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VI

VERU INC. (VERU)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 delivered continued OPEX discipline and narrower losses: operating loss from continuing operations improved to $8.1M vs $8.9M YoY; net loss from continuing operations improved to $7.9M ($0.05 per share) vs $8.7M ($0.06) YoY .
  • Clinical catalysts intensify: management expects unblinded Phase 2b safety data (QUALITY) and topline extension maintenance results in Q2 calendar 2025; End-of-Phase-2 FDA meeting targeted for Q3 calendar 2025 to define Phase 3 design .
  • Safety topline released post quarter: enobosarm + semaglutide showed positive safety profile with fewer GI AEs at 3mg and no Hy’s law liver injury; 3mg dose selected for Phase 3 advancement .
  • Funding runway: cash and equivalents were $20.0M at March 31; management indicates runway into Q4 calendar 2025 and is actively pursuing non‑dilutive funding/partnerships pending Phase 3 clarity .
  • Stock reaction catalyst: near‑term data readouts (extension maintenance efficacy/safety) and EOP2 FDA meeting are primary drivers of sentiment and potential re‑rating .

What Went Well and What Went Wrong

What Went Well

  • Clear efficacy signal: Phase 2b QUALITY met the primary endpoint with a 71% relative reduction in lean mass loss; 3mg dose achieved >99% mean relative reduction, effectively making weight loss highly fat‑selective .
  • Physical function preserved: clinically meaningful reduction in ≥10% stair climb power decline—62.4% at 3mg and 46.2% at 6mg vs semaglutide alone, supporting functional benefit in older adults .
  • Positive safety topline: no Hy’s law liver injury; fewer GI AEs at 3mg; safety consistent with prior enobosarm experience; Independent Data Monitoring Committee recommended continuing the study .

Management quote: “We are the first company to report on GLP‑1 in combination with a muscle preservation drug… this is a game changer to have a drug that will make a GLP‑1 burn only fat” .

What Went Wrong

  • Cash burn and limited runway: net cash used in operating activities YTD was $19.1M; management acknowledged additional capital will be needed to fund development beyond Q4 calendar 2025 .
  • No revenue base post FC2 sale: continuing operations reflect R&D-stage biopharma with zero product revenue, limiting near-term margin analysis and comp to estimates .
  • Split-adjusted EPS mismatch vs reported: S&P consensus uses split-adjusted EPS (later 1-for-10 split), while company reports unadjusted figures—investors must normalize for comparability .

Financial Results

P&L vs Prior Periods and Estimates

MetricQ2 2024 (oldest)Q1 2025Q2 2025 (newest)
Revenue ($USD Millions)$0.0*$3.0*$0.0*
Net Loss per Share (Reported)$(0.07) $(0.06) $(0.05)
Primary EPS Consensus Mean (S&P, split‑adjusted)$(0.60)*$(0.75)*$(0.60)*
Operating Loss from Continuing Ops ($USD Millions)$(8.9) $(10.2) $(8.1)
R&D Expense ($USD Millions)$3.0 $5.7 $3.9
SG&A Expense ($USD Millions)$5.9 $5.2 $5.2

Values marked with * retrieved from S&P Global.

Notes:

  • S&P consensus EPS is split‑adjusted following the 1‑for‑10 reverse split effective Aug 2025; company-reported EPS in Q2 2025 is unadjusted. Investors should adjust reported EPS by ×10 to compare with consensus .
  • Revenue consensus for Q2 2025 is $0.0 reflecting no commercial product revenue post FC2 divestiture .

Balance Sheet and Cash

MetricSep 30, 2024 (oldest)Dec 31, 2024Mar 31, 2025 (newest)
Cash, Cash Equivalents & Restricted Cash ($USD Millions)$24.9 $26.6 $20.0
Total Assets ($USD Millions)$60.4 $39.8 $32.7
Total Stockholders’ Equity ($USD Millions)$32.3 $26.6 $21.0

KPIs (Clinical – QUALITY Phase 2b)

KPIResultSource
Primary endpoint: relative reduction in lean mass loss vs semaglutide alone71% (all enobosarm + semaglutide)
Lean mass preservation at 3mg>99% mean relative reduction (p<0.001)
Fat mass reduction at 6mg46% greater relative loss (p=0.014)
Composition of weight loss (3mg)99.1% fat, 0.9% lean
Stair Climb ≥10% decline (placebo + semaglutide)42.6% of patients
Reduction in ≥10% decline (3mg)62.4% relative reduction (p=0.0066)

Segment breakdown: Not applicable post FC2 sale (biopharma R&D-stage) .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Phase 2b QUALITY safety (unblinded)Q2 CY25Safety blinded; DMC review ongoing Unblinded topline safety shows positive profile; fewer GI AEs at 3mg; no Hy’s law injury Raised clarity (positive)
Phase 2b extension maintenance toplineQ2 CY25Expected Q2 CY25 Expected Q2 CY25 (efficacy + safety together) Maintained timing
End-of-Phase-2 FDA meetingQ3 CY25Plan to request EOP2 Request submitted; meeting anticipated Q3 CY25 Firmed timeline
Phase 3 dose selectionN/ADose‑finding ongoing 3mg selected for Phase 3 advancement Clarified
Modified‑release enobosarm Phase 1H1 CY25Anticipated H1 CY25 On track H1 CY25; intended for Phase 3/commercialization Maintained

No financial guidance provided (revenue/margins/OpEx/Tax). Company focuses guidance on clinical/regulatory milestones .

