, but regulatory remediation is critical for near-term BLA approvals.
Il Form 6-K di Alvotech di luglio 2025 riporta le azioni di governance, commerciali, regolatorie e finanziarie intraprese dal rapporto del primo trimestre.
- Governance: Sei direttori rieletti; la veterana Linda J贸nsd贸ttir nominata CFO; il COO Faysal Kalmoua lascia il consiglio e la direzione.
- Commerciale: Partnership con Advanz Pharma ampliata a tre nuovi biosimilari (milestone fino a 160 milioni di euro) e accordo separato per AVT10 (Cimzia); co-sviluppo globale del biosimilare di Keytruda con Dr. Reddy鈥檚.
- M&A: Acquisizione del confezionatore svizzero Ivers-Lee e del team R&D svedese di Xbrane, oltre al candidato Cimzia per 275 milioni di corone svedesi.
- Pipeline: Parere positivo CHMP per AVT06 (Eylea); studio su AVT23 (Xolair) dimostra equivalenza terapeutica.
- Rischio produttivo: Ispezione FDA pre-approvazione (26 giugno鈥�4 luglio) ha emesso Form 483 evidenziando carenze operative, documentali e di controllo qualit脿; risposta dettagliata inviata il 25 luglio.
- Finanziamenti: IPO SDR sovraccolocata (39 milioni SEK) e collocamento istituzionale (750 milioni SEK) portano oltre 3.000 nuovi azionisti; modifica del prestito a termine annulla la seconda tranche, riduce il margine a SOFR+6,0%, struttura ora a 1,081 miliardi di dollari, liquidit脿 152 milioni di dollari.
Il nuovo capitale e le partnership rafforzano le prospettive di crescita, ma la risoluzione delle problematiche regolatorie 猫 fondamentale per le approvazioni BLA a breve termine.
El Formulario 6-K de Alvotech de julio de 2025 detalla las acciones de gobernanza, comerciales, regulatorias y financieras desde su informe del primer trimestre.
- Gobernanza: Seis directores reelegidos; la ejecutiva veterana Linda J贸nsd贸ttir nombrada CFO; el COO Faysal Kalmoua deja la junta y la gerencia.
- Comercial: Asociaci贸n con Advanz Pharma ampliada a tres nuevos biosimilares (hitos hasta 160 millones de euros) y acuerdo separado para AVT10 (Cimzia); co-desarrollo global del biosimilar de Keytruda con Dr. Reddy鈥檚.
- Fusiones y adquisiciones: Adquirido el envasador suizo Ivers-Lee y el equipo sueco de I+D de Xbrane, adem谩s del candidato Cimzia por 275 millones de coronas suecas.
- Pipeline: Opini贸n positiva del CHMP para AVT06 (Eylea); estudio de AVT23 (Xolair) demuestra equivalencia terap茅utica.
- Riesgo de fabricaci贸n: Inspecci贸n FDA previa a la aprobaci贸n (26 jun鈥�4 jul) emiti贸 el Form 483 se帽alando deficiencias operativas, documentales y de control de calidad; respuesta detallada presentada el 25 de julio.
- Financiamiento: IPO SDR sobresuscrita (39 millones SEK) y colocaci贸n institucional (750 millones SEK) suman m谩s de 3,000 nuevos accionistas; enmienda al pr茅stamo a plazo cancela la segunda cuota, reduce el margen a SOFR+6.0%, la facilidad ahora es de 1.081 mil millones de d贸lares, efectivo 152 millones de d贸lares.
El nuevo capital y las asociaciones mejoran las perspectivas de crecimiento, pero la remediaci贸n regulatoria es cr铆tica para las aprobaciones BLA a corto plazo.
Alvotech鞚� 2025雲� 7鞗� Form 6-K電� 1攵勱赴 氤搓碃靹� 鞚错泟鞚� 瓯半矂雱岇姢, 靸侅梾, 攴滌牅 氚� 旮堨湹 頇滊彊鞚� 靸侅劯頌� 靹る獏頃╇媹雼�.
