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Jaguar Health Reports Third Quarter 2025 Financials: Net Q3 2025 Revenue Up Approximately 4% Versus Net Q2 2025 Revenue

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Jaguar Health (NASDAQ: JAGX) reported Q3 2025 net revenue of ~$3.1M, up ~4% versus Q2 2025, with Mytesi prescription volume up ~0.9% sequentially but down ~3.6% year-over-year. The company recorded a net loss attributable to common stockholders of $9.5M and non-GAAP recurring EBITDA of -$8.9M. License revenue of $42,858 was recognized and deferred contract revenue totaled ~ $595k as of September 30, 2025.

Clinical update: investigator-initiated proof-of-concept data suggest crofelemer may extend survival and reduce parenteral support volume by up to 37% in infants with MVID, though associated toxicity was reported. Jaguar met with the FDA on October 2, 2025 to discuss an expedited approval pathway for a placebo-controlled crofelemer trial.

Jaguar Health (NASDAQ: JAGX) ha riportato ricavi netti nel terzo trimestre 2025 di ~$3.1M, in crescita di ~4% rispetto al secondo trimestre 2025, con il volume di prescrizioni di Mytesi in aumento di ~0.9% sequenziale ma in calo di ~3.6% anno su anno. L'azienda ha registrato una perdita netta attribuibile agli azionisti ordinari di $9.5M e EBITDA ricorrente non GAAP di -$8.9M. Le entrate da licenze sono state di $42,858 riconosciute e i ricavi contrattuali differiti ammontavano a ~$595k al 30 settembre 2025.

Aggiornamento clinico: dati di proof-of-concept avviati dall'investigatore suggeriscono che crofelemer potrebbe estendere la sopravvivenza e ridurre il volume di supporto parenterale fino al 37% nei neonati affetti da MVID, sebbene sia stata riportata una tossicità associata. Jaguar ha incontrato l'FDA il 2 ottobre 2025 per discutere un percorso di approvazione accelerata per uno studio controllato con placebo su crofelemer.

Jaguar Health (NASDAQ: JAGX) informó ingresos netos del 3T 2025 de ~$3.1M, un aumento de ~4% respecto al 2T 2025, con el volumen de prescripción de Mytesi aumentando ~0.9% secuencialmente pero bajando ~3.6% interanual. La compañía registró una pérdida neta atribuible a los accionistas comunes de $9.5M y un EBITDA recurrente no GAAP de -$8.9M. Los ingresos por licencias de $42,858 fueron reconocidos y los ingresos por contratos diferidos totalizaron ~$595k al 30 de septiembre de 2025.

Actualización clínica: datos de prueba de concepto iniciados por el investigador sugieren que crofelemer podría prolongar la supervivencia y reducir el volumen de soporte parenteral en hasta un 37% en bebés con MVID, aunque se reportó toxicidad asociada. Jaguar se reunió con la FDA el 2 de octubre de 2025 para discutir una vía de aprobación acelerada para un ensayo controlado con placebo de crofelemer.

Jaguar Health (NASDAQ: JAGX)2025년 3분기 순매출 ~310만 달러를 보고했으며, 이는 2025년 2분기 대비 약 4% 증가한 수치이고 Mytesi 처방량은 연속적으로 약 0.9% 증가했지만 전년 동기 대비 약 3.6% 감소했습니다. 회사는 주주귀속 순손실 $9.5M를 기록했고 비-GAAP 재발생 EBITDA -$8.9M를 보고했습니다. 라이선스 수익은 $42,858로 인식되었고 9월 30, 2025 기준 이연 계약 수익은 약 $595k었습니다.

임상 업데이트: 연구자 주도 개념 증거에 따르면 crofelemer가 MVID 영아의 생존 기간을 연장하고 말초 비경구 수액 필요량을 최대 37%까지 감소시킬 수 있다고 하지만 관련 독성도 보고되었습니다. Jaguar는 2025년 10월 2일 FDA와 만남을 가졌으며 크로페렘어의 위약 대조 시험에 대한 신속 승인 경로를 논의했습니다.

Jaguar Health (NASDAQ: JAGX) a annoncé un chiffre d'affaires net du T3 2025 d'environ 3,1 millions de dollars, en hausse d'environ 4% par rapport au T2 2025, avec un volume de prescriptions de Mytesi en hausse d'environ 0,9% en séquentiel mais en baisse d'environ 3,6% sur un an. L'entreprise a enregistré une perte nette attribuable aux actionnaires ordinaires de 9,5 millions de dollars et un EBITDA récurrent non-GAAP de -8,9 millions de dollars. Les revenus de licences de 42 858 $ ont été reconnus et les revenus contractuels différés s'élevaient à environ 595 k$ au 30 septembre 2025.

