Y-mAbs Therapeutics Inc (YMAB) Q1 2024 Earnings Call Transcript Highlights: Navigating ...
U.S. DANYELZA Net Product Sales: $18.6 million, up 11% from Q1 2023.
Global DANYELZA Net Product Sales: $19.4 million, down 4% from Q1 2023.
Total Net Product Revenue: $19.4 million for Q1 2024.
License Revenues: $500,000 for Q1 2024.
Research and Development Expenses: $13.3 million for Q1 2024.
Selling, General and Administrative Expenses: $11.4 million for Q1 2024.
Net Loss: $6.6 million for Q1 2024.
Cash and Cash Equivalents: $75.7 million as of end of Q1 2024.
2024 Revenue Guidance: Expected to be between $95 million and $100 million.
2024 Operating Expenses Guidance: Expected to be between $115 million and $120 million.
2024 Cash Burn: Expected to be between $15 million and $20 million.
Release Date: May 08, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
Y-mAbs Therapeutics Inc reported an 11% increase in U.S. net product sales of DANYELZA, reaching $18.6 million in Q1 2024 compared to the previous year.
The company has successfully expanded its U.S. commercial footprint, activating 63 sites across the U.S. with five new accounts added in Q1 2024.
DANYELZA has been launched in international markets including China, Brazil, and Mexico, through strategic partnerships, enhancing global reach.
Y-mAbs Therapeutics Inc is advancing its clinical programs, notably the GD2 and CD38 radiotherapy programs, showing promising early results without dose-limiting toxicities.
The company maintains a strong financial position with sufficient cash resources to support operations and pipeline programs into 2027.
Negative Points
Global net product sales of DANYELZA decreased by 4% in Q1 2024 compared to the same period in 2023, primarily due to lower international market purchases.
The resignation of the CFO and the separation agreement with the Chief Scientific Officer could pose challenges in leadership continuity and strategic execution.
Despite a strong U.S. market performance, international revenues declined by $2.8 million in Q1 2024 compared to Q1 2023.
The company reported a net loss of $6.6 million for Q1 2024, indicating ongoing challenges in achieving profitability.
Y-mAbs Therapeutics Inc faces intense competition in the neuroblastoma treatment market, which could impact market share and revenue growth.
Q & A Highlights
Q: Where do you see most of the current and near-term tenure of the growth coming from? Is it from activating new centers or is it from repeat use from physicians who have already treated patients previously with DANYELZA? And how are you maybe positioning your new marketing efforts to drive this? A: Susan Smith, Senior Vice President, Chief Commercial Officer at Y-mAbs Therapeutics Inc, explained that the growth is driven by both activating new centers and increasing use in high-volume centers. The company has been added to several new formularies, which is a significant focus. The new marketing campaign is designed to educate about DANYELZA's role in treating patients with partial response to induction therapy, which is expected to drive further adoption.
Q: You mentioned in your prepared remarks the potential to expand Cyota beyond oncology. What could that look like, and are there any example applications you can provide based on your preclinical work? A: Michael Rossi, President and CEO of Y-mAbs Therapeutics Inc, discussed the potential of expanding the use of their radioactive material beyond oncology into areas like endocrinology, where it could be used to treat diseases by modulating receptor responses or hormone production. This approach could offer a safe and effective treatment method for various receptor modulator diseases.
Q: As we look out for CD38 Santa Ana, do you think that the cadence of data disclosures will follow a similar pathway that G. two sort of had like will we get an initial imaging data drop followed by a complete Phase Ia set? A: Michael Rossi indicated that while there might be some early data releases, the goal is to collect significant data from a larger number of patients to ensure meaningful insights. The company aims to use learnings from previous studies to potentially expedite future studies but plans to analyze comprehensive data sets to guide development accurately.
Q: Do you have any patients yet that have entered into the Part C of the Sarta study, and where are you on dosing dose escalations for the 10101 study? A: Michael Rossi clarified that they are still in Part A of the study, focusing on determining the optimal protein load and dose timing before moving to Part B and C. They have escalated doses up to three milligrams per kilogram and are preparing to start the fifth cohort soon.
Q: On DANYELZA sales trends for the remainder of the year, are you expecting consistency from quarter to quarter, or do you expect to see more volatility? A: Susan Smith noted that while some seasonality might occur, particularly in the summer, the company anticipates a consistent upward trend in sales, supported by new programs and marketing efforts. They expect to meet their forecasted sales targets for the year.
Q: In the US, as DANYELZA grows market share, are you sensing any counter detailing or pushback from competitors, or do you feel that your share gains are being tolerated? A: Susan Smith responded that their growth speaks for itself and they have not encountered significant pushback from competitors. Y-mAbs maintains a strong share of voice and is recognized as a leading company in pediatric neuroblastoma treatment, continuing to build strong relationships with key accounts.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
This article first appeared on GuruFocus.
