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JH

Jaguar Health, Inc. (JAGX)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 revenue was $3.509M, up 13% q/q and 53% y/y, beating the single Wall Street revenue estimate ($3.130M); EPS missed materially with actual EPS of -$125.8 vs the -$18.5 consensus estimate. Management highlighted catalysts in Q2 2025 (FDA Type C meeting on OnTarget breast cancer subgroup and initial proof-of-concept IIT data in SBS-IF/MVID) as potential stock drivers . Values retrieved from S&P Global*.
  • Mytesi prescription volume rose 3.4% q/q and 9.4% y/y in Q4; company recognized $42k license revenue in Q4 and reported ~$0.7M deferred revenue tied to the European partner .
  • 2024 full-year net revenue grew ~20% to ~$11.7M; loss from operations improved by ~$3.5M y/y (to ~$30.8M) while net loss to common shareholders improved by ~$2.8M y/y (to ~$38.5M) .
  • Management’s tone was confident, focusing on regulatory pathways to expand Mytesi’s label to prophylaxis of therapy-related diarrhea in adult breast cancer patients and on rare disease programs (SBS-IF/MVID), emphasizing “near-term catalysts” and potential non-dilutive funding/licensing opportunities .

What Went Well and What Went Wrong

  • What Went Well

    • Q4 revenue acceleration: $3.5M, +13% q/q and +53% y/y, supported by Mytesi volume growth and license fees .
    • Clear regulatory path for Mytesi in breast cancer: FDA granted a Type C face-to-face meeting in Q2 2025 to discuss OnTarget subgroup results; management aims to expand indication to cancer therapy-related diarrhea prophylaxis .
    • Rare disease pipeline momentum: First IIT proof-of-concept results expected in Q2 2025 (SBS-IF/MVID), with active Phase II studies and EU/MENA site engagement; PRIME/Breakthrough pathways discussed as accelerants .

  • What Went Wrong

    • EPS miss vs consensus: Actual -$125.8 vs -$18.5 estimate on a single-analyst input; EBITDA remained deeply negative, reflecting continued investment and early-stage scale in oncology support portfolio*.
    • Non-GAAP recurring EBITDA remained a large loss in 2024 ($34.7M vs $34.5M in 2023), indicating limited near-term operating leverage .
    • Limited quantitative product-level segmentation disclosed for Q4 (e.g., Gelclair, Canalevia), constraining line-of-sight to unit economics despite commercial launch activity .

Financial Results

MetricQ4 2023Q3 2024Q4 2024
Revenue ($USD)$2.300M $3.100M $3.509M*
Diluted EPS - Continuing Ops ($)-281.43*-26.29*-125.80*
Gross Margin (%)70.13%*82.59%*84.13%*
EBITDA ($USD)-$6.684M*-$6.788M*-$7.679M*
EBITDA Margin (%)-290.61%*-218.40%*-218.84%*

Notes: Values retrieved from S&P Global*.

Segment/KPIs

  • Segment and KPI data provided by management (Q4 2024 and FY 2024):
    • License Revenue (Q4 2024): $0.042M; Deferred revenue ~ $0.7M .
    • Mytesi Rx Volume: +3.4% q/q, +9.4% y/y (Q4); +3.9% y/y (FY) .
    • Neonorm non-prescription revenues: minimal in Q4 .
    • FY 2024 OpEx highlights: R&D down ~$2.1M to $16.5M; S&M up ~$1.2M to ~$7.7M; G&A down ~$0.3M to ~$16.3M .
    • FY 2024 Loss from operations improved ~$3.5M to ~$30.8M; Net loss improved ~$2.8M to ~$38.5M .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
RevenueFY/Q4 2024Not providedNot providedMaintained: no formal guidance
MarginsFY/Q4 2024Not providedNot providedMaintained: no formal guidance
OpExFY/Q4 2024Not providedOpEx mix commentary (R&D↓, S&M↑, G&A↓)Update: directional only
Regulatory milestonesQ2 2025N/AFDA Type C meeting (breast cancer subgroup); IIT POC results expectedNew milestones disclosed

Management did not issue numeric revenue/EPS/margin guidance; focused instead on regulatory and clinical catalysts .