Actualisation clinique: des données précliniques initiées par des chercheurs suggèrent que la crofelemer pourrait prolonger la survie et réduire le volume de soutien parentéral jusqu'à 37% chez les nourrissons atteints de MVID, bien qu'une toxicité associée ait été signalée. Jaguar a rencontré la FDA le 2 octobre 2025 pour discuter d'une voie d'approbation accélérée pour un essai crofelemer en double aveugle et contrôlé par placebo.

Jaguar Health (NASDAQ: JAGX) meldete Q3 2025 Nettoumsatz von ca. $3,1 Mio, eine Steigerung von ca. 4% gegenüber Q2 2025, wobei Mytesi-Rezeptvolumen sequentiell um ca. 0,9% zunahm, aber yoy um ca. 3,6% fiel. Das Unternehmen verzeichnete einen Verlust attribuierbar an Stammaktionäre von $9,5 Mio und ein nicht-GAAP wiederkehrendes EBITDA von -$8,9 Mio. Lizenzumsatz von $42,858 wurde anerkannt und abgegrenzte Vertragsumsätze beliefen sich zum 30. September 2025 auf ca. $595k.

Klinisches Update: von Forschern initiierte Proof-of-Concept-Daten deuten darauf hin, dass Crofelemer die Überlebenszeit verlängern und das parenterale Unterstützungsvolumen bei Säuglingen mit MVID um bis zu 37% verringern könnte, obwohl eine mit der Therapie assoziierte Toxizität gemeldet wurde. Jaguar traf sich am 2. Oktober 2025 mit der FDA, um einen beschleunigten Zulassungsweg für eine placebokontrollierte Crofelemer-Studie zu diskutieren.

Jaguar Health (NASDAQ: JAGX) أبلغت عن إيرادات صافية للربع الثالث 2025 قدرها نحو 3.1 مليون دولار، بارتفاع يقارب 4% مقارنة بالربع الثاني 2025، مع ارتفاع حجم وصفات Mytesi بنحو 0.9% على أساس تسلسلي ولكنه منخفض بنحو 3.6% سنويًا. سجلت الشركة خسارة صافية تخص مساهمي الأسهم العادية قدرها 9.5 ملايين دولار و EBITDA متكرر غير-GAAP قدره -8.9 ملايين دولار. تم الاعتراف بإيرادات الترخيص البالغة 42,858 دولارًا وبلغ إجمالي الإيرادات العقدية المؤجلة نحو 595 ألف دولار حتى 30 سبتمبر 2025.

تحديث سريري: تشير بيانات إثبات المفهوم التي بدأها الباحث إلى أن crofelemer قد يطيل البقاء على قيد الحياة ويقلل حجم الدعم parenteral حتى 37% لدى الأطفال المصابين بـ MVID، على الرغم من الإبلاغ عن سمية مرتبطة. اجتمعت Jaguar مع FDA في 2 أكتوبر 2025 لمناقشة مسار موافقة سريع لتجربة crofelemer مُحكمة مع الدواء الوهمي.

Positive
  • Net revenue of $3.1M in Q3 2025 (+~4% QoQ)
  • Mytesi prescription volume +0.9% sequentially
  • Investigator data: crofelemer reduced parenteral support up to 37%
  • Company met with FDA on October 2, 2025 about expedited pathway
Negative
  • Net loss attributable to common stockholders of $9.5M
  • Non-GAAP recurring EBITDA of -$8.9M (unchanged YoY)
  • Mytesi prescription volume down 3.6% YoY
  • Investigator trial reported associated toxicity with crofelemer

Insights

Early clinical signal for crofelemer in MVID plus modest revenue stability; clinical safety and regulatory path will drive near-term value.

Jaguar Health reports consolidated net product revenue of $3.1 million in Q3 2025, about 4% above the prior quarter, with license revenue of $42,858 and deferred contract revenue near $595,000. The company recorded a net loss attributable to common stockholders of $9.5 million and non-GAAP recurring EBITDA of a $8.9 million loss; Mytesi prescription volume was roughly flat sequentially and down modestly year-over-year.