- 瓯半矂雱岇姢: 6氇呾潣 鞚挫偓 鞛劆鞛�; 氩犿厡霝� 鞛勳洂 Linda J贸nsd贸ttir CFO搿� 鞛勲獏; COO Faysal Kalmoua電� 鞚挫偓須� 氚� 瓴届榿歆勳棎靹� 韲挫瀯.
- 靸侅梾: Advanz Pharma鞕�鞚� 韺岉姼雱堨嫮鞚� 3臧滌潣 靸堧鞖� 氚旍澊鞓れ嫓氚�霟 頇曤寑(毵堨澕鞀ろ啢 斓滊寑 1鞏� 6觳滊 鞙犽) 氚� 氤勲弰鞚� AVT10(Cimzia) 瓿勳暯; Dr. Reddy鈥檚鞕� 旮�搿滊矊 Keytruda 氚旍澊鞓れ嫓氚�霟� 瓿惦彊 臧滊皽.
- M&A: 鞀れ渼鞀� 韽灔鞐呾泊 Ivers-Lee 氚� Xbrane鞚� 鞀れ洦雿� R&D 韺�瓿� Cimzia 頉勲炒 氍检鞚� 齑� 2鞏� 7,500毵� SEK鞐� 鞚胳垬.
- 韺岇澊顶勲澕鞚�: AVT06(Eylea)鞐� 雽�頃� CHMP 旮嶌爼鞝� 鞚橁铂; AVT23(Xolair) 鞐瓣惮鞐愳劀 旃橂鞝� 霃欕摫靹� 頇曥澑.
- 鞝滌“ 毽姢韥�: FDA 靷爠 鞀轨澑 瓴�靷�(6鞗� 26鞚紐7鞗� 4鞚�)鞐愳劀 鞖挫榿, 氍胳劀 氚� 頀堨 甏�毽� 攵�臁膘潉 歆�鞝來晿電� Form 483 氚滍枆; 7鞗� 25鞚� 靸侅劯 雽�鞚� 鞝滌稖.
- 鞛: 齑堦臣 觳暯霅� SDR IPO(3,900毵� SEK) 氚� 旮瓣磤 氚办爼(7鞏� 5,000毵� SEK)鞙茧 3,000氇� 鞚挫儊鞚� 鞁犼窚 欤检＜ 頇曤炒; 旮绊暅攵� 雽�於� 靾橃爼鞙茧 霊� 氩堨Ц 攵勴暊 靸來櫂 旆唽, 毵堨鞚� SOFR+6.0%搿� 於曥唽, 順勳灛 鞁滌劋 攴滊 10鞏� 8,100毵� 雼煬, 順勱笀 1鞏� 5,200毵� 雼煬.
鞁犼窚 鞛愲掣瓿� 韺岉姼雱堨嫮鞚� 靹膘灔 鞝勲鞚� 臧曧檾頃橃毵�, 雼赴 BLA 鞀轨澑鞐愲姅 攴滌牅 氍胳牅 頃搓舶鞚� 頃勳垬鞝侅瀰雼堧嫟.
Le Formulaire 6-K d'Alvotech de juillet 2025 d茅taille les actions de gouvernance, commerciales, r茅glementaires et financi猫res depuis son rapport du premier trimestre.
- Gouvernance : Six administrateurs r茅茅lus ; la cadre exp茅riment茅e Linda J贸nsd贸ttir nomm茅e CFO ; le COO Faysal Kalmoua quitte le conseil et la direction.
- Commercial : Partenariat avec Advanz Pharma 茅largi 脿 trois nouveaux biosimilaires (jalons jusqu'脿 160 millions d'euros) et accord s茅par茅 pour AVT10 (Cimzia) ; co-d茅veloppement mondial du biosimilaire de Keytruda avec Dr. Reddy鈥檚.
