Y-mAbs Therapeutics Inc (YMAB) Q2 2024 Earnings Call Highlights: Revenue Growth Driven by ...
Total DANYELZA Net Product Revenue (Q2 2024): $22.8 million, a 10% increase from Q2 2023.
US DANYELZA Net Product Revenue (Q2 2024): $15.2 million, a 4% decrease from Q2 2023.
Ex-US DANYELZA Net Product Revenue (Q2 2024): $7.6 million, a 55% increase from Q2 2023.
Total DANYELZA Net Product Revenue (First 6 months of 2024): $42.2 million, a 3% increase from the same period in 2023.
Research and Development Expenses (Q2 2024): $12.3 million, relatively flat compared to Q2 2023.
Selling, General and Administrative Expenses (Q2 2024): $17.2 million, an increase of $5.9 million from Q2 2023.
Net Loss (Q2 2024): $9.2 million or $0.21 per share, compared to a net loss of $6.3 million or $0.14 per share in Q2 2023.
Cash and Cash Equivalents (End of Q2 2024): $77.8 million, a decrease from $78.6 million at year-end 2023.
Revised Full Year 2024 Revenue Guidance: $87 million to $95 million, down from previous guidance of $95 million to $100 million.
Expected Operating Expenses (Full Year 2024): $115 million to $120 million, consistent with prior guidance.
Expected Cash Burn (Full Year 2024): $15 million to $20 million, consistent with prior guidance.
Release Date: August 12, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
DANYELZA achieved a 10% increase in net product revenue in Q2 2024 compared to Q2 2023, driven by international orders.
The company received approval for DANYELZA in Hong Kong, expanding its market presence in Eastern Asia.
Y-mAbs Therapeutics Inc (NASDAQ:YMAB) is progressing well with its SADA-PRIT technology platform, with no dose-limiting toxicities reported in the GD2-SADA Phase I trial.
The company has a strong balance sheet with cash and cash equivalents of $77.8 million as of Q2 2024.
Y-mAbs Therapeutics Inc (NASDAQ:YMAB) is actively expanding its global reach, with new distribution agreements in Turkey and plans to submit a BLA for DANYELZA in Argentina.
Negative Points
US DANYELZA net product revenues decreased by 4% in Q2 2024 compared to Q2 2023 due to competition from new therapies.
The company revised its full-year 2024 revenue guidance downwards to $87 million to $95 million from the previous $95 million to $100 million.
Y-mAbs Therapeutics Inc (NASDAQ:YMAB) reported a net loss of $9.2 million for Q2 2024, an increase from the $6.3 million loss in Q2 2023.
Increased selling, general, and administrative expenses due to legal settlements impacted financial performance.
The company faces increased competition in the US market, affecting DANYELZA's market share and growth potential.
Q & A Highlights
Q: Can you provide details on the patient enrollment for the randomized portion of the BCC study? A: Vignesh Rajah, Senior Vice President, Chief Medical Officer, mentioned that the ongoing single-arm study has enrolled 10 patients so far. The transition to a randomized study is still being evaluated, and specific patient numbers will be shared later this year.
Q: Regarding the SADA study, is it too early to consider tumor-specific expansions in Parts B or C based on GD2 expression? A: Michael Rossi, President and CEO, stated that while they are collecting data on different tumor expressions, it is too early to focus on specific tumors. This data will inform decisions as they move into Part B.
Q: When can we expect efficacy data from Part B of the GD2-SADA study? A: Michael Rossi explained that Part A is focused on safety, not efficacy. The data from Part A will inform the dose escalation in Part B, which is expected to start in early 2025.
Q: How will reimbursement work for the SADA administration involving both medical oncologists and radiation oncologists? A: Michael Rossi noted that while reimbursement strategies are being explored, the primary focus is on effectively dosing patients and utilizing resources from both infusion centers and nuclear medicine departments.
Q: Can you provide a timeline for the GD2-SADA study's Parts B and C? A: Michael Rossi expects Part A to conclude later this year, with Part B starting in early 2025. The aim is to complete Part B by late 2025 or early 2026, depending on recruitment speed and dosimetry results.
Q: How has recruitment for the GD2-SADA studies progressed, and are there any logistical challenges? A: Michael Rossi mentioned that recruitment was initially slow but has picked up speed. The first site for the CD38-SADA study has been initiated, and recruitment is expected to increase as safety data becomes available.
Q: What dose is being tested in Cohort 5 of Part A for GD2-SADA, and are there plans for a Cohort 6? A: Vignesh Rajah stated that Cohort 5 is testing a 1 mg/kg dose with a four-day interval. The decision to proceed to Cohort 6 will depend on the dosimetry results from Cohort 5.
Q: Is there an increase in the duration of DANYELZA therapy in the US, and could this contribute to growth? A: Susan Smith, Senior Vice President, Chief Commercial Officer, confirmed an increase in duration, particularly among older patients. The new campaign highlights DANYELZA's efficacy in patients with prior GD2 therapy, contributing to increased uptake.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
This article first appeared on GuruFocus.