Y-mAbs Therapeutics, Inc. (YMAB)·Q3 2024 Earnings Summary

Executive Summary

• Total net revenues were $18.5M, down 10% year over year versus $20.5M (Q3’23 included $0.5M license revenue); diluted EPS was ($0.16). U.S. DANYELZA revenue declined 5% to $15.3M, ex-U.S. declined 19% to $3.1M .
• Management reiterated FY2024 guidance: total net revenues $87–$95M, operating expenses $115–$120M, total annual cash investment $15–$20M, cash runway into 2027; CFO indicated results would likely land in the lower half of the revenue range .
• Strategic catalysts: exclusive license/distribution agreement in Japan (up to $31M milestones; $2M upfront to be recognized in Q4), named patient program launch in Turkey, and DANYELZA U.S. patent extension to Feb 2034 .
• SADA PRIT pipeline: Part A of GD2-SADA Phase 1 to complete by year-end; management expects a Part A data presentation in Q1 2025; no dose-limiting toxicities observed to date across cohorts 1–6; initial human PK/targeting consistent with preclinical models .

What Went Well and What Went Wrong

What Went Well

• Japan expansion: signed exclusive license with Nobelpharma; $2M upfront in Q4 and up to $31M milestones plus profit share upon approval. “Japan represents an important Asia region for DANYELZA” .
• DANYELZA adoption: 68 U.S. centers since launch, three new accounts in Q3; 65% of U.S. vials sold outside MSK (vs. 67% in Q2), indicating broader institutional uptake .
• SADA PRIT progress: “no dose-limiting toxicities… no treatment-related serious adverse events” and human imaging suggests GD2-SADA can “find and bind to tumors” .

What Went Wrong

• Revenue softness: Total net revenues fell 10% YoY to $18.5M, driven by declines in U.S. and ex-U.S. product revenue and lack of license revenue versus Q3’23 .
• U.S. price/mix and Medicaid adjustments: ~$1.5M charge for Medicaid-related claims contributed to a 5% U.S. revenue decline despite 5% vial growth; shipments slipping into Q4 further pressured reported results .
• Higher SG&A: SG&A rose to $13.6M in Q3 (vs. $10.2M Q3’23), reflecting CFO separation/consulting, personnel costs, and professional fees; legal settlements drove higher YTD SG&A .

Financial Results

Revenue and EPS vs Prior Periods

DANYELZA Net Product Revenue by Geography

Cost Structure and Gross Margin Indicators

Notes: Q2 and Q3 gross margins computed using net product revenues and COGS from company statements; Q1 explicit GM disclosed at ~89% .

Operating Expenses and Net Loss

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “Physician usage of DANYELZA in the U.S. continues to remain very strong… we continue to drive ex-U.S. market expansion… [and] expect to complete Part A of our GD2-SADA Phase 1 trial this year and present that data in the first quarter of next year.” — Michael Rossi, CEO .
• “We took an approximate $1.5 million charge in Q3 for Medicaid-related claims… with the adjustment, sales would have been up 4% year-over-year and quarter-over-quarter.” — Sue Smith, CCO .
• “To date, no patients in the [GD2-SADA] trial have experienced any dose-limiting toxicities… we believe we have demonstrated proof of concept in humans that GD2-SADA can both find and bind to tumors.” — Michael Rossi, CEO .
• “We feel very confident that we should land within the range of $87 million to $95 million… most probably in the lower half of that range.” — Peter Pfreundschuh, CFO .

Q&A Highlights

• Medicaid/price-mix impact: ~$1.5M Medicaid claims adjustment depressed U.S. net revenue despite underlying vial growth; some shipments slipped to Q4 .
• Q4 revenue swing factors and guidance confidence: Q4 expected to be strong; adjustments (SciClone order timing, Medicaid, Nobel upfront) suggest Q3 would have been near consensus with timing normalized; FY to land lower half of guide .
• Manufacturing strategy: Maintain CMO model for proteins and contract directly with isotope manufacturers, prioritizing investment into drug development over brick-and-mortar .
• Japan rollout and TAM: small confirmatory trial (~6 patients) before launch; potential launch timing 2H’25–early ’26; TAM incremental but smaller vs U.S. .
• SADA dosing rationale: Optimized protein dose near 1 mg/kg based on PK and preclinical modeling; dosimetry and safety guide interval/timing selection for Part B .

Estimates Context

• Wall Street consensus (S&P Global) for Q3 2024 EPS and revenue was unavailable due to S&P Global request limits at the time of query. Values would normally be sourced from S&P Global; unavailable in this instance.
• Management indicated adjusted Q3 results (normalizing for timing and Medicaid) would have been “just about where the consensus numbers were,” but did not disclose specific figures .

Key Takeaways for Investors

• Core commercial trajectory remains intact: U.S. adoption continues (68 centers; broader ex-MSK utilization), with temporary price/mix and timing issues masking underlying demand strength .
• FY guide reiterated, but plan for lower half: near-term setup implies Q4 recovery aided by timing normalization (SciClone, Nobel upfront), yet FY revenue likely at the lower half of $87–$95M .
• Strategic expansion catalysts: patent protection extended to 2034 and Japan/Turkey/Hong Kong broadening ex-U.S. optionality; Latin America and China partners ramping .
• SADA PRIT derisking: clean safety profile and human imaging support targeting; a Q1’25 Part A data set is a potential stock catalyst; watch dosimetry/tissue exposure details and Part B initiation .
• Cost normalization watch: SG&A inflation from settlements and personnel should abate; R&D down YoY on milestone timing; cash runway into 2027 provides flexibility .
• Trading implications: Near-term stock moves likely tied to Q4 print (timing normalization) and visibility on Q1’25 GD2-SADA data; Japan licensing milestones and IP extension support sentiment .
• Medium-term thesis: DANYELZA’s durable niche, ex-U.S. expansion, and SADA PRIT platform progression (including CD38 in NHL) underpin optionality; execution in SADA dose/interval and efficacy signals will be pivotal .