- Fusions & acquisitions : Acquisition de l鈥檈mballeur suisse Ivers-Lee et de l鈥櫭﹒uipe R&D su茅doise de Xbrane ainsi que du candidat Cimzia pour 275 millions de SEK.
- Pipeline : Avis positif du CHMP pour AVT06 (Eylea) ; 茅tude AVT23 (Xolair) d茅montrant une 茅quivalence th茅rapeutique.
- Risque de fabrication : Inspection FDA avant approbation (26 juin鈥�4 juillet) ayant 茅mis un Form 483 signalant des d茅ficiences op茅rationnelles, documentaires et de contr么le qualit茅 ; r茅ponse d茅taill茅e soumise le 25 juillet.
- Financement : IPO SDR sursouscrite (39 millions SEK) et placement institutionnel (750 millions SEK) ajoutant plus de 3 000 nouveaux actionnaires ; amendement du pr锚t 脿 terme annulant la deuxi猫me tranche, r茅duisant la marge 脿 SOFR+6,0 %, facilit茅 d茅sormais 脿 1,081 milliard de dollars, tr茅sorerie de 152 millions de dollars.
Le nouveau capital et les partenariats renforcent les perspectives de croissance, mais la rem茅diation r茅glementaire est cruciale pour les approbations BLA 脿 court terme.
Alvotechs Form 6-K vom Juli 2025 enth盲lt Details zu Governance-, kommerziellen, regulatorischen und Finanzierungsma脽nahmen seit dem Q1-Bericht.
- Governance: Sechs Direktoren wiedergew盲hlt; erfahrene Managerin Linda J贸nsd贸ttir zur CFO ernannt; COO Faysal Kalmoua verl盲sst Vorstand und Management.
- Kommerziell: Partnerschaft mit Advanz Pharma auf drei neue Biosimilars ausgeweitet (Meilensteine bis zu 160 Mio. 鈧�) und separater AVT10 (Cimzia)-Deal; globale Co-Entwicklung eines Keytruda-Biosimilars mit Dr. Reddy鈥檚.
- M&A: 脺bernahme des Schweizer Verpackers Ivers-Lee sowie des schwedischen F&E-Teams von Xbrane und Cimzia-Kandidaten f眉r 275 Mio. SEK.
- Pipeline: Positives CHMP-Gutachten f眉r AVT06 (Eylea); Studie zu AVT23 (Xolair) zeigt therapeutische 脛quivalenz.
- Herstellungsrisiko: FDA-Inspektion vor Zulassung (26. Juni鈥�4. Juli) stellte im Form 483 betriebliche, dokumentarische und Qualit盲tskontrollm盲ngel fest; ausf眉hrliche Antwort am 25. Juli eingereicht.
- Finanzierung: 脺berzeichnetes SDR-IPO (39 Mio. SEK) und institutionelle Platzierung (750 Mio. SEK) bringen 眉ber 3.000 neue Anteilseigner; 脛nderung des Terminkredits hebt zweite Tranche auf, senkt Marge auf SOFR+6,0 %, Kreditlinie jetzt 1,081 Mrd. USD, Cash 152 Mio. USD.
Neues Kapital und Partnerschaften st盲rken die Wachstumsaussichten, aber regulatorische Nachbesserungen sind f眉r kurzfristige BLA-Zulassungen entscheidend.
Positive
- 鈧�160 m milestone expansion of Advanz Pharma partnership covering three new biosimilars
- Global Keytruda biosimilar collaboration with Dr. Reddy鈥檚 broadens high-value oncology pipeline
- CHMP positive opinion for AVT06 and successful AVT23 efficacy study de-risk European approvals
- SEK 789 m equity raises were oversubscribed, adding >3,000 shareholders and improving liquidity
- Term-loan amendment lowers interest by 50 bp and simplifies capital structure, reducing financing costs
Negative
- FDA Form 483 cites multiple manufacturing and documentation deficiencies that could delay four pending BLAs
- Executive turnover with COO departure may disrupt operational continuity during critical remediation phase
Insights
TL;DR 鈥� Strong deals and financing offset by FDA Form 483 risk; net impact neutral.
