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ADC Therapeutics SA (ADCT)·Q2 2025 Earnings Summary
Executive Summary
- Q2 2025 total revenue was $18.84M, up 8.2% year over year; net product revenue was $18.09M, while adjusted net loss was $28.68M; GAAP EPS was $(0.50) versus $(0.38) in Q2 2024 as restructuring and higher R&D lifted operating costs .
- Against Wall Street consensus, ADCT posted a revenue beat and an EPS miss: Revenue $18.84M vs $17.86M consensus; EPS $(0.50) vs $(0.48) consensus; the top-line beat was driven by price and volume variability, while bottom line was pressured by $13.1M restructuring and impairments and higher LOTIS-5/7 and PSMA IND activities (*Values retrieved from S&P Global).
- Clinical momentum continued: LOTIS-7 (ZYNLONTA + glofitamab) showed ORR 93.3% and CR 86.7% across 30 efficacy-evaluable patients with manageable safety; enrollment expansion to 100 patients at 150 µg/kg is underway; FDA engagement and a second-half update are planned .
- LOTIS-5 remains on track to reach prespecified PFS events by year-end 2025 with top-line data to follow; sBLA submission anticipated in H1 2026; compendia inclusion targeted in H1 2027 .
- Liquidity strengthened via a $100M PIPE (net $93.1M), extending expected cash runway into 2028—a key stock catalyst alongside LOTIS-5 top-line and LOTIS-7 updates in H2 2025 .
What Went Well and What Went Wrong
What Went Well
- LOTIS-7 efficacy and tolerability: ORR 93.3%, CR 86.7%; 25 of 26 CRs remained at cutoff; CRS/ICANS largely Grade 1–2 with lower CRS at 150 µg/kg; supports expansion to 100 patients and potential compendia strategy .
- Solid revenue execution: Net product revenue of $18.09M (+6.2% YoY); total revenue $18.84M (+8.2% YoY), aided by higher sales price and volume variability; CFO reiterated revenue growth opportunity tied to expansion trials .
- Strengthened balance sheet and runway: $93.1M net proceeds from PIPE financing extended cash runway into 2028, enabling pursuit of clinical catalysts and commercialization readiness .
Management quotes:
- “We recently shared impressive efficacy data from our LOTIS-7 study… and have additional key clinical milestones anticipated through 2026.” — CEO Ameet Mallik .
- “Overall we believe we have multiple value driving catalysts within our cash runway which is expected to extend into 2028.” — CFO Jose Carmona .
What Went Wrong
- Elevated operating expenses and GAAP loss: Q2 total operating expenses were $62.99M; GAAP net loss widened to $(56.65)M, driven by $13.1M restructuring/impairment and higher R&D related to LOTIS-5/7 and PSMA IND enabling activities .
- EPS miss vs consensus: GAAP EPS of $(0.50) fell short of $(0.48) consensus as restructuring and R&D outweighed the revenue beat; adjusted net loss rose to $28.68M from $24.37M in Q2 2024 (*Values retrieved from S&P Global).
- Business rationalization: Discontinuation of early preclinical programs and planned UK facility closure (≈30% workforce reduction) reflect strategic refocus but near-term execution risk and severance/impairment costs .
Financial Results
Estimates vs Actuals
Margins (S&P Global)
S&P Global disclaimer: *Values retrieved from S&P Global.
Clinical KPIs (DLBCL, efficacy-focused)
Guidance Changes
Earnings Call Themes & Trends
Management Commentary
- “Taken together, we believe ZYNLONTA has the potential to reach peak revenues of $600,000,000 to $1,000,000,000 in the U.S.” — CEO Ameet Mallik (prepared remarks) .
- “Total first half net product revenue was $35.5M… restructuring and impairment costs in Q2 consisted of $6.7M severance and $6.4M non-cash impairments from UK facility closure.” — CFO Jose Carmona .