The clinical update is the most material operational development: an investigator-initiated proof-of-concept trial suggests crofelemer may reduce total parenteral support (PS) needs for infants with MVID by as much as 37% and potentially extend survival, but the report also states there was associated toxicity. The company completed a meeting with the FDA on October 2, 2025 to discuss a possible expedited approval pathway for a placebo-controlled trial; that regulatory engagement and the safety profile are the key determinants of program value.

Watch for three near-term milestones: (1) detailed safety and efficacy data from the ongoing placebo-controlled trial and any complete investigator-initiated dataset (timing unspecified), (2) formal FDA guidance or agreement on an expedited approval pathway and required endpoints, and (3) upcoming financial cadence including the investor webcast on November 17, 2025 and subsequent quarter filings that will show whether revenue trends and deferred revenue recognition change. The clinical signal plus FDA engagement makes the news impactful, but the stated toxicity mandates cautious interpretation until controlled-trial results and explicit regulatory feedback are published.

Initial results of ongoing investigator-initiated proof-of-concept trial demonstrate crofelemer can potentially extend the lives of infants born with intestinal failure due to microvillus inclusion disease (MVID), reducing the volume of the total parenteral support (PS) necessary for them to survive, though with associated toxicity; Groundbreaking PS reduction of up to 37%; No approved treatments exist for MVID

Company completed meeting with FDA October 2, 2025 for advice on possible expedited approval pathway to advance its ongoing placebo-controlled trial of crofelemer for potential approval for treatment of MVID

REMINDER: Today Jaguar to host investor webcast at 8:30 a.m. Eastern regarding Q3 2025 financials and company updates; Click here to register

SAN FRANCISCO, CA / ACCESS Newswire / November 17, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar" or the "Company") today reported its consolidated third-quarter 2025 financial results.

2025 THIRD QUARTER COMPANY FINANCIAL RESULTS:

  • Net Revenue: The combined net revenue for the Company's prescription products (Mytesi®, Gelclair®, and Canalevia®-CA1), including license revenue, was approximately $3.1 million in the third quarter of 2025, representing an increase of approximately 4% over the combined net revenue in the second quarter of 2025, which totaled approximately $3.0 million, and equaled the combined net revenue for the third quarter of 2024.

  • Mytesi Prescription Volume: Mytesi prescription volume increased by approximately 0.9% in the third quarter of 2025 over the second quarter of 2025, and Mytesi prescription volume in the third quarter of 2025 decreased by 3.6% compared to the volume in the third quarter of 2024. Prescription volume differs from invoiced sales volume, which reflects, among other factors, varying buying patterns among specialty pharmacies in the closed network as they manage their inventory levels.

  • License Revenue: For the third quarter of 2025, the Company recognized license fees of $42,858 from a securities purchase agreement with a European partner. As of September 30, 2025, the total deferred revenue associated with this contract amounts to approximately $595,000.

  • Neonorm: Revenues for the non-prescription Neonorm products were minimal for the third quarters of 2025 and 2024.

Three Months Ending

Financial Highlights

September 30,

(in thousands, except per share amounts)

2025

2024

$ change

% change

Net product revenue

$

3,083

$

3,108

(25

)

-1

%

Loss from operations

$

(7,238

)

$

(7,262

)

24

0

%

Net loss attributable to common stockholders

$

(9,502

)

$

(9,854

)

352

-4

%

Net loss per share, basic and diluted

$

(6.28

)

$

(26.29

)

20

-76

%

  • Cost of Product Revenue: Total cost of product revenue decreased by approximately $0.01 million, from $0.54 million for the quarter ended September 30, 2024 compared to $0.53 million for the quarter ended September 30, 2025, due to a slight decrease in the average cost of Mytesi bottle lots.

  • Research and Development: The R&D expense decreased by $0.3 million, from $3.7 million for the quarter ended September 30, 2024 compared to $4.0 million for the quarter ended September 30, 2025, primarily due to the conclusion of the Phase 3 OnTarget clinical trial, which reduced trial-related contract manufacturing services and regulatory activities.

  • Sales and Marketing: The Sales and Marketing expense decreased by approximately $0.01 million, from $2.01 million for the quarter ended September 30, 2024 to approximately $2.0 million during the same quarter in 2025. Although personnel and related benefits, together with direct marketing fees, increased by $0.6 million, this was offset by decreased third-party consulting and other expenses of $0.7 million.