Commercial wins with Advanz (鈧�160 m milestones) and Dr. Reddy鈥檚 expand the oncology & autoimmune pipeline while Ivers-Lee adds downstream capacity. SEK 789 m of fresh equity plus a 50 bp interest cut strengthen liquidity and reduce cash burn. However, the Form 483 covers multiple quality-system gaps tied to four BLAs; approval timing for AVT02/03/05/06 now depends on FDA classification, creating binary regulatory risk. Overall, strategic momentum is positive but valuation upside is capped until inspection issues are fully resolved.
TL;DR 鈥� Form 483 elevates approval risk; remediation plan is submitted but outcome uncertain.
The inspection observations span manufacturing controls, documentation and lab practices鈥攁reas often requiring re-inspection. While management claims some issues are historical, FDA follow-up could delay launch-ready assets and trigger additional costs. Positive CHMP feedback on AVT06 underscores EU progress, yet U.S. revenue inflection depends on clearing the Form 483. Investors should monitor FDA鈥檚 classification letter (OAI, VAI or NAI) and potential impact on 2025鈥�26 launch schedules.
Il Form 6-K di Alvotech di luglio 2025 riporta le azioni di governance, commerciali, regolatorie e finanziarie intraprese dal rapporto del primo trimestre.
- Governance: Sei direttori rieletti; la veterana Linda J贸nsd贸ttir nominata CFO; il COO Faysal Kalmoua lascia il consiglio e la direzione.
- Commerciale: Partnership con Advanz Pharma ampliata a tre nuovi biosimilari (milestone fino a 160 milioni di euro) e accordo separato per AVT10 (Cimzia); co-sviluppo globale del biosimilare di Keytruda con Dr. Reddy鈥檚.
- M&A: Acquisizione del confezionatore svizzero Ivers-Lee e del team R&D svedese di Xbrane, oltre al candidato Cimzia per 275 milioni di corone svedesi.
- Pipeline: Parere positivo CHMP per AVT06 (Eylea); studio su AVT23 (Xolair) dimostra equivalenza terapeutica.
- Rischio produttivo: Ispezione FDA pre-approvazione (26 giugno鈥�4 luglio) ha emesso Form 483 evidenziando carenze operative, documentali e di controllo qualit脿; risposta dettagliata inviata il 25 luglio.
- Finanziamenti: IPO SDR sovraccolocata (39 milioni SEK) e collocamento istituzionale (750 milioni SEK) portano oltre 3.000 nuovi azionisti; modifica del prestito a termine annulla la seconda tranche, riduce il margine a SOFR+6,0%, struttura ora a 1,081 miliardi di dollari, liquidit脿 152 milioni di dollari.
Il nuovo capitale e le partnership rafforzano le prospettive di crescita, ma la risoluzione delle problematiche regolatorie 猫 fondamentale per le approvazioni BLA a breve termine.
El Formulario 6-K de Alvotech de julio de 2025 detalla las acciones de gobernanza, comerciales, regulatorias y financieras desde su informe del primer trimestre.
- Gobernanza: Seis directores reelegidos; la ejecutiva veterana Linda J贸nsd贸ttir nombrada CFO; el COO Faysal Kalmoua deja la junta y la gerencia.
- Comercial: Asociaci贸n con Advanz Pharma ampliada a tres nuevos biosimilares (hitos hasta 160 millones de euros) y acuerdo separado para AVT10 (Cimzia); co-desarrollo global del biosimilar de Keytruda con Dr. Reddy鈥檚.
- Fusiones y adquisiciones: Adquirido el envasador suizo Ivers-Lee y el equipo sueco de I+D de Xbrane, adem谩s del candidato Cimzia por 275 millones de coronas suecas.