- “We believe ZYNLONTA plus glofitamab has the potential to be the preferred bispecific combination in 2L+ DLBCL.” — CEO Ameet Mallik .
Q&A Highlights
- Roche CRL impact on glofitamab in 2L DLBCL: Management cannot comment on CRL specifics; maintains confidence in unmet need and LOTIS-5/7 positioning; LOTIS-5 is large (n=420), 90% powered versus R-GemOx with assumed ~2-month PFS delta; OS maturity at top-line uncertain .
- Durability in LOTIS-7: CRs viewed as strong durability biomarker; future updates to show swimmers plots and median DOR at 6 and 12 months; early data show 25/26 CRs maintained with longest >1 year .
- Regulatory and communication plan: Will engage FDA later this year regarding LOTIS-7 paths (2L or frontline); H2 2025 data update may be company-led or at a congress to optimize follow-up length .
- Indolent lymphomas strategy: MZL IIT target ~50 patients; CR ≥40% would stand out versus ~29% historical; prefer monotherapy given high efficacy and tolerability in indolent settings; bispecific combos not needed currently .
- Commercial footprint: Field coverage at ~90% of DLBCL opportunity; MSLs to respond to physician inquiries on LOTIS-7; no planned commercial collaboration with Roche; pre-launch resource additions expected .
Estimates Context
- Q2 2025: Revenue $18.84M vs $17.86M consensus — significant beat; GAAP EPS $(0.50) vs $(0.48) consensus — modest miss, driven by restructuring charges and elevated R&D tied to LOTIS-5/7 and PSMA IND work (*Values retrieved from S&P Global).
- Q1 2025: Revenue $23.03M vs $17.71M consensus — beat on milestone/license revenues; EPS $(0.36) vs $(0.40) consensus — beat; highlights quarterly variability tied to milestones (*Values retrieved from S&P Global).
- Q4 2024: Revenue $16.91M vs $19.01M consensus — miss; EPS $(0.29) vs $(0.41) consensus — beat, aided by lower opex and other items (*Values retrieved from S&P Global).
Implication: Street likely revises near-term EPS higher on reduced restructuring drag but remains focused on LOTIS-5/7 binary catalysts for revenue trajectory; revenue estimates may inch up on sustained pricing/mix and compendia prospects.
Key Takeaways for Investors
- The quarter delivered a clean top-line beat and clinical validation in LOTIS-7; the modest EPS miss is explainable by one-time restructuring and stepped-up clinical investment — not thesis-breaking (*Values retrieved from S&P Global).
- LOTIS-5 top-line in late 2025 is the key derisking event; trial design (n=420, 90% power vs R-GemOx) targets clinically meaningful PFS delta; a positive read could enable sBLA in H1 2026 and expand addressable market materially .
- LOTIS-7 combination is emerging as best-in-class on ORR/CR with favorable CRS at 150 µg/kg; expansion to 100 patients and FDA interactions in H2 2025 set the stage for compendia inclusion and potential rapid physician adoption post-publication .
- Liquidity extended to 2028 via PIPE removes financing overhang into major catalysts; focus has tightened via restructuring, improving operating leverage prospects post LOTIS-5 .
- Near-term trading: Expect price sensitivity around H2 2025 LOTIS-7 update quality (durability, safety) and any early regulatory feedback; positioning ahead of LOTIS-5 event read may benefit risk-tolerant investors given asymmetric upside .
- Medium-term thesis: Dual-path expansion (R-chemo alternative via LOTIS-5 and bispecific combo via LOTIS-7) addresses both accessible and complex care segments; management’s $600M–$1B peak revenue potential requires successful regulatory and compendia outcomes with durable efficacy and manageable safety .
- Watch items: Clarity on OS data in LOTIS-5, compendia timelines, LOTIS-7 longer follow-up durability, and indolent lymphomas regulatory strategy; field force scaling and payer dynamics will influence ramp pace .