  • General and Administrative: The G&A expense increased by approximately $0.3 million, from $3.8 million for the quarter ended September 30, 2024 to $4.1 million during the same quarter in 2025, largely due to increased legal and compliance expenses from financing activities.

  • Loss from Operations: Loss from operations decreased by $0.1 million, from $7.2 million in the quarter ended September 30, 2024 to $7.3 million during the same period in 2025.

  • Net Loss: Net loss attributable to common shareholders decreased by approximately $0.4 million, from $9.9 million in the quarter ended September 30, 2024 to $9.5 million in the same period in 2025. In addition to the loss from operations:

    • Interest income (expense) decreased by $0.2 million, from approximately $0.2 million of interest income for the quarter ended September 30, 2024 to approximately $6,000 of interest expense in the same period in 2025, primarily due to changing the accounting of certain debt instruments designated at Fair Value Option (FVO).

    • The fair value of financial and hybrid instrument designation at FVO decreased by $0.8 million, from a loss of $3.1 million in the three months ended September 30, 2024, to a loss of $2.3 million in the same period in 2025, primarily due to fair value adjustments in liability classified warrants and notes payable designated at FVO.

  • Non-GAAP Recurring EBITDA: Non-GAAP recurring EBITDA for the third quarters of 2025 and 2024 were a net loss of $8.9 million and $8.9 million, respectively.

Three Months Ending

September 30,

(in thousands)

2025

2024

$ change

% change

(unaudited)

Net loss attributable to common stockholders

$

(9,502

)

$

(9,854

)

(352

)

4

%

Adjustments:
Interest income (expense)

6

(162

)

(168

)

104

%

Property and equipment depreciation

17

17

(0

)

-2

%

Amortization of intangible assets

463

457

(6

)

-1

%

Share-based compensation expense

135

305

170

56

%

Loss on extinguishment of debt

-

-

-

-100

%

Non-GAAP EBITDA

(8,881

)

(9,237

)

(357

)

4

%

Note Regarding Use of Non-GAAP Measures

The Company supplements its condensed consolidated financial statements presented on a GAAP basis by providing non-GAAP EBITDA and non-GAAP recurring EBITDA, which are considered non-GAAP under applicable SEC rules. Jaguar believes that the disclosure items of these non-GAAP measures provide investors with additional information that reflects the basis upon which Company management assesses and operates the business. These non-GAAP financial measures are not in accordance with GAAP and should not be viewed in isolation or as substitutes for GAAP net sales and GAAP net loss and are not substitutes for, or superior to, measures of financial performance in conformity with GAAP.

The Company defines non-GAAP EBITDA as net loss before interest expense and other expense, depreciation of property and equipment, amortization of intangible assets, share-based compensation expense and provision for or benefit from income taxes. The Company defines non-GAAP Recurring EBITDA as non-GAAP EBITDA adjusted for certain non-recurring revenues and expenses. Company management believes that non-GAAP EBITDA and non-GAAP Recurring EBITDA are meaningful indicators of Jaguar's performance and provide useful information to investors regarding the Company's results of operations and financial condition.

Participation Instructions for Webcast

When: Monday, November 17, 2025 at 8:30 a.m. Eastern

Participant Registration & Access Link: Click Here

Replay Instructions for Webcast

Replay of the webcast on the investor relations section of Jaguar's website: (click here)

About Crofelemer

Crofelemer is the only oral FDA-approved prescription drug under botanical guidance. It is plant-based, extracted and purified from the red bark sap of the Croton lechleri tree in the Amazon Rainforest. Napo Pharmaceuticals, a Jaguar family company, has established a sustainable harvesting program, under fair trade practices, for crofelemer to ensure a high degree of quality, ecological integrity, and support for Indigenous communities.

About the Jaguar Health Family of Companies

Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals (Napo) focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Napo's crofelemer is FDA-approved under the brand name Mytesi® for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar's Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications.

For more information about:

Jaguar Health, visit https://jaguar.health

Napo Pharmaceuticals, visit www.napopharma.com

Napo Therapeutics, visit napotherapeutics.com

Magdalena Biosciences, visit magdalenabiosciences.com

Canalevia-CA1, visit canalevia.com

Visit the Make Cancer Less Shitty patient advocacy program on Bluesky, X, Facebook & Instagram

About Mytesi®

Mytesi (crofelemer) is an antidiarrheal indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART). Mytesi is not indicated for the treatment of infectious diarrhea. Rule out infectious etiologies of diarrhea before starting Mytesi. If infectious etiologies are not considered, there is a risk that patients with infectious etiologies will not receive the appropriate therapy and their disease may worsen. In clinical studies, the most common adverse reactions occurring at a rate greater than placebo were upper respiratory tract infection (5.7%), bronchitis (3.9%), cough (3.5%), flatulence (3.1%), and increased bilirubin (3.1%).