- Pipeline: Opini贸n positiva del CHMP para AVT06 (Eylea); estudio de AVT23 (Xolair) demuestra equivalencia terap茅utica.
- Riesgo de fabricaci贸n: Inspecci贸n FDA previa a la aprobaci贸n (26 jun鈥�4 jul) emiti贸 el Form 483 se帽alando deficiencias operativas, documentales y de control de calidad; respuesta detallada presentada el 25 de julio.
- Financiamiento: IPO SDR sobresuscrita (39 millones SEK) y colocaci贸n institucional (750 millones SEK) suman m谩s de 3,000 nuevos accionistas; enmienda al pr茅stamo a plazo cancela la segunda cuota, reduce el margen a SOFR+6.0%, la facilidad ahora es de 1.081 mil millones de d贸lares, efectivo 152 millones de d贸lares.
El nuevo capital y las asociaciones mejoran las perspectivas de crecimiento, pero la remediaci贸n regulatoria es cr铆tica para las aprobaciones BLA a corto plazo.
Alvotech鞚� 2025雲� 7鞗� Form 6-K電� 1攵勱赴 氤搓碃靹� 鞚错泟鞚� 瓯半矂雱岇姢, 靸侅梾, 攴滌牅 氚� 旮堨湹 頇滊彊鞚� 靸侅劯頌� 靹る獏頃╇媹雼�.
- 瓯半矂雱岇姢: 6氇呾潣 鞚挫偓 鞛劆鞛�; 氩犿厡霝� 鞛勳洂 Linda J贸nsd贸ttir CFO搿� 鞛勲獏; COO Faysal Kalmoua電� 鞚挫偓須� 氚� 瓴届榿歆勳棎靹� 韲挫瀯.
- 靸侅梾: Advanz Pharma鞕�鞚� 韺岉姼雱堨嫮鞚� 3臧滌潣 靸堧鞖� 氚旍澊鞓れ嫓氚�霟 頇曤寑(毵堨澕鞀ろ啢 斓滊寑 1鞏� 6觳滊 鞙犽) 氚� 氤勲弰鞚� AVT10(Cimzia) 瓿勳暯; Dr. Reddy鈥檚鞕� 旮�搿滊矊 Keytruda 氚旍澊鞓れ嫓氚�霟� 瓿惦彊 臧滊皽.
- M&A: 鞀れ渼鞀� 韽灔鞐呾泊 Ivers-Lee 氚� Xbrane鞚� 鞀れ洦雿� R&D 韺�瓿� Cimzia 頉勲炒 氍检鞚� 齑� 2鞏� 7,500毵� SEK鞐� 鞚胳垬.
- 韺岇澊顶勲澕鞚�: AVT06(Eylea)鞐� 雽�頃� CHMP 旮嶌爼鞝� 鞚橁铂; AVT23(Xolair) 鞐瓣惮鞐愳劀 旃橂鞝� 霃欕摫靹� 頇曥澑.
- 鞝滌“ 毽姢韥�: FDA 靷爠 鞀轨澑 瓴�靷�(6鞗� 26鞚紐7鞗� 4鞚�)鞐愳劀 鞖挫榿, 氍胳劀 氚� 頀堨 甏�毽� 攵�臁膘潉 歆�鞝來晿電� Form 483 氚滍枆; 7鞗� 25鞚� 靸侅劯 雽�鞚� 鞝滌稖.
- 鞛: 齑堦臣 觳暯霅� SDR IPO(3,900毵� SEK) 氚� 旮瓣磤 氚办爼(7鞏� 5,000毵� SEK)鞙茧 3,000氇� 鞚挫儊鞚� 鞁犼窚 欤检＜ 頇曤炒; 旮绊暅攵� 雽�於� 靾橃爼鞙茧 霊� 氩堨Ц 攵勴暊 靸來櫂 旆唽, 毵堨鞚� SOFR+6.0%搿� 於曥唽, 順勳灛 鞁滌劋 攴滊 10鞏� 8,100毵� 雼煬, 順勱笀 1鞏� 5,200毵� 雼煬.