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 2024)Previous Mentions (Q3 2024)Current Period (Q4 2024)Trend
Cancer therapy-related diarrhea (CTD)OnTarget subgroup signals (breast/lung) and responder analyses; strategy to brief FDA Poster acceptance (San Antonio); continued analysis; no reverse split planned FDA Type C meeting granted for breast cancer subgroup; intent to pursue label expansion Regulatory momentum improving
Rare diseases (SBS-IF, MVID)Phase II initiation, IIT import permit; orphan designations in US/EU Multi-site IIT/Phase II planning; EU/MENA emphasis; early access pathways discussed First IIT POC results expected in Q2 2025; PRIME/Breakthrough pathway discussed Advancing toward data and potential expedited pathways
Gelclair launchAnnounced Oct 2024 US commercial launch plan; H&N focus Early commercialization comments; positioning in oncology centers Ongoing commercialization; deliberate focus in BMT and H&N radiation programs Execution-focused expansion
Financing/BDNot a focusNo reverse split; exploring institutional investor interest and partnering Bridge financing by insiders/board/C-suite; pursuing non-dilutive licensing Strengthened insider alignment; BD optionality
Regulatory/EMA PRIMEEarly framing of expedited pathways Continued planning with regulators PRIME and FDA Breakthrough pathways explicitly highlighted as potential accelerants Increasing emphasis

Management Commentary

  • “The total net Q4 2024 revenue of approximately $3.5 million increased approximately 53% versus net Q4 2023 revenue of $2.3 million and 13% versus the net Q3 2024 revenue of $3.1 million.”
  • “The FDA has granted us a Type C face-to-face meeting in the second quarter of 2025 to review the OnTarget results in breast cancer patients... to expand the approved indication of Mytesi to include the prophylaxis of cancer therapy-related diarrhea in adult breast cancer patients.”
  • “The first proof-of-concept IIT results are expected to be available in Q2 2025... additional proof-of-concept IIT results expected throughout the year.”
  • “Bridge financing... included participation from board members and C-suite; this is our opportunity for a catalyst-driven different outcome.”
  • “Gelclair launch... focused and deliberate into bone marrow transplant centers and head-and-neck radiation treatment programs.”

Q&A Highlights

  • No formal analyst Q&A in Q4; management reiterated catalyst timeline (Q2 2025 FDA Type C; IIT POC data) and commercialization focus for Gelclair .
  • From prior quarter (context for narrative continuity): No reverse split planned amid upcoming catalysts; active outreach to institutional investors and potential partners .
  • Clarification on OnTarget Stage 2 analysis timing (subset evaluation in next 3–6 months, broader completion mid-to-late next year) .

Estimates Context

MetricQ4 2024 ConsensusQ4 2024 ActualSurprise
Revenue ($USD)$3.130M*$3.509M*+$0.379M (beat)
Primary EPS ($)-$18.50*-$125.80*-$107.30 (miss)
# of Estimates (Rev / EPS)1 / 1*—Low coverage

Notes: Values retrieved from S&P Global*.

Implications: Revenue outperformance vs a single estimate was offset by a significantly larger loss per share; with very low analyst coverage, forthcoming regulatory/clinical catalysts could drive estimate revisions.

Key Takeaways for Investors

  • Revenue momentum into Q4 (+13% q/q, +53% y/y) demonstrates early traction from commercial initiatives and license fees; however earnings remain highly negative, underscoring dependence on pipeline/regulatory catalysts for valuation re-rating .
  • Near-term binary-ish catalysts: FDA Type C meeting on breast cancer CTD subgroup and first IIT POC data (SBS-IF/MVID) in Q2 2025; positive outcomes could support label expansion for Mytesi and expedited rare disease pathways (PRIME/Breakthrough) .
  • Gelclair commercialization provides incremental revenue optionality in oncology supportive care (H&N, BMT centers), potentially improving operating leverage as coverage and adoption scale .
  • Insider-backed bridge financing signal strengthens alignment and runway into Q2 catalysts; management is pursuing licensing/non-dilutive funding opportunities that could de-risk capital needs .
  • Estimate volatility likely given single-analyst coverage; traders should watch for MASCC abstract outcomes, FDA meeting read-throughs, and IIT data releases as catalysts for estimate and narrative shifts .
  • For medium-term thesis: Success in CTD (breast) and rare diseases could create a multi-asset supportive care franchise leveraging crofelemer’s mechanism across distinct formulations and indications; execution on reimbursement and partner strategy will be critical .
  • Risk factors: Ongoing operating losses, limited Q4 product-level segmentation, and clinical/regulatory uncertainty; failure to secure favorable FDA/EMA pathways or to demonstrate IIT efficacy would pressure the equity story .