See full Prescribing Information at Mytesi.com. Crofelemer, the active ingredient in Mytesi, is a botanical (plant-based) drug extracted and purified from the red bark sap of the medicinal Croton lechleri tree in the Amazon rainforest. Napo has established a sustainable harvesting program for crofelemer to ensure a high degree of quality and ecological integrity.

About Gelclair®

INDICATIONS

GELCLAIR® has a mechanical action indicated for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including oral mucositis/stomatitis (may be caused by chemotherapy or radiation therapy), irritation due to oral surgery, traumatic ulcers caused by braces or ill-fitting dentures, or disease. Also, indicated for diffuse aphthous ulcers.

IMPORTANT SAFETY INFORMATION

  • Do not use GELCLAIR if there is a known or suspected hypersensitivity to any of its ingredients.

  • No adverse effects have been reported in clinical trials, although postmarketing reports have included infrequent complaints of burning sensation in the mouth.

  • If GELCLAIR is swallowed accidentally, no adverse effects are anticipated.

  • If no improvement is seen within 7 days, a physician should be consulted.

You are encouraged to report negative side effects of prescription medical products to the FDA.

Visit www.fda.gov/safety/medwatch or call 1-855-273-0468.

Please see full Prescribing Information at:

https://www.gelclairhcp.com/pdf/prescribing-information-instructions-for-use.pdf

Important Safety Information About Canalevia®-CA1

For oral use in dogs only. Not for use in humans. Keep Canalevia-CA1 (crofelemer delayed-release tablets) in a secure location out of reach of children and other animals. Consult a physician in case of accidental ingestion by humans. Do not use in dogs that have a known hypersensitivity to crofelemer. Prior to using Canalevia-CA1, rule out infectious etiologies of diarrhea. Canalevia-CA1 is a conditionally approved drug indicated for the treatment of chemotherapy-induced diarrhea in dogs. The most common adverse reactions included decreased appetite, decreased activity, dehydration, abdominal pain, and vomiting.

Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Use only as directed. It is a violation of Federal law to use this product other than as directed in the labeling. Conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-552.

See full Prescribing Information at Canalevia.com.

Forward-Looking Statements

Certain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that it will hold an investor webcast on November 17, 2025, and Jaguar's expectation that crofelemer can potentially extend lives of MVID patients, reducing the volume of the PS necessary for them to survive. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Source: Jaguar Health, Inc.

Contact:

hello@jaguar.health
Jaguar-JAGX

SOURCE: Jaguar Health, Inc.



View the original press release on ACCESS Newswire

FAQ

What were Jaguar Health's Q3 2025 net revenues and how did they change versus Q2 2025 (JAGX)?

Jaguar reported Q3 2025 net revenue of ~$3.1M, an approximate 4% increase versus Q2 2025.

How did Jaguar's net loss and non-GAAP EBITDA look in Q3 2025 for JAGX?

Net loss attributable to common stockholders was $9.5M; non-GAAP recurring EBITDA was -$8.9M.

What clinical progress did Jaguar (JAGX) report for crofelemer in November 2025?

Investigator-initiated proof-of-concept data suggested crofelemer may extend survival and reduce parenteral support volume by up to 37% in infants with MVID, with reported toxicity.

Did Jaguar meet with the FDA about crofelemer and when (JAGX)?

Yes. Jaguar completed a meeting with the FDA on October 2, 2025 to discuss a possible expedited approval pathway for crofelemer.

How did Mytesi prescription volumes change in Q3 2025 for JAGX?

Mytesi prescription volume increased ~0.9% versus Q2 2025 but was down ~3.6% versus Q3 2024.

How material was Jaguar's license revenue in Q3 2025 (JAGX)?

Jaguar recognized license fees of $42,858 in Q3 2025, with ~$595,000 of deferred revenue tied to the contract as of 9/30/2025.
Jaguar Health Inc

NASDAQ:JAGX

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Biotechnology
Pharmaceutical Preparations
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United States
SAN FRANCISCO