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2024)Previous Mentions (Q1 2025)Current Period (Q2 2025)Trend
GLP‑1 + enobosarm strategyFramed unmet need; Phase 2b enrollment complete; efficacy endpoints defined Topline efficacy positive; DMC supportive Reinforced efficacy + function; extension maintenance study imminent Strengthening
SafetyPrior database shows mild, reversible ALT; no DILI Aggregate blinded data showed no concerns; DMC recommended continuation Positive topline safety; fewer GI AEs; no Hy’s law Improving clarity
Regulatory pathAnticipated Phase 3; FDA recognizes function endpoints (stair climb) Plan to request EOP2; propose Phase 3 design EOP2 meeting anticipated Q3; Phase 3 endpoint stair climb at 24 weeks; stratify by semaglutide/tirzepatide Advancing
Funding/runwayCash $29.2M (prior); pursuit of partnerships FC2 sale proceeds; runway into near‑term catalysts Runway into Q4 CY25; pursuing non‑dilutive partnerships Neutral, focus on BD
Tariffs/supplyNot discussedNot discussedNo significant tariff concerns; low COGS Stable
Modified‑release formulationNot discussedDeveloping MR formulation; Phase 1 planned On track for Phase 1; intended for Phase 3/commercialization Progressing

Management Commentary

  • Strategic focus: “Enobosarm represents a novel drug that… makes weight reduction more tissue selective for greater fat loss while preserving lean mass or muscle” .
  • Funding approach: “The approach should be to go for non‑dilutive funding… we are in active discussions with large pharmaceutical companies” .
  • Phase 3 design: “Primary endpoint will be the effect of enobosarm on physical function measured by the Stair Climb Test at 24 weeks… stratify semaglutide and tirzepatide” .
  • Safety posture: “We… have not seen [signals] consistent with drug‑induced liver injury by Hy’s law” .
  • Market vision: “The future of weight loss… will be an oral space… small molecules you can pair together as a fixed combination” .

Q&A Highlights

  • Funding and runway: Runway into Q4 CY25; clarity on Phase 3 after EOP2 will inform financing; preference for non‑dilutive partnerships with pharma .
  • Extension maintenance success: Aim to blunt fat regain post GLP‑1 discontinuation; potential for additional fat loss on enobosarm monotherapy; safety data first, extension data shortly thereafter .
  • Phase 3 size/dose: Approx. 200 patients per arm (~400 total); single dose likely 3mg (pending full data); stratify semaglutide/tirzepatide cohorts .
  • Safety expectations: Prior enobosarm studies show mild ALT elevations that normalize; no Hy’s law; GLP‑1s also show adaptive ALT changes .
  • Regulatory endpoints: Emphasis on clinically meaningful function; metabolic endpoints (HbA1c, LDL) discussed as complementary; body composition pathway acknowledged by FDA .

Estimates Context

  • EPS: Q2 2025 S&P consensus Primary EPS Mean was −$0.60* vs actual reported −$0.05; consensus appears split‑adjusted (post 1‑for‑10 reverse split) while company report is unadjusted—normalized comparison suggests an in‑line quarter (−$0.60 vs −$0.603*) .
  • Revenue: Consensus was $0.0* in Q2 2025 reflecting no commercial revenue; consistent with company’s post‑FC2 profile .
  • Where estimates may adjust: Positive safety topline and Phase 3 dose selection (3mg) could support medium‑term trajectory assumptions; near‑term estimate revisions will be driven by OPEX cadence and financing signals rather than top‑line revenue.

Values retrieved from S&P Global.

S&P Global Consensus Snapshot

MetricQ2 2024 (oldest)Q1 2025Q2 2025 (newest)
Primary EPS Consensus Mean*$(0.60)$(0.75)$(0.60)
Revenue Consensus Mean* ($USD Millions)$2.5$3.0$0.0
Primary EPS – # of Estimates*244
Revenue – # of Estimates*244

Values retrieved from S&P Global.

Key Takeaways for Investors

  • Catalysts stacked near term: extension maintenance topline (efficacy + safety) and EOP2 FDA meeting in Q3 could crystallize Phase 3 scope/timelines and partnership prospects .
  • Efficacy de‑risked: strong tissue-selective fat loss with preserved lean mass/function at 3mg supports a focused Phase 3 path in older adults with GLP‑1 co‑therapy .
  • Safety constructive: positive topline with fewer GI AEs at 3mg and no Hy’s law injury reduces risk of safety‑driven delays .
  • Funding watch: runway into Q4 CY25 but Phase 3 will require capital; non‑dilutive BD could be a key upside catalyst; absent BD, equity financing risk rises post EOP2 .
  • Normalization of EPS: use split‑adjusted figures for comparability with consensus due to Aug 2025 reverse split; reported −$0.05 implies ~−$0.50 split‑adjusted .
  • Competitive positioning: oral small‑molecule adjunct to GLP‑1s with demonstrated functional benefit distinguishes enobosarm vs parenteral myostatin strategies; phase 3 stratification by semaglutide/tirzepatide aligns with market leaders .
  • Trading implications: near‑term sentiment hinges on extension maintenance efficacy (fat regain suppression) and FDA feedback; partnership headlines could drive outsized moves given funding overhang .