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Rani Therapeutics Holdings, Inc. (RANI)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 delivered the company’s first contract revenue ($1.03M) tied to evaluation services, with disciplined OpEx but a non-cash $3.7M impairment driving a larger GAAP net loss; cash and securities were $27.6M with runway into Q3’25 .
  • Versus S&P Global consensus, RANI beat on EPS (Primary EPS actual −$0.1602 vs −$0.2175 est*) and EBITDA (−$10.98M vs −$12.56M est*), and posted positive revenue vs a zero estimate*; upside primarily reflects the contract revenue in the quarter and continued cost containment .
  • Pipeline momentum intensified: preclinical bioequivalence for RT-114 (GLP‑1/GLP‑2) at 111% relative bioavailability and successful oral semaglutide (RT‑116) at 107% relative bioavailability, with RT‑114 Phase 1 targeted for mid‑2025 .
  • Management emphasized capital discipline (focus on RT‑114; Phase 1 fits current budget) and flexibility to partner; cash runway maintained into Q3’25, a key near-term de‑risking element vs financing risk .

What Went Well and What Went Wrong

  • What Went Well

    • First contract revenue ($1.03M) established an external validation path via evaluation services .
    • Strong preclinical data: RT‑114 bioequivalence to SC PG‑102 (111% relative bioavailability) and oral semaglutide (RT‑116) with 107% relative bioavailability; both showed comparable PK/PD to injections .
    • Clearer clinical path: RT‑114 Phase 1 targeted for mid‑2025; CEO: “we intend to initiate a Phase 1 study of RT‑114 later this year” (mid‑2025) .

  • What Went Wrong

    • Net loss widened YoY on a non‑cash $3.7M impairment of construction‑in‑progress, lifting Q4 total OpEx to $16.0M (vs $13.4M LY) .
    • Ongoing financing risk: runway into Q3’25 implies a funding event will be needed absent new revenue/partners .
    • Tolerability and peak exposure will require attention in human studies; management flagged higher peaks with RaniPill‑delivered agents and plans dose/titration strategies to mitigate GI AEs .

Financial Results

P&L snapshot (YoY and sequential)

MetricQ4 2023Q3 2024Q4 2024
Contract Revenue ($USD Millions)$0.00 —$1.03
R&D Expense ($USD Millions)$7.61 $6.17 $6.81
G&A Expense ($USD Millions)$5.83 $5.63 $5.46
Impairment ($USD Millions)$0.00 $0.00 $3.71
Total Operating Expenses ($USD Millions)$13.44 $11.80 $15.99
Net Loss ($USD Millions)$14.06 $12.72 $15.72
GAAP EPS (Class A, basic/diluted)$(0.27) $(0.24) $(0.27)

Liquidity and runway

MetricQ2 2024Q3 2024Q4 2024
Cash, Cash Equivalents & Marketable Securities ($USD Millions, EoP)$30.9 $30.4 $27.6
Management Runway Comment—“runway into Q3’25” “sufficient to fund into Q3’25”

Estimate vs. actual (S&P Global; Primary EPS, Revenue, EBITDA)

MetricQ2 2024Q3 2024Q4 2024
Primary EPS Consensus Mean (est*)−0.2771−0.2419−0.2175
Primary EPS Actual (S&P basis*)−0.26−0.24−0.1602
Revenue Consensus Mean ($, est*)000
Revenue Actual ($, S&P basis*)——1,028,000
EBITDA Consensus Mean ($, est*)−16,158,800−15,361,680−12,558,000
EBITDA Actual ($, S&P basis*)−12,269,000−11,540,000−10,978,000

Values retrieved from S&P Global.

KPIs (biotech operating drivers)

  • Cost discipline: Full-year R&D $26.7M (vs $39.6M LY) and G&A $23.9M (vs $26.5M LY), reflecting workforce reductions and lower third‑party/insurance costs .
  • One-time item: Q4 impairment $3.7M on construction‑in‑progress equipment .
  • Capital raised in 2024: two offerings totaling ~$20M gross to extend runway into Q3’25 .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
RT‑114 Phase 1 start2025“Expected to initiate in 2025” (Q3’24) “Expected to initiate in mid‑2025” (Q4’24) Tightened (timing specified)
Cash runwayThrough Q3 2025“Runway into Q3’25” (Q3’24) “Sufficient to fund operations into Q3’25” (Q4’24) Maintained

No revenue/margin/OpEx numerical guidance was provided .

