VERU INC. (VERU)·Q1 2025 Earnings Summary

Executive Summary

• Q1 FY2025 marked a strategic pivot to a pure biopharma model post-FC2 divestiture, with no continuing revenue line presented and operating loss from continuing operations of $10.2M, but net loss per share improved to $0.06 vs $0.08 prior year on a debt extinguishment gain tied to the sale .
• Enobosarm + semaglutide achieved the prespecified primary endpoint: 71% relative reduction in lean mass loss (p=0.002) and strong functional outcomes (54.4% fewer patients with ≥10% stair climb power decline), establishing proof-of-concept for selective fat loss with muscle preservation in older overweight/obese patients on GLP-1 RAs .
• The Independent Data Monitoring Committee recommended continuing the blinded extension study; topline extension results (fat regain prevention post GLP‑1 discontinuation) are expected in calendar Q2 2025, a near-term clinical catalyst .
• Management unveiled a new cardiometabolic program: exploring sabizabulin as a broad anti-inflammatory therapy for CAD, citing favorable drug-drug interaction profile vs colchicine and an existing safety database (266 dosed patients) .
• Liquidity stood at $26.6M cash at quarter end; CFO guided cash runway through year-end 2025 but flagged need for additional capital to fund development—an important financing overhang for equity holders .

What Went Well and What Went Wrong

What Went Well

• Enobosarm met the primary endpoint with a 71% relative reduction in lean mass loss and showed dose-dependent fat loss; 3 mg dose preserved >99% of lean mass loss vs placebo (p<0.001), reinforcing dose selection and mechanistic thesis .
• Functional benefit: 54.4% fewer patients with ≥10% stair climb power decline (p=0.0049), supporting clinical meaningfulness beyond body composition .
• Management tone: “proof of concept” to retain lean mass, improve function, and shift weight loss composition to fat—“should translate to a greater quality weight reduction” over longer treatment .

What Went Wrong

• Operating loss from continuing operations widened to $10.2M vs $7.4M YoY, driven by higher R&D as the company invests in clinical development .
• No continuing revenue line presented post-FC2 sale; discontinued operations booked a $7.1M loss (including ~$4.2M loss on sale), highlighting transitional P&L noise from strategic repositioning .
• Financing risk: CFO stated the company is not profitable with negative operating cash flow and will need additional capital to support pipeline execution; cash suffices through year-end but not for the next 15 months under the operating plan .

Financial Results

P&L and Operating Metrics (trend across recent quarters)

Notes:

• Q3 FY2024 included FC2 commercial revenues; Q1–Q2 FY2025 reflect pure biopharma continuing operations with FC2 in discontinued ops .

Balance Sheet Liquidity

YoY Comparison (Q1 FY2025 vs Q1 FY2024)

KPIs (Clinical)

Guidance Changes

No revenue/EPS/margins guidance was provided in company materials .

Earnings Call Themes & Trends

Management Commentary

• “The efficacy data provides the proof of concept that you can retain lean mass, improve physical function and lose enough fat mass to make up for the lean mass retained to have the same weight loss as semaglutide alone at 16 weeks.” — Mitchell Steiner, CEO .
• “Our expectation is that when patients are treated longer with enobosarm + semaglutide, this tissue SELECTIVE and greater loss of adiposity (fat) should translate to a greater quality weight reduction than with semaglutide alone.” — Mitchell Steiner, CEO .
• CFO: “The company is not profitable and has negative cash flow from operations…we currently have sufficient capital to take the company to the end of the calendar year” — Michele Greco .
• On sabizabulin CAD: “Sabizabulin…has stable pharmacokinetics and low potential for drug-drug interactions; thus…potentially more safely [used] as a secondary therapy in combination with statin therapy.” — Company statement .

Q&A Highlights

• Dropout rate ~13%; most common reason was GLP‑1-related GI side effects; safety data remains blinded until extension completes .
• Extension topline timing reaffirmed in calendar Q2 2025; operationally tied to 12-week maintenance period and data cleaning .
• Fixed-dose oral combo potential: enobosarm’s oral profile could combine with oral GLP‑1s; management views combination as a “new generation obesity product” .
• Safety disclosure: When the study is unblinded and extension is reported, management intends to include the full safety dataset from both parts .
• Cash runway and funding emphasis reiterated; capital raise likely needed beyond year-end .

Estimates Context

• Wall Street consensus (S&P Global) for Q1 FY2025 EPS and revenue was unavailable at the time of this analysis due to data access limits; comparisons to consensus could not be performed. Default source for estimates is S&P Global; values were unavailable.

Key Takeaways for Investors

• Clinical proof-of-concept achieved: Enobosarm meaningfully shifts weight loss composition to fat while preserving muscle, with functional benefits—this differentiates vs GLP‑1 monotherapy and supports Phase 3 advancement .
• Near-term catalyst: Extension topline in calendar Q2 2025 focused on preventing fat regain after GLP‑1 discontinuation; positive data would strengthen the label strategy and combo value proposition .
• Financing overhang: Despite $26.6M cash, negative operating cash flow and stated need for capital suggest potential equity issuance or partnering; trading strategies should account for dilution risk and timing vs data readouts .
• Strategic broadened focus: Sabizabulin CAD program introduces optionality in cardiometabolic inflammation; pre-IND feedback was constructive, but timelines (tox, IND by H1 2026) make this a medium-term driver .
• Operational pivot completed: FC2 sale removed royalty liabilities and simplified the model; however, the absence of continuing revenue places more pressure on clinical and financing milestones to drive the stock .
• Dose selection insight: 3 mg enobosarm demonstrated the strongest lean mass preservation with favorable composition outcomes, guiding Phase 3 design choices .
• Regulatory dialogue: Prior FDA feedback on functional endpoints (stair climb) aligns with program design; end-of-Phase 2 meeting will be pivotal for Phase 3 protocol agreement .

Additional Relevant Press Releases for Q1 FY2025

• Positive topline Phase 2b QUALITY results (Jan 27, 2025) .
• FC2 business sale completed (Dec 31, 2024), proceeds and liability extinguishment disclosed .

Prior Quarters Searched

• Q3 FY2024 press release and transcript found (financials and study timelines) .
• Q4 FY2024 earnings materials not found in the document catalog; analysis relies on Q3 FY2024 and Q1–Q2 FY2025 disclosures [Search attempted, no result].