鞁犼窚 鞛愲掣瓿� 韺岉姼雱堨嫮鞚� 靹膘灔 鞝勲鞚� 臧曧檾頃橃毵�, 雼赴 BLA 鞀轨澑鞐愲姅 攴滌牅 氍胳牅 頃搓舶鞚� 頃勳垬鞝侅瀰雼堧嫟.
Le Formulaire 6-K d'Alvotech de juillet 2025 d茅taille les actions de gouvernance, commerciales, r茅glementaires et financi猫res depuis son rapport du premier trimestre.
- Gouvernance : Six administrateurs r茅茅lus ; la cadre exp茅riment茅e Linda J贸nsd贸ttir nomm茅e CFO ; le COO Faysal Kalmoua quitte le conseil et la direction.
- Commercial : Partenariat avec Advanz Pharma 茅largi 脿 trois nouveaux biosimilaires (jalons jusqu'脿 160 millions d'euros) et accord s茅par茅 pour AVT10 (Cimzia) ; co-d茅veloppement mondial du biosimilaire de Keytruda avec Dr. Reddy鈥檚.
- Fusions & acquisitions : Acquisition de l鈥檈mballeur suisse Ivers-Lee et de l鈥櫭﹒uipe R&D su茅doise de Xbrane ainsi que du candidat Cimzia pour 275 millions de SEK.
- Pipeline : Avis positif du CHMP pour AVT06 (Eylea) ; 茅tude AVT23 (Xolair) d茅montrant une 茅quivalence th茅rapeutique.
- Risque de fabrication : Inspection FDA avant approbation (26 juin鈥�4 juillet) ayant 茅mis un Form 483 signalant des d茅ficiences op茅rationnelles, documentaires et de contr么le qualit茅 ; r茅ponse d茅taill茅e soumise le 25 juillet.
- Financement : IPO SDR sursouscrite (39 millions SEK) et placement institutionnel (750 millions SEK) ajoutant plus de 3 000 nouveaux actionnaires ; amendement du pr锚t 脿 terme annulant la deuxi猫me tranche, r茅duisant la marge 脿 SOFR+6,0 %, facilit茅 d茅sormais 脿 1,081 milliard de dollars, tr茅sorerie de 152 millions de dollars.
Le nouveau capital et les partenariats renforcent les perspectives de croissance, mais la rem茅diation r茅glementaire est cruciale pour les approbations BLA 脿 court terme.
Alvotechs Form 6-K vom Juli 2025 enth盲lt Details zu Governance-, kommerziellen, regulatorischen und Finanzierungsma脽nahmen seit dem Q1-Bericht.
- Governance: Sechs Direktoren wiedergew盲hlt; erfahrene Managerin Linda J贸nsd贸ttir zur CFO ernannt; COO Faysal Kalmoua verl盲sst Vorstand und Management.
- Kommerziell: Partnerschaft mit Advanz Pharma auf drei neue Biosimilars ausgeweitet (Meilensteine bis zu 160 Mio. 鈧�) und separater AVT10 (Cimzia)-Deal; globale Co-Entwicklung eines Keytruda-Biosimilars mit Dr. Reddy鈥檚.
- M&A: 脺bernahme des Schweizer Verpackers Ivers-Lee sowie des schwedischen F&E-Teams von Xbrane und Cimzia-Kandidaten f眉r 275 Mio. SEK.
- Pipeline: Positives CHMP-Gutachten f眉r AVT06 (Eylea); Studie zu AVT23 (Xolair) zeigt therapeutische 脛quivalenz.
- Herstellungsrisiko: FDA-Inspektion vor Zulassung (26. Juni鈥�4. Juli) stellte im Form 483 betriebliche, dokumentarische und Qualit盲tskontrollm盲ngel fest; ausf眉hrliche Antwort am 25. Juli eingereicht.