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2, Q3 2024)Current Period (Q4 2024)Trend
Obesity pipeline (RT‑114 GLP‑1/GLP‑2; RT‑116 semaglutide)Q2: ProGen partnership; Phase 1 in 2025 . Q3: Triagonist PK data; Phase 1 still 2025 .RT‑114 bioequivalence (111% rel BA); RT‑116 semaglutide 107% rel BA; Phase 1 mid‑2025 .Strengthening momentum
Capital/runwayQ2 cash $30.9M . Q3 runway into Q3’25 .CFO: runway into Q3’25; CEO prioritizes RT‑114 given capital constraints .Maintained discipline
Manufacturing/COGSLimited prior disclosure.Aim for COGS competitive with injectables; automation/scale investments noted .Emerging focus
Business developmentQ2: ProGen deal announced .Active interest; research collaboration with large pharma (undisclosed) .Increasing engagement
R&D cost executionQ2–Q3: lower R&D/G&A vs LY on cost actions .Full-year R&D and G&A down materially YoY .Improving efficiency
Clinical planningHigh-level in prior quarters.RT‑114 Phase 1 design (SAD/MAD; obese non‑diabetics; weight loss/tolerability endpoints) .Progressing to clinic

Management Commentary

  • CEO strategic message: “We entered 2025 with strong momentum, delivering compelling preclinical data… [RT‑114] delivered… comparable to… subcutaneous… [and] semaglutide delivered via the RaniPill® capsule exhibits similar bioavailability, pharmacokinetics, and weight loss as subcutaneous administration.” .
  • CEO on prioritization/capital: “Our primary focus is on RT‑114 for this year because of the capital constraints that you alluded to.” .
  • CFO on runway: “We expect the cash, cash equivalents and marketable securities to be sufficient to fund our operations into the third quarter of 2025 without additional funding.” .
  • CEO on dose/tolerability control: “The beauty of an oral formulation is you can always take another pill… split it into 2 doses and bring the peak down, bring the trough up and potentially improve tolerability.” .

Q&A Highlights

  • Capital and trial funding: Management confirmed RT‑114 Phase 1 is included in the current budget; focus remains on RT‑114 given capital constraints; RT‑116 is not advancing to clinic now .
  • Tolerability and PK peaks: Higher Cmax observed preclinically will be managed via titration or dose‑splitting to mitigate nausea/vomiting if needed .
  • Variability and route of delivery: Transenteric route showed less variability than SC dosing in preclinical work, potentially advantaging clinical outcomes; confirmation awaits human data .
  • Clinical design: Phase 1 SAD/MAD, ~2‑month MAD in obese, non‑diabetic subjects; endpoints include tolerability and weight loss, with a Phase 2a 12‑week study contemplated next .
  • BD interest: Active partnering discussions across obesity, immunology, and rare disease; ongoing research collaboration with a large pharma (undisclosed) .

Estimates Context

  • Q4 2024 vs S&P Global consensus: Primary EPS beat (−$0.1602 actual vs −$0.2175 est*), EBITDA beat (−$10.98M actual vs −$12.56M est*), and revenue upside ($1.03M actual vs $0 est*) .
  • Trend across 2H’24: Primary EPS and EBITDA tracked improving vs consensus through Q3 and Q4 (beats*), aided by cost control; Q4 revenue outperformed zero consensus* due to evaluation services revenue .
  • Potential estimate revisions: Street models may raise near‑term “other/contract” revenue and modestly improve OpEx cadence/EBITDA loss trajectory, while leaving 2025 R&D higher as RT‑114 enters clinic (no formal guidance provided) .

Values retrieved from S&P Global.

Key Takeaways for Investors

  • Near‑term catalyst: RT‑114 Phase 1 initiation in mid‑2025 is the key stock driver; preclinical bioequivalence and semaglutide data strengthen the setup into first‑in‑human .
  • Financial de‑risking: Runway into Q3’25 reduces near‑term financing overhang, though additional capital will be required within the next 12 months absent new BD inflows .
  • Execution on cost: YoY R&D and G&A declines reflect sustained discipline; watch OpEx inflection as human studies commence (Q4 impairment was non‑recurring) .
  • Evidence of platform versatility: Oral delivery parity vs injections (RT‑114, RT‑116) supports optionality across obesity assets and partnering potential .
  • Tolerability strategy: Dose‑splitting/titration flexibility with an oral format could mitigate GI AEs, a key differentiator vs some injectable or small‑molecule orals .
  • Trading lens: Positive estimate beats and first‑time revenue should be supportive near term; shares likely to trade on RT‑114 timelines, BD updates, and financing visibility .