- Finanzierung: 脺berzeichnetes SDR-IPO (39 Mio. SEK) und institutionelle Platzierung (750 Mio. SEK) bringen 眉ber 3.000 neue Anteilseigner; 脛nderung des Terminkredits hebt zweite Tranche auf, senkt Marge auf SOFR+6,0 %, Kreditlinie jetzt 1,081 Mrd. USD, Cash 152 Mio. USD.
Neues Kapital und Partnerschaften st盲rken die Wachstumsaussichten, aber regulatorische Nachbesserungen sind f眉r kurzfristige BLA-Zulassungen entscheidend.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): July 28, 2025
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||||||
(Address of principal executive offices) (Zip Code)
Registrant’s telephone number, including area code: (877 ) 497-7497
| Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: | |||||
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d- 2(b)) | |||||
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4 (c)) | |||||
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). 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. ☐
Item 2.02 Results of Operations and Financial Condition.
On July 28, 2025, the Registrant issued a press release announcing its preliminary results of operations and financial condition as of and for the three and nine months ended June 30, 2025. A copy of the press release is attached as Exhibit 99.1 to this report and is incorporated into this Item 2.02 by reference.
The information in this Item 2.02, including Exhibit 99.1, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities thereof, nor shall it be deemed to be incorporated by reference in any filing under the Exchange Act or under the Securities Act of 1933, as amended (the "Securities Act"), except to the extent specifically provided in any such filing.
Item 7.01 Regulation FD Disclosure.
Information is being furnished herein in Exhibit 99.2 with respect to the Quarterly Investor Update slide presentation prepared for use in connection with the Company's conference call and earnings webcast for the third quarter of fiscal 2025. The Quarterly Investor Update slide presentation is dated July 28, 2025 and the Company does not undertake to update the materials after that date. This presentation is also available under the Presentations link in the Investor Relations - Events & Presentations section of the Company's website at https://pathwardfinancial.com.
The information in this Item 7.01, including Exhibit 99.2, shall not be deemed to be “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities thereof, nor shall it be deemed to be incorporated by reference in any filing under the Exchange Act or under the Securities Act, except to the extent specifically provided in any such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit Number | Description of Exhibit | |||||||
99.1 | Press Release of Pathward Financial, Inc., dated July 28, 2025 regarding the results of operations and financial condition. | |||||||
99.2 | Quarterly Investor Update slide presentation for the Third Quarter of Fiscal Year 2025, dated July 28, 2025, prepared for use with the Press Release. | |||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |||||||
SIGNATURE
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 hereunto duly authorized.
| PATHWARD FINANCIAL, INC. | ||||||||
Date: July 28, 2025 | By: | /s/ Gregory A. Sigrist | ||||||
| Gregory A. Sigrist | ||||||||
| Executive Vice President and Chief Financial Officer | ||||||||
Source:
FAQ
What regulatory setback did Alvotech (ALVO) disclose in the July 2025 6-K?
The FDA issued a Form 483 after a 26 Jun鈥�4 Jul pre-approval inspection of the Reykjavik plant, noting quality-system deficiencies.
How much capital did Alvotech raise through recent share offerings?
Alvotech raised SEK 39 m via an SDR IPO and SEK 750 m through a private placement in June 2025.
What are the financial terms of the amended term-loan facility?
Post-amendment, the entire $1.081 bn facility bears SOFR + 6.0% cash interest, 50 bp lower than before, maturing July 2029.
Which pipeline assets received positive European feedback?
AVT06 (biosimilar to Eylea) received a positive CHMP opinion, and AVT23 (Xolair) met its primary endpoint in a confirmatory study.
What is the potential value of the expanded Advanz Pharma partnership?
The agreement includes up to 鈧�160 m in development and commercial milestones plus revenue sharing.
Pathward Financial
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